You are on page 1of 2942

CODE NAME

10003 Binders, Abdominal

10014 Procedure Kit/Trays, Acupuncture

10024 Adaptometers

10025 Adenotomes

10026 Adhesive Strips

10028 Adhesive Strips, Multipurpose, Hypoallergenic


10029 Adhesive Strips, Multipurpose, Waterproof

10030 Tapes, Adhesive

10033 Adhesive Removers

10037 Stools, Adjustable

10045 Aerators, Ethylene Oxide

10046 Aerosol Generators

10051 Samplers, Environmental, Air

10053 Artificial Airways


10056 Artificial Airways, Esophageal Obturation

10057 Artificial Airways, Nasopharyngeal

10059 Artificial Airways, Oropharyngeal

10077 Dental Materials, Restorative, Alloy

10082 Amalgamators

10085 Ambulances

10088 Amnioscopes

10089 Amniotomes
10098 Ampule Openers

10124 Procedure Kit/Trays, Anesthesia

10125 Procedure Kit/Trays, Anesthesia, Brachial Plexus

10126 Procedure Kit/Trays, Anesthesia, Caudal

10127 Procedure Kit/Trays, Anesthesia, Epidural


10128 Procedure Kit/Trays, Anesthesia, Glossopharyngeal

10129 Procedure Kit/Trays, Anesthesia, Paracervical

10130 Procedure Kit/Trays, Anesthesia, Pudendal

10131 Procedure Kit/Trays, Anesthesia, Spinal


10134 Anesthesia Units

10140 Anesthesia Unit Absorbers, Carbon Dioxide

10144 Anesthesia Unit Vaporizers

10145 Ventilators, Anesthesia

10149 Stools, Adjustable, Anesthesiology


10155 Anklets

10156 Anoscopes

10164 Apex Cardiographs

10168 Ophthalmic Tonometers, Applanation

10171 Jars, Applicator

10183 Covers, Arm Board

10184 Boards, Arm


10190 Simulators, Cardiac, Electrocardiography, Arrhythmia

10198 Arthroscopes

10201 Articulators, Dental

10204 Larynxes, Artificial


10208 Aspirators

10212 Aspirators, Dental

10214 Aspirators, Airway, Nasal, Infant

10215 Aspirators, Gastric

10216 Aspirators, Airway, Nasal

10217 Aspirators, Surgical


10218 Aspirators, Thoracic

10219 Aspirators, Airway, Tracheal

10222 Aspirators, Uterine

10223 Aspirators, Wound

10228 Audiometers

10229 Audiometric Booths


10239 Autotransfusion Units

10243 Procedure Kit/Trays, Infant Care

10248 Backrests

10261 Balances

10263 Balances, Electronic

10264 Balances, Mechanical

10266 Ballistocardiographs

10274 Bandages
10278 Adhesive Strips, Wound Closure, Butterfly

10281 Bandages, Plain Gauze

10284 Bandages, Compression/Support

10286 Bandages, Compression/Support, Multitail

10289 Bandages, Traction

10297 Analyzers, Physiologic, Metabolic Rate, Oxygen/Carbon Dioxide Based

10298 Basin Stands

10302 Bassinets
10304 Boots, Bath/Shower

10306 Pillows, Bath

10326 Boards, Bed

10328 Beds, Fixed, Cradle

10334 Washer/Decontamination Units, Bedpan/Ancillary Utensil

10335 Covers, Bedpan

10336 Racks, Bedpan

10338 Warming Units, Bedpan

10339 Bedpans
10340 Bedpans, Fracture

10341 Bedrails
10342 Beds

10345 Beds, Electric, Circular Revolving

10347 Beds, Electric

10348 Beds, Electric, Flotation Therapy

10351 Beds, Electric, Radiography/Fluoroscopy

10357 Beds, Mechanical

10360 Beds, Fixed, Orthopedic


10362 Beds, Fixed, Cradle, Pediatric

10363 Beds, Electric, Rocking

10368 Stools, Adjustable, Bedside

10369 Stimulators, Electrical, Behavioral Therapy

10383 Ergometers, Bicycle

10385 Exercisers, Aerobic, Stationary Bicycle

10386 Bile Collection Bags


10396 Biofeedback Systems

10401 Procedure Kit/Trays, Biopsy

10403 Procedure Kit/Trays, Biopsy, Aspiration, Ultrasound Guided

10406 Procedure Kit/Trays, Irrigation/Lavage, Urinary Bladder/Urethra

10408 Jars, Blade

10414 Warming Units, Blanket

10415 Blankets
10416 Blankets, Aluminized

10417 Blankets, Infant


10421 Blood Administration Sets

10425 Procedure Kit/Trays, Blood Culture Sample

10429 Detectors, Blood Flow, Ultrasonic

10430 Flowmeters, Blood

10431 Flowmeters, Blood, Electromagnetic


10432 Flowmeters, Blood, Ultrasonic

10438 Procedure Kit/Trays, Sampling, Blood Gas

10446 Procedure Kit/Trays, Sampling, Blood

10447 Warming Units, Blood/Intravenous Solution


10455 Cutters, Bone

10458 Drivers, Bone Staple

10459 Bone Wax

10479 Brassieres

10480 Brassieres, Maternity

10481 Brassieres, Post-Surgical


10483 Binders, Breast

10485 Aspirators, Breast

10486 Breathing Bags

10491 Bronchoscopes

10500 Brushes

10502 Brushes, Cleaning, Instrument, Bur

10503 Brushes, Cleaning, Denture

10506 Brushes, Dental, Gingiva

10507 Brushes, Cleaning, Surgical Scrub


10510 Detectors, Air Bubble/Foam

10516 Procedure Kit/Trays, Emergency, Burn

10519 Burs

10520 Burs, Surgical, Bone, Cranial

10521 Burs, Dental


10526 Cabinets

10529 Cabinets, Treatment, Anesthesia

10531 Cabinets, Storage, Bedside

10532 Cabinets, Treatment, Dentistry

10534 Cabinets, Storage, Instrument

10535 Cabinets, Storage, Medicine


10536 Cabinets, Storage, Medicine, Narcotic Control

10538 Cabinets, Treatment, Ultraviolet

10540 Warming Units, Multipurpose

10541 Pass-Throughs, Enclosed, X-Ray Darkroom

10546 Calipers

10547 Calipers, Skinfold, Manual

10548 Stimulators, Caloric, Vestibular Function


10549 Cameras

10551 Cameras, Photographic, Ophthalmic, Fundus

10558 Cameras, Photographic, Oscilloscope

10560 Canes

10561 Cannulae

10564 Cannulae, Arterial


10566 Cannulae, Aspirating

10567 Cannulae, Intracranial

10569 Cannulae, Coronary Artery

10571 Cannulae, Ear

10572 Cannulae, Epidural


10573 Cannulae, Eye
10574 Cannulae, Eye, Cyclodialysis

10575 Cannulae, Eye, Lacrimal

10576 Cannulae, Femoral

10578 Cannulae, Nasal, Sinus

10580 Cannulae, Intrauterine

10581 Cannulae, Vena Caval


10588 Analyzers, Laboratory, Breath, Carbon Dioxide
10598 Procedure Kit/Trays, Catheterization, Cardiac

10608 Boards, Cardiac Resuscitation

10613 Cardiac Output Units

10614 Cardiac Output Units, Direct Fick

10615 Cardiac Output Units, Thermal Dilution

10634 Washers, Large Equipment, Cart


10635 Carts

10636 Carts, Treatment, Anesthesia

10641 Carts, Storage/Transport, Surgical Instrument

10642 Carts, Storage/Transport, Isolation Room Product

10644 Carts, Central Supply, Medication

10646 Carts, Central Supply, Orthopedic


10647 Carts, Treatment, Resuscitation

10650 Carts, Storage/Transport, Orthopedic Traction Attachments

10656 Cast Cutter Vacuums

10665 Cast Material

10667 Boots, Cast Protection

10668 Shoes, Cast Protection

10669 Stockinettes, Cast Padding

10671 Socks/Stockings, Cast Toe

10672 Cast Walking Heels


10676 Procedure Kit/Trays, Catheter Care

10685 Catheters

10688 Catheters, Vascular, Angiography

10689 Catheters, Vascular, Blood Pressure

10691 Catheters, Vascular, Microflow

10694 Catheters, Rectal, Barium Enema

10695 Catheters, Bartholin's Gland

10696 Catheters, Biliary


10698 Catheters, Cardiac

10700 Catheters, Cardiac, Flotation Balloon

10706 Catheters, Vascular, Perfusion, Coronary Artery

10714 Catheters, Vascular, Embolectomy/Thrombectomy

10716 Catheters, Esophageal, Balloon

10717 Catheters, Spinal, Epidural

10718 Catheters, Nasopharyngeal, Eustachian Tube


10720 Catheters, Urinary, Urethral, Drainage, Self-Retained

10725 Catheters, Vascular, Intra-Aortic Balloon

10727 Catheters, Vascular, Infusion, Peripheral

10729 Catheters, Vascular, Infusion, Central Venous

10735 Catheters, Urinary, Nephrostomy

10736 Catheters, Vascular, Occlusion

10737 Catheters, Urinary, Ureteral, Dilatation


10739 Catheters, Vascular, Perfusion

10741 Catheters, Cardiac, Pericardium Drainage

10742 Catheters, Peritoneal, Dialysis

10746 Catheters, Rectal

10747 Catheters, Cardiac, Septostomy

10748 Catheters, Vascular, Hemodialysis, Central Venous, Single-Lumen

10749 Catheters, Tracheal, Suction


10751 Catheters, Urinary, Suprapubic, Drainage

10754 Catheters, Cardiac, Flotation Balloon, Pulmonary Artery, Thermal Dilution

10756 Catheters, Vascular, Embolectomy/Thrombectomy, Balloon, Venous

10759 Catheters, Vascular, Umbilical

10760 Catheters, Cardiac, Occluder Delivery

10761 Catheters, Urinary, Ureteral

10762 Catheters, Urinary, Urethral


10763 Catheters, Urinary, Urethral, Cystography

10764 Catheters, Urinary

10765 Catheters, Urinary, External, Drainage

10767 Catheters, Urinary, Urethral, Drainage/Irrigation

10769 Catheters, Intracranial, Ventricular

10776 Manometer Sets, Venous, Central/Peripheral

10778 Centrifuges

10779 Centrifuges, Tabletop, High-Speed, Microhematocrit


10780 Centrifuges, Tabletop

10787 Chairs

10788 Chairs, Bath

10789 Chairs, Blood Drawing

10790 Chairs, Rehabilitation, Cardiac

10792 Chairs, Examination/Treatment, Dentistry


10794 Chairs, Examination/Treatment, Otorhinolaryngology

10795 Chairs, Flotation Therapy

10796 Chairs, Disabled Patient, Geriatric

10797 Chairs, Disabled Patient, Pediatric

10799 Chairs, Examination/Treatment, Podiatry

10801 Chairs, Rehabilitation

10802 Chairs, Shower


10816 Binders, Chest

10817 Drainage Systems, Pleural

10822 Radiographic Units, Chest

10824 Chisels

10827 Chisels, Surgical, Middle Ear, Mastoid

10828 Chisels, Surgical, Nasal

10829 Chisels, Surgical, Bone, Orthopedic


10831 Choledochoscopes

10832 Chromoradiometers

10833 Chronaximeters

10838 Testers, Circuit Breaker

10839 Circulatory Assist Units

10840 Circulatory Assist Units, Cardiac

10846 Circulatory Assist Units, Cardiac, Intra-Aortic Balloon

10847 Circulatory Assist Units, Cardiac, Ventricular


10849 Circulatory Assist Units, Peripheral Compression

10858 Procedure Kit/Trays, Circumcision

10859 Procedure Kit/Trays, Circumcision, Disposable

10860 Procedure Kit/Trays, Circumcision, Reusable

10861 Clamps

10864 Clamps, Surgical, Vascular, Artery, Aorta


10865 Clamps, Surgical, Vascular, Artery

10866 Clamps, Surgical, Bone

10867 Clamps, Surgical, Bronchus

10868 Clamps, Surgical, Vascular, Artery, Spring/Cross Action

10869 Clamps, Surgical, Penis, Circumcision

10870 Clamps, Surgical, Vascular, Hemorrhoid

10871 Clamps, Surgical, Intestinal

10872 Clamps, Surgical, Vascular, Ductus Arteriosus


10873 Clamps, Surgical, Vascular, Artery, Peripheral

10875 Clamps, Tubing

10876 Clamps, External Occlusion, Umbilical Cord

10894 Clip Appliers

10898 Clips

10901 Clips, Surgical, Bandage

10902 Clips, Surgical, Drape


10904 Clips, Surgical, Instrument

10905 Clips, Implantable, Vascular, Extracranial, Aneurysm

10907 Clips, Nose

10908 Clips, Surgical, Vascular, Penis

10909 Clips, Surgical, Vascular, Scalp

10910 Clips, Skin Suture

10911 Clips, Surgical, Wound Closure, Skin/Tissue Suturing

10914 Clips, Surgical, Towel

10915 Clips, Implantable, Vascular, Vena Cava


10916 Clips, Surgical, Wound Closure

10918 Clocks, Elapsed-Time

10943 Collectors, Sputum

10950 Colonoscopes

10960 Colposcopes

10961 Commode Seats

10962 Commodes, Fixed

10964 Campimeters

10965 Compresses

10966 Compresses, Gauze


10967 Compresses/Packs, Hot

10969 Circulatory Assist Units, Peripheral Compression, Intermittent

10971 Compressors

10972 Compressors, Medical-Air


10977 Computers

10985 Condoms

10986 Aprons, Conductive


10990 Testers, Conductivity

10992 Testers, Conductivity, Floor/Equipment/Cloth

10994 Testers, Conductivity, Shoe

10995 Washer/Decontamination Units, Contact Lens

10996 Contact Lenses

11001 Positive Airway Pressure Units, Continuous


11003 Contourographs

11009 Controllers

11024 Corsets (Retired)


11049 Crib Tops

11058 Prostheses, Dental, Fixed, Crown, Total, Temporary

11062 Cushions, Axillary Crutch

11063 Crutches

11066 Thermometers, Electronic, Cryogenic


11067 Cryosurgical Units, General-Purpose

11068 Cryosurgical Units, Ophthalmic

11071 Cuff Inflators

11072 Cuffs

11073 Cuffs, Blood Pressure

11079 Culdoscopes

11084 Curettes

11090 Curtains, Cubicle, Reusable

11093 Cushions
11095 Orthoses, Lower Limb, Foot, Accommodative

11097 Cushions, Ring, Foam Rubber (Retired)

11098 Cushions, Ring, Inflatable (Retired)

11099 Cushions, Stool Seat

11100 Cushions, Chair/Wheelchair Seat

11101 Cuspidors

11111 Cystometers

11112 Cystoscopes

11114 Cystourethroscopes
11127 Testers, Defibrillator

11130 Electrical Conductive Pads, Defibrillator Paddle

11132 Defibrillators

11134 Defibrillators, External, Manual

11137 Defibrillators, External, Manual, Line-Powered-Only

11141 Procedure Kit/Trays, Labor/Delivery


11145 Water Purification Systems, Filtering/Deionization

11150 Dental Materials, Cement

11155 Dental Dams

11156 Dental Engines

11158 Dental Floss

11159 Dental Materials, Restorative, Gold Foil


11161 Handpieces, Dental

11164 Stools, Adjustable, Dentistry

11165 Dental Delivery Units

11167 Dentaphones
11168 Dentifrice

11169 Cups, Denture

11170 Denture Cushions

11171 Procedure Kit/Trays, Dental, Denture Repair

11172 Dentures, Complete, Preformed


11177 Dermabrasion Units

11179 Dermatomes

11184 Dental Materials, Desensitizer

11202 Tags, Medical Device Status

11206 Electrical Conductivity Meters, Dialysate

11218 Hemodialysis Units

11219 Detectors, Air Bubble/Foam, Hemodialysis Unit


11226 Peritoneal Dialysis Units

11228 Testers, Hemodialysis Dialysate

11230 Dialyzers

11232 Dialyzers, Hemodialysis

11233 Dialyzers, Hemodialysis, Coil


11234 Dialyzers, Hemodialysis, Hollow-Fiber

11235 Dialyzers, Hemodialysis, Parallel-Plate

11238 Diapers

11239 Diapers, Adult

11240 Diapers, Pediatric

11245 Microwave Therapy Systems, Diathermy

11246 Radiofrequency Therapy Systems, Diathermy


11248 Ultrasound Therapy Systems, Physical Therapy

11254 Dilators

11255 Dilators, Surgical, Cardiac

11256 Dilators, Surgical, Biliary/Common Duct

11257 Dilators, Surgical, Esophageal, Endoscopic


11259 Dilators, Surgical, Eye, Lacrimal Canal

11260 Dilators, Nasal

11261 Dilators, Surgical, Bronchus, Endoscopic

11262 Dilators, Rectal

11263 Dilators, Surgical, Endotracheal

11264 Dilators, Surgical, Fallopian Tube, Microsurgery

11265 Dilators, Urethral


11268 Dilators, Surgical, Vascular

11278 Disinfectors

11279 Disinfectors, Liquid Germicide, Flexible Endoscope

11280 Disinfectors, Pasteurization

11283 Dispensers

11287 Dispensers, Medication, Pill, Unit-Dose, Narcotic Control


11289 Procedure Kit/Trays, Dissection

11291 Distractors

11297 Procedure Kit/Trays, Irrigation/Lavage, Vaginal Douche

11303 Drainage Bottles

11304 Drains
11305 Drains, Wound

11313 Jars, Dressing

11314 Procedure Kit/Trays, Dressing

11315 Dressings

11321 Dressings, Impregnated, Antimicrobial, Aerosol

11323 Dressings, Nonimpregnated, Synthetic, Foam

11324 Dressings, Impregnated, Antimicrobial


11329 Hand Drills

11330 Hand Drills, Biopsy

11331 Hand Drills, Surgical, Bone

11332 Hand Drills, Surgical, Bone, Cannulated

11333 Drill Bits, Surgical, Spine, Cervical


11334 Trephines, Surgical, Craniotomy, Automated Perforation

11337 Hand Drills, Fingernail

11338 Hand Drills, Surgical, Bone, Intramedullary

11339 Hand Drills, Surgical, Middle Ear

11341 Burs, Dental/Oral Surgery


11342 Drill Bits, Surgical, Craniotomy

11345 Driver/Extractors

11346 Driver/Extractors, Bone Nail-Pin

11347 Driver/Extractors, Bone Plate

11359 Duodenoscopes

11370 Droppers, Ear (Retired)

11371 Procedure Kit/Trays, Irrigation/Lavage, Ear


11375 Occlusion Plugs, Ear

11376 Syringes, Bulb, Ear/Ulcer

11381 Simulators, Cardiac, Electrocardiography

11385 Echocardiographs
11387 Echoencephalographs

11389 Scanning Systems, Ultrasonic, Ophthalmic

11393 Ejectors, Saliva


11399 Testers, Electrical Safety

11407 Electrocardiographs

11411 Electrocardiographs, Multichannel


11413 Electrocardiographs, Single-Channel

11418 Electrothermal Cautery Units

11425 Gel, Electrode

11426 Testers, Impedance, Electrode/Lead/Cable

11429 Electrode Straps


11431 Electrodes, Blood Gas
11432 Electrodes, Blood Gas, Carbon Dioxide

11433 Electrodes, Blood Gas, Oxygen

11436 Electrodes, Cystoscopic


11439 Electrodes, Cardiac, Electrocardiography

11440 Electrodes, Neurologic, Electroencephalography

11441 Electrodes, Neurologic, Myography

11442 Electrodes, Neurologic, Evoked Potential, Visual, Electronystagmography


11443 Electrodes, Neurologic, Evoked Potential, Visual, Electrooculography

11444 Electrodes, Neurologic, Convulsive Therapy

11446 Electrodes, Cardiac, External Pacemaker, Transesophageal

11447 Electrodes, Cardiac, Electrocardiography, Fetal Scalp

11452 Electrodes, Neurologic, Electroencephalography, Nasopharyngeal


11453 Electrodes, Neurologic

11454 Electrodes, Neuromuscular Stimulator

11458 Leads, Implantable Cardiac Pacemaker, Myocardial

11460 Electrodes, Neurologic, Evoked Potential, Visual, Electroretinography


11467 Electroencephalographs

11471 Electrogoniometers

11474 Electromyographs

11479 Electronystagmographs
11480 Electrooculographs

11482 Electroretinographs

11484 Stimulators, Electrical, Brain, Convulsive Therapy

11485 Stimulators, Electrical, Brain, Anesthesia


11489 Testers, Electrosurgical Unit

11490 Electrosurgical Units

11493 Electrosurgical Unit Adapters, Cable

11496 Cables/Leads, Electrosurgical Unit

11497 Surgical Instrument Holders, Electrosurgical Active Electrode

11499 Electrodes, Electrosurgical, Active, Hand-Controlled


11500 Electrodes, Electrosurgical, Return

11502 Forceps, Electrosurgical

11503 Stimulators, Electrical, Soft Tissue

11508 Elevators, Orthopedic


11515 Procedure Kit/Trays, Emergency, Medicine Administration

11522 Bowls, Emesis

11526 Encephaloscopes

11529 Endoradiographs

11530 Endoradiosondes

11531 Procedure Kit/Trays, Sampling, Endometrium


11577 Batteries, Endoscope

11578 Transformers, Constant Voltage, Endoscope

11581 Enema Bags

11582 Procedure Kit/Trays, Enema

11585 Ear/Nose/Throat Treatment Units

11588 Alarms, Enuresis


11592 Ergometers

11597 Bougies, Esophagus

11600 Analyzers, Physiologic, Peristaltic Motility, Esophageal

11603 Esophagoscopes

11604 Esthesiometers
11614 Recorders, Physiologic, Evoked Potential

11618 Procedure Kit/Trays, Blood Transfusion, Exchange

11620 Exercisers, Balance/Muscle Strength, Static Stair

11621 Footstools, Two/Three-Step

11623 Exercisers

11631 Exercisers, Continuous Passive Motion


11633 Exercisers, Flexibility, Lower Limb, Quadriceps Board

11634 Exercisers, Breathing, Spirometry

11638 Exercisers, Flexibility, Full Body, Trapeze

11652 Charts, Eye

11653 Eye Cups

11655 Procedure Kit/Trays, Irrigation/Lavage, Eye


11657 Masks, Eye

11659 Masks, Eye, Phototherapy

11661 Absorption Pads, Eye Secretion

11663 Shields, Mechanical, Eye

11667 Eyeglasses

11675 Enteral Feeding Bags

11677 Procedure Kit/Trays, Feeding, Enteral

11684 Fenestrometers
11692 Detectors, Fetal Heart

11695 Detectors, Fetal Heart, Phono

11696 Detectors, Fetal Heart, Ultrasonic

11700 Fibrillators

11701 Files
11702 Files, Bone
11703 Files, Callous

11711 Filters, Air

11712 Filters, Bacteria


11713 Filters, Blood

11716 Filters, Intravenous Tubing

11719 Finger Cots

11723 Procedure Kit/Trays, Emergency, First Aid

11736 Flicker-Fusion Units

11740 Floor Mats, Antibacterial


11744 Timers, Gas Flow

11746 Flowmeters

11748 Flowmeters, Gas

11751 Dressings, Nonimpregnated, Natural Fiber, Cotton/Gauze, Fluff

11758 Radiographic/Fluoroscopic Units, Mobile


11761 Magnetic Fluxmeters

11769 Boards, Foot

11771 Footstools

11772 Footstools, Conductive

11774 Forceps

11775 Forceps, Biopsy

11777 Forceps, Dressing

11779 Forceps, Laparoscopic

11782 Forceps, Gallbladder

11784 Forceps, Hemostatic


11785 Forceps, Intestinal

11787 Forceps, Lung

11788 Forceps, Obstetric

11790 Forceps, Specimen

11792 Forceps, Sterilizer Transfer


11793 Forceps, Stone Manipulation

11794 Forceps, Suction

11798 Forceps, Utility

11802 Procedure Kit/Trays, Forensic Evidence

11803 Procedure Kit/Trays, Forensic Evidence, Sexual Assault


11822 Mouth Gags

11825 Detectors, Beta/Gamma Radiation

11838 Gas Cylinder Stand/Holders

11848 Samplers, Environmental, Air, Gas/Vapor

11853 Gastroduodenoscopes

11854 Gastrographs

11856 Gastroscopes

11857 Gastroscopes, Flexible


11858 Gastroscopes, Rigid

11868 Cups, Feeding, Assistive Device

11879 Gloves

11880 Gloves, Postmortem

11882 Gloves, Examination/Treatment

11883 Gloves, Surgical

11884 Gloves, Surgical, Hypoallergenic


11885 Gloves, Multiuse

11893 Goniometers

11894 Gonioscopes

11895 Gouges
11897 Gowns
11898 Gowns, Medical

11901 Gowns, Medical, Disposable

11902 Gowns, Medical, Reusable

11903 Gowns, Patient

11904 Gowns, Patient, Disposable


11905 Gowns, Patient, Reusable

11908 Grafts

11910 Grafts, Bone

11912 Grafts, Skin

11913 Prostheses, Blood Vessel, Biological


11919 Testers, Ground Fault Circuit Interrupter
11920 Ground Fault Circuit Interrupters

11923 Testers, Impedance, Grounding System

11927 Guides

11930 Guides, Drill

11933 Guillotines

11937 Gustometers

11939 Clippers, Hair


11941 Analyzers, Environmental/Gas System, Halogenated Anesthetic

11958 Head Halters

11961 Shields, Splash, Face

11963 Headlights

11969 Heart-Lung Bypass Units

11973 Heat Exchangers, Heart-Lung Bypass

11974 Oxygenators, Extracorporeal Bubble


11977 Simulators, Training, Heart Sound

11978 Heat Exchangers

11985 Heating Pads

11988 Heating/Cooling Pads, Circulating-Liquid

11989 Heating Pads, Electric

11995 Surgical Helmet Systems

11996 Analyzers, Laboratory, Hematology, Cell Counting, Manual


12009 Detectors, His Bundle

12022 Laboratory Hoods, Chemical Fume

12027 Oxygen Delivery Hoods

12028 Hooks

12029 Hooks, Surgical, Spinal Cord, Cordotomy


12031 Hooks, Surgical, Middle Ear, Incus

12032 Hooks, Intrauterine Device Removal

12033 Hooks, Surgical, Nasal, Rhinoplasty

12034 Hooks, Surgical, Eye, Scleral Fixation

12035 Hooks, Surgical, Skin

12036 Hooks, Surgical, Eye, Strabismus


12037 Hooks, Surgical, Nerve/Ganglion, Sympathectomy

12038 Hooks, Surgical, Tracheal

12042 Hot/Cold Water Bottles

12047 Humidifiers

12050 Humidifiers, Artificial Airway, Heated

12051 Humidifiers, Artificial Airway

12059 Hygrometers
12061 Chambers, Treatment, Hyperbaric

12066 Radiofrequency Therapy Systems, Hyperthermia

12067 Blankets, Circulating-Liquid

12068 Warming/Cooling Units, Patient

12074 Warming/Cooling Units, Patient, Circulating-Liquid

12076 Chambers, Hypobaric

12078 Cooling Units, Patient


12081 Hysteroscopes

12082 Ice Bags

12085 Ice Bags, Collar

12088 Identification Bracelets

12094 Orthoses, Lower Limb, Ankle, Immobilizer

12095 Orthoses, Upper Limb, Total, Immobilizer

12096 Orthoses, Upper Limb, Elbow, Immobilizer


12097 Emergency Immobilizers, Whole Body, Pediatric, Infant

12099 Orthoses, Lower Limb, Knee, Immobilizer

12101 Orthoses, Upper Limb, Shoulder, Immobilizer

12102 Orthoses, Upper Limb, Wrist, Immobilizer

12103 Impedance Cardiographs

12108 Procedure Kit/Trays, Incision/Drainage


12109 Clamps, External Occlusion, Penis/Incontinence

12110 Absorption Pads, Linen Protection

12111 Incontinence Pants

12112 Incubators

12113 Incubators, Infant

12114 Incubators, Infant, Transport

12129 Injectors

12132 Injectors, Medication/Vaccine, Syringe


12134 Injectors, Thermal Dilution

12135 Procedure Kit/Trays, Emergency, Insect Sting

12142 Racks, Electric/Electronic Equipment

12143 Instrument Trays

12144 Insufflators

12156 Intrauterine Devices, Contraceptive


12161 Procedure Kit/Trays, Catheterization, Intravenous

12162 Intravenous Catheter/Needle Immobilizers

12172 Intravenous Fluid Containers

12173 Intravenous Hangers

12177 Intravenous Poles

12185 Iontophoresis Units

12199 Testers, Isolated Power System


12200 Chambers, Isolation

12222 Keratomes

12223 Waste Receptacle Liners, Kick Bucket

12235 Knife/Scalpel Handles

12236 Surgical Instrument Holders, Knife

12239 Knives

12240 Knives, Surgical, Amputation


12241 Knives, Surgical, Eye, Cataract

12242 Knives, Surgical, Heart Valve

12244 Knives, Surgical, Dura Mater

12245 Knives, Surgical, Middle Ear

12247 Knives, Keratome (Retired)

12248 Knives, Surgical, Meniscus


12250 Knives, Paraffin

12251 Knives, Orthopedic Cast

12252 Knives, Surgical, Multipurpose, Scalpel

12253 Knives, Surgical, Skin Grafting

12254 Knives, Surgical, Sternum

12255 Knives, Surgical, Throat, Tonsil


12268 Clean Room/Laminar Air Flow Equipment

12270 Dilators, Cervical Canal, Hygroscopic, Laminaria Tent

12276 Lights, Examination

12279 Phototherapy Units, Visible Light, Perineal Heat

12281 Slit Lamps


12282 Lights, Surgical

12283 Lights, Examination, Ultraviolet

12284 Lights, Germicidal, Ultraviolet

12291 Laparoscopes

12293 Laryngoscopes

12294 Laryngostroboscopes
12311 Testers, Leakage Current

12313 Baths, Leg

12315 Leg Rests

12319 Fixed Loop Instruments, Surgical, Eye Lens

12322 Lenses

12324 Lenses, Intraocular

12326 Lensometers

12327 Radiofrequency Therapy Systems, Tissue Ablation

12329 Lifts
12330 Lifts, Patient Transfer

12331 Lifts, Wheelchair, Vertical

12335 Ligators, Hemorrhoid


12340 Light Sources

12343 Light Sources, Flexible Endoscope, Fiberoptic Cable

12345 Light Sources, Fiberoptic (Retired)

12346 Light Sources, Photographic Camera, Flash


12347 Lights

12352 Lights, Examination, Dental/Intraoral

12361 Monitors, Electrical Safety, Line Isolation

12364 Radiotherapy Systems, Linear Accelerator

12368 Surgical Drapes

12370 Sheets, Operating Room Table

12374 Lingual Palatal Bars


12379 Lithotrites

12386 Recorders, Physiologic, Blood Pressure, Tape

12387 Recorders, Graphic, Trend, Heart Rate

12388 Electrocardiographs, Ambulatory, Tape

12389 Electroencephalographs, Ambulatory, Tape

12390 Recorders, Physiologic, Trend, Blood Oxygen

12391 Recorders, Physiologic, Trend

12394 Fixed Loop Instruments, Surgical, Endarterectomy

12397 Vascular Loops

12401 Lubricating Jellies


12404 Procedure Kit/Trays, Lumbar Puncture

12405 Orthoses, Spine, Lumbosacral, Support, Belt

12408 Simulators, Respiration, Lung

12409 Procedure Kit/Trays, Lymphangiography

12415 Stimulators, Electromagnetic


12416 Magnetocardiographs

12417 Magnetometers

12423 Mallets, Bone


12425 Radiographic Units, Mammography

12429 Mandrels

12440 Markers
12443 Markers, Skin

12447 Masks

12448 Masks, Air-Oxygen

12449 Masks, Air-Oxygen, Aerosol Administration

12450 Masks, Air-Oxygen, Nonrebreathing


12451 Masks, Air-Oxygen, Partial Rebreathing

12452 Masks, Air-Oxygen, Venturi

12453 Masks, Anesthesia

12459 Masks, Tracheostomy

12460 Masks, Tracheostomy, Aerosol Administration

12463 Procedure Kit/Trays, Maternal Post-Partum Care

12467 Covers, Mattress

12468 Covers, Mattress, Conductive


12469 Covers, Mattress, Waterproof

12473 Mattresses

12475 Mattresses, Bed

12478 Mattresses, Operating Table

12479 Mattresses, Vacuum

12480 Mattresses, Bed, Water

12499 Mediastinoscopes

12500 Medical Bags


12501 Medical Chart Holders

12504 Injectors, Medication/Vaccine

12505 Cups, Oral Medicine

12510 Mesh, Polymeric

12516 Detectors, Metallic Foreign Body, Magnetic

12521 Extractors, Metal, Magnetic

12524 Dilators, Cervical Canal, Balloon


12530 Microelectrode Pullers

12535 Covers, Microscope

12536 Microscopes

12537 Microscopes, Light, Examination, Ophthalmology

12538 Microscopes, Light, Operating, Otorhinolaryngology


12539 Microscopes, Light, Operating

12540 Detectors, Microwave Radiation Leakage

12542 Procedure Kit/Trays, Collection, Urine, Mid-Stream

12547 Mirrors

12549 Mirrors, Hand-Held, Larynx/Pharynx

12550 Mirrors, Hand-Held, Middle Ear


12551 Mirrors, Overhead Observation

12552 Mirrors, Posture

12553 Mirrors, Speech Therapy

12554 Tents, Mist

12557 Tents, Mist, Face

12565 Moist Heat Therapy Pack Conditioners

12570 Moleskins
12575 Monitors, Physiologic, Respiration, Ventilation/Apnea, Bedside

12585 Alarms, Occupancy, Bed

12586 Monitors, Physiologic, Blood Gas, Bedside

12599 Monitors, Physiologic, Electrocardiography, Bedside


12602 Monitors, Physiologic, Electroencephalography, Bedside

12606 Monitors, Environmental, Multigas

12609 Analyzers, Physiologic, Visual Function, Eye Movement

12636 Monitoring Systems, Physiologic

12647 Monitoring Systems, Physiologic, Acute Care

12649 Monitoring Systems, Physiologic, Stress Exercise


12657 Monitors, Physiologic, Pulse Rate, Bedside

12660 Monitors, Environmental, Ionizing Radiation

12662 Monitors, Physiologic, Respiration, Respiratory Gas/Ventilation, Bedside

12678 Monitors, Physiologic, Respiration, Ventilation/Apnea, Bedside/Intraoperative

12684 Traps, Mucus


12689 Procedure Kit/Trays, Myelography

12690 Myeloscopes

12692 Myographs

12695 Clippers, Nail

12699 Nasal Balloons

12700 Cannulae, Nasal, Oxygen Supply

12701 Cannulae, Nasal, Continuous Positive Airway Pressure


12702 Catheters, Nasal, Oxygen Supply

12709 Nasopharyngoscopes

12710 Nasoscopes

12712 Nebulizers

12719 Nebulizers, Ultrasonic

12726 Suture Needle Holding Instruments

12729 Needles

12730 Needles, Acupuncture

12732 Needles, Airway Puncture


12734 Needles, Biopsy

12739 Needles, Injection, Biliary Duct/Cholangiography

12745 Needles, Injection, Hypodermic

12747 Needles, Injection, Intra-Arterial

12748 Needles, Injection, Intravenous

12750 Needles, Pneumoperitoneum Insufflation

12752 Needles, Injection, Intravenous, Scalp-Vein/Pediatric

12753 Needles, Aspiration/Injection, Spinal


12754 Needles, Suture

12766 Nippers, Malleus

12774 Droppers, Nose (Retired)

12779 Nursing Bottles, Infant

12791 Plethysmographs, Ocular, Segmental

12799 Cardiointegraphs
12800 Osmometers, Colloid

12804 Ophthalmodiaphanoscopes
12805 Ophthalmodiastimeters

12811 Ophthalmometers

12815 Ophthalmoscopes

12817 Ophthalmoscopes, Direct

12818 Ophthalmoscopes, Indirect


12820 Ophthalmotropometers

12825 Orange Sticks

12826 Organ Preservation Systems

12830 Orthopedic Cement

12837 Orthoses

12839 Oscilloscopes
12842 Osmometers

12844 Osteotomes

12845 Osteotomes, Orthopedic

12846 Osteotomes, Plastic Surgery

12849 Otoscopes

12853 Oximeters

12855 Procedure Kit/Trays, Oxygen Administration


12861 Monitor/Controllers, Oxygen

12868 Oxygen Canisters

12873 Oxygen Concentrators

12875 Tubing, Oxygen Connection

12876 Compressed Gas Proportioners, Oxygen-Air


12893 Tents, Oxygen

12899 Ozone Generators

12900 Leads, Implantable Cardiac Pacemaker, Endocardial

12911 Pacemakers, Cardiac


12913 Pacemakers, Cardiac, Implantable

12928 Pressure Relief Pads, Air, Alternating

12935 Percussion Applicators, Respiratory Therapy

12936 Pressure Relief Pads

12940 Pressure Relief Pads, Air


12941 Pressure Relief Pads, Animal Skin

12942 Pressure Relief Pads, Foam

12943 Pressure Relief Pads, Foam, Convoluted

12944 Pressure Relief Pads, Gel

12945 Pressure Relief Pads, Mud

12946 Pressure Relief Pads, Water

12950 Pain Gauges, Cutaneous


12955 Procedure Kit/Trays, Papanicolaou Smear

12956 Baths, Paraffin, Physical Therapy

12957 Exercisers, Balance, Parallel Bars

12963 Pass-Throughs, Enclosed

12980 Pelvimeters

12986 Percussors, Manual, Airway Clearance

12990 Perforators, Amniotic Membrane (Retired)


12991 Earlobe Piercing Guns

12996 Procedure Kit/Trays, Irrigation/Lavage, Perineal

13004 Pessaries

13005 Contraceptive Diaphragms

13011 Pharyngoscopes
13017 Phonocardiographs

13018 Catheters, Cardiac, Phonocardiography

13031 Photometers, Filter, Microscopy

13037 Phototherapy Units

13043 Pinwheels

13052 Plates, Cranioplasty


13056 Plethysmographs

13059 Plethysmographs, Whole Body

13074 Testers, Pneumatic

13081 Procedure Kit/Trays, Emergency, Tension Pneumothorax


13085 Polygraphs

13090 Charts, Posture

13097 Procedure Kit/Trays, Skin Preparation

13102 Manometers

13106 Sphygmomanometers
13108 Manometers, Gastrointestinal Tract, Esophagus
13109 Manometers, Inspiratory Pressure

13116 Covers, Thermometer Probe

13119 Exploratory Probes, Eye

13120 Exploratory Probes, Eye, Lacrimal

13121 Exploratory Probes, Anal/Rectal Fistula

13124 Exploratory Probes, Nasal Sinus

13126 Proctoscopes

13127 Proctosigmoidoscopes
13129 Procedure Kit/Trays, Dental, Prophylaxis

13131 Prostheses

13136 Bladder Support Implants

13138 Prostheses, Cardiac Valve

13143 Prostheses, Ear Auricle

13146 Prostheses, Eyeball


13148 Prostheses, Fallopian Tube

13150 Prostheses, Lower Limb, Foot

13151 Prostheses, Upper Limb, Hand

13152 Prostheses, Heart

13158 Prostheses, Joint


13167 Prostheses, Penile

13168 Prostheses, Joint, Wrist

13172 Testicle Implants

13176 Prostheses, Urethral Sphincter

13177 Prostheses, Blood Vessel, Artificial

13182 Analyzers, Physiologic, Respiratory Function Mechanics, Adult


13187 Analyzers, Physiologic, Dental Pulp

13201 Pumps, Dye Dilution

13203 Pumps, Extracorporeal Perfusion

13209 Infusion Pumps, Enteral Feeding

13215 Infusion Pumps, Multitherapy


13217 Infusion Pumps, Multitherapy, Syringe

13220 Infusion-Withdrawal Pumps, Vascular

13228 Punches

13229 Punches, Surgical, Vascular, Aortic

13230 Punches, Biopsy


13232 Punches, Surgical, Eye, Corneoscleral

13234 Punches, Surgical, Hair Transplant

13236 Pupillometers

13248 Warming Units, Patient, Radiant

13249 Warming Units, Patient, Radiant, Adult

13259 X-Ray Film Duplicators


13260 Positioning Aids, Radiographic/Radiotherapeutic

13267 Radiographic Units

13269 Radiographic Units, Dental

13272 Radiographic Units, Mobile

13274 Recorders, Video, Tape


13276 Radioisotope Transfer Units

13278 Radiometers, Phototherapy

13279 Radiotherapy Systems

13280 Radiotherapy Simulation Systems

13287 Raspatories
13288 Rasps
13289 Rasps, Middle Ear

13290 Rasps, Nasal

13297 Reamers, Orthopedic

13299 Testers, Power Line Receptacle, Electrical


13300 Testers, Power Line Receptacle, Mechanical

13313 Refractors, Ophthalmic

13315 Refrigerators

13316 Refrigerators, Morgue

13318 Heat Exchangers, Regional Perfusion

13323 Regulators, High-Pressure Gas

13335 Resectoscopes
13340 Testers, Resistance, Line Cord

13341 Simulators, Respiration

13346 Restraints

13351 Restraints, Crib

13360 Resuscitators

13361 Resuscitators, Cardiac

13363 Resuscitators, Cardiopulmonary

13364 Resuscitators, Pulmonary


13366 Resuscitators, Pulmonary, Pneumatic

13367 Resuscitators, Pulmonary, Manual

13369 Retainers, Bandage

13370 Retainers, Dental, Orthodontic

13371 Retainers, Visceral

13372 Retinoscopes
13373 Retractors

13375 Retractors, Surgical, Abdominal Wall

13376 Retractors, Surgical, Urinary Tract, Bladder

13377 Retractors, Surgical, Brain

13378 Retractors, Surgical, Brain, Nerve Decompression

13379 Retractors, Surgical, Thoracic Organ, Heart

13380 Retractors, Dental/Oral Surgery


13381 Retractors, Surgical, Eye

13383 Retractors, Surgical, Multipurpose, Handheld

13384 Retractors, Laminectomy (Retired)


13385 Retractors, Surgical, Eye, Orbital

13388 Retractors, Surgical, Rectum

13389 Retractors, Surgical, Thoracic Wall, Rib

13390 Retractors, Surgical, Multipurpose, Self-Retained


13391 Retractors, Surgical, Thoracic Wall

13392 Retractors, Vaginal

13393 Retractors, Surgical, Vessel

13425 Mechanical Routers, Bone

13426 Exercisers, Aerobic, Rowing

13432 Safes, Isotope

13441 Menstrual Belts


13443 Absorption Pads, Menstruation

13448 Saws

13450 Saws, Surgical, Bone, Electric

13452 Saws, Surgical, Bone, Pneumatic

13455 Scales

13457 Scales, Clinical, Autopsy


13458 Scales, Patient, Underbed

13459 Scales, Clinical, Blood Collection

13460 Scales, Patient, Chair

13461 Scales, Patient, Floor

13462 Scales, Infant

13468 Scanning Systems


13469 Scanning Systems, Computed Tomography

13480 Scissors

13481 Scissors, Bandage

13485 Scissors, Surgical, Eye

13486 Scissors, Surgical, Eye, Corneoscleral


13487 Scissors, Surgical, Eye, Enucleation

13488 Scissors, Surgical, Eye, Iris

13489 Scissors, Surgical, Eye, Suture/Stitch Removal

13495 Scissors, Surgical, Nasal

13501 Scissors, Surgical, Intestine, Rectum

13502 Scissors, Surgical, Suture/Stitch Removal


13514 Screen Dividers, Bedside

13517 Screwdrivers, Surgical, Bone/Bone Prosthesis

13520 Scrub Dresses

13524 Scrub Suits

13526 Scrub Suits, Disposable


13527 Scrub Suits, Reusable

13532 Searchers, Mastoid

13550 Sharpeners, Dental

13561 Sheets

13564 Shields, Mechanical, Breast


13565 Orthoses, Lower Limb, Foot, Accommodative, Bunion

13570 Shields, Mechanical, Wound

13574 Covers, Shoe


13576 Shoes

13578 Shoes, Conductive

13579 Shoes, Orthopedic, Rotation Correction

13583 Procedure Kit/Trays, Postmortem Care

13586 Shunts, Arteriovenous

13594 Sigmoidoscopes

13607 Chairs, Sitz Bath


13608 Procedure Kit/Trays, Sitz Bath

13609 Baths, Sitz

13614 Dermatomes, Manual, Expanded Mesh

13622 Orthoses, Upper Limb, Total, Support, Sling

13623 Orthoses, Lower Limb, Knee, Therapeutic, Sling

13624 Orthoses, Lower Limb, Total, Support, Sling


13629 Procedure Kit/Trays, Emergency, Snake Bites

13630 Snares

13632 Snares, Tonsil

13633 Socks/Stockings

13634 Socks/Stockings, Fracture


13635 Socks/Stockings, Stump

13637 Bowls, Liquid Mixing/Storage

13643 Exploratory Probes, Urethral

13644 Exploratory Probes, Uterine

13645 Spatulas

13646 Spatulas, Surgical, Brain

13647 Spatulas, Cement (Retired)

13649 Spatulas, Surgical, Lung

13651 Spatulas, Surgical, Middle Ear


13655 Specimen Containers

13662 Specula, Aural

13663 Specula, Ocular

13664 Specula, Nasal

13665 Specula, Rectal

13666 Specula, Vaginal

13671 Sphygmographs

13673 Boards, Spine (Retired)


13674 Spirometers

13680 Spirometers, Diagnostic

13681 Splints (Retired)

13683 Orthoses, Multipurpose Splint, Pre-Shaped

13684 Orthoses, Multipurpose Splint, Pre-Shaped, Aluminum


13685 Orthoses, Multipurpose Splint, Pre-Shaped, Plastic
13686 Orthoses, Lower/Upper Limbs, Support, Padded Stay Splint
13687 Orthoses, Lower/Upper Limb, Immobilizer, Pneumatic Splint

13688 Orthoses, Lower Limb, Total, Immobilizer, Traction Splint

13689 Orthoses, Lower/Upper Limb, Immobilizer, Vacuum Splint

13690 Orthoses, Lower/Upper Limb, Immobilizer, Wire Ladder Splint

13691 Basins, Sponge (Retired)

13692 Bowls, Sponge Collection

13693 Sponge Counters, Surgical


13695 Sponges

13698 Sponges, Surgical, Dissector

13699 Sponges, Multipurpose, Multilayer

13700 Sponges, Multipurpose, Gauze

13701 Sponges, Multipurpose, Germicidal

13702 Sponges, Surgical, Neurosurgery

13703 Sponges, Multipurpose, Rayon


13704 Sponges, Surgical, Ophthalmic

13709 Retractors, Surgical, Thoracic Wall, Rib, Self-Retained

13725 Baths, Steam

13727 Stereotactic Headframes

13730 Sterilization Containers

13732 Sterilization Process Indicators, Biological

13737 Sterilizing Units


13739 Sterilizing Units, Dry Heat

13740 Sterilizing Units, Germicidal Gas, Ethylene Oxide

13741 Germicides, Liquid, Formaldehyde

13745 Sterilizing Units, Ionizing Radiation

13746 Sterilizing Units, Steam


13748 Sterilizing Units, Germicidal Vapor

13762 Stimulators

13763 Stimulators, Electrical, Peripheral Nerve, Acupuncture

13764 Stimulators, Acoustic, Auditory

13768 Stimulators, Electrical, Carotid Sinus Nerve, Blood Pressure

13770 Stimulators, Mechanical, Dentistry, Gingival

13775 Stimulators, Electrical, Neuromuscular

13780 Stimulators, Mechanical, Tactile

13782 Stimulators, Electrical, Peripheral Nerve, Analgesic, Transcutaneous


13783 Stimulators, Photic, Visual

13785 Stockinettes

13789 Socks/Stockings, Elastic Compression

13793 Cuffs, Pneumatic, Peripheral Compression

13803 Stopcocks

13805 Detectors, Strain


13810 Straps, Clavicle

13814 Stretchers

13816 Stretchers, Mobile

13818 Stretchers, Portable

13820 Stretchers, Mobile, Hospital, Patient Transfer

13833 Stylets

13834 Stylets, Bronchial Tube

13835 Stylets, Vascular, Vein

13836 Stylets, Needle


13837 Stylets, Peritoneal

13839 Stylets, Urethral

13845 Aspirator/Irrigators

13846 Procedure Kit/Trays, Airway Suction

13848 Suction Tips

13861 Orthoses, Lower Limb, Foot, Support, Arch


13862 Orthoses, Upper Limb, Arm, Support

13873 Scrotal Supports

13882 Surgical Head Coverings

13890 Suture Bolsters

13892 Procedure Kit/Trays, Suture

13894 Procedure Kit/Trays, Suture Removal


13896 Sutures

13898 Sutures, Natural, Absorbable, Surgical Gut

13900 Sutures, Natural, Nonabsorbable, Cotton

13902 Sutures, Natural, Nonabsorbable, Linen

13904 Sutures, Metallic, Stainless Steel, Multifilament

13905 Sutures, Synthetic, Nonabsorbable, Nylon


13906 Sutures, Synthetic, Nonabsorbable, Polyester

13907 Sutures, Synthetic, Nonabsorbable, Polyethylene

13908 Sutures, Synthetic, Absorbable, Polyglycolic Acid

13909 Sutures, Synthetic, Nonabsorbable, Polypropylene

13910 Sutures, Natural, Nonabsorbable, Silk

13911 Sutures, Metallic, Stainless Steel

13912 Swabs
13913 Swabs, Antiseptic

13914 Swabs, Specimen Collection

13929 Syringes

13936 Syringes, Plunger, Catheter Tip

13940 Syringes, Plunger, Hypodermic

13941 Syringes, Plunger, Insulin

13946 Binders, T (Retired)


13949 Tables
13951 Tables, Instrument, Anesthesia

13953 Tables, Autopsy


13958 Tables, Examination/Treatment

13959 Tables, Instrument

13960 Tables, Examination/Treatment, Adjustable, Obstetric

13961 Tables, Operating

13962 Tables, Examination/Treatment, Adjustable, Orthopedic

13963 Tables, Overbed

13964 Tables, Examination/Treatment, Adjustable, Physical Therapy

13967 Tables, Examination/Treatment, Adjustable, Orthopedic, Traction


13969 Tables, Examination/Treatment, Adjustable, Urological

13970 Tachistoscopes
13979 Tapes

13983 Tapes, Non-Adhesive, Umbilical

13987 Monitors, Physiologic, Multipurpose, Telemetric

13988 Monitors, Physiologic, Electrocardiography, Telemetric


13990 Monitors, Physiologic, Temperature, Telemetric

14002 Tents

14024 Laboratory Equipment Holders, Thermometer

14025 Procedure Kit/Trays, Thermometer

14028 Thermometers

14032 Thermometers, Electronic

14034 Monitors, Physiologic, Temperature, Bedside


14035 Thermometers, Electronic, Thermistor/Thermocouple, Patient

14036 Thermometers, Electronic, Infrared

14038 Thermometers, Mercury

14047 Thoracoscopes

14053 Timers

14055 Timers, Radiographic/Fluoroscopic


14056 Tinnitus Therapy Units

14064 Tongs, Skull

14067 Ophthalmic Tonographs

14071 Toothbrushes

14072 Tourniquets

14074 Tourniquets, Pneumatic


14075 Fixed Loop Instruments, Surgical, Cardiovascular Occlusion

14077 Towels, Surgical

14082 Cuffs, Tracheal Tube

14084 Stylets, Tracheal Tube

14085 Tubes, Tracheal

14089 Cannulae, Tracheostomy

14090 Procedure Kit/Trays, Tracheostomy Care


14099 Procedure Kit/Trays, Tracheostomy

14100 Orthoses, Spine, Sacroiliac, Therapeutic, Traction Belt

14101 Frames, Traction

14105 Traction Units


14106 Traction Units, Intermittent

14108 Traction Units, Intermittent, Mobile

14111 Traction Units, Static, Chair

14118 Transducers, Force


14121 Transducers, Ultrasonic

14126 Procedure Kit/Trays, Blood Transfusion

14128 Recorders, Physiologic, Transient

14141 Exercisers, Aerobic, Treadmill

14144 Tremographs
14146 Trephines

14148 Trephines, Surgical, Eye, Corneoscleral

14152 Trephines, Surgical, Craniotomy

14154 Trocars
14155 Trocars, Abdominal

14156 Trocars, Abdominal, Amniotic Membrane

14157 Trocars, Nasal Sinus

14158 Trocars, Thoracic, Cardiovascular

14159 Trocars, Abdominal, Gallbladder

14160 Trocars, Laryngeal


14161 Trocars, Thoracic

14162 Trocars, Tracheal

14169 Hernia Trusses

14171 Hernia Trusses, Infant

14172 Shields, Mechanical, Nasal

14174 Clips, Implantable, Fallopian Tube

14175 Tubes
14182 Test Tubes, Autoclavable

14183 Tubes, Blood Collection

14187 Tubes, Colon

14189 Test Tubes, Culture

14191 Tubes, Drainage (Retired)

14195 Tubes, Esophageal

14214 Tubes, Gastrostomy


14221 Tubes, Nasogastric

14226 Tubes, Rebreathing

14227 Tubes, Rectal

14230 Tubes, Nasogastric, Decompression

14238 Tubing

14239 Tubing, Synthetic Polymer, Braided


14244 Tubing, Synthetic Polymer, Nylon

14246 Tubing, Synthetic Polymer, Polyethylene

14247 Tubing, Synthetic Polymer, Polyvinyl Chloride

14252 Tubing, Synthetic Polymer, Vinyl

14256 Frames, Turning

14258 Typoscopes

14263 Washers, Labware/Surgical Instrument, Ultrasonic


14271 Power Meters, Ultrasound

14278 Scanning Systems, Ultrasonic

14285 Knives, Surgical, Urinary Tract, Ureter

14286 Bougies, Urethra

14288 Urethrometers

14289 Urethroscopes

14290 Covers, Urinal


14291 Urinals

14292 Procedure Kit/Trays, Catheterization/Collection, Urinary

14297 Urinary Drainage Units

14298 Urinary Collection Bags

14301 Irrigation Kits, Urinary

14302 Urine Strainers

14303 Specimen Containers, Urine


14307 Urodynamic Measurement Systems

14308 Flowmeters, Urine

14329 Eye Valves

14345 Vectorcardiographs
14351 Alarms, Artificial Airway Pressure

14352 Filters, Ventilator

14361 Ventilators, Intensive Care, Neonatal/Pediatric

14364 Ventriculoscopes
14375 View Boxes

14382 Analyzers, Physiologic, Visual Function

14386 Vitrectomy Units


14389 Voltmeters

14393 Walkers

14413 Washer/Sterilizing Units

14421 Waste-Disposal Units

14423 Waste-Disposal Units, Sharps


14424 Waste Receptacles

14426 Waste Receptacles, Contaminated Material

14427 Kick Buckets

14428 Waste Receptacles, Radioactive Material

14434 Water Purification Filters, Charcoal

14435 Water Purification Systems, Deionization


14437 Water Purification Systems, Reverse Osmosis

14438 Water Purification Systems, Ultraviolet

14449 Wheelchairs

14450 Baths, Whirlpool

14462 Procedure Kit/Trays, Irrigation/Lavage, Wound

14465 Orthoses, Upper Limb, Wrist, Support


14467 Xenon Systems

14473 X-Ray Film Cassette Holders

14474 Cassettes, Radiography, X-Ray Film

14475 Dryers, X-Ray Film

14480 Monitors, X-Ray Film Processor, Quality Control

14486 X-Ray Film Cassette Image Intensifying Screens

14490 Shields, X-Ray

14491 Shields, X-Ray, Apron

14493 Shields, X-Ray, Glove


14494 Shields, X-Ray, Gonadal
14498 View Boxes, X-Ray

15003 Breathing Circuits, Ventilator

15010 Detectors, Air Bubble/Foam, Heart-Lung Bypass Unit

15011 Detectors, Liquid Level, Heart-Lung Bypass Unit

15012 Heart-Lung Bypass Unit Tubing Sets

15015 Analyzers, Laboratory, Breath, Oxygen

15018 Brushes, Cytology

15021 Cannulae, Hemodialysis


15022 Catheters, Vascular, Hemodialysis

15024 Chairs, Birthing


15026 Compresses/Packs, Cold

15028 Procedure Kit/Trays, Cricothyrotomy

15030 Flasks, Dewar

15032 Transmitter/Receiver Systems, Telephone, Electroencephalography

15033 Electrodes, Cardiac, External Defibrillator


15034 Occluders, Vascular, Intravascular Embolization

15036 Analyzers, Physiologic, Peristaltic Motility, Gastrointestinal

15037 Gowns, Isolation

15038 Guillotines, Rib

15039 Hemofiltration Units

15040 Contact Lens Inserters

15044 Microscopes, Electron


15046 Oxygen Meters

15048 Pressure Reducers, Intraocular

15051 Regulators, Suction, Surgical

15053 Scales, Patient, Wheelchair

15055 Surgical Drapes, Operating Table

15057 Sigmoidoscopes, Flexible

15058 Sigmoidoscopes, Rigid


15059 Simulators

15061 Simulators, Temperature

15062 Spectrometers, Mass

15065 Suture Units, Automated

15066 Swabs, Absorbent/Cotton

15073 Bronchoscopes, Flexible

15074 Bronchoscopes, Rigid


15075 Laryngoscopes, Flexible

15076 Laryngoscopes, Rigid

15078 Aprons, Laboratory

15079 Spectrophotometers, Atomic Absorption

15080 Spectrofluorometers

15081 Spectrophotometers, Infrared

15082 Spectrophotometers, Ultraviolet

15083 Spectrophotometers, Ultraviolet/Visible

15084 Spectrophotometers, Visible


15085 Sponges, Surgical, Laparotomy

15087 Stimulators, Electrical, Bone Growth

15089 Analyzers, Laboratory, Body Fluid, Alcohol

15090 Analyzers, Laboratory, Body Fluid, Amino Acid

15091 Analyzers, Laboratory, Microbiology, Susceptibility

15092 Analyzers, Laboratory, Blood, Urea Nitrogen

15093 Analyzers, Laboratory, Breath, Carbon Monoxide

15098 Analyzers, Laboratory, Hematology, Coagulation, Automated

15100 Analyzers, Laboratory, Body Fluid, Electrolyte


15101 Analyzers, Laboratory, Body Fluid, Enzyme

15102 Analyzers, Laboratory, Body Fluid, Glucose

15103 Analyzers, Laboratory, Body Fluid, Nitrogen

15104 Analyzers, Laboratory, Hematology, Platelet Aggregation

15106 Baths, Freezing


15107 Baths, Tissue Flotation

15108 Baths, Water

15109 Bilirubinometers
15111 Burets
15112 Cytometers, Manual

15115 Centrifuges, Floor, Low-Speed, Nonrefrigerated, Blood Bank


15116 Centrifuges, Floor

15117 Centrifuges, Floor, Low-Speed, Refrigerated

15118 Analyzers, Laboratory, Body Fluid, Chloride

15119 Chromatography Columns

15120 Chromatography Systems, Gas

15121 Chromatography Systems, Liquid, Packed Column, High-Pressure

15122 Chromatography Systems, Liquid, Planar, Paper


15124 Information Systems, Data Management, Laboratory

15125 Counters, Bacteria

15126 Counters, Colony


15128 Iontophoresis Units, Sweat Test

15129 Densitometers

15130 Desiccators

15131 Dialyzers, Laboratory

15133 Diluters
15134 Dispenser/Melters, Paraffin

15135 Dispensers, Laboratory, Slide

15137 Electrodes, pH
15138 Electrophoresis Systems

15139 Evaporators

15140 Filter Papers


15141 Fluorometers

15144 Freezers, Blood Bank, Plasma

15145 Freezers, Laboratory

15146 Analyzers, Laboratory, Hematology, Hemoglobin

15149 Immunodiffusion Equipment


15151 Incubators, Laboratory, Aerobic

15152 Incubators, Laboratory, Anaerobic

15154 Lifts, Mortuary

15155 Fixed Loop Instruments, Laboratory, Inoculating

15156 Microscopes, Light, Laboratory


15157 Microtomes, Cryostat

15158 Microtomes, Rotary

15160 Microtomes, Ultra

15163 Nephelometers

15165 Photometers
15166 Pipettes

15168 Pumps, Laboratory


15169 Refractometers

15171 Refrigerators, Blood Bank

15172 Refrigerators, Laboratory, Explosion-Proof

15174 Saws, Postmortem

15175 Scales, Clinical, Laboratory

15177 Analyzers, Laboratory, Hematology, Erythrocyte Sedimentation Rate


15178 Laboratory Shakers

15179 Sharpeners, Microtome Knife

15180 Sinks, Autopsy/Dissection

15182 Slide Stainers, Hematology

15183 Slide Stainers, Cytology/Histology

15184 Counters, Scintillation


15186 Racks, Laboratory Procedure, Test Tube

15187 Test Tubes

15188 Tissue Culture Systems

15190 Tissue Processors

15192 Tubes, Blood Collection, Capillary/Microsample

15193 Centrifuges, Floor, Ultrahigh-Speed


15195 View Boxes, Rh Typing

15196 Washers, Labware

15197 Washers, Pipette

15198 Washers

15200 Oximeters, Intravascular

15201 Oximeters, In Vitro


15271 Transmitter/Receiver Systems, Telephone, Electrocardiography

15272 Incubators, Laboratory, Test Tube, Portable

15273 Incubators, Laboratory, Test Tube, Stationary

15274 Procedure Kit/Trays, Amniocentesis

15275 Awls

15276 Ampules
15277 Tubing, Synthetic Polymer, Silicone

15279 Clean Rooms, Laminar Air Flow

15280 Clean Rooms, Laminar Air Flow, Mobile

15281 Sponges, Scrub

15284 Injectors, Contrast Media, Angiography

15285 Injectors, Contrast Media, Lymphangiography

15286 Syringes, Plunger, Contrast Media, Angiography


15287 Screen Dividers, Anesthesia

15288 Entoptoscopes

15289 Nephroscopes, Flexible

15290 Nephroscopes, Rigid

15292 Pillows, Cervical

15293 Domes, Pressure Transducer

15296 Pressure Transducer Holders

15299 Analyzers, Laboratory, Blood, Iron

15300 Analyzers, Laboratory, Body Fluid, Lead


15301 Analyzers, Laboratory, Radioimmunoassay

15306 Analyzers, Laboratory, Microbiology, Susceptibility, Automated

15309 Simulators, Training, Cardiopulmonary Resuscitation

15310 Densitometers, Laboratory, Liquid, Urine

15313 Procedure Kit/Trays, Culdocentesis


15316 Procedure Kit/Trays, Arthrography

15318 Procedure Kit/Trays, Drainage, Wound, Closed Craniotomy

15321 Gel, Ultrasonic Coupling

15322 Tubes, Bronchial

15323 Tubes, Middle Ear, Myringotomy

15327 Incubators, Laboratory, Test Tube


15550 Alarms

15551 Analyzers, Laboratory, Clinical Chemistry

15552 Analyzers, Laboratory, Hematology, Coagulation

15553 Aprons

15554 Basins (Retired)

15555 Baths

15557 Binders
15558 Blades

15560 Bougies

15561 Bowls

15562 Breathing Circuits

15563 Calibrators

15564 Procedure Kit/Trays, Catheterization

15566 Chambers
15567 Charts

15568 Chromatography Systems

15569 Clippers

15571 Covers

15572 Cups

15574 Detectors, Metallic Foreign Body

15576 Droppers

15577 Dynamometers
15578 Electrodes

15579 Electrodes, Electrosurgical

15583 Freezers

15585 Procedure Kit/Trays, Irrigation/Lavage

15586 Jars
15591 Nephroscopes

15592 Oxygenators

15593 Pillows

15594 Racks

15595 Recorders

15596 Procedure Kit/Trays, Sampling


15599 Slide Stainers

15601 Spectrophotometers

15602 Specula

15605 Testers

15606 Testers, Power Line Receptacle

15607 Traction Units, Static


15610 Warming Units

15612 Water Purification Systems

15613 Ventilators

15614 Hospital Communication Systems, Nurse Call

15616 Headwall Systems, Prefabricated


15618 Tracks/Carriers

15620 Tracks/Carriers, Intravenous

15622 Injectors, Uterine

15624 Dressings, Nonimpregnated, Synthetic, Tracheostomy

15628 Forceps, Grasping, Flexible Endoscopic

15629 Retrieval Baskets, Biliary Stone

15631 Testers, Transcutaneous Peripheral Nerve Electrical Stimulator


15633 Testers, Hearing Aid

15634 Analyzers, Physiologic, Middle Ear

15635 Retractors, Surgical, Multipurpose, Fiberoptic-Illuminated

15636 Suction Tips, Fiberoptic-Illuminated

15643 Surgical Drapes, Measuring Instrument

15645 Humidifiers, Artificial Airway, Heat/Moisture Exchange

15646 Surgical Drapes, Patient, Disposable


15647 Surgical Drapes, Patient, Reusable

15648 Timers, Apgar Scoring

15650 Timers, Phototherapy

15651 Laboratory Stirrers

15652 Loupes
15656 Scanning Systems, Ultrasonic, Mammographic

15657 Scanning Systems, Ultrasonic, Obstetric/Gynecologic


15660 Lights, Illumination, Overbed

15661 Sheets, Examination Table

15662 Massage Machines, Physical Therapy

15663 Pipettors

15666 Simulators, Training

15671 Clamps, Surgical, Intestinal, Rectum


15673 Hooks, Surgical, Rectal

15674 Punches, Surgical, Ear Lobe

15675 Retractors, Surgical, Middle Ear, Mastoid Process

15676 Snares, Nasal

15677 Manipulator/Elevators, Uterine


15679 Needles, Tine Test

15682 Test Tubes, Centrifuge


15691 Pressure Relief Pads, Soft Rubber

15693 Patient Transfer Aids

15695 Charts, Acupuncture

15697 Eyewear, Safety

15698 Cabinets, Biological Safety

15699 Covers, Heel Stirrup


15700 Cushions, Heel Stirrup

15702 Crutch Tips, Rubber

15705 Surgical Drapes, Operating Table, Disposable

15706 Surgical Drapes, Operating Table, Reusable

15707 Sheets, Operating Room Table, Disposable

15708 Sheets, Operating Room Table, Reusable

15709 Analyzers, Laboratory, Blood Gas/pH

15711 Punches, Dental Dam


15712 Clamps, Dental Dam

15719 Monitors, Physiologic, Electroencephalography, Telemetric

15720 Monitors, Physiologic, Neurology, Electromyography, Telemetric

15721 Monitors, Physiologic, Neurology, Evoked Potential, Electro-Oculography, Telemet

15723 Chairs, Examination/Treatment, Ophthalmology

15726 Stretchers, Mobile, Hospital, Radiographic


15731 Phototherapy Units, Ultraviolet

15732 Beds, Electric, Birthing

15733 Surgical Scrub Stations

15735 Catheter Tube Holders

15737 Rhinomanometers

15738 Sheets, Examination Table, Disposable


15739 Sheets, Examination Table, Reusable

15741 Rasps, Bone


15742 Mailers (Retired)

15743 Transport Containers, Thermal Protection, Dry Ice, Specimen

15744 Transport Containers, Mechanical Protection, Specimen

15745 Transport Containers, Mechanical Protection, Microscope Slide

15747 Electric Signal Amplifiers, Audio, Speech

15749 Cover Implants, Bur Hole


15750 Pill Crusher/Splitters

15752 Shields, Heat Loss, Infant

15753 Transmitter/Receiver Systems, Telephone, Physiologic Monitor

15754 Cables/Leads, Electrocardiography

15756 Aspirator/Irrigators, Surgical, Ultrasonic

15760 Beds, Electric, Obese

15764 Covers, Footswitch

15765 Covers, Camera


15767 Orthopedic External Fixation Systems, Fracture

15768 Cannulae, Aortic

15770 Radiographic Quality Assurance Devices

15777 Skin Scrub Trays

15778 Covers, Clamp

15779 Animal Enclosures

15780 Timers, Radiotherapy


15781 Infusion Systems, Insulin, Closed-Loop

15783 Ventilators, Intensive Care, Adult, High-Frequency

15784 Stents

15788 Ureteroscopes

15791 Monitors, Physiologic, Neonatal/Infant, Bedside

15793 Stretchers, Portable, Scoop

15794 Scleral Buckling Devices


15795 Cardiac Output Units, Radioisotope
15798 Food Trays, Disposable

15799 Food Trays, Reusable

15800 Forceps, Dissecting

15802 Food Trays

15806 Dressings, Dental Liquid/Paste, Periodontal

15808 Intravenous Fluid Containers, Evacuated

15809 Tubes, Blood Collection, Evacuated

15810 Accelerometers
15811 Anatomic Models

15815 Cameras, Photographic, Microscope

15816 Simulators, Training, Intravenous Insertion

15817 Power Systems, Electrical, Isolated

15818 Cyclotrons

15819 X-Ray Film Cutters


15822 Silver Recovery Systems
15823 Cameras, Photographic, Multi-Image

15824 Alarms, Central Gas System

15827 Dispensers, Liquid/Foam Soap

15828 Racks, Drying

15829 Extrication Devices

15831 Floor Mats

15833 Monitors, Electrical Safety, Ground Continuity

15836 Covers, Hamper

15837 Hamper Liners


15838 Hamper Stands

15839 Hampers

15840 Hospital Communication Systems, Paging

15841 Hospital Communication Systems, Public Address

15845 Dental Pantographs

15848 Electric Plugs, Explosion-Proof

15849 Electric Plugs, Ground Connection


15850 Electric Plugs, Hospital Grade

15851 Electric Plugs, Locking

15852 Rails

15853 Rails, Bathtub

15854 Rails, Commode

15855 Rails, Wall

15857 Electric Receptacles, Explosion-Proof

15858 Electric Receptacles, Ground Connection

15859 Electric Receptacles, Hospital Grade


15860 Electric Receptacles, Locking

15863 Alarms, Line Voltage/Frequency

15864 Bowls, Wash

15866 Lights, Examination, Ceiling-Mounted

15867 Brushes, Surgical, Bone, Intramedullary

15868 Needle Guides

15869 Prostheses, Cardiac Valve, Artificial


15870 Prostheses, Cardiac Valve, Biological

15871 Shields, X-Ray, Eye

15872 Shields, X-Ray, Barrier

15874 Radiofrequency Therapy Systems, Tissue Ablation, Ophthalmic

15876 Occluders, Ophthalmic

15877 Exploratory Probes, Microlaryngeal

15878 Clamps, Surgical, Vascular, Artery, Carotid

15882 Clamps, Surgical, Vascular


15885 Catheters, Cardiac, Dye Dilution

15886 Carts, Central Supply

15887 Carts, Central Supply, Food Service

15888 Carts, Central Supply, Linen/Laundry

15889 Carts, Service/Utility

15890 Carts, Storage/Transport, Janitorial/Housekeeping


15891 Carts, Central Supply, Surgical Case

15892 Analyzers, Laboratory, Breath, Helium

15895 Casework

15896 Casework, Multipurpose

15897 Casework, Laboratory


15898 Casework, Multipurpose, Modular

15899 Casework, Nursing Station

15900 Casework, Patient Room


15901 Casework, Pharmacy

15904 Compactors

15905 Compactors, Fixed

15908 Curtains, Shower

15909 Curtains, Shower, Reusable, Antimicrobial

15910 Curtains, Shower, Disposable

15911 Curtains, Shower, Reusable

15912 Dispensers, Ice


15922 Refrigerators, Food, Walk-in

15923 Refrigerators, Food, Infant Formula

15925 Showers, Emergency

15926 Signs

15927 Signs, Directional

15928 Signs, Safety

15931 Washers, Laundry

15932 Sinks
15934 Sinks, Examination/Treatment

15935 Sinks, Laboratory

15936 Sinks, Surgical Scrub

15938 X-Ray Film Processors, Automatic

15939 X-Ray Film Processors, Automatic, Dental


15940 Conveyors, Document/Equipment/Supply

15941 Lifts, Equipment/Supply

15943 Conveyors, Food Tray


15944 Cameras, Gamma

15945 X-Ray Film Manual Processing Equipment

15948 X-Ray Film Processors, Automatic, Cine

15950 X-Ray Film Processors, Automatic, Tabletop

15952 Radiographic/Fluoroscopic Units

15955 Scanning Systems, Computed Tomography, Axial, Head

15956 Scanning Systems, Computed Tomography, Axial, Full-Body


15957 Scanning Systems, Ultrasonic, Vascular

15962 Bedside Charts

15963 Image Intensifiers

15965 Flowmeters, Gas, Respiratory, Peak Expiratory Flow

15966 Video Systems


15967 Video Systems, Endoscopic

15968 Video Systems, Microscope

15969 Video Systems, Operating Room

15971 Sutures, Metallic, Stainless Steel, Monofilament

15973 Analyzers, Laboratory, Microbiology, Blood Culture, Automated

15975 X-Ray Tube Assemblies


15976 Scanning Systems, Ultrasonic, General-Purpose

15977 Scissors, Surgical, Intestine, Rectum, Fistula

15981 Oxygen Canister/IV Pole Holders, Wheelchair

15982 Cannulae, Arthroscopy Drainage

15985 Dryers, Labware

15987 Wheelchair Trays

15988 Snares, Rectal


15992 Covers, Cart, Linen/Laundry

15993 Programmer/Testers, Implantable Cardiac Pacemaker

15998 Tubes, Gastrostomy, Decompression/Jejunal Feeding

16000 Facility Booms, Ceiling-Mounted, Operating Microscope

16005 Cushions, Commode Seat

16006 Surgical Drapes, Patient, Angiographic


16008 Recorders, Physiologic, Vital Signs, Tape

16009 Electrocardiographs, Ambulatory, Continuous, Tape

16010 Monitors, Electrical Safety, Electrosurgery, Return Electrode

16012 Shoes, Orthopedic

16014 Analyzers, Laboratory, Hematology, Blood Grouping

16016 Laundry Bags

16017 Stools

16018 Dialyzer Reprocessing Units


16020 Organ Preservation Systems, Cold Perfusion

16021 X-Ray Film Storage Units

16023 Sinks, Portable

16024 Tables, Imaging, Nuclear Medicine, Stress Exercise

16025 Spuds, Eye

16027 Orthopedic Internal Fixation Systems

16028 Clips, Implantable, Vascular

16029 Stimulators, Electrical, Neuromuscular, Bladder/Bowel Evacuation

16034 Electroglottographs
16035 Stimulators, Electrical, Auditory, Cochlear

16039 Annuloplasty Ring/Band Implants

16040 Stents, Ureteral

16041 Stents, Vaginal

16042 Mesh

16044 Orthopedic External Fixation Systems

16045 Skin Expansion Implants


16046 Orthopedic External Fixation Systems, Spinal

16048 Mesh, Metallic

16051 Catheters, Peritoneal, Hydrocephalic

16055 Screws

16057 Nerve/Tendon Sheath Implants

16058 Sheets, Cranioplasty (Retired)

16060 Pacemakers, Breath, Diaphragmatic/Phrenic Nerve


16061 Stimulators, Electrical, Brain, Analgesic

16065 Ophthalmic Conformers

16066 Ophthalmic Foil

16068 Lenses, Intraocular, Anterior Chamber

16069 Lenses, Intraocular, Iridocapsular Fixation

16070 Lenses, Intraocular, Iris Fixation

16071 Lenses, Intraocular, Posterior Chamber

16072 Prostheses, Joint, Knee


16073 Ophthalmic Implants, Symblepharon Ring

16074 Ophthalmic Implants, Eye Muscle Sheath

16077 Bolts, Bone

16081 Caps

16082 Bone Cap Implants

16083 Nerve Cap Implants

16084 Prostheses, Joint, Hip, Acetabular Component


16086 Catheters, Cardiac, Hydrocephalic

16087 Prostheses, Joint, Ankle, Talar Component

16088 Prostheses, Joint, Ankle, Tibial Component

16089 Prostheses, Joint, Wrist, Carpal Component

16090 Prostheses, Joint, Elbow, Total

16091 Prostheses, Joint, Elbow, Humeral Component


16092 Prostheses, Joint, Elbow, Radial Component

16093 Prostheses, Joint, Elbow, Ulnar Component

16095 Prostheses, Joint, Hip, Femoral Component

16096 Prostheses, Joint, Knee, Total

16097 Prostheses, Joint, Knee, Femoral Component


16098 Prostheses, Joint, Knee, Tibial Component

16099 Prostheses, Joint, Shoulder

16101 Screws, Bone

16102 Spacers, Tendon

16103 Staples, Bone

16105 Prostheses, Joint, Elbow


16107 Prostheses, Middle Ear Ossicle, Incus/Stapes

16108 Prostheses, Middle Ear Ossicle, Total

16111 Breast Implants

16112 Prostheses, Breast, External

16113 Orbital Rim Implants

16117 Mounts
16121 Prostheses, Joint, Knee, Patellar Component

16126 Restrictors, Orthopedic Cement

16127 Electrodes, Cardiac, External Pacemaker, Transthoracic

16129 Leads, External Cardiac Pacemaker, Endocardial

16130 Prostheses, Breast Nipple, External

16131 Resinous Compounds, Cranial


16132 Prostheses, Joint, Ankle

16134 Prostheses, Joint, Toe

16136 Clamps, Tubing, Hemodialysis Unit Blood Line

16140 Prostheses, Bone Cerclage


16141 Sterilizing Units, Steam, Bulk

16142 Sterilizing Units, Steam, Tabletop

16144 Pressure Relief Pads, Air, Alternating, Disposable

16145 Pressure Relief Pads, Air, Alternating, Reusable


16147 Prostheses, Middle Ear Ossicle

16150 Prostheses, Joint, Hip, Total

16151 Catheters, Intracranial, Ventricular, Hydrocephalic

16154 Prostheses, Palatal, Obturation

16155 Endoscopic Obturators


16157 Sphygmomanometers, Electronic

16158 Sphygmomanometers, Mercury

16159 Procedure Kit/Trays, Emergency

16160 Procedure Kit/Trays, Emergency, Anaphylactic

16161 Procedure Kit/Trays, Emergency, Cardiopulmonary Resuscitation


16162 Curtains

16163 Procedure Kit/Trays, Cardioplegia Solution Administration

16164 Tampons, Menstruation

16165 Prostheses, Gastroesophageal, Antireflux

16166 Bilirubinometers, Cutaneous

16167 Infusion Pumps, Syringe, Oxytocin (Retired)


16168 Beds, Fixed, Flotation Therapy, Neonatal
16172 Sterilizing Units, Steam/Ethylene Oxide, Bulk

16173 Sphygmomanometers, Electronic, Automatic

16174 Sphygmomanometers, Electronic, Manual

16176 Body Exhaust Systems

16177 Cardiac Output Units, Dye Dilution

16179 Carriers, Dental, Amalgam

16181 Dental Materials, Articulation Paper

16182 Dental Materials, Cavity Liner


16183 Dental Materials, Cavity Varnish

16184 Prophylaxis Cups

16185 Dental Materials, Casting

16187 Dental Materials, Casting, Porcelain

16188 Dental Materials, Restorative

16189 Dental Wax

16191 Extraoral Orthodontic Headgear

16192 Facebows

16193 Fluoride Gel Trays


16195 Dental Matrix Bands

16196 Dispensers, Dental, Alloy/Amalgam

16198 Orthodontic Bands

16199 Orthodontic Tubes

16202 Dental Posts, Endodontic

16203 Dental Implants, Endosteal, Plate Form

16205 X-Ray Film Holders, Dental

16206 Electrodes, Electrosurgical, Active, Foot-Controlled


16207 Cold/Hot Pack Holders

16209 Forceps, Ophthalmic

16210 Orthoses, Upper Limb, Hand-Finger, Immobilizer, Splint

16212 Radiographic/Fluoroscopic Systems, Urologic

16213 Bowls, Ear

16214 Wheelchairs, Powered

16216 Curtains, Cubicle, Disposable


16217 Analyzers, Laboratory, Immunoassay, Photometric, Enzyme (EIA)

16218 Analyzers, Laboratory, Immunoassay, Fluorimetric

16219 Caps, Hypothermia

16221 Walker Trays

16222 Protective Tips, Surgical Instrument

16227 Procedure Kit/Trays, Irrigation/Lavage, Uterine Cervix Canal


16228 Lithotripters

16229 Lithotripters, Intracorporeal, Electrohydraulic

16230 Lithotripters, Intracorporeal, Impact, Ultrasonic

16231 Electrocardiographs, Multichannel, Interpretive

16232 Orthoses, Upper Limb, Total, Support, Sling, Wheelchair

16233 Casting Stands, Orthopedic

16237 Flowmeters, Blood, Radioactive Tracer, Cerebral Xenon Clearance


16239 Video Systems, Slow-Scan

16240 Surgical Instrument Holders, Laparoscope

16241 Scanning Systems, Ultrasonic, Abdominal

16243 Leg Holders, Surgical Prep

16246 X-Ray Film Handling Equipment, Automatic, Daylight

16247 Information Systems, Picture Archiving and Communication, Radiology


16248 Simulators, Training, Orthopedic Diagnosis/Therapy

16252 Stimulators, Electrical, Peripheral Nerve, Block Monitoring

16253 Nerve Locators

16254 Nerve Locators, Facial

16256 Stimulators, Electrical, Peripheral Nerve, Somatosensory

16259 Prostheses, Joint, Wrist, Radial/Ulnar Head


16260 Scanning Systems, Magnetic Resonance Imaging

16262 Smoke Evacuation Systems, Surgical

16263 Stimulators, Electrical, Neuromuscular, Diagnostic

16266 Needles, Medication Transfer, Filtering

16267 Calipers, Skinfold, Electronic

16268 Forceps, Biopsy, Flexible Endoscopic


16269 Forceps, Biopsy, Rigid Endoscopic

16271 Recorders, Physiologic, Trend, Blood Pressure

16272 Probes, Ultrasonic

16273 Dispensers, Laboratory, Antibiotic Sensitivity Disk

16274 Dispensers, Laboratory, Liquid

16280 Electrical Conductivity Meters

16281 View Boxes, Ultraviolet


16283 Racks, Laboratory Procedure, Thin-Layer Chromatography Plate

16285 Cabinets, Storage, Desiccating

16286 Glove Boxes

16287 Hot Plates

16288 Microscopes, Light, Laboratory, Phase Contrast

16290 Shields, Mechanical, Workbench

16291 Collectors, Sweat


16292 Warming Units, Microscope Slide

16293 Electrical Resistivity Meters

16294 Training Aids

16298 Analyzers, Laboratory, Clinical Chemistry, Automated

16299 Analyzers, Laboratory, Clinical Chemistry, Automated, Discrete

16300 Analyzers, Laboratory, Clinical Chemistry, Automated, Centrifugal


16301 Analyzers, Laboratory, Clinical Chemistry, Automated, Continuous-Flow

16302 Analyzers, Laboratory, Clinical Chemistry, Manual

16303 Recorders, Physiologic, Evoked Potential, Auditory

16305 Recorders, Physiologic, Trend, Respiration Rate


16309 Foot Arch Tracing Units
16312 Cables/Leads

16313 Cables/Leads, Electroencephalography

16314 Cables/Leads, Electromyography


16315 Cables/Leads, Transcutaneous Electrical Nerve Stimulation

16321 Procedure Kit/Trays, Catheterization, Urinary, Intermittent

16324 Unit-Dose Packaging Systems

16325 Dispensers, Medication, Liquid, Unit-Dose

16327 Chambers, Environmental


16329 Radiometers, Ultraviolet

16330 Pachymeters

16334 Analyzers, Physiologic, Neuromuscular Function, Gait

16335 Chambers, Anaerobic

16336 Prostheses, Dental, Fixed, Veneer

16340 Saws, Cast, Electric


16342 Anomaloscopes

16344 Brushes, Surgical, Dermabrasion

16345 Exophthalmometers

16347 Keratoscopes

16348 Radiometers

16350 Impression Trays, Dental


16351 Alginate Mixing Systems

16352 Procedure Kit/Trays, Dental, Gingival Retraction Paste

16353 Acrylic Curing Units, Dental


16355 Apex Locators, Endodontic

16357 Crown/Inlay Removers

16358 Monitors, Environmental, Mercury Vapor

16360 Orthodontic Brackets

16362 Power Meters, Radiofrequency, Shortwave Diathermy Unit


16363 Dental Materials, Plaque Disclosing

16366 Mouth Guards

16367 Dental Materials, Restorative, Amalgam

16368 Dental Materials, Restorative, Mercury

16369 Brushes, Dental, Prophylaxis

16370 Dental Matrix Band Wedges

16371 Warming Units, Anesthetic

16373 Recorders, IVD Test, Platelet Aggregation


16375 Scanning Systems, Positron Emission Tomography

16376 Calipers, Skinfold

16378 Analyzers, Laboratory, Urine, Automated

16379 Procedure Kit/Trays, Coagulation Time

16381 Counters, Gamma

16382 Analyzers, Laboratory, Radioimmunoassay, Automated

16383 Analyzers, Laboratory, Radioimmunoassay, Semiautomated


16386 Lights, Dental Resin Polymerization

16388 Dental Materials, Adhesive, Denture/Oral Tissue


16389 Collimators, Radiographic

16396 Denture Anchors

16398 Aprons, Surgical (Retired)


16399 Tubes, Bronchial, Endoscopic Decompression

16400 Chisels, Surgical, Middle Ear

16401 Commode/Wheelchairs (Retired)

16403 Endoscopic Teaching Attachments


16404 Diluters, Blood Cell

16405 Apheresis Units

16409 Knives, Surgical, Throat, Trachea

16411 Broaches, Dental, Endodontic

16412 Burnishers

16414 Calibrators, Ophthalmic Tonometer

16415 Calipers, Surgical, Ophthalmic

16418 Cameras, Radiographic Photospot


16419 Cameras, Photographic, Ophthalmic

16420 Cannulae, Suprapubic

16421 Trocars, Abdominal, Suprapubic

16422 Cannulae, Nasal

16426 Carvers, Dental, Amalgam

16427 Carvers, Dental, Wax

16429 Catheters, Biliary, Cholangiography

16430 Catheters, Spinal, Epidural, Anesthetic


16431 Catheters, Intrauterine

16432 Catheters, Nasopharyngeal

16433 Catheters, Peritoneal

16436 Chairs, Dialysis

16437 Chairs, Examination/Treatment

16438 Light Sources, Microscope

16439 Microscopes, Light, Laboratory, Fluorescence

16441 Viscosimeters, Blood Plasma


16443 Clip Appliers, Vascular, Reusable, Aneurysm

16445 Clip Appliers, Vascular, Reusable

16449 Clamps, Cannula

16450 Clamps, Surgical, Eye

16451 Clamps, Surgical, Middle Ear

16452 Clamps, Surgical, Penis

16453 Clamps, Surgical, Uterus

16456 Laboratory Concentrators, Specimen


16460 Condensers, Dental, Amalgam

16464 Cusps, Dental

16466 Ophthalmic Fixation Units

16468 Dilators, Surgical, Ureteral

16469 Dilators, Cervical Canal

16470 Dental Disks, Abrasive

16472 Dispensers, Orthopedic Cement

16473 Dispensers, Dental, Mercury

16474 Surgical Drapes, Operating Microscope


16475 Knife Test Drums, Ophthalmic

16476 Optokinetic Drums

16477 Blankets, Fire

16478 Ear Wicks

16480 Elevators, Dental

16481 Excavators, Dental


16484 Video Systems, Patient Monitoring

16485 Dialyzers, Hemodialysis, Hollow Fiber, High-Permeability


16486 Depressors

16488 Analyzers, Point-of-Care, Whole Blood, Glucose

16489 Catheter Tube Holders, Endotracheal Tube

16490 Electrosurgical Unit Adapters

16491 Infusion Pumps, Multitherapy, Ambulatory

16492 Covers, Bedrail


16493 Carts, Storage/Transport, Laboratory, Pathology Specimen

16495 Infusion Pumps

16496 Shields, X-Ray, Mask

16497 Mirrors, Visual Feedback Therapy

16498 Incontinence Pant Liners

16499 Incontinence Pants, Liner Retention

16500 Gloves, Therapeutic, Pressure


16502 Signaling Devices, Personal Emergency

16503 Cytometers, Automated, Flow, Sorting

16504 Intravenous Poles, Ceiling-Mounted

16512 Recorders, Video, Tape, X-Ray Image

16513 Emergency Immobilizers, Whole Body


16514 Procedure Kit/Trays, Enema, Barium

16516 Pacemakers, Cardiac, External, Noninvasive Electrode


16518 View Boxes, X-Ray, Motorized

16520 Scissors, Surgical, Tonsil

16521 Procedure Kit/Trays, Drainage, Wound

16522 Cardiokymographs

16530 Analyzers, Laboratory, Body Fluid, Electrolyte, Flame Photometer

16531 Photometers, Filter, Reflectance


16532 Autopsy/Dissection Stations

16534 Cryogenic Storage Containers

16535 Liquid Nitrogen Containers

16536 Liquid Oxygen Containers

16538 Controllers, Temperature, Cryogenic


16542 Controllers, Liquid Level, Cryogenic

16544 Tables, Imaging, Radiographic

16545 Procedure Kit/Trays, Angiography

16546 Procedure Kit/Trays, Angiography, Digital

16547 Procedure Kit/Trays, Angiography, Special Procedure


16548 Densitometers, X-Ray Film

16550 Dilators, Surgical, Salivary Duct

16553 Monitors, X-Ray Tube Position

16555 Radiographic Units, Pneumoencephalographic

16556 Radiographic/Tomographic Systems, Multidirectional

16558 Batteries, Mobile Radiographic Unit

16559 Compression Devices, Radiographic

16560 Image Digitization Systems, Angiography/Cardiovascular


16561 X-Ray Film Changers

16562 Safelights, X-Ray, Darkroom

16564 Shields, X-Ray, Thyroid


16565 Test Patterns, Radiographic

16567 Thyroid Uptake Systems

16568 Darkroom Entrances, Radiographic

16571 Darkroom Interlocking Systems, Radiographic

16576 Covers, Thermometer


16579 Infusion Pump Administration Sets

16580 Razors, Skin Prep

16581 Contact Lens Cases


16582 Cytometers, Automated

16583 Knives, Adenotome (Retired)

16584 Sutures, Synthetic, Absorbable, Polydioxanone

16585 Syringes, Cartridge

16588 Insulin Pump Administration Sets

16590 X-Ray Film Changers, Cassette


16591 X-Ray Film Changers, Sheet-Film

16592 X-Ray Film Changers, Roll-Film

16597 Radiographic/Fluoroscopic Systems, Angiography/Interventional

16599 Tables, Imaging, Nuclear Medicine

16600 Tables, Imaging, Radiographic/Fluoroscopic

16601 Tables, Imaging, Radiographic/Fluoroscopic, Multiple Procedure


16602 X-Ray Generators

16603 Monitors, Video

16604 X-Ray Tubes

16606 Lights, Illumination, High-Intensity, Spotlight

16608 Analyzers, Laboratory, Microbiology


16610 Transfer Sets, Liquid

16611 Prostheses, Cranium Hair

16613 Calipers, Electrocardiogram

16614 Dental Floss Holders

16615 Procedure Kit/Trays, Catheterization, Intravenous, Central Vein

16617 Medicine Bottle Caps


16618 Oximeters/Co-Oximeters, In Vitro

16619 Swabs, Absorbent/Cotton, Ear/Nose/Throat

16627 Needles, Medication Transfer

16628 Needles, Medication Transfer, Vented

16629 Air Cleaners

16630 Stretchers, Mobile, Ambulance

16631 Intravenous Administration Sets, Nonabsorbing

16632 Tourniquets, Non-Inflatable Strap


16639 Chairs, Patient Transfer

16640 Batteries

16641 Dialysate, Hemodialysis

16642 Dialysate

16646 Procedure Kit/Trays, Ear Canal Impression

16649 Intravenous Administration Sets, General-Purpose

16651 Forceps, Dental Dam Clamp


16652 Defibrillators, Implantable

16653 Leads, Implantable Defibrillator

16654 Catheters, Cardiac, Flotation Balloon, Pacing Electrode

16655 Catheters, Cardiac, Ablation

16657 Cameras, Cine


16658 Dental Materials, Adhesive, Impression Material/Tray

16659 Dental Materials, Casting, Alloys, Nonprecious

16660 Dental Materials, Casting, Alloys, Precious

16661 Dental Materials, Casting, Alloys

16668 Burs, Dental, Carbide

16669 Burs, Dental, Steel


16670 Burs, Dental, Diamond

16671 Syringes, Plunger, Dental, Impression Material

16673 Chairs, Radiography/Fluoroscopy

16674 Dental Materials, Impression

16675 Dental Materials, Impression, Agar

16676 Dental Materials, Impression, Alginate


16677 Dental Materials, Impression, Polyether

16678 Dental Materials, Impression, Rubber-Based, Polysulfide

16679 Dental Materials, Impression, Rubber-Based, Silicone

16692 Prophylactic Units, Dental

16693 Prophylactic Units, Dental, Ultrasonic


16696 Procedure Kit/Trays, Dental, Occlusal Splinting

16697 Dental Materials, Splinting

16698 Prophylaxis Angles

16699 Dental Materials, Prophylaxis, Paste

16700 Dental Retention Pins


16701 Procedure Kit/Trays, Dental, Retention

16703 Dental Materials, Cement, Ethoxy Benzoic Acid

16704 Dental Materials, Cement, Glass Ionomer

16705 Dental Materials, Cement, Polycarboxylate

16706 Dental Materials, Cement, Zinc Oxide Eugenol, Reinforced


16707 Dental Materials, Cement, Resin Composite

16708 Dental Materials, Cement, Silicophosphate

16709 Dental Materials, Cement, Zinc Oxide Eugenol

16710 Dental Materials, Cement, Zinc Phosphate

16712 Dental Materials, Restorative, Amalgam, Capsule


16713 Dental Materials, Restorative, Amalgam, Tablet

16714 Dental Materials, Restorative, Amalgam, Powder

16715 Cleansers, Denture

16717 Monitors, Physiologic, Respiration, Artificial Airway Temperature, Bedside

16719 Stretchers, Portable, Basket

16720 Testers, Infusion Pump


16724 Dental Materials, Restorative, Composite Resin

16725 Dental Materials, Restorative, Composite Resin, Self-Cured

16726 Dental Materials, Restorative, Composite Resin, Heat-Cured

16727 Dental Materials, Restorative, Unfilled Resin

16728 Dental Materials, Manufacture/Repair, Denture Base Resin


16729 Denture Base Resins, Heat-Cured

16730 Denture Base Resins, Self-Cured

16732 Procedure Kit/Trays, Dental, Restoration

16733 Procedure Kit/Trays, Dental, Restoration, Crown/Bridge Fixation

16734 Procedure Kit/Trays, Dental, Restoration, Composite Resin

16735 Procedure Kit/Trays, Dental, Restoration, Composite Resin, Heat-Cured


16736 Procedure Kit/Trays, Dental, Restoration, Composite Resin, Light-Cured

16737 Procedure Kit/Trays, Dental, Denture Repair, Base Resin

16738 Procedure Kit/Trays, Dental, Repair, Porcelain

16739 Procedure Kit/Trays, Dental, Restoration, Unfilled Resin

16744 Dental Implants


16745 Analyzers, Laboratory, Microbiology, Susceptibility, Manual

16749 Analyzers, Point-of-Care, Whole Blood, Coagulation

16751 Tables, Radiotherapy

16752 Blood Cell Washer Bags

16758 Lithotripters, Extracorporeal

16759 Humidifiers, Room Environment

16760 Paper, Examination Table


16761 Nipples, Infant Nursing Bottle

16763 Monitors, Physiologic, Intracranial Pressure, Bedside

16764 Monitors, Physiologic, Blood Pressure, Bedside

16765 Centrifuges, Tabletop, Low-Speed, Nonrefrigerated, Cytologic

16769 Adhesive Strips, Multipurpose

16770 Analyzers, Spectrum


16771 Staples

16772 Baths, Water, Shaker

16773 Analyzers, Laboratory, Body Fluid, Lactate

16774 Needles, Aspiration

16776 Procedure Kit/Trays, Anesthesia, Saddle Block

16777 Catheters, Cardiac, Flotation Balloon, Pulmonary Artery


16781 Procedure Kit/Trays, Catheterization, Urinary, Indwelling

16783 Cannulae, Ventricular

16784 Radioaerosol Administration Sets

16786 Stretchers, Mobile, Hospital

16787 Staple Removers

16788 Cleaners, Denture

16789 Intravenous Flow Regulators, Dial-Calibrated

16792 Dialysate, Peritoneal


16793 Service Columns, Prefabricated

16798 Tubes, Nasoenteral, Feeding

16800 Charts, Eye, Visual Acuity

16801 Charts, Eye, Color Discrimination

16803 Intermittent Mandatory Ventilation Supplemental Gas Circuits

16805 Knives, Surgical, Cartilage

16807 Liquid -Dispensing Systems, Pharmaceutical


16808 Laboratory Tonometers

16809 Ophthalmic Tonometers

16810 Pitchers, Paraffin

16811 Blood Pheresis Sets

16812 Tubes, Blood Collection/Centrifuge, Serum Separation

16813 Analyzers, Laboratory, Microbiology, Urine Bacteriuria


16814 Timers, Scrub Station

16815 Centrifuges, Tabletop, Low-Speed, Nonrefrigerated, Cell Washing

16816 Recorders, IVD Test, Temperature

16817 Analyzers, Laboratory, Hematology, Blood Grouping, Automated

16818 Analyzers, Laboratory, Body Fluid, Electrolyte, Ion-Selective

16819 Analyzers, Laboratory, Body Fluid, Electrolyte, Coulometric

16824 Syringes, Plunger, Laboratory, Metered Delivery

16825 Syringe Tip Caps


16827 Procedure Kit/Trays, Anesthesia, Laryngotracheal

16828 Sterilizing Units, Dry Heat, Inoculating Loop/Needle

16831 Light Sources, Rigid Endoscope/Multipurpose, Fiberoptic Cable

16833 Procedure Kit/Trays, Biopsy, Aspiration, Bone Marrow

16834 Procedure Kit/Trays, Biopsy, Renal


16835 Procedure Kit/Trays, Biopsy, Soft Tissue

16837 Circulatory Assist Units, Peripheral Compression, Sequential

16839 Dental Materials, Casting, Dental Stone

16840 Dental Materials, Manufacture/Repair, Denture Reliner

16841 Power Meters, Ultrasound, Cleaning System

16842 Power Meters, Ultrasound, Diagnostic Unit


16843 Power Meters, Ultrasound, Therapeutic Unit

16844 Aqueous/Vitreous Humor Replacement Media

16853 Liquid Oxygen Units, Individual

16854 Ports, Injection/Infusion

16855 Monitors, Laboratory, Carbon Dioxide

16859 Boards, Dissecting

16860 Electrodes, Electrosurgical, Active


16862 Prostheses, Bone, Freeze-Dried

16865 Analyzers, Laboratory, Radioimmunoassay, Manual

16867 Cytometers, Automated, Flow

16873 Procedure Kit/Trays, Sampling, Blood, Fetal Scalp

16876 Syringes, Plunger, Laboratory, Chromatography, Gas/Liquid

16877 Syringes, Plunger, Laboratory, Chromatography, High-Pressure Liquid

16878 Syringes, Plunger, Laboratory, Sample Preparation/Injection, Micro

16881 Testers, Impedance, Electrode/Lead/Cable, Electrocardiography


16882 Leads

16884 Radiographic/Tomographic Systems, Linear

16885 Radiographic/Fluoroscopic Systems, General-Purpose

16886 Analyzers, Laboratory, Urine

16887 Analyzers, Laboratory, Urine, Semiautomated

16888 Recorders, Physiologic, pH, Upper Gastrointestinal Tract, Catheter, Tape

16889 Beds, Fixed, Air-Fluidized


16890 Projectors, Photographic Slide, Eye Chart

16891 Scanning Systems, Gamma Camera, Mobile

16892 Scanning Systems, Gamma Camera, Planar Image

16894 Controller/Timers, Automated Radiographic Exposure

16898 Pouches, Telemetry

16899 Scanning Systems, Computed Tomography, Electron Beam


16903 Flowmeters, Blood, Laser

16905 Densitometers, Laboratory, Scanning Light

16906 Chairs, Patient Transfer, Stair

16908 Analyzers, Laboratory, Immunoassay, Nephelometric

16910 Digitizers, Film

16911 Sterilizing Units, Steam, Agar

16912 Standing Frames, Mobile


16914 Glove Boxes, Isolation, Controlled Atmosphere, Anaerobic

16915 Contraceptive Sponges

16917 Power Conversion Kits, Mechanical Bed

16918 Ophthalmic Perimeters, Automated

16919 Ophthalmic Perimeters, Manual

16921 Prostheses, Joint, Shoulder, Humeral Component


16922 Prostheses, Joint, Shoulder, Glenoid Component

16924 Infusion Pumps, Analgesic, Patient-Controlled

16926 Laboratory Equipment Holders, Microscope Slide

16934 Power Supplies, Line-Voltage Stabilization

16935 Power Supplies, Regulated


16936 Power Systems, Electrical, Uninterruptible

16938 Monitors, Physiologic, Respiration, Respiratory Gas, Exhaled Carbon Dioxide, Bed

16939 Punches, Surgical, Spine

16940 Analyzers, Laboratory, Body Fluid, Calcium

16941 Lasers, Argon, Surgical

16942 Lasers, Carbon Dioxide, Surgical/Dermatologic

16943 Lasers, Nd:YAG, Surgical


16945 Lasers, Argon, Ophthalmic

16946 Lasers, Krypton, Ophthalmic

16947 Lasers, Nd:YAG, Ophthalmic

16949 Wheelchairs, Mechanical

16950 Silver Recovery Systems, Chemical Precipitation

16951 Silver Recovery Systems, Electrolytic Plating Cell

16952 Silver Recovery Systems, Metallic Replacement Cartridge

16953 Analgesia Units, Inhalation

16960 Thermometers, Electronic, Fiberoptic


16961 Slide Stainers, Microbiology

16962 Prostheses, Joint, Temporomandibular, Mandibular Condyle

16965 Video Systems, Fluoroscopic

16966 Grafts, Bone, Synthetic

16969 Adapter Cables, Pressure Transducer


16972 Radiotherapy Systems, Cobalt

16973 Radiotherapy Systems, Orthovoltage

16974 Recorders, Video, Magneto-Optical Disk

16977 Prostheses, Heart, Percutaneously Powered

16980 Exploratory Probes, Arthroscopy


16982 Stimulators, Caloric, Physical Therapy, Fluidized Medium

16984 Analyzers, Laboratory, Semen

16986 Sphygmomanometers, Electronic, Automatic, Plethysmographic

16988 Carts, Treatment, Malignant Hyperthermia

16989 Leads, External Cardiac Pacemaker, Myocardial

16991 Beds, Electric, Vertical Tilting

16992 Procedure Kit/Trays, Catheterization, Peritoneal, Dialysis


16994 Information Systems, Telemedicine, Radiology

16996 Angioscopes

16997 Service Rails, Prefabricated

17000 Lenses, Eyeglass

17001 Cameras, Video

17002 Cameras, Video, Endoscope

17003 Tubes, Lacrimal Duct

17005 Antimicrobial Reagent Disks


17017 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Enrichment, Mycoba

17019 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Selective, Mycopla

17021 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Selective

17027 IVD Test Reagent/Kits

17028 IVD Test Reagent/Kits, Hematology, Blood Cell Count, Automated Test

17031 IVD Test Reagent/Kits, Clinical Chemistry, Calibration

17032 IVD Test Reagent/Kits, Hematology, Calibration, Coagulation

17033 IVD Test Reagent/Kits, Cytology/Histology, Calibration

17034 IVD Test Reagent/Kits, Serology, Calibration

17035 IVD Test Reagent/Kits, Hematology, Calibration


17036 IVD Test Reagent/Kits, Microbiology, Calibration

17038 IVD Test Reagent/Kits, Immunoassay, Calibration, Toxicology

17039 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Urine Test

17040 IVD Test Reagent/Kits, Serology, Calibration, Virus

17042 IVD Test Reagent/Kits, Chromatography

17043 IVD Test Reagent/Kits, Chromatography, Gas

17044 IVD Test Reagent/Kits, Chromatography, Liquid, High-Pressure

17045 IVD Test Reagent/Kits, Chromatography, Liquid

17046 IVD Test Reagent/Kits, Chromatography, Thin-Layer

17048 IVD Test Reagent/Kits, Hematology, Coagulation

17049 IVD Test Reagent/Kits, Cytology/Histology, Decalcifying, Electron Microscopy

17050 IVD Test Reagent/Kits, Cytology/Histology, Decalcifying, Light Microscopy

17052 IVD Test Reagent/Kits, Cytology/Histology, Flow Cytometry


17058 IVD Test Reagent/Kits, Clinical Chemistry, Control

17059 IVD Test Reagent/Kits, Hematology, Control, Coagulation

17060 IVD Test Reagent/Kits, Cytology/Histology, Control

17061 IVD Test Reagent/Kits, Immunoassay, Control

17062 IVD Test Reagent/Kits, Hematology, Control

17063 IVD Test Reagent/Kits, Immunohematology, Control

17064 IVD Test Reagent/Kits, Microbiology, Control

17065 IVD Test Reagent/Kits, Immunoassay, Control, Radioimmunoassay

17066 IVD Test Reagent/Kits, Immunoassay, Control, Toxicology

17067 IVD Test Reagent/Kits, Clinical Chemistry, Control, Urine

17068 IVD Test Reagent/Kits, Serology, Control, Virus

17072 IVD Test Reagent/Kits, Cytology/Histology, Embedding Media


17073 IVD Test Reagent/Kits, Cytology/Histology, Embedding Media, Electron Microscop

17074 IVD Test Reagent/Kits, Cytology/Histology, Embedding Media, Light Microscopy

17076 IVD Test Reagent/Kits, Immunoassay, Immunology, Tissue Typing

17077 IVD Test Reagent/Kits, Serology, Virus

17079 IVD Test Reagent/Kits, Electron Microscopy, Stain

17080 IVD Test Reagent/Kits, Hematology, Stain

17085 IVD Test Reagent/Kits, Microbiology, Stain

17087 Projectors, Cine, Film

17088 Analyzers, Laboratory, Hematology, Erythrocyte Deformation

17090 Valves, Hydrocephalic


17091 IVD Test Reagent/Kits, Clinical Chemistry

17092 IVD Test Reagent/Kits, Cytology/Histology

17094 IVD Test Reagent/Kits, Hematology

17095 IVD Test Reagent/Kits, Immunohematology

17096 IVD Test Reagent/Kits, Microbiology

17103 Aspirators, Surgical, Liposuction

17105 Crutch Handgrips

17107 Surgical Instrument Holders, Retractor, Automatic


17109 Analyzers, Laboratory, Blood, Glycated Hemoglobin

17110 Stimulators, Caloric, Physical Therapy, Moist Air

17111 Syringes, Cartridge, Dental, Anesthetic

17112 Syringes, Plunger, Dental, Aspiration/Irrigation

17113 Dental Attachments, Precision

17114 Artificial Teeth

17116 Defibrillators, External, Automated

17120 Thermal Insulation Pads, Cardiac Surgery


17121 Stimulators, Electrical, Cardiac, Diagnostic

17126 IVD Test Reagent/Kits, Clinical Chemistry, Blood Gas/pH

17128 IVD Test Reagent/Kits, Clinical Chemistry, Control, Blood Gas/pH

17129 Chambers, Analytic Balance

17130 Cadaver Bags

17131 Collectors, Dust/Debris, Bone Surgery/Postmortem

17133 Dryers

17134 Dryers, Slide


17135 Racks, Morgue, Refrigerator

17136 Tables, Dissecting

17137 Exercisers, Continuous Passive Motion, Upper Limb, Hand/Wrist

17138 Exercisers, Continuous Passive Motion, Lower Limb

17139 Exercisers, Continuous Passive Motion, Upper Limb

17140 Analgesia Units, Cryogenic

17141 Resuscitators, Pulmonary, Exhaled Air


17142 Caps, Infant

17143 Brushes, Cleaning, Instrument, Endoscope

17144 Cystoscopes, Flexible

17145 Cystoscopes, Rigid

17147 Radiometers, Laser

17148 Oximeters, Pulse

17149 Sterilizing Units, Electrolytic


17150 Densitometers, Bone, Isotope, Dual-Photon Absorptiometry

17151 Densitometers, Bone, Isotope, Single-Photon Absorptiometry

17152 Densitometers, Bone

17153 Radiographic Systems, Film, Basic (BRS)

17154 Electrodes, Cardiac, External Pacemaker, Transcutaneous

17156 Refrigerators, Pharmacy


17157 Refrigerators, Laboratory

17158 Refrigerators, Laboratory, Chromatography

17159 Infusion Pumps, Insulin, Ambulatory

17161 Lasers, Excimer

17162 Ambulances, Air Transport


17163 Transfer Sets, Continuous Ambulatory Peritoneal Dialysis (CAPD)

17165 Allografts

17166 Radiographic Units, Specimen

17167 Silver Recovery Systems, Ion-Exchange Cartridge

17169 Valves, Demand

17170 Masks, Resuscitator

17171 Ambulances, Ground Transport


17173 Analyzers, Laboratory, Body Fluid, Catecholamine

17174 Radiographic Systems, Film

17175 Information Systems, Data Management, Radiology

17176 Analyzers, Laboratory, Hematology, Coagulation, Semiautomated

17177 Centrifuges, Floor, Low-Speed, Nonrefrigerated

17180 Needles, Injection, Subcutaneous Port

17183 Catheters, Vascular, Angioplasty


17184 Catheters, Vascular, Angioplasty, Balloon

17185 Catheters, Vascular, Angioplasty, Direct Laser Ablation

17187 Communication Aids, Voice Synthesizer

17188 Cushions, Bedrail

17190 Cardiac Output Units, Ultrasonic

17191 Electrodes, Transcutaneous Electrical Nerve Stimulation


17192 Radiographic/Fluoroscopic Systems, Cardiovascular

17195 Scales, Patient, Bedside, Sling

17196 Manometers, Muscle Compartment

17199 Spectrometers, Mass, Laboratory

17202 Gastric Balloons, Appetite-Suppressing


17203 Data Processors, Ultrasonic Scanning

17206 Warming/Cooling Units, Patient, Heart-Lung Bypass

17208 View Boxes, Microtiter

17211 Radiation Survey Meters, Geiger-Muller

17212 Radiation Survey Meters, Ionization Chamber


17213 Intravenous Hangers, Wall

17215 Leads, Electrical Stimulator, Spinal Cord, Implantable

17217 Chairs, Rotating Vestibulo-Ocular Function

17219 Monitors, Environmental, Ethylene Oxide

17220 Recorders, Bar-Code Data

17221 Bowls, Cement Mixing

17222 Information Systems


17223 Information Systems, Data Management, Bedside

17225 Identification Systems, Blood Transfusion

17226 Cryotherapy/Compression Units

17227 Emission Control Systems, Ethylene Oxide

17231 Cuffs, Pneumatic Tourniquet

17232 Protection Garments, Environmental

17233 Irrigation/Distention Systems, Arthroscopic


17234 Waste Receptacles, Chemotherapy

17236 Power Systems, Electrical, Isolated, Mobile Radiographic Unit

17240 Stimulators, Electrical, Neuromuscular, Scoliosis

17241 Stimulators, Electrical, Spinal Cord, Analgesic

17242 Biomechanics Platforms

17243 Surgical Drapes, Laser-Unit

17244 Surgical Drapes, Patient, Laser-Resistant


17245 Sutures, Synthetic, Nonabsorbable, Polybutester

17246 Sutures, Synthetic, Absorbable, Polyglyconate

17247 Mesh, Polymeric, Polyglycolic Acid

17250 Syringes, Plunger, Calibration, Spirometer/Pulmonary Function Analyzer

17251 Modular Medical Facilities, Mobile

17252 Drivers, Endarterectomy Loop

17253 Batteries, Hearing Aid

17254 IVD Test Reagent/Kits, Immunoassay, Allergy, Specific Immunoglobulin E

17256 IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Acid Glycoprotein


17257 IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsin

17258 IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-2-Macroglobulin

17259 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein

17261 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Anaerobe

17274 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Anti-Parietal Cell Antibody

17276 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Hepatitis, Antismooth Muscle

17280 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antib

17281 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid


17282 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Microsomal Antibody

17283 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyrotropin Recepto

17284 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Aspergillus Species, Antibody

17288 IVD Test Reagent/Kits, Serology, Bacteria, Bordetella pertussis, Antibody

17289 IVD Test Reagent/Kits, Serology, Bacteria, Brucella Species, Antibody

17290 IVD Test Reagent/Kits, Immunoassay, Protein, C-Reactive Protein

17291 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Candida albicans

17292 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida albicans, Antibody

17293 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic


17294 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid

17295 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Ceruloplasmin

17296 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Chlamydia Species

17297 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella pneumoph

17298 IVD Test Reagent/Kits, Serology, Bacteria, Legionella Species

17301 IVD Test Reagent/Kits, Immunoassay, Immunology, Tissue Typing, Human Leukoc

17307 IVD Test Reagent/Kits, Serology, Virus, Measles

17309 IVD Test Reagent/Kits, Serology, Virus, Epidemic Parotitis (Mumps), Antibody

17310 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycoplasma pneum

17311 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma pneumoniae, Antibody

17312 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycoplasma/Ureapl

17313 IVD Test Reagent/Kits, Immunoassay, Protein, Myelin Basic Protein


17314 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin

17315 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Neisseria Species

17316 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Neisseria gonorrhoe

17317 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Neisseria meningitid

17322 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasminogen

17323 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasminogen Activator

17325 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia Species, Antibody

17326 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism, Circulating Im

17327 IVD Test Reagent/Kits, Serology, Bacteria, Clostridium difficile, Toxin

17329 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis, Antibody


17330 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component

17332 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Cryptococcus ne

17333 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antibody

17334 IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, Antibody

17336 IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgM Antibody

17337 IVD Test Reagent/Kits, Serology, Parasite, Entamoeba Species, Antibody

17338 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Enterobacteriaceae

17339 IVD Test Reagent/Kits, Serology, Virus, Epstein-Barr

17340 IVD Test Reagent/Kits, Serology, Virus, Epstein-Barr, IgM Antibody


17342 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritin

17343 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product

17344 IVD Test Reagent/Kits, Serology, Bacteria, Francisella tularensis, Antibody

17348 IVD Test Reagent/Kits, Microbiology, Stain, Bacteria, Gram

17349 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Haemophilus Specie

17351 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Haptoglobin

17352 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Hemopexin

17353 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antibody

17354 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, IgM Antibody


17355 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody

17356 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody

17357 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antigen

17358 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be

17359 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody

17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen

17361 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
17362 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplex

17363 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex, Antibody

17364 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex, IgM Antibody

17365 IVD Test Reagent/Kits, Serology, Virus, Heterophile (Infectious Mononucleosis), A

17366 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Histoplasma capsulatum, Antibody

17367 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antibody

17368 IVD Test Reagent/Kits, Serology, Bacteria/Fungi, Hypersensitivity Pneumonitis, An

17369 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A

17370 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin D


17371 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin E

17372 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G

17373 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M

17374 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, Factor B

17376 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Pseudomonas aerug

17377 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Streptococcus Species

17378 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Retinol Binding

17379 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism, Rheumatoid Fac

17380 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia Species, Antibody

17382 IVD Test Reagent/Kits, Serology, Virus, Rubella, Antibody


17383 IVD Test Reagent/Kits, Serology, Virus, Rubella, IgM Antibody

17384 IVD Test Reagent/Kits, Serology, Bacteria, Salmonella Species, Antibody

17386 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aure

17388 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Streptococcus Speci

17390 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Streptococcus, Grou

17391 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Streptococcus, Grou

17392 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus pneumoniae

17393 IVD Test Reagent/Kits, Serology, Bacteria, Reagin Antibody, Syphilis Screening

17396 IVD Test Reagent/Kits, Serology, Bacteria, Teichoic Acid, Antibody

17397 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Tennessee Antige
17398 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroglobulin

17399 IVD Test Reagent/Kits, Serology, Virus/Parasite, ToRCH, Antibody

17400 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii, Antibody

17401 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii, IgM Antibody

17402 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Transferrin

17403 IVD Test Reagent/Kits, Serology, Parasite, Trichinella spiralis, Antibody

17404 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Trichomon

17408 IVD Test Reagent/Kits, Immunoassay, Toxicology

17410 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Feces, Occult Blood
17412 Monitors, Physiologic, Electroencephalography, Bedside, Spectral

17415 Spill Recovery Kits, Cytotoxic Material

17416 Monitors, Physiologic, Respiration, Respiratory/Anesthetic Gas, Intraoperative,

17417 Analyzers, Physiologic, Body Composition

17419 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose, Strip
17421 Iontophoresis Units, Anhidrotic

17422 Scanning Systems, Ultrasonic, Cardiac

17423 Ventilators, Portable/Home Care

17424 Aspirator/Irrigators, Endoscopy


17425 Monitors, Physiologic, Respiration, Artificial Airway Pressure, Bedside

17428 Dressings, Nonimpregnated, Synthetic, Film

17429 Ventilators, Intensive Care

17430 Cleaning Solutions, Contact Lens

17431 Wetting Solutions, Contact Lens

17432 Incubators, Infant, Mobile


17433 Warming Units, Patient, Radiant, Infant, Mobile

17435 Aspirators, Autopsy

17436 Thermometers, Electronic, Thermistor/Thermocouple, Laboratory

17437 Irradiators, Blood

17439 Microscopes, Light, Laboratory, Stereo

17440 Microscopes, Light, Laboratory, Inverted Stage

17441 Analyzers, Physiologic, Erection/Tumescence


17444 Monitors, Physiologic, Respiration, Respiratory Gas, Carbon Dioxide/Oxygen, Bed

17445 Monitors, Physiologic, Respiration, Respiratory/Anesthetic Gas, Intraoperative

17448 Stents, Tracheal

17449 Dryers, Medical Device, Breathing Circuit


17451 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Enrichment

17452 Centrifuges, Tabletop, High-Speed, Microsample

17453 Catheters, Cardiac, Valvuloplasty

17456 Analyzers, Physiologic, Somnography

17457 Cold Compress/Pack Chilling Units

17458 Polysomnographs
17460 Electrodes, Cardiac, Electrocardiography, Transcutaneous, Neonatal

17461 Stents, Vascular

17463 Valves, Automatic Shutoff, Heart-Lung Bypass

17467 Sutures, Synthetic, Nonabsorbable, Polytetrafluoroethylene

17468 Lithotripters, Intracorporeal, Laser

17469 Cables/Leads, Electrocardiography, Radiolucent


17471 Sutures, Synthetic, Absorbable, Polyglactin

17474 Analyzers, Laboratory, Breath

17475 Analyzers, Point-of-Care, Breath, Alcohol

17476 Analyzers, Point-of-Care, Breath, Hydrogen

17477 Analyzers, Point-of-Care, Breath, Methane

17478 Catheters, Cardiac, Angiography, Transseptal

17479 Prostheses, Joint, Temporomandibular, Total

17480 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine

17481 Lasers, Dye, Ophthalmic

17482 Lasers, Dye


17483 Analyzers, Laboratory, Hematology, Erythrocyte Aggregation

17486 Procedure Kit/Trays, Feeding, Oral, Infant

17487 Spill Recovery Kits, Mercury

17488 Spill Recovery Kits

17489 Washers, Microplate


17495 Electrocochleographs

17496 Cardiac Output Units, Impedance

17500 Retractors, Surgical, Scalp

17501 Intravenous Line Connectors

17502 Radiotherapy Block Shield Mold Cutting Equipment

17504 Information Systems, Data Management, Anesthesia


17505 Stimulators, Electrical, Neuromuscular, Incontinence, Nonimplantable

17506 Warming Units, Gel

17508 Printers, Video

17509 Anesthesia Unit Carbon Dioxide Absorbents

17511 Leads, External Cardiac Pacemaker, Transesophageal

17512 Pacifiers, Infant, Oral

17514 Catheter Tube Holders, Nasogastric Tube


17515 Phototherapy Units, Visible Light, Hyperbilirubinemia

17517 Brachytherapy Systems, Remote Afterloading

17518 Brachytherapy Sources

17519 Catheters, Vascular, Angioplasty, Atherectomy

17521 Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion

17522 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Apolipoprotein


17523 Saws, Cast, Pneumatic

17524 Contact Lenses, Therapeutic

17526 Baths, Water, Molded Plastic Splint

17527 Racks, Garment, Apron

17531 Alarms, Occupancy, Chair/Wheelchair

17533 Fluoroscopic Units, Portable, Radioactive Isotope

17535 Synoptophores

17536 Amblyoscopes
17537 Autotransfusion Units, Blood Processing

17538 Autotransfusion Units, Whole Blood Hemofiltration

17540 Densitometers, Bone, X-Ray

17542 Magnetic Resonance Imaging Coils, Surface

17545 Surgical Drapes, Patient, Heat Loss Prevention

17546 Analyzers, Laboratory, Body Fluid, Lithium

17547 Mattresses, Stretcher

17548 Tubes, Tracheal, Laser-Resistant


17549 Tables, Examination/Treatment, Adjustable, Gynecologic

17552 Lice Combs

17553 Mattresses, Bed, Flame-Resistant/Safety

17554 Electrode Caps, Electroencephalographic

17556 Mounts, Fluid Delivery System

17562 Radiofrequency Therapy Systems, Angioplasty

17563 Valves, Speech, Tracheostomy

17564 Chambers, Reverse Isolation

17565 Catheters, Vascular, Angioplasty, Atherectomy, Ablation


17566 Catheters, Vascular, Angioplasty, Thermal, Electrically-Heated

17567 Radius Gauges, Contact Lens


17569 Needles, Endoscopic Procedure, Sclerotherapy

17570 Warming Units, Patient

17571 Ultrasound Therapy Systems, Hyperthermia

17572 Recorders, Physiologic, Trend, Temperature


17574 Retrieval Baskets, Urological Stone

17575 Percutaneous Diskectomy Systems, Automated


17576 Tooth Preservation Systems

17577 Testers, Implantable Defibrillator/Cardioverter

17578 Catheter Introducers, Vascular, Central Venous, Hemostasis Valve

17579 Defibrillators, External, Telephonic

17580 Filters, Heart-Lung Bypass Priming

17582 Monitors, Physiologic, Neurology, Bedside


17584 Forceps, Laparoscopic Swab

17587 Spatulas, Surgical, Laparoscopy

17588 Monitors, Physiologic, Patient Transport

17591 Resuscitators, Pulmonary, Manual, Reusable

17592 Resuscitators, Pulmonary, Manual, Disposable

17593 Beds, Electric, Low-Air-Loss

17594 Probes, Pulse Oximeter

17595 Protectors, Teeth


17596 Phacoemulsification Units, Cataract Extraction

17597 Brushes, Dental, Prophylaxis, Vacuum-Supplemented

17598 Filters, Hemoconcentration

17600 Bone Matrix Implants

17601 Auditory Function Screening Devices

17602 Transmitter/Receiver Systems, Telephone


17603 Electrical Extension Cords, Multioutlet

17605 Blood Cell Washer Sets, Autotransfusion Unit

17606 Organ Preservation Solutions, Corneal Storage

17608 Orchidometers

17609 Dental Materials, Manufacture/Repair, Denture Reliners, Hard

17610 Dental Materials, Manufacture/Repair, Denture Reliners, Soft


17613 Catheters, Cardiac, Angiography, Ventricular

17614 Detectors, Esophageal Intubation, Exhaled Carbon Dioxide

17620 Wheelchairs, Mechanical, Patient Transfer

17621 Canes, Adjustable-Length, Standard-Handle

17622 Canes, Fixed-Length, Standard-Handle

17623 Canes, Adjustable-Length, Offset-Handle


17624 Canes, Pedestal Base

17625 Crutches, Axillary

17626 Crutches, Forearm

17627 Walkers, Standard

17630 Walkers, Wheeled

17631 Walkers, Single Side Support


17632 Canes, Adjustable-Length

17633 Urethrotomes

17634 Infusion Pumps, Multitherapy, Large Volume, Multichannel

17635 Pacemaker Lead Adapters, Implantable

17636 Markers, Bone


17637 Testers, Implantable Cardiac Pacemaker
17638 Testers, Implantable Cardiac Pacemaker, Transtelephonic

17639 Testers, Implantable Cardiac Pacemaker, Intraoperative

17640 Cannulae, Liposuction


17641 Stereotactic Systems, Frame-Guided, Radiosurgical, Gamma

17642 Procedure Kit/Trays, Aqueous/Vitreous Humor Replacement

17643 Oxygenators, Extracorporeal Membrane

17644 Cannulae, Coronary Sinus

17645 Analyzers, Physiologic, Thermometric Fertility Cycle


17647 Pumps, Circulating-Liquid, Localized Heating

17648 Warming Units, Patient, Circulating-Liquid

17649 Gastroplasty Bands

17650 Eyewear, Safety, Laser

17652 Shields, Mechanical, Eye, Collagen

17653 Infant Scale Liners

17654 Duodenoscopes, Video

17656 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Cholesterol, To

17658 Tapes, Adhesive, Metallic


17661 Patient Transfer Slings, Mechanical Lift

17662 Bronchoscopes, Flexible, Video

17663 Gastroscopes, Flexible, Video

17664 Sigmoidoscopes, Flexible, Video

17665 Colonoscopes, Video

17667 Oximeters, Pulse, Telemetric

17669 Radiographic Units, Podiatric

17670 Films, Postsurgical Adhesion Inhibition

17671 Washer/Decontamination Units


17672 Stents, Biliary

17673 Approximators

17674 Approximators, Tendon

17675 Approximators, Vessel

17676 Irrigation/Distention Systems

17677 Irrigation/Distention Systems, Hysteroscopic

17679 Laser Imagers


17680 Monitors, Physiologic, Blood Gas/pH, Bedside, Extracorporeal

17681 Dynamometer Exercise Systems, Computerized

17683 Catheters, Urinary, Urethral, Drainage, Intermittent

17684 Clip Appliers, Vascular, Disposable

17685 Clip Appliers, Vascular

17686 Electrodes, Blood Gas, pH


17687 Electrocardiographs, Multichannel, Noninterpretive, Signal-Averaging

17690 Ureterorenoscopes

17691 Bunsen Burners


17693 Procedure Kit/Trays, Implant Delivery, Stent, Ureter

17694 Tracheal Tube Introducers

17695 Field Strength Meters

17696 Dental Posts, Endodontic, Crown Support

17698 Analyzers, Physiologic, Respiratory Function Mechanics


17699 Analyzers, Physiologic, Respiratory Function Mechanics, Neonatal/Pediatric

17701 Intravenous Administration Sets, Noncoring Needle

17702 Lasers, Excimer, Ophthalmic

17703 Sizers, Cardiac Valve Prosthesis

17705 Knives, Surgical, Multipurpose, Scalpel, Electrothermal Cautery

17706 Spill Recovery Kits, Radioactive Material


17707 Exercisers, Aerobic, Treadmill, Hydrotherapy

17709 Clean Room/Laminar Air Flow Equipment, Surgical Site

17710 Clean Rooms, Laminar Air Flow, Pharmaceutical

17712 Testers, Ventilator


17713 Laser Beam Imaging Media

17716 Procedure Kit/Trays, Biopsy, Aspiration

17717 Stents, Pancreatic

17718 Compressors, External Vascular

17719 Microscopes, Light, Examination, Dermatology


17721 Testers, External Cardiac Pacemaker

17723 Monitoring Systems, Physiologic, Stress Exercise, Cardiac

17724 Monitoring Systems, Physiologic, Stress Exercise, Pulmonary

17725 Testers, Medical Gas System Outlet

17726 Testers, Power Line Receptacle, Electromechanical

17727 Analyzers, Physiologic, Joint Laxity


17728 Information Systems, Data Management, Blood Bank

17729 Lasers, Nd:YAG, Frequency-Doubled, Surgical

17730 Occluders

17731 Occluders, Vascular

17732 Brachytherapy Applicators, Automated

17735 Suture Units, Automated, Endoscopy, Arthroscope

17736 Monitors, Electrical Safety, Electrosurgery, Laparoscopic

17737 Dental Materials, Etching Liquid/Gel

17738 Gas Delivery Units, Argon-Enhanced Coagulation


17739 Electrosurgical Units, Monopolar, Argon-Enhanced Coagulation

17740 Analyzers, Laboratory, Hematology

17741 Analyzers, Laboratory, Hematology, Cell Counting, Automated

17742 Analyzers, Laboratory, Hematology, Cell Counting, Semiautomated

17743 Stimulators, Acoustic, Fetal

17745 Catheters, Rectal, Manometric

17746 Scanning Systems, Ultrasonic, Intravascular

17747 Densitometers, Bone, X-Ray, Dual-Energy Absorptiometry


17748 Densitometers, Bone, X-Ray, Single-Energy Absorptiometry

17751 Bone Matrix Implants, Synthetic

17753 Dispensers, Medication, Pill, Unit-Dose

17754 Dispensers, Medication, Pill, Unit-Dose, Programmable

17755 Dispensers, Medication, Pill, Unit-Dose, Manual

17756 Bone Matrix Implants, Biological

17757 Mattress Systems, Low-Air-Loss

17758 Stimulators, Electrical, Brain, Psychiatric Therapy

17759 Tables, Examination/Treatment, Adjustable, Proctologic


17760 Broaches

17762 Information Systems, Data Management

17763 Analyzers, Physiologic, Neuromuscular Function

17764 Detectors, Airway Flow

17766 Information Systems, Data Management, Cardiology, Hemodynamic

17768 Lasers, Er:YAG, Surgical


17769 Lasers, Ho:YAG, Surgical

17770 Cardiac Slings

17773 Lasers, Argon/Krypton, Ophthalmic

17774 Lasers, Nd:YAG/Carbon Dioxide, Surgical

17775 Lasers, Nd:YAG/Nd:YAG Frequency-Doubled, Surgical

17776 Pumps, Circulating-Liquid

17777 Pumps, Circulating-Liquid, Localized Cooling

17779 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Cryptospo

17780 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Giardia lam

17781 Rectosphincteric Balloons


17784 Stimulators, Electrical, Neuromuscular, Incontinence, Implantable
17786 Scanning Systems, Light, Mammographic

17787 Adapter/Connectors, Angioplasty Balloon Dilatation Catheter

17789 Fasteners, T, Percutaneous Gastrostomy

17790 Tubes, Gastrostomy, Feeding, Percutaneous Endoscopic

17791 Tubes, Jejunostomy, Percutaneous Endoscopic


17792 Exercisers, Aerobic, Climbing

17794 Pillows, Lumbar

17795 Catheters, Tracheal, Suction/Insufflation

17796 Casting Furnaces, Dental

17799 Catheters, Biliary, Manometric

17800 Pericardial Membrane Implants

17801 Collimators, Gamma Camera

17802 Exercisers, Flexibility/Passive Motion, Jaw


17803 Absorbents, Infectious Waste

17806 Laser Fiber Adapters

17807 Laser Delivery Systems, Fiberoptic

17808 Lasers, Diode, Ophthalmic

17810 Gloves, Wheelchair Pushing

17811 Shunts, Pulmonary Artery

17814 Blood Collection Tube Holders


17815 Lasers, Ruby, Dermatologic

17816 Lifts, Wheelchair, Vertical, Motor Vehicle

17817 Lifts, Wheelchair, Stairway

17818 Lifts, Patient Transfer, Stairway

17819 Lifts, Wheelchair

17823 Calibrators, Pipette

17827 Catheters, Bronchial, Balloon

17831 Driving Controls, Adaptive, Powered

17832 Driving Controls, Adaptive, Nonpowered


17833 Stereotactic Systems, Image-Guided, Biopsy, Mammographic

17834 Needles, Injection, Epidural

17835 Wheelchair Ramps

17836 Wheelchair Ramps, Portable

17837 Wheelchair Ramps, Stationary

17841 Prostheses, Dental, Fixed


17842 Anesthesia Units, Nitrous Oxide, Dental

17843 Calibrators, Spectrophotometer, Visible Light

17844 Dental Articulation Liquid

17845 Dentures, Partial

17846 Catheters, Vascular, Guiding

17847 Ovens, Laboratory, Microwave, Plasma-Thawing


17848 Biopsy Guns

17850 Filters, Pheresis

17851 Prostheses, Blood Vessel

17852 Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring

17853 Collagen, Injectable

17855 Breast Implants, Gel-Filled


17858 Saws, Surgical, Nasal, Manual

17859 Orthoses, Lower Limb

17860 Tubes, Tracheal, One-Lung Ventilation

17861 Modular Medical Facilities, Mobile, Cardiac Catheterization

17862 Modular Medical Facilities, Mobile, Urology/Lithotripsy

17863 Modular Medical Facilities, Mobile, Magnetic Resonance Imaging

17864 Modular Medical Facilities, Mobile, Mammography

17866 Laser Delivery Systems, Waveguide


17870 Orthoses, Multipurpose Splint, Moldable

17871 Catheters, Vascular, Infusion, Coronary Artery

17872 Orthoses, Upper Limb, Arm

17873 Orthoses, Lower Limb, Ankle-Foot

17874 Orthoses, Lower Limb, Knee


17876 Tissue Reconstructive Materials, Fluid

17877 Ventilators, Intensive Care, Adult, Negative-Pressure

17878 Modular Medical Facilities, Mobile, Computed Tomography


17879 Modular Medical Facilities, Mobile, Ultrasound

17881 Laser Delivery Systems

17882 Defibrillator/Pacemakers, External

17883 Batteries, Implantable Device, Cardiac Pacemaker/Defibrillator

17887 Thermometers, Electronic, Infrared, Ear

17888 Thermometers, Electronic, Infrared, Skin

17889 Stents, Urethral

17890 Condensers, Dental, Endodontic Filling Material

17891 Vacuum-Mixing Devices, Orthopedic Cement

17892 Wheelchair Restraints, Motor Vehicle


17895 Analyzers, Physiologic, Metabolic Rate, Oxygen/Carbon Dioxide Based, Stress Exe

17896 Multidose Vial Adapters

17899 Cannulae, Eye, Irrigating/Aspirating

17900 Dictation Systems, Digital

17901 Carts, Storage/Transport, Cadaver, Concealed

17902 Catheters, Cardiac, Flotation Balloon, Pulmonary Artery, Oximetric


17904 Image Digitization Systems, Computed Radiography

17905 Microwave Therapy Systems, Tissue Ablation, Prostatic

17907 Infusion Pumps, Blood/Solution Warming

17908 Ultrasound Therapy/Neuromuscular Stimulation Systems, Physical Therapy

17909 Orthoses, Spine


17910 Orthoses, Upper Limb, Elbow

17911 Orthoses, Upper Limb, Wrist

17912 Stimulators, Electrical, Neuromuscular, Ejaculation

17913 Stimulators, Electrical, Brain, Antiseizure

17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody

17916 Analyzers, Laboratory, Immunoassay, Chemiluminescent


17917 Apheresis Immunoadsorption Columns

17918 Arthroscopic Shaver Systems

17919 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe, DNA

17921 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe, RNA

17922 Monitors, Physiologic, Uterine Activity, Bedside


17923 Microscopes, Scanning Laser, Optical

17927 Catheters, Vascular, Retrieval, Snare

17928 Stents, Esophageal

17929 Analyzers, Physiologic, Neuromuscular Function, Body Motion

17930 Orthoses, Lower Limb, Hip


17931 Germicides, Liquid, Glutaraldehyde
17932 Protractor Rings, Cardiac Valve Prosthesis

17933 Springs, Eyelid

17934 Manipulators, Joint/Spinal, Electrical


17935 Tubes, Tracheal, Jet Ventilation

17936 Radiographic Quality Control Devices

17937 Radiographic Quality Control Devices, X-Ray Generator

17939 Information Systems, Data Management, Obstetric

17940 Catheters, Transtracheal, Oxygen Supply


17942 Oximeters, Cerebral

17946 Suction/Irrigation Tips, Illuminated

17947 Reading Aids, Video

17949 Handpieces, Surgical

17950 Warming Units, Patient, Forced-Air

17951 Wheelchair Tires

17952 Power Conversion Kits, Wheelchair


17953 Handpieces

17954 Hand Drills, Surgical

17955 Modular Medical Facilities, Mobile, Dental

17956 Warming Units, Patient, Radiant, Infant

17957 Stents, Bronchial

17958 Occlusion Plugs, Lacrimal Punctum

17959 Lasers, Copper Vapor, Dermatologic


17960 Information Systems, Picture Archiving and Communication

17961 Information Systems, Picture Archiving/Communication, Endoscopy

17962 Backrests, Commode

17964 Leads, Implantable Defibrillator/Cardiac Pacemaker

17966 Gloves, Cryogenic Safety


17967 Orthoses, Thoracic, Support, Sternal, Belt

17968 Injectors, Contrast Media

17969 Injectors, Contrast Media, Computed Tomography

17972 Tubing, Metallic, Stainless Steel

17973 Testers, Laser Beam

17975 Chairs, Disabled Patient, Seat-Lifting

17976 Seat Lifters


17977 Covers, Handgrip

17978 Covers, Armrest

17980 Walker/Chairs, Wheeled

17981 Walker/Chairs, Nonwheeled

17982 Standing Frames

17983 Spill Recovery Kits, Infectious Waste

17985 Valves, Speech, Tracheoesophageal


17986 Artificial Airways, Esophageal Obturation/Tracheal

17987 Filtration Systems, Semen

17988 Towelettes, Personal, Antiseptic

17989 Defibrillator/Pacemakers, Implantable

17991 Cannulae, Thoracic

17992 Prosthesis Implantation Instruments, Dental

17994 Detectors, Aseptic Barrier Penetration


17996 Monitors, Physiologic, Blood Gas, Bedside, Transcutaneous

17997 Prostheses, Penile, Inflatable

17998 Prostheses, Penile, Rod

17999 Monitors, Physiologic, Physical Activity, Telemetric

18003 Electrocardiographs, Ambulatory, Ventricular Function, Tape

18004 Organ Preservation Solutions


18006 Sterilizing Units, Germicidal Liquid

18009 Procedure Kit/Trays, Infusion, Intraosseous

18010 Backrests, Wheelchair

18011 Electrodes, Cardiac, External Defibrillator/Pacemaker

18012 Shields, Mechanical, Hip

18013 Incubators, Laboratory, Thermal Cycle


18015 Valves, Speech

18016 Radiotherapy Systems, Neutron Beam, Epithermal

18017 Catheters, Vascular, Infusion, Central Venous, Peripherally-Inserted

18019 Flowmeters, Blood, Magnetic Resonance

18020 Exercisers, Aerobic, Cross-Country Skiing

18022 Emesis Bags


18023 Prostheses, Joint, Temporomandibular, Mandibular Fossa

18024 Prostheses, Joint, Temporomandibular, Intra-Articular Disc

18025 Wheelchair Wheels

18027 Laser/Laparoscope Couplers

18028 Orthoses, Upper Limb, Total, Support

18029 Orthoses, Lower Limb, Total, Support


18031 Image Enhancement Pads, Magnetic Resonance Imaging

18032 Image Digitization Systems, Portal

18034 Image Processors, Video, Endoscopy

18036 Image Processors, Video, Operating Microscope

18037 Image Processors, Video

18038 Corneal Topography Systems

18039 Glove Liners

18040 Dryers, Medical-Air, Refrigerating

18041 Dryers, Medical-Air, Desiccating


18042 Monitors, Compressed Air/Gas, Dew-Point

18043 Monitors, Compressed Air/Gas, Carbon Monoxide

18047 Covers, Pillow, Protective

18048 Enclosures, Aerosol Treatment

18049 Ultrasound Surgical Units

18050 Dryers, Medical-Air

18051 Cryosurgical Units


18052 Scanning Systems, Ultrasonic, Small-Parts

18054 Stereotactic Systems, Radiosurgical, Linear Accelerator (Retired)

18055 Information Systems, Data Management, Materials Management

18056 Radiographic Systems, Digital, Dental

18057 Simulators, Electroencephalographic

18058 Recorders, Physiologic/Anesthetic Gas


18059 Ventilator Condensate Traps

18065 Lifts, Waste/Laundry Cart

18066 Intravenous Line Connectors, Needleless

18067 Intravenous Line Connectors, Recessed-Needle

18068 Injectors, Medication/Vaccine, Syringe, Protective

18070 Syringes, Plunger, Hypodermic, Protective

18074 Eyelid Weights, Implantable

18076 Oxygen Delivery Units, Controlled

18077 Syringes, Cartridge, Blunt Cannula


18079 Condoms, Female

18080 Condoms, Male

18081 Bidets

18082 Spacers, Teeth

18084 Spacers

18085 Circulatory Assist Units, Peripheral Compression, Sequential, End-Diastolic

18086 Sizers
18088 Germicides, Gas, Ethylene Oxide

18089 Microscopes, Electron, Scanning

18090 Microscopes, Electron, Transmission

18091 Microscopes, Electron, Scanning/Transmission

18093 Electrode Shielding Systems, Electrosurgical, Active


18094 Respirators, Air-Purifying

18095 Test Pattern Generators, Video

18096 Information Systems, Data Management, Laboratory, Anatomic Pathology

18098 Ventilators, Transport

18099 Detectors, Esophageal Intubation

18100 Information Systems, Data Management, Clinical Pharmacy

18101 Information Systems, Data Management, Physician Practice


18102 Aqueous Flare/Cell Meters

18103 Intracorneal Ring Implants

18104 Endoscope/Camera Adapters


18105 Catheters, Intrauterine, Chorionic Villus Sampling

18106 Simulators, Invasive Blood Pressure

18107 Simulators, Noninvasive Blood Pressure

18108 Scanning Systems, Magnetic Resonance Imaging, Full-Body

18109 Scanning Systems, Magnetic Resonance Imaging, Extremity


18110 Scanning Systems, Magnetic Resonance Imaging, Mammographic

18111 Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillator

18112 Air Cleaners, Particulate, High-Efficiency Filter

18113 Air Cleaners, Particulate, High-Efficiency Filter, Mobile

18114 Air Cleaners, Particulate, Electrostatic Precipitation

18115 Air Cleaners, Particulate, Electrostatic Precipitation, Mobile

18116 Information Systems, Data Management, Ambulatory Care

18117 Information Systems, Data Management, Emergency Care


18118 Information Systems, Data Management, Home Care

18119 Information Systems, Data Management, Cardiology

18120 Information Systems, Data Management, Hospital

18122 Information Systems, Data Management, Risk Management

18124 Simulators, Transducer Output, Pulse Oximetry

18125 Enteroscopes

18126 Enteroscopes, Video


18127 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific A

18128 Culture Bottles


18129 Mills, Bone

18131 Distention Systems, Mechanical, Laparoscopic

18132 Collectors, Menstrual Fluid


18134 Anastomosis Couplers

18135 Anastomosis Couplers, Gastrointestinal

18137 Anastomosis Couplers, Vascular

18138 Information Systems, Telemedicine, Videoconferencing

18139 Strollers

18140 Wheelchair/Scooter Canopies


18141 Eyelid Weights

18142 Eyelid Weights, External

18143 Scanning Systems, Ultrasonic, Portable

18144 Surface Imaging Systems, 3-D, Optical

18145 Stimulators, Electrical, Cardiac, Myoplasty

18146 Sterilizing Units, Germicidal Gas, Gaseous Plasma


18147 Mattress Systems, Alternating-Pressure

18148 Birthing Bars


18149 Cannulae, Nasal, Oxygen Supply, Carbon Dioxide Sampling

18150 Testers, Solid Material Hardness

18151 Shields, Laser, Barrier

18153 Shields, Laser, Eye

18154 Stimulators, Ultrasonic, Bone Growth


18155 Iontophoresis Units, Drug Delivery

18156 Contrast Media Conservation Sets

18157 Occlusal Splints

18158 Injectors, Contrast Media, Magnetic Resonance Imaging

18159 Germicides

18160 Germicides, Gas


18161 Germicides, Liquid

18162 Germicides, Gas, Hydrogen Peroxide

18163 Germicides, Liquid, Hydrogen Peroxide

18164 Trial Prostheses, Joint, Hip, Acetabular Component


18165 Trial Prostheses, Joint, Hip, Femoral Component
18166 Prostheses, Joint, Hip

18167 Automation Systems, Medication Dispensing


18168 Automation Systems, Medication Dispensing, Clinical Pharmacy

18169 Automation Systems, Medication Dispensing, Decentralized

18170 Automation Systems, Supplies Dispensing, Decentralized

18173 Wheelchair Brakes

18174 Wheel Locks, Wheelchair

18175 Wands, Smoke Evacuation, Electrosurgical Electrode


18176 Stereotactic Systems
18178 Stereotactic Systems, Frame-Guided, Surgical, Intracranial

18179 Stereotactic Systems, Image-Guided, Surgical, Intracranial

18180 Stereotactic Systems, Image-Guided, Biopsy

18183 Lasers, Diode, Surgical

18184 Vacuum Cleaners

18185 Vacuum Cleaners, Micrometric Filtration

18186 Resectoscopes, Gynecologic


18187 Resectoscopes, Urological

18188 Ureteroscopes, Flexible

18189 Ureteroscopes, Rigid

18190 Ophthalmoscopes, Scanning Laser

18191 Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic

18192 Aqueous Flare/Cell Meters, Laser

18193 Dermoscopes

18194 Dermoscopes, Facial

18195 Lasers, Alexandrite

18196 Lasers, Alexandrite, Dermatologic


18197 Lasers, Argon

18198 Lasers, Argon, Dental

18199 Lasers, Argon, Dermatologic

18200 Lasers, Krypton

18201 Lasers, Krypton, Dermatologic


18202 Lasers, Argon/Krypton

18203 Lasers, Carbon Dioxide

18204 Lasers, Carbon Dioxide, Dental

18205 Lasers, Copper Vapor

18206 Lasers, Dye, Dermatologic

18207 Lasers, Dye, Photodynamic Therapy

18208 Lasers, Gold Vapor

18209 Lasers, Gold Vapor, Photodynamic Therapy

18210 Lasers, Ho:YAG

18211 Lasers, Ho:YAG, Ophthalmic


18212 Lasers, Ho:YAG, Dental

18213 Lasers, Nd:YAG

18214 Lasers, Nd:YAG, Dental

18215 Lasers, Nd:YAG, Dermatologic

18216 Lasers, Nd:YAG, Frequency-Doubled

18217 Lasers, Nd:YAG, Frequency-Doubled, Ophthalmic

18218 Lasers, Nd:YAG, Frequency-Doubled, Dermatologic

18219 Lasers, Ruby

18220 Lasers, Diode

18221 Lasers, Diode, Dental

18222 Lasers, Diode, Biostimulation


18223 Lasers, Er:YAG

18224 Lasers, Er:YAG, Ophthalmic

18225 Lasers, Er:YAG, Dental

18226 Lasers, Excimer, Dental

18227 Lasers, Excimer/Ho:YAG, Ophthalmic

18228 Lasers, He:Ne

18229 Electrosurgical Units, Monopolar

18230 Electrosurgical Units, Bipolar

18231 Electrosurgical Units, Monopolar/Bipolar


18232 Electrosurgical Units, Monopolar/Bipolar, Argon-Enhanced Coagulation
18233 Procedure Kit/Trays, Nuclear Imaging
18234 Procedure Kit/Trays, Nuclear Imaging, Monoclonal Antibody

18235 Procedure Kit/Trays, Nuclear Imaging, Peptide Agent

18237 Stents, Vascular, Coronary

18238 Stents, Vascular, Peripheral

18239 Stents, Vascular, Peripheral, Self-Expanding, Iliac

18240 Blood Collection Needle Sets

18241 Blood Collection Needle Sets, Protective

18242 Needles, Blood Collection, Protective


18243 Blood Collection Tube Holders, Protective

18244 Blood Donor Set Tube Holders, Protective

18245 Hemodialysis Needle Sets

18246 Hemodialysis Needle Sets, Protective

18248 Lithotripters, Intracorporeal, Impact

18249 Papanicolaou Smear Monolayer Sample Preparation Systems

18250 Computer-Aided Detection Systems, Pathology Slide, Papanicolaou Smear, Female

18251 Frequency Counters


18252 Surgical Hand-Access Ports

18253 Grafts, Skin, Biological

18254 Grafts, Skin, Artificial

18255 Photometers, Flame

18256 Photometers, Filter

18257 Photometers, Filter, Automated

18258 Photometers, Filter, Manual

18259 Turbidimeters

18260 Luminometers
18261 Analyzers, Laboratory, Hematology, Cell Counting, Reticulocyte

18262 Centrifuges, Floor, Low-Speed

18263 Centrifuges, Floor, High-Speed

18264 Centrifuges, Tabletop, Low-Speed

18265 Centrifuges, Tabletop, Low-Speed, Refrigerated


18267 Centrifuges, Tabletop, Low-Speed, Nonrefrigerated, Blood Bank

18268 Centrifuges, Tabletop, Low-Speed, Nonrefrigerated, Microsample

18269 Centrifuges, Tabletop, Low-Speed, Nonrefrigerated, Hand-Driven

18270 Centrifuges, Tabletop, High-Speed

18271 Centrifuges, Tabletop, Ultrahigh-Speed

18272 Chromatography Systems, Gas, Capillary Column

18273 Chromatography Systems, Gas, Packed Column


18274 Chromatography Systems, Liquid

18275 Chromatography Systems, Liquid, Planar

18276 Chromatography Systems, Liquid, Packed Column

18277 Chromatography Systems, Liquid, Packed Column, High-Pressure, Ion-Exchange

18278 Chromatography Systems, Liquid, Packed Column, High-Pressure, Bonded-Phase

18279 Chromatography Columns, Capillary

18280 Chromatography Columns, Packed

18281 Chromatography Columns, Packed, Bonded Phase

18282 Chromatography Columns, Packed, Ion-Exchange

18283 Microscopes, Light

18284 Microscopes, Light, Laboratory, Brightfield


18285 Microscopes, Light, Laboratory, Darkfield

18286 Microscopes, Light, Laboratory, Polarized Light

18287 Microscopes, Light, Laboratory, Interference

18288 Microscopes, Light, Operating, Ophthalmology

18289 Microscopes, Light, Operating, Neurosurgery

18290 Microscopes, Light, Operating, Gynecology

18291 Microscopes, Light, Operating, Hand/Plastic Surgery

18292 Microscopes, Light, Examination

18294 Microscopes, Scanning Laser

18295 Thermometers, Mercury, Oral


18296 Thermometers, Mercury, Rectal

18297 Thermometers, Mercury, Axillary

18298 Thermometers, Mercury, Laboratory

18299 Thermometers, Electronic, Thermistor/Thermocouple

18301 Monitors, Laboratory, Temperature

18302 Thermometers, Liquid Crystal

18303 Trial Prostheses

18306 Trial Prostheses, Joint, Knee, Femoral Component


18307 Trial Prostheses, Joint, Knee, Patellar Component
18308 Trial Prostheses, Joint, Knee, Tibial Component
18309 Monitors, Physiologic, Fluid Absorption, Intraoperative
18310 Information Systems, Telemedicine

18311 Information Systems, Telemedicine, Pathology

18313 Shields, Mechanical, Eye, Banded

18314 Shields, Laser

18315 Shields, X-Ray, Thyroid, Collar

18316 Shields, X-Ray, Thyroid, Articulated Arm

18317 Shields, Nuclear Radiation

18318 Shields, Nuclear Radiation, Workbench

18319 Shields, Nuclear Radiation, Vial

18320 Shields, Nuclear Radiation, Barrier

18321 Shields, Nuclear Radiation, Intra-Oral

18322 Shields, Heat Loss


18323 Shields, Splash

18324 Shields, Splash, Syringe

18325 Sphygmomanometers, Electronic, Automatic, Auscultatory

18326 Sphygmomanometers, Electronic, Automatic, Oscillometric


18327 Sphygmomanometers, Electronic, Automatic, Differential Sensor

18328 Cardiographs

18329 Electrocardiographs, Multichannel, Noninterpretive


18330 Electrocardiographs, Multichannel, Interpretive, Signal-Averaging

18331 Catheters, Vascular, Infusion, Peripheral, Protective

18332 Magnetoencephalographs

18333 Electrogastrographs

18334 Recorders, Physiologic, Evoked Potential, Visual


18335 Recorders, Physiologic, Evoked Potential, Somatosensory

18337 Plethysmographs, Brain, Segmental

18338 Plethysmographs, Lower Limb, Segmental

18339 Monitors, Physiologic, Fetal, Antepartum, Bedside

18340 Monitors, Physiologic, Fetal, Intrapartum, Bedside


18341 Recorders, Physiologic

18342 Recorders, Physiologic, Anesthesia Procedure

18344 Recorders, Anesthetic Gas

18345 Capnographs

18346 Thermographs

18347 Testers, Battery

18348 Tester/Chargers, Battery

18349 Tester/Reconditioners, Battery

18350 Recorders, Audio, Tape

18352 Electrocardiographs, Ambulatory, Event, Tape


18354 Recorders, Audio, Magneto-Optical Disk

18356 Electroencephalographs, Computerized

18357 Recorders, Digital Versatile Disk

18360 Electrocardiographs, Ambulatory


18361 Electrocardiographs, Ambulatory, Continuous

18362 Electrocardiographs, Ambulatory, Event

18363 Electrocardiographs, Ambulatory, Ventricular Function

18364 Recorders, Physiologic, Blood Pressure

18365 Electroencephalographs, Ambulatory


18366 Recorders, Physiologic, pH, Upper Gastrointestinal Tract

18367 Recorders, Physiologic, Vital Signs

18369 Image Digitization Systems

18373 Tables, Examination/Treatment, Fixed

18374 Tables, Examination/Treatment, Adjustable

18375 Tables, Operating, Upper Extremity

18376 Tables, Operating, Orthopedic, Spinal

18377 Tables, Operating, Microsurgery

18378 Tables, Imaging

18379 Tables, Imaging, Magnetic Resonance


18380 Tables, Imaging, Ultrasound

18381 Tables, Instrument, Surgery

18382 Bone Ultrasonometers

18383 Beds, Electric, Alternating-Pressure

18384 Beds, Electric, Rotation

18385 Beds, Electric, Rotation/Rocking

18386 Beds, Hydraulic, Birthing

18387 Beds, Hydraulic, Radiography/Fluoroscopy


18388 Beds, Mechanical, Birthing

18389 Beds, Mechanical, Flotation Therapy

18390 Beds, Mechanical, Rotation

18391 Beds, Mechanical, Radiography/Fluoroscopy

18392 Beds, Mechanical, Cradle, Pediatric

18393 Beds, Mechanical, Neonatal

18394 Beds, Fixed

18395 Beds, Fixed, Flotation Therapy

18396 Beds, Fixed, Cradle, Adult


18397 Beds, Fixed, Neonatal

18399 Mattress Systems, Rotation

18400 Chairs, Radiography/Fluoroscopy, Head

18401 Chairs, Radiography/Fluoroscopy, Head/Torso

18402 Chairs, Mammography

18403 Commodes, Portable

18404 Chairs, Patient Recovery

18405 Chairs, Rehabilitation, Pulmonary

18406 Chairs, Disabled Patient

18407 Wheelchairs, Mechanical, Disabled Patient

18408 Wheelchairs, Mechanical, Disabled Patient, Obese

18409 Wheelchairs, Mechanical, Disabled Patient, Pediatric


18410 Wheelchairs, Powered, Disabled Patient

18412 Absorption Pads, Nursing

18413 Examination Pads, Breast

18415 Lithotripters, Extracorporeal, Electromagnetic

18416 Lithotripters, Extracorporeal, Piezoelectric

18417 Lithotripters, Extracorporeal, Spark-Gap

18418 Lithotripters, Intracorporeal

18419 Lithotripters, Intracorporeal, Impact, Electromechanical

18420 Lithotripters, Intracorporeal, Impact, Pneumatic

18421 Telephones, Bedside, Disposable


18422 Analyzers, Point-of-Care, Breath, Carbon Isotope

18423 Simulators, Training, Surgical, Beating Heart

18424 Endoscope Sheaths

18425 Radiographic Units, Chest, Automated

18426 Radiographic Units, Dental, Intraoral

18427 Radiographic Units, Dental, Extraoral

18428 Radiographic Units, Chest, Manual


18429 Radiographic Systems

18430 Radiographic Systems, Digital

18431 Radiographic Systems, Digital, Chest

18432 Radiographic Systems, Digital, Mammographic

18433 Fluoroscopic Units

18434 Fluoroscopic Units, Portable

18435 Radiographic/Fluoroscopic Units, Mobile, Extremity

18436 Radiographic/Fluoroscopic Systems


18437 Radiographic/Fluoroscopic Systems, General-Purpose, Direct-Controlled

18438 Radiographic/Fluoroscopic Systems, General-Purpose, Remote-Controlled

18439 Radiographic/Tomographic Systems

18440 Identification/Tracking/Security Systems, Person, Infant

18442 Image Digitization Systems, Photospot

18443 Scanning Systems, Computed Tomography, Spiral

18444 Scanning Systems, Gamma Camera, Single Photon Emission Tomography


18445 Scanning Systems, Laser

18446 Scanning Systems, Computed Tomography, Axial

18447 Scanning Systems, Laser, Mammographic

18448 Scanning Systems, Gamma Camera

18449 Balances, Electronic, Analytic

18450 Balances, Electronic, Precision

18451 Balances, Electronic, Microanalytic


18452 Balances, Mechanical, Precision

18453 Balances, Mechanical, Analytic

18454 Balances, Mechanical, Microanalytic

18455 Scales, Patient

18456 Scales, Patient, Platform

18457 Scales, Patient, Platform, Mechanical

18458 Scales, Patient, Platform, Electronic

18459 Scales, Patient, Bedside

18460 Scales, Patient, Bedside, Slab


18461 Scales, Patient, Chair, Dialysis

18462 Scales, Patient, Modular Transducers

18463 Scales, Infant, Warmer/Incubator

18464 Scales, Clinical

18465 Scales, Clinical, Precision

18466 Stimulators, Electrical

18467 Stimulators, Electrical, Brain


18468 Stimulators, Electrical, Brain, Tremor

18469 Stimulators, Electrical, Spinal Cord

18470 Stimulators, Electrical, Spinal Cord, Muscle Control

18471 Stimulators, Electrical, Peripheral Nerve

18472 Stimulators, Electrical, Peripheral Nerve, Analgesic

18473 Stimulators, Electrical, Peripheral Nerve, Analgesic, Implantable

18474 Stimulators, Electrical, Vagus Nerve, Antiseizure


18475 Stimulators, Electrical, Neuromuscular, Grasp

18476 Stimulators, Electrical, Neuromuscular, Muscle Strengthening

18477 Stimulators, Electrical, Neuromuscular, Gait

18478 Stimulators, Electrical, Neuromuscular, Gait, Implantable

18479 Stimulators, Electrical, Neuromuscular, Gait, External

18480 Stimulators, Electrical, Neuromuscular, Incontinence

18481 Stimulators, Electrical, Bone Growth, External

18482 Stimulators, Electrical, Bone Growth, Implantable

18483 Stimulators, Electrical, Auditory

18484 Stimulators, Electrical, Cardiac


18485 Stimulators, Acoustic

18486 Stimulators, Ultrasonic

18487 Stimulators, Photic

18488 Stimulators, Caloric

18489 Stimulators, Caloric, Physical Therapy

18490 Stimulators, Mechanical

18491 Stimulators, Mechanical, Tactile, Manual

18492 Stimulators, Mechanical, Tactile, Vibratory

18493 Stimulators, Mechanical, Dentistry

18494 Stimulators, Mechanical, Dentistry, Orthodontic

18495 Pacemakers

18496 Pacemakers, Breath

18497 Pacemakers, Cardiac, External


18499 Defibrillators, External

18500 Defibrillators, External, Semiautomated

18502 Defibrillator/Cardioverters

18503 Defibrillator/Cardioverters, Implantable

18504 Defibrillator/Cardioverter/Pacemakers, Implantable

18505 Analyzers, Point-of-Care


18506 Feeding Tube Patency Restorers

18507 Fasteners, Helical, Surgical Mesh

18508 Analyzers, Point-of-Care, Whole Blood

18509 Analyzers, Point-of-Care, Whole Blood, Multianalyte

18510 Analyzers, Point-of-Care, Whole Blood, Gas/pH

18511 Analyzers, Point-of-Care, Whole Blood, Gas/pH/Electrolyte

18512 Analyzers, Point-of-Care, Whole Blood, Lactate

18513 Analyzers, Point-of-Care, Whole Blood, Hematology

18514 Analyzers, Point-of-Care, Breath


18517 Analyzers, Point-of-Care, Urine

18518 Modular Medical Facilities

18520 Modular Medical Facilities, Mobile, Ophthalmology

18521 Modular Medical Facilities, Mobile, Audiometry

18522 Modular Medical Facilities, Mobile, Obstetrics/Gynecology

18523 Modular Medical Facilities, Mobile, Clinical Laboratory

18524 Modular Medical Facilities, Mobile, Radiography

18525 Modular Medical Facilities, Mobile, Single Photon Emission Tomography


18526 Modular Medical Facilities, Mobile, Positron Emission Tomography

18527 Modular Medical Facilities, Mobile, Blood Bank

18528 Modular Medical Facilities, Mobile, Surgery

18529 Modular Medical Facilities, Mobile, Emergency Care

18530 Modular Medical Facilities, Stationary

18531 Modular Medical Facilities, Stationary, Dental

18532 Modular Medical Facilities, Stationary, Ophthalmology

18533 Modular Medical Facilities, Stationary, Audiometry

18534 Modular Medical Facilities, Stationary, Obstetrics/Gynecology


18535 Modular Medical Facilities, Stationary, Urology/Lithotripsy

18536 Modular Medical Facilities, Stationary, Clinical Laboratory

18537 Modular Medical Facilities, Stationary, Radiography

18538 Modular Medical Facilities, Stationary, Mammography

18539 Modular Medical Facilities, Stationary, Computed Tomography

18540 Modular Medical Facilities, Stationary, Cardiac Catheterization

18541 Modular Medical Facilities, Stationary, Single Photon Emission Tomography

18542 Modular Medical Facilities, Stationary, Positron Emission Tomography


18543 Modular Medical Facilities, Stationary, Magnetic Resonance Imaging

18544 Modular Medical Facilities, Stationary, Blood Bank

18545 Modular Medical Facilities, Stationary, Surgery

18546 Modular Medical Facilities, Stationary, Emergency Care

18547 Electrophoresis Systems, Capillary

18548 Chambers, Electrophoresis


18549 Chambers, Electrophoresis, Horizontal

18550 Chambers, Electrophoresis, Vertical

18551 Electrophoresis Columns

18552 Electrophoresis Columns, Capillary

18553 Lasers, Nd:YLF

18554 Batteries, Implantable Device

18555 Lasers, Nd:YLF, Ophthalmic

18556 Batteries, External Defibrillator

18557 Power Supplies


18558 Batteries, Powered Wheelchair

18559 Power Supplies, Regulated, Electrophoresis

18560 Power Systems

18561 Power Systems, Electrical, Emergency

18562 Transformers

18563 Transformers, Isolation

18565 Orthoses, Head


18566 Microscopes, Scanning Probe

18567 Identification/Tracking/Security Systems

18568 Identification/Tracking/Security Systems, Person

18569 Viscoelastic Solutions, Intraarticular


18572 Automation Systems

18573 Automation Systems, Laboratory

18585 Stent/Grafts, Vascular

18586 Nitric Oxide Delivery Units

18587 Alarms, Occupancy


18588 Lasers, Er:YSGG

18589 Lasers, ErCr:YSGG

18590 Lasers, ErCr:YSGG, Dental

18591 Lasers, ErCr:YSGG, Dermatologic

18592 Feeding Tube Patency Restorers, Mechanical

18593 Feeding Tube Patency Restorers, Flushing

18594 Electrodes, Neuromuscular Stimulator, Garment

18595 Ophthalmoscope/Otoscopes
18596 Alarms, Cellular Telephone Detection

18597 Dental Air Abrasion Units

18598 Telemanipulation Systems

18599 Telemanipulation Systems, Surgical

18600 Telemanipulation Systems, Surgical, Minimally Invasive


18601 Telemanipulation Systems, Hazardous Environment

18602 Swabs, Absorbent/Cotton, Vaginal

18603 Swabs, Absorbent/Cotton, Proctoscopic

18604 Swabs, Medicated

18605 Swabs, Specimen Collection, Ultrathin

18606 Swabs, Specimen Collection/Transportation

18607 Stereotactic Systems, Image-Guided, Cardiac Mapping/Ablation

18608 Radiofrequency Therapy Systems, Tissue Ablation, Cardiac


18609 Catheters, Cardiac, Electrophysiology, Mapping/Ablation

18610 Cardiac Wall Stabilizers

18611 Analyzers

18612 Analyzers, Laboratory

18613 Analyzers, Laboratory, Body Fluid

18614 Analyzers, Laboratory, Blood

18615 Analyzers, Laboratory, Blood, Bilirubin

18616 Analyzers, Laboratory, Blood, Zinc Protoporphyrin


18617 Analyzers, Laboratory, Blood Gas

18618 Analyzers, Laboratory, Blood Gas/pH/Electrolyte

18619 Analyzers, Laboratory, Blood Gas/pH/Electrolyte/Metabolite

18620 Analyzers, Laboratory, Hematology, Cell Counting

18621 Analyzers, Laboratory, Hematology, Coagulation, Manual

18622 Analyzers, Laboratory, Hematology, Blood Grouping, Semiautomated

18623 Analyzers, Laboratory, Breath, Nitrogen


18624 Analyzers, Laboratory, Breath, Hydrogen

18625 Analyzers, Laboratory, Immunoassay

18626 Analyzers, Laboratory, Immunoassay, Photometric

18627 Analyzers, Laboratory, Immunoassay, Photometric, ELISA

18628 Analyzers, Laboratory, Microbiology, Blood Culture

18629 Analyzers, Laboratory, Microbiology, Blood Culture, Manual

18630 Analyzers, Laboratory, Microbiology, Blood Culture, Mycobacteria

18631 Cytometers
18632 Cytometers, Automated, Electrical Impedance

18633 Refractometers, Laboratory

18634 Refractometers, Laboratory, Urine

18635 Oximeters, In Vitro, Point-of-Care

18636 Catheters, Vascular

18637 Catheters, Vascular, Infusion

18638 Catheters, Vascular, Infusion, Midline


18639 Catheters, Vascular, Infusion, Central Venous, Tunneled

18640 Catheters, Vascular, Infusion, Central Venous, Percutaneous

18641 Catheters, Vascular, Perfusion, Cerebral

18642 Catheters, Vascular, Infusion/Perfusion

18643 Catheters, Vascular, Infusion/Perfusion, Coronary Artery


18644 Catheters, Vascular, Angioplasty, Atherectomy, Extirpative

18645 Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery

18646 Catheters, Vascular, Angioplasty, Balloon/Ultrasound Image

18647 Catheters, Vascular, Angioplasty, Thermal

18648 Catheters, Vascular, Angioplasty, Thermal, Laser

18649 Catheters, Vascular, Angioplasty, Ultrasound Ablation


18650 Catheters, Vascular, Embolectomy/Thrombectomy, Balloon

18651 Catheters, Vascular, Embolectomy/Thrombectomy, Balloon, Arterial

18652 Catheters, Vascular, Embolectomy/Thrombectomy, Hydrodynamic

18653 Catheters, Vascular, Embolectomy/Thrombectomy, Fragmentation

18654 Catheters, Vascular, Embolectomy/Thrombectomy, Blending

18655 Catheters, Vascular, Occlusion, Temporary

18656 Catheters, Vascular, Occlusion, Permanent


18657 Catheters, Vascular, Angiography, Cerebral

18658 Catheters, Vascular, Angiography, Visceral

18659 Catheters, Vascular, Angiography, Peripheral

18660 Catheters, Vascular, Cholangiography

18661 Catheters, Vascular, Biopsy

18662 Catheters, Vascular, Biopsy, Liver


18663 Catheters, Vascular, Hemodialysis, Central Venous

18664 Catheters, Vascular, Hemodialysis, Central Venous, Double-Lumen

18665 Catheters, Vascular, Umbilical, Central Venous

18666 Catheters, Vascular, Umbilical, Arterial

18667 Catheters, Vascular, Blood Pressure, Hydraulic

18668 Catheters, Vascular, Blood Pressure, Pressure Transducer

18669 Catheters, Vascular, Blood Gas/pH Monitoring


18670 Catheters, Vascular, Fiberoptic-Thermistor

18671 Catheters, Vascular, Ultrasound

18672 Catheters, Vascular, Ultrasound, Image

18673 Catheters, Vascular, Ultrasound, Doppler

18674 Catheters, Vascular, Guiding, Coronary Artery

18675 Catheters, Vascular, Retrieval

18676 Catheters, Vascular, Retrieval, Basket


18677 Catheters, Vascular, Retrieval, Grasping

18678 Catheters, Cardiac, Ablation, Radiofrequency

18679 Catheters, Cardiac, Angiography

18680 Catheters, Cardiac, Angiography, Coronary Artery

18681 Catheters, Cardiac, Angiography, High-Flow

18682 Catheters, Cardiac, Microflow

18683 Catheters, Cardiac, Septostomy, Balloon

18684 Catheters, Cardiac, Septostomy, Blade


18685 Catheters, Cardiac, Valvuloplasty, Single Balloon

18686 Catheters, Cardiac, Valvuloplasty, Double Balloon

18687 Catheters, Cardiac, Valvuloplasty, Bifoil Balloon

18688 Catheters, Cardiac, Electrophysiology

18689 Catheters, Cardiac, Biopsy

18690 Catheters, Spinal


18691 Catheters, Spinal, Intrathecal

18692 Catheters, Spinal, Intrathecal, Anesthetic

18693 Catheters, Spinal, Intrathecal, Lumbar

18694 Catheters, Spinal, Intrathecal, Lumbar, Hydrocephalic

18695 Catheters, Intracranial

18696 Catheters, Peritoneal, Percutaneous Drainage

18697 Catheters, Peritoneal, Percutaneous Drainage, Multiple Lumen

18698 Catheters, Peritoneal, Percutaneous Drainage, Single Lumen


18699 Catheters, Peritoneal, Optical

18700 Catheters, Biliary, Drainage

18701 Catheters, Biliary, Drainage, Percutaneous

18702 Catheters, Biliary, Drainage, Percutaneous, External

18703 Catheters, Biliary, Drainage, Percutaneous, Internal

18704 Catheters, Biliary, Retrieval

18705 Catheters, Biliary, Retrieval, Balloon

18706 Catheters, Biliary, Cholangiography, Endoscopic

18707 Catheters, Biliary, Stricturoplasty

18708 Catheters, Biliary, Stricturoplasty, Percutaneous


18709 Catheters, Biliary, Stricturoplasty, Percutaneous, Dilatation

18710 Catheters, Biliary, Stricturoplasty, Percutaneous, Balloon

18711 Catheters, Biliary, Stricturoplasty, Endoscopic

18712 Catheters, Biliary, Stricturoplasty, Endoscopic, Dilatation

18713 Catheters, Biliary, Stricturoplasty, Endoscopic, Balloon

18714 Catheters, Biliary, Guiding

18715 Catheters, Nasal

18716 Catheters, Nasal, Hemostatic

18717 Catheters, Nasopharyngeal, Oxygen Supply

18718 Catheters, Nasobiliary


18719 Catheters, Nasogastric

18720 Catheters, Nasogastric, Enteroclysis

18721 Catheters, Nasogastric, Injection

18722 Catheters, Nasogastric, Irrigation

18723 Catheters, Nasogastric, Injection/Irrigation

18724 Catheters, Nasogastric, Tonometry

18725 Catheters, Tracheal

18726 Catheters, Transtracheal

18727 Catheters, Bronchial


18728 Catheters, Bronchial, Diagnostic, Nosocomial Pneumonia

18729 Catheters, Bronchial, Balloon, Dilatation

18730 Catheters, Bronchial, Balloon, Hemostatic

18731 Catheters, Esophageal

18732 Catheters, Esophageal, Manometric

18733 Catheters, Esophageal, Manometric, Hydraulic

18734 Catheters, Esophageal, Manometric, Pressure Transducer


18735 Catheters, Esophageal, pH Monitoring

18736 Catheters, Rectal, Tonometry

18737 Catheters, Urinary, Urethral, Drainage

18738 Catheters, Urinary, Urethral, Dilatation

18739 Catheters, Urinary, Suprapubic

18740 Catheters, Urinary, Ureteral, Drainage

18741 Catheters, Urinary, Ureteral, Irrigation

18742 Catheters, Urinary, Ureteral, Ablation

18743 Catheters, Urinary, Ureteral, Urography


18744 Catheters, Urinary, Ureteral, Retrieval

18745 Catheters, Urinary, Nephrostomy, Dilatation

18746 Catheters, Intrauterine, Radiography

18747 Catheters, Intrauterine, Ultrasonography

18748 Catheters, Intrauterine, Fallopian Tube Cannulation

18749 Catheters, Intrauterine, Ovum Recovery

18750 Catheters, Intrauterine, Endometrial Sampling

18751 Catheters, Intrauterine, Endometrial Ablation

18752 Catheters, Intrauterine, Endometrial Ablation, Thermal Balloon


18753 Catheters, Intrauterine, Manometric

18754 Catheters, Intrauterine, Insemination/Embryo Transfer

18755 Catheters, Wound

18756 Catheters, Wound, Drainage

18757 Catheters, Wound, Drainage, Suction

18758 Catheters, Wound, Irrigation

18759 Cannulae, Femoral, Cardiac Bypass

18760 Cannulae, Aortic, Cardiac Bypass


18761 Cannulae, Vena Caval, Cardiac Bypass

18762 Cannulae, Nasal, Hemostatic


18763 Pouches, Urinary Drainage

18765 Ports, Injection/Infusion, Central Venous

18766 Ports, Injection/Infusion, Peripheral Vessel

18768 Towelettes

18769 Towelettes, Personal


18770 Towelettes, Personal, Cleansing

18771 Towelettes, Personal, Medicated

18772 Towelettes, Personal, Medicated, Perineal

18773 Towelettes, Personal, Medicated, Nasal Vapor


18774 Towelettes, Surface Cleansing

18775 Towelettes, Surface Cleansing, Antistatic

18776 Towelettes, Surface Disinfection

18777 Analyzers, Physiologic

18778 Analyzers, Physiologic, Body Composition, Hydrostatic Weighing

18779 Analyzers, Physiologic, Peristaltic Motility

18780 Analyzers, Physiologic, Peristaltic Motility, Colon/Rectum


18781 Analyzers, Physiologic, Neuromuscular Function, Dynamometric

18782 Analyzers, Physiologic, Neuromuscular Function, Posturographic

18783 Analyzers, Physiologic, Middle Ear, Impedance Tympanometry

18784 Analyzers, Physiologic, Middle Ear, Acoustic Reflectometry

18785 Otoscopes, Pneumatic

18786 Ophthalmic Perimeters

18788 Stools, Fixed


18789 Stools, Adjustable, Laboratory

18790 Stools, Adjustable, Surgery

18791 Footstools, Handrail

18792 Ventilators, Intensive Care, Adult

18793 Ventilators, Intensive Care, Neonatal/Pediatric, High-Frequency

18794 Ventilators, Intensive Care, Neonatal/Pediatric, Negative-Pressure

18797 Fasteners, Helical

18798 Resuscitators, Pulmonary, Exhaled Air, Mask


18799 Resuscitators, Pulmonary, Exhaled Air, Shield

18800 Radiofrequency Therapy Systems

18802 Radiofrequency Therapy Systems, Angioplasty, Direct Ablation

18803 Radiofrequency Therapy Systems, Tissue Ablation, Nerve Fiber

18805 Radiofrequency Therapy Systems, Tissue Ablation, Prostatic

18806 Radiofrequency Therapy Systems, Tissue Ablation, Endometrial

18807 Radiofrequency Therapy Systems, Tissue Ablation, Intraarticular


18808 Radiofrequency Therapy Systems, Tissue Ablation, Interstitial

18809 Radiofrequency Therapy Systems, Hyperthermia, Superficial

18810 Radiofrequency Therapy Systems, Hyperthermia, Interstitial

18811 Radiofrequency Therapy Systems, Vein Occlusion

18812 Microwave Therapy Systems

18813 Microwave Therapy Systems, Angioplasty

18815 Microwave Therapy Systems, Angioplasty, Direct Ablation

18816 Microwave Therapy Systems, Tissue Ablation

18817 Microwave Therapy Systems, Tissue Ablation, Cardiac


18818 Microwave Therapy Systems, Tissue Ablation, Endometrial

18819 Microwave Therapy Systems, Tissue Ablation, Interstitial

18820 Microwave Therapy Systems, Hyperthermia

18821 Microwave Therapy Systems, Hyperthermia, Superficial

18822 Microwave Therapy Systems, Hyperthermia, Interstitial

18823 Ultrasound Therapy Systems

18824 Ultrasound Therapy Systems, Angioplasty


18825 Ultrasound Therapy Systems, Tissue Ablation

18826 Ultrasound Therapy Systems, Tissue Ablation, Prostatic

18827 Ultrasound Therapy Systems, Hyperthermia, Superficial

18828 Ultrasound Therapy Systems, Hyperthermia, Interstitial

18830 Hydrothermal Ablation Systems, Endometrial

18831 Hydrothermal Ablation Systems, Endometrial, Balloon

18832 Lasers, Nd:YAG, Angioplasty

18833 Lasers, Argon, Angioplasty


18834 Lasers, Excimer, Angioplasty

18835 Lasers, Ho:YAG, Angioplasty

18836 Lasers, Diode, Photodynamic Therapy

18837 Lasers, Nd:YAG, Interstitial Thermotherapy

18838 Lasers, Diode, Interstitial Thermotherapy

18839 Lasers, Er:YAG, Dermatologic


18840 Microwave Surgical Units

18841 Microwave Surgical Units, Needle Radiator

18842 Microwave Surgical Units, Scalpel

18843 Electrothermal Cautery Units, High-Resistance, Endoscopic

18844 Densitometers, Laboratory

18845 Densitometers, Laboratory, Liquid

18846 Densitometers, Bone, Isotope

18848 Warming Units, Contrast Media


18849 Cooling Units

18850 Warming/Cooling Units

18851 Warming/Cooling Units, Patient, Forced-Air

18852 Blankets, Forced-Air

18853 Analyzers, Point-of-Care, Whole Blood, Gas/pH/Electrolyte/Metabolite

18854 Tubes, Jejunostomy

18855 Smoke Evacuation Systems, Surgical, Mobile/Portable


18856 Smoke Evacuation Systems, Surgical, Stationary

18857 Incubator/Radiant Warming Units, Infant, Mobile

18858 Lasers, Diode, Dermatologic

18859 Dry-Processing Imagers

18860 Information Systems, Data Management, Provider Order Entry

18862 Scanning Systems, Magnetic Resonance Imaging, Neurosurgical


18863 Airway Clearance Units

18868 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme

18869 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, 5'-Nucleotidase

18870 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Acid Phosphatase

18871 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Acid Phosphatase, Prostatic

18872 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Alanine Transferase

18873 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Aldolase

18874 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Alkaline Phosphatase

18875 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Alkaline Phosphatase, Isoenz
18876 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Amylase

18877 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Angiotensin Converting

18878 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Aspartate Aminotransferase

18879 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Cholinesterase

18880 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Chymotrypsin

18881 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Creatine Kinase

18882 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Creatine Kinase, Isoenzyme

18884 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Creatine Kinase, Isoenzyme,

18885 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Gamma Glutamyltransferase


18886 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Glutamate Dehydrogenase

18887 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, 2-Hydroxybutyrate Dehydrog

18888 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase

18889 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Iso

18890 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Arylamidase

18891 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lipase

18892 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lysosyme

18893 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Malate Dehydrogenase

18894 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Beta-N-Acetylhexosaminidase

18895 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Pepsin


18896 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Glucose Phosphate Isomerase

18897 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Sorbitol Dehydrogenase

18898 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Trypsin

18899 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Terminal Deoxynucleotidyl Tra

18900 IVD Test Reagent/Kits, Clinical Chemistry, Protein

18901 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Albumin

18902 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Albumin, Microalbuminaria

18903 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Glycated

18904 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Glycated Hemoglobin

18905 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Glycated, Fructosamine


18906 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total

18907 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Serum

18908 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Urine

18909 Knives, Surgical, Multipurpose, Scalpel, Protective

18910 IVD Test Reagent/Kits, Clinical Chemistry, Lipid

18911 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Cholesterol

18912 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Cholesterol, High-Density Lipopro

18913 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Cholesterol, Low-Density Lipopro

18914 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Lecithin

18915 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Lecithin/Sphingomyelin Ratio


18916 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Free Fatty Acid

18917 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Phospholipid

18918 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Triglyceride

18919 IVD Test Reagent/Kits, Clinical Chemistry, Lipid, Total

18920 IVD Test Reagent/Kits, Clinical Chemistry, Lipoprotein

18921 IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal

18922 IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Copper

18923 IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron

18924 IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron, Total Binding Capacit
18925 IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Zinc

18926 IVD Test Reagent/Kits, Clinical Chemistry, Saccharide

18927 IVD Test Reagent/Kits, Clinical Chemistry, Saccharide, Fructose

18928 IVD Test Reagent/Kits, Clinical Chemistry, Saccharide, Galactose

18929 IVD Test Reagent/Kits, Clinical Chemistry, Saccharide, Glucose

18930 IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level

18931 IVD Test Reagent/Kits, Clinical Chemistry, Hepatic Function

18932 IVD Test Reagent/Kits, Clinical Chemistry, Hepatic Function, Bile Acid

18933 IVD Test Reagent/Kits, Clinical Chemistry, Hepatic Function, Bilirubin

18934 IVD Test Reagent/Kits, Clinical Chemistry, Hepatic Function, Bilirubin, Direct
18935 IVD Test Reagent/Kits, Clinical Chemistry, Porphyrin

18936 IVD Test Reagent/Kits, Clinical Chemistry, Porphyrin Precursor

18937 IVD Test Reagent/Kits, Clinical Chemistry, Porphyrin Precursor, 5-Aminolevulinic A

18938 IVD Test Reagent/Kits, Clinical Chemistry, Porphyrin Precursor, Porphobilinogen

18939 IVD Test Reagent/Kits, Clinical Chemistry, Nitrogen Metabolite

18940 IVD Test Reagent/Kits, Clinical Chemistry, Nitrogen Metabolite, Blood Urea Nitrog

18941 IVD Test Reagent/Kits, Clinical Chemistry, Nitrogen Metabolite, Creatinine

18942 IVD Test Reagent/Kits, Clinical Chemistry, Nitrogen Metabolite, Uric Acid
18943 IVD Test Reagent/Kits, Clinical Chemistry, D-Xylose

18944 IVD Test Reagent/Kits, Clinical Chemistry, Lactate

18945 IVD Test Reagent/Kits, Clinical Chemistry, Pyruvate

18946 IVD Test Reagent/Kits, Clinical Chemistry, Oxalate

18947 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte

18948 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Ammonia/Ammonium

18949 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Bicarbonate

18950 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Calcium

18951 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Chloride


18952 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Lithium

18953 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Magnesium

18954 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Phosphorus/Inorganic Phos

18955 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Potassium

18956 IVD Test Reagent/Kits, Clinical Chemistry, Electrolyte, Sodium

18958 IVD Test Reagent/Kits, Clinical Chemistry, Control, Enzyme Test

18959 Analyzers, Environmental/Gas System

18960 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum

18961 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Normal


18962 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Abnormal

18963 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Enzyme

18964 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Lipid

18965 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Lipoprotein

18966 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Bilirubin

18967 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Protein

18968 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Albumin

18969 IVD Test Reagent/Kits, Clinical Chemistry, Control, Serum, Triglyceride

18971 Calibrators, Radiopharmaceutical


18972 IVD Test Reagent/Kits, Clinical Chemistry, Control, Cerebrospinal Fluid

18973 IVD Test Reagent/Kits, Clinical Chemistry, Control, Cerebrospinal Fluid, Normal

18974 IVD Test Reagent/Kits, Clinical Chemistry, Control, Cerebrospinal Fluid, Abnormal

18976 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Enzyme Test

18977 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Electrolyte Test

18978 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Serum Test

18979 Silver Recovery Test Kits

18980 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Blood Gas/pH Test

18981 IVD Test Reagent/Kits, Clinical Chemistry, Calibration, Cerebrospinal Fluid Test

18982 IVD Test Reagent/Kits, Clinical Chemistry, Standard

18983 IVD Test Reagent/Kits, Clinical Chemistry, Standard, Enzyme Test

18984 IVD Test Reagent/Kits, Clinical Chemistry, Standard, Electrolyte Test

18985 IVD Test Reagent/Kits, Clinical Chemistry, Buffer

18986 IVD Test Reagent/Kits, Clinical Chemistry, Buffer, Enzyme Test


18987 IVD Test Reagent/Kits, Clinical Chemistry, Buffer, Electrolyte Test

18988 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test

18989 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood

18990 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose

18991 IVD Test Reagent/Kits, Clinical Chemistry, Control, Electrolyte Test

18992 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Cholesterol, To

18994 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Cholesterol,

18995 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Cholesterol, H

18996 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Lactate

18997 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Lactate, Strip

18998 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Ethanol
18999 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Multianalyte

19001 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Single Analyte

19002 IVD Test Reagent/Kits, Serology, Bacteria, Treponema pallidum

19003 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Single Analyte, Table

19004 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Multianalyte

19005 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Multianalyte, Strip

19006 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Sediment

19007 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Feces

19008 IVD Test Reagent/Kits, Serology, Bacteria, Treponema pallidum, Antibody

19009 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Feces, Occult Blood, Strip
19010 Orthoses, Spine, Sacroiliac, Therapeutic, Traction Sling

19011 Patient Transfer Slings

19012 Patient Transfer Slings, Manual Assist

19013 Boards

19014 Boards, Patient Transfer

19015 Lifts, Patient Transfer, Overhead Track

19016 Patient Transfer Aids, Lateral Transfer

19017 Mattresses, Bed, Gel


19018 Mattresses, Bed, Static Air

19020 Stretchers, Mobile, Hospital, Fixed-Height

19021 Stretchers, Mobile, Hospital, Adjustable-Height

19022 Stretchers, Portable, Pole

19023 Stretcher/Chairs

19024 Stretcher/Chairs, Mobile

19025 Stretcher/Chairs, Portable

19026 Simulators, Cardiac

19027 Simulators, Training, Heart Beat

19028 Simulators, Respiration, Thoracic Impedance


19029 Simulators, Respiration, Breath Sound

19030 Simulators, Multiparameter

19031 Simulators, Transducer Output

19032 Simulators, Transducer Output, Pressure

19033 Simulators, Transducer Output, Invasive Blood Pressure

19034 Simulators, Transducer Output, Cardiac Output

19035 Simulators, Transducer Output, Temperature


19036 Bags, Test Lung

19037 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Febrile Agglutinin

19038 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Antinucle

19039 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus A, Antibody, Hyaluronid

19040 IVD Test Reagent/Kits, Serology

19041 IVD Test Reagent/Kits, Serology, Bacteria

19042 IVD Test Reagent/Kits, Serology, Bacteria, Escherichia coli

19043 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria gonorrhoeae

19044 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis, Antigen

19045 IVD Test Reagent/Kits, Serology, Bacteria, Helicobacter pylori

19046 IVD Test Reagent/Kits, Serology, Bacteria, Borrelia burgdorferi


19047 IVD Test Reagent/Kits, Serology, Bacteria, Mycobacterium Species

19048 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma Species

19049 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species

19050 IVD Test Reagent/Kits, Serology, Bacteria, Staphylococcus Species

19051 IVD Test Reagent/Kits, Serology, Bacteria, Listeria monocytogenes

19052 IVD Test Reagent/Kits, Serology, Bacteria, Campylobacter Species, Antigen

19053 IVD Test Reagent/Kits, Serology, Virus, Rubella, IgG Antibody

19054 IVD Test Reagent/Kits, Serology, Virus, Varicella-Zoster


19055 IVD Test Reagent/Kits, Serology, Virus, Enterovirus

19056 IVD Test Reagent/Kits, Serology, Virus, Influenza, Antibody

19057 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza, Antibody

19058 IVD Test Reagent/Kits, Serology, Virus, Respiratory Syncytial Virus

19059 IVD Test Reagent/Kits, Serology, Virus, Rotavirus, Antigen

19060 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen

19061 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antibody

19062 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen


19063 IVD Test Reagent/Kits, Serology, Virus, Hepatitis D, Antigen

19064 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E, Antibody

19065 IVD Test Reagent/Kits, Serology, Virus, Retrovirus

19066 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antigen

19067 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-2, Antigen

19068 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-2, Antibody

19069 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antigen

19070 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody

19071 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Vir

19072 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Viru
19073 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Viru

19074 IVD Test Reagent/Kits, Serology, Fungi/Yeast

19075 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Blastomyces Species, Antibody

19076 IVD Test Reagent/Kits, Serology, Parasite

19077 IVD Test Reagent/Kits, Serology, Parasite, Cryptosporidium Species, Antibody

19078 IVD Test Reagent/Kits, Serology, Parasite, Giardia lamblia, Antigen

19079 IVD Test Reagent/Kits, Serology, Parasite, Leishmania Species, Antibody

19080 IVD Test Reagent/Kits, Serology, Parasite, Schistosoma Species, Antibody

19081 IVD Test Reagent/Kits, Serology, Control

19082 IVD Test Reagent/Kits, Serology, Standard

19083 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria

19084 IVD Test Reagent/Kits, Serology, Rapid Test, Virus


19085 IVD Test Reagent/Kits, Immunoassay

19086 IVD Test Reagent/Kits, Immunoassay, Protein

19087 IVD Test Reagent/Kits, Immunoassay, Protein, Fibronectin

19088 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Light

19089 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Ligh

19090 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, Total (CH

19091 IVD Test Reagent/Kits, Immunoassay, Protein, Transport

19092 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker


19093 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Creatine Kinase M

19094 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin T

19095 IVD Test Reagent/Kits, Immunoassay, Allergy

19096 IVD Test Reagent/Kits, Immunoassay, Tumor Marker

19097 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme

19098 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Hormone

19099 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal

19100 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Alkaline Phospha
19101 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA

19102 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 15

19103 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 19

19104 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 12

19105 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein

19106 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Receptor Assay

19107 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Receptor Assay, Estrogen

19108 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone


19109 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Triiodothyronine

19110 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin

19111 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free

19112 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone Binding Protein

19113 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone

19114 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Dehydroepiandrosterone


19115 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Estradiol

19116 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hor

19117 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone

19118 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Progesterone

19119 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Prolactin

19120 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Testosterone, Dihydro/Tot


19121 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone

19122 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Estriol

19123 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gon

19124 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gona

19125 IVD Test Reagent/Kits, Immunoassay, Diabetes

19126 IVD Test Reagent/Kits, Immunoassay, Diabetes, C-Peptide

19127 IVD Test Reagent/Kits, Immunoassay, Diabetes, Insulin


19128 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism

19129 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Aldosterone

19131 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol

19132 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone

19133 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid H

19134 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone

19135 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Catecholamine


19136 IVD Test Reagent/Kits, Immunoassay, Anemia Test

19137 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin

19138 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Transferrin-Bound Iron

19139 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Iron Binding Capacity

19140 IVD Test Reagent/Kits, Immunoassay, Vitamin

19141 IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)

19142 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin

19143 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 1,25-Dihydroxyvitam


19144 IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate

19145 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug

19146 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular

19147 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Digoxin

19148 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Lidocain

19149 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant

19150 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Carbam


19151 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Phenobar

19152 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Phenytoi

19153 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic

19154 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Gentamicin

19155 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Tobramycin

19156 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Vancomycin


19157 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antiasthma

19158 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antiasthma, Theophyllin

19159 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antiasthma, Caffeine

19160 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antineoplastic

19161 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antineoplastic, Methotre

19162 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse


19163 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Amphetamine

19164 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Methamphetamine

19165 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Barbiturate

19166 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Benzodiazepine

19167 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Cannabinoid/Cannabinoid M


19168 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Cocaine/Cocaine Metabolite

19169 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Opiate

19170 IVD Test Reagent/Kits, Immunoassay, Toxicology, Acetaminophen

19171 IVD Test Reagent/Kits, Immunoassay, Toxicology, Ethanol

19172 IVD Test Reagent/Kits, Immunoassay, Toxicology, Salicylate

19173 IVD Test Reagent/Kits, Immunoassay, Autoimmune

19174 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Diabetes


19175 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue

19176 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Extractabl

19177 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic

19178 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antiganglioside A

19179 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism

19180 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody

19181 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Deo

19182 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Strep

19183 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus A, Antibody, Pyogen Tox
19184 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Celiac Disease

19185 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Hepatitis

19190 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Anti-Striated Muscle Antibody

19191 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Antineutrophil Cytoplasmic A

19192 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing

19193 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Antib
19194 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Antibo

19195 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Antibo

19196 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse

19197 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Toxicology

19198 IVD Test Reagent/Kits, Immunoassay, Calibration

19199 IVD Test Reagent/Kits, Immunoassay, Standard

19200 IVD Test Reagent/Kits, Microbiology, Bacteria

19201 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification

19202 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Campylobacter Spec


19203 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Escherichia coli

19204 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Helicobacter pylori

19205 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Nonfermenter

19206 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Treponema pallidum

19207 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus Spec

19208 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Leptospira Species

19209 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycoplasma Species

19210 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycobacterium Spec

19211 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycobacterium tuber

19212 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Rickettsia Species


19213 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Yersinia Species

19214 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Genital Bacteria

19215 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility

19216 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test

19217 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Mycoba

19218 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Automated Test, My

19219 IVD Test Reagent/Kits, Microbiology, Virus

19220 IVD Test Reagent/Kits, Microbiology, Virus, Cell/Tissue Culture Media

19221 IVD Test Reagent/Kits, Microbiology, Virus, Identification

19222 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast


19223 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification

19224 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Blastomyces Spec

19225 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Sporothrix schenc

19226 IVD Test Reagent/Kits, Microbiology, Parasite, Identification

19227 IVD Test Reagent/Kits, Microbiology, Parasite, Susceptibility

19228 IVD Test Reagent/Kits, Microbiology, Environmental Test Culture Media

19229 IVD Test Reagent/Kits, Microbiology, Stain, Bacteria

19230 IVD Test Reagent/Kits, Microbiology, Stain, Virus

19231 IVD Test Reagent/Kits, Microbiology, Stain, Fungi/Yeast

19232 IVD Test Reagent/Kits, Microbiology, Stain, Parasite

19233 IVD Test Reagent/Kits, Microbiology, Buffer

19234 IVD Test Reagent/Kits, Microbiology, Standard

19235 IVD Test Reagent/Kits, Microbiology, Rapid Test


19236 IVD Test Reagent/Kits, Molecular Assay

19237 IVD Test Reagent/Kits, Molecular Assay, Infection

19238 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria

19239 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia Species

19240 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium Speci

19241 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycoplasma Species

19242 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus

19243 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B

19244 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C


19245 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV

19246 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Cytomegalovirus

19247 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Simplex

19248 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Epstein-Barr

19249 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus

19250 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Varicella-Zoster

19265 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation

19266 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(9

19267 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(1

19268 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(1
19269 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(1

19270 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Inversion

19271 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Inversion 16 [in

19272 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing

19273 IVD Test Reagent/Kits, Hematology, Blood Cell Count

19274 IVD Test Reagent/Kits, Hematology, Hemoglobin

19276 IVD Test Reagent/Kits, Hematology, Coagulation, Screening

19277 IVD Test Reagent/Kits, Hematology, Coagulation Factor

19278 IVD Test Reagent/Kits, Hematology, Coagulation Factor I (Fibrinogen)

19279 IVD Test Reagent/Kits, Hematology, Coagulation Factor VIII (Antihemolytic Factor)
19280 IVD Test Reagent/Kits, Hematology, Coagulation Factor IX (Plasma Thromboplast

19281 IVD Test Reagent/Kits, Hematology, Coagulation Factor, Multiple

19282 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor

19283 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Antithrombin III

19284 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Protein C

19285 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Protein S

19286 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Lupus Anticoagulant

19287 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker

19288 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Platelet

19289 IVD Test Reagent/Kits, Hematology, Fibrinolysis

19290 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Fibrinogen Degradation Product,


19291 IVD Test Reagent/Kits, Hematology, Standard

19292 IVD Test Reagent/Kits, Hematology, Rapid Test, Prothrombin Time

19293 IVD Test Reagent/Kits, Hematology, Rapid Test, Activated Partial Thromboplastin

19294 IVD Test Reagent/Kits, Immunohematology, Blood Grouping

19295 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing

19296 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing

19297 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification

19298 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Cel

19299 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Ant


19300 IVD Test Reagent/Kits, Hematology, Coagulation Factor Antibody

19301 IVD Test Reagent/Kits, Immunohematology, Control, Coombs Cell

19302 IVD Test Reagent/Kits, Cytology/Histology, Chromosome Culture Media

19303 IVD Test Reagent/Kits, Cytology/Histology, Mounting Media

19304 IVD Test Reagent/Kits, Cytology/Histology, Decalcifying

19305 IVD Test Reagent/Kits, Cytology/Histology, Fixative

19306 IVD Test Reagent/Kits, Cytology/Histology, Stain

19307 IVD Test Reagent/Kits, Cytology/Histology, Antisera

19308 IVD Test Reagent/Kits, Electrophoresis

19309 IVD Test Reagent/Kits, Home Assay


19310 IVD Test Reagent/Kits, Home Assay, Whole Blood

19311 IVD Test Reagent/Kits, Home Assay, Whole Blood, Cholesterol

19312 IVD Test Reagent/Kits, Home Assay, Whole Blood, Glucose

19313 IVD Test Reagent/Kits, Home Assay, Whole Blood, Glycated Hemoglobin

19314 IVD Test Reagent/Kits, Home Assay, Whole Blood, Ketone

19315 IVD Test Reagent/Kits, Home Assay, Urine

19316 IVD Test Reagent/Kits, Home Assay, Urine, Pregnancy

19317 IVD Test Reagent/Kits, Home Assay, Urine, Drug-of-Abuse

19318 IVD Test Reagent/Kits, Home Assay, Urine, Multianalyte

19319 IVD Test Reagent/Kits, Home Assay, Feces

19320 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Hepatitis, Liver/Kidney Micro


19321 Morcellators

19322 Morcellators, Endoscopic

19323 Scanning Systems, Electrical Impedance

19324 Scanning Systems, Electrical Impedance, Mammographic

19325 Wands, Smoke Evacuation

19326 Wands, Smoke Evacuation, Surgical Laser Handpiece


19327 Electrodes, Electrosurgical, Active, Hand-Controlled, Smoke Evacuation

19328 Electrodes, Electrosurgical, Active, Foot-Controlled, Smoke Evacuation

19329 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Strep
19330 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Hepatitis, Antimitochondrial

19331 IVD Test Reagent/Kits, Immunoassay, Immunology

19332 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Automated Test

19333 IVD Test Reagent/Kits, Microbiology, Rapid Test, Urine Screening

19334 IVD Test Reagent/Kits, Home Assay, Urine, Ovulation Prediction

19335 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia Species

19336 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia Species, Antigen

19337 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia Species, IgG Antibody

19338 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia Species, IgM Antibody
19339 IVD Test Reagent/Kits, Serology, Bacteria, Escherichia coli, Antigen

19340 IVD Test Reagent/Kits, Serology, Bacteria, Escherichia coli, Toxin

19341 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria gonorrhoeae, Antigen

19342 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria gonorrhoeae, Antibody

19343 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis

19345 IVD Test Reagent/Kits, Serology, Bacteria, Treponema pallidum, IgG Antibody

19346 IVD Test Reagent/Kits, Serology, Bacteria, Treponema pallidum, IgM Antibody

19347 IVD Test Reagent/Kits, Serology, Bacteria, Helicobacter pylori, Antigen

19348 IVD Test Reagent/Kits, Serology, Bacteria, Helicobacter pylori, Antibody

19349 IVD Test Reagent/Kits, Serology, Bacteria, Helicobacter pylori, IgA Antibody

19350 IVD Test Reagent/Kits, Serology, Bacteria, Helicobacter pylori, IgG Antibody

19351 IVD Test Reagent/Kits, Serology, Bacteria, Helicobacter pylori, IgM Antibody

19352 IVD Test Reagent/Kits, Serology, Bacteria, Legionella Species, Antigen

19353 IVD Test Reagent/Kits, Serology, Bacteria, Legionella Species, Antibody

19354 IVD Test Reagent/Kits, Serology, Bacteria, Legionella Species, IgG Antibody

19355 IVD Test Reagent/Kits, Serology, Bacteria, Legionella Species, IgM Antibody
19356 IVD Test Reagent/Kits, Serology, Bacteria, Borrelia burgdorferi, Antibody

19357 IVD Test Reagent/Kits, Serology, Bacteria, Borrelia burgdorferi, IgG Antibody

19358 IVD Test Reagent/Kits, Serology, Bacteria, Borrelia burgdorferi, IgM Antibody

19361 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma Species, Antibody

19362 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma Species, IgG Antibody

19363 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma Species, IgM Antibody

19364 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma pneumoniae

19365 IVD Test Reagent/Kits, Serology, Bacteria, Salmonella Species

19366 IVD Test Reagent/Kits, Serology, Bacteria, Salmonella Species, Antigen

19367 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antigen

19369 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus pneumoniae, Antigen


19370 IVD Test Reagent/Kits, Serology, Bacteria, Staphylococcus Species, Antigen

19371 IVD Test Reagent/Kits, Serology, Bacteria, Staphylococcus Species, Toxin

19372 IVD Test Reagent/Kits, Serology, Bacteria, Listeria monocytogenes, Antibody

19373 IVD Test Reagent/Kits, Serology, Bacteria, Coxiella burnetii, Antibody

19374 IVD Test Reagent/Kits, Serology, Bacteria, Leptospira Species, Antibody

19375 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia Species, Antibody

19376 IVD Test Reagent/Kits, Serology, Virus, Rubella

19377 IVD Test Reagent/Kits, Serology, Virus, Measles, IgG Antibody

19378 IVD Test Reagent/Kits, Serology, Virus, Measles, IgM Antibody

19379 IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus


19381 IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgG Antibody

19382 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex

19383 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex, Antigen

19384 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex, IgG Antibody

19385 IVD Test Reagent/Kits, Serology, Virus, Epstein-Barr, IgG Antibody

19386 IVD Test Reagent/Kits, Serology, Virus, Varicella-Zoster, Antigen

19387 IVD Test Reagent/Kits, Serology, Virus, Varicella-Zoster, IgG Antibody

19388 IVD Test Reagent/Kits, Serology, Virus, Varicella-Zoster, IgM Antibody

19389 IVD Test Reagent/Kits, Serology, Virus, Adenovirus


19390 IVD Test Reagent/Kits, Serology, Virus, Adenovirus, Antigen

19391 IVD Test Reagent/Kits, Serology, Virus, Enterovirus, Antigen

19392 IVD Test Reagent/Kits, Serology, Virus, Influenza

19393 IVD Test Reagent/Kits, Serology, Virus, Influenza A, Antibody

19394 IVD Test Reagent/Kits, Serology, Virus, Influenza B, Antibody

19395 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza

19396 IVD Test Reagent/Kits, Serology, Virus, Respiratory Syncytial Virus, Antigen

19397 IVD Test Reagent/Kits, Serology, Virus, Respiratory Syncytial Virus, Antibody

19398 IVD Test Reagent/Kits, Serology, Virus, Epidemic Parotitis (Mumps)

19402 IVD Test Reagent/Kits, Serology, Virus, Hepatitis


19403 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A

19404 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antigen

19405 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antigen, Confirmatory

19406 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, IgG Antibody

19407 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B

19408 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgG Core Antibody

19409 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, X Protein

19410 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C


19411 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody, Confirmatory

19412 IVD Test Reagent/Kits, Serology, Virus, Hepatitis D

19413 IVD Test Reagent/Kits, Serology, Virus, Hepatitis D, Antibody

19414 IVD Test Reagent/Kits, Serology, Virus, Hepatitis D, IgM Antibody

19415 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E

19416 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E, Antigen

19417 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E, IgG Antibody

19418 IVD Test Reagent/Kits, Serology, Virus, Hepatitis E, IgM Antibody


19419 IVD Test Reagent/Kits, Serology, Virus, Hepatitis G

19420 IVD Test Reagent/Kits, Serology, Virus, Hepatitis-Associated TT Virus

19421 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1

19422 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antigen, Confirmatory

19423 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, IgG Antibody

19424 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, IgM Antibody

19425 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antibody, Confirmatory

19426 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-2

19427 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-2, Antibody, Confirmatory

19428 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV, P24 Antigen
19429 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV, P24 Antibody

19430 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2

19431 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody, Confirmator

19432 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Vir

19433 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Vir

19434 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Vir

19435 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Viru

19436 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Viru
19437 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Vir

19438 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus

19439 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida albicans

19440 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Aspergillus Species

19441 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Aspergillus Species, IgG Antibody

19442 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis

19443 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis, IgG Antibody

19444 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis, IgM Antibody

19445 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis, Exoantigen

19446 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans


19447 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen

19448 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Histoplasma capsulatum

19449 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Histoplasma capsulatum, Antigen

19450 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii

19451 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii, IgG Antibody

19452 IVD Test Reagent/Kits, Serology, Parasite, Trypanosoma cruzi, Antibody

19453 IVD Test Reagent/Kits, Serology, Parasite, Cryptosporidium Species

19454 IVD Test Reagent/Kits, Serology, Parasite, Cryptosporidium Species, Antigen

19455 IVD Test Reagent/Kits, Serology, Parasite, Taenia solium, Antibody

19457 IVD Test Reagent/Kits, Serology, Parasite, Echinococcus, Antibody


19458 IVD Test Reagent/Kits, Serology, Parasite, Trichomonas Species, Antigen

19459 IVD Test Reagent/Kits, Serology, Calibration, Bacteria

19460 IVD Test Reagent/Kits, Serology, Calibration, Parasite

19461 IVD Test Reagent/Kits, Serology, Control, Bacteria

19462 IVD Test Reagent/Kits, Serology, Control, Parasite

19463 IVD Test Reagent/Kits, Serology, Standard, Bacteria

19464 IVD Test Reagent/Kits, Serology, Standard, Virus

19465 IVD Test Reagent/Kits, Serology, Standard, Parasite

19466 IVD Test Reagent/Kits, Serology, Rapid Test

19467 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Chlamydia

19468 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Helicobacter pylori
19469 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Streptococci A

19470 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Streptococci B

19471 IVD Test Reagent/Kits, Serology, Rapid Test, Bacteria, Syphilis

19472 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Hepatitis

19473 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Hepatitis B Surface Antigen

19474 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Hepatitis C Antibody

19475 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus

19476 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1

19477 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-2

19478 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2

19479 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Cytomegalovirus

19483 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media

19484 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Dehydrated

19485 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Tube

19486 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Tube, Broth
19487 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Tube, Agar

19488 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Tube, Transport

19489 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Bottle

19490 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Bottle, Agar

19491 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Bottle, Broth

19492 IVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Plate

19493 IVD Test Reagent/Kits, Microbiology, Bacteria, Blood Culture Media

19494 IVD Test Reagent/Kits, Microbiology, Bacteria, Blood Culture Media, Manual Test

19495 IVD Test Reagent/Kits, Microbiology, Bacteria, Blood Culture Media, Manual Test,

19496 IVD Test Reagent/Kits, Microbiology, Bacteria, Blood Culture Media, Manual Test,

19497 IVD Test Reagent/Kits, Microbiology, Bacteria, Blood Culture Media, Automated Te

19498 IVD Test Reagent/Kits, Microbiology, Bacteria, Blood Culture Media, Automated Tes

19499 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Salmonella Species

19500 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Listeria monocytoge


19501 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Clostridium difficile

19502 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Francisella tularensis

19503 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Minim

19504 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Disk

19505 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Automated Test, Mi

19506 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Automated Test, Bre

19507 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Varicella-Zoster

19508 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Respiratory Syncytial Vi

19509 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Influenza

19511 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Parainfluenza

19512 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Rotavirus

19513 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus


19514 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media

19515 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media, Dehydrated

19516 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media, Tube

19517 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media, Bottle

19518 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media, Plate

19519 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media, Dip Slide
19522 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Aspergillus Speci

19523 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Coccidioides immi

19524 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Histoplasma cap

19525 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Susceptibility

19526 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa

19527 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Plasmodiu

19528 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Amoeba

19529 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Leishmani


19530 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Helminth

19531 IVD Test Reagent/Kits, Microbiology, Buffer, Culture Media

19532 IVD Test Reagent/Kits, Microbiology, Buffer, Bacteria Test

19533 IVD Test Reagent/Kits, Microbiology, Buffer, Virus Test

19534 IVD Test Reagent/Kits, Microbiology, Buffer, Fungi/Yeast Test

19535 IVD Test Reagent/Kits, Microbiology, Buffer, Parasite Test

19536 IVD Test Reagent/Kits, Microbiology, Calibration, Culture Media

19537 IVD Test Reagent/Kits, Microbiology, Calibration, Blood Culture Media

19538 IVD Test Reagent/Kits, Microbiology, Calibration, Bacteria Test

19539 IVD Test Reagent/Kits, Microbiology, Calibration, Virus Test

19540 IVD Test Reagent/Kits, Microbiology, Calibration, Tissue Culture

19541 IVD Test Reagent/Kits, Microbiology, Calibration, Fungi/Yeast Test

19542 IVD Test Reagent/Kits, Microbiology, Calibration, Parasite Test

19543 IVD Test Reagent/Kits, Microbiology, Control, Culture Media


19544 IVD Test Reagent/Kits, Microbiology, Control, Blood Culture Media

19545 IVD Test Reagent/Kits, Microbiology, Control, Bacteria Test

19546 IVD Test Reagent/Kits, Microbiology, Control, Virus Test

19547 IVD Test Reagent/Kits, Microbiology, Control, Tissue Culture

19548 IVD Test Reagent/Kits, Microbiology, Control, Fungi/Yeast Test

19549 IVD Test Reagent/Kits, Microbiology, Control, Parasite Test

19550 IVD Test Reagent/Kits, Microbiology, Standard, Culture Media

19551 IVD Test Reagent/Kits, Microbiology, Standard, Blood Culture Media

19552 IVD Test Reagent/Kits, Microbiology, Standard, Bacteria Test

19553 IVD Test Reagent/Kits, Microbiology, Standard, Virus Test

19554 IVD Test Reagent/Kits, Microbiology, Standard, Tissue Culture

19555 IVD Test Reagent/Kits, Microbiology, Standard, Fungi/Yeast Test


19556 IVD Test Reagent/Kits, Microbiology, Standard, Parasite Test

19557 IVD Test Reagent/Kits, Microbiology, Rapid Test, Urine Screening, Automated

19558 IVD Test Reagent/Kits, Microbiology, Rapid Test, Urine Screening, Manual

19559 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Neisseria gonorrhoea

19560 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Treponema pallidum

19561 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Helicobacter pylori

19562 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Legionella Species

19563 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Borrelia burgdorferi

19564 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium tuber

19565 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Salmonella Species

19566 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus Specie
19567 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus Speci

19568 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Listeria monocytogen

19569 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Pseudomonas aerugi

19570 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Escherichia coli

19571 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Campylobacter Speci

19572 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus A

19573 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus B

19574 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus pneu

19575 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Enterococcus Species
19576 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis

19577 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B, Core

19580 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis D

19581 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis E

19582 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis G

19583 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus

19584 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-1

19585 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-2

19586 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-1/2

19588 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, Human T-Cel
19589 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, Human T-Cell

19590 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, Human T-Cell

19591 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Rubella

19592 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast

19593 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Candida albicans

19594 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Coccidioides immit

19595 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Cryptococcus neo

19596 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Histoplasma caps

19597 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Blastomyces derma
19610 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy, Congenit

19611 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 21, Cong

19612 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 18, Conge

19613 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 13, Congen

19614 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Sexual

19615 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Sexual, Klinefelte

19616 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Sexual, Turner

19618 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, p53

19619 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KRAS

19620 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NRAS
19622 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RET

19623 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MYC

19625 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HER2/NEU

19627 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(8

19628 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(4

19629 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(4

19630 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(1

19631 IVD Test Reagent/Kits, Cytology/Histology, Chromosome Culture Media, Fragile

19632 IVD Test Reagent/Kits, Cytology/Histology, Stain, Powder

19633 IVD Test Reagent/Kits, Cytology/Histology, Stain, Solution

19634 IVD Test Reagent/Kits, Cytology/Histology, Stain, Solution, Papanicolaou


19635 IVD Test Reagent/Kits, Cytology/Histology, Antisera, Monovalent

19636 IVD Test Reagent/Kits, Cytology/Histology, Antisera, Polyvalent

19637 IVD Test Reagent/Kits, Cytology/Histology, Standard

19638 IVD Test Reagent/Kits, Immunoassay, Immunology, Tissue Typing, Human Leukocyt

19639 IVD Test Reagent/Kits, Immunoassay, Immunology, Tissue Typing, Human Leukocyt

19640 IVD Test Reagent/Kits, Immunoassay, Immunology, Tissue Typing, Human Leukocy

19641 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Anti

19642 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Anti

19643 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Antibod

19644 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Monoclonal Antib

19645 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Separation Media
19646 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Separation Media

19647 IVD Test Reagent/Kits, Immunoassay, Immunology, Cell Typing, Stabilization Medi

19648 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine

19649 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine, Interleukin

19650 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine, Interleukin Recepto

19651 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine, Interferon

19652 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine, Tumor Necrosis Fact

19653 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine, Tumor Necrosis Fact

19654 IVD Test Reagent/Kits, Immunoassay, Immunology, Cytokine, Colony Stimulating

19655 IVD Test Reagent/Kits, Molecular Assay, Immunology


19656 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leuk

19657 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leuko

19658 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19659 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19660 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19661 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19662 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19663 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19664 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19665 IVD Test Reagent/Kits, Molecular Assay, Immunology, Tissue Typing, Human Leukoc

19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe


19667 IVD Test Reagent/Kits, Electrophoresis, Buffer

19668 IVD Test Reagent/Kits, Electrophoresis, Stain

19669 IVD Test Reagent/Kits, Electrophoresis, Supporting Media

19670 IVD Test Reagent/Kits, Electrophoresis, Supporting Media, Gel

19671 IVD Test Reagent/Kits, Home Assay, Whole Blood, Cholesterol, High-Density Lipop

19672 IVD Test Reagent/Kits, Home Assay, Whole Blood, Fructosamine

19673 IVD Test Reagent/Kits, Home Assay, Whole Blood, Triglyceride

19674 IVD Test Reagent/Kits, Home Assay, Whole Blood, Multianalyte

19675 IVD Test Reagent/Kits, Home Assay, Urine, Bilirubin

19676 IVD Test Reagent/Kits, Home Assay, Urine, Chloride

19677 IVD Test Reagent/Kits, Home Assay, Urine, Creatinine

19678 IVD Test Reagent/Kits, Home Assay, Urine, Glucose

19679 IVD Test Reagent/Kits, Home Assay, Urine, Ketone

19680 IVD Test Reagent/Kits, Home Assay, Urine, Nitrate


19681 IVD Test Reagent/Kits, Home Assay, Urine, Occult Blood

19682 IVD Test Reagent/Kits, Home Assay, Urine, pH

19683 IVD Test Reagent/Kits, Home Assay, Urine, Protein

19684 IVD Test Reagent/Kits, Home Assay, Urine, Urobilinogen

19685 IVD Test Reagent/Kits, Home Assay, Urine, Catalase

19686 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Ketone

19687 IVD Test Reagent/Kits, Home Assay, Feces, Occult Blood

19688 IVD Test Reagent/Kits, Microbiology, Virus, Cell/Tissue Culture Media, Serum

19689 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin I

19690 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Pregnancy

19691 IVD Test Reagent/Kits, Hematology, Coagulation, Screening, Partial Thromboplast


19692 IVD Test Reagent/Kits, Hematology, Coagulation, Screening, Prothrombin Time

19697 Computer-Aided Detection Systems, Image, Breast, Mammography

19699 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine, Single Analyte, Strip

19700 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin

19701 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Albumin

19702 IVD Test Reagent/Kits, Immunoassay, Lipoprotein

19703 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Apolipoprotein A-I

19704 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein


19705 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Alkaline Phosphata

19706 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Hormone, Human Chorionic

19707 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Hormone Metabolite

19708 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig (Imm

19709 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Light

19710 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Receptor Assay, Progesteron

19712 IVD Test Reagent/Kits, Immunoassay, Diabetes, Glycated Hemoglobin

19714 IVD Test Reagent/Kits, Hematology, Blood Cell Count, Manual Test

19715 IVD Test Reagent/Kits, Hematology, Blood Cell Count, Manual Test, Reticulocyte

19717 IVD Test Reagent/Kits, Hematology, Blood Cell Count, Automated Test, Reticulocy
19718 IVD Test Reagent/Kits, Hematology, Blood Collection

19719 IVD Test Reagent/Kits, Hematology, Blood Collection, Anticoagulant

19720 IVD Test Reagent/Kits, Hematology, Blood Collection, Anticoagulant, Tube

19721 IVD Test Reagent/Kits, Hematology, Cellular Enzyme

19722 IVD Test Reagent/Kits, Hematology, Coagulation, Screening, Thrombin Time

19723 IVD Test Reagent/Kits, Hematology, Coagulation, Blood Clotting, Reptilase Time

19724 IVD Test Reagent/Kits, Hematology, Coagulation, Blood Clotting, Ecarin Time

19725 IVD Test Reagent/Kits, Hematology, Coagulation Factor II (Prothrombin)

19726 IVD Test Reagent/Kits, Hematology, Coagulation Factor II, Activated (Thrombin)

19727 IVD Test Reagent/Kits, Hematology, Coagulation Factor V (Proaccelerin)

19728 IVD Test Reagent/Kits, Hematology, Coagulation Factor VII (Proconvertin)


19729 IVD Test Reagent/Kits, Hematology, Coagulation Factor VII, Activated

19730 IVD Test Reagent/Kits, Hematology, Coagulation Factor X (Stuart-Prower Factor)

19731 IVD Test Reagent/Kits, Hematology, Coagulation Factor XI (Plasma Thromboplasti

19732 IVD Test Reagent/Kits, Hematology, Coagulation Factor XII (Hageman Factor)

19733 IVD Test Reagent/Kits, Hematology, Coagulation Factor XII, Activated

19734 IVD Test Reagent/Kits, Hematology, Coagulation Factor XIII (Fibrin Stabilizing Fact

19735 IVD Test Reagent/Kits, Hematology, Coagulation Factor XIII, Activated

19736 IVD Test Reagent/Kits, Hematology, Coagulation Factor, High Molecular Weight K

19737 IVD Test Reagent/Kits, Hematology, Coagulation Factor, Von Willebrand

19738 IVD Test Reagent/Kits, Hematology, Coagulation Factor, Prekallikrein (Fletcher Fac

19739 IVD Test Reagent/Kits, Hematology, Coagulation Factor Antibody, Factor VIII

19740 IVD Test Reagent/Kits, Hematology, Coagulation Factor Antibody, Factor IX


19741 IVD Test Reagent/Kits, Hematology, Coagulation Factor XIII Subunit Antigen

19742 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Heparin

19743 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Heparin Cofactor II

19744 IVD Test Reagent/Kits, Hematology, Coagulation, Inhibitor, Hirudin/Recombinant

19745 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Platelet F

19746 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Prostacyc

19747 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Thromb

19748 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Beta-Th

19749 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombophilia Marker, Activated


19750 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombosis Marker

19751 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombosis Marker, Fibrinopept

19752 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombosis Marker, Prothromb

19753 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombosis Marker, Thrombin-An

19754 IVD Test Reagent/Kits, Hematology, Coagulation, Thrombosis Marker, Fibrin Mon

19755 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasmin

19756 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasmin Inhibitor

19757 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasmin-Alpha2-Antiplasmin Com

19758 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasminogen Activator, Tissue-Ty

19759 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasminogen Activator, Urokinas


19760 IVD Test Reagent/Kits, Hematology, Fibrinolysis, Plasminogen Activator, Inhibitor

19762 IVD Test Reagent/Kits, Hematology, Control, Whole Blood

19763 IVD Test Reagent/Kits, Hematology, Control, Hemoglobin

19764 IVD Test Reagent/Kits, Hematology, Control, Coagulation, Plasma

19765 IVD Test Reagent/Kits, Hematology, Calibration, Whole Blood

19766 IVD Test Reagent/Kits, Hematology, Calibration, Hemoglobin

19767 IVD Test Reagent/Kits, Hematology, Standard, Whole Blood

19768 IVD Test Reagent/Kits, Hematology, Standard, Hemoglobin

19769 IVD Test Reagent/Kits, Hematology, Standard, Coagulation

19770 IVD Test Reagent/Kits, Hematology, Standard, Coagulation, Plasma

19771 IVD Test Reagent/Kits, Hematology, Buffer

19772 IVD Test Reagent/Kits, Hematology, Buffer, Coagulation

19773 IVD Test Reagent/Kits, Hematology, Rapid Test


19774 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing, Sera

19775 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing, Cell

19776 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing, D Ant

19777 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Two

19778 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Thr

19779 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Ant

19780 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Anti

19781 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification,

19782 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, En


19783 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, E

19784 IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification,

19785 IVD Test Reagent/Kits, Immunohematology, Calibration

19786 IVD Test Reagent/Kits, Immunohematology, Standard

19795 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A, Subclass

19797 IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G, Subclass

19798 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C1q

19799 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C1 Inhibi

19800 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C3/C3c

19802 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C4


19803 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C5a

19804 IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C5-C9

19806 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Lactoferrin

19807 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Transthyretin

19809 IVD Test Reagent/Kits, Immunoassay, Protein, Transport, Transcobalamin II

19811 IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Microglobulin

19812 IVD Test Reagent/Kits, Immunoassay, Protein, Beta-2-Microglobulin

19813 IVD Test Reagent/Kits, Immunoassay, Protein, Elastase

19814 IVD Test Reagent/Kits, Immunoassay, Protein, Trypsin


19816 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Apolipoprotein A

19817 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Apolipoprotein B

19818 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Apolipoprotein C

19819 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Apolipoprotein E

19820 IVD Test Reagent/Kits, Immunoassay, Lipoprotein, Particle a

19821 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Atrial Natriuretic P

19822 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Fatty Acid Binding

19823 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Glycogen Phospho
19824 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myosin Light Chain

19825 IVD Test Reagent/Kits, Immunoassay, Allergy, Histamine

19827 IVD Test Reagent/Kits, Immunoassay, Allergy, Leukotriene

19828 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostatic Acid Phos

19829 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Neuron Specific En

19830 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Thymidine Kinase

19831 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Cathepsin

19832 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Cathepsin D


19833 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Hormone, Calcitonin

19834 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Hormone Metabolite, Metan

19835 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Hormone Metabolite, 5-Hydro

19836 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Squamous Cell C

19837 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Tissue Polypeptid

19838 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Tissue Polypeptide

19839 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, CYFRA 21-1
19841 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 27

19842 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 50

19843 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 72

19844 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 19

19845 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 24

19846 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 54

19847 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen MCA

19848 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen Du-Pa

19849 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Heav

19850 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Heav

19851 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, He
19852 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Monoclonal Ig, Heav

19853 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Laminin

19854 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Chromogranin A

19855 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Nuclear Matrix Prot

19856 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, Oncogene

19858 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Urinary Bladder

19859 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Urinary Bladder, Cytokerati

19860 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Urinary Bladder, Tumor Anti

19861 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Fecal Occult Blood
19862 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Triiodothyronine, Free

19863 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Triiodothyronine, Revers

19864 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Binding Ratio

19865 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin

19866 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone Binding Protein, Globulin

19867 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione

19868 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, 17-Hydroxyprogesterone


19869 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Testosterone, Free

19870 IVD Test Reagent/Kits, Immunoassay, Fertility Protein, Sex Hormone Binding Glob

19871 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Estriol, Unconjugated

19872 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Estrone

19873 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gona

19874 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Placental Lac

19875 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Pregnancy Associated P

19876 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Pregnancy Specific Beta
19877 IVD Test Reagent/Kits, Immunoassay, Diabetes, Glucagon

19878 IVD Test Reagent/Kits, Immunoassay, Diabetes, Proinsulin

19879 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Angiotensin I/II

19880 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Renin

19881 IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Renin, Plasma Renin Acti

19882 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Calcitonin

19883 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Hor
19884 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Ho

19885 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Ho

19886 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Ho

19887 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism, Parathyroid Hormone-Rel

19888 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker

19889 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Ph

19890 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Osteocalcin


19891 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Pyridinoline

19892 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Deoxypyridinolin

19893 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Cyclic Adenosin

19894 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Procollagen Pepti

19895 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Procollagen-I C-Te

19896 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Procollagen-I N-Te

19897 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Collagen-I C-Telop

19898 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Cross-Linked C-Te
19899 IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Cross-Linked N-Te

19901 IVD Test Reagent/Kits, Immunoassay, Liver Metabolism

19902 IVD Test Reagent/Kits, Immunoassay, Liver Metabolism, Monoethylglycinexylidid

19903 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Adrenocorticotropin

19904 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Growth Hormone

19905 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Insulin-Like Growth Fac
19906 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Insulin-Like Growth Fact

19907 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Antidiuretic Hormone

19908 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Gonadotropin Releasi

19909 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Oxytocin

19910 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Melatonin

19911 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Catecholamine, Epine


19912 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Catecholamine, Norep

19913 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Catecholamine, Dopa

19914 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Serotonin

19915 IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Serotonin Uptake

19916 IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Bindin

19917 IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Bindin

19918 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone


19919 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Bombesin

19920 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Beta-Endorphin

19921 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Melanocyte Stim

19922 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Neurotensin

19923 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Substance P

19924 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Somatostatin

19925 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine Hormone, Vasoactive Intest


19926 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine, Cortisol Metabolite

19927 IVD Test Reagent/Kits, Immunoassay, Neuroendocrine, Cortisol Metabolite, 17-Hyd

19928 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Hormone

19929 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Hormone, Gastrin

19930 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Hormone, Gastric Inhibitor

19931 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Enzyme

19932 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Enzyme, Pepsinogen


19933 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Enzyme, Pepsinogen, Group

19934 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Enzyme, Pepsinogen, Group

19935 IVD Test Reagent/Kits, Immunoassay, Gastrointestinal Enzyme, Pancreatic Elasta

19936 IVD Test Reagent/Kits, Immunoassay, Prostaglandin

19937 IVD Test Reagent/Kits, Immunoassay, Rapid Test

19938 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Protein

19939 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Cardiac Marker

19940 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Cardiac Marker, Creatine Kinas
19941 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Cardiac Marker, Myoglobin

19942 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Cardiac Marker, Troponin I

19943 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Cardiac Marker, Troponin T

19944 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Tumor Marker

19945 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Tumor Marker, Prostate Specific

19946 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Tumor Marker, Urinary Bladder

19947 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Tumor Marker, Urinary Bladder,

19948 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Tumor Marker, Urinary Bladder,
19949 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Fertility

19950 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Fertility, Follicle Stimulating H

19951 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Fertility, Luteinizing Hormone

19952 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Pregnancy, Human Chorionic G

19953 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Pregnancy, Premature Rupture

19954 IVD Test Reagent/Kits, Immunoassay, Calibration, Protein

19955 IVD Test Reagent/Kits, Immunoassay, Calibration, Lipoprotein

19956 IVD Test Reagent/Kits, Immunoassay, Calibration, Cardiac Marker

19957 IVD Test Reagent/Kits, Immunoassay, Calibration, Allergy


19958 IVD Test Reagent/Kits, Immunoassay, Calibration, Tumor Marker

19959 IVD Test Reagent/Kits, Immunoassay, Calibration, Thyroid Hormone

19960 IVD Test Reagent/Kits, Immunoassay, Calibration, Fertility Hormone

19961 IVD Test Reagent/Kits, Immunoassay, Calibration, Pregnancy Hormone

19962 IVD Test Reagent/Kits, Immunoassay, Calibration, Diabetes

19963 IVD Test Reagent/Kits, Immunoassay, Calibration, Renal Metabolism Hormone

19964 IVD Test Reagent/Kits, Immunoassay, Calibration, Bone Metabolism Hormone

19965 IVD Test Reagent/Kits, Immunoassay, Calibration, Liver Metabolism

19966 IVD Test Reagent/Kits, Immunoassay, Calibration, Endocrine Hormone

19967 IVD Test Reagent/Kits, Immunoassay, Calibration, Neuroendocrine Hormone


19968 IVD Test Reagent/Kits, Immunoassay, Calibration, Gastrointestinal Hormone

19969 IVD Test Reagent/Kits, Immunoassay, Calibration, Prostaglandins

19970 IVD Test Reagent/Kits, Immunoassay, Calibration, Radioimmunoassay

19971 IVD Test Reagent/Kits, Immunoassay, Control, Protein

19972 IVD Test Reagent/Kits, Immunoassay, Control, Lipoprotein

19973 IVD Test Reagent/Kits, Immunoassay, Control, Cardiac Marker

19974 IVD Test Reagent/Kits, Immunoassay, Control, Allergy

19975 IVD Test Reagent/Kits, Immunoassay, Control, Tumor Marker

19976 IVD Test Reagent/Kits, Immunoassay, Control, Thyroid Hormone


19977 IVD Test Reagent/Kits, Immunoassay, Control, Fertility Hormone

19978 IVD Test Reagent/Kits, Immunoassay, Control, Pregnancy Hormone

19979 IVD Test Reagent/Kits, Immunoassay, Control, Diabetes

19980 IVD Test Reagent/Kits, Immunoassay, Control, Renal Metabolism Hormone

19981 IVD Test Reagent/Kits, Immunoassay, Control, Bone Metabolism

19982 IVD Test Reagent/Kits, Immunoassay, Control, Liver Metabolism

19983 IVD Test Reagent/Kits, Immunoassay, Control, Endocrine Hormone

19984 IVD Test Reagent/Kits, Immunoassay, Control, Neuroendocrine Hormone


19985 IVD Test Reagent/Kits, Immunoassay, Control, Gastrointestinal Hormone

19986 IVD Test Reagent/Kits, Immunoassay, Control, Prostaglandins

19987 IVD Test Reagent/Kits, Immunoassay, Standard, Protein

19988 IVD Test Reagent/Kits, Immunoassay, Standard, Lipoprotein

19989 IVD Test Reagent/Kits, Immunoassay, Standard, Cardiac Marker

19990 IVD Test Reagent/Kits, Immunoassay, Standard, Tumor Marker

19991 IVD Test Reagent/Kits, Immunoassay, Standard, Thyroid Hormone

19992 IVD Test Reagent/Kits, Immunoassay, Standard, Fertility Hormone

19993 IVD Test Reagent/Kits, Immunoassay, Standard, Pregnancy Hormone

19994 IVD Test Reagent/Kits, Immunoassay, Standard, Diabetes


19995 IVD Test Reagent/Kits, Immunoassay, Standard, Renal Metabolism Hormone

19996 IVD Test Reagent/Kits, Immunoassay, Standard, Bone Metabolism Hormone

19997 IVD Test Reagent/Kits, Immunoassay, Standard, Bone Metabolism Marker

19998 IVD Test Reagent/Kits, Immunoassay, Standard, Liver Metabolism

19999 IVD Test Reagent/Kits, Immunoassay, Standard, Endocrine Hormone

20000 IVD Test Reagent/Kits, Immunoassay, Standard, Neuroendocrine Hormone

20001 IVD Test Reagent/Kits, Immunoassay, Standard, Gastrointestinal Hormone

20002 IVD Test Reagent/Kits, Clinical Chemistry, Catecholamine Metabolite

20003 IVD Test Reagent/Kits, Clinical Chemistry, Catecholamine Metabolite, Vanillylmand

20004 IVD Test Reagent/Kits, Clinical Chemistry, Catecholamine Metabolite, Homovanilli


20005 IVD Test Reagent/Kits, Clinical Chemistry, Dehydroepiandrosterone Metabolite

20006 IVD Test Reagent/Kits, Clinical Chemistry, Dehydroepiandrosterone Metabolite, 17

20007 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry

20008 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

20009 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

20010 IVD Test Reagent/Kits, Immunocytochemistry, Tumor Marker, Receptor Assay (Ret

20011 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark


20012 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

20013 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Serum Transferrin Receptor

20014 IVD Test Reagent/Kits, Immunoassay, Vitamin, B1 (Thiamin)

20015 IVD Test Reagent/Kits, Immunoassay, Vitamin, B2 (Riboflavin)

20016 IVD Test Reagent/Kits, Immunoassay, Vitamin, B6 (Pyridoxal-5'-Phosphate)

20017 IVD Test Reagent/Kits, Immunoassay, Vitamin, D

20018 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite


20019 IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate/Vitamin B12

20020 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Digitoxin

20021 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Disopyr

20022 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, N-Acety

20023 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Procain

20024 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Propanol

20025 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Nadolol


20026 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Quinidin

20027 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Verapami

20028 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Mexileti

20029 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Amiodar

20030 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Propafe

20031 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Cardiovascular, Tocainid

20032 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Carbama

20033 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Ethosux


20034 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Phenytoi

20035 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Primido

20036 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic

20037 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic

20038 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Clonaz

20039 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Amikacin

20040 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Kanamycin


20041 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Netilmycin

20042 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Antibiotic, Chlorampheni

20043 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant

20044 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Cyc

20045 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tac

20046 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Sir


20047 IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, My

20048 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Cotinine

20049 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Lysergic Acid Diethylamide

20050 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Methaqualone

20051 IVD Test Reagent/Kits, Immunoassay, Drug-of-Abuse, Phencyclidine

20052 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant


20053 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant, Amitriptyline

20054 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant, Desipramine

20055 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant, Doxepin/Doxepi

20056 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant, Imipramine

20057 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant, Nortriptyline

20058 IVD Test Reagent/Kits, Immunoassay, Toxicology, Antidepressant, Protriptyline

20059 IVD Test Reagent/Kits, Immunoassay, Toxicology, Ethanol Consumption Marker


20060 IVD Test Reagent/Kits, Immunoassay, Toxicology, Ethanol Consumption Marker, Ca

20061 IVD Test Reagent/Kits, Immunoassay, Toxicology, Ethanol Consumption Marker,

20062 IVD Test Reagent/Kits, Immunoassay, Toxicology, Hydrocarbon Metabolite

20063 IVD Test Reagent/Kits, Immunoassay, Toxicology, Hydrocarbon Metabolite, Hippur

20064 IVD Test Reagent/Kits, Immunoassay, Toxicology, Hydrocarbon Metabolite, Phenol

20065 IVD Test Reagent/Kits, Immunoassay, Toxicology, Porphyrin Derivative


20066 IVD Test Reagent/Kits, Immunoassay, Toxicology, Porphyrin Derivative, Protoporph

20067 IVD Test Reagent/Kits, Immunoassay, Toxicology, Porphyrin Derivative, Uroporphy

20068 IVD Test Reagent/Kits, Immunoassay, Toxicology, Porphyrin Derivative, Coproporp

20069 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Diabetes, Insulin Autoantibod

20070 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Diabetes, Islet Cell Antibody

20071 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Diabetes, Glutamic Acid Deca

20072 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Diabetes, Protein Tyrosine Ph

20074 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Centromer


20075 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Double-S

20076 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Single-St

20077 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Jo-1 Antib

20078 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Polymyosi

20079 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Scleroder

20080 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Smith Ant

20081 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, Ribonucle

20082 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, SS-A/Ro A

20083 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, SS-B/La A

20084 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Connective Tissue, U1-snRNP


20085 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antiganglioside An

20086 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antiganglioside

20087 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antiganglioside

20088 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antiganglioside A

20089 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antiganglioside

20090 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antimyelin Antib

20091 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antimyelin Antib

20092 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Antimyelin Antib

20093 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Anti-CAR Antibod

20094 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Anti-CAR Antibod


20095 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Anti-Hu Antibody

20096 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Anti-Yo Antibody

20097 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neurologic, Anti-Ri Antibody

20098 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody

20099 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism, Anti-RA33 Anti

20100 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism, Antikeratin Ant

20101 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Rheumatism, Antiperinuclear

20102 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Streptokinase Antibody


20103 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Celiac Disease, Antigliadin A

20104 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Celiac Disease, Antiendomysi

20105 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Celiac Disease, Antitissue Tr

20106 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Histone Antibody

20107 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Antiphospholipid Antibody

20108 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Antiphospholipid Antibody, Ca

20109 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Neopterin

20110 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Goodpasture Disease Antibod


20111 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Nuclear Domain 10 Antibody

20112 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Antisperm Antibody

20113 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Antineutrophil Cytoplasmic An

20114 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Antineutrophil Cytoplasmic A

20115 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Amphetamine

20116 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Barbiturate

20117 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Benzodiazepine/

20118 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Cannabinoid/Met


20119 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Cocaine/Metabol

20120 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Opiate

20121 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Opiate, Morphin

20122 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Opiate, Codeine

20123 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Opiate, Propox

20124 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Opiate, Methad

20125 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Opiate, Meperid

20126 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Drug-of-Abuse, Phencyclidine


20127 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Toxicology, Antidepressant

20128 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Toxicology, Antidepressant, Tricy

20129 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Parathyroid Hormone

20130 IVD Test Reagent/Kits, Immunoassay, Calibration, Anemia Test

20131 IVD Test Reagent/Kits, Immunoassay, Calibration, Vitamin

20132 IVD Test Reagent/Kits, Immunoassay, Calibration, Therapeutic Drug

20133 IVD Test Reagent/Kits, Immunoassay, Calibration, Drug-of-Abuse

20135 IVD Test Reagent/Kits, Immunoassay, Calibration, Autoimmune Disease

20136 IVD Test Reagent/Kits, Immunoassay, Control, Anemia Test

20137 IVD Test Reagent/Kits, Immunoassay, Control, Vitamin

20138 IVD Test Reagent/Kits, Immunoassay, Control, Therapeutic Drug

20139 IVD Test Reagent/Kits, Immunoassay, Control, Drug-of-Abuse


20141 IVD Test Reagent/Kits, Immunoassay, Control, Autoimmune Disease

20142 IVD Test Reagent/Kits, Immunoassay, Standard, Anemia Test

20143 IVD Test Reagent/Kits, Immunoassay, Standard, Vitamin

20144 IVD Test Reagent/Kits, Immunoassay, Standard, Therapeutic Drug

20145 IVD Test Reagent/Kits, Immunoassay, Standard, Drug-of-Abuse

20146 IVD Test Reagent/Kits, Immunoassay, Standard, Toxicology

20147 IVD Test Reagent/Kits, Immunoassay, Standard, Autoimmune Disease

20149 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Glutathione Reductase

20150 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Transketolase


20151 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus A, Antibody, M Protein

20152 IVD Test Reagent/Kits, Cytology/Histology, Calibration, Flow Cytometry

20153 IVD Test Reagent/Kits, Cytology/Histology, Control, Flow Cytometry

20156 Testers, Impedance

20157 Testers, Impedance, Electrode/Lead/Cable, Electroencephalographic

20160 Monitors, Physiologic, Electroencephalography, Intraoperative, Level-of-Consciou

20161 Scanning Systems, Computed Tomography/Positron Emission Tomography


20162 Testers, Pulse Oximetry Monitor

20163 Testers, Electrical Safety/Medical Device Performance

20164 Power Meters

20165 Power Meters, Radiofrequency

20166 Power Meters, Ultrasound, Therapeutic Unit, Shock Wave

20167 Auditory Function Screening Devices, Newborn


20170 Monitors, Physiologic, Multipurpose, Bedside

20171 Monitors, Physiologic, Multipurpose, Bedside, Modular

20172 Monitors, Physiologic, Multipurpose, Bedside, Configured

20173 Monitors, Physiologic, Multipurpose, Bedside, Modular/Configured

20174 Monitors, Physiologic, Cardiac Output, Bedside

20175 Monitors, Physiologic, Neurology, Electromyography, Bedside

20176 Monitors, Physiologic, Blood Gas/pH, Bedside, Intravascular


20177 Monitors, Physiologic, Respiration, Anesthetic Gas, Intraoperative

20178 Monitors, Physiologic, Multiparameter/Anesthetic-Respiratory Gas, Beside/Intraop

20179 Monitors, Physiologic, Central Station

20181 Monitors, Physiologic, Uterine Activity, Telemetric

20182 Monitors, Physiologic, Intracranial Pressure, Telemetric


20184 Monitors, Physiologic, Glucose, Personal

20185 Monitors, Physiologic, Glucose, Personal, Implantable Sensor

20186 Monitors, Physiologic, Glucose, Personal, Noninvasive

20187 Monitors, Physiologic, Pulse Rate, Personal


20188 Monitors, Environmental

20189 Monitors, Environmental, Nitrogen Oxide/Dioxide

20190 Monitors, Compressed Air/Gas

20191 Monitors, Compressed Air/Gas, Multigas

20192 Monitors, Electrical Safety

20193 Monitors, Electrical Safety, Electrosurgery

20194 Monitors, Laboratory, Water Purity


20195 Monitoring Systems

20196 Recorders, Physiologic, Physical Activity

20197 Recorders, Physiologic, Sleep/Awake

20198 Analyzers, Point-of-Care, Breath, Carbon Monoxide

20199 Needles, Injection

20200 Needles, Injection, Hypodermic, Dental

20201 Needles, Injection, Hypodermic, Ophthalmic


20202 Needles, Injection, Intramuscular

20203 Needles, Aspiration/Injection, Biliary Duct

20204 Needles, Injection, Intraligamentary

20205 Needles, Injection, Intraligamentary, Dental

20206 Needles, Injection, Intraosseous

20207 Needles, Injection, Intraosseous, Dental

20208 Needles, Aspiration, Cardiac

20209 Needles, Aspiration, Ophthalmic

20210 Needles, Aspiration, Uterine

20211 Needles, Aspiration, Uterine, Ovum Collection

20212 Needles, Aspiration/Injection


20213 Needles, Aspiration/Injection, Brain

20214 Needles, Aspiration/Irrigation

20215 Needles, Aspiration/Irrigation, Uterine

20216 Needles, Aspiration/Irrigation, Uterine, Ovum Collection

20217 Needles, Aspiration/Irrigation, Dental

20218 Needles, Aspiration/Irrigation, Ophthalmic

20220 Needles, Ligature

20221 Needles, Local Block

20222 Needles, Local Block, Pudendal

20223 Needles, Local Block, Retrobulbar

20224 Needles, Local Block, Peripheral

20225 Needles, Local Block, Peripheral, Insulated


20226 Needles, Dental Procedure

20227 Needles, Dental Procedure, Filling/Impression Material

20228 Needles, Ophthalmic Procedure

20229 Needles, Hemodialysis

20230 Needles, Hemodialysis, Arteriovenous Fistula

20231 Needles, Endoscopic Procedure

20232 Needles, Endoscopic Procedure, Bronchial Aspiration

20233 Needles, Endoscopic Procedure, Cardiac

20234 Needles, Brachytherapy


20236 Needles, Biopsy, Soft Tissue

20237 Needles, Biopsy, Breast

20238 Needles, Biopsy, Brain

20239 Needles, Biopsy, Amniocentesis

20240 Needles, Biopsy, Intraosseous

20241 Needles, Biopsy, Intraosseous, Bone Marrow

20242 Needles, Lesion Localization

20243 Needles, Lesion Localization, Breast


20244 Needles, Catheter Introduction

20245 Needles, Suture, Surgical

20246 Needles, Suture, Surgical, Cutting Edge

20247 Needles, Suture, Surgical, Taper Point

20248 Needles, Suture, Surgical, Blunt Point

20249 Needles, Suture, Ophthalmic

20250 Needles, Suture, Ophthalmic, Cutting Edge

20251 Needles, Suture, Ophthalmic, Taper Point

20252 Needles, Suture, Dental

20253 Needles, Suture, Dental, Cutting Edge

20254 Needles, Suture, Postmortem


20255 Syringes, Plunger

20257 Syringes, Plunger, Luer Slip

20258 Syringes, Plunger, Protective, Luer Slip

20259 Syringes, Plunger, Luer Lock

20260 Syringes, Plunger, Protective, Luer Lock

20261 Syringes, Plunger, Fixed Needle

20262 Syringes, Plunger, Protective, Fixed Needle

20264 Syringes, Plunger, Luer Slip, Eccentric Tip

20265 Syringes, Plunger, Protective, Luer Slip, Eccentric Tip


20266 Syringes, Plunger, Luer Lock, Eccentric Tip

20267 Syringes, Plunger, Protective, Luer Lock, Eccentric Tip

20268 Syringes, Plunger, Fixed Needle, Eccentric Tip

20269 Syringes, Plunger, Protective, Fixed Needle, Eccentric Tip

20270 Syringes, Plunger, Catheter Tip, Aspiration/Irrigation

20271 Syringes, Plunger, Insulin, Luer Slip

20272 Syringes, Plunger, Insulin, Protective, Luer Slip

20273 Syringes, Plunger, Insulin, Luer Lock

20274 Syringes, Plunger, Insulin, Protective, Luer Lock


20275 Syringes, Plunger, Insulin, Fixed Needle

20276 Syringes, Plunger, Insulin, Protective, Fixed Needle

20277 Syringes, Plunger, Tuberculin/Allergy, Luer Slip

20278 Syringes, Plunger, Tuberculin/Allergy, Protective, Luer Slip

20279 Syringes, Plunger, Tuberculin/Allergy, Luer Lock

20280 Syringes, Plunger, Tuberculin/Allergy, Protective, Luer Lock

20281 Syringes, Plunger, Tuberculin/Allergy, Fixed Needle

20282 Syringes, Plunger, Tuberculin/Allergy, Protective, Fixed Needle

20283 Syringes, Plunger, Arterial Blood Sampling, Luer Lock

20284 Syringes, Plunger, Arterial Blood Sampling, Protective, Luer Lock


20285 Syringes, Plunger, Arterial Blood Sampling, Luer Slip

20286 Syringes, Plunger, Arterial Blood Sampling, Protective, Luer Slip

20287 Syringes, Plunger, Contrast Media

20288 Syringes, Plunger, Dental

20289 Syringes, Plunger, Dental, Filling Material

20290 Syringes, Plunger, Prefilled

20291 Syringes, Plunger, Prefilled, Medication

20292 Syringes, Plunger, Prefilled, Medication, Luer Lock

20293 Syringes, Plunger, Prefilled, Medication, Protective, Luer Lock

20294 Syringes, Plunger, Prefilled, Medication, Blunt Cannula

20295 Syringes, Plunger, Prefilled, Catheter Flush


20296 Syringes, Plunger, Prefilled, Catheter Flush, Luer Lock

20297 Syringes, Plunger, Prefilled, Catheter Flush, Blunt Cannula

20298 Syringes, Plunger, Laboratory

20299 Syringes, Plunger, Laboratory, Sample Preparation/Injection

20300 Syringes, Plunger, Laboratory, Sample Preparation/Filtering

20301 Syringes, Plunger, Laboratory, Chromatography

20302 Syringes, Plunger, Laboratory, Chromatography, Thin-Layer

20303 Syringes, Plunger, Calibration

20304 Syringes, Cartridge, Luer Lock


20305 Syringes, Cartridge, Protective, Luer Lock

20306 Syringes, Cartridge, Dental

20307 Syringes, Cartridge, Dental, Anesthetic, Protective

20308 Syringes, Cartridge, Dental, Impression/Filling Material

20309 Syringes, Cartridge, Insulin

20310 Syringes, Cartridge, Insulin, Penlike

20311 Syringes, Bulb

20312 Syringes, Bulb/Barrel

20313 Syringes, Air System

20314 Syringes, Air System, Dental

20315 Injectors, Medication/Vaccine, Syringe, Insulin


20316 Staplers

20317 Staplers, Surgical

20318 Staplers, Surgical, Linear

20319 Staplers, Surgical, Linear, Gastrointestinal

20320 Stapler/Cutters, Surgical, Linear, Gastrointestinal Tract

20321 Staplers, Surgical, Linear, Vascular

20322 Staplers, Surgical, Circular


20323 Staplers, Surgical, Circular, Hemorrhoid

20324 Staplers, Skin

20325 Staples, Bone, Compression

20326 Staples, Bone, Compression, Separate-Leg

20327 Staples, Bone, Compression, Heat Reshaping

20328 Staples, Gastrointestinal/Internal Organ

20329 Staples, Vascular

20330 Staples, Skin


20332 Power Supplies, Regulated, Staple Reshaping

20333 Pacemakers, Gastric

20334 Programmer/Testers

20335 Programmer/Testers, Implantable Gastric Pacemaker

20336 Showers

20337 Showers, Emergency, Portable

20338 Tables, Decontamination


20339 Tables, Decontamination, Portable

20340 Modular Medical Facilities, Stationary, Personnel Shower/Decontamination

20341 Modular Medical Facilities, Mobile, Personnel Shower/Decontamination

20342 Protection Garments, Environmental, Decontamination/Cleaning

20343 Protection Garments, Environmental, Contaminated Area Rescuer


20344 Protection Garments, Environmental, Decontamination Re-Dressing

20345 Gloves, Chemical Resistant

20346 Covers, Shoe, Chemical Resistant

20347 Tags

20348 Tags, Medical Triage

20349 Tags, Emergency Controlled Access

20350 Tags, Cadaver


20351 Alarms, Gravity Infusion

20352 Brachytherapy Systems

20353 Brachytherapy Systems, Intravascular

20354 Catheters, Vascular, Brachytherapy

20355 Computer-Aided Detection Systems

20356 Computer-Aided Detection Systems, Image, Lung Nodule

20357 Monitors, Laboratory


20358 Respirators

20359 Respirators, Air-Purifying, Particulate

20360 Respirators, Air-Purifying, Gas/Vapor

20361 Respirators, Air-Purifying, Particulate/Gas/Vapor

20362 Respirators, Air-Supplying

20363 Respirators, Air-Supplying, Stationary Source

20364 Respirators, Air-Supplying, Self-Contained


20365 Respirators, Air-Supplying, Stationary Source/Emergency Container

20366 Monitors, Physiologic, Respiration, Respiratory Gas, Inspired Oxygen, Bedside/Int

20369 Water-Jet Surgical Units

20370 Water-Jet Surgical Units, Arthroscopic

20371 Eye-Drop Delivery Aids

20372 Microspheres, Embolization, Brachytherapy


20373 Gel, Postsurgical Adhesion Inhibition

20374 Solutions, Postsurgical Adhesion Inhibition

20375 Pacemakers, Cardiac, Implantable, Resynchronization

20376 Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization

20377 Leads, Implantable Defibrillator/Pacemaker, Resynchronization

20378 Scanning Systems, Ultrasonic, Endoscopic


20379 Lasers, Carbon Dioxide, Transmyocardial Revascularization

20380 Lasers, Ho:YAG, Transmyocardial Revascularization

20381 Lasers, Ho:YAG, Percutaneous Myocardial Revascularization

20382 Catheters, Cardiac, Laser Percutaneous Myocardial Revascularization

20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

20384 Stents, Vascular, Coronary, Balloon-Expandable, Bioactive-Coated

20385 Analyzers, Point-of-Care, Whole Blood, Glycated Hemoglobin


20386 Analyzers, Point-of-Care, Whole Blood/Urine, Multianalyte, Diabetes

20387 Stereotactic Systems, Image-Guided, Surgical, Otorhinolaryngology

20388 Automation Systems, Operating Room

20389 Video Systems, Endoscopic, Chip Camera


20390 Video Systems, Endoscopic, Video Adapter

20391 Video Systems, Endoscopic, Ingestible Camera

20392 Cameras, Video, Ingestible

20393 Information Systems, Data Management, Perioperative


20394 Noncontact Normothermic Wound Therapy Systems

20395 Negative-Pressure Wound Therapy Systems

20398 Prostheses, Heart, Transcutaneously Powered


20399 Microspheres

20400 Microspheres, Embolization

20401 Syringes, Plunger, Protective

20402 Microspheres, Embolization, Hyperthermia

20403 Microspheres, Embolization, Drug Delivery

20404 Microspheres, Regional Blood Flow Measurement

20405 Microspheres, Device Calibration/Laboratory


20409 Gowns, Splash, Protection

20410 Programmer/Testers, Implantable Incontinence Stimulator

20411 Programmer/Testers, Implantable Infusion Pump

20412 Occluders, Vascular, Intravascular Embolization, Particulate

20413 Occluders, Vascular, Presacral Bleeding

20414 Occluders, Cardiac, Septum

20415 Occluders, Fallopian Tube

20416 Occluders, Umbilical Cord


20417 Ear Muffs

20418 Stents, Biliary, Polymeric

20419 Stents, Biliary, Metallic

20420 Stents, Biliary, Metallic, Balloon-Expandable

20421 Stents, Biliary, Metallic, Self-Expanding

20422 Stents, Vascular, Coronary, Balloon-Expandable

20425 Stents, Vascular, Coronary, Self-Expanding

20426 Stents, Vascular, Carotid


20427 Stents, Vascular, Carotid, Self-Expanding

20428 Stents, Vascular, Renal Artery

20429 Stents, Vascular, Peripheral, Balloon-Expandable

20430 Stents, Vascular, Peripheral, Self-Expanding

20431 Stents, Bronchial, Polymeric

20432 Stents, Bronchial, Metallic

20433 Stents, Bronchial, Metallic, Balloon-Expandable

20434 Stents, Bronchial, Metallic, Self-Expanding


20435 Stents, Tracheal, Polymeric

20436 Stents, Tracheal, Polymeric, T-Shaped

20437 Stents, Tracheal, Metallic

20438 Stents, Tracheal, Metallic, Balloon-Expandable

20439 Stents, Tracheal, Metallic, Self-Expanding

20440 Stents, Tracheobronchial

20441 Stents, Laryngeal


20442 Stents, Esophageal, Polymeric

20443 Stents, Esophageal, Metallic

20444 Stents, Esophageal, Metallic, Self-Expanding

20445 Stents, Pancreatic, Polymeric

20446 Stents, Pancreatic, Metallic

20447 Stents, Pancreatic, Metallic, Self-Expanding

20448 Stents, Pancreatic, Metallic, Balloon-Expandable


20449 Stents, Colonic

20450 Stents, Dental

20451 Stent/Grafts

20452 Stent/Grafts, Vascular, Coronary

20453 Stent/Grafts, Vascular, Aortic

20454 Stent/Grafts, Vascular, Aortoiliac


20455 Stent/Grafts, Vascular, Peripheral

20456 Needles, Injection, Subcutaneous Port, Protective

20459 Airway Clearance Units, Insufflation/Exsufflation

20460 IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Influenza

20461 Syringes, Plunger, Insulin, Protective

20462 Digitizers

20463 Digitizers, Document


20464 Digitizers, Video

20465 Digitizer/Recorders, Video

20466 Aprons, Infant Evacuation

20467 Syringes, Plunger, Tuberculin/Allergy

20468 Syringes, Plunger, Tuberculin/Allergy, Protective

20469 Syringes, Plunger, Oral Medication

20470 Syringes, Plunger, Arterial Blood Sampling


20471 Syringes, Plunger, Arterial Blood Sampling, Protective

20472 Syringes, Cartridge, Protective

20473 Syringes, Cartridge, Dental, Anesthetic, Intraligamentary

20474 Syringes, Air/Water Systems, Dental

20475 Endoscopes

20476 Endoscopes, Respiratory Tract

20477 Endoscopes, Gastrointestinal Tract

20478 Endoscopes, Gastrointestinal Tract, Upper Tract

20479 Endoscopes, Gastrointestinal Tract, Lower Tract

20480 Choledochoscopes, Percutaneous

20481 Choledochoscopes, Laparoscopic

20482 Choledochoscopes, Transduodenal


20483 Endoscopes, Urinary Tract

20484 Laparoscopes, Diagnostic

20485 Laparoscopes, Surgical

20486 Encephaloscopes, Rigid

20487 Encephaloscopes, Flexible

20488 Sialoscopes

20489 Specula, Pharyngeal

20490 Prostheses, Cardiac Ventricle


20491 Prostheses, Cardiac Ventricle, Percutaneously Powered

20492 Prostheses, Cardiac Ventricle, Transcutaneously Powered

20493 Detectors

20494 Detectors, Environmental


20495 Detectors, Environmental, Chemical Agent

20496 Detectors, Environmental, Chemical Agent, Nerve

20497 Detectors, Environmental, Chemical Agent, Blister


20498 Detectors, Environmental, Chemical Agent, Toxic Industrial Material

20499 Detectors, Environmental, Chemical Agent, Remote Sensing

20500 Detectors, Environmental, Chemical Agent, Telemetric

20501 Detectors, Environmental, Chemical Agent, Telemetric, Air-Drop Sonde

20502 Detectors, Environmental, Biological Agent


20503 Detectors, Environmental, Biological Agent, Remote Sensing

20504 Detectors, Environmental, Biological Agent, Telemetric

20505 Detectors, Environmental, Biological Agent, Telemetric, Air-Drop Sonde

20506 Detectors, Environmental, Ionizing Radiation

20507 Detectors, Environmental, Ionizing Radiation, Low-Level


20508 Detectors, Environmental, Ionizing Radiation, High-Level

20509 Detectors, Environmental, Explosive Trace

20510 Detectors, Environmental, Narcotic Trace

20511 Detectors, Environmental, Explosive/Narcotic Trace

20512 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, pH, Strip
20513 IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Chemical Agent

20514 Detection Kits

20515 Detection Kits, Chemical Agent

20516 Detection Kits, Chemical Agent, Strip-Reagent


20517 Detection Kits, Chemical Agent, Colorimetric Tube

20518 Detection Kits, Chemical Agent, Water Testing

20519 Detection Kits, Biological Agent

20520 Detection Kits, Explosive Trace


20521 Monitors, Environmental, Chemical Agent

20522 Monitors, Environmental, Chemical Agent, Nerve/Blister

20523 Monitors, Environmental, Chemical Agent, Toxic Industrial Material

20524 Simulators, Environmental Detector/Monitor


20525 Simulators, Environmental Detector/Monitor, Chemical Agent

20526 Simulators, Environmental Detector/Monitor, Chemical Agent, Chemical Simulant

20527 Simulators, Environmental Detector/Monitor, Chemical Agent, Nonchemical Simu

20528 Simulators, Environmental Detector/Monitor, Biological Agent

20529 Simulators, Environmental Detector/Monitor, Ionizing Radiation

20530 Simulators, Environmental Detector/Monitor, Ionizing Radiation, Gamma

20531 Simulators, Environmental Detector/Monitor, Ionizing Radiation, Alpha/Beta


20532 Modular Medical Facilities, Mobile, Chemical/Biological Agent Detection

20533 Samplers

20534 Samplers, Laboratory

20535 Samplers, Laboratory, Manual

20536 Samplers, Laboratory, Automated

20537 Samplers, Environmental


20538 Samplers, Environmental, Air, Biological Agent

20539 Samplers, Environmental, Water

20540 Procedure Kit/Trays, Sampling, Hazardous Material

20541 Needles, Injection, Bifurcated

20542 Needles, Injection, Bifurcated, Protective


20543 Procedure Kit/Trays, Vaccination, Smallpox

20544 Radiotherapy Systems, Neutron Beam

20545 Radiotherapy Systems, Neutron Beam, Fast Neutron

20546 Radiotherapy Systems, Proton Beam

20547 Radiotherapy Simulation Systems, Radiographic/Fluoroscopic-Based

20548 Radiotherapy Simulation Systems, Computed Tomography-Based


20549 Catheters, Pleural

20550 Catheters, Pleural, Drainage

20551 Procedure Kit/Trays, Drainage, Pleural

20552 Decontaminants

20553 Decontaminants, Physical Removal

20554 Decontaminants, Physical Removal, Nonplastic Kaolin


20555 Decontaminants, Chemical Neutralization

20556 Decontaminants, Chemical Neutralization, Oxidizing

20557 Decontaminants, Chemical Neutralization, Oxidizing, Foam

20558 Decontaminants, Chemical Neutralization, Oxidizing, Foam, Binary

20559 Decontaminants, Chemical Neutralization, Oxidizing, Gel

20560 Decontaminants, Chemical Neutralization, Strong Base


20561 Decontaminants, Chemical Neutralization, Strong Base, Solution Number 2

20562 Decontaminants, Chemical Neutralization, Microemulsion

20563 Decontaminants, Chemical Neutralization, Microemulsion, C8

20564 Decontaminants, Chemical Neutralization, Catalytic Enzyme

20565 Decontaminants, Physical Removal/Chemical Neutralization, Resin

20566 Decontaminants, Physical Removal/Chemical Neutralization, Viscous Solution


20567 Procedure Kit/Trays, Decontamination

20568 Procedure Kit/Trays, Decontamination, Skin

20569 Procedure Kit/Trays, Decontamination, Skin, Chemical Neutralization

20570 Procedure Kit/Trays, Decontamination, Personal Gear


20571 Procedure Kit/Trays, Decontamination, Personal Gear, Removal/Neutralization Res

20572 Procedure Kit/Trays, Decontamination, Skin/Personal Gear

20573 Procedure Kit/Trays, Decontamination, Skin/Personal Gear, Nonplastic Kaolin


20574 Procedure Kit/Trays, Decontamination, Training

20575 Towelettes, Personal, Skin/Personal Gear Decontamination

20576 Decontamination Units

20577 Decontamination Units, Physical Removal

20578 Decontamination Units, Physical Removal, High-Pressure Water

20579 Decontamination Units, Physical Removal, High-Pressure Gas/Particulate


20580 Decontamination Units, Chemical Neutralization

20581 Decontamination Units, Chemical Neutralization, Microemulsion

20582 Decontamination Units, Chemical Neutralization, Spray

20583 Decontamination Units, Physical Removal/Chemical Neutralization

20584 Decontamination Units, Physical Removal/Chemical Neutralization, Ultrasonic

20585 Decontamination Systems


20586 Decontamination Systems, Outdoor Equipment/Vehicle/Facility

20587 Decontamination Systems, Multiple Garment/Personal Gear

20588 Decontamination Systems, Antidispersive/Blast Foam

20589 Chambers, Decontamination

20590 Chambers, Decontamination, High-Pressure Carbon Dioxide/Particulate

20591 Cabinets, Storage


20593 Cabinets, Storage, Medicine, Computerized

20594 Cabinets, Storage, Medicine, Narcotic Control, Refrigerator-Mounted

20595 Cabinets, Storage, Instrument, Wall-Mounted

20596 Cabinets, Storage, Instrument, Stand-Alone

20597 Cabinets, Storage, Endoscope

20598 Cabinets, Storage, Catheter


20599 Cabinets, Storage, Catheter, Computerized

20600 Cabinets, Storage, Desiccating, Inert Atmosphere

20601 Cabinets, Storage, Acid/Corrosives

20602 Cabinets, Storage, Acid/Corrosives, Strong Acid

20603 Cabinets, Storage, Flammable Liquid

20604 Cabinets, Storage, Flammable Liquid, Paint/Ink

20605 Cabinets, Storage, Flammable Liquid, Drum

20606 Cabinets, Storage, Medical Gas Cylinder


20607 Cabinets, Storage, Bedpan/Urinal

20608 Cabinets, Storage, Isotope

20609 Cabinets, Storage, Radiotherapy Blocking Tray

20610 Cabinets, Storage, Fire Extinguisher

20611 Cabinets, Storage, Fire Blanket

20612 Cabinets, Storage, Tool

20613 Cabinets, Storage, Small Component/Supply


20614 Cabinets, Storage, Key

20615 Cabinets, Storage, Key, Computerized

20616 Cabinets, Storage, Laboratory

20617 Cabinets, Storage, Laboratory, Pathology Specimen

20618 Cabinets, Storage, Kitchen/Food Supply

20619 Cabinets, Food Display


20620 Cabinets, Storage, General-Purpose

20621 Cabinets, Storage, General-Purpose, Stand-Alone

20622 Cabinets, Storage, General-Purpose, Wall-Mounted

20623 Cabinets, Storage, General-Purpose, Undercounter

20624 Cabinets, Storage, Intravenous Solution, Pole-Mounted

20625 Cabinets, Storage, General-Purpose/Wardrobe


20626 Cabinets, Treatment

20627 Cabinets, Treatment, Otorhinolaryngology

20628 Cabinets, Treatment, Ophthalmology

20629 Cabinets, Filing

20630 Cabinets, Filing, Lateral


20631 Cabinets, Filing, Lateral, Fire-Resistant

20632 Cabinets, Filing, Vertical

20633 Cabinets, Filing, Vertical, Fire-Resistant

20634 Cabinets, Filing, Pedestal

20635 Cabinets, Filing, Pedestal, Fire-Resistant


20636 Cabinets, Filing, Card

20637 Cabinets, Filing, Card, Fire-Resistant

20638 Cabinets, Filing, Medical Chart

20639 Cabinets, Filing, Multimedia

20640 Cabinets, Filing, Multimedia, Fire-Resistant

20641 Cabinets, Filing, Audio Cassette


20642 Cabinets, Filing, Compact Disk

20643 Cabinets, Filing, Video Cassette

20644 Cabinets, Filing, Digital Versatile Disk

20645 Cabinets, Filing, Slide

20646 Cabinets, Filing, Embedding Ring/Cassette

20647 Cabinets, Filing, Large Document

20648 Cabinets, Filing, Large Document, Flat Storage

20649 Cabinets, Filing, Large Document, Vertical Storage


20650 Cabinets, Filing, Large Document, Rolled Storage

20651 Cabinets, Storage, General-Purpose/Lateral Filing

20652 Cabinets, Biological Safety, Class I

20653 Cabinets, Biological Safety, Class II

20654 Cabinets, Biological Safety, Class III


20655 Pass-Throughs

20656 Pass-Throughs, Enclosed, Clean Room

20657 Pass-Throughs, Enclosed, Clean Room, Personnel

20658 Pass-Throughs, Enclosed, Laboratory

20659 Pass-Throughs, Revolving

20660 Pass-Throughs, Open

20661 Warming Units, Food


20662 Controllers, Air/Nitrogen Pressure

20663 Procedure Kit/Trays, Decontamination, Skin, Removal/Neutralization Resin

20664 Analyzers, Laboratory, Hematology, Blood/Component Volume

20665 Syringes, Plunger, Prefilled, Blood Volume Tracer, Luer Lock


20666 Nucleic Acid Processors, Purification

20667 Nucleic Acid Processors, Replication

20668 Analyzers, Laboratory, Molecular Assay

20669 IVD Test Reagent/Kits, Immunoassay, Pregnancy, Phospholipid/Albumin Ratio

20670 Pipette Fillers, Safety


20671 Orbital Floor Implants

20672 Air Pressure Therapy Units, Middle Ear

20673 Tissue Bulking Agents, Gastrointestinal

20674 Procedure Kit/Trays, Bulking Agent Injection, Gastrointestinal

20676 Signs, Identification

20680 Syringes, Plunger, Protective, Radiopharmaceutical


20681 Needles, Catheter Introduction, Protective

20682 Water Purification Systems, Reverse Osmosis, Hemodialysis

20683 Water Purification Systems, Reverse Osmosis, Hemodialysis, Mobile/Portable

20684 Occluders, Fallopian Tube, Transcervical


20686 Brachytherapy Applicators, Manual, Interstitial/Intracavitary, Liquid Radioisotope

20687 Catheters, Intracranial, Brachytherapy, Liquid Radioisotope

20688 Prostheses, Intervertebral Disk

20689 Prostheses, Intervertebral Disk, Total

20690 Prostheses, Intervertebral Disk, Partial

20691 Wheelchairs, Powered, Climbing/Lifting


20692 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Brain Natriuretic P

20693 Analyzers, Physiologic, Metabolic Rate

20694 Analyzers, Physiologic, Metabolic Rate, Oxygen Based

20697 Information Systems, Data Management, Bar-Code

20698 Information Systems, Data Management, Bar-Code, Medication Administration


20699 Information Systems, Data Management, Bar-Code, Specimen Collection

20700 Protection Garments, Environmental, Chemical/Biological Agent

20701 Protection Garments, Environmental, Chemical/Biological Agent, Undergarment

20702 Masks, Chemical/Biological Agent Protection

20703 Respirators, Air-Purifying, Particulate/Gas/Vapor, Chemical/Biological Agent


20704 Testers, Protective Mask/Respirator Leakage

20705 Shelters

20706 Shelters, Chemical/Biological/Radioactive Particle Protection

20707 Environmental Control Units

20708 Environmental Control Units, Chemical/Biological/Radioactive Particle

20709 Air Cleaners, Particulate

20710 Air Cleaners, Particulate/Gas/Vapor


20711 Air Cleaners, Particulate/Gas/Vapor, Toxic Industrial Contaminant

20712 Air Cleaners, Particulate/Gas/Vapor, Chemical Agent

20713 Filters, Air, Particulate

20714 Filters, Air, Particulate, Low-Efficiency

20715 Filters, Air, Particulate, High-Efficiency

20716 Filters, Air, Particulate, Ultra-Low Penetration


20717 Filters, Air, Particulate, Mask/Respirator Cartridge

20718 Filters, Air, Gas/Vapor

20719 Filters, Air, Gas/Vapor, Toxic Industrial Contaminant

20720 Filters, Air, Gas/Vapor, Toxic Industrial Contaminant, Mask/Respirator Cartridge

20721 Filters, Air, Gas/Vapor, Chemical Agent

20722 Filters, Air, Gas/Vapor, Chemical Agent, Mask/Respirator Cartridge

20723 Procedure Kit/Trays, Emergency, Chemical/Biochemical Agent Protection


20724 Procedure Kit/Trays, Emergency, Chemical/Biochemical Agent Protection, Adult

20725 Procedure Kit/Trays, Emergency, Chemical/Biochemical Agent Protection, Infant

20726 Tissue Bulking Agents

20727 Tissue Bulking Agents, Urologic

20728 Capnometers
20729 Capnometers, Exhaled Gas

20730 Capnometers, Sublingual Tissue

20731 Monitors, Physiologic, Gastrointestinal Tissue, Carbon Dioxide, Bedside

20732 Probes, Sublingual Tissue Capnometer

20733 Airway Clearance Units, Positive Expiratory Pressure

20734 Airway Clearance Units, Positive Expiratory Pressure, Oscillatory


20735 Airway Clearance Units, Positive Expiratory Pressure, Oscillatory, Flutter Valve

20736 Airway Clearance Units, Positive Expiratory Pressure, Oscillatory, Magnetic Valve

20737 Airway Clearance Units, Oscillatory Intrapulmonary Percussion

20738 Airway Clearance Units, High-Frequency Chest Wall Oscillation

20739 Airway Clearance Units, High-Frequency Chest Wall Oscillation, Percussion


20740 Airway Clearance Units, High-Frequency Chest Wall Oscillation, Vest

20741 Airway Clearance Units, High-Frequency Chest Wall Oscillation, Cuirass

20742 Positive Airway Pressure Units

20743 Positive Airway Pressure Units, Bi-Level

20744 Positive Airway Pressure Units, Expiratory


20745 Positive Airway Pressure Units, Intermittent

20746 Ventilators, Noninvasive Positive Pressure

20747 Stimulators, Electrical, Vagus Nerve

20748 Detectors, Air Bubble/Foam, Apheresis Unit

20749 Detectors, Liquid Level

20751 Detectors, Air Bubble/Foam/Fluid Level


20752 Detectors, Blood Leakage, Hemodialysis Unit

20753 Detectors, Strain, Eyeglass Lens

20754 Detectors, Blood Flow

20755 Detectors, Esophageal Intubation, Suction

20756 Detectors, Dental Caries

20757 Detectors, Dental Caries, Induced Fluorescence

20758 Detectors, Dental Caries, Electrical Impedance

20759 Dental Materials, Caries Detection, Dye


20760 Voltmeters, Electrostatic

20761 Microspheres, Embolization, Uterine Artery

20762 Syringes, Plunger, Prefilled, Embolization Agent

20763 Dictation Systems, Digital, Speech Recognition/Transcription

20764 Image Storage Plates, Radiography

20765 Cassettes, Radiography, Image Plate


20766 Image Digitization Systems, Computed Radiography, Mammography

20767 Detectors, X-Ray, Digital Radiography, Intraoral

20768 Image Digitization Systems, Computed Radiography, Dental

20770 Physiologic Monitor Modules

20771 Physiologic Monitor Modules, Electrocardiography


20772 Physiologic Monitor Modules, Invasive Blood Pressure

20773 Physiologic Monitor Modules, Noninvasive Blood Pressure

20774 Physiologic Monitor Modules, Cardiac Output


20775 Physiologic Monitor Modules, Apnea/Respiratory Rate

20776 Physiologic Monitor Modules, Exhaled Carbon Dioxide

20777 Physiologic Monitor Modules, Inspired Oxygen


20778 Physiologic Monitor Modules, Anesthetic Gas

20779 Physiologic Monitor Modules, Temperature

20780 Physiologic Monitor Modules, Transcutaneous Blood Gas


20781 Physiologic Monitor Modules, Pulse Oximetry

20782 Physiologic Monitor Modules, Intravascular Oximetry


20783 Physiologic Monitor Modules, Electroencephalography

20784 Physiologic Monitor Modules, Multiparameter

20787 Cassettes, Radiography


20788 Cassettes, Radiography, Image Plate, Mammography

20789 Image Storage Plates

20790 Image Storage Plates, Radiography, Mammography

20791 Detectors, X-Ray, Digital Radiography

20792 Detectors, X-Ray, Digital Radiography, Mammography

20793 Radiographic Systems, Digital, Table

20794 Reader/Digitizers, Image Plate, Radiography


20795 Reader/Digitizers, Image Plate, Mammography

20796 Workstations, Digital Radiography

20797 Workstations, Digital Radiography, Dental

20798 Workstations, Digital Radiography, Mammographic

20799 Workstations, Radiotherapy


20800 Information Systems, Data Management, Oncology, Radiotherapy

20801 Molecular Assay Microarray Arrayers

20802 Analyzers, Laboratory, Molecular Assay, Infectious Microorganism

20803 Analyzers, Laboratory, Molecular Assay, Genetic Testing


20804 Analyzers, Laboratory, Molecular Assay, Microarray

20805 Reader/Digitizers, Molecular Assay Microarray

20806 Incubators, Laboratory, Thermocycling, Microarray

20807 Chambers, Laboratory, Microarray Hybridization

20808 Nucleic Acid Processors


20809 Nucleic Acid Processors, Sequencing

20810 Nucleic Acid Processors, Replication, Isothermal

20811 Nucleic Acid Processors, Replication, Thermal Cycle

20812 Nucleic Acid Processors, Synthesis

20813 Protein/Peptide Processors

20814 Protein/Peptide Processors, Sequencing


20815 Protein/Peptide Processors, Synthesis

20816 Molecular Microarrays

20817 Molecular Microarrays, Expression Analysis

20818 Molecular Microarrays, Comparative Genomic

20819 Molecular Microarrays, Mutation/Polymorphism


20820 Molecular Microarrays, Mutation/Polymorphism, Gene CYP2D6/CYP2C19

20821 Analyzers, Laboratory, Clinical Chemistry/Immunoassay

20850 Stimulators, Electrical, Joint, Analgesic, Transcutaneous

20851 Leads, Implantable Cardiac Pacemaker

20858 Electrothermal Cautery Units, High-Resistance, Transcatheter, Angioplasty


20859 Electrothermal Cautery Units, High-Resistance, Transcatheter

20860 Electrothermal Cautery Units, High-Resistance, Transcatheter, Intervertebral Disc

20861 Catheters, Spinal, Intervertebral Disc, Electrothermal Cautery

20862 Catheters, Spinal, Intervertebral Disc, Radiofrequency Ablation

20863 Probes, Electrothermal Cautery


20864 Probes, Electrothermal Cautery, Covered

20865 Probes, Electrothermal Cautery, Covered, Irrigated

20866 Probes, Electrothermal Cautery, Uncovered

20867 Radiofrequency Generators

20884 Sutures, Synthetic, Absorbable, Poliglecaprone

20888 Fire Extinguishers, Portable


20913 Brachytherapy Applicators

20914 Brachytherapy Applicators, Manual

20915 Brachytherapy Applicators, Manual, Topical

20916 Brachytherapy Applicators, Manual, Interstitial/Intracavitary

20917 Brachytherapy Applicators, Automated, Topical

20918 Brachytherapy Applicators, Automated, Interstitial/Intracavitary


20919 Brachytherapy Applicators, Automated, Interstitial/Intracavitary, Tandem/Ovoid

20920 Brachytherapy Applicators, Automated, Intravascular

20921 Procedure Kit/Trays, Biopsy, Aspiration, Breast Duct Cell

20922 Brachytherapy Templates

20923 Brachytherapy Templates, Rigid

20924 Brachytherapy Templates, Flexible

20932 Gloves, Examination/Treatment, Hypoallergenic

20933 Catheters, Intracranial, Brachytherapy


20935 Catheters, Breast

20936 Catheters, Breast, Cytology

20937 Catheters, Breast, Brachytherapy

20938 Catheters, Breast, Brachytherapy, Balloon

20939 Catheters, Bronchial, Brachytherapy

20941 Catheters, Biliary, Brachytherapy


20943 Catheters, Esophageal, Brachytherapy

20944 Automation Systems, Medication Dispensing, Outpatient Pharmacy

20945 Prostheses, Joint, Ankle, Total

20969 Microscopes, Scanning Laser, Optical, Endoscopy

20970 Image Digitization Systems, Microscopy


20971 Image Digitization Systems, Microscopy, Confocal Scanning Laser

20972 Anaerobic Culture Pack/Pouch Kits

20977 Approximators, Nerve

20979 Approximators, Rib

20980 Approximators, Skin


20981 Approximators, Sternum

20984 Approximators, Vessel, Microsurgery

20985 Awls, Bone

20986 Awls, Cartilage

20987 Awls, Bone, Mandible

20990 Awls, Bone, Sternum

20991 Awls, Bone, Zygomatic Arch

20992 Awls, Bone, Subchondral


20994 Awls, Cartilage, Nasal

20995 Bougies, Bronchus

20996 Bougies, Ear Canal/Eustachian Tube

21002 Bougies, Esophagus, Mercury-Filled

21003 Bougies, Esophagus, Tungsten-Filled

21004 Bougies, Esophagus, Olive-Tip

21005 Bougies, Esophagus, Filiform

21007 Bougies, Urethra, Filiform


21008 Broaches, Surgical, Bone

21009 Broaches, Surgical, Bone, Intramedullary Canal

21010 Broaches, Dental

21012 Carvers, Dental

21013 Carvers, Dental, Amalgam, Occlusal Surface

21014 Carvers, Dental, Amalgam, Proximal Surface

21015 Carvers, Dental, Composite Filling

21016 Chisels, Dental

21019 Chisels, Dental, Operative


21020 Chisels, Dental/Oral Surgery

21023 Chisels, Postmortem

21024 Chisels, Postmortem, Skull

21026 Chisels, Surgical

21027 Chisels, Surgical, Bone

21028 Chisels, Surgical, Bone, Sternum

21030 Chisels, Surgical, Bone, Outgrowth

21031 Chisels, Surgical, Bone, Outgrowth, Microsurgery

21032 Chisels, Surgical, Bone, Orthopedic, Mortising


21033 Chisels, Surgical, Pituitary Gland

21034 Chisels, Surgical, Middle Ear, Foot Plate

21035 Chisels, Surgical, Middle Ear, Microsurgery

21036 Chisels, Surgical, Nasal, Rhinoplasty

21037 Chisels, Surgical, Nasal, Septum

21038 Chisels, Surgical, Spine

21039 Chisels, Surgical, Spine, Cervical Discectomy

21040 Chisels, Surgical, Spine, Laminectomy

21053 Scar/Keloid Inhibition Sheets, Silicone


21054 Scar/Keloid Inhibition Sheets, Silicone Gel/Foam

21055 Topical Solution/Cream/Gels, Injured Skin, Scar/Keloid Inhibition, Silicone Gel

21056 Cleansers, Scar/Keloid Inhibition, Silicone Sheet

21068 Conveyors

21069 Conveyors, Laundry

21073 Dryers, Laundry

21076 Dryers, Medical-Air, Membrane

21077 Dryers, Gel


21080 Dryers, Forensic Evidence

21083 Dryers, Forensic Evidence, Swab

21084 Dryers, X-Ray Film, Manual

21085 Dryers, X-Ray Film, Automated

21086 Ovens, Laboratory

21087 Ovens, Laboratory, Forced-Air Convection


21088 Ovens, Laboratory, Vacuum

21090 Laundry Presses

21091 Laundry Folding Units

21094 Condensers, Dental

21095 Condensers, Dental, Amalgam, Manual

21096 Condensers, Dental, Amalgam, Powered

21097 Condensers, Dental, Endodontic Filling Material, Vertical

21098 Condensers, Dental, Endodontic Filling Material, Spreading

21103 Brushes, Cytology, Biliary Tract, Endoscopic


21104 Brushes, Cytology, Bronchus, Endoscopic

21107 Brushes, Cytology, Esophagus

21108 Brushes, Cytology, Esophagus/Stomach, Endoscopic

21112 Brushes, Cytology, Colon, Endoscopic

21115 Brushes, Cytology, Urinary Tract/Bladder, Endoscopic

21120 Brushes, Cytology, Cervix/Uterine Endometrium

21123 Brushes, Cytology, Mouth


21124 Brushes, Cytology, Eye Surface

21125 Brushes, Surgical

21126 Brushes, Surgical, Bone

21128 Brushes, Surgical, Bone, Acetabular

21129 Brushes, Surgical, Bone, Intramedullary, Narrow Canal

21130 Brushes, Surgical, Bone, Intramedullary, Femoral Canal

21131 Brushes, Dental

21132 Brushes, Dental, Topical Application


21133 Brushes, Dental, Resin Application

21134 Brushes, Cleaning

21135 Brushes, Cleaning, Instrument

21139 Brushes, Cleaning, Instrument, Endoscope, Channel

21140 Brushes, Cleaning, Instrument, Endoscope, Valve/Head

21143 Brushes, Cleaning, Instrument, Esophageal Dilator

21144 Brushes, Cleaning, Instrument, Tracheostomy Tube Cannula

21145 Brushes, Cleaning, Instrument, Multiuse

21146 Brushes, Cleaning, Denture, Disabled Person


21147 Brushes, Cleaning, Hearing Aid

21148 Brushes, Cleaning, Labware

21149 Toothbrushes, Electric

21150 Toothbrushes, Manual

21151 Toothbrushes, Manual, Gingiva/Interproximal

21154 Toothbrushes, Ultrasonic

21155 Dental Applicators, Resin/Cement (Retired)

21158 Dental Applicators, Endodontic (Retired)

21159 Analyzers, Physiologic, Visual Function, Macular Integrity


21162 Washers, Cuvette

21171 Washer/Decontamination Units, Surgical Instrument

21179 Washer/Sterilizing Units, Surgical Instrument

21180 Washer/Sterilizing Units, Cart

21193 Clamps, Dental


21194 Clamps, Dental, Gingiva

21195 Clamps, Surgical

21196 Clamps, Surgical, Bone, Fracture Reduction

21197 Clamps, Surgical, Bone, Fracture Reduction, Reposition

21198 Clamps, Surgical, Bone, Meniscus

21199 Clamps, Surgical, Bone, Plate Holding

21200 Clamps, Surgical, Cartilage

21201 Clamps, Surgical, Eye, Eyelid


21202 Clamps, Surgical, Eye, Orbital Muscle

21203 Clamps, Surgical, Fallopian Tube

21204 Clamps, Surgical, Intestinal, Colon

21205 Clamps, Surgical, Intestinal, Colon, Locking

21206 Clamps, Surgical, Intestinal, Small Intestine

21207 Clamps, Surgical, Intestinal, Small Intestine, Locking

21208 Clamps, Surgical, Kidney

21209 Clamps, Surgical, Kidney Pedicle


21210 Clamps, Surgical, Liver

21211 Clamps, Surgical, Stomach

21212 Clamps, Surgical, Stomach, Pylorus

21213 Clamps, Surgical, Lung

21214 Clamps, Surgical, Middle Ear, Ossicle Holding

21219 Clamps, Surgical, Penis, Circumcision, Disposable

21220 Clamps, Surgical, Penis, Circumcision, Reusable

21221 Clamps, Surgical, Strap Muscle

21222 Clamps, Surgical, Thyroid Gland


21223 Clamps, Surgical, Urethral Meatus/Caruncle

21226 Clamps, Surgical, Ureter

21227 Clamps, Surgical, Uterus, Cervical

21228 Clamps, Surgical, Uterus, Myomectomy

21229 Clamps, Surgical, Uterus, Parametrium

21231 Clamps, Surgical, Vascular, Artery, Aorta, Anastomosis

21232 Clamps, Surgical, Vascular, Artery, Aorta, Aneurysm

21233 Clamps, Surgical, Vascular, Artery, Pulmonary


21234 Clamps, Surgical, Vascular, Artery, Spring/Cross Action, Microsurgery

21237 Clamps, Surgical, Vascular, Microsurgery

21238 Clamps, Surgical, Vascular, Microsurgery, Infant

21239 Clamps, Surgical, Vascular, Vena Cava

21240 Clamps, Surgical, Vascular, Vena Cava, Indwelling Cannula

21241 Clamps, Surgical, Heart Auricle

21242 Clamps, Surgical, Vasectomy

21243 Clamps, Postmortem


21247 Clamps, External Occlusion

21248 Clamps, Towel

21249 Clamps, Tubing, Intravenous Infusion

21250 Clamps, Tubing, Suction

21251 Clamps, Tubing, Laboratory

21252 Clamps, Beaker/Flask, Laboratory

21257 Clamps, Test Tube, Laboratory

21258 Clamps, Examination/Operating Table

21263 Clip Appliers, Fallopian Tube


21267 Clip Appliers, Fallopian Tube, Laparoscopic

21268 Clip Appliers, Gastrointestinal, Endoscopic

21269 Clip Appliers, Skin Suture

21270 Clip Appliers, Vascular, Disposable, Scalp

21272 Clip Appliers, Vascular, Reusable, Scalp

21273 Clip Appliers, Vascular, Reusable, Aneurysm, Intracranial

21275 Clips, Implantable

21276 Clips, Implantable, Eye


21279 Clips, Implantable, Eye, Wound

21280 Clips, Implantable, Eye, Iris

21282 Clips, Implantable, Cystic Duct

21283 Clips, Implantable, Gastrointestinal

21289 Clips, Implantable, Vascular, Intracranial

21290 Clips, Implantable, Vascular, Intracranial, Aneurysm

21291 Clips, Implantable, Vascular, Scalp

21292 Clips, Implantable, Vascular, Peripheral

21298 Clips, Umbilical Cord Occlusion

21299 Clips, Surgical


21300 Clips, Surgical, Vascular

21303 Clips, Surgical, Vascular, Aneurysm

21304 Clips, Surgical, Vascular, Microsurgery

21307 Curettes, Biopsy

21308 Curettes, Biopsy, Bronchus, Endoscopic

21310 Curettes, Biopsy, Bronchus, Endoscopic, Flexible

21311 Curettes, Biopsy, Bronchus, Endoscopic, Rigid


21312 Curettes, Biopsy, Nasal

21314 Curettes, Biopsy, Uterine, Endometrium

21317 Curettes, Biopsy, Uterine, Endometrium, Cervical Canal

21318 Curettes, Biopsy/Surgical, Uterine, Suction

21319 Curettes, Surgical

21321 Curettes, Dental

21322 Curettes, Dental, Periodontal

21323 Curettes, Dental, Periodontal, Operative


21324 Curettes, Dental, Periodontal, Scaling

21325 Curettes, Dental, Periodontal, Scaling, Parallel Cutting Edges

21326 Curettes, Dental, Periodontal, Scaling, Single Cutting Edge

21327 Curettes, Dental/Oral Surgery

21330 Curettes, Surgical, Bone

21331 Curettes, Surgical, Bone, Microsurgery

21332 Curettes, Surgical, Bone, Spinal

21333 Curettes, Surgical, Bone, Spinal, Disc


21334 Curettes, Surgical, Skin

21335 Curettes, Surgical, Ear

21338 Curettes, Surgical, Eye

21339 Curettes, Surgical, Eye, Chalazion

21340 Curettes, Surgical, Eye, Corneal

21341 Curettes, Surgical, Joint

21342 Curettes, Surgical, Joint, Endoscopic

21343 Curettes, Surgical, Middle Ear


21348 Curettes, Surgical, Middle Ear, Microsurgery

21352 Curettes, Surgical, Nasal

21353 Curettes, Surgical, Nasal, Adenoid

21354 Curettes, Surgical, Nasal, Ethmoid

21355 Curettes, Surgical, Nasal, Sinus

21360 Curettes, Surgical, Pituitary Gland

21361 Curettes, Surgical, Uterine

21363 Curettes, Surgical, Uterine, Placenta/Ovum


21368 Burs, Surgical

21369 Burs, Surgical, Bone

21372 Burs, Surgical, Middle Ear

21373 Burs, Surgical, Middle Ear, Cutting

21374 Burs, Surgical, Middle Ear, Cutting, Mastoid

21375 Burs, Surgical, Middle Ear, Microsurgery


21377 Burs, Surgical, Middle Ear, Polishing

21378 Burs, Surgical, Nasal

21379 Burs, Surgical, Nasal, Septum

21380 Burs, Surgical, Eye

21382 Burs, Surgical, Eye, Corneal Abrasion

21383 Burs, Surgical, Eye, Corneal Abrasion, Rust Ring Removal


21386 Burs, Surgical, Spine

21387 Burs, Surgical, Spine, Microsurgery

21388 Burs, Foot Care

21389 Carriers

21390 Carriers, Cleaning

21391 Carriers, Cleaning, Cotton/Gauze Pad

21394 Carriers, Cleaning, Cotton/Gauze Pad, Endoscope


21395 Carriers, Dental

21396 Carriers, Dental, Cement/Paste, Root Canal

21400 Carriers, Dental, Cement/Paste, Root Canal, Powered

21401 Carriers, Surgical

21402 Carriers, Surgical, Cotton/Sponge/Swab

21406 Carriers, Surgical, Cotton/Sponge/Swab, Endoscopic

21408 Carriers, Surgical, Cotton/Sponge/Swab, Microsurgery

21409 Passers
21410 Passers, Ligature

21411 Passers, Ligature, Bone

21413 Passers, Ligature, Vascular

21414 Passers, Ligature, Vascular, Aorta

21415 Passers, Wire

21416 Passers, Wire, Bone Cerclage

21417 Passer/Knot Tiers, Ligature

21423 Passer/Knot Tiers, Ligature, Endoscopic

21443 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Aeromonas Species
21444 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Aeromonas salmonic

21445 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bartonella Species

21446 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bartonella Species,

21447 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bartonella henselae,

21448 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bartonella quintana,

21449 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bordetella Species

21450 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bordetella Species,

21451 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bordetella parapertu

21452 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Bordetella pertussis,

21453 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Borrelia Species

21484 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Borrelia burgdorferi,

21485 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Brucella Species
21486 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Brucella Species, DN

21487 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Brucella Species, RNA

21488 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Brucella abortus, DNA

21489 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Brucella melitensis,

21490 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Brucella suis, DNA

21502 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Campylobacter Speci

21503 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Campylobacter coli,

21504 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Campylobacter jejun

21505 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Campylobacter lari,

21512 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia Species,

21513 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomat

21514 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomat
21515 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachoma

21526 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydophila Speci

21527 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydophila pne

21528 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydophila pne

21529 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydophila pne

21530 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydophila psitta

21536 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Coxiella Species

21537 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Coxiella burnetii, DNA

21542 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Ehrlichia Species

21543 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Ehrlichia canis, DNA

21544 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Ehrlichia chaffeensis

21551 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Enterococcus Specie
21552 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Enterococcus Species

21555 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Francisella Species

21556 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Francisella tularensis

21557 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Francisella tularensis

21560 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Gardnerella vaginalis

21561 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Gardnerella vaginalis

21562 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Gardnerella vaginalis
21566 Warming/Cooling Units, Patient, Circulating-Liquid, Intravascular

21567 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Haemophilus Species

21568 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Haemophilus ducreyi

21569 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Haemophilus influen

21570 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Haemophilus influen

21571 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Haemophilus influen

21583 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Helicobacter Species
21584 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Helicobacter pylori,

21587 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Anaplasma phagocy

21589 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Legionella Species,

21590 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Legionella Species, r

21591 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Legionella pneumoph

21592 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Legionella pneumoph

21597 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Leptospira Species

21598 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Leptospira Species,

21600 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Listeria Species
21601 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Listeria monocytoge

21605 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium Spec

21606 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium aviu

21607 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium avi

21608 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium avi

21609 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium intrac

21610 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium tuber

21611 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium tuber

21612 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycobacterium tuberc

21621 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycoplasma Species
21622 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycoplasma pneumo

21623 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Mycoplasma pneumo

21627 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Neisseria Species

21628 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Neisseria gonorrhoe

21629 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Neisseria gonorrhoea

21630 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Neisseria meningitidi

21633 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Pasteurella Species

21634 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Pasteurella Species,

21635 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Pasteurella multocid

21639 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Pseudomonas Specie

21640 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Pseudomonas Specie
21644 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Rickettsia Species

21645 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Rickettsia Species, R

21646 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Rickettsia prowazekii

21647 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Rickettsia rickettsii,

21661 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Salmonella Species,

21662 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus Spec

21663 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus Spec

21664 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aure

21665 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aure
21666 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureu

21672 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus A, rRN

21673 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus B, rRN

21674 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus C

21675 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus D

21676 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus F

21677 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus G

21678 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Streptococcus pneu

21680 Printers
21702 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Treponema Species

21706 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Tropheryma Species

21707 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Tropheryma whippelii

21714 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Yersinia Species

21715 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Yersinia pestis

21716 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Yersinia pestis, DNA

21724 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Aeromonas Species

21728 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Bartonella Species

21729 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Bordetella Species

21730 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Borrelia Species

21732 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Brucella Species

21733 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Enterococcus Specie


21734 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Enterococcus Specie

21737 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Gardnerella vaginalis

21739 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Haemophilus ducreyi

21740 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella Species

21741 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Listeria Species

21742 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycobacterium av

21743 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Mycobacterium tuber

21747 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Vibrio Species

21751 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Yersinia pestis

21752 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella bacilliformis, Antibody

21753 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella elizabethae, Antibody

21754 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella henselae, Antibody

21755 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella henselae, IgG Antibody
21756 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella henselae, IgM Antibody

21757 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella quintana, Antibody

21758 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella quintana, IgG Antibody

21759 IVD Test Reagent/Kits, Serology, Bacteria, Bartonella quintana, IgM Antibody

21762 IVD Test Reagent/Kits, Serology, Bacteria, Bordetella parapertussis, Antigen

21763 IVD Test Reagent/Kits, Serology, Bacteria, Bordetella parapertussis, Antibody

21764 IVD Test Reagent/Kits, Serology, Bacteria, Bordetella pertussis, IgG Antibody

21765 IVD Test Reagent/Kits, Serology, Bacteria, Bordetella pertussis, IgM Antibody

21766 IVD Test Reagent/Kits, Serology, Bacteria, Brucella Species, IgG Antibody

21767 IVD Test Reagent/Kits, Serology, Bacteria, Brucella Species, IgM Antibody

21768 IVD Test Reagent/Kits, Serology, Bacteria, Brucella abortus, Antibody

21769 IVD Test Reagent/Kits, Serology, Bacteria, Brucella abortus, IgG Antibody

21770 IVD Test Reagent/Kits, Serology, Bacteria, Brucella abortus, IgM Antibody

21771 IVD Test Reagent/Kits, Serology, Bacteria, Brucella melitensis, Antibody

21772 IVD Test Reagent/Kits, Serology, Bacteria, Brucella melitensis, IgG Antibody

21773 IVD Test Reagent/Kits, Serology, Bacteria, Brucella melitensis, IgM Antibody
21774 IVD Test Reagent/Kits, Serology, Bacteria, Brucella suis, Antibody

21775 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia trachomatis, IgA Antibody

21776 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia trachomatis, IgG Antibody

21777 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydia trachomatis, IgM Antibody

21778 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila pneumoniae, Antibody

21779 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila pneumoniae, IgA Antib

21780 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila pneumoniae, IgG Antib

21781 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila pneumoniae, IgM Antib

21782 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila psittaci, Antibody

21783 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila psittaci, IgA Antibody

21784 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila psittaci, IgG Antibody

21785 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila psittaci, IgM Antibody

21786 IVD Test Reagent/Kits, Serology, Bacteria, Chlamydophila psittaci, Antigen

21787 IVD Test Reagent/Kits, Serology, Bacteria, Clostridium Species

21788 IVD Test Reagent/Kits, Serology, Bacteria, Clostridium botulinum, Toxin


21789 IVD Test Reagent/Kits, Serology, Bacteria, Clostridium difficile

21790 IVD Test Reagent/Kits, Serology, Bacteria, Clostridium perfringens, Toxin

21795 IVD Test Reagent/Kits, Serology, Bacteria, Coxiella burnetii, IgG Antibody

21796 IVD Test Reagent/Kits, Serology, Bacteria, Coxiella burnetii, IgM Antibody

21797 IVD Test Reagent/Kits, Serology, Bacteria, Ehrlichia Species, Antibody

21798 IVD Test Reagent/Kits, Serology, Bacteria, Ehrlichia Species, IgG Antibody

21799 IVD Test Reagent/Kits, Serology, Bacteria, Ehrlichia Species, IgM Antibody

21800 IVD Test Reagent/Kits, Serology, Bacteria, Ehrlichia chaffeensis, Antibody

21801 IVD Test Reagent/Kits, Serology, Bacteria, Ehrlichia chaffeensis, IgG Antibody

21802 IVD Test Reagent/Kits, Serology, Bacteria, Ehrlichia chaffeensis, IgM Antibody

21803 IVD Test Reagent/Kits, Serology, Bacteria, Francisella tularensis, IgA Antibody

21804 IVD Test Reagent/Kits, Serology, Bacteria, Francisella tularensis, IgG Antibody

21805 IVD Test Reagent/Kits, Serology, Bacteria, Francisella tularensis, IgM Antibody
21806 IVD Test Reagent/Kits, Serology, Bacteria, Haemophilus influenzae, IgG Antibody

21807 IVD Test Reagent/Kits, Serology, Bacteria, Haemophilus influenzae B, Antibody

21808 IVD Test Reagent/Kits, Serology, Bacteria, Haemophilus influenzae B, IgG Antibod

21809 IVD Test Reagent/Kits, Serology, Bacteria, Anaplasma phagocytophilum, Antibody

21810 IVD Test Reagent/Kits, Serology, Bacteria, Anaplasma phagocytophilum, IgG Anti

21811 IVD Test Reagent/Kits, Serology, Bacteria, Anaplasma phagocytophilum, IgM Anti

21812 IVD Test Reagent/Kits, Serology, Bacteria, Leptospira Species, IgG Antibody

21813 IVD Test Reagent/Kits, Serology, Bacteria, Leptospira Species, IgM Antibody

21814 IVD Test Reagent/Kits, Serology, Bacteria, Leptospira Species, Antigen


21815 IVD Test Reagent/Kits, Serology, Bacteria, Listeria Species

21816 IVD Test Reagent/Kits, Serology, Bacteria, Listeria monocytogenes, IgG Antibody

21817 IVD Test Reagent/Kits, Serology, Bacteria, Listeria monocytogenes, IgM Antibody

21818 IVD Test Reagent/Kits, Serology, Bacteria, Mycobacterium avium Complex, Antig

21819 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma pneumoniae, IgG Antibod

21820 IVD Test Reagent/Kits, Serology, Bacteria, Mycoplasma pneumoniae, IgM Antibod

21821 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis, Antibody

21822 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis A, Antigen

21823 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis A, IgG Antibody

21824 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis B, Antigen

21825 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis C, IgG Antibody
21826 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis C, Antigen

21827 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis Y, IgG Antibody

21828 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis Y, Antigen

21829 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis W135, Antigen

21830 IVD Test Reagent/Kits, Serology, Bacteria, Neisseria meningitidis W135, IgG Anti

21836 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia Species, IgG Antibody

21837 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia Species, IgM Antibody

21838 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia prowazekii, Antibody

21839 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia prowazekii, IgG Antibody

21840 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia prowazekii, IgM Antibody

21841 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia rickettsii, Antibody

21842 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia rickettsii, IgG Antibody
21843 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia rickettsii, IgM Antibody

21844 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia typhus Group, Antibody

21845 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia typhus Group, IgG Antibody

21846 IVD Test Reagent/Kits, Serology, Bacteria, Rickettsia typhus Group, IgM Antibody

21848 IVD Test Reagent/Kits, Serology, Bacteria, Staphylococcus aureus, Antigen

21850 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus A, Antigen

21851 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus B, Antigen

21852 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus C, Antigen

21853 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus D, Antigen

21854 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus F, Antigen


21855 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus G, Antigen

21858 IVD Test Reagent/Kits, Serology, Bacteria, Treponema Species, Antibody

21859 IVD Test Reagent/Kits, Serology, Bacteria, Treponema Species, IgG Antibody

21860 IVD Test Reagent/Kits, Serology, Bacteria, Treponema Species, IgM Antibody

21861 IVD Test Reagent/Kits, Serology, Bacteria, Thermoactinomyces Species, Antibody

21862 IVD Test Reagent/Kits, Serology, Bacteria, Thermoactinomyces Species, IgG Anti

21863 IVD Test Reagent/Kits, Serology, Bacteria, Thermoactinomyces candidus, Antibod

21864 IVD Test Reagent/Kits, Serology, Bacteria, Thermoactinomyces sacchari, Antibody

21865 IVD Test Reagent/Kits, Serology, Bacteria, Thermoactinomyces vulgaris, Antibody

21866 IVD Test Reagent/Kits, Serology, Bacteria, Thermoactinomyces vulgaris, IgG Anti

21872 IVD Test Reagent/Kits, Serology, Bacteria, Vibrio Species, Antigen

21873 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia Species, IgA Antibody
21874 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia Species, IgG Antibody

21875 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia enterocolitica, Antibody

21876 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia enterocolitica, IgA Antibody

21877 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia enterocolitica, IgG Antibody

21878 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia pestis, Antigen

21879 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia pseudotuberculosis, IgA Antib

21880 IVD Test Reagent/Kits, Serology, Bacteria, Yersinia pseudotuberculosis, IgG Antib

21887 Wire Crimpers

21889 Wire Crimpers, Surgical

21890 Wire Crimpers, Surgical, Middle Ear

21892 Wire Crimpers, Surgical, Orthopedic


21894 Wire Crimpers, Surgical, Oral/Maxillary

21897 Seal Crimpers, Bottle/Vial/Tube

21900 Seal Decrimpers, Bottle/Vial/Tube

21907 Bone/Cartilage/Fascia Crushers

21913 Pill Crushers

21914 Pill Splitters

21915 Waste-Disposal Units, Glass Crushing

21916 Syringe/Needle Destroyers


21921 Syringe/Needle Destroyers, Mechanical

21930 Syringe/Needle Destroyers, Needle Burning

21934 Clippers, Hair, Manual

21935 Clippers, Hair, Electric

21936 Clippers, Hair, Electric, Preoperative

21939 Clippers, Nail, Finger

21941 Clippers, Nail, Finger, Disabled Person


21942 Clippers, Nail, Toe

21944 Clippers, Nail, Toe, Disabled Person

21945 Fetal Decapitators

21947 Computers, Personal

21948 Computers, Personal, Desktop


21949 Computers, Personal, Laptop

21950 Computers, Handheld

21952 Workstations

21953 Workstations, Radiotherapy, Record/Verify


21955 Workstations, Radiotherapy, Planning

21957 Workstations, Cardiac Catheterization Laboratory

21959 Workstations, Stress Exercise

21961 Workstations, Gamma Camera/Single Photon Emission Tomography


21966 Workstations, Stereotactic Surgery

21968 Workstations, Picture Archiving and Communication System

21969 Workstations, Picture Archiving and Communication System, Three-Dimensional

21972 Workstations, Multiple Modality, Three-Dimensional Image


21973 Network Servers

21980 Wire Crimpers, Dental, Orthodontic

21985 Backpacks, Medical Device/Gas Cylinder

21986 Orthopedic Cement Extraction Systems, Ultrasonic

21987 Orthopedic Cement/Bone Cutting/Extraction Systems, Ultrasonic

21988 Orthopedic Cement/Bone Cutting/Extraction Systems, Powered Drilling


21989 Videonystagmographs

21990 Manometers, Vascular Aneurysm

21995 Centrifugal Blood Cell Processors, Autologous Platelet Separation

21996 Depressors, Tongue, Blade/Stick

22000 Depressors, Surgical


22001 Depressors, Surgical, Sclera

22005 Depressors, Surgical, Brain

22006 Depressors, Surgical, Uterus

22007 Depressors, Surgical, Tongue

22008 Depressors, Surgical, Humeral Head

22010 Refrigerators, Laboratory, Flammable Material


22011 Refrigerators, Laboratory, Lead-Lined

22012 Refrigerators, Laboratory, Multiuse

22014 Refrigerators, Laboratory, Multiuse, Upright

22016 Refrigerators, Laboratory, Multiuse, Undercounter


22018 Refrigerators, Laboratory, Multiuse, Walk-In

22020 Refrigerators, Pharmacy, Upright

22021 Refrigerators, Pharmacy, Walk-In

22022 Refrigerators, Morgue, End-Opening


22026 Refrigerators, Morgue, Side-Opening

22027 Refrigerators, Morgue, Walk-In

22028 Refrigerators, Food

22029 Refrigerators, Food, Upright

22032 Refrigerators, Food, Undercounter


22034 Refrigeration Chamber Equipment

22036 Freezers, Blood Bank

22039 Freezers, Blood Bank, Ultralow Temperature


22041 Freezers, Blood Bank, Ultralow Temperature, Chest

22043 Freezers, Blood Bank, Ultralow Temperature, Upright

22045 Freezers, Blood Bank, Cryogenic

22048 Freezers, Blood Bank, Cryogenic, Electromechanical


22050 Freezers, Blood Bank, Cryogenic, Liquid Nitrogen

22052 Freezers, Blood Bank, Cryogenic, Vapor Phase Nitrogen

22054 Freezers, Laboratory, Multiuse


22056 Freezers, Laboratory, Multiuse, Upright

22057 Freezers, Laboratory, Multiuse, Undercounter

22059 Freezers, Laboratory, Multiuse, Walk-In

22063 Freezers, Laboratory, Flammable Material


22064 Freezers, Laboratory, Explosion-Proof

22065 Freezers, Laboratory, Ultralow Temperature

22068 Freezers, Laboratory, Ultralow Temperature, Upright

22069 Freezers, Laboratory, Ultralow Temperature, Chest


22070 Freezers, Laboratory, Cryogenic

22072 Freezers, Laboratory, Cryogenic, Electromechanical

22073 Freezers, Laboratory, Cryogenic, Liquid Nitrogen

22074 Freezers, Laboratory, Cryogenic, Vapor Phase Nitrogen


22075 Freezers, Pharmacy

22076 Freezers, Pharmacy, Upright

22077 Freezers, Pharmacy, Undercounter

22078 Freezers, Pharmacy, Walk-In


22079 Freezers, Postmortem

22080 Freezers, Food

22081 Freezers, Food, Upright

22082 Freezers, Food, Walk-In

22083 Freezers, Food, Chest


22084 Freezing Chamber Equipment

22106 Identification/Tracking/Security Systems, Asset

22110 Identification/Tracking/Security Systems, Asset, Surgical Instrument

22114 Identification/Tracking/Security Systems, Asset/Person

22115 Identification/Tracking/Security Systems, Pharmaceutical


22122 Dermatomes, Manual

22123 Dermatomes, Electric

22129 Dermatomes, Pneumatic

22130 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite

22131 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Babesia Species

22132 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Babesia Species, DNA

22133 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Babesia microti, DNA

22134 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Amoeboid Protozoa

22135 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Entamoeba histolytic

22136 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Giardia Species
22137 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Leishmania Species

22138 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Leishmania Species,

22139 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Taenia Species

22140 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Taenia Species, DNA

22141 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Taenia saginata, DNA

22142 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Taenia solium, DNA

22143 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Toxoplasma Species

22144 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Toxoplasma Species,
22145 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Toxoplasma gondii, D

22146 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trichinella Species

22147 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trichinella Species, D

22148 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trichomonas Species

22149 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trichomonas vaginali

22150 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trichomonas vaginali

22151 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trypanosoma Species

22152 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trypanosoma brucei,

22153 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trypanosoma cruzi, D

22154 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Protozoa, Giardia Sp


22155 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Toxoplasma gondii

22156 IVD Test Reagent/Kits, Microbiology, Parasite, Identification, Trypanosoma Specie

22157 IVD Test Reagent/Kits, Serology, Parasite, Babesia microti, Antibody

22158 IVD Test Reagent/Kits, Serology, Parasite, Babesia microti, IgG Antibody

22159 IVD Test Reagent/Kits, Serology, Parasite, Babesia microti, IgM Antibody

22160 IVD Test Reagent/Kits, Serology, Parasite, Babesia Species, Antibody

22161 IVD Test Reagent/Kits, Serology, Parasite, Leishmania Species, IgG Antibody

22162 IVD Test Reagent/Kits, Serology, Parasite, Leishmania Species, IgM Antibody

22163 IVD Test Reagent/Kits, Serology, Parasite, Leishmania Species, K39 Antigen, IgG

22164 IVD Test Reagent/Kits, Serology, Parasite, Paragonimus Species, Antibody

22165 IVD Test Reagent/Kits, Serology, Parasite, Schistosoma Species, IgG Antibody

22166 IVD Test Reagent/Kits, Serology, Parasite, Taenia saginata, Antibody


22167 IVD Test Reagent/Kits, Serology, Parasite, Taenia Species, Antibody

22168 IVD Test Reagent/Kits, Serology, Parasite, Entamoeba Species, Antigen

22169 IVD Test Reagent/Kits, Serology, Parasite, Entamoeba histolytica, Antibody

22170 IVD Test Reagent/Kits, Serology, Parasite, Entamoeba histolytica, IgG Antibody

22171 IVD Test Reagent/Kits, Serology, Parasite, Entamoeba histolytica, IgM Antibody

22172 IVD Test Reagent/Kits, Serology, Parasite, Entamoeba histolytica, Antigen

22173 IVD Test Reagent/Kits, Serology, Parasite, Fasciola hepatica, Antibody

22174 IVD Test Reagent/Kits, Serology, Parasite, Giardia Species, Antibody

22175 IVD Test Reagent/Kits, Serology, Parasite, Giardia Species, Antigen

22176 IVD Test Reagent/Kits, Serology, Parasite, Giardia lamblia, Antibody

22177 IVD Test Reagent/Kits, Serology, Parasite, Giardia lamblia, IgA Antibody

22178 IVD Test Reagent/Kits, Serology, Parasite, Giardia lamblia, IgG Antibody
22179 IVD Test Reagent/Kits, Serology, Parasite, Giardia lamblia, IgM Antibody

22180 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma Species, Antibody

22181 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii, IgA Antibody

22182 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma gondii, IgE Antibody

22183 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma Species, IgA Antibody

22184 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma Species, IgE Antibody

22193 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma Species, IgG Antibody

22194 IVD Test Reagent/Kits, Serology, Parasite, Toxoplasma Species, IgM Antibody
22195 IVD Test Reagent/Kits, Serology, Parasite, Trichinella Species, Antibody

22196 IVD Test Reagent/Kits, Serology, Parasite, Trichinella spiralis, IgE Antibody

22197 IVD Test Reagent/Kits, Serology, Parasite, Trichinella spiralis, IgG Antibody

22198 IVD Test Reagent/Kits, Serology, Parasite, Trichinella spiralis, IgM Antibody

22199 IVD Test Reagent/Kits, Serology, Parasite, Trypanosoma cruzi, IgG Antibody

22200 IVD Test Reagent/Kits, Serology, Parasite, Trypanosoma cruzi, IgM Antibody

22201 Printers, Computer/Network, Laser, Monochromatic

22202 Printers, Computer/Network, Laser, Color


22203 Printers, Computer/Network, Ink-Jet

22204 Printers, Computer/Network, Dot Matrix

22205 Document Scanners, Bar-Code, Handheld Computer

22260 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Adenovirus

22261 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Adenovirus, DNA

22262 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Adenovirus, rRNA

22263 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Astrovirus

22264 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Astrovirus, RNA
22265 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, DNA

22266 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Coxsackievirus

22267 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Coxsackievirus A, RNA

22268 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Coxsackievirus A Subtyp

22269 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Coxsackievirus B, RNA

22270 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Coxsackievirus B Subtyp

22271 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Cytomegalovirus, DNA

22272 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Dengue

22273 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Dengue 1/2/3/4, RNA

22274 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Eastern Equine Encephali

22275 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Eastern Equine Encephal
22276 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Ebola, RNA

22277 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Echovirus

22278 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Echovirus, RNA

22279 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Echovirus Subtype, RNA

22280 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Enterovirus, RNA

22281 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Epidemic Parotitis (Mum

22282 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Epstein-Barr, DNA

22283 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hantavirus

22284 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hantavirus, RNA
22285 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis A

22286 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis A, RNA

22287 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B, DNA

22288 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B, Genotype

22289 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B, rRNA

22290 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C, Genotype

22291 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C, RNA

22292 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C, rRNA

22293 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis D, RNA
22294 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis G, RNA

22295 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis-Associated TT

22296 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Simplex, DNA

22297 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Simplex 1, DNA

22298 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Simplex 1/2, DNA

22299 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Simplex 2, DNA

22300 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Virus 6, DNA

22301 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Virus 7, DNA

22302 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Herpes Virus 8, DNA

22303 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Metapneumoviru
22304 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus,

22305 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus,

22306 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus,

22307 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus,

22308 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus,

22309 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus,

22310 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza

22311 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza A


22312 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza A, RNA

22313 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza A, Avian Subty

22314 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza A/B, RNA

22315 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Influenza B, RNA

22316 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Japanese Encephalitis, R

22317 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, JC Virus, DNA

22318 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, La Crosse, RNA

22319 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Measles

22320 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Measles, RNA

22321 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Norwalk/Norwalk-Like Vi


22322 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza

22323 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza 1, RNA

22324 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza 2 RNA

22325 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parainfluenza 3, RNA

22326 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Parvovirus B19, DNA

22327 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Rabies, RNA

22328 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Respiratory Syncytial Vi

22329 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-1, DNA

22330 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-1, RNA

22331 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-1, Genot

22332 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV-2, DNA
22333 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, Human T-Cel

22334 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, Human T-Cell

22335 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Rhinovirus, RNA

22336 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Rotavirus, RNA

22337 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Rubella, RNA

22338 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Saint Louis Encephalitis,

22339 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Severe Acute Respirat

22340 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Vaccinia Virus, DNA

22341 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Varicella-Zoster, DNA

22342 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Venezuelan Equine Encep
22343 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, West Nile Virus, RNA

22344 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Western Equine Encephal

22345 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Yellow Fever, RNA

22346 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Adenovirus

22347 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Human Papilloma Virus

22348 IVD Test Reagent/Kits, Serology, Virus, Adenovirus, IgG Antibody

22349 IVD Test Reagent/Kits, Serology, Virus, Adenovirus, IgM Antibody

22350 IVD Test Reagent/Kits, Serology, Virus, Arenavirus

22351 IVD Test Reagent/Kits, Serology, Virus, Arenavirus, IgM Antibody

22352 IVD Test Reagent/Kits, Serology, Virus, Arenavirus, Antigen


22353 IVD Test Reagent/Kits, Serology, Virus, Arenavirus, Lassa Virus, IgG Antibody

22354 IVD Test Reagent/Kits, Serology, Virus, Arenavirus, Lassa Virus, IgM Antibody

22355 IVD Test Reagent/Kits, Serology, Virus, Arenavirus, Lassa Virus, Antigen

22356 IVD Test Reagent/Kits, Serology, Virus, Arenavirus, Lymphocytic Choriomeningitis

22357 IVD Test Reagent/Kits, Serology, Virus, Arbovirus, IgG Antibody

22358 IVD Test Reagent/Kits, Serology, Virus, Arbovirus, IgM Antibody

22359 IVD Test Reagent/Kits, Serology, Virus, Astrovirus, Antigen

22360 IVD Test Reagent/Kits, Serology, Virus, BK Virus, Antibody

22361 IVD Test Reagent/Kits, Serology, Virus, Cache Valley, Antibody

22362 IVD Test Reagent/Kits, Serology, Virus, California Encephalitis, Antibody

22363 IVD Test Reagent/Kits, Serology, Virus, California Encephalitis, IgG Antibody
22364 IVD Test Reagent/Kits, Serology, Virus, California Encephalitis, IgM Antibody

22365 IVD Test Reagent/Kits, Serology, Virus, Coxsackievirus A, Antibody

22366 IVD Test Reagent/Kits, Serology, Virus, Coxsackievirus B, Antibody

22367 IVD Test Reagent/Kits, Serology, Virus, Dengue, Antibody

22368 IVD Test Reagent/Kits, Serology, Virus, Dengue, IgG Antibody

22369 IVD Test Reagent/Kits, Serology, Virus, Dengue, IgM Antibody

22370 IVD Test Reagent/Kits, Serology, Virus, Eastern Equine Encephalitis, Antibody

22371 IVD Test Reagent/Kits, Serology, Virus, Eastern Equine Encephalitis, IgG Antibody

22372 IVD Test Reagent/Kits, Serology, Virus, Eastern Equine Encephalitis, IgM Antibody

22373 IVD Test Reagent/Kits, Serology, Virus, Ebola, Antibody

22374 IVD Test Reagent/Kits, Serology, Virus, Ebola, IgG Antibody


22375 IVD Test Reagent/Kits, Serology, Virus, Ebola, IgM Antibody

22376 IVD Test Reagent/Kits, Serology, Virus, Echovirus, Antibody

22377 IVD Test Reagent/Kits, Serology, Virus, Echovirus Subtype, Antibody

22378 IVD Test Reagent/Kits, Serology, Virus, Enterovirus, Antibody

22379 IVD Test Reagent/Kits, Serology, Virus, Enterovirus, IgM Antibody

22380 IVD Test Reagent/Kits, Serology, Virus, Epidemic Parotitis (Mumps), IgG Antibody

22381 IVD Test Reagent/Kits, Serology, Virus, Epidemic Parotitis (Mumps), IgM Antibody

22382 IVD Test Reagent/Kits, Serology, Virus, Epstein-Barr, Nuclear Antigen, IgG Antibo

22383 IVD Test Reagent/Kits, Serology, Virus, Epstein-Barr, Viral Capsid, IgG Antibody

22384 IVD Test Reagent/Kits, Serology, Virus, Epstein-Barr, Viral Capsid, IgM Antibody
22385 IVD Test Reagent/Kits, Serology, Virus, Hantavirus, Antibody

22386 IVD Test Reagent/Kits, Serology, Virus, Hantavirus, IgG Antibody

22387 IVD Test Reagent/Kits, Serology, Virus, Hantavirus, IgM Antibody

22388 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1, Antibody

22389 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1, IgG Antibody

22390 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1, IgM Antibody

22391 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1, Antigen

22392 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 2, Antibody

22393 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 2, IgG Antibody
22394 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 2, IgM Antibody

22395 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 2, Antigen

22396 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1/2, Antibody

22397 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1/2, IgG Antibody

22398 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1/2, IgM Antibody

22399 IVD Test Reagent/Kits, Serology, Virus, Herpes Simplex 1/2, Antigen

22400 IVD Test Reagent/Kits, Serology, Virus, Herpes Virus 6, IgG Antibody

22401 IVD Test Reagent/Kits, Serology, Virus, Herpes Virus 6, IgG/IgM Antibody

22402 IVD Test Reagent/Kits, Serology, Virus, Herpes Virus 7, IgG Antibody

22403 IVD Test Reagent/Kits, Serology, Virus, Herpes Virus 7, IgG/IgM Antibody
22404 IVD Test Reagent/Kits, Serology, Virus, Herpes Virus 8, IgG Antibody

22405 IVD Test Reagent/Kits, Serology, Virus, Human Metapneumovirus, Antibody

22406 IVD Test Reagent/Kits, Serology, Virus, Influenza A

22407 IVD Test Reagent/Kits, Serology, Virus, Influenza A, IgG Antibody

22408 IVD Test Reagent/Kits, Serology, Virus, Influenza A, IgM Antibody

22409 IVD Test Reagent/Kits, Serology, Virus, Influenza A, Antigen

22410 IVD Test Reagent/Kits, Serology, Virus, Influenza B

22411 IVD Test Reagent/Kits, Serology, Virus, Influenza B, IgG Antibody

22412 IVD Test Reagent/Kits, Serology, Virus, Influenza B, IgM Antibody


22413 IVD Test Reagent/Kits, Serology, Virus, Influenza B, Antigen

22414 IVD Test Reagent/Kits, Serology, Virus, Japanese Encephalitis, IgM Antibody

22415 IVD Test Reagent/Kits, Serology, Virus, La Crosse, Antibody

22416 IVD Test Reagent/Kits, Serology, Virus, La Crosse, IgG Antibody

22417 IVD Test Reagent/Kits, Serology, Virus, La Crosse, IgM Antibody

22418 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 1, IgG Antibody

22419 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 1, IgM Antibody

22420 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 1, Antigen

22421 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 2, IgG Antibody

22422 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 2, IgM Antibody

22423 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 2, Antigen

22424 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 3, IgG Antibody


22425 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 3, IgM Antibody

22426 IVD Test Reagent/Kits, Serology, Virus, Parainfluenza 3, Antigen

22427 IVD Test Reagent/Kits, Serology, Virus, Parvovirus B19, Antibody

22428 IVD Test Reagent/Kits, Serology, Virus, Parvovirus B19, IgG Antibody

22429 IVD Test Reagent/Kits, Serology, Virus, Parvovirus B19, IgM Antibody

22430 IVD Test Reagent/Kits, Serology, Virus, Poliovirus, Antibody

22431 IVD Test Reagent/Kits, Serology, Virus, Poliovirus 1, Antibody

22432 IVD Test Reagent/Kits, Serology, Virus, Poliovirus 2, Antibody

22433 IVD Test Reagent/Kits, Serology, Virus, Poliovirus 3, Antibody

22434 IVD Test Reagent/Kits, Serology, Virus, Rabies, Antibody

22435 IVD Test Reagent/Kits, Serology, Virus, Rabies, Antigen

22436 IVD Test Reagent/Kits, Serology, Virus, Respiratory Syncytial Virus, IgG Antibody
22437 IVD Test Reagent/Kits, Serology, Virus, Respiratory Syncytial Virus, IgM Antibody

22438 IVD Test Reagent/Kits, Serology, Virus, Saint Louis Encephalitis, Antibody

22439 IVD Test Reagent/Kits, Serology, Virus, Saint Louis Encephalitis, IgG Antibody

22440 IVD Test Reagent/Kits, Serology, Virus, Saint Louis Encephalitis, IgM Antibody

22441 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coron

22442 IVD Test Reagent/Kits, Serology, Virus, Vaccinia, Antibody

22443 IVD Test Reagent/Kits, Serology, Virus, Venezuelan Equine Encephalitis, IgG Anti

22444 IVD Test Reagent/Kits, Serology, Virus, Venezuelan Equine Encephalitis, IgM Anti

22445 IVD Test Reagent/Kits, Serology, Virus, West Nile Virus, IgG Antibody

22446 IVD Test Reagent/Kits, Serology, Virus, West Nile Virus, IgM Antibody

22447 IVD Test Reagent/Kits, Serology, Virus, Western Equine Encephalitis, IgG Antibody

22448 IVD Test Reagent/Kits, Serology, Virus, Western Equine Encephalitis, IgM Antibod

22449 IVD Test Reagent/Kits, Serology, Virus, Yellow Fever, IgG Antibody
22450 IVD Test Reagent/Kits, Serology, Virus, Yellow Fever, IgM Antibody

22451 IVD Test Reagent/Kits, Serology, Virus/Parasite, ToRCH, IgG Antibody

22452 IVD Test Reagent/Kits, Serology, Virus/Parasite, ToRCH, IgM Antibody

22453 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Blastomyces derma

22454 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Candida Species

22455 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Candida albicans,

22456 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Candida Species,

22457 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Coccidioides immi

22458 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Coccidioides immit
22459 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Cryptococcus neo

22460 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Histoplasma caps

22461 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Histoplasma caps

22462 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Pneumocystis jirov

22463 IVD Test Reagent/Kits, Molecular Assay, Infection, Fungi/Yeast, Pneumocystis jiro

22464 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Blastomyces derm

22465 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Candida Species

22466 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Pneumocystis Spe

22467 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Pneumocystis jiro

22468 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Multifungi


22469 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Multifungi, Autom

22470 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Multifungi, Manua

22471 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Blastomyces Species, IgG Antibody

22472 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Blastomyces Species, IgM Antibody

22473 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Blastomyces Species, Antigen

22474 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida Species

22475 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida Species, IgA Antibody

22476 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida Species, IgG Antibody

22477 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida Species, IgM Antibody

22478 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Candida Species, Antigen


22479 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis, IgA Antibody

22480 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Coccidioides immitis, IgE Antibody

22481 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus Species

22482 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus Species, Antibody

22483 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus Species, Antigen

22484 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Histoplasma capsulatum, IgG Antib

22485 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Pneumocystis jiroveci

22486 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Pneumocystis jiroveci, Antigen

22487 Hospital Communication Systems

22488 Hospital Communication Systems, Telephonic


22489 Hospital Communication Systems, Telephonic, Wireless

22490 Hospital Communication Systems, Paging, Staff

22491 Hospital Communication Systems, Paging/Telephonic, Wireless

22499 Information Systems, Data Management, Cardiology, Electrocardiography

22500 Information Systems, Data Management, Hospital, Integrated


22501 Information Systems, Data Management, Hospital, Master Patient Index

22502 Information Systems, Data Management, Hospital, Admission/Discharge/Transfer

22503 Information Systems, Data Management, Financial

22504 Information Systems, Data Management, Coding/Reimbursement

22505 Information Systems, Data Management, Human Resources


22506 Information Systems, Data Management, Centralized Scheduling

22507 Information Systems, Data Management, Health Record

22508 Information Systems, Data Management, Oncology

22509 Information Systems, Picture Archiving and Communication, Cardiology


22510 Workstations, Hemodialysis

22526 Printers, Label

22534 Needles, Injection, Epidural, Protective

22539 Bone Tamps, Inflatable

22540 Syringes, Plunger, Inflation, Bone Tamp

22546 Drainage Bags, Cerebrospinal Fluid

22547 Floor Mats, Antiskid


22548 Antiskid Strips

22550 Ophthalmic Surgery Kits, Frontalis Suspension

22556 Leads, External Cardiac Pacemaker

22558 Dressing Aids

22560 Ballasting Rings, Laboratory Glassware

22561 Procedure Kit/Trays, Drainage, Biliary


22565 Electromechanical Adapters, Line Voltage/Frequency

22568 Facial Tissues

22569 Tensiometers

22570 Endoscope Sleeves, Sterilizing

22571 Caps, Shampoo

22573 Procedure Kit/Trays, Spinal Surgery


22574 Ventilation Hoods

22597 IVD Test Reagent/Kits, Skin Test, Allergy

22609 Catheters, Vascular, Cooling/Warming

22612 Facility Booms


22613 Facility Booms, Ceiling-Mounted

22617 Facility Booms, Wall-Mounted

22621 Colonoscopes, Video, Confocal Laser Microscopy

22624 Manometers, Vascular Aneurysm, Radiofrequency


22625 Manometers, Vascular Aneurysm, Ultrasound

22626 Transducers, Pressure, Vascular Aneurysm

22628 Transducers, Pressure, Vascular Aneurysm, Radiofrequency

22629 Transducers, Pressure, Vascular Aneurysm, Ultrasound


22630 Orthopedic Cement Extraction Systems

22632 Orthopedic Cement Extraction Systems, Manual

22633 Orthopedic Cement/Bone Cutting/Extraction Systems

22644 Sinks, Kitchen

22645 Sinks, Janitorial/Housekeeping Service

22651 Trephines, Biopsy


22653 Trephines, Biopsy, Bone

22658 Trephines, Biopsy, Bone Marrow

22659 Trephines, Biopsy, Skin

22660 Trephines, Surgical

22661 Trephines, Surgical, Eye

22666 Trephines, Surgical, Eye, Chalazion


22667 Trephines, Surgical, Eye, Lacrimal

22670 Trephines, Surgical, Nasal Frontal Sinus

22671 Trephines, Surgical, Bone Harvesting

22672 Trephines, Dental

22673 Trephines, Dental, Endodontic File/Silver Point Recovery

22677 Trephines, Dental, Implant Removal

22678 Trephines, Dental, Artificial Tooth Root Implantation


22687 Punches, Biopsy, Bone

22689 Punches, Biopsy, Larynx

22690 Punches, Biopsy, Pleura

22691 Punches, Biopsy, Skin

22693 Punches, Biopsy, Skin, Reusable

22694 Punches, Biopsy, Skin, Disposable

22695 Punches, Biopsy, Uterine Cervix

22696 Punches, Dental


22697 Punches, Dental, Prosthesis

22698 Punches, Urinary Drainage Catheter

22700 Punches, Surgical

22701 Punches, Surgical, Bone

22703 Punches, Surgical, Bone, Graft/Prosthesis Insertion

22704 Punches, Surgical, Bone, Skull

22705 Punches, Surgical, Bone, Sternum

22707 Punches, Surgical, Tonsil


22708 Punches, Surgical, Middle Ear

22709 Punches, Surgical, Nasal

22710 Punches, Surgical, Nasal, Adenoid

22711 Punches, Surgical, Nasal, Paranasal Sinus

22712 Punches, Surgical, Nasal, Ethmoid Bone

22713 Punches, Surgical, Sella Turcica

22714 Punches, Surgical, Eye

22716 Punches, Surgical, Eye, Corneoscleral, Bench-Mounted

22717 Punches, Surgical, Eye, Trabecular Meshwork


22718 Punches, Surgical, Skin

22720 Punches, Surgical, Spine, Cervical Discectomy

22721 Punches, Surgical, Spine, Laminectomy

22722 Punches, Surgical, Vascular

22724 Biopsy Guns, Side-Notch

22725 Biopsy Guns, End-Cut


22726 Biopsy Guns, End-Cut, Disposable

22727 Saws, Cast

22734 Saws, Cast, Electric, Oscillating

22736 Saws, Cast, Electric, Reciprocating

22740 Saws, Cast, Pneumatic, Oscillating

22741 Saws, Cast, Pneumatic, Reciprocating

22742 Saws, Cast, Manual


22750 Saws, Postmortem, Electric

22751 Saws, Postmortem, Electric, Oscillating

22752 Saws, Postmortem, Electric, Rotary

22754 Saws, Postmortem, Manual

22755 Saws, Postmortem, Manual, Spinal

22757 Saws, Postmortem, Pneumatic

22758 Saws, Surgical

22759 Saws, Surgical, Amputation


22760 Saws, Surgical, Amputation, Finger/Toe

22761 Saws, Surgical, Bone

22762 Saws, Surgical, Bone, Electric, Oscillating

22763 Saws, Surgical, Bone, Electric, Reciprocating

22764 Saws, Surgical, Bone, Electric, Reciprocating, Sternum

22766 Saws, Surgical, Bone, Electric, Sagittal

22768 Saws, Surgical, Bone, Manual

22769 Saws, Surgical, Bone, Manual, Wire


22774 Saws, Surgical, Bone, Pneumatic, Oscillating

22775 Saws, Surgical, Bone, Pneumatic, Reciprocating

22776 Saws, Surgical, Bone, Pneumatic, Reciprocating, Sternum

22777 Saws, Surgical, Bone, Pneumatic, Sagittal

22778 Saws, Surgical, Middle Ear, Manual, Microsurgery

22786 Saws, Laboratory, Electric, Rotary

22788 Glove Boxes, Basic


22789 Glove Boxes, Basic, Mail Processing

22790 Glove Boxes, Isolation

22792 Glove Boxes, Isolation, Controlled Atmosphere

22795 Glove Boxes, Containment

22797 Glove Boxes, Containment, Biohazardous Material


22803 Glove Boxes, Isolation/Containment

22805 Carts, Computer/Video Monitor

22807 Information Systems, Decision Support, Financial

22808 Information Systems, Decision Support, Clinical


22809 Information Systems, Data Management, Hospital, Bed Management

22810 Information Systems, Data Management, Telephone Triage

22811 Information Systems, Data Management, Staff Education/Credentialing

22812 Information Systems, Data Management, Patient Education


22814 Information Systems, Data Management, Human Resources, Time/Attendance

22815 Information Systems, Data Management, Radiology, Mammography

22818 Tube/Stylet Tip Locators, Nasoenteral

22824 Punches, Postmortem, Liver

22839 Stimulators, Electromagnetic, High-Intensity, Brain/Spinal Cord


22840 Stimulators, Electromagnetic, Low-Intensity, Brain/Spinal Cord

22849 Bladder Support Implants, Synthetic

22852 Printer/Graphic Recorders

22853 Data Interface Units, Physiologic Monitor/Computer, Temporary Storage

22854 Data Interface Units, Physiologic Monitor/Computer


22855 Monitors, Physiologic, Pulse Oximetry, Personal

22856 Physiologic Monitor Module Housings

22857 Physiologic Monitor Module Housings, Signal Processing

22858 Keypads, Computer/Computerized System, Remote Control

22859 Data Interface Units, Physiologic Monitor/Information System


22860 Alarms, Physiologic Monitoring System, Remote

22877 Sutures, Natural

22883 Sutures, Natural, Absorbable, Surgical Gut, Chromium-Treated

22884 Sutures, Natural, Nonabsorbable

22891 Sutures, Synthetic


22892 Sutures, Synthetic, Absorbable

22899 Sutures, Synthetic, Nonabsorbable

22902 Sutures, Synthetic, Nonabsorbable, Polyester, Monofilament

22903 Sutures, Synthetic, Nonabsorbable, Polyester, Multifilament

22904 Sutures, Synthetic, Nonabsorbable, Polyvinylidene Fluoride Homopolymer/Hexafl

22908 Sutures, Synthetic, Nonabsorbable, Nylon, Monofilament


22909 Sutures, Synthetic, Nonabsorbable, Nylon, Multifilament

22910 Sutures, Metallic

22915 Sutures, Metallic, Titanium

22939 Scissors, Dental

22940 Scissors, Dental, Prosthetic Material

22941 Scissors, Dental/Oral Surgery, Gum/Soft Oral Tissue


22945 Scissors, Surgical

22946 Heimlich Maneuver Assist Devices

22959 Scissors, Surgical, Brain

22962 Scissors, Surgical, Eye, Lens Capsule

22963 Scissors, Surgical, Eye, Eyelid

22965 Scissors, Surgical, Eye, Extraocular Muscle/Strabismus


22967 Scissors, Surgical, Eye, Vitrectomy

22968 Scissors, Surgical, Eye, Microsurgery

22970 Scissors, Surgical, Middle Ear

22971 Scissors, Surgical, Middle Ear, Ossicular Wire Prosthesis

22972 Scissors, Surgical, Middle Ear, Microsurgery

22973 Scissors, Surgical, Nasal, Turbinate


22974 Scissors, Surgical, Nasal, Septum

22975 Scissors, Surgical, Nasal, Sinus

22976 Scissors, Surgical, Facelift

22977 Scissors, Surgical, Larynx

22978 Scissors, Surgical, Larynx, Endoscopic

22980 Scissors, Surgical, Bronchus, Endoscopic


22982 Scissors, Surgical, Pituitary

22983 Scissors, Surgical, Abdominal/Thoracic Cavity Tissue Dissection

22989 Scissors, Surgical, Heart

22992 Scissors, Surgical, Heart, Minimally Invasive

22993 Scissors, Surgical, Heart, Valve

22994 Scissors, Surgical, Abdominal Wall


22995 Scissors, Surgical, Intestine

22997 Scissors, Surgical, Laparoscopic

22998 Scissors, Surgical, Laparoscopic, Hooking Jaw

22999 Scissors, Surgical, Gall Bladder

23000 Scissors, Surgical, Biliary Duct

23001 Scissors, Surgical, Spinal


23002 Scissors, Surgical, Spinal, Microsurgery

23003 Scissors, Surgical, Urinary Tract, Endoscopic

23005 Scissors, Surgical, Uterine

23007 Scissors, Surgical, Uterine, Parametrium/Hysterectomy

23008 Scissors, Surgical, Uterine, Fetal Decapitation

23010 Scissors, Surgical, Episiotomy


23011 Scissors, Surgical, Vascular

23012 Scissors, Surgical, Vascular, Artery

23013 Scissors, Surgical, Vascular, Artery, Coronary

23014 Scissors, Surgical, Vascular, Artery, Coronary, Circumflex

23015 Scissors, Surgical, Vascular, Artery, Carotid/Endarterectomy


23016 Scissors, Surgical, Vascular, Microsurgery

23017 Scissors, Surgical, Cartilage

23019 Scissors, Surgical, Dura Mater

23020 Scissors, Surgical, Arthroscopic

23021 Scissors, Surgical, Nerve

23022 Scissors, Surgical, Tendon


23025 Scissors, Surgical, Wire Cutting

23026 Scissors, Umbilical Cord

23027 Scissors, Wound Debridement

23028 Scissors, Postmortem

23031 Scissors, Cast

23032 Scissors, Finger Nail/Cuticle

23036 Scissors, Toenail


23068 Probes, Gamma Radiation Detection

23069 Probes, Gamma Radiation Detection, Lymphatic Mapping

23070 Probes, Gamma Radiation Detection, Head/Neck Surface

23071 Probes, Gamma Radiation Detection, Abdominal

23072 Probes, Gamma Radiation Detection, Thoracic

23082 Centrifugal Blood Cell Processors


23087 Centrifugal Blood Cell Processors, Glycerolization/Deglycerolization

23095 Printers, Video, Monochromatic

23098 Vein Graft Holding Instruments, Surgical

23099 Suture Units, Endoscopic, Lower Esophageal Sphincter

23101 Printers, Video, Color


23103 Printers, Computer/Network

23106 Printers, Computer/Network, Laser

23109 Printers, Label, Bar-Code

23115 Contrast Media Injector Kit Assemblies, Syringe, Reusable

23116 Contrast Media Injector Kit Assemblies, Angiography, Manifold, Disposable

23117 Contrast Media Injector Kit Assemblies, Angiography, Syringe/Manifold


23123 Contrast Media Injector Kit Assemblies, Angiography, Controller, Disposable

23134 Apheresis Units, Blood Donor

23135 Apheresis Units, Blood Donor, Platelet

23136 Apheresis Units, Blood Donor, Plasma

23137 Apheresis Units, Therapeutic


23138 Apheresis Units, Therapeutic, Phototherapy

23139 Apheresis Units, Therapeutic, Low-Density Cholesterol

23146 Blood Cell Washer Sets

23147 Blood Pheresis Sets, Closed

23148 Blood Pheresis Sets, Open

23151 Waste-Disposal Units, Liquid


23152 Needles, Injection, Hypodermic, Penlike Cartridge Syringe, Protective

23154 Stimulators, Electromagnetic, Low-Intensity

23156 Stimulators, Electromagnetic, Low-Intensity, Soft Tissue/Wound

23163 Data Interface Units

23170 Keypads

23171 Computer/Computerized System Keypads


23176 Auxiliary Displays

23177 Auxiliary Displays, Physiologic Monitor

23178 Auxiliary Displays, Physiologic Monitor, Interactive

23179 Auxiliary Displays, Physiologic Monitor, Noninteractive

23206 Prostheses, Joint, Finger/Thumb


23305 Prostheses, Joint, Shoulder, Total

23306 Prostheses, Joint, Temporomandibular

23318 Prostheses, Joint, Wrist, Carpal Lunate

23320 Prostheses, Joint, Wrist, Carpal Scaphoid

23321 Prostheses, Joint, Wrist, Carpal Trapezium


23322 Prostheses, Joint, Wrist, Total

23339 Prostheses, Upper Limb

23348 Prostheses, Upper Limb, Finger/Thumb

23354 Prostheses, Upper Limb, Hand, Passive


23358 Prostheses, Upper Limb, Hand, Mechanical

23360 Prostheses, Upper Limb, Hand, Electrical

23365 Prostheses, Upper Limb, Hand, Myoelectric

23367 Prostheses, Upper Limb, Hook


23368 Prostheses, Upper Limb, Hook, Mechanical

23369 Prostheses, Upper Limb, Hook, Electrical

23371 Prostheses, Upper Limb, Hook, Myoelectric

23372 Prostheses, Upper Limb, Wrist Component


23373 Prostheses, Upper Limb, Wrist Component, Mechanical

23374 Prostheses, Upper Limb, Wrist Component, Electrical

23375 Prostheses, Upper Limb, Wrist Component, Myoelectric

23376 Prostheses, Upper Limb, Wrist Disarticulation


23378 Prostheses, Upper Limb, Below Elbow

23379 Prostheses, Upper Limb, Elbow Component

23380 Prostheses, Upper Limb, Elbow Component, Mechanical


23381 Prostheses, Upper Limb, Elbow Component, Electrical

23383 Prostheses, Upper Limb, Elbow Component, Myoelectric

23384 Prostheses, Upper Limb, Elbow Disarticulation


23385 Prostheses, Upper Limb, Above Elbow

23386 Prostheses, Upper Limb, Shoulder Component

23387 Prostheses, Upper Limb, Shoulder Component, Mechanical

23388 Prostheses, Upper Limb, Shoulder Component, Electrical


23389 Prostheses, Upper Limb, Shoulder Disarticulation

23390 Prostheses, Upper Limb, Total

23393 Prostheses, Lower Limb


23398 Prostheses, Lower Limb, Foot, Energy Storing

23399 Prostheses, Lower Limb, Foot, Partial

23403 Prostheses, Lower Limb, Ankle Disarticulation

23404 Prostheses, Lower Limb, Ankle Component


23405 Prostheses, Lower Limb, Below Knee

23406 Prostheses, Lower Limb, Knee Component

23407 Prostheses, Lower Limb, Knee Disarticulation

23408 Prostheses, Lower Limb, Above Knee


23409 Prostheses, Lower Limb, Hip Component

23410 Prostheses, Lower Limb, Hip Disarticulation

23411 Prostheses, Lower Limb, Total

23418 Flowmeters, Blood, Ultrasonic, Transcranial

23419 Air Cleaners, Particulate/Gas/Vapor, Germicidal, Ultraviolet Light


23423 Testers, Logic Circuit

23424 Electrothermal Cautery Units, Infrared

23425 Purified Water Storage/Delivery Systems, Laboratory

23426 Hemodialysis Units, Renal, Continuous Replacement Therapy


23427 Hemodialysis Units, Hepatic

23429 Hemodialysis Units, Hepatic, Continuous Replacement Therapy

23430 Shaker/Orbiters, Laboratory

23431 Incubators, Laboratory, Shaker/Rotator, Platelet


23432 Heating Mantles, Laboratory

23433 Tissue Cassette Paraffin Trimmers

23434 Keypads, Access Control

23435 Video Image Processors, Format Conversion

23436 Probes, Ultrasonic, Phacoemulsification Unit

23437 Physiologic Monitor Modules, Neuromuscular Block


23441 Cameras, Photographic

23442 Network Routers

23443 Network Switches

23444 Document Scanners, Filmstrip/Photo Slide

23445 Image Processors, Gel Quantifying, Fluorescent Label


23446 Image Processors, Gel Quantifying

23447 Slit Lamp/Camera Adapters

23448 Workstations, Ophthalmology

23449 Electric Signal Amplifiers, Audio/Video

23450 Masks, Resuscitator, Adult

23451 Masks, Resuscitator, Pediatric


23452 Masks, Resuscitator, Infant

23454 Radioactive Technetium/Carbon Particle Encapsulated Gas Generators

23455 Testers, Endoscope, Air Leak

23456 Analyzers, Point-of-Care, Whole Blood, Hematology, Hemoglobin

23457 Counters, Particle, Environmental

23458 Samplers, Laboratory, Automated, High Pressure/Temperature


23459 Slide Stainers, Immunohistochemistry

23460 Laboratory Stirrers, Magnetic

23461 Laboratory Concentrators, Specimen, Centrifugal/Vacuum

23462 Hot Plate/Stirrers

23463 Centrifuge Rotors


23465 Analyzers, Laboratory, Multitechnology

23468 Sterilization Process Indicator Kits, Biological

23470 Image Processors, Video, Laboratory Microscope

23472 Workstations, Intensive Care

23473 Defibrillators, Wearable, Automated


23474 Retractors, Surgical, Abdominal Wall, Self-Retained, Laparoscopy, Disposable

23475 Alarms, Foot Load

23481 Analyzers, Point-of-Care, Whole Blood, Ammonia

23482 Analyzers, Point-of-Care, Whole Blood, Multianalyte, Cardiovascular Marker

23484 Automation Systems, Operating Room, Endoscopy


23487 Cameras, Video, Intraoral

23489 Chambers, Laboratory, Thermostatic Controlled, Chromatography Column

23490 Controllers, Chromatography System

23491 Cystoscopes, Flexible, Video

23492 Waxers, Dental Laboratory

23494 Dispensers, Disinfecting Spray, Powered

23496 Disinfectors, Vapor Germicide, Formaldehyde/Ammonia, Enclosure


23499 Electrodes, Neuromuscular Stimulator, Dysphagia

23500 Electrometers

23501 Electropalatographs

23502 Endoscopes, Gastrointestinal Tract, Lower Tract, Video/Ultrasound

23503 Endoscopes, Gastrointestinal Tract, Upper Tract, Video/Ultrasound


23504 Endoscopic Telescopes

23505 Procedure Kit/Trays, Vessel Harvesting, Minimally Invasive, Endoscopic

23506 Ergometers, Cyclic Arm Exerciser

23507 Exercisers, Muscle Strength, Lever/Pulley-Cable, Upper Limb/Trunk, Arm


23508 Exercisers, Flexibility

23509 Exercisers, Muscle Strength, Lever/Pulley-Cable, Upper Limb/Trunk, Chest Press

23510 Exercisers, Continuous Passive Motion, Lower Limb, Hip

23511 Exercisers, Muscle Strength, Lever/Pulley-Cable, Lower Limb, Hip Rotation

23512 Exercisers, Muscle Strength, Lever/Pulley-Cable, Lower Limb, Leg Press


23513 Exercisers, Aerobic, Upper/Lower Limb, Cycler

23514 Eyeglasses, Nystagmus Test

23515 Eyeglasses, Corrective Lens, Telescopic

23516 Eyeglasses, Corrective Lens, Telescopic, Automated Focus

23517 Fluorescent Plates, Ionizing Radiation Alignment


23518 Geiger Tubes

23519 Laryngoscope Handles, Fiberoptic

23520 Height Measurement Instruments, Portable, Neonate/Infant

23521 Laboratory Hoods, Polymerase Chain Reaction

23522 Image Digitization Systems, Ophthalmic

23523 Insufflators, Endoscopic


23524 Ionization Chambers

23525 Irrigators, Dental/Oral

23526 Irrigators, Ear Canal

23527 Irrigators, Surgical Site

23528 Irrigators, Surgical Site, Electrosurgery

23529 Irrigators, Upper Urinary Tract


23530 Laboratory Degassers, Flowing Liquid

23531 Laryngoscopes, Flexible, Video

23532 Laryngoscopes, Rigid, Video

23533 Laryngoscopes, Flexible, Lower Larynx/Glottis

23534 Laryngoscope Blades

23536 Manometers, Maximum Inspiratory/Expiratory Pressure


23537 Manometers, Muscle Performance Assessment

23539 Nasopharyngoscopes, Flexible, Video

23540 Suture Needle Holding Instruments, Endoscopic

23541 Oral Feeding Aids, Electromechanical

23542 Ovens, Annealing, Thermoluminescent Detector

23544 Phototherapy Units, Infrared, Pulse Lamp/Laser


23545 Power Systems, Electromechanical, Surgery

23547 Pumps, Laboratory, Peristaltic

23548 Pumps, Laboratory, Vacuum

23549 Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometry

23550 Shoes, Balance Training

23551 Sphygmomanometers, Electronic, Automatic, Wrist


23552 Testers, Power Line Disturbance

23553 Video Systems, Endoscopic, Chip Camera, Laryngoscopic Intubation

23554 Vacuum Cleaners, Laboratory Fluid

23555 Volume Measurement Kits, Hand

23556 Washers, Slide

23558 Simulators, Training, Airway Management/Intubation


23565 Dental Implants, Endosteal, Root Form

23585 Prostheses, Nasal

23588 Prostheses, Beard/Mustache/Sideburns

23592 Stents, Eustachian Tube

23594 Stents, Laryngeal, Keel

23595 Tubes, Esophageal, Temporary Reconstruction


23603 Prostheses, Dental

23605 Prostheses, Dental, Fixed, Complete

23606 Prostheses, Dental, Fixed, Partial

23608 Prostheses, Dental, Fixed, Inlay

23610 Prostheses, Dental, Fixed, Onlay

23614 Prostheses, Dental, Fixed, Crown


23615 Prostheses, Dental, Fixed, Crown, Partial

23616 Prostheses, Dental, Fixed, Crown, Total

23619 Prostheses, Dental, Fixed, Crown, Total, Post

23620 Prostheses, Dental, Fixed, Crown, Total, Abutment

23625 Dentures

23626 Dentures, Complete

23635 Dentures, Complete, Overlay


23636 Dentures, Complete, Immediate

23637 Dentures, Partial, Overlay

23638 Dentures, Partial, Immediate

23641 Retainers, Dental

23642 Retainers, Dental, Orthodontic, Fixed

23643 Retainers, Dental, Orthodontic, Removable

23644 Retainers, Dental, Fixed Prosthesis


23645 Retainers, Dental, Partial Denture

23646 Retainers, Dental, Matrix Band

23647 Dental Prosthesis Pontics

23648 Dental Prosthesis Connectors

23649 Denture Plates

23653 Dental Implants, Endosteal

23656 Dental Implants, Endosteal, Zygomatic

23658 Dental Implants, Endosteal, Partial Removable Denture


23659 Dental Implants, Transosteal

23660 Dental Implants, Subperiosteal

23661 Dental Inserts, Intramucosal

23672 Electric Signal Amplifiers

23673 Monitors, Environmental, Oxygen

23674 Analyzers, Environmental/Gas System, Carbon Dioxide


23675 Exercisers, Computer-Aided Training, Balance

23676 Drill Chucks

23679 Ophthalmoscope/Retinoscopes

23680 Bur/Drill Bit Guards

23681 Surgical Retractor Handrests


23682 Injectors, Chromatography, Automated

23683 Analyzers, Physiologic, Visual Function, Visual Acuity/Macular Integrity, Bright Lig

23684 Manometers, Plantar Foot Pressure

23685 Photometers, Skin Melanin Content/Erythema


23686 Analyzers, Physiologic, Body Pressure Distribution, Back/Seating

23688 Exercisers, Balance, Patient Lifting

23690 Injectors, Chromatography, Manual

23693 Liquid Nitrogen Container Transfer Connectors

23694 Analyzers, Physiologic, Visual Function, Tear Structure


23696 Cables, Handpiece/Power Console

23697 Manifolds, Liquid, Chromatography

23698 Casework, Multipurpose, Adjustable Height

23699 Eyeglass Lens Edgers

23700 Surgical Instrument Holders

23701 Surgical Retractor Blades

23708 Retinometers
23710 Diagnostic/Therapeutic Kits, Ophthalmic

23712 Video Camera/Power Supply/Signal Generator Adapters

23713 Analyzers, Environmental/Gas System, Oxygen

23714 Analyzers, Point-of-Care, Breath, Nitric Oxide

23715 Surgical Retractor Bars

23717 Monitors, Physiologic, Respiration/Exhaled Carbon Dioxide/Pulse Oximetry, Bedsi


23718 Lifts, Unoccupied Wheelchair/Scooter, Motor Vehicle

23719 Operating Table Pedestals

23721 Cold Plates

23722 Distractors, Surgical, Ankle

23724 Exercisers, Computer-Aided Training, Virtual Reality

23725 Hydrotherapy Pools


23726 Injectors, Ear Canal Impression, Hearing Aid Mold

23727 Injectors, Intracordal, Vocal Cord Augmentation

23729 Exercisers, Muscle Strength, Lift Test Platforms

23730 Retractors, Surgical, Bone, Femur

23731 Operating Tabletops, Orthopedic


23732 Operating Tabletops, Spinal

23733 IVD Blotters, Nucleic Acid, Vacuum Capillary Transfer

23734 Viscosimeters

23735 Turbines, Whirlpool Bath

23736 Patient Bathing Units

23737 Lifts, Patient Transfer, Swimming Pool


23741 Recorders, Environmental, Air Temperature

23743 Dynamometers, Pinch Force

23744 Exercisers, Continuous Passive/Active Motion, Lower/Upper Limb

23745 Exercisers, Balance

23746 Exercisers, Aerobic, Trampoline


23747 Exercisers, Aerobic, Elliptical Motion

23748 Exercisers, Muscle Strength, Lever/Pulley-Cable, Upper Limb/Trunk, Abdominal C

23749 Exercisers, Muscle Strength, Free Weight, Dumbbell

23750 Exercisers, Muscle Strength, Lever/Pulley-Cable, Upper Limb/Trunk

23751 Distractors, Surgical, Shoulder


23753 Head/Chin Rests, Ophthalmic Test

23756 Calipers, Surgical

23760 Calipers, Surgical, Bone

23766 Calipers, External Anthropometry

23776 Electrogoniometers, Single-Axis


23777 Electrogoniometers, Double-Axis

23778 Torsiometers

23779 Sizers, Breast Implant

23780 Sizers, Nasal Implant

23782 Sizers, Vascular Graft

23783 Sizers, Penile Prosthesis


23784 Sizers, Tracheoesophageal Speech Prosthesis

23785 Sizers, Corneal Diameter

23788 Eyelid Weight Sizer Sets

23793 Osmometers, Freezing Point

23794 Osmometers, Vapor Pressure

23803 Timers, Darkroom


23804 Timers, Laboratory

23808 Dynamometers, Hand Grip

23809 Dynamometers, Hand Grip, Bulb Squeeze

23812 Dynamometers, Hand Grip, Spring

23814 Dynamometers, Hand Grip, Hydraulic


23816 Dynamometers, Pinch Force, Hydraulic

23818 Dynamometers, Hand Grip/Pinch Force, Bulb Squeeze

23820 Dynamometers, Multipurpose, Push-Pull

23825 Ergometers, Bicycle, Table-Mounted


23827 Ergometers, Treadmill

23840 Drill Bits

23844 Breast Implants, Saline-Filled

23846 Dura Mater Implants

23849 Penile Tissue Expanders

23850 Penile Tissue Expanders, Traction


23851 Ligament/Tendon Implants

23855 Testicle Implants, Saline-Filled

23856 Testicle Implants, Solid

23858 Stents, Eye, Glaucoma Drainage

23860 Augmentation/Reconstruction Implants

23861 Augmentation/Reconstruction Implants, Facial


23865 Augmentation/Reconstruction Implants, Facial, Cheek

23866 Augmentation/Reconstruction Implants, Facial, Chin/Mandible

23868 Augmentation/Reconstruction Implants, Facial, Nasal

23871 Augmentation/Reconstruction Implants, Muscle

23872 Augmentation/Reconstruction Implants, Muscle, Calf

23873 Augmentation/Reconstruction Implants, Muscle, Pectoral


23874 Augmentation/Reconstruction Implants, Muscle, Bicep/Tricep

23875 Augmentation/Reconstruction Implants, Muscle, Gluteal

23876 Dental Attachments

23878 Dental Attachments, Clasp

23881 Dental Attachments, Clasp, Partial Denture

23882 Dental Attachments, Clasp, Overlay Partial Denture


23886 Dental Attachments, Precision, Partial Denture

23887 Dental Attachments, Precision, Partial Denture, Intracoronal

23888 Dental Attachments, Precision, Partial Denture, Extracoronal

23889 Dental Attachments, Precision, Partial Denture, Implant

23890 Dental Attachments, Precision, Overlay Partial Denture


23892 Dental Attachments, Semiprecision

23895 Dental Attachments, Semiprecision, Partial Denture

23896 Dental Attachments, Semiprecision, Partial Denture, Intracoronal

23897 Dental Attachments, Semiprecision, Partial Denture, Extracoronal

23898 Dental Attachments, Semiprecision, Partial Denture, Implant


23899 Dental Attachments, Semiprecision, Overlay Partial Denture

23901 Dental Root Studs

23903 Dental Root Studs, Radicular

23904 Dental Root Studs, Intraradicular

23906 Denture Anchors, Ball

23907 Denture Anchors, Bar

23909 Breast Implants, Nipple


23916 Stimulators, Electrical, Neuromuscular, Dysphagia

23917 Phototherapy Units, Infrared

23918 Mouthwash

23919 Artificial Saliva

23920 Air Cleaners, Particulate/Gas/Vapor, Germicidal

23921 Electric Signal Amplifiers, Audio

23928 Electric Signal Amplifiers, Video


23929 Network Hubs

23930 Vessel Harvesting Systems

23932 Procedure Kit/Trays, Vessel Harvesting

23940 Procedure Kit/Trays, Vessel Harvesting, Minimally Invasive


23943 Endoscopes, Subcutaneous Tunnel, Vessel Harvesting

23947 Incubators, Laboratory, Shaker/Rotator

23950 Image Processors

23958 Information Systems, Data Management, Critical Care

23959 Information Systems, Data Management, Patient Portal

23965 Silicone Oil, Intraocular


23981 Testers, Endoscope, Leak/Fluid Detection

23982 Nucleic Acid Processors, Replication, Thermal Cycle, Real-Time Quantification

23993 Information Systems, Telemedicine, Ophthalmology

23995 Ventricular Restraint Implants

23996 Scanning Systems, Ultrasonic, Abdominal, Liver Stiffness


23998 Radiofrequency Therapy Systems, Tumor Treatment

23999 Endoscopes, Gastrointestinal Tract, Upper Tract, Double Balloon

24000 Catheters, Nasal, Sinus Dilatation, Endoscopic

24001 Procedure Kit/Trays, Catheterization, Nasal Sinus

24002 Tags, Radiofrequency Identification, Patient


24008 Tags, Radiofrequency Identification, Patient, Implantable

24009 Procedure Kit/Trays, Catheterization, Spinal, Intervertebral Disc

24013 Scanning Systems, Computed Tomography/Single Photon Emission Computed To

24018 Electrothermal Cautery Units, High-Resistance


24022 Laryngoscope Handles

24023 Laryngoscope Blades, Fiberoptic

24024 Nasopharyngoscopes, Rigid, Video

24026 Needles, Injection, Hypodermic, Penlike Cartridge Syringe

24027 Needles, Injection, Hypodermic, Protective

24028 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly

24029 Controllers, Disabled-Patient-Assistance, Voice-Activated


24030 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Diso

24031 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Disom

24032 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Diso

24033 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Disom

24034 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Disom

24035 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Diso

24036 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Disom

24037 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Uniparental Diso
24038 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24039 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24040 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24041 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(2

24042 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24043 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(4

24044 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24045 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(4

24046 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(5

24047 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(6
24048 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(8

24049 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24050 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(8

24051 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24052 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(9

24053 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24054 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24055 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(1

24056 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(


24057 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24058 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24059 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24060 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24061 Computer-Aided Detection Systems, Image, Breast, Magnetic Resonance

24062 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24063 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t

24066 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(

24067 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, t(1
24068 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy

24069 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 7, Congen

24070 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 8, Congen

24071 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 9, Congen

24072 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy, Acquired

24073 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 12, Acqui

24074 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 7, Acquir

24075 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 8, Acquir

24076 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Trisomy 9, Acquir
24077 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Deletion

24078 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Deletion, 22q11.

24079 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Deletion, 22q13.

24080 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Deletion, 15q11.

24092 Analyzers, Point-of-Care, Feces, Occult Blood

24096 Washer/Decontamination Units, Endoscopic Channel Flushing

24097 Monitors, Physiologic, Tissue, Oximetry, Bedside


24099 Analyzers, Physiologic, Respiratory Function Mechanics, Adult, Oropharynx, Acous

24100 Analyzers, Physiologic, Respiratory Function Mechanics, Adult, Nasal

24101 Analyzers, Physiologic, Respiratory Function Mechanics, Adult, Nasal, Acoustic Re

24104 Orthoses, Lower/Upper Limb, Functional, Powered, Myoelectric

24105 Orthoses, Lower Limb, Total, Gait, Powered, Myoelectric

24106 Orthoses, Upper Limb, Total, Functional, Powered, Myoelectric


24107 Catheter/Stylet Tip Locators, Central Venous

24108 Stylets, Catheter, Central Venous, Tip Locator

24110 Catheters, Vascular, Embolectomy/Thrombectomy, Fragmentation/Thrombolysis

24111 Exercisers, Muscle Strength, Lever/Pulley-Cable, Lower Limb, Hip Abduction/Addu

24112 Detectors, Periodontal/Oral Tissue Abnormality, Induced Fluorescence


24113 Ultrasound Surgical Units, Dental

24115 Topical Solution/Creams, Nasal

24116 Magnetic Resonance Imaging Coils, Endorectal

24117 Information Systems, Data Management, Financial, Registration

24118 Information Systems, Data Management, Case Management

24119 Information Systems, Data Management, Financial, Claims/Denial Management


24120 Information Systems, Data Management, Clinical Pharmacy, Electronic Medicatio

24124 Simulators, Training, Automated External Defibrillator

24125 Warming/Cooling Units, Laboratory

24126 Injectors, Contrast Media, Ultrasound

24128 Scanning Systems, Laser, Near-Infrared Spectroscopy, Intravascular


24129 Readers, Thermoluminescent Dosimeter

24130 Spinal Disc Diagnostic Systems, Intradiscal Pressure/Volume

24131 Analyzers, Physiologic, Respiratory Function Mechanics, Adult, Nasal, Breathing

24132 Analyzers, Laboratory, Microparticle Characteristic

24133 Hemorrhoid Ligation Units, Endoscopic, Ultrasound Guided


24138 Laboratory Hoods

24145 Laboratory Hoods, Chemical Fume, Walk-in

24146 Laboratory Hoods, Chemical Fume, Distillation/Tall Equipment

24147 Laboratory Hoods, Chemical Fume, Perchloric Acid

24148 Laboratory Hoods, Chemical Fume, Ductless

24150 Laboratory Hoods, Chemical Fume, Ductless, Mobile


24151 Laboratory Hoods, Fingerprint Development

24153 Laboratory Hoods, Radioisotope

24154 Laboratory Hoods, Laminar Flow

24158 Laboratory Hoods, Laminar Flow, Horizontal

24160 Laboratory Hoods, Laminar Flow, Vertical

24162 Laboratory Hoods, Laminar Flow, Vertical, Polymerase Chain Reaction


24164 Laboratory Hoods, Laminar Flow, Vertical, Forensic Evidence

24165 Oxygen Delivery Hoods, Adult

24166 Oxygen Delivery Hoods, Infant

24167 Oxygen Delivery Hoods, Infant, Disposable

24169 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly

24170 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion

24171 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, ATP7A
24172 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, AZF1

24173 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, BS

24174 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, AGPAT2

24175 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, DM

24176 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, ELN

24177 Electrocardiographs, Ambulatory, Loop-Recording, Implantable

24179 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, FSHMD1A

24180 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, GALC
24181 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, JAG1

24182 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, Mitochondrial

24183 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, Mitochondrial,

24184 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, Mitochondrial,

24185 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, Mitochondrial,

24186 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, NR0B1

24187 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, NSD1

24188 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, OCA2

24189 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion, PAX6

24190 Mesh, Collagen


24191 Irrigators, Wound, Ultrasound Debridement

24192 Wheelchair Handcycles, Mechanical

24193 Wheelchair Handcycles, Powered

24194 Warming Units, Infant Nutritionals

24196 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Purification

24197 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Sequencing
24198 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication

24199 Orthoses, Upper Limb, Total, Functional, Powered

24200 Orthoses, Upper Limb, Total, Functional, Powered, Neuro-Myoelectric

24201 Orthoses, Upper Limb, Total, Functional, Powered, Autonomous

24202 Orthoses, Upper Limb, Total, Functional, Powered, Autonomous/Neuro-Myoelectri

24203 Orthoses, Lower Limb, Total, Gait, Powered


24204 Orthoses, Lower Limb, Total, Gait, Powered, Neuro-Myoelectric

24205 Orthoses, Lower Limb, Total, Gait, Powered, Autonomous

24206 Orthoses, Lower Limb, Total, Gait, Powered, Autonomous/Neuro-Myoelectric

24207 Orthoses, Lower/Upper Limb, Functional, Powered

24208 Orthoses, Lower/Upper Limb, Functional, Powered, Neuro-Myoelectric


24209 Orthoses, Lower/Upper Limb, Functional, Powered, Autonomous

24210 Orthoses, Lower/Upper Limb, Functional, Powered, Autonomous/Neuro-Myoelectri

24213 Dispensers, Protection Garment

24214 Dispensers, Protection Garment, Multiple


24215 Dispensers, Protection Garment, Multiple, Controlled Delivery

24216 Dispensers, Protection Garment, Glove

24217 Dispensers, Protection Garment, Glove, Controlled Delivery

24224 Racks, Sterilizing Units

24225 Sterilizing Unit Baskets


24227 Plethysmographs, Lower/Upper Limb, Segmental

24228 Testers, Oxygen Concentrator

24229 Recorders, Physiologic, Urodynamic

24230 Video Systems, Operating Room, Head Camera


24231 Stimulators, Photic, Visual, Relaxation/Therapeutic

24232 Laboratory Stirrers, Motorized

24233 Stirring Bars, Magnetic

24237 Computer-Aided Detection Systems, Pathology Slide, Prostate Tissue

24239 IVD Test Reagent/Kits, Home Assay, Whole Blood, Sampling


24243 Electroporators

24245 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Staphylococcus aure

24248 Computer-Aided Detection Systems, Pathology Slide, Blood Cell Classification

24249 Electrocardiographs, Ambulatory, Loop-Recording


24250 Electrocardiographs, Ambulatory, Loop-Recording, External

24254 Blood Drawing Stands, Adjustable Height

24255 Adsorbers, Extracorporeal, Lipopolysaccharide

24263 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation

24275 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ABCA4

24276 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ABCC8
24277 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ABCD1

24278 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ACADM

24279 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ACAT1

24280 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ACTA1

24281 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ACVRL1

24282 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, AGXT

24283 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, AIPL1

24284 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ALDH5A1
24285 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ALMS1

24286 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ALX4

24287 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, APC

24290 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, APOE

24291 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, APP

24292 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, APTX

24293 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, AQP2

24295 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, AR

24297 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ARG1
24298 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ARG2

24299 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ARSA

24300 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ASL

24301 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ASPA

24302 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ASS1

24303 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ATM

24304 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ATPT7A

24305 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ATPT7B

24306 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ATRX

24308 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, AVPR2
24309 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BBS1

24310 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BCKDHA

24311 Scanning Systems, Computed Tomography, Cone-Beam

24312 Scanning Systems, Computed Tomography, Cone-Beam, Head/Neck

24313 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BCKDHB

24314 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BCL2
24315 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BCL6

24316 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BCOR

24317 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BLM

24318 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BMPR1A

24319 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BRCA1

24321 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BRCA2

24322 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BSCL2

24323 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BTD

24324 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BTK

24325 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CACNA1A
24326 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CACNA1S

24327 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CAPN3

24329 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CBS

24331 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CCND1

24332 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CCR5

24333 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CDH1

24334 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CDKN1C

24335 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CFTR

24338 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CHM
24339 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CHRNA4

24340 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CHRNB2

24341 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CKN1

24342 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLA2

24343 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLN1

24344 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLN2

24345 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLN3

24346 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLN5

24347 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLN6

24348 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CLN8
24349 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CMT

24350 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CNGA3

24351 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CNGB1

24352 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CNGB3

24353 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COCH

24354 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL11A1

24355 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL11A2

24356 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL1A1

24359 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL1A2
24360 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL2A1

24361 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL3A1

24362 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL4A3

24363 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL4A4

24364 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL4A5

24365 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL5A1

24366 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL9A1

24367 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL9A2

24368 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COL9A3

24369 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, COMP

24370 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CP


24371 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CPS1

24372 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CPT2

24373 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CRB1

24374 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CREBPP

24375 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CRX

24376 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CTNNB1

24377 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CTNS

24378 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP1B1

24379 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP21A2
24380 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP2D6

24381 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, DBT

24382 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, DGCR2

24383 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, DHCR7

24384 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, DMD

24385 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, DMPK

24386 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, DYSF

24387 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ECGF1

24388 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EDA
24389 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EDAR

24390 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EGFR

24391 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EGR2

24392 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EIF2B1

24393 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EIF2B2

24394 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EIF2B3

24395 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EIF2B4

24396 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EIF2B5

24397 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ELA2
24398 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ELN

24399 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EMD

24400 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ENG

24401 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ERCC6

24402 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ETM1

24403 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ETM2

24404 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EXT1

24405 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EXT2

24406 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, EYA1

24407 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, F2

24410 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, F5

24415 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, F7

24416 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, F8


24421 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, F9

24422 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FANCA

24423 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FANCC

24424 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FANCF

24425 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FANCG

24426 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FBN1

24427 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FCMD

24428 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FGFR1

24429 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FGFR2
24430 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FGFR3

24431 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FKRP

24432 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FLNA

24433 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FOXL2

24434 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FRDA

24435 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, G6PD

24436 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GALC

24437 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GALT

24438 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GBA

24439 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GCDH
24440 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GCH1

24441 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GCK

24442 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GDAP1

24443 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GFAP

24444 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GJB1

24445 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GJB2

24446 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GJB6

24447 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GLI3

24448 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GLA
24449 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GLUD1

24450 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GNE

24451 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GPC3

24452 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GPR56

24453 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GUCY2D

24454 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, H19

24455 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HADHA

24456 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HADHB
24457 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HAMP

24459 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HBA1

24461 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HBB

24465 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HEXA

24468 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HFE

24469 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HJV

24471 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HMCGL

24472 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HPRT1

24473 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HPS1

24474 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HPS3
24475 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HRAS

24476 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HSPB1

24477 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HYAL1

24478 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, IDUA

24479 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, IKBKAP

24480 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, IKBKG

24481 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KRIT1

24485 Controllers, Specialty Bed/Mattress System


24487 Controllers, Specialty Bed/Mattress System, Percussion/Vibration Therapy

24490 Controllers, Specialty Bed/Mattress System, Low-Air-Loss Therapy

24491 Controllers, Specialty Bed/Mattress System, Lateral Rotation Therapy

24493 Infusion Systems, Medication, Vascular

24494 Tubing, Metallic

24496 Tubing, Rubber/Latex

24498 Tubing, Synthetic Polymer


24499 Tubing, Synthetic Polymer, Teflon

24500 Tubing, Synthetic Polymer, Tygon

24501 Tubing, Synthetic Polymer, Polyurethane

24502 Tubing, Glass

24503 Tubing, Glass, Borosilicate

24506 Walkers, Standard, Adjustable Width


24508 Walkers, Standard, Folding

24510 Walkers, Wheeled, Adjustable Width

24511 Walkers, Wheeled, Folding

24512 Walkers, Wheeled, Knee Support

24517 Document Scanners

24518 Document Scanners, Flat/Sheet Bed


24519 Data Processors

24520 Data Processors, Tape Recording

24522 Data Processors, Tape Recording, Electrocardiography

24523 Data Processors, Tape Recording, Electroencephalography

24524 Data Processors, Electronic Recording


24525 Data Processors, Electronic Recording, Electrocardiography

24526 Data Processors, Electronic Recording, Electroencephalography

24545 Ophthalmic Cross Cylinder Lens Sets

24547 Ophthalmic Cross Cylinder Lenses

24548 Refractors, Ophthalmic, Automated

24549 Refractors, Ophthalmic, Manual


24553 Aberrometers

24554 Lensometers, Manual

24555 Lensometers, Automated

24562 Gonioscopes, Indirect

24563 Gonioscopes, Direct

24570 Heterophoria Assessment Rods


24574 Safety Pins

24575 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, IL2RG

24576 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, IRF6

24577 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, JAG1

24578 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNE1

24579 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNE2

24580 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNH2

24581 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNJ11

24582 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNJ2
24583 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNQ1

24584 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KCNQ4

24585 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KIF21A

24586 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KAL 1

24587 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KRAS2

24588 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KRT14

24589 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KRT5

24590 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, L1CAM

24591 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LAMA2

24592 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LARGE
24593 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LITAF

24594 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LMNA

24595 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LMX1B

24596 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LPL

24597 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MADH4

24598 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MAN2B1

24599 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MAPT

24600 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MATN3

24601 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MCOLN1

24602 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MECP2

24603 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MEFV
24604 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MEN1

24605 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MLC1

24606 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MFN2

24607 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MLH1

24608 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-CO2

24609 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MMAA

24610 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MMAB

24611 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MPZ

24612 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MSH2

24613 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MSH6

24614 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MSX2
24616 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-ATP6

24617 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-CYB

24618 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MTHFR

24620 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MTM1

24621 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-ND1

24622 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-ND4

24623 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-ND5

24624 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, LGMD2B

24625 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-ND6

24626 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-RNR1
24627 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-TK

24628 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-TL1

24629 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MT-TS1

24630 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MUT

24631 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MXI1

24632 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, MYOC

24633 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NAGS

24634 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NBN

24635 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NDP
24636 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NEFL

24637 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NF1

24638 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NF2

24639 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NOTCH3

24640 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NPC2

24641 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NPC1

24642 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NPHS1

24643 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NR0B1

24644 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, NSD1
24645 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GPR143

24646 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, OCA2

24647 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, OCRL

24648 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, OTC

24649 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PABPN1

24650 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PAH

24651 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PANK2

24652 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PARK2

24653 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PAX3
24654 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PAX6

24655 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PCCA

24656 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PCCB

24657 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, C10orf2

24658 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PEX1

24659 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PEX10

24660 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PEX12

24661 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PEX6

24662 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PEX7
24663 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PHOX2B

24664 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PKD1

24667 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PKD2

24668 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PKHD1

24669 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PLP1

24670 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PMM2

24671 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PMP22

24672 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, POMGnT1
24684 Tubing, Metallic, Stainless Steel, Flexible

24688 Exercisers, Aerobic

24691 Exercisers, Aerobic, Stationary Bicycle, Recumbent

24692 Exercisers, Aerobic, Stationary Bicycle, Upright


24695 Exercisers, Aerobic, Climbing, Stair/Stepper

24699 Exercisers, Aerobic, Climbing, Stair/Stepper, Nonpowered

24700 Exercisers, Aerobic, Climbing, Stair/Stepper, Powered

24701 Exercisers, Aerobic, Jumping Rope


24702 Exercisers, Muscle Strength

24703 Exercisers, Muscle Strength, Free Weight

24712 Exercisers, Muscle Strength, Free Weight, Barbell

24713 Exercisers, Muscle Strength, Lever/Pulley-Cable

24714 Exercisers, Muscle Strength, Lever/Pulley-Cable, Neck


24729 Exercisers, Muscle Strength, Lever/Pulley-Cable, Upper Limb/Trunk, Back, Pulldo

24731 Exercisers, Muscle Strength, Lever/Pulley-Cable, Upper Limb/Trunk, Back, Row

24733 Exercisers, Muscle Strength, Lever/Pulley-Cable, Lower Limb

24736 Exercisers, Muscle Strength, Lever/Pulley-Cable, Lower Limb, Leg Curl

24737 Exercisers, Muscle Strength, Lever/Pulley-Cable, Lower Limb, Leg Extension


24738 Exercisers, Muscle Strength, Lever/Pulley-Cable, Full Body

24739 Exercisers, Muscle Strength, Constrained Barbell

24740 Exercisers, Muscle Strength, Elastic Resistance

24743 Exercisers, Muscle Strength, Elastic Resistance, Hand/Finger

24750 Exercisers, Flexibility, Upper Limb/Trunk


24751 Exercisers, Flexibility, Upper Limb/Trunk, Inverse Position

24752 Exercisers, Flexibility, Lower Limb

24754 Exercisers, Flexibility, Full Body

24755 Exercisers, Balance, Board

24756 Exercisers, Balance Board, Wobble

24757 Exercisers, Balance, Board, Rocker


24758 Exercisers, Balance, Dome

24759 Exercisers, Balance, Disk

24760 Exercisers, Balance, Roller

24761 Exercisers, Balance, Ball

24763 Exercisers, Computer-Aided Training

24765 Exercisers, Continuous Passive Motion, Upper Limb, Shoulder

24766 Exercisers, Continuous Passive Motion, Lower Limb, Knee


24775 Flowmeters, Gas, Respiratory

24781 Flowmeters, Gas, Respiratory, Anesthetic/Medical Gas

24782 Flowmeters, Gas, Respiratory, Oxygen

24783 Flowmeters, Gas, Inspection/Maintenance


24784 Flowmeters, Liquid, Inspection/Maintenance

24785 Flowmeters, Intravenous Infusion Rate

24794 Spirometers, Screening

24796 Analyzers, Physiologic, Respiratory Function Mechanics, Adult, Nasal Resistance

24802 Manometers, Gastrointestinal Tract

24803 Manometers, Calibration/Inspection


24810 Ophthalmic Tonometers, Indentation

24811 Ophthalmic Tonometers, Noncontact

24814 Dressings, Impregnated

24815 Dressings, Impregnated, Saline

24816 Dressings, Impregnated, Charcoal

24817 Dressings, Impregnated, Petrolatum

24822 Dressings, Impregnated, Antimicrobial, Silver

24823 Dressings, Impregnated, Antimicrobial, Iodine

24824 Dressings, Impregnated, Antimicrobial, Zinc Oxide


24825 Dressings, Impregnated, Antimicrobial, Bismuth Tribromophenate

24826 Dressings, Impregnated, Combined

24827 Dressings, Nonimpregnated

24828 Dressings, Nonimpregnated, Natural Fiber

24829 Dressings, Nonimpregnated, Natural Fiber, Alginate

24831 Dressings, Nonimpregnated, Natural Fiber, Cotton/Gauze

24836 Dressings, Nonimpregnated, Biological

24837 Dressings, Nonimpregnated, Biological, Collagen

24838 Dressings, Nonimpregnated, Biological, Acellular Matrix

24841 Dressings, Nonimpregnated, Synthetic


24842 Dressings, Nonimpregnated, Synthetic, Fabric/Gauze

24847 Dressings, Nonimpregnated, Synthetic, Hydrocolloid

24849 Dressings, Nonimpregnated, Synthetic, Hydrofiber

24850 Dressings, Nonimpregnated, Synthetic, Hydrogel

24852 Dressings, Nonimpregnated, Synthetic, Hyaluronic Acid

24853 Dressings, Nonimpregnated, Synthetic, Silicone

24854 Dressings, Nonimpregnated, Combined

24855 Dressings, Nonimpregnated, Combined, Composite

24856 Dressings, Nonimpregnated, Combined, Alginate/Collagen


24858 Analyzers, Physiologic, Peristaltic Motility/Gastric Accommodation, Barostatic

24860 Gloves, Chemical Resistant, Chemotherapy

24861 Scanning Systems, Ultrasonic, Vascular Access

24863 Healthcare Equipment Movers

24866 Healthcare Equipment Movers, Bed/Stretcher


24867 Healthcare Equipment Movers, Wheelchair

24868 Gas Delivery Systems, Stable Xenon

24871 Microscopes, Light, Examination/Operating, Dentistry

24873 Controllers, Disabled-Patient-Assistance

24874 Environmental Controllers, Disabled-Patient-Assistance, Switch-Activated

24875 Thermoplastic Tubing Sterile Sealers


24876 Thermoplastic Tubing Sterile Sealers, Connection

24877 Thermoplastic Tubing Sterile Sealers, Separation

24878 Gas Delivery Units, Heliox

24880 Readers, Thermoluminescent Dosimeter, Passive, Automated

24884 Orthoses, Upper Limb, Elbow, Functional, Powered, Myoelectric


24890 Prostheses, Anal Sphincter

24891 Orthopedic External Fixation Systems, Fracture, Bone Lengthening/Reshaping

24896 Hemodialysis Units, Renal

24897 Hemodialysis Units, Renal, Intermittent

24898 Foot Implants


24899 Foot Implants, Fracture

24900 Foot Implants, Hammertoe

24901 Foot Implants, Subtarsal

24903 Procedure Kit/Trays, Implant Delivery, Foot Implant

24904 Bladder Support Implants, Biological

24905 Bladder Support Implants, Bioengineered


24906 Procedure Kit/Trays, Implant Delivery

24907 Procedure Kit/Trays, Implant Delivery, Bladder Support

24909 Procedure Kit/Trays, Implant Delivery, Bladder Support, Transvaginal

24910 Procedure Kit/Trays, Implant Delivery, Bladder Support, Transobturator


24911 Procedure Kit/Trays, Implant Delivery, Bladder Support, Suprapubic

24912 Procedure Kit/Trays, Implant Delivery, Bladder Support, Prepubic

24913 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, POMT1

24914 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, POU3F4

24915 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PPT1

24916 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRF1

24917 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRKAR1A
24918 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRKCG

24919 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRNP

24920 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PROP1

24921 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRP3

24922 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRP8

24923 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRSS1

24924 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRX

24925 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PSAP

24926 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PSEN1

24927 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PSEN2
24928 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PTCH

24929 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PTEN

24930 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PTPN11

24931 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PXMP3

24932 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PEX5

24933 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PYGM

24934 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RB1

24935 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PRPH2

24936 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RECQL4
24938 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RHO

24939 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RLBP1

24940 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RNASEL

24941 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RP1

24942 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RPE65

24943 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RPGRIP1

24944 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RPS6KA3

24945 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RS1

24946 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RYR1

24947 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RYR2

24948 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SACS
24949 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SALL4

24950 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SCN4A

24951 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SCN5A

24952 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SDHB

24953 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SDHD

24954 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TRAPPC2

24955 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SERPINA1

24956 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SGCA

24957 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SGCB
24958 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SGCD

24959 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SGCE

24960 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SGCG

24961 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SH2D1A

24962 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SHH

24965 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SIX3

24966 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC12A3

24967 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC17A5

24968 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC22A1L

24969 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC25A19
24970 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC26A2

24971 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC26A4

24972 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SLC2A1

24973 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SMN1

24974 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SNCA

24975 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SOD1

24976 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SPAST

24977 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SPG20

24978 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SPG3A

24979 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SPG7
24980 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SPINK1

24981 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SPTLC1

24982 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SRY

24983 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, STK11

24984 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TBX5

24985 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TCOF1

24986 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TCB2

24987 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TRB2

24988 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TCG2

24989 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TGFB1

24990 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TGIF1
24992 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TGM1

24993 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TH

24994 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TIMM8A

24995 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TPMT

24996 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TPP1

24997 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TSC1

24998 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TSC2

24999 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TTN

25000 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TTPA

25001 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TTR
25002 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TWIST1

25003 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, TYR

25004 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, UBE3A

25005 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, UGT1A1

25006 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, UROD

25007 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, USH2A

25008 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, VHL

25009 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, BEST1

25010 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, WAS
25011 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, WFS1

25012 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, WT1

25013 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ZIC2

25014 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats

25018 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats, C

25020 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,

25021 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,

25022 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats, C

25023 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,
25024 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,

25025 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,

25026 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,

25027 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats, C

25028 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats,

25029 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Trinucleotide Repeats, C

25030 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats, C

25032 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats,
25035 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats, C

25036 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats, CT

25038 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats,

25039 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats, C

25041 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats,

25042 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats, G

25044 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats,

25045 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats, G

25047 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Trinucleotide Repeats,

25048 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Pentanucleotide Repeats
25049 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Pentanucleotide Repeats,

25050 IVD Test Reagent/Kits, Molecular Assay, Gene Disorder, Pentanucleotide Repeat

25051 Detectors, Blood Leakage, Hemodialysis, Extracorporeal Circuit/Needle Site

25052 Bassinet Baskets

25065 Eyeglasses, Nystagmus Test, Video

25066 Eyeglasses, Corrective Lens

25067 Eyeglasses, Sun/Ultraviolet Protection

25074 Flowmeters, Gas, Respiratory, Medical-Air


25076 Image Digitization Systems, Bioluminescence/Fluorescence

25095 Emergency Stop Switches

25096 External Shock Wave Therapy Systems, Electromagnetic, Orthopedic

25097 Printers, Cytology/Histology Slide

25098 Monitoring Systems, Patient Position, Radiotherapy


25099 Alarms, Environmental Emergency, Fire/Smoke

25100 Detectors, Photon Radiation, Radiotherapy

25102 Implant Delivery Kits, Dental, Guided Surgery


25104 Dental Prosthesis Design/Manufacturing Systems, Computer-Aided

25105 Stereotactic Systems, Image-Guided, Surgical

25106 IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin

25107 Endodontic Obturation Units, Heated


25108 Endodontic Obturation/Extrusion Units, Heated

25109 Analyzers, Physiologic, Facial Skin Characteristics

25110 Tables, Examination/Treatment, Adjustable, Tilt Test

25111 Computer-Aided Detection Systems, Image, Virtual Colonoscopy


25112 IVD Test Reagent/Kits, Hematology, Coagulation, Activated Clotting Time, Kaolin

25113 IVD Test Reagent/Kits, Hematology, Coagulation, Activated Clotting Time, Celite

25115 Leads, Electrical Stimulator

25119 Microinjectors
25121 Snares, Ear

25122 Snares, Eye, Enucleation

25124 Snares, Respiratory Tract, Endoscopic

25125 Snares, Gastrointestinal Tract, Endoscopic


25126 Snares, Uterine, Endoscopic

25127 Snares, Urinary Tract, Endoscopic

25128 Snare Wires

25129 Snare Wire Loops, Surgical

25130 Guides, Snare Wire


25131 Fixed Loop Instruments

25148 Fixed Loop Instruments, Ear Canal

25155 Implant Delivery Units, Polymer Pin, Ultrasonic

25161 Bandages, Retention

25162 Bandages, Retention, Elastic

25163 Bandages, Retention, Non-Elastic

25164 Bandages, Retention, Non-Elastic, Cotton/Gauze

25168 Bandages, Compression/Support, Crepe

25169 Bandages, Compression/Support, Multilayer


25170 Bandages, Casting

25171 Bandages, Casting, Plaster

25172 Bandages, Casting, Synthetic

25173 Bandages, Liquid

25174 Bandages, Medicated

25175 Bandages, Medicated, Zinc Oxide

25181 Samplers, Laboratory, Automated, Cytology

25188 Digitizers, Laboratory Slide

25189 Water-Jet Surgical Units, Wound


25191 IVD Electronic Quality Controls, Coagulation Analyzer, Clotting Time

25192 Transmitter/Receiver Systems, Telephone, Patient Location/Communication

25193 Telephones, Patient Location/Communication

25207 Docking/Charging Stations, Physiologic Monitor

25208 Cooling Units, Patient, Circulating-Liquid


25209 Monitors, Physiologic, Vital Signs

25210 Height Measurement Instruments, Wall-Mounted, Mechanical

25211 Cooling Units, Operating Room Personnel

25212 Cooling Garments, Operating Room Personnel


25213 Height Measurement Instruments, Wall-Mounted, Electronic

25215 Operating Tabletops

25217 Operating Tabletops, Multi-Specialty

25222 Evaporators, Rotary


25224 Samplers, Breast Cell, Noninvasive

25225 Adhesive Strips, Multipurpose, Antimicrobial

25226 Adhesive Strips, Wound Closure

25302 Volume Measurement Kits

25451 Nitrogen Concentrators


25452 Computer/Computerized System Mice

25473 Vein Finders, Infrared Light

25577 Vaginal Rings, Drug Delivery

25578 Facility Booms, Floor-Mounted


25581 Detectors, Extravasation, Intravenous Fluid

25585 Loupes, Binocular

25586 Hospital Communication/Entertaining Systems

25593 Simulators, Training, Surgical

25595 Mixers, Otologic Cement


25597 Analyzers, Physiologic, Body Pressure Distribution

25598 Infusion Pumps, Multitherapy, Ambulatory, Elastomeric, Single-Patient

25606 Tapes, Adhesive, Cloth

25607 Tapes, Adhesive, Cloth, Hypoallergenic

25608 Tapes, Adhesive, Cloth, Waterproof

25609 Tapes, Adhesive, Cloth, Hypoallergenic/Waterproof

25610 Tapes, Adhesive, Cloth, Medicated

25611 Tapes, Adhesive, Cloth, Medicated, Zinc Oxide


25612 Tapes, Adhesive, Paper

25613 Tapes, Adhesive, Plastic

25614 Tapes, Adhesive, Plastic, Foam

25615 Tapes, Adhesive, Plastic, Foam, Hypoallergenic

25616 Tapes, Adhesive, Plastic, Film

25617 Tapes, Adhesive, Plastic, Film, Hypoallergenic

25631 Power Supply/Signal Generators, Video Camera

25633 Anemometers, Environmental


25679 Workstations, Electrocardiography

25698 Valves, Demand, Oxygen

25699 Valves, Demand, Analgesic/Anesthetic Gas

25700 Audiometer/Otoscopes

25701 Needles, Injection, Cystoscopic


25702 Analyzers, Physiologic, Visual Function, Eye Structure

25704 Morcellators, Endoscopic, Phlebectomy

25705 Bronchoscopes, Flexible, Video/Ultrasound

25706 Bronchoscopes, Flexible, Video, Image-Guided, Extended-Reach


25707 Radiofrequency/Ultrasound Therapy Systems

25708 Cardiovascular Patch Implants

25709 Circulatory Assist Units, Peripheral Compression, Warming/Cooling

25724 Wheelchair Handcycles

25725 Exercisers, Computer-Aided Training, Gait


25726 Exercisers, Computer-Aided Training, Upper Limb

25731 Distractors, Surgical

25732 Distractors, Surgical, Hip

25733 Distractors, Surgical, Knee

25746 Auxiliary Displays, Touchscreen


25747 Controllers, Hearing Aid, Remote

25785 Warming Units, Patient, Conductive Layer

25786 Warming Units, Patient, Conductive Layer, Infant

25790 Volume Measurement Kits, Arm/Forearm

25791 Volume Measurement Kits, Foot


25794 Analyzers, Physiologic, Cardiovascular Function

25797 Compresses, Medicated

25798 Compresses/Packs, Cold, Chemical

25799 Compresses/Packs, Cold, Gel

25800 Compresses/Packs, Hot, Chemical

25805 Compresses/Packs, Hot, Gel


25806 Compresses/Packs, Cold/Hot

25813 Radioaerosol Administration Sets, Radioactive Technetium/Carbon Particle

26030 Cameras, Photographic, Endoscope

26140 Hemostatic Agents, Surgical

26221 Exercisers, Computer-Aided Training, Neurologic Rehabilitation

26332 Consistometers
26333 Cameras, Video, Endoscope Tip

26334 Cameras, Video, Surgical

26335 Cameras, Video, Laparoscopic

26591 Alarms, Central Gas System, Pressure

26592 Alarms, Central Gas System, Oxygen Depletion

26601 Alarms, Equipment Temperature


26602 Alarms, Equipment Temperature, Refrigerator/Freezer

26608 Alarms, Environmental Emergency

26613 Alarms, Environmental Emergency, Carbon Monoxide

26614 Alarms, Environmental Emergency, Oxygen Depletion


26615 Drilling Machines, Dental, Laser-Guided

26620 Injectors, Chromatography

26624 Compressed Gas Proportioners

26625 Lice Treatment Kits

26626 Hemostatic Agents, Surgical, Non-Absorbable

26627 Prostheses, Biological Cardiac Valve/Synthetic Vascular Graft


26628 External Shock Wave Therapy Systems, Electromagnetic, Cardiac

26629 Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator

26630 Topical Solution/Cream/Gels

26631 Topical Solution/Creams, Ultraviolet Protection

26632 Topical Solution/Creams, Podiatric


26633 External Shock Wave Therapy Systems, Piezoelectric, Orthopedic

26639 Tubes, Jejunostomy, Pancreatic Drainage

26652 Dilators, Ureteral, Access Sheath

26654 Disinfectors, Liquid Germicide, Transesophageal Echocardiography Probe

26655 Controllers, Infusion Pump Systems, Programmable


26658 Irrigators

26659 Cleaning/Lubricating Units, Dental Handpiece

26660 Exercisers, Aerobic, Treadmill, Patient-Lifting

26661 Information Systems, Data Management, Hospital, Patient Flow/Queuing

26663 Irrigators, Nasal/Nasal Sinus


26673 Simulators, Training, Endoscopic, Bronchial

26677 Irrigators, Wound

26679 Aspirator/Irrigators, Colon

26681 Aspirator/Irrigators, Eye Surface

26685 Aspirator/Irrigators, Surgical


26686 Aspirator/Irrigators, Gastric

26688 Aspirator/Irrigators, Laparoscopy

26695 Tubes, Tracheal, One-Lung Ventilation, Double Lumen

26698 Tubes, Tracheal, One-Lung Ventilation, Single Lumen


26700 Tubes, Tracheostomy/Laryngectomy

26708 Software, Physiologic Monitoring

26709 Software

26710 Software, Physiologic Monitoring, Blood Gas


26711 Software, Physiologic Monitoring, Blood Pressure

26712 Software, Physiologic Monitoring, Cardiac Output

26713 Software, Physiologic Monitoring, Electrocardiography

26714 Software, Physiologic Monitoring, Electroencephalography


26715 Software, Physiologic Monitoring, Fetal

26716 Software, Physiologic Monitoring, Glucose

26719 Software, Physiologic Monitoring, Intracranial Pressure

26720 Software, Physiologic Monitoring, Neurology


26721 Software, Physiologic Monitoring, Multipurpose

26722 Software, Physiologic Monitoring, Vital Signs

26723 Software, Physiologic Monitoring, Respiration

26724 Software, Physiologic Monitoring, Uterine Activity


26727 Software, Physiologic Monitoring, Electro-Oculography

26728 Software, Physiologic Monitoring, Electromyography

26729 Software, Physiologic Monitoring, Acute Care

26730 Software, Physiologic Monitoring, Cardiac Catheterization


26731 Software, Physiologic Monitoring, Cardiac Electrophysiology

26732 Software, Physiologic Monitoring, Stress Exercise

26735 Software, Physiologic Monitoring, Remote Alarm

26738 Software, Anesthetic Gas Monitoring


26739 Software, Physiologic Recording

26740 Software, Physiologic Recording, Blood Pressure

26741 Software, Physiologic Recording, Electrocardiography

26742 Software, Physiologic Recording, Electroencephalography

26743 Software, Physiologic Recording, Respiration


26744 Software, Physiologic Recording, Temperature

26745 Software, Physiologic Recording, Evoked Potential

26746 Software, Physiologic Recording, Electromyography

26747 Software, Physiologic Recording, Physical Activity

26748 Software, Physiologic Recording, Somnography

26749 Software, Physiologic Recording, Plethysmography


26751 Software, Anesthetic Gas Recording

26752 Software, Physiologic Measurement

26753 Software, Physiologic Measurement, Spirometry

26754 Software, Physiologic Measurement, Transcranial Ultrasonic Blood Flow

26756 Software, Infusion Pump, Dose Error Reduction


26760 Software, Device Testing

26761 Software, Device Testing, Electrical Safety

26762 Software, Device Testing, External Defibrillator

26763 Software, Device Testing, Electrosurgical Unit


26764 Software, Device Testing, External Cardiac Pacemaker

26765 Software, Device Testing, Infusion Pump

26766 Software, Device Testing, Ventilator

26767 Software, Device Programming/Testing


26772 Software, Device Programming/Testing, Implantable Cardiac Pacemaker

26773 Software, Device Programming/Testing, Implantable Infusion Pump

26774 Software, Physiologic Analysis

26775 Software, Physiologic Analysis, Body Composition


26776 Software, Physiologic Analysis, Erection/Tumescence

26777 Software, Physiologic Analysis, Joint Laxity

26778 Software, Physiologic Analysis, Metabolic Rate

26779 Software, Physiologic Analysis, Middle Ear


26780 Software, Physiologic Analysis, Neuromuscular Function

26781 Software, Physiologic Analysis, Neuromuscular Function, Body Motion

26782 Software, Physiologic Analysis, Neuromuscular Function, Dynamometric

26783 Software, Physiologic Analysis, Neuromuscular Function, Gait


26784 Software, Physiologic Analysis, Neuromuscular Function, Posturographic

26785 Software, Physiologic Analysis, Peristaltic Motility

26786 Software, Physiologic Analysis, Respiratory Function Mechanics

26787 Software, Physiologic Analysis, Somnography


26788 Software, Physiologic Analysis, Visual Function

26789 Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection

26790 Stents, Vascular, Aorta, Balloon Expandable

26791 Catheters, Vascular, Stent Delivery, Aorta

26792 Filtration Systems, Intravascular Procedure


26793 Electroporation Therapy Systems, Tissue Ablation

26794 Software, Environmental Monitoring

26795 Software, Environmental Monitoring, Temperature

26796 Software, Environmental Monitoring, Carbon Dioxide

26797 Software, Environmental Monitoring, Ethylene Oxide


26798 Software, Environmental Monitoring, Multigas

26799 Software, Laboratory Measurement

26800 Software, Laboratory Measurement, In-Vitro Oximetry

26801 Software, Laboratory Analysis

26802 Software, Laboratory Analysis, Clinical Chemistry


26803 Software, Laboratory Analysis, Hematology

26804 Software, Laboratory Analysis, Hematology, Coagulation

26805 Software, Laboratory Analysis, Immunoassay

26806 Software, Laboratory Analysis, Microbiology

26807 Software, Laboratory Analysis, Molecular Assay

26808 Software, Laboratory Analysis, Molecular Assay, Infectious Microorganism


26809 Software, Laboratory Analysis, Molecular Assay, Genetic Testing

26810 Software, Laboratory Analysis, Urine

26811 Software, Point-of-Care Analysis

26812 Software, Chromatography System

26813 Software, Chromatography System, Gas

26814 Software, Chromatography System, Liquid


26815 Software, Chromatography System, High-Pressure Liquid Chromatography

26816 Software, Electrophoresis System

26817 Software, Electrophoresis System, Capillary

26818 Software, Workstation Management


26819 Software, Workstation Management, Clinical Chemistry/Immunoassay Analyzer

26822 Software, Computer-Aided Detection System, Pathology Slide

26823 Software, Computer-Aided Detection System, Pathology Slide, Papanicolaou Sme

26824 Software, Automation System


26825 Software, Automation System, Laboratory

26826 Dock/Battery Chargers, Physiologic Monitoring/Recording Module

26828 Software, Workstation Management, Cardiac Catheterization

26829 Software, Workstation Management, Dental Digital Radiography


26830 Software, Workstation Management, Mammographic Digital Radiography

26831 Software, Workstation Management, Gamma Camera/Single Photon Emission To

26834 Software, Workstation Management, Hemodialysis

26835 Software, Workstation Management, Nuclear Medicine


26836 Software, Workstation Management, Picture Archiving and Communication Syste

26838 Software, Workstation Management, Picture Archiving and Communication Syste

26842 Software, Workstation Management, Radiotherapy Record/Verify


26843 Software, Workstation Management, Radiotherapy Treatment

26844 Software, Workstation Management, Radiotherapy Planning

26845 Software, Workstation Management, Stereotactic Surgery


26847 Software, Workstation Management, Stress Exercise

26848 Software, Identification/Tracking/Security System

26852 Software, Identification/Tracking/Security System, Asset

26853 Software, Identification/Tracking/Security System, Person

26854 Software, Identification/Tracking/Security System, Infant


26855 Software, Identification/Tracking/Security System, Pharmaceutical

26856 Software, Information System

26857 Software, Information System, Data Management

26858 Software, Information System, Data Management, Administrative

26859 Software, Information System, Data Management, Hospital


26860 Software, Information System, Data Management, Clinical

26861 Mills, Cryogenic

26862 Neutralizing Stations, Disinfectant, Glutaraldehyde/Aldehyde-Based

26863 Dental Inserters, Small Prosthesis, Pressure-Sensitive

26864 Syringe Tips, Dental Material


26865 Software, Information System, Telemedicine

26867 Software, Information System, Educational

26869 Software, Picture Archiving and Communication System

26870 Software, Video System

26871 Software, Video System, Endoscopic


26872 Software, Video System, Operating Room

26873 Software, Video System, Patient Monitoring

26874 Software, Computed Tomography

26875 Software, Computed Tomography Study


26876 Software, Computed Tomography Study, Bone Mineral

26877 Software, Computed Tomography Study, Cardiac

26878 Software, Computed Tomography Study, Dental

26879 Software, Computed Tomography Study, Blood-Flow


26880 Software, Computed Tomography Study, Blood-Flow, Cerebral

26881 Software, Computed Tomography Study, Pulmonary

26882 Software, Computed Tomography/Positron Emission Tomography


26886 Software, Computed Tomography/Single Photon Emission Tomography

26890 Software, Electrical Impedance Scanning

26891 Software, Electrical Impedance Scanning, Mammography

26892 Software, Gamma Camera Scanning


26893 Software, Gamma Camera Scanning, Planar Image

26894 Software, Gamma Camera Scanning, Single Photon Emission Computed Tomogra

26895 Software, Ultrasonic Scanning

26896 Software, Ultrasonic Scanning, General Purpose

26897 Software, Ultrasonic Scanning, Abdominal


26898 Software, Ultrasonic Scanning, Cardiac

26899 Software, Ultrasonic Scanning, Endoscopy

26900 Software, Ultrasonic Scanning, Intravascular

26901 Software, Ultrasonic Scanning, Mammographic

26902 Software, Ultrasonic Scanning, Obstetric/Gynecologic

26905 Software, Ultrasonic Scanning, Ophthalmic


26906 Software, Ultrasonic Scanning, Small-Parts

26907 Software, Ultrasonic Scanning, Vascular

26908 Software, Ultrasonic Scanning, Intracardiac

26909 Software, Magnetic Resonance Imaging Scanning

26910 Software, Magnetic Resonance Imaging Scanning, Extremity


26911 Software, Magnetic Resonance Imaging Scanning, Full-Body

26912 Software, Magnetic Resonance Imaging Scanning, Mammographic

26913 Software, Magnetic Resonance Imaging Scanning, Neurosurgical

26914 Software, Magnetic Resonance Imaging Scanning, Endoscopic

26915 Software, Magnetic Resonance Imaging Study


26916 Software, Magnetic Resonance Imaging Study, Cardiac

26917 Software, Magnetic Resonance Imaging Study, Prostatic

26918 Software, Magnetic Resonance Imaging Study, Blood-Flow

26919 Software, Magnetic Resonance Imaging Study, Mammographic


26920 Software, Nuclear Medicine Study

26921 Software, Nuclear Medicine Study, Thyroid Function

26922 Software, Nuclear Medicine Study, Cardiac Stress Exercise/Thallium

26927 Software, Nuclear Medicine Study, Liver


26928 Software, Nuclear Medicine Study, Pulmonary

26929 Software, Nuclear Medicine Study, Renal

26930 Software, Nuclear Medicine Study, Whole-Body/Bone

26931 Software, Light Scanning


26932 Software, Light Scanning, Mammographic

26933 Software, Laser Scanning

26934 Software, Laser Scanning, Optical Coherence Tomography, Ophthalmic

26935 Software, Computer-Aided Detection System

26936 Software, Computer-Aided Detection System, Image


26937 Software, Computer-Aided Detection System, Image, Lung Nodule

26938 Software, Computer-Aided Detection System, Image, Mammographic

26939 Software, Image Digitization System

26940 Software, Image Digitization System, Angiographic/Cardiovascular


26943 Software, Image Digitization System, Computed Radiography

26944 Software, Image Digitization System, Computed Radiography, Dental

26945 Software, Image Digitization System, Computed Radiography, Mammography


26946 Software, Image Digitization System, Microscopy

26947 Software, Image Digitization System, Microscopy, Confocal Laser

26948 Software, Image Digitization System, Ophthalmic


26949 Software, Digital Radiographic System

26950 Software, Digital Radiographic System, Chest

26951 Software, Digital Radiographic System, Dental

26952 Software, Digital Radiographic System, Mammographic


26953 Software, Radiographic/Fluoroscopic System

26956 Software, Radiographic/Fluoroscopic System, Angiographic/Interventional

26959 Software, Radiographic/Fluoroscopic System, Cardiovascular


26960 Software, Radiographic/Fluoroscopic System, Urologic

26961 Software, Radiographic/Tomographic System

26964 Software, Radiotherapy System

26965 Software, Radiotherapy System, Cobalt


26966 Software, Radiotherapy System, Linear Accelerator

26967 Software, Radiotherapy System, Neutron Beam

26968 Software, Radiotherapy System, Orthovoltage

26969 Software, Radiotherapy System, Proton Beam


26970 Software, Stereotactic System

26971 Software, Stereotactic System, Image-Guided Biopsy

26972 Software, Stereotactic System, Image-Guided Biopsy, Mammographic

26973 Software, Stereotactic System, Image-Guided Cardiac Mapping/Ablation


26976 Software, Stereotactic System, Image-Guided Surgery

26978 Software, Stereotactic System, Image-Guided Surgery, Intracranial

26979 Software, Stereotactic System, Image-Guided Surgery, Spinal

26980 Software, Stereotactic System, Image-Guided Surgery, Orthopedic

26981 Software, Stereotactic System, Image-Guided Surgery, Otolaryngology


26982 Software, Stereotactic System, Image-Guided Surgery, Trauma

26983 Software, Stereotactic System, Image-Guided Radiosurgery

26984 Software, Stereotactic System, Image-Guided Radiosurgery, Gamma

26985 Software, Stereotactic System, Image-Guided Radiosurgery, Linear Accelerator


26986 Software, Stereotactic System, Imageless Surgery

26987 Software, Stereotactic System, Imageless Surgery, Orthopedic

26988 Software, Stereotactic System, Frame-Guided

26990 Software, Stereotactic System, Frame-Guided, Neurosurgery

26991 Software, Stereotactic System, Frame-Guided, Radiosurgery


26992 Software, Stereotactic System, Frame-Guided, Radiosurgery, Gamma

26993 Software, Stereotactic System, Frame-Guided, Radiosurgery, Linear Accelerator

26995 Software, Automation System, Operating Room

26996 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP2C9

26997 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, VKORC1
26998 IVD Test Reagent/Kits, Molecular Assay, Gene Expression

26999 IVD Test Reagent/Kits, Molecular Assay, Gene Expression, Cancer Recurrence

27000 IVD Test Reagent/Kits, Molecular Assay, Gene Expression, Cancer Recurrence, Bre

27001 IVD Test Reagent/Kits, Molecular Assay, Gene Expression, Cancer Recurrence, Co
27008 Hemostatic Agents, Surgical, Absorbable

27009 Embolectomy/Thrombectomy Systems, Hydrodynamic, Intravascular

27010 Ophthalmic Implants, Pupil Dilator Ring

27011 Ophthalmic Implants, Capsular Ring

27012 Ophthalmic Implant Inserters, Flexible Ring


27014 Artificial Airways, Laryngeal Mask

27024 Cuffs, Vascular Closure, External Compression

27030 Ohmmeters

27032 Electrical Impedance Meters

27036 Ammeters
27039 Kilovoltmeters

27040 Electrical Multimeters

27049 Pumps, Catheter Balloon Inflation, Manometric

27064 Height Measurement Instruments

27066 Height Measurement Instruments, Wall-Mounted


27068 Height Measurement Instruments, Mobile

27070 Height Measurement Instruments, Portable

27080 Computer-Aided Detection Systems, Pathology Slide

27081 Scanning Systems, Laser/Light, Dental Impression

27082 Organ Preservation Systems, Warm Perfusion


27083 Electrosurgical Units, Monopolar/Bipolar, Tissue Fusion

27086 Casework, Dentistry

27087 Casework, Examination Room

27089 Casework, Kitchen

27090 Casework, Operating/Procedure Room

27109 Tubes, Nasoenteral


27113 Tubes, Esophageal, Balloon Tamponade

27116 Tubes, Esophageal, Decompression

27120 Tubes, Esophageal, Decompression, Infant

27125 Tubes, Nasogastric, Feeding

27134 Tubes, Nasoenteral, Decompression

27135 Tubes, Nasoenteral, Decompression, Weighted


27141 Tubes, Gastrostomy, Feeding

27142 Tubes, Gastrostomy, Feeding, Surgical

27144 Tubes, Gastrostomy, Decompression/Duodenal Feeding

27146 Tubes, Jejunostomy, Surgical

27150 Tubes, Colon, Enema


27151 Tubes, Colon, Colostomy/Cecostomy

27154 Tubes, Rectal, Enema

27155 Tubes, Rectal, Enema, Barium

27161 Tapes, Adhesive, Plastic, Film, Hypoallergenic, Double-Sided

27175 Blades, Manual Hair Clipper

27176 Blades, Electric Hair Clipper

27178 Blades, Electric/Pneumatic Dermatome

27183 Blades, Electric/Pneumatic Saw


27186 Blades, Electric/Pneumatic Saw, Reciprocating

27188 Blades, Electric/Pneumatic Saw, Reciprocating, Cast

27189 Pre-Staining Stations, Immunohistochemistry

27190 Driving Control Units, Gantry, Multi-Axis

27191 Vascular Occlusion Crossing Systems

27192 Catheters, Vascular, Guiding, Occlusion Crossing, Peripheral Artery


27193 Blades, Electric/Pneumatic Saw, Oscillating

27195 Blades, Electric/Pneumatic Saw, Oscillating, Cast

27200 Blades, Surgical Scalpel

27204 Blades, Manual Saw

27208 Blades, Surgical Scalpel, Microsurgery

27209 Blades, Electric/Pneumatic Saw, Sagittal

27211 Blades, Electric/Pneumatic Saw, Rotatory

27213 Blades, Manual Razor


27216 Blades, Electric Razor

27218 Razors

27219 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing

27222 Blades, Trephine

27223 Blades, Trephine, Biopsy

27224 Blades, Trephine, Surgical

27225 Blades, Trephine, Surgical, Eye

27227 Blades, Trephine, Surgical, Skull


27229 Blades, Trephine, Dental

27233 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication, The

27247 Sterilizing Units, Germicidal Gas

27250 Sterilizing Units, Germicidal Gas, Chlorine Dioxide


27252 Sterilizing Units, Low Pressure-Temperature Steam/Formaldehyde

27257 Sterilizing Units, Filtration

27268 Blades, Manual Dermatome

27273 Blades, Adenotome

27278 Blades, Microtome


27280 Hearing Aid Cleaning Units, Vacuum

27281 Endoscopes, Gastrointestinal Tract, Upper Tract, Single Balloon

27282 Counters, Gamma, Intraoperative


27284 Periodontal Regeneration Membrane Implants, Absorbable

27285 Environmental Disinfection Systems

27286 Environmental Disinfection Systems, Chemical, Hydrogen Peroxide Vapor


27287 Environmental Disinfection Systems, Ultraviolet Light

27290 Stereotactic Systems, Image-Guided

27296 Stereotactic Systems, Image-Guided, Surgical, Spinal

27299 Stereotactic Systems, Image-Guided, Surgical, Orthopedic


27302 Stereotactic Systems, Image-Guided, Surgical, Multiprocedure

27304 Stereotactic Systems, Image-Guided, Radiosurgical

27307 Stereotactic Systems, Frame-Guided

27308 Stereotactic Systems, Frame-Guided, Radiosurgical


27309 Stereotactic Systems, Imageless

27311 Stereotactic Systems, Imageless, Surgical

27312 Stereotactic Systems, Imageless, Surgical, Orthopedic

27313 Stereotactic Systems, Imageless, Surgical, Multipurpose


27319 Stereotactic Systems, Frame-Guided, Radiosurgical, Linear Accelerator

27326 Simulators, Training, Dental

27328 Nucleic Acid Processors, Sequencing, Pyrogenic

27331 Luminometers, Organic Contamination, Adenosine Triphosphates, Portable


27332 Birthing Pools

27333 Scanning Systems, Light, Dental Impression

27334 Milling/Drilling Machines, Dental

27335 Milling/Drilling Machines, Dental, Computer-Aided


27336 Software, Computer-Aided Design/Manufacturing System, Dental Prosthesis

27337 Dry Eye Test Strips

27338 Scanning Systems, Laser, Optical, Coherence, Tomography, Intravascular

27367 Software, Infusion Pump System, Control/Programming


27368 Vibration Therapy Units, Whole Body

27369 External Shock Wave Therapy Systems, Pneumatic, Orthopedic

27371 Dental Materials, Impression, Rubber-Based

27372 Dental Materials, Impression, Vinyl Polysiloxane

27374 Dental Materials, Impression, Vinyl Polysiloxane-Polyether


27375 Dental Materials, Impression, Zinc Oxide-Eugenol

27377 Dental Materials, Impression, Compound

27378 Dental Materials, Impression, Compound, Wax

27379 Dental Materials, Impression, Compound, Synthetic Resin

27405 Information Systems, Decision Support


27406 Software, Information System, Data Management, Clinical, Cell Therapy, Cord Bl

27407 Retrieval Bags, Laparoscopy

27408 Smartphones

27417 Infusion Pumps, Multitherapy, Ambulatory, Electronic, Single-Patient


27418 Stent Delivery Kits

27427 Dispensers, Medication

27428 Dispensers, Medication, Pill

27437 Dispensers, Medication, Liquid

27440 Dispensers, Otoscope Specula

27442 Dispensers, Scrub Brush

27443 Dispensers, Cytology Brush

27444 Dispensers, Protection Garment, Gown


27446 Dispensers, Protection Garment, Mask

27448 Dispensers, Dental

27456 Dispensers, Paper/Plastic Cup

27460 Dispensers, Toilet Paper

27461 Dispensers, Paper Towel

27462 Dispensers, Disinfecting Spray

27464 Dispensers, Laboratory

27476 Photographic Stations, Pathology


27477 Information Systems, Data Management, Patient Entertainment/Wellness

27478 Anti-Fogging Solution/Gels, Endoscope Lens

27479 Anti-Fogging Solution/Gels

27480 Monitors, Physiologic, Neurology, Electromyography, Intraoperative

27481 Knives, Biopsy


27482 Knives, Biopsy, Uterine, Cervical

27489 Knives, Dental

27490 Knives, Dental, Periodontic

27492 Knives, Dental, Periodontic, Gingivectomy

27495 Knives, Dental, Periodontic, Interdental

27497 Knives, Dental, Prosthodontic

27498 Knives, Dental, Prosthodontic, Plaster

27503 Knives, Dental, Prosthodontic, Compound

27507 Knives, Postmortem


27509 Knives, Postmortem, Grossing

27511 Knives, Postmortem, Dissection

27516 Knives, Surgical

27520 Knives, Surgical, Bone

27522 Knives, Surgical, Bone, Acetabular

27524 Knives, Surgical, Bone, Interosseous

27539 Knives, Surgical, Middle Ear, External Canal, Revolving

27541 Knives, Surgical, Middle Ear, Myringotomy

27548 Knives, Surgical, Middle Ear, Microsurgery


27554 Knives, Surgical, Nasal

27557 Knives, Surgical, Nasal, Septum

27559 Knives, Surgical, Eye

27564 Power Systems, Electromechanical, Surgery, Otolaryngology

27566 Knives, Surgical, Eye, Cataract, Microsurgery

27569 Knives, Surgical, Eye, Corneal Splitting

27571 Knives, Surgical, Eye, Capsulotomy


27579 Knives, Surgical, Throat

27585 Knives, Surgical, Laparoscopic

27589 Knives, Surgical, Nerve

27592 Knives, Surgical, Spinal

27596 Knives, Surgical, Tumor, Microsurgery

27598 Knives, Surgical, Blood Vessel, Microsurgery

27600 Knives, Surgical, Multipurpose, Scalpel, Microsurgery

27611 Knives, Surgical, Thyroid


27614 Knives, Surgical, Urinary Tract

27615 Knives, Surgical, Urinary Tract, Bladder/Urethra, Endoscopic

27619 Knives, Surgical, Urinary Tract, Ureter, Endoscopic

27624 Knife/Scalpel Handles, Microsurgery

27641 Monitors, Environmental, Differential Pressure

27642 Sponge Detectors, Surgical, Radiofrequency


27643 Cryotherapy Systems, Tissue Ablation, Cardiac

27644 Catheters, Cardiac, Ablation, Cryotherapy

27645 Transepidermal Water Loss Measuring Instruments

27646 Analyzers, Laboratory, Urine, Semiautomated, Toxicology Screening


27647 Radiotherapy Systems, Linear Accelerator, Spiral Scanning

27648 Dispenser/Melters, Low-Melting Alloy

27649 Autologous Fat Transfer Units

27650 Ovens, Laboratory, Forced-Air, Convection, Plasma Thawing

27651 Simulators, Bio-Acoustic


27652 Software, Information System, Data Management, Clinical, Cell Therapy

27653 Dental Materials, Manufacture/Repair, Zirconia

27654 Humidifiers, Laparoscopic Insufflation, Heated

27655 Catheters, Small Intestine, Indwelling


27657 Aspirators, Airway

27675 Alarm Systems, Occupancy

27687 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Culture Media, Selective

27702 Funnels

27703 Funnels, Vacuum


27706 Funnels, Dropping

27707 Funnels, Filter

27708 Funnels, Powder

27709 Funnels, Separation

27710 Funnels, Thistle

27711 Funnels, Weighing

27722 Pipettors, Plunger, Positive Displacement

27723 Pipettes, Measuring, Serological


27726 Calorimeters, Isothermal Titration

27727 Workstations, Pharmacy, Medication Dispensing

27728 Exercisers, Computer-Aided Training, Upper Limb, Hand/Wrist

27737 Topical Solution/Creams, Eye Lubrication

27738 Viscoelastic Solutions, Intravesical, Sodium Hyaluronate

27739 Protection Garments, Whole Body Cryotherapy


27740 Chambers, Treatment, Whole Body, Cryotherapy

27741 Topical Solution/Creams, Ear Cleaning/Wax Softening

27747 Computer-Aided Detection Systems, Image, Angiographic, Fluorescent

27750 Orthopedic Cement, Antimicrobial


27759 Dental Materials, Restorative, Composite Resin, Light-Cured

27769 Dental Materials, Primer

27788 Dental Materials, Disinfection, Endodontic

27789 Dental Materials, Sealing, Endodontic, Calcium Hydroxide

27807 Scrub Tops


27808 Scrub Pants

27810 Guide Wire External Torque Devices

27811 Hemostasis Valves

27813 Cheiroscopes

27814 Ocular Convergence Assessment/Training Instruments, Eccentric Fixation


27815 Mattresses, Bed, Medicated Filling

27817 Curtains, Cubicle, Reusable, Antimicrobial

27821 Bone Tamps

27826 Safety Pins, Diaper

27853 Digital Data Copiers, Compact/Digital Versatile Disk

27854 Eyeglass Frames


27855 Pumps, Irrigation, Catheter

27856 Carts, Filing

27857 Carts, Filing, Radiographic Film/Cassette

27858 Carts, Treatment

27859 Carts, Treatment, Endoscopy


27860 Carts, Treatment, Endoscopy, Video System

27861 Carts, Treatment, Casting/Splinting

27862 Carts, Central Supply, Sterile Product

27863 Carts, Central Supply, Intravenous Solution Bag/Container

27864 Carts, Central Supply, Multipurpose, Foldable


27865 Carts, Service/Utility, Open, Wire

27866 Carts, Service/Utility, Open, Solid Metal/Hard Plastic

27867 Carts, Service/Utility, Platform

27868 Carts, Service/Utility, Enclosed

27869 Carts, Storage/Transport, Book/Magazine

27870 Carts, Storage/Transport, Gas Cylinder


27871 Carts, Storage/Transport, Gas Cylinder, Single/Double

27872 Carts, Storage/Transport, Physiologic Monitor

27873 Carts, Storage/Transport, Tool

27874 Racks, Storage

27875 Racks, Storage, Exercise Weight

27876 Racks, Storage, Cane/Crutch

27877 Racks, Storage, Book/Magazine

27878 Racks, Laboratory Procedure, Refrigerator/Freezer


27879 Racks, Garment

27880 Racks, Garment, Hat/Coat

27881 Racks, Filing

27882 Racks, Filing, Large Document

27886 Cabinets, Storage, Automated External Defibrillator

27887 Blood Drawing Stations

27888 Incubators, Laboratory


27889 Infusion Pumps, Multitherapy, Large Volume, Single-Channel

27890 Tourniquets, Pneumatic, Automated

27891 Carts, Service/Utility, Pallet

27892 Simulators, Rehabilitation, Car Access


27893 Infusion Pumps, Analgesic, Implantable, Intrathecal

27894 Topical Solution/Cream/Gels, Injured Skin

27897 Collectors, Dust/Debris, Dental Laboratory

27898 Dental Model Trimmers

27899 Thermoplastic Forming Units, Vacuum, Dental Laboratory


27900 Orthoses, Lower Limb, Foot, Accommodative, Shoe Insert

27902 Cement, Otologic

27910 Periodontal Regeneration Membrane Implants, Nonabsorbable

27915 Carts, Central Supply, Multipurpose

27916 Carts, Central Supply, Medication, Single-Patient Dose


27917 Carts, Treatment, Wound Care

27918 Carts, Treatment, Dentistry

27919 Carts, Storage/Transport

27920 Carts, Storage/Transport, Washer/Sterilizer

27921 Carts, Storage/Transport, Radioactive Material


27925 Electric Plugs

27929 Occlusion Plugs

27930 Electric Receptacles

27937 Spatulas, Cytology

27945 Spatulas, Dental

27946 Spatulas, Dental, Mixing

27947 Spatulas, Dental, Mixing, Cement


27949 Spatulas, Eye Surface

27950 Spatulas, Postmortem

27953 Spatulas, Surgical

27954 Spatulas, Surgical, Abdominal/Intestinal

27955 Spatulas, Surgical, Bone

27957 Spatulas, Surgical, Brain, Microsurgery

27958 Spatulas, Surgical, Eye

27960 Spatulas, Surgical, Eye, Adhesion Dissection

27965 Spatulas, Surgical, Eye, Glaucoma


27969 Spatulas, Surgical, Eye, Intraocular Lens Implant

27970 Spatulas, Surgical, Eye, Microsurgery

27974 Spatulas, Surgical, Middle Ear, Microsurgery

27976 Spatulas, Surgical, Vaginal

27979 Cooling Garments

27984 Spatulas, Surgical, Bone Cement

27994 Lasers, Alexandrite/Nd:YAG, Dermatologic


27995 Cataract Extraction Phacoemulsification/Vitrectomy Systems

27996 Lasers, Diode, Assisted Reproduction

27997 Modular Medical Facilities, Mobile, Intensive Care

27998 Tubes, Intravenous Administration Extension, Contrast Media

27999 Ophthalmic Tonographs, Ambulatory


28000 Contact Lenses, Diagnostic, Intraocular Pressure

28001 Software, Physiologic Recording, Intraocular Pressure

28002 Tracheoscopes, Flexible, Video, Intubation

28003 Workstations, Healthcare, Medical Diagnostic Kiosk, Self-Operated

28004 Carts, Treatment, Sensorial Therapy


28007 Computer/Computerized System Joysticks

28013 Computer/Computerized System Touchscreens

28014 Computer/Computerized System Trackballs

28015 Morcellators, Endoscopic, Gynecology

28017 Eye-Hand Coordination Assessment/Training Instruments

28018 Stimulators, Photic, Visual, Diffraction Grating


28019 Exercisers, Ocular Muscle Training

28025 Intravenous Port/Connector Disinfecting Caps

28028 Viscoelastic Solutions, Intravesical, Chondroitin Sulfate

28032 Water Chillers

28033 IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid

28034 IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Total
28035 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Adenosine Deaminase

28037 IVD Test Reagent/Kits, Immunoassay, Protein, Cystatin C

28038 Adhesives, Tissue, Synthetic, Cyanoacrylate

28039 Multitherapy Systems, External Energy Stimulation, Musculoskeletal Treatment

28040 Multitherapy Systems, External Energy Stimulation

28041 Topical Tablets, Vaginal


28043 IVD Test Reagent/Kits, Cytology/Histology, Seminal Fluid, DNA Fragmentation

28044 Dispenser/Placement Instruments, Laboratory, Minimum Inhibitory Concentration

28045 Radioactive Rubidium 82 Chloride Solution Generators

28047 Dock/Battery Chargers

28048 Endoscope Distal Tip Attachments, Submucosal Dissection

28049 External Shock Wave Therapy Systems, Electrohydraulic


28050 Transport Containers, Thermal Protection, Passive Isolation, Blood/Blood Product

28051 Radiofrequency Therapy Systems, Tissue Ablation, Bronchial

28052 Analyzers, Physiologic, Neuromuscular Function, Posturographic, Spinal

28054 Reading Aids, Video, Handheld

28055 Topical Solution/Creams, Throat


28057 Infusion Pumps, Multitherapy, Large Volume

28059 External Shock Wave Therapy Systems, Electromagnetic/Pneumatic, Orthopedic

28063 Infusion Pumps, Multitherapy, Large Volume, MRI Safe/Conditional


28066 Infusion Pumps, Multitherapy, Large Volume, Hyperbaric Chamber Compatible

28069 Infusion Pumps, Multitherapy, Syringe, MRI Safe/Conditional


28071 Infusion Pumps, Multitherapy, Ambulatory, Electronic

28074 Infusion Pumps, Insulin

28076 Infusion Pumps, Insulin, Implantable


28077 Infusion Pumps, Analgesic

28080 Infusion Pumps, Analgesic, Patient-Controlled, Ambulatory

28081 Infusion Pumps, Analgesic, Implantable


28082 Infusion Pumps, Anesthesia, Syringe

28086 Infusion-Withdrawal Pumps, Laboratory

28091 Cane/Crutch Spikes

28093 Analyzers, Physiologic, Neuromuscular Function, Functional Capacity Evaluation

28094 Cabinets, Treatment, Infant Resuscitation


28095 Incubators, Laboratory, Aerobic, Carbon Dioxide

28097 Simulators, Rehabilitation, Driving

28099 Milling/Drilling Machines

28101 Bristled Mats, Physical Therapy


28102 Ear Candles

28103 Skin Elasticity Measuring Instruments, Suction

28104 Dry Mud/Paraffin, Physical Therapy

28105 Topical Solution/Creams, Anesthetic

28121 Carts, Storage/Transport, Gas Cylinder, Multiple


28143 Carts, Central Supply, Sterile Product, Wrap

28161 Lasers, Femtosecond Pulse

28164 Carts, Service/Utility, Open

28169 Mechanical Routers, Dental Laboratory

28170 Monitors, Video, High Definition


28175 Digital Data Copiers, Forensic

28176 Surgical Glue Delivery Instruments

28190 Cryotherapy Systems

28191 Cryotherapy Systems, Tissue Ablation

28199 Dressing Aids, Clothing


28201 Dressing Aids, Shoe

28205 Dressing Aids, Stocking/Sock

28208 Dressing Aids, Button/Zipper

28212 Dressing Aids, Elastic Shoelace

28220 Test Tubes, Polymerase Chain Reaction

28221 Mills

28233 Catheters, Pleural, Tension Pneumothorax


28234 Drivers, Ultrasonic Probe, Endoscopic

28236 Software, Magnetic Resonance Imaging/Positron Emission Tomography

28243 Stents, Vascular, Intracranial Artery

28244 Warming Garments

28245 Stents, Paranasal Sinus


28246 Procedure Kit/Trays, Implant Delivery, Stent, Paranasal Sinus

28247 Topical Solution/Cream/Suppositories, Rectum

28248 Milling/Drilling Machines, Dental, Manual

28251 Drilling Machines

28258 Drilling Machines, Dental


28261 Table/Platforms, Floor Vibration Isolation

28262 Workstations, Clinical Laboratory, Automation

28263 Milling/Drilling Machines, Orthopedic, Computer-Aided

28264 Software, Computer-Aided Design/Manufacturing System, Orthopedic


28280 Recorders, Physiologic, Respiration, Breath Sounds

28286 Software, Physiologic Recording, Respiration, Breath Sounds

28292 Breath Sounds Measuring Instruments

28306 Software, Luminometer, Adenosine Triphosphate Organic Contamination

28309 Software, Computer-Aided Detection System, Pathology Slide, Prostate Tissue


28312 Computer-Aided Detection Systems, Image

28316 Software, Computer-Aided Detection System, Pathology Slide, Blood Cell Classific

28318 Sponge Detectors, Surgical

28321 Sponge Counters, Surgical, Holding Rack

28322 Sponge Counters, Surgical, Radiofrequency Identification

28323 Sponge Counters, Bar-Code Identification


28324 Inclinometers, Mechanical

28328 Inclinometers, Digital

28341 Radiofrequency Therapy Systems, Ophthalmic, Conductive Keratoplasty

28344 Inclinometers
28345 Catheter Storage Solutions, Disinfection/Anticoagulant

28346 Injectors, Subcutaneous Gas, Carbon Dioxide

28348 Gaseous Plasma Cleaners

28349 Consoles, Radiographic/Fluoroscopic/Tomographic Systems

28350 Catheters, Colon


28355 Catheters, Colon, Indwelling

28357 Catheters, Small Intestine

28367 Humidifiers, Laparoscopic Insufflation

28372 Humidifiers, Room Environment, Heated

28373 Stretchers, Bath/Shower


28374 Scanning Systems, Laser, Near-Infrared Spectroscopy

28387 Lasers, Ti:Sapphire

28390 Software, Workstation Management, Ophthalmology

28391 Lasers, Er:Glass

28392 Lasers, Er:Glass, Dermatologic

28407 Stylets, Nasoenteral Tube, Electromagnetic Tip


28417 Photographic Stations

28442 Retractors, Surgical, Abdominal Organ

28443 Retractors, Surgical, Abdominal Wall, Self-Retained

28444 Pumps, Irrigation

28448 Analyzers, Physiologic, Skin

28463 Scanning Systems, Ultrasonic/Near-Infrared Spectroscopy Laser, Intravascular


28465 Catheters, Vascular, Ultrasound/Near-Infrared Laser Spectroscopy

28473 Microarray Washer/Stainers

28477 Simulators, Training, Surgical, Ophthalmology

28478 Stimulators, Photic/Acoustic/Tactile, Relaxation/Therapeutic

28479 Dental Implants, Endosteal, Root Form, Screw

28480 Dental Implants, Endosteal, Root Form, Roller


28481 Dental Implant Pillars

28482 Simulators, Training, Surgical, Laparoscopy

28486 Thermoplastic Forming Units, Positive Pressure, Dental Laboratory

28487 Video Systems, Microscope, IVD Oocyte Imaging

28488 Chambers, Laboratory, In Vitro Fertilization


28489 Chairs, Examination/Treatment, Obstetric/Gynecology

28490 Dilators, Catheterization, Fascial

28491 Dilators, Catheterization, Fascial, Endovascular

28492 Electromechanical Surgical Units, Neurology

28493 Laparoscopy Ports, Single-port Surgery


28494 Stents, Vascular, Intracranial Artery, Aneurysm Bifurcation

28495 Water Recovery Systems, Steam Sterilizing Unit

28496 Washers, Multipurpose, Steam

28497 Laboratory Equipment Holders, Bottle

28498 Samplers, Environmental, Air, Nitrous Oxide


28499 Detectors, Chromatography, Liquid, Charged Aerosol

28500 Data Interface Units, Computer/Hearing Aid, Programming

28501 Software, Device Programming/Testing, Hearing Aid

28502 Topical Solution/Cream/Gels, Vaginal, Lubrication

28503 Topical Solutions/Creams/Gels, Oral Cavity


28504 Analyzers, Physiologic, Temperature/Base Screening

28505 Computer-Aided Detection Systems, Pathology Slide, Karyotyping

28506 Analyzers, Physiologic, Skin Electrical Resistance-Based Screening

28507 Analyzers, Physiologic, Neuromuscular Function, Functional Age


28508 Massage/Tissue Heating Machines, Physical Therapy

28539 Emergency Immobilizers

28540 Emergency Immobilizers, Whole Body, Adult

28541 Emergency Immobilizers, Whole Body, Pediatric

28544 Emergency Immobilizers, Head/Cervical


28547 Emergency Immobilizers, Head/Cervical, Adult

28548 Emergency Immobilizers, Head/Cervical, Adult, Extrication Collar

28550 Emergency Immobilizers, Head/Cervical, Pediatric

28551 Emergency Immobilizers, Head/Cervical, Pediatric, Extrication Collar

28553 Emergency Immobilizers, Head/Cervical, Pediatric, Infant


28555 Orthoses, Head, Therapeutic

28557 Orthoses, Head, Therapeutic, Cranial Deformity

28559 Orthoses, Spine, Cervical

28560 Orthoses, Spine, Cervical, Immobilizer

28561 Fiberoptic Cable Caps, Energy Diffusion


28563 Orthoses, Spine, Cervical, Immobilizer, Rigid Collar

28570 Orthoses, Spine, Cervical, Immobilizer, Poster Style

28573 Orthoses, Spine, Cervical, Support, Soft Collar

28576 Orthoses, Spine, Cervicothoracic

28577 Orthoses, Spine, Cervicothoracic, Immobilizer

28580 Orthoses, Spine, Cervicothoracic, Immobilizer, Vest


28582 Orthoses, Spine, Cervicothoracic, Immobilizer, Sternal Plate

28583 Orthoses, Spine, Cervicothoracic-Lumbosacral

28584 Orthoses, Spine, Cervicothoracic-Lumbosacral, Therapeutic, Brace

28587 Orthoses, Spine, Lumbosacral

28588 Orthoses, Spine, Lumbosacral, Immobilizer

28597 Orthoses, Spine, Lumbosacral, Support


28603 Orthoses, Spine, Lumbosacral, Support, Corset

28605 Orthoses, Spine, Thoracic-Lumbosacral

28606 Orthoses, Spine, Thoracic-Lumbosacral, Immobilizer

28614 Orthoses, Spine, Thoracic-Lumbosacral, Immobilizer, Triplanar Control

28617 Orthoses, Spine, Thoracic-Lumbosacral, Immobilizer, Triplanar Control, Custom Ja

28618 Orthoses, Spine, Thoracic-Lumbosacral, Support


28619 Orthoses, Spine, Thoracic-Lumbosacral, Support, Corset

28620 Orthoses, Spine, Sacroiliac

28621 Orthoses, Spine, Sacroiliac, Support

28622 Orthoses, Spine, Sacroiliac, Support, Corset

28623 Orthoses, Spine, Sacroiliac, Therapeutic

28626 Orthoses, Thoracic


28627 Orthoses, Thoracic, Support

28628 Orthoses, Thoracic, Support, Whole Thorax

28631 Orthoses, Thoracic, Support, Rib, Belt

28633 Orthoses, Upper Limb

28635 Orthoses, Upper Limb, Total

28643 Orthoses, Upper Limb, Total, Support, Lapboard, Chair/Wheelchair


28645 Orthoses, Upper Limb, Total, Functional

28660 Orthoses, Upper Limb, Shoulder

28664 Orthoses, Upper Limb, Shoulder, Support

28666 Orthoses, Upper Limb, Shoulder, Support, Abduction

28674 Orthoses, Upper Limb, Forearm

28675 Orthoses, Upper Limb, Forearm, Support


28680 Orthoses, Upper Limb, Shoulder-Elbow

28681 Orthoses, Upper Limb, Shoulder-Elbow, Support

28682 Orthoses, Upper Limb, Shoulder-Elbow, Support, Abduction

28684 Orthoses, Upper Limb, Shoulder-Elbow, Functional, Mobile Arm, Wheelchair

28687 Orthoses, Upper Limb, Shoulder-Elbow-Wrist, Therapeutic

28692 Orthoses, Upper Limb, Elbow, Immobilizer, Splint

28693 Orthoses, Upper Limb, Elbow, Support


28698 Orthoses, Upper Limb, Elbow, Therapeutic

28699 Orthoses, Upper Limb, Elbow, Therapeutic, Long Arm Cast

28700 Orthoses, Upper Limb, Elbow, Therapeutic, Dynamic Splint

28701 Orthoses, Upper Limb, Elbow, Functional

28702 Orthoses, Upper Limb, Elbow, Functional, Powered

28709 Orthoses, Upper Limb, Wrist, Therapeutic


28711 Orthoses, Upper Limb, Wrist, Therapeutic, Volar Splint

28712 Orthoses, Upper Limb, Wrist, Therapeutic, Flexion

28713 Orthoses, Upper Limb, Wrist, Therapeutic, Extension

28714 Orthoses, Upper Limb, Wrist, Functional, Dorsal Splint

28715 Orthoses, Upper Limb, Wrist-Hand

28716 Orthoses, Upper Limb, Wrist-Hand, Therapeutic


28717 Orthoses, Upper Limb, Wrist-Hand, Therapeutic, Platform Splint

28718 Orthoses, Upper Limb, Wrist-Hand, Therapeutic, Articulated

28719 Orthoses, Upper Limb, Wrist-Hand, Functional

28720 Orthoses, Upper Limb, Wrist-Hand, Functional, Ratchet Mechanism

28721 Orthoses, Upper Limb, Wrist-Hand, Functional, Wrist-Driven


28724 Orthoses, Upper Limb, Wrist-Hand, Functional, Powered

28727 Orthoses, Upper Limb, Wrist-Hand-Finger

28728 Orthoses, Upper Limb, Wrist-Hand-Finger, Immobilizer, Splint

28729 Orthoses, Upper Limb, Wrist-Hand-Finger, Therapeutic

28730 Orthoses, Upper Limb, Wrist-Hand-Finger, Therapeutic, Wide Platform Splint

28731 Orthoses, Upper Limb, Wrist-Hand-Thumb, Immobilizer


28733 Orthoses, Upper Limb, Hand

28734 Orthoses, Upper Limb, Hand, Functional/Therapeutic

28735 Orthoses, Upper Limb, Hand-Finger

28738 Orthoses, Upper Limb, Hand-Finger, Therapeutic

28739 Orthoses, Upper Limb, Hand-Finger, Therapeutic, Splint

28740 Orthoses, Upper Limb, Hand-Finger, Therapeutic, Soft Roll


28741 Orthoses, Upper Limb, Hand-Finger, Functional

28746 Orthoses, Upper Limb, Finger

28748 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint

28749 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Immobilizer

28752 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Therapeutic

28753 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Therapeutic, Swan-Neck Spl
28754 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Functional

28755 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Functional, Split Ring

28756 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Proximal

28757 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Proximal, Immobilizer

28758 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Proximal, Therapeutic

28759 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Proximal, Therapeutic, Bout

28761 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Proximal, Therapeutic, Dyna
28762 Orthoses, Upper Limb, Finger, Inter-Phalangeal Joint, Distal

28763 Orthoses, Upper Limb, Finger, Metacarpo-Phalangeal Joint

28766 Orthoses, Upper Limb, Finger, Metacarpo-Phalangeal Joint, Therapeutic

28768 Orthoses, Upper Limb, Finger, Metacarpo-Phalangeal Joint, Therapeutic, Alignmen

28770 Orthoses, Upper Limb, Finger, Metacarpo-Phalangeal Joint, Functional

28771 Orthoses, Upper Limb, Finger, Metacarpo-Phalangeal Joint, Functional, Ulnar Devia
28772 Orthoses, Upper Limb, Finger, Carpo-Metacarpal/Metacarpo-Phalangeal Joint

28774 Orthoses, Upper Limb, Finger, Carpo-Metacarpal/Metacarpo-Phalangeal Joint, Fun

28775 Orthoses, Upper Limb, Finger, Carpo-Metacarpal/Metacarpo-Phalangeal Joint, Fun

28779 Orthoses, Lower Limb, Total

28781 Orthoses, Lower Limb, Total, Immobilizer

28787 Orthoses, Lower Limb, Total, Gait


28789 Orthoses, Lower Limb, Total, Gait, Self-Propelled

28790 Orthoses, Lower Limb, Total, Gait, Self-Propelled, Reciprocating

28802 Orthoses, Lower Limb, Hip, Therapeutic

28803 Orthoses, Lower Limb, Hip, Therapeutic, Dislocation Prevention

28804 Orthoses, Lower Limb, Hip, Therapeutic, Developmental Dysplasia

28809 Orthoses, Lower Limb, Hip, Therapeutic, Abduction, Pediatric


28812 Orthoses, Lower Limb, Hip, Therapeutic, Abduction, Pediatric, Ambulatory

28817 Orthoses, Lower Limb, Hip, Therapeutic, Abduction, Pediatric, Night Use

28821 Orthoses, Lower Limb, Knee, Support

28822 Orthoses, Lower Limb, Knee, Support, Brace

28823 Orthoses, Lower Limb, Knee, Therapeutic

28824 Orthoses, Lower Limb, Knee, Therapeutic, Flexion/Extension


28828 Orthoses, Lower Limb, Knee, Gait

28830 Orthoses, Lower Limb, Knee, Gait, Ligament Brace

28837 Orthoses, Lower Limb, Knee, Gait, Orthotic Joint

28839 Orthoses, Lower Limb, Knee, Gait, Orthotic Joint, Hyperextension

28840 Orthoses, Lower Limb, Knee, Gait, Orthotic Joint, Locking

28841 Orthoses, Lower Limb, Knee, Gait, Orthotic Joint, Stance Control
28842 Orthoses, Lower Limb, Knee-Ankle-Foot

28843 Orthoses, Lower Limb, Knee-Ankle-Foot, Therapeutic

28844 Orthoses, Lower Limb, Knee-Ankle-Foot, Therapeutic, Infant Bowleg

28847 Orthoses, Lower Limb, Knee-Ankle-Foot, Therapeutic, Infant Bowleg, Static Brace

28849 Orthoses, Lower Limb, Knee-Ankle-Foot, Therapeutic, Infant Bowleg, A-Frame

28851 Orthoses, Lower Limb, Knee-Ankle-Foot, Therapeutic, Infant Bowleg, Dynamic Br


28853 Orthoses, Lower Limb, Knee-Ankle-Foot, Gait

28855 Orthoses, Lower Limb, Knee-Ankle-Foot, Gait, Stance Control

28856 Orthoses, Lower Limb, Knee-Ankle-Foot, Gait, Knee-Lock

28857 Orthoses, Lower Limb, Ankle

28864 Orthoses, Lower Limb, Ankle-Foot, Therapeutic

28866 Orthoses, Lower Limb, Ankle-Foot, Therapeutic, Anti Foot-Drop

28869 Orthoses, Lower Limb, Ankle-Foot, Gait


28870 Orthoses, Lower Limb, Ankle-Foot, Gait, Rigid Ankle

28872 Orthoses, Lower Limb, Ankle-Foot, Gait, Rigid Ankle, Floor Reaction

28875 Orthoses, Lower Limb, Ankle-Foot, Gait, Articulated Ankle

28878 Orthoses, Lower Limb, Ankle-Foot, Gait, Articulated Ankle, Floor Reaction

28879 Orthoses, Lower Limb, Ankle-Foot, Gait, Neuropathic Walker

28881 Orthoses, Lower Limb, Foot


28894 Orthoses, Lower Limb, Foot, Support, Arch, Pediatric

28895 Orthoses, Lower Limb, Foot, Gait

28897 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier

28899 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier, Rocker Sole

28901 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier, Wedge

28902 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier, Flare

28903 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier, Elevation


28904 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier, Extended Shank

28905 Orthoses, Lower Limb, Foot, Gait, Shoe Modifier, Spring-Loaded

28907 Orthoses, Lower/Upper Limb

28908 Orthoses, Lower/Upper Limb, Immobilizer

28917 Orthoses, Lower/Upper Limb, Functional

28923 Orthoses, Multipurpose Splint

28927 Orthoses, Multipurpose Splint, Moldable, Aluminum


28928 Orthoses, Multipurpose Splint, Moldable, Plastic

28932 Shoes, Orthopedic, Spring-Loaded

28961 Procedure Kit/Trays

28982 Procedure Kit/Trays, Angiography, Contrast Media Injector

29069 Procedure Kit/Trays, Catheterization, Intravenous, Peripheral Vein


29114 Procedure Kit/Trays, Irrigation/Lavage, Gastric

29123 Procedure Kit/Trays, Irrigation/Lavage, Upper Urinary Tract

29135 Turntables, Laboratory, Petri Dish Inoculation, Powered

29196 Radiofrequency Therapy Systems, Diathermy, Dermatologic

29197 Lights, Photographic Station


29199 Gastrointestinal Liners, Endoscopically-Deployed

29200 Stimulators, Electrical, Neuromuscular, Physical Therapy/Massage

29245 Procedure Kit/Trays, Dental

29253 Procedure Kit/Trays, Dental, Restoration, Composite Resin, Self-Cured

29298 Procedure Kit/Trays, Drainage


29341 Procedure Kit/Trays, Implant Delivery, Stent

29384 Contrast Media Injector Kit Assemblies

29576 Computer-Aided Detection Systems, Image, Spine, Skin Surface

29577 Software, Computer-Aided Detection Systems, Image, Spine, Skin Surfacing


29579 Defibrillators, External, Automated/Manual

29700 Brushes, Dental, Micro-Application

29711 Dock/Battery Chargers, Laptop Computer

29712 Dock/Battery Chargers, Handheld Telephones

29715 Dock/Battery Chargers, Powered Cart


29717 Viscoelastic Solutions, Intraocular

29718 Scanning Systems, Body Pressure, Plantar

29721 Microinjection Systems

29725 Monitors, Video, High-Definition, Medical Image

29768 Monitors, Video, High-Definition, Medical Image, Double-Head

29780 Monitors, Video, High-Definition, Medical Image, Mammography


29787 Monitors, Video, High-Definition, Medical Image, Multiple

29819 Scanning Systems, Laser, Optical Coherence Tomography

29821 Catheters, Vascular, Optical Coherence Tomography Imaging

29896 Stents, Paranasal Sinus, Drug-Eluting

29964 Catheters, Vascular, Optical Coherence Tomography Imaging, Coronary Artery


29966 Software, Laser Scanning, Optical Coherence Tomography, Intravascular

30171 Cytometers, Automated, Scanning Laser Microscopy

30185 Occlusal Splints, Dental

30213 Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining

30219 Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Mandibular Repositioning


30221 Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Palate Lifting

30254 Organ Preservation/Transport Containers, Cold Perfusion

30360 Ventilators, Hyperbaric Chamber Compatible

30472 Exploratory Probes

30482 Testers, Steam Sterilization Unit/Process

30483 Hemostatic Agent Applicators, Topical


30485 Sample Coaters, Electron Microscopy, Metal Sputtering/Carbon Evaporation

30549 Dock/Battery Chargers, Hearing Aid

30556 Reading Aids

30648 Software, Neuropsychological Assessment


30699 Urethral Prostate Retraction Implants

30701 Urethral Prostate Retraction Implant Delivery Units

30705 Catheters, Vascular, Occlusion Crossing

30708 IVD Blotters, Protein


31008 Incubators, Laboratory, Aerobic/Anaerobic

31124 Catheters, Vascular, Occlusion Crossing, Coronary Artery

31127 Tourniquets, Non-Inflatable Strap, Emergency

31131 Tourniquets, Non-Inflatable Strap, Emergency, Self-Application


31132 Tourniquets, Pneumatic, Manual

31133 Tourniquets, Pneumatic, Manual, Emergency/Self-Application

31134 Tourniquets, Pneumatic, Automated, Electric-Powered

31135 Tourniquets, Pneumatic, Automated, Compressed Gas


31141 Cuffs, Pneumatic Tourniquet, Single Bladder

31153 Cuffs, Pneumatic Tourniquet, Single Bladder, Standard

31158 Cuffs, Pneumatic Tourniquet, Single Bladder, Standard, Disposable

31160 Cuffs, Pneumatic Tourniquet, Single Bladder, Standard, Reusable


31162 Cuffs, Pneumatic Tourniquet, Single Bladder, Contoured

31166 Cuffs, Pneumatic Tourniquet, Single Bladder, Contoured, Disposable

31167 Cuffs, Pneumatic Tourniquet, Single Bladder, Contoured, Reusable


31168 Cuffs, Pneumatic Tourniquet, Double Bladder

31169 Cuffs, Pneumatic Tourniquet, Double Bladder, Standard

31170 Cuffs, Pneumatic Tourniquet, Double Bladder, Standard, Disposable


31171 Cuffs, Pneumatic Tourniquet, Double Bladder, Standard, Reusable

31172 Cuffs, Pneumatic Tourniquet, Double Bladder, Contoured

31174 Cuffs, Pneumatic Tourniquet, Double Bladder, Contoured, Disposable


31175 Cuffs, Pneumatic Tourniquet, Double Bladder, Contoured, Reusable

31176 Cuffs, Roll-On, Exsanguination

31178 Exsanguination Garments, Pneumatic Tourniquet

31179 Exsanguination Garments, Roll-On


31180 Carts, Medication, Computerized

31181 Phototherapy Units, Ultraviolet, Ophthalmic, Collagen Cross-Linking

31183 Endodontic Paper Points

31184 Exploratory Probes, Eye, Canaloplasty

31192 Dose Calibration Kits, Nuclear Medicine, Quality Control, Linearity


31193 Controllers, Cardioplegia Perfusion Pump

31196 Controllers, Infusion Pump, Remote

31197 Analyzers, Physiologic, Attention Level

31204 Wheelchair/Bicycles

31212 Arthroplasty Templates


31213 Arthroplasty Templates, Knee

31215 Software, Information System, Telemedicine, Diagnostic Image

31224 Low-Melting Alloys

31251 Shields, Radiotherapy Block

31259 Casting Stations, Low-Melting Alloy, Radiotherapy Block Shields


31262 Urinals, Portable, Female

31263 Drug of Abuse Test Systems, IVD Screening

31264 Video Systems, Microscope, Capillaroscopy

31265 Heating Units, Laparoscopic Insufflation Gas


31266 Disinfectors, Vapor Germicide, Ultrasonic Transducer Probe

31267 Analyzers, Physiologic, Extracellular Limb Fluid, Electrical Impedance

31268 Ophthalmoscope/Otoscope/Vital Signs Measuring Systems

31525 Lasers, Yb:YAG


31667 Germicides, Gas, Chlorine Dioxide

31668 Germicides, Liquid, Ortho-phthalaldehyde

31688 Sheets, Patient Bed, Reusable

31964 Mechanical Routers

32015 Stimulators, Mechanical, Auditory, Middle Ear

32021 Canes, Fixed-Length


32023 Canes, Fixed-Length, Offset-Handle

32024 Crutches, Forearm Platform

32025 Crutches, Triceps

32030 Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery

32031 Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Intracranial Artery


32035 Analyzers, Physiologic, Cardiovascular Function, Heart Rate Variability

32036 Stimulators, Magnetic, Menopause Symptom Relief

32038 Monitors, Physiologic, Pulse Oximetry, Telemetric

32039 Sheets, Patient Bed, Disposable

32595 Surgical Drapes, Patient


32650 Driving Units, Gantry/Table

32654 Driving Units, Gantry/Table, Single-Axis

32656 Driving Units, Gantry/Table, Rotatory

32657 Data Interface Systems


32658 Data Interface Systems, Medical Device/Information System

32660 Data Interface Systems, Information/Information System

32662 Software, Data Interface Unit/System


32668 Stimulators, Electrical, Vagus Nerve, Blocking

32674 Testers, Radiographic System, Quality Assurance

32682 Eyeglass Lens Manufacturing Machines, Computer-Aided

32683 Trephines, Surgical, Tracheal Fenestration

32684 Thyroplasty Implants


32685 Procedure Kit/Trays, Thyroplasty

32686 Sizers, Thyroplasty Implant

32687 Procedure Kit/Trays, Irrigation/Lavage, Peritoneal

32699 Trocars, Abdominal, Laparoscopic

32704 Trocars, Thoracic, Cardiovascular, Minimally Invasive Surgery


32729 Insufflators, Nasal, Eustachian Tube Dysfunction

32730 Phototherapy/Surgical Units, Multiple Modality Light Source

32731 Lasers, Dye/Nd:YAG, Dermatologic

32732 Lasers, Dye/Alexandrite, Dermatologic

32735 Positioning Aids, Radiographic/Radiotherapeutic, Cephalometry

32741 Calipers, External Anthropometry, Craniotomy


32742 Calipers, External Anthropometry, Craniometry, Occlusal Vertical Dimension

32754 IVD Electronic Quality Controls

32759 Tags, Healthcare

32762 Tags, Clinical Sample

32766 Collectors, Dust/Debris

32777 Thermoplastic Forming Units


32779 Bowls, Guide Wire

32783 Software, Computer-Aided Detection System, Image, Virtual Colonoscopy

32784 Clean Rooms

32789 Stimulators, Magnetic, Analgesic

32792 Hooks, Surgical


32793 Hooks, Surgical, Bone

32794 Hooks, Surgical, Dura Mater

32795 Hooks, Surgical, Eye

32796 Hooks, Surgical, Eye, Lens

32797 Hooks, Surgical, Eye, Microsurgery

32798 Hooks, Surgical, Eye, Tendon


32799 Abdominal Wall Suction Cup Units, Intraoperative

32802 Hooks, Surgical, Middle Ear

32803 Hooks, Surgical, Middle Ear, Foot Plate

32804 Hooks, Surgical, Middle Ear, Microsurgery

32805 Hooks, Surgical, Middle Ear, Oval Window

32806 Hooks, Surgical, Middle Ear, Stapes


32807 Hooks, Surgical, Nasal

32808 Hooks, Surgical, Nasal, Microsurgery

32809 Hooks, Surgical, Nasal, Polyp

32810 Hooks, Surgical, Nerve/Ganglion

32813 Apheresis Units, Blood Donor, Red Blood Cell


32815 Apheresis Units, Therapeutic, Platelet/Plasma Exchange

32816 Apheresis Units, Therapeutic, White Blood Cell

32817 Apheresis Units, Therapeutic, Stem Cell Harvesting

32818 Feces Collection Bags


32822 Catheters, Rectal, Indwelling

32825 Procedure Kit/Trays, Catheterization/Collection, Feces

32828 Hooks, Surgical, Rectal, Fistula

32830 Hooks, Surgical, Spermatic Cord

32836 Hooks, Surgical, Spinal Cord

32838 Hooks, Surgical, Tendon


32839 Hooks, Surgical, Tonsil

32840 Computer/Peripheral Device Switches

32841 Hooks, Surgical, Tonsil, Suturing

32842 Hooks, Surgical, Uterine Fibroid

32843 Hooks, Surgical, Vasectomy

32844 Hooks, Surgical, Vessel


32845 Hooks, Postmortem

32846 Hooks, Biopsy

32857 Topical Tablets

32864 Mirrors, Hand-Held

32865 Mirrors, Hand-Held, Dental

32866 Mirrors, Hand-Held, Nasal


32872 Cabinets, Clean Room

32873 Cabinets, Clean Room, Garment

32875 Phototherapy Units, Red/Near Infrared, Blood Irradiation

32877 Modular Medical Facilities, Stationary, Physical Therapy/Rehabilitation

32878 Physiologic Monitoring Modules, Neurology, Level-of-Consciousness, Entropy


32879 Software, Physiologic Monitoring, Neurology, Level-of-Consciousness, Entropy

32880 Testers, Endoscope, Image Quality

32882 Microwave Therapy Systems, Tissue Ablation, Sweat Glands

32883 Computer-Aided Detection Systems, Image, Melanoma

32890 Exploratory Probes, Periodontal


32892 Simulators, Training, Biopsy, Thyroid, Ultrasonic

32895 Blankets, Weighted

32899 Capsules, Esophageal, pH Recording

32900 IVD Test Reagent/Kits, Immunoassay, Lipoprotein-Associated Enzyme Phospholip

32907 Software, Physiologic Recording, Esophageal pH


32908 Procedure Kit/Trays, Spinal Surgery, Kyphoplasty/Vertebroplasty

32917 Bone Tamps, Vertebral Cavity Expansion Balloon

32919 Spinal Surgery Percutaneous Introducers

32923 Dispensers, Orthopedic Cement, Spinal Surgery

32935 Compressed Gas Proportioners, Oxygen-Nitrous Oxide


32940 Compressed Gas Proportioners, Oxygen-Heliox

32945 Ophthalmic Implants, Retina

32946 Compressed Gas Proportioners, Oxygen-Nitrogen, Central Supply

32957 Compressed Gas Proportioners, Oxygen-Nitric Oxide


32962 IVD Test Reagent/Kits, Hematology, Coagulation, Activated Clotting Time

32965 IVD Test Reagent/Kits, Hematology, Coagulation, Activated Clotting Time, Glass

32974 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain

32986 Microscope Stages, Automated Positioning


32992 Orthopedic Rod Implants, Scoliosis

32993 Orthopedic Rod Implants, Scoliosis, Mechanical Distraction

32995 Orthopedic Rod Implants, Scoliosis, Magnetic-controlled Distraction

32996 Osmometers, Electrical Impedance

32997 Osmometers, Electrical Impedance, Tear Film


33001 Procedure Kit/Trays, Sampling, Endoscopic Aspiration

33004 Ovens, Laboratory, Microwave

33007 Ovens, Laboratory, Microwave, Cytology/Histology

33016 Stimulators, Electrical, Peripheral Nerve, Antinausea/Emesis Prevention

33027 Seal Decrimpers, Bottle/Vial/Tube, Manual


33028 Seal Decrimpers, Bottle/Vial/Tube, Automated

33031 IVD Test Reagent/Kits, Electron Microscopy, Stain, Gold

33032 IVD Test Reagent/Kits, Electron Microscopy, Stain, Phosphotungstic Acid

33033 IVD Test Reagent/Kits, Electron Microscopy, Stain, Osmium Tetroxide

33034 IVD Test Reagent/Kits, Electron Microscopy, Stain, Ruthenium Tetroxide

33035 IVD Test Reagent/Kits, Electron Microscopy, Stain, Silver Nitrate

33036 IVD Test Reagent/Kits, Electron Microscopy, Stain, Uranyl Nitrate


33052 Gas Delivery Units, Oxygen/Nitrous Oxide

33053 Defibrillator/Pacemaker/Physiologic Monitors

33054 Tracheoscopes, Rigid, Orotracheal Intubation

33055 Stents, Vascular, Peripheral, Balloon-Expandable, Iliac

33056 Detectors, Electrosurgical Unit Activity, Noise Suppression


33059 Contrast Media Removal Systems, Coronary Sinus

33060 Microdissection Systems, Laser

33063 Lasers, Nitrogen

33065 Monitoring Systems, Patient Position, Radiotherapy, Infrared


33066 Monitoring Systems, Physiologic, Hemodynamic

33070 Monitoring Systems, Patient Position, Radiotherapy, Laser

33071 Dosimeters, Noise

33076 Stapler/Cutters, Surgical, Linear, Multipurpose


33078 Microscopes, Light, Examination, Ophthalmology, Specular

33081 Racks, Garment, Gown

33084 Racks, Filing, Lateral

33086 Racks, Storage, Food

33093 Racks, Storage, Food, Refrigerator/Freezer

33096 Racks, Storage, Key

33098 Racks, Storage, Luggage

33101 Racks, Storage, Multipurpose

33102 Racks, Laboratory Procedure


33103 Racks, Laboratory Procedure, Staining

33107 Regulators, High-Pressure Gas, Spray Delivery

33109 Racks, Ultrasound Procedure, Probe

33110 Racks, Mail

33111 Racks, Time Card

33112 Racks, Laboratory Slip

33116 Stylets, Vascular

33117 Stylets, Vascular, Artery

33118 Stylets, Vascular, Artery, Aorta


33119 Stylets, Vascular, Artery, Coronary

33120 Stylets, Vascular, Vein, Vena Cava

33128 Retractors, Dental/Oral Surgery, Cheek/Lip

33131 Retractors, Dental/Oral Surgery, Tongue

33134 Retractors, Surgical

33135 Retractors, Surgical, Brain, Self-Retained


33138 Retractors, Surgical, Middle Ear

33143 Retractors, Surgical, Thoracic Wall, Sternum

33144 Retractors, Surgical, Thoracic Wall, Sternum, Self-Retained

33145 Retractors, Surgical, Thoracic Organ

33146 Retractors, Surgical, Thoracic Organ, Heart, Atrial

33147 Retractors, Surgical, Thoracic Organ, Heart, Aortic Valve

33148 Retractors, Surgical, Thoracic Organ, Lung


33149 Retractors, Surgical, Urinary Tract

33150 Retractors, Surgical, Urinary Tract, Urethra

33151 Retractors, Surgical, Urinary Tract, Bladder, Self-Retained

33152 Retractors, Surgical, Urinary Tract, Prostatic

33153 Retractors, Surgical, Urinary Tract, Renal Sinus

33154 Retractors, Surgical, Anal/Sphincter

33157 Retractors, Surgical, Vagina


33159 Retractors, Surgical, Vessel, Aorta

33160 Retractors, Surgical, Vessel, Peripheral Vein

33162 Retractors, Surgical, Nerve

33163 Retractors, Surgical, Amputation

33164 Retractors, Surgical, Esophagus

33165 Retractors, Surgical, Thyroid

33166 Retractors, Surgical, Tracheal


33167 Retractors, Surgical, Perineal Wall

33169 Retractors, Surgical, Perineal/Pelvic Wall, Self-Retained

33170 Retractors, Surgical, Pelvic Organ

33171 Retractors, Surgical, Multipurpose

33172 Retractors, Surgical, Bone

33174 Retractors, Surgical, Maxillofacial


33177 Retractors, Surgical, Maxillofacial, Multipurpose

33178 Retractors, Surgical, Maxillofacial, Multipurpose, Self-Retained

33179 Retractors, Surgical, Maxillofacial, Chin

33180 Retractors, Surgical, Maxillofacial, Nasal

33182 Retractors, Surgical, Nasopharyngeal

33183 Retractors, Surgical, Nasopharyngeal, Palate/Pillar


33186 Retractors, Surgical, Nasopharyngeal, Palatine Uvula

33187 Retractors, Surgical, Skin

33188 Retractors, Surgical, Subcutaneous Tissue

33189 Retractors, Surgical, Eye, Eyelid

33190 Retractors, Surgical, Eye, Iris

33191 Retractors, Surgical, Eye, Lacrimal Sac

33192 Retractors, Surgical, Abdominal Wall, Self-Retained, Laparoscopy


33196 Retractors, Surgical, Bone, Tibia

33197 Retractors, Surgical, Bone, Humerus

33198 Retractors, Surgical, Joint Tissue

33199 Retractors, Surgical, Joint Tissue, Shoulder

33200 Retractors, Surgical, Joint Tissue, Elbow

33201 Retractors, Surgical, Joint Tissue, Hip


33202 Retractors, Surgical, Joint Tissue, Knee

33203 Retractors, Surgical, Spine

33204 Retractors, Surgical, Spine, Cervical

33206 Retractors, Surgical, Spine, Lumbar

33208 Retractors, Surgical, Spine, Lumbar, Laminectomy


33210 Retractors, Surgical, Hand/Finger

33213 Retractors, Surgical, Hand/Finger, Self-Retained

33217 Surgical Retractor Kits

33218 Surgical Retractor Kits, Brain


33222 Surgical Retractor Kits, Subcutaneous Tissue

33223 Surgical Retractor Kits, Subcutaneous Tissue, Internal Mammary Artery

33224 Surgical Retractor Kits, Abdominal

33225 Surgical Retractor Kits, Sternum


33227 Surgical Retractor Kits, Perineal

33228 Surgical Retractor Kits, Perineal, Rectum

33229 Surgical Retractor Kits, Perineal, Vagina

33230 Surgical Retractor Kits, Spine

33232 Surgical Retractor Kits, Spine, Total


33233 Surgical Retractor Kits, Spine, Cervical

33234 Surgical Retractor Kits, Spine, Thoracic

33235 Surgical Retractor Kits, Spine, Lumbar

33236 Surgical Retractor Kits, Urinary Tract

33240 Surgical Retractor Kits, Joint


33242 Surgical Retractor Kits, Joint, Shoulder

33243 Surgical Retractor Kits, Joint, Hip

33244 Surgical Retractor Kits, Joint, Knee

33245 Surgical Retractor Kits, Multipurpose

33251 Demagnetizers, Surgical Instrument


33255 Bandages, Compression/Support, Multilayer, Emergency

33256 Lights, Examination, Wall-Mounted

33257 Lights, Examination, Stand-Alone

33260 Lights, Examination, Ultraviolet, Portable/Handheld

33261 Lights, Examination, Visible/Infrared, Newborn

33262 Lights, Surgical, Wall-Mounted


33263 Lights, Surgical, Wall-Mounted, Single-Head

33264 Lights, Surgical, Wall-Mounted, Multiple-Head

33265 Lights, Surgical, Stand-Alone

33266 Lights, Surgical, Stand-Alone, Single-Head

33267 Lights, Surgical, Stand-Alone, Multiple-Head

33268 Lights, Surgical, Ceiling-Mounted


33269 Lights, Surgical, Ceiling-Mounted, Single-Head

33270 Lights, Surgical, Ceiling-Mounted, Multiple-Head

33271 Lights, Illumination

33272 Lights, Illumination, Ceiling-Mounted

33273 Lights, Illumination, Wall-Mounted

33274 Lights, Illumination, Stand-Alone

33275 Lights, Illumination, Tabletop


33276 Lights, Dental Resin Polymerization, Intraoral

33277 Lights, Dental Resin Polymerization, Laboratory

33285 Sponges, Surgical

33294 Sponges, Multipurpose

33296 Electrodes, Cardiac

33298 Electrodes, Cardiac, Electrocardiography, Transesophageal


33299 Electrodes, Cardiac, Electrocardiography, Transcutaneous

33303 Electrodes, Cardiac, External Pacemaker

33304 Electrodes, Cardiac, External Pacemaker, Transvenous

33309 Digital Versatile Disk Players

33310 Photocoagulation Systems, Laser, Ophthalmic


33340 Laser Delivery Systems, Fiber Optic, Pattern Scanning

33344 Commodes, Portable, Shower

33356 Magnetic Resonance Imaging Coils

33380 Magnetic Resonance Imaging Coils, Endoscopic, Esophageal

33387 Digital Data Copiers

33400 Digital Data Copiers, Hard Drive


33406 Digital Data Copiers, Security Digital Card

33408 Software, Forensic Data Copier

33414 Electrophoresis Tray Combs

33416 Information Systems, Data Management, Hospital, Directory/Wayfinding

33426 Driver/Extractors, Dental Implant

33427 Screwdrivers, Dental Implant


33428 Screwdrivers

33429 Drill Bits, Dental, Implant Driving

33441 Information Systems, Data Management, Hospital, Asset/Maintenance

33446 Software, Information System, Data Management, Hospital, Asset/Maintenance

33457 IVD Test Reagent/Kits, Microbiology, Bacteria, Susceptibility, Manual Test, Minimu

33463 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Susceptibility, Minimum Inhibito


33467 Scanning Systems, Laser/Light, Orthopedic Impression

33468 Milling/Drilling Machines, Orthopedic

33473 Laryngeal Implants, Vocal Fold Medializing


33476 Photocoagulation Systems, Laser, Ophthalmic, Multi-Spot

33477 Controllers, Pressure, Catheter/Endoscopic Tube, Balloon Inflation

33482 Deblisters, Pill/Capsule, Automated

33484 External Shock Wave Therapy Systems


33486 External Shock Wave Therapy Systems, Electrohydraulic, Orthopedic

33487 External Shock Wave Therapy Systems, Electromagnetic

33488 External Shock Wave Therapy Systems, Piezoelectric

33496 Tubes, Tracheal, One-Lung Ventilation, Double Lumen, Video

33499 Tubes, Tracheal, One-Lung Ventilation, Single Lumen, Video


33507 Stents, Vascular, Coronary, Bifurcation

33511 Pens, Handwriting Digitization

33515 Sedation/Physiologic Monitoring Systems, Gastrointestinal Endoscopy

33522 Samplers, Laboratory, Automated, Frozen Sample

33527 Pumps, Catheter Balloon Inflation


33533 Catheters, Nasal, Eustachian Tube Dilatation, Endoscopic

33534 Nasoscopes, Sinus/Eustachian Tube

33538 Pipettes, Volumetric

33541 Pipettes, Measuring

33542 Pipettes, Measuring, Mohr

33546 Pipettes, Measuring, Serological, Blow-Out


33548 Pipettors, Plunger, Air Displacement

33552 Pipette Fillers

33559 Physiologic Monitoring Modules, Fetal

33561 Monitors, Environmental, Hydrogen Peroxide

33567 Workstations, Healthcare


33570 Workstations, Healthcare, Registration/Administrative Data

33573 Workstations, Healthcare, Medical Diagnostic Kiosk

33575 Workstations, Healthcare, Medical Diagnostic Kiosk, Staff-Operated

33576 Workstations, Healthcare, Medical Monitoring Kiosk


33577 Software, Workstation Management, Healthcare, Registration/Administrative Dat

33578 Software, Workstation Management, Healthcare, Medical Diagnostic Kiosk

33579 Software, Workstation Management, Healthcare, Medical Monitoring Kiosk

33581 Projectors
33583 Projectors, Photographic Slide

33586 Projectors, Microscope Slide

33587 Projectors, Photographic/Microscope Slide

33589 Projectors, Cine, Digital


33591 Projectors, Video

33592 Projector Screens

33601 Carts, Storage/Transport, Electromechanical/Electronic Instrument/Equipment

33605 Carts, Storage/Transport, Catheter

33611 Carts, Storage/Transport, Suture

33614 Carts, Storage/Transport, Dressing/Bandage


33622 Carts, Storage/Transport, Cadaver

33633 Carts, Storage/Transport, Laboratory

33634 Carts, Storage/Transport, Laboratory, Acid/Alkali Resistant

33635 Carts, Storage/Transport, Laboratory, Glassware

33636 Carts, Storage/Transport, Exercise Weight

33642 Carts, Storage/Transport, Facsimile/Printer

33644 Carts, Treatment, Otorhinolaryngology


33647 Carts, Central Supply, Surgical Case, Open

33648 Carts, Central Supply, Surgical Case, Enclosed

33649 Carts, Central Supply, Latex-Free Product

33650 Carts, Central Supply, Linen/Laundry, Bulk

33652 Carts, Central Supply, Food Service, Bulk

33653 Carts, Central Supply, Food Service, Tray

33654 Carts, Central Supply, Food Service, Tray, Patient Floor


33656 Carts, Central Supply, Food Service, Tray, Kitchen

33657 Carts, Filing, Medical Card/Chart

33659 Carts, Filing, Multimedia

33661 Carts, Filing, Slide

33663 Monitors, Telemetric, Physical Activity/Physiologic


33664 Recorders, Physiologic, Physical Activity/Sleep/Awake

33674 Prostheses, Cardiac Valve, Biological, Tissue Leaflets, Transcatheter, Aortic (Retir

33675 Procedure Kit/Trays, Implant Delivery, Cardiac Valve, Transcatheter

33676 Testers, Endoscope, Microscopic Lumen Visualization

33720 Infant Care Stations, Radiant Warming


33721 Pill Packing Units, Counting/Verification

33722 Software, Pill Counting/verification

33742 Photographic Stations, Gel Documentation

33749 Occluders, Cardiac, Left Atrial Appendage

33750 Resectoscopes, Transverse Carpal Ligament


33752 Scanning Systems, Body Pressure

33754 Patient Motion Management Systems, Radiotherapy, Breathing

33756 Procedure Kit/Trays, Catheter Repair

33770 Suppository Preparation Molds

33773 Trial Prostheses, Joint, Shoulder

33774 Trial Prostheses, Joint, Shoulder, Glenoid Component

33775 Trial Prostheses, Joint, Shoulder, Humeral Component


33777 Dispenser/Melters, Dental Hydrocolloid Duplication (Retired)

33785 Viscoelastic Solutions

33791 Viscoelastic Solutions, Intravesical

33795 Gas Cylinder Depletion Switches, Carbon Dioxide/Nitrogen

33796 Electric Signal Switches, Multiport

33799 Infant Care Stations


33802 Software, Physiologic Analysis, Neuromuscular Function, Functional Age

33807 Handpieces, Surgical, Central Nervous System

33809 Detectors, Chromatography

33810 Detectors, Chromatography, Liquid


33813 Detectors, Chromatography, Liquid, Electrochemical

33814 Detectors, Chromatography, Gas

33816 Detectors, Chromatography, Gas, Flame-Ionization


33817 Detectors, Chromatography, Gas, Thermal Conductivity

33819 Software, Physiologic Analysis, Temperature-Based Screening

33828 Transport Containers

33830 Transport Containers, Mechanical Protection


33832 Transport Containers, Thermal Protection

33834 Transport Containers, Thermal Protection, Dry Ice

33835 Transport Containers, Thermal Protection, Wet Ice

33836 Transport Containers, Thermal Protection, Wet Ice, Blood/Blood Product


33839 Transport Containers, Thermal Protection, Passive Isolation

33841 Lasers, Tm:YAG

33842 Exercisers, Muscle Strength, Eccentric Training, Lower Limb

33845 Recorders, Environmental, Air Humidity/Pressure/Temperature

33849 Programmer/Testers, Hearing Aid


33853 Turntables

33856 Turntables, Laboratory

33859 Turntables, Laboratory, Petri Dish Inoculation, Manual

33863 Thermoplastic Forming Units, Injection, Dental Laboratory

33873 Hand Drills, Biopsy, Bone Marrow

33876 Hand Drills, Foot Care


33881 Drill Bits, Biopsy

33882 Drill Bits, Surgical

33883 Drill Bits, Surgical, Bone

33884 Drill Bits, Surgical, Bone, Routing

33885 Drill Bits, Surgical, Bone, Cannulated

33886 Drill Bits, Surgical, Bone, Wire Pass


33887 Drill Bits, Surgical, Spine

33888 Drill Bits, Surgical, Craniotomy, Slot

33889 Burs, Fingernail

33893 Needles, Earlobe/Body Piercing

33899 Software, Physiologic Analysis, Hearing

33904 Scanning Systems, Computed Tomography, Cone-Beam, Mammographic


33913 Cuffs, Pneumatic

33919 Wheelchair Pushrims

33923 Prostheses, Cardiac Valve, Artificial, Caged-Ball

33924 Prostheses, Cardiac Valve, Artificial, Tilting-Disc

33925 Prostheses, Cardiac Valve, Artificial, Bileaflet

33926 Prostheses, Cardiac Valve, Biological, Whole Valve

33932 Prostheses, Cardiac Valve, Biological, Whole Valve, Transcatheter, Pulmonary


33935 Prostheses, Cardiac Valve, Biological, Tissue Leaflet

33937 Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic

33942 Procedure Kit/Trays, Implant Delivery, Cardiac Valve

33944 Procedure Kit/Trays, Implant Delivery, Cardiac Valve, Transcatheter, Pulmonary


33945 Fermenter/Bioreactors

33949 Fermenter/Bioreactors, Microbiology

33958 Fermenter/Bioreactors, Microbiology, Single-Use Chamber

33963 Fermenter/Bioreactors, Cell Culture


33972 Fermenter/Bioreactors, Cell Culture, Single-Use Chamber

33977 Software, Laboratory Fermenter/Bioreactors

33990 Tissue Culture Stimulation Units, Mechanical Strain

33993 Recorders, Environmental, Soot


33995 Power Systems, Electrical, Solar Energy

34001 Absorption Pads

34004 Electrical Conductive Pads

34007 Electrodes, Neurologic, Evoked Potential


34008 Electrodes, Neurologic, Evoked Potential, Visual

34009 Electrodes, Neurologic, Evoked Potential, Auditory

34010 Electrodes, Neurologic, Evoked Potential, Somatosensory

34011 Cushions, Table

34021 Catheter Introducers


34022 Catheter Introducers, Vascular

34023 Catheter Introducers, Vascular, Peripheral

34024 Catheter Introducers, Vascular, Peripheral, Ultrasound-Guided

34025 Catheter Introducers, Vascular, Midline


34027 Catheter Introducers, Vascular, Central Venous, Directly Inserted

34028 Handpieces, Surgical, Endoscopic Transverse Carpal Ligament Resection

34029 Blades, Resectoscope Handpiece, Transverse Carpal Ligament Resection

34031 Catheter Introducers, Vascular, Central Venous, Peripherally Inserted


34032 Catheter Introducers, Vascular, Central Venous/Midline, Peripherally Inserted, U

34043 Boots

34047 Mattress Systems, Patient Repositioning

34048 Brachytherapy Systems, Electronic X-Ray Source


34049 Punches, Dry Sample Disc, Automated

34062 Analyzers, Laboratory, Mass Spectrometry, Microorganism Identification

34068 Software, Physiologic Analysis, Skin Electrical Resistance-Based Screening

34072 Darkfield Illuminators, Photographic Station

34073 Darkfield Illuminators, Microscope Pathology Slide


34080 Urinals, Portable

34081 Urinals, Portable, Male

34084 Urinals, Wall-Mounted

34089 Topical Solution/Cream/Gels, Vaginal

34098 Software, Computer-Aided Detection System, Pathology Slide, Karyotyping

34100 Anatomic Models, Head


34101 Anatomic Models, Torso

34102 Anatomic Models, Limb

34103 Anatomic Models, Skeleton

34104 Manikins

34106 Manikins, Adult


34112 Manikins, Child

34116 Manikins, Infant

34120 Simulators, Training, Endovascular Procedure

34131 Simulators, Training, Nursing Skills


34132 Simulators, Training, Tension Pneumothorax

34146 Simulators, Training, Surgical, Arthroscopy

34151 Simulators, Training, Surgical, Pelvis

34165 Simulators, Training, Endoscopic


34172 Simulators, Training, Endoscopic, Gastrointestinal

34178 Simulators, Training, Endoscopic, Urologic

34183 Simulators, Rehabilitation

34205 Tissue Culture Stimulation Units, Electric Field


34209 Stimulators, Electrical, Neuromuscular/Peripheral Nerve, Transcutaneous

34210 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Protein, S 100B

34223 Dental Materials, Restorative, Endodontic Gutta Percha Point

34224 IVD Test Reagent/Kits, Immunoassay, Protein, Platelet Factor 4/Polyanionic Comp

34229 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile,

34231 Procedure Kit/Trays, Scleral Shell Prosthesis Fixation


34245 Polysomnographs, Portable

34281 Dilators, Surgical

34285 Dilators, Surgical, Cardiac, Mitral Valve

34286 Dilators, Surgical, Colon, Endoscopic

34287 Dilators, Surgical, Tracheostomy


34290 Dilators, Surgical, Umbilical

34297 Dilators, Surgical, Vascular, Microsurgery

34298 Dilators, Cervical Canal, Hygroscopic

34300 Dilators, Catheterization, Fascial, Urologic

34313 Catheters, Vascular, Angioplasty, Balloon, Coronary


34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery

34323 Prostheses, Scleral Shell

34338 Topical Solution/Cream/Gels, Injured Skin, Scar/Keloid Inhibition

34340 Topical Solution/Cream/Gels, Injured Skin, Scar/Keloid Inhibition, Germicidal

34342 Condensers, Dental, Endodontic Filling Material, Powered, Heated

34343 Mesh Pouches, Spinal Implant/Bone Graft


34344 External Shock Wave Therapy Systems, Electrohydraulic, Dermatologic

34345 Shock Wave Applicators, Electrohydraulic

34346 Detection Kits, Biological Agent, Surface Contamination, Ultraviolet Fluorescence

34347 Procedure Kit/Trays, Protective, Hemorrhagic Fever Care

34348 Procedure Kit/Trays, Protective, Hemorrhagic Fever Care, Ebola

34349 Tents, Patient Isolation


34353 Magnetic Resonance Imaging Simultation Systems

34354 Analyzers, Point-of-Care, Whole Blood, Glucose/Lipid Profile

34355 Money Handling Drawers

34356 Stimulators, Electrical, Vagus Nerve, Analgesic, Transcultantaneous

34357 Eyeglasses, Frames, Trial

34362 Analyzers, Physiologic, Animal


34367 Animal Impactor Systems

34371 Sphygmomanometers, Electronic, Animal

34373 Stimulators, Electrical, Brain, Motor Evoked Potential

34376 Drivers, Embolectomy/Thrombectomy, Catheters, Fragmentation

34377 Embolectomy/Thrombectomy Systems, Mechanical Fragmentation, Intravascular

34381 Lasers, Tm:YAG, Surgical


34382 Corneal Collagen Cross-Linking Solutions

34384 Software, Video System, Capillaroscopy

34391 Hemostatic Agent Delivery Units

34393 Tables, Operating, Orthopedic

34394 Monitoring Systems, Physiologic, Hemodynamic, Non/Minimally Invasive


34397 Visualization Strips, Microsurgical, Vascular Anastomosis

34398 Clamps, Tubing, Vascular Perfusion, Artery Line, Remote-controlled

34399 Simulators, Bone Sound Conduction, Mastoid

34400 Simulators, Acoustic Impedance, Ear

34401 Calibrators, Sound Measuring Instrument

34403 Monitors, Video, High-Definition, Medical Image, Endoscopic


34406 Defibrillators, Implantable, Subcutaneous

34407 Leads, Implantable Defibrillator, Subcutaneous

34408 Monitoring Systems, Physiologic, Pulmonary Artery Pressure/Heart Rate, Telemetr

34409 Scanning Systems, Computed Tomography, Peripheral Skeleton


34411 Monitors, Physiologic

34412 Monitors, Physiologic, Multipurpose

34415 Monitors, Physiologic, Neonatal/Infant


34416 Monitors, Physiologic, Neonatal/Infant, Telemetric

34417 Monitors, Physiologic, Pulse Oximetry, Bedside

34419 Monitors, Physiologic, Blood Pressure, Bedside, Noninvasive

34420 Monitors, Physiologic, Blood Pressure, Bedside, Invasive


34421 Monitors, Physiologic, Electrocardiography

34422 Monitors, Physiologic, Electrocardiography/Vital Signs

34425 Monitors, Physiologic, Electrocardiography/Vital Signs, Telemetric

34426 Monitors, Physiologic, Electroencephalography


34428 Monitors, Physiologic, Fetal

34429 Monitors, Physiologic, Fetal, Antepartum

34433 Monitors, Physiologic, Fetal, Antepartum, Telemetric

34435 Monitors, Physiologic, Intracranial Pressure

34437 Monitors, Physiologic, Neurology


34440 Monitors, Physiologic, Neurology, Intraoperative

34441 Monitors, Physiologic, Neurology, Evoked Potential

34442 Monitors, Physiologic, Neurology, Evoked Potential, Intraoperative

34444 Monitors, Physiologic, Neurology, Electromyography

34445 Monitors, Physiologic, Pulse Rate


34446 Monitors, Physiologic, Temperature

34447 Monitors, Physiologic, Uterine Activity

34448 Monitors, Physiologic, Pulse Oximetry

34450 Monitors, Physiologic, Glucose

34453 Monitors, Physiologic, Glucose, Telemetric


34455 Monitors, Physiologic, Respiration

34456 Monitors, Physiologic, Respiration, Respiratory Gas

34461 Monitors, Physiologic, Respiration, Ventilation/Apnea

34464 Monitors, Physiologic, Respiration, Ventilation/Apnea, Neonatal/Infant, Telemetric

34473 Gas Cylinder Depletion Switches


34475 Deblisters, Pill/Capsule, Manual

34480 Exercisers, Muscle Strength, Eccentric Training

34486 Patient Motion Management Systems, Radiotherapy

34490 Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Spectral

34492 Software, Laboratory Analysis, Mass Spectrometry, Microorganism

34503 Hair Graft Harvesting Units


34504 Electrical Power Strips

34506 Stimulators, Electrical, Soft Tissue, Wound

34509 Ophthalmic Implants, Iris

34511 Testers, Leakage Current, Ultrasonic Transducer Probe/Lead

34513 Warming Units, Plastic Eyeglass Frames

34514 Blood Substitutes, Platelet


34519 Animal Enclosures, Aquatic

34526 Clocks

34527 Warming Units, Animal

34530 Recorders, Environmental


34533 Recorders, Environmental, Air Humidity

34535 Recorders, IVD Test

34536 Recorders, IVD Test, pH

34537 Pacemakers, Cardiac, Implantable, Leadless


34538 Mesh Pouches, Implantable, Pacemaker/Defibrillator, Antibacterial

34542 Ballistocardiographs, Accelerometer

34546 Grafts, Bone, Synthetic, Biological Additives

34551 Patient Positioning Aids, Obstructive Sleep Apnea/Anti-Snoring

34552 Patient Positioning Aids, Obstructive Sleep Apnea/Anti-Snoring, Side-Sleeping

34553 Topical Solution/Cream/Gels, Analgesic, Joint


34554 Additive Manufacturing Machines

34555 Hospital Communication Systems, Neonatal, Remote

34556 Procedure Kit/Trays, Vascular Ablation, Lower Limb

34557 Washers, Large Equipment

34559 Stretchers, Mobile, Hospital, Patient Transfer, MR Conditional Safe


34560 Encephalographs

34562 Force Myographs

34563 Impedance Myographs

34566 Recorders, Physiologic, Electromyography/Evoked Potential


34573 Plethysmographs, Lower/Upper Limb

34574 Plethysmographs, Lower/Upper Limb, Strain Gauge

34576 Plethysmographs, Lower Limb

34579 Plethysmographs, Lower Limb, Impedance


34591 Monitors, Physiologic, Neurology, Acceleromyography, Intraoperative

34595 Washers, Large Equipment, Wheelchair

34598 Chin Rest Paper Sheets

34599 Condensers, Dental, Endodontic Filling Material, Powered, Mechanically Driven

34600 Tattooing Machines


34602 Tissue Culture Systems, Cellular Injury, Toxic Substance Exposure

34603 Simulators, Respiration, Tobacco Smoking

34607 Electrical Extension Cords

34608 Outdoor Canopies

34609 Platelet Storage Solution, Plasma Replacement

34610 Oximeters/Co-Oximeters, Pulse


34611 Laser Aimers, Mobile Radiographic/Fluoroscopic Unit

34613 Mass Spectrometer Sample Ionizers, Real Time

34614 Plethysmographs, Lower/Upper Limb, Photo

34633 Recorders, Audio


34634 Recorders, Audio, Hard Disk

34635 Recorders, Audio, Solid State Drive

34636 Recorders, Audio, Compact Disk

34640 Recorders, Audio, Voice Processing


34641 Recorders, Video

34642 Recorders, Video, Hard Disk

34643 Recorders, Video, Solid State Drive

34645 Computer-Aided Detection Systems, Image, Angiographic, Fluorescent, Laparosco

34650 Mounts, Photographic/Video/Cinema Camera


34652 Washers, Equipment Tubing

34654 Cabinets, Storage, Money/Jewelry

34655 Procedure Kit/Trays, Emergency, First Aid, Multi-Person

34656 Procedure Kit/Trays, Emergency, First Aid, Multi-Person, Combat

34657 Testers, Light Intensity

34658 Testers, Light Intensity, LED Source


34660 Tables, Operating, Orthopedic, Fracture/Trauma

34666 Laboratory Equipment Holders

34673 Laboratory Equipment Holders, Pipette

34685 Recorders, Blu-Ray

34686 Audio Players

34687 Audio Players, Compact Disk


34688 Audio Players, Tape

34692 Blu-Ray Players

34695 Video Tape Players

34701 Dispensers, Protection Garment, Shoe Cover, Automated Donning

34702 Shoe Cover Removers, Automated

34703 Testers, Ear Plug/Muff Fitting


34704 Software, Device Testing, Ear Plug/Muff Fitting

34722 Sterilizing Units, Germicidal Gas, Hydrogen Peroxide

34737 Screen Dividers

34743 Cardiac Ablation Processors, Contact Force Display

34746 Tags, Radiofrequency Identification, Asset


34747 Tags, Radiofrequency Identification, Asset, Temperature Sensor

34748 Tags, Radiofrequency Identification, Asset, Humidity Sensor

34749 Calibrators, Positive Pressure Airway Unit, Titration

34842 Spectrographs

34869 Liquid Nitrogen Sterilization Equipment


34870 Testers, Endoscope, Optical System/Lens

34872 Analyzers, Physiologic, Cardiovascular Function, Central Blood Pressure

34876 Software, Physiologic Analysis, Cardiovascular Function

34878 Sample Preparation Equipment, Laboratory, Mass Spectrometry

34879 Baths, Decalcifying Solution, Tissue, Ultrasonic


34880 Audio Systems, Language Interpretation

34881 Analyzers, Environmental/Gas Systems, Carbon Isotope

34889 Software, Drug of Abuse Test Systems, IVD Screening

34900 Sample Coaters, Electron Microscopy, Carbon Evaporation

34901 Sample Coaters, Electron Microscopy, Metal Sputtering


34910 Power Systems, Electromechanical, Surgery, Orthopedic/Plastic

34912 Radiotherapy Systems, Linear Accelerator, Intraoperative, Mobile

34913 Catheters, Spinal, Intervertebral Disc, Radiofrequency Ablation, Cervical

34914 Catheters, Spinal, Intervertebral Disc, Radiofrequency Ablation, Lumbar


34917 Washers, Materialographic/Metallographic Sample, Ultrasonic

35258 Monitoring Systems, Physiologic, Patient Turn Management

35260 Photoactivation Units, Blood

35261 Fixed Loop Instruments, Dental, Subgingival Administration

35263 Preserved Blood Components

35265 Preserved Blood Components, Whole Blood


35266 Preserved Blood Components, Red Cells

35267 Preserved Blood Components, Platelet

35268 Preserved Blood Components, Plasma

35271 Preserved Blood Components, Plasma, Cryoprecipitated Antihemophilic Factor

35273 Blood Substitutes

35274 Blood Substitutes, Oxygen-Carrying


35280 Blood Volume Expansion Solutions

35297 Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversion

35307 Detectors, Head Impact, Wearable

35322 Readers, Radiofrequency Identification Tags

35330 Procedure Kit/Trays, Implant Delivery, Deep Brain Tunneling


35338 Cables/Leads, Apnea Monitors

35339 Leads, Electrical Stimulator, Neuromuscular

35350 Leads, Evoked Potential Recorder

35354 Leads, Electromyograph

35361 Talc, Sterile, Pleurodesis

35370 Stretchers, Animal


35373 Anesthesia Systems

35374 Anesthesia Units, Animal

35375 Anesthesia Units, Nitrous Oxide

35376 Anesthesia Units, Nitrous Oxide, Portable


35387 Warming Units, Plastic Eyeglass Frames, Hot Air

35388 Warming Units, Plastic Eyeglass Frames, Heated Pan

35391 Defibrillator/Cardioverters, Implantable, Subcutaneous

35392 Equipment Tube Cleaning Machines

35399 Power Systems, Electromechanical, Surgery, Neurosurgery/Small Bones

35415 Ovens, Dental, Endodontic Gutta Percha Point Obturator


35416 Power Systems, Electromechanical, Dental, Endodontic

35421 Strollers, Wheelchair Attachable


35429 Nucleic Acid Processors, Preanalytic Unit

35437 Oximeters/Co-Oximeters

35442 Esthesiometers, Corneal

35509 IVD Blotters


35528 IVD Blotters, Nucleic Acid

35535 IVD Blotters, Nucleic Acid, Electric Gradient Transfer

35605 Power Systems, Electrical

35810 Buckets

35813 IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Glucose-6-Phosphase Dehydr


35816 Flowmeters, Blood, Ultrasonic, Intraoperative

35832 Procedure Kit/Trays, Implant Delivery, Hyoid Bone/Tongue Suspension

35836 Radiotherapy Systems, Linear Accelerator, Intraoperative

35854 Audio Systems

35856 Radiofrequency Therapy Systems, Tissue Ablation, Intervertebral Disk


36158 Computer-Aided Design/Manufacturing Systems

36160 Computer-Aided Design/Manufacturing Systems, Orthopedic

36161 Computer-Aided Design/Manufacturing Systems, Orthopedic, Foot Orthosis/Prosth

36162 Computer-Aided Design/Manufacturing Systems, Orthopedic, Spinal Orthosis/Pros


36163 Computer-Aided Design/Manufacturing Systems, Ophthalmic

36170 Light Sources, Endoscope

36171 Light Sources, Endoscope, Fiberoptic Cable

36172 Light Sources, Endoscope, Direct Attachment

36173 Light Sources, Flexible Endoscope, Direct Attachment

36174 Light Sources, Rigid Endoscope, Fiberoptic Cable

36175 Light Sources, Rigid Endoscope, Direct Attachment


36176 Light Sources, Rigid Endoscope/Multipurpose, Handheld Instrument, Direct Atta

36179 Workstations, Computer-Aided Design/Manufacturing

36180 Workstations, Computer-Aided Design/Manufacturing, Orthopedic

36181 Scanning Systems, Laser/Light, Orthopedic Impression, Foot Orthosis/Prosthesis

36418 Scanning Systems, Mechanical Contact, Orthopedic Impression, Plantar Digitizer


36419 Milling/Drilling Machines, Orthopedic, Computer-Aided, Foot Orthosis/Prosthesis

36420 Workstations, Computer-Aided Design/Manufacturing, Orthopedic, Foot Orthosis/P

36421 Software, Computer-Aided Design/Manufacturing Systems, Orthopedic, Foot Ortho

36422 Scanning Systems, Laser/Light, Orthopedic Impression, Spinal Orthosis/Prosthesi


36427 Milling/Drilling Machines, Orthopedic, Computer-Aided, Spinal Orthosis/Prosthesi

36428 Workstations, Computer Aided Design/Manufacturing, Orthopedic, Spinal Orthosis

36429 Software, Computer-Aided Design/Manufacturing Systems, Orthopedic, Spinal Ort

36431 Software, Computer-Aided Design/Manufacturing System


36432 Exercisers, Muscle Strength, Pneumatic

36433 Exercisers, Muscle Strength, Pneumatic, Lower Limb

36434 Exercisers, Muscle Strength, Pneumatic, Lower Limb, Squat

36435 Exercisers, Muscle Strength, Pneumatic, Lower Limb, Hip Abduction

36436 Exercisers, Muscle Strength, Pneumatic, Lower Limb, Hip Adduction


36437 Exercisers, Muscle Strength, Pneumatic, Lower Limb, Leg Curl

36438 Exercisers, Muscle Strength, Pneumatic, Lower Limb, Leg Extension

36439 Exercisers, Muscle Strength, Pneumatic, Trunk

36440 Exercisers, Muscle Strength, Pneumatic, Trunk, Low Back

36441 Exercisers, Muscle Strength, Pneumatic, Trunk, Hip Rotation

36442 Exercisers, Muscle Strength, Pneumatic, Trunk, Abdominal Crunch


36443 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk

36444 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk, Chest Press

36445 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk, Chest Fly

36446 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk, Seated Dips

36447 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk, Pulldown

36448 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk, Rowing


36449 Exercisers, Muscle Strength, Pneumatic, Upper Limb/Trunk, Shoulder Press

36458 Tinnitus Therapy Units, Ear Canal

36485 Sample Preparation Equipment, Laboratory, Cryo-Electron Microscopy

36486 Electric Signal Amplifiers, Biosignal, Brain

36487 Chairs, Disabled Person, Sexual Relations

36488 Cooling Units, Animal Urine


36497 Aerosol Exposure Systems, Automated, Animal

36503 Pumps, Subcutaneous Infiltration

36507 Monitoring Systems, Physiologic, Hemodynamic, Invasive

36520 Software, Physiologic Monitoring, Hemodynamic

36525 Infusion Pumps, Multitherapy, Syringe, Hyperbaric Chamber Compatible

36528 Tubing Sets, Intravenous Administration, Extension, Hyperbaric Chamber


36532 Chambers, Treatment, Hyperbaric, Monoplace

36535 Chambers, Treatment, Hyperbaric, Multiplace

36544 Monitors, Applied Dermal Pressure

36549 Covers, Mattress, Moisture/Temperature Control

36551 Crematories
36556 IVD Test Reagent/Kits, Microbiology, Fungi/Yeast, Identification, Dermatophyte

36560 Dehumidifiers, Room Environment

36587 Crosslinkers, Ultraviolet Light

36594 Dryers, Medical Device

36616 Tables, Downflow

36617 Scanning Systems, Light, Spectroscopy, Uterine Cervix

36618 Chambers, Radiation Containment


36620 Software, Workstation Management, Bone Histomorphometry

36627 Magnets, Nuclear Magnetic Resonance

36628 Waterjet Massage Units

36640 Calibrators, Manometer

36641 Calibrators, Oscilloscope

36644 Water Tanks


36645 Dispenser/Melters, Hydrocolloid Duplication
36666 Amalgam Separators

36667 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP2C19

36668 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, H

36669 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, KIF6

36670 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, RHD

36671 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, TO

36672 IVD Panels, Human Genetics, Blood Typing, Erythrocyte Antigen

36673 IVD Panels, Human Genetics, Bone Disorder, Scoliosis

36674 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Bladder


36675 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Glioblastoma

36676 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Pancreatic

36677 IVD Panels, Human Genetics, Comprehensive

36678 IVD Panels, Human Genetics, Liver Disorder, Inherited Intrahepatic Cholestasis

36679 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Leukemia, Myeloid, Acut

36680 IVD Panels, Human Genetics, Pharmacogenetic

36681 IVD Panels, Human Genetics, Pharmacogenetic, Cardiovascular

36682 IVD Panels, Human Genetics, Pharmacogenetic, Psychiatric


36683 IVD Panels, Human Genetics, Pharmacogenetic, Pain

36684 IVD Panels, Human Genetics, Pharmacogenetic, Substance Abuse

36685 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification, DNA Methylatio

36686 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification, DNA Methylati

36687 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification, DNA Methylation

36688 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Deletion, 5q

36689 IVD Test Reagent/Kits, Immunoassay, Rheumatism

36690 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Ovarian Cancer

36691 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Prostate Cancer

36692 IVD Test Reagent/Kits, Mass Spectrometry, Lung Cancer


36693 IVD Test Reagent/Kits, Molecular Assay, Intergenic Polymorphism, 9p21

36694 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Autoantibody, Lung Cancer

36695 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Translocation, 2p

36696 IVD Test Reagent/Kits, Multimodal Assay

36697 IVD Test Reagent/Kits, Multimodal Assay, DNA Methylation/Gene Anomaly/Immun

36698 IVD Test Reagent/Kits, Multimodal Assay, Cytology/DNA Quality/Gene Anomaly/Lo

36699 IVD Test Reagent/Kits, Multimodal Assay, Gene Anomaly/Immunoassay/Immunocy

36700 IVD Test Reagent/Kits, Multimodal Assay, RNA Expression/Immunoassay


36716 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

36717 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marke

36718 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

36719 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

36720 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

36721 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification, DNA Methylation

36722 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, GNAS

36723 IVD Test Reagent/Kits, Molecular Assay, Chromosome Anomaly, Loss of Heterozyg

36724 IVD Test Reagent/Kits, Serology, Fungi/Yeast, Saccharomyces Cerevisiae, Antibod


36725 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ATG16L1

36726 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, ECM1

36741 Ambulances, Water Transport

36742 Ladders

36761 Dental Appliance Cases

36762 Dispensers, Occlusion Plug, Ear

36767 Topical Solution/Cream/Gels, Nail

36775 Charts, Dental, Tooth Color


36782 Stents, Gastroduodenal

36783 Dryers, Lyophilization

36784 Intravenous Port/Connector Disinfecting Swabs


36785 Intravenous Port/Connector Disinfecting Tips

36796 Hyoid Bone/Tongue Suspension Implants

36808 IVD Panels, Human Genetics, Prenatal Screening, Fetal Aneuploidies

36812 IVD Panels, Human Genetics, Male Infertility

36814 Exhibition Booths

36818 Spacers, Prostate/Rectum

36820 IVD Panels, Human Genetics, Pregnancy Loss

36825 Cryoprotective Solutions


36826 Exercisers, Aerobic, Stationary Bicycle, Hydrotherapy

36827 Phosphor Image Erasing Light Boxes


36828 Topical Solution/Creams, Pediculicidal

36829 Procedure Kit/Trays, Otorhinolaryngologic Examination

36831 Cables, Audio

36834 Collection Canisters, Amalgam Separator

36863 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, IL1B

36864 IVD Panels, Human Genetics, Periodontal Disease Susceptibility

36872 IVD Panels, Human Genetics, Renal Disorder, Nephrotic Syndrome

36879 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Kidney Tumor
36883 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Cervical Tumor

36884 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Myeloid Neoplasm

36886 IVD Panels, Human Genetics, Preimplantation Screening/Diagnosis

36947 IVD Panels, Human Genetics, Addiction, Opiate

36948 IVD Panels


36949 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification

36953 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification, DNA Methylatio

36959 IVD Test Reagent/Kits, Molecular Assay, Epigenetic Modification, DNA Methylation

36970 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, FCGR3A

36983 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP1A2
36985 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, CYP2B6

36987 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PROC

36990 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, PR

36991 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, PROS1

36993 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, PR

36994 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, SERPINC1

36997 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Deletion/Duplication, SE

36998 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HLA-A

37001 IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly, Mutation, HLA-B

37013 Hydrogen Generators

37032 Cable Tie Tensioners


37034 Cable Ties

37104 Photoactivation Unit Bags

37106 Cupping Sets

37111 Socks/Stockings, Antiskid

37115 IVD Panels, Human Genetics, Pharmacogenetic, Chemotherapeutic

37117 IVD Panels, Human Genetics, Cancer, Familial, Sarcoma

37118 IVD Panels, Human Genetics, Cancer, Familial, Basal Cell Nevus Syndrome

37119 IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Mark

37123 IVD Panels, Human Genetics, Cancer, Somatic Mutation, Myeloid Neoplasm, Myel
37124 IVD Panels, Human Genetics, Cancer, Familial, Endometrial

37125 IVD Test Reagent/Kits, Immunoassay, Alzheimer Disease

37126 IVD Test Reagent/Kits, Immunoassay, Alzheimer Disease, Neural Thread Protein

37128 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika

37135 Software, Ultrasonic Scanning, Small-Parts, Bladder

37184 Waste Receptacle Liners

37187 Waste Receptacle Liners, Biohazardous Material

*Universal Medical Device Nomenclature System (UMDNS). ECRI Institute.


*Concept Definitions. Release Version: November 2016 (201611)
Definition
Binders designed to encircle the abdomen to provide support to the abdominal walls and keep the abd
appropriate position. These devices are usually made of wide flexible pieces of elastic fabric with hook
(e.g., Velcro) or metal fasteners with small teeth that grab onto and secure the elastic fabric for adjust
binders; the binders are available in several sizes. Abdominal binders are used to support and compre
muscles and other abdominal structures for rehabilitation after childbirth or abdominal surgery (e.g., l
binders may be also used by women after labor to support the relaxed abdominal walls. They may als
pain and strain.

Prepackaged collections of the devices and supplies (i.e., either custom or standard) needed for perfo
needles along specific pathways or meridians (i.e., acupuncture procedures). Items in these kits usual
needles, a point detector, tweezers, lancets, alcohol swabs, and sharps collectors. The kits are frequen
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
Acupuncture procedure kits and trays are mainly intended for use in the prevention and treatment of
such as arthritis, back, neck, knee and shoulder pains, and carpal tunnel syndrome; they are sometim
with pressure, heat, and/or electric stimulation.

Ophthalmic measuring instruments designed to determine dark adaptation by providing a stimulating


varying controlled intensities. The devices usually consist of a computerized control panel, light source
response recording mechanism to provide light stimuli of varying brightness to the subjects. Adaptom
detection of night blindness and its associated underlying conditions, as well as other eye problems.

Surgical instruments designed for excision of hypertrophic lymphoid tissue in the nasopharynx (i.e., ph
adenoids). These manual, handheld devices typically consist of a long slender instrument with cutting
end and a handle with a mechanism to operate the cutting blades. Other surgical instruments, especi
are also used for the excision of the adenoids (adenoidectomy).

Short (usually less than 4 inches/10 cm) in length and narrow (typically 1 to 2 inches/2.5 to 5 cm) flex
covered on one side with a pressure-sensitive adhesive, which are designed to cover a wound and/or a
edges of a wound, or to attach dressings or other small devices (e.g., intravenous catheters) to the sk
usually made of cloth (e.g., cotton), plastic, paper, and/or other materials; some strips include a centr
Adhesive strips are intended for single use (i.e., disposable); they are usually supplied in precut sizes
packaged sterile. Multipurpose adhesive strips with hypoallergenic, waterproof, and/or antimicrobial p
dedicated strips intended for wound closure are also available.

Multipurpose adhesive strips made of materials (e.g., latex-free) and/or covered with adhesives that a
lower potential for producing an allergic reaction (i.e., hypoallergenic). These strips typically are short
inches/10 cm) length and narrow (typically 1 to 2 inches/2.5 to 5 cm) flexible strips evenly covered on
pressure-sensitive adhesive. Hypoallergenic adhesive strips are intended for single use (i.e., disposab
supplied in precut sizes and/or shapes that may be packaged sterile. These devices are mainly intend
wounds and/or to attach objects (e.g. dressings) to the skin in patients sensitive to standard strips and
Multipurpose adhesive strips made of materials and/or coated with an impermeable or water-resistant
waterproof). These strips typically are short (usually less than 4 inches/10 cm) in length and narrow (t
inches/2.5 to 5 cm) flexible strips evenly covered on one side with pressure-sensitive adhesive. Water
are mainly intended to cover small wounds and/or to attach objects (e.g. dressings) to the skin.

Tapes coated on one or both sides with an adhesive. Adhesive tapes are usually very long (e.g., severa
narrow (typically 0.5 to 3 inches/12 to 76 mm) strips or bands made of materials such as cloth (e.g., c
and/or other materials. Adhesive tapes are intended to attach objects (e.g., dressings, bandages, tube
body or other surfaces; tape may also be applied in several layers, one overlapping the other (i.e., str
exert pressure on a body part (e.g., a limb). Adhesive tapes with particular properties (e.g., hypoallerg
both) are also available.

Solvent material designed to remove adhesive tape or other adhesive-based products (e.g., bandages
wafers, etc.) and the associated adhesive residue from the skin or other surfaces. The solvent is typica
various forms for application, e.g., spray bottles or pre-soaked pads or swabs.
Stools including adjustable seat-height capabilities. These stools are usually metallic with an upholste
include backrest, armrests, and/or casters; the height adjustment may be either mechanical (e.g., rev
pneumatic, or sometimes hydraulic. Adjustable stools are designed to provide seating to the healthca
or dental procedures (e.g., examination, treatment, surgery).
Equipment that includes an enclosure (e.g., a cabinet) equipped with mechanisms appropriate for ra
residues of ethylene oxide (EtO) from the surfaces of EtO-sterilized devices.
Devices designed to produce (i.e., generate) gaseous suspensions of extremely small particles of a liq
generators typically include a micro-ultrasonic, or pneumatic pumping mechanism capable of creating
mist appropriate for delivery to the patient's airways and/or for lung deposition. Aerosol generators ar
of sizes and configurations according to the clinical procedure and/or the device used for aerosol deliv
connected through flexible hoses or tubes to face masks, ventilator breathing circuits, or aerosol tents
an integral part of fixed and/or portable nebulizers. Aerosol generators are used mainly to produce an
saline solutions and drug formulations; some dedicated devices are intended to produce a radioactive
_x000D_

Environmental samplers designed to obtain samples of the air. Most of these devices can automaticall
computerized controllers that permit either on-call or periodic collection. The samples obtained may b
detectors to characterize particular types of air components (e.g., gases, aerosols, and particles, inclu
and/or biological agents). Air samplers are used to collect samples from healthcare facilities, workplac
outdoor places where air is or may be polluted and/or contaminated.

Devices designed to permit the passage of gases (e.g., air, oxygen) to the lungs while preventing obst
upper airway. These airways include a variety of devices according to the technique used to facilitate
the intended application, and the expected time of use. In emergency and/or for short-time use, esoph
one- or two-lumen tubes and oropharyngeal artificial airways are typically used. For a few days of intu
nasopharyngeal artificial airways are the most commonly used devices, while for longer periods (up to
endotracheal tubes are the preferred devices. When long-term mechanical ventilation is needed, trach
used. Artificial airways are available in a variety of configurations from newborn to adult sizes.
Artificial airways designed for insertion through the mouth into the esophagus, permitting the passage
lungs while occluding the esophagus. These airways typically consist of an esophageal tube with a dis
the esophagus, securing the patient's airway and decreasing the risk of regurgitation; a mask that sea
and a nasally inserted small-diameter tube for breathing. Esophageal obturation artificial airways are
sizes to accommodate the patient's anatomic characteristics. They are intended for temporary use in
healthcare personnel with minimum training to facilitate breathing and/or for resuscitation; the airway
suctioning through them.

Artificial airways designed for insertion through one of the nostrils, permitting the passage of oxygen
airways typically consist of a hollow, curved plastic tube with a protruding rim (flange) at the proximal
is inserted, the flange rests against the nostril, the curvature of the artificial airway follows the contou
nose, and the distal end opens into the posterior pharynx. Nasopharyngeal artificial airways are availa
accommodate the patient's anatomic characteristics. They are intended for use in unconscious or sem
who cannot maintain an open natural airway; insertion of the artificial airway should be performed on
healthcare personnel. Suction through the airway may be performed using appropriate catheters.

Artificial airways designed for insertion through the mouth to keep the tongue from occluding the upp
the passage of oxygen to the lungs. These airways typically consist of a hollow, large-diameter curved
protruding rim (flange) at the proximal end; when inserted the flange rests against the lips, the curvat
airway follows the contour of the tongue, and the distal end opens into the pharynx. Oropharyngeal ar
available in several sizes to accommodate the patient's anatomic characteristics. They are intended fo
during resuscitation and/or in unconscious patients to permit or facilitate breathing and also to facilita
it.

Restorative dental materials consisting of metal alloys designed to be combined with mercury (i.e., to
amalgam) for in situ restoration of the appearance, structure and/or function of a patient's teeth. Thes
product of the fusion of several metals (e.g., silver, tin, zinc, and copper) to form an alloy that is appro
mercury; dental alloys are used in dentists' offices when dental amalgam is not available or in-situ mix
other reasons.

Devices, usually electrically powered, intended to mix, by shaking, amalgam capsules containing mer
particles. The capsule may be an integral part of the amalgamator or a separate component placed in

Vehicles designed for transporting the sick or wounded that are equipped with the necessary devices
maintain or improve the clinical status of the patient during transport. These vehicles may operate on
air.
Endoscopes designed for direct insertion through the cervical canal into the closed sac between the e
membrane involving it (i.e., the amniotic cavity) for visual examination, biopsy, and/or treatment of t
membrane is broken. Amnioscopes usually consist of an outer sheath, a lighting system, and a workin
and operative devices; these endoscopes may be rigid or flexible.
Surgical instruments designed for rupturing, cutting, or tearing the membrane containing the fetus (i.
or amnion) during labor. Amniotomes are manual, small handheld instruments that may consist of slen
with a protected sharp point at the distal end; instruments that tear the amniotic membrane without p
perforation; or devices used as a finger sheath (ring-like) with an attached hook at the distal end that
examination and rupture of the membrane in one operation. Amniotomes are mostly intended to rupt
membrane during labor to facilitate birthing.
Manually-operated devices designed to be used to break open the ampule so that the contents of the
accessed. Typically, ampules are broken open by snapping the neck/stem of the container, which can
(e.g., due to the fact that ampules are manufactured from glass or plastic). Manual ampule openers ar
provide a method for protecting the user's fingers from the sharp edges, e.g., they guard against cuts
manual ampule openers include a small cutting blade inside the opener that scores the ampule stem
break.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
anesthesia to nerve roots. Items in these kits usually include needles, anesthetics, syringes, iodine, fe
preparation applicators, gauze sponges, adhesive bandages, and underpads. The kits are frequently s
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Anesth
trays are intended for use in the block of local nerve roots during diagnostic and/or therapeutic proced
anesthesia procedure kits and trays are available for a variety of procedures, such as epidural, spinal,
caudal, paracervical, laryngotracheal, pudental, and saddle block procedures.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
anesthesia to the arm distal to the shoulder. Items in these kits usually include sterile towels, gauze p
with local anesthetics, sterile gloves, marking pen, surface electrodes, a needle for skin infiltration, a
kits may also include a peripheral nerve stimulator. The kits are frequently supplied in supporting tray
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Brachial-plexus anesthe
trays are intended for use in the block of axillary brachial plexus roots during diagnostic and/or therap

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
anesthetic solution into the caudal portion of the epidural space, usually through the sacral hiatus. Ite
include syringes, needles (e.g., scalp vein-needle), sterile gauze, and povidone. The kits are frequentl
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
anesthesia procedure kits and trays are intended for use in the block of sacral and lower lumbar nerve
diagnostic and/or therapeutic procedures.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
anesthesia into the epidural space. Items in these kits usually include a hypodermic needle, an aspira
plastic and glass syringes, povidone-iodine solution, lidocaine hydrochloride, sodium chloride, a syring
set, a catheter connector and support pad, fenestrated drape, a sharps stick pad, gauze, and other pr
as cups, towels, and swabs. The kits are frequently supplied in supporting trays (i.e., procedure trays)
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Epidural anesthesia procedure kits and trays are
during procedures to reduce inflammation and pain in the back and/or legs.
Prepackaged collections of the devices and supplies (either custom or standard) needed for providing
the glossopharyngeal nerve. Items in these kits usually include sterile towels, gauze packs, a syringe
anesthetics, sterile gloves, a marking pen, a needle for skin infiltration, and a bevel needle. The kits a
in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border aroun
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
Glossopharyngeal anesthesia kits and trays are intended for use in the block of glossopharyngeal nerv
diagnostic and/or therapeutic procedures (e.g., laryngoscopy, esophagoscopy, bronchoscopy, tonsillec
intubations.

Prepackaged collections of the devices and supplies (either custom or standard) needed for providing
the area around the uterine cervix (i.e., paracervical). Items in these kits usually include a procedure n
needle guide, gauze pads, underpads, sterilization indicator, a speculum, dilators, and anesthetics (e.
saline/buffered lidocaine). The kits are frequently supplied in supporting trays (i.e., procedure trays) c
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Paracervical anesthesia kits and trays are intend
of paracervical nerve roots during minor gynecologic diagnostic and/or therapeutic procedures (e.g., r
warts, vulvar biopsy, laser treatment of lesions, hysteroscopy).

Prepackaged collections of the devices and supplies (either custom or standard) needed for providing
the pudendal nerve located in the pudendal canal. Items in these kits usually include a procedure nee
metal trumpet needle, gauze pads, underpads, a sterilization indicator, and lidocaine. The kits are freq
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
anesthesia kits and trays are intended for use during diagnostic and/or therapeutic procedures in the
especially during pregnancy, producing a pudendal nerve block.

Prepackaged collections of the devices and supplies (either custom or standard) needed for providing
the subarachnoid space around the spinal cord. Items in these kits usually include an anesthetic admi
Luer tip with needle, a syringe with pre-attached needle, anesthetics (e.g., lidocaine), a povidone iodin
swab sticks, gauze pads, towel(s), a fenestrated drape, a sharps stick pad, and adhesive bandages. T
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Spinal anesthesia kits and trays are usually intended for use in a nerve block limited to the regions be
abdomen during diagnostic and/or therapeutic procedures.
Devices that continuously or intermittently administer a mixture of gases (e.g., oxygen, nitrous oxide,
liquid such as halogenated hydrocarbon), varying the proportion of gases in order to control an individ
consciousness. These devices are also designed to facilitate spontaneous, controlled, or assisted vent
mixtures. An anesthesia unit is typically comprised of four basic subunits: a gas supply and control cir
ventilation circuit, a scavenging system to help prevent the escape of exhaled gases, and a set of fun
circuit monitors (e.g., inspired oxygen concentration, breathing circuit integrity). Also included in some
number of monitors and alarms that indicate levels and variations of several physiologic variables and
associated with cardiopulmonary function and/or gas and agent concentrations in breathed-gas mixtu
units are also equipped with a battery back-up in case central power supplies fail. Some anesthesia un
specifically for use in magnetic resonance imaging (MRI) environments (i.e., MRI-compatible anesthes
from nonmagnetic materials so that they can be safely used in an MRI suite. Dedicated anesthesia un
research animals and units that do not need a vaporizer and deliver mixtures of air and nitrous oxide g
anesthesia units) are also available. Anesthesia units are the main component of an anesthesia system
more enhanced capabilities than those that are required for the minimum standards for anesthesia un

Devices designed to absorb expired carbon dioxide circulating in the patient breathing circuit before t
back through the anesthesia system to the patient. Typically, these absorbers consist of canisters in li
from the breathing bag to the patient or canisters with appropriate valves for inclusion in a circle syste
is typically absorbed in soda lime (calcium hydroxide plus additives) or another mixture with similar p

Devices designed to vaporize and add a controlled amount of anesthetic agent to the gas mixture del
through an anesthesia unit. Vaporizers are usually installed in the low-pressure circuit of the anesthes
liquid anesthetic agent after the gases pass the control valve and flowmeter. These devices may cons
bypass type vaporizer (the stream of gas is split into bypass gas which does not enter the vaporizing c
gas which flows over the liquid agent), or (2) heated blender vaporizer (the anesthetic agent is evapo
pressurized to a high pressure); another option (3) is to "inject" the anesthetic agent directly into the
from the flow meters (direct injection vaporizers). Dedicated vaporizers intended for use with only one
(e.g., isoflurane, desflurane, sevoflurane) are also available. Anesthesia vaporizers are needed becaus
anesthetic agents (except nitrous oxide N2O) exist as liquids at room temperature and sea-level press
to add anesthetic vapor into the gas flow in a way that the output of the system delivers the set conce
agent accurately.

Ventilators designed to use positive pressure to deliver a prescribed mixture of respiratory and anesth
to the patient's lungs during surgical procedures that require general anesthesia; the mixture is produ
unit. Many anesthesia ventilators are time-cycled devices that have only one mode of operation, but
other modes (e.g., synchronized intermittent mandatory ventilation). Anesthesia ventilators are usua
critical care ventilators. Most anesthesia units include these ventilators either as an integral part or a

Height-adjustable stools that are designed for anesthesiologist use during surgical procedures. These
metallic and may include backrest and casters; they usually do not include armrests. Some anesthesi
conductive upholstery (e.g., conductive vinyl)
Devices designed to embrace the ankle, providing limited support and protection. These devices cons
material that is integral (e.g., straps). They are typically made of elastic fabrics that may be combined
Anklets are used for temporary treatment of minor ankle injuries such as sprains and during rehabilita
exercise. They may also provide compression to increase venous activity.

Endoscopes designed for direct insertion through the anal canal in the lower gastrointestinal tract for
biopsy, and treatment of lesions of the interior of the anal canal and lower rectum (e.g., fissures, fistu
These devices are rigid endoscopes that may include fiberoptic light sources.

Cardiographs designed to make a graphical record of the movements (pulsations) of the precordium o
apex of the heart. These cardiographs include a noninvasive transducer (e.g., piezoelectric pressure) t
movement (i.e., vibrations) of the soft tissue enclosed in the intercostal space and a graphical recorde
results as an apex cardiogram. Apex cardiographs are typically used to assess left ventricular function
dynamics of myocardial motion under various pathological conditions.

Ophthalmic tonometers designed to determine intraocular pressure by measuring the force required t
apex by a fixed amount. These instruments are typically small and reusable instruments and are attac
tonometer includes a tip to be applied to the cornea and a manually controlled spring that applies a v
cornea through the tip. The application of the tonometer tip flattens the cornea, producing a thin circu
into two green semicircles when viewed through the slit lamp oculars; then the force applied is adjust
semicircles just overlap and the force value is shown in the instrument scale as pressure (typically in m
(electronic penlike devices) and pneumatic applanation tonometers (i.e., pneumatotonomers) are also
ophthalmic tonometers (e.g., Goldman and Barraquer types) can measure the amount of force applied
mainly for assessing ocular hypertension (intraocular pressure between 10 and 24 mm Hg is considere
screen patients for glaucoma.

Jars used as containers to store manual applicators (e.g., swabs, towelettes) free from contamination.
either disposable (e.g., single-use) or reusable cylindrical containers with no handles made of stainles
frequently, plastic or glass with a tight lid that is usually made of the same material; they are supplied
according to the applicator dimensions. Applicator jars are used to keep applicators intended for clean
collecting of samples and/or for applying medications in a closed environment, minimizing the possibi
they are frequently used to store applicators used in procedures performed in the ear, nose, throat, m
vagina. Medicated applicators are usually stored in single-use jars.

Covers designed to wrap around arm boards while in use in order to protect a patient's arms. Arm boa
consist of sleeves made from either absorbent or non-absorbent, non-woven material to minimize cros
patients who use the arm boards. Arm board covers are made in different sizes to match the sizes of t
whether for adult, child, or infant patients.
Boards designed to stabilize a patient's arm. Arm boards are typically constructed of hard plastic; they
curved to accommodate the arm and/or wrist. Arm boards are mostly used to maintain the patency of
catheters such as those connected to an intravenous or intra-arterial line. Some arm boards are used
operating table) extensions (attachments).
Electrocardiographic simulators designed to mimic a set of abnormal electrocardiographic signals (e.g
ventricular tachycardia). These simulators usually can also generate waveforms to check the performa
being tested, including sine, square, triangular, and pulse waveforms; some can also simulate pacema
Arrhythmia simulators are used to test complex functions of arrhythmia monitoring and recording dev
healthcare personnel. Typically, they can also be used to check patient lead continuity and alarms fun

Endoscopes designed for percutaneous insertion into a joint (e.g., wrist, elbow, knee) for visual exami
treatment of lesions of the articulation, especially during surgical procedures. Arthroscopes usually co
sheath, a lighting system, and a working channel for catheters and operative devices. Most arthroscop
camera on the distal tip, typically in the form of a microchip (a charge-coupled device [CCD]). The ima
transmitted through wires in the endoscope for external processing, display, and recording of video im

Dental instruments designed to simulate the movement of the upper and lower jaw (i.e., the moveme
arch in relation to the maxillary arch); maxillary and mandibular casts are usually attached to the artic
articulators typically include two hinge-jointed arms; each arm has segments connected to a hinge joi
elements, one integral to each segment of an arm. The articulator elements determine the degree and
movement, as well as the capability of the articulator to closely simulate the movement of the mandib
characteristics, such as horizontal axis of rotation, condylar inclination, intercondylar distance, adjusta
side-shift movement (Bennett angle and movement, respectively), and incisal guidance, determine th
of mandibular dynamics. Dental articulators are available as nonadjustable articulators (Class I, limite
closing arcs about a fixed axis, or Class II, capable of lateral movement), semiadjustable articulators (
lateral, protrusive, and Bennett movement), and fully adjustable articulators intended to simulate all m
mandible. Dental articulators are used for dental restorative procedures, modeling and diagnosis, dete
an artificial dental prosthesis to obtain the best placement, occlusion, and articulation during the resto
class of articulator used in each procedure is chosen according to the characteristics of the procedure
modeled (e.g., placement of partial and complete dentures or individual crowns, diagnosis of temporo
dysfunction).

Speech assistive devices designed to deliver sounds resembling the normal voice (i.e., artificial larynx
vocal cords during normal speech. These devices are usually available as battery-powered electromec
as a transcervical or neck-type artificial larynx) that move a plastic or metal probe that generates a so
the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth throu
appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i
these devices may be modified using dedicated attachments for intra-oral or cheek use. Transcervical
include pitch and volume controls. Other types of artificial larynxes are available, such as the pneuma
lung air (i.e., lung powered) for sound generation; the exhaled air moves through a cup-like external a
the tracheostoma to a cylindrical vibrating chamber where a sound is generated; this sound is deliver
external tube to the mouth for modulation as voice. Other electromechanical devices designed specifi
(e.g., the Cooper-Rand larynx) are also available. Artificial larynxes are intended mainly to make possi
communication after proper training for people who have their natural larynx removed (laryngectomy
Devices designed to evacuate gas, fluid, tissue, or foreign materials from the body by means of vacuu
devices usually consist of a powered (or less frequently) manual vacuum pump, a regulator and gauge
or more collection canisters, plastic tubes connecting the components to each other, and an overflow
bacteria filter. Typically the pump creates a vacuum in the suction (e.g., tubes, catheters, cannulae) tu
into the cavity; then the debris is removed and routed to a specimen container. The vacuum capacity
400 mm Hg or more to as low as 80-120 mm Hg or less; free flow rates may be as low as 5 liter/min o
liter/min. Aspirators may be portable or mobile and line- or battery-powered. Dedicated aspirators are
procedures (e.g., general surgery, liposuction, and uterine suction); for breast milk extraction; and/or
during dental; gastric; wound, and airway procedures. They are mainly used when suction from a cent
not available or appropriate.

Aspirators designed to evacuate oral secretions, water, blood, and tooth debris from the mouth by me
during dental diagnostic, treatment, and/or surgical procedures. These aspirators generally consist of
(typically a low-pressure, high-volume evacuator), plastic tubes connecting the components to each o
collection containers, a control valve or switch and suction tubes or cannulae which are inserted into t
aspirators may be portable or mobile and they are either line- or battery-powered. Aspiration using a c
is also available.

Airway aspirators designed to evacuate secretions, liquids (e.g., blood), and/or foreign bodies from the
infants. These aspirators consist of a device that provides the suction, such as a manually operated bu
pump, or a device including a long tube placed against the nostril while the operator (e.g., the parents
to draw mucus out of the child's nose.
Aspirators designed to evacuate gastric secretions and toxic solutions (e.g., poison, overdosed medica
stomach by means of an intermittent vacuum suction. These devices usually consist of a lined-powere
user-selectable vacuum settings (e.g., as low as 60 mm Hg and as high as 120 mm Hg), a regulator an
bottle or canister, plastic tubes connecting the components to each other, overflow protection and/or
the suction tubing. The vacuums frequently use the thermotic principle of alternately expanding the a
contracting the air upon cooling.

Airway aspirators designed to evacuate nasal secretions, liquids (e.g., blood), and/or foreign bodies fro
The devices usually consist of a battery-powered pump (or less frequently) manual vacuum pump, a n
collection cup. Nasal aspirators are used mainly for adults and, more frequently, for babies and childre
nasal congestion.
Aspirators designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgica
high vacuum suction during surgical procedures. These devices usually consist of a powered vacuum p
gauge, one or more collection canisters, plastic tubes connecting the components to each other, and o
and/or bacteria filter, and the suction tubing (e.g., tubes, catheters, cannulae). The vacuum capability
400 mm Hg; free-flow rates are usually higher than 25 liter/min. Surgical aspirators may be portable o
battery-powered. They are mainly used when suction from a central vacuum system is not available o
Aspirators designed to provide suction for evacuation of gas, body fluids, or foreign materials that ma
the lung and chest wall (i.e., pleural space). These aspirators typically consist of a powered low-vacuu
high-volume (> 20 liter/min) pump; collection canisters; plastic tubes connecting the components eac
protection and/or bacteria filter; and suction tubing (e.g., tubes, catheters, cannulae). The devices ca
powered, mobile or portable. Thoracic aspirators are intended to evacuate gas and body fluids after th
in the chest, or after cardiac bypass surgery. They are used mainly when suction from a central vacuu
available or appropriate.

Airway aspirators designed to evacuate obstructive secretions, gas, liquids (e.g., blood), and/or foreign
trachea and/or bronchial tubes. These devices usually consist of a powered (or less frequently) manua
pressure regulator and gauge, one or more collection canisters, plastic tubes connecting the compone
overflow protection and/or bacteria filter; an endotracheal tube is usually attached to the aspirator. Tra
usually portable and battery powered. The typical vacuum level is from 80 mm Hg to 120 mm Hg to re
trauma. Tracheal aspirators are used to remove secretions and to maintain the airway of an intubated
mainly used when suction from a central vacuum system is not available or appropriate.

Aspirators used to evacuate gas, fluid, tissue, or foreign materials from the uterus by means of suction
typically include a powered high-vacuum (less than or equal to 400 mm Hg) and high-flow (>30 liter/
collection canisters; plastic tubes connecting the components to each other; an overflow protection an
and suction tubing (e.g., tubes, catheters, cannulae). The aspirators are usually mobile units that may
powered, and mobile. Uterine aspirators are used mainly for dilation and evacuation therapy, to termi
up to 12 weeks, to treat incomplete spontaneous abortions or to remove some tissues after labor. Oth
diagnostic dilation and curettage intended to remove the outermost layer of uterine lining (endometri
biopsy.

Aspirators designed to evacuate gas, liquid, tissue and/or other debris from a wound by means of vacu
devices usually consist of a powered (or less frequently) manual vacuum pump with a low flow rate; s
regulator and gauge; one or more collection canisters; and plastic tubes connecting the components t
include overflow protection and/or a bacteria filter. The aspirators may be portable or mobile, line- or b
pumps may use the thematic technique or they may provide either a continuous or intermittent suctio
are intended to promote wound healing and they are mainly used when suction from a central vacuum
available or appropriate.

Instruments designed to measure and characterize hearing loss by determining the lowest audible lev
threshold) of a patient for pure test tones, signals (e.g., speech), or both. These devices include tone g
and sound-level monitors. Audiometers are intended for conducting diagnostic tests for hearing disord
other otologic disorders diagnosis.
Enclosures designed to provide a consistent and controlled acoustic environment and keep backgroun
acceptably low level in order to provide a calibrated acoustical test area that meets requirements for c
research. The walls consist of solid steel panels on the outside, perforated steel panels on the inside,
material in between. Single-wall booths are constructed from a single-wall and layer of sound-absorbi
used primarily for pure tone air conduction testing. Double-wall booths employ "booth inside a booth"
further reduces outside noise interference, and are preferred for bone conduction, sound field, and spe
Devices designed to collect and reinfuse blood lost by a patient (i.e., perform an autologous transfusio
typically include vacuum suction and blood processing devices that use anticoagulants; they may rein
into the patient after collection (i.e., whole blood recovery) or after a procedure that involves separati
blood components (i.e., blood processing). Autotransfusion units are used mainly during surgery or in
intensive care units after trauma.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
care. Items in these kits may include a nasal aspirator, gauze, cotton swabs, absorbent pads, baby wip
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure. In
and trays are intended to provide post-delivery care to babies, and to take care of their hygiene and h
procedure kits and trays are used in maternity hospitals and infant nurseries.

Cushions or pads that the patient leans against in order to relieve or prevent back pain caused by exte
sitting, herniated disks, surgery pain, tension, muscle spasms, poor posture, or problems associated w
Backrests are usually nylon-covered foam but can also be inflatable or gel-filled for adjustable support
hard plastic for solid support. They can be used in chairs, wheelchairs, or car seats.

Measuring instruments designed to determine the mass of a body, using the force of gravity on the bo
for comparison. The result read from the balance is generally taken as a measure of the quantity weig
calculations are done only in exceptional cases. In practice, most balances measure in grams, althoug
ounces and grains are also used. Balances are mostly used for clinical laboratory measurements; they
a vibration-free workbench.

Balances that include an electronic circuit that senses the deviation of the balance beam from the equ
strain gauge sensor) and applies a restoring electromagnetic force, usually through a solenoid or torqu
current required to produce the balancing force in units of weight is displayed on a digital display. Mos
include automatic calibration, temperature change compensation, and taring capability for easy subtr
the container. Electronic balances frequently include a built-in interface so that they can communicate
computers, and data-processing units.

Balances designed to weigh by restoring the deviation of the balance beam to the equilibrium point b
mechanical force.
Cardiographs designed to measure and record data and graphics (i.e., a ballistocardiogram) of the ext
the body caused by thrust of the heart during systolic ejection of the blood. Ballistocardiographs were
devices such as dedicated tables and chairs capable of measuring the displacement of the body cause
function; some devices were also capable of measuring velocity (i.e., displacement first derivative). Li
devices (known as digital ballistocardiographs and also as seismographs) based on sensors that meas
the body movement are currently used, especially for detecting early cardiac abnormalities and to cha
diseases.

Long pieces of material designed for holding dressings and/or small devices (e.g., intravenous needles
superficial wounds, or to support and compress body parts. Bandages may be made of elastic or none
are typically available in rolls and are single-use (i.e. not reusable). Bandages supplied as liquids that
drying are also available.
Adhesive strips designed with broad, wing-shaped ends, linked by a narrow segment known as a bridg
usually made of porous cloth or plastic materials; the wings are covered on one side with pressure-sen
the bridge is not covered with adhesives. Butterfly wound closure strips are packaged sterile and inten
dedicated butterfly strips with hypoallergenic and/or waterproof properties are also available.

Rolls of fabric (e.g., cotton) made of open weave and differing degrees of fineness used to hold (i.e., fo
and/or other small devices (e.g., intravenous needles) in place, to cover and protect small superficial w
moderate compression to body parts.
Elastic bandages designed to apply pressure and to provide support to a body part. These bandages t
elastomeric material that provides extension only along its length (i.e., one-way stretch); the bandage
an adherent substance. Compression/support bandages can provide light (usually less than 20 mm Hg
mm Hg), or high (40 to 60 mm Hg) pressure. They are intended for treatment of sprains and strains, ly
venous leg ulcers.

Elastic bandages with a solid central part ending in many tails at both sides. These bandages are typic
tying the tails together or by overlapping the tails and fixing them with pins. Multitail bandages are in
provide compression and support to the abdomen or other body parts (e.g., face, limbs); they may ad
dressings in place.
Bandages designed to place and fit orthoses and other orthopedic devices. These bandages typically c
made of crepe, linen, foam rubber or other materials with sturdy fabric backing and may include an ad
traction bandages are usually placed on the skin and connected to hanging weights or traction units. T
manage fractures (e.g., to keep bones aligned in the case of fracture or dislocation) or to immobilize a
joint; traction bandages are more frequently used in elderly patients during orthopedic-traction proced

Metabolic rate physiologic analyzers designed to measure exhaled (i.e., produced) carbon dioxide and
(VO2) and estimate the metabolic rate based on indirect calorimetry by performing algorithms that us
devices usually include carbon dioxide and oxygen analyzers, airflow measurement devices (e.g., pne
controls, and a computerized system that integrates the measurements and brings the result in energ
consumption/carbon dioxide production based metabolic rate physiologic analyzers are used to assess
and CCU units and for other medical applications (e.g., sports medicine, nutritional support, spatial an
they are frequently available mounted on carts (i.e., "metabolic" carts).

Frames used to hold a basin at an elevated height or to transport basins throughout the hospital. They
constructed of metal and are on casters for mobility. Some basin stands are designed specifically for u
resonance imaging [MRI] environments, i.e., MRI-compatible basin stands, and are made from nonmag
they can be safely used in an MRI suite.
Small, compact beds with low sides specifically designed for very young infants (i.e., neonates). Bassi
in healthcare environments typically consist of a metal or wooden frame with a top that is designed to
or to provide an appropriate sleeping surface for the infant. Designs range from basic stands/frames t
shelves, cabinets and/or drawers intended to provide storage. Certain designs may incorporate woven
retractable hoods. In healthcare environments, bassinets typically are wheeled devices used to move
locations. Some designs may incorporate over-the-bed/wheelchair accessible features.
Boots intended to be worn while bathing or showering to provide traction and to help prevent falls. Th
hygiene by protecting the feet from contact with microorganisms in shared bathing facilities. They are
woven nylon fabric for quick drainage, are stretchable, are made in several sizes based on shoe sizes,
soles, and may be disposable or reusable. Bath/shower boots designed specifically to be worn over ca

Pillows that are placed behind or around the neck, back, or head to relieve or prevent pain by providin
stressed areas during bathing. They are generally inflatable, made of waterproof plastic or rubber, an
cups for attachment to the web tub wall.
Boards designed to be used on a bed in such a way (on top of or under the mattress) as to increase th
patient-supporting surface. These boards are typically constructed to match the dimensions of bed an
other stiff (e.g., hard plastic) material. Bed boards are used to provide an appropriate rest surface for
orthopedic (e.g., spinal) traumas or disorders.
Fixed beds designed using a configuration resembling a baby cradle to protect patients. These beds ty
fixed endrails and movable and latchable siderails and/or a fabric framed canopy. Cradle fixed beds re
passively and avoid the risk of patient falls; both adult and child cradle beds are available.

Washer/sterilizing units designed for the automatic or semiautomatic washing (i.e., elimination of dirt
removing organic debris (e.g., blood, fat, bone), and killing all microorganisms, including spore-formin
very high numbers), from ancillary devices and small receptacles such as bedpans. These units typica
two corrosion-resistant chambers with front (i.e., roll-in/roll-out models) or front-and-back doors that p
carts (i.e., tunnel type), a control panel, and appropriate pumps, jets (booms), and other accessories n
washing and sterilizing cycles on the soiled carts. Cart washer/sterilizing units perform a cycle of oper
include mechanical removal of contaminants by water jets, detergent wash, germicide application (us
high-pressure booms), and thermal drying. They are used mainly in the central supply area of a health

Covers designed to fit over or within bedpans to provide a protective barrier between the bedpan and
Bedpan covers are made of plastic for disposal after use, or of a biodegradable and flushable material
include an anti-odor absorbent pad or waste treatment powder that absorbs liquid waste and turns it i
proof gel.
Racks designed to hold bedpans after they have been washed and/or sterilized. These racks typically
steel hinged ladder-type frame with horizontal and/or longitudinal bars and curvatures designed to ac
and urinals. They are usually wall mounted for maximum space utilization and some may include a dr
are used in hospitals and other healthcare units.
Warming units designed to store and warm bedpans before use. These units include a cabinet with ap
warm several (e.g., 5 to 10) bedpans simultaneously; the temperature range is typically from room te
degrees C (140 degrees F)
Devices used by a bedridden patient as receptacles for urine and feces.
Devices used by bedridden patients as receptacles for urine and feces. Fracture bedpans are designed
an edge of minimal height to ease insertion under those patients who may have difficulty rolling onto
their buttocks high enough to allow for use of a regular bedpan. Examples of such patients include tho
fractures of the hip, pelvis, spine, femur, tibia/fibula, etc.

Bars that are mounted to the sides (and foot) of hospital and homecare beds to prevent patients from
sleeping or during transport. They are typically made of steel and either telescope or fold down when
Furniture designed with a comfortable surface appropriate for supporting the lying body of a person. B
a horizontal surface or support appropriate to hold a mattress and/or mattress and spring-box; they m
and/or foot frame and sometimes lateral rails (i.e., siderails). Beds are mainly used in healthcare facili
nursing homes) and at home for resting and sleeping and also during recuperation and/or medical trea
fixed height and width and beds that permit the adjustment of the height and contour of the resting s
mechanical, electric, and/or hydraulic mechanisms are also available. Some beds are intended for par
such as to provide alternating pressure, for birthing, and to perform radiographic procedures.

Electric beds designed to turn a semi-circle (i.e., 180 degrees) along the vertical plane of the bed, mo
supine to prone position and vice versa; the bed surface may tilt to a variety of different positions. The
include a surface and restraints that are appropriate for use as a mattress and to keep the patient in a
rotating. Circular revolving electric beds are intended to provide caregivers total access to critically ill
need to handle or disturb the patient.

Beds designed with one or more built-in electric motors and remote electric or pneumatic controls tha
the patient or staff members to adjust the bed surface, contour, or both. In most electric beds the ma
divided into three or more pivoted sections that can adjust the height and assume Gatch positions or
and knees elevated) or tilt to Trendelenburg and reverse Trendelenburg positions (body straight; feet e
respectively). Most electric beds include movable and latchable siderails. Some beds may incorporate
fabric framed canopy. Electric beds are mainly used in healthcare facilities (e.g., hospitals, nursing hom
resting and sleeping and also during recuperation and/or medical treatments (e.g., alternating pressur
(e.g., birthing, radiography).

Electric beds designed to provide a soft surface for the patient similar to that provided by floating on a
typically include a mattress filled with some appropriate substance, such as air, water, or gel; the mat
permeable to air and water vapor but not to liquids. Floatation therapy electric beds are used to treat
moderate to high risk for developing decubitus ulcers and whose clinical status requires high head ele
transfer, and/or ambulation.

Electric beds designed to permit radiographic and/or fluoroscopic procedures on a patient. These beds
radiolucent mattresses and supporting surfaces, raising and lowering mechanisms that do not interve
the radiation source and image intensifiers, and dimensions and clearances that facilitate placement o
under the bed. Radiography/fluoroscopy electric beds are mainly used for bedside procedures using m
fluoroscopic units.

Beds designed with one or more mechanisms operated by manual crank handles or other controls tha
the patient or staff members to adjust the bed surface, contour, or both. In most mechanical beds, the
divided into three or more pivoted sections that can adjust the height and assume Gatch positions or
and knees elevated) or tilt to Trendelenburg and reverse Trendelenburg positions (body straight; feet e
respectively). Most mechanical beds include movable and latchable siderails. Some beds may incorpo
fabric framed canopy. Mechanical beds are mainly used in healthcare facilities (e.g., hospitals, nursing
for resting and sleeping and also during recuperation and/or medical treatments (e.g., alternating pres
(e.g., birthing, radiography).

Fixed beds designed for orthopedic treatment. These beds typically include a resting surface that has
height and contour and one or more pre-attached traction (e.g., weights, pulleys) devices. Orthopedic
used in long-term treatment procedures due to illness or trauma (e.g., fractures).
Cradle fixed beds designed for child use. These beds have a size appropriate for children; they typical
resembling a baby cradle, incorporating fixed endrails and movable and latchable siderails and/or a fa
Pediatric cradle fixed beds restrain children passively and avoid the risk of patient falls while providing
patient by the staff.
Electric beds designed to periodically tilt patients a small angle (e.g., 15 degrees) from the horizontal
alternately in the Trendelenburg and reverse Trendelenburg positions following a rocking motion. Thes
controls for adjustment of the speed and/or degree of tilting. Rocking electric beds are intended mainl
breathing by using the weight of the abdominal contents to move the diaphragm; they are also used i
diseases to improve circulation.

Height-adjustable stools that usually include a metallic tubular structure with an upholstery seat. Heig
performed mechanically by turning a revolving seat. Bedside adjustable stools usually do not include
they are designed to provide seating for clinicians during bedside examination of patients.

Electrical stimulators designed to apply harmless but unpleasant electrical impulses to a patient (e.g.,
modify undesirable behavior (e.g., self-injury). Most of these stimulators are used for aversion therap
by a therapist in clinical programs and/or at home. Some behavioral therapy stimulators also include
stimulus for sound or sound/electric aversion conditioning. These stimulators are used in the treatme
obsessive/compulsive behavior and drug abuse.

Ergometers designed to measure the work (i.e., the amount of force multiplied by the distance over w
applied) or rate of work (i.e., power) performed by the leg muscles while pedaling a static bicycle (tha
part of the ergometer) under controlled conditions. Bicycle ergometers determine work and power by
exerted during pedaling (e.g., using mechanical or electromagnetic brakes) and the speed of the peda
the bicycle imposes a workload that is independent of the body weight. Bicycle ergometers are used i
determine whether patients have cardiovascular or pulmonary diseases; they are frequently used in te
a stress exercise physiologic monitoring system. Ergometers attached to examination/treatment table
mechanism for pedaling in a supine or, less frequently, seated position are also available.

Aerobic cycle exercisers designed to simulate the motions of riding a bicycle; the bicycles remain stat
move. These exercisers are usually self-powered devices; they may use friction belts or wheels, magn
to increase resistance. Some stationary bicycles may include a motor to regulate speed. The bicycles
program modes that can adjust resistance and a monitor to display the workout time, distance, speed
heart rate; they often have handlebars with grip pulse sensors, and some bicycles have heart-rate con
the resistance level to suit the targeted heart rate. Stationary bicycle exercisers are intended to increa
endurance by keeping the heart and pulmonary rate elevated for a continuous period of time. Addition
strength and endurance to the lower-limb muscles (e.g., quadriceps, hamstrings, calves, gluteus). Ded
upright and recumbent sitting positions for users are available.

Collection bags designed for collection of bile (fluid secreted by the liver and passed to the small intes
from a drainage tube inserted into the patient's duodenum. Bile collection bags are usually plastic or e
devices; patient-worn and independent bile collection bags are also available.
Systems that provide a visual or auditory signal corresponding to the status of one or more of a patien
functions (e.g., brainwave activity, muscle activity, blood pressure). These systems detect changes in
function that are normally outside of normal awareness, amplify them, and provide the signal to the p
to develop some degree of conscious control over a usually involuntary function. Biofeedback system
tension headache control, muscle relaxation, and rehabilitation and behavioral research.

Prepackaged collections (either custom or standard) of equipment and supplies used for performance
(i.e., the removal of a small piece of living tissue from an organ or other part of the body for microscop
confirm or establish a diagnosis, estimate prognosis, or follow the course of disease in a patient). Typi
procedures include aspiration biopsies, needle biopsies, punch biopsies, and surface biopsies.

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
under ultrasonic guidance. Items in these kits usually include a cup, gauze, lidocaine, needles, syringe
cap, a scalpel, and towels; kits may also include a coaxial needle, a biopsy gun, a wrap, and a steriliza
are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed recepta
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Ultrasound aspiration biopsy procedure kits and trays are used during the removal of living
guidance for microscopic (in-vitro) laboratory examination for diagnostic and/or therapeutic purposes.

Prepackaged collections of the devices and supplies (either custom or standard) needed for the liquid
urethra and/or urinary bladder. Items in these kits usually include a needleless bulb or plunger syringe
protector, a waterproof drape, and an alcohol prep pad; some kits also include a dedicated urethral ca
used for irrigation in the kit may be also used for aspiration (i.e., removal) of the irrigating fluid and/or
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Urinary bladder/urethra irrigation kits and trays are used for therapeutic treatment of infecti
they are also used to remove clots (e.g., after surgical procedures) and/or to instill drugs.

Jars used as clean containers to store blades (the cutting part of a surgical instrument such as a knife
contamination. These devices are either disposable (e.g., single-use) or reusable cylindrical containers
of stainless steel or, less frequently, plastic or glass with a tight lid that is usually made of the same m
supplied in a variety of sizes according to the blade dimensions. Blade jars are used to store disposab
use (attached to a handle) in treatment and/or surgical procedures performed in hospitals, doctors' offi

Warming units designed to heat blankets. These units usually include a high capacity (e.g., 0.2 to 0.5
appropriate perforated shelves for blanket positioning, avoiding contact with very hot surfaces to prev
steam or dry hot air is typically circulated to heat the blanket in a temperature range from 30 degrees
degrees to 200 degrees F)
Large pieces of woven fabric or other appropriate material used for body covering or wrapping.
Blankets that consist of a plastic (e.g., polyester) film coated with vapor-deposited aluminum on one o
blankets provide thermal insulation, offering protection against heat loss under cold conditions or hea
radiation; they also offer some protection against other environmental agents (e.g., rain, wind). Alum
mostly used for rescue teams to protect injured or ill people in places such as the scene of an acciden
transportation, and at first-aid stations.

Blankets of appropriate size, material, and configuration for infant use.


Tubing designed for administration of blood products (e.g., transfusion). The tubing is typically constr
incorporates accessories such a roller clamps, filters, spike (e.g., single or double) necessary for trans

Prepackaged collections of the devices and supplies (either custom or standard kits) needed for obtain
patient's blood for microbiological culture. Items in these kits usually include a blood collector, a steril
needles, a needle holder, a specimen transport bag, and alcohol prep pads. The kits are frequently su
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. These
trays are intended for in-vitro detection of infections present in the bloodstream (e.g., bacteremia, sep
procedure kits and trays are used in medical offices, hospitals (e.g., clinical laboratories), and/or in oth

Blood-flow detectors that use ultrasonic techniques (e.g., Doppler effect) to determine the extent of p
blood flow restrictions (e.g., clots, stenosis). These devices typically consist of a radio-frequency unit w
transducer probe; and an audio or visual indicator. Ultrasonic blood flow detectors can sense transcuta
all vessels outside the skull and thorax (i.e., vessels not blocked by bone or air); they are used in the a
atherosclerosis, varicose veins, and venous thrombosis; and also in the diagnosis of the vascular state

Flowmeters designed to measure the rate and the volume of blood flow through a particular organ (e.
or vessel of the circulatory system. Most blood flowmeters measure blood flow transcutaneously in all
blocked by bone or air (i.e., outside the skull or thorax). Some instruments have probes that are place
vessel during surgical procedures; other probes are threaded through a catheter to measure blood flow
vessel. Dedicated electronic blood flowmeters are available using a variety of techniques, including el
ultrasound, and laser devices; some external instruments using ultrasonic and near infrared spectogra
invasive blood flow measurements inside the cranium (i.e., transcranial flowmeters). Blood flowmeters
applications such as the assessment of air embolism, atherosclerosis, varicose veins, and venous thro
used to measure blood flow after coronary artery bypass, organ transplant, and other vascular recons

Blood flowmeters designed for invasive measurement of blood flow electromagnetically. These device
principle that when an electrical conductor moves through a magnetic field a voltage is induced on th
flowmeters blood is the moving electric conductor, a catheter (placed in or around a blood vessel) wit
provides the magnetic field, and electrodes are used to detect the induced voltage in the blood. The t
an electromagnet powered by an external power source and a C-shaped lumen (i.e., cuff) probe and a
electromagnetic probes at their tips that are introduced into the vessels for intravascular instruments.
flowmeters mainly are intended to measure and facilitate the blood flow in vessels after coronary arte
transplant, and other vascular reconstructive surgery.
Blood flowmeters designed to measure blood flow using ultrasound frequency (typically several mega
continuously or in pulses (using the Doppler effect). These flowmeters typically consist of a radiofrequ
cables, a probe with ultrasound transducers, controls, and a display and have computerized capabilitie
instruments that use pulsed ultrasound waves, the wave reflected by the blood is sent back to the me
and the frequency shift is a measure of the blood flow velocity (Doppler effect); instruments that use c
include two separate crystals: one to create and deliver ultrasound waves and the second to detect th
wave. Dedicated ultrasound blood flowmeters are available to perform noninvasive measurements (us
against the skin close to the target vessel) that may include vessels inside the cranium (i.e., transcran
invasive measurements (using a very tiny probe placed in direct contact with the vessel); or minimally
measurement (a ring-shaped probe placed at the tip of a catheter is introduced into the vessel). Instru
sensor clamp to measure blood flow in external tubing during cardiopulmonary bypass and/or other pr
vivo external processing of blood are also available. Clinical applications include diagnosis and/or trea
atherosclerosis, postphlebitic syndrome, varicose veins, or venous thrombosis. Some devices can also
ventricular function at rest or during exercise by measuring flow through the aortic arch.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for o
sample intended for in-vitro determination of blood gases. Items in these kits usually include a sample
needle with needle protector, a syringe, a protective cap, gauze, alcohol pads, and a specimen bag. T
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Blood gas sampling procedure kits and trays are intended for puncturing an artery with a needle and s
amount of blood in order to determine the most important blood gases (i.e., the partial pressure of car
oxygen); frequently the bicarbonate level and pH are also determined. They are used mainly in clinica
hospitals, and other healthcare facilities.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for o
for in-vitro tests. Items in these kits usually include a hypodermic syringe, needles, needle holders, glo
pads, a rubber stopper, alcohol, test tubes, and labels. The kits are frequently supplied in supporting t
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Blood sampling procedu
intended for obtaining samples for in-vitro diagnostic or monitoring the levels of blood components. T
hospitals, clinical laboratories, and in other healthcare facilities.

Warming units designed for in-line heating of banked blood, blood products, and intravenous (IV) solut
degrees Celsius to near body temperature (e.g., 35 to 37 degrees Celsius) before infusion. These unit
disposable bag or coil of tubing and a heat exchanger (e.g., dry heat, radio-frequency, circulating fluid
units include temperature controls and/or alarms. Usually, the blood or solution is warmed as it passe
tubing that is exposed to the heat exchanger. Blood/solution warming units are typically mounted on
infusion bag and the patient's venous line; they are used to minimize adverse thermal reactions in the
are also used to heat irrigation solutions for use in arthroscopy, laparoscopy, and other procedures.
Cutters designed to penetrate with a sharp edge or to separate in two parts bones. These devices typ
manual, non-powered, metallic instrument with one or more sharp edges; some bone cutters include t
two short handles working on a pivot resembling forceps or cutting pliers. Bone cutters are mainly use
surgical procedures and in oral surgery.
Drivers designed for delivering staples into bones. These drivers typically consist of handheld devices
simple metallic devices acting as mechanical holders; other drivers consist of a mechanism that includ
staple holding, an extension rod for staple delivery, and a sliding piece for hammering the staple to its

Substances designed to control bleeding from cut or damaged bone surfaces by acting as a mechanic
is typically used during surgical procedures or in treating traumatic injuries.
Undergarments designed to be worn to support the weight of women's breasts. They are constructed
chest band that wraps around the woman's torso and two fabric cups to hold the breasts. Brassieres ty
shoulder straps; some are made without straps. Some brassieres include flexible underwires inserted
cups to add support. The brassieres are typically fastened by a hook-and-eye closure in either the fron
at the back of the bra. Bras intended for use during sleep or during athletic activities typically do not h
pulled on over the head and breasts. Bras designed to be worn without removal by a mother while bre
and support the breasts post-surgery, are also available.

Brassieres designed to be worn by women during pregnancy and by lactating women post-pregnancy
(or nursing) their infants. Maternity brassieres are designed to be stretchy, typically include wide strap
and extra hooks and eyes on the band to allow size adjustments. They are constructed of an elasticize
that wraps around the woman's torso, two fabric cups to hold the breasts, and typically, two shoulder
brassieres are strapless and some include convertible straps that can either be removed or used as ha
style across the back. Some include flexible underwires inserted at the bottom of the cups to add supp
brassieres are typically fastened by a hook-and-eye closure in either the front between the cups or at
Some have no fasteners and can be put on or removed by pulling over the head. Maternity brassieres
women are designed to facilitate breastfeeding without the need to remove the brassiere. These brass
flaps that can be opened easily with one hand and can be pulled aside to allow easy access to the nip
once breastfeeding is complete, the flap or cup can be replaced and held closed with a simple clasp o
brassieres worn by lactating women might include removable, absorbent, replaceable nursing pads to
lactation.

Brassieres designed to be worn continuously to protect and stabilize breasts, and to protect and secur
stitches, and drains, during the post-surgical healing period. Surgical procedures might include breast
breast implants, mastectomy, or breast reconstruction. Post-surgical bras are constructed of an elastic
that wraps around the woman's torso, two cups to hold the breasts, and two shoulder straps. They are
a hook-and-eye closure in either the front between the cups or at the back of the bra on adjustable ba
surgical bras are designed to provide compression all around the torso for women with chest or breast
mastectomy bras include pockets in the cups into which external breast prostheses can be placed.
Binders designed to encircle the thorax to provide support and keep the women patient's breasts in th
These devices are usually made of wide pieces of elastic fabric with hook-and-loop closures (e.g., Velc
with small teeth that grab onto and secure the elastic fabric for adjustment of the size of the binders;
available in several sizes. Breast binders are used to support and compress the breasts and/or other a
structures for rehabilitation after surgery (e.g., cardiothoracic surgery); they may also provide relief fr

Aspirators designed to obtain milk from the breast of breastfeeding mothers by means of vacuum suc
consist of an electric (battery- or line-powered) vacuum pump with a low flow rate, a cone-shaped cup
and a milk collection container. Manual breast aspirators with a pump that includes a handle, lever, or
also available.
Disposable, elastomeric reservoir sacs that store breathing gas during the respiratory cycle. Breathing
implemented on the inspiratory or expiratory limb of a breathing circuit depending on the breathing c
Breathing bags may also act as maximum pressure limiting devices during spontaneous or manually a

Respiratory tract endoscopes designed to view the interior of the respiratory tract, particularly the tra
the lungs for therapeutic or diagnostic purposes. These endoscopes usually consist of an outer sheath
and a working channel for catheters and operative devices; these endoscopes may be flexible or rigid
bronchoscopes (with operating channels) may be used to perform biopsies and laser surgery, remove
aspirate fluids, and administer diagnostic agents or therapy using devices such as lasers, electrosurgi
instruments. These endoscopes may be flexible or rigid.

Devices consisting of a handle and bristles, fibers, or spines that are usually mounted along a single p
or radiate from a central shaft. The shaft handle may be flexible or rigid, and the bristles may be soft
brushes are designed to be used to clean a surface, to gather tissue samples (i.e., cytology), for surgic
personal hygiene, or to apply materials to a surface or tissue. Most brushes are designed as manual, h
however, some brushes are designed to be used with a powered handpiece (e.g., attached to the revo
the handpiece).

Instrument cleaning brushes designed to remove debris from burs. These brushes typically include sti
stainless steel) bristles that are mounted in several layers along a single plane on a rigid handle or rad
shaft for proper manipulation. Bur cleaning brushes can also be used to clean bone rasps and files an
serrations.
Cleaning brushes designed to remove debris from dentures. These brushes typically include a set of s
are mounted at the distal end of a rigid handle resembling a toothbrush; however, denture brushes ar
bristles are angled specifically to fit the shape of a denture. Denture cleaning brushes are used for per
daily) cleaning of dentures, typically over a bowl of water or a folded towel after dentures are remove
Dedicated denture brushes (i.e., clasp brushes) are available to remove plaque from the inside surface

Dental brushes designed to remove deposits from the tissue surrounding the teeth (i.e., gingival tissu
prophylaxis and/or restorative procedures. These brushes typically include a set of soft bristles or othe
the distal tip and a handle for proper manipulation. Gingival brushes are also used for massaging the

Cleaning brushes designed for personal scrubbing of the hands, including the fingers (especially the n
before surgical or other healthcare procedures for which a high degree of personal hygiene is required
typically include a strong, flat handle covered with stiff bristles or spines on the underside.
Detectors designed to discover air bubbles (e.g., gas embolus, typically of 0.5 ml or larger), micro bub
microliter), and/or foam in extracorporeal perfusion lines and/or devices intended to deliver blood and
into the vascular system. These devices usually detect the gas embolus using photoelectric or ultraso
frequently trigger alarms and activate automated mechanisms to stop the infusion. Air bubble/foam d
mainly in equipment designed to provide temporary total or partial external circulation for therapeutic
(e.g., heart-lung bypass, hemodialysis and apheresis units).

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
treatment. Items in these kits usually include burn ointments and sterile sheets, towels, gloves, banda
appropriate for burn treatment. The kits are frequently supplied in supporting trays (i.e., procedure tra
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Burn emergency procedure kits and trays are in
procedures for the initial treatment of thermal, friction, electrical, and chemical burns. They are used i
emergency rooms, and in other healthcare facilities.

Small instruments designed to be held and rotated by a device (e.g., handpiece, drilling machine) to e
reshape, and/or excise objects, tissue, or other anatomic parts. These instruments typically consist of
other hard metal with a well-differentiated working head of various shapes (e.g., cone, cylinder, invert
distal end; a tapered, notched, or elongated proximal end to fit into the rotary device; and a neck that
the working part. Dedicated burs are used in a variety of dental and surgical (e.g., orthopedic, ophtha
procedures.

Bone surgical burs designed to excavate the cranium and adjacent areas, frequently to open holes in
burs typically consist of a shank made of steel or tungsten carbide with a well-differentiated working h
sizes and shapes (e.g., round, cylinder, inverted cone) on the distal end; a tapered, notched, or elonga
into the rotary device; and a neck that connects the shank to the working part. Cranial burs are used m
procedures (e.g., craniotomies) involving the brain; they are usually intended for reuse after sterilizati

Burs designed to be held and rotated by a dental handpiece (manual, electrical, or pneumatic powere
and/or dental restorations. These burs typically consist of a shank made of tungsten carbide or, less fr
well-differentiated working head (sometimes with bound diamond chips or covered with diamond film)
and shapes (e.g., round, cylinder, inverted cone, pear, end/side cutting) on the distal end; a tapered, n
proximal end to fit into the rotary device; and a neck that connects the shank to the working part. Ded
available for many different uses, including removal of carious material from teeth, dental cavity prep
and polishing of teeth and restorations (e.g., porcelain, metal). They are usually intended for reuse af
disposable (single use) burs (e.g., diamond burs) are also available.
Furniture consisting of enclosed repositories typically with doors and that may include shelves, drawer
compartments. This furniture is available in free-standing, wall-mounted, wall-recessed, and under- or
mounted configurations. Cabinets may include small (e.g., one- or two-inch diameter) wheels to facilit
and/or some means for control of the internal temperature, air circulation, and/or humidity (e.g., desic
used in healthcare facilities to display and store medical devices, drugs, and utensils and to facilitate
medical and/or associated treatments and/or procedures (e.g., anesthesia, endoscopy, laboratory) but
treatments inside the enclosure. Cabinets are also used to store food, chemicals, ancillary material, s
miscellaneous materials; some other cabinets are intended to file documents such as medical and/or a
and cards.

Cabinets designed to store, display, and provide ready access to small equipment, instruments, and m
administration of anesthetics. These cabinets are usually constructed using materials that avoid build
charges (typically metals such as stainless steel). They typically consist of a stand-alone multiple draw
cabinet with an appropriate working top for placement of anesthetics, instruments, vials, or other sma
cabinets include lockers, intravenous poles, oxygen holders, and electrical outlets.

Cabinets designed to store patient daily-use utensils and/or other products or devices (e.g., telephone
units) needed for short- or long-term patient care that are usually placed close to the patient bed. This
consists of metallic or wooden closed cabinet with drawers, shelves, and doors or, less frequently, of o
shelves and one or more drawers. Bedside cabinets are used in homes, hospitals, and other healthcar
available either as separate units or combined with other furniture (e.g., bed, chairs, bookcases) that
and/or style conforming to a patient room furniture set.

Cabinets designed to store, display, and provide ready access to dental instruments, devices, and ma
anesthetics, cement) during dental treatments; they also have a working surface (e.g., the top of the
include a sink intended to facilitate the dental procedure. This furniture typically consists of a stand-a
multiple drawer, shelf, or shelf/drawer cabinet, they may have hinged or sliding (either glass or solid)
may have attachments for handpieces, a high volume evacuator, and a saliva ejector; some also inclu
outlets, security locks, and/or small wheels for easy movement. They are used in dental clinics and offi
performance of dental procedures, including oral surgery.

Cabinets designed for organized storage and display of surgical instruments; they may also store sma
supplies. This furniture typically consists of multiple drawers, shelf, or drawer/shelf closed cabinet; som
compartments for materials. Instrument-storage cabinets are available in multiple configurations (e.g.
mounted), the cabinets usually include sliding or hinged glass or stainless steel doors; some also inclu
are typically manufactured using stainless steel to avoid corrosion and permit ease of cleaning and ste
cabinets are mostly used in operating and procedure rooms, including dental and ophthalmologic clini

Cabinets designed to store medicines and other disposable products of frequent use in healthcare (e.g
dressing). These cabinets are usually constructed of metals (e.g., stainless steel), plastics, wood, or co
materials. They frequently consist of stand-alone or wall-mounted units (either recessed or surface mo
shelves; many medicine cabinets include a swing door externally covered with a mirror. Some cabinet
surface appropriate for medicine preparation. Medicine cabinets are used in many different locations,
stations in healthcare facilities, nursing centers, and homes.
Medicine cabinets designed to store narcotics and other controlled medicines under strict security req
cabinets usually consist of a sturdy wall-mounted (either recessed or surface mounted) metallic unit w
door/double-lock or single-door/double-lock combination; less frequently, they are manufactured as st
Narcotics control cabinets are used to ensure that only authorized personnel have access to controlled

Cabinets with the interior walls lined with ultraviolet lamps to allow full body exposure with even distr
radiation for the treatment of dermatological disorders.
Warming units designed in multiple configurations and including a wide variety of accessories accordi
devices, materials, or solutions to be heated. These units typically consist of a cabinet with appropria
system (e.g., electric resistor, steam tubes), temperature controls, and overheat alarms. Multipurpose
be used to warm solutions (e.g., peritoneal dialysate, irrigation solutions), bedpans, and blankets; the
other heating needs in the hospital, such as in surgery, obstetrics, and emergency rooms.

Enclosed pass-throughs designed to exchange x-ray film cassettes to and from the darkroom without
These pass-throughs typically consist of metallic structures with a lead linen to provide x-ray shielding
wall mounted and include automated interlocks that close one door when the opposite is opened. X-ra
throughs are also used for temporary storage of loaded cassettes isolated from the radiation source.

Instruments designed for the accurate measurement of the diameter or thickness of an object or, less
distance between two points on a plane. These instruments are typically metallic, compasslike, handh
two adjustable, frequently curved, hinged legs or jaws; some instruments display the results of measu
(e.g., mechanical scales) or digital (electronic) displays. Metallic and/or rigid plastic calipers are availa
frame with a linear scale along its longer arm and a second L-shaped sliding arm with an auxiliary gra
facilitate fine adjustment and to increase the accuracy of measurement (i.e., vernier calipers). Dedica
intended mainly to measure organ and/or tissue (e.g., bones, eyes, skin) diameters and/or thicknesse
to determine length and distances on graphic recordings (e.g., electrocardiograms).

Skinfold calipers designed to assess body fat in subcutaneous adipose tissue by measuring the thickn
gathered at various areas of the body by mechanical means. These instruments are typically manuall
metallic, and/or rigid plastic calipers with an L-shaped frame with a linear scale along its longer arm a
sliding arm that may include an auxiliary graduated scale to facilitate fine adjustment and increase th
measurement (i.e., vernier calipers); the long L-shaped arm is usually spring-loaded to ensure even pr
conformed for easy grasping by the operator. Devices with other shapes are also available. Some calip
graduated scales (gauges) to facilitate reading. Skinfold calipers are used mainly to measure the skinf
aspect of the upper arm; measurements are also frequently performed on the thighs or back or over t

Caloric stimulators that apply a stream of air or water to the ear canal. Vestibular function stimulators
system that includes a pump, valves, heaters, and regulators to control the rate of flow and temperatu
stimulation of the semicircular canal produces involuntary eye movements, which are measured using
These stimulators are used for vestibular function testing in assessing the patient's balance system.
Devices designed to capture and record images. There are a variety of cameras according to the chara
images to be captured and/or the technical characteristics of the device; they include photographic ca
obtain still images and/or a limited sequence of images, video cameras intended to get a set of image
that can be retrieved in video displays and/or recorded; cine cameras that takes a series of images on
retrieved using a movie projector; and gamma cameras that can obtain a physiologic image of the dis
ray-emitting radioisotopes within the human body after the injection or ingestion of a radiopharmaceu
photographic, cine, and video cameras intended for particular (e.g., surgery, microscope, endoscope,
dental) applications are also available.

Ophthalmic photographic cameras designed to take still images of the ocular fundus and associated b
fundus oculi) of the eye. These devices typically consist of dedicated high-resolution photographic (eit
cameras that may include specific controls to facilitate the operation and image devices for observatio
attached to a low-power microscope. Fundus cameras are frequently intended for observation of the o
administration of pupil dilatation drugs (known as mydriatic cameras); cameras that provide images w
(i.e., nonmydiatric cameras), or for both conditions are also available. The cameras are used for scree
checking treatment progress in patients suffering or at risk of retinopathy (e.g., macular degeneration

Photographic cameras designed to take pictures of an oscilloscope screen. These cameras are usually
need special, rapid response films (e.g., instant films); the camera is typically attached to the oscillosc
handheld device. Oscilloscope cameras are used to record a permanent copy of oscilloscope images.

Assistive devices using a single shaft designed to aid the user while walking by providing additional su
usually consist of a straight shaft including a handle at the proximal end and a rubber tip at the distal
typically made of sturdy materials such as wood (e.g., walnut), light metals (e.g., aluminum), plastics
fiberglass, or a combination of these. Most patients use only a single cane but a few may use two can
dedicated canes with a variety of handles and/or special characteristics (e.g., spring-loaded tips) are a
base canes have several (e.g., three or four) distal tips to improve floor contact. Also available are can
visually impaired. Frequently having a white shaft and/or red tips, these canes are intended to guide v
and alert others to that impairment.

Short, hollow cylinders or tubes for insertion into a canal, vessel, passageway, body cavity, or duct. Ca
of a small-length rigid or semirigid plastic or metal tube, a handle, and a valve. The valve regulates th
cavity. Most cannulae are fitted with a trocar or stylet during insertion. After insertion, the trocar is wit
rigid or semirigid structure that can be connected to an external tube, catheter, or connector for the in
of substances. Cannulae may also provide a port through which diagnostic or surgical instruments are
to and operate on internal structures. They can be used in a great variety of therapeutic and diagnost

Cannulae for insertion into an artery (usually the coronary, radial, or femoral artery) for procedures su
pressure monitoring, blood analysis, arterial infusion/aspiration, or perfusion during cardiopulmonary b
extracorporeal membrane oxygenation. They are also typically interfaced with an arterial catheter, wh
interfaced with oscilloscopes for continuous measurement of arterial blood pressure.
Cannulae designed for use with a surgical aspirator in multiple procedures, including general and plas
cannulae typically consist of a plastic or metal tube attached to the surgical aspirator that is manipula
during the procedure; some cannulae are attached to a dedicated handpiece that may also be used w
instruments. Surgical aspirating cannulae are intended for evacuation of liquid and debris; they are al
irrigation of the surgical area. Dedicated cannulae intended for particular procedures (e.g., bronchial,
liposuction, thoracentesis), that are typically used attached to specifically designed aspirators, are als

Cannulae designed to be inserted into the cranium, providing access to the brain (e.g., for a therapeu
procedure). These cannulae are typically short, rigid or semirigid, plastic, or less frequently, metallic t
cannulae are frequently connected directly or via an external tube or catheter to an irrigator and/or as
infusion, or withdrawal of substances. Intracranial cannulae may also provide a port through which ins
probes are passed to perform a variety of diagnostic, treatment, or surgical procedures.

Arterial cannulae that are inserted into the coronary artery to administer solutions during cardiac surg
as administration of cardioplegic solutions during bypass surgery. They are also used in diagnostic pro
coronary arteriography. They are typically interfaced with a coronary artery infusion catheter or a coro
catheter, depending on the procedure.
Cannulae that are inserted into the outer ear canal to provide a channel for suction or irrigation or the
device.
Cannulae that are placed in the epidural space, usually to deliver drugs for pain management.
Cannulae used to drain the eye of fluid or to aspirate the eye during ophthalmologic procedures.
Eye cannulae or handpieces used to create a channel between the anterior chamber of the eye and th
space in the treatment of glaucoma.
Devices used to extract the cortex lentis, or softer, external part of the lens of the eye. Additionally, t
remove certain fluids from the eye during an ophthalmologic procedure.
Cannulae designed specifically for insertion into a femoral artery or a femoral vein. They are typically
of a continuous invasive monitoring set-up/system; there are also specifically designed femoral cannu
procedures such as cardiac surgery, e.g., as a component in a circulatory support set-up/system.

Nasal cannulae designed to be inserted into the nostrils until the distal tip reaches one of the nasal sin
are typically short, rigid or semirigid, plastic or, less frequently, metal tubes that may include a stylet
of cannula and stylet is known as a trocar) that is usually removed after insertion; they are frequently
via an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal o
sinus cannulae may also provide a port through which instruments and/or probes are passed to perfor
diagnostic, treatment, or surgical procedures.

Cannulae designed to be inserted into the uterus. These cannulae are typically short rigid or semirigid
frequently, metallic tubes; they are frequently connected directly or via an external tube or catheter t
aspirator for irrigation, infusion, or withdrawal of substances. Intrauterine cannulae may also provide a
instruments and/or probes are passed to perform a variety of gynecologic/obstetric diagnostic, therap
procedures.

Cannulae designed for insertion into the superior or inferior vena cava.
Laboratory breath analyzers used to determine the carbon dioxide (CO2) content in a breath sample.
typically use chemical titration, infrared spectroscopy, gas chromatography, or mass spectrometry. CO
to aid in determining the patient's ventilatory, circulatory, and metabolic status.
Prepackaged collections of the devices and supplies (either custom or standard) needed for the insert
catheter through the vasculature (usually from the groin or the arm) into the right or left side of the h
kits usually include a basin, a catheter, a syringe prefilled with sterile water, waterproof underpads, a
absorbent rayon or cotton balls, a lubricant packet, sterile gloves, a cleansing solution, a removable p
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure; th
covered or wrapped. Cardiac catheterization procedure kits and trays are intended for diagnosis or th
conditions. They are used in cardiac catheterization rooms and other areas in hospitals and other heal

Boards designed to be placed under a patient to offer back support to chest compression applied duri
resuscitation. These boards are typically kept attached to or near beds and stretchers for use during s
cardiac arrest.
Instruments designed to measure the volume and flow rate of blood pumped by the heart. The measu
displayed on the device in terms of liters and liters per minute respectively. These instruments typical
computerized unit, generators (e.g., radiofrequency, ultrasound), controls, a display, and appropriate
is a vital indicator of overall cardiac status and the quality of tissue perfusion. There are several meth
cardiac output, including thermal, impedance, radioisotope, dye dilution, and ultrasonic techniques.

Cardiac output units that measure blood volume and flow rate from the heart based on the Fick's law
Fick method is based on an assumed value of body oxygen consumption rather than a real measurem
measurement of cardiac output processes the measurements of oxygen consumption, venous blood o
blood oxygen; a computer unit (or a standard computer) using an algorithm calculates the approximat
output as the quotient of total body oxygen consumption divided by the difference in oxygen content
mixed venous blood. This technique is currently used infrequently to measure cardiac output.

Cardiac output units that measure blood flow from the heart using the indicator dilution technique in w
cold water) is injected upstream of the heart and monitored on the downstream side. These devices in
(flow directed) catheter with a temperature probe (e.g., a thermistor) that is placed in the right side of
the output flow temperature and an electronic unit that processes the signal from the thermistor and d
dilution curve from which cardiac output and other hemodynamic parameters such as stroke volume c

Washers designed for automatic removal of dirt and/or stains (i.e., washing) from hospital carts (also k
These washers typically consist of a stainless steel cabinet with front (i.e., roll-in/roll-out models) or fro
that permit pass-through of carts (i.e., tunnel type); a control panel; and appropriate pumps and other
perform the washing cycle. Cart-cleaning washers perform a cycle of operations typically including wa
treatment, detergent washing, and heated rinse. The process may include mechanical removal of con
and/or water jets (some devices including mechanical removal of contaminants are considered washe
units). Some washers include drying capabilities. Full-size washers with a high throughput (e.g., 12 ca
portable, low-capacity, cart washers are also available.
Mobile equipment designed for transportation, storage, organization, and distribution (supply) of a var
materials, and devices. Carts typically consist of either an open or closed (cabinet-like) structure that
drawers, boxes, and/or compartments. They are mounted on medium or large (usually at least 7.5 cm
facilitate their mobility through the healthcare facility. The configuration, size, strength, and materials
the carts (e.g., solid metal, wire, hard plastic) should be appropriate for the intended use; carts are us
but electrically (battery) operated carts are also available. _x000D_
Most carts are used in healthcare facilities for the storage and transport of medical devices, drugs, ute
central location (e.g., central supply) to the area of use or are used inside a department or area of the
used to facilitate the performance of medical treatments and/or associated procedures (e.g., anesthes
endoscopy) and for the general transport of chemicals, ancillary devices, and miscellaneous materials
used for the filing and transport of documents such as medical and/or administrative records and card
intended for use in magnetic resonance imaging (MRI) environments are also available. Mobile cabine
small wheels (typically a diameter of 5 cm/2 in or less) intended to facilitate their location inside a roo
carts.

Carts designed for organized storage, transport, and to facilitate the use of instruments, anesthetics,
during anesthesia procedures. These carts are usually constructed using materials that avoid build-up
charges (typically metals such as stainless steel). They usually include a multiple drawer or shelf/draw
structure, with an appropriate working top for placement of anesthetics, instruments, vials, or other sm
carts include lockers, intravenous poles, oxygen holders, and electrical outlets. Anesthetic carts are us
room during surgical procedures involving anesthesia; they include appropriate swivel casters (e.g., 3
easy displacement.

Carts designed for organized storage, display, and easy access of surgical instruments and supplies; t
manufactured using stainless steel to avoid corrosion and permit ease of cleaning and sterilization. Th
either an open shelf or an enclosed cabinet-like structure; enclosed carts may have multiple drawers o
and sliding or hinged glass or stainless steel doors. Some carts also include security locks and/or spec
materials. Surgical instrument carts are mostly used in operating and procedure rooms, including den
clinics and offices.

Carts designed for organized storage of germicidal solutions, cloth (e.g., gowns, gloves), and/or other
used in areas where patient isolation procedures are performed. They also include containers for cont
trash. These carts typically consist of closed, cabinet-like structures with drawers that are painted in b
yellow) to alert patients, visitors, and personnel that isolation procedures are under way. They typicall
(at least 3 inch/7.5 cm) casters. Isolation procedure carts frequently include trash containers, hampers

Central supply carts designed for distribution of medicines and other supplies, such as cups and syring
location such as the clinical pharmacy or a nurse station to the patient room. Typically the carts are lo
location with the required medicines and other supplies properly labeled. Medicines carts are available
configurations and sizes. Medication carts are used to improve the accuracy and speed of medicine di
unit-dose and computerized medication carts are also available

Central supply carts designed for organized storage and transport of instruments, and materials used
procedures from a central location to emergency rooms and orthopedic treatment areas. These carts t
multiple drawer, shelf, or shelf/drawer cart; they usually have sliding doors, swivel casters with a whe
10 cm (4 inch).
Carts designed for organized storage, transport, and to facilitate the use of instruments, drugs, and su
cardiopulmonary resuscitation (CPR) procedures. These carts are usually constructed using hard, dura
typically have swivel casters of at least 12.5 cm (5 inches) wheel diameter and soft perimeter bumper
of impacts. The carts typically include a multiple drawer cabinet-like structure, with an appropriate wo
placement of drugs, instruments, vials, or other small devices. Resuscitation carts are pre-stocked wit
needed for CPR, including a defibrillator/monitor, a pulmonary resuscitator, an oxygen tank, a backboa
and other supplies and drugs. Resuscitation carts are used by emergency teams performing CPR when
arrest occurs.

Carts designed for organized storage, transport, and easy access of mechanical set-ups used in orthop
treatments. These carts usually consist of sturdy structures to facilitate handling of heavy cast iron w
bars, and other accessories typically used in combination with traction tables and/or stands. Some car
enclosure appropriate for devices and other supplies used by orthopedic technicians. Orthopedic tract
orthopedic departments to transport heavy devices from and to traction tables and/or stands.

Vacuum cleaners designed to collect and filter out the dust and debris created by cast cutters (i.e., pn
cast saws) during cast removal. These devices typically consist of a dedicated portable vacuum cleane
vacuum pump, filters, and bags or cartridges for dust collection. Cast cutter vacuum cleaners are avai
units but are more frequently offered as an accessory or integral part of cast cutters.

Materials (e.g., plastic, fiberglass, plaster) used to construct a stiff, solid dressing (cast) for immobiliza
diseased joints, painful sprains, and other injuries.
Boots intended to be worn by patients who are using plaster or fiberglass casts or orthopedic walking
protection boots are designed to be worn over casts to protect them from water and other contaminan
bathing and/or showering, or outdoors in various weather conditions. They are waterproof, made of ab
and designed to be easily applied by the patient. They are usually made of a specialized membrane th
breathable; some are also latex-free; they come in various sizes, from ankle-high to over-the-knee-hig
They can be adjusted to fit over any size foot and cast with adjustable straps, zippers, and/or elasticiz
weatherproof cast protection boots are designed with a pump and a vacuum seal and with a tight fit a
the cast. The pump is used to vacuum out all of the air from inside the cast cover; this makes a waterp
the cast from water, sand, and dirt. This type of boot can be worn at the beach, in the ocean, or in swi

Shoes designed to protect a foot embedded in cast. These shoes typically consist of an external cover
conforms to cast contours; they are made of plastic materials, fabric (e.g., canvas), and/or rubber with
(e.g., Velcro) and/or straps. Cast shoes are intended to be worn over the cast, providing a comfortable
both the cast and the foot from dirt, moisture, and shock.
Stockinettes designed to be used under casts or some orthotic devices. These stockinettes are seamle
made of stretch (may be multilayered) cotton with appropriate thickness to provide padding. Cast pad
frequently provided in pre-cut rolls or in individual sterile segments.
Socks or stockings designed to be worn on the toes of the feet of patients who are using open-toe cas
walking boots, or who have a bandaged foot with exposed toes. Cast toe socks are worn in order to ke
warm, and protected. Cast toe socks are usually made of synthetic, washable fibers and can be worn o
sized to fit either an adult's or child's foot and they can be secured with an adjustable strap.

Hard rubber devices designed to be incorporated directly into the sole of a cast to aid the patient in w
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for s
manipulation of catheters. Items in these kits usually include a sterile small plastic tray, a wash cloth,
balls and/or gauze pads, antiseptic solution, sterile gloves, and a plastic disposable bag. The kits are f
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
care procedure kits and trays are intended to prevent the introduction of infectious microorganisms du
check and/or remove catheters; they are also used to take care of reusable catheters (e.g., Foley) in p
in hospitals, homes, and healthcare facilities.

Tubes designed for insertion into canals, vessels, passageways, or body cavities to permit injection or
other substances. Most catheters consist of long, flexible tubes with many different shapes and tip co
perform or permit a great variety of therapeutic (e.g., hemodialysis, urinary drainage) and diagnostic
cardiac, biliary).
Vascular catheters designed to inject contrast media into main and/or branch vessels in the cerebral,
vasculature. These catheters are available in a multitude of tip configurations, from the single-end-ho
pigtail, including numerous side holes. Most of these catheters include tip configurations intended to f
catheter entry into the branch vessels (e.g., visceral, peripheral, cerebral). Angiographic vascular cath
manufactured from a variety of materials (e.g., polyurethane, polyethylene) and usually incorporate ra
markers.

Vascular catheters designed to measure intravascular blood pressure (i.e., invasive blood pressure). T
usually attached to monitors that display the maximum and minimum blood pressure values (i.e., syst
pressures); some of them also display a mean pressure value. Blood pressure vascular catheters are m
the blood pressure in peripheral arteries (e.g., radial artery) in emergencies, surgery, and critically ill p
be used for blood sampling and/or infusion.

Vascular catheters designed for catheterization of small-lumen (typically less than 1 mm) vasculature.
typically consist of 1.5 or 1.8 Fr, soft, usually elastic tubes that are typically flow-directed into the vasc
catheters are directed using a very thin (e.g., 0.25 mm diameter) hydrophilic wire that does not exten
catheter. Microflow vascular catheters are mostly used for endovascular treatment of vascular lesions
system, such as aneurysms, cerebral arteriovenous malformations, tumors, and fistulas.

Rectal catheters designed for administering barium, a contrast medium. These catheters consist of a r
that sometimes also includes a silicone rubber balloon (i.e., retention balloon) tip. Barium enema cath
colonoscopy; catheters including balloons are mostly used in incontinent patients who are extremely d
without use of a balloon tip.
Catheters designed to form a passageway from either of the two small reddish glands (Bartholin's glan
the vaginal orifice to the space where the urethra and the vagina open (vaginal vestibulum). These ca
5 cm) plastic tubes; some catheters include a balloon at the tip to ensure retention within the gland. T
used for drainage in the treatment of Bartholin's gland cysts and abscesses.

Catheters designed for insertion into the biliary tree. These catheters have particular characteristics a
use (e.g., drainage, gallstone extraction, cholangiography, stricturoplasty).
Catheters designed for insertion into the vascular system that are long enough to advance and locate
heart and/or the pulmonary or coronary arteries. These catheters usually include distal tips that may b
proximal ends bonded to hubs or connecting devices. The distal tips can be modified by attaching ball
devices or by placing holes for injection of contrast medium. Vascular catheters may be stiff or flexibl
nonthrombogenic, strong, flexible, and biocompatible, and they must retain their preshaped tip config
memory) while permitting torque control. Most cardiac catheters are made of polymers (e.g., silicone
polyurethane) and may also include metals (e.g., stainless steel). Cardiac catheters are used in thera
valvuloplasty) and diagnostic (e.g., angiography, cardiac output measurement) procedures.

Cardiac catheters that include a small balloon at their distal tip that is carried by the returning venous
through the heart. These catheters are used to facilitate distal tip passage to the desired location wit
cardiac vasculature (e.g., pulmonary artery).
Perfusion vascular catheters designed for transmission of blood to the distal coronary bed. These cath
central lumen, a balloon near the catheter's tip, and side holes proximal to the balloon. Typically, bloo
lumen through the side holes due to native coronary (aortic) pressure and exits beyond the balloon in
artery, bypassing the occlusion. These catheters are used for temporary perfusion of the coronary arte
myocardial infarction.

Vascular catheters designed for removal of clotted blood and/or other formed elements (e.g., calcium
causing vascular obstruction at the point of their formation (thrombus) or brought by the blood from a
forced into a smaller one, thus obstructing the circulation (embolus). These catheters are used for rem
thrombus in native vessels, as well as in artery and hemodialysis access grafts.

Esophageal catheters that include an inflatable balloon near their distal tips. These catheters typically
French plastic tube and a balloon that can be inflated at a larger diameter (e.g., 0.25 inch to 0.60 inch
catheter is usually introduced over a guide wire; when the catheter tip reaches an esophageal strictur
is inflated to a diameter slightly larger than the lumen of the esophagus stricture. Balloon esophageal
used in infants and children to dilate esophageal strictures (e.g., after surgical repair of congenital dis
esophagus).

Spinal catheters used in the space (epidural space) outside the outermost membrane (dura mater) co
the epidural space separates the spinal dura mater from the enclosing vertebrae. These catheters are
special needles, and their distal tip is advanced into the epidural space to the desired spinal segment
spinal catheters may be tunneled, using either an external injection hub or a subcutaneous port for bo
infusion via an external pump; these systems are used for temporary procedures (e.g., surgery, delive
whose life expectancy is very short. Otherwise, the epidural catheters are attached to a subcutaneous
pump for continuous infusion in relatively long-term procedures, such as steroid treatment of inflamm
nerve roots or opioid (e.g., morphine) administration to cancer patients with long life expectancy.

Nasopharyngeal catheters designed to open the tube that connects the middle ear and the nasophary
These catheters usually consist of a curved metal tube. The distal tip of the catheter is passed along t
and turned into the Eustachian tube, and air from an air bag is blown through the catheter, forcing air
Eustachian catheters are used for temporary equalization of the pressure on both sides of the eardrum
cannot open the Eustachian tube physiologically.
Drainage urethral catheters designed for continuous bladder catheterization, often over an extended
purposes of draining urine from the bladder. These catheters typically consist of a dual-lumen, large-c
elastomer (e.g., polyurethane, silicone) tube that includes an inflatable balloon close to its distal tip; a
drainage lumen is attached to an external collection bag. The external tubing also contains a port for
via a syringe). Once in the bladder, the ballon is inflated (e.g., with sterile liquide) to keep the cathete
bladder. The catheter, drainage tube and the collection bag are frequently configured as a closed urin
Self-retained drainage urinary catheters are used for short- and long-term continuous catheterization
traumatic injuries and in patients who are critically ill or suffering severe disability; they may also be u
purposes.

Vascular catheters designed to be inserted into the aorta to augment the heart's pumping capability. T
tipped catheters are available in a variety of volumes; 30.0 to 50.0 cc balloons are common for adult p
20.0 cc are common for pediatric use. These catheters are usually inserted percutaneously into one of
using the Seldinger technique and advanced to the descending thoracic aorta using fluoroscopic imag
balloon has been positioned, an external pump alternately inflates and deflates the balloon in a cycle
cycle (counterpulsation), facilitating ejection during systole and limiting regurgitation during diastole.
catheters are used to provide temporary circulatory support to treat a number of cardiovascular condi
following open-heart surgery, to treat unstable angina, to reduce myocardial problems).

Infusion catheters designed for insertion in percutaneously accessible blood vessels of the extremities
vasculature) and are short in length to keep their distal tip near the insertion site. These catheters typ
cm (1 to 3 inches) plastic tube with a metal stylet inside its lumen (over-the-needle catheters). Periph
are the most commonly used infusion devices for short dwelling time (typically seven days or less) ad
irritating fluids, electrolyte, vitamins, medication, and for the injection of certain anesthetics into the p
of patients with good venous access.

Infusion catheters that are inserted and advanced to locate the distal tip in a central vein, typically th
vena cava. These catheters may be inserted directly into a central vein, using surgical procedures, or
through the peripheral vasculature. Central venous infusion catheters are used when central venous p
are required, when larger volumes of solution must be rapidly administered, or to ensure rapid dilution
high-viscosity fluids (e.g., packed cells), hyperosmolar fluids (e.g., hyperalimentation solutions), or cer
damaging to blood vessels (e.g., cytotoxins, highly acidic or alkaline drugs) must be infused.

Catheters used for insertion through the skin (i.e., percutaneously) into the renal pelvis to gain access
tract. These catheters consist of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube, usu
tip; some include expanding wings on their tips. Urinary nephrostomy catheters are used to perform d
supravesical obstructions and are also used for a variety of procedures involving the upper urinary tra
strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, and ure

Vascular catheters designed for temporary or permanent interruption (occlusion) of the blood flow in v
veins).
Ureteral catheters designed for elimination of areas of narrowing (i.e., strictures) in the ureters, thereb
lumen. These catheters typically consist of a flexible plastic tube with a special tip (e.g., olive tip); 7 F
hydraulic balloons inflated from 12 to 26 Fr are also used.
Vascular catheters mainly designed for the passage of blood through a vascular bed. These catheters
organ protection (e.g., cerebrum, abdominal organs) during total or partial circulatory arrest during so
catheterization procedures (e.g., aortic surgery, carotid angioplasty).
Cardiac catheters designed for the drainage of effusion from the pericardial sac (pericardium); they us
wall, flexible plastic (e.g., polyethylene) tube with a J-shaped distal tip that includes multiple holes in b
concave sides. These catheters are inserted into the pericardium, either over the wire as part of a per
echocardiographic-assisted procedure or after a surgical pericardiotomy (typically a subxiphoid perica
under local anesthesia. After insertion, they are anchored in place and attached to water-seal drainage
Pericardium drainage catheters are used for temporary drainage (e.g., some days or a few weeks) in t
cardiac tamponade; they are also used for irrigation and instillation of drugs (e.g., antibiotics, cytotoxi
pericardium.

Peritoneal catheters designed to infuse a solution (dialysate) into the peritoneal cavity that allows me
water to diffuse from the blood using the peritoneum as the dialyzing membrane. Most of these cathe
silicone and are provided with Dacron cuffs that promote tissue growth inside to seal the catheter, pre
fluid leaks and bacterial penetration. Most of these catheters are percutaneously inserted for both per
conditions, but some permanent catheters require surgical implantation, and other semirigid catheter
one-session dialysis. Peritoneal dialysis catheters are used in manual (continuous ambulatory peritone
automated (continuous cyclic peritoneal dialysis) therapies. These catheters may also be used for intr
chemotherapy (e.g., pancreatic or colorectal cancer) and to eliminate fluid overload in congestive hea

Catheters designed to be introduced into the rectum; some of them are long enough to be advanced a
located in the proximal portion of the colon. These catheters are usually made of rubber or silicone ru
catheters are used for rectal injections; for the purpose of clearing out the bowel; for administration o
media, or food; or for manometric measurements. Some of these catheters are also used in the mana
ileostomy.

Cardiac catheters designed to create septal openings in an infant's heart by passing from the right atr
septum to the left atrium. These catheters are used to allow interatrial blood mixing in infants with tra
vessels.
Central venous hemodialysis catheters that consist of a single-lumen silastic tube that may be used o
hemodialysis systems. These catheters are usually inserted via the external (or, less frequently, the in
the subclavian vein and advanced to the superior vena cava; insertion through the femoral vein to the
less frequently used alternative.
Tracheal catheters designed for periodic aspiration of liquids and/or semisolids from a patient's upper
catheters are flexible (e.g., plastic) tubes, usually 40 to 56 cm (16 to 22 inches) in length and small en
through the endotracheal tube without a large increase in airway resistance. They usually have smoot
configurations and end and side holes. Most include a finger-controlled valve to regulate the suctionin
suction catheters are externally attached through a large-diameter extension tube to the vacuum syst
These catheters are used to remove excessive internal secretions, such as mucus, from the lungs, bro
pharynx.
Suprapubic urinary catheters designed to drain urine from the bladder into an external collection devi
consist of a flexible tube, typically ending in a tightly curled distal tip (i.e., "pigtail"); at the proximal e
is attached to an external collection bag. Suprapubic urinary catheters are mostly used for short- and
catheterization in patients with urethral obstruction or erosion (e.g., patients that are critically ill or wh
disabilities, those requiring postsurgical or traumatic injury treatment).

Pulmonary artery catheters designed to deliver an indicator (e.g., saline or dextrose) solution at a tem
the blood into the heart. These catheters include an exit port for the indicator solution and an electric
resistance varies with the temperature (i.e., a thermistor) at their distal tip. The distal tip is advanced
artery while the exit port remains into the right atrium; when a known volume of solution is rapidly inj
venous blood into the heart, which in turn pumps it into the pulmonary artery. The changes in temper
measured by the thermistor are graphically displayed versus time as a thermal dilution curve, from wh
(L/min) and other hemodynamic parameters are automatically derived by an external unit.

Balloon embolectomy/thrombectomy catheters designed for use in the veins. These catheters usually
distal tip that permits passage through the venous valves, minimizing injury. Venous embolectomy/thr
are used for retrograde extraction of emboli in small- and large-diameter veins (typical catheter diame
especially in the lower limbs, by introduction through the femoral vein.

Vascular catheters designed for umbilical vessel access in neonates during its first two weeks. These c
used in arterial catheterization procedures, but venous catheterization is used sometimes as an altern
vascular catheters provide convenient and reliable access to newborn vasculature. They are mostly us
intensive care units for infusion, blood gas analysis, and pressure monitoring.

Cardiac catheters designed for insertion of occluders (e.g., umbrella, double umbrella, buttons) to clos
septal defects (ASD and VSD, respectively) as well as patent ductus arteriosus (PDA). These catheters
plastic tube with a lumen, typically 7 to 23 French in size, according to the type and size of the occlud
include a delivery cable with a mechanism that allows carrying and releasing of the occluder after ade
Occluder delivery cardiac catheters are used for treatment of PDA, secundum ASD, and, less frequent
percutaneous techniques.

Urinary catheters designed to be introduced into the upper urinary tract through a cystoscope; some c
introduced using a nephroscope. These catheters typically consist of a flexible 3 to 12 Fr radiopaque t
configurations that may include inflatable balloons. Ureteral catheters are used mostly for ureter dilat
obstructions, retrograde urography, brush biopsy, and stone retrieval.

Urinary catheters designed for introduction into the urinary tract through the urethra and usually adva
tip is located in the urinary bladder. These catheters are mostly used for urinary drainage, irrigation, u
contrast injection, hemostasis, to collect reliable urine specimens, for urodynamic evaluation, for radio
cystograms), to assess residual urine, and for drug administration.
Urethral catheters designed to infuse a contrast medium in the bladder. These catheters consist of a fl
tube with one or more openings at the distal tip; some designed for female use include a balloon at th
placed in the bladder and another balloon that remains outside at the proximal end of the urethra. Cy
catheters are used for cystography and/or radiography of the bladder and urethra during micturition v
cystouretography), frequently to delineate abnormalities of structure or function of the bladder and ur
detection of vesicoureteral reflux and stress incontinence.

Catheters designed for introduction into one or more segments of the passage from the kidney to the
urinary tract), including the ureters, bladder, and urethra.
External urinary catheters designed to drain urine from outside the body instead of within the bladder
males. These catheters consist of a plastic condom ending in an open tube that is attached to a drain
connecting tube. The diameter of the condom is chosen to match the diameter of the penis; they may
attached by pressure. External-drainage urinary catheters are mostly used for urinary incontinence m
who can void spontaneously but do not retain urine.

Urethral urinary catheters designed for simultaneous drainage and irrigation of the bladder. These cat
of a triple-lumen plastic (e.g., polyurethane, silicone) tube that includes a balloon close to its distal tip
has a port for balloon inflation and a second port used for irrigation purposes. Drainage/irrigation urin
for the continuous or intermittent irrigation (e.g., after prostatic surgery) and/or drug administration (e
chemotherapy) into the bladder.

Intracranial catheters designed to be introduced into brain cavities that are filled with cerebrospinal flu
catheters are used for external drainage, pressure measurements, and radiographic procedures (ventr
devices allow drainage of CSF from the ventricle or injection of fluid into the ventricle while simultane
intracranial pressure. Ventricular intracranial catheters may also be used for treatment of hydrocepha

Devices designed for measuring and recording the central or peripheral venous pressure, or the differ
and peripheral venous pressure, by means of an indwelling catheter and a pressure manometer.

Laboratory devices that apply centrifugal force to a specimen (e.g., suspended cells in a liquid), causin
according to component density. Centrifuge basic components are an electric motor, a shaft, and a ro
centrifuge head turns. The two most common designs of rotors are fixed angle and horizontal or swin
centrifuges can operate with several interchangeable heads. Centrifugation of body fluids, commercia
of both with other additives is one of several sample preparation steps commonly required in the clini
measuring analytes in a patient sample. The use of basket-style heads and draining-chamber inserts
models allows the continuous introduction of materials to be separated into the centrifuge until the ba
intermittent-flow mode); this mode is used to separate suspensions and emulsions.

High-speed tabletop centrifuges used to determine the ratio of the red cell volume to the whole blood
a decimal, a fraction, or a percentage. These centrifuges usually operate in the range of 10,000 to 25
generate a relative centrifugal force of at least 10,000 gravities to efficiently pack cells in a short time
Microhematocrit centrifuges require a smaller sample size than the sample used in low-speed convent
(macrohematocrit method). The hematocrit hematological test is used in diagnosing blood loss and a
including erythrocyte count above or below normal.
Centrifuges designed to be mounted on a tabletop or bench and to process a small volume of specime
in a small number of test tubes. These centrifuges are typically compact, stationary structures and co
motor, a shaft, and speed and time controls; they also include a rotor on which one of several intercha
mounted. The rotor head includes slots into which tubes, cups, flasks, microplates, test tubes, and/or
can be fitted. The two most common rotor designs are fixed angle and swinging bucket (also known as
mounted centrifuges working at low speed (usually up to 10,000 rpm) and high speed (typically from
and ultracentrifuges with a speed usually between 30,000 and 120,000 rpm are available; some mode
capabilities to keep the rotor chamber cool. Tabletop centrifuges are used mainly in the clinical labora
procedures such as centrifugation of body fluids, reagents, or mixtures of both in preparation for analy
equipment.

Furniture consisting of a single seat with a back and with or without arms, specially designed for patie
examination, treatment, rehabilitation). Chairs are usually movable. Note: In definitions commonly f
chair is a seat with a back that may include arms or not, and a stool is a seat without a back or arms;
practice in medical furniture literature to use "chair" when the furniture is designed for patient use an
furniture typically used by the health personnel (physicians, nurses, dentists, etc.), regardless of whet
or arms. This convention is used in the stool and chair terms.

Chairs with back and side rests that provide support to impaired persons or patients with balance prob
bath. Bath chairs must permit easy drainage and full accessibility to all body surfaces. These chairs a
rustproof metals and/or plastic materials. Most of these chairs include nonslip legs that level on the su
some that are attached to a manual or powered lift to move the chair into a tub of water and back out

Chairs made of easy cleaning materials, with an adjustable arm board (usually, lateral and height adju
so the patient arm can be positioned in a location that is easily accessible for blood drawing and ensu
for venipuncture. These chairs may include a tray and/or a storage shelf or drawer.

Rehabilitation chairs designed to help cardiac patients assume a posture that assists in their rehabilita
These chairs typically have special characteristics (e.g., headrest, height adjustment, back and arm po
that facilitate rapid patient positioning in the appropriate posture; they may also be designed to facilit
monitoring. The chairs may be mechanically or electrically adjustable. Some chairs also permit limited
and/or include a table for patient use (e.g., dining, writing). Cardiac rehabilitation chairs are widely us
settings as well as for short-term and long-term rehabilitation; they are intended for patients with chro
who may benefit from being out of bed, such as those suffering from congestive heart failure.

Examination/treatment chairs designed to facilitate dental examination, treatment, and/or minor surg
chairs are typically adjustable up to a height that allows the healthcare staff to perform procedures wh
chairs usually include head- and armrests, a reclining back that may be tilted from a vertical to a horiz
horizontal position, and rotating capabilities to facilitate examination and/or treatment. The chairs ma
operated or hydraulic or electrically powered; some chairs can be programmed for several standard p
examination and/or treatment devices (e.g., lights, irrigation) may be partially or completely attached
components of the chair or may stand separately as self-supported, wall-mounted, or ceiling-suspende
delivery units); dental delivery systems including a suspended patient chair are also available.
Examination/treatment chairs designed to facilitate ear, nose, throat (i.e., ENT, otorhinolaryngology) e
and/or minor surgical procedures. These chairs are typically adjustable to a height that allows the hea
procedures while standing; the chair usually includes head- and armrests, a reclining back that may b
to a horizontal or near-horizontal position, and rotating capabilities (frequently up to 360 degrees) tha
and/or treatment. The chairs may be mechanically operated or hydraulic or electrically powered; some
programmed to several standard positions. ENT examination and/or treatment devices (e.g., otoscope
be partially or completely attached as integral components of the chair or, more frequently, stand sep
supported, wall-mounted, or ceiling-suspended units.

Chairs in which the patient rests on cushions containing air, water, gel, or an other appropriate materi
permeable to air and water vapor but not to liquids. These chairs are designed to treat patients who a
risk of developing decubitus ulcers and whose clinical status requires high head elevation, frequent tr
ambulation.
Chairs for disabled elderly patients, made of easily washable materials and designed with a high back
from upright to several tilted positions, according to patient's needs and comfort. These chairs usually
table (e.g., wraparound, cut-out) for patient use (e.g., dining, writing), a safety belt, and casters for ea
Most chairs also include other accessories or restraints according to the patient's disabilities. Some ge
rocking-motion capability.

Chairs for disabled children, made of easily washable materials and designed with a back that can be
to several tilted positions according to children's needs and comfort. These chairs usually include foo
wraparound, cut-out) for children use (e.g. dining, school work). Some chairs also include other acces
according to children's disabilities.
Examination/treatment chairs designed to facilitate podiatric examination, treatment, and/or minor su
These chairs are typically adjustable in height and include armrests, a reclining back that may be tilte
horizontal or near-horizontal position, and individual leg sections and footrests with lifting and rotating
facilitate examination and treatment. The chairs may be mechanically operated or hydraulic or electri
chairs can be programmed to several standard positions. Foot examination and/or treatment devices m
completely attached as integral components of the chair (and may be operated using the chair contro
stand separately as self-supported or wall-mounted units.

Chairs designed to help patients assume a posture that assists in their rehabilitation and mobilization.
have special characteristics (e.g., headrest, height adjustment, back and arm positioning, footrests, sa
facilitate rapid patient positioning in the appropriate posture; the chairs may be mechanically or elect
Some chairs also permit limited indoor transportation. Rehabilitation chairs are widely used in acute c
for short-term and long-term rehabilitation; they are intended for patients with a variety of chronic dis
chairs for cardiac and/or pulmonary rehabilitation are also available.

Chairs with back- and siderests that provide support to balance impaired patients while taking a show
permit easy drainage and full accessibility to all body surfaces. These chairs are usually made of rustp
plastics. Most of these chairs include swivel casters that permit the transport of the patient from the b
Binders designed to encircle the chest providing support and keeping the anterior part of the thorax (i
the appropriate position. These devices are usually made of wide pieces of elastic fabric with hook-an
Velcro) or metal fasteners with small teeth that grab onto and secure the elastic fabric for adjustment
available in several sizes. Chest binders are used mainly to support and compress the chest muscles,
anatomical structures for rehabilitation after (e.g., cardiothoracic) surgery; they may also provide relie

Drainage systems designed for aspiration of abnormal fluid accumulation (e.g., effusions) from the po
by the pleura (i.e., the pleural cavity). These systems usually consist a water seal ("underwater") drain
with three separate chambers for suction control, a water seal (acting as a one-way valve), and fluid c
drain tube inserted in the patient's pleural cavity with the proximal end attached to the collection cha
that is connected to the suction-control chamber using a suction line. Pleural drainage systems are us
to restore normal lung function to patients following chest or mediastinal surgery (e.g., open-heart sur
used for continuous drainage of the pleura in medical conditions such as malignant or nonmalignant p
pneumothorax and/or hemothorax treatment.

Radiographic units used for imaging the thorax, the most common radiologic procedure. The standard
performed at a long source-to-image distance (typically 182 cm [72 in]). These radiographic units are
lung disorders (e.g., tuberculosis, cancer), assessing respiratory function, identifying cardiac problems
for additional diagnostic tests, and imaging inhaled objects.

Instruments designed to cut and shape solid materials and hard tissues such as tooth and bone with a
on one side. These instruments typically consist of a manual, handheld device with a flat blade with th
working end; chisels may be conformed with or attached to a handle. Chisels are used mainly in clinic
contour bones in surgical (e.g., middle ear, orthopedic), dental, and postmortem (e.g., autopsy) proce

Middle-ear surgical chisels designed to fenestrate the protruding part of the bone located in the skull b
mastoid process) and/or the mastoid cells. These chisels typically consist of a sturdy handheld, manua
a flat blade with a cutting edge that is beveled on one side at the distal end and a proximal end appro
mallet impacts. Mastoid chisels are used frequently in procedures intended to drain infection products
cavity (i.e., mastoid antrum).

Surgical chisels designed to cut and shape cartilage of the nose. These chisels typically consist of a ha
blade instrument with a cutting edge that is beveled on one side at the distal end and an integral han
of different sizes and shapes are available, including chisels with concave rounded operative ends; ch
or curved to the right or left; or chisels with a side probe guard. Dedicated chisels intended to perform
nose (i.e., rhinoplasty) are also available.

Bone surgical chisels designed to excise bone during orthopedic surgical procedures. These chisels typ
sturdy handheld, manual instrument including a wide (more than one inch is typical) straight or slight
with a beveled cutting edge and a handle. Orthopedic surgical chisels are used in many orthopedic pr
fracture treatment); dedicated orthopedic chisels intended to create bone cavities for prosthesis impla
available.
Endoscopes designed for insertion into the biliary tract for visual examination, biopsy, removal or crus
treatment of lesions of the interior of the pancreaticobiliary tree, especially of the common bile duct. C
usually include a lighting system and a working channel for catheters and operative devices. These en
flexible, and they may be inserted percutaneously, during laparoscopic procedures, or through the duo
(transduodenal). Therapeutic choledochoscopes (with operating channels) may be used to perform bio
and other procedures, such as fragmenting and removing stones.

An apparatus once used for estimating radiation exposure by means of the color changes produced in
the skin.
Instruments for measuring the minimal duration current flow necessary to stimulate a threshold musc
chronaxy). The measurements are typically made at double the voltage necessary to produce a twitch
rheobase). Chronaximeters are used mainly to establish the state of innervation of a muscle, especial
are suspected.
Testers designed to assess the electrical characteristics of circuit breakers, usually by means of curren
testers typically consist of a high-output current source, a high-accuracy ammeter, a multirange timer
display, and controls; some testers include additional measuring capabilities (e.g., time delay, trip cur
such as overload relays and/or ground-fault interrupters.

Devices designed to either partially or completely support the patient's blood circulation. These units
either for direct cardiac assistance or to assist the peripheral circulation; cardiac assist units usually co
of a main external (e.g., pumps) unit and internal (e.g., cannulae, balloons) devices, while peripheral
consist of completely external compression devices. Most circulatory assist units are intended for tem

Circulatory assist units designed to facilitate cardiac blood pumping, either by reducing the load to the
the heart in its pumping function. There are several types of cardiac circulatory assist units, including
intracardiac balloons. Most circulatory cardiac assist units are used to maintain the body's heart funct
patients who suffer cardiomyopathy or after open-heart surgery.
Circulatory assist units that produce mechanical counterpulsation to reduce the afterload to the heart
and cerebral blood flow. These devices consist of an inflatable balloon catheter, which is placed in the
external unit that includes a pneumatic system, regulating the automated inflation and deflation of th
synchronism with the cardiac cycle; they include monitors of the physiologic parameters of the patien
arterial pressure) and also of balloon pressure and volume. The inflated intra-aortic balloon forces the
during each diastolic phase of the cardiac cycle. Intra-aortic balloon circulatory assist units are used to
cardiovascular functioning during cardiac failures that constitute life-threatening emergencies.

Circulatory assist units designed to assist one of the ventricles (most frequently, the left ventricle) of a
weakened heart in pumping blood. These units typically consist of a mechanism that includes a pump
venous blood to the pump and deliver it back to the aorta or pulmonary artery (according to left or rig
respectively), valves, and a unit that controls pump operation. Ventricular assist units are used to imp
in patients with a debilitated heart; the main components of these devices work external to the body,
such as cannulae and/or balloons, are inserted in the circulatory system. Ventricular assist units are in
use either while the heart is healing or as a bridge to a heart transplant.
Circulatory assist units designed to apply and release pressure on a patient's arms or legs, facilitating
through the veins. They can be used to minimize venous stasis during and immediately following surg
long periods of immobility, reducing the risk of deep venous thrombosis, which can produce pulmonar
units typically consist of an electric air-compression pump, a pressure-control mechanism, a timing me
connectors, and tubing that conducts the air from the pump to cuffs or pneumatic stockings. Peripher
units are used in clinical facilities or at home; some units are designed to treat chronic edema, includi

Prepackaged collections (either custom or standard) of devices and supplies needed to surgically rem
penis (i.e., perform a circumcision). Items in these kits usually include instruments (e.g., tweezers, pro
scissors, scalpels/knives, circumcision clamp, scissors) and supplies such as dressings, skin prep solut
anesthetics (e.g., lidocaine), and antibiotics. The kits may be supplied in supporting trays (i.e., proced
a flat-bottomed receptacle with a border around the periphery supporting all the instruments and sup
procedure; the trays are usually covered or wrapped. Circumcision kits and trays are used in hospitals
healthcare facilities; both single-use (i.e., disposable) and reusable kits are available.

Prepackaged collections (either custom or standard) of single-use (i.e., disposable) devices and suppli
remove the foreskin of the penis (i.e., perform a circumcision). Items in these kits usually include instr
tweezers, probes, hemostats, scissors, scalpels/knives, circumcision clamp, scissors) and supplies suc
prep solutions (e.g., disinfectant), anesthetics (e.g., lidocaine), and antibiotics. The kits may be suppli
(i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery sup
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Disposa
and trays are used in hospitals, at home, and in other healthcare facilities.

Prepackaged collections (either custom or standard) of reusable devices and supplies needed to surg
foreskin of the penis (i.e., perform a circumcision). Items in these kits usually include reusable instrum
probes, hemostats, scissors, scalpels/knives, circumcision clamp, scissors) and supplies such as dressi
solutions (e.g., disinfectant), anesthetics (e.g., lidocaine), and antibiotics. The kits may be supplied in
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Reusable circumcisi
used in hospitals and in other healthcare facilities.

Devices designed to compress a structure and/or to bring together several isolated objects and/or ana
pressing, fastening, or binding them firmly. Clamps are usually handheld, manual instruments with a w
permits a large jaw opening and a handle and without a preferred resting state; dedicated clamps are
of shapes and sizes according to the procedure to be performed or the object to be held. Clamps are c
dental, surgical, and postmortem instruments and/or to hold ancillary devices during those procedure
intended to hold objects (e.g., test tubes, small instruments).

Vascular surgical clamps designed for the atraumatic compression of the aorta during open-surgery pr
resection, graft placement, coronary artery bypass, cardiac valve replacement/repair), usually to caus
temporary occlusion (i.e., coarctation). These clamps are typically handheld, manual instruments inclu
at the center with serrated, straight, or curved distal blades and a ratchet-locking mechanism. The se
frequently has a central, nonserrated trough running its length to prevent trauma to the aorta.
Vascular surgical clamps designed for the atraumatic compression of an artery during open-surgery pr
cause total or partial temporary occlusion (i.e., coarctation). These clamps are typically handheld, man
including two parts pivoted at the center with serrated, straight, or curved distal blades, and a ratchet
The serrated region frequently has a central, nonserrated trough running its length to prevent trauma
Dedicated artery clamps are available for specific arteries (e.g., aorta, carotid, pulmonary) and/or proc
anastomosis).

Surgical clamps designed to hold, grasp, and/or manipulate bones. These clamps typically are handhe
with two strong blunt curved distal jaws that may be either fixed or adjustable in size; some devices re
Bone clamps are mainly used in orthopedic procedures.
Surgical clamps designed to provide a firm grip on the bronchi. These clamps are typically handheld, m
including two parts pivoted at the center; they usually have atraumatic curved, right-angled, or obtus
with longitudinal serrations. Bronchus clamps are mainly used during thoracic surgery.

Vascular surgical clamps designed for the atraumatic compression of an artery to arrest or prevent he
spring or cross-action mechanism (known as bulldog clamps). These clamps are typically handheld, m
two metallic parts that are conformed at the distal end as strong, straight or curved blades (frequently
or plastic) and at the proximal end as flat handles (for easy manipulation with the thumb and fingers),
locking spring; the two parts are joined by a swivel pin at the center. Some spring clamps include scis
facilitate holding and operation; other clamps have a cross-action mechanism instead of a spring and
spring artery clamps are available in a variety of shapes and sizes appropriate for specific arteries and
smaller versions of the clamps are available for use in vascular microsurgery.

Surgical clamps designed to to crush the inner and outer skin of the foreskin together to cause hemos
circumcision. These clamps are typically manual instruments that provide protection for the glans; us
excised with a knife or scissors. Circumcision clamps are available in a variety of shapes and sizes, inc
single-use devices and adult and infant sizes.
Vascular surgical clamps designed for the atraumatic compression of varicose dilatations (i.e., hemorr
rectum, usually to cause temporary occlusion during surgical procedures. These clamps are typically h
instruments including two parts pivoted at the center with straight or curved distal blades that freque
triangular, serrated jaws. Hemorrhoid surgical clamps are used in procedures intended to excise hemo

Surgical clamps designed for the atraumatic grasping or compression of a portion of the intestines du
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
or curved distal serrated blades and appropriate handles. Dedicated intestinal clamps are available ac
characteristics of the intestinal areas for which they are intended (e.g., colon, small bowel) and/or the
resection, anastomosis) to be performed; some intestinal clamps include a mechanism to lock the blad

Vascular surgical clamps designed for the atraumatic compression, after birth, of an abnormal persiste
connecting the left pulmonary artery to the descending aorta (i.e., patent ductus arteriosus), during o
procedures, usually to cause temporary occlusion. These clamps are typically handheld, manual instru
parts pivoted at the center with serrated distal blades that are straight or curved; some devices are ca
inch) on the outside edges of the tips. Ductus arteriosus vascular clamps are available mainly in infan
Vascular surgical clamps designed for the atraumatic compression of one of the major peripheral arter
surgery procedures, usually to cause total or partial temporary occlusion (i.e., coarctation). These clam
handheld, manual instruments including two parts pivoted at the center with serrated distal blades th
right angled) or slightly curved. Dedicated peripheral artery clamps are available for occlusion of femo
and other peripheral arteries.

Clamps designed to grasp and compress tubing (e.g., infusion line, hemodialysis) without damaging it
available in a variety of sizes and configurations according to the tubing to be clamped and the proced
they frequently include a mechanism (e.g., a roller) to partially or completely obstruct the line. Dedica
clamps are available for use in infusion and suction/wound drain lines, hemodialysis, and other proced
general purpose tubing clamps are used with a range of tubing/tubing sets found in various patient ca
feeding), and the clinical laboratory.

Clamps designed for external atraumatic compression and temporary occlusion of the umbilical cord a
cutting the cord. These clamps are typically handheld, manual instruments including two parts pivoted
distal serrated blades or devices including a mechanism that is operated from the handle. Dedicated s
including two clamps (one for the mother site and other for the child site) and a cutter are frequently
occlusion and cutting of the umbilical cord.

Surgical instruments designed for the atraumatic (i.e., without intentional piercing) delivery of clips to
temporary or permanent occlusion of anatomic tubular structures. Clip appliers may consist of a meta
instrument with special jaws to hold and deliver the clips or instruments including a mechanism for sin
insertions of clips. Dedicated clip appliers are available for specific procedures, including fallopian tub
hemostasis (both direct blood vessel occlusion and gastrointestinal lining closure); some clip appliers
through the working channel of endoscopes or through laparoscopes.

Devices designed for attachment or occlusion of anatomic structures (e.g., blood vessels, fallopian tub
and accessories (e.g., towels, drapes, bandages) used in surgical procedures without intentionally pier
atraumatic); some clips are intended for use as permanent implants or for temporary occlusion of exte
umbilical cord) anatomic structures. Surgical temporary clips usually permit only a small jaw opening,
closed resting state, and are frequently applied manually; dedicated implantable clips include a variet
metallic or plastic devices in different shapes and sizes that are typically delivered using clip appliers.

Surgical clips designed to hold and/or manipulate bandages and/or dressings during surgical procedur
typically small metal instruments with two blades crossed at the midportion, permitting manipulation
joined at the midportion, resembling forceps or scissors. Bandage clips have blunt ends that do not pe
damage objects. The instrument is designed to temporarily attach or hold a bandage or dressing durin
be used in other medical procedures.

Surgical clips designed to hold drapes used to isolate and/or protect a surgical site. These clips are typ
instruments with two blades crossed at the midportion, permitting manipulation in a cross-action, or jo
midportion, resembling forceps or scissors. Drape clips have blunt ends that do not perforate, tear, or
instrument is designed to temporarily attach or hold a drape during surgical procedures; it may also b
medical procedures.
Surgical clips designed to hold small surgical instruments (e.g., needle holders, cannulae) during surg
clips are typically small metal instruments with two blades crossed at the midportion, permitting man
action, or joined at the midportion, resembling forceps or scissors. Instrument clips have blunt ends th
tear, or damage instruments. Surgical instrument clips are designed for temporarily holding or attachi
surgery; they may also be used in other medical procedures.

Implantable vascular clips designed for extravascular occlusion of aneurysms in the vasculature outsid
clips are typically small metal devices that are externally applied to the aneurysm using dedicated ap
extracranial implantable blood vessel clips are used mainly for hemostasis, to facilitate surgical proce
blood circulation into a vessel aneurysm.
Clips designed to be applied to the external portions of the nose; depending on the location of applica
provide a method for occluding the external orifices of the nose (i.e., nares), blocking the nasal passag
preventing air movement through the nose. Alternatively, if these clips are applied to the nasal septum
seperates the two nostrils), they can be used to apply pressure on the trigeminal nerve in the septum
the nasal passage and thereby serving as a breathing aid. These clips are typically small instruments
at the midportion or made from a single alpha-shaped part; they are made out of metal or plastic with

Vascular surgical clips designed for the temporary atraumatic occlusion of blood vessels irrigating the
procedures. These clips are typically small, reusable metal instruments with two blades joined at the m
from a single alpha-shaped part. Penis vascular clips are typically applied manually; they are mainly u

Vascular surgical clips designed for the temporary atraumatic occlusion of blood vessels irrigating the
procedures. These clips are typically small, usually metal instruments with a cylindrical or triangular c
typically delivered using a forceps-like applier. Scalp clips usually do not include a handle or other pro
manipulation; they are used mainly for hemostasis.
Clips designed to close skin wounds by permanently (i.e., after the suturing procedure is finished) hold
edges of the skin tissue. These clips are typically small, usually metal, devices with sharp points prope
skin efficiently and hold with minimal trauma; they are frequently applied using dedicated instrument
Typically, a set of implantable clips is applied in each procedure. Skin suture clips are single-use devic
in nondegradable materials requiring removal after healing or as biodegradable (absorbable) devices.

Surgical wound clips designed for the temporary atraumatic approximation of the edges of wounds (e
tissue) to facilitate suturing procedures. These clips are typically small, usually metallic instruments w
angled to grasp skin and/or other tissue efficiently and to hold it with minimum trauma; the blades are
midportion or made from a single alpha-shaped part. Surgical suturing clips are used mainly during m
to facilitate the application of suture clips.

Surgical clips designed to hold and/or manipulate towels during surgical procedures. These clips are ty
instruments with two blades crossed at the midportion, permitting manipulation in a cross-action, or jo
resembling forceps or scissors. Towel clips have either sharp or blunt ends; they are designed for temp
holding towels during surgical procedures; they may also be used in other medical procedures.

Implantable vascular clips designed for partial extravascular occlusion of the vena cava. These clips a
devices that are externally applied to the vena cava to prevent the passage of thromboemboli without
Surgical clips designed for temporary atraumatic approximation of the edges of wounds during surgica
clips are typically small, usually metal instruments with two blades joined at the midportion or made o
shaped part. They are typically applied manually. Surgical wound clips are mainly used for hemostasis
available to facilitate placing of suture placement to close wounds.

Clocks that are used to indicate the amount of time that has passed since a specified start time. Elaps
also be used as countdown timers by indicating the seconds, minutes, hours, and days remaining to re
date or time. These clocks also can include a standard time display. Elapsed time clocks are typically u
emergency services, intensive care, and procedure rooms and can be freestanding or attached to a wa

Containers used to retrieve sputum samples from patients for diagnostic testing (e.g., sputum culture
bacilli identification). They are typically constructed of plastic and are packaged as single-use sterile i
collectors are designed to capture a sputum specimen directly from a patient with a productive cough
to be attached to a suction catheter for collecting sputum via an endotracheal tube.

Flexible endoscopes designed for direct insertion through the rectum in the lower gastrointestinal trac
examination, biopsy, and treatment of lesions of the interior of the colon; some of these devices can b
large intestine. Colonoscopes usually consist of a flexible outer sheath, a lighting system, and a worki
catheters and operative devices.
Specula designed for the examination of the vagina that permit a direct view of the tissues of the vag
Colposcopes usually include an illumination system and magnifying lenses, which allow better examin
than a common vaginal specula.
Seats designed for use on a commode. They are typically rectangular, horseshoe-shaped, or ring-shap
commode via hinges that allow the seat to be lifted up. They are typically made of plastic and may co

Permanent fixtures into which human waste is excreted and then removed via sewer and/or water line
typically consist of a base, seat, lid, handle that triggers a flush response, and small water tank, and a
ceramic or metal.
Ophthalmic instruments designed to measure the central (usually 30 degrees) visual field by presentin
screen. These instruments usually consist of a white screen, which provides one or multiple static or m
the patient's fixation, and one or more static or mobile test stimuli. The patient focuses on the fixation
perception of his or her response to the test stimuli is assessed. Campimeters can be manually or auto
using a camera to monitor the patients' fixation and computerized components to present different st
analyze, and plot the visual field; they are used mainly to detect glaucoma and other eye disorders.

Thick layers of materials designed to apply pressure, heat or cold, or medication to a specific body sur
generally consist of soft pads made of several layers of cotton cloth, linen cloth or gauze. Compresses
reduce pain, joint stiffness and muscle spasms, reduce skin inflammation, or stop bleeding in a wound
compresses designed to apply cold, moist heat or medications are also available.

Compresses made of a piece of gauze folded into several layers. Gauze compresses are intended mai
a specific area or body surface; they are used mainly to stop bleeding in a wound or are used in any in
Compresses or packs designed to apply moist heat therapy to a specific body surface. These devices t
pads made of several layers of cotton, gauze, or linen (i.e., compresses), or compact plastic or fabric b
may contain heat-retaining substances such as gels, or rice, corn, or micro beads that are capable of c
contour of the body. Hot compresses can be warmed by immersion in hot water or by using a microwa
compresses become hot due to a chemical reaction. They draw moisture from the humidity in the air o
water (e.g., moist heat therapy pack conditioner). Hot compresses and/or packs are used mainly to im
and reduce pain, muscle spasms, and joint stiffness.

Peripheral circulatory assist units designed for intermittent compression. These units include pneumat
chamber stockings that are inflated and deflated periodically, applying and releasing pressure in the
Intermittent peripheral circulatory assist units are used to improve venous blood flow.

Instruments or accessories designed for pressing a body part, closing a gap, and/or diminishing its vol
its density. Some compressors are used to flatten body parts in order to improve the resolution of rad
other are instruments used to compress organs or other anatomic structures (e.g., veins).

Compressed air system components that are used to mechanically compress atmospheric air.
Electronic devices (hardware) designed to store, retrieve, and process data, typically in digital form, fo
instructions of one or more programs stored internally, either temporarily or permanently (i.e., softwa
respectively). Computers typically perform their work in three well-defined steps: accepting input data
data according to predefined rules (programs), and producing output data as results. Computers typic
processing unit (CPU) with components (e.g., processors, memories) that perform simple, well-defined
include electronic displays and input and output ports for connection to peripheral devices for data inp
output (e.g., printers, plotters), and/or storage (e.g., optical discs). Computers are available in a variet
capacities and configurations, including large-capacity, powerful computers installed in racks or shelv
and mainframes) that can simultaneously support hundreds or even thousands of users and small, sin
known as personal computers. Standard or dedicated computers with appropriate configuration and c
definition display and using specialized programs intended to perform a particular function (e.g., data
processing from ultrasound, cardiology, and radiotherapy procedures), can interface with workstations
systems in healthcare facilities.

Contraceptive devices intended to be worn before engaging in coitus to prevent sperm from gaining a
reproductive tract by providing a physical barrier between the penis and the vagina in order to preven
also be used to provide protection against sexually transmitted infections by preventing microorganism
transmitted from one partner to another. Condoms are sheaths with one closed end and one open end
seamless polyurethane, nitrile, latex, molded silicone, or lamb intestine; they are soft, thin, and transp
pre-lubricated.

Aprons designed to prevent the development of an electrostatic charge by providing a path of low imp
from accidental contact with energized electrical equipment and lines. They are usually made of reinfo
thermoplastic polymers, or elastomer with adjustable straps and non-metallic buckles. Conductive apr
enough to cover the front or to wrap around both the front and back of the person wearing it.
Testers designed to measure the capability of electric current conduction (i.e., conductivity) by a devic
Conductivity testers usually include instruments and accessories that can measure conductivity in the
according to the physical characteristics and configuration of the material or device under test.

Electrical testers designed to measure the conductivity (or its inverse, resistivity) of conductive equipm
floors. These testers are typically an instrument that can measure conductivity from a few to several h
hundreds of ohms to some megohms) at several voltage levels (e.g., 90, 500V) and probes appropriat
measured (e.g., heavy, wide-surface probes for floor surface measurements). Some testers also includ
colored lights) to indicate that the measured conductivity is below preestablished safety values. Floor
conductivity testers are used to measure conductivity on the floor and equipment surfaces in surgical
sheets (e.g., bed, table sheets) and garments (e.g., gowns) of the surgical staff; they are used in room
explosive environments.

Electrical testers designed to measure the conductivity (or its inverse, resistivity) of shoes. These test
instrument that can measure conductivity from a few to several hundred mA (i.e., from hundreds of oh
megohms) and two metal plates intended to support the wearer, who stands with a foot on each; som
visual signals (e.g., colored lights) to indicate that the measured conductivity is below preestablished
Conductivity is usually measured from one plate to the other through both shoes and the caregiver's b
testers are used to assess personnel-to-floor conductivity before personnel enter operating rooms and
explosive environments.

Devices designed for automated washing and/or decontaminating of contact lenses; some devices ma
of disinfection by killing or inactivating several types of microorganisms. These units usually perform t
decontaminating procedures on the lenses using several automated cycles of cleaning and performing
variety of decontamination or disinfection methods. Those decontamination methods include the use
and/or different forms of energy such as thermal (i.e., heat), ultrasonic, and mechanical energy. The m
consist of a miniature washing machine that combines the mechanical action with standard solutions
cleaning of lenses, thermal units use heat to decontaminate/disinfect the lenses without chemical clea
ultrasonic units only use water or saline solutions in the procedure. Contact lens washer/decontamina
intended for rigid contact lenses but may be used for some types of reusable soft contact lenses.

Ophthalmic lens made of glass or plastics, designed to be worn on the front surface of the eye, used f
refractive errors, therapeutic, diagnostic, or cosmetic purposes.
Devices designed to apply continuous positive airway pressure during both inspiration and expiration
performing spontaneous breathing. Continuous positive airway pressure (CPAP) units typically consist
including a threshold resistor, such as an underwater seal, a weighted ball, or a spring-loaded valve. A
device that exerts a predictable, quantifiable, and constant force at the expiratory limb, creating a thr
must be exceeded to allow flow through the valve. The units also include a high-flow gas source and a
pressurized air to the patient; many devices include a manometer. CPAP units usually maintain a base
5 to 20 cm of H20 throughout the whole respiratory cycle; the devices require a gas flow greater than
flow to maintain the desired positive airway pressure. These units are intended to provide noninvasive
breathing assistance therapy through a mask (either nasal or oronasal), a mouthpiece, or lipseal; they
treat central sleep or obstructive apnea disorders. They are not intended for continuous breathing sup
Graphic recorders in which continuous, time-varying signals are segmented and stacked sequentially a
manually or using a computer. These recorders may be used in measurements of blood pressure, ECG
periodic wave. Contourographs can be used for assessing the time variation of physiological paramete
longer than the inherent cycle length of the variable being recorded.

Devices designed to regulate the operation of a device, equipment, or system. These devices may con
mechanical, electrical, electromechanical, or electronic components or component sets according to t
they may also consist of modules that, when used with a parent device (e.g., a specialty bed/mattress
additional ability to control such functions. Controllers frequently are used in healthcare facilities to co
conditions, equipment operation variables (i.e., temperature and fluid pressure or level), and/or the fu
complex devices such as electrosurgical units and radiographic systems. Controllers can be an integra
and systems or available as stand-alone devices that are used in conjunction with the devices/system

Orthopedic devices that encircle and support a part, as worn in certain spinal injuries or deformities.
Structures designed to cover pediatric beds (i.e., cribs) to increase children's safety. These coverings a
and/or plastic structure that is permanently attached to the top of the crib; typically a rigid structure i
transparent plastic (e.g., vinyl) foil enclosing the entire crib. Crib tops are intended to protect children
injuries; dedicated crib tops for use in hospitals, homes, and/ or day cares (e.g., canopylike) are also a

Total dental crown prostheses designed for temporary (usually no more than a few weeks) restoration
tooth by fitting around the remains of the tooth, covering the entire natural crown surface, and affixin
tooth. These crowns are typically preformed devices made of plastics (e.g., cellulose acetate, polycarb
metals (e.g., aluminum); they are usually fixed to the tooth using self-adhesive or light-curing resins. D
available in a variety of sizes and shapes for anterior teeth (e.g., incisors, canines) and posterior teeth
molars). Temporary total crowns are mainly intended for use as a restoration during dental treatments
permanent prosthesis is available.

Cushions designed to be attached to the upper end of axillary crutches. These cushions are crescent s
made of padded washable soft fabric or plastic materials; they are usually attached to the crutch usin
or slipped onto the tops of the crutches. Crutch cushions are intended to alleviate the pressure and pr
the armpit, reducing the possibility of skin breakdown.
Assistive devices consisting of a shaft that bifurcates at some point from the distal tip. They are desig
additional support to the user while walking. These devices usually consist of a shaft that bifurcates p
distal tip (i.e., base); a handle at the proximal end finished in a soft pad; and a rubber tip at the distal
have several (e.g., three to four) distal tips to improve floor contact. Crutches are typically made of st
wood (e.g., walnut), light metals (e.g., aluminum, titanium), fiberglass, or a combination of these. Mos
crutches include axillary (i.e., underarm) and forearm designs. Other dedicated (e.g.; platform and trip
available. Crutches are adjustable for the user's height and arm length and are commonly used in pair

Electronic thermometers designed to measure very low (i.e., cryogenic) temperatures, typically below
(-202 degrees Fahrenheit). These devices typically consist of a very sensitive sensor (e.g., a silicone c
appropriately packaged to withstand very low temperatures, that is integrated in a probe; a cable; and
with a display that shows the temperature. Cryogenic thermometers may read temperatures as low as
(-454 degrees Fahrenheit).
Cryosurgical units designed for use in general surgical procedures, such as in dermatology, oral surge
urology, otolaryngology, and proctology.
Cryosurgical units designed for applying extreme cold to eye tissues to destroy abnormal cells. These
of a hollow probe (cryoprobe) that circulates a cryogenic substance (e.g. liquid nitrogen) to form an ic
the cells, which freezes the cells of the tissues with which it comes into contact. Ophthalmic cryosurgi
mainly to treat eye tumors (e.g., retinoblastoma), to relieve ingrown eyelashes (trachiasis), for cryoex
intracapsular cataracts, and/or to repair retinal detachment.

Devices used to add air to a cylindrical chamber. Cuff inflators typically consist of a rubber bulb, tubin
mechanism that retains air in the chamber.
Bandlike devices encircling a body part or another device. Cuffs used in medical procedures or monito
with air or fluid.
Devices that have an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and
These devices are used in conjunction with another device to determine a patient's blood pressure.

Endoscopes designed for direct insertion through the fundus of vagina (i.e., posterior vaginal fornix) in
cavity for visual examination, biopsy, and treatment of lesions of the cavity and organs located in it, e
rectovaginal pouch and the pelvic viscera. Culdoscopes usually consist of an outer sheath, a lighting
channel for catheters and operative devices; these endoscopes may be rigid or flexible.

Instruments designed with a spoon-like working end intended for mechanical scraping and/or removal
of an anatomic cavity or surface. These devices are typically manual, handheld, or endoscopic instrum
fenestrated (e.g., a ring, loop) working end that resembles a spoon with blunt or sharp edges, a shaft,
other end; some curettes are used through the working channel of an endoscope. Curettes are typical
tissue, either for use as a laboratory sample (biopsy) or during dental and/or surgical procedures.

Reusable cubicle curtains are intended to partition off an area (i.e., form a cubicle). They are used in m
healthcare facilities such as holding areas, preparation areas, procedure areas, overflow areas, examin
rooms, and inventory areas. They are designed to block out light and/or provide privacy by keeping pe
curtain from being able to see inside. These curtains usually consist of a piece of fabric hung from a c
curtains are manually or power operated; they can come in a variety of shapes, sizes and materials (e
nylon, vinyl). Fire-retardant, tear and mildew-resistant, and liquid-repellant cubicle curtains are availab
curtains are able to withstand institutional laundering.

Devices resembling soft pillows or pads designed to provide comfort, alleviation of pain, and/or to faci
person. These devices typically consist of a soft material (e.g., foam) frequently inserted in a waterpro
case; some cushions are manufactured as inflatable (e.g., vinyl, rubber) devices. Cushions with a hole
cushions) are also available to accommodate a person during specific activities (e.g., commode seats)
hemorrhoids, or after surgical or other procedures (e.g., labor).
Foot orthoses made of soft cushioning materials that are designed for accommodation and protection
the foot. They are usually inserted inside the shoe, providing comfort and some degree of foot control
consist of a prefabricated device made of soft and/or flexible materials (e.g., fabrics, plastics, foam) or
these. Accommodative foot orthoses are available with a shape and size appropriate for the user; they
alleviate metatarsal pain and other minor foot disabilities. Dedicated accommodative orthoses intend
also available.

Round or oval-shaped cushions with a hole in the center used to alleviate pressure on the tailbone. Th
of foam rubber and are used to relieve pain from hemorrhoids, after surgery, after pregnancy, or durin
injury.
Round or oval-shaped cushions with a hole in the center used to alleviate pressure on the tailbone. Th
made of inflatable vinyl and are used to relieve pain from hemorrhoids, after surgery, after pregnancy
from an injury.
Cushions designed for use on a stool seat to provide comfort, alleviation of pain, and/or to facilitate po
These cushions are usually devices made of soft cushioning materials (e.g., high-density foam) or, les
The cushions are usually attached to the stool using permanent hardware (e.g., bolts, rivets); sometim
cushioning is provided by cushions that include ties or elastic skirts that fit around the sides and unde
place. Stool cushions provide comfort and protection of the coccyx (i.e., tailbone) and/or perineal area
by healthcare staff but may be used also by patients undergoing rehabilitation or by geriatric patients

Cushions designed for use on a chair or wheelchair seat to provide comfort, alleviation of pain, and/or
of a person. These devices are usually inflatable cushions or devices made of soft cushioning material
foam); some cushions include a hole in the center (i.e., a ring cushion). The cushion is usually attache
wheelchair using, ties, or elastic skirts that fit around the sides and under the seat to hold it in place.
cushions are intended to provide comfort and protection of the coccyx (i.e., tailbone) and/or perineal a
mainly by patients undergoing rehabilitation or by geriatric patients. The cushions are frequently desi
pressure points, helping in the prevention of tissue damage; dedicated cushions intended for rehabilit
surgery are also available.

Vessels (e.g., round bowls) into which the patient may expectorate during and after dental procedures
component of the dental procedures unit and have a water valve to allow flushing of the cuspidor to w
expectorate (e.g., blood, debris, etc.)
Instruments for studying the neuromuscular mechanism of the bladder by means of measurements of

Urinary tract endoscopes designed for visual examination, biopsy, removal or crushing of stones, and
the urethra and urinary bladder. They usually consist of an outer sheath, an optical system, and a wo
catheters and operative devices.
Urinary tract endoscopes for visual examination, biopsy, removal or crushing of stones, and treatment
urinary bladder and posterior urethra. They usually consist of an outer sheath, an optical system, and
catheters and operative devices.
Testers designed to assess the performance of cardiac defibrillators. These testers usually can measur
and/or record a set of defibrillator parameters and/or waveforms, such as defibrillation and cardiovers
voltage and current, and synchronization of cardioversion. Defibrillator testers typically consist of an e
a display, measuring devices (e.g., energy, voltage, time), and appropriate sensors; some testers can
electrocardiographic signals and arrhythmia waveforms to verify the monitoring capabilities of the defi
intended for external defibrillator frequently include test sequence protocols to test both semi- and fu
defibrillators

Electrical conductive pads designed to provide a conductive path between the skin and a defibrillator
may consist of thin devices made with conductive materials (e.g., conductive rubber, gel, carbon film)
one side and include a defibrillator paddle contact on the other side or pads that are adhesive on both
paddle pads minimize the damage to the skin during defibrillation procedures by increasing the condu
electrode and the skin. The pads may be also used in other cardiac procedures such as cardioversion
pacing. The pads are available in adult and pediatric sizes.

Cardiac electrical stimulators that apply brief high-voltage electroshocks to the heart. These stimulato
normal rhythm and contractile function in patients who are experiencing ventricular fibrillation or vent
that is not accompanied by a palpable pulse. Some defibrillators may also be used to correct certain n
dysrhythmias (called synchronized defibrillation or cardioversion), using relatively low-level discharge
patient's ECG waveform.

External defibrillators that require the operator to observe the ECG waveform, confirm ventricular fibri
the necessary operations to charge the capacitors to the appropriate voltage and discharge the stored
paddles into the patient. Manual external defibrillators are typically battery operated, but most device
operated from line power. Most of these defibrillators include an electrocardiographic monitor as an in
defibrillators that do not include a monitor should be used with an ECG monitor or electrocardiograph
abnormal cardiac rhythm may be corrected with an electric shock (i.e., to identify a "shockable" rhyth

Manual external defibrillators that only operate from line power. Most of these devices are movable, u
their use is limited by the availability of line power, so they cannot be used during patient transport in
emergency vehicles. Line-powered defibrillators are typically used in locations where nonambulatory p
continuously monitored (e.g., intensive care, emergency rooms).
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed durin
and labor. Items in these kits usually include sterile gowns, gloves, needles, syringes, anesthetics (e.g
scissors, scalpels, cord clamps, obstetric pads, and drapes. The kits are frequently supplied in support
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Delivery and labor p
trays are intended for use during labor and subsequent delivery of the baby and placenta from the ute
vagina to the outside world (i.e., obstetric delivery). They are mainly used in maternity hospitals and o
healthcare facilities.
Water purification systems designed for filtration, carbon adsorption, and removal of charged particles
from the water. These systems typically consist of several containers intended to perform some or all
sequence of operations; (1) filtering to eliminate large particulates; (2) addition of a softener to elimin
magnesium; (3) elimination of low-molecular weight organic materials using a carbon bed; (4) deioniz
cationic and anionic resins. Filtering/deionization water purification systems when used alone do not e
microorganisms; they are intended to provide soft "treated" water (i.e., a low content of metals such
magnesium) for use in healthcare facilities in areas such as clinical laboratories, pharmacies, and/or fo
(e.g., hemodialysis); the systems are also used in healthcare facilities and at home for purposes differ

Dental materials designed to produce a mechanical interlocking effect upon hardening inside the mou
materials typically consist of two bonding substances (a basic powder and an acidic liquid) that are m
viscous paste immediately before use, setting to a hard mass. Dental cement materials provide sealin
leakage and have good esthetics and proper thermal and chemical resistance in the oral environment
irritating to pulp and gingiva. These dental materials include glass ionomer, polycarboxilate and zinc o
They are used in dentists' offices as luting (cementing) agents, as protective, insulating, or sedative b
restorative materials.

Dental dams are thin square or rectangular sheets used by dentists to isolate a tooth or teeth during d
procedures. They usually range in size between 4 in. to 6 in. (10 cm to 15 cm), come in various colors
natural rubber latex or of elastic plastomers (polymer material which combines qualities of elastomers
with patients and staff who are sensitive to latex. To place the dental dam, a hole is punched in the de
placement around the tooth or teeth undergoing treatment, and the dam is placed in a frame and clam
teeth, which holds the dam in place within the patient's mouth during the procedure. Some dental dam
with built-in flexible frames. They are used in dentists' offices to minimize the risk of contamination by
fluids of the mouth, to provide a clean operating field, and to prevent aspiration by the patient of dent
or instruments.

Machines designed to provide power for operation of rotary dental instruments. These machines inclu
and hydraulic or compressed air (i.e., pneumatic) systems with appropriate attachments for connectio
instruments (e.g., adapters to handpieces).
Soft dental materials consisting of a thread or thin tape designed to clean the interdental spaces (i.e.,
dislodging debris. Dental floss is usually available in small plastic containers (dispensers) that contain
(30 to 150 feet) of floss. Typically the user pulls out the desired amount of floss and then cuts it using
included on the container. Dental floss may be waxed or not, some dental floss may be also flavored.
home and in healthcare facilities for personal hygiene of the mouth.

Restorative dental materials, whose main component is gold, designed for in situ restoration of the ap
and/or function of a patient's teeth. These restorative dental materials consist of pure gold rolled into
Restorative gold foils have non-toxic properties and provide patients long-lasting restorations. They ar
offices for crown repairs and as small fillings in areas where mastication forces are weak.
Handpieces designed to operate dental rotary instruments, such as dental burs and polishers. They ar
to remove tooth structures, polish dental restorations, clean teeth, and other dental procedures. Dent
driven by connection to a power source, either a pneumatic (compressed air) system or an electric mo

Height adjustable stools that include a seat and an adjustable backrest appropriate for operator use d
procedures; those used by dental assistants also include a long armrest that can be appropriately adju
can also be used as a siderest or abdominal rest. These stools usually include a four- or five-caster ba
locking casters and pneumatic mechanisms (possibly foot controlled) for height adjustment. Some de
attached to the dental chair so they can revolve 270 degrees around the chair and retracted close to t
use.

Equipment combined in a single unit designed to deliver dental care. These units typically combine al
devices needed to provide dental services, such as handpieces, lights, and cuspidors; they also includ
for their operation, such as compressed air, suction, electricity, and water. Dental delivery units are fr
stand-alone units, but some units are attached to a dental chair. Dental delivery units are the main co
systems that may also include x-ray devices, cabinets, stools, sterilization units, and other ancillary eq

Instruments used to enable deaf persons to hear sounds propagated through their teeth.
Dental materials designed to clean and polish the teeth that are used in conjunction with a toothbrush
materials usually contain a mild abrasive, a detergent, a flavoring agent, and a binder. Dentifrices are
paste form (i.e., toothpaste) filling a plastic tube; dentifrices in liquid and powder forms are also availa
may contain therapeutic agents (e.g., fluoride) to inhibit dental caries and/or to prevent gingivitis; den
substances appropriate for people having sensitive gums are also available. They are widely used sev
help maintain acceptable oral hygiene.

Thin rubber disks, usually with a hole in their center to fit over a button that is larger than the hole; w
tissue surface of a denture, the cup adheres to the mucous membrane through suction.
Prefabricated or non-custom-made, disposable devices used to improve the fit of a loose or uncomfort

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
dentures. Items in these kits usually include a set of teeth (e.g., 6 upper anterior and 6 lower anterior
denture acrylic resins and bonding adhesives, a professional strength denture cleaner, and a booklet w
kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed rec
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Denture repair procedure kits and trays are intended for use during reparation of dentures.
in dental offices and dental laboratories.

Complete dentures designed using a set of preformed teeth that are bonded to a custom-made dentu
the patient's mouth as a mold; the denture is intended for replacement of all the teeth in the upper (i.
(i.e., mandible) jaw. These dentures are typically assembled in a dental laboratory or, less frequently,
they usually consist of a dental plate that comes in standard sizes that can be contoured to custom fit
and a set of artificial teeth that cover a full arch (either the upper or lower). Preformed complete dent
use on edentulous alveolar ridges after tooth removal; they are no longer frequently used in current d
Mechanical devices such as wire brushes or emery paper cylinders that are used to plane the skin (su
epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wri
irregularities of the skin.
Surgical instruments designed to rapidly excise (harvest) and/or process large, uniform-thickness skin
instruments may be a manually operated device (e.g., a handheld mechanical frame and cutting blad
a powered (e.g., electrical, pneumatic) device with a cutting blade. Powered (e.g., Castroviejo, Reese,
Davol-Simon, Zimmer) dermatomes typically use a rapidly oscillating blade that is manually advanced
Dermatomes are used mainly to obtain skin grafts from donor sites, but they are sometimes used in o
to remove tattoos). Dedicated instruments are available to expand the skin graft (i.e., expanded mesh
increasing the area of damaged skin that can be covered with a given graft.

Dental materials consisting of gels, solutions, or creams that are used to prevent tooth sensitivity that
dentin due to gingiva recession, enamel loss, dry mouth (xerostomia), or dental procedures or injuries
applied to all dentin surfaces, including cavity, crown, and cervical areas. They can also be placed und
such as amalgam restorations, adhesive-composite restorations, or dental prostheses. They can be ap
tooth bleaching, scaling or root planning, or other dental procedures that may expose dentin. Desensi
hydroxyethyl methacrylate or hydroxyapatite, and can include glutaraldehyde and/or fluoride. Desens
crystals that seal dentinal tubules and cracks in the enamel when applied to the dentin and/or ename
blocking the exposed dentin and relieving pain.

Tags designed to be attached to a medical device to indicate the operating and/or calibration status o
calibrated, repair/calibrate, out of service). These tags typically include at least the date of service, a
of the person who performed the action. Some tags are designed to follow the requirements of specifi
calibration or quality control (e.g., ISO, AHA, JCAHO). Device-status tags are sometimes attached to th
maintenance personnel, usually after repairing and/or inspecting the device.

Electric conductivity meters designed to measure and display the electric conductivity of a solution de
the meter may be a component or an accessory of a hemodialysis machine. These devices typically co
instrument that can measure within the range of conductivity usually found in dialysate solutions (typ
the instruments include the appropriate sensors, transducers, electronic circuits, and a display for the
Dialysate conductivity meters are commonly used as an integral part of the dialysis system, but some
alone units for inspection, maintenance, or calibration of the dialysate circuit of hemodialysis machine

Equipment designed to perform hemodialysis, a treatment intended to remove large amounts of wate
from the blood. Typically blood is taken via an extracorporeal circuit, passed through an extracorporea
biochemical abnormalities as well as fluid, electrolyte, and acid-base imbalances, and then returned to
Hemodialysis units are used mainly for partial substitution of the kidney (i.e., renal) or liver (i.e., hepa
also used to treat other acute diseases.

Detectors designed to discover air bubbles and/or foam in the blood that is returned to the body (usua
venous fistula) by the extracorporeal blood circuit of a hemodialysis machine. These devices may dete
also foam) using either ultrasonic sensors that detect changes in acoustic density or less frequently ph
that detect infrared light by a photocell when a bubble is passing, otherwise the light is interrupted by
Hemodialysis unit air bubble/foam detectors usually trigger alarms and activate automated mechanism
Devices designed to remove metabolic wastes through selective diffusion across the peritoneum by c
specially designed solution (i.e., a dialysate) into and out of the abdominal cavity (i.e., peritoneal dialy
consist of a machine that performs automated dialysis cycles, typically while the patient sleeps, by co
dialysate. Peritoneal dialysis units infuse and remove dialysate by means of a catheter and a sterile di
system. A temporary catheter, or more frequently a permanently implanted abdominal catheter, prov
peritoneal cavity. Peritoneal dialysis is used less frequently than hemodialysis, it is especially indicated
unable to tolerate hemodialysis (e.g., the elderly, and patients with diabetes and/or other vascular car
conditions).

Testers designed to measure and display the main parameters of the dialysate used to remove metab
blood during hemodialysis procedures. These testers typically consist of an electronic unit that include
for conductivity, temperature, and pH; some testers have an extended range of temperature and cond
measurements to check heat disinfection temperature and/or acid and bicarbonate solution conductiv
dialysate testers are used to check the dialysate in hemodialysis machines before patient treatment.

Devices designed to perform dialysis, a procedure that combines the separation of molecules with diff
through a semipermeable membrane (diffusion) and the simultaneous movement of fluid through the
imposed pressure gradients (ultrafiltration). These devices typically consist of three basic elements: a
containing the solution to be dialyzed (e.g., blood), a second compartment containing the solution tha
(i.e., dialysate), and a semi-permeable membrane separating them. Dialyzers are used frequently as c
hemodialysis unit or system; dedicated laboratory dialyzers used in clinical laboratories for sample pre
concentration are also available.

Devices designed to perform in-vivo blood dialysis, a procedure that combines the separation of mole
characteristics through a semipermeable membrane (diffusion) and the simultaneous movement of flu
membrane under imposed pressure gradients (ultrafiltration). These devices typically consist of three
compartment containing the blood to be dialyzed, a compartment containing the solution that perform
dialysate), and a semi-permeable membrane separating them. Dialyzers may be reusable for a single
(i.e., only one time) components of a hemodialysis system. Hollow fiber (also known as capillarity) des
common design in dialyzers; parallel plate dialyzers are less frequently used. Coil dialyzers are rarely
present time. Hemodialysis dialyzers (also known as artificial kidneys) are used to cleanse a patient's
caused by acute failure or more frequently chronic malfunction of the kidneys.

Hemodialysis dialyzers consisting of dialysis membrane tubing wound in a circular manner around a c
supporting mesh separating the coils. The blood flows inside the tubing, and the dialysate flows throu
by the supporting plastic mesh.
Dialyzers designed to perform blood dialysis, a procedure that combines the separation of molecules w
characteristics through a semi -permeable membrane (diffusion) and the simultaneous movement of fl
membrane under imposed pressure gradients (ultrafiltration), with the membrane in the form of hollo
dialyzers typically consist of cylindrical containers with several hundreds or thousands of longitudinall
capillary tubes; the tube walls work as a semi-permeable membrane. Blood enters and exits through
fibers and travels through their lumens, while the dialysate flows through the container outside of the
hemodialysis dialyzers are used to cleanse a patient's blood from impurities caused by acute failure o
chronic malfunction of the kidneys; they are the most common type of dialyzer in current hemodialysi
high-permeability (also known as high-flow) hollow fiber dialyzers using large-pore membranes are als

Dialyzers designed to perform blood dialysis, a procedure that combines the separation of molecules w
characteristics through a semi -permeable membrane (diffusion) and the simultaneous movement of fl
membrane under imposed pressure gradients (ultrafiltration), with the membrane in the form of paral
dialyzers typically consist of sheets of semi permeable membrane that are placed between support pl
layers; the blood and dialysate circulate in separate alternating compartments. Parallel-plate hemodi
used to cleanse a patient's blood from impurities caused by acute failure or more frequently chronic m
kidneys. Some dialyzers may include sheets of semi -permeable membranes used as disposable (sing
permanent (reusable) support plates. Dedicated high-permeability parallel-plate dialyzers using large-
also available but not frequently used.

Absorbent pads designed to be worn as underpants or pants liners for the purposes of absorbing urine
moisture away from the skin that comes in contact with the diaper.
Absorbent pads designed to be worn as underpants or pants liners for the purposes of absorbing and
and wicking moisture away from the skin that comes in contact with the diaper. Adult diapers are spec
worn by persons other than infants and children.
Absorbent pads designed to be worn as underpants or pants liners for the purposes of absorbing and
and wicking moisture away from the skin that comes in contact with the diaper. Pediatric diapers are s
be worn by infants and children (e.g., who are not toilet-trained).

Microwave therapy systems designed to warm localized body tissues one to two centimeters below th
resistance to the pass of high-frequency electromagnetic radiation. These systems typically include a
(frequency of 2.45 GHz is typical) and applicators that act as reflectors to focus the wave onto the des
diathermy systems radiate energy that can be more directly focused than radio-frequency (shortwave
particularly useful in heating high-water-content tissues. Most of these systems are used to promote
(e.g., to treat muscle spasms and joint contractures) and in the treatment of neurological problems (e

Radio-frequency (RF) therapy systems designed to warm localized body tissues using their resistance
frequency electromagnetic radiation. These systems include a RF generator in the range of 10 to 100
MHz), a power amplifier, and applicators to deliver the energy to the patient. Diathermy RF systems a
in heating high-water-content tissues. They are used to promote healing and pain relief (e.g., to treat
contractures) and for treatment of neurological problems (e.g., sciatica).
Ultrasound therapy systems designed to produce and deliver ultrasonic waves that penetrate tissues
thermal and nonthermal (e.g., mechanical and cavitation) effects. These systems consist of a radio-fr
generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy
an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tis
Physical therapy ultrasound systems are used for pain relief and as an aid in the healing of soft-tissue
ulcerations; bursitis; muscle, tendon, or joint pain).

Instruments designed for mechanically enlarging, frequently augmenting the diameter (caliber) of ext
other anatomic structures (ducts) of the body. These instruments may consist of a variety of common
specula, balloon catheters, stents), according to the procedure to be performed and the part of the bo
Dedicated dilators are available for examination or treatment of body cavities (e.g., nostrils, vagina, re
during surgical procedures on internal ducts (e.g., bile duct, heart valves).

Surgical dilators designed for mechanically enlarging, frequently by augmenting the diameter (caliber
heart valves, coronary arteries, and/or heart-associated vascular structures during surgery. These surg
a variety of different instruments, typically including malleable shafts and oblique distal ends with spe
opening blades to incise the heart or vessel at the selected site without damaging the opposite wall. S
may also keep the edges of the incision apart without forceps or traction sutures as well as to expand
arterial incision. Surgical cardiac dilators are usually used during cardiac surgery (e.g., aortocoronary,
surgery, sequential anastomosis in coronary artery bypass). Some dedicated cardiac dilators are inten
heart valves.

Surgical dilators designed for mechanically augmenting the diameter (caliber) of the biliary ducts, inc
gallbladder) and biliary common ducts during surgery. These surgical dilators typically consist of an el
instrument attached to a thin shaft facilitating placement and in some occasions, displacement of tiss
surfaces; dilators with several different diameters of dilator heads are available. Biliary/common duct
used in exploring the common duct and gall bladder ducts; flexible dilators placed over guiding cathet
used during laparoscopic procedures. Some dedicated dilators are used in percutaneous procedures in
obstructed biliary ducts.

Surgical dilators designed for mechanically augmenting the diameter of the esophagus during endosc
surgical dilators typically consist of a slender hollow or solid-body instrument made of metal, plastic o
material in a cylindrical form to facilitate placement; some instruments include balloons that are expa
injection of liquid (e.g., saline, water, radiopaque contrast). Some balloons are designed to expand to
others are designed to inflate to multiple diameters. The dilators are designed to be used through the
esophagoscopes and can be wire-guided or non-wire guided (fixed wire). Esophageal endoscopic dilato
endoscopic visualization and provide radial force directly to the stricture site. They are used during ga
procedures to open narrowed areas or strictures in the esophagus due to several causes (e.g., peptic s
Rings, achalasia). Dilation of the esophagus can also be performed with bougies (a non-surgical proce
Surgical dilators designed for mechanically augmenting the diameter of the lacrimal canal during oph
surgical dilators typically consist of a handheld instrument with a very fine, blunt, tapered distal end t
some are double-ended instruments. Lacrimal canal dilators vary according to the surgical procedure
smooth tapered end lacrimal canal dilators typically made of stainless steel are used for dilation of the
punctum, frequently followed by irrigation of the nasolacrimal system. Lacrimal canal dilators are used
procedures (e.g., to release mucous plugs or concretions, to produce temporary relief in a case of sten
and/or prior to inserting punctum plugs and syringes).

Dilators designed for mechanically augmenting the caliber of the nasal passage. These dilators usuall
non-abrasive, flexible materials which are inserted into the nostril and kept in place by gentle pressur
walls and the dilator. Nasal dilators are breathing devices placed and retained within the nostril in ord
passage. They are used to improve breathing and may be used for treatment of nasal obstruction due
or inflammation of the nasal membranes.

Surgical dilators designed for mechanically augmenting the caliber of the anatomic structures of the l
bronchi) during endoscopic surgery. These surgical dilators typically consist of an instrument with an o
balloon to facilitate placement and to displace tissue near angled surfaces. Bronchus dilators in a vari
balloon diameters are available; some dilators have radiopaque markers located under the balloon to
reference points under fluoroscopy. Bronchium dilators are usually used for endoscopic dilatation of st

Dilators designed for mechanically augmenting the diameter of the rectum. These dilators usually con
tube-shaped instrument with a small hole on the tip to prevent pressure build up. Rectal dilators are a
lengths and diameters. They are typically used to dilate the anal sphincter and canal when the size of
interfere with its function or the passage of an examining instrument, as well as to prevent the canal f
surgery.

Surgical dilators designed for mechanically augmenting the caliber of tracheal strictures/passages by
the mouth and vocal apparatus into the trachea during surgery. These surgical dilators typically consis
instrument having a distal blunt end and a proximal open end comprising a hollow mouth with sidewa
holding the distal end of an endotracheal tube. Endotracheal dilators may have a solid or hollow proxi
a distal end of a nasal endotracheal tube in place. Endotracheal dilators are used to maintain an open
conduit through which to administer certain drugs, and sometimes for passing tracheal tubes.

Surgical dilators designed for mechanically augmenting the diameter of the internal lumen of the fallo
surgery. Fallopian tube dilators vary according to the surgical procedure to be performed; they are usu
dilators with a very thin tapered blunt distal tip, either straight or angled that is attached to a solid ha
diameter to facilitate placement. They are used in a variety of gynecologic and obstetric procedures, i
the Fallopian tubes and in-vitro fertilization.

Dilators designed for mechanically augmenting the diameter (caliber) of urethra. These dilators usual
metal rod with either a round or flat distal end. Urethral dilators with a more pronounced curve at the
pronounced tips are available; longer double-ended urethral dilators with rounded and slightly bent en
There is a great variety of dilators according to the procedure to be performed and the sex of the patie
are mainly used by urologists to be inserted into the male or female urethra, for the purpose of stretch
stricture.
Surgical dilators designed for mechanically augmenting the caliber of the vasculature (usually arteries
surgical dilators typically consist of an instrument with an oblique distal end that expands arteries wit
prevents damage to adjacent tissue and other areas of the body due to a decrease or loss in the amou
Vascular dilators are usually inserted into vessels with very little pressure to minimize the risk of injuri
be dedicated for use during surgical procedures involving the dilation of the coronary, pulmonary, and

Equipment designed to kill or inactivate many microorganisms (e.g., fungi, viruses, bacteria) from inst
and other clinical devices and utensils, automatically or semiautomatically. These disinfectors typically
microorganisms including mycobacterium, all fungi, and small nonlipid viruses (providing low-level an
disinfection); some disinfectors can also kill spore-forming bacteria (except when there is a large num
providing a high-disinfection level (near-sterile disinfection). This equipment typically uses temperatu
100?C or immersion in sterilants for periods of time not sufficient to completely sterilize the devices. D
inactivate microorganisms in medical devices when complete sterilization is not needed or justified. D
using vaporized germicidal (i.e., formalin, oxygen peroxide) solutions to disinfect closed containers are

Liquid germicide disinfectors designed to kill or inactivate many microorganisms (e.g., fungi, viruses,
endoscopes. These disinfectors typically kill microorganisms including mycobacteria, all fungi, and sm
(medium-level disinfection). Some of these disinfectors can also kill spore-forming bacteria (except wh
number) providing high-level disinfection (near-sterile disinfection). Flexible endoscope disinfectors ty
chemical germicide (e.g., 2% glutaraldehyde) to the endoscope, using mechanisms (e.g., channel tub
circulation of the germicide through all working channels of the endoscope, usually for a period shorte
sterilization. These disinfectors are used after manual cleaning of the endoscopes (i.e., removal of bio
though some devices include several washing steps in their disinfection cycle.

Disinfectors designed to kill or inactivate many microorganisms from instruments, containers, and oth
immersion in hot water, automatically or semiautomatically. These disinfectors are typically devices w
hot water bath that reaches temperatures of less than 100 degrees Celsius (C) (212 degrees Fahrenhe
apply temperatures in the range of 70 to 75 degrees C (158 to 167 degrees F) for 20 minutes. Temper
are usually included. Pasteurization disinfectors are used to disinfect devices when complete sterilizat
justified.

Devices designed to deliver small controlled quantities of substances or other supplies. Dispensers us
enclosure made of metal, plastic or a combination of these with an opening to obtain the required sub
Dispensers may be battery powered or hand operated; they are intended to deliver accurate quantitie
to avoid the user's contact with the remaining supplies. These devices may be mounted on the wall, o
installed as self-standing dispensers. Dispensers are used in healthcare to deliver multiuse supplies (e
towelettes, gloves). Dedicated dispensers intended for use in dental offices (e.g., amalgam), clinical la
microscope slides), and other specialty areas are also available.

Unit dose medication pill dispensers designed to store and deliver controlled narcotics in the correct s
an individual patient. These dispensers usually consist of a container with medication compartments t
of pills. Narcotic control unit-dose dispensers may be manually operated including a tamper-proof secu
operated managing access, control and tracking of unit-dose controlled substances. They are common
facilities.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for c
tissue by means of a scalpel or with scissors (i.e., dissection). Items in these kits usually include disse
and forceps; they may also include probes, teasing needles, pipettes, and rulers. The kits are frequent
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
procedure kits and trays are used to obtain body tissue samples intended for in-vitro determination of
either through direct visual or microscopic examination. They are used in hospitals' pathology rooms a
units.

Devices designed to separate the surfaces of a joint without displacement and/or rupture of the ligam
These distractors are typically a mechanism that may include clamps, screws, and levers. Distractors
use during surgical procedures in the joints, but some dedicated distractors are used for physical ther
frequently after joint surgery and/or to provide stable traction for reduction and fixation of joint and ot
Dedicated distractors intended for use in the hand, wrist, shoulder, knee, spine, and hip articulations a

Prepackaged collections of the devices and supplies (either custom or standard) needed for the liquid
of tissue and/or debris from the vagina. Items in these kits usually include a douche pan or an inflatab
pad (i.e., a Kelly pad), tubing, a container, waterproof drape, an alcohol prep pad, a syringe with a rub
with side perforations, and a sterile solution (e.g., antiseptics, astringents, or physiologic saline) accor
needs. These kits may be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottom
border around the periphery supporting all the instruments and supplies needed for the procedure; th
covered or wrapped. Vaginal douche irrigation/lavage kits and trays are intended for hygienic purpose
also to help in the prevention of suppurative inflammation; some kits included tips appropriate to deli
through the rectum.

Bottles designed with an appropriate shape and made of materials (e.g., glass, plastics) that facilitate
and safe storage of the drained products. These bottles may consist either of reusable glass (e.g., Pyr
withstand repeated high temperature sterilization and chemical action or disposable, sterile plastic co
react with the drained products. Drainage bottles are available in several sizes (typically two-liter bott
indelible marks for easily determination of the fluid content. Drainage bottles are used mainly in abdo
pleural) drainage procedures, either individually as a component of a drainage kit or in sets of two or
suction control, water seal, and fluid collection in underwater drainage systems.

Devices designed to establish a channel for the exit of fluids (e.g., air, serum, blood, lymph, bile) or pu
cavity, wound, or infected area. Drains usually consist of flexible, hollow devices (e.g., tubes) with one
are typically made of Silastic, polyvinyl chloride, or, less frequently, rubber; a drain may include a troc
drains are used either as components of open drainage systems (i.e., through capillary action and gra
systems that usually apply low negative pressure through the drain lumen. Dedicated tubes, catheter
also used for drainage of anatomic sites such as biliary ducts (e.g., T tubes, catheters), the urethra, th
nasogastric tubes), and the brain ventricle (e.g., hydrocephalus catheters, shunts)._x000D_
Drains designed to establish a channel for the exit of fluids (e.g., serum, blood) or purulent material fr
more commonly, a surgical wound that is not directly connected to an anatomic (e.g., abdomen, chest
urinary, biliary). These drains usually consist of tubular, flexible, hollow devices; they are typically ma
chloride, or, less frequently, rubber. Wound drains may allow fluid to drain via capillary action into abs
Penrose drains) as open drainage systems or may be attached to an external calibrated receptacle (es
drainage is expected after surgery) in a closed drainage system in which gentle suction is applied by c
springlike or bulblike device. Drains are placed in wounds when a large amount of fluid accumulation,
healing, is anticipated.

Jars used as clean containers to store dressings and bandages free from contamination. These devices
(e.g., single-use) or reusable cylindrical containers with no handles made of stainless steel or, less fre
with a tight lid that is usually made of the same material; they are supplied in a variety of sizes accord
and/or bandage dimensions. Dressing jars are used to store dressings and/or bandages that are intend
wound or diseased tissue during examination, treatment, and/or surgical procedures performed in hos
and at home.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for a
and/or protective dressings to a wound. Items in these kits usually include a mask, swabs, prep applic
gauze sponges, sterile gloves, bandages, labels, and adhesive/tape. The kits are frequently supplied in
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Dressing procedure
intended to protect a wound from additional injury and/or infections, for bleeding control, as well as to
are used at home, in doctors' offices and hospitals, and in other healthcare facilities.

Sterile pieces of material designed to protect, cover, and provide a healing environment. Dressings m
nonimpregnated material or material impregnated with an agent or substance. Wound dressings are s
mainly used to keep a moist environment, absorb exudates, and protect wounds from contact with ba
dressings may include an adhesive layer. Dedicated nonimpregnated dressings from natural fibers (e.g
origin (e.g., pig skin), synthetic (e.g., polymeric), or a combination of all three are available; dressings
substances that facilitate their use (e.g., odor, moisture control) or with antimicrobial drugs are also a

Antimicrobial impregnated dressings designed to be applied over a wound by means of gaseous suspe
small particles of a liquid or solid (i.e., aerosols). Aerosol dressings are typically made of antimicrobial
combination of antimicrobial and other substances (e.g. haemostatic agents) that, once applied (i.e., e
wound, solidify to provide a protective barrier for the wound and to prevent infection.

Synthetic dressings made of hydrophilic synthetic polymers (typically a polyurethane foam containing
These dressings are usually made of thick plastic film (i.e., sheets) or porous sponge-like materials tha
to vapors and oxygen but impermeable to liquids and bacteria. Foam dressings usually absorb wound
used mainly in wound management.
Dressings impregnated with antimicrobial agents (e.g., silver). The most common substrate used in th
but alginate, foam, hydrocolloid, and hydrogel are also used. Antimicrobial dressings reduce the numb
microorganisms (bacteria, fungi and viruses); they are intended mainly to reduce the risk of infections
skin grafts.
Handheld instruments designed to hold and provide rotatory movement (i.e., torque) to integral or de
drills consist of a manually propelled (some are known as braces) or powered (e.g., electric, pneumati
typically include a chuck and work with other detachable components such as drill bits, burs, reamers
hand drills are used with special guides and/or to work over a guide wire. Hand drills may include an in
particular use; battery operated electric drills provide autonomous operation without connection to ex
Hand drills are primarily intended to excavate cylindrical holes on objects, tissues, and/or other anato
they are used in healthcare for a variety of biopsy, surgical, dental, postmortem, and/or other procedu
also used for installation and maintenance tasks on healthcare devices.

Hand drills designed to obtain specimens intended for biopsy procedures. These instruments consist
or powered (e.g., electric, pneumatic) instrument that typically includes a chuck and other detachable
drill bits, drill needles, and trephines; some biopsy drills are used with special guides. Biopsy hand dril
integral drill bit for a particular (e.g., spinal) use; battery operated electric drills provide autonomous o
connection to external power sources. Biopsy hand drills are used for a variety of purposes, they may
for taking samples of bone, soft tissue (e.g., pulmonary, thyroid, and/or breast), and bone marrow; bio
also used for harvesting bone and/or medullar tissue.

Hand drills used during orthopedic surgical procedures involving the bones. These devices consist of
or powered (e.g., electric, pneumatic) instrument that typically includes a chuck and other detachable
drill bits and reamers; some bone drills are used with special guides and/or over a guide wire. Manual
an integral drill bit for a particular use (e.g., intramedullary reaming); battery operated electric drills p
operation without connection to external power sources. Bone surgical hand drills frequently include s
work over a pin or guide wire (i.e., cannulated hand drills); they are used for a variety of purposes, inc
implants and implantable prostheses and the fixation of bones using plates, bolts, pins, and other com

Hand drills designed for use during orthopedic surgical procedures involving the bones. These devices
guide wire. These instruments consist of a manually propelled or powered (e.g., electric, pneumatic) in
typically works following the direction of a previously inserted pin or guide wire and frequently using a
guide; the drill includes a chuck and other detachable components such as hollow drill bits and reame
surgical hand drills are used for a variety of orthopedic trauma and reconstructive procedures, such as
pins for fixation of plates and other bone implants.

Surgical drill bits designed to be held and revolved by a rotary device to excavate, perforate, or excise
cervical spine, including the vertebrae following the direction of a previously inserted pin or guide wire
typically consist of a cylindrical hollow shank of stainless steel or other hard metal alloy with a uniform
include a working end with cutting edges (e.g., twisted, helicoidally) and a notched or elongated proxi
rotary device (e.g., a hand drill, handpiece); they may also include stoppers to avoid perforation beyo
depth. Dedicated spine surgical drills are available for a variety of procedures and/or segments of the
lumbar, thoracic), including reshaping the spine and implantation of prostheses during orthopedic sur
intended for reuse after sterilization, but can be disposable (single-use).
Skull trephines designed for automatic or semiautomatic cutting of circular sections of the skull (know
perforators). These instruments consist of two coaxial drills, a drive shank that connects to a powered
handpiece, and a built-in clutch mechanism. The inner drill extends slightly beyond the outer drill in s
the inner drill penetrates the inner table of the skull, the clutch mechanism disengages the cutters fro
preventing penetration or nicking of the membrane that contains the cerebrospinal fluid and protectin
mater). Automatic cranial perforators are used to make holes to alleviate intracranial pressure or to ob
fluid samples. They are also used to drill perforations that define the border of a cranial bone flap; a s
used to complete a beveled cut between adjacent drills completing the bone flap in procedures such a
and treatment of cerebral aneurysms. Automated cranial perforators are available as reusable or disp
designed for use with specific electric and/or pneumatic handpieces.

Handheld instruments designed to hold and provide rotatory movement (i.e., torque) to integral or de
burs that are used on the fingernails. Fingernail hand drills consist of high-speed powered (e.g., electr
typically include a control unit and an attached handpiece with a chuck and work with detachable com
bits, burs, and filing/polishing devices. Fingernail hand drills are primarily intended for shaping and fili
therapeutic or cosmetic procedures; they can be also used under the nails and/or to conform the cutic
may also be usedon the toenails.

Surgical bone drill bits designed to excavate the intramedullary bone canal when held and revolved b
propelled or powered device (e.g., a handpiece or hand drill). These devices typically consist of a hollo
steel or other hard metal with a uniform cross-section. They include a working end with cutting edges
elongated proximal end that may be an integral part of a manually propelled instrument or fit into the
Intramedullary cannulated drill bits are frequently used to excise tissue from the bone stem in orthope
prosthesis implantation.

Hand drills designed used during otologic surgical procedures involving the middle ear structures. The
manually propelled or powered (e.g., electric, pneumatic) instrument that typically includes a chuck a
components such as drill bits and burs; some middle ear drills are used with special guides. Battery op
provide autonomous operation without connection to external power sources. Middle-ear surgical hand
include special guides for particular procedures such as stapedectomy and the placing of choclear imp

Burs designed to be held and rotated by a dental handpiece (manual, electric, or pneumatic) to excav
hard tissue in the oral cavity. These burs typically consist of a shank made of tungsten carbide or, less
a well-differentiated working head (sometimes with bound diamond chips or covered with diamond film
and shapes (e.g., round, cylinder, inverted cone, pear) on the distal end; a tapered, notched, or elong
into the rotary device; and a neck that connects the shank to the working part. Dedicated burs are av
periodontal procedures (e.g., impaction, alveolectomy, periapical surgery), and other oral surgery proc
reduction of abnormal bone tissues (exostosis and maxillary or mandibular tori). They are usually inte
sterilization, but disposable (single use) burs are also available.
Surgical bone drill bits designed to perforate the cranium when held and revolved by a rotary device (
handpiece). These devices typically consist of a cylindrical shank of steel or other hard metal with a u
They include a working end with cutting edges (e.g., usually twisted), and a notched or elongated pro
rotary device. Craniotomy drill bits are usually combined with dedicated hand drill attachments (know
attachments, devices that help provide protection for soft tissues when cutting through bones) to prot
mater) by avoiding penetration or damage to the membrane that contains the cerebrospinal fluid. The
obtain openings in the cranium that facilitate aspiration of intracranial fluids using a ventricular cathe

Instruments designed to insert and extract implants and/or prostheses by applying force or torque dur
procedures. Driver/extractors are typically manual, handheld instruments with a working end that con
be driven and a proximal end that can accept impact, pressure, or rotating forces according to the dem
procedure. They are used mainly for the insertion and extraction of implants and prostheses (e.g., bon
plates) during orthopedic procedures.

Surgical driver/extractors designed to insert and extract nails and/or pins into or from bones by applyi
torque during orthopedic procedures. Instruments applying linear force are typically manual, handheld
working end that accommodates nails and pins (e.g., a hollow adjustable cylinder), a handle for manip
sliding sleeve between the tip and the handle for hitting (hammering) the working end; instruments in
usually include a threaded working end (either male or female), a rotating shaft, and a concentric, T-s
configured handle appropriate to apply manual torque. Bone nail and pin driver/extractors are used m
procedures (e.g., femur, hip prostheses implantation); dedicated instruments are available for specific
specialized prostheses (e.g., medullary nails).

Surgical driver/extractors designed to insert and extract bone plates into or from the surface of bones
force during orthopedic procedures. These instruments are typically manual, handheld devices with a
the plate (e.g., by threading to it) and a handle for manipulation. Bone plate driver/extractors are used
insertion of templates in orthopedic procedures (e.g., femur, knee prostheses implantation); dedicated
available for particular plates used in specialized prostheses (e.g., patella templates).

Flexible endoscopes designed for direct insertion through the mouth in the upper gastrointestinal trac
examination, biopsy, and treating lesions of the interior of the proximal portion of the small intestine f
jejunum (i.e., duodenum). Duodenoscopes usually consist of a flexible outer sheath, a lighting system
channel for catheters and operative devices.
A hollow tube, open at both ends, usually having an aspiration bulb attached to one end, intended for
volume of liquid so the liquid may be dispensed in single drops into the ear canal. Droppers are usual
plastic.
Prepackaged collections of the devices (either custom or standard) and supplies needed for the liquid
external auditory canal and/or structures of the middle ear. Items in these kits usually include a needl
syringe (typically 50/60 cc for adults and/or 20/30 cc for children), a container, a tip protector, a water
alcohol pad; they may also include a catheter to facilitate the irrigation when using gravity force. The
irrigation in the kit may be also used for aspiration (i.e., removal) of the irrigating fluid and/or debris (
kits may be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacl
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Ear irrigation/lavage kits and trays are intended mainly for use during diagnostic and/or ther
extraction of excessive wax) procedures.
Occlusion plugs designed for temporary insertion and occlusion of the external ear canal. These plugs
cylindrical devices made of soft rubber, rubber-like materials (e.g., soft silicone), or wax. They are mai
the wearer's ears from loud noises or the intrusion of water, foreign bodies, dust, or excessive wind. E
available for many particular needs (e.g., sleeping, travelling, shooting, and/or studying). Special-use
filters that seal out water but allow sounds to pass through for swimming, damping-air pressure chang
cabins), or attenuate high-frequency sounds while allowing normal conversation are also available. So
are attached to headbands to facilitate their use.

Bulb syringes with appropriate volume, size, and tips to irrigate and/or aspirate fluids to and from the
ulcers.
Cardiac simulators designed to mimic the electrical signals of the normal sinus rhythms of the heart. T
analog circuit generator and/or digitally recorded signals in their memory. When activated they produ
electrocardiographic wave (including the P wave, QRS complex, and T wave), usually at a set of prees
30, 60, 90 beats per minute), at several possible amplitudes, and with up to 12 lead outputs. Some sim
measure, evaluate, display, and/or record a set of data of the electrocardiographic device parameters
typically including gain, frequency response, common mode rejection ratio, alarms, paper speed, dyna
and rate alarms; they may also simulate pacemaker signals. Electrocardiographic simulators are used
precision of electrocardiographic devices (e.g., recorders, monitors), to check patient lead continuity a
and to train healthcare personnel to properly operate devices used in cardiac procedures (e.g., cardiop
resuscitation, cardiac catheterization). Most electrocardiographic simulators can also simulate a set of
electrocardiographic signals to test arrhythmia monitors and recorders.

Cardiographs used for recording ultrasonic waves directed through the heart and reflected backwards
instruments consist of a main unit that includes an RF generator, a recorder, and detachable probes w
transducers (typically piezoelectric) located in a housing at the distal tip that are connected to the rec
integral cable. The transducers convert electrical signals into ultrasonic signals and vice versa; they a
the ribs (a transthoracic [TTE]) and other areas of the upper abdomen to send the ultrasonic signal tow
detect the echoed signal. The signal is then converted into moving pictures showing the beating hear
other structures of the heart. Echocardiographs capable of showing two- and/or three-dimensional pic
well as devices based on the Doppler effect to record the movement of the blood through the heart ar
Dedicated probes, less frequently used, intended for placing inside the esophagus (transesophageal c
also available. Echocardiographs are used for evaluation of recorded information of the heart condition
intended for real-time assessment of the cardiac conditions.
Encephalographs designed for recording ultrasonic waves directed through the brain and surrounding
backwards (i.e., echoed). These instruments consist of a main unit that includes an RF generator, a re
probes with ultrasonic transducers (typically piezoelectric) located in a housing at the distal tip that ar
recorder through an integral cable. The transducers convert electrical signals into ultrasonic signals an
located externally on the scalp to send the ultrasonic signal towards the brain and to detect the echoe
then converted into images of the brain showing its structures and the presence of tumors, hemorrhag
abnormalities. Echoencephalographs capable of showing two- and/or three-dimensional pictures of the
devices that can also measure the movement of the blood through the brain (i.e., the blood flow) usin
are also available. Echoencephalographs are used for evaluation of recorded information of the brain c
intended for real-time assessment.

Ultrasonic scanning systems that include an ultrasonic scanner (usually operated in A or B mode), tran
of 7.5 to 10.0 MHz are typically used because high-resolution imaging is needed), dedicated software,
subsystem, and a printer. Most ophthalmic ultrasonic scanning systems are used to measure the axia
assess eyes in which opacity prevents direct ophthalmologic examinations, and to study both intraocu

Apparatus for the removal of saliva and water from the mouth of the patient during dental procedures
Testers designed to manually and/or automatically verify the safety of electrically powered medical de
include an electric current meter that can measure the alternating current (AC) and direct current (DC
milliamperes (mA) with a frequency response that complies with appropriate standards. Electrical safe
AC and DC leakage-current measurements (typically from 1 A to 20 mA) and resistance-to-ground ass
and/or four-terminal techniques in devices up to several ohms; many testers can perform patient lead
multiple-electrode devices. Some testers can also assess the safety of other electrical devices and acc
voltage/wiring in receptacles and the integrity and operation of ground-fault circuit interrupters; they
signals with appropriate frequencies and waveforms to test several types of medical devices (e.g., pac

Cardiographs designed for recording the variations of the electric potential caused by the electrical ac
muscle, usually detected at the body surface. These instruments consist of a main unit that includes a
processors, and detachable leads that are connected to disposable electrodes fixed on some anatomic
the distal tip. The electrodes and leads transmit the bioelectrical signals to the recorder, which is capa
their characteristics in an amplitude versus time graph (electrocardiogram). Electrocardiographs (ECG
cardiac abnormalities, determine the response to drug therapy, and reveal trends or changes in the he
Electrocardiographs that measure and record only the signal from one channel at a time (i.e., single-c
accurate instruments appropriate to record signals from two or more leads simultaneously (i.e., multic
available. Electrocardiographs are not intended for a real-time assessment of the electrocardiogram o
conditions.

Electrocardiographs (ECGs) designed for recording the variations of the electric potential caused by th
the heart muscle, usually detected at the body surface from two or more leads simultaneously. The in
records several ECG signals automatically; permitting a simultaneous analysis of the electrocardiograp
Multichannel ECGs are used to diagnose cardiac abnormalities, determine the response to drug therap
changes in the heart function. Multichannel electrocardiographs are not intended for a real-time asses
electrocardiogram or other cardiac conditions; instruments that can perform computerized automated
interpretation of the ECG are also available.
Electrocardiographs (ECGs) designed for recording the variations of the electric potential caused by th
the heart muscle, usually detected at the body surface from only one lead at a time. The instrument m
several ECG leads sequentially, either automatically or operator selected. Single-channel ECGs are us
abnormalities, determine the response to drug therapy, and reveal trends or changes in the heart func
are not intended for a real-time assessment of the electrocardiogram or other cardiac conditions

Devices designed to coagulate and/or destroy tissue by applying an electric current to a high-resistan
mainly to control bleeding and for therapeutic procedures. Electrothermal cautery units do not deliver
tissue; the high-resistance tip becomes heated when an electric current is passed through it or when a
guide converts infrared radiation to heat. These devices typically include a power source (either line o
the electric current; appropriate controls; a pencil- or pistol-like handle (handpiece), including the ther
electric cord to connect the probe to the power source. Most units are available with a set of probes fo
(e.g., dermatologic, gynecologic, hemorrhoid treatment); some probes include an internal irrigation sy
electrocautery units using high-resistance elements or infrared lamps are available. The units are freq
computer that facilitates the selection of the appropriate temperature and/or energy level.

Conducting media (jelly or paste) that is applied to the surface of the body to transmit the electrical s
surface to an electrode, usually in electrocardiography.
Testers designed to measure the impedance between surface electrodes and the skin; most testers ar
detecting faulty lead wires and/or cables. These testers include an impedance-measuring instrument t
low frequencies (e.g., 10 Hz, 30 Hz), measuring impedances from a few ohms to several hundred kilo-
visual and/or audible alarms that indicate when the measured value is outside a predetermined range
capable of measuring interference voltages that may be stored in the electrodes (i.e., offset voltage).
testers are used to assess the ability of electrodes to conduct bioelectrical signals (e.g., cardiac, encep
skin to the electrodes and through the leads and cables to the measuring unit.

Adhesive bands used to hold electrodes in place.


An electrode used in chemical analysis of the blood for the concentration of dissolved gases or pH.
Electrodes used in chemical analysis of the blood for concentration of carbon dioxide. The carbon diox
blood sample quickly equilibrates through a plastic membrane covering the glass electrode and is me
the resulting pH of the bicarbonate solution in which the electrode is located.

Electrodes used in the chemical analysis of the blood for the concentration of oxygen. The electrode u
platinum wire or dropping mercury; oxygen concentration in blood samples is measured by polarograp

An electrical conductor that is placed in contact with the bladder to stimulate it and/or record its elect
diagnostic examination.
Cardiac electrodes designed to detect and transmit bioelectric signals from the heart usually to an ele
cardiac monitor. Electrocardiography (ECG) electrodes are available in a variety of configurations that
transcutaneous (also known as skin or superficial electrodes) use or for transesophageal or transveno
electrodes are detachable from leads and/or cable leads. Implantable and catheter mounted ECG elec
integral part of implantable leads and catheters, respectively) are also available. ECG cardiac electrod
measuring, recording, and/or monitoring the cardiac rhythm that is typically displayed in a graphic kn
electrocardiogram; they are used in diagnostic, therapeutic, and surgical procedures.

Neurologic electrodes designed to detect and transmit bioelectric signals for measuring, recording, an
brain function (i.e., electroencephalography); they are typically placed on a patient's scalp. These elec
or disk-shaped and are affixed to the scalp by means of a conductive adhesive or gel. The electrodes p
connected to an electroencephalogram (EEG) head box containing electrode lead connectors that amp
signals to be recorded and/or displayed in a graphic form. Careful placement of electrodes is necessar
interpretation. Electroencephalography electrodes are used in observing and diagnosing a variety of n
including epilepsy, related convulsive disorders, and brain death. Dedicated encephalography electrod
specific anatomic locations (e.g., nasopharyngeal EEG electrodes) are also available.

Neurologic electrodes designed to detect and measure the electrical potential present on the skin, nea
or muscle group in consequence of a muscle contraction. These electrodes may be non-invasive small
electrodes which are applied at the desired locations on the skin using either tape or water-soluble pa
needle and fine-wire electrodes intended for deep muscles. Using appropriate placement, the voltage
related to the activity of a single or specific group of muscles; the signal is represented as a trace that
increasing from zero up to tenths or hundreds of microvolts as the muscle becomes activated. Myogra
typically used in motion analysis to assess muscle function, with application in sports, ergonomics, oc
rehabilitation medicine; they are also used for investigation of both muscle activation and muscle phy
characteristics.

Neurologic electrodes designed to detect and measure bioelectrical signals generated by eye moveme
(electronystagmography, ENG) as the result of cold and/or warm fluids entering the ears. These device
electrodes that are placed above, below, and on each side of the eyes. As the eye moves, the electrod
signal caused by eye movement and relay it to one or more channels, where it is amplified. Electrode
conventional three-point configuration ENG (i.e., one electrode on each eye and one on the forehead)
used to measure the potential from both eyes simultaneously. Electrodes used in a configuration requ
each eye that are intended to perform electronystagmography measuring eye movement in any direc
and horizontal, known as vector-electronystagmography, are also available. The electrodes are placed
center of each eye at right angles on the vertical and horizontal axes, resulting in less error than with
configuration. ENG electrodes are used to assess the functioning of the brain's acoustic and oculomoto
used to determine the causes of visual problems, vertigo, and/or dizziness. The electrodes are also us
measure eye movements resulting from involuntary, periodic and rapid movement of the eyeballs (i.e
the application of any external stimuli.
Visual evoked potential electrodes designed to be placed on the nasal and lateral canthi of each eye t
potentials generated by ocular activity; the electrodes typically measure the gradual change in the ele
measured between the retina and cornea during dark-to-light adaptation. These electrodes are typica
operating in a similar manner to those used in electroencephalography; tape may be used to attach th
the eye. Two or more electrodes may be used in electrooculography to monitor both eyes concurrentl
electrodes are frequently used in analysis combining electrooculography and electroretinography stud
certain retinal diseases.

Neurologic electrodes designed to apply electrical current through the brain in order to induce a gene
convulsive therapy). These electrodes are typically flat in shape, one or two inches in diameter, and a
application to the head. The electrical current delivered from a power source flows through the brain b
placed on the head. The electrodes are usually placed above each temple, or one electrode is placed a
the other is placed in the middle of the forehead. Hand-held electrodes or single-use adhesive gel-pad
used. Convulsive therapy (also known as electroshock) electrodes are currently used to induce a gran
for treating various psychiatric illnesses such as bipolar disorders and severe depression in cases whe
medication, psychotherapy, or both have proven ineffective.

External pacemaker electrodes designed to be placed in the esophagus via the mouth or nose to deliv
heart. The esophagus lies directly behind the heart and has relatively thin tissue whose moisture is be
transmission. These electrodes typically consist of flexible insulated electrical conductors with the pro
an external pacemaker pulse generator and the distal end applied into the esophagus; transesophage
usually disposable. Transesophageal cardiac pacemaker electrodes are usually intended to regulate at
used in the diagnosis and temporary treatment of atrial arrhythmias, they also can be used to induce
diagnosis of heart disease.

Electrocardiography (ECG) electrodes designed for application directly to the fetal scalp after rupture
transmits bioelectric signals from the fetal heart to an intrapartum fetal monitor. These electrodes ma
is insulated except at the metal prongs which work as electrodes; a clip with a single or double spiral e
distal end; or electrodes that use other means for fixing to the scalp. The electrodes are usually dispo
of fetal scalp EGC electrodes after sterilization is possible. Fetal scalp ECG electrodes are mainly inten
transmit bioelectric heart signals for measuring, recording, and/or monitoring the cardiac rhythm of th
perinatal period. They are used to assess the progress of labor and the well-being of the fetus.

Neurologic electrodes designed to detect and transmit bioelectric signals for measuring, recording, an
brain function (i.e., electroencephalography, EEG) that are placed in the nasopharyngeal region. Thes
typically transdermal, thin, stiff silver rods or needles covered with sleeves and ending in an exposed
contact. These electrodes are inserted bilaterally through the nostrils to come to rest against the back
Nasopharyngeal EEG electrodes can also detect the brain's response to repetitive stimuli along a spec
evoked potential).
Electrodes designed to transmit or receive bioelectric signals from the nervous system and/or to apply
the system. These electrodes are available in a variety of configurations including scalp electrodes (al
superficial electrodes), transcutaneous electrodes (e.g., transdermal needles), and implantable electro
neurology electrodes are used for a variety of procedures, such as to detect and transmit bioelectric s
nervous system, including the measurement recording, and/or monitoring of the brain function (i.e.,
electroencephalography), to deliver periodic electric stimuli to the brain (e.g., to alleviate tremors and
provide brain shock (i.e., electroconvulsive therapy), and to detect the brain and central nervous syst
several types of stimuli (i.e., evoked potential measurement). Electrodes capable of performing severa
also available.

Electrodes designed to apply electrical stimuli to nerves and/or muscles from external and/or implanta
stimulators. These electrodes may be external devices fixed on the skin over the nerves and muscles,
probes appropriate for insertion in the natural cavities of the body, or implantable devices fixed direct
nerves and muscles. Dedicated neuromuscular stimulator electrodes are available for a variety of diag
applications, including gait, grasp, muscle strengthening, incontinence, bladder evacuation, swallowin

Implantable cardiac pacemaker leads designed to conduct electrical pacing signals from the pulse gen
implantable pacemaker to electrodes placed on the outer surface of the heart (i.e., myocardial) and th
bioelectric cardiac signals back to the unit. These leads typically consist of flexible wires that are com
at the electrode tip that makes contact with the heart. Myocardial (also known as epicardial) leads are
the surface of the heart using open surgery; the other end of the leads is attached through a connecto
generator that is usually implanted in a surgical pocket located in the upper chest near the collarbone
pacemaker myocardial lead configurations may be unipolar, with one active electrode contact on the h
two active contacts. Lead size, connector type, and other characteristics of the leads must be compat
generator used.

Visual evoked potential electrodes designed to be placed on the cornea (i.e., at the front of the eye) to
change in the electrical potential of the retina in response to a sudden flash of light (i.e., electroretino
electrodes typically include speculum structures used for holding the eye open and a contact lens with
electrode) supported by a small spring that floats on the cornea. They are gently placed on each eye w
similar to a contact lens inserter; an additional electrode is placed on the skin to provide a ground for
signals produced by the retina. The information from the corneal electrodes measuring the electrical a
response to the flash of light is transmitted to a monitor where it is displayed. Reference skin electrod
above and below the eye. ERG electrodes are commonly used in procedures for evaluating both inher
acquired disorders of the retina; they are also used in analysis combining electrooculography and elec
studies to help diagnose certain retinal diseases.
Encephalographs designed for recording the variations of the electric potential caused by the electrica
usually detected on the scalp. These recorders consist of a main unit that includes memory (e.g., strip
signal processors, and a cable that is connected at the distal tip through a head box (amplifying unit)
The electrodes are typically placed on a cap or net fixed on the scalp in an array of standardized posit
electrodes are used in very specific procedures. The electrodes and leads transmit the bioelectrical sig
which is capable of storing their characteristics for later display in an amplitude versus time graph (i.e
electroencephalogram); some recorders can also provide a spectral analysis of the signals using a ded
Electroencephalographs (EEGs) are used to help in the diagnosis of neurological diseases (e.g., epilep
localizing tumors and lesions inside the cranium, and also facilitate the assessment of the status of pa
brain death). Ambulatory and dedicated computerized EEG recorders intended to provide further anal
also from data taken from sleep disorder studies and/or to evaluate the electrical response of the brai
(i.e., evoked potentials) are also available. EEGs are not intended for a real-time assessment of the ele
other brain conditions.

Electromechanical goniometers designed for automated measuring of angles; clinical electrogoniomet


measure the angle of displacement (i.e., bending) of a joint (usually from 0 to 180 degrees or more) u
and appropriate sensors and transducers. Electrogoniometers may consist of a small-diameter flexible
blocks on each end, a strain-gauge mechanism housed inside the spring that changes its electrical res
to the change in angle between the longitudinal axes of the end blocks, and an electric meter (i.e., ga
are attached to the limb segments with double-sided adhesive tape. These devices are biaxial, enablin
measurement of sagittal and frontal plane motions; they are available in various sizes to accommodat
knee, elbow, shoulder, finger). A variety of potentiometric goniometers are available; they are designe
potentiometer shaft to rotate proportionally to the joint angle being measured. Electrogoniometers are
rheumatologists and physiotherapists to assess joint function and in the diagnosis and treatment of lo
diseases; they are frequently included as a component of gait and/or joint laxity analyzers.

Myographs designed for detecting, amplifying and recording the electrical potential of skeletal muscle
activity. These recorders typically consist of signal amplifiers, filters (to suppress interference), memor
optical/magnetic disc), a loudspeaker, and a display. They also include detachable surface electrodes
(or, for more accurate measurements, needle- or fine-wire electrodes are placed within the muscle). T
displayed as a graphic of the measured voltages vs. time (an electromyogram); as the signals occur a
they can be amplified and reproduced using a loudspeaker which facilitates the identification of specifi
Electromyographs are mainly used to assess the functional ability of the peripheral nerves, helping in
neurological and neuromuscular disorders.

Recorders designed to record the electrical potential created by eye movements. These recorders con
that includes electronic memory (e.g., electronic, hard disk) and a set of detachable electrodes. The re
include one or two channels for simultaneously measuring the potential from both eyes to allow the m
potential in magnitude and direction as a vector. Electronystagmographs are used to detect the perfor
and oculomotor nerves whose dysfunction may cause dizziness or vertigo and may be affected in dise
sclerosis, vestibular dysfunctions, the presence of drugs, and by other specific disorders characterized
movement (nystagmus).
Visual evoked potential (EP) recorders designed for detecting, amplifying, and recording the changes i
between the retina and the cornea in response to specialized external visual stimuli (e.g., alternation
conditions). The results may be displayed as a graphic of the measured voltages versus time (an elect
recorders typically consist of detachable electrodes usually placed on the nasal and lateral canthi of e
suppress interference); memory (e.g., electronic or optical/magnetic disc); and a display. Electrooculog
capabilities to induce light adaptation and to provide additional stimuli at an appropriate repetitive lev
bioelectric response needed for recording. Electrooculographs measurements (typically in microvolt) a
as the ratio of the maximum value obtained during the light period to the minimum value at the dark
Arden ratio). Decreases in this ratio are associated with retinal pigment disorders. Some recorders wi
capabilities to perform electroretinography, other specialized forms of visual EP response, and/or for r
the short, fast movements of the eyes made during reading and sleep (i.e., saccadic velocity) are also

Visual evoked potential recorders designed for detecting, amplifying and recording the transient chan
potential on or near the surface of the cornea to a reference distal point on the body, following stimula
external repetitive stimuli. The results may be displayed as a graphic of the measured voltages vs. tim
electroretinogram); the graph usually shows the a-wave is the first large negative component, followe
is corneal positive and usually larger in amplitude. These recorders typically consist of detachable ele
on the cornea (e.g., similar to a contact lens) and on the skin near the eyes; signal amplifiers; filters (t
interference); memory (e.g., electronic, optical/magnetic disc); and a display. The recorder may includ
external stimuli (e.g., reversible checkerboard patterns, flashlights) at an appropriate repetitive level t
response needed for recording. Electroretinographs are mainly used in studies intended to diagnose a
inherited retinal diseases, including retinitis pigmentosa. Recorders with additional capabilities for rec
the short, fast movements of the eyes made during reading and sleep (i.e., saccadic velocity) are also

Electrical brain stimulators that apply stimuli (electric shock) to a patient's brain to induce convulsions
consciousness. The stimuli are applied through electrodes placed on an unshaved scalp or on bare sk
stimuli are not usually targeted toward specific areas of the brain. These stimulators typically consist
controls, displays and printers, and electrodes; some also include monitors (e.g., electrocardiograph, e
to display vital signs during treatment. The shape, duration, and repetition rate of the electrical stimu
stimulators determine the amount of energy reaching the brain. Convulsive therapy electrical stimula
patients with major depression, schizophrenia, and mania.

Devices that apply stimuli (typically pulsed electric currents of 5 to 50 mA) to a patient's brain for sev
a state resembling that of chemically induced anesthesia. These stimulators usually include an electr
controls to vary pulse rate, pulse width, and voltage or current. The current is normally passed throug
the frontal and occipital regions via large-area electrodes covered with saline-soaked gauze sponges.
Testers designed to assess the performance of electrosurgical units (ESUs). These testers can usually
display, and/or record ESU generator power, current, peak voltage output, and radio-frequency curren
appropriate test load. Most testers can also verify the operation of the neutral electrode contact qualit
testers are typically an electronic unit with measuring devices (e.g., wattmeter, ammeter), displays, a
loads, and test leads. ESU testers can test monopolar and bipolar ESUs; they may be manually operat
programmable to run automatic test protocols for a specific ESU.

Units that perform surgery using a high-frequency electric current. The electrosurgical heating effect t
destruction is provided by tissue resistance to the high-frequency, high-density current rather than by
electrocautery devices. Electrosurgical units deliver and receive electric current through cables and el
include a detachable footpedal for switching on foot-controlled active electrodes. These units are use
scalpels for cutting tissue and controlling bleeding by causing coagulation (i.e., hemostasis) at the sur
capillary beds in the liver or spleen), as well as providing a combination of cutting and coagulation.

Adapters designed to interconnect cables from a different manufacturer and/or model to an electrosur
may also be used to connect cables to discontinued and/or obsolete models, to perform special (e.g.,
minimally invasive, or laparoscopic surgery) procedures, or to increase safety of connection. These ad
of a dedicated electrical (e.g., bipolar-coaxial) connector intended for a particular use. Adapters may b
attached devices capable of connecting to a standard plug in one end and to a recessed plug in the co
ESU at the other. Electrosurgical unit cable adapters are used to facilitate electrosurgical procedures a
possibility of electric shock due to an improper connection of the cables.

Combinations of cables and leads designed for electrical connection between electrodes placed on or
electrosurgical unit (ESU). These combined devices may consist of a cable with one or two leads (for m
surgery respectively) attached to active electrodes; monopolar surgery typically involves using pen-lik
bipolar surgery is performed usually using the tips of surgical instruments such as forceps or scissors
Monopolar surgery requires an additional cable that is usually attached directly to a dispersive (i.e., re
cables/leads are used to pass high density radiofrequency energy through the tissues while performin

Holders (sometimes called holsters) designed to temporarily hold the active electrodes used during el
they are not in immediate use. They are usually made from a sturdy plastic non-electroconductive sha
the electrosurgical instrument to form a protective casing should the instrument be inadvertently turn
electrosurgical electrode holders are made to be sterilized for reuse while others are single-use dispos

Active electrosurgical electrodes controlled by a hand switch designed to deliver radiofrequency (RF) e
body tissues. These electrodes deliver the RF energy received through insulated cables from an RF ge
electrosurgical unit; they are usually a component of a handpiece or surgical instrument (for monopol
respectively) that is manipulated by the surgeon; the handpiece also includes a hand switch that allow
surgeon. Hand-controlled active electrosurgical electrodes may apply monopolar or bipolar current. Th
procedures intended to cut tissues, stop bleeding, and/or for tissue fusion.
Electrodes designed for returning the radiofrequency (RF) current from the patient to the electrosurgic
surgery procedures. These electrodes typically consist of conducting pads that are attached to the pat
from the surgical site; they conduct back (i.e., return) the dispersed current to the RF generator throug
without burns or other effects to the patient due to the pad's large contact area. Return electrosurgica
used in conjunction with active electrosurgical electrodes during monopolar procedures.

Forceps used to grasp, cut, and remove tissue and control bleeding during electrosurgical procedures.
to a generator by a cable, regulated by a footswitch or a handswitch, and have an attached electrode
frequency, low-voltage current to the tissue.
Electrical stimulators designed to apply electrical stimuli to soft tissues. These stimulators typically co
generator that delivers weak current signals to the tissues. Soft-tissue electrical stimulators are intend
healing process; they are used mainly in the treatment of chronic wounds and/or ulcers.

Retractors for elevating or repositioning the zygomatic bone and/or arch.


Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
medicine administration. Items in these kits usually include syringes and antiseptic bandages, gauze,
also include vials with basic emergency drugs such as amyl nitrite, ammonia, atropine, epinephrine, a
glucose, and antihistamines. The kits are frequently supplied in supporting trays (i.e., procedure trays
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Medicine administration emergency procedure k
intended for use in the quick and effective treatment of common patient emergencies including those
asthma, diabetes, allergic reactions, fainting, and heart attacks. They are used in the field, at home, in
and in other areas of healthcare facilities.

Bowls used to collect/contain vomit or oral secretions. Emesis bowls may be reusable (e.g., made of m
(e.g., made of cardboard or plastic), and often contain an indentation around the lip of the bowl to acc

Endoscopes designed for insertion through a hole in the skull into one of the cavities of the brain for v
biopsy, and treatment of lesions of the brain, especially during surgical procedures. Encephaloscopes
outer sheath, a lighting system, and a working channel for catheters and operative devices

Instruments that radiographically demonstrate the condition of internal organs and cavities by means
materials.
Small radio transmitters inserted within a body cavity or tube, as within the intestinal lumen to measu

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for s
intended to obtain endometrium samples for in-vitro tests. Items in these kits usually include a device
(e.g., a plastic aspirator, a swab), a specimen collector, a slide, a speculum, and anesthetics (e.g., lido
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Endometrium sampling procedure kits and trays are used to obtain endometrial tissue samp
analysis in order to diagnose diseases based upon tissue examination. They are used in hospital clinic
doctors' offices, and in other healthcare facilities.
Batteries designed to deliver energy to the lamp (e.g., halogen) of some rigid endoscopes (e.g., otosc
ophthalmoscopes) and illuminators (e.g., larynx, nasopharynx). These batteries usually consist of a se
alkaline cells or nickel-cadmium rechargeable cells. Some of these batteries are mounted in the handl
some rechargeable batteries may be attached to a specially designed recharger unit or directly to a p
recharging purposes. Endoscopic batteries are used to provide a stable voltage to endoscopic lights,
illumination while performing diagnosis or other medical procedures. Some of these batteries are also
enough power to operate an electrocautery unit.

Constant-voltage transformers designed to deliver energy to the lamp (e.g., halogen) of some rigid en
otoscopes, ophthalmoscopes) and illuminators (e.g., larynx, nasopharynx). These transformers are usu
line voltage (e.g., 120 V, 240 V) at the input and deliver a low voltage (e.g., 2.5 V) at the output. Endo
voltage transformers are used to deliver a steady voltage to endoscopic lights, thus providing constan
performing diagnosis or other medical procedures. Some of these transformers are also capable of de
to operate an electrocautery unit.

Bags designed to store liquids to be delivered into the rectum for the purposes of stimulating defecati
bags typically consist of a flexible plastic, calibrated container with a self-closing valve and a plastic tu
permits the solution to drain quickly and completely. These bags are frequently part of an enema kit t
lubricated tips, clamps, waterproof underpads, and soap. Dedicated enema bags for use for infants an
available.

Prepackaged collections of the devices and supplies (either custom or standard kits) needed for the in
into the rectum (i.e., enema administration). Items in these kits may include an administration tip, tub
clamps, and a reservoir for the solution. The kits are frequently supplied in supporting trays (i.e., proc
of a flat-bottomed receptacle with a border around the periphery supporting all the instruments and s
procedure; the trays are usually covered or wrapped. Enema procedure kits and trays may be intende
gastrointestinal tract cleansing, and/or for diagnostic or therapeutic purposes. They are used at home
other healthcare facilities.

Devices intended to support the patient during an ear/nose/throat examination or treatment. These u
specialized features for examination and/or treatment. They typically incorporate the table and/or cha
system.
Alarms designed to activate a visual or more frequently audible (e.g., a buzzer sound) alarm when we
involuntary small discharge of urine during sleep (i.e., enuresis) is detected. These devices typically c
sensor that is attached to a pad, sheet, or the underwear of a patient (usually a child), an electronic u
alarm located on or near the bed. When a child begins to wet the bed an alarm is triggered and wakes
finish urinating in the toilet. Enuresis (also known as bed wetting) alarms are used mainly to facilitate
modification treatment intended to get control of the urinary bladder in otherwise healthy children; th
geriatric/long-term care settings to manage incontinence.
Instruments designed to measure mechanical work (i.e., the amount of force multiplied by the distanc
is applied) or rate of work (i.e., power) including work produced by the force of muscular contraction p
or group of muscles, typically under controlled conditions. Clinical instruments are typically associated
(e.g., a bicycle, treadmill) that is usually an integral part of the ergometer; the variables measured by
on the associated exerciser. Ergometers measure the work exerted by patients on a treadmill by deter
the ratio of the treadmill's elevation to its length (i.e., usually expressed as percent grade); those used
determine the work and power by measuring the force exerted during pedaling and the speed of the p
treadmill ergometers are used in tests intended to determine whether patients have cardiovascular or
they are frequently used in tests that include use of a stress exercise physiologic monitoring system.

Bougies designed for passing through the esophagus, usually to dilate and/or calibrate strictures. The
instruments consist of a strong-walled rubber tube that is filled with mercury (or tungsten) or a set of
shaped tips, devices that are inserted via a previously swallowed string. Esophageal bougies are inten
stenosis, esophagitis, and/or cardiospasm; some esophageal bougies permit the introduction of an ext
tube (a filiform) via their lumen for use as a guide or for dilation of very thin strictures.

Peristaltic motility analyzers designed to determine the motility of the esophagus by measuring the pr
catheter at several points. These analyzers usually include nonperfusion catheters to measure the eso
directly and/or perfusion catheters and extracorporeal transducers to measure the pressure indirectly.
motility analyzers also measure pH, respiration, and swallowing using appropriate sensors. These ana
evaluation of patients with dysphagia, acid reflux (heartburn), and/or noncardiac chest pain; they are
connective tissue and neuromuscular diseases.

Endoscopes designed for direct insertion through the mouth into the upper gastrointestinal tract for vi
biopsy, retrieval of foreign bodies, and treatment of lesions of the interior of the esophagus. Esophago
of an outer sheath, a lighting system, and a working channel for catheters and operative devices; thes
rigid or flexible.
Instruments designed for measuring tactile sensation, sensitivity, pain, or thermal stimuli thresholds i
sensorineural dysfunction such as hypoesthesia or hyperesthesia. They can be used to test different p
hand, lip, cheek, etc.). Esthesiometers (also called anesthesiometers or anesthesimeters) are handhel
which sensation is measured by pressure applied through the esthesiometer's tips designed for differe
are either monofilaments of varying lengths or diameters (used to quantify the pressure transmitted a
bending stress), firm vinyl tips (used to measure sensory pain threshold), or semi-conductor heat pum
metal plate (used to measure heat sensation). Esthesiometers may be attached to systems to store an
readings, and may be computer-controlled to limit the amount of pressure or heat applied to the test s
be non-powered handheld devices. Esthesiometers used to test cornea nerve sensitivity with a contro
stimulation are also available.
Physiologic recorders designed for detecting, amplifying and recording the brain's bioelectric response
potential [EP]) to visual, auditory, and/or somatosensory external stimuli. These recorders typically co
electrodes usually placed on the scalp and/or the skin over the spine; signal amplifiers; filters (to supp
memory (e.g., electronic or optical/magnetic disc); and a display. EP recorders usually include capabili
stimuli (e.g., electric, visual) appropriate to elicit the bioelectric response needed for recording. EP rec
in studies intended to diagnose auditory lesions and sensory function abnormalities; they are also use
auditory function in infants as well as the sensory function after trauma or in comatose patients. Devi
and myographic recording capabilities are also available.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for re
blood and replacement with transfused blood from a donor until most part of the patient's blood has b
exchange or exsanguination transfusion). Items in these kits usually include a stopcock extension tub
umbilical), syringes, and needles. The kits are frequently supplied in supporting trays (i.e., procedure
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Exchange transfusion procedure kits and trays a
counteracting the effects of serious jaundice (i.e., icterus) and/or other diseases in newborns; they are
blood diseases such as sickle cell anemia. They are used in newborn, emergency, and intensive care a
other healthcare facilities.

Exercisers designed to improve balance and muscle strength. These exercisers are usually wooden sta
to support the balance of the user. Static stair exercisers are mainly intended to improve balance and
strength and endurance, particularly in the lower body (e.g., quadriceps, hamstrings, gluteus, hip flex
used mainly in physical therapy and rehabilitation.
Footstools that include platforms at two or three different heights (i.e., two or three steps); some inclu
a high-level step, while others include two low-level steps and a central high-level platform. These sto
wood or consist of a tubular metallic structure with a nonconducting material (e.g., rubber, plastic) co
platforms. Two/three-step stools assist patients getting on and off treatment and examination tables;
testing exercises and for foot examination.

Devices designed to facilitate physical exertion of body muscles by voluntary contraction and relaxati
controlling the body part (i.e. active exercisers) or by motion imparted on the body part by the device
exercisers). Active exercisers usually are intended to keep and improve the cardiorespiratory function
and to increase muscle strength (e.g., hands, limbs, back) and to improve balance and/or flexibility; th
during physical therapy and rehabilitation. Passive exercisers mainly are intended for physical therapy
after illness, trauma, or aging (e.g., upper and/or lower limbs). Computer-aided exercisers intended to
patients by using a dedicated computerized unit are also available.

Passive exercisers designed to apply controlled movements (e.g. flexion, extension, rotation) on limb j
exertion. These exercisers typically consist of an electronically-controlled electromechanism that is att
limb to provide periodic, rhythmic movements through a range of motion. Continuous passive motion
to prevent joint stiffness; they are used for physical therapy and rehabilitation after illness, trauma, an
treatment. Dedicated exercisers for the upper limb and lower limbs are available.
Lower-limb flexibility exercisers designed to improve the range of motion (i.e., flexibility) around a join
muscles in the lower limbs. These exercisers usually consist of wooden boards that form two triangles
and control the movement of the knee; usually the height and angle of the quadriceps board are adju
boards are intended to improve the flexibility of the muscles in the lower limbs; they may also increas
strength.

Breathing exercisers designed to increase and measure the capabilities of the lungs, such as the maxi
that can be expired from the lungs (i.e., expiratory vital capacity [EVC]) and/or the maximum volume
inspired into the lungs (i.e., the inspiratory vital capacity [IVC]). These devices are a spirometer with a
resistance to the respiratory effort (also known as an incentive spirometer). Patients perform the respi
inhaling with the additional effort needed to overcome the device resistance; typically, one or more ba
measure of inhalation effort. Respiratory exercisers using spirometry techniques are intended mainly f
after pulmonary procedures; some devices employ spoken or auditory prompts to increase patient usa
assistance and guidance.

Full-body flexibility exercisers designed to improve the range of motion (i.e., flexibility) around the join
major muscle groups in the body using trapezoid-like bars. These exercisers may consist of short mov
from springs supported by a metal frame installed on a horizontal table or of triangle steel bars hangin
supported by a metal frame attached to a bed; both types assist users in many kinds of stretching exe
limbs, trunk, and lower limbs (and may also help users to change their positions in bed). Trapeze exer
short wooden or steel bar hanging from two ropes or chains supported from above, used in acrobatics
also available. Trapeze exercisers are mainly intended to improve the flexibility of the muscles in the u
lower limbs; they can also increase muscle strength, balance, coordination, and/or cardiovascular end
frequently used in physical therapy and rehabilitation.

Charts designed to present a set of symbols/characters intended to be used in assessing visual functio
usually consist of graphical charts with symbols (e.g. shapes, dots) arranged in particular patterns, eit
substrate (e.g., paper, plastic), an electronic screen, or overhead projector images. Eye charts are use
facilities, ophthalmologist offices, and in the field to assess visual abnormities; dedicated charts inten
particular characteristics (e.g., visual acuity, color vision, contrast sensitivity) are available.

Small receptacles designed to be filled with water or eye wash solution and placed around the eye soc
rinsing or cleansing the eye or applying medication. These cups are typically made of plastic, glass, or
sterile.
Prepackaged collections of the devices and supplies (either custom or standard) needed for the liquid
Items in these kits usually include a bulb or plunger syringe, a dedicated cannula or blunt needle, a co
protector, a waterproof drape, and an alcohol prep pad; the syringe used for irrigation in the kit may b
aspiration (i.e., removal) of the irrigating fluid and/or debris. These kits may be supplied in supporting
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Eye irrigation/lavage kit
during diagnostic, therapeutic, and/or surgical procedures.
Masks designed to cover both eyes with an opaque material that does not allow the passage of light. T
consist of an external covering made of plastic or other appropriate material and a padded liner (e.g.,
may include shielding for visible, infrared, or invisible light between the external covering and the line
attached to the head using a cap, straps, and/or adhesives; some masks also include nasal cushioning
usually disposable devices that are intended to facilitate rest or sleeping in illuminated environments
dedicated masks used during phototherapy treatments for neonates are also available.

Eye masks designed to occlude the passage of light during phototherapy treatments. These masks typ
external covering made of plastic or other appropriate material and a padded liner (e.g., foam, gauze)
include shielding for visible, infrared, or invisible light between the external covering and the liner acc
wavelength of the light used in the treatment. Phototherapy eye masks are usually disposable devices
the head using a cap, straps, and/or adhesives; they are mainly intended for newborn and infant phot
as radiant warming and bilirubinemia treatment.

Small pads designed for absorption of secretions from the eyes. These pads typically consist of layers
such as soft cotton enclosed in non-woven fine mesh gauze. Eye pads usually absorb tears, blood, or o
accidental injuries, diseases, or ophthalmic surgery.
Mechanical shields used for protection of one or both eyes following surgery or trauma. These shields
metallic.
Devices consisting of two lenses mounted in a frame that holds the lenses in an appropriate position b
assist vision. The metal or plastic frame is placed on the nose and is attached to two hinged legs that
ears. The lenses are usually graduated to improve the visual acuity of the user and may be configured
trifocal, or progressive. Eyeglasses are used mainly as a vision aid (i.e., corrective or assistive eyeglas
dedicated eyeglasses are used to perform special tests (e.g., nystagmus), to protect the eye (e.g., sun
aesthetic purposes.

Sacklike devices designed to hold enteral nutrition solutions. These devices are typically designed wit
adapter for connection to a feeding tube as a single-use, disposable unit. They are typically constructe
(e.g., plastic) with graduations for measuring the amount of solution. Enteral feeding bags are intende
and are changed frequently, per nursing, dietary, or other appropriate protocols. Frequently, they are
enteral feeding kit, along with a label and other enteral feeding accessories, for use with an enteral fe

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for d
fluids and/or medicines through a tube into the upper gastrointestinal tract for patients that are not ab
enteral feeding). Items in these kits may include a feeding tube and connector, a reservoir bag to hold
preparation, and a label. The feeding tube is attached to a nasogastric tube (i.e., a tube inserted into
the nares) or to a gastric tube (i.e., a tube inserted through an incision into the stomach or small intes
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Enteral feeding procedure kits and trays are intended to administer food and/or drink when
difficult, unsafe, or impossible to feed otherwise. They are used in hospitals, homes, nurseries, and ot
facilities.

Instruments used primarily for measuring ear drum performance, (e.g., during myringotomy).
Detectors designed to provide audible and/or or visual information about the fetal heart status by indi
from the surface of the maternal abdomen. These devices can detect fetal heartbeats early in pregnan
detectors may use ultrasonic, electrocardiographic, or phonocardiographic techniques; some detector
measuring the fetal heart rate.
Fetal heart detectors that can detect and measure the fetal heartbeat using acoustic methods similar
A sensitive microphone is placed on the maternal abdomen, and the signal picked up by the micropho
increase the signal-to-noise ratio and amplified to make it audible. The filtered signal is delivered to a
speaker, headphone) and/or to a cardiotachometer (that may be either external or an integral part of
measure the instantaneous fetal heart rate.

Fetal heart detectors that use ultrasonic waves to provide audible and/or visual information. They con
frequency electrical generator and appropriate ultrasound transducers housed in a probe that is place
abdomen. Ultrasonic heartbeat detectors amplify the audible frequency shift (i.e., Doppler effect) sign
ultrasonic waves and deliver it to speakers or headphones; the heart rate is determined either by mea
the peaks in the Doppler signal or, more accurately, by using automated autocorrelation procedures. T
detect fetal heart activity as soon as 10 weeks after conception.

Electric or electronic devices designed to induce fibrillation of the heart. These devices include cardia
electrodes and a power unit that can deliver a variable electric output of several volts (typically up to
frequencies (e.g., 50, 60, 85 Hz); they may be line or battery operated. Fibrillators are used for contro
heart during open heart surgery or in electrophysiology studies to test the effectiveness of therapy by
fibrillation in patients who normally have cardiac arrhythmias.

Devices with a finely serrated edge used to form or to smooth surfaces.


Metal devices with a roughened surface for shaping bones.
Files designed to be rubbed back and forth over the skin in order to remove hardenings that protrude
callous).
Filters designed to remove unwanted material from the air stream that passes through them. Filters m
particulate filtration and/or gas and vapor removal (air cleaning), the mechanisms for particulate filtra
removal are very different from each other. Air filters are used in many different equipment, including
heating, ventilation, and air conditioning (HVAC) systems. Small disposable filters (e.g., cartridges, can
respirators and masks for personal protection.

Filters designed to retain bacteria from a circulating current of fluid (gas, liquid, or both); some filters c
types of viruses. Bacteria filters can retain very small particulates; they are intended for uses such as
gases in patient care devices (e.g., ventilators, tracheostomy tubes), especially in patients whose upp
been bypassed; avoiding cross-contamination between isolated patients and the environment; and filt
biological (chemical) masks used in contaminated areas. Bacteria filters are also used in water purifica
Dedicated bacteria filters are available in a variety of shapes and sizes; they may include connectors
devices such as masks and ventilation systems.
Filters designed to remove particles from blood. These filters are typically made of porous material tha
and/or foreign particles (i.e. debris) from circulating blood, permitting easy passage with minimum da
components. Blood filters may be placed internally in the patient's circulatory system (i.e., intravascu
filter blood that is infused into the patient, frequently from an extracorporeal device (e.g., hemodialys
cardiopulmonary bypass unit, hemofiltration device). Intravascular filters may be intended for tempor
carotid artery during surgery) or as a permanent implant (e.g., vena cava filters); filters intended for e
blood into the arteries may also be able to trap air bubbles.

Filters used to remove microorganisms (fungi and bacteria) and particulate matter (e.g., fibers, drug p
residues, and fragments of glass, metal, and rubber) from solutions. Some filters are designed to remo
lines.
Sheaths designed to be worn on fingers or thumbs as protective covers. They are tissue-thin and tear-
latex or nitrile, made anti-static or static dissipative, and can be lightly powdered or powder-free. Fing
serve as protective covers to keep contamination, moisture, and dirt out of small cuts, burns, blisters,
on the patient's fingers. They are also for use by caregivers or health personnel for inserting supposito
ointments, creams, and medication, or during rectal examinations.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for fi
variety of emergency situations. Items in these kits usually include small devices such as scissors and
including tape, sterilized bandages and compresses, gauze and eye pads; and antiseptics such as alco
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
sterile wrap and may be included in a solid bag appropriate for transportation. First-aid emergency pro
with a limited number of devices and supplies are used mainly in the field and at home; complete first
extended variety of devices and supplies are intended for working areas, emergency rooms, and othe
facilities.

Ophthalmic instruments designed to measure critical flicker frequency (CFF), the transition point at wh
sensation of an intermittent light (i.e., flicker) disappears, becoming stable for the observer, as indicat
response at the points (i.e., the frequency value) at which he or she can perceive flickering and can no
flickering. The devices usually consist of variable frequency light sources, digital controls, an LCD disp
Flicker-fusion units are intended for assessment of a variety of problems (e.g., trauma, drug effects, al
reflected in the visual function.

Floor mats that help stop the spread of bacteria by trapping and/or killing it. Most antibacterial floor m
surface and when someone walks on it, dirt and bacteria on the soles of their shoes are removed and
Some of these mats also include germicide on the surface which kills bacteria. These sticky mats can
reusable; once dirty, the disposable type can be discarded and replaced with a new mat; the reusable
Another type of antibacterial floor mat consists of a mat with rubber teeth on the surface and edges th
sides than the bottom of the mat, creating a well into which disinfectant is poured. The disinfectant ki
also rub their shoes over the rubber teeth on the surface of the mat to physically remove dirt, debris,
Timers designed to measure the duration of the circulation of compressed gases delivered at a fixed p
section of a conduit or pipe. These timers are usually electrical or electronic time-measuring instrume
output ports for the measured gas and an analog or digital display that shows elapsed time in discrete
hour) up to several hours. Clinical gas-flow timers are intended mainly to measure the duration of resp
compressed air, oxygen) delivery during an emergency, chronic pulmonary illness, or tests; some time
gas flowmeters.

Measuring instruments designed to determine the flow rate of a fluid (i.e., liquid, gas) that circulates t
structure (e.g., vessel, airway, organ) or a conduit (e.g., tube, pipe). Flowmeters may be mechanical o
and measurements are based on electromechanical, laser, electromagnetic, or ultrasound techniques
computerized capabilities. Dedicated flowmeters are used in healthcare facilities to measure the flow
respiratory gases, and urine flow in anatomic natural ducts; other flowmeters are intended to measure
inspection, repair, and calibration of medical devices or medical gas systems.

Flowmeters designed to measure the rate of gas flow that circulates through an anatomic structure (ty
the conduits of a medical device (e.g., anesthesia machine) or medical gas system. Gas flowmeters ar
instruments with computerized capabilities that measure flow using electromechanical, laser, electrom
and/or other techniques. Gas flowmeters are used in healthcare facilities to measure oxygen, air, and/
gas flows; instruments intended to measure and/or calibrate gas flow in medical devices (e.g., ventila
machines) or medical gas systems during inspection and/or calibration procedures are also available,
integral part of dedicated equipment testers (e.g., pneumatic testers). Dedicated instruments intende
respiratory gas volume (i.e., spirometers) and flow in diagnostic tests are available.

Plain (nonimpregnated) dressings made of natural, soft, absorbent materials (e.g., cotton or linen gau
fluffed. Typically, these dressings are made from prewashed, fluff-dried gauze and are supplied in vari
precut squares. Fluff dressings are intended to cover wounds and absorb wound exudates; they are us
management.
Radiographic/fluoroscopic units usually consisting of two wheeled carts, one supporting the C-arm and
and the other holding display monitors and image processing and recording devices. The C-arm stand
arm (constructed so that it can perform both linear and rotating motions) with an x-ray tube mounted
emerging from the patient carry the image information to the input phosphor of an image intensifier o
detector on the other end of the arm. Systems with image intensifiers use a video camera (usually a C
the image and transmit it to a remote display monitor and incorporate an automatic brightness stabili
control console on the C-arm stand is mounted on top of the x-ray generator housing. The typical size
intensifier (diameter of the input phosphor) is 23 to 15 cm (9 to 6 inches) in dual mode or 23/15/11 cm
trimode. Some units can save the image displayed on the monitor in digital memory, on a video disk,
that can store several hundred images. Digital memories on C-arms permit such functions as last-imag
mode. Mobile radiographic/fluoroscopic units are used for imaging patients who cannot be moved to t
department or when patient transport is contraindicated, such as for patients undergoing surgical, ort
or emergency care procedures.
Measuring instruments designed to measure the total magnetic flux and determine the flux intensity (
flux density (B) close to the instrument. These devices typically consist of an electronic unit, magnetic
induction coils, Hall-effect strips), and a display that shows the value of the magnetic flux intensity (m
and/or oersted) and/or magnetic flux density (measured in tesla and/or gauss). Fluxmeters are used in
for accurate measurement of magnetic fields, frequently to determine if the magnetic field may produ
with the operation of a medical device and/or during the evaluation of an appropriate location for new
be affected by magnetic fields (e.g., magnetic resonance imaging scanners).

Boards designed to provide support to the feet. Most footboards consist of a horizontal or slanted piec
material (e.g., hard plastic) that is placed on the floor to accommodate a sitting patient's feet. Other f
to keep the feet in a vertical position when the patient is on a bed; they are usually attached to the be
lateral cushions to prevent foot rotation. Some footboards are used as table extensions (attachments)
patients or as vertical footrests.

Furniture typically consisting of a platform covered with nonskid (e.g., rubber) material that is mounte
stainless steel tubular low structure (e.g., 20 to 30 cm height). Footstools are used for supporting the
patient or as an aid for a patient to reach a high surface such as a bed or table.
Footstools designed to provide good electrical conductivity from the foot-supporting platform to the flo
typically consist of a platform covered with a conductive material (e.g., conductive rubber) that is mou
structure (typically 20 to 30 cm [8 to 12 inches] tall); the conductive material usually covers also the f
Conductive footstools are used on conductive surfaces of operating rooms to avoid accumulation of el
patients and/or healthcare staff, minimizing the risk of electric shock.

Instruments that consist of two handles or sides, either joined or separate, each attached to a blade, t
surgical procedures to handle, compress, join, pull, grasp, hold firmly, or exert traction upon tissue, eq
that are inconvenient or impractical to seize with the fingers. They are usually constructed of stainles
of forceps are used during procedures in the following categories: surgery, dentistry, dermatology, ga
gynecology, home care, internal medicine, nephrology, neurosurgery, obstetrics, oncology, ophthalmo
pathology, plastic surgery, pulmonary medicine, and urology.

Forceps used to seize, cut, and collect biopsy specimens from tumors or other diseased tissue during
procedures. They typically are comprised of two joined handles, each attached to a sampling jaw (wit
toothed-jaw cutting edges), and a stabilizing needle or spike between the sampling jaws to seize and
They can be reusable or single use.
Forceps with scissorlike handles, used to grasp and remove lint, drainage tubes, necrosed tissue, and
bodies from wounds. They are for general use but are mostly used in surgery, dentistry, and home ca

Surgical forceps designed to grasp and manipulate during laparoscopic procedures. These forceps are
instruments with scissor-like handles that may include a ratchet mechanism; a long slender shaft, and
action distal tip, and rotating jaws (e.g., duck-bill, alligator) controlled by a knob on the handle. Laparo
introduced through a laparoscope in the abdominal or pelvic cavities to grasp internal structures to fa
excision, or biopsy procedures.

Forceps used to grasp, firmly hold, and exert traction or compression on the gallbladder during gallsto

Forceps, usually with scissorlike handles, used to seize and constrict blood vessels in order to control b
hemorrhage during surgery. They are equipped with a catch in order to lock the blades together.
Surgical forceps designed for atraumatic grasping and/or compression of the intestines. These forceps
handheld metallic (e.g., stainless steel) instruments with two long, frequently serrated, working ends
shapes (e.g., looped, triangular) and integral handles with rings at the proximal end; both parts are us
center. Some intestinal forceps can retain a position once they are set (e.g., self-retained forceps). Ded
grasping forceps are available for the small intestine (e.g., duodenum) and for the colon and/or rectum
temporary occlusion of the intestine and/or for approximation of the intestine edges during anastomo

Forceps with scissorlike handles, used to atraumatically grasp, hold, and exert traction or manipulation
parenchyma during surgery. They typically have broad, flat blades (usually triangularly shaped or cur

Forceps used to gently grasp, extract, and apply traction to or rotation of the head of a newborn in ord
and removal of the newborn from the birth canal (the channel formed by the cervix, vagina, and vulva
separate sides or handles and are manually squeezed together using both hands.

Forceps with scissorlike handles, used to grasp and extract specimens or tissue samples during surgic
remove specimens from deep containers in a laboratory setting. They are typically long and have fine

Forceps with specially designed blades used to handle sterile instruments or implants.
Forceps intended for use in procedures such as percutaneous nephrolithotomy or ureteroscopy to trea
nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract, respectively). T
designed to securely grasp and/or manipulate the stone and to remove it from the body in conjunction
such as a ureteroscope or nephroscope.
Forceps used to remove a newborn from the birth canal by suction and gentle grasping of the head du
They are also used to remove a spontaneously or mechanically aborted fetus from the uterus or fallop
and suction.
Forceps with scissorlike handles, used to grasp and extract foreign bodies from body cavities during su
have flat, dull blades for grasping.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for c
gathering information related to a crime scene. Items in these kits usually include an appropriate blac
duster brush, crime-scene tape, a magnifier, gloves, a pipette, peel/stick print folders, cello tape, dust
products (e.g., magnesium sulfate, calcium carbonate), and a graphite block. The kits are frequently s
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Forens
kits and trays are used during the investigation of crimes to gather scientific evidence which may be u
proceedings. These trays are mainly used in the field and in forensic laboratories.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for g
preserving physical evidence following sexual assault. Items in these kits usually include gloves, comb
swabs, blood collection tubes, clear glass slides, envelopes, nail picks, and labels. The kits are frequen
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
assault forensic evidence procedure kits and trays are intended for collecting and preserving scientific
victims during the investigation of sexual crimes for potential use in the legal system. They are used i
laboratories, and in other healthcare facilities.
Retractors designed for temporary separation of the jaws (known as mouth gags), keeping the mouth
providing access to other tissues, organs, or oral structures during dental and/or oral surgery procedu
retractors are manual, handheld instruments including two adjustable blunt blades at the distal ends;
frequently have a ratchet mechanism to keep the blades in a self-retained position during the procedu
surgical and dental procedures, mouth gags are frequently used for airway management after trauma

Detectors designed to locate and record beta and/or gamma radiation emissions primarily from the hu
injection or ingestion of a radiopharmaceutical (i.e., radioactive drug). These detectors may use analo
imaging or digital (nonimaging) display devices are available. Nonimaging detectors are available as fi
while imaging detectors are typically fixed units; both types are usually part of a system capable of de
quantifying targeted radiation emissions from specific locations or the whole body using a multichann
collected emission information may then be displayed as numerical data, graphs, count-rate maps, or
3-dimensional images. Beta/gamma radiation detectors are also used to detect radiation from a locali
device or from radioactive material.

Holders and stands used to hold cylinders of compressed gas (e.g., oxygen, air, helium) to prevent the
or to hold them stationary in a convenient location. They are typically constructed of sturdy metal and
meet the size of the cylinders they hold. Some gas cylinder stands/holders may be mounted to the flo
or other location) and include straps or other fasteners to prevent the cylinders from moving around o
may have small wheels for mobility.

Environmental samplers designed to obtain gas and/or vapor samples from the air. These devices can
(e.g., benzene, trichloroethylene), mercury vapors, and other organic and inorganic gases. The sample
typically used in laboratory analyzers to characterize the contaminants and their concentration. These
mainly to detect toxic gases in potentially contaminated areas (e.g., operating room, clinical laborator
facilities and other indoor installations (e.g., factories).

Flexible endoscopes designed for insertion, either directly through the mouth or by an incision in the g
upper gastrointestinal tract for visual examination, biopsy, and treatment of lesions of the interior of t
proximal portion of the small intestine from the pylorus to the jejunum (i.e., duodenum). Gastroduode
include a flexible outer sheath, a lighting system, and a working channel for catheters and operative d

Graphic recorders of the motility of the stomach and/or the esophagus. These recorders use a sensor
attached to a nasogastric tube, implanted strain gauges) and appropriate transducers.
Endoscopes designed for direct insertion through the mouth in the upper gastrointestinal tract for visu
biopsy, retrieval of foreign bodies, and treatment of lesions of the interior of the stomach. Some devic
examination and treatment of the esophagus. Gastroscopes usually include a lighting system and a w
catheters and operative devices; these endoscopes may be rigid or flexible.

Gastroscopes with a nonrigid (i.e., flexible) structure, which are capable of being manipulated and poi
directions through the lumen of the curved path of the upper gastrointestinal tract. Flexible gastrosco
fiberoptic illumination and imaging system that facilitates the examination and performance of therap
sheath is usually made of plastic.
Gastroscopes with a nonflexible (i.e., rigid) structure that can only follow a straight path through the u
tract. They include illumination and imaging systems that enable the examination of the esophagus a
sheath is usually made of stainless steel.
Cups designed to be used by individuals who have difficulty using ordinary drinking cups. These cups
designed to control the flow of liquids or allow for drinking without lifting the head, or have features su
handles or contoured shapes that can assist individuals with limited dexterity or mobility.

Garments designed to cover the hands with separate sections for each of the fingers and thumb and f
part way up the arm. Gloves are usually made of fabrics, plastics, latex, leather or a combination of th
available in reusable or disposable varieties. Dedicated gloves intended for clinical use (e.g., examina
surgery) and/or for manipulation of chemicals such as products used in chemotherapy procedures are
intended for non-clinical use in healthcare facilities (e.g., housekeeping, central supply handling) are a
gloves used by patients such as therapeutic pressure gloves and gloves worn while pushing a wheelch

Gloves designed for hand protection to prevent contamination and/or infection of healthcare personne
other postmortem procedures. These gloves are usually made of natural rubber latex but gloves made
materials are also available. Postmortem gloves should have chemical, snag, puncture, abrasion, and
providing an excellent grip on wet or dry surfaces. Postmortem gloves should provide good dexterity,
elasticity, and protection against chemical hazards. They are mainly used by pathologists to manipula
perform gross dissection and other dedicated dissection procedures in hospital, other healthcare facili

Gloves designed for hand protection and/or to prevent contamination and/or infection of both patients
personnel. These gloves are usually made of latex, nitrile, vinyl, or synthetic materials; they should fit
remain watertight and be strong enough to resist tears or holes. Examination/treatment gloves are us
facilities to provide a barrier during diagnostic and treatment procedures, preventing the transmission
diseases from patients to healthcare personnel and vice-versa.

Gloves designed for use by healthcare workers at the surgical site. These gloves are usually made of n
(NRL); the gloves must provide a barrier against blood and other body fluid pathogens. Staff use facili
gloves have appropriate characteristics of tactility, comfort of use, ease of donning, adequate sterility
puncture resistance, elasticity, and sizing consistency.Surgical gloves are used mainly as a two-way ba
the patient and the staff against contamination caused by microorganisms. Synthetic surgical gloves i
prevent the risk of NRL (i.e., hypoallergenic) are also available.

Surgical gloves designed to protect both the patient and wearer from the risk of allergic reactions (i.e.
latex. These gloves are usually made of synthetic (e.g., polyisoprene, styrene-ethylene-butylene-styre
gloves provide a barrier against blood and body fluid pathogens. Staff use should be facilitated becau
appropriate characteristics of tactility, comfort of use, ease of donning, adequate sterility, tensile stre
puncture, elasticity, and sizing consistency. Hypoallergenic surgical gloves are used mainly as a two-w
allergic and/or potentially allergic patients and/or staff members against contamination caused by mic
Gloves designed to cover and protect the hands during the performance of a variety of different tasks
usually made of materials (e.g., cotton, polyurethane, leather, or a combination of these) appropriate
protection of the hands; they are usually resistant to snags and abrasions. Some gloves may provide w
and/or have other particular characteristics. Multiuse gloves are intended for tasks that do not involve
patients, body fluids, and/or other clinical use; they are widely used in health care facilities for tasks s
food manipulation, and central supply material handling.

Measuring instruments designed to measure angles, clinical goniometers are intended to measure the
of a joint (usually from 0? to 180? or more) using mechanical gauges (e.g., protractors). These goniom
consist of a central protractor that permits the measurement of angles with two moving arms of appro
pivoted at the center of the protractor; other types of mechanical goniometers are available, including
on a protractor dial (gauge) that refers to an internal liquid level and a gravity-type goniometer (frequ
inclinometer) consisting of twin rotating dials with a locking mechanism and a strap for fixing to the b
goniometers are used mainly in clinical applications to measure the range of movement of joints (i.e.,
ankle, spine). Dedicated instruments intended for accurate measurement of one particular joint (e.g.,
available. Mechanical goniometers are used by rheumatologists and physiotherapists to assess joint fu
diagnose and treat locomotor system diseases; they are frequently included as a component of gait a
analyzers.

Ophthalmic diagnostic instruments designed for examining the angle of the anterior chamber of the e
cone-shaped contact lens. Gonioscopes usually consist of a three- or four-mirror contact lens (indirect
less contact lens (direct gonioscopes), through which the light projecting from the anterior chamber a
and a slit-lamp microscope or handheld microscope, and an illumination source to obtain a magnified
chamber. Gonioscopes that use light reflected from the contact lens mirror (i.e., indirect gonioscopes)
use reflected light (i.e., direct gonioscopes) for examination of the anterior chamber of the eye are av
mainly in the diagnosis, monitoring, and treatment of glaucoma.

Hollow chisels for cutting and removing hard tissue or bone.


Gowns are loose, flowing garments designed to be worn by patients and healthcare professionals. Gow
many different styles and lengths, depending on their intended use. Gowns are made from various wo
materials and are available in many sizes for men, women, and children. Most gowns have snap, tie, o
Medical gowns are designed to be worn over clothing by healthcare professionals, facilities staff, and v
are mainly intended to protect clothing from physical contamination. Medical gowns typically have op
breathability. They can be used in almost all areas of healthcare facilities including examination rooms
procedure rooms, laboratories, and supply and preparation areas. Patient gowns are designed to be w
by patients in doctors' offices, hospitals, and other healthcare facilities. Patient gowns are usually ligh
thigh-length garments made of woven or non-woven materials and are intended to facilitate easy acce
examinations and medical procedures. Isolation gowns are intended to protect the wearers from infec
covering their clothing. Isolation gowns usually provide more coverage than other gowns, including a
sleeves with elastic cuffs.
Medical gowns are designed to be worn over clothing by healthcare providers, healthcare facilities sta
gowns are mainly intended to protect clothing from physical contamination such as splashes from bod
chemicals, water used for bathing patients, and other fluids, liquids, or debris. These gowns are typica
available in various sizes and styles (e.g., long sleeved, short sleeved, ankle-length, thigh-length, ope
aprons). They usually have snap, tie, or Velcro closures. Medical gowns are made of light weight, fluid
breathable materials. Both disposable and reusable medical gowns are available. Medical gowns are u
healthcare facilities including, but not limited to, examination rooms, operating rooms, procedure room
supply and preparation areas.

Disposable medical gowns are intended to be worn once and then discarded. They are designed to be
healthcare providers, healthcare facilities staff, and visitors. These gowns are mainly intended to prote
physical contamination such as splashes from bodily fluids, waste, drugs, chemicals, water used for ba
other fluids, liquids, or debris. These gowns are typically loose and flowing, and are available in variou
long sleeves, short sleeves, ankle-length, thigh-length, open or full back). They usually have have sna
closures. Disposable medical gowns are made of light-weight, fluid resistant, and breathable, non-wov
polypropylene. Disposable medical gowns are used in many areas of healthcare facilities including, bu
examination rooms, operating rooms, procedure rooms, laboratories, and supply and preparation area

Reusable medical gowns are intended to be worn once, laundered, and worn again. They are designed
clothing by healthcare providers, healthcare facilities staff, and visitors. These gowns are mainly inten
from physical contamination such as splashes from bodily fluids, waste, drugs, chemicals, water used
and other fluids, liquids, or debris. These gowns are typically loose, flowing, and are available in variou
(e.g., long sleeves, short sleeves, ankle-length, thigh-length, open or full back). They usually have hav
closures. Reusable medical gowns are made of light-weight, fluid-resistant and breathable, washable w
as cotton and polyester. Reusable medical gowns are used in many areas of healthcare facilities, inclu
to, examination rooms, operating rooms, procedure rooms, laboratories, and supply and preparation a

Patient gowns are designed to be worn instead of clothing by patients in doctors' offices, hospitals, an
facilities. Patient gowns are usually loose-fitting, light-weight, short-sleeved, thigh-length garments m
woven materials (e.g., cotton, polyester) and are intended to facilitate easy access to patients during
medical procedures. These gowns are available in various sizes for men, women, and children. Most g
Velcro closures in either the front or back. Patient gowns are available in many different styles and len
their intended use; patient gowns specifically designed for radiographic, mammographic, and gynecol
also available.

Disposable patient gowns are designed to be worn once and then discarded. These gowns are worn in
patients in doctors' offices, hospitals, and other healthcare facilities. Disposable patient gowns are usu
weight, short-sleeved, thigh-length garments made of non-woven materials such as paper and plastic
facilite easy access to the patients during examinations and medical procedures. These gowns are ava
for men, women, and children. Most gowns have tie closures in either the front or back. Disposable pa
available in many different styles and lengths, depending on their intended use; disposable patient go
designed for radiographic, mammographic, and gynecological procedures are also available.
Reusable patient gowns are intended to be worn once, laundered, and worn again. They are designed
clothing by patients in doctors' offices, hospitals, and other healthcare facilities. Reusable patient gow
fitting, light-weight, short-sleeved, thigh-length garments made of woven washable materials like cott
are intended to facilitate easy access to patients during examinations and medical procedures. These
various sizes for men, women, and children. Most reusable gowns have snap, tie, or Velcro closures in
back. Reusable patient gowns are available in many different styles and lengths, depending on their in
patient gowns specifically designed for radiographic, mammographic, and gynecological procedures a

Tissues obtained from a donor or produced artificially that are intended to replace a patient's diseased
grafts). Grafts used in humans may be of biological origin, obtained from the body of the same person
another person (i.e., allograft), or from a different species (i.e., xenografts); of artificial origin, made fr
Dacron, ceramic) materials; or made from a combination of natural and synthetic materials, including
synthetic materials developed using bioengineering techniques (i.e., bioartificial). Dedicated grafts for
available, including bone, skin, blood vessel, tendon, and dura mater.

Grafts obtained from a donor or produced artificially (i.e., synthetic) for the structural replacement of
bone. These grafts may be of biological origin, obtained from the body of the same person (i.e., autog
person (i.e., allograft, typically from cadavers), from other natural sources (e.g., natural hydroxyapatit
from a different animal species (i.e., xenografts). These grafts may be made of synthetic materials suc
synthetic polymer or a combination of natural and synthetic materials (i.e., composite grafts), includin
synthetic materials developed using bioengineering techniques (i.e., bioartificial). Bone grafts are use
and/or plastic surgery to increase body mass and provide mechanical support; they may also provide
growth.

Grafts obtained from a donor or produced artificially (i.e., synthetic) that are intended to replace an ar
injured skin. Skin grafts used in humans may be of biological origin, obtained mainly from the body of
autograft), from another person (i.e., allograft, typically from cadavers), and less frequently, from a di
xenografts); synthetic polymeric membranes (e.g., hydrogels); or a combination of natural and synthe
composite grafts), including living elements and synthetic materials developed using bioengineering t
bioartificial). Skin grafts are used in the healing of extensive skin losses, including large wounds and b
autografts and some bioengineered products are intended for use as permanent implants, while other
removed after a few days.

Blood vessel prostheses manufactured from processed biological tissue.


Testers designed to assess the electrical integrity and operation of ground fault circuit interrupters. Th
introduce a test current in the system under test to simulate safe and faulty conditions of the ground
mechanical operation and determine the trip current of the ground fault circuit interrupter; some teste
operation of line isolation monitors.
Devices designed to interrupt (i.e., trip, cutting out power) an electric circuit if a ground fault occurs c
beyond a predetermined level. These devices operate based on variations of magnetic flux when curre
fault circuit interrupters (GFCI) are usually installed as outlets intended to supply power to electric equ
current limited to 4 to 6 mA for personal protection. Devices intended to protect equipment but not pe
trip at higher leak currents (e.g., 6 to 50 mA) and are frequently called equipment leakage electric int
should operate in a very short time (e.g., typically less than 25 milliseconds) to offer appropriate prote
need a manual reset after a ground fault occurs. GFCI are mainly intended for areas where water, high
other hazardous electrical conditions may be present; they are available as outlets for equipment con
personal protection) or fixed to equipment for protection.

Electrical testers designed to measure the impedance in a section of the grounding system, usually by
the voltage between the point under test and a reference point to the current applied to the point und
consist of a direct-current source (e.g., a battery) and/or an alternating-current line power supply (e.g.
transformer); a measuring instrument; a display that shows the results, typically in ohms; and long-wi
test leads appropriate for connection to both the test point and the ground reference point. Grounding
used to measure the integrity and electrical characteristics of hospital grounding systems; some teste
apply a resistance of known value between the phase and ground conductors to simulate a fault, mea
loop impedance.

Devices designed to position and facilitate the operation of moving (i.e., guide) components of equipm
during the performance of manual or endoscopic procedures improving their accuracy. These guides t
mechanical device that may be attached to instruments (e.g., drills, saws, snares) to facilitate the use
components (i.e., drill bits, saw blades, snare wires) or to function as independent guides intended to
(e.g., needles) during manual (e.g., suturing) and endoscopic procedures.

Devices designed to simultaneously direct the placement of the drill hole and protect the surrounding

Instruments designed to cut objects, tissue, and/or organs using a movable sliding blade. These instru
a mechanism (e.g., crank, shaft) that operates the blades by moving (e.g., dropping) them along guid
(e.g., sets of papers, x-ray film). Dedicated guillotines are available for use as surgical instruments (e.
cutting).
Devices designed to provide a galvanic stimulus resulting in taste sensation. These devices typically in
electrodes that are placed on a particular target (e.g., on both sides of the tongue). Gustometers are u
assess local taste acuity (e.g., in the diagnosis of taste disturbances); they are also sometimes used in
or ear-nose-throat departments for differential diagnosis of Bell's palsy.

Clippers designed to cut the hair above the skin surface using a mechanism that performs a two-blade
clippers are typically handheld instruments, either manually or electrically powered, and are used ma
hygiene and grooming. Dedicated hair clippers intended for hair removal before surgical or other relat
(e.g., cathetrization, labor) are also available. Hair clippers are usually manipulated by an operator or
remove a patient's hair. Other instruments such as scissors and razors are also used to cut hair.
Environmental/gas system analyzers designed to measure and display the concentration of halogenat
anesthesia; some analyzers can also measure nitrous oxide concentration. These analyzers are typica
either on an optical interference photometer (i.e., interferometer) or on an infrared spectrophotomete
anesthetic analyzers are mostly used to check anesthesia unit vaporizer accuracy usually at the gas o
procedures; they are also used to check leaks in anesthesia systems, or in the environment, especially
accumulated gases would affect personnel (e.g., anesthesiologists).

Devices designed to provide traction to the cervical vertebrae by pulling the head using force from an
These devices typically combine several padded straps in a lightweight structure; usually one of the s
the chin, a second strap is placed on the back of the head, and a third strap is placed around the neck
other straps. A head halter includes one or more rings at the top that permit its connection to the cab
traction unit that usually includes a pulley and a set of weights. Head halters intended for horizontal a
(frequently including spreading bars) traction are available; they are used in orthopedic and/or physic
including fracture treatment and widening of the intervertebral spaces in the spine.

Splash shields worn over the face to protect the healthcare worker from blood and other body fluid sp
performing a clinical procedure. These shields are usually transparent.
Light fixtures (e.g., bands, helmets) intended to be worn on the user's head to provide intense illumin
diagnostic, or therapeutic procedures. These devices are typically battery operated, lightweight, comf
ergonomically balanced to optimize comfort; they are sometimes attached to an external light source.
available in different shapes and configurations appropriate for use by dentists, surgeons, and other p

Equipment that provide temporary external circulatory support to the cardio-pulmonary functions, by
venous supply of blood and pumping it back into the arterial system; bypass units can perform circula
filtration of the blood. These units are usually assembled in a console, which main components consis
backup arterial pump, one or two suction pumps, an arterial vent pump, a cardioplegia pump, and a b
also includes some disposable components such as an oxygenator/heat exchanger, a cardiotomy rese
tubing. Heart-lung bypass units are mostly used during open heart surgery, bypassing the heart to fac
organ (e.g. , cardiac valve replacement, coronary artery bypass grafting); they are also used for extra
oxygenation in patients with severe respiratory disorders.

Heat exchangers designed to warm or cool blood and/or perfusion fluids flowing through the device, a
bypass procedure. These heat exchangers are frequently combined with an oxygenator as a disposabl
lung bypass equipment. Heart lung bypass heat exchangers are used to lower the temperature of the
metabolic requirements of the heart and the oxygen demand of the brain and other organs during sur
the blood at the end of the surgical procedure.

Oxygenators designed to perform gas exchange by bubbling oxygen from tanks or from a central hosp
column of blood. These oxygenators usually include a defoamer to break up the bubbles caused by th
and an arterial reservoir that collects defoamed blood; a gas flowmeter and a filtering system are usu
oxygen line. Bubble oxygenators are mostly used in short-term procedures, lengthy operation of these
increase the risk of emboli, blood damage, and protein denaturization.
Simulators designed to produce sounds and murmurs mimicking the timing and pitch of actual heart s
the normal heart sounds, the simulators can mimic other sounds such as clicks, snaps, murmurs, and
simulators usually include an anatomic model of the torso or head, with the neck and torso showing th
landmarks. The torso model is also used to detect and recognize the correct anatomic locations of the
simulators include capabilities for simultaneous electrocardiograph and/or phonocardiograph display,
auditorium listeners, and auscultation units for group listening of a patient's heart sounds. Heart-soun
for training of healthcare staff in the auscultation of normal and abnormal heart sounds; some simulat
breath and/or bowel sounds.

Equipment designed to increase or decrease the temperature of a fluid by transmitting heat from one
equipment typically consist of a device either with two contiguous reservoirs or two sets of coils in clo
heat interchange between the two fluids; they also include heating and/or refrigerating modules. Typic
temperature should be adjusted (e.g., blood) is circulated through a set of coils inside the exchanger,
fluid (e.g., water) circulates through a second set of coils. By adjusting the temperature of the control
interchange is regulated

Pads designed to provide heat to an area of the human body. These pads are usually made of several
natural fibers, plastics) materials sealed in a fabric or plastic outer covering. The pads may include: (1
(e.g., wires) connected to an external power source, (2) a heat conducting layer (e.g., carbon polymer
(e.g., viscoelastic foam) pad that conducts heat supplied by a low voltage power source, or (3) a set o
appropriate to circulate warm liquids from an external pump. Heating pads are mainly used to alleviat
muscle spasms and joint stiffness; they are also used to prevent hypothermia. Dedicated heating pads
variety of shapes and sizes according to the anatomic part to be heated.

Pads designed to provide heat or cold to an area of the human body by circulating liquids. These pads
several layers of flexible materials (e.g., natural fibers, plastics) sealed in a fabric or plastic outer cove
a set of or channels appropriate to circulate warm or cold liquids from an external pump. Heating/cool
used to alleviate pain, help in treating muscle spasms and joint stiffness, to cool feverish patients, and
hypothermia. Dedicated circulating liquid pads are conformed in a variety of shapes and sizes accordi
to be heated or cooled.

Pads designed to provide heat to an area of the human body by including electric heating elements. T
made of several layers of soft (e.g., natural fibers, plastics) materials sealed in a fabric or plastic oute
may include heating elements (e.g., wires) connected to an external power source or a heat conductin
polymer) placed on a flexible (e.g., viscoelastic foam) pad that conducts heat supplied by a low voltag
may also include temperature regulators. Electric heating pads are mainly used to alleviate pain, help
spasms and joint stiffness, and to prevent hypothermia. Dedicated electric heating pads are conforme
shapes and sizes according to the anatomic part to be heated.

Systems consisting of a helmet frame, a loose-fitting disposable hood or gown with a face shield, inflo
filters, and a battery pack. Surgical helmet systems are intended to protect healthcare workers and pa
infection during surgery.
Cell-counting hematology analyzers designed for manual blood cell counting procedures and analysis.
consist of a glass block with a depression of definite depth, the floor of which is ruled off into squares
Blood cells are counted with the aid of a microscope in the known volume between the ruled squares
Detectors designed for detection of the normal electrical transmission (or failure) of electrical impulse
the ventricles through a group of highly specialized natural fibers (i.e., the His bundle) in the heart. Th
consist of a specialized electrocardiographic unit that includes a pacemaker and a cardiac catheter wi
catheter is advanced up the inferior vena cava, across the tricuspid valve and into the right ventricle;
withdrawn across the tricuspid valve, and into the right ventricle until a combination of atrial and vent
recorded (i.e., atrial and ventricular electrograms). His bundle detectors are used in operating and cat
rooms to determine the electrical activity of each part of the atrioventricular conduction system (i.e.,
electrograms of the His bundle); they are used in electrophysiology conduction studies, to determine t
myocardium, in arrhythmia studies, and in other applications related to the bioelectrical characteristic

Ventilated hoods designed to confine and exhaust materials that may be flammable, irritating, corrosi
noxious. These enclosures typically consist of a plastic or metal cabinet-like structure with an open fro
products; they typically include a sash to regulate the front opening, blowers to produce an inward flo
hood, and an exhaust system. Most hoods exhaust the contaminated air to the outside, but some hoo
recirculate it into the room. These hoods may work either at a constant air volume (either conventiona
and its variations, auxiliary-air and reduced-air subtypes) or less frequently at a variable air volume (g
conventional hoods). Fume hoods are intended to remove fumes as well as vapors, gases, mists, aeros
particulate materials, reducing workers exposure; they offer some protection against accidental releas
explosions. Chemical fume hoods are mainly used for manipulation of chemicals in open containers an
containment for chemical laboratory equipment; dedicated fume hoods are manufactured for particula
distillation and handling radioactive materials or perchloric acid. Chemical fume hoods are not biologic
they should not be used when handling infectious or potentially infectious materials.

Hoods designed to deliver oxygen to a patient's respiratory system (i.e., for administration of oxygen)
consist of a rigid plastic shell that may enclose the head of an adult or infant or an infant's entire body
sensors to determine oxygen concentration, temperature, and humidity. Oxygen supply hoods are use
volumes of oxygen at high concentrations; dedicated hoods are available to provide oxygen therapy t
and adults (frequently, the adults are simultaneously under hyperbaric chamber treatments).

Instruments designed to temporarily secure tissues or organs by catching and/or pulling them during
and/or to perform other procedures with minimal trauma. Hooks are handheld manual instruments wit
the distal end (usually at angles from 135 to 180 degrees) and have a blunt or sharp tip; hooks typica
the proximal end. Some hooks (also known as forks) include two or more prongs at the distal tip. Dedi
available for surgical, post-mortem, and biopsy procedures. Hooks may be used as manual retractors
procedures.

Surgical hooks designed to temporarily secure or isolate the spinal cord by catching and/or pulling it d
excision, and/or to perform other procedures with minimal trauma during cordotomy surgery. These su
consist of handheld manual stainless steel instruments with a shank bent near the distal end (usually
180 degrees) and finished in a blunt tip; the hooks typically include a handle at the proximal end. Cord
usually supplied as fine half-round hooks, fixed at right angles on the end of a delicate handle. They a
during cordotomy procedures for the relief of severe and persistent pain.
Middle-ear surgical hooks designed to temporarily secure the incus by catching and/or pulling it during
and/or to perform other otological surgical procedures with minimal trauma. These middle-ear surgica
consist of handheld manual sterilizable stainless steel or plastic instruments with a shank bent near th
angles from 135 to 180 degrees) and finished in a blunt or sharp tip that fits into the convenient cavit
include a handle at the proximal end. Incus hooks are available in different sizes (small, medium, large
type of surgery. They are used during otological surgical procedures (e.g., to steady and minutely lift t
a prosthesis).

Hooks designed for removal of intrauterine devices (IUD). These instruments are slender, handheld, m
which the distal end includes the hood and that usually has a closed loop and/or a sliding spring at the
facilitate grasping the hook while performing the removal of the IUD. IUD removal hooks are used in h
gynecologists' offices to assist in reproductive care procedures; the hooks may also be used for retriev
other intrauterine devices.

Nasal surgical hooks designed to temporarily secure nasal tissues by catching and/or pulling them dur
excision in plastic surgical procedures with minimal trauma. Nasal surgical hooks typically consist of h
stainless steel instruments with a shank bent near the distal end (usually at angles from 135 to 180 d
blunt tip. Rhinoplasty surgical hooks usually include two prongs at the distal tip and are available in di
be supplied with an angled shaft to utilize the strength in the hand and provide an effective grip. Thes
used in plastic surgery procedures for reshaping the nose (e.g., rhinoplasty).

Eye surgical hooks designed to temporarily secure suture material around the sclera during dissection
perform other surgical procedures with minimal trauma. These eye surgical hooks typically consist of
stainless steel instruments sharply bent at the working end (usually at angles from 135 to 180 degree
include a slender handle at the proximal end. Eye sclera fixation hooks with a sharp two-prong hook a
fixation hooks are available in different sizes (small, medium, large) according to the type of surgery. T
ocular surgical procedures (e.g., placement of suture material around an extraocular muscle or partial
for purposes of immobilizing and controlling the position of the globe).

Surgical hooks designed to temporarily secure the skin by catching and/or pulling it during dissection,
perform other surgical procedures with minimal trauma. These surgical hooks typically consist of hand
steel instruments curved and with a fine sharp prong at the working end; the hooks typically include a
proximal end. Skin surgical hooks can be supplied double pronged and with a thin and delicate shaft;
long shafts are also available to provide excellent retraction of dense tissue. Skin surgical hooks are u
procedures (e.g., for handling soft tissues) in hospitals, surgery centers, and specialty clinics.

Eye surgical hooks designed to temporarily secure extraocular muscles during dissection, excision, an
surgical procedures with minimal trauma. These eye surgical hooks typically consist of handheld manu
instruments sharply bent at the flat working end (usually at angles from 135 to 180 degrees) and with
typically include a flat serrated handle at the proximal end. They are available in different sizes (small
with several degrees of depth of the working end. Eye strabismus hooks are used during ocular surgic
correct the misalignment of the eyes).
Nerve/ganglion surgical hooks designed to temporarily secure nerves/ganglions during sympathectom
by catching and/or pulling them during dissection, excision, and/or to perform other procedures with m
nerve/ganglion surgical hooks typically consist of handheld manual stainless steel instruments with a
distal end (usually at angles from 135 to 180 degrees) and finished in a blunt tip; hooks typically inclu
proximal end. Nerve/ganglion sympathectomy hooks are usually double ended with a dissector at the
hook. They are used in sympathectomy surgical procedures (e.g., endoscopic thoracic sympathectomy

Surgical hooks designed to temporarily secure an airway proximate to the trachea during surgical proc
hooks typically consist of translucent handheld manual instruments with a shank bent near the distal
from 135 to 180 degrees) and finished in a blunt or sharp tip. Also available are tracheal surgical hook
a channel connected to the hook as well as a scalpel positioned in the channel. They can include a ligh
illuminate an area proximate to it. Some tracheal surgical hooks are included in a surgical airway kit o
instrument tray. Tracheal surgical hooks are used during surgical procedures (e.g., mostly for stabilizin
procedures commonly referred to as a cricothyrotomy or tracheostomy).

Flexible containers intended to be filled with hot or cold water and applied to the body's external surfa
or cold therapy to a particular area of the body.
Equipment designed to increase the moisture of a closed environment by adding a water mist directly
through the air supply. Humidifiers typically consist of equipment that may use one of several differen
ultrasound vibration, evaporation, and rotation. Most humidifiers include sensors and controls for the t
humidity; some humidifiers include heaters to provide a warm mist of water. Room humidifiers are us
facilities and at home to increase the moisture in patient rooms and/or in other areas of the home or t
humidifiers intended to increase the humidity in artificial airways and/or in inside the abdominal or tho
laparoscopic procedures are also available.

Humidifiers designed to add moisture and heat to the gases flowing in the inspiratory artificial airways
The humidifiers are inserted in the inspiratory lines typically leading from the outlet of a critical care o
These humidifiers can introduce the moisture either by forcing the incoming gas through a heated res
(bubble-through units) or by passing the incoming gas over a wet surface (pass-over units) or heated
airway humidifiers are intended for use when an artificial airway supplies air through devices such as
endotracheal tubes, bypassing the normal warming and humidification of respired gases.

Humidifiers designed to add moisture to the gases flowing in the inspiratory artificial airways, thus inc
the gas delivered into the lungs. The humidifiers are inserted in the inspiratory lines typically leading
critical care or anesthesia ventilator. These humidifiers can introduce moisture either by forcing the in
the water in a heated reservoir of sterile water (bubble-through units), or by passing the incoming gas
water reservoir (pass-over humidifier) or over a wet wick (wick humidifier, a variation of the pass-over
airway humidifiers are intended mainly for use when an artificial airway supplies air through devices s
or endotracheal tubes, bypassing the normal humidification process for respired gases.

Instruments that measure atmospheric relative humidity or some other parameter of the amount of m
Chambers designed for patient treatment in which the air pressure is raised more than two times abov
pressure while the patient breathes near 100% medical grade oxygen. The elevated ambient pressure
chamber reduces the size of gas bubbles trapped in vascular beds and accelerates their dissipation. C
restored to tissue in which the blood supply has been blocked or compromised. Typically, pure oxygen
breathing, either by a mask or hood or by oxygen pressurization of monoplace chambers. Hyperbaric
treat any condition in which gas bubbles form in the blood, including pulmonary and cerebral air embo
decompression sickness, and less frequently iatrogenic gas embolism that may occur during hospital p

Radiofrequency (RF) therapy systems designed to heat solid tumors to several degrees centigrade abo
typically from 42 to 45 degrees C (108 to 113 degrees F); these temperatures do not damage normal
include a RF generator, appropriate delivery systems, and electrodes for selectively heating and main
temperatures. The procedure typically lasts from 30 to 60 minutes; it is usually repeated several time
day). Hyperthermia RF systems are used to treat solid, malignant tumors, frequently in combination w
(thermoradiotherapy) or chemotherapy (thermochemotherapy).

Blankets usually made of two plastic sheets that are thermically sealed together; they include channe
circulation. These blankets are attached to a central unit that delivers the heating or cooling liquid to
available in many different configurations and sizes, and may be reusable or disposable.

Units designed to regulate a patient's temperature by heating or cooling. These units usually include
heating and refrigerating capabilities, controls, alarms, and some means (e.g., blankets) to deliver the
patient. Patient warming/cooling units are used to warm patients who are hypothermic, to maintain no
temperature during and after surgery, to cool feverish patients, or to induce hypothermia to lower me
cardiac surgery, neurosurgery).

Units designed to warm or cool a patient by circulating liquid. These units consist of a central device in
system (similar to a household refrigerator), a heating element, and pumps for circulating liquid; a spe
reusable or disposable blanket with appropriate channels for liquid circulation; controls; and alarms. P
typically monitored with a thermometer. Circulating-liquid patient warming/cooling units are used for r
postanesthesia care units, to help prevent intraoperative hypothermia or to induce hypothermia in the
to cool feverish patients.

Chambers that are used to simulate a pressure less than 1 ATM. They are used to simulate hypoxia, de
explosive decompression with very low temperatures, loss of oxygen, and loss of cabin pressure. The
compartments: (1) the high altitude chamber and (2) the decompression chamber. They also contain
communication system, a video system, oxygen and pressurized air supplies, physiological monitoring
microprocessor. They are capable of "low" decompression (15 seconds to decompress to 18,000 feet)
decompression (1 second to decompress to 10,000 feet). They are large, roomlike enclosures that can
people.

Cooling units designed to regulate a patient's temperature by removing heat. These units usually incl
with a refrigerating system, control, and alarms and some means (e.g., blankets) to deliver the therma
patient. Patient-cooling units are used to treat patients who are hyperthermic or feverish; they are als
hypothermia, thus lowering metabolism (e.g., during cardiac surgery or neurosurgery).
Endoscopes, either rigid of flexible, designed for direct insertion through the canal of the uterine cervi
uterus for visual examination, biopsy, and treatment of lesions of the interior of the cervix and the cav
Hysteroscopes usually consist of an outer sheath, a lighting system, and a working channel for cathet
devices; they may be flexible or rigid.
Bags designed to be filled with ice to provide cold therapy for a limited external area of the body. Thes
consist of a small, flexible rubber or soft plastic, hollow container with a detachable cap that can be th
fixed to the bag once it is filled; the bag may include external attachments (e.g. tabs, velcro) to facilit
Ice bags are intended to alleviate pain and/or to promote healing in minor injured areas of the body (e
surgery, bruises, tissue swelling). Dedicated ice bags especially intended for use around the neck (i.e.
wrapping around the limbs are also available.

Ice bags designed to be placed around the neck, covering the throat, as a collar. These devices consis
plastic bag with an appropriate size and shape for comfortable use as a collar. They include a cap that
otherwise fixed to the bag once the bag is filled and may also include external attachments (e.g., tabs
fixing around the throat. Collar ice bags are intended to alleviate pain and/or to promote healing in mi
throat, neck, and/or head (e.g., after minor surgery, tonsillectomy, to alleviate sore throat).

Single-piece circular bands designed for use around the wrist (i.e., bracelets) to provide identification
about a patient. These bracelets typically consist of a slender, thin, soft, plastic band with a self-lockin
usually includes printed information with the name, date of birth, patient registration number, and oth
permit clear and easy identification of a patient. Some bracelets include additional bar-code informati
with a computerized reader/scanner. Identification bracelets are used in hospitals and other healthcar
time that a patient is admitted in the institution from registration to dismissal.

Lower-limb ankle orthoses designed for maximum restriction of movements and/or total immobilizatio
These immobilizers usually consist of prefabricated or custom-made orthoses, including semi-rigid leg
components that unload the pressure on the ankle joint, reducing partially or completely its motion. Im
orthoses are intended mainly to reduce the pressure on the ankle during rehabilitation after traumatic
surgery.

Total upper-limb orthoses designed for maximum restriction of movements and/or total immobilization
These orthoses may consist of a variety of devices worn by the person, typically including a modified
means (e.g., trunk or shoulder straps) for fixed attachment to the user's body. Some orthoses are part
wheelchair, rack). Total upper-limb immobilizer orthoses are used mainly for rehabilitation after injurie

Elbow upper-limb orthoses designed for maximum restriction of movements and/or total immobilizatio
These orthoses may consist of a variety of devices worn by the person, typically including a semi-rigid
plastic structure with aluminum stays and closure straps. Elbow upper-limb immobilizers are used dur
surgery or trauma; dedicated splints intended for use as elbow immobilizers are also available.
Whole-body emergency immobilizers designed for maximum restriction of movement and/or immobili
entire body. These immobilizers usually consist of rigid structures (typically a backboard) with a size a
infants that permit the rigid attachment of the child's entire body. The board is frequently made of lig
plastic radiolucent materials. Infant whole body immobilizers are mainly used after traumatic injuries
situations, allowing easy transportation and/or diagnosis. Dedicated infant immobilizers mainly intend
procedures are also available.

Knee lower-limb orthoses designed for maximum restriction of movements and/or total immobilization
These immobilizers usually consist of prefabricated or custom-made orthoses including long semi-rigid
that unload the pressure on the knee joint, reducing partially or completely its motion. Immobilizer kn
intended mainly to reduce the pressure on the knee in patients with severe arthritis destruction of the
be also used during rehabilitation after traumatic injuries or knee surgery.

Shoulder upper-limb orthoses designed for maximum restriction of movements and/or total immobiliza
joint. These orthoses consist of a variety of devices worn by the person, typically including a modified
means (e.g., trunk or shoulder straps) for fixed attachment to the user's body. Shoulder immobilizer o
mainly during rehabilitation after injuries and/or trauma.
Wrist upper-limb orthoses designed for support and maximum restriction of movements and/or total im
wrist joint in a desired fixed position (i.e., without allowing movement of the joint) but usually permitti
fingers. These orthoses typically consist of a variety of devices including a semi-rigid foam or lightwei
with aluminum stays and closure straps. The orthosis is usually placed from the mid part of the forear
hand with the wrist flexed or in extended position. Wrist immobilizer orthoses are used mainly to keep
hand while preventing wrist and/or hand deformities in brain-injured patients.

Cardiographs designed for recording the variations of the thoracic electrical impedance caused by the
muscle and its effect on the blood flow in the aorta, usually detected at the body surface. These instru
main unit that includes a high-frequency (e.g., 100 kHz) RF generator, a recorder, and typically a set o
leads with electrodes attached at the distal tips. Two electrodes are placed on the neck and other two
surface; one electrode of each pair delivers a low-intensity current of constant amplitude from the gen
body. The other two electrodes sense the voltage variations that are proportional to the thoracic impe
mainly due to the blood flow in the aorta. The values of the variations of the impedance and the graph
the impedance and its first derivative versus time (i.e., impedance cardiograms) are used for calculati
parameters, such as cardiac output and stroke volume.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for m
to provide a drain for fluid from inside tissue, a cavity or wound. Items in these kits usually include sca
catheters, specimen collection swabs and culture tubes, disinfectant swabs, tape, forceps, and dressin
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Incision and drainage procedure kits and trays are mainly intended for allowing purulent ma
an abscess and/or infections to be treated. They are used at home, as well as in hospitals and other h
External occlusion clamps designed to prevent urine flow through the penis by atraumatic compressio
external occlusion) of the meatus through external pressure to the penis, either to prevent urine leaka
or to facilitate a clinical procedure. Penis occlusion clamps are typically handheld, manual, spring-like
soft pads at the working ends. These clamps are used for treatment of incontinence in male patients;
temporarily hold anesthetics or radiography contrast media in the urethra.

Pads designed for absorption of liquids to protect bed linens. These pads typically consist of back-to-b
materials such as soft cotton or polymers that are placed on top of the bed linen and under the patien
pads are intended to keep patients dry and also to prevent damage to bed linens and mattresses due

Underwear designed to retain urine in incontinent adults and older children. These pants usually cons
man's brief or woman's panty with external softness and shape resembling regular underwear and an
shell capable of retaining urine from patients with light or medium incontinence while keeping the skin
pants are used at home, healthcare institutions, and during normal daily activities. Reusable incontine
a single-use pant liner or a tube that deliver the urine to a bag placed on or around one leg (for heavy
available.

Equipment designed to maintain optimal environmental conditions (e.g., temperature, humidity) for li
including infants, usually in an integral enclosure. Incubators typically consist of a closed chamber wh
environmental conditions are provided using heat and humidity sources, gas supplies, controls (e.g., t
gas composition), and measuring instruments; they may also include recorders and displays for contin
incubator chamber conditions. Many different types of dedicated clinical incubators both for infant car
and cultures are available.

Incubators designed to provide a closed controlled environment to maintain appropriate temperature


infants. These incubators typically consist of a clear removable plastic hood with a mattress; they also
to warm the infant, providing heated air (either by natural flow or forced) or through a warm water ma
usually include temperature controls that work automatically either by measuring the air temperature
temperature sensor attached to the infant skin. Most incubators also include humidity controls. Infant
mainly for premature infants and in other newborns that cannot regulate body temperature.

Incubators used to transport infants outside or within the medical facility. These incubators provide a
environment by circulating heated air for the purpose of maintaining appropriate temperature and hu
premature infants. These units are typically mounted on casters, which may be equipped with brakes.

Instruments designed to inject fluids using an automated mechanism. Most of these instruments are a
powered using either electric, electronic (typically battery powered), or pneumatic mechanisms. Some
manually, mechanically operated. Injectors are used mainly to introduce bolus injections of viscous flu
media, medications, mold casting materials, vocal cord augmentation material) into the subcutaneous
veins, or lymphatic vessels, or body cavities such as the ear and larynx; some injectors are used in lab
(e.g., chromatography systems).

Medication/vaccine injectors consisting of a mechanism that facilitates the administration of subcutan


intramuscular injections using a standard or modified plunger syringe with an appropriate needle. Syr
medication/vaccine injectors are used in hospitals, other health care facilities, and in the field when fr
necessary.
Injectors designed to administer bolus injections of indicator solution (e.g., cooled saline solution) into
rapid and consistent injections. These devices typically consist of a pressurized gas system and an ele
that directs the gas to a piston that delivers the solution into a syringe that in turn injects it through a
the right atrium of the heart. Thermal dilution injectors are used for reproducible cardiac output meas
catheterization laboratories and critical care units; they can also be used for determination of cardiac
dye and performing a similar indicator-dilution technique.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for e
insect stings. Items in these kits usually include a bee and wasp extractor (may be a vacuum device),
germicides, and dressings. The kits are frequently supplied in supporting trays (i.e., procedure trays) c
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered by a sterile wrap and may be included in a solid bag appropr
Insect sting emergency procedure kits and trays are intended for treatment of insect (e.g., bee, wasp)
in the field, in emergency rooms, in other areas of healthcare facilities, and at home by persons allerg
wax.

Racks designed for providing safe storage to electrical and electronic instruments (e.g., recorders, mo
other medical equipment. These racks usually consist of a heavy metal frame with open sides and pre
facilitate access to wires and cables bundles; they also typically include fixed and/or adjustable rails o
surfaces. These racks can be stationary, wall-mounted, or rolling. Electric and/or electronic instrument
clinical and surgical departments, warehouses, and maintenance departments of healthcare facilities.

Flat open containers (i.e., trays) designed for holding, carrying, and storing sterile surgical instrument
metallic trays with coved corners and large bead edges allowing easy handling, stacking, and cleaning
be made of different materials such as stainless steel, aluminum, enamel and plastic. These trays are
without covers, in a variety of styles and sizes and can accommodate several instruments. The trays a
healthcare facilities during surgical procedures as well as for sterilization, autoclaving, and storage.

Devices used to blow vapor or gas (e.g., CO2, NO2) into a body cavity to maintain a regulated pressur
Insufflators may be simple pneumatic devices or electronic devices that typically include a gas deliver
regulators, flow sensors, a pressure transducer, a gauge or display, a pressure-relief mechanism, and
insufflators are used during surgical procedures to produce and maintain a gas-filled cavity around the
upon.

Contraceptive devices that are made of soft, flexible plastic shaped like the letter "T" and that are abo
inches tall with a thread or string on the end, which facilitates checking on placement and to assist wi
intended to be inserted by a healthcare practitioner into a woman's uterus (i.e., intrauterine) to preve
are two types of intrauterine devices (IUDs): (1) hormonal, and (2) copper wrapped. The hormonal IUD
amount of levonorgestrel, a progestin hormone. Hormonal IUDs prevent conception by damaging or ki
thickening cervical mucus, making it impenetrable to sperm. Copper IUDs have copper wire coiled aro
arms. Copper is highly toxic to sperm; it disrupts sperm mobility and damages sperm.
Prepackaged collections of the devices and supplies (either custom or standard) needed for insertion o
vasculature. Items in these kits usually include sterile gloves, gauge needles, appropriate intravenous
tourniquet, alcohol swabs, gauze pads, transparent dressing, an IV bag with solution, and tubing. The
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Dedicated intravenous catheterization procedure kits and trays intended mainly for the infusion of me
the peripheral and central vasculature are available; they are also used in a variety of procedures perf
doctors' offices, and other healthcare facilities.

Devices designed to immobilize an intravenous catheter and needle placed into the circulatory system
include a variety of shapes and designs; most are based on dedicated dressings or dressing strips but
a hollow cylinder (i.e., tube-like) holding the needle and catheter that is fixed to the body (usually to a
strap, or other security attachment. The devices may also consist of semirigid domes. Catheter-needle
intended to keep safe and secure an intravenous line access with less risk of detachment of the cathe
combination.

Containers designed to store intravenous (IV) solutions that are intended for a single patient. These co
filled in the clinical pharmacy, either manually or from an IV solution compounder. IV fluid containers a
plastic; they are available either open or presealed after obtaining a relative vacuum in their interior.

Hangers designed for the overhead suspension of intravenous (IV) administration fluid containers (e.g
bottles). These hangers are typically metal structures with one or more hooks (e.g., ram's horn) appro
containers. IV fluid container hangers are used mounted on IV poles, directly on the wall, or fixed to th
or by a track-and-carrier system; the hangers are also used to hang fluid containers during other patie
irrigation, enteral feeding).

Slender stands (i.e., poles) designed for the suspension of containers (e.g., plastic bags, glass bottles)
intravenous (IV) administration to patients. These poles usually consist of a metal stand-alone structu
base with several (four or five is typical) legs with or without casters, and a hanger with one or more h
Most IV pole rods are telescoping structures with a base rod and an internal rod that permits height ad
intended for ceiling, wall, and/or equipment (e.g., cart, stretcher, wheelchair, tabletop) mounting are a
of accessories may be attached to IV poles, such as urinary hooks, temporary pacemakers, patient ha
and tank holders. Some IV poles are designed specifically for use in magnetic resonance imaging [MRI
MRI-compatible IV poles, and are made from nonmagnetic materials so that they can be safely used in

Devices that introduce soluble ions into the body by means of electric current (i.e., iontophoresis). Th
current generator and electrodes which are connected to the generator by lead wires. The electrodes
solution (typically electrolytic) and attached to the skin. A low amplitude, direct current, supplied by th
then conducted between the electrodes, transporting the ions transdermally (a form of electrohydrosi
are used for therapeutic drug administration and sweat tests; they are also used to control hyperhydro

Testers designed to assess the main characteristics of an isolated power system. These testers typical
electronic measuring unit including a display, a current generator, controls to select the test, and app
isolated power system testers can test line voltage, line isolation current, and line isolation monitor an
interrupter operation and trip current; they are used after installation, in preventive maintenance proc
power system modification or repair.
Patient treatment chambers designed to keep a patient isolated, protecting other hospital patients an
exposure to airborne infections (e.g., tuberculosis) or aerosol medications while the patient is being t
chamber is filtered before it is returned to the normal atmosphere outside the enclosure.

Surgical instruments designed for incision of the cornea, often for shaving the outer layer of the corne
typically consist of devices that are either manually operated or electrically powered and include appr
mechanisms; some instruments use a high-pressure waterjet to shave sections of the cornea. Keratom
during corneal grafting procedures (e.g., keratoplasty), especially for partial-thickness implants. Dedic
used for incision of the cornea.

Liners typically made of plastic materials that are used to cover the interior of kick buckets for the pur
clean and facilitating the monitoring (e.g., counting surgical sponges) and disposal of the contents.

Surgical instrument (i.e., knife or scalpel) handles designed to hold and manipulate a compatible cutti
These devices typically consist of a straight, reusable handheld instrument made of either metal or pl
appropriate shape for easy manipulation and a distal tip that can hold a disposable blade with a mech
exchange. The combination of the handle and the attached blade results in a surgical knife/scalpel.

Holders designed to hold surgical knives (i.e., scalpels) during operative or dental procedures. These h
of a plastic case that partially or completely encloses the cutting blade and/or permits the positioning
the blade down. Knife holders typically support several knives in separate compartments simultaneou
appropriate organization of the knives to be used in a surgical or dental procedure; most holders are d
are discarded with the knives. The holders may be provided with adhesive tape to fix them to a workin
procedure tray) or to another convenient place (e.g., surgical table, standing rack, pole).

Instruments designed with a blade that is appropriate for cutting objects, tissues, and other anatomic
devices typically consist of manual, handheld instruments including a proximal handle and a distal bla
sharp edges. Knives are available in a variety of shapes and sizes and these may vary depending on t
Dedicated knives are used in surgical (e.g., ophthalmic, orthopedic, middle ear, plastic), dental (e.g., p
prosthodontic), biopsy (e.g., uterine) and postmortem (e.g., autopsy) procedures. Some knives may be
specific materials (e.g., paraffin). Small knives known as scalpels that are designed for easy cutting or
tissue are also available.

Surgical knives designed for cutting tissues, bone, and/or other anatomic structures during amputatio
devices consist of manual, sturdy, handheld instruments of a variety of geometric shapes and sizes. T
straight or curved handle and a single or double edge, are frequently serrated with a cutting blade at
Amputation surgical knives are used for amputation of the limbs.
Eye (ophthalmic) surgery knives designed to make incisions in eye tissue during procedures intended
opacity (i.e., cataract) and/or to implant artificial intraocular lenses. These knives may have different s
according to the surgical procedure used to extract the lens (e.g., phacoemulsification, sutureless non
cataract extraction). Because each procedure includes the incision of tissue in different eye locations
cutting techniques, more than one type of knife is used in a given procedure. Cataract knives are avai
devices with diamond blades that permit a smooth cut, causing little refraction distortion or injury to a
single-use stainless steel devices with advantages regarding cost and transmission of infection, but w
performance. Use of disposable silicon blades with a performance similar to diamond blades is emergi
blade edge shapes, including phaco (blunt and sharp), crescent, straight, and micro-phaco (for micro i
surgery) are available. Most cataract surgery knives are specific to a particular procedure (e.g., phaco
tunneling, bimanual phacoemulsification), but some cataract knives may be used in other ophthalmic

Surgical knives designed to cut heart-valve tissue. These knives are typically handheld, manual instru
straight or curved, sharp metal (e.g., stainless steel) blade at the distal end. There is usually a handle
to the surgeon's finger. They are appropriate to perform resections in the heart valves. The blades ma
the knife or detachable (disposable). Heart-valve surgical knives are used mainly to relieve valve sten
procedures (i.e., commissurotomy); dedicated knives designed for a particular heart valve (e.g., mitra

Surgical knives designed for cutting the dura mater. These knives consist of manual, handheld instrum
slender, straight, flat, or triangular handle and a flat cutting blade. These blades typically end in a sha
like shape at the distal tip. Dural knives are used mainly to incise the dura mater in neurosurgical proc
damage to the meninges.
Surgical knives designed for cutting the anatomical structures of the middle ear and the external audi
knives typically consist of manual, slender, handheld instruments that may have a variety of different
sizes. They frequently include a straight, swivel, or bayonet-shaped handle and a small thin blade with
cutting distal end. Middle-ear surgical knives are used mainly in middle-ear surgery procedures; dedic
with a revolving cutting component are also available.

Blades designed to be attached as a component to a manually operated or electrically powered surgic


(shave) corneal tissue. These blades typically consist of a flat piece of metal (e.g., stainless steel) with
at the working end; the blade is configured at its proximal end to permit its attachment to only a parti
Keratome blades typically are supplied sterile and are intended for single use.

Surgical knives designed for cutting the crescent-shaped disks of fibrocartilage attached to bones (i.e.
knives typically consist of manual, sturdy, handheld instruments with a wide, straight handle. Often a
proximal end is a small perpendicular plate which permits application of pressure. The blade is long, fl
may have a straight or concave, U-shaped distal end. Meniscus knives are mainly used in orthopedic
orthopedic meniscectomy of the tibia at the knee joint.
Knives designed to cut paraffin blocks. These knives usually consist of a sturdy blade made of a hard m
copper) that retains heat well and a shank that is permanently attached to a handheld heat source. Th
source (e.g., thermoelectrical) travels through the shank and penetrates the blade. Usually, the tempe
controlled from room temperature to 100 degrees Celsius (212 degrees Fahrenheit). Paraffin knives ar
paraffin in clinical laboratories (e.g., for histology and pathology embedding) and also for other paraffi
physical therapy).

: Knives designed to cut plaster cast while it is in situ on the patient's body. These knives typically con
handheld instruments with a straight (e.g., wood, metal, ebonite) long handle and a curved sharp blad
distal tip. Cast knives are mainly used to remove orthopedic casts.
Multipurpose small surgical knives designed to cut or dissect tissue. These scalpels may consist of ma
with a straight handle and an integral blade with a sharp convex edge. They are available as reusable
instruments. Scalpels may also consist of a combination of a reusable handle and a detachable single
placed at the distal end. Multipurpose scalpels are used in general, plastic, and in a variety of other ty
procedures. Dedicated scalpels intended for microsurgical procedures are also available.

Surgical knives designed to cut uniform skin strips of predetermined thickness at the donor site for gr
typically consist of a handheld instrument that has a single-use blade with a sharp edge that is lateral
handle. Skin-graft knives are used to obtain grafts used to cover damaged or lost skin in several treatm
surgical procedures (e.g., plastic surgery, burn treatment).
Bone surgery knives designed for cutting the long bone plate forming the anterior wall of the thorax (i
knives typically consist of manual, sturdy, handheld instruments usually with a tubular T-shaped hand
This facilitates grasping and application of pressure. At the distal end there is a wide cutting blade wh
the shaft. Sternum knives are used mainly in surgical procedures that require opening the thoracic cav
cardiothoracic surgery).

Throat surgical knives designed to cut and excise the lymphoid almond-shape masses located in the o
palatine tonsils). These knives are typically handheld, manual instruments with a straight, flat handle
sharp angled or curved blade with a blunt distal end. Tonsil surgical knives are used in tonsillectomy p
Equipment designed to provide a clean environment in an enclosure. These rooms are characterized b
number of particles per unit volume allowed inside an enclosure (i.e., cleanliness classes, typically exp
cubic foot from 1 to 100,000). This equipment may be configured to create air flow with uniform veloc
direction (i.e., laminar air flow), or to produce a partially laminar or turbulent pattern, according to the
intended use of the clean room. The equipment usually consist of air gross pre-filters to eliminate big
high-efficiency particulate-air (HEPA) filters (which typically remove 99.97% of particles of 0.3 micron
penetration air (ULPA, typically removes 99.99% of particles of 0.12 micron or bigger) filters to provide
inside the enclosure free from fine air particles and liquid droplets; and blowers, ducts, controls, and o
regulate the air velocity, temperature, and humidity of the environment. Typically, air is drawn from t
the enclosure by the negative pressure created by a blower; the particulates are removed using the fi
filtered air is circulated into the enclosure (e.g., a chamber, a room) and exhausted into the environme
and recirculated into the enclosure) using a system of blowers and air pathways. This equipment is us
environments in operating rooms, clinical laboratories and pharmacies, to isolate patients to avoid th
(isolation chambers) and/or the contamination of other patients and healthcare personnel from the pa
chambers). Clean room/laminar air flow equipment may be supplied for installation in existing rooms
of a standard or custom-designed clean rooms, chambers, or hoods.

Cervical canal (i.e., uterine cervix) dilators consisting of an expansible plug (i.e., a tent) of dried Lamin
seaweeds); they are usually available as sterilized devices that have a strong thread attached for anch
removal. These tents gradually swell to several times their original diameter by the absorption of mois
a period of several hours (typically 12 to 14), producing a gradual cervical dilatation. Laminaria tent c
used to perform intrauterine obstetric maneuvers, especially to perform midterm abortions.

Lights designed to provide intensely focused light directly on the area where the examination is being
lights are intended to emit their useful radiation mainly in the visible spectra; some dedicated examin
in the infrared or ultraviolet spectra. Incandescent, fluorescent, halogen, as well as LED (i.e., light emi
available. Examination lights are available in stand-alone, wall-mounted, ceiling-mounted, and portab
configurations. Examination lights are used in dental and physician offices for patient examinations; th
during minor surgical procedures.

Phototherapy units designed to heat the perineal region by applying the radiation of a conventional vi
units usually consist of portable and/or handheld lamp fixtures that include switches, light intensity co
mechanical protection to avoid direct contact of the light bulb with the area under treatment, prevent
phototherapy units are used to help in the treatment of infections, lesions, and in other (e.g., obstetric
the region.

Ophthalmic diagnostic instruments designed for examining the eye (mostly the anterior part of the ey
illumination system combined with a binocular microscope. The instruments usually consist of illumina
mechanism that provides a slit beam of light into the eye with different types of illumination (e.g., dire
diffuse, background illumination), a binocular microscope for viewing the magnified slit image, and a c
adjusting the focus of the microscope and the slit (e.g., slit rotation, slit width); some also have refrac
light to a camera mounted above the microscope. Slit lamps provide a magnified view of eye structure
iris, crystalline lens, cornea); some instruments can also examine the retina using specific lenses. Slit
in the diagnosis of eye conditions.
Lights designed to provide illumination to the surgical site for a prolonged period of time on a flat and
in a deep surgical cavity to assist medical personnel during a surgical procedure. These units typically
arms that are free to rotate continuously at every joint to satisfy various heights and angles needed d
lights provide high-intensity illumination while reducing shadows and producing minimal color distorti
bulbs (e.g., incandescent, compact fluorescent lamp [CFL], halogen, light-emitting diodes [LED]) and a
in fixtures (e.g., lamps) of several shapes and sizes. They may be ceiling-mounted, stand-alone or wal

Lights designed to provide radiation mainly in the 100 to 380 nm wavelength range on the area being
ultraviolet (UV) lights typically consist of low-pressure mercury vapor tubes that emit radiations that a
naked eye; however, when they are emitted from an ultraviolet lamp and directed at the surface of th
are often transformed into visible colors. Most UV examination lights include an optically ground and p
to provide a clearer viewing area. Ultraviolet examination lights are used for observing and diagnosing
to the skin and eye including detection of corneal scratches, foreign bodies, blocked tear ducts, head
bacterial infections. They are used in medical offices, emergency rooms, and other healthcare facilitie

Ultraviolet (UV) lights designed to kill airborne microorganisms, reducing their concentration in closed
lights usually consist of bulbs or tubes similar in appearance to standard fluorescent tubes used for illu
germicidal lights are very effective in destroying the DNA of microorganisms, leaving them unable to p
functions. They are intended to eliminate and or prevent the spread of microorganisms in the air, on s
Germicidal ultraviolet lamps are available in different sizes, shapes, and configurations (e.g., freestand
mounted, duct-mounted, ceiling-mounted, portable).

Endoscopes inserted through an artificial orifice in the abdominal wall (i.e., percutaneously) for observ
treatment of the organs in the abdominal cavities. These endoscopes usually include a system of relay
fiberoptic light systems for illumination and imaging that facilitates the examination and performance
surgical procedures. Most laparoscopes incorporate camera heads that employ charged-coupled devic
display, documentation, and processing of the endoscopic images. Laparoscopes are usually manufac
types: one for diagnostic (viewing laparoscopes) and other for surgery (operating laparoscopes).

Respiratory tract endoscopes designed for direct insertion through the mouth into the air tract for visu
biopsy, and treatment of lesions of the larynx; they are also used for intubation of the trachea. Laryng
either as rigid or flexible devices. Some laryngoscopes are designed specifically for use in magnetic re
environments, i.e., MRI-compatible laryngoscopes, and are made from nonmagnetic materials so that
used in an MRI suite.

Laryngoscopes designed to observe the glottic action during phonations by focusing a stroboscopic lig
Laryngostroboscopes usually include a constant and/or flashing light source, a camera, and a microph
attached to a recording system and printer. These devices provide a slow-motion view of the vocal fold
cords) as they vibrate, permitting the assessment of phonatory function; detect lesions; and follow the
for the patient. Laryngostroboscopes are mostly used for larynx and vocal cord examination during ph
voice-diagnosing laboratories.
Testers designed to perform alternating-current (AC) and direct-current (DC) leakage current measurem
range from 1 A to 20 mA). These testers typically consist of an instrument that can measure AC and D
range and accessories designed to perform the assessment according to the physical characteristics o
test. Leakage current testers are typically used to assess the leakage current flowing to ground, as we
applied part) and chassis (i.e., enclosure) leakage currents.

Water baths designed for treatment of the leg(s). These are typically electrically heated and may hav
features built in.
Devices designed to support and provide comfort to the legs while the user is sitting or lying. These d
of a cushioned structure with shape and size appropriate for placing one or both legs; they are typical
metal, plastic, or a combination of these materials. Leg rests are usually an integral part or may be at
wheelchairs, operating tables, commodes, or other furniture. They are used to facilitate examination,
procedures and also during rehabilitation and/or for long-term use by disabled or geriatric patients.

Fixed loop surgical instruments designed for eye lens extraction and manipulation and/or irrigation of
ophthalmic procedures. These instruments typically consist of a manual, handheld instrument with a s
metallic wire loop (frequently serrated) at its distal tip and a handle for easy manipulation; the instrum
a channel (e.g., cannula) for eye irrigation from an external irrigator. Lens fixed loop instruments (i.e.,
a variety of ophthalmic surgery procedures requiring accurate gentle manipulation of delicate tissues.

Pieces of transparent materials, such as glass and plastic, so shaped as to converge or scatter the ray
the visual acuity of the human eye. Lenses may be specially design to be mounted in appropriate fram
other instruments, to be placed directly on the eyes (contact lenses), or to be implanted in the eyes (i

Lenses designed to be implanted permanently, they are usually intended to replace the natural catar
human eye lens and restore useful vision. These lenses, typically made of plastic, are mostly implante
removal (i.e., in aphakic eyes). Some intraocular lenses may be used for refractive correction without
the natural lens.
Ophthalmic measuring instruments designed to measure the optical characteristics of lenses (e.g. sph
power, cylinder axis, prismatic power, lens diameter). The instruments measure how the light is refrac
through the lens. Lensometers can be manual or automatic. Lensometers are used mainly to determin
characteristics and the prescription match.
Radio-frequency (RF) therapy systems designed for tissue coagulation necrosis at temperatures above
tissue water vaporization above 100 degrees C (i.e., thermal ablation), usually at frequencies below 5
mechanism for ablation at radio frequency occurs by heating due to tissue electrical resistance when
through them. These systems typically consist of a RF generator, a delivery cable, an applicator or ca
electrodes. The active electrode, including temperature sensors, is placed on the tissue volume to be
applicator or catheter, and a large-area neutral electrode that reduces current density to avoid tissue
the body surface. Some systems include needlelike electrodes (applicators) that are introduced into t
the volume of the treated tissue.

Mechanical devices designed for hoisting or lowering objects or persons from one place to another tha
height. Most specialized lifts in healthcare facilities and homes are used to transfer disabled persons a
to overcome vertical barriers, typically limited to a difference of about 6 m (20 feet); some are used to
vehicles.
Lifts designed for hoisting and transferring a patient safely and with minimal physical effort. These lift
or U-shaped support base usually including casters, a vertical mast, a pivoting boom, a swivel bar, a s
the lifting mechanism; they are manually, electrically, or battery operated using hydraulic or screw jac
Patient lifts are frequently used to transfer patients (e.g., to and from a wheelchair, toilet, or bathtub),
injury to those assisting with the transfer (typically only one person) and of patient drop. Some patien
mounted on tracks to permit patient transfers between rooms or different vertical levels.

Wheelchair lifts designed to provide a means of vertical access for people with physical disabilities. M
consist of a platform onto which the patient wheels the wheelchair, using controls to go up or down; s
lifting the wheelchair, its occupant, and an attendant. Wheelchair lifts are used in places such as hosp
and stores; some are specially designed for vehicle access.
Devices designed to cut off blood flow to hemorrhoidal tissue.
Devices designed to provide light illumination in an area distant from the device output port. These de
of a lamp fixture that may include a variety of light sources [e.g., , xenon, halogen, incandescent light
(LEDs)] and a delivery system such as a fiberoptic cable; some battery-powered light sources may be
proximal end of instruments (e.g., endoscopes) that include optical transmission capabilities. Light sou
in endoscopic and microscopic procedures performed for diagnosis, therapy, or surgery.

Light sources designed to provide light illumination at the distal end of a flexible endoscope by deliver
fiberoptic cable attached to the proximal end of the endoscope. These devices consist of a lamp fixtur
variety of light sources [e.g., xenon, halogen, incandescent, light emitting diodes (LED)] and a fiberop
adapters are frequently necessary for particular types of flexible endoscopes. Fiberoptic cable flexible
sources are used in endoscopic procedures performed for diagnosis, therapy, or surgery.

Instruments that provide light for viewing surgical fields and body cavities when using rigid and flexib
laparoscopes, gastroscopes) or other surgical accessories (e.g., retractors). They are intended to prov
observation and surgical procedures while minimizing tissue heating. Light sources eliminate the add
cost that would be incurred if the source were incorporated in each instrument. Fiberoptic light source
projectors to which flexible and rigid endoscopes can be attached using a flexible fiberoptic cable. Als
light sources, projectors, illuminators.

Light sources designed to provide high intensity light typically during very short periods of time (i.e., a
order of a few milliseconds). These devices typically consist of a portable unit that includes a light fixt
bulb, light emitting diode (LED)], a battery, and a switch. Flash light sources are frequently attached t
camera allowing the flash to be triggered and synchronized by the camera obturator. Flashlights are u
taking photographic pictures in dark environmental conditions.
Devices designed to provide illumination and/or radiant energy. Lights usually convert electrical powe
radiation, typically in a wavelength range that may include the infrared, visible, and/or ultraviolet spe
illumination emit light mainly in the visible spectrum (i.e., the part of the wavelength range that is vis
some infrared and ultraviolet lamps may be also used for examination. These devices include high int
healthcare for examination and diagnostic procedures; infrared and ultraviolet lights are mainly used
(e.g., heating and germicidal use, respectively). Lights intended for therapeutic use are usually known
and are not included in this category. Lights are available in stand-alone, wall-mounted, ceiling-moun
portable/handheld configurations.

Lights designed to provide intense focused light directly on intraoral areas. These lights are typically
emitting diodes) and halogen lights which greatly improve visibility for healthcare staff, including dent
oral surgeons to see inside the mouth and pinpoint desired subject areas. Some dental examination lig
contrast filter for oral exam beyond normal visualization capabilities. These intraoral examination ligh
during dental treatment, clinical consultation, and minor emergency surgery. They are available in sta
mounted, ceiling-mounted, and portable configurations.

Monitors designed to continuously measure and display data on one or more of the environmental con
to which individuals may be exposed in healthcare facilities. These monitors may include computerize
process information. Environmental monitors are used to assess the concentration of gases (e.g., oxyg
and/or the physical conditions of the environment (temperature, humidity, ionizing radiation, particle
include audible or visual alarms to alert patients and/or healthcare personnel to unsafe conditions.

Radiotherapy systems designed to produce electron beams of varying energies in addition to high-ene
linear accelerator (linac) as a generator. A linear accelerator consists of a modulator, an electron gun,
power source (either a magnetron or a klystron), and an accelerator guide. The range of the energy le
is very wide, from 4- to 6-megavolt (MV) photons for low-energy units to 25 MV photons and up to 22
electrons in high-energy units. These systems also include control units, filters, and collimators. Low-e
accelerator systems are mostly used to treat tumors of the head, neck, and breast; high-energy syste
deep-seated neoplasms and tumors of the pelvis and thorax.

Devices designed to provide a bacteria-proof barrier between the unsterile surfaces they cover and th
Their flexible, cloth-like properties allow them to cover the contours of patients, instruments, and ope
drapes are resistant to abrasions and punctures. Surgical drapes help create the sterile environment r
procedures such as angiographic, ophthalmic, and orthopedic procedures and to cover medical instrum
operating microscope). These drapes are available as reusable woven or as disposable nonwoven mat

Sheets designed to be placed on the surface of an operating table. These sheets usually consist of abs
fabrics providing some protection for the patient and for the table, but not sterile conditions during su
Operating room table sheets can be disposable or reusable. Some sheets are specifically made to fit o
are used in operating rooms for surgical procedures.
Major partial denture connectors extended to cover the cingula of the lower anterior teeth.
Instruments designed for the manual mechanical crushing of renal stones (calculi) in the urinary tract
devices are typically consist handheld manual instruments with a distal end appropriate for grasping a
and an attached handle designed to manipulate the instrument and apply the manual force needed to
Lithotrites are used, frequently through the working channel of a cystoscope, to crush renal stones un
small enough to be extracted using irrigation and suctioning devices.

Data tape recorders that include a noninvasive sphygmomanometer (e.g., oscillometric, auscultatory)
commonly used in ambulatory patients for assessing blood pressure variations during normal patient

Trend graphic recorders used to record the heart rate. Some recorders also record the number of abno

Electrocardiography tape recorders that include chest surface electrodes and an electrocardiograph am
basic type of recorders: real-time and retrospective (according to the point at which analysis is perform
are commonly used in ambulatory patients to detect transient ventricular arrhythmias, after myocardi
detecting other heart origin diseases.
Ambulatory electroencephalographs (EEGs) that include scalp electrodes and an electroencephalograp
EEGs are commonly used in ambulatory patients to study a variety of neurological conditions (e.g., ep
psychiatric disorders.
Trend graphic recorders used to record the partial oxygen tension (pO2) in the blood, usually by taking
monitor (e.g., pulse oximeter).
Graphic recorders designed to record changing physiologic variables (e.g., heart rate, temperature, re
their positive or negative changes from a preset "normal" value over a period of time up to one or two
recorders include an sensor appropriate for the variable to be measured or data taken from patient m
speed is very slow (e.g., 1 cm/hr), allowing continuous recording without the need to replace the pape
are used to evaluate the long-term changes in patients' conditions.

Fixed loop instruments designed to grip and shear arteriosclerotic deposits from the lumen of an arter
procedures. These instruments typically consist of a fixed rigid wire loop attached to a handle which ro
the application of torsion forces to the loops; the shearing action is typically achieved by pulling the lo
Endarterectomy fixed loop instruments may incorporate a shear force gauge designed to measure and
applied to the loops.

Devices designed as flexible bands used in occluding, retracting and identifying vessels (i.e., arteries
tendons and nerves during surgical procedures. These devices typically consist of long, thin, radiopaq
constructed from synthetic materials such as medical-grade silicone); they are often color-coded acco
red for arteries, blue for veins, white for tendons, yellow for nerves). Vascular loops are intended to be
vessel or other structure; some designs include a needle attached to one end of the band to facilitate

Substances, typically petroleum-based or water-soluble, intended to be applied as a surface film in ord


between moving parts. For example, these substances are applied to devices such as catheters and th
insertion, or to gloved fingers, e.g., for a medical exam.
Prepackaged collections of the devices and supplies (either custom or standard) needed for collecting
(CSF) from the subarachnoid space and frequently also for measuring cerebrospinal fluid pressure. Ite
include anesthetics (e.g., lidocaine), syringes, a spinal needle with metal hub, a three-way stopcock, a
may also include a two-piece manometer, an infiltration needle, sponge sticks, gauze pads, a fenestr
adhesive strip, and puncture site bandages. The kits are frequently supplied in supporting trays (i.e., p
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Lumbar puncture procedure kits
for use during diagnostic and/or therapeutic purposes performed in doctors' offices, hospitals, and oth

Lumbosacral spine support orthoses consisting of a relatively narrow strip of soft of semi-rigid materia
provide support and some degree of movement restriction of the lumbar and sacral segments of the s
usually consist of soft (e.g., fabric, leather, plastic, or combinations of these) narrow structures that ca
encircling of the lumbar spine. Lumbosacral spine support orthoses provide limited restriction of the lu
lateral and rotational motion; they are used mainly to alleviate pain.

Respiration simulators designed to mimic the pulmonary mechanics of the lungs by taking in air and t
Typically, they can simulate the normal adult, pediatric, and/or infant breathing characteristics (e.g., b
and expiratory times, tidal volume). Most simulators can also simulate abnormal (e.g., diseased) cond
simulators typically consist of a mechanism that includes one or more chambers, elastomer bellows, a
They may also include measuring instruments (e.g., volume, time, pressure) and capabilities to adjust
airway resistance and/or to simulate leaks. Lung simulators are used to test the performance of mech
spirometers, and anesthesia devices and/or for training purposes. Some lung simulators can display a
performance of devices being tested (e.g., ventilators) using computing capabilities.

Prepackaged collections of the devices and supplies (either custom or standard) needed to inject a rad
medium or dye for performing the examination of lymph nodes and lymph vessels (i.e., a lymphangio
kits usually include tourniquets, a pressure injector, needles, syringes, a cannula, cleansing swabs, an
dye. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bott
a border around the periphery supporting all the instruments and supplies needed for the procedure;
covered or wrapped. These procedure kits and trays are intended for use during diagnostic purposes
location of lymph vessels and lymph nodes; oftentimes the tests are performed to evaluate the extent
Lymphangiography procedure kits and trays are used at hospital radiology departments and/or other h

Stimulators designed to apply electromagnetic energy to the tissues. These stimulators typically apply
pulsed, radiofrequency energy. Electromagnetic stimulators that apply low-intensity flux density (typic
micro- or millitesla) signals to the tissues (e.g., soft tissue, brain) without thermal effects or that are in
intensity (in the order of several tesla) flux density to the brain are available.
Cardiographs designed for recording the variations of the biomagnetic field caused by the electrical ac
muscle detected externally from the body. The magnetic field is picked up with superconductive coils
externally from the body and then detected with very sensitive sensors, such as an array of supercond
interference devices (SQUIDs). The SQUIDs are housed in a cryogenic container (known as a Dewar). A
signal-to-noise ratio the detected signals are amplified and displayed as magnetic field and/or electric
equipment also includes a computerized unit with dedicated software (a workstation) to process the m
magnetocardiographs should be used inside magnetic shielded locations. Magnetocardiographs are m
sources of arrhythmia, diagnose fetal cardiac disorders, and screen for ischemic heart diseases; they a
real-time assessment of cardiac conditions.

Measuring instruments designed to detect and measure the magnetic flux strength (scalar magnetom
direction (vector magnetometers) close to the instrument. These devices typically consist of an electr
field detectors, and a display that shows the value of the magnetic flux level (typically measured in m
Magnetometers are used mainly in healthcare facilities to measure weak magnetic fields around medi
determine if the magnetic field may produce any interference with the operation of the medical devic
also used to evaluate an appropriate location for new equipment that may be affected by magnetic fie
resonance imaging scanners).

Mallets designed to strike a chisel or other driving or cutting instrument into bone.
Radiographic units designed for breast imaging. These units include a high frequency or constant pote
(usually from 20 to 35kV), an automatic exposure control, filters, a collimator, patient positioning feat
devices) and an image recording system. Most mammographic units use intensifying screen-film comb
recording; some consist of an electrostatic recording system that uses a charged photoconductive pla
(xeromammography). Mammographic units are primarily used to detect and diagnose breast cancer in
women, and also to evaluate palpable masses and other breast lesions.

Shafts designed to hold a rotating device, such as a grinding wheel, abrasive disk, circular saw, or hea
shafts in handpieces that hold a disk, stone, or cup used for grinding or polishing.
Devices used to make marks that allow measurement or identification.
Devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or ma
accurate blood pressure measurement.
Devices that cover the nose and mouth to maintain aseptic conditions or to administer inhaled anesth
They are typically composed of rubber, plastic or paper products.
Devices used to deliver air, oxygen, or a mixture of the gases to a patient's airway. Air-oxygen masks
gas source with tubing and typically include head straps for stabilization. The devices are made of pla

Devices used to deliver air, oxygen, or a mixture of the two gases containing aerosol particles to the p
oxygen masks used for aerosol administration are typically connected to the gas source with wide bor
head straps for stabilization. The devices are typically made of plastic.
Devices used to deliver a high concentration of oxygen to the patient's airway. Nonrebreathing masks
valve that prevents rebreathing of gases and a reservoir bag used for fresh gas. These devices are co
source with tubing and include head straps for stabilization. Nonrebreathing masks are constructed o
Devices used to deliver a mixture of air and oxygen to the patient's airway. Partial rebreathing masks
used for inhaling a mixture of exhaled and fresh gases. These devices are typically connected to an o
tubing and include head straps for stabilization. Partial rebreathing masks are constructed of plastic.

Devices used to deliver a precise mixture of air and oxygen to the patient's airway. Venturi masks typ
of adapters that allow air entrainment in controlled amounts to provide a desired oxygen concentratio
connected to an oxygen source with tubing and include head straps for stabilization. Adapters are typ
connection to a humidity source. Venturi masks are constructed of plastic.

Devices used to deliver anesthetic agents and medical gases to patients in the operating room. Anes
usually constructed of rubber and cover the nose and mouth with a tight seal against the skin. The de
for short-term procedures.
Devices used to deliver oxygen or a mixture of oxygen and air to patients via their tracheostomy airw
typically connected to an oxygen source with tubing and are constructed of plastic. Tracheostomy mas
tracheostomy tube or stoma, and are typically fastened around the patient's neck via a disposable str
devices are frequently referred to as "trach collars" or "tracheostomy collars."

Devices used to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to p
tracheostomy airway. The masks are typically connected to an oxygen source and nebulizer with wide
constructed of plastic. Trachostomy masks for aerosol administration can be used over a tracheostom
are typicially secured with a strap or ties around the patient's neck.

Prepackaged collections of the devices and supplies (either custom or standard) needed for maternal
postpartum and/or perinatal phases of pregnancy. Items in these kits usually include perineal irrigator
antiseptic towelettes, wipes and cleaners, cool and warm perineal pads, and nursing-bra pads. The kit
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Maternal post-partum care kits and trays are used in the care of the mother during the period around
of the baby at home, maternity hospitals, and/or other healthcare facilities.

Covers designed to protect mattresses from stains, odors, dust, and body fluids such as urine, vomit, b
drainage. They can also reduce friction, helping to reduce injury to a patient's skin. Mattress covers ca
the top and sides of the mattress with sidewalls and elastic straps or to completely encase the mattre
zippers. Mattress covers are usually made of non-allergenic waterproof vinyl, nylon, stretchable knit, c
fabric. They can be made anti-microbial and / or hypoallergenic, and can be either disposable or reusa
can be used for either foam or spring bed mattresses and for air-fluidized or low-air-loss mattresses.

Mattress covers made of conductive fabrics designed to provide electromagnetic field shielding, help c
discharge and the accumulation of static charges, and to help eliminate electrical interference. Condu
are usually made from thermoplastic films and synthetic fibers, or metalized fabrics woven or plated w
Conductive mattress covers are usually fluid-proof and antimicrobial and provide comfort to the patien
Mattress covers designed to be used on mattresses used for incontinent patients. Waterproof mattress
of vinyl, or cotton, rayon, or polyester (or a combination) with a vinyl backing. They can be made to co
of the mattress with sidewalls and elastic straps or to completely encase the mattress and be closed w
covers are usually made of non-allergenic waterproof vinyl, nylon, stretchable knit, cotton, or polyeste
made anti-microbial and/or hypoallergenic, and can be either disposable or reusable. Waterproof matt
used for either foam or spring bed mattresses and for air-fluidized or low-air-loss mattresses.

Casings of strong cloth, other fabric, or plastic filled with some soft material (e.g., cotton, foam), fluid
gel; they are often quilted or tufted at intervals and used on or as a bed. Some mattresses are made w
(i.e., inner-spring mattresses). Mattresses are used in home care, nursing homes, and hospitals on bed
on examination and operating tables for patient comfort, support, transport, examination, treatment,
rehabilitation.

Mattresses with appropriate dimensions for use on beds in hospitals and nursing homes and/or for hom
mattresses are usually filled with foam, include inner springs (e.g., wire coils), or are a combination of
typically made of fire-retardant materials and are enclosed in waterproof antimicrobial covers. Some b
designed to gatch in the typical positions of a hospital bed (e.g., Fowler). Bed mattresses made in an a
pediatric use or to support the weight of obese and morbidly obese patients (e.g., bariatric mattresses

Mattresses with appropriate dimensions for use on operating tables. These mattresses are typically fil
may include inner springs (e.g., wire coils). Operating-table mattresses are made of fire-retardant mat
in waterproof antimicrobial covers. Some operating-table mattresses use conductive covers.

Mattresses that mold to the contours of the patient's body when a relative vacuum is obtained by pum
them. These mattresses are typically made of a strong fabric (e.g., vinyl/polyester laminate) filled with
polystyrene) beads; the air is evacuated from the mattress using a manual pump. Vacuum mattresses
immobilization of patients during transportation, also providing thermal insulation; they are used to t
by using their own handles or by placing them on a portable or ambulance stretcher.

Bed mattresses filled with water to provide a pressure relief surface to the patient. These mattresses
several interconnected sections of water bladders enclosed in a strong plastic casing (e.g., vinyl). Wat
typically filled through a valve that adapts to standard hoses; they are used to reduce the pressure de
surface to the patient's skin (for the prevention of pressure sores [decubitus ulcers]).

Endoscopes designed for percutaneous insertion in the jugular notch of the sternum (the notch on the
sternum between the clavicular notches) for visual examination, biopsy, and treatment of lesions of th
in the cavity between the lungs (i.e., mediastinum), including the heart and its large vessels. Mediasti
consist of a rigid outer sheath, a lighting system, and a working channel for catheters and operative d

Bags designed for transportation of medical devices, instruments, and/or supplies. These bags are typ
handheld containers made of plastic, fabric, or leather and typically include attachments for easy han
for closure and/or locking. The internal space is typically appropriately configured for the intended con
stethoscopes, sphygmomanometers, drugs). Dedicated medical transportation bags are available for a
and/or users, including specialized bags for physicians, nurses, first-aid providers, and paramedics._x0
Holders designed to hold patients' medical charts in a convenient and organized fashion. These medic
be made of metal, wood, plastic, or a combination of these materials and have slots to hold one or mo
chart holders may be freestanding or mountable on a wall or other surface.
Injectors designed to deliver subcutaneous and/or intramuscular medicines (e.g., anesthetics, antibiot
vaccines. These injectors may consist either of a hand-held mechanism where standard plunger syring
needles are placed or mechanisms using high pressure (e.g., carbon dioxide cartridges) to inject the li
systems). Medication/vaccine injectors are used in hospitals, other health care facilities, and in the fie
injections are necessary.

Small cups intended to be used for administrating medicine that is swallowed. They may be used to h
both. These cups are typically made of plastic, stainless steel, or paper, and may vary in size. They m
sterile, and some are graduated to allow for dose measurement.
Mesh made of a biocompatible polymer with appropriate mechanical characteristics. Polymeric mesh i
absorbable materials (e.g., polyglycolic acid, polycarbonate) or nonabsorbable materials (e.g., polypro
Dacron, nylon). Nonabsorbable polymeric mesh is used mainly in surgical procedures (e.g., reinforcem
groin hernia repair, treatment of pelvic floor prolapse); absorbable mesh is used mainly for temporary
temporary scaffold for tissue regeneration (i.e., tissue engineering).

Detectors designed to identify/locate ferromagnetic foreign objects in a patient's body and/or discrimi
foreign objects from nonferromagnetic foreign objects. These detectors typically consist of a handheld
(e.g., dials and knobs), a display and/or a speaker, and one or more attached probes. Some detectors
probe that can be placed on/near the patient's body surface (e.g., in wounds). Typically, a drive coil ge
magnetic field and two search coils in the sides of this field are positioned in such a way that the signa
coil cancels the signal from the other in the absence of a magnetic body. When a ferromagnetic object
of the two coils, the balance is upset, generating voltage that produces an audible signal and/or deflec
foreign-body detectors are used mainly to locate foreign bodies in the eyes, but they are also used in
as to locate metallic implants in the body (e.g., before a magnetic resonance imaging scan) and objec
left in the patient during a surgical procedure.

Metal extractors designed to pullout small ferromagnetic foreign objects from the eye and/or the surfa
body. These devices may consist of a handheld instrument with a magnet at one end and a wire loop a
mechanical extraction; or, less frequently, of an electric unit that includes the electromagnet, a power
the intensity of the magnetic field, and switches; usually they also include several detachable probes
to provide better access and minimum trauma to the eye and/or other points in the surface of the bod

Cervical canal dilators consisting of catheters tipped with one or two inflatable silicone balloons that a
mechanically augmenting the caliber of the uterine cervical canal before obstetric labor induction. The
catheter is inserted into the uterine cervical opening. Saline is injected through the catheter to expan
balloons, which then apply pressure to the cervix causing the cervix to slowly open or dilate. The sing
places the balloon to the uterine side of the cervix and the double balloon dilator places a balloon on
balloon on the vaginal side of the cervix; the catheter is placed through both balloons. The catheter is
cervix has dilated enough (to about 3 cm) for the balloon or balloons to be removed.
Devices intended to allow the fabrication of micropipettes or needles from glass capillaries by first hea
stretching the glass. Glass heating is typically accomplished via a metal filament through which electr
a laser. Force used to induce glass stretching may be provided by a motorized drive in the case of pull
capillary horizontally or by gravity with or without the assistance of a motorized drive in the case of pu
capillary vertically. These devices typically allow the user to modify the heat level and the timing and
stretching, which, in turn, alters the characteristics of the fabricated micropipette/needle (e.g., taper,
Micropipettes/needles generated using these devices are used in various laboratory procedures includ
and single-cell injection studies.

Covers designed to be placed over microscopes to protect them from dust and spills when they are no
covers are usually made of cloth or of transparent vinyl and in various sizes to fit over differently sized

Instruments designed to obtain a magnified image of small objects and reveal details of structure not
distinguishable by the naked eye. A variety of microscopes are available according to the technique u
samples and the device's intended use. The three main types of microscopes are (1) light microscopes
specimen is viewed by being placed in a light path (which may be white light composed of all visible w
light, or, less frequently, infrared light), for laboratory or surgical use; (2) electron microscopes, in whi
instead of light for illumination, forming an image for viewing on a fluorescent screen or by photograp
greater magnification and resolution than is possible with the light microscope, for observing cellular a
structures; (3) scanning microscopes, in which a monochromatic light source delivered from a scannin
performance of scanning-laser microscopes in terms of optical resolution, depth contrast, and sensitiv
reportedly better than in conventional light microscopes. Scanning-laser microscope images are displa
video monitors. Microscopes are used mainly in healthcare facilities for examination, surgery, and clin

Examination light microscopes, usually stereoscopic, designed for examination of the anterior eye me
lens and anterior vitreous). These microscopes are used to observe and identify disease processes, to
to evaluate corneal injuries and the presence of foreign bodies. Some ophthalmic microscopes are use
designed illumination sources (both attached to a common base) in a system known as a slit lamp.

Operating light microscopes designed to magnify minute structures (e.g., nerves, vessels) in the perfo
ear, nose, and/or throat (ENT) surgical procedures, which require high magnification and adjustable fo
microscopes typically consist of a stereo microscope (standard or modified) and a mobile floor stand o
The microscope is usually held by an adjustable arm attached to the support mechanism. Most operat
equipped with motorized focusing, adjustable magnification systems (manual, zoom, or both), backup
tubes that permit the surgeon to see the field from a vertical perspective while keeping his or her hea
multiple-observation capability and the optical integration of still, motion picture, and TV cameras are
otorhinolaryngoscopy microscopes.
Light microscopes used to magnify minute structures (e.g., nerves, vessels) in the performance of del
procedures which require high magnification and adjustable focusing. Operating microscopes typicall
microscope (standard or modified) and a mobile floor stand or wall or ceiling mount. The microscope
adjustable arm attached to the support mechanism. Most operating microscopes are equipped with m
adjustable magnification systems (manual, zoom, or both), backup lamps, and inclined tubes that perm
the field from a vertical perspective while keeping the head erect. Dual- or multiple-observation capa
integration of still, motion picture, and TV cameras are common features of these microscopes.

Detectors designed to provide a relative indication of the power of microwave radiation leakage. Thes
hand-held battery powered device that includes a sensitive probe that may use either thermal (e.g., a
thermocouple sensor) or electrical conversion (e.g., a semiconductor diode sensor) technologies to de
(i.e., leaked) microwave power, and a qualitative display. Microwave leakage detectors are used mainl
from microwave ovens and other high-powered microwave equipment (e.g., heaters, dryers), typically
fittings, and hinges.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for o
sample after the first urine containing urethral contaminants is voided; the sample thus obtained (i.e.,
is free of most germs normally found on the urethra and/or skin of the perineal area. Items in these ki
plastic containers/bags, a collecting tube, an inlet ring, disposable towelettes, an identification label, a
sterile gloves, and a clip or clamp. The kits are frequently supplied in supporting trays (i.e., procedure
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Mid-stream urine collection procedure kits and t
to protect specimens against external contamination and/or patient handling before, during, and after
mainly used in hospital clinical laboratories and in other healthcare facilities.

Devices designed to reflect an image of an object placed in front of them. Mirrors typically have a glas
sufficiently polished to reflect enough undiffused light to yield images of the objects; mirror images m
according to the intended purpose of the mirror. Small handheld mirrors are available for use as dedic
during diagnostic, dental, and/or surgical procedures; larger mobile or wall mounted mirrors are also a
clinical purposes such as posture analysis and the perinatal process.

Hand-held mirrors designed for visualization of the larynx and/or pharynx through the mouth cavity. T
consist of a small lightweight round glass device that is compact and easy to manipulate and whose s
polished to reflect an image of the pharynx and or larynx. They have a very thin metal (e.g., stainless
supports the mirror and is also used as a handle. Larynx/pharynx hand-held mirrors are available in a
and sizes; the handles may be permanently attached to the mirror or detachable, permitting the use o
handles (e.g., extra thin, octagonal, chuck-type) with the same mirror. Larynx/pharynx mirrors are use
also for some other otolaryngology procedures (e.g., removal of foreign objects, excision of tissue).

Hand-held mirrors designed for visualization of the middle-ear structures through the ear canal. These
consist of a small lightweight round glass device whose surface is sufficiently polished to reflect an im
cavity and the middle-ear structure. Middle-ear mirrors are compact and easy to manipulate and have
(e.g., stainless steel) shaft that supports the mirror and is also used as a handle. Middle-ear hand-held
available with the mirror mounted at a 45-degree angle from the straight shaft. Middle-ear mirrors are
otolaryngology (i.e., ENT) offices.
Large convex mirrors designed to show a full or partial image of patients in a hospital bed or on an ex
mirrors are placed overhead (wall or ceiling mounted) and are often used to provide women in labor a
view of the development of the birthing process. They may also be used in other applications where o
desired, such as operating rooms, intensive care units, and recovery rooms.

Full-length mirrors designed to show an image of the full body of an individual placed in front of them.
typically consist of polished glass which reflects an accurate, almost distortion-free image of the comp
to the user. Posture mirrors are available as stand-alone, mobile, and/or wall-mounted units; stand-alo
three separate mirrors hinged together are also available to provide a reflection from multiple angles.
are available to facilitate the examination of the body posture in several positions during examination
treatments.

Mirrors designed to show the head and neck of a person placed in front of them during speech therap
mirrors typically consist of a shatter-proof glass or metallic device that provides a visual feedback to t
"sound formation" from any desired angle. The mirrors can be supplied as wall-mounted, for table-top
casters (i.e., mobile). Speech therapy mirrors are intended to improve the skills needed for appropria
rehabilitation of patients that lost speech capabilities; they are also used by speech therapists to help
speech and language skills by letting them watch themselves and others form sounds and words.

Tents designed to provide a suspension of liquid or solid particles (i.e., aerosol) for patient breathing. T
consist of a pliable plastic sheet held by a plastic or metallic frame that is suspended as a canopy abo
aerosol treatment tents typically cover only the head and part of the torso. The tents are usually conn
source through wide-bore tubing. The use of aerosol treatment tents avoids the need to directly attach
mask, or endotracheal tube to the patient. These tents are especially useful for treatment of breathing
asthma) in patients who cannot tolerate such attachments.

Oxygen administration tents designed to rest against the chin while remaining away from the face, pr
enriched and humid environment for patient breathing. These tents typically consist of a small rigid pl
contoured around the chin and attached to head straps for stabilization; they provide a semi-enclosed
respiration. Face tents are usually connected to a high-flow oxygen source and/or humidifier through w
are typically used with patients who cannot use a mask or nasal prongs, usually due to facial surgery

Devices designed to keep hot packs (also known as hydrocollator packs) warm at a consistent temper
usually consist of a stainless steel container where water is heated to a thermostatically controlled tem
165?F); hot packs are immersed in the water. Moist heat therapy pack conditioners are used to store a
The packs are wrapped in towels and used to provide moist heat therapy.

Thick cotton fabrics with a soft pile/felt on one side that are typically used for lining splints or casts to
often have adhesive tape on the backside to help keep them in place.
Physiologic monitors designed to continuously measure and display the characteristics of the respirato
(i.e., the inspiration and expiration cycle) including the cessation of breathing for a period longer than
lapse of time (i.e., apnea). These monitors are hard-wired to the patient at the bedside. These monito
respiration indirectly, such as the detection of changes in the electric impedance of the thoracic cavity
electrodes (i.e., impedance pneumography). Other monitors use more direct methods that include the
dioxide sensors (i.e., capnography). Ventilation/apnea monitors typically measure several breathing pa
respiratory rate, volume of air); some monitors can also measure heart rate. The monitors usually incl
alarms which allow the user to set threshold limits for the time span needed to activate the alarms. Ve
monitors intended for newborns and infants are also available.

Occupancy alarms designed to activate audible and/or visual signals when unattended patients attem
These alarms typically consist of pressure pad sensors placed underneath or on top of the mattress. T
deployed to determine the patient's location and are connected to an electronic control unit; some be
can interface with nurse call systems providing remote alarms. Bed occupancy alarms are used to aler
patient has or is attempting to move. Bed occupancy alarms can help reduce the likelihood of falls and
assistance to patients who have already fallen by alerting caregivers that a patient who should not ge
is doing so.

Bedside monitors designed to continuously measure and display the partial pressure (concentration) o
(PCO2) and/or oxygen (PO2) gases in blood; some monitors can also measure pH. These monitors incl
that are capable of acquiring and processing signals from one or more sensors, one or more visual dis
numeric), and audible/visual alarms. Bedside blood gas monitors may use several mechanisms to acq
blood gas concentrations and/or blood pH, including (1) a transcutaneous method, which uses electrod
the patient's skin surface; (2) an extracorporeal method, which uses a sensor cassette that is inserted
arterial catheter tubing system (these devices typically include a bundle of three detectors that comb
a fluorescent dye [i.e., fluorescent optodes] at their distal tip); and (3) an intravascular method, which
catheter equipped with three detectors that combine an optical fiber with a fluorescent dye (i.e., fluor
their distal tip. Blood gas bedside monitors are used in a wide range of applications intended to asses
and metabolic status.

Physiologic monitors designed for continuous measurement and display of information of the electrica
and its associated electrocardiogram (ECG) that are hard-wired to the patient at the bedside. These m
central unit with electronic circuits that can process a signal from the electrodes and display the nume
waveform. They can perform other functions such as arrhythmia detection, ST-segment analysis, and
visual/audible alarms. The bioelectric signals are obtained using detachable multileads (e.g., 3, 5-, 6 le
associated electrodes that are usually attached to the thoracic skin. Some bedside monitors provide a
such as 12-lead ECG monitoring and diagnostic interpretation; the monitors are frequently used as a c
physiologic monitoring system that also includes a central station and/or auxiliary displays.
Physiologic monitors designed for continuous measurement and display of information of the electrica
and the associated electroencephalogram (EEG) that are hard-wired to the patient at the bedside. The
central unit with electronic circuits that can process a signal from electrodes that may be placed on a
forehead; intracranial (e.g., subdural, epidural) and nasopharyngeal electrodes are sometimes used. B
can display the numerical values and trends of the received signals, the EEG waveform, and may supp
processing and display techniques, depending on the application (e.g., monitoring of intensive care pa
may be used as a component of a physiologic monitoring system that also include a central station an
Dedicated bedside monitors intended for spectral analysis such as compressed spectral array and/or d
are also available.

Environmental monitors designed to simultaneously measure and display several gas concentration le
determine the lower explosive limit percentage of combustible-gas concentrations. These monitors ty
(e.g., solid state, electrochemical, infrared), a built-in sampling pump, electronic circuitry, and a displa
include alarms, recording capabilities, and/or a transmitter for remote central monitoring. Multigas en
are used to continuously measure the concentration of gases (e.g., oxygen, carbon monoxide, nitroge
facility environments (e.g., operating rooms, intensive care units).

Visual function physiologic analyzers designed to observe and analyze eye movement. These analyze
lamps to illuminate the eyes, a screen (typically located on the back of the analyzer) on which images
projected, and a set of photocells that continuously monitor eye movement. The analyzer records and
signals from the photocells, providing an analysis of eye movement.

Monitoring systems designed for continuous assessment of vital physiologic parameters. These system
central station monitor that receives, consolidates, and displays the information and a set of monitors
the patient (bedside monitors) to provide the required data from each patient; many systems also incl
transmitters (with appropriate sensors), receivers, and antennas (telemetry systems) to allow monitor
patients. Physiologic monitoring systems are used to evaluate and observe trends in patients in comp
conditions; they are used mostly in intermediate care units and in general medical and surgical areas.
systems can assess conditions that are vital for patient life (e.g., anesthetic gas concentrations).

Physiologic monitoring systems designed for continuous checking of vital physiologic parameters in cr
These systems typically include a central station monitor configured to display and electrocardiogram
being monitored (other waveforms can be displayed instead of or in addition to ECG); modular bedsid
adapt to the changing conditions of patients (e.g. monitoring of cardiac output, arrhythmia, pulse oxim
noninvasive blood pressure). Acute care monitoring systems are typically used in critical care areas (e
units, cardiac care units, emergency departments, post-anesthesia recovery units) and other areas wh
continuous monitoring of vital signs and other physiologic parameters.

Monitoring systems designed to evaluate the physiologic response of a person to physical stress, typic
individual is performing exercise on a treadmill, bicycle ergometer, or other equipment. These system
diagnose coronary artery diseases, to differentiate between cardiac and pulmonary diseases, and to d
the course of pulmonary and vascular diseases.
Monitors designed for continuous measurement and display of the number of rhythmic expansions (pu
per minute (i.e., pulse rate in beats per minute). These units are hard-wired to the patient at the beds
consist of a main electronic unit that is capable of acquiring and processing signals from one or more
audible and/or visual alarms that are triggered when the patient's pulse rate drops below or exceeds p
multipurpose and electrocardiography monitors are capable of pulse rate monitoring.

Environmental monitors designed to continuously detect, measure, and display data on alpha, beta, g
radiation, usually expressed in sievert or roentgen per hour. These monitors typically consist of a radia
of assessing radiation levels ranging from normal background to catastrophic and an electronic unit in
monitors include alarms; some include recording and/or telemetric capabilities. Ionizing radiation envi
are used in nuclear medicine areas, radiotherapy rooms, or where radiation is used or present.

Physiologic monitors designed for continuous measurement and display of information of the respirato
to the gas composition of the breathing inspired or exhaled gases and/or the respiratory function mec
These units are hard-wired at the bedside. These monitors consist of a central unit with electronic circ
data from attached sensors and display the numerical values and the respiratory cycle waveforms. Re
intended to measure the pressure and concentration of the breathing gases, to assess the inspiratory
(i.e., respiratory function mechanics, known as ventilation) including parameters such as respiration ra
cessation of breathing (apnea), and/or to measure the conditions (e.g., temperature, pressure) in the v
the artificial airways).

Physiologic monitors designed to continuously measure and display the characteristics of the respirato
(i.e., the inspiration and expiration cycle), including the cessation of breathing for a period longer than
lapse of time (i.e., apnea). These units are hard-wired at the bedside and/or the operating room. Thes
use sensors and electronic circuits to measure and display the respiratory rate, volume of air moved (
volume), and inspiratory and expiratory pressures (e.g., mean airway pressure and positive and expira
as to detect cessation of breathing (apnea). Some of these monitors can also asses and display the fra
oxygen and/or the end-tidal carbon dioxide concentration. Ventilation/apnea monitors are intended for
patients require continual monitoring of respiration/ventilation status (e.g., intensive care units). Intra
monitors connected to the ventilation breathing circuit during the delivery of anesthesia is also possib

Traps designed to collect mucus overflow (i.e., mucus traps) from the first mucus collection canister us
surgical, uterine) that are intended to collect tissue secretions, blood, irrigation fluids, and debris from
typically consist of disposable or more, frequently, reusable bottles or canisters (that may include a di
Mucus traps are typically used as a second container in series with a first mucus canister or bottle bet
field or other anatomic site (e.g., the uterus) and the suction source; mucus traps often include an ove
floating) mechanism in the cap to prevent aspirates from entering the aspirator pump or valves and/o
environment. Some traps also include bacteria filters. Mucus traps are used to postpone the need to d
canister, giving the operator additional time to notice the rising level of aspirates and/or automatically
Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
by injection of a contrast material into the fluid-filled space around the spinal cord or surrounding area
myelography). Items in these kits usually include gauge needles, a spinal needle/stylet, syringes, lidoc
Pprep swabs, gauze pads, specimen tubes, a fenestrated drape, and a puncture site bandage. The kits
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Myelography procedure kits and trays are intended for use in hospital radiology departments and/or d
procedures intended to diagnose disorders of the spinal canal and cord, such as nerve compression.

Endoscopes designed for percutaneous insertion into the spinal cord to examine sites in the lumbar re
lumbar epidural space, the subarachnoid space, and syrinx cavities. These endoscopes have very sma
(e.g., from 0.5 to 2.3 mm). Myeloscopes may be used either preoperatively to obtain morphologic info
useful in diagnoses and planning surgical strategy, or intraoperatively to examine areas outside the fi
microscopes.

Recorders designed to measure and record data and graphics (i.e., a myogram) of the physical and/or
characteristics of the neuromuscular system. Myographs are usually intended to record one or severa
and graphics: (1) Forces produced by muscular contraction (force myographs); (2) the electrical poten
muscles during muscular activity (electromyographs); and (3) changes in the electrical impedance of
modifications in the muscle composition (impedance myographs). Myographs are intended for the eva
information on the status of muscles under several conditions, including muscular diseases and/or tra
on myography intended for other purposes, such as those based on acceleromyography (used for intr
and wire and pressure in-vitro assessment of soft tissue (e.g., blood and lymphatic vessels) are also av

Clippers designed for trimming the fingernails or toenails using a mechanism that performs a two-blad
These clippers are typically, small, manually operated, handheld or tabletop instruments with two arti
used for personal hygiene and grooming. Nail clippers are usually manipulated by an individual to trim
Dedicated clippers designed especially to cut toenails and/or for use by disabled individuals (e.g., tabl
for fingernails, pistol-grip clippers for toenails) are also available. Other manual instruments that perfo
such as scissors and nippers, are also used to cut nails.

Balloons consisting of a hollow rubber structure, expandable with either liquid or air. Nasal balloons ar
bleeding (epistaxis) either of the anterior or posterior nasal cavity; to treat glue ear in children; and/or
structure and patency of the nasal canal.
Nasal cannulae designed for delivery of oxygen into the nasal cavities. These cannulae typically consi
mm (1/4 inch) in diameter that includes two prongs that project about 1 cm into the nose on both side
nasal cannulae are used for short-term oxygen administration (e.g., in the immediate postoperative p
used for long-term oxygen therapy in patients with chronic oxygen-dependent respiratory failure (e.g.
pulmonary disease, interstitial fibrosis, diffusion defect).

Nasal cannulae designed to apply continuous positive airway pressure (CPAP) through the nostrils. Th
a plastic tube with two plastic prongs shaped to fit snugly into each nostril; silicone rubber is placed o
to achieve an airtight seal. CPAP nasal cannulae are used to decrease the number of apneic episodes
patients. Nasal masks have been used as an alternative to these cannulae.
Nasal catheters designed for delivery of oxygen into either of the nasal cavities. These catheters typic
plastic tube with an internal diameter of 3 to 6 mm (l/8 to 1/4 inch); the distal tip is foam-collared and
Oxygen-supply nasal catheters are mostly used for short-term oxygen administration (e.g., in the imm
period); these catheters can be used in patients with a nasogastric tube in situ in the other nostril.

Respiratory tract endoscopes designed for direct insertion into the nasal cavity for visual examination
of lesions of the nasal cavity, pharynx, and pharyngeal end of the auditory tube. Nasopharyngoscopes
outer sheath, a lighting system, and a working channel for catheters and operative devices; they may

Respiratory tract endoscopes designed for direct insertion and visual examination of the nasal cavity.
include a lighting system (e.g., fiberoptic) and are capable of seeing pictures from the tip of the device

Devices designed to provide aerosolized medication and/or humidification to the patient airways. Thes
both vapor and finely dispersed water droplets in the liquid phase (aerosol mist); they are typically us
or in a breathing circuit. Most nebulizers are either pneumatic (driven by compressed air) or ultrasonic
include a heating element to provide a warm, humid aerosol.
Nebulizers designed to provide an aerosol mist by means of ultrasonic frequency oscillations. These n
consist of an electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a
and a fan. A high-frequency (typically 1-2 MHz) electrical current is applied to a piezoelectric crystal w
circuit, which changes the applied electrical signal into mechanical vibrations. These vibrations, in tur
sound waves in the coupling basin. The coupler (water or saline) transmits the sound waves to the (m
the nebulizer chamber. When the sound waves reach the fluid-air interface, the fluid forms a geyser a
fine-particle aerosol mist. The size of the mist particles is determined primarily by the vibrating frequ
frequency the smaller the particles. Ultrasonic nebulizers produce particles in the size range of 0.5 to

Handheld surgical instruments designed to hold a surgical suturing needle while suturing. These sutur
usually made of metal and have a clamp mechanism at their distal end to lock the needle in place, a j
middle, and a handle at their distal end to be held by the user. The jaws of the clamp are often texture
to the handles. Suture needle holding instruments come in many shapes and are usually specific to th
that they can hold.

Slender instruments designed to penetrate by puncturing into the tissues, blood vessels, and/or organ
consist of a hollow, metallic (e.g., stainless steel) cannula beveled at one end to form a point; the othe
mounted in a hub, which has a specially formed cavity called a female Luer connector. Most needles a
infusion, and/or withdrawal (aspiration) of gases, liquids, and semisolids; some needles are designed f
for other special procedures, including biopsy, dental, ophthalmic, cardiac, and surgical procedures.

Needles designed for insertion in predetermined sites (i.e., acupuncture points) of the body to perform
procedures. These needles typically consist of sharp metallic devices of small diameter (0.12 to 0.30 m
to 30 mm length; most needles include an easy-grip ring handle. Treatments using acupuncture needl
relieve pain, for surgical anesthesia, or other therapies.
Needles designed for puncture of the upper airway at the level of the cricothyroid membrane (anterio
These devices typically consist of sharp-point, high-caliber needles. Airway puncture needles are used
emergency airway during upper airway obstructions.
Needles designed to penetrate either into soft tissue and organs or in hard tissues (i.e., bones) to harv
laboratory analysis. These devices usually include two concentric needles, an inner needle with a shar
needle (cannula) to cut and capture the tissue into the specimen notch. Needles including either tips t
visualized using ultrasonic imaging equipment (i.e., echogenic tips) or those specially designed to wor
resonance imaging guidance are available. Biopsy needles are used to obtain histologic information fo
characterization of suspected malignant lesions; they are frequently attached to special devices desig
biopsy guns).

Needles designed for percutaneous transhepatic injection into the biliary ducts. These devices typical
flexible needles (typically 22 or 23 gauge, 6- to 8-inch length); higher-caliber needles (e.g., 18, 20 gau
inject the contrast media into the passage connecting the head of the gall bladder and the common b
duct). These needles are mostly used in radiographic procedures of the bile ducts (cholangiography).

Needles designed to inject fluid under the skin (hypodermic) and/or other soft tissues (e.g., eye, mout
typically consist of hollow, sharply pointed, metal devices with the distal end finished in a connector (
Luer lock) that can be easily attached to a syringe. Hypodermic needles typically have a small diamet
gauge) and length (typically 13 to 25 mm [0.5 to 1 inch]). Needles with smaller diameters used for su
(e.g., tuberculin, insulin) are usually marketed as hypodermic needles.

Injection needles designed to administer fluids into the arteries. These devices typically consist of nee
configuration and tips (e.g., bulbous) to offer minimum blood- flow resistance. Intra-arterial needles ar
introduce drugs for local treatment, such as the infusion of papaverine into the internal mammary arte
bypass grafting.
Injection needles designed for fluid injection into the veins. Some intravenous needles (e.g., scalp-vein
deliver short-term direct infusion into the veins, while other needles are used in conjunction with intra
catheters, and/or bags for long-term infusion procedures.
Needles designed for insufflation or withdrawal of gases to and/or from the peritoneal cavity. These de
of very sharp, long (e.g., 5 to 6 in, 12 to 15 cm), thin needles attached to an appropriate handle. Pneu
are used either for peritoneal insufflation in laparoscopic procedures and/or as an aid to radiologic pro
used to withdraw gases that occur spontaneously due to abnormal processes (e.g., subphrenic absces
needles are inserted using a spring-loaded mechanism.

Intravenous injection needles designed for short-term therapeutic infusion of fluids into the scalp vein
peripheral veins, and the veins of pediatric patients. These needles typically include a thin-walled, sta
cannula (18 to 27 gauge is typical), usually 3/4 inches (19 mm) in length, for introduction into the vein
the insertion and add protection to inadvertent pullout; and a tube (e.g., 30 cm in length) to be attach
other infusion device.

Needles designed to penetrate into the spinal column for aspiration and/or injection of fluids such as a
or steroid substances (usually from the subarachnoid space in the lumbar region). These devices typic
27-gauge needles 50 to 150 mm (2 to 6 in) in length, with appropriate tips (e.g., pencil, Quincke, Whit
cutting and/or lesion of tissues, nerves, and dura fibers. The needles are usually attached to catheters
and/or aspiration of fluids. Some spinal needles include wings and/or depth marks to facilitate accurat
positioning; they are also available in pediatric size, typically ranging from 1 to 2.5 inches (25 to 63 m
needles are used for lumbar punctures in diagnostic and treatment procedures and to administer regio
labor and delivery and in some surgical procedures.
Needles designed to thread sutures through tissue, frequently to close surgical or traumatic wounds. T
consist of high-quality, stainless steel, curved or, less frequently, straight needles with a hole (eye) in
insertion of the suture and a sharp tip at the other end; many suture needles have a flat central part
manipulation using needle holders. Suture needles are usually characterized by their size from tip to e
3) and the fraction of the circle they cover (e.g., 1/2, 3/8). Suture needles are available for general su
for other specialty uses, such as dental suture, ophthalmic suture, encirclement of the cervix uteri (ce
postmortem uses.

Surgical instruments designed to snip/cut small pieces of hard bony tissue from a tiny bone shaped lik
the middle ear (i.e., malleus). These devices typically consist of a forceps-like instrument with small b
and appropriate handles. The stationary blade on the working end typically ends in a sharpened anvil
with various angled blades. In the anvil design, the sliding blade opens and closes a second sharpene
anvil. In the hook design, the sliding blade closes against the hook.

Hollow tubes, open at both ends, with an aspiration bulb attached to one end, intended for aspirating
volume of liquid in single drops into the nasal passages. Droppers are usually made of glass or plastic

Nursing bottles designed for liquid feeding of infants. These devices usually consist of glass or plastic
cap and a nipple made of rubber or silicone; the bottles have a graduated scale on the outside for fee
Infant nursing bottles are used mainly to feed infants with infant formula or breast milk; they are avail
shapes and sizes (e.g., 4 oz/120 mL, 6 oz/180 mL, or 8 oz/240 mL).
Plethysmographs designed for non-invasive measuring and recording of data and graphics (i.e., a plet
volume and variations in the volume of the blood flow in the eyes due to the flow of blood in the ophth
major branch of the internal carotid artery). Data is based on the measurement of the eye volume pre
amplitude. This technique is also known as ocular segmental plethysmography, and ocular pneumo pl
devices typically consist of a unit that measures, records, and displays the results, usually in graphic f
in the volume of the eye produced by pulsatile blood flow in the ophthalmic artery. The device also inc
resembling contact lenses that apply vacuum to the sclera which results in occlusion of the ophthalmi
pulsatile changes in the eye pressure. The pressure at which systolic ocular pulsations reappear and it
following occlusion is an indirect measurement of the ophthalmic artery pressure and consequently of
pressure. A reduction in arterial pulse pressure in the eye and/or a delay in pulsation is a sign that a c
blocked or narrowed.

Electrocardiographs that subject the successive point values in one or more leads of the standard elec
analysis to mathematical integration. The resulting values are plotted on a display matrix, which resem
circles, one inside the other. The area between the circles represents the "normal" range of distributio
derived falls outside the limits, the value is considered abnormal. Cardiointegraphs are intended to be
of coronary disease in the absence of abnormalities in the standard resting electrocardiogram.
Osmometers designed for direct determination of the osmotic pressure (i.e., osmolality) in a solution t
with a mass greater than 30,000 atomic mass units (i.e., Daltons), such as serum proteins. Colloid osm
as oncometers) measure osmotic pressure directly by subjecting the sample to a protein-specific osmo
cell is made up of two chambers of fluid separated by a semipermeable membrane, which is permeab
molecules (e.g., crystalloids, ions) and impermeable to large molecules (i.e., colloids). The clinical use
is different from other osmometers; they are intended to measure the decrease in osmotic pressure du
protein concentration in a wide variety of body fluids (e.g., urine, serum, plasma, cephalospinal fluid,
fluid) and consequently to measure the risk of edema (e.g., pulmonary edema), facilitating the manag
fluid therapy.

Instruments for examining the back of the eye (retina) by transillumination through the Buccal cavity.
Ophthalmic measuring instruments designed to determine the distance between the pupils. The instru
of a light source to generate the reflection from the cornea, a target object for eye fixation, an alignm
adjusting the reflection lines on the pupils, a sensor for detecting the light reflection, data processing
for displaying the result. Ophthalmodiastimeters are used mainly to establish the distance required be
making prescription eyeglasses.

Ophthalmic measuring instruments designed for objectively determining the curvature of the anterior
the refraction of the eye (e.g., diopter, cylinder axis) by projecting illuminated images onto the patien
instruments usually consist of light sources, a pair of objects to be projected onto the cornea, a telesc
lenses for reflecting and observing images, a device for adjusting the positions of the reflected images
appropriate to calculate the corneal curvature and the refractive power. Ophthalmometers are used m
preassessment for refractive corneal surgery and for contact lens fitting.

Ophthalmic diagnostic instruments designed for examining the eye (mostly the back of the eye, the fu
usually consist of a light source incorporated into a wheel of lenses of varying strength (direct ophthal
source attached to a headband and a converging lens put in front of the eye of the patient (indirect op
provide a magnified image of the eye, especially the fundus. Ophthalmoscopes are used mainly to de
eye diseases.

Handheld ophthalmoscopes designed for examining the eye (mostly the back of the eye, the fundus)
noninverted image of the eye. The instruments usually consist of a light source to project the light into
pupil, a mirror, and a wheel of lenses of varying strength to provide a magnified view of the eye and t
the view. They produce an upright, or unreversed, magnified image of the eye, at approximately 15 tim
Direct ophthalmoscopes are used mainly to detect eye conditions or eye diseases.

Head-worn ophthalmoscopes designed for examining the eye (mostly the back of the eye, the fundus)
inverted image of the fundus. These instruments usually consist of a light source attached to a headb
into the eye through the pupil and a converging lens placed in front of the patient's eye. They produce
reversed, image of 2 to 5 times magnification of the entire retina, a field of view much larger than tha
ophthalmoscopes. Indirect ophthalmoscopes are used mainly to detect eye conditions or eye diseases
Ophthalmic instruments designed to measure the amount of misalignment of the eyes (strabismus). A
use light sources, light sensors, and data analyzers to produce images and measure the light reflectio
well as the pupils of both eyes; manual instruments typically consist of an illuminated screen that pre
examinee wears special eyeglasses (so the green light stimuli is perceived as red light) and points a h
flashlight at the screen. The examiner performs the assessment by comparing the actual location of th
perceived location of red light by the patient. Ophthalmotropometers are used to detect and assess th
strabismus.

Wooden sticks intended for medical and/or cosmetic uses. These devices are thin, flat sticks made of fi
(originally orange wood), providing a smooth finish and good tensile strength. Orange sticks may be u
on the skin, for manicuring fingernails, or to depress the tongue during oral examination; they are also
tests that help determine proper mandible function (e.g., to assess possible mandible fracture).

Systems designed to maintain organ viability until the organ can be implanted. These systems may co
intended for hypothermic ischemic storage frequently using cold crystalloid solutions; some other sys
organ viability combining hypothermia with hyperbaric oxygenation, or hypothermia with continuous p
preservation systems used with appropriate solutions can preserve organ viability for a period from se
days, depending on the preservation system used and the type of organ to be transplanted.

Cements, whose main component is polymethyl methacrylate (PMMA), designed to produce a mechan
upon hardening. These cements usually consist of a powder (PMMA, prepolymerized PMMA, or methyl
polymer), a liquid (methylmethacrylate monomer), an initiator, an inhibitor, and a stabilizer that are m
Orthopedic cements are typically applied as runny liquids that set up into a solid hardened material in
be tailored to the surgeon's needs. They are used in orthopedic procedures to anchor metal or plastic
bone or used alone in the spine to treat osteoporotic compression fractures.

Devices designed for external modification of the structural and/or functional characteristics of the wh
part (i.e., orthoses), usually pertaining to the neuromuscular and/or skeletal systems. These devices s
and/or align the neuromuscular or skeletal system Orthoses are intended for physical medicine, physi
rehabilitation treatments, frequently associated with orthopedic procedures. These devices are usually
the physical (anatomic) body part where they are applied (e.g., head, spine, thorax, lower or upper lim
orthoses (e.g., immobilization, support, therapeutic, functional); and the physical characteristics (e.g.,
and/or material used to make the orthosis (metal, plastics or a combination of these). Dedicated ortho
custom made, intended for a particular body part and/or function are available. They are commonly kn
slings, belts, splints, braces, and immobilizers.

Electronic instruments designed primarily to show graphs of electric signals on a display. Usually the g
signals change with time; typically the vertical (Y) axis represents the amplitude or intensity of the sig
(X) axis the variation over time. The brightness of the displayed signal is frequently called the Z axis.
typically consist of an electronic unit (usually digital, less frequently analog) for processing the incomi
output ports; controls (e.g., vertical and horizontal amplitude, trigger, brightness); and an electronic d
includes appropriate measuring probes. Oscilloscopes are typically used in maintenance work to calib
assess functioning of medical devices and other equipment used in healthcare.
Clinical laboratory measuring instruments designed to determine a solution's osmotic pressure, a vari
particle concentration (i.e., osmolality) of an aqueous solution such as body fluid, including whole bloo
urine. These readings are used to determine levels of solute concentrations that control the movemen
body tissues. Two main types of osmometers (freezing point and vapor-pressure osmometers) intende
particle osmolality (i.e., crystalloids such as glucose or urea, ions such as sodium or chlorine) are avai
intended to measure osmolality due to molecules of a greater mass (i.e., colloids) and particles with a
30,000 atomic mass units (i.e., Daltons) such as serum proteins are also available (i.e., colloid osmom
oncometers). An abnormal ratio between the osmolality values for urine and serum can indicate renal
insipidus, or secretion of abnormal levels of antidiuretic hormone; water and electrolyte imbalances ar
patients with acute poisoning and shock trauma.

Surgical instruments designed to cut and/or shape bone. These devices are typically handheld chisel-l
sharp distal end that is often beveled on both sides; they are usually stronger than surgical chisels. De
are available for several orthopedic, plastic (e.g., nasal), spinal, and oral surgery procedures; they are

Osteotomes designed to cut and/or shape bone during orthopedic procedures. These osteotomes are
handheld chisel-like instruments with a sharp distal end (either straight or curved) that is often bevele
Dedicated osteotomes with appropriate shapes are available for specific orthopedic procedures, includ
procedures involving femoral and tibial cutting. _x000D_
Osteotomes designed to cut and shape small bones and/or cartilage during plastic surgery. Osteotome
handheld chisel-like instruments with a sharp distal end (either straight or curved), that is often bevel
Dedicated osteotomes are available for several plastic surgery procedures such as nasal cartilage sha
used to cut small bones during surgery (e.g., hand surgery).
Instruments designed to inspect the ear, especially the outer ear canal and the tympanic membrane.
include a light source (e.g., halogen lamp), batteries, magnifying glasses, a specula, (may be disposab
Some of these instruments also include other accessories, according to their intended use (e.g., diagn

Measuring instruments designed primarily for determining the oxygen saturation in arterial blood (SpO
relative amount of hemoglobin forms (e.g., oxygenated and deoxygenated hemoglobin). These instru
sources of two or more wavelengths, usually in the red and infrared spectrum; photo detectors; and p
can also determine several hemoglobin forms (e.g., carboxyhemoglobin, methemoglobin). In vitro oxi
samples as laboratory analyzers; pulse and most point-of-care and other oximeters make in vivo meas
mostly used as blood-oxygen monitors.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for a
patients from oxygen generators, canisters, and/or concentrators. Items in these kits usually include t
adapters; the kits may also include nasal cannulae and/or transtracheal catheters. The kits are freque
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
administration procedure kits and trays are intended to supply oxygen in both chronic and acute patie
at home, in hospitals, and in other healthcare facilities.
Controllers designed to measure and control the concentration of oxygen in an enclosed atmosphere.
typically consist of an electronic unit with a display to show actual values of percentage of oxygen con
enclosed atmosphere, appropriate temperature-compensated electrodes and sensors to detect oxyge
knobs or buttons, and alarms to alert when oxygen values are beyond a predetermined range. Some d
capable of controlling the concentration of dissolved oxygen in aqueous solutions (usually in ppm). O
used mainly in laboratory equipment (e.g., incubators, glove boxes); they are integral parts of some d

Small containers (i.e., canisters) designed for temporary storage of oxygen before delivery to a single
containers may store oxygen gas or liquid oxygen (LOX). Oxygen gas canisters may store the equivale
pressure) of two to three liters of oxygen at relatively high pressures or the equivalent of 20 to 25 liter
LOX canisters usually consist of a small-capacity (e.g., one liter) double-vessel tank; an insulated inne
liquid oxygen at a temperature of -183?C (-297?F) and an outer vessel for protection; one liter of liquid
liters of gas. Vacuum in the space between both vessels insulates the liquid oxygen from the environm
a thermos bottle; the canister may include a vent line for slow release of the gas from the boiling liqui
are intended mainly for use with individual ambulatory oxygen delivery units; they are typically refille
containers located at users' homes.

Gas concentrators designed to increase the percentage of oxygen in a mixture of gases, usually air. O
usually filter out nitrogen from atmospheric air, providing a gas mixture with a concentration of oxyge
higher than 90%. An oxygen concentrator usually works by filtering out nitrogen (typically using absor
filter) and sending it back to the atmosphere; the remaining high-oxygen-concentration gas is delivere
a cannula and/or mask. Oxygen concentrators are available as stand-alone units and also as portable
deliver volumes up to five liter/minute and three liter/minute respectively. Oxygen concentrators are m
oxygen therapy to patients by providing to the respiratory tract a gas mixture with a considerably high
oxygen than the usual concentration found in air (about 19%).

Tubing designed for external connection of an oxygen delivery source (e.g., hospital oxygen line, oxyg
and, at the patient end, a device used to administer oxygen such as a nasal oxygen cannula; nasal, na
transtracheal oxygen catheter; or oxygen mask. This tubing is typically disposable (single-use) rubber
of small diameter (three to five mm/ 1/8 to 3/16 inch), thick walls, and usually include tapered connec
rings that hold securely when pressure is applied. Oxygen connection tubing is used in hospitals, in th
administer oxygen to patients who need additional oxygen supply.

Compressed gas proportioners designed to mix compressed air and oxygen to achieve oxygen concen
to 100 percent at either high- or low-output flows. Typically, the device receives air and oxygen from t
pipeline or from other compressed gas sources. Oxygen-air proportioners are usually equipped with a
mechanism and connectors for the primary gas sources and the delivery of the blended gas. The mixe
passed through a humidifier or nebulizer and delivered to patients at flows ranging from 1 L/min to mo
using ventilators, tracheostomy tubes, endotracheal tubes, oxygen tents, oxygen hoods, or masks. Th
healthcare facilities, medical offices, and at home.
Tents designed to provide an oxygen-enriched and humid environment for patient breathing. These te
a pliable plastic sheet held by a plastic or metallic frame that is suspended as a canopy above the bed
only the head and part of the torso. Oxygen administration tents are usually connected to an oxygen s
humidifier through wide-bore tubing. The use of these tents avoids the need to directly attach a nasal
endotracheal tube to the patient. These tents are especially useful to facilitate the treatment of breath
cardiopulmonary disorders that limit the body's supply of oxygen by providing a higher concentration
normally present in the air. Small dedicated tents designed to be attached to the patient's chin and st
neck (face tents) are also available._x000D_

Devices designed to deliver ozone gas. These generators are typically a device that provides high-volt
two sets of electrodes, converting gaseous oxygen into ozone when oxygen passes through the high-e
generators usually include devices to measure the output ozone concentration and a mechanism to in
unused ozone; the generators should be used at the site of application because it is not possible to st
been used clinically for treatment of several different diseases and is delivered by rectal administratio
reinfusion, or direct infusion in the vasculature, with controversial results. Ozone is also used as a disin

Leads designed to conduct electrical pacing signals from the pulse-generating unit of an implantable c
electrodes placed on the internal lining of the heart/heart structures (i.e., endocardial or transvenous
conduct the bioelectric cardiac signals back to the unit. These leads typically consist of flexible wires t
isolated except at the electrode tip that makes contact with the heart. The leads are positioned in the
ventricle through the vascular system (e.g., subclavian vein, superior vena cava). They may be fixed u
type terminals (i.e., active fixation) or through flanges or tinned tips (passive fixation). The other ends
attached through a connector to the pulse generator that is usually implanted in a surgical pocket in t
the collarbone. Implantable cardiac pacemaker endocardial lead configurations may be unipolar, with
contact on the heart or bipolar, with two active contacts. Lead size, connector type, and other charact
must be compatible with the pulse generator used.

Pacemakers designed to apply a repetitive electrical stimulus to regulate the rhythm of the heart. The
electronic circuitry that produces electrical pulses and senses the cardiac activity; they may be line p
powered either using internal batteries or through attached modular batteries. Pacemakers can delive
stimulus either in fixed-rate mode (asynchronous), demand mode (synchronous), or both. They may a
only one of the heart chambers (most frequently to the ventricle), but some pacemakers pace both th
atrium (dual chamber or universal pacing). These stimulators are used to restore normal heart rate, in
and stimulating myocardial contraction when the hearts own pacing or conduction systems have been
Cardiac pacemakers that provide permanent pacing by using an implantable pacemaker pulse genera
pacemakers usually consist of a small unit including a pulse generator with electronic circuitry and a b
cardiac activity and produces the pacing electrical pulses, and external leads with electrodes at the di
heart (e.g., myocardial or endocardial) that conduct the electrical signals to and from the heart. Pacem
variety of technologies and implantation positions; the pacing unit is typically implanted in a surgical
inside the abdomen and attached to the cardiac leads. Most pacemakers permit noninvasive reprogra
parameters following implantation (i.e., multiprogrammable pacemakers), and some dynamically incre
pacing rate in response to patient physiological activity (i.e., rate-modulated or rate-responsive pacem
pacemakers are mostly used in the permanent treatment of slowed heart rhythms (bradycardia), in ce
arrhythmias, and in other irregular heart rhythms that need permanent pacing treatment. Some pacem
include leads (known as leadless pacemakers) and can be implanted inside the heart using catheteriz
also available.

Cushioning pads filled with air that are designed to reduce pressure on specific areas of the body by p
deflation. These pads consist of a sealed plastic (e.g., vinyl) enclosure filled with air; the enclosure inc
allows the pads to inflate/deflate periodically using an external automated pump. Dedicated alternatin
may be conformed in a variety of shapes and sizes. They are mainly used in the care of patients at ris
have compromised skin surfaces (e.g., burn, decubitus ulcers). Alternating air pads are frequently use
wheelchairs, and beds to prevent or alleviate pressure sores.

Percussion applicators designed to apply percussion to the chest to obtain a high-frequency oscillation
column in the conducting airways. These applicators typically consist of a handheld device that has a
made of rubber or plastic material at one end and a handle for manipulation. The applicator is connec
clearance unit that provides electric or pneumatic power and regulates the frequency and intensity of
Respiratory therapy percussion applicators are used to facilitate secretion removal in therapeutic proc
treatment of cystic fibrosis and other pulmonary, neuromuscular, or neurological disorders that affect
mucous from the airways.

Cushioning devices (pads) designed to reduce pressure on specific areas or the whole body. These pad
mass of soft material (e.g., gel, foam) that may be wrapped into a flexible cover as a small cushion or
filled with a fluid (e.g., air, water). Dedicated pressure relief pads may be conformed in a variety of sh
are mainly used to distribute localized pressure to larger body areas or to shift the body weight to a di
especially to prevent or alleviate pressure sores. The pads are frequently used on top of chairs, wheel
beds; some of these pads are also used as positioning aids.

Cushioning pads filled with air that are designed to reduce pressure on specific areas of the body. The
sealed plastic (e.g., vinyl) enclosure filled with air; the enclosure may include a valve to inflate and de
Dedicated air pressure relief pads may be conformed in a variety of shapes and sizes. They are mainly
localized pressure to larger body areas or to shift the body weight to a different position, especially to
pressure sores. Air pads are frequently used on top of chairs, wheelchairs, tables, and beds.
Cushioning pads made of animal skin or synthetic material resembling animal skin that are designed t
specific areas or the whole body. These pads consist of pieces of appropriate animal skin (e.g., lambsk
some backing fabric or plastic material. Dedicated animal skin pressure relief pads may be conformed
and sizes. They are mainly used to distribute localized pressure to larger body areas, especially to pre
pressure sores. The pads are frequently used on top of chairs, wheelchairs, tables, and beds.

Cushioning pads made of synthetic foam that are designed to reduce pressure on specific areas or the
pads consist of a mass of soft foam that may be wrapped into a flexible cover as a small cushion. Ded
relief pads may be conformed in a variety of shapes and sizes. They are mainly used to distribute loca
body areas, especially to prevent or alleviate pressure sores. The pads are frequently used on top of c
tables, and beds; some of these pads are also used as positioning aids.

Cushioning pads made of convoluted synthetic foam that are designed to reduce pressure on specific
body. These pads consist of synthetic foam (e.g., polyethylene) that is manufactured using a process t
the saturation of the plastic material with a thermosetting resin. This creates a convoluted surface wit
(e.g., egg-crate-shaped) providing good cushioning and air circulation. Dedicated convoluted foam pre
available in a variety of shapes and sizes. They are mainly used to distribute localized pressure to larg
especially to prevent or alleviate pressure sores. The pads are frequently used on top of chairs, wheel
beds.

Cushioning pads designed to reduce pressure on specific areas or the whole body that are filled with g
of a sealed plastic (e.g., vinyl) enclosure filled with liquid gel; the enclosure may include several interc
allow the movement of the gel when pressure is applied. Dedicated gel-filled pressure relief pads may
variety of shapes and sizes. They are mainly used to distribute localized pressure to larger body areas
weight to a different position, especially to prevent or alleviate pressure sores. Gel-filled pads are freq
chairs, wheelchairs, tables, and beds.

Cushioning pads filled with mud that are designed to reduce pressure on specific areas of the body. Th
sealed plastic (e.g., vinyl) enclosure filled with a semi-liquid mixture of water and refined earth; the en
valve to fill and/or refill the pad. Dedicated mud-filled pressure relief pads may be conformed in a vari
sizes. They are mainly used to distribute localized pressure to larger body areas or to shift the body w
position, especially to prevent or alleviate pressure sores. The pads may be used on top of chairs, whe

Cushioning pads filled with water that are designed to reduce pressure on specific areas of the body. T
sealed plastic (e.g., vinyl) enclosure filled with water; the enclosure may include a valve to fill or empt
mainly used to distribute localized pressure to larger body areas or to shift the body weight to a differ
to prevent or alleviate pressure sores. Water-filled pads are frequently used on top of chairs, wheelcha

Algesimeters designed to determine sensitivity to pain (i.e., pain threshold) produced by a sharp pin a
gauge. These instruments typically consist of a sharp needle, a blunt tip, and a strain gauge. The pres
the pain produced by the sharp point of the needle, as measured by the pressure exerted on an adjac
unaffected areas, is used to determine the pain threshold (15 grams is considered typical). Exaggerat
responses relative to the unaffected area are defined as hyperalgesia and hypoalgesia, respectively; t
defined as anesthesia. Pin strain gauge algesimeters are used to evaluate the effects of pain after the
(e.g., morphine) and/or during diagnosis and/or treatment of nerve injuries and neuropathies.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for c
lower part of the uterus that opens at the top of the vagina (i.e., uterine cervix). Items in these kits us
specula, holding forceps, sponges, glass slides, and gloves. The kits are frequently supplied in support
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Papanicolaou smear
trays are intended for in-vitro detection of the presence of both premalignant and malignant cells with
mainly used for periodic screening of cervical cancer in hospitals and other healthcare facilities.

Tubs filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's
hands or fingers) are placed to relieve pain and stiffness. Also called wax baths.
Balance exercisers designed to improve the user's ability to maintain a proper walking posture; the us
bars, thus relieving his/her weight when walking. These exercisers usually consist of two parallel wood
each supported by two poles and base plates; the height and width of the bars are often adjustable. P
are intended to improve the user's balance, coordination, flexibility; and muscle strength in the lower
physical therapy and rehabilitation and can also be used for body fitness in gymnastics.

Pass-throughs consisting of an enclosed, chamberlike plastic or metallic structure and that include doo
opposite) sides to permit access from two contiguous rooms isolating one from the other. These pass-t
mounted either in a wall common to both rooms or on the floor. Mounting brackets and other appropri
usually supplied with each cabinet model. Enclosed pass-throughs are usually constructed with interlo
one door to be open at a time, preventing the passage of air, light, humidity, radiation, or other enviro
are typically used in healthcare facilities to pass samples from the patient room to the clinical laborato
and/or personnel from contaminated areas to environmental clean rooms; and to transfer x-ray film ca
the dark room.

Instruments designed to measure pelvic dimensions, either externally (e.g., to determine the external
internally through the vagina, usually to measure the diameters of the pelvic cavity (e.g., the anterop
pelvis inlet, also known as the diagonal conjugate). These instruments are typically manual, handheld
dedicated curved calipers (i.e., Martin and Collyer pelvimeters) and, less frequently, transparent ruler
auxiliary instruments (e.g., graduated metal rulers) are also used for indirect pelvis cavity measureme
examiner's fingers. Pelvimetry is also frequently performed using imaging methods, including x-rays,
imaging, and/or ultrasound. Multipurpose curved calipers used for breadth (anthropometric) measurem
abdomen, pelvis) are also used as external pelvimeters.

Devices designed for manual percussion of the chest wall to aid in the airway clearance from secretion
devices are typically made of plastics (e.g., vinyl) with a shape that resembles a cup; they are availab
appropriate for adults, children, or babies. Manual percussors permit a uniform percussion of the ches
providers and at home in patients suffering from diseases such as cystic fibrosis, muscular dystrophy,
other respiratory deficiencies.

Perforators designed to puncture the membrane containing the fetus (i.e., amniotic membrane or amn
typically consist of a small device that includes a ring for use around the finger and a pointed distal en
membrane. Amniotic membrane perforators are available for the right and the left hand; the instrume
examination of the membrane and rupture of the membrane if needed in only one operation. Amniotic
may be performed also using long devices with a protected sharp point (i.e., amniotomes), and dedica
Instruments designed for mechanical piercing the lobe of the ear auricle (i.e., the earlobe). These inst
devices resembling a gun which include a mechanism that forces a sharpened point (usually a starter
earlobe. Earlobe piercing guns come in both disposable and reusable models that are primarily of two
Disposable devices typically include a spring that stores potential energy; a starter earring and its ma
placed in opposite parts of the instrument. When the earlobe is placed between the two parts and the
instrument closes with enough pressure to force the sharpened stud of the earring through the earlob
friction back. Reusable devices are very similar in design, but the detachable stud and clasp holders a
entirely disposable to avoid cross-contamination. Some devices use the energy of the handgrip of the
spring energy; earlobe piercing guns are only intended for piercing the ear lobe.

Prepackaged collections of the devices and supplies (either custom or standard) necessary for the liqu
area between the thighs, bounded in the male by the scrotum and anus and in the female by the vulv
perineal area). Items in these kits usually include a syringe, a container, a tip protector, waterproof d
prep pad; the syringe used for irrigation in the kit may be also used for aspiration (i.e., removal) of the
debris. These kits may be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottom
border around the periphery supporting all the instruments and supplies needed for the procedure; th
covered or wrapped. Perineal irrigation/lavage kits and trays are used for therapeutic treatment of infe
inflammation; they are also used for cleansing of the area before surgical procedures.

Devices, typically made from silicone or rubber, designed to be inserted in the vagina for nonsurgical
support defects/conditions such as uterine prolapse, uterine retroversion, stress incontinence, or cervi
They are designed to support the uterus, vagina, bladder, or rectum. These devices are intended for t
permanent placement.
Reusable contraceptive devices that are inserted intra-vaginally against a woman's cervix to provide a
barrier is designed to prevent sperm from gaining access to the female reproductive tract. The contra
made of soft latex or silicone and is shaped as a shallow dome or a cup with a flexible spring molded i
seals the diaphragm against the cervix or the vaginal walls. Diaphragms are made in various circumfe
from 60 mm to 90 mm.

Respiratory tract endoscopes designed for direct insertion through the nasal cavity into the air tract fo
biopsy, and treatment of lesions of the pharynx pharyngeal end of the auditory tube. Pharyngoscopes
outer sheath, a lighting system, and a working channel for catheters and operative devices; they may
Cardiographs designed for recording heart sounds at the thoracic body surface. These instruments co
that includes a recorder, electroacoustic transducers, signal processors, and detachable probes that in
(e.g., microphones) at the distal tip that are fixed to anatomic areas on the thorax. The action of heart
frequency sounds, typically in the range of the audio spectrum that are detected at the body surface a
recorder which is capable of reproducing their characteristics in an amplitude versus time graph (i.e.,
Phonocardiographs are used to assess low-frequency sounds (associated with atrial and ventricular ga
relatively higher frequency sounds (associated with mitral regurgitation and ventricular septal defect)
assess both normal sounds (known as S1 and S2 sounds) and abnormal sounds (known as S3 and S4)
indicate heart dysfunctions*. Some phonocardiographs are capable of recording signals at frequencies
the audio spectrum (i.e., subsonic, nonacoustic vibrations) that are mainly produced by the apex of th
(apexcardiography); the phonocardiographs may also include as an integral unit a single-channel elec
appropriate electrodes to work as a reference for the phonocardiogram.

Cardiac catheters designed for sensing and recording heart and great vessel sounds near their origin
from extravascular events. These catheters usually consist of a 4 to 8 Fr single or double lumen plasti
sound transducer (e.g., piezoelectric, micromanometric, condenser microphones) attached to its dista
Phonocardiographic cardiac catheters are intended to provide information about cardiac contractile st
acquired and congenital disorders of the heart and great vessels. Some of these catheters may be als
the renal artery pulse (phonorenogram).

Filter photometers designed for use attached to a microscope, some of them in the same way as a ph
These photometers allow the quantitative analysis of microscopic images and may be coupled to reco
computerized systems.
Equipment designed to irradiate patients with light to produce beneficial bioeffects (i.e., phototherapy
intended to apply electromagnetic radiation of all or some part of the spectrum covering the near infr
1,400 nm), visible (from 380 to 780 nm), and/or ultraviolet (typically from 170 to 400 nm) spectrum. M
is specialized for some particular application, such as treatment of hyperbilirubinemia (jaundice) in ne
newborns and physiotherapy using infrared lights, and dermal treatments (e.g., psoriasis) using ultrav

Manual stimulators designed to determine tactile sensibility by patient discrimination of the diameter
disc. These devices consist of a handheld disc at the distal end with protruding rods that differ in diam
rotary pin; the disc is manually rotated on the patient skin by moving an integral handle at the proxim
simple devices typically used in physician offices to detect peripheral neuropathy and/or in the diagno
leprosy.

Implantable plates designed to be used to repair skull defects. These plates are typically made of shee
materials such as metal (e.g., titanium, stainless steel), polymerized plastic resins, or, less frequently,
usually preformed before surgery, but some plates (e.g., tantalum) may be reshaped during surgery w
physical or chemical properties. Preformed skull plates generally have a central convex curvature mat
the forehead, side, or rear of the human skull; they are usually fixed to intact cranial bones using appr
other fasteners. Cranioplasty plates are used to repair defects created or caused by injury, surgical tu
congenital anomaly or disease.
Recorders designed to measure and record data and graphics (i.e., a plethysmogram) of the volume a
of organs and/or other anatomic parts that are mainly due to the presence and flow of air or blood. So
are intended to record the intra-thoracic or pulmonary gas volume and variations (i.e., whole body ple
plethysmographs are used in the determination of blood volume and flow in particular areas of the bo
eyes, or genitals. Plethysmographs may use a variety of techniques to obtain data and graphics. The t
pulmonary assessment (e.g., residual volume) consists of an airtight cabinet (known as body box) whe
variations are measured while the patient is breathing. Some of the techniques mostly used for blood
plethysmography are: (1) changes in volume or variations in the pulse volume waveform and amplitud
plethysmography); (2) changes in the impedance; (3) changes in the optical properties of tissues (pho
Other techniques also used are based on the variation of capacitance, inductance, and pressure using
Dedicated plethysmographs intended for assessment of the blood volume and changes in specific ana
the limbs, eyes, brain, and genitals are available.

Plethysmographs designed to measure and record data and graphics (i.e., a plethysmogram) of thorac
hold in the lungs when the muscles of respiration are relaxed (i.e., the functional residual capacity [FR
plethysmographs usually consist of a relatively small sealed chamber that includes a mouthpiece, pre
nasal clips; the equipment may include a computerized unit with software to process the information a
The patient is placed inside the sealed chamber and then starts breathing through the open or closed
nostrils closed using the nasal clips. The volume of air within the lungs is calculated using the Boyle's
the conditions within the tight closed chamber. Values of the FRC can be used to assess diseases and
restrictions; FRC increased values are a sign of obstructive diseases because some airways do not em
decreased values are signs of a restrictive disease.

Testers designed to measure, display, and/or record equipment air or other gas variables, such as flow
positive or negative (i.e., vacuum) pressures in a wide range of values and with an accuracy that is m
device under evaluation. These devices typically consist of several flow and volume meters, pressure
displays, various diameter inlets and outlets for gases, pressure regulators, and electronic circuitry; so
pressure transducers and flow resistance elements. Pneumatic testers are used to check the gas supp
performance of pneumatic devices such anesthesia machines, ventilators, resuscitators, suction devic
insufflators, and evacuation pumps.

Prepackaged collections of the necessary devices and supplies (i.e., either custom or standard kits) us
treatment of patients suffering tension pneumothorax. Items in these kits usually include devices such
vents, scalpels, occlusion plugs, needles, trocars, and tubing sets. They also include supplies (e.g., dra
anesthetics) appropriate for the emergency situation that they are intended to treat. The kits are frequ
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supports all the instruments and supplies needed for the procedure. The trays are usually covered by
be included in a solid bag appropriate for transportation. Pneumothorax emergency procedure kits an
intended for use in the field and in emergency rooms after spontaneous or traumatic tension pneumo
Multichannel physiologic graphical recorders designed for the simultaneous recording of instantaneou
variations of a number of different physiologic parameters (e.g., electrocardiogram; electroencephalog
respiration, blood pressure), usually under conditions of physical or mental stress. Dedicated multicha
recorders are available for recording a variety of parameters used in different types of assessments (e
the term is frequently associated with polygraphs intended to assess the truth of people's statements

Full-length charts containing large grids used to analyze posture of an individual for the purpose of ide
documenting range of motion, and/or comparing posture before and after treatment. Charts are gener
walls or doors of clinician offices and used as a backdrop against which patients stand for posture asse

Prepackaged collections of the devices and supplies (either custom or standard) needed for preparing
surgical procedure will be performed (e.g., open surgery sites, permanent catheter insertion). Items in
include supplies for shaving, cleansing and/or making the surgical site sterile. These kits may be supp
(i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery sup
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Skin pr
kits and trays are intended to reduce the number of microorganisms in the field of operation and prev

Instruments designed to measure the pressure of liquids, gases, and/or vapors. These instruments ma
mechanical and/or, electromechanical techniques, such as U-shaped columns of liquid (e.g., mercury,
air, and variations in electrical resistance; they frequently include hoses or tubes from the point of me
instrument. Electronic manometers consisting of a pressure transducer, a power supply, and a signal p
display (usually digital) are also available. Dedicated manometers with particular sensors and/or that
specific physiologic measurements such as blood pressure (i.e., sphygmomanometers), intracranial pr
(e.g., esophageal, rectal) pressure, and compartmental pressure are also available; manometers are a
medical device inspection and calibration procedures.

Instruments used for the indirect (noninvasive) measurement of arterial blood pressure.
Gastrointestinal manometers designed to measure the pressure in the esophagus (i.e., intraesophage
typically be an external pressure measuring instrument with a display or gauge and appropriate esoph
Esophageal manometers may be instruments that measure and display pressure externally using esop
perfusion catheters with openings at different levels or electronic instruments that process and displa
of built-in pressure transducers located in a catheter; the instruments frequently include a pH sensor.
assess pressure at various points in the esophagus, typically in the upper esophageal sphincter, at sev
the lower esophageal sphincter. The instruments are intended to assess patients with dysphagia, acid
upper gastrointestinal tract diseases.
Manometers designed to measure the maximum negative pressure produced orally against an occlud
the mouth after the complete expiration of residual volume followed by a single inspiration of maximu
inspiratory pressure). These manometers are typically a measuring instrument (e.g., an electrical resis
connected with a tubing set to a mouthpiece or tracheal tube adapter. The measurement of maximal i
sustained maximal inspiratory pressure, and inspiratory contraction time are accepted noninvasive ind
muscle strength and endurance. Inspiratory pressure measuring units are intended for the assessmen
strength and endurance, compromised pulmonary function, and upper airway obstruction in children d
they are also used to determine the appropriateness of discontinuing (i.e., weaning) mechanical venti

Thermometer covers designed to sheathe or encase the elongated ear canal probes of tympanic therm
sanitary protective barrier to prevent cross-contamination during temperature taking. Ear thermomete
disposable and are made of thin, flexible, transparent plastic.
Exploratory probes designed for introduction into the eye and that are intended mainly for exploratory
probes typically consist of slender flexible metal or plastic cylinders with appropriate size for passing t
structures that may be attached to a handle at the proximal end; they can be flexible or rigid. Dedicat
particular areas of the eye, such as the lacrimal duct or during surgical procedures such as a trabecule
available.

Exploratory eye probes designed for introduction into the lacrimal passages that are intended mainly
purposes. These probes typically consist of slender flexible metal or plastic cylinders with that can be
lacrimal duct. They may be attached to a handle at the proximal end. They can be flexible or rigid. So
have rods of differing diameter attached coaxially to each end of a flat, narrow holding member (e.g.,
Lacrimal exploratory probes and sounds are used in probing the lumen of the lacrimal passages, to dil
of lacrimal ducts; they may be double-ended or one-sided.

Exploratory probes designed for introduction into an anal or rectal fistula and that are mainly intended
purposes. These probes typically consist of slender flexible metal or plastic cylinders with that can be
fistula. They may be attached to a handle at the proximal end; fistula probes can be flexible or rigid. A
probes are inserted through the external opening of the fistula, usually to find the complete path of th
the internal openings of the fistula. Fistula exploratory probes are intended to be used in diagnostic an
procedures on anal/rectal fistulas; they may also be used in some renal and arteriovenous fistula surg

Exploratory probes designed for introduction through the nasal cavity into the nasal sinuses and that a
exploratory purposes. These probes typically consist of slender metallic or plastic cylinders that can b
sinuses. They may be attached to a handle at the proximal end; they can be flexible or rigid. Nasal sin
are intended for inspecting the anatomical structures inside the nasal sinuses.

Endoscopes designed for direct insertion through the anal canal in the lower gastrointestinal tract for
biopsy, and treatment of lesions of the interior of the rectum. Proctoscopes usually consist of a rigid o
system, and a working channel for catheters and operative devices.
Endoscopes designed for direct insertion through the rectum into the lower gastrointestinal tract for v
biopsy, and treatment of lesions of the rectum and the lower (i.e., sigmoid) part of the colon. Sigmoido
of a flexible outer sheath, a lighting system, and a working channel for catheters and operative device
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for d
tooth cleaning). Items in these kits usually include a dental mirror, a periosteal probe, a dedicated cur
curette), and a sickle scaler. The kits are frequently supplied in supporting trays (i.e., procedure trays)
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Dental prophylaxis procedure kits and trays are
for routine dental cleanings; they may be used also to evaluate the oral cavity for any other problems

Functional, reconstructive, and/or cosmetic artificial or, less frequently, biological passive replacemen
disabled, or abnormal tissues, organs, or other body parts. These devices may be externally attached
earlobe, upper limb, denture) or totally or partially implanted (e.g., joint prosthesis, ossicles). Prosthes
insertion into tubular body structures (e.g., biliary duct, ureter) to provide support and/or to maintain
called stents or endoprostheses; implantable prosthetic devices intended mainly for passive replacem
tooth root, ureter) are usually known as implants. Dedicated prostheses are available in many differen
materials. They are used mainly in orthopedic (e.g., limbs, joints), cardiac (e.g., valves, heart ventricle
procedures; to improve a patient's capabilities (e.g., dentures, eye lenses); and for reconstructive and
(e.g., facial and body muscle enhancements).

Implants designed for stabilizing the urethrovesical junction by providing compression of the urethral
the urinary bladder. These implants are typically sling-shaped devices made either of biological (i.e., a
xenograft), synthetic (e.g., silicone-elastomer), or bioengineered materials that are intended for ureth
placement during surgical procedures using a transvaginal, prepubic, suprapubic, or transobturator a
are fixed to the posterior pubic bone by sharp-tipped bone anchors. Bladder support implants are inte
patients with stress urinary incontinence caused by sphincter deficiency or urethral hypermobility.

Prostheses designed to replace natural heart valves. These prostheses may consist of biological or art
Bioprosthetic valves consist of either processed cardiac valves from human cadavers (i.e., allografts) o
xenografts) or valves manufactured from tissue (e.g., pericardium, dura mater) taken from the same s
are typically made of metals and plastics or silicone rubber. Cardiac valve prostheses are available in
configurations to replace any of the cardiac valves, namely the mitral, tricuspid, aortic, and pulmonary
prostheses are indicated for patients in whom extensive valvular damage resulting from acquired or c
precludes repair.

Prostheses designed for total or partial replacement of the external part of the ear (i.e., the ear auricle
within the head. These prostheses usually consist of a piece of plastic (e.g., polymer) resembling the s
characteristics (e.g., texture, color) of the natural ear; a part of the prosthesis is frequently implanted
secured to the bone. Ear auricle prostheses are used to reconstruct a damaged ear, to restore body im
the patient's hearing capabilities.

Prostheses designed to fill the natural orbital volume of the eye for cosmetic but not functional replac
These prostheses usually consist of a plastic or, less frequently, glass sphere; the prosthesis requires s
resemble the shape and other characteristics (e.g., color) of the natural eyeball. Porous prostheses co
hydroxyapatite that allow vascular growth inside the eyeball are available; prostheses that can be atta
implants in the bony orbit of the missing eye are also available. Eyeball prostheses are used after enu
of the eye due to injuries, diseases, or inborn abnormalities (i.e., an anophthalmic eye).
Prostheses designed to partially replace and/or maintain patency of any of the tubes that extend from
cornu of the uterus to a region of the ovary of the same side (i.e., fallopian tube). These prostheses ar
plastic or, less frequently, allograft structure that surrounds the fallopian tube; some prostheses may
tube and/or connect two separated segments of a fallopian tube that were previously severed. Fallopia
used typically during reconstructive gynecologic surgery procedures.

Lower limb prostheses designed for functional and/or cosmetic replacement of the missing distal porti
limb. These prostheses typically consist of external devices (some may include totally or partially imp
such as sensors) that resemble a natural foot and that are made of metal (e.g., cobalt-chromium alloy
polyethylene), carbon fibers, or a combination of materials; they are usually fixed with a socket to the
some degree of customization. Foot prostheses are usually passive, but some may include mechanism
(e.g., an energy-storing dynamic prosthetic foot); they are used mainly in patients who have congenit
suffered amputations due to illness (e.g., diabetes) or traumatic accidents. Partial foot prostheses inte
missing front parts of the foot are also available.

Prostheses designed for cosmetic and/or partial functional replacement of a missing hand. These pros
of an external component but may also include totally or partially implantable components (e.g., elect
are usually fixed with a socket to the wrist and require some degree of customization. Hand prosthese
metal (e.g., cobalt-chromium alloys), hard plastics (e.g., polyethylene), carbon fibers, or a combination
prostheses may be passive, mechanically operated, electrical or pneumatic powered, or use electronic
skin electrodes to detect myoelectric signals. Prostheses are available in a great variety of configurati
prostheses may be used alone as a replacement for a lost hand or as a terminal component of a below
elbow, or total upper limb prosthesis in patients who have suffered amputations due to illness (e.g., d
accidents. Prostheses that resemble mechanical hooks are also used to replace amputated hands.

Prostheses designed for total replacement of the biological natural heart. These devices typically cons
mechanism that includes one or more pumps, valves, cannulae, and a power source. Heart prostheses
blood circulation to patients with a debilitated or completely failed heart. Some devices are designed
pumping mechanism with a physical connection to an external power source (e.g., electrical, pneuma
totally implantable but may need a wireless, transcutaneous transmission of power from an external s
powered prostheses are mostly intended for temporary use before a heart transplant is possible; trans
heart prostheses are intended for permanent use.

Implantable prostheses designed for total or partial replacement of a joint. These prostheses typically
articulated components; they are usually made of metal (e.g., cobalt-chromium alloys), hard plastics (
a combination of materials. Many joint prostheses include a component that resembles a ball and ano
socket. Some joint prostheses components may be used alone as a partial prosthesis; a total prosthes
the components to permit complete replacement of the joint. Joint prostheses are implanted to replac
the knee, hip, ankle, shoulder, and elbow; they are used mainly in patients who suffer from osteoarthr
arthritis, as well as after trauma.
Prostheses designed for implantation in the penis to provide penile tumescence and permit sexual con
may consist of inflatable tubes that are implanted in the penis and a liquid (e.g., saline with or withou
opacifiers) with appropriate abdominal implantable hydraulic components (e.g., conducts, pumps, res
rigidity by applying pressure to the liquid or rigid or semirigid plastic bars that are implanted in the pe
are intended for patients who suffer from erectile dysfunction.

Implantable prostheses designed for partial or total replacement of the wrist joint. Partial wrist prosthe
several components. The carpal (distal) component typically has two metal stems that are inserted in
and metacarpal bone marrow cavities, respectively; the opposite metal-ball-shaped end fits into the s
radius. The radial component typically consists of a flat metal device with a long stem at one end that
hollow center of the distal end of the radius; a very hard, slick plastic cup at the other end forms a soc
The radial component is almost exclusively used in combination with the carpal component to form a
Both components are usually metal, with a high-density, tough, slick plastic (e.g., polyethylene) space
frequently, a prosthesis with a single, across-the-joint component (usually made of a silicone elastome
prostheses are used to stop bones from rubbing against each other; they may restore wrist motion an
patients who suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma (e.g., fracture).
prostheses intended to replace only the carpal lunate, scaphoid, or trapezium bone are also available.

Implantable devices designed for cosmetic testicle reconstruction and/or augmentation. These implan
solid elastomer (e.g., silicone) or a liquid-filled device that has an outer shell with a hollow lumen, a liq
and a patch to seal the shell once it is filled during the surgical procedure just before implantation. Tes
available in a variety of shapes and sizes. Testicular implants are used to provide or restore normal ph
(e.g., for cosmetic reasons) in patients with loss (e.g., trauma, illness) or absence of one or both testic
intended for functional replacement of the testicles.

Implantable prostheses designed for functional replacement of the male urethral sphincter. These pro
hydraulic devices including an intra-abdominal fluid-filled reservior, an inflatable and deflatable cuff th
urethra, and a mechanism that includes a small pump situated beneath the scrotal skin. Urethral sphi
used to help control moderate to severe incontinence, often after prostate surgery.

Vascular grafts of synthetic (artificial polymers) origin that are intended to replace, bypass, or shunt a
injured blood vessel. These grafts are typically made of woven or knitted polyethylene terephthalate
polytetrafluoroethylene fabrics. Synthetic grafts are best suited for large diameter (more than 10 mm)
replacement such as aortoiliac artery reconstruction and for hemodialysis access and extra-anatomic
Synthetic vascular grafts are used in many vascular procedures (e.g., femoral popliteal, axilloaxillary a
those involving the coronary arteries.

Respiratory function mechanics analyzers designed to assess the volume, airflow (i.e., diffusion and d
gases), and derived parameters (e.g., airway compliance and resistance) through the respiratory tract
children (typically older than 12 years of age). These devices typically include a spirometer, a gas ana
electronic unit with computerized capabilities and appropriate software. Adult respiratory function me
measure, in addition to diagnostic spirometer measurements, parameters such as functional residual
capacity of the lungs for carbon monoxide, and airway resistance. The analyzers are intended to provi
ventilatory function as well as identify respiratory impairments.
Physiologic analyzers designed to evaluate the pulpal vitality of teeth by electrically stimulating the n
The electric current needed to obtain a patient response to the stimulus is a measure of the condition
These analyzers usually consist of a high-frequency electronic oscillator, cables, and electrodes to app
some units include a display. Dental pulp physiologic analyzers are used to determine pulp necrosis, p
involvement of teeth that are near lesions.

Syringe pumps designed for drawing blood through a densitometer to produce dye dilution curves for
determination.
Pumps designed for extracorporeal gas exchange and reinfusion of blood, typically during heart-lung b
These pumps (known as extracorporeal perfusion or arterial pumps) consist of either a mechanism tha
force (i.e., centrifugal pump) or rollers that cyclically compress the arterial line tubing (i.e., roller pum
perfusion pumps typically receive blood from the vena cava and deliver it back through the aorta by m
cannula after processing the blood in an oxygenator/heat exchanger, bypassing the heart and lungs c
backup arterial pump and connection to an emergency power system are necessary to ensure reliable

Infusion pumps designed for enteral (i.e., via the digestive tract) administration of feeding solutions (e
prepared formulas, blenderized foods) that provide an accurate control of the flow of liquid. These pum
linear or rotary peristaltic mechanisms; less frequently, cassette pumps, which repeatedly compress a
fluid into a cassette, are used. Rotatory mechanisms consist of a section of flexible tubing that is held
revolving rollers by tension on the anchored section of the tubing. Linear peristaltic pumps push fluids
of tubing with a series of fingerlike projections and an opposing surface. Many pumps include memory
dose settings, and volume infused, as well as visible and/or audible alarms to alert the user to flow ch
Enteral feeding pumps are used in patients who are unable or unwilling to consume adequate nutrien
gastrointestinal complications. Enteral pumps deliver the feeding solutions to various locations in the
through temporary feeding tubes (e.g., nasogastric tubes) or surgically implanted tubes (e.g., gastros
jejunostomy tubes). They are used in healthcare facilities (e.g., hospitals, nursing homes) and at home

Infusion pumps designed to deliver different types of liquid medications and other solutions through in
epidural, and/or subcutaneous routes at pre-established accurate flow rates capable of being used in a
therapies (i.e., multitherapy). These pumps may be intended to deliver large and/or small volumes of
can deliver infusion liquids through only one channel (i.e., single-channel pumps) or simultaneously us
(i.e., multi-channel pumps). Pumps capable of delivering high volumes of infusion solutions usually co
devices that include a pumping (e.g., peristaltic, cassette) mechanism to move fluid from the solution
IV set to the patient. Other pumps using syringe-based mechanisms are usually intended to deliver sm
pumps may also include controls to select the dose or volume to be infused; recording capabilities to
infusion volume and rate; and audible and/or visual alarms to indicate abnormal or dangerous conditio
(known as "smart pumps") include software capable of detecting medication administration errors (i.e
systems) are also available. Multitherapy infusion pumps are used mainly in hospitals and other healt
doctors' offices, and at home.
Infusion pumps designed to deliver relatively small volumes of liquid medications and other solutions
(IV), epidural, and subcutaneous routes at pre-established accurate flow rates (e.g., down to 0.1 ml/ho
mechanism. These pumps usually consist of a syringe; a motor that drives a screw or gear mechanism
the plunger or barrel of the syringe at a predetermined rate; electronic controls used to select the dos
infused; and audible and/or visual alarms to indicate abnormal conditions. In most pumps the syringe
must be manually replaced once it has emptied to continue the infusion. Syringe infusion pumps exhib
even at very low flow rates, and are especially appropriate for neonatal, infant, and critical care applic
volumes of concentrated drugs are to be delivered over an extended period; the pumps are used main
other healthcare facilities. Some pumps (known as "smart pumps") include software capable of detect
administration errors (i.e., dose error reduction systems) are also available. Syringe multitherapy infu
intended for IV pole mounting and/or tabletop placement; they are used mainly in hospitals, other hea
doctors' offices and at home; syringe pumps that are small enough to be worn or carried by patients (
are also available. Dedicated syringe pumps calibrated in appropriate units that are intended to delive
medications (e.g., insulin, oxytocin, anesthetics) are also available.

Pumps designed for use in delivering and withdrawing solutions in the vascular system at pre-establis
simultaneously and/or sequentially. These pumps typically consist of a syringe pump with a piston me
and withdrawing the infusate (e.g., indocyanine green dye) and/or other solutions. The pumps may de
relatively small volume of liquids; they are usually intended for pole mounting or tabletop use. Such v
withdrawal pumps have been used to inject contrast media and later withdraw blood samples from th
determine the concentration of the dye; the results are used to determine the value of the cardiac out

Instruments designed to excise or perforate a segment of material or tissue usually in the form of a di
typically handheld, manual instruments with a movable, sharp, mechanism (e.g., a hollow tube, jaw) a
end operated by squeezing a handle (e.g., scissor-like rings, two-part hand) without rotary movement
are available to take samples (e.g., skin, bone, uterus) for biopsy, for use in surgical procedures (e.g.,
ear), for dental device/prosthesis (e.g., rubber dam) perforation, or to make holes in devices (e.g., dra
specific materials.

Vascular surgery punches designed to excise a segment of tissue from the aorta wall (usually in the fo
surgical procedures. These punches are typically handheld, manual instruments with a tubular configu
sliding mechanism (i.e., the punching mechanism). Punches may include a set of interchangeable cutt
sizes and diameters appropriate for punching the aorta walls and are operated by a handle. Aorta pun
during anastomosis procedures.

Punches designed to excise a segment of tissue (usually in the form of a disc) intended for laboratory
(i.e., biopsy); these devices are designed to remove tissue from an anatomic structure with minimal sa
tissue damage. Biopsy punches are typically handheld, manual instruments with a movable, sharp ech
tube, jaw) at the distal end, operated by a handle (e.g., ring-, pistol-like). Dedicated biopsy punches a
anatomic structures and/or tissue such as bone, skin, pleura, larynx, and the uterine cervix.
Eye (ophthalmic) surgery punches designed to excise a segment of tissue (frequently in the form of a
cornea of a patient or from grafts taken from (cadaver) donors. These punches are typically handheld,
with a set of sharp hollow tips at the distal end (a rotary mechanism that may be either integral or as
operated by squeezing a two-part handle. Corneoscleral eye surgical punches are used mainly to perf
implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. Dedicated corneo
consisting of a bench-mounted apparatus intended to shape grafts of cadaver donors are also availab

Surgical punches designed to excise small plug-like skin segments containing hair follicles from a don
holes in the site of implantation. These punches are typically handheld, manual, hollow tubular instrum
sharpened distal end that punches the round graft out of the donor site so it can be moved into the ar
generally the frontal hairline; they are also used to facilitate the implantation of the follicular unit graf
by performing small punch holes.

Ophthalmic measuring instruments designed to determine the diameter of the pupil by measuring its
stimuli. These instruments may consist of a camera system with light sources to make digital photogr
videography, a microcontroller, and image processing software to image, record, analyze, and display
different light stimuli (pupillography). Other pupillometers are handheld instruments that illuminate th
pupil and iris images and superimpose a millimeter ruler on the image so the examiner can read the p
as handheld infrared pupillometers). Pupillometers are used mainly in ocular surgery assessment and
some disorders or drug or alcohol impairment.

Patient warming units that use broadband energy sources that radiate a significant amount of energy
spectrum (e.g., quartz tubes or incandescent lamps). Radiant patient warming units are used for the
patients suffering hypothermia.
Radiant warming units designed to provide thermal stability to adults. These units usually include ove
a temperature sensor typically placed on the skin of the patient, automatic and/or manual controls, an
include a transparent plastic canopy with distributed heat elements on it to provide a comfortable uni
around the patient (e.g., burn units).
Devices designed to produce diagnostic-quality copies of radiographic images on duplicating film that
based emulsion on one side. The duplicating film is laid over the original x-ray film, and both films are
duplicator. The films are then exposed to a light source (usually ultraviolet), and the image of the orig
onto the duplicating film. The duplicate is then processed in an x-ray processor. Some duplicators are
subtraction, enlargement, reduction, and enhancement. X-ray film duplicators are used to make copie
imaging technologies (e.g., computed tomography, magnetic resonance imaging, dental radiography)
by surgeons, as teaching aids, as evidence in legal proceedings, and for record keeping at patient tran
then be stored to maintain the integrity of central files.
Devices designed to facilitate patient positioning to make possible and/or improve the results of radio
radiotherapy procedures. These devices may consist of relatively soft materials (e.g., Styrofoam, spon
formed to a shape (e.g., cylindrical, triangular) appropriate to the procedure to be performed (e.g., ch
radiography, abdominal radiotherapy) and/or the characteristics of the patient's anatomy. Positioning
mechanical devices that restrict a patient's movement for lateral chest radiography (also known as Va
as devices intended for patient positioning during head radiography (e.g., cephalometric devices). Mo
radiographic/radiotherapeutic positioning aids are radiolucent, appearing dark in x-ray radiographies.
aids for procedures performed on the extremities, head and neck, torso, or for multiple procedures are
devices are intended for use only in particular procedures and/or for pediatric use.

Units that include an x-ray source to irradiate the portion of the patient to be examined, and an image
in some form of latent image the array of x-rays that were differentially attenuated within the patient.
converted, usually in another device (e.g., a film image processor), into a visible image (i.e., a radiogr
internal structure of the irradiated patient region. The interpretation of these images by a physician c
clinically useful diagnosis. Radiographic units do not include patient supports (e.g. tables) or any othe
image processing or transference (e.g., computerized processors).

Radiographic units designed for dental and/or oral cavity imaging. These units include an x-ray gene
(usually with stationary anode), a collimator, an exposure timer, patient positioning features and a con
configuration of these components depends on the type of radiography performed and the type of x-r
Most dental radiographic unit x-ray tubes have a voltage range from 50 to 100 kV, and a current rang
Dental radiographic units are used for imaging dentition, individual tooth anatomy and dental problem
orthodontic planning and assessment.

Radiographic units consisting of a manually driven or motor-driven wheeled cart that transports an x-r
tube and tube stand, collimators, and a film cassette or flat-panel detector storage drawer (for film an
respectively). There are three different types of mobile radiographic units, which are categorized acco
line-powered transformers, capacitor-discharge generators, and battery-powered transformers. Most m
units utilize one of several types of digital imaging; advantages of digital imaging over film include gre
reduced patient radiation exposure, and the ability to integrate with digital picture archiving and comm
(PACS). Mobile radiographic units are used for imaging patients who cannot be moved to the radiology
patient transport is contraindicated, such as for patients in intensive care and critical care units or ope
rooms.

Video recorders designed to store the video on magnetic tapes. _x000D_


These recorders usually consist of an electromechanical device that includes external connectors to p
cameras or other sources of video and audio signals (e.g., cable boxes, video cameras); data processo
heads for writing/reading; and an open external slot to place a video cassette (reel-to-reel tape record
The recorders use a format known as video home systems (VHS) and usually have playing capabilities
audio signals, either through integral amplifiers, displays, and loudspeakers (typical in portable player
output to video reproduction systems (e.g., monitors or television sets). Videocassette tape recorders
tabletop, rack mounted, and portable versions.
Devices designed for safe transfer of radioisotopes, protecting the user from harmful radiation. These
of a metal (stainless steel) or plastic container with a lead liner and appropriate handles for easy man
of the lead shielding (e.g., 0.25, 0.5, or 1 inch) depends of the quantity and quality of the radioactive
transferred. Radioisotope transfer units are used for intra- and interhospital transportation of syringes
devices containing radioisotopes.

Phototherapy radiometers are used to measure light energy used during phototherapy. Usually photo
used for hyperbilirubinemia in newborns. Too much light energy can lead to brain damage. A probe o
the device. The probe contains infra red and visible blocking filter so the reading of non-therapeutic ir
obtained. These probes or sensors are connected to a machine that contains either a meter or digital
amount of light energy. Some models are able to measure the duration of treatment and calculate the

Systems designed to deliver high-energy ionizing radiation, including photon radiation (e.g., x-rays, ga
particle radiation (e.g., electrons, neutrons). Most systems are designed for external radiation therapy
high-energy machines that radiate gamma rays, electrons, or x-rays (e.g., linear accelerators, cobalt u
typically include control units and may also include radiation-delivery devices. The intensity of the bea
expressed in kilo- or megavolts, determines both the depth of penetration into the body tissues and th
electrons produced by secondary ionization within the tissues. Radiotherapy systems are used in the t
neoplasms and occasionally in the treatment of certain benign conditions.

Systems designed to replicate the motions and beam-positioning ability of specific radiotherapy units
linear accelerators). These systems perform radiotherapy simulation and establish the area to be trea
radiographic/fluoroscopic device with imaging capabilities or a computed tomography scanner. Radiot
systems are used in radiotherapy planning to define the region of the actual tumor and the surroundin
considered to be at risk (i.e., the tumor volume) and to develop a treatment technique to deliver a ho
radiation to the tumor while minimizing the dose to surrounding normal tissue.

Surgical instruments intended for use to smooth the edges of a divided bone.
File-like devices designed to scrape and smooth the surface of bone.
Small, metal, file-like instruments with a ridged surface designed to scrape and smooth the bony struc

Metal, file-like surgical instruments with a ridged surface designed to scrape and smooth the internal
and sinus cavities
Manual surgical instruments used to open and enlarge the medullary canal for the insertion of various
prosthesis implantation or fracture fixation procedures.
Power line receptacle testers designed to measure and assess the electrical characteristics of a power
testers consist of a plug-in device that can detect open (e.g., ground, live, neutral) lines and inverted
or neutral); they usually include a display and/or visual and audible alarms to indicate correct or faulty
connections. Power line receptacle testers are used to assess the electrical characteristics of the most
facility receptacles (e.g., three-wire, 125-volt line supply); some testers can also determine the trippin
fault circuit interrupters by injecting a variable leakage current.
Power line receptacle testers designed to measure and assess the mechanical holding force between
receptacle and the male prong of a plug. These testers include a tension-measuring device to assess t
to show whether the measured value exceeds a predetermined safety value. Mechanical power line re
used mainly to assess the holding force of the ground connection.

Ophthalmic measuring instruments designed to determine the refractive index of the eye, usually me
These instruments are manual, consisting of a mechanism and a set of lenses with different refractive
combination with an external chart; and automated, electronically powered refractors that use a set o
electronically controlled mechanism, and a digital display intended for measurement with minimal ope
Automated refractors are frequently combined with keratometers in a single measuring device.

Equipment designed to keep a thermally insulated compartment at cool temperatures above the freez
0 degrees Celsius [32 degrees Fahrenheit]), typically between 2 and 10 degrees Celsius (35 and 50 d
This equipment is used mainly for storage of perishable products. Refrigerators used in healthcare fac
dedicated equipment manufactured with appropriate technical characteristics, such as range of tempe
accuracy, reliability, and configuration according to uses (e.g., clinical laboratories, blood banks, pharm
refrigerators for general use (e.g., food preservation) are also available. Some refrigerators include a s
chamber to keep products at a temperature below the freezing pointof water.

Refrigerators designed to slow decomposition of stored cadavers in the morgue either during autopsy
cadaver is disposed of; the refrigerator usually operates at temperatures between 4 and 10 degrees C
degrees Fahrenheit). These refrigerators typically consist of one or more chambers made with corrosio
stainless steel) interiors, minimizing the risk of adulteration, contamination, and/or corrosion of conten
configuration appropriate for storage and easy manipulation of cadavers; a compressor, condenser, ev
controls, and alarms for dependable long-term storage according to morgue procedures. Morgue refrig
in end-opening, side-opening, and walk-in configurations for a single cadaver or, more frequently, for

Heat exchangers designed for warming blood, typically by transfer of heat across a membrane. These
used when perfusing extremities and organs other than the heart.
Regulators designed to reduce the output pressure of gases stored in high-pressurized gas containters
cylinders) to provide a controlled pressure (typically 50psi/3.5bar) and flow rate appropriate for delive
These regulators include controllers and may also include a manometer to measure the output pressu
pressure gas regulators are placed between the output port of the high-pressure gas container at one
breathing circuit at the other end. The regulators are mainly used for delivery of respiratory (e.g., oxyg
gases at an appropriate pressure.

Endoscopes designed for removal or resection of tissues and/or for biopsy of lesions. These instrumen
cautery and coagulating capabilities or other means for tissue resection. Most of these resectoscopes
sheath, a lighting system (e.g., fiberoptic), a wide-angle telescope, electrosurgical wire loops, and a w
catheters and other operative devices. They may also include a television camera on the distal tip. D
have the appropriate dimensions and characteristics for insertion and operation in the natural canals
intended to be used (e.g., urinary tract, female genital tract); other simpler resectoscopes are intende
through incisions performed in minimal-access surgery procedures (e.g., wrist).
Electrical resistance testers designed to measure resistance to the direct current (DC) of a circuit cond
are simple units that detect continuity and show the results using lighted displays (e.g., LEDs). Other
terminal technique to measure the resistance (e.g., in milliohms) and display the numeric results; they
power supply (e.g., a battery). Line cord resistance testers may include visual or audible signals that a
circuit is open and/or the resistance is under a predetermined value; they are used to determine the c
and other low resistances such as the contact resistance in receptacles.

Simulators designed to mimic some characteristics (e.g., rate, sound, thoracic impedance variation) o
abnormal functioning of the human respiration cycle.
Devices designed to restrict and/or control a person's movement to the extent that is necessary for tre
or protection of the person or others. Examples of such devices include, but are not limited to a wristle
straight jacket, body/limb holder, etc.
Restraints designed to totally or partially limit the movement of infants and/or toddlers when they are
restraints typically consist of devices that directly restrain the child's movement (e.g., belts, straps) or
crib top that limit the child's movement indirectly (e.g., covers, nets). Crib restraints are used mainly t
from falling out of the crib or climbing the crib rails.
Devices designed to restore or assist the physiologic function of a patient's cardiac and/or respiratory
when the performance of one or both of those systems is inadequate to sustain life or is completely a
resuscitators are simple in design and operation, permitting their use in emergencies both inside and
and also during transportation. Resuscitators are typically used in emergency rooms, ambulances, pa
throughout the hospital, and in emergency rescue.

Resuscitators designed to artificially create blood circulation in a patient under cardiac arrest. These re
mechanical compression cyclically to the thorax, compressing the sternum at least five centimeters (t
the heart to eject blood. Some resuscitators use a load-distributing band to compress the thorax. Mos
are pneumatically or electrically driven, but a manually operated cardiac press has also been used. C
may be used as a substitute for manual external cardiac compression to prevent fatigue of emergency
provide better consistency in the applied force and rate of compression to ventilation ratio.

Resuscitators that combine in units the capabilities artificially create blood circulation and provide ven
who is apneic or exhibits inadequate respiration and is simultaneously under cardiac arrest. These res
mechanical compression cyclically to the thorax, producing a compression of the sternum at least five
inches), forcing the heart to eject blood; pulmonary resuscitation is performed by using an integral pn
resuscitator, typically applying time-cycled ventilation. Cardiopulmonary resuscitators are used as a s
external cardiac compression to prevent fatigue of emergency personnel and to provide a better cons
force and rate of compression to ventilation ratio. These resuscitators may be used during emergenci
cardiopulmonary arrest if an oxygen cylinder or an oxygen-piped wall outlet is present; they can also b
transportation in ambulances.

Resuscitators designed to provide or assist ventilation in patients who are apneic or exhibit inadequat
life. These resuscitators may deliver air, oxygen, or a mixture of the two gases through a connector to
tube, or other appropriate artifical airway attached to the patient. Most pulmonary resuscitators are p
devices.
Pulmonary resuscitators designed to provide respiratory support from regulated-pressure (usually 50 p
supplies. These resuscitators typically consist of a standard mask, a connector that has an outlet app
standard mask (22 mm in diameter) or attach to an endotracheal or tracheostomy tube (15 mm in dia
devices (e.g., automatic frequency and tidal volume settings, manual operation). Most of these resus
batteries for control and display device operation. Pneumatic pulmonary resuscitators deliver high flo
oxygen concentrations and avoid direct rescuer/patient contact; they may be used during emergencie
arrest if an oxygen cylinder, a piped wall outlet, or a breathing air supply is present.

Pulmonary resuscitators designed to provide respiratory support to a patient by manually squeezing a


resuscitators typically consist of a polymeric (e.g., resilient rubber) self-refilling bag, a nonrebreathing
patients from rebreathing their own carbon dioxide. an adapter that has an outlet appropriate to fit an
mm in diameter) or attach to an endotracheal or tracheostomy tube (15 mm in diameter), and an oxy
include an oxygen reservoir and/or accept positive end-expiratory pressure valves. Manual pulmonary
mostly used during emergencies involving pulmonary arrest or for ventilated patient transport.

Retainers used to fix a bandage in an appropriate position. These retainers typically consist of an open
mesh made of plastics (e.g., nylon and spandex). These retainers are manufactured in several sizes ac
intended use (e.g., fingers/toes, knee, elbow), they are available either in rolls or in precut, ready to u
retainers are used on patients that are sensitive or allergic to adhesive tape and/or in parts of the bod
tape.

Retainers designed to hold teeth in place during the period of functional adaptation while surrounding
gums) and bone adjusts to a new position following corrective orthodontic treatment. Orthodontic reta
(i.e., nonremovable) metallic wires placed around tooth abutments or removable retainers that typical
wire surrounding the teeth or, less frequently, a transparent plastic device that fits over the entire too
retainers are frequently used after the removal of or braces are removed to prevent rehearsal at the M
positions of the teeth and jaws gained by orthodontic procedures.

Devices designed to retain organs (i.e., viscera) and/or omentum (a fold of the peritoneum) in appropr
abdominal wounds are sutured, frequently at the close of surgical procedures. These retainers typicall
synthetic materials with a central opening; they are placed through the wound internally on the perito
include an attached string with a proximal ring that is kept outside the body during the procedure; aft
completely closed the foldable retainer is pulled out. Viscera retainers are available as sterile, individu
use devices in several sizes appropriate for children and adults. The retainers are intended to facilitate
suturing of abdominal wounds.

Ophthalmic measuring instruments designed for the automated detection and measurement of refrac
projecting light into the examinee's eye through the pupil and assessing its reflection. These instrume
handheld devices with a light source, a lens, and a mirror that throw either a streak or a spot of light t
patient. The examiner moves the instrument and observes the movement of the shadow of the reflect
the same or the opposite direction of the device; a set of trial lenses is used to neutralize the reflex. T
lenses and other data (e.g., the distance between the instrument and the examinee) are used to calcu
errors. Retinoscopes are used mainly for lens fitting and for refractive surgery assessments.
Instruments designed to temporarily separate and hold back the edges of incisions usually performed
procedures, exposing and/or giving access to other tissues or organs. Some retractors are used to hold
parts during dental and oral surgery procedures. Retractors are available in a variety of shapes and st
the tissue and/or organ to be exposed or retracted. Some retractors can retain a position once they ar
retractors); other retractors incorporate a fiberoptic system to illuminate deep surgical sites. Dedicate
available for many dental and surgical procedures; other dedicated retractors intended for use in the n
usually classified as specula.

Surgical retractors designed to temporarily separate and hold back the full thickness of an abdominal
and providing access to other tissues, organs, or abdominal structures. Abdominal wall surgical retrac
handheld, manual or mechanically operated instruments that are available in a variety of shapes and
mechanically operated instruments can retain position once set (i.e., self-retained retractors). The retr
facilitate surgical procedures inside the abdomen. Dedicated abdominal wall retractors are available f
structures and/or organs (e.g., ribs, liver).

Urinary tract surgical retractors designed to temporarily separate and hold back the urinary bladder, e
access to other tissues, urinary tract, and associated structures. These retractors are usually handheld
available in a variety of shapes and sizes and selected according to the structure or organ to be expos
include fiber optics to provide illumination to the surgical area. Dedicated self-retained bladder retract
appropriate mechanisms are also available.

Surgical retractors designed to temporarily separate and hold back segments of (or the entire) brain, t
access to other tissues and/or intracranial structures. These retractors are frequently manual, handhe
consisting of flat, malleable, doubled-ended strips that are either straight or curved (e.g., following an
retractors come in a variety of sizes in order to accommodate the brain sulcus, fissure, or margin to be
available are self-retained brain retractors capable of retracting the entire brain..

Brain surgery retractors designed to temporarily separate and hold back a segment of the brain, open
nerve inside the brain (usually the trigeminal nerve), exposing and providing access to blood vessels c
the intracranial nerve. These retractors are frequently manual, handheld instruments consisting of flat
a curved blade at the distal end and a flat or rounded handle at the proximal end. Self-retained brain r
appropriate mechanisms intended to retract the whole brain are also available. Nerve decompression
surgical procedures to relieve the symptoms (pain, muscle twitching) caused by compression of a nerv

Thoracic organ surgical retractors designed to temporarily separate and hold back the heart or any pa
associated vascular structure, exposing and providing access to other tissues or heart structures. Thor
retractors are handheld, manual instruments usually including a blunt blade at the distal end. Dedicat
cardiac atrium and cardiac valves are also available.
Retractors designed to temporarily separate and/or hold the complete mouth open or to hold back any
incisions performed in various oral anatomical structures, exposing and providing access to other tissu
structures during dental and/or oral surgery procedures. Most of these retractors are manual, handhel
in a variety of shapes and styles according to the oral structure to be retracted; they usually include b
Some dental/oral surgical retractors used to keep open the whole mouth (i.e., mouth gags) can retain
(i.e., self-retained retractors). Dedicated dental/oral surgical retractors are available for particular oral
lips, cheeks, tongue, and palate tissue flaps.
Surgical retractors designed to temporarily separate and hold back the edge of soft tissue incisions an
the eye, exposing and providing access to other tissues or eye structures. Eye (i.e., ophthalmic) retrac
manual instruments available in a variety of shapes and styles usually including a blunt working end a
according to the tissue and/or eye structure to be exposed or retracted. Some eye retractors can retai
(i.e., self-retained retractors). Dedicated eye retractors are available for particular eye parts (e.g., eye

Multipurpose surgical retractors designed to temporarily separate and/or hold back the edge of incisio
many different anatomic structures, exposing and providing access to other tissues, organs, or structu
procedures that are held by the surgeon. These retractors usually consist of manual, handheld instrum
variety of shapes and styles typically including one or more sharp or blunt distal blades and a handle;
the retractors depend on the anatomic structure to be retracted and/or the procedure to be performed
multipurpose surgical retractors are available for particular anatomic structures (e.g., skin edges, eyes
surgical procedures (e.g., plastic, ophthalmic, or orthopedic surgery).

Instruments for holding back the margins of a surgical wound in order to excise a vertebral posterior a
Eye (ophthalmic) surgical retractors designed to temporarily separate and hold back soft tissues in the
exposing and providing access to other anatomic parts of the orbit. These retractors are typically slen
stainless steel) instruments with a two-pronged, forklike blunt working end and an integral flat and se
eye retractors are used mainly during surgical procedures, but they may be also used for examination

Surgical retractors designed to temporarily separate and hold back the edges of abdomino-perineal su
exposing and/or giving access to the rectum stump. Rectum perineal retractors usually consist of large
instruments with two large curved blades at the distal end and two scissors-like handles with a ratche
retention. Rectum retractors are used mainly in surgical procedures for excision of the rectum; other d
intended to expand the natural anal canal and rectum are usually classified as rectal specula.

Thoracic wall surgical retractors designed to temporarily separate and hold back the edges of an incis
exposing and providing access to tissues, thoracic structures, and/or organs. These retractors consist
instruments available in a variety of shapes and styles, usually including blunt distal blades and an int
retractors can retain the position once it is set (i.e., self-retained retractors). Mechanically operated re
self-retained mechanism with gears that permit a wide separation of the ribs during the surgical proce
spreaders) are also available.

Multipurpose surgical retractors designed to temporarily separate and/or hold back the edge of incisio
many different anatomic structures, exposing and providing access to other tissues, organs, or structu
procedures that permit self-retention once they are set. These retractors usually consist of manual ins
blades at the distal end with cross-action that joint join together at the proximal end and include a loc
(known as ratchet catch) that provides self-retention; some self-retained retractors include blades mou
that provides self-retention. Dedicated self-retained surgical retractors are available for particular ana
skin edges, abdominal and thoracic wounds) or surgical procedures such as plastic, cardiothoracic, an
Surgical retractors designed to temporarily separate and hold back the full thickness of a thoracic wal
providing access to other tissues, organs, or abdominal structures during surgical procedures. Thoraci
of manual, handheld or mechanically operated instruments that are available in a variety of shapes an
mechanically operated instruments can retain the position once it is set (i.e., self-retained retractors).
retained thoracic wall retractors are available to open the ribs (commonly known as rib spreaders) and

Instruments used to maintain vaginal exposure by separating the edges of the vagina and holding bac

Surgical retractors designed to temporarily separate and hold back segments of the vasculature, expo
access to other anatomical structures. These retractors consist of handheld, manual instruments in a v
sizes, including double-ended instrument with perpendicular blunt blades and retractors including ang
a blade perpendicular to the shaft at the distal end. Vascular retractors are used in a great variety of s
including thoracic, abdominal, brain, and peripheral surgery procedures. Dedicated vessel retractors in
aorta and the peripheral vessels are also available.

Mechanical routers designed for making smooth (e.g., rounded) edges and/or to mill out the surface o
template. Orthopedic routers typically consist of a portable or benchtop machine with an electric moto
vertical spindle, and cutting tools (e.g., bits). The routers may include lights to provide illumination an
piece (e.g., a vise clamped to a bench) that is being conformed. Orthopedic mechanical routers are m
reshaping bones during orthopedic procedures, including minimally access surgery of the articulations
to reshape bones in orthopedic workshops.

Aerobic exercisers designed to simulate the motions of rowing (i.e., propelling a boat forward using oa
usually consist of a chain or belt drive, glide wheels, pivot handlebars or a rope-pull system that simul
that can slide back and forth mounted on rollers; the resistance is provided by pneumatic, hydraulic, o
mechanisms. Rowing exercisers usually include workout program modes that can adjust resistance an
the number and speed of strokes, workout time, distance, calories burned, and heart rate; some may
controls to adjust resistance level to suit the targeted heart rate. Rowing exercisers are intended to in
endurance by keeping the heart and pulmonary rate elevated for a continuous period of time. Addition
strength and endurance to the muscles in the arms, shoulders, abdomen, back, and legs.

Receptacles (e.g., cabinets) designed for safe storage of radioisotopes, protecting healthcare provider
harmful radiation. These safes typically consist of heavy metallic key-locked boxes with a thick (e.g., t
shielding.
Narrow belts designed to keep sanitary (i.e., menstruation) napkins or pads in the appropriate place. T
consist of a narrow, frequently elastic, belt that encircles the woman's pelvis. The belt usually includes
sanitary napkin or pad and metal and/or plastic hooks in the front and back to hold the sanitary napki
menstruation belts are intended for use during the menstruation period.
Absorption pads designed to be worn by women during their menstrual periods to absorb menstrual fl
worn by new mothers at the post-partum period to help with discharge. They are held in place betwee
and her undergarment either by being adhered onto the user's undergarment or wrapped around the
gusset. Rarely, they are held in place by being attached to clips or pins on a menstrual belt worn arou
Some menstruation pads are designed to be worn once and disposed after use; others are designed to
by washing and drying them after wearing. Reusable pads are usually made of cotton fabric pockets in
cotton fleece leak-resistant pads are inserted. The absorbent inserts can be layered to accommodate
heavy menstrual flow. They are held in place by wrapping extended fabric tabs around the undergarm
flaps may include snaps to help hold the pad in place. Single use disposable pads are usually made of
permeable layer (usually made of plastic) which is held against the undergarment; an absorbent layer
polyacrylate gel, or wood cellulose fibers, or other absorbent material); and a soft, perforated, plastic
held against the wearer's body. Disposable pads are available in several different sizes, such as mini,
accommodate light, moderate, or heavy menstrual flow.

Instruments designed to cut objects and tissue using one or more thin metal blades with a serrated ed
piece, handheld, manual instruments including the blade and a handle or, less frequently, stationary,
electrical, pneumatic) instruments with a combination of a driving mechanism and appropriate blades
include other attachments. Dedicated saws and blades are available according to the object or tissue
procedure to be performed (e.g., surgery, cast cutting, amputation, postmortem).

Bone surgery saws driven by electric (either line or battery) power designed to cut bone and other ha
are typically, small, handheld, power instruments with an electric motor and a mechanism to drive an
reciprocating, or sagittal blade. Bone surgery electrical saws are used in orthopedic, cardiothoracic, an
procedures.
Bone surgery saws driven by pneumatic power designed to cut bone and other hard tissue. These saw
handheld, powered instruments with a pneumatic motor; a mechanism to drive an oscillating, reciproc
blade; and a hose connected to the pressurized gas source. Pneumatic power bone surgery saws are s
than electric saws, but they produce a larger amount of debris in the environment. They are used in o
cardiothoracic, and other surgical procedures.

Measuring instruments designed to determine the weight of bulk materials or large discrete objects. S
methods for weighing, including gravimetric scales in which other masses are used to compare the m
the same way that balances work; spring scales, in which the gravitational force on the unknown is m
force of known constant; electromechanical scales using transducers and linear transformers or torque
electronic scales using different types of sensors (e.g., strain gauges). Scales are used in the field of m
patients for diagnostic or for some special treatments (e.g., dialysis, newborns), for clinical determina
diapers, blood in sponges), and also for general use (e.g., food weighing) in hospitals, nurseries, and a

Clinical scales that incorporate a detachable pan that hangs as part of a spring scale or is on the top o
electronic scale. These scales typically have a capacity up to 3 to 15 kg (6 to 33 lb) and 10 to 20 g (0.
readability. Autopsy scales are used to weigh organs and other anatomic parts in autopsy rooms, morg
pathology laboratories.
Patient scales that are positioned under the hospital bed by lifting the bed off the floor so that the whe
transducers (load cells). Underbed scales may have a weighing capacity of up to 600 kg (1,300 lb) and
(0.25 lb). These scales typically consist of a platform with ramps to roll the bed onto the transducers;
connected to a separate control and display unit. Most underbed scales are electronic; the changes th
passing through the strain gauges are electronically processed and displayed as weight. Other scales
electromechanical techniques. Underbed scales are used for constant monitoring of nonambulatory pa
small changes are critically important, such as in hemodialysis or for severe burn trauma, thus elimina
injury in these critically ill patients.

Clinical scales designed to weigh the amount of blood drawn from a donor. These scales usually consis
mechanism and some type of arrangement for automatic cutoff of blood flow when the correct weight
withdrawn (e.g., trip balance); their capacity is typically 1 kg (2.2 lb), with 5 to 10 g (0.0125 to 0.025 l
collection scales are mostly used in blood banks to weigh the blood drawn from a donor as it is filling a
them are portable and can be mounted on a pole. Some of these scales are part of a blood mixer, whi
weighing and mixing blood with an anticoagulant simultaneously.

Patient scales that include as integral parts a horizontal platform that is placed on the floor, a chair fo
vertical column with measuring, control, and/or display capabilities. Some models do not use platform
incorporate the weighing mechanism under the seat of the chair and a control and display unit on the
Chair scales usually have a weighing capacity of up to 150 to 300 kg (330 to 660 lb) and an accuracy
These scales may use mechanical, electromechanical, or electronic weighing technologies; they may a
adjustable footrest to facilitate patient access. Chair scales are used for routine intermittent weighing
stand on a conventional scale.

Patient scales designed as stand-alone units to be placed on the floor. These scales are either mechan
springs) or electronic; they usually include the meter or display as an integral part. Most floor scales h
capacity of up to 135 to 160 kg (300 to 350 lb) and a readability of 0.25 to 0.5 kg (0.5 to 1 lb); some e
weigh up to 360 kg (800 lb). These scales are mostly used for diagnostic and weight control in physici
and at home.

Scales designed to weigh infants that are either mechanical (e.g., beam lever system, spring type) or
scales usually include a weighing platform with a tray; according to the weighing system, they either
weight along a balance beam to obtain balance (beam lever system), a moving dial to show the weigh
display (electronic system). Infant scales usually have a weighing capacity up to 10 to 15 kg (22 to 33
of 10 to 100 g (0.025 to 0.25 lb). Some of these scales include diaper-weighing capabilities, typically p
weight determination up to one kilogram (2.2 lb) with one gram (0.0025 lb) accuracy. These scales are
time or periodic general infant care in the hospital, in a pediatrician's office, or at home.

Systems that produce an image by moving a beam (e.g., x-ray, electron) across an object or by sensin
around an object. Scanning systems are used in the field of medicine to obtain and display images (m
tomographic) of the body using x-rays, ultrasound, magnetic resonance, or other means. These system
scanner and computerized processing devices and may also include digital capabilities.
Scanning systems that use a radiographic technique and computerized processing to generate thin cr
(tomographic) images, or "slices" of a transverse plane of the body. Most computed tomography (CT)
capable of three-dimensional (3-D) image reconstruction. During a scan, the x-ray beam is moved acr
the x-ray attenuations along many lines in the tissue slice can be determined and stored in a compute
system consists of an x-ray subsystem (i.e., x-ray generator, x-ray tube, gantry); a computer subsyste
for image processing, display monitors, and a data storage unit; and an operator console. The set of to
the human body reconstructed by the computer are used for a wide variety of medical procedures and

Instruments designed to cut objects, materials, and/or tissues using two metallic (e.g., stainless steel)
edges that slide past each other (i.e., shearing action). The blades are usually attached to handles wit
conformed as a ring to facilitate holding and operation with the fingers; both parts are joined by a swi
Squeezing the two handles together and then pulling them apart causes the cutting edges to cut the m
between the blades. Some scissors intended for delicate surgical procedures (e.g., ophthalmology, ne
microsurgery) have flat handles and frequently flat springs, providing a more uniform and/or sensitive
quality scissors are often manufactured using tungsten carbide blades to increase precision and durab
to facilitate smooth tissue cutting with a razor-sharp edge (super-cut blade) are also available. Dedica
clinically used to cut materials (e.g., bandages, dressings, sutures), tissues during surgical (e.g., ophth
obstetric), dental, and postmortem (e.g., autopsy, dissection) procedures, and also for grooming and h
to cut the fingernails).

Scissors designed to cut bandage, gauze, and dressing. These scissors are typically strong, handheld,
with two metallic (e.g., stainless steel) blades with sharp edges that slide past each other (i.e., shearin
blade is longer than the other and finished in a sharp or probe-like tip while the shorter blade has a ro
are usually attached to handles with the proximal end conformed as a ring to facilitate holding and op
fingers; both parts are joined by a swivel pin in the center.

Surgical scissors designed to cut eye tissues during ophthalmic procedures. These scissors are typical
instruments with two metallic (e.g., stainless steel) blades with sharp or blunt tips that slide past each
action). The blades are usually attached to handles with the proximal end conformed as a ring to facili
operating with the fingers; both parts are joined by a swivel pin in the center. Small, fine scissors with
handles to provide a safer grip and inserted flat springs to avoid uneven tension and provide a more u
manipulation are also available. Dedicated scissors with a variety of tips and blades are available to c
cornea, lens capsule, and other eye tissues during eye surgery procedures (e.g., capsulotomy, sclerot

Eye (ophthalmic) surgery scissors designed to cut corneal and/or scleral tissues during ophthalmic sur
These scissors are typically small handheld, manual instruments with two metallic (e.g., stainless stee
blades (frequently beveled) and sharp or blunt tips that slide past each other (i.e., shearing action). Th
to handles with the proximal end conformed as a ring to facilitate holding and operating with the finge
swivel pin in the center; some corneal scissors are flat and include wider rings (e.g., ribbon style). Scis
handles with inserted flat springs to provide a safer grip and provide a more uniform and/or sensitive
uneven tension are also available; they may be used in microsurgical procedures. Corneoscleral eye s
used in keratoplasty, corneal transplant, corneal section, and other ophthalmic procedures involving t
sclera.
Eye (ophthalmic) surgery scissors designed for removal of the eyeball (i.e., eye enucleation). Enucleat
scissors are used to remove teh eyeball after th eye muscles and eye nerve have been severed. These
strong handheld, manual instruments with two heavy, rounded metallic (e.g., stainless steel) slightly o
blades with blunt tips that slide past each other (i.e., shearing action). The blades are attached to han
end conformed as a ring to facilitate holding and operating with the fingers and are joined by a swivel

Eye (ophthalmic) surgery scissors designed to cut the iris tissue during ophthalmic procedures. These
very small handheld, manual instruments with two metallic (e.g., stainless steel) blades with straight
that slide past each other (i.e., shearing action). The blades are attached to handles with the proximal
ring to facilitate holding and operating with the fingers and are joined by a swivel pin in the center. Th
attached to serrated flat handles to provide a safer grip with inserted flat springs that avoid uneven te
more uniform and/or sensitive manipulation. Iris surgery scissors are used for complete (i.e., sector) o
peripheral) surgical excision of the iris in procedures intended to enlarge small pupils and to treat glau
diseases. These scissors are frequently used in microsurgical procedures.

Eye (ophthalmic) surgery scissors designed to cut sutures and/or to remove stitches. These scissors ar
held, manual instruments with two metallic (e.g., stainless steel) blades with straight or curved sharp
each other (i.e., shearing action); a blade may include a notch to facilitate rapid pickup and cutting. T
to handles with the proximal end conformed as a ring to facilitate holding and operating with the finge
swivel pin in the center. The blades are typically attached to serrated flat handles to provide a safer g
springs that avoid uneven tension and provide a more uniform and/or sensitive manipulation. Eye sur
larger finger rings and flat shanks to facilitate operation (e.g., ribbon style) are also available.

Surgical scissors designed to cut hard nasal (e.g., bony, cartilage) tissue during plastic and/or reconstr
These scissors are typically handheld, manual instruments with two long metallic (e.g., stainless steel
or angled sharp tips that slide past each other (i.e., shearing action). The blades are attached to hand
end conformed as a ring to facilitate holding and operating with the fingers; both parts are joined by a
center.

Surgical scissors designed to cut tissue from the rectum. These scissors are typically handheld, manua
metallic (e.g., stainless steel) straight, curved, or bayonet-shaped blades with sharp tips that slide pas
shearing action) and a long shank. The blades are attached to handles with the proximal end conform
facilitate holding and operating with the fingers; both parts are joined by a swivel pin in the center. Re
in surgical procedures of the rectum and anal canal.

Surgical scissors designed to cut sutures and/or to remove stitches. These scissors are typically small
instruments with two metallic (e.g., stainless steel) blades with straight or curved sharp tips that slide
shearing action); a blade may include a notch to facilitate rapid pickup and cutting. The blades are att
the proximal end conformed as a ring to facilitate holding and operating; with the fingers both parts a
pin in the center; scissors with larger finger rings and flat shanks to facilitate operation (e.g., ribbon st
Suture cutting and stitch removal scissors are used in general surgery and in most types of surgical pr
cardiothoracic surgery, abdominal surgery, orthopedics); dedicated smaller scissors are available for v
procedures (e.g., ophthalmology, neurosurgery).
Screen dividers designed to separate the bed or examination table providing the patient and the clinic
facilitating the procedure. These screens are typically opaque or translucid stand-alone structures tha
means to hold them; some screen dividers may include brackets for attachment to the ceiling and/or w
dividers are mainly used to provide a permanent (e.g., in semi-private patient rooms) or temporary b
patient bed or table (e.g., multibed patient rooms, catheterization laboratories).

Surgical screwdrivers designed to apply torque to screws and bolts used to attach bone prostheses (e.
implants to each other or to bones during orthopedic surgery. These screwdrivers typically consist of a
instrument consisting of a cylindrical handle and an axial shaft with a slotted or cruciform (i.e., Philips
appropriate to handle screws and bolts used in orthopedic procedures. Surgical bone/bone prosthesis
tips appropriate for square or hexagonal socket heads are also available; powered screwdrivers using
Bone/bone prosthesis screwdrivers can be dedicated to fixation (e.g., spinal) and/or manipulation of p
orthopedic prostheses.

Dresses designed to be worn by medical personnel. Scrub dresses are made of reusable woven mater
cotton, a combination of both). They have minimal places for dirt to adhere to and are easy to launder
usually stain resistant; they sometimes have pockets, belts, ties, and side vents. Some healthcare fac
uniform scrub dresses.
Garments designed to be worn by personnel and visitors in hospitals or other healthcare facilities. The
consist of two pieces of lightweight fabric apparel (i.e., a shirt and pants). Some scrub suits are one-pi
long sleeves and full-length pant legs which can be worn over clothing. Scrub suits are made of either
disposable nonwoven materials. They are easy to launder and inexpensive to replace if damaged or st
Scrub suits are mainly intended to provide a clean barrier in sterile and other clinical treatment enviro
emergency rooms, labor and delivery areas, and intensive care units. To prevent people from carrying
on their clothing into these environments, medical and facilities personnel, as well as visitors, are ofte
into clean scrub suits before entering the area. Some healthcare facilities also require the wearer to ch
scrub suit before leaving certain areas of the facility to help prevent the spread of infectious materials

Scrub suits that are intended for single use and are usually worn by nurses, surgeons, and other medi
medical procedures. Disposable scrub suits are usually one or two pieces of apparel, a full body suit or
are typically made from nonwoven paper or plastic materials. Disposable scrub suits are mainly intend
barrier in sterile environments and other clinical treatment environments such as emergency rooms, l
areas, and intensive care units. To prevent people from carrying infectious materials on their clothing
environments, medical and facilities personnel, as well as visitors, are often required to change into cl
entering the area. Some healthcare facilities also require the wearer to change out of the used scrub s
certain areas of the facility to help prevent the spread of infectious materials out of those areas. Disp
typically worn during one procedure and then discarded.
Scrub suits that are intended for multiple uses and are usually two pieces of apparel, a shirt and pants
materials such as polyester, cotton or a combination of both. Reusable scrub suits are mainly intende
barrier in sterile and other clinical treatment environments such as emergency rooms, labor and deliv
intensive care units. To prevent people from carrying infectious materials on their clothing into these
and facilities personnel, as well as visitors, are often required to change into clean scrub suits before e
Some healthcare facilities also require the wearer to change out of the used scrub suit before leaving
facility to help prevent the spread ofinfectious materials out of those areas. Reusable scrub suits can
after each use, and re-worn multiple times.

Surgical instruments designed for exploration of the mastoid bone during middle-ear surgical procedu
typically a handheld, manual, metal (e.g., stainless steel) instrument with a very thin tapered distal en
shaft to facilitate manipulation of the tip, and a flat handle at the proximal end. Mastoid searchers ma
exploratory probes in all common middle-ear surgical procedures.

Devices for grinding the edge of a dental cutting instrument in an effort to make it thin and sharp, the
cutting capability.
Devices used to cover the surface of a bed and/or operating and examination table. Sheets consist of
pieces of fabric serving as basic articles of bedding and are made of woven (e.g. cotton and/or polyes
nonwoven materials (e.g., tissue, paper). Some sheets are specifically made to fit adjustable beds and
examination tables and have wings and anchor straps designed to keep the sheets tucked in and tigh
widely used in healthcare facilities, hospitals, nursing homes, medical offices, and at home. Dedicated
examination and/or operating room tables and for patient beds are also available.

Mechanical shields in form of a cup or dome mostly used to protect women's nipples during nursing.
Accommodative foot orthoses designed to provide comfort and protection to users with a bunion (i.e.,
of the great toe). These orthoses typically consist of a prefabricated device made of soft and/or flexibl
fabrics, plastics, foam) or a combination of these. These are typically inserted inside the shoe and ma
appropriate for bunion accommodation. Bunion soft supports are intended to alleviate pain by prevent
making direct contact with the shoe and/or preventing rubbing or pressure between the shoe and the
devices that cover the bunion without touching it are also available.

Mechanical shields designed to form a protective cagelike structure over injured skin. The structure a
and permits access to the injured area while protecting against accidental damage.
Covers designed to encase the footwear of healthcare personnel to protect shoes against dirt, grime,
contaminants; to help maintain surgically-sterile operating rooms; and to help with infection control. S
disposable and can be ankle- or knee-high and with an elastic opening at the top. They can be made o
polyethylene film making them waterproof and lint-free, or of a breathable non-woven polypropylene
shoe covers are made skid-free or non-slip with treads added on the bottom to provide traction. Non-w
carbon strips can be added to the bottom of shoe covers to protect static sensitive devices in the work
wearers from injury.
Outer coverings for the human foot that are designed for long-term use and usually extend no higher
typically consist of a rigid or semirigid external covering for the foot, including heels, linings, soles, an
they are usually made of leather, fabric, plastic, and/or other appropriate material. Dedicated shoes in
purposes such as the prevention and/or correction of deformities of the feet and/or to improve their fu
shoes) are available; dedicated shoes with particular characteristics needed for a specific use, such as
and conductive shoes worn by healthcare workers during surgical procedures in rooms with conductiv
available.

Shoes designed to prevent the development of electrostatic charge in the user. These shoes are made
materials (e.g., conductive rubber), providing a path of low impedance from the user to a conductive fl
are intended for use on conductive floors in environments where the risk of fire and/or explosion is pre
rooms where flammable anesthetics are administered) or that contain equipment that is especially su
from electrostatic discharge.

Orthopedic shoes designed to correct abnormal rotation of the feet, either pronation (i.e., by turning t
supination (i.e., by turning the feet inward). These shoes may include wedges or friction disks attache
internal devices (e.g., inner heel wedges) intended for similar purposes. Rotation correction orthopedi
mainly to correct foot position while gaiting in the treatment of diseases such as metatarsus varus and
especially in infants and toddlers.

Prepackaged collections of the devices and supplies (either custom or standard) needed for providing
body of a deceased person (i.e., cadaver). Items in these kits usually include cadaver bags, identificat
tags or ankle bands), chin straps/ties, absorbent pads, and string or other appropriate materials (e.g.,
cadaver's limbs). These kits may be supplied in supporting trays (i.e., procedure trays) consisting of a
receptacle with a border around the periphery supporting all the instruments and supplies needed for
Postmortem care procedure kits and trays are intended for use in preparing cadavers for transfer to th

Shunts designed to create a graft fistula, a passage between an artery and a vein (typically in an arm)
for hemodialysis procedures. These shunts typically consist of a synthetic (e.g., polytetrafluoroethylen
thin wall and appropriate size (6 mm [0.25 inch] in diameter is the most common) and configuration t
A hollow tunneler is used to implant the shunt under the skin; a straight shunt is placed between the r
antecubital vein, and a loop shunt is placed between the brachial artery and the antecubital vein. Arte
used for hemodialysis procedures when it is not possible or convenient to create a direct fistula betwe
vein. Percutaneous shunts (e.g., Quinton-Scribner, Thomas) intended for arm and/or leg use are no lon
for hemodialysis.

Endoscopes designed for direct insertion through the rectum into the lower gastrointestinal tract for v
biopsy, and treatment of lesions of the lower (i.e., sigmoid) part of the colon. Sigmoidoscopes usually
outer sheath, a lighting system, and a working channel for catheters and operative devices.

Chairs designed for comfortable and convenient application of aqueous solutions to perineal, genital,
of these chairs have removable water pans and electric heaters.
Prepackaged collections of the necessary devices and supplies (either custom or standard) used to ad
by immersing the hips and buttocks of a patient in water or a water solution (i.e., Sitz baths). Items in
include a basin; an irrigation set with a bag, tubes, and usually a clamp; and towels. Some kits include
(e.g., a spray wand) and/or products (e.g., salts, herbs) to be mixed with the water. The basin usually
size and shape and is made of materials that permit its use on a standard toilet. These kits may be su
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Sitz ba
trays are used for hygiene and for external hydrotherapy to alleviate pain and/or discomfort caused by
cramps, labor, and/or conditions involving the pelvis, abdominal, and perineal areas. Reusable Sitz ba
including rigid plastic basins) and disposable kits (with inflatable plastic basins) are available; dedicat
with specific characteristics may be also available.

Tubs filled with water that are used in external hydrotherapy to relieve pain or pruritis and to accelera
inflamed or traumatized tissues of the perineal and perineal areas. The patient immerses only the hip
the legs being outside the tub.
Manual dermatomes designed to expand large, uniform-thickness skin slices, increasing the area of da
be covered with a given graft. These dermatomes are typically manually operated, benchtop instrume
drum, a handle, a graft fixation piece, and a set of cutting blades. The blades are used to perform par
on a previously excised graft (i.e., to expand the graft as a mesh), improving graft stretching capabilit
graft permeable to subcutaneous secretions. Expanded mesh dermatomes facilitate skin graft conform
damaged (e.g., burnt) skin areas.

Total upper-limb support orthoses designed to provide support and some degree of movement restrict
means of a soft sling. These orthoses typically consist of a loop of fabric or other soft material, includi
from the neck and/or shoulder and a wider segment around the forearm. Sling upper-limb support orth
used to assist the limb function by positioning it in an appropriate resting position during rehabilitation
trauma; they are also used to assist the limb by positioning it in an appropriate position, thus compen
weakness. Additional movement restriction is possible by attaching the sling to the user trunk. Dedica
an external (e.g., wheelchair) bar are also available.

Therapeutic knee orthoses designed to provide support and some degree of movement restriction to t
consist of a hanging sling that hold one or both knees suspended during traction therapy. These ortho
a flexible fabric (e.g., canvas) suspended from a bed, post, or other structure. The sling may have app
to be connected to a cable and pulley mechanism or other system intended to exert traction on the kn
orthopedic therapy.

Total lower-limb support orthoses consisting of a suspended sling. These devices are designed to prov
degree of movement restriction to the limb. The slings typically consist of a wide piece of fabric (e.g.,
from a bed, orthopedic table, or wheelchair. Sling supports are frequently used to keep the lower limb
position during rehabilitation after injuries or disease.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
treatment of snake bites. Items in these kits usually include adhesive bandages, ammonia inhalant, an
suction pump with adapter, insect sting wipe-ups, a lancet appropriate to treat snake bites, povidone-
and a tourniquet. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Snake bites emergency procedure kits and trays are intended f
puncture wounds inflicted by snakes' fangs before anti-venom can be administered. They are used in
in emergency rooms.

Surgical instruments designed to position and tighten fine gauge flexible or semirigid adjustable wire
of tissue for mechanical and/or electrosurgical resection and hemostasis. These devices typically cons
structure (e.g., a cannula), with one or more adjustable wire loops (rings) that protrude at the working
include a stationary loop and a sliding loop. A mechanism at the proximal end (handle) controls how m
of the channel and the movement of the sliding (cutting) loop. Some snares allow circulation of RF ele
the isolated metal loop (i.e., acting as an active electrode) and an external neutral electrode to heat th
cutting and coagulation. Snares are used mainly to remove polyps, tumors, and other abnormal tissue
snares are used in procedures such as gastrointestinal (upper and lower tract) and airway polyp resec

Snares designed to position and tighten fine-gauge, flexible, adjustable, wire loops around the tonsils
resection. These devices typically consist of a hollow tubular structure (e.g., a cannula), with one or m
loops (rings) that protrude at the working end; frequently they include a stationary loop and a sliding
the proximal end controls how much wire extends out of the channel and the movement of the sliding
handle is usually straight (e.g., Eves and Bruning types) or at a right angle to the cannula (e.g., Tyding
are usually reusable devices; they are used for partial or total removal of the tonsils (i.e., tonsillectom

Garments designed to be worn on the users' feet and legs to provide warmth, comfort, to wick moistu
and/or cushioning. Socks or stockings are typically knit as stretchy fabric tubes open at the leg end an
for ease in fit; they can be washed and reused. They are made from natural plant fibers such as cotton
animal fibers such as wool, silk, cashmere, or mohair; or synthetic fibers such as nylon, acrylic, polyes
spandex; or a combination of two or more of these fibers.

Socks or stockings designed to be worn next to the skin under splints, braces, or removable casts bein
during fracture healing. Fracture socks or stockings are usually made with a combination of a plant or
cotton or wool), a synthetic fiber (such as polypropylene), and an elastic fiber for ease of fit. They prov
patient and wick moisture away from the skin. They can be washed and reused. Lower limb fracture so
available in above- or below-the-knee length; each type may have open-toe or full-foot design. Upper
available for use under casts, braces, or splints for the upper arm, lower arm, hand, or wrist.
Socks or stockings designed to be worn by leg and arm amputees over the residual limb (i.e., stump)
protection, to add padding or cushioning, to reduce friction, to provide a more comfortable prosthetic
moisture away from the skin. Stump socks or stockings are made in various sizes to fit above-knee or
amputation stumps, or to fit arm stumps. They are typically knit as stretchy fabric tubes and in variou
They are washable and made from natural plant fibers, animal fibers, or synthetic fibers, or a combina
these fibers. Stump socks or stockings are made either with one closed end and one open end, or with
small hole in the other end intended for use with locking prosthetic liners.

Bowls used to store, mix, and/or collect solutions. These bowls may be reusable (e.g., made of metal t
cleaned/autoclaved) or disposable (e.g., made of plastic).
Exploratory probes designed for introduction into the urethra and that are intended mainly for explora
devices typically consist of a slender metallic or plastic cylinder that can be passed through the urethr
attached to a handle at the proximal end; they can be flexible or rigid. Urethral exploratory probes are
obstructions, measuring, and/or to provide better visualization of the urethral passage. Urethral probe
cryosurgical procedures are also available.

Exploratory probes designed for introduction through the vagina and into the uterus and that are inten
exploratory purposes. These devices typically consist of a slender metallic or plastic cylinder that may
cervix. They may be attached to a handle at the proximal end; they can be flexible or rigid. Uterine ex
intended mainly for examination of the cervix and uterus; they may be also used to determine uterine

Instruments designed to remove cells or tissues from a surface or cavity, spread materials on a surfac
Spatulas typically consist of a metallic (e.g., stainless steel) or plastic handheld instrument, with a stra
flat, blunt distal working tip. Some spatula handles have working tips on both ends. Dedicated spatula
dental and orthopedic cements and other compounds, for superficial removal of cells for cytology, and
dissect tissues during surgical procedures.

Spatulas designed to manipulate and/or dissect brain tissue during surgical procedures. These devices
metallic (e.g., stainless steel) handheld instrument with a straight or curved very thin, flat, blunt dista
spatulas are flexible and include a silicone coating to make their use less traumatic to the delicate bra
very small and delicate brain spatulas are also available for microsurgical procedures.

Spatulas designed to mix and spread bone cement. These instruments typically consist of a metallic (
handheld instrument with a straight or curved thin flat blunt distal tip. Most bone cement spatulas are
finishes so that the cement will not stick to them. Bone cement spatulas are used in the preparation o
also to spread the cement during orthopedic procedures.
Spatulas designed to manipulate and/or dissect lung tissue during pulmonary surgical procedures. The
consist of a metallic (e.g., stainless steel) handheld instrument with a straight or curved very thin, flat
Typically, lung surgical spatulas have wider, curved, flat working ends designed to more easily manipu
tissue. Lung surgical spatulas are used to manipulate and/or dissect lung tissue during pulmonary surg

Spatulas designed to manipulate and/or dissect middle ear tissue during surgical procedures. These d
of a metallic (e.g., stainless steel) handheld instrument with a straight or curved very thin, flat, blunt d
enough to enter the middle ear structures. Dedicated middle ear surgical spatulas are available for m
Surgical middle ear spatulas are used to manipulate and/or dissect middle ear tissue during otologic s
Containers designed for collection, short-term storage, and/or transportation of clinical samples (i.e., s
urine, feces, or sputum collected for diagnostic testing. These containers usually consist of glass or pl
bags, or tubes with appropriate caps to prevent leakage and to seal the specimen from the environme
available as sterile, single-use items.
Specula designed for expanding the ear canal. These instruments typically consist of a hollow, funnel-
specula may be used directly to perform examination and manual procedures in the ear canal and mid
an otoscope for examination or surgery. Both disposable (e.g., plastic) and reusable ear specula are av
sizes and shapes; some include a lighting system.
Specula designed to keep the eyelids apart. These specula typically consist of a mechanical device wi
introduced under the eyelids; some include a mechanism to control the degree to which its branches a
specula are used for examination and/or treatment of the outer surface of the eye (e.g., extraction of

Specula designed for expanding the nasal cavity. These instruments typically consist of a mechanical
includes two pivoted arms. The portions closer to the pivot point are usually the handle, while the dis
inserted in the nasal cavity. Nasal specula are used for examination and treatment of the inner surface
They are usually stainless steel instruments available in many different sizes and shapes (e.g., bi-valv
include a lighting system.

Specula designed to expand the anal canal, rectum, and/or sigmoid colon. These specula typically con
funnel-like device or a mechanical instrument that frequently includes two pivoted arms. The portions
point are usually the handle, while the distal portions are inserted through the anal canal into the rect
used directly to perform examinations and manual procedures or as part of an anoscope, proctoscope
examination or surgery (e.g., hemorrhoid treatment). Both disposable (e.g., plastic) and reusable recta
in different sizes and shapes; some include a lighting system.

Specula designed to expand the vagina. These specula typically consist of a mechanical instrument th
pivoted arms. The portions closer to the pivot point are usually the handle, while the distal portions ar
vagina. Vaginal specula permit direct performance of examination and manual procedures in the inte
and/or uterine cervix.
Graphical recorders designed to record the waveform, strength, and variations of the arterial pulse. Th
consist of a lever, the short end of which rests on a superficial artery, typically the radial artery at the
sensor; and a stylet, which makes a graphical record (usually on a moving paper) of the excursions of
Sphygmographs are used for noninvasive evaluation and recording of the pulse strength and its variat

Boards designed to ensure spinal immobilization during patient transportation. These boards consist o
wood, hard plastic, aluminum) that usually includes multiple strap and handhold openings. Typically fu
41 cm (72 x 16 inches) and small-size boards of 81 x 33 cm (32 x 13 inches) are available. Spine boar
or placed on stretchers (e.g., basket stretchers) when spinal injuries are suspected.
Instruments designed to measure the volume and flow rate of air inhaled and/or exhaled from the lun
variables needed for pulmonary function assessment. These instruments are typically a mechanical or
device with volume and/or flow sensors and a gauge or display; they may also include a computerized
data and a graphical recorder. Simple, usually handheld instruments that are capable only of measurin
volume of gas that can be expired from the lungs (i.e., expiratory vital capacity [EVC]) used for pulmo
screening and diagnostic spirometers (i.e., both tabletop and handheld instruments) that can perform
needed for a complete pulmonary function assessment are available. Spirometers are intended for the
pulmonary status and the diagnosis of patients with pulmonary diseases (e.g., emphysema, asthma).
intended to increase and measure the respiratory capacity of the lungs using spirometry techniques (a
spirometers) are also available.

Spirometers designed to perform all respiratory gas volume and flow measurements needed for diagn
pulmonary functions. These instruments measure quiet breathing, determining tidal volume, and trac
evaluating variables such as the maximum volume of gas that can be expired from the lungs (i.e., exp
[EVC]) and the maximum volume of gas that can be inspired into the lungs (i.e., inspiratory vital capa
may be performed under static conditions (e.g., to determine the vital capacity) or as a dynamic test u
against time (e.g., to determine forced expiratory volume [FEV]). Diagnostic spirometers consist of a m
electromechanical device with a computerized unit to process the data, volume and/or flow sensors, a
recorder. Some instruments can also determine other parameters, such as oxygen intake and carbon d
either for both lungs simultaneously or for each one independently. These spirometers are intended to
status, to monitor diseases, and/or to evaluate treatment effectiveness and/or disability; they cannot
volume, residual pulmonary, or total lung capacity. Instruments combining spirometry and pulse oxim
also available.

Rigid or flexible appliances of plastic, wood, metal, or plaster that are used to immobilize and protect
fractures, sprains, dislocated joints, and muscle strains. They are also used during x-ray and before ca
injured part stable. Generally, splints are placed on the posterior side of the body part and are kept o
or by wrapping a bandage around both the body part and splint.
Multipurpose pre-shaped splints that are designed for customization to the appropriate shape to fit the
point of care. These devices typically consist of a thin metallic (e.g., aluminum) and/or thermosetting
can be modified to a limited degree according to the body part and the needs of the patient. Pre-shap
intended mainly for emergency treatment of patients suffering fractures, sprains, dislocations, and/or
limbs, neck, and/or other body parts. Aluminum and plastic pre-shaped moldable splints are available
orthoses intended for a particular body part (e.g., arm, forearm, leg) are also available.

Splints made of aluminum that are pre-shaped.


Splints made of plastic that are pre-shaped.
Lower/upper-limb orthoses designed to provide support and some degree of movement control to inju
of a padded strip (i.e., a padded stay splint). These orthoses typically consist of a rigid or semi-rigid m
supporting stay that is appropriately padded and kept in place using straps or other elastic material. P
mainly used to support injured limbs or limb segments (e.g., legs, hands, arms, wrists) during rehabili
Lower/upper-limb immobilizer orthoses designed for maximum restriction of movements and/or total i
upper and/or lower limb using a pneumatic (i.e., inflated) splint that encircles the limb. These splints u
or more plastic chambers that can be inflated with air supplied by an air pump or using the mouth; the
a control valve. Pneumatic splint limb orthoses are used mainly in emergency situations to immobilize
limb; the orthoses may also help to control bleeding. Dedicated pneumatic splints intended only for th
are also available, both in adult and pediatric sizes.

Total lower-limb orthoses designed for maximum restriction of movements and/or total immobilization
orthoses may consist of a variety of devices using different techniques (e.g., direct mechanical forces,
apply traction while immobilizing the lower limb. Traction splint lower-limb orthoses are intended for a
traction has been used to properly align a limb. The orthoses are mainly used for immediate treatmen
fractures.

Lower/upper-limb immobilizer designed to provide maximum restriction of movements and/or total im


splint that is conformed to the appropriate shape (i.e., molded) by applying suction to remove the air
point of care site. Vacuum splints typically consist of a flexible plastic structure that can be molded aro
limb(s) becoming rigid to provide immobilization when air is removed by applying vacuum. The orthos
sealing valve to keep the vacuum inside the splint. Vacuum moldable splints are mainly used for emer
fractures (e.g., arms, legs), sprains, dislocations (e.g., shoulders), and other traumatic injuries.

Lower/upper-limb orthoses designed for maximum restriction of movements and/or total immobilizatio
lower limb using a pliable splint that resembles a ladder. These orthoses usually consist of moldable m
with plastic (e.g., vinyl) that can be bent in many different configurations that are appropriate to immo
lower limb. The orthoses may also include bandage and safety pins to secure the splint. Wire ladder o
mainly as a first aid to immobilize a limb after traumatic injuries.

Basins designed to store and/or collect sponges during surgical procedures. These basins typically con
stainless-steel metallic device of 15 to 25 cm (6 to 10 inches) diameter and 7 to 10 cm (3 to 4 inches)
attached to a mobile (caster) stand. Sponge basins are used to collect sponges during surgical proced
have a configuration that facilitates sponge count after the procedure is finished.

Bowls used to store and/or collect used sponges during surgical or other procedures. These bowls may
made of metal that can be cleaned/autoclaved) or disposable (e.g., made of plastic).
Counters designed to verify the quantity of sponges used during a surgical procedure to help prevent
sponges inside the patient before closure of the operative field. These counters may consist of a mech
to facilitate the manual count of the sponges or devices that can detect, identify, and count the quant
typically based either on the identification of radiofrequency (RF) labeled sponges or on the reading o
sponges. Bar-coded readers can also identify and count the sponges and related devices at the beginn
steps of a surgical procedure.
Single-use pieces of absorbent porous synthetic or semi-synthetic materials resembling natural spong
organisms with bodies full of pores and channels) designed for a variety of purposes, such as to prote
promote wound healing. Synthetic sponges are typically made of gauze, gauze and cotton, or polyure
non-sterile sponges are available. Sponges are used in healthcare for a variety of different non-clinica
surface and clinical laboratory countertop cleaning) and clinical (e.g., to keep a moist environment, ab
protect wounds from contact with bacteria) purposes. Dedicated sponges for contraception, scrubbing
dissection, laparotomy, neurosurgery, ophthalmology) are also available.

Sponges designed for use during surgical procedures where precise sponging/absorption is needed. Th
typically sterile single-use devices made of absorbent porous materials (e.g., cotton twill, gauze, rayo
include an x-ray radiopaque element. Dissecting sponges are typically small in size, and are available
(e.g., rosebud, peanut, cherry, round, Kittner); they are usually supplied as disposable sponges in pac
units to facilitate sponge count. Dissector sponges are intended for use during a variety of procedures
in general surgery to delicate neurosurgical procedures.

Multipurpose sponges designed with thin even films distributed over each layer creating a multi-layer
sponges are typically made of folded absorbent gauze with thin, even films of cotton or rayon distribu
they are very soft, provide ample dressing volume and increase its absorption power quickly with little
Multilayer sponges are intended for external or internal application to disperse exudates and to provid
capability; they are mainly used to treat wounds and during surgery.

Multipurpose sponges that are typically made of non-woven, open-mesh fabrics such as cotton or a sim
sponges may be sterile or non-sterile; they are available in multiple shapes and sizes. Gauze sponges
cleaning and applying medication to minor cuts, scrapes, and burns as well as to help in cleaning wou
irritation; they can also be used as absorbent dressings.
Multipurpose sponges designed and manufactured with an impregnated germicide. These devices are
sterile sponges made of cotton and/or other porous absorbent non-woven materials tightly impregnat
solutions; the sponges are available in a variety of sizes and shapes. Germicidal sponges are mainly in
wounds and tissues against contamination as well as to absorb fluids and control bleeding; they are u
emergency and operating rooms), other healthcare facilities, and at home.

Sponges designed for use during open surgical procedures inside the central nervous system; a neuro
conforms to the tissue contours on which it is placed. These devices are typically sterile and flexible s
made from a variety of materials including cotton, rayon, and polyester; the outer components of the
made of a porous plastic material which prevents the sponge from adhering to the tissue and avoids t
removed. Some neurosurgical sponges may include detectable (e.g., x-ray elements, radiofrequency l
and/or a string attached to it for easy identification.

Multipurpose sponges made of rayon (regenerated cellulose fiber, also known as viscose) designed wi
for a higher level of absorbency. These sponges are made with a soft outer facing; they are typically tr
solution to keep them pliable and to prevent bacteria from growing inside. Rayon sponges are mainly
cleaning purposes; single-use as well as reusable rayon cellulose sponges are available. Dedicated ray
intended for use in wound care and surgical procedures in addition to other clinical purposes such as c
equipment and counters, and for bathing patients.
Sponges designed for use during surgical procedures (e.g., vitrectomy, cataracts) on the eyes. These
non-adherent, soft and fast-wicking devices typically made of folded gauze, cotton, or rayon and have
spears, disks, shields) according to the procedure to be performed. Some ophthalmic sponges can be
cleaning of the microsurgical instruments used in the procedures. Ophthalmic surgery sponges are ma
absorb fluids from the operative field.

Thoracic wall surgical retractors designed to temporarily separate and hold back the edges of an incis
exposing and providing access to tissues, thoracic structures, and/or organs, with a mechanism that re
set (i.e., self-retained retractors). These retractors usually include a very sturdy mechanism with blunt
strong enough to hold back the ribs widely separated; the opening mechanism usually includes two bl
along a frame that ensures that the blades remain parallel to one another as they move apart. Self-re
retractors (also known as rib spreaders) are provided in a variety of blade shapes and configurations.

Baths designed to apply hot steam to a patient, the patient is typically enclosed to obtain the full effe
baths typically consist of a steam generator, a heat regulating mechanism that also provides safeguar
environment, and a cabinet or similar structure where the patient receives the treatment. Steam bath
therapy treatments.
Devices that are affixed to a patient's skull to allow precise localization of an area within the brain targ
neurosurgical or radiosurgical procedure. These units typically consist of a head ring assembly with fix
an arc system for setting target coordinates and localizer frames and adapters for CT, MRI and other i

Containers designed to provide an enclosure during the various steps of the sterilization cycle and sub
transport of sterilized devices. Most of these containers consist of a box with silicone rubber gaskets t
lid and base are held together by latches (some include locks with keys) and are perforated to permit
bacterial filters cover the perforations to maintain the sterility of the contents during storage. Surgica
secured in an instrument tray with pegs or dividers and placed, unwrapped, into the sterilization conta
containers may be also used to return soiled instruments and supplies to the central sterilization servi

Sterilization process indicators consisting of a standardized viable population of microorganisms (usua


bacteria or bacterial spores) with known resistance to the mode of sterilization being monitored. Biolo
procedure indicators are usually sent to specialized laboratories for further testing of the effectiveness
procedure (e.g., steam sterilization).
Equipment designed for total inactivation of microorganisms that are or may be present on medical de
products. These units usually consist of a treatment chamber that may include appropriate shelves on
be sterilized are placed, means to introduce the sterilizing agent in the chamber, and controls to regu
(e.g., time, temperature) of the procedure. Sterilizing units are available in a several shapes and sizes
a variety of technologies (e.g., liquid immersion, electrolysis, filter, heat) and/or particular agents (e.g
liquids and/or gas sterilants) are also available; some dedicated units are intended for sterilization of a
devices (e.g., inoculating loops) or substance (e.g., agar).
Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
sensitive to high temperature using dry heat. These units usually include a treatment chamber with sh
devices to be sterilized are placed, usually after being cleaned of gross debris; a heat source (e.g., ele
heat to the chamber; and controls to regulate the time and/or temperature of the procedure. The heat
chamber either by natural convection or the use of forced air (e.g., fans, high-speed hot air jets) to ac
more uniform the process. Units that transfer heat to the devices under sterilization (e.g., dental instr
available. Frequently the time and temperature of the sterilizing cycles are pre-established according
be sterilized and/or the type of microorganism that may be present; typical sterilization temperature r
300 degrees Celsius (320 to 572 degrees Fahrenheit), usually the time needed for sterilization is short
temperatures. Sterilizing units are available in a variety of shapes and sizes; dedicated large stand-alo
bulk sterilization and smaller tabletop models are available.

Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
ethylene oxide gas with low humidity content. These units usually include a treatment chamber with s
devices to be sterilized are placed, usually after being cleaned of gross debris and packed in gas-perm
introduce the gas into the chamber; and controls to choose one of the sterilization cycles. Some units
integral purging system to eliminate the vapor residues, which is activated after the sterilization cycle
oxide gas sterilizing units are available in a variety of shapes and sizes including both stand-alone and
units are used to sterilize devices and supplies that are sensitive to high temperature and humidity, su
plastic and rubber components.

Liquid agents in which formaldehyde is the active ingredient that is used to achieve sterilization or dis
germicides also include those that are a mixture of formaldehyde and other compounds.
Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
ionizing radiation (typically gamma, but x-ray and electron beams are also used) sources. These units
treatment chamber with shelves on which packed devices to be sterilized are placed; a source of ioniz
gamma radiation, typically obtained from a cobalt 60 source); and controls to regulate the time of the
radiation sterilizing units are available in a variety of shapes and sizes; these units are frequently supp
installations and their use requires special safety protection for the operators. Radiation sterilizing uni
manufacturers to irradiate single-use medical devices (e.g., syringes, needles) and supplies, even afte
packed and ready to deliver; they may be used also in large healthcare facilities that sterilize a great

Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
sensitive to high temperature, water, or steam using pressurized steam (i.e., to provide moist heat). T
include a treatment chamber with shelves on which the devices to be sterilized are placed, usually aft
gross debris and then packed; means to introduce the steam into the chamber; and controls to regula
temperature of the procedure. Frequently the time and temperature of the sterilizing cycles are pre-es
the type of device to be sterilized; typical sterilization temperature range is 121 to 135 degrees Celsiu
Fahrenheit). After the sterilization cycle is complete, the steam is exhausted. Sterilizing units are avail
shapes and sizes; dedicated large stand-alone units intended for bulk sterilization and smaller tableto
Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
vapors from appropriate germicidal solutions (e.g., solutions having a low content of formaldehyde) w
content. These units usually include a treatment chamber with shelves on which the devices to be ste
usually after being cleaned of gross debris; means to introduce the vapor into the chamber; and contr
of the procedure. After the sterilization cycle is complete an integral purging system to eliminate the v
usually activated. Vapor sterilizing units are available in a variety of shapes and sizes; usually as table
sterilizing units are used for devices and supplies that are sensitive to high temperature and humidity
rubber devices.

Instruments used to excite (stimulate) functional activities by generating and applying an external ag
ultrasonic stimulus). Most stimulators allow for control of the specific duration, intensity, and frequen
stimulus. Stimulators are used for diagnostic, monitoring, functional, therapeutic, experimental, or oth
tissue ablation.
Electrical stimulators that apply the stimuli to acupuncture sites. These stimulators typically consist of
intensity, low-frequency (usually 1 to 100 pulse/sec) pulse multimode generator and electrodes. The
placed either on the skin or through acupuncture needles that penetrate the skin at acupuncture poin
stimulators include probes to detect the acupuncture sites using visual or audio signals.

Devices that apply stimuli (e.g., pure tones, speech) to a patient's acoustic system. Most sound stimu
components in devices such as audiometers, auditory evoked-potential recorders, and auditory functio

Peripheral-nerve electrical stimulators that apply stimuli to the carotid sinus nerve (Hering's nerve) to
pressure. These stimulators are usually completely implantable. They are used in the control of high b

Mechanical stimulators used in dentistry for gingivae and gingival papillae massage and cleansing. So
stimulators include a sharp rubber tip for massaging the interproximal gingival papillae (interdental pa

Electrical stimulators designed to cause controlled muscular contractions. Neuromuscular stimulators


near or directly to the nerves that control muscle activity.
Mechanical stimulators that apply mechanical stimuli (e.g., pressure, vibration), usually to some area
(typically to the great toe) to determine the status of the touch (tactile) sense. Most of these stimulat
detecting peripheral neuropathy.
Analgesic peripheral-nerve electrical stimulators that consist of external stimulators and electrodes th
skin in such a way that the body is not penetrated at any time, so the electrical stimulus is applied thr
(transcutaneously) to the painful area. These stimulators typically include several predetermined stim
options (e.g., pulse frequency, pulse duration). Most of these stimulators are portable, battery-powere
worn on a belt or carried in a pocket. These analgesic stimulators (also known as transcutaneous elect
[TENS]) are used to treat pain associated with surgery, trauma, musculoskeletal problems, bursitis, an
procedures; they are also used in physical therapy and during labor and delivery.
Photic stimulators designed to apply light (i.e., photo) stimuli to the patient's eyes. These stimulators
light source that delivers the stimuli (e.g., shifting patterns); the stimuli may be transmitted through a
(optical stimulators) or viewed directly from an illuminated screen (direct-view stimulators). Visual pho
available as independent units or as components of several types of devices, such as refractors, scann
visual-evoked potential recorders, and electroretinographs.

Seamless tubing bandage typically open at both ends that are designed to be used around the extrem
usually made of stretch cotton and supplied in long rolls that are typically cut in situ in segments of ap
the intended use. Stockinettes are mainly used to hold bandages in place or to place uniform pressure
extremity, such as a leg, finger, or arm; they are also used as a covering for an amputation stump (e.g
worn on the stump). Dedicated stockinettes intended for use as padding under a cast or splints are als

Elastic socks or stockings designed to provide continual pressure or compression to help stimulate circ
legs or feet. Compression is graduated from greatest pressure around the ankles to lesser pressure ar
thighs. Different styles of compression socks or stockings offer various compression supports, ranging
hg), medium (15-20 mm hg), moderate (20-30 mm hg), firm (30-40 mm hg), extra firm (40-50 mm hg
Hg). The heights of compression socks or stockings can vary from ankle-high, mid-calf, to the knee, or
thigh; they can be fashioned as pantyhose, leggings, sport socks, or calf sleeves. They are usually ma
nylon, spandex, Lycra, or rubber, or combinations of these fibers, with open toe or closed toe, and the
reinforced toes and heels, extra cushioning, and large toe boxes. Compression socks or stockings are
for circulation irregularities or vascular conditions, such as varicose veins, edema, lymphedema, or po
syndrome. They are also worn by people who have mild leg swelling or who have to stand all day; dur
surgery; or after a vein treatment. Sizes are based on shoe size.

Pneumatic cuffs that are double-walled pressure garments usually made of polyurethane-coated nylon
the patient's legs or arms and are connected to intermittent peripheral compression circulatory assist
compression pneumatic cuffs are used for prophylaxis against deep vein thrombosis and to reduce ed
The pneumatic compression cuff air chambers are inflated and deflated by the circulatory assist unit p
predetermined waveform and operating pressure parameters. When inflated, the pneumatic compress
and lymph out of the pressurized area; when deflated, blood flow to the leg or arm is increased. Pneum
can be made in ankle-high, full-leg or half-leg length or arm length; they can be sized for adult or ped

Devices designed to regulate and/or stop the flow of fluid through a conduit (e.g., a pipe, tubing) or at
are frequently used in healthcare facilities as integrated components of medical devices and laborator
burettes) and in central gas or liquid supply lines; they are also available as separate components to r
devices and/or as general supplies (e.g., for use in intravenous therapy).

Detectors designed to sense the deformation produced in an object by an applied force (i.e., strain). T
determine the presence of strain and also if it is beyond some pre-established limit, but usually do not
the intensity of the strain. Strain detectors are based in the change of some characteristic of a physica
due to the strain, such as variations in electric resistivity, conduction of ultrasonic waves, or polarizati
translucent objects.
Straps designed to support the shoulders in an appropriate position for a patient with a clavicle fractu
shaped straps are typically made of mesh fabric and padded with polyurethane foam; they usually ha
closures (e.g., Velcro) used to adjust the size of the straps.
A patient conveyance device consisting of a platform (e.g., a sheet of canvas, a coach) supported by a
an individual can be carried, usually in a supine or prone position. Stretchers are mostly used for trans
persons. Mobile stretchers intended for use in health care facilities and ambulances as well as portabl
available; stretchers designed to carry laboratory research animals are also available. Some stretchers
specifically for use in magnetic resonance imaging (MRI) environments (i.e., MRI-compatible stretcher
nonmagnetic materials so that they can be safely used in an MRI suite.

Stretchers that include a wheeled frame to facilitate the transportation of recumbent patients expedie
flat surface.
Stretchers that typically include a light framework (e.g., folding U-frames, plastic frames) and a canva
(e.g., vinyl, nylon) fabric body. Some stretchers can be folded or hinged for compact storage; they ma
wheels to facilitate patient transport. Portable stretchers make it possible for two people to lift and car
lying down; they are used mainly to transport patients at first-aid sites and are sometimes used in em

Mobile hospital stretchers designed for atraumatic movement of patients by hospital personnel withou
patients body position or lifting, rolling, or dragging them. These stretchers include a patient-transfer
mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. Patient-transfer h
used to reduce injuries to both patients and staff while transferring nonambulatory, comatose, or neur
patients between beds, tables, stretchers, or during other intrahospital patient transportation.

Very thin metallic wires or flexible rods which are inserted into the cavity of a hollow cylindrical device
needle, catheter, cannula, or a tube, usually to ease introduction into the body by providing rigidity an
cylinder patent. The stiffness provided by the stylet makes the device easier to insert, advance, and/o
otherwise soft hollow devices into the body (e.g., intubation, peritoneum access) or through a natural
artery). Stylets may be extracted after the hollow device is placed or kept in the lumen to stiffen and/
of the structure; some stylets are used to clear (i.e., keep the patency of) a tube. Dedicated stylets are
a variety of catheters, tubes, cannulae, and/or needles.

Stylets designed for use in the lumen of bronchial tubes and/or catheters. These stylets typically are v
or flexible rods; they may be used during the complete procedure of bronchial intubation or only durin
introduction of the bronchial tube. Bronchial stylets, when used after the placement of a bronchial tub
stiffen the tubes and/or help in maintaining the shape of the structure. Dedicated bronchial stylets ma
supplied as a component of bronchial tubes and catheters.

Stylets designed for use in the lumen of intravenous catheters. These stylets typically are very thin m
rods with a beveled sharp distal end to pierce the skin and vein; then the catheter is threaded into the
removed so only the hollow catheter remains in the vein. Dedicated intravenous stylets are available
be punctured and/or the catheter used.
Stylets designed for use in the lumen of a hollow needle. These stylets typically are very thin metallic
needle pierces the skin into a body cavity the metal stylet is removed leaving only the hollow needle i
aspiration of fluids. Dedicated needle stylets are used mainly for aspiration of small amounts of fluids
laboratory (e.g., fine core biopsy) procedures.
Stylets designed for use in the lumen of catheters intended for transcutaneous insertion in the periton
catheters). These devices typically are very thin metallic (e.g., stainless steel) wires or flexible rods; th
in the lumen of the tube after placement to stiffen and/or maintain the shape of the structure. Dedica
are available for temporary use during the introduction of peritoneal (e.g., dialysis) catheters (e.g., str
other dedicated stylets (both single-use and reusable) are also available for peritoneal tunneled cathe

Stylets designed for use in the lumen of catheters intended to pass through the urethra and into the u
urethral catheters). These stylets typically are very thin metallic wires or flexible rods that make the c
move along the urethra; usually once the catheter is introduced into the bladder the metal stylet is re
hollow catheter remains. Urethral stylets are only used in male urethras. A dilator or stent may be pla
treat urethral strictures.

Equipment designed for automated or semiautomated aspiration (i.e., suction) and irrigation of body c
body areas. These devices typically include pumps that deliver the liquid and/or suction the debris, an
pistol-like) handpiece that usually has a clamp to control the power of the irrigation/suctioning flush, a
to connect the handpiece to the main suction and irrigation unit. The equipment is frequently supplied
auxiliary irrigation kits that may include connectors, splash shields, and adapters; some devices use t
system. Aspirator/irrigators are intended to clean and improve visualization of clinical or surgical proce
cavities) by irrigating and removing fluids, necrotic tissues, and debris. Dedicated aspirator/irrigators a
surgical, ophthalmic, dental, wound care, and uterine procedures; devices intended for endoscopic an
procedures are also available.

Prepackaged collections of the devices and supplies (either custom or standard) needed for suctioning
airways. Items in these kits usually include sterile gloves, a suction catheter, and a container for steril
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Airway suction procedure kits and trays are intended to remove airway secretions by inserti
into the upper airways.

Devices designed for the rapid removal of bulk matter (e.g., vomitus, mucus, debris) from natural or s
tips are usually transparent, short, wide, rigid tubes (either straight or bent) with an integral handle fo
the tip is attached to the distal end of suction hoses or tubes that are in turn connected to high-level s
Suction tips are used mainly in the upper respiratory tract (nasal cavity and pharynx) and during surg
suctioning speed rather than control is needed; both reusable and plastic tips are available. Dedicated
available for particular procedures performed in the ear, nose, pharynx, and other natural or surgically
Other hollow-shaft devices such as suction tubes with integral tips, cannulae, curettes, and catheters
suctioning when attached to appropriate aspirators.

Foot orthoses designed to support the foot arch by providing some degree of movement control and p
These orthoses typically consist of a semi-rigid prefabricated device that is inserted inside the shoe. T
of several layers of different materials (e.g., fabrics, hard plastics) with a shape and size appropriate f
Prefabricated foot arch flexible or semi-rigid supports intended for a rigid flatfoot are used for cushion
More rigid orthoses intended for flexible flat foot (i.e., a foot that becomes flat only when standing) an
therapy to correct the deformity in children are also available.
Upper-limb arm orthoses designed to support the arm by providing soft-tissue compression to maintai
stabilization of the arm bone (i.e., humerus). The orthoses permit movement of the adjacent joints (i.e
These orthoses typically consist of loops and/or straps of fabric or other soft material that are tightene
stockinette previously placed on the arm; some include bi-valved devices that allow an easier adjustm
of use. Upper-limb arm orthotic braces (also known as functional braces) are used instead of rigid cast
types of closed fractures of the humerus during rehabilitation.

Abdominal supports designed to provide support, protection, and some degree of movement restrictio
These supports usually consist of soft or semi-rigid structures (e.g., dedicated briefs) supporting the s
frequently made of fabrics combined with light metal or plastic components. Scrotum supports provid
support to the testes during working activities that involve heavy weight lifting and/or the practice of
prevent formation and/or displacement of hernias into the scrotum. Dedicated scrotum supports (know
for the reduction of hernias are also available.

Garments designed to be worn on the heads of personnel or patients while they are inside the restrict
areas of the healthcare facility (e.g., operating room, cardiac catheterization suite, sterile processing d
are intended to be used to protect the sterility within these areas by preventing contamination with co
hair, squamous skin cells, etc.
Devices designed for the temporary support and/or cushioning of a suture in an appropriate position.
consist of a small, pillow-like piece of gauze, plastic, or other rolled or tubular soft material. Suture bo
suturing procedure and prevent excessive suture tension and laceration of tissues by distributing the
anatomic area (usually the surrounding tissue). They are typically fixed to the skin in the postoperativ
procedures (e.g., eyelid and ear surgery, skin grafting, vesicourethral reconstruction and other perinea

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for c
wound (i.e., suturing/stitching) on the skin. Items in these kits usually include an anesthetic (e.g., lido
syringes, probes, sutures, suture needles, scalpels, scissors, disinfectant swabs, and dressings. The ki
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Suture procedure kits and trays are intended for suturing lacerations, minor cuts, and superficial woun
pain and help heal faster. They are mainly used in the field and in hospitals' emergency rooms.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for s
these kits usually include gauze sponges, forceps, suture cutters, suture removers, and/or suture sciss
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Suture removal procedure kits and trays are intended for use at home and also in hospitals
facilities.
Threads of natural, synthetic, or metallic material intended to sew a wound or incision together (i.e., a
and provide a method for wound closure). Sutures are either absorbable (e.g., surgical gut, polyglicolic
nonabsorbable (e.g., silk, nylon, polypropylene, stainless steel). A suture may consist of only one threa
or several threads (i.e., multifilament) that are frequently twisted or braided. The type of suture used
and location of the wound, the strength and period of use required, cosmetic effect desired, and/or oth
needs. Sutures are typically available in sterile sections (e.g., 18, 30 inches/45, 76 cm long) attached
as an integral device; they are frequently colored for easy identification during surgery.

Natural sutures made of surgical gut, a biodegradable (absorbable) material consisting of collagen de
beef intestinal mucosa. These sutures are typically available in sterile thread sections (e.g., 18, 30 in [
attached to a single-use needle as an integral device; they are frequently colored for easy identificatio
Surgical gut sutures keep their tensile strength for 7 to 10 days, and complete absorption occurs in les
intended use includes repair of rapidly healing tissues, ligating superficial blood vessels, and suturing
Natural surgical gut sutures are usually packed in a solution to prevent drying and to preserve their ph
absorbing (five to seven days) surgical gut sutures for epidermal use and surgical gut sutures impregn
salts to prolong tensile strength and retard absorption are also available.

Nonabsorbable natural sutures made of twisted long cotton fibers. Cotton sutures lose about 50% of t
a six-month period and become encapsulated within body tissues. These sutures are typically availabl
multifilament braided thread sections (e.g., 18, 30 in [45, 76 cm] long) attached to a single-use needl
they are frequently colored for easy identification during surgery. Their intended use includes suturing
tissues, and vessels (e.g., in nephrostomy procedures); their current use is limited due to their low str
adverse reactions within tissues.

Nonabsorbable natural sutures made of long, textile (usually flax) fibers. These sutures are typically a
twisted multifilament thread lengths (e.g., 18 inches, 30 inches [45 cm, 76 cm] long) attached to a sin
integral device; they are frequently colored for easy identification during surgery. Linen sutures becom
the body tissues; they are intended for use during gastrointestinal surgery and as ligatures. Use of line
current surgical practice.

Stainless steel sutures made of several filaments (i.e., multifilament) medical-grade stainless steel all
typically available in sterile, uncoated twisted thread sections (e.g., 18, 30 in [45, 76 cm] long) that m
single-use needle as an integral device. Multifilament stainless steel sutures keep their tensile strengt
of time and are not absorbed by tissues; their intended use includes orthopedic procedures including
hernia repair, sternum closure (after sternotomy), and abdominal wound closure.

Synthetic sutures consisting of nylon fibers made from nonabsorbable (i.e., nonbiodegradable) aliphat
polymers. These sutures are typically available in sterile coated thread sections (e.g., 18, 30 in [45, 76
a single-use needle as an integral device; they are frequently colored for easy identification during su
keep their tensile strength for very long periods of time; nylon is not absorbed, but hydrolysis may res
tensile strength over time. Nylon nonabsorbable synthetic sutures' intended use includes general soft
and suturing of internal organs and tissues.
Synthetic sutures made of polyester fibers, a nonabsorbable (i.e., nonbiodegradable) polymer. These s
available in sterile monofilament or multifilament thread sections (e.g., 18, 30 inches/45, 76 cm long)
use needle as an integral device; they are frequently colored for easy identification during surgery. Po
their tensile strength for very long periods of time and are not absorbed by tissues; their intended use
tissue approximation and placement of prosthetic devices.

Synthetic sutures made of ultrahigh-molecular-weight polyethylene, a nonabsorbable (i.e., nonbiodegr


These sutures are typically available in sterile multifilament noncoated thread sections (e.g., 18, 30 in
attached to a single-use needle as an integral device; they are frequently colored for easy identificatio
Polyethylene sutures keep their tensile strength for very long periods of time and are not absorbed by
use includes attachment of soft tissue to bone (e.g., the rotator cuff) and/or bone anchors.

Synthetic sutures made of polyglycolic acid, an absorbable (i.e., biodegradable) polymer. These suture
available in sterile braided multifilament coated (e.g., magnesium stearate) thread sections (e.g., 18,
long) attached to a single-use needle as an integral device; they are frequently colored for easy identi
Polydioxanone absorbable synthetic sutures keep their tensile strength for several days to a few week
absorption occurs in 60 to 90 days; their intended use includes suturing of subcutaneous, abdominal,
tissues during surgical procedures.

Synthetic sutures typically made of an isomer of linear propylene, a nonabsorbable (i.e., nonbiodegrad
sutures are typically available in sterile monofilament uncoated-thread sections (e.g., 18 and 30 in [45
attached to a single-use needle as an integral device; they are frequently colored for easy identificatio
Polypropylene nonabsorbable synthetic sutures keep their tensile strength for up to two years and are
tissues; their intended use includes subcuticular closure, pull-out sutures, and suture of contaminated
wounds. The sutures usually have a smooth surface but some sutures are made of barbed threads. No
polypropylene barbed thread sutures are mainly used to suture without using knots (also known as kn
can also be used for cosmetic procedures (e.g., face-lifting, cosmetic breast lifting).

Nonabsorbable natural sutures made of raw silk spun by silkworms (an animal protein). Silk sutures ar
nonabsorbable, but they are subject to a slow (e.g., two year) process of proteolysis absorption. These
available in sterile multifilament twisted or braided thread sections (e.g., 18, 30 inches/45, 76 cm long
use needle as an integral device; they are usually characterized by their excellent handling properties
frequently available with beeswax or silicone coating; they are frequently colored for easy identificatio
intended use includes suturing of internal organs and tissues; noncoated silk sutures are usually inten
surgery.

Metallic sutures made of nonabsorbable (i.e., nonbiodegradable) medical-grade stainless steel alloys.
of single (i.e., monofilament) or multifilament sterile threads; their use depends on the size and locati
strength and period of use required, cosmetic effect desired, and/or other clinical or physical needs. S
keep their tensile strength for very long periods of time and are not absorbed by tissues; their intende
orthopedic procedures such as cerclage, tendon and hernia repair, sternum closure (after sternotomy)
wound closure.

A small amount of material such as cotton, polyester, or calcium alginate firmly attached to one or bo
plastic, or wooden stick; swabs may be either sterile or not. Most swabs are disposable.
Swabs including tips (e.g., cotton, polyurethane foam) presoaked with an antiseptic (e.g., isopropyl alc
chloride); some include agents that effectively kill pathogenic microorganisms (germicides), such as io
iodine (Betadine). Most antiseptic swabs inhibit the growth and development of microorganisms witho
them; they are used to clean wounds, cuts, and abrasions.
Swabs that include a sterile wad suited for good specimen recovery (e.g., rayon, calcium alginate) firm
of a plastic or wooden stick. Specimen-collection swabs are used to collect samples (e.g., nose, throat
specimens) for microbiological examination and/or culture.
Instruments designed to inject, infuse, or withdraw fluids, usually through a fixed or attached needle.
of a hollow, transparent cylinder (barrel) ended in a tip and a plunger (i.e., plunger syringes); other sy
fluids from a prefilled, changeable cartridge that is inserted into the barrel (i.e., cartridge syringes). Sy
either a barrel and a plastic or rubber bulb attached to one end (bulb/barrel syringes) or a rubber or p
tapped prolongation (bulb syringes) are also used for some applications. Syringes are usually manufa
transparent plastic materials (e.g., polyethylene, polypropylene) or glass, but some are metallic or inc
Syringes are frequently used for subcutaneous (i.e., hypodermic), intramuscular, or intravenous (eithe
catheters) injection; irrigation of cavities or wounds; and aspiration/withdrawal of blood or other body
are specially designed for clinical laboratory applications, including general laboratory use and chrom

Plunger syringes with a long male tapering fitting (tip) designed to inject and/or withdraw fluids from t
introduction of the syringe tip into the catheters proximal end. Catheter-tip syringes are available for s
intravenous infusion, irrigation of the lower urinary tract (e.g., bladder), and/or irrigation of the gastro
colon).
Small-caliber plunger syringes used to administer liquids (e.g., drug solutions) through a hollow needl
(i.e., hypodermic needle). These syringes typically include a small-diameter, low-volume cylinder, cali
centimeters (cc) or milliliters (mL); some are specially designed to inject specific drugs (e.g., insulin, t
hypodermic syringes attached to appropriate needles may also be used for intramuscular and/or intra

Plunger syringes designed for subcutaneous injection of precise low-volume doses of insulin. These sy
a small-diameter, low-volume cylinder, usually of 1/3, 1/2, or l mL size, accurately calibrated in insulin
units of insulin per mL) using permanent lines on their barrels. Insulin syringes are available with shor
gauge needles (26 to 31 gauge is typical) attached or fixed to them.

Binders designed in the shape of the letter "T."


Furniture used within the field of medicine that consists of a smooth, flat slab fixed on legs.
Instrument tables including an appropriate (e.g., metal, plastic) top surface usually supported by a mo
base. Most tables include shelves, drawers, and instrument trays. These tables are designed for the
general anesthetist surgical procedures.
Tables with an appropriate (e.g., stainless steel) top surface that is smooth and polished, with no crevi
and that has raised rims, rounded corners, and a flat surface that slopes toward a table or sink drain.
designed to provide a working surface for postmortem examination/autopsy procedures, to collect and
discharged from the cadaver, to facilitate table cleaning and decontamination, and to prevent the acc
microorganisms.
Tables designed to facilitate patient examination and/or treatment while the patient is lying on the tab
usually have a padded top surface covered with dirt- and stain-resistant material (e.g., vinyl) to facilita
decontamination and to increase the useful life of the table. Examination/treatment tables may allow
(e.g., tilt) adjustments; they may also include leg extensions, casters, and other accessories (e.g., stir
storage drawers). Dedicated tables intended for specific examinations and/or treatments (e.g., gyneco
urological, orthopedic) are available.

Tables including an appropriate (e.g., stainless steel) top surface with no crevices, screws, or rivets. M
telescoping pedestals for height adjustment and swivel caster bases. These tables are designed for k
sterile instruments and to facilitate their cleaning and decontamination. Some instrument tables are d
use in magnetic resonance imaging [MRI] environments, i.e., MRI-compatible Mayo stands, and are ma
materials so that they can be safely used in an MRI suite.

Adjustable examination/treatment tables that include knee crutches, traction handles, and heel stirrup
designed to support the woman's body in appropriate positions during labor and delivery and in other
pregnancy.They may also be able to accommodate C-arm radiographic/fluoroscopic studies.

Tables that include an appropriate (e.g., metal, plastic) top surface supported by a fixed pedestal or a
base. Most tables are divided into three or more hinged sections (e.g., head, body, legs) and are raise
mechanical or hydraulic systems using manual or electric controls. These tables support the patient's
procedures, stabilizing the patient's position and providing for optimal exposure of the surgical field. O
also designed to protect the patient from excessive manipulation, trauma, and abrasion.

Adjustable examination/treatment tables that include a base, pedestal, and upper-body support (e.g.,
padding), a perineal post, an apparatus for lower-body support (e.g., abductor bars), and any number
accessories. These tables and their individual segments are raised and lowered by mechanical or hyd
manual or electric controls. Orthopedic tables provide an elevated surface for supporting the patient'
apparatus for supporting and/or providing traction for the patient's limbs during upper- and lower-extr
procedures. Orthopedic tables may include traction devices and accommodate C-arm radiographic/flu

Tables designed to be moved directly over the bed to provide the capability for patients to eat, read, o
located in a hospital bed.
Adjustable examination/treatment tables that are height and position adjustable, including vertical tilt
upright. These tables may also incorporate foot supports and may have exercisers (e.g., pulleys, rotat
accessories (e.g., cervical bars, arm slings) attached. These tables are designed for treatment of disea
exercises and massage, to enhance blood circulation to the lower limbs in patients with neurological d
cord injury), and to aid in muscle training and sense of balance.

Orthopedic tables designed to perform traction procedures (e.g., lumbar, cervical). These tables usua
interchangeable accessories, typically head halters, pelvis belts, and traction boots.
Adjustable examination/treatment tables including an appropriate (e.g., metal, plastic) top surface sup
pedestal. Most tables include knee crutches and traction handles and may be raised, lowered, and til
hydraulic systems using manual or electric controls; also, they may incorporate supports for irrigation
instrument trays. These tables support the patient's body in adequate position during urological exam
procedures, and both transurethral and open surgery of the urinary tract.

Devices designed to flash words or images at different speeds.


Very long (e.g., several yards/meters) and narrow (typically 0.5 to 3 inches/12 to 76 mm) strips or ban
to attach objects or devices to the body. These tapes can be made of natural fibers, plastics, paper, or
materials. Most tapes are coated on one or both sides with an adhesive; nonadhesive tapes (such as u
available. Adhesive tape is typically packaged in multiuse rolls intended for dispensing different length
range of general patient care applications, such as attaching various devices (e.g., bandages, periphe
catheters, nasogastric tubes) to a patient's skin or other surfaces, or labeling various items (e.g., IV lin
that have particular characteristics (e.g., hypoallergenic, waterproof, medicated) are also available.

Nonadhesive tapes designed for application to the remnant of the umbilical cord of a newborn to stop
umbilical cord is cut or for use in a variety of surgical procedures (e.g., retraction). These tapes are us
strips supplied in rolls. These tapes are usually made of braids of strips made of material such as cotto
ends are attached each other using a fastener (e.g., a safety pin). Umbilical tapes are also used in oth
such as to tie off the umbilical stump during a catheterization procedure. Umbilical cord tapes are freq
sterile containers.

Telemetric monitors designed for continuous measurement and transmission of several vital physiolog
central station or a bedside monitor. These monitors typically consist of a portable transmitter with an
sensors (e.g., leads and electrodes) that are connected to the patient, as well as a transceiver incorpo
station or bedside monitor that receives, consolidates, and displays the information collected from one
Telemetric monitors are typically used to monitor electrocardiographic and electroencephalographic si
and other physiologic signals in ambulatory patients who require continuous monitoring (e.g., patients
areas).

Physiologic monitors designed for continuous measurement and display in a central station of informa
activity of the heart and its associated electrocardiogram (ECG) taken from a distant location through
or other appropriate communication link (i.e., telemetric). Telemetric electrocardiography (ECG) monit
a small electronic unit connected by several lead wires attached to cardiac electrodes that are usually
patient's chest and include a pocket-sized, battery-powered transmitter that is clipped to the patient's
pouch at the remote place, They also consist of a receiver that is integral or associated to the central
information is displayed. Most of these monitors can also detect deviation from the normal rhythm of
(arrhythmia) by processing the received signal from the patient's transmitter, detect ventricular fibrilla
rhythm analysis (e.g., detect ventricular tachycardia). Some monitors can also process and display inf
physiologic parameters such as pulse oximetry and blood pressure. ECG telemetric monitors are used
areas, intermediate care and stress exercise units, and in cardiac rehabilitation exercise rooms.
Monitors designed for continuous measurement and display at a central station of the temperature of
the body (core temperature) and/or the skin and subcutaneous (shell) temperature. This information i
location through a point-to-point radio or other appropriate communication link (i.e., telemetric). Thes
consist of a main unit clipped to the patient's gown (or carried in a pouch) which includes electronic ci
signals from temperature-sensing probes; a transducer; a display; and audible and/or visual alarms th
the patient's temperature drops below or exceeds preset limits; the monitor also includes a receiver th
associated to the central station where the information is displayed. Most multipurpose and electrocar
monitors are capable of temperature monitoring.

Nonrigid enclosures designed to keep a controlled atmosphere for patient breathing; they may include
delivering gases and/or suspensions of liquid and particulates (i.e., aerosols) to the airways. These ten
pliable, transparent plastic sheet held by a plastic or metallic frame that is suspended as a canopy ab
either the whole bed or only the patient's head and upper torso. These enclosures are usually connect
or other gas sources through wide-bore tubing. The use of tents avoids the need to directly attach a n
mask, hood, or endotracheal tube to the patient. These tents are especially useful for treatment of bre
infant and pediatric patients or for adult patients who cannot tolerate such attachments.

Holders designed to hold long glass thermometers in a certain position (e.g., upright in a beaker) whil
laboratory or other setting to do temperature readings, usually of liquids. These holders can be variou
are usually made of metal or plastic or a combination of these materials. Thermometer holders usually
clamp on one end to attach to a surface (e.g., a beaker, glassware, or a lab stand) and an apparatus t
clamp and holds the thermometer on the other end; the thermometer-holding end may consist of ano
with holes into which the thermometer is inserted. Thermometer holders typically have some type of
padding to keep the thermometer from breaking while it is being held in a certain position.

Prepackaged collections of the devices and supplies (either custom or standard) needed for taking car
storing, using) thermometers intended for measuring body temperature. Items in these kits usually in
thermometer holders, cases, vials, and sheaths. These kits may be supplied in supporting trays (i.e., p
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Thermometer care procedure kits
intended for individual use to eliminate reprocessing, to reduce the risk of breakage and cross-contam
variance caused by the use of more than one thermometer in a given patient.

Measuring instruments for determining the temperature of matter. Most thermometers used in the fie
designed for measuring human body temperature or for use in the clinical laboratory. Thermometers u
temperature in degrees Celsius and/or Fahrenheit.
Thermometers that include an electronic device and attached sensors that detect and transduce chan
into variations of some electric characteristic (e.g., resistance, voltage). These variations of the electr
processed in electronic circuits and, in turn, displayed as temperature readings.
Monitors designed for continuous measurement and display of the temperature of the internal regions
temperature) and/or the skin and subcutaneous (shell) temperature and are hard-wired to the patient
monitors consist of a main electronic unit that is capable of acquiring and processing signals from one
sensing probes, a transducer, a display, and audible and/or visual alarms that are triggered when the
drops below or exceeds preset limits. Most multipurpose and electrocardiography monitors are capabl
monitoring.
Thermistor/thermocouple electronic thermometers with a digital display or analog meter, designed to
temperature. The probe and meter can be attached by a cable or integrated into a one-piece pencil-li
thermometers use the same type of probe for oral, axillary, and rectal sites, and others provide probe
particular uses (e.g., rectal, skin); disposable probe covers are typically used to prevent cross-contam
thermometers may display a final temperature after sensor thermal equilibrium (steady state) and/or
temperature value extrapolated from the measurement of the initial rate of temperature change. Pati
thermometers are used to take periodic body temperature measurements as primary diagnostic indica

Electronic thermometers that assess the temperature by determining the intensity of infrared light em
thermometers consist of an infrared probe, electronic circuitry, and a display. Schematically, infrared
resemble a photographic camera, consisting of a shutter, a reflective barrel (in place of a camera lens
infrared detector (in place of film). These thermometers take a sample of the thermal radiation, usua
the measured object, and display the temperature within a few seconds.

Thermometers in the form of slender, hollow tubes made of glass, that are sealed at the top and botto
base filled with mercury. When heat raises the temperature of the bulb, the mercury expands and fills
proportionally. The height of the mercury column, as measured on a graduated scale on the glass, ind
temperature.
Endoscopes designed for percutaneous insertion through an intercostal space in the body cavity situa
and the respiratory diaphragm (i.e., thoracic cavity) for visual examination, biopsy, and treatment of l
pleural cavity, and/or mediastinum; they are also used to drain fluid from the pleural cavity (thoracent
usually consist of a rigid outer sheath, a lighting system, and a working channel for catheters and ope
thoracoscopes include a television camera at their tip that sends a video signal through the endoscop
monitor.

Instruments designed for accurate measurement of a length of time. These instruments typically cons
electromechanical, or electronic (e.g., quartz oscillator) time measuring unit with an analog or digital d
primarily intended to measure the duration of a given procedure, such as the application of diagnostic
radiation (e.g., radiography, fluoroscopy, radiotherapy, phototherapy) and the performance of clinical
anesthesia, dialysis) and/or laboratory procedures; timers are also used during inspection and/or calib
equipment. Many timers use display signals (e.g., alarms) to show that a preestablished period of time
devices may include appropriate attachments to control the operation of other devices following a pro
are frequently an integral part of medical and/or laboratory devices.

Timers designed for automated measuring of the active duration of exposure to x-rays during a fluoro
imaging procedure. These timers typically consist of an x-ray detector that is placed in the beam path
made, an electronic time measuring instrument, and a display. Radiographic/fluoroscopic timers are u
instruments intended for use with a variety of radiographic and fluoroscopic units (e.g., half- and/or fu
timers that are hard-wired to the control unit of radiographic/fluoroscopic units are frequently an integ
Stand-alone radiographic/fluoroscopic timers are used mainly for inspection, calibration, and/or quality
x-ray generators and units; the timers are frequently an integral component of kilovolt meter instrume
control.
Sound generators and emitters that are used for therapy by patients with tinnitus; by listening to thes
can change or reduce their perception of the tinnitus over time. These sounds, which can be customiz
could include white noise, pink noise, or environmental sounds such as rain or waterfalls. The sounds
controller, which may be handheld, or include computers, television sets, or stereos. The sounds are t
speakers; the speakers could be free standing or placed within the patient's pillow or worn inside the p
Tinnitus therapy units usually include a shut-off timer and a volume control.

Tongs designed to perform traction on the cervical spine by applying an upward force to the skull that
hyperextension of the head and neck. These devices are typically a two-arm pivoted instrument that i
using pins (either partially implanted or not); the proximal end includes a mechanism (e.g., an adjusta
nut) for the application of the traction force. Some devices include straps that allow the connection of
traction unit that usually includes a cable, a pulley, and a set of weights. Skull traction tongs are used
procedures for fractured spines; tongs attached to external traction units are used in the managemen
cervical spinal column damages (e.g., to avoid further spinal cord injury) caused by trauma (e.g., fract

Graphic recorders incorporated in tonometers for recording the gradual changes in intraocular pressur
consist of the tonometer probe or plunger and the electric unit to collect intraocular pressure (IOP) sig
into electronic signals, and to record the IOP waveforms on the graphic paper. Some recorders are com
computers for waveform storage and analysis. The devices are used to facilitate the diagnosis and eva

Brushes designed for personal cleaning of the teeth. These brushes may be mechanical, electrical, or
bristles are usually made of nylon or hog-bristle (natural bristle); they are intended mainly for persona

Devices designed to circumferentially constrict/compress an extremity for a limited period of time to c


arterial blood flow. The pressure is applied to the extremity upon the limb surface and underlying tissu
pressure is then transferred to the blood vessels causing a temporary occlusion. Pneumatic tourniquet
during surgical procedures to provide a bloodless operative field; mechanical (i.e., non-inflatable) tour
intended for use in an emergency to control hemorrhage after serious limb accidents.

Tourniquets designed to circumferentially constrict/compress an extremity for a limited period of time


amount of pressure using a gas-inflated cuff. The pressure is applied upon the limb surface and under
cuff; pressure is then transferred to the blood vessels causing a temporary occlusion. The pressure ap
equal or higher than the minimum required to occlude the blood flow (i.e., limb occlusion pressure [LO
typically include an inflatable cuff, a compressed gas source, and tubes. Manual devices may use an in
a manual pump as compressed air source while automated tourniquets include a control unit that sup
gas from a central supply system, a small gas container (e.g., a cylinder), or from an integral electric p
tourniquets are used mainly during surgical procedures on the extremities enabling surgeons to perfo
in bloodless operative fields.
Fixed loop instruments designed for temporary occlusion of large vascular and cardiac structures to co
surgical procedures (also known as cardiovascular tourniquets). These instruments typically consist o
with a proximal handle and a detachable stylet placed inside. The stylet includes at the distal end an e
temporarily occlude large vascular and/or cardiac structures. The instrument may be intended for han
include a ratchet mechanism that permits attachment to the body, avoiding the need of manual holdi
procedure. Cardiovascular occlusion surgical fixed loop instruments are used in cardiothoracic surgery
procedures such as repair of heart valves and treating of large vessels after traumatic accidents.

Sterile towels designed for use during surgical procedures. These towels, usually made from absorben
in different sizes and colors. Surgical towels are used mainly in surgical and/or other procedures for pu
keeping a sterile environment for the incision site and wiping or absorbing exudates or other fluids; th
liners for procedure trays. The towels are supplied in sanitized packages for single use or as nonsterile

Balloonlike devices surrounding tracheal tubes. They are typically filled with air via a pilot line to prov
mechanical ventilation and are positioned below the vocal chords.
Stylets designed for use in the lumen of endotracheal tubes during intubation procedures, especially t
passage of the tracheal tube though the upper airway and vocal cords. These stylets usually are wires
rods that are inserted into the tracheal tube prior to intubation. Tracheal tube stylets are designed to b
the tracheal tube to avoid damage to the airways during passage; they are usually withdrawn after in
successfully completed. Some dedicated tracheal stylets are for specific laryngoscopes used in intuba

Tubes designed for insertion through the mouth, or less frequently, through the nose, into the trachea
provide an airway for gases and vapors to the lungs. Orotracheal intubation is performed by passing t
mouth and larynx and into the trachea; in nasotracheal intubation, a tube is inserted through the nose
typically consist of a clear, single-lumen, plastic (e.g., polyvinyl chloride) tube that may include a cuff,
syringe tips, and connectors to match external ventilation/anesthesia devices; some tubes are totally
x-rays (e.g., with a radiopaque line throughout the length of the tube). Tracheal tubes are used during
resuscitation, and anesthesia procedures; they are also used in other situations when the patient is no
Dedicated tubes appropriate for one-lung or jet ventilation are available. Tracheal tubes with high resi
radiation are also available.

Cannulae that are internal independent components of a metallic or plastic tracheostomy tube; they a
the stoma clear. Inner cannulae are typically small plastic tubes that are inserted into a tracheostomy
usually includes a lock to prevent device expulsion by coughing. Tracheostomy internal cannulae may
reuse (device must be pulled out and cleaned before reinsertion, typically 3 or 4 times per day) or for
disposable cannulae).

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for c
incision of the trachea, as well as for replacing the inner cannula of the tracheostomy tube (i.e., trache
these kits usually include a basin, vinyl gloves, pre-sewn tracheal dressing, drapes, gauze sponges, a
tipped applicators, pipe cleaners drape, twill tape, plastic forceps, and paper wrap. The kits may be su
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Tracheo
kits and trays are intended for cleaning and maintaining the patency of the airway and to prevent infe
breakdown of the skin surrounding the site.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed to ke
permanent opening in the trachea by inserting a tube after an incision is made through the neck (i.e.,
procedure). Items in these kits usually include a flexible PCV tube with inner cannula, dilators, an obtu
sponge applicators, gauze sponges, fenestrated drapes with tabs, povidone-iodine, needles, scalpel, p
lidocaine. The kits may also include a tracheal tube holder, a swivel adapter, and introducer needle, a
guiding catheter. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Tracheostomy procedure kits and trays are intended for placing
opening in the trachea to provide an artificial airway and/or to remove secretions from the lungs. They
operating and emergency rooms.

Sacroiliac spinal orthoses designed to provide therapeutic traction to the lower spine including the lum
These orthoses typically consist of a padded belt (e.g., cotton, vinyl) that is placed around the waist; t
more straps with rings at the end that permit its attachment to the cable of an external traction unit t
pulley and a set of weights. Some belts include additional rings for attachment to a spreader bar. Trac
provided using portable devices that use hydraulic force applied and controlled by a handheld pump w
valve. Traction belts are used mainly for relief of low-back pain and to maintain normal alignment of th

Adjustable frames that are usually attached to the patient's bed for management of various orthopedi
frames typically consist of a steel tubing frame that includes brackets and/or pulleys; they include a p
headboard and footboard and an adjustable length top bar or rail with a hanging trapeze. Traction fram
use in combination with weights and/or other attachments to produce the desired traction in patients
freedom of motion; they are used for treatment of patients with fractures and in some other orthoped
hip, cervical). Some traction frames designed for particular treatment (e.g. e.g. cervical or pelvic tract
to the footboard or headboard.

Devices designed to apply traction forces by means of harnesses attached to a particular site of the p
as the cervical or lumbar vertebrae, pelvis, or extremities. These devices typically consist of several s
combination of pulleys and cords, and (typically) either a set of weights or a motor with a control unit
traction forces. The use of weights provides only one mode of operation (i.e., static or continuous mod
motors and appropriate control devices permits the application of traction forces in several modes (e.g
progressive/regressive, cyclic). Adjustable spreader bars vary the angle at which the cord applies tract
used in orthopedic and/or physical therapy procedures, including fracture treatment and widening of t
spaces in the spine.
Traction units designed to apply forces from a motor through harnesses that are typically attached to
vertebrae. These devices usually consist of an electrical motor and a control unit used to generate an
the mechanical forces and a cord (e.g., braided nylon) that is clamped to the harness and transmits th
spreader bars attached to the control unit are frequently used to vary the angle at which the cord app
powered units can be operated in several different modes, including short-term continuous (static) mo
in which intermittent action is automatically generated and relieved according to a preset maximum a
duration; and two more elaborate modes (used in conjunction with intermittent traction), one of which
relieves force in predetermined steps (i.e., progressive/regressive mode) while the other repeats the p
mode in intermittent cycles (i.e., cycled mode). Powered traction units are used mainly to widen the in
usually for treatment of prolapsed intervertebral disks, facet joint osteoarthritis and capsulitis, and dis
degenerative disk diseases. They are available in several configurations, one configuration permits eit
vertical cervical traction or table attachment for horizontal cervical and lumbar traction (i.e., universa
configuration allows use of the traction unit on a pedestal connected to a traction table (i.e., table-mo
horizontal cervical and lumbar traction; a third configuration allows the unit to be placed on mobile ca
for horizontal traction or to a traction chair for vertical cervical traction.

Powered traction units designed to be placed on a mobile cart that can be rolled either to a table to ap
force or to a chair to apply vertical traction by means of harnesses attached to the cervical or lumbar
devices typically consist of an electrical motor and a control unit used to generate and regulate the m
cord (e.g., braided nylon) that is clamped to the harness and transmit the force; adjustable spreader b
to the control unit are frequently used to vary the angle at which the cord applies the traction. Most of
operated in static or intermittent modes or in variations of the intermittent mode (i.e., progressive/reg
modes). Mobile powered traction units are used for cervical traction and also to widen the interverteb
treatment of prolapsed intervertebral disks, facet joint osteoarthritis and capsulitis, and disk protrusio
disk diseases.

Static (nonpowered) traction units designed to be wall mounted for vertical traction application to the
These units typically consist of several specialized harnesses, a combination of pulleys and cords, and
weights that hang from cords as the source of the traction force (other systems, including some devic
patient's own weight as the source of the traction force, are also available). Adjustable spreader bars m
the angle at which the cord applies the traction. These units are used to provide vertical cervical tract
are typically seated on specially designed chairs (i.e., traction chairs); simpler units for home use (e.g
temporarily attached to a door) are also available.

Transducers designed to convert mechanical forces into electrical signals with values that vary accord
the force. These transducers typically consist of strain gauges that convert physical deformation into a
is processed by an electronic unit and displayed, recorded, and/or monitored in force units (e.g., lbs, k
frequently known as load cells, are used in clinical applications as components of devices such as phy
measure muscle forces, scales to measure weight, and some laboratory equipment; they are also use
applications.
Transducers designed to convert electrical signals into mechanical energy in the form of sound (i.e., u
vice versa. These devices typically consist of an active element (e.g., ceramic or piezoelectric polyme
attenuation, high-density material that is used to control the vibration of the transducer by absorbing
from the back face of the active element (i.e., a backing element); some transducers also include a we
the transducer element from the environment. Features available for ultrasonic transducers include ar
connecting more than one transducer in series or in parallel. Ultrasonic transducers are typically hous
an ultrasonic probe) that is attached through an integral cable to ultrasound medical equipment (e.g.,
ultrasonic scanners); ultrasonic transducers used with therapeutic devices (e.g., lithotripters) only tran
into ultrasound waves.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for b
procedures. Items in these kits may include needles, intravenous (IV) cannulae with wings, blood bags
tubes, a tube holder, gloves, a tourniquet, a marker/pencil, and a blood administration set with air inle
are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed recepta
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Transfusion procedure kits and trays are intended for transferring blood or blood-based prod
patient's blood circulation through a vein. They are used mainly in hospitals and other healthcare facil

Electronic data storage recorders that use a high-speed analog-to-digital converter to capture and hol
of an analog signal. These recorders have the ability to record the signal preceding the trigger point b
recording continuously, using the trigger to stop the recording process and freeze the data in memory
information can be output from memory in analog or digital form and can be displayed on any analog
oscilloscope, graph recorder).

Aerobic exercisers designed to allow the user to exercise by walking and/or running on a moving belt.
consist of a continuous tread made of polymeric material and electric motors to move the belts, but th
moved by the user while walking or jogging (passive treadmills); a monitor that displays workout feed
time, calories burned, and heart rate; and controls for the belt speed and slope. Treadmill exercisers a
cardiovascular endurance by keeping the heart and pulmonary rate elevated for a continuous period o
they provide strength and endurance to muscles used while walking or running (i.e., quadriceps, ham
Dedicated treadmills intended for use immersed in water for hydrotherapy systems that allow remote
and slope of the belt by clinicians, and/or treatmills that include monitoring devices for patient physio
electrocardiogram, heart rate) are available.

Graphical recorders designed to record involuntary trembling or quivering (i.e., tremors) of a body par
Some recorders include a mechanism with a stylus that records the movements directly from a sensor
bellows suspended from a bracket) located on a finger, hand, or arm; other recorders consist of an ele
records the movements after a transducer converts the movements to electrical signals. Tremographs
the diagnosis and assess the progress of treatment in patients suffering from conditions (e.g., Parkinso
cause tremors.
Instruments designed to cut and remove circular sections of an object or anatomic structure when driv
(i.e., torque). Trephines may consist of a manual, handheld instrument with a blade and an integral ha
frequently, of detachable blades and a rotary manual or power (e.g., electrical, pneumatic) drill or han
blades are usually hollow cylinders with a circular-saw-like beveled working edge that may include a c
center for guiding purposes. Dedicated trephines are available for cutting and removing sections of tis
(i.e., biopsy) and for use in surgical procedures of the skull, eyes, and other tissue and organs.

Eye (ophthalmic) surgery trephines designed to cut and remove circular sections of the cornea (corne
scleral tissue from a patient or from grafts taken from (cadaver) donors. These trephines typically are
with hollow cylindrical detachable blades of different diameters, a circular-saw-like working edge, and
manually operated or power (e.g., electrical) surgical handpiece. Some trephines include a coaxial pie
guiding purposes. Corneoscleral surgical trephines are used mainly to perform ophthalmic graft impla
obtain grafts from the sclera of cadaver donors.

Surgical trephines designed to cut circular sections of the skull. These devices are typically handheld,
with two coaxial drills and a drive shank attached to an integral T-shaped handle for manipulation (i.e.
torque); some instruments include a graduated scale on the cutting cylinder. Typically, the external cu
circular-saw-like working edge and the internal blade at the center is used for guiding purposes. Some
detachable blades and a manually operated (i.e., a hand brace) or power (e.g., electrical) rotary hand
trephines are used to open small holes in the cranium for insertion of catheters and/or encephaloscop
treatment purposes, such as to alleviate intracranial pressure, obtain cerebrospinal fluid samples, and
dyes. Automated powered devices (known as cranial perforators) are more frequently used for skull pe
manually propelled trephines; dedicated hand drills including guards and/or footplates are also used t

Sharp instruments designed to puncture the wall of body cavities, typically for the purpose of draining
instruments to access the target cavity. These instruments typically consist of a manual, handheld dev
pyramidal (e.g., three sided) or conical strong and solid pointed rod and a proximal large handle. Many
tube or sheath as part of the instrument set. Trocars are usually fitted into a cannula, tube, or sleeve;
pierce the skin and the wall of a body cavity or canal (e.g., percutaneously) and then it is usually remo
cannula or sleeve in place. Trocars are intended to provide access to body cavities, to aspirate fluids, t
or solution, or to guide the placement of a cannula, tube, or sleeve (i.e., a hollow sheath) used for diag
and/or surgical procedures. Dedicated trocars are also used in laparoscopic surgery to provide access
devices such as surgical instruments and video cameras. Both reusable and single-patient-use trocars
Trocars designed to puncture the abdominal wall in order to provide access to the peritoneum and/or a
These instruments typically consist of a manual, handheld device with a sharp pyramidal or conical st
rod and a proximal large handle. Abdominal trocars are usually fitted into a cannula, or sleeve; the tro
the skin and the abdominal wall (i.e., percutaneously) and then it is usually removed, leaving only the
place. Abdominal trocars are intended to provide access to the cavity permitting the aspiration of flui
hydrocele); to instill medications or solutions; or to guide the placement of a cannula or sleeve (i.e., a
for diagnostic, therapeutic, and/or surgical procedures. Dedicated abdominal trocars are also used in l
provide access for introduction of devices such as surgical instruments and video cameras.

Trocars designed for trans-abdominal percutaneous puncture of the uterus and the tissue of the thin w
providing access to the amniotic fluid and the fetus. These instruments typically consist of a manual, h
the trocar) that is fitted in an outer cannula which remains in place and becomes a port to allow passa
the amniotic sac. There are two basic types of amniotic membrane trocars: cutting trocars that incorp
plastic rod with a cutting pyramidal or conical tip, and dilating trocars with a tip which radial expansio
dilates tissue as force is applied. Amniotic membrane trocars are used to pierce the amniotic sac wall
removed, leaving the cannula or sleeve in place. Amniotic membrane trocars are used to provide a ch
aspirate amniotic fluid and/or to pass instruments in surgical procedures involving the fetus.

Instruments designed to puncture the wall of any of the paranasal sinuses (i.e., frontal, ethmoid, and m
These instruments typically consist of a manual, handheld instrument with a strong sharp pyramidal o
straight or curved, pointed rod and a proximal large handle. Antrum trocars are usually fitted into a m
trocar is used to pierce the skin and the wall of the antrum and then it is usually removed, leaving the
Antrum trocars are intended to provide access to the nasal sinuses to permit the aspiration of fluids, t
to provide access for diagnostic, therapeutic, and/or surgical devices.

Trocars designed for use in puncturing the thoracic wall in order to provide access to the heart and the
system. These instruments typically consist of a manual, handheld device with a sharp pyramidal or c
pointed rod at the distal end and a proximal large handle. Cardiovascular trocars are usually fitted into
the trocar is used to pierce the skin and the thoracic cavity wall (i.e., percutaneously) and then it is us
the cannula or sleeve in place. Cardiovascular thoracic trocars are used in the treatment of cardiac tam
cardiovascular diseases. Dedicated trocars are used in minimal-access surgery to provide access for in
such as surgical instruments.

Trocars designed to puncture the abdominal wall in order to provide access to the gallbladder. These i
consist of a manual, handheld device with a sharp pyramidal or conical strong and solid pointed rod a
handle. Gallbladder trocars are usually fitted into a cannula, or sleeve; the trocar is used to pierce the
abdominal wall (i.e., percutaneously) reaching the gallbladder and then removed, leaving the cannula
tube in place. The cannula usually includes a lateral secondary tube (e.g., Ochsner trocar) for externa
Gallbladder trocars are intended to provide access to the gall bladder, permit the aspiration of fluids, a
medications or solutions. They are used for diagnostic procedures or to empty an enlarged bladder pr

Surgical instruments with a sharp pyramidal or conical point used to puncture body cavities during ea
(ENT) surgery.
Trocars designed to puncture the thoracic wall, providing access to the thoracic cavity and organs. The
typically consist of a manual, handheld device with a sharp pyramidal or conical strong pointed rod at
proximal large handle. Thoracic trocars are usually fitted into a cannula, or sleeve; the trocar is used t
the thoracic wall (i.e., percutaneously) and then it is usually removed, leaving the cannula or sleeve in
trocars are intended to provide access to the cavity to aspirate fluids (e.g., blood, air), to instill medica
to guide the placement of a cannula or sleeve (i.e., a hollow sheath) used for diagnostic, therapeutic,
procedures. Dedicated thoracic trocars are also used for spontaneous pneumothorax and cardiovascu
cardiac tamponade), and in minimal-access surgery to provide access for introduction of devices such
instruments.

Trocars designed for percutaneous puncture of the tracheal tube through the skin and cricothyroid me
instruments typically consist of a manual, handheld device with a sharp pyramidal strong, short, and c
the distal end and a proximal large handle. Tracheal trocars are usually fitted into a metal cannula and
skin and the cricothyroid membrane reaching the trachea and are then removed, leaving the cannula
perform a tracheotomy or cricothyrotomy). Tracheal trocars (e.g., Ueckermann trocars) are intended to
trachea in emergency situations, providing an opening for the insertion of a tracheotomy tube.

Abdominal supports designed to retain a reduced hernia into the abdominal cavity by pressure. These
consist of fabric, plastic, or metal devices or a combination of these that support and compress mecha
preventing its expansion outside the abdominal cavity. Hernia trusses in different sizes and shapes (e
dedicated elastic supports) are available. Dedicated hernia trusses intended for scrotal, inguinal, and/
also available.

Abdominal support hernia trusses designed to retain an infant reduced hernia (frequently umbilical) in
cavity by pressure. These devices usually consist of a hard plastic or rubber pad (i.e., a compress) atta
navel using straps and/or dressings. Infant hernia trusses in different sizes and shapes are available; t
in infants for several months up to a year. Hernia trusses for other less frequent types of infant hernia
also available.

Shields designed for mechanical protection and support of the nose. These trusses typically consist of
thermoplastic, or metallic cup-like prefabricated or custom-made device that is attached to the face u
straps. Nose mechanical shields are mainly used to protect the external nasal bones and cartilage from
illness, and/or surgery (e.g., rhinoplasty). Dedicated masks intended mainly to shield the nose are also

Implantable clips designed for occlusion of the fallopian tubes in open surgery or laparoscopic procedu
typically small metal devices that are externally applied to the tubes using dedicated appliers. Implan
clips are intended for contraceptive (i.e., sterilization) procedures.
Hollow cylindrical devices designed with a diameter, length, and other physical and/or chemical chara
for a particular use. Tubes may be rigid, semi-rigid, or flexible; they are typically made of metals, meta
plastics, or glass. Dedicated tubes are available for direct use in clinical procedures (e.g., gastrointesti
enteral feeding, and tracheostomy); as components of or attachments for medical devices; for use in
and also for a diversity of applications in the healthcare environment. Tubes are frequently a compone
hemodialysis tubing sets).
Tests tubes designed to withstand repeated sterilization cycles at high temperature (i.e., autoclaving).
reusable test tubes made of high-temperature-resistant glass (e.g., borosilicate) or plastic. Autoclavab
tubes are frequently available with autoclavable (e.g., polypropylene, phenol) plastic caps; they are us
require a completely sterile enclosure, such as in bacteriology and tissue culturing.

Tubes designed to store blood samples drawn from a venipuncture through a blood-collection set. The
connected using an adapter to a needle (that may include a Luer lock), which in turn punctures the st
collection set. These tubes frequently contain an appropriate substance to inhibit or enhance coagulat
intended use of the blood sample (e.g., heparin for chemical analysis, sodium citrate for plasma coagu
are usually color coded accordingly. Blood-collection tubes are made of glass or plastics; they are avai
presealed after obtaining a relative vacuum in their interior.

Tubes designed to access the colon through the rectum for examination, treatment, or other purposes
typically consist of a single-lumen rubber or plastic (e.g., silicon) tube of 14 to 20 French diameter or l
inches) long, that is inserted through the anus and rectum and then into the colon. Colon tubes are us
diagnostic or therapeutic purposes, including enema delivery; dedicated colon tubes intended for ante
(e.g., cecostomy tubes) are also available.

Test tubes designed for tissue culture in clinical laboratories. These devices are usually glass or plastic
or flat bottom and an open top without a rim (lip); they may include external threads for screw caps, m
codes, and/or graduation marks on the surface. Tissue culture test tubes are available in a variety of s
special physical or chemical characteristics; some culture tubes include graduation marks and/or colo
tissue culture tubes made of special materials and/or including particular physical characteristics such
temperature tests and/or repeated sterilization (i.e., autoclaving) are available; the tubes are also use
and other laboratory procedures.

A hollow device made of plastic or metal that is used as a conduit to remove fluids or purulent materia
wound, or infected area._x000D_
Tubes designed to access the esophagus through the mouth or nose for examination, treatment, or ot
devices typically consist of rubber or polymeric flexible tubes with a diameter, length, and other physi
appropriate for reaching the esophagus. Dedicated esophageal tubes are used to facilitate the diagno
diseases, to treat hemorrhage (i.e., tamponade) from esophageal varices, to provide suction of liquids
materials, and to be used as a first step in esophagus reconstruction; they may also be used to assess
diseases. Dedicated tubes intended for patient rewarming may be also available.

Tubes designed for insertion through a permanent artificial gastric fistula from the anterior gastric wal
abdominal wall; the distal tip remains in the stomach. These tubes may be placed surgically (i.e., lapa
percutaneous endoscopic procedure. Gastrostomy tubes are mostly used for feeding patients who req
feeding but who are unable to maintain sufficient oral intake, such as patients who have severe neuro
those with tumors of the mouth, larynx, or esophagus; and infants who require enteral nutrition. The t
variety of sizes and materials according to the intended use and the insertion procedure. Some of the
for drainage or for feeding and drainage.
Tubes designed to access the stomach through the nose, nasopharynx, and esophagus for examinatio
purposes. These devices typically consist of a single-lumen rubber or plastic tube of 14 to 18 French d
markings that serve as insertion guides; the tube is inserted through the nose, down the throat, and t
its tip is positioned in the stomach. Nasogastric tubes can be used to remove air and liquids from the
(decompression) by connection to intermittent suction units and as temporary feeding tubes; they are
very ill or comatose patients. Nasogastric tubes are intended only for short-term use; keeping in place
weeks can cause nasal septum necrosis. Dedicated tubes used for decompression, both single- and d
small-bore tubes intended for feeding are also available.

Tubes designed to increase the carbon dioxide content in the patient's breathing by partially feeding b
exhaled air (i.e., rebreathing). These devices typically consist of a tube that can adjust the proportion
air in the patient's breath. Rebreathing tubes stimulate hyperventilation; they are intended to reduce
complications, such as incomplete expansion of the lungs (atelectasis) and posterior pneumonia, espe
Small portable rebreathing devices that include several internal interconnected chambers are also ava

Tubes designed to access the rectum for examination, treatment, or other purposes. These devices ty
single-lumen rubber or plastic (e.g., silicon) tube of 14 to 30 French diameter or larger, about 10 cm (4
inserted through the anus into the rectum. Rectum tubes are used mainly for diagnostic or therapeuti
enema delivery.
Nasogastric tubes designed for use with an external continuous low-suction apparatus to remove air a
decompression and drainage) from the stomach. These devices may consist of a single-lumen tube ty
intermittent low-suction pump (e.g., Levin tube) or devices consisting of a double-lumen plastic tube o
diameter with side ports that is inserted through the nose, down the throat, through the esophagus, a
(e.g., Salem sump tube); they usually include an antireflux valve and may be connected to higher suc
smaller inner tube vents the larger suction-drainage tube to the atmosphere by way of an opening at
tube. Decompression nasogastric tubes are used to remove air and liquids from the stomach, frequen
procedures and/or in an emergency.

Small-diameter, hollow cylinders designed for the transfer of materials, typically liquids or gases. Thes
rigid, semirigid, or flexible; they are typically made of metals, metal alloys, rubber, plastics, or glass w
(e.g., one-ply, braided, reinforced) according to the intended use. Tubing is usually available in standa
variety of diameters and wall thicknesses (i.e., gauges) that can be cut into segments of different size
tubes may be shaped or modified in other ways (e.g., by attaching connectors) appropriate for a given
application in the healthcare facility (e.g., intravenous fluid administration tubes, laboratory tubes).

Tubing made of synthetic polymers such as nylon, polyurethane, and silicone that include interwoven
materials (e.g., stainless steel, Dacron) to increase their strength (i.e., braided tubes). Braided polyme
hollow cylinder designed for the transfer of fluids, either liquids or gases, at high pressures. These dev
semirigid according to the intended use. Braided polymer tubing is usually available in standardized le
of diameters and wall thicknesses (i.e., gauges) that permit the use of segments of different sizes app
application in the healthcare facility.
Synthetic polymer tubing made of nylon (polyamide). Nylon tubing is typically a small-diameter, hollo
cylinder designed for the transfer of fluids, either liquids or gases; they are typically made with differe
braided, reinforced) according to the intended use. Nylon tubing is usually available in standardized le
of diameters and wall thicknesses (i.e., gauges) that permit the use of segments of different sizes app
application in the healthcare facility.

Synthetic polymer tubing made of polyethylene. Polyethylene tubing is typically a small-diameter, hol
flexible cylinder designed for the transfer of fluids, either liquids or gases; they are typically made wit
(e.g., braided, reinforced) according to the intended use. Very-low-density polyethylene is used to man
tubing. Polyethylene tubing is usually available in standardized lengths and in a variety of diameters a
(i.e., gauges) that permit the use of segments of different sizes appropriate for a given application in t

Synthetic polymer tubing made of polyvinyl chloride (PVC). This tubing is typically a hollow, rigid or se
cylinder designed for the transfer of fluids, either liquids or gases. PVC tubing is usually available in st
and in a variety of diameters and wall thicknesses (i.e., gauges) that that permit the use of segments
appropriate for a given application (e.g., drain tubes, laboratory equipment tubes, electrical conduits)
facility.

Synthetic polymer tubing made of vinyl. This tubing is typically a transparent, flexible, strong, hollow
the transfer of fluids, either liquids or gases; vinyl is chemically resistant to alkalis, oils, and some acid
usually available in standardized lengths and in a variety of diameters and wall thicknesses (i.e., gaug
of segments of different sizes appropriate for a given application (e.g., equipment tubing, general labo
healthcare facility.

Mechanical frames designed for turning patients 180? along the longitudinal axis of the body (i.e., from
positions and vice versa). These frames typically consist of a two-component metallic structure resem
the patient is placed in supine position on one of the frame components and the other is adjusted on t
him/her tight. The table also has a mechanism intended to allow one healthcare provider to turn the p
are intended for critically ill patients suffering from pulmonary and/or spinal traumas or diseases.

Vision assistive devices designed to facilitate reading by highlighting the lines of print being read. The
consist of a black plastic or cardboard piece with one or more slots that is placed over the text, permit
showing only one or a few lines of print. Typoscopes eliminate glare from the printed paper; they are i
as low-vision aids.
Surgical instrument washers designed for automatic removal of dirt, stains, and/or biological debris (i.
labware (e.g., glass and plastic beakers, test tubes), surgical instruments, and/or other critical devices
energy. The process is performed by delivering ultrasonic waves to a tank filled with a warm cleaning
detergents formulated for ultrasonic cleansing). These systems typically include a radiofrequency gen
from 25 to 40 kHz are typical), ultrasonic transducers, a heating unit, and a stainless steel tank with b
Cleaning is performed by the scrubbing action of the ultrasonic vibration and also by the implosion of
cavitation effect). Surgical instrument ultrasonic washers may include two or three tanks to perform a
washing, rinsing, and drying; they may also include heating capabilities. This equipment may provide
disinfection by killing and/or inactivating several microorganism species; it is commonly used after ge
before thermal or chemical disinfection. Both stand-alone and tabletop units are available for use in c
departments of healthcare facilities.
Power meters designed to measure the power output of ultrasonic equipment. These meters usually m
using an appropriate transducer to detect the ultrasonic pressure; a measuring device such as a mech
electronic load cell; and a display. Ultrasonic power meters are used to verify the accuracy and/or to c
(e.g. ultrasonic scanners) and/or therapeutic (e.g., ultrasonic physical therapy units).

Scanning systems that use sound waves at frequencies (typically in the range of 2 to 15 MHz) well abo
hearing to generate an image of tissue in a transverse plane of the body. These systems convert an e
ultrasonic energy that is transmitted into tissues. The intensity, time, and direction of the echoes are
processed to generate an amplitude display (A-mode), a two-dimensional "brightness modulated" ima
or a one-dimensional graphic display of a moving structure (M-mode). Ultrasonic scanners are compos
convert electrical signals to sound waves and sound waves to electrical signals); scanners that measu
and direction of the reflected (echoed) sound waves; and scan converters that display the image on a
high-resolution monitor). Ultrasonic scanning systems are used in many diagnostic procedures, includ
obstetric, cardiac, vascular, endoscopic, thyroid, and breast procedures. Some ultrasonic devices usin
are used to display blood flow information.

Surgical knives designed to cut the anatomical structures of the upper urinary tract (i.e., ureters) duri
surgery) procedures. These devices may consist of manual handheld instruments that usually have a
long narrow blade with a sharp cutting edge at the distal end. Ureter surgery knives are used mainly f
ureter to open a temporary external passage during treatment of strictures and/or benign polyps. Ded
ureter surgical knives are also used in a variety of minimal access procedures in the upper urinary tra

Bougies designed to explore (e.g., to search for stones) and/or dilate the urethra. These manual, hand
typically hollow metallic or plastic cylinders that often have a tapered working end. Some urethral bou
introduction of an extremely slender solid tube (a filiform) through their lumen for use as a guide or fo
strictures.
Instruments designed to measure the functional length andor to dilate and measure the lumen of the
are typically manual, handheld instruments consisting of a set of cylindrical (e.g., metallic, plastic) ure
several sizes and a mechanism that displays the diameter and/or degree of dilation (i.e., expansion) o
on a dial. Instruments intended to measure the functional length of the urethra (urethral profile) are a
Urethrometers are intended to measure the urethra during procedures such as urethral stricture dilati
abnormality studies.

Endoscopes designed for direct insertion into the urinary tract for visual examination, biopsy, removal
and treatment of lesions of the urethra. Urethroscopes usually consist of an outer sheath, a lighting sy
channel for catheters and operative devices.
Covers designed to fit over or within portable, handheld urinals to provide a protective barrier betwee
patient's skin. Urinal covers are made of plastic for disposal after use, or of a biodegradable and flush
urinal covers include an anti-odor absorbent pad or waste treatment powder that absorbs liquid waste
odorless, spill-proof gel.
Devices consisting of containers or fixtures that are designed to collect and that may hold urine. Urina
healthcare are typically handheld portable containers with appropriate openings for direct urination. T
of plastic (for single patient use) or made of glass or metal (reusable); the shape may be conformed fo
sex (i.e., unisex) or for use only by males or females. Some urinals include attached lids and/or other
spills. Portable urinals are used mainly by bedridden patients and people with disabilities or incontinen
intended for use in bathrooms may resemble small toilets to be used while sitting on them or, more fr
attached to the walls for urination while standing (mainly intended for male users). Some wall-installe
by several people simultaneously.

Prepackaged collections (either custom or standard) of the necessary equipment and supplies for inse
into the bladder via the patient's urethra and immediately collecting the patient's urine (e.g., for a dia
included in these kits usually include materials for prepping the patient, such as a sterile drape, germ
sterile gloves, cotton/rayon balls, and forceps, as well as the urinary catheter and supplies needed for
(e.g., lubricant) and a urine collection containers (e.g., a sterile urine specimen cup, pouch or bag). Th
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Urinary catheterization/collection kits and trays are used at home, in hospitals, and in other healthcar

Prepackaged collections of devices and supplies (i.e., kits) intended to facilitate collection of urine from
catheterized with an indwelling catheter. These kits typically include urine drainage tubes and contain
include other components, such as a metered funnel or drip container or pouch, filters, and/or antirefl
drainage kits are available in closed configurations (usually vented) and in open configurations, includ
types. They are used to collect and dispose of urine from the patient while minimizing damage to the
and preventing bacteria infection.

Collection bags designed for capturing urine from either an indwelling catheter, a surgical opening (st
(e.g., ureterostomy), or natural miction in incontinent patients. These bags are usually plastic or elast
devices; independent collection bags and bags that can be fixed to the patient's skin using adhesive a
collection bags may include drainage capabilities to other containers or for disposal of urine into the t
intended for urine sample collection from natural miction, frequently including an internal and an exte
supplied as kits.

Prepackaged collections of the necessary equipment and supplies for the liquid cleansing of urinary sy
as the urethra, bladder, or ureters. Items in these kits include a syringe, a container, a tip protector, a
an alcohol prep pad.
Devices designed to collect stones (i.e., calculi) from the urine during normal micturation. These strain
a sieve with handles (e.g., built-in ridges) for easy manipulation; they are frequently attached to spec
sample is sent to the clinical laboratory after stone collection for a pre-determined time period (usuall
strainers are used every time the patient urinates during several days or weeks, typically until there a
in the urine for several days. Determination of the chemical composition (e.g., calcium, cystine, uric a
facilitates diagnosis and/or therapeutic treatment of the patient.

Specimen containers designed for short term storage and/or transportation of urine samples. These co
in a variety of sizes, including smaller specimen cups (e.g., 100 mL) to larger containers (e.g., 2.5 L) t
collection of urine samples over an extended period of time (e.g., 24 hours). The containers are typica
glass, and often include graduations (for measuring). Most containers are supplied as sterile, single-us
Systems designed to measure and evaluate the storage and transportation of urine in the urinary trac
consist of a set of units that are combined to perform all the measurement functions as well as display
devices. The systems include uroflowmeters and uroflow transducers for external measuring of the ur
voided, peak flow, and voiding time; manometers to determine the urethral pressure profile; cystomet
gaseous to measure bladder capacity and response; and recorders with appropriate sensors to assess
muscle activity. Many systems also include video urodynamics capabilities to allow radiographic and u
be performed with synchronous display and recording of urodynamic studies and cystourethrography
measuring systems are used in diagnosing neurogenic bladder diseases, stress incontinence, urinary p
spastic sphincters.

Flowmeters designed to measure the rate of urine flow from a patient, typically by delivering spontan
a special funnel or from an indwelling bladder catheter that is connected to the flowmeter. Some inst
determine volume, peak flow, delay, voiding times, and maximum and average flow rates. These flow
include a mechanical or electromechanical measuring unit, probes with appropriate transducers that a
the base of a commode chair, urine collection reservoirs (usually for urine volume measurement), a fu
display. Urinary flowmeters may be intended for measurement during normal urination and/or from an
Disposable single-piece flowmeters intended to facilitate patient self-evaluation of urinary constriction
available; they typically consist of a transparent tube with a profiled orifice at the base. Urine flowmet
evaluation of the lower urinary tract function and/or in determining whether normal urine flow is obstr

Valves designed to regulate liquid flow between the anterior chamber and the conjunctiva space of th
when the pressure in the chamber is above a preset value (e.g., 8 to 10 mm Hg). These devices usual
slit) valves that are frequently implanted in the eye as a component of an eye stent. Eye valves typica
with advanced glaucoma disease when, despite the use of medication regimens, laser treatments, or
filtration procedure (trabeculectomy), the addition of a drainage tube and valve is recommended.

Electrocardiographs designed for recording a graphical representation of the sequence of changes in m


direction (i.e., vector representation) of the electric potentials in one or more complete cardiac cycles
vectorcardiogram). These instruments record cardiac events in three orthogonal planes (i.e., X, Y, Z) a
recording: (1) isolated cardiac contractions (i.e., beat-to-beat recording); (2) continuous (timed) record
separate graphics of the ECG signals for each plane. Vectorcardiographs typically consist of dedicated
including appropriate detachable electrodes, computing capabilities, and software, as well as printers
that can display the vector cardiogram from the electrocardiographic signals. Instruments based on th
signals to an oscilloscope for graphic representation of the vectorcardiogram of isolated cardiac contra
obtained as a photo of the loop displayed on the oscilloscope screen) may be also used. Vectorcardiog
diagnose abnormal and pathologic conditions of the heart; instruments providing continuous recording
detection and/or monitoring of arrhythmias. Some multichannel interpretative electrocardiographs ma
vectorcardiogram using appropriate computer algorithms.
Alarms designed to activate audible (i.e., sound) and/or visual warnings when the gas pressure within
artificial airway of mechanically ventilated patients is outside a pre-established range. These devices
pressure sensing line that is ideally attached to the breathing circuit at its junction with the endotrach
tube, an electronic unit, and visual and/or sound alarms. Airway pressure alarms are mainly used with
nonintensive care ventilators and/or anesthesia ventilators that do not include an airway pressure alar
component. Low pressure alarm may signal ventilator failure, breathing circuit disconnections, extuba
endotracheal tube; high-pressure alarms alert for conditions that can cause lung damage (i.e., barotra

Devices used to prevent dust and bacteria from reaching the patient's airway, or to prevent exhaled b
the atmosphere during mechanical ventilation. Ventilator filters are typically housed in plastic and ma
paper, fibrous material, or copper threads.
Intensive care ventilators designed for neonatal and/or pediatric respiratory support; most are time-cy
devices. These ventilators typically include flexible, small-bore (e.g., 1 cm diameter) tubing and contin
pressure (CPAP) and/or positive end-expiratory pressure (PEEP) controls. CPAP is useful for infants with
disease or decreased lung compliance and alveolar collapse (infants with hyaline membrane disease);
volume and prevents alveolar collapse. Neonatal/pediatric intensive care ventilators are used for prete
infants with respiratory failure.

Endoscopes for examining the cerebral ventricles and for cauterizing the choroid plexus.
Boxes that include lamps and a translucent glass or plastic surface to get evenly diffused light for visu
some image (e.g., radiographs) or to observe a process (e.g., Rh typing) which results can be assesse

Physiologic analyzers that measure and evaluate the main physical characteristics of vision, the visua
eye structures. These analyzers usually determine near, intermediate, and far visual acuity; depth and
muscle balance (heterophoria); visual fields; and interior eye structures that are integral to proper visi
include computer processing and result-recording capabilities. Dedicated visual function analyzers to
macular integrity, tear structure, and interior eye structures are also available. Visual function analyze
for vision screening and for selecting patients that would benefit from certain ophthalmological proced

Ophthalmic surgical units designed to remove vitreous gel from the eye (vitrectomy). The units may c
handheld cutter (vitrectomy cutter) to cut and aspirate the vitreous gel a fiberoptic light source to illum
cavity, a gravity-fed infusion device to infuse fluid into the eye to maintain the intraocular pressure, a
contact lens to provide a magnified image of the interior eye, and microsurgical instruments (e.g., forc
remove scar or other tissue. During surgery, the eyes can be filled with air or a mixture of air and gas
detachment or to close a macular hole. Laser treatment can also be performed in the surgery with a la
blood vessels in the retina (photocoagulation). Vitrectomy units are used mainly in vitrectomy to treat
retinal detachment, intraocular injury or infection, and other eye disorders.
Measuring instruments designed to measure the difference of electric potential (either of direct, DC, a
current, AC) between two points of an electric or electronic circuit, usually expressed in volts. These in
consist of electromechanical (analog) or more frequently electronic (usually digital) instruments with a
Practical instruments can perform the most common voltage measurements performed by technicians
electronic equipment, circuits, and components. Voltmeters are mainly used in healthcare facilities in
maintenance, repair, and calibration of medical devices and other hospital equipment. Dedicated instr
measure high voltages in the order of kilovolts are also available.

Metal structures (i.e., frameworks) designed to help users to stand and walk (i.e., walkers). Walkers ar
(some also include hard plastics) structure that frames the front and sides of users at waist level and t
multiple (two to five are typical) legs; they usually include supports (i.e., grips, platforms) for the hand
intended for the permanent assistance of disabled (e.g., infirm) patients and/or for use during rehabili
Standard (i.e., rigid, nonwheeled), wheeled, foldable, adjustable, and one-side two-leg walkers are ava
may include seats and/or other detachable accessories (e.g., trays, pouches). Combinations of walkers
(i.e., walker/chairs) are also available.

Equipment designed for automatic or semiautomatic washing (i.e., elimination dirt and/or stains), rem
(e.g., blood, fat, bone), and killing all microorganisms, including spore-forming bacteria (except in very
providing high-level, nearly sterile disinfection. Using a cycle of operations that includes water prewas
detergent wash, heated rinse, and sterilization (usually by steam or germicide), the process may also
contaminants using water jets. Washer/sterilization units are used in the central supply area of a healt
dedicated devices are available to process clinical instruments and instrument carts.

Equipment designed for the safe collection, storage, transformation, and/or disposal of hazardous was
units may consist of a hard plastic or metal structure with a mechanism to transform hazardous mater
products (e.g., glass crushing devices); devices intended for the storage of products (e.g., radioactive
become safe; devices that directly dispose of the hazardous material (mainly used for liquid disposal);
that include accessories to mitigate risks posed by the enclosed hazardous products (e.g., sharps). Th
leakproof and sealed, and the complete unit may be intended for disposal. Waste disposal units are us
other healthcare facilities to facilitate and/or perform waste disposal, decreasing the risks of contamin
staff. Dedicated units intended for sharps, glass crushing, liquid waste, and radioactive materials are a

Puncture-resistant containers used for the disposal of sharps, including syringes, needles, laboratory g
lancets, blades, scissors, trocars, and scalpels, without recapping, cutting, or bending. These units are
of plastic (polypropylene, polycarbone, or high-density polyethylene) or cardboard (compressed fiberb
containers have absorbent liners to hold fluids that may be left in syringes or ampules. Container inlet
to be inserted either vertically or horizontally. Circular disposal slots are typically designed for vertical
ports are designed for horizontal insertion. Mailbox slots have fixed or moving parts that stack the con
that points are not directed upward or downward. Some inlets are designed to automatically lock out w
Some units are translucent or have translucent lids or windows to allow monitoring.
Containers designed for the collection and storage of waste materials. These receptacles typically con
plastic reusable or disposable structure, frequently with a disposable (e.g., paper, plastic) liner approp
material; the receptacles usually have separate or attached (e.g., hinged) covers; they are frequently
colors (e.g., red, blue, yellow) and/or include labels (e.g., biohazardous, infectious, radioactive, cytoto
intended contents. Dedicated waste receptacles are available for general hospital use (i.e., noncontam
for contaminated materials such as cytotoxic, radioactive, and biohazardous waste. Waste receptacles
the final disposal of waste or the transformation of hazardous waste into safe products.

Waste receptacles designed for the collection and storage of contaminated and/or otherwise hazardou
These receptacles typically consist of a metal or hard plastic reusable structure, frequently with a disp
plastic) liner appropriate for the contaminated waste material and usually separate or attached (e.g.,
Contaminated material waste receptacles usually include gaskets around the covers to prevent leakag
cytotoxic biohazard symbols) to identify their intended contents; they are used for collection of hazard
healthcare facilities, doctors' offices, and nursing homes. Dedicated containers are available for collec
radioactive, and cytotoxic materials.

Buckets mounted in frames on wheels or casters that can be moved easily by the foot (i.e., kick) aroun
operating room. Kick buckets are tip resistant and include removable stainless steel basins placed in f
rubber bumpers. The basins typically include handles at the top to facilitate lifting from the frame for
are used as receptacles for medical and / or surgical waste, such as sponges, used during medical pro

Waste receptacles designed for the collection and storage of radioactive materials, including containe
those materials (e.g., scintillation vials). These receptacles typically consist of a metal or hard plastic
frequently with an internal radiation shield (e.g., lead liner) and usually separate or attached (e.g., hin
shielded covers. The receptacles usually allow temporary and final closure options. Radioactive waste
mainly in radiology, nuclear medicine, and oncology treatment areas.

Water purification systems designed to remove charged particles (i.e., eliminate both cations and anio
metal ions) using deionization procedures. These systems consist of one or more containers (known a
contain appropriate resins beads (both cationic and anionic) for the deionization procedure. There are
mixed-bed, containing both cationic and anionic resins in a single vessel, and dual-bed systems, wher
a separate vessel. For most medical uses, including hemodialysis, mixed-bed systems should be used
frequently used after a reverse osmosis when ionic contamination is such that reverse osmosis (RO) a
water of acceptable quality. Dedicated deionization systems used in hemodialysis procedures, both st
portable, are also available.

Water purification systems designed to remove charged particles (i.e., eliminate both cations and anio
metal ions) using deionization procedures. These systems consist of one or more containers (known a
contain appropriate resins beads (both cationic and anionic) for the deionization procedure. There are
mixed-bed, containing both cationic and anionic resins in a single vessel, and dual-bed systems, wher
a separate vessel. For most medical uses, including hemodialysis, mixed-bed systems are often used.
frequently used after a reverse osmosis when ionic contamination is such that reverse osmosis (RO) a
water of acceptable quality. Dedicated deionization systems used in hemodialysis procedures, both st
portable, are also available.
Water purification systems designed to remove salts, bacteria, metal ions, and particulates using reve
These systems typically consist of a container with a central semi-permeable membrane separating th
from the purified water. Hydrostatic pressure high enough to exceed the osmotic pressure is then app
contaminated water section. The membrane is permeable to water but impermeable to the solutes pr
on the other side of the membrane. The contaminated water is discarded when the osmotic pressure i
that it is not possible to continue the process. Reverse osmosis systems may be used after filtration of
performed, especially if the water is highly contaminated with particulates. Deionization, ultrafiltration
with ultraviolet radiation may be needed after reverse osmosis if the presence of contaminants is high
RO removes percentages (e.g., 95 to 99 percent) rather than fixed quantities of contaminants. Dedica
intended for use in hemodialysis procedures are also available.

Water purification systems designed to kill bacteria, viruses, and other microorganisms using germicid
radiation. These systems typically consist of a water flow chamber that include UV light sources (typic
wavelength from 100 to 280 nm) encaged in transparent protectors; the UV radiation kills or renders i
microorganisms present in the water. UV water purification systems are mainly used as a last step of a
system intended to obtain pure water, typically after previous filtering, deionization, and/or reverse os
performed. Dedicated UV systems used in hemodialysis procedures are also available.

Chairs mounted on large wheels, usually 55 to 66 cm (22 to 26 in), designed for indoor (e.g., hospital,
outdoor transportation of patients or individuals with impaired walking ability.
Equipment designed to provide a turbulent (jet) water bath in a large container for the user (i.e., whirl
baths typically include a large container (e.g., a stainless steel tank) with capabilities for easy filling a
may be mounted on casters. Whirlpool baths include a turbine to provide the turbulent water supply a
they may also include other accessories such as patient lifts and seats. Whirlpool baths are used clinic
hydrotherapy during physical therapy and/or rehabilitation procedures.

Prepackaged collections of the devices and supplies (either custom or standard) designed for the liqui
Items in these kits usually include a needleless bulb or plunger syringe, a container, waterproof drape
pad. The syringe used for irrigation in the kit may be also used for aspiration (i.e., removal) of the wou
and/or debris. These kits may be supplied in supporting trays (i.e., procedure trays) consisting of a fla
with a border around the periphery supporting all the instruments and supplies needed for the proced
usually covered or wrapped. Wound irrigation kits and trays are intended for therapeutic treatment (e
debridement) of wounds, including ulcers and surgical wounds.

Upper-limb wrist flexible orthoses designed to encircle and support the wrist joint that also provide som
joint movement. These devices are usually made of wide pieces of elastic fabric with hook-and-loop cl
adjustment of the size and they are available in several sizes. Wrist supports are used mainly to suppo
wrist in an appropriate position and to provide relief from pain and strain of the wrist joint after traum
arthritis diseases, and/or excessive use of the joint. They can also be used for rehabilitation therapy a
extended use during normal functioning of the wrist.
Systems that provide a safe and efficient means for the delivery and/or disposal of xenon radioisotope
Xe 127 is also used). These systems usually include a xenon-delivery unit, a gas trap, carbon dioxide a
filters placed in the mouthpiece. Xenon-delivery systems are mostly used in pulmonary function studie
inhaled, a gamma camera produces images of the lungs showing regional ventilation and displaying t
intake. Xenon-delivery systems are also used during xenon-enhanced computed tomography and dyn
emission computed tomography (CT and SPECT respectively) studies.

Holders designed to hold large x-ray film cassettes during radiographic procedures on an external par
holders typically are made of sturdy metal frames with clamps or slots to hold the x-ray film cassettes
cassette holders are made for use on a tabletop and may have non-skid footings, while others may be
with feet or wheels. The frames that hold the x-ray film cassettes may be fixed in one position or adju

Cassettes designed for holding a sheet of x-ray film during exposure to radiation by an x-ray (radiogra
typically, a screen that converts x-rays to light is also inserted in the cassette. The cassettes are usua
cassette holder in the radiography unit. These devices typically consist of a metal or plastic housing w
to facilitate film transport and provide protection from environmental light. After x-ray exposure, the c
transferred to a manual or automated processor to develop the radiographic image on the film.

Dryers designed to remove moisture from x-ray film using heat (e.g., forced warm air) after the film ha
fixed, and washed. These dryers may consist of an enclosure where the film is dried using heat (manu
automated drying unit that rolls the film at a predetermined speed while applying pressure and/or hea
at their output port. X-Ray film dryers usually include temperature and/or time controls; automated fil
included as an integral part of x-ray film processors that perform the whole x-ray film processing (i.e.,
washing, and drying).

Monitors designed to measure and continuously display the quality characteristics of the processing c
automatic x-ray film processor. These monitors typically have the capabilities to measure density, sen
determination), and temperature; they may also display other characteristics of the process, such as fi
replenishment rates, and service needs. Frequently these monitors are attached as an integral part of
processor; the quality control may also be performed manually using a densitometer, a sensitometer,

Screens designed to intensify the latent image on x-ray films used in radiography. These screens typic
sheet of celluloid or other radiolucent material, coated with a thin layer of a suspension of dehydrated
phosphors on the cassette side that is in contact with the film when it is mounted in the cassette. Whe
phosphors they glow with a visible light intensifying the generation of the latent image on the film. Th
patient exposure to x-rays usually in a range of 10 to 40 times.

Shields used for protection from x-ray radiation. These shields are intended to attenuate or block x-ray

X-ray radiation shields used as aprons and designed for front or front and back protection of the health

X-ray radiation shields used as gloves and designed for hands protection of the healthcare worker.
X-ray radiation shields used for patient's and/or healthcare worker gonad protection during x-ray proce
View boxes that include visible light lamps covered by a translucent surface appropriate for observatio
radiographs. X-Ray view boxes are available for a single radiograph observation or as a multiple set (i.
permits the simultaneous observation of several radiographies.
Breathing circuits used to deliver room air or oxygen-enriched gas from a ventilator to a patient. They
connections for devices that humidify, deliver medications, and/or monitor gas within the breathing ci

Detectors designed to discover air foam and/or bubbles in the blood that is returned to the body (usua
from a heart-lung bypass unit. These devices may detect the air bubbles (an also foam) using either u
detect changes in acoustic density or less frequently photoelectric sensors that detect infrared light b
bubble is passing, otherwise the light is interrupted by the blood flow. The detectors usually consist of
sensor; they usually trigger alarms and activate automated mechanisms to turn off the blood flow whe
One-way valves and filters are also included in heart-lung bypass units to prevent infusion of large am

Detectors designed to discover when blood falls below acceptable levels either in the oxygenator, car
other component of the heart-lung bypass unit. These devices typically consist of optical detection or
they usually trigger alarms and activate automated mechanisms to turn off the blood flow when an ab
level occurs.
Tubing sets designed for external delivery of blood from the patient's circulatory system to a heart-lun
back. Blood is diverted from the vena cava through a cannula into the tubing set to an arterial pump
heart-lung bypass unit; after oxygenation the blood is pumped back through the tubing set to a cannu
aorta, bypassing the heart and lungs. These tubing sets typically consist of plastic, pre-sterilized, disp
manufactured and assembled for this specific use.

Laboratory breath analyzers used for intermittent (usually periodic) measurements of oxygen content
respiratory gas sample. These analyzers usually require manual aspiration of a quantity of gas into a s
These analyzers may operate on several basic principles (e.g., paramagnetism). Oxygen breath analy
pulmonary function tests and to monitor critically ill patients, such as infants in incubators and patien
supplemental oxygen added.

Brushes designed to scrape and collect cells from a particular area of the body to provide a specimen
These manual, handheld brushes may consist of a cluster of metallic bristles attached to a wire, possi
plastic sleeve, that runs back to a handle (for endoscopic use) or, less frequently, a set of stiff bristles
distal tip attached to a handle for direct manipulation. Dedicated cytology brushes are designed to co
tissue (e.g., bronchial, endometrial); cytology brushes may be intended for reuse or single use.

Cannulae inserted into an arteriovenous fistula for placement of an arteriovenous shunt.


Vascular catheters designed for extracorporeal dialysis of the blood. These catheters are used for with
blood to the patient; the blood is circulated via an extracorporeal blood circuit through the dialyzer an
patient following a closed loop.
Chairs designed to allow the woman to give birth in sitting position instead of lithotomy position. The
to the perineum and are usually adjustable in height and also between horizontal and vertical position
Compresses or packs designed to apply cold therapy to a specific body surface. These devices consist
made of several layers of cotton, gauze, or linen (i.e., compresses), or compact plastic or fabric bags (
contain temperature-retaining substances such as gels that are capable of conforming to the contour
compresses or packs are cooled in cold water, a refrigerator, or a freezer; some compresses become c
reaction. Cold compresses or packs are used mainly to reduce pain, swelling, bruising, and/or bleeding

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
the skin, and the cricoid and thyroid membranes (i.e., a cricothyrotomy). Items in these kits usually in
needle, a plastic cannula, an endotracheal tube, a syringe, a dilator, and a curved hemostat for clamp
kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed rec
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. These procedure kits and trays are intended for use during emergency procedures for the r
airway. Cricothyrotomy procedure kits and trays are mainly used in emergency and operating rooms.

Containers (flasks) designed for temporary storage of cryogenic liquids. These flasks typically are a do
consisting of two metallic or glass vessels nested one inside the other and sealed together at the neck
surfaces of the two vessels are covered with metal or other reflective coating to avoid heat transmissi
insulated inner vessel contains the cryogenic liquid at very low temperatures (typically up to -200?C/-
in the space between the vessels provides insulation to minimize heat transfer to the liquid from the e
convection and/or conduction; the container should include a vent line for slow release of the gas from
cryogenic liquid due to the higher room temperature, especially when the container is not used for a l
Large capacity Dewar flasks (30, 50 liter capacity or more) are used in supply centers and in most larg
for storage of cryogenic gases before their distribution; smaller flasks are used for particular applicatio

Telephone transmitter/receiver systems designed to transmit and receive electroencephalographic (EE


telephone channels. These systems typically include at the transmitting site an electronic device (e.g.
modifies signals from medical (e.g., external, ambulatory) devices such as EEG monitors or recorders
transmissible through telephone lines. At the receiving end, another electronic device (i.e., the receive
incoming signal and provides an output signal appropriate for display on EEG monitors (e.g., central s
and/or for further transmission and processing by healthcare information systems. EEG telephonic tra
systems are typically used to send signals from patients' homes, doctors' offices, and/or remote locati
other healthcare facilities using standard telephone lines. Dedicated systems intended for single-chan
electroencephalographs may be also available.

Cardiac electrodes designed for delivering an electric shock to the heart from external defibrillators. T
applied to the thorax surface using dedicated paddles or self-adhesive pads with a large surface (80 to
placed either in the anterior-posterior position (i.e., one electrode over the heart and one directly behi
anterior-anterior position (i.e., one electrode near the apex of the heart and one on the right chest). T
external defibrillators may also be applied directly to the heart during surgical procedures using smal
defibrillators can deliver powerful transthoracic shocks (e.g., up to 36o Joules) to the heart; when the
directly to the heart the energy is limited to less than 100 joules. External defibrillator electrodes prov
to terminate fibrillation, assist in resuscitating patients, and/or to correct arrhythmias.
Vascular occluders designed for intravascular embolization, promoting complete vascular occlusion an
occluders typically consist of a small device (e.g., detachable balloon, metallic coil) or substance (e.g.
glue-based) that is deployed using guide wires and appropriate catheters. Intravascular embolization
permanent occlusion of venous malformations and lesions in spinal and cerebral vessels (e.g., aneury
used for abdominal (e.g., inferior vena cava) and peripheral vascular lesions. These devices are also u
aortopulmonary collaterals, pulmonary arteriovenous fistulas, and some small (typically less than 4 m
arteriosus.

Peristaltic motility analyzers designed to determine gastric and/or small intestine (usually the duoden
measuring the pressure on an intragastric probe at several points. These analyzers usually also includ
measure the acidity of the stomach contents. Gastrointestinal motility analyzers are used to evaluate
stomach and small intestine, including the prediction of duodenal and/or gastric ulcers.

Gowns designed to protect the wearer against physical contamination from patients with infectious di
are usually ankle-length and have long sleeves with elastic cuffs, full front and back coverage, and tie
Isolation gowns are intended to fully cover the external clothing of the wearer (e.g., healthcare provid
facilities staff, and visitors). They are typically made of light-weight, fluid-resistant and breathable ma
woven (e.g., polypropylene) and reusable woven (e.g., polyester, cotton) isolation gowns are available

Surgical guillotines designed to cut transversally (i.e., transect) one or more ribs. These guillotines are
manual instrument that includes a sliding blade at the working end that is operated (e.g., by squeezin
mechanism in the handle. Rib guillotines are used mainly in surgical procedures that require opening

Equipment designed to remove specific toxins or wastes from the blood (i.e., hemofiltration). Typically
extracorporeal circuit and passed through a high flux membrane that convectively extracts water and
molecular waste; a sterile replacement solution with similar electrolytic concentration as a dialysis sol
the same amount as the solution that is filtered out from the bloodstream. No dialysis procedure is pe
hemofiltration. Hemofiltration units are intended to decrease biochemical abnormalities as well as flui
base imbalances; the procedure results in the flushing of larger molecules (e.g. medium-sized molecu
substances from the bloodstream than hemodialysis. Hemofiltration is used mainly for blood purificati
unstable patients or in those suffering from cardiovascular problems; hemofiltration units are frequent
devices to conform continuous renal replacement therapy (CRRT) units.

Handheld devices designed to be used to place a contact lens over the lens of the eye. Contact lens in
insert contact lenses and avoid contaminating the lens with dirt, oil, etc., that may be on a person's fi

Microscopes designed to magnify an image using an electron beam instead of light, which allows grea
(500,000x is typical) and resolution than a light microscope. The images are usually observed on a flu
through photographs. There are two basic types of electron microscopes: the transmission electron m
basically operates like a light microscope but uses an electron beam, and scanning electron microscop
provide a three-dimensional image of the surface of the examined object; some electron microscopes
techniques. TEMs intended for clinical use permit highly detailed visualization of tissue, individual cell
SEMs are intended mainly for research and, less frequently, for clinical applications.
Instruments designed to measure the concentration of dissolved oxygen (DO) in solutions. These instr
consist of an electronic unit that processes the electric signal from a sensor and displays the oxygen c
and probes with a sensor that detects the DO level and a transducer that converts the oxygen values
Some meters have computerized capabilities and dedicated software to process the information. The
temperature compensation and salinity correction to enable measurements to be taken in salt water. D
intended mainly to measure DO in water, salt water, and/or aqueous solutions. The instruments frequ
that permit measuring oxygen concentration in the environment and software with algorithms that pe
determination of biological oxygen demand (BOD). Portable and laboratory instruments are available.

Devices designed to reduce the internal pressure of eye fluid by applying external, controlled mechan
an inflatable (i.e., pneumatic) balloon. These devices typically consist of a headband with inflatable be
pressure gauge (i.e., manometer), and tubing. Pneumatic balloon intraocular pressure reducers are ty
ophthalmic surgery for temporary reduction of internal ocular pressure achieving a condition known a
which is characterized by a reduction of vitreous pressure and helps prevent hemorrhages, reducing r
ophthalmic surgical procedures.

Suction regulators designed to control the high levels of negative pressure (usually from 400 to 600 m
surgical site; some regulators permit the application of full line suction from wall vacuum outlets. Thes
include the pressure-regulation mechanism, pressure-adjusting controls, and a calibrated manometer.
regulators are usually a component of a suction system connected to the wall outlet of a central vacuu
used to control the removal of secretions (e.g., vomitus, mucus, blood) during surgical procedures as w
wound cavities after surgery.

Patient scales typically including a weighing platform that is large enough and low enough for wheelch
also include ramps to facilitate rolling the scales on and off the platform. Wheelchair scales usually ha
capacity of up to 275 to 450 kg (600 to 1,000 lb) and an accuracy of 100 g (0.25 lb). These scales may
electromechanical, or electronic weighing technologies. Wheelchair scales are used for routine periodi
who cannot stand on a conventional scale.

Surgical drapes designed to provide a bacteria-proof barrier between the unsterile surface of the oper
and the sterile surgical field. These surgical drapes consist of a broad rectangular piece of fabric. Oper
drapes are made of soft woven or nonwoven material. They are impermeable to moisture and bacteria
and low-linting operating table surgical drapes are also available. These surgical drapes are used in op
surgical procedures.

Sigmoidoscopes with a nonrigid structure, capable of being manipulated and pointed in different direc
lumen of the curved path of the lower (i.e., sigmoid) part of the colon. Flexible sigmoidoscopes usually
illumination and imaging system that facilitates the examination and performance of therapeutic proc

Sigmoidoscopes with a nonflexible (i.e., rigid) structure that can only follow a straight path through th
colon; they include illumination and imaging systems enabling the examination and treatment of the s
sheath is usually made of stainless steel.
Testers designed to mimic physical or physiologic process by artificial means, in such a way that a me
measures with the same accuracy when tested with the simulator that it displays when measuring a p
devices mimic one or more functions of human organs or tissues (e.g., using a computer program, by
analogous behavior); they typically can reproduce bioelectric signals (e.g., electrocardiographic), pres
pressure), gas flows (e.g., respiratory), movement, and/or other characteristics of the human body. So
generate electrical signals that mimic the electrical output of transducers (e.g. pressure, temperature
mostly used to test and or calibrate monitors (e.g., non-invasive blood pressure), recorders (e.g., elect
and/or measuring instruments (e.g., thermometers); transducer simulators perform the test of devices
device's transducer. Simulators may be also specially designed and/or used for training of healthcare
a variety of physiologic characteristics and/or medical device use.

Simulators designed to mimic temperatures in the range of normal and abnormal human body variatio
typically include heating and cooling devices, a chamber for the device or probe being tested, controls
thermometer. The temperature may be adjusted in a continuous range (e.g., 0 to 100 degrees C) or at
values. Temperature simulators are used to test and/or calibrate thermometers and temperature mon

Analytical instruments designed to identify and quantify elements and compounds by sorting of gaseo
and/or electromagnetic fields to determine their mass-to-charge ratio using electrical detection.. Thes
consist of a sample inlet, a high vacuum system, an ionization chamber with an ion source to produce
particles, a mass analyzer to separate the beam in its components, an electrical detector, and comput
Samples can be inserted directly into the sample inlet or injected into a gas or liquid chromatograph p
the sample into individual components. Mass spectrometers are frequently classified according to the
used (e.g., magnetic sector, double focusing, ion trap). They are used in the clinical laboratory and als
dedicated to measure inspired and/or exhaled gas concentrations (e.g., oxygen, nitrogen, halogenated
surgical procedures.

Suture units designed to apply conventional sutures to tissue with reduced operator intervention. This
consists of a suture-delivery mechanism, frequently including needles; a suture-carrier accessory (e.g
attachment to manipulate the equipment and control the suture delivery. Automatic suture units are a
configurations according to the type of suture to be delivered and the placement of sutures. Dedicate
percutaneous sealing of the vasculature after catheterization procedures and to apply sutures to the s
automated suture units used through endoscopes (e.g., in the gastrointestinal tract), arthroscopes, an
also available.

A wad of cotton or other absorbent material firmly attached to one or both ends of a wood or plastic s
be sterile; they are appropriate for saturating with liquid medications or antiseptics. Absorbent/cotton
to apply medication, remove material, or to collect samples for microbiological examination.

Bronchoscopes with a nonrigid (i.e., flexible) structure, capable of being manipulated through the lum
of the respiratory tract. The sheath is usually made of plastic.
Bronchoscopes with a nonflexible (i.e., rigid) structure that can only follow a straight path through the
bronchoscopes include illumination and imaging systems that enable the examination and treatment
bronchi of the lungs.
Laryngoscopes with a nonrigid (i.e., flexible) structure, capable of bending to follow the curved passag
the patient cannot be manipulated for direct visualization. Flexible laryngoscopes usually include a fib
and imaging system that facilitates the examination and performance of therapeutic procedures

Laryngoscopes designed with a nonflexible (i.e., rigid) structure that can only follow a straight path th
are constructed of metal and contain straight or curved blades for manipulation of the tongue and pha
procedures. Rigid endoscopes are frequently used for insertion of endotracheal tubes.

Aprons designed to be worn as protective clothing by laboratory personnel. They are usually fitted wit
waist so that the fit can be adjusted to the individual wearer. They include a bib attached to front pane
the front of the body. They are usually tear- or abrasion-resistant, and can be made of synthetic rubbe
or other chemical-resistant materials. They are designed to be resistant to spills or splashes of chemic
clinical laboratory, such as alcohols or acids.

Spectrophotometers in which the analytical determination of elements is based on the absorption of r


The atom cloud necessary for atomic absorption measurements is produced by supplying sufficient th
sample (typically using an air-acetylene flame or an electrically heated graphite furnace) to dissociate
components into free atoms. These instruments include a light source (usually hollow cathode lamps)
monochromator, a photomultiplier to measure the absorbed light, appropriate electronics to process t
a means to display the results. Atomic absorption spectrophotometers may be used on body fluids an
electrolytes, essential trace elements, and metals used in therapy and to monitor for exposure to indu
environmental pollutants.

Spectrophotometers that determine the emission of electromagnetic radiation by a substance at one w


absorbed radiation at another wavelength. These instruments usually determine the presence of fluo
placing the sample in a beam of light (most frequently ultraviolet [UV]) where fluorescent compounds
visible light. Their principal components are a stable light source (e.g., a mercury vapor lamp), a grat
certain range of wavelengths to strike the sample, a sample cuvette (glass for exciting wavelengths a
otherwise quartz), a secondary filter that removes scattered UV from the beam, and usually a photom
detector.

Spectrophotometers that operate in the infrared spectrum (usually in a wavelength range from 750 to
instruments generally use special cuvettes (made of NaCl or KBr) for the far infrared region. Infrared s
have fewer biomedical applications than ultraviolet and visible light spectrophotometers and are gene
determine whether specific functional groups are present or absent and also to identify compounds by
spectra with those in a library of pure compounds.

Spectrophotometers that operate in the ultraviolet spectrum (usually in the wavelength range from 19
instruments generally use hydrogen, deuterium, or xenon arc lamps and usually hold rectangular qua

Spectrophotometers that operate in the ultraviolet (UV) and visible spectrum (usually in the waveleng
800 nm). These instruments generally use ordinary tungsten lamps and usually hold rectangular silic
wavelength is above 330 nm) cuvettes. Some recording UV/visible spectrophotometers use a double
automatically scans the entire spectrum and produces a graph relating the transmittance or absorban
wavelength.

Spectrophotometers that operate in the visible spectrum (usually in the wavelength range from 400 to
instruments generally use ordinary tungsten lamps and usually hold rectangular glass cuvettes.
Sponges designed for use during open surgical procedures in the abdominal cavity. These sponges typ
absorbent prewashed cotton to soak up fluids around the surgical field, keeping the field as dry as pos
surgeons to clearly visualize the area of interest and to apply pressure to help stop bleeding. Sterile a
laparotomy sponges are available in a variety of different sizes; some laparotomy sponges include det
elements, radiofrequency labels) components. Laparotomy sponges are intended to control bleeding o
liquids and to hold organs or other anatomic parts in place.

Electrical stimulators that apply a stimulus directly or externally to bones to promote their growth (ost
electric bone-growth stimulators are used to heal nonunion fractures or as an adjunct to spinal fusion
degenerative vertebral diseases.
Laboratory analyzers used to determine the alcohol (usually ethanol) concentration in body fluids (e.g
concentration of ethyl alcohol in whole blood is commonly expressed as percent by weight or volume
deciliter (g/dl). Most dedicated laboratory alcohol analyzers are based on gas chromatography or enz
photometric measurement techniques. These devices are frequently used as supporting evidence of a

Analyzers used to detect and quantify primary and secondary amino acids in physiologic fluids (e.g., p
acid analyzers generally use ion-exchange or reversed-phase high-pressure liquid chromatography tec
dedicated laboratory amino acid analyzers are automated. These analyzers are typically used in the c
monitor treatment of inborn metabolism errors and other genetically produced disorders in protein me
phenylketonuria).

Laboratory analyzers designed to identify microorganisms in body fluids and to evaluate the in vitro su
isolated pathogen to a variety of antimicrobial agents that prevent bacterial growth. These analyzers
interpretative results (e.g., susceptible, intermediate, resistant) and/or determining minimum inhibitor
and minimum lethal concentration (MLC). The results derived from these analyzers are used to treat p
proper antimicrobial agents.

Laboratory blood analyzers used for the analysis of plasma or serum urea content, commonly reported
nitrogen. Both direct and indirect methods are used to determine urea content, using spectrophotome
detectors. These analyzers are used to determine increases in blood-urea nitrogen (azotemia), which m
renal, or postrenal causes.
Laboratory breath analyzers used to determine the carbon monoxide (CO) content in a breath sample
typically use gas chromatography or infrared spectroscopy techniques. CO analyzers are mostly used
diffusing capacity during pulmonary function testing.
Laboratory blood coagulation analyzers that process batches of specimens, adding reagents and spec
These analyzers may include ultrafiltration devices to separate plasma from the blood cells, but most
previous centrifugation of the sample to obtain plasma samples. Automated blood coagulation analyz
incubation container (e.g., a test tube), timing devices, a clot formation detector (e.g., turbidimeter, n
spectrophotometer), and computerized capabilities for sample handling and data management. Autom
coagulation analyzers are used in laboratories with heavy workloads.

Laboratory analyzers designed to measure some or all of the most common ions (e.g., sodium [Na+],
chloride [Cl-], bicarbonate [HCO3-]) present in human body fluids. Electrolyte laboratory analyzers are
abnormal electrolyte levels that may result from disorders, including overhydration and dehydration, c
failure, diabetes, and gastrointestinal or kidney diseases.
Laboratory analyzers that measure enzymes (e.g., lactate dehydrogenase) in terms of their catalytic a
activity units (usually in international units [IU]). The actual mass or molar concentrations are seldom
enzymes are present in low concentrations and in a matrix containing a large number of chemically si
other biochemicals. These analyzers may have adjustable temperature controls and mechanical devic
and samples automatically and to process multiple specimens in sequence. The progress of the react
to allow the analyst to conform the linearity of the reaction or monitored automatically within microco
measurements that do not have acceptable linearity. Dedicated enzyme analyzers are used in the dia
of several diseases (e.g., myocardial infarction).

Laboratory analyzers dedicated to measure glucose in body fluids (usually in plasma, serum, or urine,
perform tests on whole blood, cerebrospinal fluid, or saliva). Most dedicated glucose analyzers use am
(electric current is measured through an electrochemical cell while a constant electric potential is app
enzyme electrodes); some others use chemical methods. Laboratory glucose analyzers use different m
(point-of-care) glucose analyzers and measure a larger concentration range. Some of these analyzers
physician offices and clinical locations outside the central laboratory.

Laboratory analyzers designed to measure total nitrogen content in a body fluid speciment (typicallyu
Certain devices may also be capable of measuring nitrogen levels found in breath (gas) samples.

Laboratory blood coagulation analyzers used to evaluate the adhesion of platelets to one another. Th
the aggregation process by adding an aggregating agent, such as adenosine diphosphate (ADP) or ris
aggregation analyzers use optical density (turbidmetric), electrical impedance, or bioluminescence me
Usually, these analyzers require previous sample preparation, including centrifugation, to obtain plate
and platelet-poor plasma (PPP) samples; but, some analyzers that use the impedance method of analy
blood. Platelet aggregation analyzers are used to distinguish between different types of platelet dysfu
in platelet release substances, poor platelet adhesion to injured tissue).

Baths used for the cooling of a patient in order to lower the body temperature rapidly.
Temperature-controlled water baths designed to be used in conjunction with a microtome. Tissue spe
surface of the bath as they are sliced by the microtome.
Baths used to increase, decrease, or hold constant the temperature of bodies or vessels immersed in

Instruments designed to measure the concentration of bilirubin in the blood.


Graduated glass tubes used in volumetric chemistry to deliver a measured amount of liquid.
Cytometers that require technician involvement in all the steps of each analysis, including dilution, co
differentiation of cells. These cytometers usually include a counting chamber and a microscope. Manu
frequently used for measuring cells in body fluids such as cerebral, spinal, and pleural fluids and is als
patients with thrombocytosis, thrombocytopenia, leukocytosis, or leukopenia.

Nonrefrigerated low-speed floor centrifuges used to centrifuge solutions of suspended red blood cells,
agglutination and promoting the formation of packed cells at the bottom of the container (e.g., tubes,
bank centrifuges have a timer connected to the motor that allows timed use, and mechanical or elect
is an available option in some models.
Free-standing centrifuges designed to process a large volume of specimens, possibly contained in a la
tubes. These centrifuges are typically large stationary structures and consist of an electric motor, a sh
speed and time controls; they also include a rotor on which one of several interchangeable heads is m
includes slots into which tubes, cups, flasks, microplates, test tubes, and/or other sample holders can
common rotor designs are fixed angle and swinging bucket (also known as horizontal). Floor-mounted
low speed (usually up to 10,000 rpm) and high speed (typically from 12,000 to 25,000 rpm) and ultrac
speed usually between 30,000 and 120,000 rpm are available; some models have refrigerating capab
chamber cool and/or facilitate performance of temperature-sensitive assays. Floor centrifuges are use
laboratory for a variety of procedures such as centrifugation of body fluids, reagents, and/or mixtures
for analysis using other equipment.

Low-speed (typically up to 10,000 rpm) free-standing centrifuges designed with a mechanism to keep
cool. These centrifuges are typically large stationary structures and consist of an electric motor, a sha
speed and time controls; they also include a rotor on which one of several interchangeable heads is m
compressor and other associated devices needed to keep the rotor chamber cool. The refrigeration co
refrigerated centrifuges are used mainly to keep the rotor chamber from overheating and to control th
facilitate performance of temperature-sensitive laboratory assays such as enzyme and complement te

Laboratory analyzers used to determine the concentration of chloride in body fluids (e.g., serum, plasm
analyzers are based on amperometric, colorimetric, or mercury titration methods. Dedicated chloride
assess abnormal concentration of chloride found in the serum of patients with chronic pyelonephritis,
lactic acidosis, renal failure, and diabetic acidosis.
Tubes that contain the stationary phase and through which the mobile phase flows. These columns ar
part of the separation process in a chromatography system. Chromatography columns are usually ma
glass, or plastic and which may vary from 10 to 200 cm in length and 1 to 50 mm in internal diameter
withstand high pressures (typically up to 10,000 psi). In column chromatography, migration of the mo
stationary phase results in sample components within the mobile phase eluting at different rates, perm
fractions at different times.

Chromatography systems in which the separation process is accomplished by forcing a gaseous mixtu
mobile phase (e.g., an inert gas, such as nitrogen or helium) through a column of the stationary phase
in the mixture is based on the relative differences in their vapor pressures and their interaction with th
basic gas chromatograph consists of a gas reservoir and flow control device, an injector, the separatio
online detector (sometimes a mass spectrometer), and, usually, a computer.

Packed-column liquid chromatography systems that use a relatively high pressure to pump the liquid t
and in which the stationary phase works with high efficiency (i.e., a high-performance packed column)
usually classified according to the principle used in separating components; the most used techniques
chromatography, bonded-phase (or partition) chromatography (there are two types of bonded-phase t
phase and the more commonly used reverse phase), ion-exchange chromatography, and steric-exclus
chromatography.

Planar liquid chromatography systems in which the stationary phase substrate is a specially prepared
Data management information systems designed to provide clinical and administrative information re
laboratory procedures. These systems can automate laboratory procedures, such as test ordering, res
quality assurance and quality control; they are also used in administrative tasks, including instrument
scheduling and billing transactions and to facilitate the flow of information in and out of the laboratory

Devices that provide a lighted surface on which bacteria colonies can be counted accurately. The surfa
plate into grids so that the operator can count the colonies in each grid and keep track of which CFUs
counted.
Devices used to determine the number of bacterial colonies present on a bacteriological culture mediu
Electrical stimulators designed to induce sweating by the transdermal introduction of water-soluble el
(e.g., pilocarpine) into the sweat glands using electric stimulus (iontophoresis). These stimulators typi
direct-current generator and two electrodes connected to the generator by cords. After the stimulus is
where the positive electrode was located is cleaned with a sponge, and a filter pad or gauze covered w
thermoplastic, self-sealing film is placed for about one hour to collect sweat. The pad is removed and
if enough sweat was collected and sent to the clinical laboratory to analyze the chloride and/or sodium
Transdermal iontophoresis sweat induction stimulators are used for diagnosis of cystic fibrosis in infan
analyzers combining the stimulator with the chemical analyzer are also available.

Measuring instruments used to determine the amount of mass per unit of volume. By extension, the t
the measurement of any unit per unit of volume, area, or length. Some densitometers can also determ
density of a substance to the density of a standard substance (usually water) at a specific temperatur
specific gravity.
Small transparent enclosures designed to keep objects in storage free from moisture. Most desiccators
glass enclosure, the lower portion of which includes a rim to hold a ceramic sample plate that has sev
desiccant agent (e.g., silica gel) and that is placed on the bottom; the cover is adjusted to ensure an a
using grease or silicone O-rings on the contact flanges. Some desiccators include an opening in the co
stopper with a hole to apply a vacuum pump for fast moisture removal. Desiccators are mostly used to
hygroscopic chemicals and/or biological compounds in clinical laboratories.

Dialyzers designed to perform in-vitro separation of molecules in a laboratory sample solution accordi
their rates of diffusion through a semi-permeable membrane. These dialyzers typically consist of three
container for the solution to be dialyzed (e.g., a multi-well cell), a container for the solution that perfo
dialysate);, and a semi-permeable membrane separating them. Laboratory dialyzers are used in clinic
several procedures such as electrophoresis and chromatography sample preparation, especially when
samples (e.g., cerebrospinal fluid, serum, urine) are required; for salt and/or detergent removal; and in

Instruments designed for use in laboratories to make repeatable, accurate dilutions of sample and rea
solutions.
Dispensers designed to store and deliver an even flow of molten wax (i.e., paraffin). These dispensers
thermostatically controlled in a temperature range of 20 to 75 degrees Celsius (68 to 167 degrees Fah
dispensers usually have a stainless steel outer casing; a clear plastic (e.g., Lexan) lid which permits ea
paraffin levels without contamination; and a reservoir filter screen which prevents foreign matter and/
the delivery tap. They may also include heating elements for accurate regulation of the delivered para
dedicated sterile paraffin dispensers used for tissue embedding in clinical laboratories; and dispensers
of therapeutic paraffin (used by physical therapy and rehabilitation specialists and/or massage therap

Laboratory dispensers designed to store and deliver microscope slides. These dispensers accommoda
different thickness in a container and release them one at a time clean and dust free. Laboratory slide
of plastic and/or metal. Some of these dispensers come with a clear molded plastic cover to allow for
unused slides and a knob on either side to dispense them. They are commonly used in clinical and ph
laboratories.

Devices used in the measurement of the acid-base status of a substance.


Systems designed to separate mixtures of ionic solutes by the differences in their rate of migration in
field. These systems usually include an electrophoresis chamber, support media, a temperature contro
and/or heating), a densitometer, and a power supply; the procedures require the use of reagents. Som
can perform the operations automatically (e.g., apply samples to the gels, perform the electrophoresis
the results) and include computerized data processing capabilities; other, less expensive systems are
configured using separate modules. Electrophoresis systems may perform one or more electrophoresi
zone electrophoresis, gel electrophoresis, and isoelectric focusing electrophoresis. They are useful for
assessment of most solutes of interest in clinical chemistry, including proteins in serum, plasma, urine
and other body fluids and tissues.

Devices used in chemical laboratories for evaporation, the conversion of a liquid into a vapor for the p
from another liquid of higher boiling point, or from a solid which is dissolved in it. Evaporators use one
enact evaporation, including heating, nitrogen blowdown, or vacuum. Evaporators using heat include
heated bath with temperature controls, pumps, and a condenser. Heat sources include water baths, or
aluminum particles, or hot air. Nitrogen blowdown evaporators or concentrators use a jet of gas to con
layer of air that is saturated with vapor just above the surface of the liquid to be evaporated, thereby
rate; these are useful for small sample volumes, under 50 mL. Vacuum evaporators use vacuum pump
phase of the evaporating solvent. To increase evaporation, samples are shaken, creating liquid vortexe
greater surface area. Evaporators that provide rotation of the vessels holding the samples are availab

Disposable (single-use) papers appropriate for removing particles (i.e., filtration), typically from liquids
purpose cellulose fiber filter papers are used mainly for clarifying and removing particles in gravity an
procedures; they can usually retain particles of micron or larger. Papers intended for filtration are typic
variety of shapes and sizes (e.g., rectangle, square, circle, fluted circle for use in a conical funnel); the
classified as fine (1 to 3 microns), medium (3 to 10 microns), or coarse (more than 20 microns) accord
they can retain. Filter papers are used in a variety of procedures performed in clinical laboratories; de
are available for use in vacuum filtration systems and for low-ash or ashless paper filtration.
Filter photometers that determine the emission of electromagnetic radiation from a substance at one
substance has absorbed radiation at another wavelength. These instruments usually determine the p
compounds by placing the sample in a beam of light (most frequently ultraviolet), where fluorescent c
emitting visible light. Their principal components are a stable light source (e.g., a mercury vapor lamp
that removes visible light from the excited beam, a sample cuvette (glass for excited wavelengths abo
quartz), a secondary filter that removes scattered light from the beam, and usually a photomultiplier t

Freezers designed to store blood plasma at temperatures at or below -18 degrees Celsius (-0.4 degree
a year; the freezer temperature is frequently set at values lower than minimum requirements, such as
22 degrees Fahrenheit); internal shelving is appropriate for storage and easy location of plasma conta
These freezers are usually made with a corrosion-resistant (i.e., stainless steel) interior, minimizing th
contamination, and corrosion of contents; forced-air circulation and automatic defrost capability, keep
all chambers within preestablished limits; sensors, controls, monitors, chart recorders (week-long reco
alarms (over temperature, under temperature, power failure) for dependable long-term (e.g., 12 mont
plasma, up to 5 years with a anticoagulant preservative) storage of plasma and red blood cells followi
standards. Plasma freezers frequently include backup electrical power sources for control panel functi
failures. They are available in several sizes and configurations (e.g., stand-alone, undercounter).

Freezers designed to store laboratory products and samples. These freezers are usually made with a c
(typically stainless steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion
defrost capability; and sensors, controls, monitors, recorders, and alarms for dependable long-term sto
freezers are typically available in three different temperature ranges: standard, from 0 to -20 or -30 de
or -22 degrees Fahrenheit); ultralow, from -40 to -90 degrees Celsius (-40 to -130 degrees Fahrenheit);
reaching temperatures of -130 degrees Celsius (-192 degrees Fahrenheit) or lower. Programmed (e.g.,
control of the freezing rate is possible in most laboratory freezers; some freezers are designed for flam
and/or include explosion-proof capabilities. A wide variety of capacity and freezer configurations are a
upright, undercounter, and walk-in models.

Laboratory hematology analyzers designed to determine the quantity of hemoglobin (the oxygen carr
erythrocytes) in blood, using a standard spectrophotometric method that measures the 540 nm absor
cyanmethemoglobin. The procedure is performed after a suitable reagent has been added to the spec
to hemolyze red cells and convert hemoglobin to cyanmethemoglobin.

Instruments used in the diffusion of antigen and antibody in a gel medium until both combine and form
Various techniques of immunodiffusion include the double diffusion test (Oudin test) and the single diff
(Ouchterlony test).
Laboratory incubators designed to maintain a controlled environment with molecular oxygen at a leve
than the atmosphere at a pre-determined constant temperature, usually in the range of 30 to 42 degr
degrees Fahrenheit). These incubators typically consist of a chamber with electrical heating elements
units include also heating elements at the walls); the heated air circulates through the chamber by co
fans. Some incubators provide the appropriate temperature by including a jacket between the outer w
wall to circulate heated water. The incubators usually include a thermostat, a temperature display, an
also include humidity controls, recorders, and other accessories. The incubators are used for growing
cells that require oxygen for growth (e.g., bacteriology, virology cultures); they are also used in other
genetics, cancer tests, and in vitro fertilization procedures. Aerobic laboratory incubators are available
supported (i.e., floor) units; dedicated incubators providing controlled carbon dioxide to the chamber a

Laboratory incubators designed to maintain a controlled and suitable oxygen-free (i.e., anaerobic) env
determined range of temperatures. These incubators typically consist of a chamber, a vacuum system
heating system, and a reusable or disposable gas mixture supply (e.g., a gas typically including hydro
dioxide) generator or gas tank to fill the chamber after the extraction of the air. The incubators usually
a temperature display, an oxygen concentration sensor, and alarms; they may also include humidity c
carbon dioxide injectors, and other accessories. Small anaerobic incubators using several different typ
arrangements that may use different means to remove the oxygen (including a catalyst) are also avai
laboratory incubators are mainly used for growing pathologic anaerobic microorganisms; they are freq
anaerobic chambers or anaerobic glove boxes.

Lifts designed to hold up and transfer a corpse safely and with minimal physical effort. These lifts are
configurations (e.g., suspended trays, fork type, scissors type); they are either mechanic, hydraulic, o
(from the line or from a battery). Mortuary lifts are used to transfer corpses to and from stretchers, au
racks, and refrigerators.
Fixed loop instruments designed to deliver very accurate small volume (e.g., 1, 10 microliters) sample
laboratory procedures. These instruments typically consist of a manual, handheld instrument made of
platinum-iridium, nickel-chromium), rigid, metallic wire or plastic loop attached to a slender handle. In
metal loops are usually reusable, while those with plastic loops are usually disposable. Inoculating fixe
used in clinical laboratories and in the field for bacterial inoculation (e.g., accurate inoculums volume
well as in procedures such as sampling, serial dilutions, and urine counts.

Light microscopes used in the clinical laboratory. These microscopes consist of a stand that supports t
the instrument, an ocular body (head) in which the eyepieces are mounted, a nosepiece to support th
specimen stage, a condenser to focus the light on the specimen, and the light source (e.g., tungsten,
port. Laboratory microscopes may have only one ocular for visual observation or photography, two oc
observation (binocular), or a third ocular (trinocular) incorporated for photomicrographic, observation,
These microscopes may include multiple observation capabilities and optical integration of still, motio
cameras. Magnification is the product of the power of the objective and ocular (sometimes an addition
which case magnification is the product of all three lenses). Most laboratory microscopes use intercha
use parts (e.g., objectives, condensers), permitting the observation of samples using several contrast
field, phase contrast).
Microtomes contained in a temperature-controlled stainless steel cabinet called a cryostat. The cryos
microtomists to section frozen tissue specimens for histopathologic analysis. The microtome, tissue sp
housed in a thermostatically controlled chamber insulated with polyurethane foam. The operator pass
through an opening in the chamber and places it on a refrigerated holder near the microtome. The mi
specimen with an aerosol-propelled freezing agent before placing it in the chamber or inserts it into an
freezing specimen holder or polyglycol matrix.

Microtomes that cut tissue specimens for microscopic analysis in the histopathology laboratory using
carbide-tipped, or glass knife and that employs a drive wheel either to step the specimen into a statio
across the blade or to advance the knife toward a fixed specimen block. They are specially designed t
tissue that have been embedded in a medium (e.g., paraffin, plastic) and are convenient for high-volu
Tissue-block sections can be cut at 2 to 6 um. The major components are the feed pawl system, which
into the knife or the knife into the specimen; the specimen cylinder; the flywheel; and the knife holde
holder system is adjustable and designed to accommodate various types of knives and to lock the kni
cutting

Microtomes with superior stability and accuracy that cut tissue specimens for microscopic analysis in t
laboratory using a steel, tungsten-carbide-tipped, or glass knife. They are specially designed to cut th
that have been embedded in a medium (e.g., paraffin, plastic) and are convenient for high-volume rou
block sections can be cut at 0.5 to 0.2 um. The major components are the feed pawl system, which st
the knife or the knife into the specimen; the specimen cylinder; the flywheel; and the knife holder sys
system is adjustable and designed to accommodate various types of knives and to lock the knife into

Filter photometers that use a light source that directs the light through a suspension (e.g., containing
photodetector positioned at an angle from the incident beam to detect only scattered light. Nephelom
particles (e.g., bacteria) in suspension at much lower concentration than is possible using turbidimete

Measuring instruments designed to estimate the intensity of light or the relative intensity of different
Glass or plastic tubes with both ends open that are used for manual transfer of controlled amounts of
container to another. Most pipettes are used to transfer liquid volumes between one and one hundred
may be designed to deliver a specific volume of liquid (i.e., volumetric pipettes) or calibrated to perm
different amounts of liquid with the same pipette (i.e., measuring pipette). Bulb fillers are usually atta
end of the pipette (traditionally known as the mouthpiece); mouth pipetting is an unsafe practice used
the pipette not allowed currently in most laboratories. Volumetric and measuring pipettes of several ty
healthcare facilities, mainly in clinical laboratories.

Pumps designed to transfer or deliver fluids (gas and/or liquid) to support environmental conditions an
specific tasks required in clinical laboratories and associated procedures. A wide variety of laboratory
different technologies (e.g., peristalsis, centrifuges); pumps are usually made of metal alloys, plastics,
materials. Some pumps provide additional features such as temperature control and/or vacuum capab
laboratory pumps are available to perform specific procedures such as the transfer of highly corrosive
chromatography, filtering, and solvent recovery.
Measuring instruments used to determine the ratio of the velocity of light in a vacuum to the velocity
medium (i.e., index of refraction).
Refrigerators designed to store blood bank products and samples, such as reagents, plasma, and red b
periods at temperatures typically between 1 and 8 degrees Celsius (34 and 45 degrees Fahrenheit). Th
frequently set at 4 degrees Celsius (39 degrees Fahrenheit). These refrigerators typically consist of a c
corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulteration, contaminatio
contents; internal shelving appropriate for storage, easy location, and handling (e.g., rotating shelves,
blood bank products (typically blood bags); a compressor, condenser, evaporator, and tubing; sensors
temperature recording chart, and alarms for dependable long-term storage following blood bank stand
emergency power supply for the refrigerator and alarm.

Laboratory refrigerators designed to prevent ignition of flammable materials (vapors and/or gases) at
1 and 10 degrees Celsius (34 and 50 degrees Fahrenheit); the flammable materials may be present ou
or the result of vapors leaking from improperly sealed containers inside the refrigerator. These refrige
switches, and thermostats are insulated to prevent arcing that can ignite flammable air-vapor mixture
explosions inside and/or outside the unit. All explosion-proof refrigerators must be hardwired directly t
rigid metal wires rather than connected by cord-and-plug assemblies. Explosion-proof laboratory refrig
areas in which a flammable atmosphere may develop; they are usually available in upright and underc

Saws designed to cut hard tissue during autopsy and dissection (i.e., postmortem) procedures. These
manual instruments with a serrated-edge blade and a handle, or heavy-duty powered (e.g., electric, p
that drive a circular rotating or oscillating blade. Postmortem saws are used to cut bones (e.g., craniu
tissue; they are frequently provided with an extraction unit and a container for collecting bone/tissue

Clinical scales designed for general use in the clinical laboratory; they include appropriate top surface
great variety of laboratory scales exist, and their capacity ranges from 0.5 to 200 kg (1 to 440 lb), wit
1 to 100 g (0.0025 to 0.25 lb). Laboratory scales are used to determine the weight of bulk materials, s
discrete objects when it is not necessary to have the accuracy of a laboratory balance, when the weig
of a laboratory balance, or when specimens must be weighed in special conditions (e.g., in fume hood

Hematology laboratory analyzers designed for automated measurement and display of the rate of sin
in a volume of well-mixed venous whole blood sample (i.e., erythrocyte sedimentation rate, or ESR, ty
millimeters per hour). These analyzers include specially designed sample cuvettes and sensors (e.g.,
erythrocyte sedimentation rate is usually due to elevated plasma proteins; moderate elevation usually
inflammatory diseases and/or anemia; marked increases may be related to hyperfibrinogenemias,
hypergammaglobulinemias, and other abnormal conditions. Erythrocyte sedimentation rate can also b
manually by measuring the distance that the top of the column of erythrocytes falls in an undisturbed
sample in a specified time interval, following standardized (e.g., Westergren) methods.
Shakers designed mainly for the agitation of liquids during laboratory procedures. These devices are t
electrically powered, countertop unit that shakes (usually to-and-fro vibration) liquid containers (e.g.,
tubes) in several internal or external holders; shakers may include controls for the frequency and/or d
Laboratory shakers are intended for use in many analytic procedures, including drug analysis, water p
hemolysis. Dedicated tabletop shakers appropriate for operation inside fume hoods, incubators, and/o
devices are also available.

Devices that mechanically restore the cutting angle of knives that are used to cut thin tissue sections
examintion. Some sharpeners use a reciprocating process in which the microtome knife is affixed to a
extending from the drive mechanism of the device. The arm lowers the knife onto a stationary, abrasi
copper sharpening plate and moves the knife back and forth. Other sharpeners use a sliding mechani
back and forth across pairs of honing and stropping wheels. Another method uses an arm to hold the b
horizontal lapping disk that contains an abrasive compound. Most sharpeners allow the operator to ad
knife; many instruments also have automatic controls for setting the duration of the knife sharpening.

Sinks designed to collect and drain fluids discharged from a cadaver during autopsy and/or dissection
usually configured to permit the direct collection of the fluids from dissection and autopsy tables witho
manipulation of the bodies. These sinks typically consist of a metallic structure with one or more stain
seamless and without crevices construction including several faucets, cold and hot water supply, a va
dispensers, and appropriate tubing for drainage. The sinks may also include sponge bowls to rinse and
instruments, exhaust ducts for connection to the building ventilation system, drawers for instruments
electrical receptacles. Autopsy/dissection sinks are available in stand alone and wall-mounted configu

Slide stainers that automate the staining of peripheral blood and other hematologic smears to facilitat
microscope differential counts using Wright's stain, a Romanowsky stain. The operator inserts slides in
a time or programmed procedure. Linear transport slide stainers have a transport arm that moves bas
out of parallel regent vessels. Robotic arm stainers allow the user to program the stainer to move the
the slides to the desired bucket. Centrifugal stainers spray reagents onto slides placed in a rotating ca
centrifugal force to remove excess reagents and dry the slides. Linear transport and triaxial arm stain
controlled. The centrifugal slide stainer is controlled by a microprocessor that regulates the amount of
solution sprayed onto the slide and centrifugation time and speed. Platen stainers apply reagents by c
are placed in grooves on conveyor spirals and moved face down along a platform.

Slide stainers that automate the staining of prepared cytology and/or histology tissue specimens by d
specimens through surface adsorption, direct staining, indirect staining, or mordant staining. The two
used by automated slide stainers are rotating and linear transport. Rotating systems usually use a tra
a basket to the appropriate staining or wash vessel located on a circular platform and then lowers and
and out of the vessels. The linear transport system uses either a conveyor belt that transports the slid
vessel or a transport basket with one or more linear transport arms and a series of parallel staining an
designs have built-in fume hoods or lids affixed to each staining vessel to prevent laboratory personne
devices incorporate programmable microprocessor controls.

Radiation counters used to measure gamma radiation in nonimaging nuclear medicine procedures, su
thrombosis scan or the renogram.
Racks designed for holding test tubes during the performance of a laboratory procedure. These racks
metal, wooden, and/or plastic framework with holes across it to slide the test tubes and hold them in p
culture procedures are usually intended to hold the test tubes in a nearly horizontal position in order t
of the culture medium inside the tubes. Test tube racks are mainly used in clinical laboratories (e.g., to
surgery centers, and research laboratories.

Small-diameter cylindrical tubes designed for use in performing laboratory tests. These devices are us
tubes with a rounded, conical, or flat closed bottom and an open top; they may include external threa
marking spots, color codes, and/or graduated markings on the surface. Test tubes are available in a va
may be intended for reuse or as disposable (i.e., single use) devices. Some test tubes are made of spe
of withstanding high temperatures and/or repeated sterilization (i.e., autoclaving). Test tubes are used
for procedures such as tissue culture, bacteriology, clinical chemistry, and blood typing

Systems designed to provide optimum conditions for microorganisms and/or cell cultures under contr
anaerobic, conditions. These systems typically include a main unit, the incubation chamber, consisting
electromechanical apparatus with a mechanism (e.g., stirring, shaking, rocking, waving) that provides
chamber, a heating/cooling system (e.g., heat exchanger, water-jacket), gas sources (e.g., oxygen, ca
for aerobic and anaerobic cultures, and process controls (e.g., temperature, gas concentration, pressu
usually include other devices, such as pumps, mixing devices, and scales. Tissue culture systems are
cultures performed in plant, insect, and mammal cells (including human cells), and tissues.

Devices that automate the fixation, dehydration, clearing and infiltration of tissue specimens to help p
of their cellular components for light or electron microscopy. In moving basket processors, reagents an
baths-usually glass, ceramic, or plastic beakers that are located either in sequence below the advanci
circular array beneath a carriage supported by a central master shaft. Tissues are placed in individual
each of which is placed a larger perforated tissue basket, which is then attached to the motor driven a
carriage. The carriage moves the basket to each reagent, which enters the basket. Stationary chambe
alternately fill and drain the chamber holding specimens with fixative, dehydrating agents, clearing ag
fluids as required. Small pumps add and withdraw fluid to and from the chamber; some units use a va
chamber and pressure to drain the chamber and fluid lines.

Blood-collection tubes designed to draw capillary blood into a microtube usually by capillary action. Ty
of the capillary tube touches the drop of blood, the blood flows up into the tube via capillary effect as
of the tube remains open. These devices are typically very small size glass or plastic-wrapped glass tu
of the tube end-to-end defines a specific amount (usually on the order of microliters) of collected bloo
usually available as plain tubes or with an internal coating; the type of coating (e.g., an anticoagulant
depends on the intended use of the sample being collected, and for this reason the tubes are usually
of the cap. Capillary/microcollection blood-collection tubes are used to obtain samples by skin punctur
patient populations, including infants, for serum, plasma, and whole-blood determinations.

Floor centrifuges which operate usually at speeds of 30,000 to 120,000 rpm and relative centrifugal fo
800,000 gravities. Ultracentrifuges must be refrigerated because air friction created at ultrahigh spee
could decompose the components being centrifuged. These devices are used for lipoprotein separatio
enzymes, and blood fractions for analysis and also make possible the fractionation of DNA and RNA an
structures and functions within the cell.
View boxes equipped with visible light lamps, and a translucent, heated, horizontal surface, which is u
agglutination. The surface of the box should be maintained at a temperature in the range of 40 to 50
provide the proper temperature for reaction between red blood cells and antisera.
Washers designed for the automatic removal of dirt and/or stains (i.e., washing) from labware such as
beakers, test tubes, and glass slides. These washers typically consist of a stainless steel washing com
resistant to high water temperatures and corrosive chemicals, horizontal loading tracks or perforated
headers, which are rows of hollow rods that allow water to penetrate difficult-to-reach vessel interiors.
carrier baskets that slide onto the horizontal loading tracks or perforated shelves of the washer compa
Labware/surgical instrument washers perform cycles of operations that typically include water prewas
detergent wash, heated rinse, and drying. The washers are available in freestanding, undercounter, re
(pass-through) configurations; they are used in clinical laboratories and in hospital central supply depa

Washers designed for the automatic removal of dirt and/or stains (i.e., washing) from pipettes (e.g., se
These washers typically consist of a stainless steel or plastic (e.g., high-density polyethylene) washing
resistant to high water temperatures and corrosive chemicals, as well as appropriate containers and h
Pipette washers perform cycles of operations that typically include water prewash, enzyme treatment
chemical wash, and cold and/or heated rinse; the process usually includes mechanical removal of con
and/or other procedures such as intermittent siphoning to produce a turbulent fill-and-empty cycle in
washers include drying capabilities. Pipette washers are used mainly in clinical laboratories; they are a
of pipette lengths (e.g., [38, 61, or 81 cm] 15, 24, and 32]). Multipurpose labware washers may also b
pipettes, but their use is usually limited to pipettes a maximum length of a few inches.

Equipment designed for the automatic or semiautomatic removal of dirt and/or stains (i.e., washing) f
utensils, labware, devices, laundry, and/or other objects using physical and/or chemical procedures. W
perform a cycle of operations that may include prewash, enzyme treatment, detergent washing, and r
washers are used to clean surgical instruments and/or ancillary devices, hospital carts, and laundry an
in clinical laboratories (e.g., labware, pipettes, microplates, cuvettes). Washers that mechanically rem
scrubbing or using water jets or ultrasound energy (i.e., performing some kind of physical decontamin
washer/decontamination units; those devices may also provide some degree of disinfection.

Oximeters that measure the mixed venous blood-oxygen saturation (SvO2) using a catheter that inclu
These oximeters include LED light sources, which generate light of different wavelengths and are tran
fiberoptic channel to the tip of the catheter, where they are absorbed, refracted, and reflected by the
blood reflectance changes, which depend on hemoglobin forms, are processed and displayed as SvO2
oximeters are used in diagnostic cardiac catheterization, cardiac surgery, and sometimes to evaluate
through an umbilical artery. Some instruments may be coupled with dedicated pulmonary arterial cat
continuous display of both SvO2) and hemodynamic measurements.

Oximeters designed primarily for determining the relative amount of oxygenated and deoxygenated h
HHb, respectively) by measuring light absorbance changes in blood samples and displaying the result
of hemoglobin in arterial blood (SpO2). The operation of these oximeters is based in measuring the lig
passes through a blood sample at different wavelengths, either using photometric or spectrophotome
oximeters are used in central clinical laboratories and also at the point of care in surgical areas and cr
Telephone transmitter/receiver systems designed to transmit and receive electrocardiographic signals
channels. These systems typically include at the transmitting site an electronic device (e.g., a modem
from medical (e.g., external, ambulatory, implanted) devices such as electrocardiography (ECG) monit
makes them transmissible through telephone lines. At the receiving end, another electronic device (i.e
processes the incoming signal and provides an output signal appropriate for display on ECG monitors
recording, and/or for further transmission and processing by healthcare information systems. ECG tel
transmitter/receiver systems are typically used to send signals from patients' homes, doctors' offices,
locations to hospital and other healthcare facilities using standard and/or cellular telephone lines. Ded
intended for single-channel and multi-channel electrocardiographs may be also available.

Test tube laboratory incubators designed to be easily carried by a person (i.e., portable). These incuba
appropriate temperature (typically 37 degrees Celsius/98.6 degrees Fahrenheit) to test tubes placed e
partially introduced into the incubator. These incubators typically consist of a portable unit with heate
temperature controls; and a display to show the temperature. They also include a metallic block that h
and/or other small containers in a vertical position. The unit may provide batteries and/or appropriate
electric power from batteries commonly used in vehicles. Portable test tube incubators are used to ke
emergency situations and/or for transportation of embryos, semen, and other sensitive cells and/or tis

Laboratory incubators designed to provide appropriate temperature (typically 37 degrees Celsius/98.6


for test tubes placed either on top of or partially introduced into the incubator that are intended for st
These incubators typically consist of an electronic unit with heaters to provide dry heat; temperature
to show the temperature values. They also include a metallic block that holds the test tubes and/or ot
a vertical position. Stationary test tube incubators are used in blood banks and in clinical laboratories
tests and/or to keep viable embryos, semen, and other cells and/or tissue.

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
perforation of the uterus to obtain amniotic fluid (i.e., amniocentesis). Items in these kits usually inclu
syringes, anesthetics (e.g., lidocaine ampules), collection tubes with caps, sponge applicators, a ruler,
absorbent towels, fenestrated drapes, and bandages. The kits are frequently supplied in supporting tr
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Amniocentesis procedur
intended for use during labor and delivery to assess fetal lung maturity, to establish rupture of memb
infection, to evaluate fetal well-being, or to evaluate for chromosomal abnormalities.

Surgical instruments designed for marking the surface of or piercing small holes in rigid or semirigid t
cartilage) and/or exploring or initiating access through cortical bone during surgical procedures. Awls a
handheld, manual instruments with a handle and a straight or curved pointed distal end.

Small, sterile, sealed containers, typically manufactured from glass or plastic, that are designed to con
(e.g., a single dose) of a substance (e.g., a drug solution). An example of an ampule design would inc
that has a short body and a thin long neck/stem that can be manually snapped off in order to open the
the contents (e.g., with a syringe and needle).
Synthetic polymer tubing made of silicone, an elastomer also known as silicone rubber. Silicone tubing
diameter, hollow, flexible or semirigid cylinder designed for the transfer of fluids, either liquids or gase
different structures (e.g., reinforced) according to the intended use. Silicone tubing is usually available
lengths and in a variety of diameters and wall thicknesses (i.e., gauges) that permit the use of segme
appropriate for a given application in the healthcare facility, especially when high resistance to oils an

Clean rooms designed to provide a flow of air within the enclosure with uniform velocity and parallel d
air flow), distorted only by objects in the flow pathway. These rooms include blowers appropriate for l
(either vertical or horizontal), high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA)
and temperature controls. Fixed laminar air flow clean rooms are used to provide the cleanest air poss
mainly to be used in health care facilities for clinical laboratory, biotechnology, pharmaceutical, and s

Laminar air flow clean rooms mounted on casters or other means for ease of movement. These clean
a very low particle content environment; class 100 or better (ISO 5 or less) are typical, which reduces
the room environment. The laminar flow may be either vertical (e.g., from the ceiling down) or, less fr
distorted only by objects (e.g., surgical lamps) and staff in the flow pathway. Mobile laminar air flow cl
consist of a metallic or plastic structure typically including rigid plastic coverings, high-efficiency parti
lighting fixtures, and/or working surfaces. Mobile clean rooms are used to provide a contamination-fre
applications (e.g., surgery) and/or for emergency situations in healthcare facilities.

Sponges designed for thorough cleansing and disinfection of the hands, fingers, nails, and arms when
cleanliness is required before surgical and other (e.g., catheterization) procedures. These sponges are
improved cleaning; scrub sponges are made of absorbent porous materials (e.g., rayon, plastic, rubbe
treated with an antibacterial agent that prolongs sponge life. Disposable and reusable scrub sponges
combination of scrub brushes and sponges are available.

Contrast media injectors designed to inject the contrast media through a small catheter into the vascu
angiographic studies. These devices typically consist of automated electromechanical injectors with s
either reusable, disposable, or both; pneumatic mechanism are less frequently used. Angiographic co
are capable of delivering with the pressure, flow range, and volume required for angiographic studies,
synchronize the delivery with the electrocardiographic cycle and/or the x-ray generator. They are used
examine the coronary and renal arteries, the great vessels and the vasculature of the heart, brain, ab
extremities.

Contrast media injectors designed to inject the contrast media through small catheters or cannulae in
system for lymphangiography procedures. These devices typically consist of automated electromecha
syringes that may be either reusable, disposable, or both; they can control the injection rate of two s
permitting unilateral or bilateral injection. Lymphatic contrast media injectors are capable of deliverin
the pressure, flow range, and volume required for lymphangiographic studies. They
diagnostic procedures, especially in the lower extremities

Contrast-media plunger syringes designed for injection into arteries or veins for radiographic angiogra
of these syringes are incorporated into automated contrast media injectors, usually an electromechan
the piston in and out of the syringe barrel.
Screen dividers designed to separate the anesthesiologist working area and the surgical site during su
These screens are typically opaque or translucid stand-alone structures that include appropriate mean
screen dividers may include brackets for attachment to the ceiling and/or walls. Anesthesia screen div
to provide a permanent or temporary barrier between the sterile surgical area and the anesthesia staff

Ophthalmic diagnostic instruments designed for assessing the retinal circulation of the eyes and the v
media opacity; the instruments permit the patient to visualize the leukocytes flowing in the patient's p
capillaries when viewed against a field of pure blue light (blue field entoptic phenomenon). These inst
consist of a light source, a lens system, and a light filter; they project a shortwave blue light into the e
retina, centering the light at the fovea in such a way that the patient can view his or her own white bl
perifoveal retinal vessels. The patient reports his/her observations regarding the location of the corpu
the whole field (e.g., number, movement, distribution, and where there are very few corpuscles). Ento
mainly to evaluate macular pathologies and retinal circulation for detection of some disorders (e.g. gla
predict potential visual function before cataract surgery.

Nephroscopes designed with a nonrigid (i.e., flexible) structure, capable of being manipulated through
from an incision in the skin to the kidney. The sheath is usually made of plastic.
Nephroscopes designed with a nonflexible (i.e., rigid) structure that can only follow a straight path fro
skin to the kidney. The sheath is usually made of stainless steel.
Pillows that are shaped to conform to the natural curvature of the neck, which promotes correct head
patients sleeping on their back or side and prevents interference from the shoulder and upper arm in
their side. They usually are rectangular with one or more sides thicker than the center. Some are cres
around the neck; others are the shape of a standard pillow but are filled with gel, water, or air (inflatab
the natural curvature of the neck.

Dedicated caps or connectors that couple with and fit on pressure transducers which are used to invas
pressure or pressures of other liquids or gases. These domes can be various sizes and are usually mad
feature one or more stopcocks to direct the flow of the liquid or gas onto a diaphragm or membrane w
sensed by various methods by the pressure transducer. Pressure transducer domes may be sterilizabl

Holders designed to hold pressure transducers in the correct position on a patient's body or on a stand
near a patient's bed. These holders typically contain one or more clips or slots to hold the transducers
attach to the patient's body (using straps or other fasteners) or to a stand or pole near a patient's bed
holders are usually made of plastics and are sized to the type of transducers that they are meant to h

Laboratory blood analyzers dedicated to measure serum iron, total iron binding capacity, and transfer
analyzers may be automated. The results are frequently obtained by comparison with a calibration cu
absorbance of iron standard working solutions. These assays are useful only in screening for chronic i
and for confirmation and monitoring of acute iron poisoning in children; they are therefore unreliable f
deficiency.

Laboratory analyzers used to determine the concentration of lead in anticoagulated blood (lead is con
erythrocytes) or urine. Most laboratory lead analyzers are based on atomic absorption spectrometry o
chromatography/mass-spectrometry methods. Dedicated lead analyzers are mostly used to determin
concentration (as an indicator of toxicity) in patients.
Immunoassay analyzers that attach a radioactive substance (e.g., iodine 125) as a label to the antigen
the concentration of the ligand (the substance being analyzed) in the specimen under analysis using t
antigen-antibody reaction. These analyzers usually include a sampler; pipetting, mixing, and incubati
separation mechanism (to separate the free ligand from the ligand-binder complex), a radioactivity co
counter), and a data-processing (data reduction) computerized device. Radioimmunoassay analyzers
technique for measuring analytes (e.g., hormones, vitamins, viruses) in patient body-fluid samples, su

Susceptibility microbiological analyzers that perform the analysis with minimal involvement from the t
automation in most steps of the test procedure, including automated reading of the test, reduction of
generation of an interpretation of the test results; most analyzers include integral incubators, and som
culture preparation process. Most of these analyzers use photometric, fluorimetric or video-image ana
include sample containers (e.g., vials, trays), a reader module to scan the containers, and a computer
data processing.

Simulators designed for use in cardiopulmonary resuscitation (CPR) training. The anatomic models use
typically include a model of the head, neck, and torso with anatomical landmarks such as nose, mouth
The simulators also include devices such as masks, gloves, and inflatable bags (with face shields on th
be inserted in the model's torso to represent the lungs. Many of these anatomic models provide realis
compressions. Instructors can use the CPR simulators and the anatomic models to demonstrate variou
CPR is needed and possible patient reactions. Emergency medical technicians and other healthcare w
practice their CPR skills, rescue breathing, and choking first-aid instruction using CPR simulators. Anat
these simulators are available in different body types and sizes such as infant, child, adult, and bariat

Dedicated laboratory liquid densitometers used for determining the specific gravity of urine samples.
instruments consist of a hydrometer--a long, slender glass float with a small metallic weight at the low
glass or plastic cylinder for the urine sample. The hydrometer, graduated in specific gravity units, is p
containing the sample; the depth to which the float sinks indicates the urine's specific gravity.

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
peritoneal fluid from the recto-uterine pouch posterior to the vagina through a needle (i.e., culdocente
kits usually include a speculum, antiseptic swabs, chlorohexidine, lidocaine, a gauge spinal needle, sy
tenaculums. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. These procedure kits and trays are intended for use during diag
procedures to check for abnormal fluid in order to identify pelvic inflammatory diseases, ectopic pregn
Culdocentesis procedure kits and trays are used in doctors' offices, hospitals, and other healthcare fac
Prepackaged collections of the devices and supplies (either custom or standard) needed for preparing
delivering an injection of a contrast medium into the joint space in order to visualize a joint by radiogr
arthrography). Items in these kits usually include a syringe, needles, a contrast medium (e.g., iodine),
cotton pads. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Arthrography procedure kits and trays are intended for use in h
healthcare facilities to allow visualization of the articular space by injection of a contrast medium (e.g
cause of unexplained joint pain).

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed to dr
for closed craniotomy wounds. Items in these kits usually include disposable containers attached to su
suction pumps, disinfectant swabs, tape, and dressings. The kits are frequently supplied in supporting
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Craniotomy closed wou
kits and trays are intended for draining potentially harmful fluids, such as blood, pus, sanguineous flui
secretions from craniotomy wounds. They are used mainly in operating rooms but may be used in oth
facilities.

Gel designed to act as an ultrasonic conductive media (i.e., an acoustic coupling agent) to enhance th
ultrasound waves from the ultrasonic probe to the body of the patient and vice versa. This gel is appli
probe and the skin surface of the area being examined and/or treated. Ultrasonic coupling gel is main
or treatment procedures with ultrasound energy.
Tubes designed for access to the bronchi through the mouth or nose for examination, treatment, or ot
ventilation. These tubes typically consist of very small diameter rubber or polymeric flexible hollow cy
and other physical characteristics (e.g., flexibility) appropriate for reaching the bronchi. Bronchial tube
the diagnosis of pulmonary diseases, to treat hemorrhage (i.e., tamponade), and/or to provide suction
substances. Dedicated tubes intended for use in endoscopic procedures (i.e., bronchoscopic tubes) are

Tubes designed to provide communication between the middle ear and the external ear canal through
tympanic membrane (i.e., myringotomy, also known as tympanoplasty). These devices typically consi
lumen polymeric (e.g., Teflon, Silastic) or, less frequently, metallic tube. Myringotomy tubes provide v
from the middle ear, reducing the risk of infections; they are intended mainly for children five years ag
the healing period in cases of secretory otitis media. The tubes are frequently used to bypass a blocke
providing ventilation of the middle-ear cavity via the external ear canal.

Laboratory incubators designed to provide appropriate temperature (typically 37 degrees Celsius/98.6


test tubes placed either on top of or partially introduced into the incubator. These incubators typically
unit with appropriate heaters to provide dry heat; temperature controls; and a display to show the tem
also include a metallic block that holds the test tubes and/or other small containers in a vertical positi
dedicated stationary test tube incubators used in blood banks/clinical laboratories and portable incuba
for field use.
Devices designed to send a clearly distinctive signal (e.g., visible, audible) when the value of a physic
main feature of a patient or device is out of its normal range jeopardizing the health status, equipmen
performance of a procedure. These devices typically consist of an independent (e.g., electromechanic
is connected to sensors (e.g., temperature, gas concentration, position), amplifiers, controls, and visua
that may be located at the site, at a central station, and/or in other remote location. Alarm devices are
continuous display or accurate measurement of the detected parameters; some other devices (e.g., m
clinical and laboratory equipment) may include alarm systems as an integral part. Alarms used in hea
include, in addition to common alarms (e.g., fire, smoke, environmental hazards, electric and other eq
dedicated alarms such as those used to warn of failures in vital gas supplies (e.g., central gas systems
patient ambulation (e.g., bed and/or chair occupancy), abnormal conditions in clinical procedures (e.g
and environmental hazards related to gases and other substances used in healthcare procedures.

Laboratory analyzers designed to examine samples of compounds or mixtures to determine the natur
their constituents and/or separate them into their constituent substances by means of chemical reage
perform additional physical processes (e.g., centrifugation). Most clinical chemistry laboratory analyze
determine the concentration of certain metabolites, electrolytes, proteins, and/or drugs in body fluids
urine, cerebrospinal fluid).

Laboratory hematology analyzers used to detect abnormalities in the process of complete normal bloo
these analyzers determine prothrombin, activated partial thromboplastin, and thrombin times; they al
chromogenic, and coagulation factor assays. These analyzers typically use photometric electrical impe
electromagnetic techniques to detect changes in the sample when the clot forms. Blood coagulation a
detect clotting-deficiency-related-diseases (e.g., hemophilia, impaired liver function) and to monitor th
(e.g., heparin, warfarin) and of blood components therapy.

Garments designed to be worn to protect the front of the user's body and the user's clothing. Aprons a
cloth or plastic and tied around the waist and the neck. They are usually fitted with ties at neck and w
be adjusted to the individual wearer and include a bib attached to the front panel. Aprons often includ
made to be disposable or reusable. Also available are aprons intended to facilitate hands-free evacuat
conductive aprons; and aprons intended for use by laboratory personnel. Dedicated aprons intended t
staff during x-ray procedures (examination, dental) are considered to be shields.

Open vessels, usually circular or kidney-shaped, used to hold fluids for washing, soaking, or treating o
device. They are typically made from metal or plastic that can withstand high temperatures for autocl

Devices used to influence other objects, media, a human's body or body part in order to transfer the t
which the bath is intended to the object. Purposes can be, e.g., cleansing, therapeutic, temperature c
reaction, etc. Objects can also be exposed to mechanical influence, e.g., ultrasonic waves, water jets
massage, or other forms of reaction.
Special types of bandages, typically with an encircling structure, designed to fit and support a specific
These devices are usually made of single pieces of elastic fabric that have hook-and -loop closures (e.
adjustment of the size of the binders. Binders are used mainly to support and compress the muscles o
surgery and/or to provide relief from pain and strain; they can also be used to keep dressings in place
in different shapes and sizes; dedicated binders designed to support abdomen, ankle, breast, chest, w
also available.
Devices designed for cutting purposes typically attached to a handle or as a component of a specializ
typically consist of a flat piece of metal (e.g., stainless steel) with a sharp edge; they may be intended
single-use. Dedicated blades are available for use with manual or powered cutting instruments (e.g., k
trephines). Blades used for purposes other than cutting, which are usually components of other instru
laryngoscopes and retractors), are not included in this category.

Slender surgical instruments designed for passing through thin anatomic tubular structures (e.g., ear
esophagus) for the purposes of calibrating and/or dilating the structure, guiding another instrument th
dislodging an object. These handheld, manual instruments are typically flexible, rod-shaped, frequent
metal, plastic, or rubber; they come in a variety of shapes and diameters. Dedicated bougies are avai
shapes at their distal tip, such as bulbous or olive-shaped. Some bougies allow the introduction of a fil
small caliber (i.e., a filiform) through the hollow core and/or include a balloon at the distal tip.

Containers that are typically round or kidney shaped, concave, and wider than they are deep. These c
holding, mixing, and/or storing foods, liquids, bodily fluids, and/or devices/supplies. These containers
made of metal or ceramics that can be cleaned/autoclaved) or disposable (e.g., made of plastic or car

Devices that deliver oxygen, air or other gases to a patient. They are typically constructed of rubber o
tubing and are available in reusable and disposable types.
Devices designed to determine and/or adjust the accuracy of a measuring instrument so that the instr
make measurements that are accurate to within a specified tolerance. Most calibrators assess the me
measurements deviations from a standard; others are high-accuracy simulators used to calibrate instr
capable of adjustment. A calibrator should be several times (e.g., 4 to 10 times) more accurate than t
calibrated. Calibrators are also used in nuclear medicine to assess the radiation dose of radionuclides
administration to patients.

Prepackaged collections of the devices and supplies (either custom or standard) needed for insertion o
body cavity, duct, or vessel. Items in these kits usually include a catheter, drapes, syringes, under-pad
cotton or rayon balls, a lubricant packet, and povidone-iodine solution; catheterization kits may also in
containers and a collection bag. The kits are frequently supplied in supporting trays (i.e., procedure tr
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Catheterization procedure kits and trays are int
catheters used for drainage and administration of fluids, and/or permit access by surgical instruments
catheterization kits for particular procedures such as intravenous, cardiac, and urinary tract catheteriz

Completely enclosed rooms, spaces, or cavities that are kept at a quickly established, controlled, and
environment to protect the materials, patients, animals, plants, or substances contained within them f
contaminants, interference, or conditions. They typically consist of main chambers, transfer chamber
series of audible and visual alarms to alert operators to altered conditions, compressors, air filters, vac
quick response systems, view ports for observation, monitors/controls, and air-lock systems. They als
compressors, pumps, and controls to create and maintain a specific environment regulated by a progr
microprocessor. Depending on the type of chamber, they are used in pharmaceuticals, laboratories, a
emergency medicince, clinical use, experimental science, infection control, hematology, and patholog
A sheet of information in the form of a table, graph, diagram, or image used for the purpose of evalua
testing.
Systems used to separate mixtures of chemical compounds into individual components depending on
which various substances moving in a stream (mobile phase) are retarded by a stationary material (st
they pass over it. These devices include as principal components the adsorbing material support syst
layer), a developing or eluting solvent mixture, and a detector to identify the separated components (
This technology can be used to measure trace quantities of chemicals in body fluids as well as to purif
compounds, and quantify levels.

Instruments designed for cutting using a mechanism that performs a two-blade clipping action to cut
(e.g., hair, nails) placed between the blades. Clippers are typically handheld instruments, either manu
powered, used for personal hygiene or grooming; they are available in a variety of shapes. Standard a
clippers are used in healthcare applications mainly for cutting nails or hair (on the head and/or body)
procedures; some clippers are designed specially for disabled individuals. Other instruments, such as
nippers, are also used to cut hair and/or nails.

A physical barrier used to protect clothing, devices, instruments, or furniture from pathogens, heat, co
allergens, or other environmental exposures. Covers can also provide protection and a comfortable su
barrier can be flexible or inflexible and can be made of a number of different materials, such as plastic
non-woven), and can be absorbent or non-absorbent, depending on the intended uses. The cover can
contents of hampers or laundry carts.

Devices that are hand-held and used as receptacles to hold beverages for consumption, medication in
other objects. Cups are typically taller than they are wide, made of glass, plastic, metal, or paper, and
disposable.
Detectors designed to locate a metallic foreign object in a patient's body. These detectors are typically
use one of several techniques (e.g., tuned oscillators, low-intensity electromagnetic fields); dedicated
to locate only ferromagnetic metals and/or discriminate between ferromagnetic and nonferromagnetic
the identification and removal of foreign bodies that entered the patient accidentally (e.g., ingested o
fragments), were implanted (e.g., prosthesis), or were inadvertently left in the patient (e.g., following
detectors (i.e., photographic metal detectors) can be coupled to imaging systems to provide an image
and the surrounding tissue that resembles a radiographic image taken with a conventional x-ray unit.
detectors are typically used to facilitate the extraction of foreign objects and/or to detect objects befo
resonance imaging scan.

Hollow tubes, open at both ends, with an aspiration bulb attached to one end, intended for aspirating
volume of liquid in single drops. Droppers are usually made of glass or plastic.
Instruments designed to measure mechanical force, including the force produced by muscular contrac
intended for clinical use are available in a variety of designs and using different mechanisms (e.g., squ
spring-type) to measure muscle strength, according to the anatomic part (e.g., hand, back, leg), the fo
the intended evaluation, and the level of precision needed. Clinical dynamometers are intended main
strength after illness or trauma and as a tool to evaluate an individual's progress during treatment (e.
therapy). Dedicated clinical dynamometers are available to measure hand grip, pinch, and leg and/or
dynamometers are used for inspection, repair, and/or calibration of medical devices and instruments.
Devices consisting of electrical conductors, usually metallic, that are designed to transmit electrical si
instrument, equipment, or system. Electrodes used in healthcare include a great variety of reusable a
devices according to the intended application. They include electrodes used to: (1) detect and transm
electrocardiography, electroencephalography, electromyography) signals from the human body; (2) pr
to the body (e.g., defibrillator, pacemaker, neuromuscular stimulation); (3) perform electrosurgery; an
diagnosis (e.g., blood gas, pH) analysis. Some electrodes may be intended for a combination of differe
electrocardiography and pacing). Dedicated electrodes intended for one or several types of healthcare
available; specific types of electrodes can be classified based on the particular characteristics of the s
and/or measured, the stimuli to be delivered, or the environment existing during the procedure.

Electrodes designed to deliver or receive radiofrequency (RF) electric current to body tissues from ele
(ESUs). Electrosurgical electrodes can apply monopolar or bipolar current; bipolar ESUs have two activ
deliver RF energy to the tissues to be ablated while monopolar ESUs have one active electrode and a
dispersive) electrode which only functions to close the electric circuit loop. The current is delivered in
includes an RF generator located in the electrosurgical unit; insulated cables; active electrodes that ar
of a handpiece; patient tissues; and one or more return (dispersive) electrodes attached to the skin wh
ESU. The current circulation is controlled using hand or foot controllers (switches); some active electro
mechanisms for smoke evacuation. Electrosurgical unit electrodes are used in procedures intended to
bleeding, and/or for tissue fusion.

Equipment designed to maintain a thermally insulated compartment at temperatures below the freezi
0 degrees Celsius [32 degrees Fahrenheit]). This equipment is used mostly to rapidly freeze and store
Freezers used in healthcare facilities are usually dedicated equipment manufactured with appropriate
characteristics, such as range of temperature, size, shelving, accuracy, reliability, and configuration a
uses (e.g., in clinical laboratories, blood banks, pharmacies); standard devices for general use (e.g., fo
also used.

Prepackaged collections of the small (e.g., handheld) devices and supplies (either custom or standard
instillation and drainage of fluid into a body structure, cavity, or wound for the purpose of cleansing or
items in these kits include a bulb or plunger syringe, a container, a tip protector, a waterproof drape,
device (e.g., a clamp), and an alcohol prep pad. The syringe used for irrigation in the kit may be also u
removal) of the irrigating fluid and/or debris. These kits may be supplied in supporting trays (i.e., proc
of a flat-bottomed receptacle with a border around the periphery supporting all the instruments and s
procedure; the trays are usually covered or wrapped. Dedicated irrigation/lavage kits and trays intend
procedures, such as lavage of the urinary bladder, ear, eye, and peritoneum, are available.

Cylindrical containers with no handles that usually have a wide mouth and a lid. These devices are eit
single-use) or reusable containers made of plastic, glass, porcelain, or metal; the lid may be made of t
material or a combination of materials (e.g., glass container and a stainless steel lid); they are supplie
according to the dimensions and/or use of the objects to be preserved. Jars are typically used as clean
disposable instruments (e.g., blades, applicators, tongue depressors) and/or other products (e.g., dres
frequently used in diagnostic, treatment, and/or surgical procedures performed in hospitals, doctors' o
minimizing the possibility of contamination.
Endoscopes designed for percutaneous insertion through an incision in the renal pelvis for visual exam
removal or crushing of stones, and treatment of lesions of the interior of the ureters and kidneys. Nep
consist of an outer sheath, a lighting system, and a working channel for catheters and operative devic
flexible or rigid.
Devices designed to oxygenate venous blood. Gas exchange occurs between blood and gaseous oxyg
oxygen to blood while taking out carbon dioxide from it. These devices are usually manufactured for e
transfer; most oxygenators incorporate a heat exchanger to control the temperature of the blood. Two
are in current use: the bubble oxygenator and the more widely used membrane oxygenator; Oxygena
attached to heart-lung bypass units during open-heart surgery, they are also used in patients with res
syndrome or respiratory insufficiencies.

Cushions or pads that are placed behind or around the neck, back, or head to provide comfort or to re
by providing proper support to the stressed areas. They are generally cloth bags filled with feathers, s
fiber, or foam. Sometimes they are inflatable or gel filled for adjustable support.

Open frames designed for holding, storing, or arranging objects for display. Racks typically consist of a
and/or plastic framework with rails, bars, hooks, shelves, or pegs on which articles are deposited. Ded
for temporary holding of garments (e.g., coats, gowns, aprons), storage (e.g., bedpan, magazine), filin
drying, or for other particular purposes are available. Some racks have small wheels to facilitate place

Devices primarily designed for recording data, waveforms, and other graphic, sound, or visual informa
physiologic events for examination after the events have occurred. Recorders usually consist of an ele
electronic device that includes amplifiers, data processors, and memory (e.g., electronic, optical, mag
information. Some recorders may include a display and/or integral printers; other recorders provide ou
analysis of the recorded information employing dedicated software. Most recorders include external sl
for compact, magneto-optical, or digital versatile disks and/or external memory cards. Recorders using
(e.g., cassette) memory or a rotatory cylinder (i.e., chart recorders) are less frequently used. Recorder
are mostly intended to assess the physiologic parameters of people (i.e., physiologic recorders), to rec
equipment performance (e.g., IVD equipment) and/or on environmental characteristics inside healthca

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
obtain samples for in-vitro tests. Items in these kits usually include instruments, supplies, drugs, and/o
to the sample to be obtained and the body part from which the sample is taken. The kits are frequentl
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
procedure kits and trays are intended to obtain biological (e.g., blood, blood gas, endometrial), enviro
hazardous chemicals), and/or other samples for laboratory analyses.
Laboratory equipment designed to automate the staining of fixed samples intended for microscopic ex
stainers may use several different techniques, including surface adsorption, direct and indirect stainin
staining. Automated slide stainers perform staining faster and more uniformly than manual methods;
procedure usually improves the quality and consistency of results. Dedicated slide stainers are availab
hematology, microbiology, and cytology/histology; slide stainers that can perform immunostaining of
specimens (i.e., for immunohistochemistry, histochemistry, and/or in situ hybridization) are also availa

Photometers that determine the absorbance or transmission of the light energy transmitted through a
any narrow adjustable (typically from 0.1 to 10 nm) bandwidth. Their principal components are a stab
dispersing device (grating or prism monochromator), a cuvette, an adjustable slit, a photodetector, ap
process the detector signal, and a means of displaying the results. These instruments have clinical ap
the quantitative analysis of biological substances and enzymes or drugs and their metabolites in spec

Mechanical instruments (retractors) designed to be used to separate the walls of a cavity to make exa
treatment possible. These instruments frequently include two pivoted arms. The portions closer to the
usually the handle, while the distal portions are inserted into the cavity; specula may be of many diffe
When force on the specula handle is exerted, the blunt distal tips open the cavity. Other specula consi
devices. Specula are used for examination and/or treatment through natural canals of internal tissues
human body that are otherwise inaccessible, frequently by inserting other instruments through them.
(typically made of stainless steel) or disposable (usually plastic) specula are available for many applic
include a lighting system.

Devices designed primarily to measure, assess, simulate, or calibrate the performance and/or safety c
medical devices and accessories; testers are usually dedicated equipment used to measure and/or ev
parameters of the device under test. Testers may include measuring instruments, electronic data proc
recorders. Most testers are used during the periodical and postrepair evaluation and/or calibration of t
mechanical, or other physical characteristics (e.g., pressure, temperature) of medical devices; some te
simulate some physical characteristic of the human body (i.e., phantoms) or of the functioning of an o
simulator of bioelectric signals).

Testers designed to measure and assess the electrical and/or mechanical characteristics of electrical p
receptacles. These testers are used to assess the safety of receptacles used as outlets for electric pow
facilities.
Traction units designed to apply constant traction forces by means of harnesses attached to a particul
anatomy (e.g., cervical or lumbar vertebrae, extremities) and hanging weights or other nonpowered te
typically consist of several specialized harnesses, a combination of pulleys and cords, and, frequently,
hang from cords as the source of the traction force (other systems, including some devices that use th
as the source of the traction force, are also available). Adjustable spreader bars may be used to vary t
cord applies the traction. Static traction units are used in several orthopedic and/or physical therapy p
can provide only a continuous (i.e., static) mode of operation in which fixed forces are applied for the
procedure, limiting the capabilities of the system. They are available in configurations that allow the u
mounted for vertical cervical traction (with patients usually seated on a chair) or attached to a table fo
and lumbar traction (i.e., universal models), with patients lying on traction tables.
Devices that use some heating element (e.g., electric resistor, radiant energy) or system to warm a su
fluid, or device or to regulate body temperature. Warming units typically contain a power supply (eithe
batteries or a connection to the power line), the heating element, and a way to transfer the heat or cir
(e.g., blowers, coils, tubing, etc.) They may be stationary units, movable (on casters or wheels) or por

Systems designed to provide water that is free of contaminants. These systems can eliminate one or m
physical, chemical, and/or microbial) contaminants found in the water supplied (frequently tap water)
The main steps for a complete purification of the contaminated water include: (1) initial filtration (to e
larger than 10 micron); (2) addition of a softener to remove calcium and magnesium; (3) use of carbon
(usually by absorption) low-molecular weight organic chemicals, especially chloramines frequently fou
reverse osmosis, a process that removes salts, bacteria, metal ions, and particulates; (5) deionization
particles (e.g., salts, metal ions); (6) ultrafiltration (to filter out particulates larger than 0.05 microns) t
bacteria pyrogens; and (7) ultraviolet radiation to kill microorganisms. Health care facility water purific
intended to provide a centralized supply of water in normal conditions or in emergency situations (e.g
may also be used in clinical laboratories and other areas of the facility. Water purification systems are
to perform hemodialysis procedures. Dedicated water purification systems that perform only one or a
steps (e.g., reverse osmosis, deionization, and ultraviolet radiation) according to the type of contamin
water are also available.

Devices designed to provide temporary ventilation and/or respiratory assistance by delivering an appr
to the respiratory airways. Most ventilators deliver gas to the lungs using positive pressure by means
mask, tracheostomy, or an endotracheal tube, but some of them (e.g., tank ventilators) are based on
negative pressure to the body surface or chest wall. Ventilators are used in patients who cannot brea
require assistance to maintain adequate ventilation because of illness, trauma, congenital defects, or
anesthetics.

Hospital communication systems designed to provide communication between the staff and patient ro
patients via wires. These systems typically consist of a central console with a switching device that all
with each patient or patient room, power supplies, call buttons at the patient end, and interconnecting
frequently include corridor or intermediate station signaling lights. Some systems permit two-way con
a handset, headset, or speaker/microphone. Nurse call communication systems allow patients and sta
with visual and/or audible signals for routine or emergency needs; some systems can also be used to
resuscitation teams and/or to locate staff on a nursing floor.

Prefabricated surface mounted or wall-recessed units used to organize the utility services (e.g., electr
devices at the head of the patient's bed. These systems may be either frame-type or cabinet type, the
and pre-piped; and usually designed and manufactured from a standard system of components. Frame
metallic (e.g., steel) frame members to form the structural frame, the rear of the unit open; while cab
use modules much like steel cabinets with integral back panels.. A typical headwall system includes:
vacuum station outlets; electrical power receptacles; provision for nurse call and code buttons; teleph
physiological monitor support brackets; and various types of lighting (ambient, reading, examination,
Combinations of metal or hard plastic structures (tracks) and sliding devices (carriers) that can be disp
track channels; tracks and carriers are designed to suspend hangers from the ceiling. The tracks are t
[20 feet]) straight or curved, hollow sections of extruded metal (e.g., steel, aluminum) or hard synthet
nylon) with an appropriate profile. The carriers typically consist of a set of one or more wheels or slidin
carriers are used mainly on the ceilings of bed areas of hospitals, nursing centers, and other healthcar
devices are available to hang curtains providing temporary privacy to a patient and/or to hang intrave
containers.

Tracks and carriers designed to support intravenous fluid (IV) container pendants (e.g., poles, hangers
administration of IV fluids. These devices typically consist of long (e.g., 6 m [20 feet]) sections of meta
aluminum) or hard plastic hollow structures (tracks) and sliding carriers (e.g., wheels or bars) capable
weight of the IV containers (typically up to 30 or 40 kg [66 to 88 pounds]). IV container tracks and car
movement of patients connected to IV containers or site changes in bed areas, operating rooms, and o

Injectors designed to administer liquids into the uterus and/or fallopian tubes. These injectors typically
tipped catheter or cannula that is introduced into the uterus, an introducing sheath, and an external m
manipulate the catheter usually including a handle. Uterine injectors are used mainly for injection o
the uterine cavity and fallopian tubes during radiographic procedures intended to evaluate tubal pate
are also appropriate for manipulation or repositioning of the uterus during diagnostic and/or surgical p

Plain (nonimpregnated) dressings made of synthetic materials that are cut to fit around a tracheostom
drainage site (e.g., with a keyhole in the middle of the dressing). The dressing materials can be either
polyurethane film and viscose. Tracheostomy dressings are used to absorb and disperse the exudates
they are used mainly in the management of wounds after tracheostomy.

Forceps used in conjunction with flexible endoscopes to atraumatically grasp, retract, manipulate, and
flexible endoscopic procedures. They typically have toothed blades for more effective grasping.

Instruments designed to trap, retrieve, and/or manipulate stones for the treatment of conditions such
presence of calculi in the bile duct or gallbladder). These instruments typically comprise a flexible she
self-expanding (typically nitinol) basket at the distal end and a handle at the proximal end designed to
rotate the basket. These devices are intended to be used through the working channel of an endoscop
as endoscopic retrograde cholangiopancreatography (ERCP) or laparoscopic cholecystectomy.

Testers designed to assess the performance of analgesic peripheral nerve electrical stimulators. These
an electronic unit including instruments to measure current and charge and visual indicators (e.g., LED
signal when the current and charge are within therapeutic limits (e.g., 10 mA and 7 to 75 micro Coulo
some testers can also include indicators for the presence of therapeutic output and to check lead cont
values outside preestablished limits. Transcutaneous analgesic stimulator testers are used for quick ch
stimulators and during preventive maintenance procedures.
Testers designed to assess the characteristics of hearing aids; they can usually measure, evaluate, dis
hearing-aid characteristics, such as insertion gain, sound pressure level, frequency response, and harm
as graphs or as numbers. Many testers use composite signals instead of pure frequency tones for test
testing of nonlinear hearing aids and making detection of intermodulation distortion easier. These test
signal generators, audio transducers (e.g., microphones, loudspeakers), a display, and computing and
Hearing-aid testers are used to fit and periodically test analog, digital, and/or programmable hearing a
include capabilities for both test chamber and real ear measurements.

Physiologic analyzers that measure and evaluate some physical aspects of the ear's conductive appar
detection of middle-ear fluid. These analyzers are used as adjuncts to visual (or pneumatic) otoscopy
managing middle ear disease, particularly in children, including obstructions and otitis media effusion
evaluate stiffness or flaccidity of the tympanic membrane.
Multipurpose surgical retractors designed to temporarily separate and/or hold back the edge of incisio
many different anatomic structures, exposing and providing access to other tissues, organs, or structu
procedures that include a fiberoptic bundle to deliver light for illumination of the surgical site. These r
of manual, handheld or self-retained instruments with an integral or attached fiber optic bundle that d
surgical site from an external light source. Dedicated fiberoptic surgical retractors are available for pa
structures (e.g., throat, perineal) or surgical procedures such as plastic, vaginal, gynecologic, or ortho
particular types of retractors permit the attachment of fiberoptic bundles to them.

Suction tips that include a fiberoptic bunch to provide illumination at the distal end. These tips usually
rigid tubes (either straight or bent) with an integral handle for easy manipulation; the handle is attach
suction hoses or tubes that are in turn connected to high-level suction aspirators that include a fiberop
Fiberoptic suction tips are used mainly in the upper respiratory tract (nasal cavity and pharynx) and d
procedures when speed and excellent illumination are needed; these tips are usually reusable devices
suction tips are available for particular surgical procedures and also for procedures performed in the o

Drapes designed as a bacteria-proof barrier on which to place surgical instruments. These drapes are
rooms during surgical procedures and usually have sterile pouches in which to secure instruments. Su
drapes with adhesive strips on each end of the pouch to hold it in place are also available. Many have
Reusable and disposable surgical instrument drapes are available.
Artificial airways humidifiers designed to collect the heat and moisture from the expired breathing air
the following inspiration. These humidifiers are usually simple devices consisting of a layered aluminu
include a paper or plastic component treated with a hygroscopic chemical to retain humidity; most of
include an air filter. They are used for spontaneously breathing patients and also for patients who are
support, such as patients staying in post-operative or in intensive care units.

Disposable patient surgical drapes are designed to provide a barrier between the unsterile skin of the
surgical field and are intended to be used once and then discarded. They provide a bacteria-proof barr
unsterile surfaces they cover and the sterile surgical field. These patient surgical drapes are made of n
(e.g., tissue, cellulose/polyethylene). Disposable patient surgical drapes do not need laundering, inspe
sterilization because they are supplied new and pre-sterilized and are meant to be disposed of after th
Though they are absorbent, disposable patient surgical drapes are also impermeable and non-linting w
risk of infection.
Patient surgical drapes intended for multiple uses to provide a barrier between the unsterile skin of th
sterile surgical field. These patient surgical drapes provide liquid-proof protection while allowing swea
increased comfort for patients. Reusable patient surgical drapes are used once and then disinfected; t
many materials such as cotton, polyester, or a blend of both.

Timers designed to produce audible signals (e.g., a beep) at predetermined intervals (typically 1, 5, an
baby is born to indicate to the healthcare providers that assessments of the health status of the baby
The timer is usually set when the baby is born, and a health status assessment (known as Apgar score
(color), pulse, grimace (reflex), activity (muscle tone), and respiration (breathing) is performed, each i
maximum value of 10. These instruments typically consist of a mechanical or electronic timer with a d
generator; some devices include a recorder to store the birth time and the values of the Apgar score.
performed following the timer beeps. Apgar score timers are intended to facilitate the evaluation of th
newborn.

Timers designed to measure the active length of time of an exposure during a phototherapy treatmen
typically consist of an appropriate light detector for sensing light at the same frequency of the light so
ultraviolet, infrared), an electronic time-measuring instrument, and a display; the timers are usually b
instruments. Phototherapy timers are typically dedicated instruments intended for use attached to a p
therapeutic light; they are usually an integral part of the phototherapy unit, frequently attached to the
Phototherapy timers are also used for inspection and/or calibration of phototherapy units.

Laboratory devices designed to stir liquids. These devices may consist of either an electrically driven
motorized stirrer) or a magnetic spinning bar that is immersed in the liquid to be stirred (i.e., a magne
stirrers are used in clinical laboratories to stir chemical solutions; magnetic stirrers are typically used f
volume low-viscosity solutions, and motorized stirrers are used mainly for medium- and high-volume a
solutions.

Convex lenses for magnifying or for concentrating light upon an object.


Ultrasonic scanning systems that include an ultrasonic scanner, transducers (frequencies of 7.5 to 15.
because of the high resolution needed), dedicated software, an image recorder (e.g., videocassette), a
systems generally use high-frequency broadband transducers, and some also include continuous-wav
Doppler capabilities and a spectrum analyzer. Most mammographic ultrasonic scanning systems are u
mammography to distinguish cystic from solid lesions in the breast, but some high-resolution digital u
include Doppler capabilities are also used to differentiate between malignant and benign tissue in the

Ultrasonic scanning systems that consist of an ultrasonic scanner, transducers (typically from 2 to 5 M
obstetric/gynecologic calculation package software, an image recorder (e.g., videocassette), and a col
Obstetric/gynecologic ultrasonic systems usually include transducers with a linear array, but most of t
mechanical and/or electronic sector scanning configurations. These systems are used in obstetric and
examinations, including in utero fetal scans, and in other abdominal procedures and diagnoses (e.g., c
Lights designed to provide illumination on the surface of a patient bed. These illumination lights conve
emitted radiation mainly in the visible spectrum. Overbed lights are available in several shapes and si
types of bulbs such as incandescent, halogen, and light-emitting diodes (LED), fluorescent tubes, and/
lights are typically several feet in length, providing uniform light over the entire head of the bed; they
and indirect lighting options that allow the lights to be centered directly over any part of the patient's
typically have durable and resistant clear polycarbonate or translucent polycarbonate covers to provid
lighting. These lights can typically provide several different light intensities appropriate to shine again
soft room light and to read.

Sheets designed to be placed on the surface of an examination table. These sheets usually consist of
fabrics that offer some degree of protection to patients and to the table during the medical examinati
Examination table sheets are made of disposable or reusable materials. They are widely used in healt
hospitals, nursing homes, and medical offices.
Devices used during physical therapy to apply pressure or strokes (i.e., massage), rhythmic tapping (i
vibration when placed against the patient's skin to massage the muscles or tissues. These therapies h
tension, increase blood circulation, and decrease lymphatic congestion. Some physical therapy massa
programmed to deliver consistent pressure, percussion, or vibration at pre-determined intervals. They
different applicators, such as multi-pronged or round firm-rubber domes, or percussion adapters, and
Physical therapy massagers are powered by batteries or electrical sources, and can be mounted on a
set on a tabletop, or attached to the wall. They are used in physical therapy, chiropractic, and rehabili
Physical therapy massage machines that provide heat as well as massage are available.

Instruments designed for automated or semi-automated transfer of programmed volumes of liquids fr


another container. Pipettors typically consist of powered (e.g., electronic) benchtop or manually opera
that can transfer (i.e., dispense) very small, pre-established volumes of liquid (usually from 0.1 microl
milliliters). Some pipettors include detachable disposable tips. Most pipettors work by displacing a plu
other mechanisms are used in some electronic units. Single-channel and multichannel pipettors are us
laboratories; they improve the precision of measurements and lessen the possibility of cross-contamin
when compared with manual pipetting procedures.

Simulators designed for training in one or more of particular clinical or surgical procedures that usuall
anatomic model, either of the whole body (i.e., a manikin) or a partial model for a particular anatomic
torso, or an extremity according to the procedure to be trained. Training simulators also include a set
the simulated training in the performance of the procedure as close as possible to the real activity. Tra
intended for a variety of purposes, such as learning device functioning (e.g., external defibrillators), th
(e.g., ophthalmic, intravenous infusion), surgical and/or endoscopic procedures (e.g., arthroscopy, lapa
(e.g., hemodynamic status), and other procedures are available. The simulators facilitate the training
personnel with less need for practice on human beings or animal models.

Intestinal surgical clamps designed for the atraumatic grasping or compression of the rectum and/or a
surgery procedures. These clamps are typically handheld, manual instruments including two parts piv
a size appropriate for the manipulation of the rectum; the instruments usually include long, serrated,
or curved distal blades and appropriate handles. Dedicated rectum clamps are available for resection
Surgical hooks designed to temporarily secure rectal tissues by catching and/or pulling them during d
and/or to perform other surgical procedures with minimal trauma. Surgical hooks typically consist of h
stainless steel instruments with a shank bent near the distal end (usually at angles from 135 to 180 d
a blunt or sharp tip; the hooks typically include a handle at the proximal end. Rectal surgical hooks in
styles are available. They can be supplied with a barb at the working end for better holding. Rectal su
used during surgical procedures (e.g., removal of papillae and drainage of various types of perirectal a

Surgical punches designed to excise a segment of tissue (frequently in the form of a disc), typically ca
earlobe and, less frequently, from surrounding anatomic structures. These punches are typically hand
instruments with a mechanism (e.g., a jaw) at the distal end operated through a handle (e.g., ring-like
handle. Earlobe punches are not appropriate for middle-ear (i.e., endaural) procedures.

Middle-ear surgical retractors designed to temporarily separate and hold back the tissues and other a
surrounding the mastoid prominence of the temporal bone, exposing and providing access to the mas
mastoid process). Mastoid process retractors are manual instruments available in a variety of shapes
usually include two adjustable blades at the distal end that are pivoted at the center and that have at
threaded mechanism or scissors-like handles with a ratchet that retain the position once set (i.e., self-
They are used mainly in surgical procedures of the temporal bone mastoid process and surrounding m

Snares designed to position and tighten fine-gauge, flexible, adjustable wire loops around a region of
mechanical or electrosurgical resection and hemostasis. These devices typically consist of a hollow tu
cannula), with one or more adjustable wire loops (rings) that protrude at the working end; frequently t
stationary loop and a sliding loop. A mechanism at the proximal end (handle) controls how much wire
channel and the movement of the sliding (cutting) loop as the loop is withdrawn into the cannula; the
straight (e.g., Krause type) to the cannula or offset (bayonet type, also known as Lange type). Nasal s
use (i.e., disposable) or reusable; they are used mainly to remove polyps, tumors, and other abnorma
cavities.

Instruments intended to be inserted into the uterus to lift and manipulate the uterus.
Needles designed for tine (tuberculin) tests. These devices consist of a set of needles (typically four) a
handle and coated with drip-dried tuberculin (a dried broth of Mycobacterium tuberculosis). The set of
into the skin of the forearm, where it deposits a preestablished dose of tuberculin. Any induration grea
mm in diameter around one or more of the puncture sites after 48 to 72 hours is considered a positive

Test tubes designed to hold chemical substances, biological products, or body fluid samples during lab
procedures. These devices typically consist of a glass (e.g., borosilicate) or plastic (e.g., polypropylene
closed and an open top; the tubes are usually closed with a stopper and/or using a threaded or snap c
Centrifuge test tubes are available in a variety of shapes, materials, and special physical or chemical
tubes include graduation marks and/or colored caps. They are intended to support the centrifugal forc
the rotatory part of a laboratory centrifuge, avoiding cross-contamination and providing a secure cont
(e.g., blood, DNA samples) under test.
Cushioning pads made of rubber that are designed to reduce pressure on specific areas of the body. T
mass of natural or synthetic soft rubber that may be wrapped into a flexible cover as a small cushion.
pressure relief padsmay be conformed in a variety of shapes and sizes. They are mainly used to distrib
to larger body areas especially to prevent or alleviate pressure sores. The pads are frequently used on
wheelchairs, tables, and beds.

Aids designed to simplify the process of transferring a person with a physical disability (e.g., nonambu
neuromuscular-impaired, arthritic, or comatose patients) that require partial or total assistance when
bed, stretcher, operating table, wheelchair, or other place. A variety of devices are available in very d
using very different transfer methods, such as lifts, sliding boards, slings, and rotating disks. Patient tr
recommended to transfer patients only for one or two meters (a few feet); they reduce the risk of drop
injuring the patient and those assisting with the transfer. Some aids are also used to reposition people
rehabilitation departments.

Anatomical charts showing acupuncture point targets and their related effects intended to be used for
Charts range in size from small (e.g., wallet-sized) to large (e.g., wall poster) and may include informa
pathways, elemental points, and treatments for the entire body or parts of the body.

Eyeglasses designed to protect the eyes from hazardous mechanical and/or light intensity/frequency c
user safety. Safety eyewear for mechanical protection typically consists of two thick, shatter-resistant,
protect the eyes from flying debris (e.g., blood splatter) mounted in a frame that holds them in an app
before the eyes to assist vision and a metal or plastic frame that rests on the nose with two hinged leg
by the ears; other safety eyewear includes lenses that filter out high-intensity light (e.g., laser beams)
light. Safety eyewear is used clinically to protect patients and healthcare providers in situations in wh
body fluids are manipulated, laser radiation is produced during therapeutic and surgical procedures, a
is used during phototherapy and in some clinical laboratory procedures. Safety eyewear may be also g
the visual acuity of the user.

Cabinets designed as a partial or total containment enclosure for safe manipulation of moderate and/o
microorganisms and other biological hazardous materials (i.e., they offer biological safety). These cab
a vertical laminar flow; they are available in three general types (class I, II, and III) according to their p
characteristics and applications. Class I cabinets protect the operator and the environment but not the
cabinets protect the operator, the product, and the environment; and class III cabinets offer the maxim
protection to the product, operator, and environment. Biological safety cabinets are used for handling
human pathogens (e.g., bacteria, virus, parasites) and other biohazardous materials, extreme toxic ag
chemotherapy drugs), and also for tissue culture and tumor virus work.

Covers designed to be placed over the stirrups attached to examination tables in order to provide a so
surface for the patient's heels when they place their feet in the stirrups during examination and/or tre
covers can help prevent cross-contamination between users. Heel stirrup covers are usually latex free
of cloth, neoprene, polyurethane, or foam and are held in place on the stirrups with elastic or ties in th
Cushions designed to be attached to heel stirrups that are usually attached to healthcare tables. Thes
consist of soft material (e.g., fabrics, plastics) with appropriate shape and size for location on the heel
usually supplied in pairs. Some heel stirrup cushions are shaped as boots, allowing a better accommo
during the therapeutic or surgical procedure. Heel stirrup cushions are mainly used for patients lying i
during obstetric, urologic, colonic, or rectal procedures.

Detachable rubber tips applied to the distal end of crutches (i.e., crutch tips) designed to provide skid
These tips, typically hollow cylinders made of rubber, are open only at the top; the tips slide high enou
inches) up the shaft of the crutches to secure them onto the crutches. Treads on the bottom surface o
frictional engagement to the floor. Rubber crutch tips help the crutch user gain traction on the ground
shoulder, and prevent other injuries from accidental falls. They can easily be replaced when worn out

Operating table surgical drapes intended for single use that provide a bacteria-proof barrier between t
the operating table they cover and the sterile surgical field. These operating table surgical drapes con
rectangular piece of fabric. They are made of nonwoven materials such as tissue, cellulose or polyeth
impermeable to moisture and bacteria. Disposable operating table surgical drapes are supplied new a
in the operating room for one surgical procedure and then disposed of after the procedure.

Operating table surgical drapes intended for multiple uses that provide a barrier between the unsteril
operating table they cover and the sterile surgical field. These operating table surgical drapes consist
piece of fabric. They are made of woven materials that also provide liquid-proof protection. Reusable o
drapes are used in the operating room for one procedure and can then be disinfected and used again.
many different materials such as cotton, polyester, or a blend of both.

Operating room table sheets intended for single use to be placed on the surface of an operating table
table sheets are used for just one surgical procedure and then discarded. Disposable operating room t
of nonwoven materials (e.g., tissue, paper) for maximum absorbency and strength; they protect again
and aid in infection control. They are used in operating rooms for surgical procedures.

Operating room table sheets intended for multiple uses to be placed on the surface of an operating ta
operating room table sheets are made of soft and woven fabrics (e.g., cotton and/or polyester) able to
laundering. They are used in operating rooms for surgical procedures.
Laboratory blood gas analyzers used to directly measure pH and partial pressure of carbon dioxide (PC
usually in arterial whole blood specimens. Measurements are made using three different sets of electr
blood gas/pH analyzers calculate other parameters, such as oxygen total content and bicarbonate HCO
electrolyte and/or hematologic determinations (e.g., hematocrit). These analyzers are used to determ
acid/base balance and oxygen/carbon dioxide exchange for diagnosis and regulation of therapy.

Dental punches designed to make holes in dental dam material. These punches are typically manual,
with two distal ends attached to handles and articulated in the middle. One working end has a plunge
wheel with several sized holes facing the plunger, the wheel can be adjusted to make several spaced
holes, each with the desired diameter. The holes permit the location of the dental dam over the crown
Dental clamps designed to be placed around the tooth, fitting a dental dam over the designated tooth
typically steel, handheld, manual instruments with a spring; some include buccal and/or dental wings
opposite the holes punched into the dental dam. Dental dam clamps are available in several sizes; the
using dental dam clamp forceps that spread the gripping edges of the clamp around the tooth.

Physiologic monitors designed for continuous measurement and display at a central station of informa
activity of the brain and its associated electroencephalogram (EEG) taken from a distant location throu
radio or other appropriate communication link (i.e., telemetric) . Telemetric EEG monitors typically con
electronic unit connected by several lead wires attached to brain electrodes that are usually placed on
They include a pocket-sized, battery-powered transmitter that is clipped to the patient's gown or carri
receiver that is integral or associated to the central station where the information is displayed. Teleme
electroencephalography monitors are used in ambulatory, neurologically affected patients; they are a
the pattern changes in the brain waves and the neurologic status of patients in intensive care units.

Physiologic monitors designed for continuous measurement and display of information at a central sta
potential of skeletal muscle and its associated electromyogram (EMG). This information is taken from
through a point-to-point radio or other appropriate communication link (i.e., telemetric). These monito
small electronic unit with a display that is connected, by several detachable lead wires, to skin surface
electrodes inserted into specific muscles) to carry the electrical signal from the muscles to the transm
monitor also includes a pocket-sized, battery-powered transmitter that is clipped to the patient's gown
and a receiver that is integral or associated to the central station where the information is displayed. T
monitors are used in patients with neurologic conditions (e.g., cerebral palsy, stroke) and to re-educat
to identify malfunctioning muscles in cases of soft tissue injury (e.g., strain) or chronic pain (e.g., myo
and to evaluate overuse or ergonomic problems that arise at work or during participation in sports.

Physiologic monitors designed for continuous measurement and display of information related to the e
generated between the retina and the cornea due to ocular motion in response to visual stimuli (elect
This information is obtained through point-to-point radio or other appropriate communication links. Th
consist of a main computerized electronic unit and detachable surface electrodes placed on the latera
capture the electric signal resulting from the visual stimuli. The telemetric monitor also includes a poc
powered transmitter that is clipped to the patient's gown (or carried in a pouch) and a receiver that is
to the central station where the information is displayed. Telemetric EOG monitors are used to help dia
retinal and/or neurologic diseases and to assess the short, fast movements of the eyes made during re

Examination/treatment chairs with lifting and rotating capabilities and headrests that facilitate the eye
other procedures. The devices for examination and treatment may be partially or fully attached to the
separately as a self-supported, wall-mounted, or ceiling-supported procedure unit.

Mobile hospital stretchers designed for performing radiographic and/or fluoroscopic procedures. These
radiolucent platforms, radiographic grids, and film cassette holders.
Phototherapy units designed to irradiate patients with ultraviolet (UV) light for therapeutic purposes.
apply UV radiation according to the treatment performed (e.g., typically in the range of 250 to 350 nm
are also used to photoactivate drugs by providing UV radiation on the skin. UV phototherapy units are
stand-alone, and hand-held devices.
Electric beds designed to permit women to assume more natural delivery positions and minimize the
and risks during birthing. These beds typically have three sections: backrest, seat, and foot. The back
and bed height are adjustable, and the foot section can be removed to permit access to the mother's
birthing beds lessen the lapse of time associated with transfers between beds, stretchers, and labor/d
allowing the mother to remain in the same bed throughout labor and delivery.

Installations designed for thorough cleaning and disinfecting (i.e., scrubbing) of the hands and arms b
procedures that require a certain level of cleansing by participating personnel in order to reduce or pr
of infections to patients. These stations typically consist of multiple stainless steel sinks with seamless
crevices. They include several faucets; cold and hot water supply; water filters; soap and brush dispen
water pressure, and/or time controls. They may also include ultraviolet lamps. Surgical scrub stations
using automated infrared sensors, knee controls, and/or timers; they are used by surgeons and other
approaching a designated sterile area (e.g., the surgical suite).

Devices designed to hold an externally inserted catheter tube and securely attach it to the anatomy o
supporting and/or securing the catheter tube during the whole catheterization procedure. Catheter tu
shaped specifically to the anatomical part where they are attached and/or the catheter tube that they
endotracheal tube, nasogastric tube, urinary catheter tube, biliary catheter tube). They are usually ma
fabric, wood, metal or a combination of these materials. They also include some type of locking mech
the portion of the catheter tube that is external to the patient, as well as sections (e.g., wings, straps)
adhesive or other attachment mechanisms (e.g., hook-and-loop closures [Velcro]) that can be used to
the patient's anatomy.

Manometers designed to measure the pressure in the nasal airways; most instruments can also determ
gradient and the airflow through the upper airways. These manometers typically consist of a measurin
instrument (e.g., electronic) with probes that include pressure transducers (e.g., capable of reading va
several centimeters or water/several hundred kPa and air flow up to 1000 ml/s); some rhinomanomete
determine the pressure and airflow. The use of a set of nose tips and masks of different sizes permits
active anterior and posterior rhinomanometry in both children and adults. Some rhinomanometers inc
capabilities or connections to personal computers for data processing and storage. Rhinomanometers
measure nasal respiratory resistance for diagnosis (e.g., septum deviation, allergy tests, adenoid or to
control of therapy progress after surgery or to assess efficiency of applied medications.

Examination table sheets intended for single use to be placed on the surface of an examination table.
table sheets are used for one examination and then discarded. Disposable examination table sheets a
materials (e.g. tissue, paper) for maximum absorbency and strength; they protect against stains and s
infection control. These sheets are widely used in healthcare facilities, hospitals, nursing homes, and m
Examination table sheets intended for multiple uses to be placed on the surface of an examination tab
examination table sheets are made of woven materials (e.g., cotton and/or polyester). They are widely
facilities, hospitals, nursing homes, and medical offices.
Metal, file-like instruments with a ridged surface designed to scrape and smooth the surface of bone.
Containers designed to be used to transport materials via mail services, such as the U.S. Postal Servic
These containers typically consist of boxes, tubes, or envelopes that provide appropriate protection fo
insulation to preserve temperature sensitive materials (e.g., clinical samples), and/or special pockets
facilitate the transportation of several objects simultaneously. Mailers are used in health care facilities
clinical (i.e., laboratory) samples, microscope slides, and other sensitive or fragile products. Mailers ar
single use or reusable.

Containers designed to provide mechanical protection and a very cold environment to preserve tempe
specimens (i.e., samples) during transportation using refrigerants such as dry ice (solid carbon dioxide
These containers typically consist of a thermally isolated container (e.g., a thick polystyrene box) with
the dry ice and the wrapped samples that are transported together, avoiding direct contact between t
samples. Dry ice transport containers are used to provide thermal insulation and protection for fragile
bottles, or tubes containing the specimens during transportation to the clinical laboratory.

Containers designed to provide appropriate mechanical protection during transportation of clinical spe
using mail services or other transportation means. These containers may consist of one of a variety of
envelopes) made of different shapes, materials, and sizes and/or having other special characteristics (
pockets) appropriate to provide protection for fragile items such collection/transportation vials, bottles
clinical samples (e.g., urine, feces) sent to the clinical laboratory.

Containers designed to provide appropriate mechanical protection during transportation of microscope


services or other transportation means. These containers may consist of one of a variety of solid conta
shapes, materials (e.g., hard plastic, cardboard), and sizes and/or having other special characteristics
that close tightly on the slides which provide appropriate mechanical protection. Microscope slide tran
used for transportation of light and/or electron microscope slides for further laboratory and/or clinical

Electric audio signal amplifiers designed to amplify speech signals, typically in a range from a few hun
These amplifiers typically consist of a wide-band, high-fidelity, electronic amplifier with audio signal in
to amplify the signal, controls (e.g., gain, frequency response), appropriate output ports for the amplifi
power supply. Speech amplifiers have particular characteristics according to the intended use; they ar
as attached units and/or integral parts of hearing aids, cochlear implants, artificial larynxes, telephone
aids for people with very weak voices.

Cover implants designed to fit into and over bur holes or bone gaps made by a cranial perforator durin
cover implants are usually button- or flat-shaped and made of metal (e.g., titanium alloy) or biodegra
polyester. Bur hole cover implants can also be used to reattach cranial bone removed during surgery.
Devices designed to crush (i.e., reduce to a powder) or split a pill in two halves. Crushers are typically
instruments; the lower part is usually intended for crushing pills while a hinged cap on top is capable
compressed tightly. Pill crusher/splitters are used to facilitate the intake of pulverized drugs, either dir
liquids or soft food; pills splitters are also used to facilitate the administration of drugs (e.g., vitamins)
dose of a whole pill.

Heat loss shields used to reduce heat loss due to evaporation (i.e., insensible water loss) during radian
mostly premature newborns.
Telephone transmitter/receiver systems designed to transmit and receive one or more signals from a p
through telephone channels. These systems typically include at the transmitting site an electronic dev
modifies signals from medical (e.g., external, ambulatory, implanted) physiologic monitors or recorder
transmissible through telephone lines. At the receiving end, another electronic device (i.e., the receive
incoming signal and provides an output signal appropriate for display on dedicated monitors (e.g., ce
recording, and/or for further transmission and processing by healthcare information systems. Physiolo
transmitter/receiver systems are typically used to send signals from patients' homes, doctors' offices,
locations to hospital and other healthcare facilities using standard telephone lines. Dedicated systems
particular parameters, such as fetal and pulmonary function assessment may be also available.

Combinations of a cable and several leads designed for connection between electrodes, which are pla
and an electrocardiograph (ECG) or ECG monitor. These combined devices typically consist of flexible
leads) that are completely isolated except at the electrode end (known as patient leads) and an integr
connected to the leads at one end and to the electronic recorder or monitor at the other end. ECG cab
recording and/or displaying in real time the waveforms (i.e., electrocardiograms) of the biologic electr
heart.

Aspirator/irrigators designed to fragment and remove soft tissue during surgical procedures. These de
vibration at ultrasonic frequencies while also providing suction and/or irrigation. These devices typical
unit that includes a generator which delivers an ultrasound energy output. They also include a pump u
irrigation, and a set of detachable handpieces that are usually frequency-specific according to the plac
tissue. The ultrasonic energy is converted in mechanical vibration in the dedicated handpiece; the vib
applied to the tissues at a frequency appropriate for debridement. Ultrasound surgical aspirator/irrigat
variety of general surgery, neurosurgery, and laparoscopic procedures. They are also used in liposucti
tissue surgical procedures performed in places such as the liver, spleen, and kidneys.

Electric beds designed to support obese patients. These beds typically include a sturdier and wider fra
beds, giving extra support and facilitating the ingress and egress of patients weighing 300 pounds (14
Overweight-patient electric beds used for obese patients are mainly used for patients who cannot turn
minimal assistance and are at risk of skin breakdown.
Covers intended to encase footswitches to reduce wear and to keep them clean. Footswitch covers are
usually made of clear polyethylene in different sizes to fit different footswitches models. They are clos
cloth ties, or with cinch locks.
Covers intended to encase cameras to protect them from contamination and fluids. They are usually m
polyethylene in different sizes to fit different camera models and can be used with either photographi
cameras.
External orthopedic fixation systems designed stabilize fractured bones other than those in the verteb
systems typically consist of an external plastic and/or metal fixator and other external and/or implanta
as clamps, bone screws, cams, bushings, and collars; the systems may also include some instruments
attaching the implants (e.g., screwdrivers, punch impactors, drills). Fracture external orthopedic fixati
intended for better and quicker healing of fractured bones compared to plaster casting by providing a
fragment immobilization during the healing process. They are used mainly to help the healing of the p
of long bones such as the femur and in joint fractures of the wrist, elbow, knee, and hip. Dedicated sy
specific type of fracture fixation are available.

Cannulae designed for insertion into the aorta. The cannulae are used to transfer cardioplegic solution
cardiopulmonary bypass surgery perfusion and cerebral blood flow studies and are also used as outflo
ventricular assist devices.
Devices that are capable of measuring and logging multiple variables for the maintenance of imaging
diagnostic radiology department. Quality assurance kits generally contain a dosimeter, focal spot tes
cassette, timer, and beam alignment and collimator test pool. Quality assurance addresses administra
technical issues. Quality control, which is part of quality assurance, comprises a series of technical pr
ensure optimum performance of equipment in the radiology department.

Prepackaged collections (either custom or standard) of the necessary equipment and supplies for hea
use for thorough cleaning and hard rubbing (i.e., scrubbing) of the hands and arms before surgery or o
require a certain level of cleansing by participating personnel in order to reduce/prevent the transmiss
patients. These trays (also known as kits) typically include a scrub brush impregnated with an antimic
(e.g., povidone-iodine, chloroxylenol, etc.) and are packaged as single-use, sterile items.

Covers into which the arms of clamps are inserted. Clamp covers are intended to increase clamp grip
facilitated occlusion less traumatic. Clamp covers can be made of silicone rubber or non-fibrous fabric
contoured and sized to fit a variety of instruments with color-coding by size; they can also be trimmed

Enclosures or containers used to house or transport animals. They may be made of wood, metal, plast
these and can have solid or latticed sides and usually have one or more doors or lids; they can also co
adding food, water, and other equipment. Animal enclosures are available in many sizes according to
confined; some are shaped to fit on racks or carts and can house small animals (e.g., mice, rats, rabbi
larger enclosures may be used to house larger animals (e.g., dogs, swine, primates). Leak-proof anima
be filled with water (aquatic enclosures) are also available.

Timers designed for automated measuring of the active duration of exposure to high-dose radiation (e
from a radiotherapy unit, such as a cobalt unit or a linear accelerator. These timers typically consist of
placed in the beam path while radiation is delivered, an electromechanical or electronic time measurin
display. Radiotherapy timers are usually dedicated instruments intended to detect a particular type of
electrons, gamma rays); timers that are hard-wired to the control system are frequently an integral pa
unit (e.g., orthovoltage, linear accelerator, stereotactic radiosurgery) and used to control the intensity
parameters of the treatment. Stand-alone radiotherapy timers are used mainly for inspection, calibrat
control of radiation generators and radiotherapy systems.
Infusion systems designed for automated maitenance blood glucose in a preselected range of values.
sensors for periodic sampling and detection of the insulin level in blood; an electronic unit which asse
and automatically sends commands to an external infusion pump for administration of a pre-establish
dextrose; and the infusion pump that delivers the required drug. Closed-loop insulin infusion systems
temporary use in critical care for diabetic or metabolically affected patients during surgery, labor, and
systems for daily use by diabetic patients are in development.

Adult intensive care ventilators that use positive pressure to deliver breaths at frequencies much high
breathing rate (usually at 100 or more times per minute) and at a reduced tidal volume. The most com
are conventional high-frequency positive pressure, high-frequency oscillation ventilation, and high-fre
Conventional positive pressure ventilators typically operate at frequencies up to 150 cycles/minute, w
ventilators operate at frequencies of 400 to 2400 cycles/minute, and jet ventilators operate from 100
These ventilators are designed to reduce pressured-induced lung damage (i.e., barotrauma) and the e
volume and positive pressure used in conventional ventilation. High-frequency intensive care ventilat
patients who cannot tolerate the airway pressures needed for ventilation at typical volumes or when m
required for surgery near the airways; most of them are also capable of ventilation at normal breathin

Devices conformed (e.g., molded) according to anatomic structures of the human body. Most stents ar
support and/or to maintain patency within the body's tubular structures, such as blood vessels and ga
or biliary ducts. These devices typically consist of a metallic (e.g., wire mesh) or polymeric (e.g., plas
Metallic stents usually become a permanent implant a few weeks after deployment. Stents are typical
ducts patent after dilatation of strictures (e.g., angioplasty); some are used for anastomosis (e.g., ves
types of specialized stents are used in dentistry (e.g., antihemorrhagic, drainage, occlusal, periodonta
surgery.

Endoscopes designed for direct insertion into the urinary tract for visual examination, biopsy, removal
and treatment of lesions of the ureters. Ureteroscopes usually consist of an outer sheath, a lighting sy
channel for catheters and operative devices; they may be flexible or rigid.
Physiologic monitors designed for continuous checking of vital physiologic parameters of newborns an
monitors should include sensors with appropriate size and design for infant use; they may also include
hemoglobin oxygen saturation (SpO2) through transcutaneous sensors that measure both transcutane
and transcutaneous carbon dioxide (tcPCO2) saturation. Neonatal monitors are used for newborn and
especially those that are under critical care.

Portable stretchers typically used in the prehospital setting and that can be separated lengthwise into
adjustable halves; each half is slid under the patient from each side in a scissors action to move ("sco
without lifting or log-rolling the patient. These stretchers include brackets or knobs to join the two halv
secure the patient; some also include accessory back splints. Scoop stretchers are used to pick up ser
especially those with suspected neural-axis injuries, with minimal body movement; the use of these s
the patient lie in a flat surface with access from both sides.

Devices intended to be implanted on the sclera to aid in retinal reattachment.


Cardiac output units that measure the blood flow from the heart using the indicator dilution technique
radioisotope is injected upstream of the heart and monitored on the downstream side. These devices
detector and an electronic unit that processes the data from the detector and displays the cardiac ou
Trays designed for single use to hold, separate, carry or serve food. These trays are used once and the
be made of plastic, paper, foam or cardboard. Disposable food trays can come in varied shapes and si
needs. They may be divided into several sections and may have built-in handles. Food trays are mainl
facilities by inpatients, visitors and staff; they are also used for in-home care.

Trays designed for multiple uses to hold, separate, carry or serve food. These trays are used and then
they can be made of wood, metal, glass, fiberglass or ceramics. Reusable food trays can come in varie
serve different needs. They may be divided into several sections and may have built-in handles. Food
in healthcare facilities by inpatients, visitors and staff; they are also used for in-home care.

Small forceps with scissorlike handles, used to grasp, hold, and exert traction or compression on a spe
dissection. Their blades are typically finely pointed and serrated. They are generally used in surgery

Flat open containers (i.e., trays) designed for holding, separating, carrying or serving food. These tray
different reusable materials such as wood, metal, glass, fiberglass, and ceramics or disposable materi
paper, foam and cardboard. Food trays can come in varied shapes and sizes to serve different needs.
into several sections and may have built-in handles. Food trays are mainly used in healthcare facilities
and staff; they are also used for in-home care.

Dental dressings in the form of paste or liquid designed to cover and protect a wound and reduce infe
teeth. They are usually made of zinc oxide and/or eugenol and other ingredients such as alcohol and o
dressings are used mainly to cover a surgical wound after gingival surgery.
Containers with a relative vacuum in their interior that are designed to be filled with intravenous (IV) fl
typically consist of empty, presealed containers (e.g., glass bottles), with appropriate shape and size (
2,000 mL) for IV solutions. IV evacuated containers are mainly intended to facilitate filling by IV fluid c
used in clinical pharmacies and/or other healthcare departments and facilities.

Blood-collection tubes with a relative vacuum in their interior designed to store a predetermined volum
drawn from a venipuncture through a blood-collection set. These devices are typically plastic or glass
working end is presealed after obtaining a relative vacuum. They are usually connected using an adap
may include a Luer lock), which in turn punctures the stopper of the blood-collection set. Evacuated b
frequently contain a substance appropriate to inhibit or enhance coagulation according to the intende
sample (e.g., heparin for chemical analysis, sodium citrate for plasma coagulation); the tube caps are
accordingly.

Devices designed to measure the rate of change of an object's velocity. These devices typically consis
transducer, an amplifier, and extension cables for connection to an electronic measuring unit. They w
seismic mass: this mass is restrained by a spring, and when the transducer case is accelerated, the m
the case and exerts a force on the spring. The acceleration is calculated by measuring mass displacem
on the spring, converted to an electrical signal. Acceleration transducers are available using strain gau
piezoresistive), capacitive elements, and piezoelectric elements. Clinical accelerometers are intended
including measuring the acceleration of body parts to assess a patient's mobility and/or activity (alone
activity monitors and gait analyzers respectively); assess tremor (e.g., in patients with Parkinson's dis
pacemakers according to the patient's position (e.g., upright).
Models designed to resemble the whole human body or body parts. Human anatomic models consist o
dimensional representation in whole (i.e., manikins) or in part of the body; they may consist of organs
anatomic systems (e.g., skeletal, nervous, and muscular), and or other structures (nasal cavities, midd
anatomy. Anatomic models are made of natural (e.g., hair, bone, metal, wood) and or synthetic (e.g.,
rubber) materials or a combination of these. Anatomic models are used for demonstration and learnin
structures of the anatomy. They may be used in combination with other dedicated devices and/or com
calibrate or test devices and/or as components of simulators used for training in particular examinatio
surgical, or postmortem procedures.

Photographic cameras designed to provide still images from the proximal end of a microscope. These
the lens system of the microscope to enlarge the image of the field; the camera may be intended to b
the microscope or through a dedicated adapter attached to the microscope. Photographic microscope
mainly in clinical laboratories for documentation of images of microscope slides and to facilitate diagn
therapeutic procedures.

Simulators designed for use in training healthcare personnel in various intravenous device insertion te
simulators include a model of a human upper extremity (i.e., arm) with an accessible replica of the va
models included in the simulators are made from foam, vinyl or other plastics which are molded to loo
flesh. The anatomic models can be accessed with the same equipment used on actual patients. Instru
model of the arms to demonstrate various medical techniques performed during intravascular line ins
including the insertion of various types of intravenous needles, cannulae, and catheters in normal and
vasculature systems. Intravenous therapy anatomic models are available in different body types and s
child, adult, and bariatric arms.

Electric power systems designed for general, nonspecialized power distribution in which neither load c
grounded. These systems usually consist of a wall-mounted power distribution system fixture; they m
such as a line isolation monitor (LIM) or ground-fault detector to monitor the isolation degradation and
operate at a limit between 2 to 5 mA. Isolated power systems are used in operating rooms and other a
and in "wet" locations; their installation must be performed in some of these places according to code
Periodic inspection and testing of these systems, including the function of the LIM, are also required.

Equipment designed to accelerate particles (typically protons or deuterons) to high energies by combi
field and an oscillating electric field. The path formed is a spiral or a circle. The accelerated particles a
used as a radiotherapy treatment beam on the patient, either directly or after passing a suitable targ
used more frequently for in situ production of short-term positron-emitting radiopharmaceuticals (radi
positron-emission tomography (PET) systems.

Instruments designed to cut x-ray film after it has been developed, fixed, and washed.
Equipment designed to recover silver from solutions for later use. These systems employ one of a var
technologies to recover the silver, including chemical precipitation, electrolysis, gravity, and ion excha
are used mainly in healthcare facilities to recover silver from the solutions used during radiographic fi
Photographic cameras used to capture digital images created by diagnostic imaging systems such as
(CT), magnetic resonance imaging (MRI), position-emission tomography (PET), gamma camera, and ul
reproduce them in variable image formats on radiographic films. These cameras use several optical, m
electronic methods to record each image; they usually have adjustments that allow the operator to de
images will be recorded on one film sheet (multiformatting, usually from 1 to 128 images on a single s
cameras are typically self contained with a television monitor that receives the video signal to be reco

Alarms designed to activate audible (i.e., sound) and/or visual alarms when a central gas system featu
outside predetermined operating characteristics. These devices typically consist of an independent el
amplifiers, level controls, and visual displays and/or audible warnings that may be located at the site a
station. Dedicated area alarms for central gas systems are used to warn users of abnormal conditions
values and oxygen depletion.

Dispensers designed to store and deliver controlled amounts of liquid or foam soap. These dispensers
and/or plastic container that can often be mounted on walls and counters. Liquid/foam soap dispenser
power operated, and are available in different styles and sizes. When soap is dispensed in liquid form
essentially a pump. The most popular soap dispensers of this type are plastic pump bottles, many of w
They can also dispense detergent, lotions and other viscous substances. Solid and powder dispensers
Liquid/foam soap dispensers are widely used in hospitals, stores, public places, and homes.

Racks designed to hold clothing and utensils for air drying. These racks typically consist of a metal, wo
framework with spaced bars, pegs, tiers, or hangers on which clothes or utensils are held; some may a
These racks can be wall-mounted, collapsible, as well as movable. Drying racks are used in hospitals
units.
Powered, usually hydraulically operated tools (e.g., spreaders, saws, chisels, cutters) that are used to
removal of entrapped victims of automobile accidents.
Mats used on the floor to help prevent fatigue, slipping, skidding, and to help trap moisture or dirt. Flo
made of rubber but can also be made from other materials (e.g., woven fabrics, plastics). They often i
or ridges to provide traction and trap water, grease, oil or dirt. Some floor mats have antibacterial pro
floor mats may be used to help prevent fatigue from standing for long periods of time.

Electrical safety monitors designed to assess defects or loss of the ground connection of electrical equ
instruments and alarm if the ground impedance is more than a pre-established limit. Some monitors p
path to ground should the equipment ground become faulty. These monitors are mostly used to detec
explosive environments.
Covers designed to overlie the top openings and/or to fit around hamper stands to protect laundry fro
and other contaminants. Hamper covers are made in many shapes and sizes to fit different hamper si
of polyethylene, steel, polyvinyl chloride, or cloth. Hamper covers help with odor prevention and cross
between users and soiled linen.
Liners designed for use as an inner cover of a hamper. They typically consist of a disposable plastic or
used to keep the hamper clean and to facilitate storage and manipulation of the hamper contents. Lar
used in fixed hampers (which are frequently centrally located on patient floors) for temporary storage
smaller liners are typically intended for use in portable units used in isolation procedures or located in
temporary storage of contaminated products (e.g., cloth, bandages), minimizing cross-contamination
Stands designed to hold one or more hamper bags (i.e., hamper liners) without slipping. These stands
slender metallic frame structure and frequently include a plastic (e.g., polypropylene) cover for the at
stands may be used for temporary storage of laundry; smaller, lighter, and portable hamper stands th
sterilization (e.g., steam sterilization) are used in isolation procedures for temporary storage of contam
cloth, bandages), minimizing cross-contamination and odor. Disposable plastic hamper stands for sing
available._x000D_

Containers designed for temporary collection and storage of used disposable products and/or dirty lau
typically consist of a ventilated basket (e.g., made of wicker or plastic) with a cover; an internal dispos
plastic bag) to keep the hamper clean and to facilitate storage and manipulation of the hamper conte
the inner surface of the hamper. Hampers are also available as a combination of a hamper stand (a m
appropriate hamper bags held by the stand. Large hampers are typically used for temporary storage o
is moved to a final destination for washing; smaller, portable, typically single-use units are used main
procedures and in regular patient rooms for temporary storage of contaminated products (e.g., cloth,
cross-contamination and odor until their disposal. Some hampers are designed specifically for use in m
imaging [MRI] environments, i.e., MRI-compatible hampers, and are made from nonmagnetic material
safely used in an MRI suite.

Hospital communication systems designed to page, summon, or locate people via radiated electromag
signals. These systems typically consist of a central transmission unit including a switching device tha
communication with each user, power supplies, electromagnetic (e.g., radiofrequency, microwave) sig
appropriate antennas and portable reception devices (i.e., pagers, beepers) that are carried by individ
attract their attention with an audible, tactile, or visual signal when a message is received. Hospital pa
systems may allow the delivery of brief messages to the individuals carrying receivers; they are used
emergency paging.

Hospital communication systems designed to provide voice information to the staff, patients, and/or v
healthcare facility (e.g., in patient and waiting rooms). These systems typically consist of a central con
microphone, amplifiers, and power sources; interconnecting wiring to most healthcare facility areas; a
to reproduce the voice message with enough volume to permit easy hearing in crowded areas. Public
communication systems allow users to summon and/or warn patients, visitors, and staff for routine or

Graphic recorders for the angle between the upper and lower jaw. A marking pen is attached to the lo
the device and makes recording on paper as the patient's mouth opens. These recorders are used to a
restorative and prosthetic dental devices.
Electric plugs designed for insertion into matching electric receptacles in damp, corrosive, or hazardou
some type of explosion might occur. These electric plugs are usually grounded and greatly insulated. E
plugs also eliminate the risk of drawing excessive current beyond maximum continuous rating on equ
usually intended to be used in designated wet locations where other types of electric plugs are not cli

Electric plugs designed to be permanently connected to earth (i.e., grounded) through an appropriate
receptacle. These plugs usually include three prongs (e.g., neutral, live, and earth) instead of only two
couples to the receptacle in such a way that is permanently connected to the ground; in the event of c
equipment chassis, the electricity flows through the ground wire to earth. Ground connection electric
to connect an appliance to a power supply; they must be plugged into a properly wired receptacle to p
against shock and damage to sensitive equipment.
Electric plugs designed to provide a higher level of protection from corrosion, impact, and electrical ha
plugs when connected to an appropriate matching electric receptacle. These hospital-grade plugs are
insulated and coated in heavy duty plastic to prevent damage to the plug; they have solid prongs that
plated, and include an internal cable retention device or strain relief to prevent any stress to the plug'
Hospital-grade electric plugs are intended for safe and reliable connection of an appliance to the powe
used in hospital and healthcare facilities to provide protection against electric mishaps and prevent in

Electric plugs designed to ensure that they remain in their own receptacles when connected through a
matching electric receptacle unless they are intentionally disconnected. These electric plugs usually h
with the holes in the electric receptacle; they are inserted into the receptacle, then twisted in one dire
place by the prongs, ensuring that the plugs are not accidentally removed from the receptacle. Lockin
used to connect an appliance to a power supply. They are used in hospitals and healthcare facilities w
protection against accidental disconnection is required.

Bars that are attached to something stable to be used for support by frail, infirmed, or disabled patien
attached to bathtubs, beds, commodes, or walls and are usually made of stainless steel or plastic.

Bars used for bathtub safety that can be attached to shower walls or clamped to the sides of the tub.
made of stainless steel and are used by infirm or disabled patients who need help balancing, sitting, a
the bathtub or shower.
Bars that are attached either to the walls and floor surrounding the commode or to the commode itsel
infirm and disabled patients in sitting and standing. They are typically made of stainless steel.

Bars that are attached to walls and are used for support by infirm and disabled patients. They can be
of a bathroom, line corridor walls, or any other place where it is likely a patient will need help balancin
walking.
Electric receptacles designed to establish an electrical connection with an inserted plug in damp, corro
locations where some type of explosion might occur.These electric receptacles commonly have slots o
combination of the two into which electric plugs may be inserted; the slots or holes have metal contac
on the opposite side of the receptacle to electrical wiring. Explosion-proof electric receptacles are usu
used in areas designated by hospitals as wet locations where other types of electric receptacles are n

Electric receptacles designed to establish an electrical connection with an appropriate inserted plug p
to ground. These receptacles commonly have slots or holes, or a combination of the two into which de
of the slots or holes have metal contacts that are connected to physical ground (i.e., earth) through a
the event of current leakage to the chassis, the electricity flows through the ground wire to earth. Gro
receptacles are used in homes, hospitals, and other healthcare facilities to avoid electric shocks to eq

Electric receptacles designed to establish an electrical connection with an inserted plug and provide a
protection from corrosion, impact, and other electric hazards than regular receptacles. These electric r
have slots or holes, or a combination of the two into which devices are plugged; the slots or holes hav
are connected to electrical wiring. The receptacles are very heavily insulated and coated in heavy dut
them from damage.
Electric receptacles designed with a latching mechanism to prevent unintentional removal of an insert
receptacles commonly have slots or holes, or a combination of the two into which devices are plugged
have metal contacts that are connected to electrical wiring. Plugs are inserted into the receptacles, th
direction and locked up into place by the prongs. This insures that the plugs are not accidentally remo
receptacle. Locking electric plugs are used mainly in hospitals and healthcare facilities to connect an a
supply where increased protection against accidental disconnection is required.

Alarms designed to activate audible (i.e., sound) and/or visual warnings when the power line voltage a
outside pre-established values (e.g., voltage values plus or minus 5% and/or frequency values plus or
their nominal values). These alarms typically consist of a battery operated electronic unit that include
that automatically compare the line voltage and frequency with a pre-established range of values; som
interconnected to voltage regulators that can keep the line voltage at useful values when the line volt
brownouts) or high, and/or activate emergency power units for blackouts or for low or high line voltag
cannot regulate. These alarms may be intended for the general power supply of a healthcare facility,
room in the facility, or specifically for devices whose failure may cause severe consequences to health
device. Voltage/frequency alarms are also available as an integral part of environmental and electrica
other equipment.

Bowls used to hold water for the purpose of bathing patients. They may also be used for limb soaking
reusable (e.g., made of metal that can be cleaned/autoclaved) or disposable (e.g., made of plastic, pa
cardboard).
Examination lights that are fixed to the ceiling. The light fixtures typically have highly flexible and adju
for movement and placement of the light head in the precise position needed. Ceiling-mounted exam
typically used in dental and medical offices for patient examinations; they may also be used during m
procedures.
Bone surgery brushes designed to prepare (i.e., clean and debride) a bone canal (i.e., intramedullary)
cement. These brushes typically consist of a flexible, twisted, metallic (e.g., stainless steel) wire with
radiating from the shaft; the wire is attached to a handle or conformed for direct manual manipulation
or powered handpiece at the proximal end. Dedicated intramedullary bone brushes are available for fe
narrower bone canal preparation; they aid the removal of blood clots and bone debris.

Guides designed to lead a needle to its proper course during clinical and/or surgical procedures. Dedic
available for many different procedures, such as plastic guides with magnifiers for insulin injection, sta
with a finger ring for transrectal prostate biopsy, guides for ultrasound-guided percutaneous puncture
and guides for stereotactic breast biopsy.
Cardiac valve prostheses made of metals, synthetic materials or a combination of these without includ
component. These prostheses are usually made of strong and very durable materials such as titanium
that may be combined with synthetic materials (e.g., silicone rubber, Teflon, polypropylene); the size a
used depend on the type of cardiac valve to be replaced (i.e., mitral, tricuspid, aortic, or pulmonary) a
characteristics of the particular patient. Artificial cardiac valves may use several different mechanical
caged ball, tilting disk, and bileaflet.
Cardiac valve prostheses manufactured using human or animal tissues. These valves may consist of w
taken from human cadavers (i.e., allografts) or from animals such as pigs or cows (i.e., xenografts); th
processed and may be mounted on stents. Biological cardiac valves may also be manufactured from t
pericardium, dura mater) usually taken from cows or horses. Biological cardiac valve prostheses may
several sizes and types, depending on the cardiac valve to be replaced (i.e., mitral, tricuspid, aortic, o
anatomic characteristics of the particular patient.

X-ray radiation shields, usually cup-shaped lead-glass lenses held by a cord to fit to the patient or hea
shields are designed for protection of the patient's eye lens during therapeutic and diagnostic imaging

X-ray radiation shields that usually consist of a protective screen including a transparent lead-plastic s
shields are designed to provide visibility while protecting healthcare personnel from radiation when do
procedures (e.g., cardiac catheterization). Barrier radiation shields may be a stand-alone fixed or mob
attached to a wall-, ceiling- or table-mounted articulated arm. Some portable, usually height-adjustab
used for shielding patients in such procedures as chest, skull, and spine radiography.

Tissue ablation radio-frequency (RF) therapy systems designed to ablate regions in the eye. These sy
generator (13.56 MHz is typical) with power and time controls and a handpiece with appropriate elect
interstitial) according to the intended application. Ophthalmic tissue ablation RF systems are used for
procedures, including coagulation necrosis of intraocular tumors; coagulation is also used in retinal rea
procedures.

Occluders designed to temporarily prevent or attenuate (i.e., occlude) the passage of light to one or b
occluders are typically a handheld plastic or metal device with one or two opaque covers for the eyes;
translucent and/or include pinholes for special tests. Ophthalmic occluders are used in tests, including
cover test), eye-movement monitoring, and visual field.
Exploratory probes designed for introduction into the throat and through the larynx and that are inten
exploratory purposes. These probes typically consist of very slender flexible metal or plastic cylinders
angled, and can be passed through the larynx. These devices may be attached to a handle at the prox
can be flexible or rigid. Microlaryngeal exploratory probes are intended for exploring the throat and la
overall view of the path through the larynx during microlaryngeal surgical procedures.

Vascular surgical clamps designed for the grdual atraumatic compression of the carotid artery during o
procedures, usually to cause total or partial temporary occlusion (i.e., coarctation). These clamps are t
manual instruments with a clamping, usually threaded mechanism at the distal tip that is operated by
Dedicated carotid artery clamps are available for controlled gradual occlusion and/or for hemostasis o
mainly used during surgery of the intracranial vasculature.

Surgical clamps designed for the atraumatic compression of veins or arteries during open-surgery pro
cause total or partial occlusion (i.e., coarctation). These clamps are typically handheld, manual instrum
parts pivoted at the center with straight or curved, serrated distal blades. The serrated region frequen
nonserrated trough running its length, to prevent trauma to the enclosed vessel. Vascular surgical clam
variety of surgical procedures (e.g., resection, anastomosis).
Cardiac catheters designed to rapidly inject a bolus of dye (usually indocyanine green) into the venou
right atrium. These catheters typically consist of a large-bore, flexible tube with end and side holes at
flow injection; they are usually inserted peripherally. A sample of the blood is usually withdrawn contin
peripheral artery and passed through a densitometer, which determines the dye concentration. These
determine the cardiac output during catheterization procedures, mostly when thermodilution methods
possible (e.g., quantification of left-to-right shunts in the heart).

Carts designed for delivery of supplies (e.g., surgical instruments, medicines, linen, intravenous soluti
central location (e.g., central material management, sterilization room, laundry facility, kitchen) to oth
healthcare facility, such as nurse stations, operating rooms, and patient rooms. These carts typically c
clean heavy duty large metallic or plastic structure, either open or enclosed, mounted on extra-large w
in or more in diameter) that are usually an integral part of the cart to facilitate its movement througho
halls, elevators); the carts are usually moved manually but electrically (battery) operated carts are als
supply carts may be also used to keep a minimum inventory of supplies by performing a periodic reple
carts) or to be exchanged for a new replenished cart (exchange carts); they are frequently also used t
devices to the central location for reprocessing. Dedicated central supply carts manufactured with ma
size, or including attachments that make them appropriate to transport a particular type of products,
instruments, medication, laundry, intravenous solutions, or food are also available. The carts are not i
storage.

Central supply carts designed for food distribution in healthcare facilities usually from a central distrib
kitchen, satellite kitchens). These carts are typically manufactured in an easy to clean, metallic, heavy
even surface free of crevices; they are frequently made of stainless steel. Food service carts are availa
sizes and configurations, according to their intended use and/or the number of patients to be served.
distribution in bulk and/or in trays are available.

Central supply carts designed for organized storage and distribution of clean laundry from a central lo
stations, operating rooms and other locations in a healthcare facility; some carts are also used to deliv
laundry facilities. Linen/laundry carts usually have a metal open structure that does not include side p
solid and/or wire shelves or baskets, hangers, and/or individual compartments for folded clothing. Car
dirty or clean linen/laundry without capabilities for appropriate transport of folded or hung cloth are al

Carts designed for non-specialized temporary storage and local transportation of devices, materials, a
carts typically consist of an open or enclosed structure made of solid metal, hard plastic, wire, or a com
materials; the structure is mounted on medium-sized (e.g., 7.5 cm/3 in) wheels that are usually an int
The carts are usually moved manually but electrically (battery) operated carts are also available. Serv
mainly used for products that do not require any special transportation conditions.

Carts designed for transport and easy access of utensils and products for cleaning healthcare facilities
consist of a metallic or plastic open structure with appropriate attachments for transporting buckets a
cleaning products, dustpans, dispensers, wringers, warning signals, trash bags, and a trash container.
large wheel casters that usually include caster bumpers. Some dedicated carts are manufactured com
magnetic materials for cleaning areas with high magnetic fields (e.g., magnetic resonance imaging ro
Central supply carts designed for organized storage and transport in separate containers of sterile sup
necessary for single surgical procedures (i.e., a surgical case). Typically the carts are loaded in the ste
required supplies and instruments for the procedure and then the filled cart is properly labeled. The ca
the operating room and unloaded. After the procedure, the contaminated supplies are returned to the
to the decontamination area of the hospital. Surgical case carts are available in a wide variety of confi
Surgical case carts are used to facilitate surgical procedures, transferring the duties of instrument pre
to the central supply department. Surgical case carts manufactured with open and closed structures a

Laboratory breath analyzers used to determine the helium content in a breath sample. These analyze
chromatography, mass spectrometry, or gas chromatography techniques. Helium analyzers are most
the dilution level of the testing gases during pulmonary function (diffusing capacity) testing.

Furniture consisting of a series of units (e.g., cabinets, shelves, racks) that are assembled or combined
with an interior storage space. This furniture is usually constructed using thicker panels and specialize
may be different from those used in domestic cabinetry; casework is frequently fixed to the walls, floo
typically installed in such a manner that inside access is easy and the space required for the furniture
storage area is maximized; casework may also provide working surfaces. Casework is typically design
of an entire area of a healthcare facility, such as clinical laboratories, nursing stations, pharmacies, an
designed for special functions/spaces as needed.

Casework designed for general, nonspecialized storage within healthcare facilities. This casework usu
nonspecialized storing units, such as cabinets, drawers, boxes, and shelves usually fixed to the wall, fl
is typically installed in such a manner that inside access is easy and the space required for the furnitu
the storage area is maximized; casework may also provide working surfaces. Multipurpose casework i
cover the needs of nonspecialized area of a healthcare facility, such as a doctor's office or a reception

Casework designed specifically for use in a clinical laboratory.


Multipurpose casework composed of a set of nonspecialized, independent (e.g., cabinets, drawers, bo
units (modules) that can be arranged in a variety of ways. Modular multipurpose casework is usually fi
or both and installed in such a manner that access is easy and the space for the furniture is minimized
area is maximized; casework may also provide working surfaces. Modular multipurpose casework is in
needs of nonspecialized areas of a healthcare facility, such as a doctor's office or a reception area; mo
be rearranged to change its configuration and/or to include additional modules as needed.

Casework designed for use in nursing stations. This furniture typically includes cabinets and shelves a
of small devices and instruments (e.g., thermometers, sphygmomanometers), utensils, and medicines
include filing cabinets to keep patient records. Nursing station casework is used in hospitals, nursing h
healthcare facilities.
Casework designed for use in patient rooms. This furniture usually includes bedside tables, bookcases
television sets and telephones; patient room furniture may also include other wall and/or stand-alone
casework is usually made of hard plastics, metal, or wood with an appropriate finish for ease of cleani
Patient room casework is used in hospitals and other healthcare facilities to provide comfort, facilitate
communication, and permit storage of patient belongings.
Casework designed for use in clinical pharmacies. This furniture usually includes cabinets and shelves
materials that protect against corrosion and strong chemicals; they are intended to store chemicals, m
and small instruments; some include sinks. Pharmacy casework is used in hospitals, nursing homes, a
facilities.
Equipment designed to reduce the volume of solid waste material by mechanical compression. This eq
consists of a container with mechanisms that compress the waste material (e.g., metals, plastic), redu
several times; compactors are available in a variety of sizes and configurations, from big stand-alone
large quantities of waste to small, portable units. Waste compactors are used in healthcare facilities to
manipulation and transportation of waste material to the final disposal locations.

Large, stand-alone waste compactors designed to reduce the volume of solid waste material by mech
These units usually consist of a large container with mechanisms that compress the waste material (e
reducing its volume several times; the compactors are available in a variety of sizes and configuration
compactors are used in healthcare facilities for facilitating the manipulation of large quantities of was
inless storage room being required before waste material is sent to the final disposal locations.

Curtains designed to block water from splashing out of the shower area while providing privacy to the
shower. These curtains usually consist of a piece of fabric hung from a wall-mounted rod or a ceiling tr
are often manually operated. They come in a variety of materials (e.g., cotton, polyester, nylon). Fire r
stain, and odor resistant shower curtains are available. Shower curtains are widely used at homes, and
(e.g., nursing homes, hospitals, doctors' offices).

Reusable antimicrobial shower curtains inhibit the growth of a large variety of bacteria, fungi, and viru
shower curtains usually consist of a piece of plastic or cloth fabric with an antimicrobial agent integrat
Antimicrobial reusable shower curtains are able to withstand institutional laundering and maintain the
They are hung from a wall-mounted rod or a ceiling track and are often manually operated. These sho
retardant and mildew, stain, and odor resistant. They are widely used at homes, hotels and healthcare
homes, hospitals, doctors' offices).

Shower curtains designed to be used for a short period of time and then discarded, eliminating mainte
disposable curtains usually consist of a piece of lightweight plastic hung from a wall-mounted rod or a
often manually operated. Some of these shower curtains are fire retardant and mildew, stain, and odo
widely used at homes and healthcare facilities (e.g., nursing homes, hospitals, doctors' offices).

Shower curtains designed to be used many times and withstand institutional laundering. These reusab
usually consist of a piece of plastic or cloth fabric hung from a wall-mounted rod or a ceiling track and
operated. Most of these shower curtains are fire retardant and mildew, stain, and odor resistant. They
homes and healthcare facilities (e.g., nursing homes, hospitals, doctors' offices).

Dispensers designed to store and deliver ice. The ice is kept in a storage chamber to be power- or man
needed. Some dispensers can also include a freezing mechanism to transform water from the liquid to
different shapes (e.g., cubes, flakes, crushed). Healthcare facility ice makers/dispensers are intended
uncontaminated ice for use in baths; for temporary preservation of blood, organs, and tissues; and for
such as cold therapy.
Food refrigerators with a cabinet-like storage compartment large enough to permit a person to enter;
storage of food products at temperatures typically between 4 and 10 degrees Celsius (39 and 50 degr
refrigerators typically consist of a chamber made with a corrosion-resistant or corrosion-proof (typicall
interior, minimizing the risk of adulteration and/or contamination of contents; internal shelving approp
location and handling of food products once the user is inside the chamber; a compressor, condenser,
tubing; temperature sensors and controls and possibly a temperature recording chart and alarms for d
storage. Walk-in food storage refrigerators are available completely assembled or as separate structur
doors, panels, floors) and units (e.g., refrigeration system, condensing unit) for assembly at user facili

Food refrigerators designed to quickly lower the temperature of heated infant formula to a temperatur
infant ingestion (usually between 38 and 41 degrees Celsius [100 and 106 degrees Fahrenheit]). Thes
consist of a small chamber for one or more containers and a refrigeration system that can provide qui
chamber unit, lowering the infant formula to the desired temperature. Infant formula cooling units are
feeding of babies when breast feeding is not possible or desirable with a milk-based substitute or less
formulas (e.g., soy based) depending on the infant's requirements.

Showers designed for decontamination in emergency situations. These devices typically consist of sho
sudden and abundant flow of water to the person. They are used in hospitals, especially in locations s
laboratories, where the probability of contamination is greater.
Boards, placards or other written or image displays used for identification, direction, warning or other
concern. Signs are used in health care facilities to identify laboratories, offices, patient rooms, and oth
directions to staff, patients, and visitors; or to warn from biological, chemical, radioactive, and/or othe
potentially hazardous conditions.
Signs intended to give visual directions within a healthcare facility. These signals typically consist of b
legends such as "Exit", "Examination Room", "Mammography", or "Reception," frequently followed by
the appropriate direction. Directional signs are placed throughout healthcare facilities to facilitate staff
orientation.
Signs intended to give visual warning of biological, chemical, radioactive, and/or other hazardous or p
conditions within a healthcare facility. These signals typically consist of boards or placards with legend
Use", "Radiation", or "Isolation Room." Safety signs are placed throughout healthcare facilities to prote
visitors from accidents.
Washers designed for automatic or semiautomatic removal of dirt and/or stains (i.e., washing) from so
(i.e., laundry) using physical and/or chemical procedures. These washers typically perform one or mor
cycles of operations that may include prewash, enzyme treatment, detergent washing, and rinsing. La
typically include a rotary drum for cleaning, filters, temperature and speed controls, and hoses for wa
evacuation. Standard and heavy-duty top-load and front-load laundry washers are available for use in

Installations designed for washing, collecting of fluids, and drainage. These devices typically consist o
with water supply, faucets, and connection to drainage; they may include garbage disposal units. Ded
in healthcare facilities in examination rooms, clinical and dental offices, clinical laboratories, dissection
and for surgical scrub; standard sinks are also used for common tasks such as food preparation, clean
service utensils, and housekeeping. Portable sinks for use in the field, during emergencies, and/or by
also available.
Sinks designed primarily for cleaning the hands of healthcare personnel in hospital examination and/o
including physician and dental offices, and nurse stations. These sinks typically consist of one or more
with a seamless construction without crevices, that include several faucets, cold and hot water supply
tubing for drainage; the sinks may include electrical receptacles, and/or drawers for instruments and s
are frequently operated using infrared devices or footpedals. Healthcare staff handwashing is used to
transmission of infection to patients; the sinks are usually available as stand-alone equipment, but ma
an integral part of a nurse station. Examination/treatment sinks are usually located throughout health
facilitate personnel handwashing and/or cleaning of small devices and supplies close to the site of pat

Sinks designed for cleaning and manipulation of laboratory devices, instruments, and supplies. These
of one or more non-absorbent and resistant to acids, salts, and solvents bowls (e.g., made of epoxy re
with a seamless, without crevices, and rounded corner construction that includes several faucets, cold
water supply, soap dispensers, and appropriate tubing for drainage. The sinks may also include exhau
to the building ventilation system and a waste bin. They are usually operated using hand and/or foot p
laboratory sinks are available as stand alone units or more frequently to be mounted on standard labo
alone bigger, deeper, and wider laboratory sinks intended to wash glassware are also available.

Sinks designed for thorough cleaning and disinfecting (i.e., scrubbing) of the hands and arms before s
procedures that require a certain level of cleansing by participating personnel in order to reduce or pr
of infection to patients. These sinks are single units consisting of one stainless steel bowl, with a seam
without crevices. They that may include several faucets, cold and hot water supply, and a soap dispen
surgeons and other medical staff before approaching a designated sterile area (e.g., surgical suite).

Processors that develop film exposed to various forms of energy, ranging from x-ray to visible light. T
processing by automatically developing, fixing, washing, and drying films.
Devices used for automatically developing, fixing, washing, and drying dental x-ray film.
Conveyors designed for automated movement of equipment and/or containers filled with documents a
healthcare facility. These conveyors typically consist of a moving belt with appropriate attachments fo
cleats, scoops, or buckets), a powered mechanism, and controls to regulate the movement and/or spe
Document/materiel conveyors are used to move documents and/or materiel (i.e., equipment, devices,
also used to move laboratory samples and/or drugs while preserving their integrity and preventing an
tampering.

Lifts designed to vertically transfer equipment, apparatus, and supplies. Materiel lifts may consist of d
configurations according to the load to be transferred, such as cages or platforms, and their hoisting m
and supply lifts are used in healthcare facilities to transfer supplies in warehouses, engineering depar
food supplies, and other clinical and/or service departments; they are not appropriate for transporting

Conveyors designed for automated movement within a healthcare facility of trays filled with food and
after food consumption. These conveyors typically consist of a moving belt with appropriate attachme
powered mechanism, and controls to regulate the movement and/or speed of the belt. Food tray conv
include some kind of heating system to keep the food warm during transport. They are used to move
kitchen to a food distribution center and/or back to the kitchen tray washers.
Cameras designed to obtain a physiologic image of the distribution of gamma-ray-emitting radioisotop
body after the injection or ingestion of a radiopharmaceutical. These cameras include a collimator to
a detector (e.g., a sodium iodide crystal, an array of multiple crystals) that converts the gamma rays i
(scintillation), photomultiplier tubes that convert light to electrical current, electronic circuitry to deter
magnitude of scintillation events, and a display. Gamma cameras are mostly used in the detection of
nuclear cardiology studies, and cerebral blood flow images; they are frequently used in nuclear medic
physiological imaging scanning systems.

Set of devices intended for manual processing (i.e., developing) of x-ray films to obtain a visible imag
The procedure consists of developing (i.e., reduce the silver salt to metallic salt), fixing (halt of the de
unexposed silver salts, and harden the gelatin), washing, and drying. The equipment includes appropr
developing, fixing, and washing; heaters and timers to control the temperature and time of the proced
(illuminators) to regulate the light in the darkroom permitting operator work while avoiding film dama
bins to prevent fogging of stored film. Other equipment frequently used to facilitate the manual proce
darkrooms include identification printers to insert the patient ID on the film, pass-through cabinets to
and out the darkroom, viewers for observation of radiographies, and interlocks for the doors.

Devices used to process long rolls of 16 or 35 mm film, specifically those used for cinefluorography, w
picture camera to record a fluoroscopic image formed on the output phosphor of an image intensifier
film processors.
Processors that are built to make in-house film developing cost-effective for small offices, clinics, sate
facilities, and mobile installations. These processors develop film exposed to various forms of energy,
visible light. They mechanize film processing by automatically developing, fixing, washing, and drying
small enough to be placed on tabletops or workbenches.
Units that combine radiographic and fluoroscopic capabilities. These systems produce instantaneous
images (fluoroscopies) and latent x-ray images that can be converted using a film processor or a digit
a visible image (a radiograph) for detailed study and for archiving.
Axial computed tomography scanning systems designed to generate an image of the tissue density in
of the head. These scanners are used for a wide variety of diagnostic procedures, including those for h
and malignancies and to examine the cerebral ventricles and large blood vessels in the head.

Axial computed tomography scanning systems designed to generate an image of the tissue density in
of the whole human body. These scanners are used for a wide variety of diagnostic procedures, includ
injuries, lesions, and abdominal and pelvic malignancies; to examine the cerebral ventricles, the ches
blood vessels; and to assess musculoskeletal degeneration.
Ultrasonic scanning systems that include an ultrasonic scanner, transducers (frequencies of 5 to 12 M
vascular scanning), dedicated software, an image recorder (e.g., videocassette), and a printer. Most va
scanners include continuous-wave and pulsed-wave Doppler capabilities (including a spectrum analyz
velocity and location of blood flow; they can be operated in mode, color flow mapping mode, and tripl
simultaneous acquisition and display of 2-D gray-scale, spectral Doppler, and color flow data). Vascula
systems usually display images of the vessels in conjunction with spectrum analysis to depict the ves
obstructions. Some vascular scanners use a low-frequency (typically 2 MHz) Doppler transducer to obt
velocity recording in the intracranial arteries. These systems are used for transdermal examination an
diseases, occlusions, and obstructions in the peripheral vascular system, including a profile of the bloo
area under examination. Most of them also include capabilities for small-part examinations.

Devices that hold the patient data (in the form of printouts and/or notes) that is collected at each clini
bedside charts are typically in the form of a three-ring binder, clipboard, or manila folder with fastene
hook or lip that allows them to hang from patient beds or handrails.
Devices designed for brightening the screen image (i.e., intensifying) in fluoroscopic procedures, redu
needed. An image intensifier converts radiation to electrons, which in turn are accelerated and conver
devices consist of metal or glass electron tube including a photocatode, accelerating electrodes, an in
end, and an output phosphor at the other end. The amplification in brightness is proportional to the re
between the input and output phosphors. Image intensifiers are typically described in terms of their
diameter (e.g., 15, 30 cm). The output phosphor image is usually taken by a TV camera or CCD conve
display in a fluoroscopic television system

Breathing flowmeters designed to measure the maximum rate of expiratory gas flow from the lungs, u
of the expiration. These flowmeters typically consist of a manual, handheld instrument with a tube for
easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. Peak respiratory gas
intended for periodic self-evaluation of respiratory status and to help in the treatment of patients suffe
less frequently, of patients with chronic respiratory disorders (e.g., emphysema).

Systems designed for obtaining images from one point and transferring them to another point. These
consist of a device (e.g., camera) that detects variations in light at the source and converts them into
light sources; a processor that transforms the electronic signal to a useful format for transmission, dis
and devices to record and display the images, such as video monitors, tape and optical recorders, and
video systems are designed for image processing and display using computerized techniques and dev
designed for transmission and display of images and sound according to standards identical or similar
television broadcasting (i.e., television systems). Television systems may be used either for transmiss
or over cables (e.g., closed-circuit television systems). Video systems are used in healthcare facilities
performance and keep records of procedures in which endoscopes (e.g., colonoscopes, laparoscopes)
are used, to allow simultaneous visualization of surgical procedures (e.g., for educational purposes), f
fluoroscopic images, and to send images to distant locations for diagnostic and information exchange
videoconferencing).
Video systems designed to obtain images of the interior cavities of the body (e.g., gastrointestinal tra
peritoneum). These systems typically consist of a video-image detection and processing system, inclu
a light source, an image processor, monitors, and recording devices. Video endoscopy systems are use
therapeutic procedures, such as gastrointestinal endoscopy, laparoscopy, and arthroscopy.

Video systems designed to display images from a microscope in a video monitor or video printer. Thes
consist of an adapter that may be used to attach a video camera (typically a charge-coupled device [C
system of the microscope and an image processor; they also include monitors and recording devices.
additional devices for measuring and marking the microscopic images. Video systems for microscopes
laboratory and/or clinical applications (e.g., measurement of tissue cross-sections and blood vessel dia
systems with an adapter specially designed for operating microscopes are used in diagnostic and ther
including colposcopy.

Video systems designed to transmit images and sound from the operating field to monitors, recorders
These systems typically consist of standard or high-bandwidth overhead television cameras, television
and high-definition video recorders, monitors, and printers. Operating room television systems permi
operatory field simultaneously by several surgeons in the operating room, transmission of images to r
for educational purposes), and record keeping of the procedures. Some systems include adapters to p
of images from endoscopes and/or operating microscopes.

Stainless steel sutures made of single filaments (i.e., monofilament) medical-grade stainless steel allo
typically available in sterile, uncoated thread sections (e.g., 18, 30 in [45, 76 cm] long) that may be a
needle as an integral device. Monofilament stainless steel sutures keep their tensile strength for very
and are not absorbed by tissues; their intended use includes orthopedic procedures including cerclage
repair, sternum closure (after sternotomy), and abdominal wound closure.

Microbiology laboratory blood culture analyzers that automatically test blood cultures, process test da
interpretation of test results using computing programs. These analyzers detect carbon dioxide produ
using radiometric or infrared spectrophotometry or detect microbial activity using photometric or fluor
measurements. Other analyzers use microcalorimetry, pH, electrical impedance, or flow cytometry te
blood culture analyzers are used in laboratories that perform large quantities of tests, providing more
increasing productivity when compared to manual analyzers. Some blood culture analyzers can also b
microbial growth in other body fluids.

Assemblies typically consisting of an X-ray tube housing encasing an x-ray tube and a set of lead plate
collimators) attached to the housing aperture (port). X-ray tube assemblies are usually mounted in tu
ceiling, wall), they may be also mounted under fluoroscopic tables and/or in the arms of mobile or C-a
Ultrasonic scanning systems that include an ultrasonic scanner and transducers (e.g., 3.5 and 5.0 MHz
include dedicated software (e.g., obstetric/gynecologic calculation package), an image recorder (e.g.,
printer; other systems send the images directly to a picture archiving and communication system. The
use transducers with linear array and mechanical or electronic sector scanning configurations. Gener
scanning systems are used for general radiology purposes, including abdominal and obstetric/gynecol
most of them include additional transducers to facilitate specialized procedures such as small-parts, v
examinations. Optional capabilities, such as Doppler and color flow mapping, and additional analysis s
(e.g., vascular, urology) are usually available.

Rectum surgery scissors designed to dissect tissue (e.g., adhesions, fibrotic tissue) from fistulas betwe
vagina (i.e., rectovaginal) or between the rectum and urinary bladder (rectovesical). These scissors ar
manual instruments with two metallic (e.g., stainless steel), very fine, either straight or curved blades
slide past each other (i.e., shearing action) and a long shank. The blades are attached to handles with
conformed as a ring to facilitate holding and operating with the fingers; the two parts are joined by a s
Fistula rectum scissors are used in surgical procedures of the rectum intended to suppress abnormal r

Devices used to mount oxygen canisters and poles for intravenous lines to wheelchairs during patient
oxygen canister/IV pole holders are typically constructed of sturdy metal and contain clamps or other
mount them onto the wheelchair frame. They come in various styles and sizes and are usually interch
models of wheelchairs.
Cannulae that are inserted into a joint during arthroscopic surgery to drain distention/irrigation solutio

Dryers designed to remove moisture from laboratory glassware (e.g., burets, beakers, test tubes) usin
typically consist of an electric heat source and an enclosure with appropriate holders and shelves for t
devices include an internal ventilator to provide forced air. Labware dryers are used after labware is p
labware washers frequently integrate washing and drying capabilities.

Flat boards (i.e., trays) designed for use as wheelchair accessories that are mainly intended to facilita
such as eating, writing, and reading. These trays are typically made of metal, hard plastic, or wood an
or sides of the wheelchair using clamps or hinges. Dedicated wheelchair trays filled with gel and/or sp
(i.e., tactile) stimulation for disabled patients are available; wheelchair lapboards to support the arm a

Snares designed to position and tighten fine-gauge, flexible, adjustable wire loops around a region of
polyps) for mechanical or electrosurgical resection and hemostasis. These devices typically consist of
straight or bent structure (e.g., a cannula, typically with a length of 8 to 18 inches/20 to 45 cm) with o
wire loops (rings) that protrude at the working end; frequently they include a stationary loop and a slid
loops are made of monofilament or braided wires that may be attached at the proximal end to an elec
monopolar) unit that provides circulation of radio-frequency electric current between the isolated met
an active electrode) and an external neutral electrode to heat the tissues and facilitate resection and
and single-use (i.e., disposable) rectal snares are intended mainly for electrosurgical removal of polyp
abnormal tissue from the rectal mucosa, but devices that provide only mechanical resection are also a
Covers intended to be placed around a linen/laundry cart in order to protect the clean linen or laundry
in the carts. The cart covers are reusable and are usually made of nylon, vinyl, polyester, or cotton fab
wide variety of sizes. Linen/laundry cart covers are fastened to the carts with elastic, zippers, hook-an
with ties used to secure the cover to cart posts.
Programmer/testers designed to noninvasively test and/or change the electrical characteristics (i.e., p
implanted cardiac pacemakers. These devices typically consist of a computerized unit with programm
recording capabilities that can interact with the implanted pacemaker to interrogate the pulse genera
previously stored, perform diagnostic tests, generate printed reports, and/or reprogram the pacemake
pacemaker programmer/testers are used to test and/or change the pacing conditions of implanted car
during patient checkups; they are usually appropriate only for a particular set of implantable pacemak
programmer/testers have capabilities to interact with implanted cardioverter-defibrillators.

Gastrostomy tubes designed for stomach decompression and jejunal feeding. They may be placed sur
surgery, laparotomy) or by using a percutaneous endoscopic procedure with minimum sedation in out
bedside. These devices typically consist of a dual-lumen plastic (e.g., polyurethane) tube of 12 to 18 F
balloon at each tip. The tube is inserted and advanced through the pylorus; the balloon is inflated with
through the duodenum into the jejunum. The tip of the second lumen of the tube is positioned in the s
decompression/jejunal feeding tubes are intended to provide jejunal feeding using standard gastrosto
procedures; they are used to feed patients who require long-term enteral feeding but who are unable
oral intake (e.g., patients who have severe neurologic impairment; they are also used in patients who
mouth, larynx, or esophagus) who also require stomach decompression.

Structures suspended from the ceiling that are designed to support operating microscopes. These boo
a ceiling fixture, a support system equipped with a movable arm, a pendant head, and an equipment
microscope. A steel tube on the ceiling fits the pivot bearing of the support system below it, which gen
vertical support arm and a movable single-support arm that allows rotation of the pendant head. The
attaches below the pendant and supports the microscope. Operating microscope ceiling-mounted boo
installed in surgical rooms and used in procedures such as neurosurgery, microsurgery, and ophthalm
be installed in dental surgery cabinets.

Cushions designed for use on a commode seat to provide comfort, alleviation of pain, and/or to facilita
person. These cushions may consist of an inflatable device or a device made of soft cushioning mater
foam); commode seat cushions usually have a hole in the center (i.e., ring cushions) and a waterproof
are usually snapped or strapped onto the commode or toilet seat, and there are some that are made t
like a steering-wheel cover. Sacroiliac accommodative cushions provide comfort and protection of the
and/or perineal area; they are mainly used by patients undergoing rehabilitation or by geriatric people

Patient surgical drapes intended to provide a bacteria-proof barrier between the unsterile skin of the p
surgical field during angiographic procedures. These patient surgical drapes usually consist of a film la
impervious protection against strikethrough of blood and other body fluids, as well as solutions used f
and the cleaning of guide wires and catheters which reduces the need for multiple patient surgical dra
angiographic patient surgical drapes include transparent side panels to ensure unobstructed view and
operating table controls. Most angiographic patient surgical drapes are made of disposable materials
also available. These patient surgical drapes are used in femoral angiography and angioplasty proced
Data tape recorders that include sensors and amplifiers for measuring and recording two or more vita
(e.g., electrocardiogram and blood pressure). These recorders are commonly used in patients to asse
conditions.
Ambulatory electrocardiographic tape recorders in which the recording function is always active. Thes
typically used for a period of 24 to 48 hours to assess patients suffering from cardiac diseases.
Electrical safety electrosurgical monitors designed to assess the electrical impedance in the return pa
the electrical generator, particularly the contact impedance between the return electrode and the skin
monitors deliver a test signal to the return electrode via the return electrode cable, the signal is then
which continuously measures the value of the impedance and alarm if its value is more than a pre-est
electrode safety monitors are used during monopolar electrosurgical procedures.

Shoes designed to protect, support, and/or improve the function and/or correct deformities of the feet
include heels, linings, soles, and/or reinforcements with particular characteristics according to the fun
abnormalities of the patient. Orthopedic shoes are intended for temporary or permanent use to preve
musculoskeletal deformities of the feet and/or to improve their function; dedicated shoes for tempora
therapeutic and/or rehabilitation procedures (e.g., cast use) are also available.

Hematology analyzers designed to perform grouping and other basic blood-processing tests. Most of t
previous centrifugation of the sample to separate the red cells from the plasma. A positive result for b
usually occurs when a known antiserum agglutinates those red blood cells having a corresponding ant
analyzers usually perform tests that include ABO grouping and subgrouping, Rh and other red cell phe
antibody detection. Some of these analyzers can perform other tests (e.g., for syphilis or hepatitis) tha
in pretransfusion procedures.

Bags designed for temporary storage of soiled linen, frequently at the location where it was used. The
mesh, canvas, or plastic bags; some bags are color-coded according to the potential hazard of the inte
colors may signify used cloth, contaminated/potentially contaminated linen, or operating room linen).
available for independent storage or for use with hamper stands; bags that dissolve either partially or
wash cycle to prevent staff contact with soiled linen are also available.

Furniture typically consisting of a single seat without back or arms, usually designed for healthcare pe
performing an examination or other clinical procedure (e.g., surgical, dental, anesthesiology) include a
backrest. Most stools are movable, and many include casters. Note: In definitions commonly found in
a seat with a back that may include arms or not, and a stool is a seat without a back or arms; but it is
medical furniture literature to use a chair when the furniture is designed for patient use and a stool fo
used by the healthcare personnel (I.e., physicians, nurses, dentists), regardless of whether it has a ba
convention has been used consistently in the development of all the stool and chair terms. Some stoo
specifically for use in magnetic resonance imaging [MRI] environments, i.e., MRI-compatible adjustabl
from nonmagnetic materials so that they can be safely used in an MRI suite.

Automated equipment designed for rinsing, cleaning, and resterilizing (i.e., reprocessing) hemodialysi
reuse. Following dialysis, this equipment performs a cycle that includes water rinsing; removing blood
blood components deposited on the dialyzer membrane with a cleaning agent (e.g., hydrogen peroxid
resterilizing, typically with a solution of formaldehyde.
Organ preservation systems that provide oxygenated cold perfusion to the organ. These systems typic
standing or mobile unit (e.g., a cart) consisting of a combination of a small refrigerator, a continuous p
chamber container (one chamber is intended for the organ and the other chamber includes a membra
exchanger, and a bubble trap). The dual-chamber container, after filling the lower chamber with ice, m
portable unit for transportation if used in combination with the continuous pump. Cold perfusion orga
that include an oxygenator are mainly intended to preserve kidneys, but may be also used for other o
pancreas, and heart. These systems are used to keep organs viable for a period of time (a few hours)
while waiting for the transplantation procedure and/or for transportation of organs between facilities (
place to the recipient hospital).

Units (typically cabinets) designed to store x-ray film. These units are designed to prevent unwanted
incorporating a limit switch that automatically turns off the lights when the drawers are opened.

Sinks designed for cleaning the hands of healthcare personnel, patients, or other individuals without c
water supplies and/or drainage. These sinks typically consist of a structure made of plastic and/or met
include a freshwater tank, a wastewater tank, tubing, and faucets; they a soap dispenser, a paper tow
electrically powered water pump. Portable sinks are used in field operations during emergencies, in m
and shelters, and for disabled patients who cannot move from a location.

Nuclear medicine tables that include an exerciser, usually an ergometer bicycle, and shoulder/chest h
Most tables allow adjustment of the patient's vertical position, permitting radionuclide imaging under
from upright to supine.
A slender, probe-like device that is used to grasp and extract foreign bodies from superficial tissue of
trauma to that tissue.
Groups of orthopedic devices, including a case, trays, a number of implants, and the appropriate instr
used to correct or reconstruct serious bone fractures and spinal injuries or defects that cannot be stab
splinting. They can also be used for bone lengthening. The systems, consisting of any combination of
pins, wires, rods, and nails, are used to support and compress the fractured bone and prevent it from

Implantable clips designed for extravascular occlusion of blood vessels (either veins or arteries) in ope
laparoscopic procedures. These clips are typically small metal devices that are externally applied to th
dedicated appliers. Implantable vascular clips are mainly used to prevent and/or control bleeding (i.e.
dedicated clips are available to occlude aneurysms.
Neuromuscular electrical stimulators used to facilitate emptying of the urinary bladder and/or the bow
applying stimuli to the cone-shaped end of the spinal cord (conus medullaris). Most of these stimulato
implanted receiver with electrodes placed around the patient's sacral spinal nerve roots and an extern
sending the stimulating pulses transcutaneously to the implanted receiver. Some of these devices ca
activate erection in men by stimulating a particular pair of nerve roots without bladder contraction. B
evacuation stimulators are used in paraplegic patients who have complete transection of the spinal co
to empty their urinary bladder and/or bowels by reflex means or by the use of catheters.

Graphic recorders of the changes in electrical potential or impedance as a result of the movement of t
respiration and phonation, using an appropriate sensor. These recorders are used for assessing the de
vocal cords in the treatment of voice disorders and in the study of the laryngeal mechanism
Auditory electrical stimulators designed to apply electrical stimuli containing sound information to the
stimulators consist of an electrode array that is surgically implanted in one cochlea; a receiver that is
near the ear and connected to the electrode array; and a speech processor, including a microphone an
worn externally. The microphone picks up sound from the environment and transduces it into electrica
speech processor reconfigures the signal and delivers it to the transmitter and to the implanted receiv
stimulates the cochlea through the electrode array. Cochlear auditory stimulators are used for the par
auditory sensation to profoundly deaf patients (typically more than 90 dB hearing loss).

Implants designed for plastic repair of a cardiac valve by restoring its anatomic shape and size, usuall
circumference of its annulus. These implants typically consist of a rigid, semirigid, or flexible metal (e.
synthetic (e.g., silicone elastomer, polyethylene) ring that is inserted around the natural annular struc
sometimes an incomplete ring, known as a "C-ring," or band, is used. Dedicated annuloplasty ring and
used to restore mitral (e.g., to prevent regurgitation) and/or tricuspid (e.g., to treat insufficiency) valve

Stents designed for deployment into the urinary tract between the kidney and the bladder (i.e., the ur
support and/or to maintain patency within the duct. These devices usually consist of a plastic (e.g., po
multiple holes and either protrusions or a coil (pigtail) on each end to avoid migration; one end stays
other in the urinary bladder. Ureteral stents are available in several different shapes and sizes, and th
coated to give them special capabilities (e.g., to avoid urine crystallization); in addition, many uretera
radiopaque marks. Ureteral stents are placed using endoscopic procedures or during nephrostomy; th
bypass a blockage in the ureter, in treatments to remove kidney stones, or to let a ureter heal after su
removed or replaced after a short time; bioabsorbable ureteral stents are also under development.

Stents designed for long-term placement in the vagina to provide support and/or to prevent shrinking
available in many different configurations and sizes. Some stents are custom-made plastic (e.g., silico
consist of inflatable silicone-elastomer envelopes with valves and internal drains. Vaginal stents are us
the vagina after female surgery or radiation procedures, after vaginoplasty in masculine-feminine tran
introduce radioactive isotopes during cervical brachytherapy procedures.

Flat, woven (e.g., knitted) materials with an open texture and evenly spaced holes. Mesh used for med
typically made of a biocompatible substance that is synthetic (e.g., a polymer), metallic (e.g., surgical
biological (e.g., collagen), or a combination of these materials. A mesh is typically implanted to suppo
in surgical procedures (e.g., to prevent relapse of hernias, to protect tissue during abdominal wall reco
surgery) and/or bone in orthopedic reconstructive procedures (e.g., cranioplasty). Absorbable mesh is
tissue engineering as a scaffold for tissue regeneration.

Systems of devices/components that are designed for external application for the purpose of stabilizin
fastening (i.e., fixation) bones. External orthopedic fixation systems are used mainly for temporary sta
and/or otherwise weakened bones during the healing process.
Devices designed for temporary implantation under the skin to produce tension and an increase in the
These devices are typically balloons that are inserted under the skin and periodically expanded by inje
saline solution). The excess of skin grown (e.g., on the back or buttocks) can be harvested and used a
where skin was lost due to trauma, burns, or wounds; the technique is sometimes used for breast reco
after radical mastectomy to facilitate the subsequent implantation of a permanent (e.g., a silicone) br
External orthopedic fixation systems designed to stabilize adjacent segments (i.e., vertebrae) of the s
typically consist of an external plastic and/or metal fixator and other external and/or implantable com
plates, rods, pins, and bone screws; the systems may also include some instruments appropriate for a
(e.g., screwdrivers, punch impactors, drills). Spinal external orthopedic fixation systems are intended
immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine
patients suffering of segmental instability or chronic back pain.

Mesh made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechan
Metallic mesh is used alone or in combination with synthetic materials (e.g., polymers) in reconstructi
(e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopedic proced
cranioplasty, femoral reconstruction)._x000D_
Peritoneal catheters designed to drain the cerebrospinal fluid into the peritoneal cavity; they are used
the treatment of obstructions of the cerebrospinal fluid pathways accompanied by an accumulation of
(CSF) within the skull (hydrocephalus). To place the catheters, an incision is made in the abdomen, th
muscle, down to the peritoneum. A small nick is made in the peritoneum and the catheter is inserted
introducer, the proximal end of the catheter is slipped subcutaneously up to the anterior abdomen an
where it is attached to the valve fluid from a valve and/or a reservoir connected to a proximal cathete
the fluid from a ventricle of the brain; these devices as a whole are known as ventriculoperitoneal shu
are used as part of a ventriculoperitoneal shunt in treating children and adults with hydrocephalus, wh
or a result congenital malformations, neoplasms of the brain, brain cysts, or traumatic injuries.

Cylindrical metal rods incised with helical or advancing spiral threads designed to attach or tighten tw
use of nuts or washers, when driven by rotating a manual screwdriver or by a powered rotary handpie
clinically in oral, dental, orthopedic, and other procedures; dedicated screws are available for particula
internal fracture fixation, oral (maxillary and dental) surgery, and attachment of prostheses (e.g., long
during orthopedic procedures.

Implantable tubular devices typically designed for temporary (e.g., one week, several weeks) use as a
tendon sheath. These devices may consist of synthetic (e.g., silicone elastomer) or biodegradable ma
frequently, autograft or allograft implants and may have one closed end. Nerve/tendon sheath implan
surgical procedures; they are used for nerve repair and/or protection during healing and/or to cap the
prevent the formation of neural (e.g., in the optic or peripheral nerves) tumors (i.e., neuromas) or to fa
a tendon (e.g., hand flexor).

Metallic sheets designed to repair small cranial bone defects (i.e., cranioplasty) intraoperatively. These
consist of an inert, malleable metal (typically tantalum) perforated sheet that can be shaped to the de
mallet and a wood block and cut with shears to the appropriate dimension. Prefabricated metallic plat
manufactured from metallic sheets, are frequently used to repair larger cranial bone defects.

Breath pacemakers that apply electrical stimuli to the phrenic nerve to rhythmically contract the diaph
pacemakers usually consist of an implanted receiver with electrodes that are placed around a patient'
external transmitter for sending the stimulating pulses transcutaneously to the implanted receiver.
Electrical stimulators that apply stimuli to subsurface areas of a patient's brain for pain-relief purpose
stimulators may consist of an implanted lead/electrode system (attached to a passive electronic circui
and/or signals are inductively coupled from outside the body, typically at radio frequencies) or a totall
contained stimulator (that carries its own energy source and has no inherent dependence upon extern
stimulators are used to treat chronic severe intractable pain for which drug therapy is undesirable or n

Temporary convex shields worn under the eyelids over the surgical site after eye evisceration or enuc
maintain space in the orbital cavity, prevent closure or adhesions during the healing process, prevent
eyelids, or in some cases, enable the positioning of biological tissue to the ocular surface without the
Ophthalmic conformers are usually made of sturdy acrylic (e.g., polymethylmethacrylate) or glass; som
material inserts in the conformers (e.g., amniotic membranes) as therapy for various eye diseases. Op
come in various sizes (usually small [pediatric], medium, and large) and various curvatures to fit diffe
cavities; some may have holes in them for drainage of secretions and applying antibiotics.

Thin plastic films (foils) designed to partially or totally block light when applied to an existing eyewear
manually cut, typically using scissors, from a thin plastic sheet in a shape that conforms to the interio
usually use only water for attachment. Ophthalmic foil is intended for prophylactic (e.g., to prevent laz
and/or therapeutic uses such as the treatment of double vision (diplopia) and in the absence of an eye
(aphakia).

Intraocular lenses, typically made of plastic, intended to be implanted in the anterior chamber of the e
bounded in front by the cornea and a small portion of the sclera and behind by a small portion of the c
and the part of the crystalline lens that presents through the pupil). These lenses are implanted to rep
human lens, typically following cataract removal.
Intraocular lenses, typically made of plastic, intended to be implanted and fixed to both the iris and to
of the eye, typically with a totally encircling loop. These lenses are implanted to replace the natural h
cataract removal.
Intraocular lenses, typically made of plastic, intended to be implanted and fixed to the iris (e.g., lobste
lenses are implanted to replace the natural human lens following cataract removal, frequently when l
bag is not possible because of inadequate capsular support.
Intraocular lenses, typically made of plastic, intended to be implanted in the posterior chamber of the
bounded in front by the iris, and behind by the lens and suspensor ligament). These lenses are impla
natural human lens, typically following cataract removal.
Implantable prostheses designed for total or partial replacement of the knee joint. Partial knee prosthe
femoral component including a metal part that replaces the distal surface of the femur, a tibial compo
plastic spacer and metal tray that is attached to the tibia, or a patellar component (usually a plastic ca
surface of the kneecap. The prosthesis components can be anchored to the bone using orthopedic cem
by integration using mechanical attachments (e.g., bolts) that hold the prosthesis in place until bone g
prostheses typically include all three (i.e., femoral, tibial, and patellar) components. Knee joint prosthe
bones from rubbing against each other in patients who suffer from osteoarthritis or rheumatoid arthrit
trauma (e.g., fracture).
Convex-shaped rings that are fitted in the anterior eye socket over the eye globe to prevent adhesion
retraction of the fornices. Symblepharon rings are usually made of plastic (e.g., polymethylmethacryla
polished edges to prevent trauma to the eye; they may come in various sizes (e.g., small [20 mm], me
large [24 mm]). Symblepharon rings (also known as open fornices conformers) are implanted without
helping to reduce scarring by keeping the eyelids way from an irritated eye. They are intended to mai
after surgery in situations where conjunctival cicatricial disease is present, or after ocular trauma such
avulsion of the conjunctiva. In the case of surgery or trauma, they should be inserted as soon as possi
adhesions and/or shortening of the fornices and cul-de-sacs. Some rings may be used over prosthetic

Ophthalmic implants made of non-reactive material (usually silicone) that are formed into sheaths and
the extraocular muscles at the posterior end of the sheath and to the sclera of the eye at the anterior
(usually by means of sutures) and that serve as a template for connective tissue growth to promote at
extraocular muscles to the sclera. Since the material of the sheath does not react with the connective
can later be removed when the fibrous growth and muscle attachment is complete. Eye muscle sheath
are used to correct strabismus caused by esotropias or Duane's syndrome.

Bolts designed to be inserted through the hole created in a bone and then secured by nuts and washe
typically consist of metallic or plastic pins or rods that are either threaded at one end with a head at t
threaded at both ends; bone bolts are usually supplied with washers for both ends and one or two nut
mainly for direct compression reduction and/or fixation of the proximal end of the tibia or ulna after fra
bolts are used to lock to the bone long intramedullary nails used for tibia and femoral fractures.

Devices made of soft, flexible materials that fit snugly over and cover an individual's head. Caps are t
hygiene purposes (e.g., shampoo caps, surgical head coverings) or to help regulate/alter a patient's b
chemotherapy cooling caps, infant head caps).
Implantable devices designed to cover the severed end of a long bone after amputation. These implan
hollow plastic or ceramic cylinder with one end closed and the other open to permit insertion of the bo
cap implants are intended to control bone overgrowth of amputated limb bones (e.g., humerus, tibia)

Implantable devices designed to cover the severed end of a nerve to facilitate its healing. These impla
a plastic (possibly biodegradable) or elastomeric (e.g., silicone rubber) hollow cylinder with one end cl
open for the insertion of the nerve extremity, encasing and capping the nerve. Nerve cap implants are
nerve scars and to minimize the formation of neural tumors (i.e., neuromas).

Implantable prostheses designed to be inserted into the acetabulum, replacing the socket of the hip jo
provide a partial substitution of the hip articulation; they typically consist of a metal (e.g., cobalt or ch
plastic (e.g., high-linked polyethylene) cup that serves as the bearing surface. Made of ceramics, poly
of materials, the prostheses may be intended for use either with or without bone cement and may inc
component hip joint prostheses are used mainly in patients suffering from osteoarthritis or rheumatoid
after trauma.
Cardiac catheters designed to drain the cerebrospinal fluid into the atrium of the heart; they are usua
subclavian or internal jugular catheterization. A radiographic controlled method using a guide wire ins
vein has been also used. Hydrocephalic cardiac catheters typically deliver the cerebrospinal fluid from
reservoir connected to a proximal catheter, which in turn drains the fluid from a ventricle of the brain;
whole are known as ventriculoatrial shunts. Hydrocephalic cardiac catheters are used as distal cathet
obstructions of the cerebrospinal fluid pathways accompanied by an accumulation of cerebrospinal flu
skull (hydrocephalus).

Implantable prostheses designed to replace the upper portion of the talus (i.e., the first bone of the fo
[dorsiflexion] and down [plantar flexion]), a component of the ankle joint. These prostheses provide a
the ankle articulation; they typically consist of a metal (e.g., cobalt or chromium alloy) device that is a
that serves as the bearing surface. Made of ceramics, polymers, or a combination of materials, the pro
intended for implantation with or without bone cement. Talar component ankle joint prostheses are us
suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma.

Implantable prostheses designed to be affixed to the distal tibia bone, replacing the socket of the ankl
prostheses provide a partial substitution of the ankle articulation; they typically consist of a metal (e.g
alloy) base-plate tray that is attached to the tibia and a hard plastic (e.g., medical-grade polyethylene
the bearing surface. Made of ceramics, polymers, or a combination of materials, the prostheses may b
implantation with or without bone cement. Tibial component ankle joint prostheses are used in patien
osteoarthritis or rheumatoid arthritis, as well as after trauma.

Implantable prostheses designed for replacement of the carpal component (both the lunate and scaph
joint. These prostheses usually have three parts: a carpal head, a carpal plate, and a stem; they are a
carpal head and carpal plate sizes. The use of these prostheses requires the removal of both the lunat
carpal bones. Carpal wrist joint component prostheses are used to restore wrist motion in patients wh
osteoarthritis or rheumatoid arthritis, as well as after trauma (e.g., fracture).

Implantable prostheses designed for total replacement of the elbow joint. These prostheses typically c
combination of a humeral component (consisting of a long stem that anchors it in the hollow center of
end and a hinge with a bearing and pin at the articulation point) and an ulnar component (consisting o
anchors it in the hollow center of the ulna with a hollow end that fits in the humeral component hinge
point); they may include also a radial head component to prevent instability and decrease stress in th
Total elbow joint prostheses made of metal or a combination of metal and polymeric materials with diff
technologies are available; the prostheses may be intended for implantation with or without bone cem
prostheses are used in patients who suffer from osteoarthritis or rheumatoid arthritis, as well as after

Implantable prostheses designed to replace the distal end of the humerus at the articulation point. Th
a partial substitution of the elbow articulation; they typically consist of a long stem that is anchored in
the humerus at one end and a hinge with a bearing and pin at the articulation point. Made of metal or
metal and polymeric materials, the prostheses are usually intended for use without bone cement. Hum
joint prostheses are used in patients who suffer from osteoarthritis or rheumatoid arthritis, as well as a
fracture).
Implantable prostheses designed to replace the proximal end of the radius at the articulation point. Th
provide a partial substitution of the elbow articulation. They typically consist of a short stem that is an
center of the radius (i.e., the radial component) and attached to a ball that replaces the radial head at
Some prostheses consist of two separate parts, the ball that replaces the radial head and a stem, perm
implant heads and stems that mate appropriately with the patient's anatomy and are easier to insert
implant. Radial component elbow joint prostheses are usually made of polymers or a combination of m
materials; the prostheses may be intended for implantation with or without bone cement. They are us
suffer from osteoarthritis, rheumatoid arthritis, or recent trauma (e.g., fracture), in which the radius ca
with stable internal fixation.

Implantable prostheses designed to replace the upper end of the ulna at the articulation point. These
partial substitution of the elbow articulation; they typically consist of a short stem that is anchored in
the ulna (i.e., the ulnar component) with a hollow end that fits in the humeral component hinge at the
Made of metal or a combination of metal and polymeric materials, the prostheses may be intended fo
without bone cement. Ulnar component elbow joint prostheses are used in patients who suffer from os
rheumatoid arthritis, as well as after trauma (e.g., fracture).

Implantable prostheses designed to be inserted in the marrow cavity of the femoral bone, replacing th
hip joint. These prostheses provide a partial substitution of the hip articulation; they typically consist o
or chromium alloy) stem inserted in the marrow cavity of the femoral bone, that ends with a neck whe
attached to serve as the bearing surface. Made of ceramics, polymers (e.g., high-linked polyethylene)
materials, the prostheses may be intended for use either with or without bone cement. Femoral comp
prostheses are used mainly in patients who suffer from osteoarthritis or rheumatoid arthritis, as well a

Implantable prostheses designed for total replacement of the knee joint. These prostheses typically co
component including a metal part that replaces the distal surface of the femur, a tibial component con
spacer and metal tray that is attached to the tibia, and a patellar component (usually a plastic or plas
replaces the surface of the kneecap. Total knee joint prostheses made of metal or a combination of me
materials with different shapes and technologies are available; the prostheses may be intended for im
bone cement or without (with mechanical attachments to hold the prostheses in place until bone grow
combination of both technologies. Total knee joint prostheses are used to stop bones from rubbing aga
patients who suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma (e.g., fracture).

Implantable prostheses designed to replace the distal surface of the femur at the articulation point. Th
provide a partial substitution of the knee articulation; they typically consist of a metal cap that is anch
one side with the opposite, convex side facing the articulation point. Femoral component joint prosthe
in the bone using orthopedic cement (e.g., epoxy); in procedures that do not use cement, the prosthe
end of the previously tapered femur and held in place by friction. They are mainly used in patients wh
osteoarthritis or rheumatoid arthritis, as well as after trauma (e.g., fracture).
Implantable prostheses designed for total replacement of the knee joint. These prostheses typically co
component including a metal part that replaces the distal surface of the femur, a tibial component con
spacer and metal tray that is attached to the tibia, and a patellar component (usually a plastic or plas
replaces the surface of the kneecap. Total knee joint prostheses made of metal or a combination of me
materials with different shapes and technologies are available; the prostheses may be intended for us
cement or without (with mechanical attachments to hold the prostheses in place until bone grows) or
both technologies. Total knee joint prostheses are used to stop bones from rubbing against each other
from osteoarthritis or rheumatoid arthritis, as well as after trauma (e.g., fracture).

Implantable prostheses designed to totally or partially replace the shoulder joint. Partial shoulder pros
either of a humeral component (consisting of a long stem that is anchored in the hollow center of the
and a cup that is attached at the other end forming the ball of the articulation) or a glenoid componen
tray with a short stem that is anchored directly to the scapula and a plastic cup that replaces the glen
shoulder blade at the articulation point). The prosthesis components can be anchored in the bone usin
(e.g., epoxy) or by integration using mesh. Total shoulder joint prostheses typically include both hume
components. Shoulder joint prostheses are used in patients who suffer from osteoarthritis or rheumato
frequently, after trauma (e.g., fracture).

Threaded metal rods used for internal fracture fixation. They attach plates or nails to bone, fasten sof
most commonly, provide interfragmentary stabilization for bone.
Spacers that are temporarily implanted within a tendon sheath during the first stage of a two-stage te
procedure. These spacers are intended to hold apart the inner surfaces of the tendon sheath and prom
pseudosheath, a reorganization of tissue around the spacer that resembles a natural tendon sheath an
tendon graft implanted in the second stage of the procedure. Tendon spacers are typically made of po
come in various sizes that may be cut and shaped as needed.

Staples designed for fixation of bones. These staples are usually U-shaped metallic wires with tapered
(i.e., serrated legs) to avoid "backing out" after they are driven into the bones. The staples are typical
appliers (e.g., staple drivers). Bone staples are mostly used as general fixation devices in orthopedic p
shoulder ligament repair and corrective bone procedures than involve cutting of bone (osteotomy); th
displaced scaphoid fractures and other orthopedic procedures.

Implantable metal or metal- and polymeric-prostheses designed for total or partial replacement of the
elbow prostheses may be either a humeral component (consisting of a long stem that is anchored in t
humerus at one end and a hinge with a bearing and pin at the articulation point) or an ulnar compone
shorter stem that is anchored in the hollow center of the ulna and fits in the humeral component hing
point). The prosthesis components can be anchored in the bone using orthopedic cement (e.g., epoxy
bone using mesh. Total elbow joint prostheses typically include humeral and ulnar components and m
component. Elbow joint prostheses are used in patients who suffer from osteoarthritis or rheumatoid a
trauma (e.g., fracture).
Implantable ossicular prostheses designed to replace one or both of the middle and innermost middle
and stapes, respectively). These prostheses are typically made of bioactive materials such as hydroxy
glasses, silastic, stainless steel, titanium, or high-density polyethylene sponge (HDPS); some material
cartilage between the prosthesis and the tympanic membrane to prevent extrusion. Sculpted autogra
less frequently used as ossicular prostheses. Incus and/or stapes prostheses are used mainly to reest
sound-conducting mechanism; they are also used to repair congenital abnormalities in the ossicles, im
hearing capabilities.

Implantable prostheses designed for total replacement of the small middle ear bones (i.e., the ossicles
stapes) that transmit sound. These prostheses are typically made of bioactive materials such as hydro
glasses, silastic, stainless steel, titanium, or high-density polyethylene sponge (HDPS); some material
cartilage between the prosthesis and the tympanic membrane to prevent extrusion. Total ossicular im
to reestablish the middle ear sound-conducting mechanism; they are also used to repair congenital ab
middle ear ossicles, improving patient's hearing capabilities.

Implantable devices designed for breast reconstruction and/or augmentation. These implants typically
shell (e.g., silicone elastomer) that may include single or double (i.e., one shell inside the outer shell)
filler, and a patch to seal the shell once filled. The shell may be prefilled or filled during the surgery; s
filler volume adjustment after implantation. Breast implants are available in a variety of surfaces, shap
thicknesses; they are usually filled with liquid (typically saline) and gel (typically silicone gel).

External prostheses designed for replacement of a breast that has been altered or removed. These pro
manufactured so that they may be attached to the body with special adhesive strips or, more frequen
brassiere. Breast prostheses are made of materials such as silicone, foam, or fiberfill; they are custom
manufactured in a range of sizes and shapes as well as different degrees of firmness. External breast
available as full breast prostheses and partial breast prostheses (known as equalizers); they are frequ
mastectomy to restore a woman's body image or for breast enhancement purposes.

Ophthalmic implants designed for the total or partial reconstruction and/or augmentation of the extra
the inferior (i.e., orbital floor), lateral (i.e., orbital wall), and superior parts of the rim. These implants a
variety of sizes and shapes according to the intended use; they are typically made of high-density pol
polyethylene) that are frequently reinforced with an embedded metal (usually titanium) mesh. The im
to fit the patient's orbital anatomy. Dedicated orbital rim implants are available for use in procedures s
of the orbital floor and wall augmentation of the inferior and lateral rim, augmentation of the lateral a
rims in patients who are hypoplasic, and to support the lower eyelid and lateral canthus in patients wh
support. These implants are used mainly to repair traumatic damage (e.g., fractures), to improve the f
for cosmetic and/or reconstructive reasons.

Assembled structures or combinations of objects designed to fix or place a device or equipment for ac
and/or use. Mounts typically consist of supports, backings, settings, clamps, and accessories that perm
devices to a wall, ceiling, or other permanent element of a building; some mounts are intended for fix
devices on independent stand-alone structures or furniture (e.g., beds, stretchers, racks, frames, pole
are used in healthcare facilities to fix specific devices (e.g., infusion pumps, ventilators, monitors, tele
systems) to building elements or to stand-alone structures.
Implantable prostheses designed to replace the surface of the patella facing the groove on the femur
point. These prostheses provide a partial substitution of the knee articulation; they typically consist of
metal/plastic cap with a flat side attached to the patella and the opposite gliding, convex side facing t
Patellar component joint prostheses are usually anchored to the patella using orthopedic cement (e.g.
in patients who suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma (e.g., fracture

Small plugs inserted into the medullary canal during orthopedic surgery to restrict the area where orth
injected.
External pacemaker electrodes designed for transthoracic attachment to the external surface of the h
pulses to the heart. These electrodes are typically disposable needle or hook-like devices to facilitate
and/or location; the proximal end is connected to an external pacemaker pulse generator. The electrod
during surgical procedures or in emergency situations by pushing the leads into the right ventricle thr
and then through the ventricular wall. Transthoracic pacemaker electrodes are only intended for temp
heart when it is not possible or desirable to use external or other invasive (e.g., transesophageal, tran
pacing; they are mainly used after open-heart surgery until the heart recovers, and in an emergency u
be surgically implanted.

Leads designed to conduct electrical pacing signals from the pulse-generating unit of an external card
electrodes placed on the internal lining of the heart/heart structures (i.e., endocardial or transvenous
vasculature. Some leads may also conduct the bioelectric cardiac signals back to the unit. These leads
flexible wires that are completely isolated except at the electrode tip that makes contact with the hea
leads are configured according to the pacemaker characteristics and/or the technique used for signal
variety of lead systems, including single- and multiple-lead, subcutaneous array, and patch is availabl
type, and other characteristics of the leads must be compatible with the pulse generator and the ther
Endocardial external cardiac pacemaker leads are used in temporary procedures (e.g., surgery, emerg
electrophysiology studies).

External breast prostheses designed for replacement of the nipple and/or areola. These prostheses are
manufactured so that they may be attached to the body with appropriate adhesives or worn inside a b
prostheses are made of materials such as silicone, polyurethane, and/or foam in a range of sizes and s
nipples can match the size, shape, color, and firmness of the natural nipples. Nipple prostheses are fre
breast surgery to restore a woman's body image.

Resin composite materials (compounds) appropriate for skull-defect repair (i.e., cranioplasty). These c
consist of self-curing acrylic resin (e.g., polymethyl methacrylate) or a two-part resinous material of se
frequently including methyl ester of methacrylic acid. Cranial resinous compounds may be conformed
(i.e., allograft) in the appropriate shape (e.g., plate) needed to repair the skull defect, using intraopera
compositions or preoperatively fabricated porous custom implants. They are used also as bone cemen
Implantable prostheses designed to totally or partially replace the ankle joint. Partial ankle prostheses
a tibial component (consisting of a metal base-plate tray that is attached to the tibia and a hard plasti
polyethylene] cup that serves as the bearing surface and is used to substitute for the socket of the an
component (consisting of a metal [e.g., cobalt-chromium alloy] device that replaces the top of the talu
prostheses may consist of a combination of both a tibial component and talus component or, more fre
designs that include three or more components. Ankle joint prostheses may permit constrained or sem
movements according to the design; they may be intended for implantation with or without bone cem
prostheses are used mainly in patients who suffer from osteoarthritis or rheumatoid arthritis, as well a

Implantable prostheses designed to replace one of the phalange joints of a toe. These prostheses typi
articulated silicone elastomer or, less frequently, ceramic or metal components with a flat end and a s
has stems at both ends for introduction in the hollow marrow cavity previously made in the bones tha
The prosthetic joint usually permits only constrained movement of the joint. Toe joint prostheses are u
the articulation of the first phalange of the big toe, preventing dislocation of the joint in patients who
osteoarthritis, rheumatoid arthritis, joint infections, or claw-toe deformities.

Tubing clamps designed to manually grasp and compress the arterial and/or venous blood line of a he
without damaging it. These clamps are usually available in several sizes and configurations as integra
according to the hemodialysis line to be clamped and the hemodialysis machine characteristics; some
identification (e.g., color coding) to differentiate between venous and arterial clamps. Hemodialysis lin
close the blood flow from and/or to the patient at the beginning or end of the hemodialysis procedure
to stop the procedure; the hemodialysis unit also includes as an integral part an additional venous line
automated closing of blood infusion to the patient when a problem in the hemodialysis procedure (e.g
leaks) is detected.

Prostheses designed for fixation of long bone fractures by encircling the shaft of the bone. These pros
metal alloy (e.g., stainless steel, cobalt-chromium) bands or sheets that are wrapped around and anch
the bone using screws; self-locking plastic (e.g., nylon) straps may also be used for bone cerclage. Bon
are used mainly for spiral fractures and for fractures in which the bone is splintered or crushed (i.e., co
the prostheses may be surgically removed (i.e., temporary) or left in place (i.e., permanent) after hea
cerclage prostheses are made of bioabsorbable materials.
Steam sterilizing units designed for total inactivation of microorganisms that are or may be present on
are not sensitive to high temperature, water, or steam using pressurized steam; the units are intended
sterilization of large quantities (i.e., bulk) of medical devices. These units usually consist of a free-stan
large treatment chamber with shelves on which the devices to be sterilized are placed, usually after b
debris and then packed; means to remove air prior to the sterilization (usually gravity and/or vacuum
introduce the steam (typically from an external boiler using a dedicated line) into the chamber; and co
time and/or temperature of the procedure. Frequently the time and temperature of the sterilizing cycle
according the type of device to be sterilized; typical sterilization temperature range is 121 to 135 deg
275 degrees Fahrenheit). After the sterilization cycle is complete, the steam is exhausted; partial vacu
to facilitate the extraction. Bulk steam sterilizing units are used mainly in hospital central supply depa
other healthcare facility areas that perform a great deal of sterilization.

Steam sterilizing units designed for total inactivation of microorganisms that are or may be present on
pressurized steam; the devices should not be sensitive to high temperature, water, or steam; these un
sterilization of small quantities of medical devices and/or supplies. This equipment usually consist of a
including a treatment chamber of less than 0.015 cubic meters (5 cubic feet) with shelves on which th
sterilized are placed, usually after being cleaned of gross debris and then packed; means to introduce
chamber typically from an integral steam generator; and controls to regulate the time and/or tempera
Frequently the time and temperature of the sterilizing cycles are pre-established according the type o
sterilized; typical sterilization temperature range is 121 to 135 degrees Celsius (250 to 275 degrees Fa
sterilization cycle is complete, the steam is exhausted. Units that use gravity or partial vacuum to faci
are available. Tabletop steam sterilizing units are used mainly in operating suites, labor and delivery a
laboratories; they are also used in physicians' offices, outpatient medical-surgical facilities, and dentis

Cushioning pads filled with air that are designed to reduce pressure on specific areas of the body by p
deflating and that are intended for disposal after use by one patient. These pads consist of a sealed p
enclosure filled with air; the enclosure includes a valve that allows the pad to inflate/deflate periodica
automated pump. Disposable alternating pressure relief pads may be conformed in a variety of shape
mainly used in the care of patients at risk for, or who already have, compromised skin surfaces (e.g., b
Alternating air pads are frequently used on top of chairs, wheelchairs, and beds to prevent or alleviate

Cushioning pads filled with air that are designed to reduce pressure on specific areas of the body by p
deflating and are intended for reuse. These pads consist of a sealed plastic (e.g., vinyl) enclosure filled
easily washed and disinfected; the enclosure includes a valve that allows the pad to inflate/deflate pe
external automated pump. Reusable pressure relief pads may be conformed in a variety of shapes and
mainly used in the care of patients at risk for, or who already have, compromised skin surfaces (e.g., b
Alternating air pads are frequently used on top of chairs, wheelchairs, and beds to prevent or alleviate
Implantable prostheses designed for partial or total replacement of the small middle ear bones (i.e., o
sound. These prostheses are typically made of bioactive materials such as hydroxyapatite, bioactive g
stainless steel, titanium, or high-density polyethylene sponge (HDPS); some materials require placem
between the prosthesis and the tympanic membrane to prevent extrusion. Sculpted autografts and al
frequently used as ossicular prostheses. Ossicular implants are used mainly to reestablish the middle
mechanism; they are also used to repair congenital abnormalities in the middle ear ossicles, improvin
capabilities. Prostheses intended to replace the stapes, stapes and incus, or the total ossicular bones

Implantable prostheses designed for total replacement of the hip joint. These prostheses consist of a c
and acetabular components. The femoral component typically consists of a metal stem inserted in the
femoral bone, that ends with a neck where a metal ball component is attached to replace the femoral
component consist of a metal (e.g., cobalt-chromium alloy) or plastic cup-like component that is impla
acetabulum to replace the acetabular socket. Total hip joint prostheses with several different shapes a
available; they may be made of ceramics, polymers (e.g., medical-grade polyethylene), or a combinat
prostheses may be intended for use either with or without bone cement. Total hip joint prostheses are
patients who suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma.

Ventricular intracranial catheters designed to be used as proximal catheters in the treatment of obstru
cerebrospinal fluid pathways accompanied by an accumulation of cerebrospinal fluid within the skull (
are usually made of silicone elastomers (silastic). These catheters are usually placed in the anterior h
ventricle through a small burr hole, typically in the right parietooccipital region. Hydrocephalic ventric
typically connected through a valve and/or a reservoir to another catheter that drains the cerebrospin
peritoneum or the left atrium of the heart; these devices as a whole are known as ventriculoperitonea
shunts, respectively. Hydrocephalic ventricular catheters are used in treating children and adults with
may be idiopathic or the result of congenital malformation, neoplasms of the brain, brain cysts, or trau

Palatal prostheses designed to cover, or obturate, a fistula or opening in the roof of mouths in infants
These palatal obturation prostheses aid infants with cleft palates in sucking and breastfeeding activiti
air flow. Palatal obturation prostheses are constructed from a mold of the patient's mouth; they are us
metal. Most palatal obturation prostheses are intended to be used temporarily while waiting for surge

Devices inserted into blood vessels or other body cavities through trocars, endoscopes, cannula, or ot
that are intended to provide stiffening, support, or occlusion to the indwelling sheaths or instruments
cystoscopies, arthroscopes, or laparoscopes) being introduced into the body. Endoscopic obturators in
stability sleeves to allow for dilated entry sites after removal of introducer sleeves.
Sphygmomanometers designed for noninvasive measurement of blood pressure. These electronic dev
pressure, volume, displacement, or other pressure-dependent variable sensors placed externally on th
transducer for conversion into an electric signal; and an electronic unit that converts and displays the
pressure values. Electronic sphygmomanometers that measure blood pressure by detecting and trans
turbulences (Korotkoff sounds) and/or air pressure fluctuations (i.e., auscultatory and oscillometric me
available; other instruments may use different techniques (e.g., plethysmography). Electronic sphygm
used mainly for routine blood pressure measurement in hospital outpatient departments, doctor's offic
healthcare facilities; they are not usually intended to monitor or record blood pressure. Devices intend
or automatic cuff inflation are available.

Sphygmomanometers that consist of an inflatable cuff that fits around the arm, a bulb for controlling t
the cuff, and a mercury manometer.
Prepackaged collections of the necessary devices and supplies (i.e., either custom or standard kits) us
an emergency (e.g., an unforeseen or sudden occurrence, such as an accident). Items in these kits us
devices (e.g., syringes, injectors, needles), medicines, gauze, and anesthetics according to the emerg
they are intended to treat. The kits may be supplied in supporting trays (i.e., procedure trays) consisti
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Emergency procedure kits and trays are intended to meet imm
needs in life-threatening medical situations. Dedicated emergency kits and trays intended to treat situ
anaphylactic reaction, snake bite, burn, emergency medicine administration, cardiopulmonary resusci
insect sting are available. They are used in the field, at home, in emergency rooms, and in other healt

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
treatment of a patient in a case of anaphylactic reaction (i.e., a life-threatening type of allergic reactio
usually include a syringe, a needle, cotton/gauze, and a variety of specific medications that are gener
anaphylactic crisis (e.g., epinephrine and antihistamines). The kits are frequently supplied in supportin
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Anaphylactic emerg
and trays are intended for administering medication to a person suffering from an anaphylactic reactio
Dedicated kits for treatment of specific allergies and/or patients are also available. Anaphylactic kits a
home, in emergency rooms, and in other healthcare facilities.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for e
of cardiopulmonary resuscitation (CPR) procedures. Items in these kits usually include a one-way valve
examination gloves, antimicrobial dressing and/or swabs, masks for mouth-to-mask ventilation, and h
disposal bags. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered by a sterile wrap and may be included in a solid bag appropriate for transpo
Cardiopulmonary resuscitation emergency procedure kits and trays are intended for use during CPR; t
the field, at home, in emergency rooms, and in other areas of healthcare facilities.
Devices designed to block out light and/or provide privacy by keeping people outside the curtain from
inside. These devices usually consist of a piece of fabric hung from a wall-mounted rod or a ceiling tra
operated with cords, by hand, by press-button pads or by remote-controlled computers. They come in
sizes, and materials (e.g., cotton, polyester, nylon). Curtains are widely used at home and healthcare
homes, hospitals, doctors' offices). Disposable and reusable curtains are available. Dedicated shower
curtains (curtains used to form a partition ) are also available.

Prepackaged collections of the devices and supplies (either custom or standard) needed for administe
concentration of a cold solution to the heart to induce cardiac arrest (i.e., induced cardioplegia) during
kits may be used also to rewarm the heart after the procedure is finished. Items in these kits usually in
a filter, a temperature probe, and cardioplegia solutions; kits may also include protective chemical ad
cardioplegia solution such as potassium and glucose. The kits are frequently supplied in supporting tra
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. These trays are intende
surgery to prevent myocardial injury during the arrest and reperfusion phases. Cardioplegia solution a
trays are used in operating rooms.

Tampons designed to be worn by women during their menstrual periods by being inserted into the vag
menstrual fluids. Menstruation tampons are made of absorbent material (typically cotton, rayon, or a
pressed together to form a cylinder-like shape, usually between 1.5 to 3 inches in length (38 mm to 76
come with aids to facilitate insertion; these aids are typically made of plastic or cardboard and are eith
the tampon, or guide sticks. Tampons usually have cotton strings attached to the bottom to help with
tampon after use. They are intended to be used once and disposed after use. They are made with diff
accommodate light, moderate, or heavy menstrual flow.

Prostheses designed to be introduced into the esophagogastric sphincter to reduce a sliding hiatal her
reflux of gastric contents into the esophagus. These prostheses typically consist of a toroidal, C-shape
with a silicone gel and a polyester tie to secure the ring around the esophagogastric junction. Antireflu
intended for surgical implantation under the diaphragm to hold the lower esophagus in place as an alt
surgical fixation of the stomach (i.e., gastropexy) or fundoplication.

Bilirubinometers that measure the concentration of bilirubin in neonate blood through the skin. A ligh
the newborn's skin, usually on the forehead or sternum, and the reflected light is split into two beams
455 nm and 575 nm), which are measured by optical detectors. The blood bilirubin concentration can
measured light absorbance.
Syringe infusion pumps calibrated in units specific for delivery of oxytocin.
Fixed beds designed to provide a soft surface for infants and neonates similar to that provided by floa
beds typically include a mattress filled with some appropriate substance, such as air, water, or gel; th
may be permeable to air and water vapor but not to liquids. Neonatal and infant beds are appropriate
environmental conditions (e.g., softness, illumination levels) for a neonate and also provide good work
healthcare staff members. They are frequently mounted on wheels and may include or permit attachm
Neonatal flotation therapy beds are intended for continuous care of newborns as well as ill and/or prem
Sterilizing equipment that combines the use of steam and ethylene oxide gas in one unit; the equipm
total inactivation of microorganisms that are or may be present on medical devices that are not sensit
temperature, water, or steam. The units are intended for simultaneous sterilization of a large volume
devices. These units are usually a free-standing equipment including a large treatment chamber with
be sterilized are placed on, usually after being cleaned of gross debris and then packed; means to intr
(typically from an external boiler using a dedicated line) and/or the ethylene oxide gas into the chamb
regulate the time and/or temperature of the procedure. Frequently the time and temperature of the st
established according the type of device to be sterilized; the typical sterilization temperature range is
Celsius (250 to 275 degrees Fahrenheit). After the sterilization cycle is complete, the steam and gas r
frequently using partial vacuum to facilitate the extraction. Bulk steam/ethylene oxide sterilizing units
hospital central supply departments and/or in other healthcare facility areas that perform a great deal

Electronic sphygmomanometers designed with a self-contained program for proper function and autom
measurement cycles. These instruments usually display current heart rate and mean arterial pressure
and diastolic blood pressure. Most automatic electronic sphygmomanometers will sound an alarm if bl
preset limits, and some can be set to take readings continuously. Although these instruments are not
for recording purposes, they may include a printer and keep a record of several measurements.

Electronic sphygmomanometers whose cuff is manually inflated and deflated. These devices usually s
pressure in a digital display.
Clothing, frequently including a helmet, with accessory evacuation devices that permit recovery of she
Body exhaust systems are worn by surgical staff (e.g., for orthopedic procedures) in order to provide a
environment for the patient.
Cardiac output units that measures the blood flow from the heart using the indicator dilution techniqu
injected upstream of the heart by a balloon-tipped (flow directed) catheter and monitored on the down
devices consist of a dye-dilution catheter used to inject a bolus of dye (e.g., lidocaine); a densitomete
concentration, typically from a sample in a peripheral artery; and an electronic unit to process and dis

Dental carriers designed to hold, transport, and deposit freshly prepared amalgam into the prepared t
carriers are typically slender, handheld devices that have hollow working ends (barrels) into which the
Single- and doubled-ended carriers are available with a variety of barrel sizes.
Dental materials which consist of papers designed to identify contact points between the maxillary an
(i.e., articulation) during natural tooth occlusal adjustments. These articulation materials are soft and
with brightly colored materials (e.g., dye or wax) that mark the points of contact made by the teeth w
grinds on it. Dental articulating papers should produce a sharp and clean field of markings on surfaces
porcelain, synthetic resins and dental metals) in a wet or dry field; they also may show different inten
corresponding to occlusal pressure. Articulation papers are usually supplied as pre-cut strips or sheets
dentists' offices to locate uneven occlusal areas in the bite.

Cavity lining dental materials designed for use as a coating inside of the wall surfaces of a dental cavi
preparation to facilitate the placement of other materials (i.e., cavity primers), and to enhance bondin
restorative) materials to the tooth surfaces. There are a variety of dental primers which composition is
restorative materials to be used (e.g., composites, amalgam). Primer cavity lining materials are used i
during operative dental procedures.
Cavity lining dental solutions designed for use as a very thin protective coating over the surfaces of a
placement of restorative materials. These dental materials consist of clear solutions of a resinous ma
a suitable organic solvent (e.g., ether or chloroform), that quickly evaporate and leave the resin as a v
preparation. Cavity varnish is not intended for use with composite resins since the varnish retards the
with their bonding. They are used in dentists' offices during operative dental procedures primarily to s
tubules and to help prevent seepage of fluids, microorganisms, and/or debris between a restoration an
microleakage).

Prophylaxis attachments used to apply polishing agents during dental prophylaxis (cleaning). These d
a small rubber cup at the distal tip and an appropriate configuration at the proximal end that can be a
prophylaxis angle, which is attached to a slow-speed rotary dental handpiece. Prophylaxis cups are ty
teeth as part of the prophylaxis procedure; they are frequently a component of a tooth-polishing set.

Dental materials designed to make a positive copy of a given area of the oral cavity using a mold prev
dentist's office. These dental materials include casting alloys, porcelains, and dental stones. The mate
poured into a mold which contains a hollow cavity of an appropriate shape to fit teeth and/or oral tissu
solidify and then ejected or broken out of the mold to complete the process. Casting alloys and porcel
compatible with oral tissues; they are used mainly in dental laboratories to make fixed prostheses (e.g
implants) and full or partial dentures; dental stone is typically used to make special castings (e.g., for

Dental casting materials, whose main component is porcelain, designed to make a positive copy of a g
cavity using a mold previously taken at the dentist's office. These dental porcelains consist of biologic
esthetically pleasing materials that have considerable strength, whiteness, and a high resistance to ch
thermal shock. The materials are usually poured into a mold which contains a hollow cavity of an appr
teeth and/or oral tissue, allowed to solidify and then ejected or broken out of the mold to complete the
casting materials are used mainly in dental laboratories to make bridges, crowns, and veneers.

Dental materials such as gold foil, mercury, metal alloys, and other materials designed for in situ resto
appearance, structure and/or function of a patient's teeth. These dental materials usually consist of sp
substances whose occurring chemical reactions can be predictable and/or controllable. Restorative de
fillings easy to manipulate and shape; they include amalgams, composite resins and unfilled resins. Re
materials are used in dentists' offices.

Mixtures of natural and synthetic waxes, resins, coloring agents, and other additives, used to produce
casting custom dental prostheses, such as crowns and bridges. Thes mixtures are also used in the con
metallic denture bases, to register jaw relations, and as an aid in dental laboratory work.
Devices used in conjunction with orthodontic appliances to exert pressure on the teeth from outside th
headgear typically has a strap that wraps
Caliper-like devices used to record the positional relationship of the maxillary arch to the temporoman
opening axis of the jaw) and to orient dental casts in the same relationship to the opening axis of the

Receptacles, typically made of Styrofoam, used to apply fluoride topically to the teeth. The patient bi
has been filled with a fluoride gel or solution.
Stainless steel bands designed to externally contour and confine dental restorative materials (e.g., res
insertion in teeth. These bands typically consist of 0.015- to 0.05-inch - (0.0381 to 1.27 mm) thick sta
The bands may be held in place by a mechanical retainer capable of drawing the band snugly around
may be preformed (e.g., welded) in a loop that seals tightly around the tooth when used with a moistu
without using a retainer (i.e., retainerless matrix). Dedicated matrix bands are available for specific te
tooth, premolar, molar); matrix bands are also available in rolls intended for contouring segments to t
and shape for the characteristics of the tooth being restored as well as the position of the adjacent tee

Dental dispensers designed to measure and deliver dental alloys and amalgams. These dispensers typ
container that pours a pre-determined amount of dental mercury (in droplet form) and a pre-measured
pellets (a combination of silver, tin, copper, and zinc) into a mixing capsule. Some dispensers deliver
be mixed with the mercury externally. These dental alloy/amalgam dispensers are mainly used in dent

Devices (typically constructed of metal) that can be affixed to a tooth to provide a foundation for anch
appliances so that pressure can be exerted on the teeth.
Small metallic tubes designed for welding to the outside of a molar band in orthodontic treatments. Th
include slots to hold arch wires, lip bumpers, facebows, and other orthodontic devices. Orthodontic (al
tubes are used mainly in procedures intended to exert pressure on the teeth (e.g., to push teeth back
for other teeth).
Long, slender, dental devices, either custom-made or preformed, designed for insertion in the root can
retain and strengthen restorative materials. These posts are typically solid, cylindrical, metal (e.g., sta
pieces that are fixed, usually cemented, into a previously treated root canal; dedicated posts intended
prostheses on top are also available. Smaller devices intended for insertion in the healthy dentine are
pins.

Endosteal dental implants designed for total or partial implantation into the lower mandibular bone an
anchoring and/or stabilization. These implantable dental plates typically consist of a multipin metallic
pins) that is inserted through drilled holes in the mandible and fixed using either nuts or compression
use of an appropriate fitted dental prosthesis (e.g., denture). Mandibular implantable bone plates are
implants for patients who are edentulous and who have deformed mandibles, contributing to the reco
severely atrophic mandibles.

Holders designed to hold small x-ray films inside the mouth during dental radiographic procedures. Th
are typically made of plastic radiolucent materials with a small clasp or window frame on the end of a
inside of the mouth while holding a small x-ray film in a flat or angled position.
Active electrosurgical electrodes controlled by a foot switch that are designed to deliver radiofrequenc
to the body tissues. These electrodes deliver the RF energy received through insulated cables from an
in the electrosurgical unit at the points where the current effect is required. The electrodes are usually
handpiece or surgical instrument (for monopolar and bipolar units respectively) that is manipulated by
include a foot-pedal that works as an electric power switch. Foot-controlled active electrosurgical elec
monopolar or bipolar current. They are mostly used in procedures intended to cut tissues, stop bleedin
fusion.
Devices designed to hold one or more cold or hot packs externally to the body of a patient, frequently
securing the use of the pack during a therapeutic procedure. These holders are usually shaped specifi
part where they are attached and/or the pack that they are holding. Cold/hot pack holders are typicall
material (e.g., fabric, foam) with a pouch or pocket to hold a hot or cold pack and keep it close to, but
with, the skin; they usually include some type of fasteners (e.g., cord ties, hook-and-loop closures [Ve
the body part (e.g., arm, leg, wrist) to hold the hot/cold pack in place.

Small forceps used to grasp, firmly hold, and exert traction or compression on structures of the eye, p
cornea, during ophthalmic surgery such as lens implantation or iris suturing.
Hand-finger upper-limb immobilizer orthoses designed to stabilize and provide maximum restriction o
total immobilization of the hand, fingers, and thumb by providing a static (fixed) position using a fixed
typically consist of a splint that is placed encircling the distal segment of the forearm and/or wrist and
rigid component used to hold in an appropriate static position the hand and fingers. Immobilizer hand
used mainly to protect the hand and fingers from further damage during rehabilitation after traumatic

Radiographic/fluoroscopic (R/F) systems that usually have power-assisted tabletops to facilitate longitu
movement. Operating controls are typically located on the base of the table and include foot controls
and lateral positioning. These tables achieve a wide range of height and tilt positions, including a ver
urological radiographic procedures. Urological tables are usually provided with a foot support on whic
and with shoulder braces or handgrips to prevent the patient from sliding. Some of these systems can
sectional images (tomography) and narrow-angle tomography (zonography). Urological R/F systems m
recording devices, cine cameras, and some digital acquisition and processing capability. Urological R/F
endoscopic examination of the urinary tract (cystoscopy), urological diagnostic procedures, transureth
prostate), and a wide range of other general urological, surgical, and gynecologic procedures requiring

Bowls used with ear cleaning kits for the purpose of catching water as the ear is being flushed. These
made of plastic or metal and have a depression that fits around the ear.
Powered wheelchairs with the capability of climbing curbs and stairs and/or allowing the occupant to o
while lifted in a balanced seated position to the eye level of a standing person. They may have additio
as displacement on uneven surfaces (e.g., gravel, sand, grass) and operation under remote control wh
sitting in the wheelchair. These wheelchairs typically consist of a seating structure, including a seat, a
footrests, and other components and/or accessories; a power system, including a motor, a battery, an
computerized unit for easy and reliable device operation; and a control unit operated by the occupant
powered wheelchairs (as typical for powered wheelchairs) are customized for each patient's needs; th
appropriate for both indoor and outdoor use.

Disposable cubicle curtains are intended to partition off an area (i.e., form a cubicle). They are used in
healthcare facilities such as holding areas, preparation areas, procedure areas, overflow areas, examin
rooms, and inventory areas. They are designed to block out light and/or provide privacy by keeping pe
curtain from being able to see inside. These curtains usually consist of a piece of fabric hung from a c
curtains are manually or power operated; they can come in a variety of shapes, sizes, and materials (e
nylon, vinyl). Fire-retardant, tear and mildew-resistant, and liquid-repellant cubicle curtains are availab
curtains are used once and then discarded, eliminating maintenance.
Photometric immunoassay analyzers that use the catalytic properties of enzymes to detect and/or qua
reactions. An enzyme substrate is attached as a label to either an antigen or an antibody, and then th
concentration of the ligand (the substance being analyzed) are measured using the result of the antig
Enzyme immunoassay analyzers are clinically used in the analysis of drugs and endogenous substanc
plasma, cerebrospinal fluid, urine).

Immunoassay analyzers that attach fluorescent substances, which emit light at a wavelength after the
at a different particular wavelength (either natural substances or dyes), as a label to either an antigen
then measure the concentration of the ligand (the substance being analyzed) in the specimen under a
result of the antigen-antibody reaction. These analyzers usually include an autosampler, a reagent dis
(e.g., a tungsten-halogen lamp), a filter or monochromator, and a detection system (fluorometer or sp
some also include computerized data processing devices. Some fluorimetric immunoassay analyzers u
(lanthanide) chelates and time-resolved procedures to overcome background fluorescence. Fluorimetr
have better sensitivity and reagent stability and use shorter assay time than photometric devices. Flu
quantify cardiac glycosides, antiasthmatics, antibiotics, antineoplastics, anticonvulsants, antiarrhythm

Caps that fit snugly over the patient's head to cool the scalp to reduce blood flow, typically for the pur
loss (alopecia) related to chemotherapy. These caps are typically cooled to approximately -20 degrees
ice or a freezer before use. Hypothermia caps may come with ear straps that help to keep the cap sec

Flat boards (i.e., trays) designed for use as walker accessories that are mainly intended to facilitate a
such as eating, writing, or reading. These trays are typically made of metal, hard plastic or wood and a
sides of the walker using clamps or hinges. Dedicated walker trays filled with gel and/or special paints
tactile) stimulation for disabled patients are available; walker arm boards used to support the arm are

Flexible sheaths that are designed with one open end into which the tip of a surgical instrument is ins
are designed to be placed on the tips/edges of surgical instruments to protect them from damage (e.g
sterilization). Typical surgical instrument tip protectors are made from plastic, paper, or foam and are
on the tips/edges of sharp surgical instruments such as forceps, scissors, needle holders, hooks, knive
chisels, K-wires, and fine microsurgical and endoscopic instruments. Certain designs (e.g., vented prot
interior surface with longitudinal channels and ribs that permit the flow of steam or gases over the tip
instrument to sterilize the instrument while the protector is in place. Some tips are color coded to faci
instrument identification.

Prepackaged collections of the devices and supplies (either custom or standard) needed for the liquid
of tissue and/or debris from the mucous membrane lining the cervical canal (i.e., endometrium). Item
include a bulb or plunger syringe, a container, a curette, waterproof drape, a pipette, and alcohol prep
for irrigation in the kit may be also used for aspiration (i.e., removal) of the irrigating fluid and/or debr
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Uterine cervix canal irrigation/lavage kits and trays are used for obstetric and gynecologic procedures
histology, and surgery; they are also used in fertility studies and treatments (e.g., to remove a mucou
Therapeutic devices used to fragment stones located in the kidney or urinary tract. Many of these de
to disintegrate stones located in the gallbladder, bile duct, or pancreatic duct. Some lithotripters can
salivary stones.
Intracorporeal lithotripters that use plasma-induced shock waves to fracture stones. A generator-powe
pulses at the stone, while the probe is irrigated with a saline solution. The collapse of the resulting pla
hydraulic shock that fragments the stone into several pieces that can then be removed using a graspe

Intracorporeal lithotripters that use a probe consisting of an ultrasound transducer and a hollow steel
generator powers piezoceramic elements and produces high-frequency (20 to 27 kHz) sound waves.
converts the sound waves to vibrations that propagate along the hollow probe to a movable impact tip
in contact with stones and the probe vibrations cause the stones to fragment. In some units, the prob
suction pump, which aspirates stone fragments through the probe lumen.

Multichannel electrocardiographs (ECGs) designed for recording the variations of the electric potentia
electrical activity of the heart muscle, usually detected at the body surface from two or more leads sim
perform a computerized automated measuring and interpretation of the ECG. These instruments inclu
that can process the ECG signals, compare those signals with an internal algorithm, and print out the
interpretation that can be used as an auxiliary tool by the cardiologist; some instruments can also pro
vectorcardiogram. Instruments that can perform the measuring and interpretation of the ECGs by ave
of the signal are also available. Interpretative multichannel electrocardiographs are not intended for a
of the electrocardiogram or other cardiac conditions.

Sling total upper-limb support orthoses designed for attachment to a wheelchair bar that are designed
and some degree of movement restriction to the upper limb. These orthoses typically consist of a loop
material including a band suspended from springs that are attached to a bar that is an integral part of
loop includes a wider loop segment around the forearm. Wheelchair sling upper-limb support orthoses
the limb by positioning it in an appropriate position thus compensating for muscle weakness. They ma
rehabilitation after injuries and/or trauma.

Metal structures (frames) designed to hold and support an extremity in the appropriate position during
procedure. These stands typically consist of an adjustable metallic frame with a set of detachable com
limb-positioning attachments to maintain optimal joint alignment, supports for resting limbs, and blad
Typically, the extremity is placed on a blade and the cast material is wrapped around it; after the cast
blade slides providing space for improved circulation and patient comfort. Most orthopedic casting sta
the upper and lower extremities.

Blood flowmeters designed to assess regional cerebral hemodynamics by measuring the concentratio
radioactive xenon tracer (e.g., Xe-127, Xe-133) previously administered either by inhalation or by intra
These units typically consist of a set of scintillation detectors, controls, computerized circuits, and a di
numerical and graphical results (e.g., the xenon clearance curve). The results (e.g., the cortical and de
flow) are automatically calculated from the clearance curve. Xenon clearance cerebral blood flow eval
assess cerebrovascular disease, head trauma, epilepsy, stroke, and other pathological conditions in th
and psychiatry.
Video systems designed to transmit fixed (i.e., still) images through narrow-band communication syste
techniques. These systems typically consist of a standard television camera with its output signal con
that slows the stream of images to match and audio circuit capacity (i.e., a scan converter), resulting
motion (I.e., still picture). The signal is transmitted to a remote location through a narrow-band chann
telephone line), where it is reconverted using a second scan converter and displayed in a standard tel
image television systems are used in remote places to get fast and adequate evaluations of images,
and computed tomography scans; they are also used for information exchange in teleconferences.

Holders designed to hold laparoscopes in position above the patient during laparoscopic procedures. T
typically made of a sturdy metal arm that is fixed at one end to the side of the operating table or othe
operating theater and at the other end provide a clamp or holding mechanism to hold the laparoscope
patient's body. Some laparoscope holders have robotic features and controls to maneuver them into p
manually operated.

Ultrasonic scanning systems consisting of an ultrasonic scanner, transducers (typically from 2 to 5 MH


calculation package software (e.g., renal), an image recorder (e.g., videocassette), and a printer. Abdo
systems usually include linear array and mechanical and/or electronic sector scanning configurations.
used for abdominal examination (e.g., cysts, tumors) and diagnoses (e.g., hernias).

Leg holders designed for use during perioperative procedures. These devices may consist of rigid or a
mechanisms that hold and secure one or both legs in appropriate position before, during, and/or after
to facilitate the performance of the procedure with minimum additional stress for the legs and leg arti
providing padding to avoid damage of the skin and/or muscles and nerves. Some surgical leg holders
leg holders, usually plastic single-use (i.e., disposable) devices are also available. Perioperative leg ho
for arthroscopic surgery of the knee or heel.

Equipment designed for diagnostic x-ray film processing in any room under normal lighting conditions
consist either of a centralized unit that integrates cassette loading, unloading, and processing function
that automatically unloads the exposed film and passes it to the attached or integral processor; or a m
includes specially designed or modified conventional cassettes, a film-loading dispenser, a cassette fil
integral identification-labeling system, and an automated x-ray film processor to which the unloader is
daylight film handling equipment allows an unassisted technologist, or one in an area remote from a d
diagnostic examination without leaving the area or losing sight of the patient. The use of daylight film
reduces the time spent waiting for film processing, sometimes eliminating the need for darkrooms and

Picture archiving and communication systems (PACS) designed to store and retrieve digital images fro
other digital-imaging systems, including computed tomography (CT), magnetic resonance imaging (M
These systems consist of a host computer that controls image capture and display, networking, storag
printer output, as well as image-display stations that allow database management and include high-re
printers. Most of these systems provide more than one image-display monitor to more closely mimic
on the conventional view box used by radiologists; they also include interfaces for digital dictation dev
(mini-PACS) are configurable to serve a specific imaging area, such as MRI, CT, or ultrasound imaging.
simultaneous access to images for surgeons, referring physicians, and emergency room personnel; th
problems associated with storing radiographic films.
Simulators designed for training in external orthopedic procedures, including diagnosis and treatment
Orthopedic training simulators frequently consist of: (1) a whole (i.e., a manikin) or partial anatomic m
torso, or an extremity. The anatomic model usually has the external appearance of a human body or b
an internal skeleton where normal and injured conditions (e.g., fractures, dislocations, and luxations) c
(2) a central electronic unit that may control the simulation of the physical characteristics of the injuri
sensors, controls, and motors. The training simulator may also mimic the radiographic images that wo
actual event. Orthopedic therapy simulators can assess the corrective therapeutic procedures perform
facilitating the training of healthcare personnel with less need for practice on human beings or animal

Peripheral-nerve electrical stimulators that apply stimuli to a nerve (e.g., ulnar, facial, lower extremity
the adequacy of neuromuscular block during surgery and its reversal during the recovery period. The
battery- or line-powered and usually use four types of stimulation: twitch, train-of-four, tetanic, and do
monitoring stimulators typically use conventional electrocardiographic electrodes and/or bipolar surfa
electrodes).

Devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing mu
probe is moved. Once the pathways are located, their transmission capabilities can be assessed by co
muscle responses with the expected maximum contractions. These devices typically include a periphe
stimulator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audib
display.

Nerve locators designed to locate a facial nerve by applying an electrical stimulus with a probe and co
responses as the probe is moved. These devices typically include a peripheral nerve electrical stimula
electrodes, sensors to detect muscle response (e.g., strain gauges, electrical sensors), and audible an
Most facial nerve locator stimulators generate rectangular waveform currents to stimulate nerve fiber
muscular contractions; some also produce triangular-waveform currents. Some units include monitorin
the surgeon when there is a risk of injury to a patient's facial nerve. Nerve locators are used during d
assessment of nerve function, to locate nerves during surgery (reducing the chance of accidental inju
progress of nerve regeneration after surgery.

Electrical stimulators used to apply precisely timed and repeatable stimuli to the peripheral nerves. Th
usually multiple-channel external stimulators, using external surface electrodes or invasive (i.e., need
Somatosensory electrical stimulators are used for evoked-potential procedures and also for other rese
functional mapping in epilepsy). Some of these stimulators are used as components of more complex
somatosensory evoked-potential recorders.

Implantable prostheses designed for partial replacement of the distal radioulnar head (i.e., radioulnar
These prostheses typically consist of two pieces: a metal (e.g., cobalt-chrome) ball resembling the uln
stem that is surgically introduced in a hole drilled in the intramedullary canal of the ulnar bone; the st
cemented to the bone. Radial/ulnar head partial wrist prostheses are intended to replace a damaged u
and stabilizing it relative to the distal radioulnar joint. Radial/ulnar head partial wrist prostheses used
rheumatoid and degenerative arthritis or after trauma (e.g., fracture) of the radioulnar joint, typically
resection arthroplasty.
Scanning systems that use strong magnetic fields, radio-frequency (RF) radiation, and computerized p
hydrogen nuclei distribution (some systems can translate other nuclei exhibiting nuclear magnetic res
into images of anatomic structures. Following exposure to high magnetic and RF fields, body-tissue nu
signals that are detected by the system RF receiver. The computer uses these RF data to construct an
tissue. Magnetic resonance imaging (MRI) systems consist of a primary magnet (resistive, supercondu
gradient magnets; an RF subsystem, including an RF transmitter/receiver and coils; a patient table; a
including software for image processing, display monitors, and a data storage unit; and an operator co
systems are used to obtain high-resolution images with good contrast of tissues without using ionizing
these systems are used to distinguish normal from diseased tissue and to diagnose and track the prog
diseases (e.g., cancer, brain edema, iron storage).

Smoke evacuation systems designed to capture smoke generated during surgical procedures (e.g., las
electrosurgery) including minimally access, endoscopic, and laparoscopic procedures in which there is
systems capture the plume (smoke composed of carbonized cell fragments, water vapor, and hydroca
tissue near its origin before it becomes air-dispersed and deposits in the respiratory tracts of the surgi
smoke evacuation systems consist of a single-use or reusable capture tube or wand and four element
smoke: user interface, filters, suction source, and exhaust; they are used to minimize staff exposure a
health risks to create a more comfortable working environment.

Neuromuscular electrical stimulators designed to apply electrical stimuli to a peripheral muscle and/o
monitoring the response in a different peripheral muscle or nerve. These stimulators typically consist
generator and attached electrodes; most diagnostic neuromuscular stimulators use external electrode
bipolar electrodes, ring electrodes), but some also use needle electrodes to obtain very localized activ
neuromuscular stimulators control the duration, amplitude, and frequency of the pulses but usually do
stimuli signals. They are mainly used for the stimulation of a peripheral nerve or muscle in motor-nerv
(e.g., posterior tibial nerve) and/or sensory-nerve conduction studies (e.g., ulnar nerve).

Medication transfer needles that include a filter (e.g., microporous stainless steel) that retains microm
drugs or drug vials. These needles are used for medication transfer and handling to eliminate or reduc
associated particle contamination.
Skinfold calipers designed to assess body fat in subcutaneous adipose tissue by measuring the skinfol
processing the data electronically. Measurement of the thickness of folds of skin gathered at various a
displayed on the device. These instruments are typically electrically powered (usually with batteries),
metallic and/or rigid plastic calipers with curved working ends that apply even pressure to the skinfold
calipers help to perform fast and repetitive measurements on the posterior aspect of the upper arm, t
the lower ribs; the instruments typically show the results as percent body fat (e.g., using an standard
Jackson-Pollack formula) in a digital display.

Forceps used to seize, cut, and collect biopsy specimens from tumors or other diseased tissue when a
designed flexible endoscopes during endoscopic surgical and diagnostic procedures. They consist of t
each attached to a sampling jaw (with either smooth, serrated, or toothed-jaw cutting edges) and a st
spike between the sampling jaws to seize and stabilize the specimen. They can be reusable or single-u
biopsy in which the sampling jaws are electrically warmed before collecting the specimen sample; tha
diathermic handle.
Forceps used to seize, cut, and collect biopsy specimens from tumors or other diseased tissue when a
designed rigid endoscope during endoscopic surgical and diagnostic procedures. They consist of two
attached to a sampling jaw (with smooth, serrated, or toothed-jaw cutting edges), and a stabilizing ne
the sampling jaws to seize and stabilize the specimen. They can be reusable or single use. In hot biop
are electrically warmed before collecting the specimen sample; these forceps have a diathermic hand

Trend graphic recorders used to record one or more blood pressure parameters (e.g., systolic, diastolic

Probes designed to transmit ultrasonic energy to and receive energy from a patient when connected t
that includes a radiofrequency generator (e.g., echocardiograph, ultrasonic scanner). These probes ty
enclosure (housing), with ultrasonic transducers (typically piezoelectric) that convert electrical signals
and vice versa and an integral cable to transmit and receive the electrical signal to and from the ultra
Ultrasonic probes are frequently placed on the skin after an acoustic coupling gel has been applied; de
intended for specific ultrasonic equipment and/or applications are also available.

Laboratory dispensers designed to store and deliver disks intended for antibiotic sensitivity tests. The
composed of two parts, a specially constructed stand and dispensing equipment. They release antibio
from cartridge rolls in the container to a receptacle provided with wells for receiving the disks. Antibio
dispensers have the advantage of spacing the disks regularly on the inoculated plates with minimal op
contamination. Some of them are made of a combination of tempered aluminum and stainless steel, e
handling, refrigeration, and autoclaving. These dispensers can simplify antibiotic test procedures and
are commonly used in clinical and pharmaceutical laboratories.

Laboratory dispensers designed to deliver and measure laboratory liquids (acids, reagents, alkaline so
dispensers consist of a container that pours out the material without human contact with the sample.
dispensers are equipped with self-closing faucets for convenient, controlled dispensing of hazardous li
and mechanical pipette-like dispensers). These dispensers are mainly placed on shelves or in tilt stand
manually or power operated. They are commonly used in clinical and pharmaceutical laboratories.

Measuring instruments designed to measure electrical conductivity, a measure of the capability of a s


electric charges when a voltage is applied; conductivity is the inverse of resistivity. Conductivity is usu
Siemens (S) per unit length (S/meter). Conductivity meters typically consist of electromechanical or m
electronic instruments; the meters include a display and attached leads with appropriate electrodes. P
usually measure in fractions of Siemens (e.g., milli- or micro-Siemens) per meter or cm (e.g., mS/cm;
conductivity meters are used to measure solid material and/or liquid conductivity; some are incorpora
the inspection and/or maintenance of medical devices and other healthcare facility equipment. Combi
instruments measuring also high values of electric resistance (i.e., megohmmeters) and/or resistivity
conductivity) are available.

View boxes designed for visual examination of a process and/or its results using ultraviolet (UV) light.
typically include UV lamps of one or more frequencies (254, 312, and 366 nm are typical), a transluce
filters. UV view boxes are used mainly in clinical laboratories for visual examination of a process and/o
assessing thin layer chromatographs, electrophoresis gels); they are also used in photo documentatio
include a photographic camera with appropriate filters and adapters.
Racks designed to hold chromatography plates. These racks typically consist of a metal box or framew
two sides and has evenly spaced brackets or slots for holding and stacking the plates. Thin-layer chrom
placed in the rack to dry. These racks are used in clinical and research laboratories.

Cabinets designed to promote and/or keep free from moisture objects in storage. This furniture typica
metallic (e.g., stainless steel), glass, or plastic (e.g., acrylic) cabinet that includes several trays or she
to locate a desiccant agent (e.g., silica gel); some cabinets also include hygrometers to check the hum
cabinets are used to store products that need controlled storage conditions (e.g., anhydrous and hygro
chemical compounds, electronic and other components, samples) protected from ambient moisture an
desiccating cabinets can be placed in refrigerators and/or freezers.

Air-tight enclosures (boxes) designed to provide a confined atmosphere in which procedures may be p
from the general laboratory environment; all operations inside the box are performed through relative
attached to ports in the box walls. These boxes may include a transfer chamber for introduction and/o
materials, adjustable pressure capabilities (either positive or negative), and cock valves for purging. T
impermeable materials such as fiberglass, stainless steel, aluminum, or a combination of materials; so
or portable. The boxes may also include capabilities for low- and/or high-temperature processing. Basi
only limited protection to the samples, the operator, and the environment. Containment boxes are ope
pressure to protect the operator and/or the environment from material processed inside the box and is
operated under positive pressure to protect the product inside the box from the operator and/or the en
containment/isolation boxes are also available. Some glove boxes may offer protection similar to biolo

Tabletop devices designed to heat substances (i.e., solid, liquids) in containers placed on them. These
consist of a flat surface that is heated by electrically powered heating coils or, less frequently, by gas-
plates are available in single-, double-, and multiple-burner configurations; they are intended for a var
laboratory warming/heating of solutions (typically in glassware containers), nurse station procedures,

Laboratory light microscopes in which optics alter the phase of the light diffracted by the specimen by
wavelength as compared to the undeviated direct light passing through or around the specimen, perm
observed without fixation and staining. The areas within the specimen where the rapidly changing ref
the most diffraction appear either dark (positive-contrast microscopy) or light (negative-contrast micro
contrast microscopes can also be configured for bright-field observation; the combined configurations
and hematology. Phase-contrast microscopes are also used in cytology and microbiology.

Mechanical shields usually made of high-impact transparent plastics attached to or placed on the labo
shields are used in clinical laboratories to protect the workers from explosions, flames, spurting liquids
chemical reactions.
Devices designed to collect sweat produced by a person, for the purposes of diagnostic or other types
testing). Typical sweat collectors include patches/pads that are attached to patients' skin that are also
stimulation device (e.g., electrode) and/or analyzer (e.g., an iontophoresis system) or absorbent, singl
that are applied to patients' skin for an extended period of time and then removed.
Warming units designed to heat slides and prepared paraffin specimens. These units usually consist o
compact device that heats up to 70 degrees C (160 degrees F); they warm the slides or paraffin speci
Slide-warming units are used in the clinical laboratory (e.g., histology) to warm slides for better frozen
and also to smooth wrinkles and/or bubbles in paraffin-embedded sections.

Measuring instruments designed to measure electric resistivity; a measure of the opposition of a subs
electric charges when a voltage is applied. This parameter is frequently represented by a lowercase rh
measured in ohm per meter. Resistivity meters typically consist of electromechanical or more frequen
instruments with appropriate leads. Practical instruments usually measure in multiples of ohms (e.g.,
meter. Dedicated resistivity meters are used to measure solid materials (either surface or volumetric r
frequently liquid resistivity; some are incorporated in testers used in the inspection and/or maintenan
and other healthcare facility equipment. Combined electronic instruments measuring high electric res
and/or its inverse, conductivity, are also available.

Devices designed to facilitate and/or improve the skills to perform healthcare procedures and/or the u
Training aids may consist of printed and audiovisual materials that provide text; still or moving (e.g., v
dedicated devices (e.g., masks, shoes); or kits and training simulators. Training simulators usually incl
mimic the whole human body and/or anatomic models resembling the characteristics and/or performa
parts (e.g., organs). Training simulators permit the simulation and training in a clinical, endoscopic, or
Training aids are used for teaching or to improve the capabilities of the healthcare staff (e.g., surgeon
they may also be used to train patients in the performance of healthcare and/or rehabilitation procedu
exercisers) by themselves.

Clinical chemistry laboratory analyzers designed to perform multiple laboratory tests with complete a
steps (e.g., specimen processing, measurements) of whole process, providing a standardized method
and reproducible chemical concentration values. These analyzers may be used to examine general an
(e.g., albumin, protein, alcohol), electrolytes (e.g., sodium, potassium), and drugs of abuse, as well as
clinical laboratory analyses.

Automated clinical chemistry laboratory analyzers that keep the specimens in separate reaction vesse
pack, compartment) during the entire analysis process as reagents are added and measurements are
may perform only one test at a time (single channel) or several tests simultaneously (multichannel). M
use photometric methods (e.g., filter photometers, spectrophotometers) to evaluate the analytes and
electrodes to measure the concentration of electrolytes (e.g., sodium potassium).

Automated discrete clinical chemistry laboratory analyzers that use a rotor (centrifugal) head for mixi
specimens and for measuring. The rotor usually has an outer ring of sample wells and an inner ring of
the rotor spins, the reagents in the inner portion of the disk are forced along channels to the outer por
they mix with the specimens. The resulting mixtures are forced out of the transfer disk into transparen
they are measured, usually using photometric devices.
Automated clinical chemistry laboratory analyzers in which the chemical reactions take place in a con
stream of fluid in such a way that each specimen in the batch passes through the same continuous pa
sample carousel. Each specimen is also subjected to the same analytical reactions at the same rate as
specimen. These analyzers usually include peristaltic pumps to maintain the movement of fluid, and
selective electrode methods for measuring the concentration of analytes.

Laboratory clinical chemistry analyzers that require the manual insertion of reagents and/or samples i
each test. Most of these chemical analyzers are used to determine concentrations of analytes (e.g., ch
electrolytes), to provide certain hematology values (e.g., hemoglobin concentrations), and to assay so
(e.g., theophylline). Manual clinical chemistry analyzers are used as primary instrumentation, for sma
backup for automated analyzers.

Evoked potential physiologic recorders designed for detecting, amplifying and recording the brain's bi
the evoked potential, EP) to auditory external stimuli. These recorders typically consist of a detachabl
placed on the scalp at the vertex and a reference electrode placed on the earlobe; signal amplifiers; fi
interference); memory (e.g., electronic or optical/magnetic disc); and a display. The non-stimulated ea
noise whose intensity is above the hearing level. Auditory EP recorders usually include capabilities to
(e.g., clicks) at an appropriate repetitive level to elicit the bioelectric response needed for recording. A
are mainly used in studies intended to diagnose the function of the auditory pathways and to differen
metabolic factors from a coma due to structural damage. They are also used for screening the auditor

Trend graphic recorders used to record the respiration rate.


Units for tracing the outline of the arch of the foot or footprints.
Combinations of leads and cables designed for connection between electrodes, which are placed on o
electric or electronic device. These combined devices typically consist of flexible wires that are compl
the electrode end (known as patient leads) and an integral cable that is connected to the leads at one
or electronic device at the other end. Cable/leads are used with a variety of healthcare equipment inc
monitors, and stimulators usually to detect bioelectric signals and/or to deliver electric energy to the b

Combinations of a cable and several leads designed for connection between electrodes placed on the
electroencephalograph (EEG) or EEG monitor. These combined devices typically consist of flexible wire
that are completely isolated except at the electrode end (known as patient leads) and an integral cabl
the leads at one end and to the electronic recorder or monitor at the other end. EEG cable/leads are u
and/or displaying in real time the waveforms (i.e., electroencephalograms) of the biologic electric sign

Combinations of a cable and several leads designed for connection between electrodes (e.g., surface,
electromyograph (EMG). These combined devices typically consist of flexible wires that are completely
electrode end (known as patient leads) and an integral cable that is connected to the leads at one end
recorder or monitor at the other end. EMG cable/leads are used for recording and/or displaying in real
(i.e., electromyograms) of the biologic electric signals from the muscles.
Combinations of a cable and several leads designed for connection between electrodes placed on the
stimuli are needed and a transcutaneous electro-analgesic nerve stimulator (TENS). These combined d
consist of flexible leads, usually 2 or 4 leads for single- and dual-channel units respectively, that are c
except at the electrode end (known as patient leads) and an integral cable that is connected to the lea
the stimulator at the other end. TENS cable/leads are intended to provide stimuli to relieve acute and
associated with surgery, trauma, musculoskeletal problems, bursitis, and dental problems and proced
pain relief in the course of physical therapy and during labor and delivery.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
catheter into the bladder via the patient's urethra. Items in these kits may include lubricant, a urinary
specimen container and/or urine collection bags, a sterile drape, germicide, underpads, sterile gloves,
forceps. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-
with a border around the periphery supporting all the instruments and supplies needed for the proced
usually covered or wrapped. Intermittent urinary catheterization procedure kits and trays are intende
procedures to drain urine from the bladder as needed (e.g., at scheduled intervals) in patients with ch
conditions. They are used in intensive care and other areas of hospital and/or healthcare facilities.

Equipment designed for packaging medications in the amount needed for a single dose for an individu
separate containers or in multiple containers with separate compartments for each single dose. These
consist of a small, light way packaging unit with limited packaging capability; most unit-dose packing
printing capabilities for labeling the packaged drugs. Unit-dose packaging systems are used in hospita
other long-term health care centers.

Unit dose liquid medication dispensers designed to store and deliver the correct single liquid dose nee
patient. These dispensers deliver unit-doses of a liquid medication from a medication container; they
liquid products (e.g. vaccines, biopharmaceuticals). Liquid medication unit-dose dispensers can be ma
operated. These dispensers are usually made of plastic, metal or a combination of these. They are com
and at healthcare facilities. Medication dispensers are not usually devices intended for direct administ
patients, they supply the medications and/or medication devices used for administration of medicines

Laboratory chambers where climate conditions can be adjusted to simulate a specific environment in
register their effects upon sample materials. Light, temperature, relative humidity, and other parame
Most environmental chambers have an observation window and may be mobile.
Radiometers designed to measure the radiant flux (also known as radiant power) in the ultraviolet (UV
instruments typically include a prefilter to filter out the light of a wavelength not in the intended spec
ultraviolet A from 400 to 315 nm; ultraviolet B from 315 to 280 nm; ultraviolet C from 280 nm to 100 n
consisting of a temperature-stabilized, solid-state (e.g., selenium, indium-gallium-arsenide) diode use
electronic circuits, including an amplifier; an electric meter; a power source (e.g., a battery); and a dis
results in either analog or digital format. Radiometers intended for measuring UV radiant flux are dedi
a power measuring range, accuracy, and resolution appropriate to their use; UV radiometers are used
intensity of radiation during some therapeutic procedures (e.g., ultraviolet A and/or B during psoriasis
check the germicidal properties of UV lamps (UV-C radiometers). Power (i.e., electromagnetic radiation
typically measured in microwatts, and power density in microwatt/cm2.

Ophthalmic measuring instruments designed to determine the thickness of the cornea. The instrumen
contact devices using ultrasonic technology that generate pulses and measure the time differences of
noncontact devices that use an optical technology that includes a microscope with a light source to ge
an alignment component to adjust and measure the light reflection from the cornea. Other instrument
camera system with image processing software to image, measure, and analyze the anterior part of th
are used mainly to detect glaucoma or for planning refractive surgery.

Neuromuscular function analyzers that measure and evaluate the human walking cycle (gait). To make
evaluation of human gait, these analyzers should include measuring instruments capable of determin
space, the forces exerted on the ground, and the muscle function pattern during walking movement. T
used for gait analysis including dynamic and static body balance and the analysis of joint movement d
(e.g., cerebral palsy, stroke), posttrauma studies, and monitoring of rehabilitation.

Large laboratory airtight chambers filled with a mixture of oxygen-free gases (i.e., an anaerobic enviro
laboratory personnel to culture specimens, observe growth, perform subsequent testing, and/or incub
these conditions.
Dental prostheses designed to cover the surface of teeth to improve their appearance. These prosthes
a thin custom-made laminate (i.e., a shell) usually made of porcelain or, less frequently, of resin comp
are bonded to the tooth surface (sometimes only the front surface) after removing about 0.5 mm of to
(approximately the same thickness of the veneer). Porcelain veneers resist stains and mimic the light
tooth enamel better than resin veneers, but the less frequently used resin veneers are thinner and req
tooth enamel. Dental veneers may modify the color, shape, size, and/or length of teeth; they are used
reasons on discolored, misaligned, worn, and chipped or broken teeth. Dental fixed veneers usually la
procedure is considered irreversible, and after 10 years the veneers should be replaced.

Saws driven by electricity (either line or battery power), designed to cut casts. These saws are powere
electric motor, a mechanism to drive the blade, and an electric cable. Electric cast saws are available
instruments or, less frequently, as stationary tabletop devices; oscillating or reciprocating saws are us
damaging the patient's body; rotary saws are not appropriate for this use. Electric power cast saws ar
using dedicated plaster or fiberglass blades for cast removal, creation of a hinged cast, or to open a w
view underlying tissue.
Ophthalmic measuring instruments designed to determine the anomalies of color vision by assessing
matches yellow light with a mixture of green and red light. The devices consist of a system of light sou
slit mechanism, eyepieces, and controls with scales for adjusting the intensity and wavelength of the
digital display for light parameter values. A patient observes the field in the eye-piece, half of which p
and half of which presents a mixing of red and green light, and matches the two half fields by adjustin
yellow light and/or the proportion of the red/green mixture. Anomaloscopes are used mainly for the as
vision and the detection of color vision deficiency.

Surgical brushes designed for removal of the epidermis and/or partial removal of the dermis. These de
of a wire brush that is conformed for use attached to a rotary handpiece. Dermabrasion brushes are u
cosmetic procedures intended to remove irregularities of the skin such as congenital lesions, hamarto
lesions), tattoos, or fine wrinkles.
Ophthalmic measuring instruments designed to determine the amount of abnormal protrusion of the e
exophthalmos) by measuring the distance between the lateral orbital rim and the apex of the cornea.
consist of arc supports integrated with mirrors or prisms, including scales that are positioned against t
and footplates with scales that are positioned against the lateral orbital rims; other devices are clear p
scales that permit the observation of the corneal apex against the scales. Exophthalmometers are use
extent of exophthalmos.

Ophthalmic measuring instruments designed for objectively determining the curvature of the anterior
refractive error (astigmatism) by projecting concentric rings on the cornea. These devices typically co
with a series of concentric rings (also known as Placido's disk) whose images are projected onto the co
images of the rings are viewed by the examiner and/or are recorded using a video camera (videokerat
camera (photokeratoscope) for later examination. Keratoscopes are used mainly for preassessment fo
surgery, contact lens fitting, or diagnosis of some corneal disorders.

Instruments designed to measure the radiant flux (also known as radiant power) in a predetermined s
radiometers measure the thermal effect produced by radiation falling on the instrument, using a sens
radiation and increases its temperature accordingly (frequently called a bolometer). The temperature
with a thermometer attached to the bolometer. Radiometers intended for the measurement of light ra
a semiconductor diode that produces mobile electric charges when struck by photons (i.e., photodiode
current meter; they are intended for measuring light in different ranges of the spectrum (e.g., visible,
within a given power range, accuracy, resolution, and/or other parameters. These instruments also inc
the results in either analog or digital format. To obtain accurate measurements, radiometers should be
according to the source of light to be measured (e.g., lamp, LED, laser), the transmission medium (e.g
optics), and the characteristics of the detector chosen. Power is typically measured in watts, and powe
Most radiometers used for clinical purposes are intended to measure light radiation during photothera
to assess the light intensity emitted by light sources (e.g., lamps, LEDs, fiber optics); dedicated instru
light intensity during therapeutic (e.g., bilirubin, skin) treatments and laboratory procedures and/or fro
germicidal lights, lasers) are available.

Horseshoe shaped receptacles made of metal or other suitable material used to carry the impression
to confine the material in opposition to the surfaces to be recorded, and to control the impression mat
form the impression.
Mixers designed to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if n
dental impression material that sets rapidly and irreversibly. These devices typically consist of an elec
a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and extern
the mixer. Alginate mixers are used to obtain smooth and uniform mixtures of dental impression mate
dentist office.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
tissue and leaving the field dry (i.e., gingival retraction) using a gingival retraction paste. Items in the
a gingival retraction product that consists of a green-colored paste provided in glass cartridges; they m
metal dispenser gun used to express the paste through a disposable metal dispensing tip into the ging
instruction manual and/or video. The kits are frequently supplied in supporting trays (i.e., procedure tr
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Gingival retraction procedure kits and trays are
during procedures for tissue retraction prior to impression making or prosthesis cementation. They are

Devices used to provide heat- or cold-curing of the base resins that comprise most acrylic dentures.
Electronic devices designed to accurately locate the apex (i.e., apical foramen) of a tooth root. Operat
instruments is based on the constant relationship of electrical resistance (impedance) between the pe
oral mucosa. Several accurate methods are used, including measuring the voltage gradient, measurin
impedance at different frequencies, as well as a completely automatic method known as Root ZX. Som
the length of the root canal. Apex locators are used in endodontic procedures to determine the length
is needed and to determine perforations and their communication with the periodontal membrane. So
component of a dental handpiece, used to stop its rotation upon reaching the apex.

Devices intended for use to remove cemented castings from the teeth. Typically, these devices consis
is applied to the cervical margin of the casting retainer; the weight against the handle provides the le
dislodges the crown.
Environmental monitors designed to measure and display the concentration levels of gaseous mercur
differentiate between elemental and ionic forms. These monitors typically include a mercury-vapor se
control unit, and a display; they may also include alarms activated at predetermined concentrations a
capabilities. Mercury-vapor environmental monitors are used mostly for continuous or periodic monito
dental offices, and clinical laboratories.

Devices (typically plastic or metal) that are bonded to an orthodontic band or directly to a tooth. Thes
hold an orthodontic wire and/or other appliance (e.g., rubber bands) that are used to apply pressure to
alter the position of the tooth.
Radiofrequency power meters designed to assess the power output characteristics of shortwave diath
operated at 13.56 or 27.12 MHz. These devices are capable of measuring a continuous range of frequ
10 to 30 MHz; the results are usually expressed in watts in a range from zero to one kilowatt. These m
power measuring instruments that measure on a 50-ohm load and probes appropriate for coupling wit
capacitive diathermy units.
Dental materials designed to highlight the presence of dental plaque on tooth surfaces by means of h
dental materials consist of a dye (i.e., coloring) agent such as iodine and excipients. Plaque disclosing
prophylactic or therapeutic action, but by staining the region indicating the presence of plaque show t
dental healthcare providers the areas where more brushing and flossing are needed. They are availab
form and are used at home and in dentists' offices.

Intraoral devices designed to tightly overlay the occlusal surfaces of the upper and/or lower arch of th
to be worn during contact sports to help protect the teeth, jaw, lips, and tongue of the wearer from blo
play. Mouth guards are also called mouth protectors or athletic mouth guards. Mouth guards are fabric
and positive pressure according to a dentist's instructions to custom fit the individual user's mouth. Fi
made of the user's teeth, which is then used to model the mouth guard. They can be translucent or cl
colors and are made from polymers, ethyl vinyl acetate resins, or thermoplastic. Mouth guards can als
shelf in pre-formed sizes; these cannot be individually fitted; some come with attached loop straps tha
attachment to a helmet. Some mouth guards can be individually fitted by the user with a "boil-and-bit
pre-formed mouth guard is softened by boiling in water, placed in the user's mouth who then bites do
to his/her own mouth, and then cooled, thus retaining the shape.

Restorative dental materials designed to be used as metallic fillings for in situ restoration of the appea
and/or function of a patient's teeth. These restorative dental materials consist of a mixture of liquid m
mostly of silver, tin, zinc, and copper. Amalgam restorative dental materials do not adhere to tooth str
of cements or techniques which lock in the filling; they are strong, resistant to wear, malleable, durab
capsule, powder, and tablet forms. Amalgam restorative dental materials are usually placed on the re
metallic color is not an aesthetic match with natural tooth enamel. They are used in dentists' offices.

Restorative dental materials consisting of mercury designed to be combined with appropriate dental a
dental amalgam) for in situ restoration of the appearance, structure, and/or function of a patient's tee
for use as a restorative dental material usually consists of liquid mercury appropriate to mix with dent
mercury is used in dentists' offices when dental amalgam is not available or in-situ mixing is desirable

Dental brushes designed to remove deposits and/or polish tooth surfaces (e.g., occlusal, facial, lingua
prophylaxis procedures. These brushes typically include a set of tapered bristles at the distal tip and a
configuration at the proximal end to be attached to a slow-speed rotary dental handpiece. Prophylaxis
also used to polish teeth as part of the prophylaxis procedure; they are frequently a component of a to

Dental devices designed to slightly separate teeth, securing dental matrix bands in place during inser
restorative materials. These wedges are typically made of absorbable materials (e.g., linden wood) th
expand, facilitating a tight contact between the matrix band and the tooth surface; they are placed in
of teeth. Matrix band wedges are frequently supplied with matrix bands.

Warming units designed to heat containers of anesthetic solutions before administration. These units
powered electric heater and appropriate racks or shelves to place the container during warming.

Graphic recorders used for continuous recording of the changes in platelet shape and platelet aggrega
are coupled to platelet aggregation analyzers to store the information according the measuring metho
density, electric impedance).
Scanning systems that detect back-to-back gamma ray (photon) emissions as the result of the combin
positron and a free electron and that use computerized processing to generate in vivo cross-sectional
administered positron-emitting radiopharmaceutical. These systems consist of scintillation detectors a
rings around the patient and photomultiplier tubes; coincidence circuits; a patient table; a computer s
software for image processing, display monitors, and a data storage unit; and an operator console. Cli
systems include demonstration of biological functions and the assessment of the physiology and path
and tissues.

Calipers designed for assessing body fat in subcutaneous adipose tissue by measuring the thickness o
at various areas of the body. These calipers are either manually operated, handheld instruments with
scale to facilitate fine adjustment, increasing accuracy of the measurement, or electronic instruments
display the information based on algorithms. Skinfold calipers are used mainly to measure the skinfold
aspect of the upper arm; measurements are also frequently performed on the thighs or back or over t

Laboratory urine analyzers that, once the urine is placed in the analyzer, are dispensed onto the dipst
then determined and a report is generated with minimal involvement of technicians. In addition to an
of these analyzers, can measure the specific gravity of the urine specimen and/or examine urinary se
intelligent microscope techniques, so the final report includes the results of the chemical analysis, the
the microscopic analysis.

Prepackaged collections of the devices and supplies (either custom or standard) needed for measurem
required for a fresh blood sample to coagulate. Samples are usually obtained from a small purposely i
wound. Items in these kits usually include needles, syringes, bandages, and heparinized collecting tu
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. These procedure kits and trays are intended for use during the examination of shortages an
various blood coagulation factors, and bleeding tendency of patients. Coagulation time procedure kits
medical offices, anticoagulation clinics, hospitals (e.g., emergency departments, operating rooms, cat
laboratories), and/or other healthcare facilities.

Instruments based on the principle of photoluminescence that are used to measure trace quantities o
significant substances that occur in patient samples of serum, urine, or other body fluids.
Radioimmunoassay analyzers that require minimal involvement of technicians and provide complete a
and reagent pipetting; mixing, incubation, and separation of bound and free ligand; counting; and dat
Automated radioimmunoassay analyzers provide a standardized method of obtaining accurate and rep
reduce throughput time, and make assays easy to perform. These analyzers are intended for medium
or large reference laboratories.

Radioimmunoassay analyzers that require reduced involvement of a technician, using automation in s


the test procedure such as sample and reagent pipetting, mixing, incubation, and separation procedur
automated gamma or beta counters and computerized data-reduction devices. These analyzers are in
laboratories or as backup for automated analyzers in clinical laboratories.
Dental lights designed to accelerate the polymerization process of light-cured dental resin-based com
typically have a powerful emission of visible light and a small emission in the ultraviolet light A spectr
400mm); polymerization is usually accomplished by the emission of specific wavelengths keyed to the
packages involved. Intraoral polymerization dental resin lights used in dental procedures performed d
the patient and lights intended for curing resin composites in dental laboratories are available.

Compounds (typically in powder or paste form) used to stabilize dentures in the mouth.
Collimators designed to define the dimensions and direction of a beam of x-ray radiation, usually by e
peripheral, more divergent part of the x-ray beam. These collimators typically consist of tubes, cones,
systems of diaphragms made of radiation-absorbing materials and interposed in the pass of the beam
collimators are widely used in radiographic and fluoroscopic units and systems.

Dental devices designed to support (i.e., anchor) a removable denture in the oral cavity. These anchor
natural support such as a tooth (e.g., extracoronal anchor) or the gingiva acting as a retaining compon
be also fixed to dental implants (e.g., ball-and-bar anchors). Denture anchors usually include locking c
soldering caps, castable threads); they are intended to support a variety of (either rigid or resilient) de
overdentures with different characteristics, provided that the denture-locking component matches the
Dedicated denture anchors may be used as the fixed component of a two-component dental attachme

Aprons designed to be worn as protective clothing by surgical personnel.


Decompression bronchial tubes designed to remove air, liquid, or other substances from the bronchi (
through an endoscope. These devices typically consist of a clear single or double-lumen plastic tube (
stylets) that is inserted into the bronchi through the working channel of a bronchoscope and connecte
suction device at its proximal end to provide suction of secretions, mucous, or foreign objects. Bronch
used in patients who have chronic bronchial obstructions, after tracheal surgery, and in cases of copio
very serious pneumopathies.

Surgical chisels designed to cut and shape bone, cartilage, and associated tissue of the middle ear. Th
consist of a handheld, manual flat-blade instrument with a cutting edge that is beveled on one side at
integral handle. A great variety of middle-ear chisels of different sizes and shapes are available, includ
a proximal end appropriate to withstand mallet impacts intended for mastoid process fenestration, ch
stapes surgery, and very small chisels, usually with a knurled handle, intended for otologic microsurge

Furniture that combines de capabilities of a wheelchair and a commode. This furniture may consist of
open seat that can be used over a stationary flushing commode or include a collecting box as an integ
contained wheelchair/ commode). Commode/wheelchairs usually include an additional detachable or
permits the use of the units as standard wheelchairs.
Devices designed to couple with the eyepiece of a fiberoptic endoscope to transmit images of the end
second eyepiece. These devices typically consist of a clip-on side-articulated arm attachment with an
may include a beam splitter. Endoscopic teaching attachments are used to permit an observer to follo
endoscope procedure simultaneously with the endoscope operator. Video converters, devices that con
charged coupled device video camera that is applied to the eyepiece of the fiberoptic endoscope and
a video monitor, are also used to permit image visualization for the operator, assistants, and/or observ
Fully automated or semi-automated devices used to make appropriate dilutions of a blood sample for

Equipment designed to automate the separation, collection, and reinfusion of blood components such
and leukocytes. Typically, one or more components are separated and collected and the rest of the blo
reinfused in the blood donor or patient. Apheresis units usually consist of a pheresis set (i.e., a tubing
patient to the apheresis unit), pumps (e.g., rotary peristaltic pumps), a centrifugation chamber, bowls
controls (e.g., centrifuge and pump speed, volume of solution added), alarms, and bubble detectors. A
used in hospitals, dialysis centers, and/or blood banks for collection of blood components from healthy
diseases by removing a pathologic component or toxin from patient blood.

Throat surgical knives designed to cut the anatomical structures of the trachea. These knives consist o
handheld instruments that usually have a straight handle and a long, narrow, sharp blade with a blunt
surgery knives are used in a variety of surgical procedures in the trachea, including abscess and tumo
of fistulas.
Dental broaches designed to enlarge the root canal. An endodontic broach is often one of the first inst
perform an endodontic procedure. These devices typically are thin, flexible, manual, handheld instrum
and pointed working end. They are smooth or, more frequently, have a series of sharply pointed barbe
backward and obliquely and have a handle. Barbed broaches are used primarily to remove intact pulp
root-canal broaches are also used as explorers.

Dental instruments designed to smooth and finish dental restorations after carving and/or to remove s
amalgam surface by rubbing. Burnishers typically consist of a handheld, manual instrument with beve
variety of shapes; they are available in single- and double-ended types. Dental burnishers are also use
and polishing of dentures.
Calibrators designed to test the accuracy of ophthalmic tonometers. These calibrators usually include
area) instruments with physical characteristics and measuring ranges appropriate to assess the type o
indentation, applanation, noncontact) under test. Calibrators may be supplied as accessories to ophth
some tonometers include self-calibration capabilities. Ophthalmic tonometer calibrators are used for p
tonometers; new types of tonometers are frequently calibrated in laboratories and/or factories by com
vitro manometric intraocular pressure measurements.

Surgical calipers designed to measure the distance between two points of the eye during ophthalmic s
These instruments are typically handheld, metallic, compasslike instruments with two adjustable, cen
either straight, angled, or curved sharp, rigid tips; the proximal end (i.e., the handle) usually includes
a screw to adjust the separation of the legs (i.e., Castroviejo calipers, also used in other surgical proce
ophthalmic calipers are available that are articulated at the proximal end with a scale at the working
cataract incision measurement (i.e., Osher calipers).

Modified motion-picture cameras designed to obtain images directly from the output phosphor of the
These cameras are similar to standard motion-picture (movie) cameras, but expose films in a higher fo
photospot cameras are frequently used for direct radiography imaging during barium studies.
Photographic cameras designed to obtain still images of the eye. Typically several photographs are ta
close to the eye. These cameras usually include one or more lenses positioned in the front of the cam
that operates the camera and frequently also triggers a light flash, and controls to modify the focus, o
The camera also includes a film or an image sensor for film and digital cameras respectively. Ophthalm
to provide diagnostic data of eye conditions; dedicated ophthalmic cameras are available to obtain pic
document the pathology of the ocular fundus and associated blood vessels (i.e., fundus cameras).

Cannulae that are inserted percutaneously into the bladder through the suprapubic region for the drai
insertion of a catheter or surgical device.
Trocars designed to puncture the abdominal wall at a point above the pubic arc in order to provide acc
tract. These instruments typically consist of a manual, handheld device with a sharp pyramidal or con
pointed rod at the distal end and a proximal large handle. Suprapubic trocars are usually fitted into a c
trocar is used to pierce the skin and the abdominal wall (i.e., percutaneously) reaching the urinary bla
and then are removed, leaving the cannula in place. Suprapubic trocars are mainly intended to provid
bladder for insertion of a drainage catheter (or tube) through the anterior abdominal wall when access
through the urethra is very difficult or not desirable.

Cannulae designed to be inserted into the nostrils, with the distal tip typically intended to sit in the no
nasal cannulae tips may be intended to be advanced into the nasal sinuses. These cannulae are typic
semirigid, plastic or, less frequently, metal tubes; they are frequently connected directly or via an exte
to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. Nasal cannulae ma
through which instruments and/or probes are passed to perform a variety of diagnostic, treatment, or
Dedicated nasal cannulae are available to supply breathing gases to the patient (e.g., oxygen, continu
pressure) and/or for carbon dioxide sampling, for hemostatic purposes (i.e., plugging the nostrils), and
sinuses.

Dental carvers designed to shape or cut amalgam restorations in tooth to approximate the original too
carvers are typically slender single- or doubled-ended, handheld, manual instruments with sharp cutti
amalgam carvers are available for carving amalgam restorations on specific tooth surfaces (e.g., resto
proximal and occlusal dental surfaces). They are used after the amalgam is condensed into the tooth
are double-ended instruments with different designs at each end and can be used to carve other subs
wax, carious dentin) in addition to dental amalgam.

Dental carvers designed to shape or cut dental wax. These carvers are typically slender, handheld, ma
a distal blunt blade in a variety of sizes and shapes; they are frequently heated to soften the wax whil
Dental wax carvers are used in a variety of dental procedures, including formation of bite patterns for
prostheses, construction of nonmetallic denture bases, and registration of jaw relations. Some carvers
instruments with different configurations at each end and can be used to carve other substances (e.g.
addition to dental wax.

Biliary catheters designed to inject contrast medium into the biliary (sometimes also into the pancrea
radiographic examination purposes (cholangiography).
Epidural spinal catheters used for continuous or repeated injection of local anesthetic into the epidura
sensory nerves from the lower limbs, pelvis, or abdomen. These catheters are used in surgical proced
used for diagnostic or temporary relief of chronic pain of the limbs, pelvis, abdomen, or lumbar spine.
Catheters designed for introduction through the vagina and cervix into the uterus; some of them are l
possible the advance and location of their distal tip in the fallopian tubes. Intrauterine catheters are u
polyurethane or silicon rubber. These catheters are used in many gynecologic and/or obstetric proced
radiography, insemination, ablation, pressure measurement).
Catheters designed for introduction into either of the nostrils and long enough to advance the distal ti
These catheters consist of a 5 to 15 cm (2 to 6 inch) plastic or rubber tube; they are typically lubricate
gel before insertion.
Catheters designed for insertion into the cavity surrounded by the double-layer sac that lines the abdo
covers most of the viscera contained therein (peritoneum). These catheters have particular characteri
clinical use (e.g., drainage, dialysis) or use as distal catheters in hydrocephalus shunts.

Chairs made of easily washable materials, with appropriate accessories (e.g., arm rests, foot rests, rec
intended to be used to position the patient who is connected to a hemodialysis unit and undergoing tr
are designed to provide a variety of positions aimed at patient comfort, as well as the ability to be pla
as Trendelenburg/reverse Trendelenburg for patient safety.

Chairs used to position the patient for easy access and comfort during examination, treatment, or min
Most of these chairs are adjustable in height and include head, arm- and foot-rests, and a reclining ba
from a vertical to a horizontal or near-horizontal position. Some examination/treatment chairs are hyd
powered.
Light sources designed to provide illumination during microscopic procedures. These devices typically
fixture that may include one of a variety of light sources [e.g., , xenon, halogen, incandescent, light e
controls for light intensity and time, and light delivery systems that may include flexible fiberoptic cab
lenses and mirrors. Microscope light sources are available in several configurations according to the co
intended use of the microscope, such as clinical laboratories (e.g., sample preparation, dissection), ex
dermatology, foot care), and operating rooms (e.g., dental and neurologic microsurgery).

Laboratory light microscopes in which light (typically ultraviolet) that has been absorbed by the specim
longer wavelength is observed (as visible light) through the eyepiece. Appropriate filters are used to s
wavelength of incoming beam to excite the fluorescent compound and eliminate the unwanted incide
fluorescent light source (i.e., the specimen). Some fluorescence microscopes can also be configured fo
phase-contrast observation. These microscopes are used in histopathology and microbiology, common
fluorescent dyes. The use of a vertical illuminator and dichroic mirrors (epifluorescence) offers some a
fluorescence microscopy using transmitted illumination.

Viscosimeters designed to measure the viscosity of blood plasma. These viscosimeters typically consis
instruments that use mechanical methods to measure the viscosity, including dedicated falling ball, ro
(e.g., Harkness) viscosimeters; some instruments can process blood by taking samples directly from t
Viscosimeters using fluorescent molecules that are viscosity sensitive have also been developed. Bloo
viscosimeters are intended to detect anomalies in blood plasma viscosity that may be associated with
diabetes, hypertension, infection, myeloma, rheumatoid arthritis, and cardiac infarction.
Reusable vascular clip appliers designed for application of atraumatic microclips for the total or partia
aneurysms, separating the aneurysm from the vasculature, and/or to prevent bleeding (i.e., hemostas
aneurysms. These appliers are available in a variety of shapes and sizes; they frequently include a me
insertions of aneurysm clips. The aneurysm clips are usually applied to the neck of the aneurysm; the
intended for temporary use during the surgical procedure or as permanent implants.

Vascular clip appliers designed for application of small atraumatic clips for blood vessel ligature to sto
bleeding (i.e., hemostasis). These appliers may include a mechanism for single or multiple insertions o
reloaded with new clips to perform more than one surgical procedure. Dedicated reusable clip appliers
surgery on particular anatomic sites (e.g., arteries, scalp vessels); the applied clips may be intended f
during the surgical procedure or as permanent implants.

Clamps designed for grasping and/or compressing a cannula without damaging it. These clamps are a
sizes and configurations according to the cannula to be clamped and the procedure to be performed;
flexible plastic mechanism that may be operated by a spring and attached to the cannula. Some cann
available as an integral part of a specialized device (e.g., a cannula attached to a hemodialysis fistula
clamps are used mainly in procedures (e.g., cardiopulmonary bypass surgery, hemodialysis procedure
require a temporary closing of the cannula (i.e., the cannula is no longer patent).

Surgical clamps designed to temporarily and atraumatically grasp, join, or compress eye tissue and/or
structure. These clamps are typically small, handheld, manual instruments; dedicated eye clamps are
surgery (e.g., cyst treatment) and to grasp the orbital muscle and conjunctiva in procedures involving
correction and plastic surgery of the eyelids.
Surgical clamps designed to atraumatically grasp middle-ear structures. These clamps are typically ha
manual instruments with delicate jaws appropriate to hold tiny anatomic structures. Dedicated middle
available for holding the ossicles.
Surgical clamps designed for the atraumatic grasping or compression of the penis during surgical proc
are typically handheld, manual instruments available in a variety of shapes and sizes according to the
performed. Dedicated penis clamps may include two hinged parts with rectangular distal blades cover
and a built-in adjustable locking mechanism at the other end and spring-actuated wire clamps with so
dedicated clamps intended for circumcision of males are also available.

Surgical clamps designed for the atraumatic grasping, compression, and/or manipulation of the uterus
tissue during open-surgery procedures. These clamps are typically handheld, manual instruments incl
pivoted at the center with straight or curved distal blades that may be smooth or serrated, and a hand
mechanism with variable settings. Dedicated uterine clamps are available for use on the uterine cervi
parametrium, and/or to perform specific procedures (e.g., myomectomy, repair of bleeding uterine wa

Dedicated laboratory concentrators designed to increase the relative content of substances in a samp
facilitate their analysis. These concentrators may use several technologies such as evaporation; a filtr
including a filtration chamber, a pump (e.g., a syringe pump), and collection tubes; or filtration memb
capacity absorbent. Most concentrators include a dead stop to prevent samples from drying out. Spec
used mainly in clinical laboratories to concentrate proteins in body fluid samples (e.g., urine) before im
or immunofixation.
Condensers designed to pack amalgam filling material into a tooth-cavity preparation. These condens
manual instruments with smooth or serrated hammer-like working ends or powered devices with vibra
action; dental amalgam condensers may also be used for condensable (i.e., packable) resin composite

Devices designed to provide an artificial cusp (a projection on the chewing surface of the tooth) to ach
(a proper bite).
Ophthalmic devices designed to facilitate gaze fixation on a fixed and/or moving light. These instrume
mount with a headrest and a light source on which the patient fixes his or her gaze; the light source c
to the head rest. Ophthalmic fixation units are used mainly for diagnosis and treatment of eye conditio
gaze is fixed.
Surgical dilators designed for mechanically augmenting the caliber of the internal lumen of the ureter
dilators are usually, hollow, cylindrical, handheld instruments with a thin, tapered oblique distal end to
they are usually coated with hydrophilic materials to facilitate introduction and use. Ureteral dilators a
ureter during surgical urological procedures of the upper urinary tract; they are available in a variety o
the surgical procedure to be performed.

Dilators designed for mechanically augmenting the caliber of the uterine cervical canal. The dilators a
uterine cervical canal to slowly dilate the canal which facilitates the access to the uterus; they can be
purposes (e.g., cervical stenosis, placement and removal of intrauterine devices, drainage of the uteri
biopsy, uterine curettage, suction cannula aspiration, or labor induction). Cervical canal dilators usual
expandable conic instruments with a flexible and smooth surface and long tapered tips.

Circular plates that have abrasive materials bonded to the surface and/or edge, either the inside (safe
outside (safe inside). Abrasive disks are used with straight or contra-angled handpieces for low revolu
finishing a cavity preparation and for cutting or polishing dental restorations.

Dispensers intended to store and inject orthopedic fluid cement into bone cavities. These dispensers a
operated syringe-like devices. Orthopedic cement dispensers regularly include a transfer channel with
dispensing the fluid cement and another opening through which this fluid cement exits through an ap
cavity. These dispensers may be made of plastic (e.g., acrylic), metal (e.g., stainless steel), or a comb
are commonly used in orthopedic surgical procedures.

Dental dispensers designed to store and deliver measured amounts of liquid mercury. These dispense
container usually made of metal or plastic and they frequently include a funnel for accurate control an
Dental mercury dispensers can be manually operated. Dental mercury dispensers are not frequently u
dentistry; they are usually combined with dental alloy dispensers to deliver dental amalgam.

Surgical drapes designed to provide a bacteria-proof barrier between the unsterile surface of the oper
cover and the sterile surgical field. These surgical drapes consist of a very thin, transparent heat-resis
which is adapted to completely house an operating microscope, including its support arms. Operating
drapes are usually made of disposable materials, but reusable ones are also available. They are used
surgical procedures.
Devices designed for testing the sharp penetrating point of surgical knives used in ophthalmic proced
typically consist of two concentric cylinders made of materials such as wood or plastics; the external c
to slip over the smaller internal one. When properly placed, a piece of soft material is adjusted on the
same way as the raw skin is drawn upon a drum head. The knives are tested by pressing the point gen
of the soft material (e.g., kidskin, sheepskin). The point will penetrate easily and smoothly without any
sharp; imperfect cutting and a popping sound are signs that the knife needs sharpening or should be

Diagnostic ophthalmic devices designed to elicit and evaluate the regular, involuntary movement of th
nystagmus). The devices are typically drum-like cylinders covered with uniform white and dark vertica
The rotation of the devices can induce optokinetic nystagmus, and then the examiner observes the pa
responses. Optokinetic drums are used to diagnose a variety of visual problems.

Blankets made of a fire-resistant fiber (e.g., fiberglass, treated wool). These blankets usually include h
are big enough to completely wrap a person. Some of them are stored in a wall-mounted cabinet to fa
blankets are used to extinguish a fire burning on a person and for protection during escape from fire; t
to rescue nonambulatory patients during fire emergency evacuation.

Devices, usually small, compressed sponges or gauze typically made of cotton or cellulose, that are in
canal. They are compressed for ease of insertion; they expand once in place and after the addition of
that can be instilled into the ear canal through the ear wicks. They are used to hold medicine, such as
antifungals, within the ear canal for patients with otitis externa. They can also be used to help reduce
to prevent stenosis of the external ear canal following otic surgery. The wicks are single use and dispo
be changed frequently.

Handheld surgical instruments used to displace and remove teeth and roots that cannot be engaged b
forceps or to loosen teeth and roots before forceps application. They use a blade to engage the teeth
them from the alveoli through leverage applied to the handle.
Hand instruments designed for cutting and removing the carious dentin of a decayed tooth.
Video systems designed for remote observation of patients in healthcare facilities. These systems typ
located in patient rooms and monitors in appropriate places, such as nurse stations. Patient-monitorin
are typically manufactured using the same standards and devices that are used in commercial televis

Hollow-fiber hemodialysis dialyzers whose design includes hollow fiber membranes with relatively larg
increased surface areas resulting in a higher permeability membrane than standard dialyzers. High pe
permit higher removal rates [(defined as having an in vitro ultrafiltration coefficient ([Kuf)] greater tha
per conventional millimeter of mercury)] than those possible with standard hollow-fiber membrane dia
typically consist of cylindrical containers with a few thousand longitudinally arranged hollow-fiber cap
walls work as a semi -permeable membrane. Blood enters and exits through the ends of the hollow fi
through their lumens, while the dialysate flows through the container outside of the fibers. High-perm
hemodialysis dialyzers are typically used for fast cleansing of a patient's blood from impurities caused
kidneys due to drug overdose or poisoning; their use has increased in new hemodialysis machines use
treatments.
Devices designed to displace tissue or organs by compression, facilitating the examination of body sit
access to them during surgical procedures. Depressors are typically handheld, manual instruments in
sizes; depressors used for oral examination (tongue depressors) are usually disposable or reusable an
time. Surgical depressors usually consist of reusable metal devices that may be held or fixed to the or
uterus, brain, sclera) for a longer period; some depressors are used to facilitate evaluation of organs b
procedure.

Point-of-care whole blood analyzers dedicated to measuring the concentration of glucose in capillary b
also use venous and/or arterial blood. Most of these analyzers use reflectance photometry methods (i.
produced by an LED and reflected from a reagent-impregnated test pad that has reacted with the bloo
or electrochemical methods (i.e., electric current is measured when glucose oxidase converts glucose
blood-dampened reagent strip). Some blood glucose analyzers are capable of cholesterol-level determ
purposes. These glucose analyzers are used for health professionals and diabetic patients to manage
for transient high or low glucose levels (e.g., during surgery); they are also used in sports medicine.

Devices designed to hold an endotracheal tube in place where it enters a patient's mouth, frequently
securing the tube throughout its use. These holders usually have adjustable straps that can be secure
head and that attach to a housing holding the portion of the endotracheal tube that comes out of the
are usually made of plastic, glass, fabric, wood, metal or a combination of these materials; they also in
fasteners or locking mechanisms to secure the tube in place. Endotracheal tube holders come in adult

Adapters designed to couple electrosurgical units to accessories of different models and/or manufactu
also to connect cables to discontinued and/or obsolete models, to perform special procedures (e.g., bi
minimally invasive, or laparoscopic surgery), or to increase safety of connection. These adapters may
electrical connectors, cables, plugs, jacks, and/or other dedicated devices; they are usually intended f
Electrosurgical unit adapters are used to facilitate particular electrosurgical procedures (e.g., bipolar,
laparoscopic) and/or to lessen the possibility of electric shock due to an improper connection.

Infusion pumps small enough to be worn or carried by patients that are designed to deliver relatively s
medications and other solutions through intravenous (IV), epidural, or subcutaneous routes at pre-esta
rates. These pumps usually consist of a pumping (e.g., peristaltic, syringe-driven) mechanism to move
solution container to the patient; they also include flow controls to select the dose or volume to be inf
also include a display showing prompts and/or audible or visual alarms to indicate abnormal condition
ambulatory pumps are mainly used to administer therapeutic drugs either continuously or intermitten
ambulatory pumps (both reusable and single-use) intended for administration of particular medication
insulin) are also available.

Covers designed to be placed over, and to cover the gaps between, the rails on the sides, head and/o
patient's bed. Bedrail covers can be made of waterproof fabrics and may be padded. This provides pro
with fragile skin or sensitive limbs. They can be attached to the bed rails by ties, elastic bands, or hoo
Laboratory carts designed to transport and/or store tissue specimens for pathologic analysis. These ca
a set of wire shelves appropriate to accommodate containers with a preservative liquid (e.g., formalde
pathological samples (usually organ tissue) are immersed. The cart trays usually provide spill-proof co
preservative liquid and include some means (e.g., pads) to absorb and/or neutralize the spills. Some p
carts can be handled inside ventilated cabinets including doors that provide a safe and easy storage o

Infusion devices designed to deliver solutions typically through intravenous (IV), epidural, and/or subc
established accurate flow rates. Infusion pumps may use one of a variety of different technologies for
including peristaltic, rotary, cassette, syringe-driven, and elastomeric mechanisms. These pumps are
large and/or small volumes of liquids through one or several channels simultaneously. Infusion pumps
mounting on poles, for ambulatory use, or for implantation. Infusion pumps intended for a variety of th
(i.e., multitherapy), as well as for particular therapies that use specific medications such as insulin, an
anesthetics, are available.

X-ray radiation shields that include a lead-glass lens inserted in an x-ray shielded frame that provides
beam and scattered radiation, usually placed on the face with an adjustable headband. Most of these
eyeglasses and are vented to reduce fogging. These shields are used by healthcare personnel during
and other lengthy fluoroscopic procedures.
Mirrors designed to provide visual feedback to patients with an amputated or semi-paralyzed limb._x0
These devices, commonly known as mirror boxes, typically consist of a box open on one side and on th
dividing the box in half. The front of the box contains two arm or leg holes; the patient places the disa
opening of the mirror box, obscuring it from view and the unaffected limb in the side facing the mirror
the working limb and watches its reflection in the mirror; the reflection of the working limb creates the
disabled limb appearing as if it were fully intact and moving as well. Repetitive use of these mirrors is
visual feedback and modify the patient brain response. Visual feedback therapy mirrors are used to ac
phantom limb pain and for rehabilitation following stroke, limb injury, or surgery.

Pant liners designed to retain urine. These liners typically consist of disposable pad or shell that fit un
specially designed underwear (brief, panty) using adhesive strips or other means of attachment. Incon
used by adults or older children at home, healthcare institutions, and during normal daily activities.

Incontinence pants designed to retain urine in a disposable liner. These pants usually consist of a reu
woman's panty with external softness and shape resembling regular underwear with an internal single
liner consisting of a pad or isolated shell capable of retaining urine leaks from patients with light or m
while keeping the skin dry. Liner retention Incontinence pants are used by adults and older children at
institutions, and during normal daily activities.

Therapeutic gloves designed to apply gentle pressure to the hands. These garments are typically cott
including an elastic material (e.g., Lycra, Spandex) that provides compression to the hands to prevent
are frequently available with open fingertips to permit better feeling and/or with integrated sleeves th
elbow, or even the axilla. The seams are usually on the outside of the glove; seamless pressure gloves
Dedicated therapeutic pressure gloves are intended to control edema and/or scarring due to arthritis o
manage lymphedema.
Systems designed to summon help through the telephone system by people who are unable to dial a
systems usually consist of a portable wireless radiofrequency transmitter and a receiver console that
telephone system. Typically, the user wears the transmitter around the neck, on a belt, or on a wrist; p
initiates the system's response sequence. The system may be activated by people who cannot operat
transmitter button using other means, including pressure bars that are located on the forearm and tha
the chin; breath-activated transmitters are also available. Personal emergency response systems (PER
two types: programmed calling PERSs designated to alert responders (e.g., neighbors, relatives, emer
directly and monitored PERSs that call an emergency response center that in turn communicates with
are used mainly by the elderly and others with chronic illnesses or disabilities.

Automated flow cytometers that are capable of separating ("sorting") subpopulations of cells. Cells ca
single or multiple characteristics and remain unaltered through the process. Most devices can accomp
procedure under sterile conditions, enabling the resulting cells to be cultured.
Intravenous (IV) poles designed to be mounted on the ceiling, usually attached to a track-and-carrier s
movement of the pole along a track. These poles typically consist of a slender metal structure includi
that permits height adjustment, an assembly at the upper part for attachment to the ceiling fixture or
with one or more hooks at the lower end. Ceiling-mounted IV poles are mainly used in healthcare area
of IV fluids is frequent and/or the amount of floor space is critical.

Video tape recorders where the picture elements of the image-intensifier output (i.e., radiographic and
are converted into electric signals and recorded. These recorders allow the repeated examination of ra
the detection of abnormalities using still-frame or slow-motion playback.

Immobilizers designed to reduce or eliminate motion of a patient's entire body following injury or surg
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for fi
rectum with barium sulfate by means of an enema administered via the rectum. Items in these kits us
administration tip, catheter, tubing, the barium solution, clamps, and a reservoir for the enema solutio
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Barium enema procedure kits and trays are intended for use during radiologic procedures in
and diagnosing problems in the colon and/or other segments of the lower gastrointestinal tract. They
and gastroenterology departments of hospitals and also in other healthcare facilities.

External cardiac pacemakers that use external (noninvasive) electrodes to stimulate all chambers of t
simultaneously. These pacemakers include the electronic circuitry that controls the pulse rate and ou
typically a two-lead cable used to connect it to two pregelled disposable adhesive electrodes. During
stimuli from the pacemaker are conducted across the skin through one electrode, then collected throu
in such a way that part of the current is conducted through the heart, inducing it to contract. Externa
pacemakers are mostly used to assist in resuscitating patients, to correct arrhythmias, or to temporar
procedures that might inadvertently induce bradyarrhythmia and/or asystole.
X-Ray view boxes designed to present pre-loaded radiographs in a sequence by means of an electro-m
mechanism. These boxes typically consist of a stand-alone unit, frequently using multiple displays wit
panels, electric switches, and individual light controls for each section. Some units are mobile. Mot
are used to facilitate and reduce radiologic examination time, they are also used for consultation
teaching.

Surgical scissors designed to cut and excise the lymphoid almond-shape masses located in the oropha
tonsils). These scissors are typically handheld, manual instruments with two metallic (e.g., stainless st
blades with long shanks and straight or curved blunt tips that slide past each other (i.e., shearing acti
attached to handles with the proximal end conformed as a ring to facilitate holding and operating with
are joined by a swivel pin in the center. Scissors with larger finger rings and flat shanks to facilitate op
style) are also available. Tonsil surgical scissors are used in tonsillectomy procedures.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for d
in these kits may include drain catheters, specimen-collection swabs and tubes, disinfectant swabs, ta
kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed rec
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Wound drainage procedure kits and trays are intended for draining fluids and/or purulent m
wound, or infected area. They are used in the field, doctors' offices, and in healthcare facilities.

Cardiographs designed to be used to record heart-wall motion, (primarily anterior left ventricular moti
versus-time graph (cardiokymograph). These recorders consist of a transducer (e.g., a flat coil) that is
which works as a component of a high-frequency, low-power oscillator. Motion within the electromagn
electric parameters (e.g., capacitance), producing a change in the frequency of the oscillator. Cardioky
focal and can only detect motion of vectorial components perpendicular to and directly under their co
for noninvasive detection of regional ischemic contractions.

Laboratory electrolyte analyzers that measure the electrolyte concentration using flame photometry t
sample is aspirated into a flame, and the thermally excited atoms emit light of characteristic wavelen
measure of the amount of the element present. The concentration of electrolyte in a test solution is d
comparing its intensity with that obtained from a standard solution and is usually displayed in millimo

Filter photometers that measure the amount of light emitted by a light source (e.g., light-emitting diod
the sample. These devices usually use a photodiode for light detection.
Installations designed for use in the performance of complete autopsy and dissection procedures on a
stations typically consist of an autopsy/dissection table and sink that are permanently or that may be
other; they may include a scale appropriate to weigh body parts. The table has a smooth, polished su
and rounded corners and no crevices, screws, or rivets. The tabletop slopes toward a sink with one or
bowls, configured to permit the direct collection of fluids from the table without additional manipulatio
sinks typically include several faucets, cold and hot water supply, a vacuum aspirator, soap dispenser
unit, and appropriate tubing for drainage. Autopsy stations may include exhaust ducts that connect to
ventilation system, drawers for instruments and supplies storage, and electrical receptacles. Autopsy
to provide a complete installation for postmortem examination and whole-body dissection, to collect a
discharged from the cadaver, to facilitate cleaning and decontamination, and to prevent the accumula
microorganisms. Additional equipment, such as dictation and/or photo documentation systems, is incl
autopsy/dissection stations.

Containers designed to store cells, tissue, organs, and/or biological samples (e.g., red blood cells, bon
low temperatures, usually -180 degrees Celsius (-292 degrees Fahrenheit) or lower. These devices typ
inner vessel for containing a cryogenic fluid, and an outer vessel for insulating the cryogenic liquid fro
that keeps the cryogenic liquid at low temperatures. The containers are equipped with a pressure-relie
pressure-controlling valve. Cryobiological storage containers are partially filled with liquid nitrogen or,
another appropriate liquefied gas (e.g., helium, argon); the biological products are usually immersed i
Some devices keep the products above the liquid nitrogen (i.e., in cold nitrogen vapor), avoiding cross
providing a higher and less stable temperature (about -140 degrees Celsius [-220 degrees Fahrenheit]
immersion.

Connectors designed to withdraw liquid nitrogen from vessels containing the cryogenic liquid (e.g., De
connectors can regulate the pressure and the flow of the liquid nitrogen (e.g., up to 8 or 10 liters/minu
attached to Dewar flasks of several different capacities (e.g., 25, 50 liter) following appropriate proced
connection; the content of the Dewar flask usually can be replenished without removing the connecto
container transfer connectors are mainly used for safe transference of the liquid to other devices such
cryogenic container.

Containers designed for temporary storage of liquid oxygen (LOX) prior to its distribution and use. The
consist of a large capacity (e.g., 10, 100 liter) double vessel bulk tank; an insulated inner vessel for co
oxygen at a temperature of -183?C (-297? F) and an outer vessel for protection. Vacuum in the space
provides insulation to the liquid oxygen from the environment temperature; the container should inclu
release of the gas from the slowly boiling liquid oxygen due to the higher room temperature, especiall
not used for a long period of time. Liquid oxygen containers are used in supply centers and in most la
before distribution of oxygen either as liquid or gas; some smaller containers are used at home to fill
portable oxygen delivery units.

Temperature controllers designed to keep temperatures in a container between preestablished limits w


point of water (i.e., cryogenic temperatures, below -130 degrees Celsius [-202 degrees Fahrenheit]); ty
-200 degrees Celsius (-238 to -328 degrees Fahrenheit). These controllers usually include temperature
thermometers, an electronic unit that may include microprocessors, a display, and connecting cables;
include alarms. Cryogenic temperature controllers are used mainly in healthcare facilities for containe
preservation of biological tissues (e.g., embryos, bone), in cryosurgical units, and in blood bank cryoge
store red blood cells).
Liquid-level controllers designed to keep the level of cryogenic liquids in a container (i.e., liquids below
[-202 degrees Fahrenheit]) between preestablished limits. These controllers usually consist of a level s
capacitor, solenoid-based devices), an electronic unit that may include microprocessors, a display, and
the devices may also include alarms. Some liquid-level controllers can actuate automatic mechanisms
cryogenic liquid when it reaches a minimum level. Cryogenic liquid-level controllers are designed to m
cryogenic liquids (e.g., argon, nitrogen, oxygen) inside a tank (e.g., a Dewar flask) and in other cryoge
cryosurgical units, freezers, containers).

Imaging tables with a rectangular table top made of a radiolucent material (e.g., carbon fiber) and a fi
radiographic grids located directly under the tabletop. Most tables may be raised, lowered, and tilted
hydraulic systems, using manual or electric controls. These tables support the patient's body in adeq
radiographic examinations.
Prepackaged collections (either custom or standard) of devices and supplies designed for use typically
components of injectors intended for automated injection of radiopaque fluids into the arteries and/or
cardiac and/or surrounding vasculature (i.e., angiography). Items in these kits usually include a pressu
micro filter, a coronary control syringe, a solid plunger, a swivel nut connector, syringes filled with sali
a temporary sharps holder, angiographic needles, a regular bevel scalpel, a medicine cup, and a guide
also include curved forceps, gauze pads, cloth towels, towel clamps, sponge sticks, a back table cover
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure; th
covered or wrapped. Angiography procedure kits and trays are intended for use during angiographic p

Prepackaged collections of the devices and supplies (either custom or standard) needed for radiologic
to obtain digital images of the blood vessels of and/or around the heart (i.e., a digital angiography pro
kits usually include gauge needles, an introducer needle, plastic syringes, anesthetics (e.g., xylocaine
pressure stopcock and connecting tubing, gauze sponges, and fenestrated drapes; kits may also inclu
povidone-iodine packet, swab sticks, puncture site bandage, and a sterile indicator. The kits are freque
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
angiography procedure kits and trays are intended for use to prepare the patient undergoing the digit
visualization of the arteries of the heart and sometimes of other particular organ, system, or body par

Prepackaged collections of the devices and supplies (either custom or standard kits) needed for visua
during special radiography procedures (i.e., special procedure angiography). Items in these kits usuall
gowns, plastic syringes, connecting tubing, gauge needles, scalpels, gauze, towels and bowls; kits ma
povidone-iodine packet, swab sticks and puncture site bandages. The kits are frequently supplied in su
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Special procedure a
kits and trays are intended for use during interventions such as stent placements, discography, placem
vascular access ports and peripherally inserted central catheters (PICCs), and placement of devices/gr
Densitometers used to determine the degree of darkening (optical density) of developed radiographic
usually by means of a light source and a photocell that measures light transmission through a given a
densitometers are used to determine the radiation recorded on the film and are frequently included as
control process.
Surgical dilators designed for mechanically augmenting the diameter (caliber) of the salivary duct dur
procedures. These dilators typically consist of an instrument with an oblique distal end attached to a r
predetermined diameter to facilitate placement. They can also provide endoscopic access for stone re
dilators can be used for working under radiological guidance. Salivary duct dilators are mainly used du
salivary gland diseases.

Monitors designed to continuously measure and display, usually in digital format, the parameters of th
tube, such as tube angulation (i.e., angle in degrees), focal spot-to-film distance (in centimeters or inc
image distance relative to the Bucky tray, tabletop, or floor. Some monitors also display additional par
magnification factor and field size. X-ray tube monitors are usually ceiling-mounted (in overhead tube
are frequently attached to the positioning control.

Radiographic units including a chair designed for proper patient positioning. These units were used fo
visualization of the fluid-containing structures of the brain after cerebrospinal fluid is withdrawn and re
oxygen, air).
Radiographic/tomographic systems that use a pattern of x-ray tube movement (e.g., spiral, elliptical, c
blurring in both directions of the plane. These systems are mostly used to examine the lungs and oth
little natural contrast, particularly using narrow-angle tomography (i.e., zonography).

High-capacity batteries designed to deliver energy through a transformer to the x-ray generator of a m
unit. These batteries typically consist of a stack of several sealed lead-acid or, less frequently, nickel-c
capacity up to 25,000 milliamperes second. The whole power supply unit also includes an inverter, a t
battery charger; it is usually an integral part of a mobile radiographic unit.

Accessories or parts of diagnostic and/or therapeutic radiographic units or systems used to flatten (by
stabilize a specific part of the body (e.g., breast) to be examined or treated. Compression devices use
be mechanically, electronically, or software controlled by the x-ray system.
Image digitization systems designed to convert an input signal taken from a television (TV) camera or
device (CCD) into a digital signal and process the digital signal to obtain images that can be displayed
(usually after a digital-to-analog conversion) or in other computerized imaging systems. Hard-copy x-r
can also be made using a multi-image camera or a laser imager. These systems consist of an analog-
high-speed digital memory, a digital storage device (e.g., optical disk), a digital-to-analog converter, a
computer. Angiographic image digitization systems are designed to be added to existing angiographi
radiographic/fluoroscopic systems to perform a variety of computer- assisted x-ray image acquisition,
display functions. Most of these combined systems are primarily used for digital subtraction angiogra
involves the subtraction of a previous digital image from new images obtained after injecting a contra
patient.
Devices designed for rapid change of the x-ray films of radiographic devices when a very quick seque
physiologic events is necessary. The process of film change consist of sending a film from a protected
site, and to allow the exposed film to be withdrawn and replaced for another film prior to the next exp
changers are capable of moving an x-ray film either in rolls or sheets; some changers can move casse

Lights designed to provide illumination from parts of the visible spectrum to which x-ray sensitive mat
completely insensitive under dark room conditions. These safelights use a low-wattage bulb (e.g., 7 to
damage or fogging to the x-ray materials, located inside a lamp housing. A safelight filter is mounted
in the housing and filters the light produced by the bulb making the device safe for use with photosen
are available in different sizes, shapes (circular, linear) and configurations (wall-mounted, ceiling-mou
penlight). Darkroom x-ray safelights allow x-ray technologists to see in dark rooms.

X-ray radiation shields used for thyroid protection during x-ray examinations and other procedures.
Devices designed to provide a test pattern appropriate for measurement, calibration, and quality cont
procedures. These test patterns typically consist of metal (e.g., lead-foil, copper mesh, gold-nickel allo
sandwiched between two plastic plates; the choice of the pattern configuration, either linear or circula
characteristics depends on the particular measurement (e.g., focal spot size, resolution, modulation tr
performed. Radiographic test patterns are intended for radiographic and/or fluoroscopic units and syst
equipment such as image intensifiers and video systems. Dedicated patterns for mammographic units
patterns used to assess fluoroscopic equipment, and test patterns in digital signal format (e.g., digital
are also available.

Systems designed to measure the amount of radioactive iodine in the thyroid gland after a predeterm
following ingestion (i.e., thyroid uptake). These systems typically consist of a detector system (compo
crystal and a photomultiplier tube), collimators, a high-voltage power supply, amplifiers, a pulse-heigh
display unit; many systems include computerized capabilities for data processing. Thyroid uptake syst
assess thyroid gland activity; the normal range for thyroid uptake 24 hours after administration varies

Entrances (e.g., doors) designed to allow personnel to access x-ray processing dark rooms without per
or disturbing the film processing in other ways. These entrances may consist of a two-door system wit
revolving doors, or plastic doors that allow one to see into the dark room while still protecting the film
Radiographic dark room entrances are typically used in high-volume x-ray film processing department

Interlock systems designed to prevent accidental exposure of x-ray films being processed in a dark ro
typically include an electronic control unit; film bin, processor, and door locks (e.g., solenoids) ; and w
Radiographic film interlocking dark room systems ensure that the doors are locked and white lights ar
bin is open or until an exposed film is fully entered into processor, they also ensure that the film bins a
is open and/or a white light is turned on.

Covers designed to sheathe or encase clinical thermometers, providing a sanitary protective barrier to
contamination during temperature taking. Thermometer covers are disposable and are made of thin, fl
plastic film. Different sizes of thermometer covers are available for either digital or mercury thermome
oral, rectal, or axillary temperature taking, and for thermometers sized for adult or pediatric use.
Primary intravenous administration sets designed for liquid administration from a bag or bottle throug
either to a hub catheter or needle at the patient site, or to an extension tube set attached to the patie
typically consist of plastic tubing, a check valve, a roller clamp, a Y-site connector for secondary tub
luer adapters at both ends (either male or female). Most infusion pump administration sets include an
mechanism, they may be vented or unvented, some sets are manufactured with special characteristi

Razors designed to remove hair from the surface of the skin to prepare the area for surgical or related
devices may be manually operated, disposable handheld instruments with an appropriate razor blade
electrically powered, handheld instruments with vibrating or rotating disposable blades. Skin preparat
include integral combs at the operating edge to lift and separate the hair from the skin. This helps avo
between the blade and the skin to prevent cutting or skin nicks.

Containers (typically made of plastic material) for the storage of contact lenses.
Cytometers that require minimal technician involvement, completely automating all processes (e.g., s
counting, differentiation, sorting). Automated cytometers measure thousands of cells per minute, yield
quantitative information about the cell population and enabling the detection of rare cells. Automated
standardized method of obtaining accurate and reproducible results, reduce throughput time, and ma
perform.

Surgical blades designed for mounting in an adenotome, providing the cutting component for the exci
the nasopharynx. These blades typically consist of a flat piece of metal (e.g., stainless steel) with one
the working end; the blade is configured at its proximal end to permit its attachment to a particular ty
Adenotome blades may be intended for reuse or for single use.

Synthetic sutures made of polydioxanone, an absorbable (i.e., biodegradable) polymer. These sutures
in sterile monofilament uncoated thread sections (e.g., 18, 30 inches/45, 76 cm long) attached to a sin
integral device; they are frequently colored for easy identification during surgery. Polydioxanone abso
sutures keep their tensile strength for two to several weeks, and complete absorption occurs in less th
intended use includes extended wound support and ophthalmic and pediatric cardiovascular surgery.

Syringes designed to inject solutions from a changeable, prefilled, disposable, sealed cartridge that us
or a blunt cannula attached to one end. Cartridge syringes typically consist of a barrel appropriate for
cartridge and an attached plunger that can be fitted tightly onto the distant end of the cartridge. Thes
inject drugs that are supplied in cartridges (e.g., anesthetics, vaccines, medications)..

Sets of devices designed to deliver insulin to ambulatory individuals with diabetes. Typically, a cathete
infusion pump to a needle inserted subcutaneously in the abdomen. The administration sets include a
(similar to a syringe) filled with insulin, a portable battery-operated pump, and a control (e.g., a comp
the patient to control the amount of insulin delivered. The devices are usually contained in a plastic c
attached to a belt or inserted in a pocket.

X-ray film changers that transport cassettes containing film sheet, rather than film. The cassettes also
compatible intensifying screens with adequate pressure to ensure good film-screen contact. Cassette
accommodate cassettes ranging in size from 30 x 120 cm (12 x 47 inches) to 35 x 90 cm ( 14x 36 inch
in exams (e.g., peripheral angiography) not requiring the higher film rates provided by sheet or roll ch
X-ray film changers designed to transport single sheets of film of a specific size from a supply magazi
intensifying screens to a receiving bin at a fast rate, e.g., several films per second. Typical sheet-film c
major components: a mounting stand, a film changer, a supply magazine, a receiving magazine, and a
operating cycle of the x-ray film changer typically consists of a transport period (i.e., when the film is
stationary period (i.e., when the film is held still for exposure). Sheet-film x-ray film changers are typic
radiographic/fluoroscopic procedures such as angiography and cardiac catheterization.

X-ray film changers that transport roll films of a specific size from a supply magazine through an expo
receiving magazine, in a manner very similar to the path of film through a movie projector. Typical roll
five major components: mounting stand, changer, supply magazine, receiving magazine, and program
operating cycle of the changer comprises a transport period, when the film is in motion, and a station
film is held still for exposure.

Radiographic/fluoroscopic (R/F) systems designed for visualizing the vascular anatomy. These system
generator and x-ray tubes with rotating anodes; image intensifiers, typically from 38 to 41 cm (12 to 1
camera and display monitors; image recording devices; and a patient table. The typical angiographic
configuration consists of a C-arm, a U-arm, or a parallelogram gantry system that holds the x-ray tube
and the intensifier and video camera tube at the other end. Most systems also include digital recordin
tabletops, cine cameras, and digital acquisition and processing capability (e.g., digital subtraction cap
systems may include only one gantry arm (single-plane systems) or two orthogonal gantries (biplane
is usually ceiling mounted. Biplane systems provide simultaneous recording and viewing of images fr
projections. Angiographic/interventional systems are used to provide real-time images of blood flow a
activity after trauma, disease, or surgery; in neurological procedures; for observing abnormal vasculat
tumor growth; and for providing anatomic and physiological information before and during interventio
procedures are typically conducted in a special imaging suite (angiographic or special procedures room
imaging system, an injector for introducing contrast medium into the patient, physiologic monitoring e
additional equipment to manage cardiovascular emergencies.

Imaging tables with a contoured table top made of a radiolucent material (e.g., carbon fiber) usually c
mattress and including head, arm, and foot rests. Most tables have wheels on their base and their mo
horizontal, vertical) can be controlled either manually or automatically for fast and accurate patient po
support the patient's body in adequate position during nuclear medicine imaging procedures (e.g., SP
planar).

Imaging tables with a rectangular table top made of a radiolucent material (e.g., carbon fiber, Formica
radiographic grids located directly under the tabletop. Radiographic/fluoroscopic tables are designed
undertable x-ray tube for fluoroscopy and to be raised, lowered, and tilted up to 90 degrees in either d
or hydraulic systems using manual or electric controls. These tables support the patient's body in ade
radiographic and fluoroscopic examinations.

Imaging radiographic/fluoroscopic tables with multiple interchangeable tops (e.g., cradle top) and exte
board, longitudinal feet), allowing patient-on removal of tops and allocation of an under-table x-ray tu
compatible with most x-ray tubes, image amplifiers, and serial film changers and include accessories
it possible to support the patient's body using only one table during cardiac, neurologic and vascular s
Equipment designed to provide an appropriate voltage and current, usually measured in kilovolt (kV) a
to an x-ray tube that in turn delivers an x-ray beam with the desire characteristics; some devices may
as an integral part of the generator unit. These generators typically consist of a step-up transformer,
including rectifiers, a filament circuit, a timing circuit, and a control panel with time, kV, and mA contr
are microprocessor controlled. The control panel is used to initiate radiographic exposures and to sel
for radiographic and fluoroscopic examinations. The secondary voltage waveform supplied to the x-ra
diversity of forms (e.g., single-phase, full-wave rectified; three-phase, six-pulse; high-frequency, multi
potential). Additional features include automatic exposure control, automatic brightness control, anato
falling load technique. X-ray generators are an integral part of radiographic, and radiographic/fluorosc
systems, including mammographic units and computed tomography (CT) scanners; some x-ray genera
radiotherapy units.

Monitors designed to display electronic images either in real time as they are obtained using a video c
or digital versatile disk player, a television system, or from a digital computer or computerized networ
typically include electronic circuitry to process the video signal and a screen (e.g., cathode ray tube, li
display, projection sets) to display the image. Video monitors may be used for many purposes, includi
activity and displaying non-diagnostic images during surgical, endoscopic, and fluoroscopic procedure
images with a higher definition than the standard television monitors (i.e., high-definition video monit

Electron tubes designed for emission of x-rays usually by converting the energy of fast-moving electro
energy. These tubes typically consist of a sealed glass vacuum enclosure that includes a heating filam
electrons), high-voltage plates (i.e., the anode) to accelerate the electrons, and an area of the metallic
point) where the electrons are slowed by impact; the slowed-down electrons become the source of x-r
the main component of x-ray generators used in devices (e.g., radiographic units and systems, radioth
for diagnostic, therapeutic, and/or other procedures. Dedicated x-ray tubes used in particular applicat
anode and fixed anode, cold cathode) are also available.

Lights designed to provide intense, structured illumination on a surface or restricted area. These illum
electric power into emitted radiation typically in a wavelength range that includes the visible spectrum
available in several shapes and sizes and use various types of bulbs such as incandescent, compact fl
and light-emitting diodes (LED)._x000D_
They are available mounted in fixtures of a wide range of shapes and sizes in ceiling-mounted, stand-
and handheld (i.e., portable) configurations; some have a fully articulating head that may be aimed pr
High-intensity illumination spotlights can be used for inspections in large areas and/or for long distanc
applications.

Laboratory analyzers designed to detect the presence of, identify, and/or evaluate the in vitro (e.g., in
cultures) susceptibility of a pathogen to antimicrobial agents. The results derived from these analyzer
diagnosis and/or to determine the proper antimicrobial agent for a patient's treatment.
Sets of devices and disposable supplies designed for the transfer of liquids (e.g., drugs, vaccines, solu
container (e.g., a vial) to a second container (e.g., infusion bag), typically under aseptic conditions. A
transfer sets are available and include tubes, connectors, syringes, and caps according to the liquid to
blood, medicine), the procedure to be performed, and/or the physical characteristics of the containers
transfer. Dedicated liquid transfer systems are available using special devices and/or configurations to
such as intravenous solution transfer and peritoneal dialysate transfer, as well as transfer line assemb
radiographic contrast media conservation systems.

Prostheses designed to replace missing hair from the scalp (i.e., cranium) in individuals with cranial ha
prostheses typically consist of a cap intended for attachment of the hair; strings of hair (wefts), made
synthetic hair, that are sewed to the cap; and adjustable tapes (e.g., elastic, Velcro) in the back to allo
the cranium. Hair prostheses are available in a variety of sizes (e.g., from 21.5 to 22.5 inches in diame
textures, and lengths intended to totally or partially cover the cranium. Cranium hair prostheses are in
and/or modify the physical appearance of the body, protect the cranium against ultraviolet radiation,
regulation of body temperature in patients suffering from alopecia that may be secondary to other dis

Calipers designed to measure the distance between two points on a printed electrocardiogram wavefo
are typically metallic, compasslike, handheld instruments with two adjustable, straight, hinged legs w
Electrocardiogram calipers are intended for manual processing and assessment of electrocardiograms
used to measure sections of other physiologic waveforms or electronic image prints.

Holders designed to hold taut a small length of dental floss between two prongs to make it easier to fl
teeth to dislodge debris. The dental floss holders usually are made of hard plastic and are shaped with
two prongs coming off the distal end with a notched end on each prong to hold the dental floss in posi
prongs. Some dental floss holders (usually disposable after one use) come equipped with dental floss
holder.

Prepackaged collections of the devices and supplies (either custom or standard) needed for the insert
tip will reach the central venous system. The catheters are usually inserted into a large vein in the ne
jugular vein), chest (subclavian vein), or groin (femoral vein). Items in these kits may include gauge n
appropriate intravenous (IV) catheters, alcohol swabs, gauze pads, IV bags with solution, and tubing. T
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Central intravenous catheterization procedure kits and trays are intended for use during a variety of p
the administration of fluids (e.g., medication, parenteral feeding), to perform central venous pressure
for other blood tests. They are used in hospitals (e.g., intensive and emergency care) and other health

Caps designed for closure of the tip of medicine bottles usually providing sealing from the external en
devices typically consist of plastic caps that may include a glued or cemented liner (e.g., rubber or pla
threaded for screwing on the bottle. Medicine bottle caps are frequently made in a way that make the
by requiring push-down and turn to open)and/or difficult for tampering.
Devices designed for the simultaneous determination in blood samples of (1) the relative amount of o
deoxygenated hemoglobin (O2Hb and HHb, respectively) by measuring light absorbance changes resu
blood flow pulsations and displaying the results as percent saturation of hemoglobin in arterial blood (
percentages of total hemoglobin concentration (tHb) and hemoglobin derivates (co-oximetry) such as
with oxidized hemoglobin, SpMet), carboxyhemoglobin (blood with carbon monoxide content, COHb).
instruments is based in measuring the light intensity that passes through a blood sample at several d
(usually four or more). The wavelengths are selected either by a filter wheel (photometric technique)
(spectrophotometric technique). From these measurements these instruments calculate oxygenation d
oxygen saturation, content, and capacity. In vitro oximeters/co-oximeters are used in central clinical la
catheterization suites, surgical suites, and critical care units.

Absorbent/cotton-tip swabs usually including a reusable metallic (e.g., nickel-silver, stainless steel, co
triangular or twisted tip appropriate for use in the ear, nose, or oral cavities.
Needles designed to transfer medication from vials in hospital pharmacies. These devices are short, b
1.6 cm [5/8 inch]), long enough to penetrate the vial stoppers but short enough to remove all medicat
of 20 gauge to provide high flow rate with minimum coring.
Medication transfer needles with a thin channel cut along their outer surface, forming an integral vent
pressure in vials and/or other containers. These needles are used for medication transfer and handling
transferring drugs from vials to intravenous bags), minimizing risk of contamination.

Equipment designed to cleanse room air by drawing the air through a filter or set of filters and then re
cleansed air. These cleaners, depending upon the characteristics and efficiency of the filter(s), can rem
particulates (aerosols) and/or gases and vapors. They are available as ceiling, wall, or stand alone uni
mounted on wheeled platforms are also available. Some air cleaners are capable of exhausting air to c
pressure (i.e., isolation) room. Air cleaners are used in healthcare facilities, isolation and clean rooms,
shelters.

Mobile stretchers designed for recumbent patient transportation in an ambulance (e.g., land, air). The
consist of a patient platform (may be height adjustable) mounted on casters; they are lighter and less
stretchers. Most ambulance stretchers provide mattresses to improve patient comfort, handles for lifti
restraint straps to secure the patient; some include provisions for attaching and/or storing accessories
treatments (e.g., intravenous poles).

Intravenous administration sets manufactured with low absorption plastics to avoid partial absorption
the infused solution. These sets typically consist of plastic tubes made or lined with nonabsorbing pla
polyethylene, Teflon), avoiding the direct contact of polyvinyl chloride (PVC) components with the infu
typically includes plastic tubing, a check valve, a roller clamp, a Y-site connector for secondary tubing
clip to avoid free flow, and Luer adapters at both ends (i.e., male, female). Nonabsorbing intravenous
used mainly in high-flow infusion pumps for administration of solution-containing products (e.g., nitrog
absorbed by PVC materials.

Tourniquets designed to circumferentially constrict/compress an extremity for a limited period of time


arterial blood flow with a non-inflatable strap. These tourniquets usually consist of a plain (e.g., rubbe
that may include some means (e.g., clips) for fixing around the limb. Strap non-inflatable tourniquets
phlebotomy and/or intravenous infusion procedures; dedicated tourniquets are also available for use i
to control hemorrhage.
Chairs made of lightweight materials, usually including swivel casters, used for safe and easy patient
are designed for transferring patients across any type of floor and through narrow halls and doorways
chairs include a pair of carrying handles and fixed or detachable footrests and arms.

Power supplies consisting of a set of electrochemical cells designed to store chemical energy and rele
electrical power; the cells are usually connected in series. Single electrochemical cells used as electric
also commonly called batteries. Every cell, regardless of its chemical composition, consists of a negat
positive electrode, an ionic conducting material (electrolyte), a separator to electrically isolate the ele
the electric current flows externally from the positive to the negative electrode . Batteries are usually
characteristic of their chemical composition (e.g., nickel-cadmium, zinc-carbon, lithium); they may be
a primary battery) or rechargeable (i.e., a secondary battery). Batteries are mostly used in the field of
supplies for implantable medical devices (e.g., pacemakers, neural stimulators) and external medical
defibrillators, pacemaker programmers), for backup power for programmable devices that must retain
and in portable or other medical devices when it is not possible or convenient to use the line supply.

Solutions prepared for use in hemodialysis for exchange of solutes below a certain molecular size (det
threshold of the membrane material) across a semipermeable membrane.
Solutions of purified water (i.e., excluding inorganic contaminants and microorganisms) with an electr
similar to blood, that are mainly intended for use in the dialyzer of hemodialysis machines. The dialys
patient blood in the dialyzer (usually through membranes) to remove metabolic waste and also as an
the appropriate concentrations of electrolytes and pH level in blood before returning it to the patient;
frequently bicarbonate is included in the dialysate as a buffering agent. Dedicated dialysate solutions
dialysis procedures, such as peritoneal dialysate (a solution that is hyperosmolar relative to plasma an
buffer) and hepatic dialysate, are also available. Dialysate is usually discarded after use in a dialysis p

Prepackaged collections of the devices and supplies (either custom or standard) needed for placing m
the ear canal to create impressions. Items in these kits usually include foam blocks with strings attach
silicone impression material (i.e., a two-part compound consisting of a base and a hardener); they ma
electrical/battery-operated handheld gun with pre-filled vulcanized silicone cartridges. These kits may
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
impression procedure kits and trays are intended to be used during the making of impressions for cus

Tubing and clamps used to deliver a variety of intravenous solutions from the infusion device to the in
They are typically constructed of plastic material.
Forceps with pronged jaws used to place dental dam clamps in position by engaging the jaws of denta
they may be separated to pass over the widest buccolingual contour of a tooth.
Defibrillators that are permanently inserted (implanted) abdominally, pectorally, or subcutaneously. Pe
abdominally implanted defibrillators are connected to the patient's heart through a set of epicardial or
These defibrillators consist of a hermetically sealed container, including a lightweight battery, electron
cardiac activity and produce the electrical pulses (shocks), and electrode leads that conduct the myoc
defibrillator and the electrical defibrillating pulses to the patient, when needed. Implantable defibrillat
ventricular fibrillation and initiate defibrillation by applying an electric shock to the heart to depolarize
Some of these stimulators have memory modules for storage and retrieval of the cardiac electrical ac
programmable capabilities. Subcutaneous implanted defibrillators that are connected to leads and ele
under the skin above but not touching the heart are also available. Implantable defibrillators are used
mainly for tachycardia, ventricular fibrillation, and cardiac arrest.

Leads designed to conduct electrical pacing signals from the pulse generating unit of an implantable d
defibrillator/cardioverter (i.e., an implantable cardioverter/defibrillator [ICD]) to the heart and conduct
signals back to the unit. These leads typically consist of flexible wires that are completely isolated exc
that makes contact with the heart. The leads are directly attached to the surface of the heart during o
epicardial leads) or threaded into the heart through the vascular system avoiding open chest surgery;
lead is attached through a connector to the pulse generator implanted in the abdomen or chest. A var
including single- and multiple-lead, is available. Lead size, connector type, and other characteristics o
compatible with the defibrillator or ICD pulse generator and the therapy prescribed.

Flotation balloon cardiac catheters designed to deliver pacing stimuli to the heart; usually they can als
signals from the heart. These catheters include electrodes at or near their distal tip; the electrodes ar
the ventricles. The electrodes are connected through the catheter lumen to an external pulse generat
generates the electrical pacing impulses; they also make possible the display of the electrocardiograp
electrode catheters are mostly used in emergencies during bradycardia or asystole until a pacemaker
control the heart rate during and/or after surgery; and during cardiac catheterization procedures (e.g.
studies).

Cardiac catheters that eliminate (ablate) regions of endocardial tissue that give rise to or support card
(arrhythmogenic myocardium). Multielectrode catheters for radio-frequency ablation at several hundre
mostly used, but several different catheters have been used or tested for cardiac ablation, including m
for DC ablation that typically apply 200 to 400 J discharges from a defibrillator; microwave ablation ca
helical antennas, thermocouples, and special electrodes; and double-lumen infusion catheters for seq
of mapping and ablation injectants into endocardial target sites. These catheters may be used for inte
atrioventricular (AV) conduction pathways, treatment of AV nodal reentrant tachycardia, creation of co
some cases of atrial arrhythmias, treatment of atrial flutter/fibrillation, and treatment of ectopic atrial

Modified motion picture cameras that record fluoroscopic images onto 16 or 35 mm roll film. The imag
camera from the output phosphor of an image intensifier tube for later playback on cine projectors. Th
of eight basic parts: a converging lens system, an iris diaphragm, a shutter, an aperture, a pull-down a
film-transport mechanism, and a supply and take-up reel. Cine cameras are mostly used for complex c
cardiac catheterization); they are also used in some angiographic procedures and gastrointestinal exa
Dental materials designed to increase the adhesion of a completed dental impression to the tray upon
mouth. These dental materials usually consist of silicone-based adhesives and colorants that when ap
impression trays enhance the adhesion of dental impression materials. Dental impression material/tra
supplied in liquid form packaged in bottles. They are used in dentists' offices.

Dental casting materials, whose components are nonprecious metal alloys, designed to make a positiv
of the oral cavity using a mold previously taken at the dentist's office. These dental materials consist o
nonprecious metals (e.g., copper, zinc, tin, nickel). The materials are usually poured into a mold which
cavity of an appropriate shape to fit teeth and/or oral tissue, allowed to solidify and then ejected or br
complete the process. They are typically resistant to corrosion and tarnish and should be compatible w
Nonprecious casting materials are used in dental laboratories for inlays, frameworks for fixed prosthes
dentures, for restoration posts, dental cores, and splints.

Dental casting materials, whose components are precious metal alloys, designed to make a positive c
the oral cavity using a mold previously taken at the dentist's office. These dental materials consist of a
metals (e.g., gold, silver, palladium, platinum). The materials are usually poured into a mold which con
of an appropriate shape to fit teeth and/or oral tissue, allowed to solidify and then ejected or broken o
complete the process. Precious casting materials are highly resistant to corrosion and tarnish and shou
oral tissues. They are used in dental laboratories to make inlays, frameworks for fixed prostheses and
restoration posts, dental cores and splints.

Dental casting materials, whose components are metal alloys, designed to make a positive copy of a g
cavity using a mold previously taken at the dentist's office. These casting materials may be made of n
alloys. The materials are poured into a mold which contains a hollow cavity of an appropriate shape to
tissue, allowed to solidify and then ejected or broken out of the mold to complete the process. Dental
are typically resistant to corrosion and tarnish; they also should be compatible with oral tissues. Denta
materials are used in dental laboratories for inlays, frameworks for fixed prostheses and partial dentur
posts, dental cores, and splints.

Dental burs made of tungsten carbide that are usually intended for use with ultra-high-speed rotary d
These burs typically consist of a shank with a well-differentiated working head in a variety of sizes and
cylinder, inverted cone, pear) on the distal end; a tapered, notched, or elongated proximal end to fit in
and a neck that connects the shank to the working part. Dedicated carbide dental burs are available f
including removal of carious material from teeth, dental cavity preparation, and finishing and polishing
restorations (e.g., porcelain, metal). They are usually intended for reuse after sterilization, but disposa
carbide burs are also available.

Dental burs made of steel that are usually intended for use with low-speed rotary dental handpieces.
consist of a shank with a well-differentiated working head in a variety of sizes and shapes (e.g., cone,
cone, pear) on the distal end; a tapered, notched, or elongated proximal end to fit into the rotary devi
connects the shank to the working part. Dedicated steel dental burs are available for many different u
of carious material from teeth, dental cavity preparation, and finishing and polishing of teeth and rest
porcelain, metal). They are usually intended for reuse after sterilization, but steel burs rapidly become
dental enamel or other very hard materials.
A rotary cutting device, the working end of which is made from steel coated with small diamond crysta
fit into a dental handpiece and intended to cut hard structures in the mouth, such as teeth or bone. D
be used to cut hard metals, plastics, porcelains, and similar materials. Dental burs with a working hea
diamond chips or is covered with diamond film are usually intended for use with ultra-high-speed rota
These burs typically consist of a shank with a well-differentiated working head in a variety of sizes and
cylinder, inverted cone, pear) on the distal end; a tapered, notched, or elongated proximal end to fit in
and a neck that connects the shank to the working part. Dedicated diamond dental burs, either dispos
available for many different uses, including removal of carious material from teeth, dental cavity prep
and polishing of teeth and restorations (e.g., porcelain, metal); they are particularly useful to prepare
restorations.

Plunger syringes designed to introduce impression materials under high pressure during dental proced
typically consist of a barrel (e.g., octagon shaped), a screw-type plunger, and a threaded tip to attach
other syringes are all-plastic disposables. Impression-material dental syringes are used to obtain a neg
impression) of dental or related structures (e.g., dental arch), typically for construction or assembly of
denture.

Chairs that have lifting and rotating capabilities and usually include sections made of radiolucent mat
locked in any desired position to enable radiographic or fluoroscopic procedures.
Dental materials designed to make an accurate negative reproduction of a given area of the oral cavit
materials usually are inserted into the mouth while they are soft by means of a customized tray know
materials then become solid in a few minutes and when removed from the mouth retain the shape of
and/or soft (e.g., tongue, cheeks, gums) tissues. Dental impression materials unite into a solid mass w
oral tissues and most of them have dimensional stability. They flow at temperatures which do not inju
Dental impression materials include alginate, polyether and vinyl polysiloxane. They are used in denta
models for study and for production of restorative prosthetic dentures.

Dental impression materials with elastic and thermoplastic properties, whose main component is reve
hydrocolloid, designed to make an accurate negative reproduction of a given area of the oral cavity. T
materials consist of agar, water, chemicals (e.g., borax, potassium sulfate) and fillers that increase the
stiffness. Agar dental impression materials are usually supplied in plastic tubes or in plastic or glass ca
syringe. These dental impression materials are not frequently used in modern dental practices, althou
complex impressions in advanced restorative work. They are often used in dental laboratories to dupli
they can be reused many times.

Dental impression materials with elastic properties, whose main component is irreversible alginate hy
make an accurate negative reproduction of a given area of the oral cavity. These dental impression m
soluble alginate, reactors (e.g., calcium sulfate) which cause the alginate to gel, and retarders (e.g., s
sulfate) which prevent gelation from occurring too rapidly. Alginate dental impression materials with fa
available; dust free and/or antimicrobial alginate products are also available. These dental impression
in powder form, either in bulk or in measured portions packed in foil envelopes, pouches, or bags. The
offices for border molding, final impressions, partial and complete denture cases, and orthodontics.
Dental impression materials with elastomeric properties whose main component is polyether which is
accurate negative reproduction of a given area of the oral cavity. These dental impression materials co
(polyether), a cross-linking agent (e.g., sulfate), a catalyst (e.g., glycol-based plasticizer) and a filler (e
dental impression materials with fast setting time are available. They are less rigid for easier removal.
impression materials are supplied in bulk, cartridges, packages, and tubes; automix and autodispensin
available. They are used in dental offices for crowns and bridges, inlays and onlays, functional impress
abutments.

Dental impression materials with elastomeric properties whose main component is polysulfide. They a
an accurate negative reproduction of a given area of the oral cavity. These dental impression material
(mercaptan polysulfide), a cross-linking agent (e.g., sulfur and/or lead peroxide) and catalysts (e.g., co
peroxide, organic hydroperoxide). Polysulfide rubber-based dental impression materials with a fast set
These dental impression materials are supplied in paste form and are packed in tubes. They are used
crowns, bridges, inlays, and temporary denture relines.

Dental impression materials with elastomeric properties whose main component is silicone. They are d
accurate negative reproduction of a given area of the oral cavity. These dental impression materials co
(silicone), a catalyst (e.g., tin compounds), a reactor (e.g., alkyl silicate) and a filler (silica). Silicone ru
impression materials with a fast setting time are available; varying the amount of chemical reactors is
changing the setting time. These dental impression materials are supplied in paste or liquid form and
bottles, and cartridges. They are used in dental offices for fixed partial prosthodontics, quadrant inlay,
impressions

Dental equipment designed to dislodge plaque, calculus, and stain from teeth. These devices typically
electronic unit that includes a generator that may operate at sonic (6 kHz is typical) or ultrasonic frequ
kHz), a water spray, a handpiece with a probe that includes interchangeable specialized tips (e.g., uni
sickle [for fine debridement and/or sensitive teeth]), a switch, and a cable to connect the handpiece to
prophylactic units are intended for preventive dentistry; they are used for prophylactic periodontal, pe
orthodontic procedures. Dedicated units using sonic and/or ultrasonic frequencies are available.

Dental prophylactic units designed to dislodge plaque, calculus, and stain from teeth using ultrasonic
typically consist of an electronic unit including a radiofrequency generator that operates at frequencie
water spray, a handpiece with a probe that includes an ultrasonic transducer and interchangeable spe
universal, periodontal, sickle [for fine debridement and/or sensitive teeth]), a switch, and a cable to co
to the generator. Ultrasonic dental prophylactic units are intended for preventive dentistry; they are u
periodontal, pedodontic, and orthodontic procedures.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
rigid or flexible appliances that overlay the occlusal surfaces of the teeth (i.e., dental splints). Items in
include a fiberglass ribbon soaked in a bonding agent and metal application clips; they may also inclu
kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed rec
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Occlusal splinting kits and trays are used mainly to maintain the position of displaced or mo
treat clenching and bruxism. Occlusal splints are usually fixed originally at the dental offices and then
either continuously or during sleeping. Devices intended only for treatment of snoring and/or sleep ap
orthoses.

Dental materials designed to be placed on the teeth to provide stabilization and immobilization (i.e., s
protect teeth from grinding or moving out of place. These dental materials usually consist of stainless
cure composites, or modeling compound that are bonded to teeth in clinical applications. This helps ke
that may have been replanted or have fractured roots. Dental splinting materials should have physica
the dentist to curve and manipulate them into the desired shape; they should not have memory as re
Splinting materials are used in dentists' offices where tooth stabilization is required.

Angled connectors that attach to dental handpieces at their proximal end and that have special coupli
that connect to prophylactic tools (e.g., prophylaxis brushes or cups) to facilitate access to the teeth.
usually made of sturdy plastics (which are disposable) or metal (which are reusable), and some are lat

Dental materials designed to clean and polish teeth by the dental care staff. These dental materials u
semisolid mixture (i.e., a paste or cream) comprising several abrasive compounds; some dental paste
their preparation. Prophylaxis pastes usually start out coarse and gradually break down into smaller p
resulting in less abrasion to the dentin and enamel; they provide a high-luster enamel polish. Prophyla
available in different levels of coarse formulation (e.g. extra, medium, and fine); they are usually supp
in boxes. They are used in dentists' offices for prophylactic treatments.

Dental pins designed for insertion in the healthy dentine of a tooth to provide retention and/or stabiliz
for dental restorations. These pins are typically small-diameter metal (e.g., stainless steel, titanium) c
range of 1.0 to 3.2 mm (0.04 to 0.125 inch) that are inserted in a previously drilled hole in the tooth a
cement and/or threading or friction. A cylindrical hole with a beveled top is predrilled in the tooth to re
end of the pin; pins with a diameter larger than the accommodating hole may be fixed by friction alon
the pin provides a surface for securely attaching the restoration (e.g., a reconstructed coronal portion)
devices intended for insertion into the root canal are called dental posts.
Prepackaged collections (either custom or standard) of devices and supplies needed for providing rete
stabilization of dental restorations. These kits usually include retention pins of several sizes (e.g., 2.0,
0.1, 0.12 inch), a variety of dental burs and drills, and a tool with a socket that provides a flat surface
manipulating the pin (i.e., a manual pin driver). A cylindrical hole with a beveled top is predrilled in th
threaded end of the pin; the pin provides at the other end a surface for securely attaching the restora
reconstructed coronal portion to the tooth). Sometimes unthreaded pins with a diameter larger than th
accommodating hole are fixed by friction alone. Dental retention procedure kits and trays are used for
of pins in the healthy dentin, providing retention and/or stabilization of dental restorations. They are u
offices.

Cement dental materials, whose main component is ethoxy benzoic acid, designed to produce a mech
effect upon hardening inside the mouth. These cements usually consist of a basic powder (zinc oxide,
an acidic liquid (ethoxy benzoic acid) that are mixed together in a viscous paste immediately before u
mass. Ethoxy benzoic acid cements have proper thermal and chemical resistance in the oral environm
resistant to dissolution in oral fluids, and non-irritating to pulp and gingiva. These cements are used in
sedative bases and for temporary restoration.

Cement dental materials, whose main components are an aqueous polyalkenoic acid and a glass com
produce a mechanical interlocking effect upon hardening inside the mouth. These cements usually co
acid-soluble calcium fluoro-aluminosilicate glass) and an acid liquid (e.g., tartaric, itaconic, maleic) th
in a viscous paste immediately before use, setting to a hard mass. These cements should be resistant
fluids, and non-irritating to pulp and gingiva. Glass ionomer cements have anticariogenic properties d
fluoride; they have proper thermal and chemical resistance in the oral environment. Metal-reinforced a
glass ionomer cements are also available. Glass ionomer cements are used in dentists' offices as lutin
as intermediate bases under restorations and for restoring pits and fissures.

Cement dental materials, whose main components are zinc oxide and polycarboxylic acid, designed to
interlocking effect upon hardening inside the mouth. These cements consist of a basic powder (zinc, m
oxides and an acidic liquid (polyacrylic, itaconic) that are mixed together in a viscous paste immediate
to a hard mass. Polycarboxylate cements have proper thermal and chemical resistance in the oral env
be resistant to dissolution in oral fluids, and non-irritating to pulp and gingiva. They are used in dentis
cementing medium of cast alloys, porcelain restorations and orthodontic appliances, as a cavity liner,
base under restorations, or as temporary restorative materials.

Zinc oxide eugenol (ZOE) cements dental material, with hydrogenated resins added, designed to prod
interlocking effect upon hardening inside the mouth. ZOE cements consist of a powder (zinc oxide), a
plasticizer (vegetable or mineral oil) and resins (polymethyl methacrylate) that are mixed together in
immediately before use, setting to a hard mass. Reinforced ZOE cements have significantly higher str
ZOE cements; they also have anesthetic and antibacterial properties, low thermal conductivity, and ar
and gingiva. They are used in dentists' offices for minor restoration (e.g., fractured teeth, lost restorat
pulpitis) and as temporary cementing medium and pulp capping.
Cement dental materials, whose main components are polymeric resins, designed to produce a mecha
effect upon hardening inside the mouth. These cements consist of polymethyl methacrylate, silica pow
that are mixed together in a viscous paste immediately before use, setting to a hard mass. Resin com
good esthetics, proper thermal and chemical resistance in the oral environment, mechanical strength,
storage stability; they also should be resistant to dissolution in oral fluids, and non-irritating to pulp an
used in dentists' offices to attach ceramic or resin inlays and onlays, veneers, or metal restorations to
used as cementing medium of orthodontic appliances (e.g., bands, brackets).

Cement dental materials, whose main components are silicate and zinc phosphate, designed to produ
interlocking effect upon hardening inside the mouth. These cements consist of calcium silicate, wollas
acid, and dissolved metallic ions (e.g., zinc, aluminum) that are mixed together in a viscous paste imm
setting to a hard mass. Silicophosphate composite cements have good esthetics, proper thermal and c
the oral environment, mechanical strength, workability, and storage stability. They are used in dentist
restorative materials and as cementing medium of orthodontic appliances (e.g., bands, brackets), for
and also for porcelain crowns.

Cement dental materials, whose main components are zinc oxide and eugenol, designed to produce a
interlocking effect upon hardening inside the mouth. These cements consist of a powder (zinc oxide),
a plasticizer (vegetable or mineral oil) that are mixed together in a viscous paste immediately before
mass. Zinc oxide eugenol cements have antibacterial properties, low thermal conductivity and are non
gingiva. They are used in dentists' offices for minor restorations (e.g., fractured teeth, lost restorations
pulpitis), as temporary cementing medium, and for pulp capping.

Cement dental materials, whose main components are phosphoric acid and zinc oxide, designed to pr
interlocking effect upon hardening inside the mouth. These cements consist of a basic powder (zinc ox
(phosphoric acid), and water that are mixed together in a viscous paste immediately before use, settin
phosphate cements have proper thermal and chemical resistance in the oral environment; they also s
dissolution in oral fluids. Zinc phosphate cements must be placed on a dental cavity liner or sealer to
They are used in dentists' offices as cementing medium of inlays, crowns, bridges and orthodontic app
brackets), as intermediate bases, or as temporary restorative materials.

Amalgam restorative dental materials in capsule form designed to be used as metallic fillings for in sit
appearance, structure and/or function of a patient's teeth. These amalgam restorative dental material
of liquid mercury and high compressive strength alloys whose main constituents are silver, tin, and co
contain zinc which therefore minimizes the risk of fracturing the restoration. The metal powder and m
appropriate portions, but separated in the capsule. The user activates the capsule thereby mixing the
in a convenient and safer way to mix the constituent components. Amalgam restorative dental materi
capsules ensure a long lasting restoration and their sufficient condensation enables an easy way of pa
adhere to tooth structure without the aid of cements or techniques which lock in the filling; these ama
dental materials are strong, resistant to wear, malleable, durable and are usually placed on the rear m
metallic color is not an aesthetic match with natural tooth enamel. They are used in dentists' offices.
Amalgam restorative dental materials in tablet form designed to be mixed with liquid mercury and us
for in situ restoration of the appearance, structure and/or function of a patient's teeth. These amalgam
materials consist of a mixture of liquid mercury and high strength alloys whose main constituents are
they do not contain zinc and therefore minimizes the risk of fracturing the restoration. Amalgam resto
supplied as tablets ensure a long lasting restoration and do not adhere to tooth structure without the
techniques which lock in the filling. These amalgam restorative dental materials are strong, resistant t
durable, and can be triturated by hand or used by amalgamators; the amalgam is usually placed on th
metallic color is not an aesthetic match with natural tooth enamel. They are used in dentists' offices.

Amalgam restorative dental materials in powder form designed to be mixed with liquid mercury and u
for in situ restoration of the appearance, structure and/or function of a patient's teeth. These amalgam
materials consist of high strength powder alloys with irregular particle shape whose main constituents
copper; they do not contain zinc which therefore minimizes the risk of fracturing the restoration. Amal
materials supplied as powder ensure a long lasting restoration and do not adhere to tooth structure w
cements or techniques which lock in the filling. These amalgam restorative dental materials are strong
malleable, durable, and can be used in dispensing amalgamators without clogging and agglomeration
dental materials are usually placed on the rear molars since their metallic color is not an aesthetic ma
enamel. They are used in dentists' offices.

Dental materials designed to safely remove stains, deposits, and debris from the surfaces of dentures
materials consist of a variety of products that by means of immersion and/or brushing of the dentures
and remove food particles that can cause gum irritation. Denture cleansers are supplied in paste, pow
tablet form; they keep dentures clean and fresh. They are mainly used by denture wearers for persona

Respiration monitors designed for continuously measuring and displaying information on the tempera
the ventilation artificial airway (e.g., inspiratory limb, Y-piece). These monitors are hard-wired at the b
consist of a central unit with electronic circuits that can process data from temperature sensors attach
airways and a display. They typically also include a transducer, a cable, alarms (audible and/or visual)
sensor. Artificial airway temperature monitors provide real-time information on the temperature of gas
under assisted ventilation, especially when a heated humidifier is incorporated in the inspiratory line o
circuit.

Portable stretchers that consist of a cradlelike structure ("basket") to carry the patient. These stretche
metallic or plastic frame, suspension bridles, an oblong plastic shell used as the basket, straps to secu
adjustable footrest. Basket stretchers are used to move patients to or from high places and/or over de

Testers designed to assess the performance of infusion pumps; they can accurately measure, evaluate
record a set of pump variables (typically output flow, volume delivery, and occlusion pressure needed
alarms). Some testers can assess additional pump characteristics, such as keep-vein-open flow and lo
testers usually consist of a computerized electronic unit, measuring devices (e.g., volume, flow, press
and a recorder. Infusion pump testers are used to test general-purpose, syringe, and ambulatory infus
testers can measure several channels simultaneously and/or perform the small-volume bolus measure
assess patient-controlled analgesic pumps. Infusion pump testers may be manually operated or user p
automatic test protocols for a specific model of infusion pump.
Restorative dental materials designed to be used as plastic fillings for in situ restoration of the appear
function of a patient's teeth. These restorative dental materials consist of a synthetic organic resin ma
particles (e.g., glass, quartz, silica) acting as fillers are dispersed. Composite resin restorative dental m
in a single-paste or in a two-paste system. They are usually strong, durable, easy to manipulate and s
restorative dental materials are placed in highly visible areas (e.g., the central incisors or any other te
when smiling) or in areas where conservation of tooth structure is a top priority. Heat-cured, self-cured
composite resin restorative dental materials are available. They are used in dentists' offices.

Composite resin restorative dental materials designed to be used as plastic fillings, for in situ restorat
structure and/or function of a patient's teeth and require an activator and a catalyst to activate polym
composite restorative dental materials consist of a synthetic organic self-polymerizable resin matrix in
particles (e.g., glass, quartz, silica) acting as fillers are dispersed. Self-cured composite resin restorativ
supplied in a two-paste system (activator and catalyst); both pastes are mixed in appropriate proporti
solid resin without the use of external heat. They are usually strong, durable, easy to manipulate and
in highly visible areas (e.g., the central incisors or any other teeth that can be seen when smiling), in
where conservation of tooth structure is a top priority or in areas inaccessible to light. They are used i

Composite resin restorative dental materials designed to be used as plastic fillings for in situ restorati
structure and/or function of a patient's teeth and require heat to activate polymerization. These comp
materials consist of a synthetic organic heat-polymerizable resin matrix in which a blend of particles (
silica) acting as fillers are dispersed. Heat-cured composite resin restorative dental materials are supp
system that is polymerized in situ by the application of heat. They are usually strong, durable, easy to
shape, and are placed in highly visible areas (e.g., the central incisors or any other teeth that can be s
in areas where conservation of tooth structure is a top priority. Heat-cured composite resin restorative
used in dentists' offices.

Restorative dental materials designed to be used as resin-based sealants for in situ restoration of the
and/or function of a patient's teeth. These restorative dental materials typically consist of resins that d
additional modifiers such as fillers, colorants, dispersants, plasticizers, wetting agents, levelers, or def
restorative dental materials can be light-cured supplied in a single-paste system that is polymerized in
application of ultraviolet or visible light; they can also be self-cured supplied in a two-paste system po
resin without the use of external heat. Unfilled resins are easy to manipulate and shape, and are usua
occlusal surfaces of posterior teeth to seal their irregularities (i.e., pits and fissures) preventing the ca
used in dentists' offices.

Dental materials whose main component is an acrylic resin designed for use in manufacturing and/or
(i.e., denture rebase). These dental materials usually consist of polymethyl methacrylate or dimethacr
dimethacrylate) composite resins, usually obtained by mixing an acrylic monomer liquid with acrylic p
fillers. Denture base resins usually resemble natural tissue coloration and have resistance to flexure fa
present in the oral environment; they are available in different esthetic shades. Denture-base resins a
packages or single-unit packets. They are used in dental laboratories usually to perform a major repai
(i.e., replace all the denture plastic material but the teeth).
Denture base resins that need heat during the polymerization process. These resins usually consist of
of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethyl methacr
mixed with a catalyst such as benzoyl peroxide (typically supplied as a liquid); reinforcing fillers may b
to increase its strength and/or durability. Heat-cured resins used for denture bases should be biocomp
oral cavity fluids, provide good mechanical and esthetic properties, and should be also easy to repair.
dental laboratories.

Denture base resins that polymerize after the addition of the catalyst without the addition of heat (i.e.
cold-cured). These resins usually consist of an acrylic monometer of methyl methacrylate (typically su
that becomes a polymer (polymethyl methacrylate or PMMA) when mixed with a catalyst such as benz
supplied as a liquid); reinforcing fillers may be included in the resin to increase its strength and/or dur
resins used for denture bases should be biocompatible and resistant to oral cavity fluids, provide good
esthetic properties, and should be also easy to repair. They are used in dental laboratories.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
appearance, structure and/or function of teeth. Items in these kits usually include a dental syringe or
pad, brushes, and filling materials. The kits are frequently supplied in supporting trays (i.e., procedure
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Restorative procedure kits and trays are used in
dental restoration. Dedicated restoration dental kits using several different materials, such as compos
available.

Prepackaged collections (either custom or standard) of the equipment and supplies needed for crown
(i.e., attachment) on natural teeth. Items in these kits usually include tips, finishing discs, polishing pa
and a tips gun. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Crown and bridge fixation procedure kits and trays are intended
in dental offices.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
appearance, structure and/or function of teeth. Items in these kits usually include a dental syringe, a m
mixing pad, brushes, and composite resin. The kits are frequently supplied in supporting trays (i.e., pr
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Composite resin restorative proc
are used in dental offices for dental restoration in highly visible areas (e.g., the central incisors or any
be seen when smiling) or in areas where conservation of tooth structure is a top priority.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
appearance, structure and/or function of a patient's teeth, requiring heat to activate polymerization of
Items in these kits usually include a dental syringe, a mixing palette, a mixing pad, brushes, and heat
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure. He
resin restorative procedure kits and trays are intended for use in dental offices for dental restoration in
(e.g., the central incisors or any other teeth that can be seen when smiling) or in areas where conserv
is a top priority.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
appearance, structure and/or function of a patient's teeth, requiring light to activate polymerization of
Items in these kits usually include a dental syringe, a mixing palette, a mixing pad, brushes, and light
they may also include liquid etching products and a shade guide. The kits are frequently supplied in su
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Light-cured compos
procedure kits and trays are intended for use in dental offices for dental restoration in highly visible ar
incisors or any other teeth that can be seen when smiling) or in areas where conservation of tooth stru

Prepackaged kits (either standard or custom) containing the resins and other devices and/or materials
and manufacture complete or partial removable dental prosthesis (i.e., denture) bases. These kits usu
to the resin monometer (typically an acrylic monometer of methyl methacrylate), a catalyst intended
the monometer and products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). Den
used in dental laboratories; dedicated kits are available both with resins that polymerize when heat is
resins) and with resins that polymerize without the addition of heat (i.e., self-cured, also called cold-cu

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
damaged and/or fractured porcelain dental restorations, artificial teeth, and metal-ceramic crowns. Ite
usually include an opaque agent, a porcelain etching gel and a porcelain primer; they may also includ
instruction manual. The kits are frequently supplied in supporting trays (i.e., procedure trays) consistin
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Dental porcelain procedure kits and trays are used mainly in de
the repair of ceramic-based prostheses.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
appearance, structure and/or function of teeth using unfilled resins. Items in these kits usually include
mixing palette, a mixing pad, brushes, and unfilled resin. The kits are frequently supplied in supportin
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Unfilled resin restorative
kits and trays are used in dental offices for minor dental restoration.

Prosthetic devices designed for total or partial implantation into oral tissues to provide retention and s
removable dental prostheses (i.e., dentures), working as an artificial tooth root. Dental implants are us
resembling a screw and made of alloplastics (e.g., metal) materials; titanium (and/or titanium alloy) is
used metal due to its ability to become incorporated in the bone structure (i.e., fused to the bone, kno
osseointegration). Dental implants are usually surgically embedded in the bone and work as a dental
fixed or removable dental prostheses (i.e., dentures); when used to support a single tooth, the post to
tooth attaches is fixed to the implant. Dedicated dental implants may be intended for placing in the b
passing through the bone (i.e., transosteal), or resting on top of the bone (i.e., subperiosteal); dental i
or partially supported by gingival tissue are also available. Dental implants are available in a variety o
including implants appropriate for individual teeth, several teeth (i.e., fixed partial prostheses, also kn
denture support.
Susceptibility microbiological analyzers that require the human manipulative effort in all steps of each
preliminary screening, culture preparation, incubation, insertion of reagents and samples, panel readin
patterns, and recording of results. These analyzers typically use either broth-based or disk diffusion m
these analyzers may include automated data entry and/or automated data interpretation using a com

Point-of-care whole blood analyzers designed primarily to detect abnormalities in the components req
normal blood clotting. Most analyzers perform at least one or more of the following assays on whole b
clotting time (ACT), activated partial thromboplastin time (WBAPTT), prothrombin time (WBPTT), recal
heparin dose response, heparin/protamine titration, and high-dose thrombin time (HiTT).These analyz
mechanical impedance, or electromagnetic techniques (or sometimes combinations of techniques) to
process. Whole blood point-of-care coagulation analyzers are used to detect clotting deficiencies and t
of drugs (e.g., heparin) and of blood component therapy.

Tables with a rectangular table top in which three-dimensional movement can be controlled either ma
for fast and accurate patient positioning. These tables may include removable panels, allowing treatm
table. Most tables include head, arm, and foot rests and breast boards. These tables support the pati
position during radiotherapy procedures and are used typically in treatments based on Cobalt-60 or lin

Bags designed for the storage and processing of red blood cells in blood cell transfusion washers. The
consist of a flexible plastic (usually polyvinyl chloride [PVC]) container of either 800 or 1,000 mL capa
bags are opened and submitted to a centrifugation and saline washing procedure to separate red bloo
After the washing cycles are finished, other bags containing packed washed red cells are stored for tra
should be used within 24 hours.

Lithotripters that noninvasively disintegrate stones using focused external shock waves. These device
shock-wave generator, an examination/treatment table, an imaging system, and a control console. Sh
delivered through a treatment head consisting of an enclosed, water-filled cylinder that protrudes thro
table and has a cushion that touches the patient's skin. An ellipsoid or acoustic reflector focuses the s
stone as the waves travel through the water and the patient's body. Some older units utilize a water b
examination/treatment table. Extracorporeal lithotripters are intended for the treatment of urolithiasis
also known as kidney stones); lithotripters of several different technologies, such as those using elect
piezoelectric, and spark-gap generators are available. Some extracorporeal lithotripters may be used
stones.

Humidifiers designed to add moisture to the air in a closed room environment. These humidifiers typic
equipment that may use one of a variety of different technologies, including: (1) ultrasonic humidifier
nebulizer; (2) evaporative humidifiers using a fan to blow air over a wet wick; (3) rotating disk (centrif
humidifiers include sensors and controls to regulate the humidity in the environment. Room humidifie
in three configurations, i.e., tabletop, mobile consoles, and in-duct installation.; they are used in healt
hospitals and nursing homes and also at home to help in the prevention of dryness in the airways and
especially for babies, the elderly, and patients with serious illness.

Paper intended for placing on examination tables, providing a clean contact surface for patients. Exam
usually consists of a single-use (i.e., disposable) sheet of light color smooth or crepe paper. The paper
is available in different lengths and widths for different types of examination tables (e.g., adult or child
chiropractic examination tables).
Nursing bottle nipples are usually silicone or latex devices designed to mimic a female nipple and are
feeding of infants. They have wide bases and various nipple sizes based on the age and/or size of the
with nursing bottles to deliver expressed breast milk, formula or other liquid (i.e., water) to infants. Th
disposable and are available in different flow speeds (i.e., slow, medium), limiting how quickly babies
other liquids, in an effort to help prevent chocking and colic.

Monitors designed for continuous measurement and display of the cerebrospinal fluid (CSF) pressure i
the meningeal membranes and are hard-wired to the patient at the bedside. These monitors typically
computerized electronic unit for data processing, a display, pressure transducers (e.g., strain gauge, fi
interface cable. Bedside intracranial pressure monitors can measure directly within one of the brain ve
(intraventricular), beneath the duramater (subarachnoid), or outside the duramater (epidural); they ar
cranial trauma or surgery and also in some hydrocephalic patients.

Monitors designed for continuous measurement and display of blood pressure values that are hard-wir
the bedside. These monitors typically include sensors, a processor, and a display. Blood pressure mon
of the electrical signals from the sensor as maximum and minimum values of blood pressure (i.e., syst
pressures); most monitors also display a mean pressure calculated from the measured values using an
pressure monitors using invasive or external (noninvasive) sensors are available, and are known as in
(IBP) and non-invasive blood pressure (NIBP) respectively.

Nonrefrigerated low-speed tabletop centrifuges used to concentrate cells and other components of bio
fluid matrix onto a glass microscope slide. They are particularly useful for slide preparations from spe
fluid-to-cell ratios. These centrifuges use dedicated rotors and trunnion carriers, and they usually allo
select the acceleration rate (low, medium, or high) according to the specimen characteristics.

Adhesive strips designed for a variety of different applications, including to cover small wounds and to
other small devices (e.g., intravenous catheters) to the skin. These strips typically are short (usually le
cm) in length and narrow (typically 1 to 2 inches/2.5 to 5 cm) flexible strips evenly covered on one sid
sensitive adhesive. The strips are usually made of cloth (e.g., cotton), plastic, paper, and/or other mat
include a central wound pad. Multipurpose adhesive strips are intended for single use (i.e., disposable
supplied in precut sizes and/or shapes that may be packaged sterile. Adhesive strips with hypoallerge
antimicrobial properties are available.

Analyzers designed to measure and display the amplitudes of the sinusoidal components of a signal a
frequency (i.e., frequency domain representation or spectrum). These analyzers are electronic instrum
combination of a heterodyne radio receiver, a signal strength meter, and a graphic plotter or display;
meter reading (amplitude) versus the frequency as the receiver is tuned from one end of the band to
analyzers may be used to analyze or check the spectrum of bioelectrical or medical device signals and
electromagnetic interference (EMI) coming from other equipment and/or from natural sources (e.g., th
spectrum analyzers perform real-time spectrum analysis with high accuracy and resolution using digit
techniques based on the fast Fourier transform (FFT); they are especially useful when low-frequency (
or very fast measurements are needed (e.g., speech analysis).
Small pieces of thin metallic wires, typically U-shaped, that are appropriate for mechanically fastening
staples are made of stainless, non-absorbable, biocompatible metals (e.g., stainless steel, chromium,
alloys; they are available in several different shapes and calibers according to the intended use (e.g.,
Staples are used in surgery to join many types of organs and tissues, especially in the anastomosis of
as the gastrointestinal tract and vasculature; other staples are used for skin wound closure. Most stap
dedicated instruments (e.g., staplers, drivers). Stapling is generally faster and produces less tissue tra
suturing techniques.

Large volume reservoirs for temperature controlled liquid bath with smoothly operating shaking mech
designed for a variety of reactions requiring either, or both, agitation and incubation -- enzyme reactio
incubations, tissue cultures, fermentations, extractions, dialyses, etc.
Laboratory analyzers dedicated to measure lactate in the body fluids (usually in plasma, serum, whole
cerebrospinal fluid). Most lactate analyzers use amperometric methods (electric current is measured t
electrochemical cell, while a constant electric potential is applied to immobilized enzyme electrodes).
used in the clinical laboratory (and also in STAT labs) to determine lactate acidosis and assess other d
cerebrovascular accidents and decreased liver perfusion.

Needles designed for aspirating fluids from cavities, cysts, and wounds. These devices typically consis
needles, either with sharp or blunt tips, and opposite ends that include a female Luer slip or Luer-lock
a syringe or other collection/aspiration device.
Prepackaged collections of the devices and supplies (either custom or standard) needed for providing
the subarachnoid cerebrospinal fluid space. Items in these kits usually include needles (e.g., lancet po
wheal, withdrawal), syringes, a needle stick pad, a procedural filter, anesthetics (e.g., lidocaine), epine
applicators, towel(s), gauze sponges, a fenestrated drape, and antiseptic solution. The kits are frequen
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
block anesthesia kits and trays are intended for use in a nerve block limited to the regions correspond
the buttocks, and the inner aspect of the thighs during diagnostic and/or therapeutic procedures.

Flotation balloon cardiac catheters designed to be wedged into a pulmonary artery branch. These cat
of a multilumen, soft, flexible body and a balloon tip that is inflated when the distal tip is in a thoracic
carries it into the right atrium, through the tricuspid valve and the right ventricle, into the pulmonary
pulmonary artery branch; they typically also include a thermistor. Pulmonary artery catheters are used
atrial, pulmonary arterial, and pulmonary capillary wedge pressures, to monitor pulmonary artery tem
blood samples from the atrium and pulmonary artery, to administer drugs, and to infuse thermal indic
cardiac output measurement using the thermodilution method.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
catheter into the bladder via the urethra for an extended period of time. Items in these kits usually inc
catheter with a small balloon on the end to keep the catheter securely in the bladder (e.g., a Foley cat
bags, urine flow meters, urine drainage tubing, fenestrated drape, germicide, underpads, a specimen
gloves, cotton/rayon balls, forceps, prefilled sterile water inflation syringe and lubricant. The kits are f
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
urinary catheterization procedure kits and trays are intended for collecting and/or measuring the urine
during long-term procedures. They are used in hospital and healthcare facilities.

Cannulae that are inserted into a ventricle of the heart during cardiopulmonary bypass surgery to dec
pressure in the left ventricle. These semirigid or rigid cannulae are usually made of plastic (polymers)

Disposable kits that typically consist of a nebulizer to generate the radioactive aerosol, several one-w
flow of aerosol to the patient, transport tubing to carry the aerosol from the nebulizer to the patient, a
bacteria filter to trap any exhaled aerosol.
Mobile stretchers designed to permit one attendant (e.g., nurse, aide) to transport a recumbent patien
facility. These stretchers typically consist of a patient platform (may be height adjustable) mounted on
cm (8 in) diameter. Most hospital stretchers provide mattresses to improve patient comfort, adjustable
patient falls, straps to restrain patients, and provisions for attaching and/or storing accessories require
intravenous poles, oxygen tanks). Mobile hospital stretchers are also frequently used as treatment tab
recovery, and labor rooms; they are also used as beds in intensive and specialized care units and as h
disasters and other high patient census conditions.

Handheld instruments designed for removing staples from the skin. These removers typically consist o
two-handle, pivoted, tonglike instrument ended in a fine point. Staple removers permit a quick remov
minimal trauma.
Devices that consist of a container for mechanically agitating a denture cleansing solution. These dev
use to clean dental prosthetic appliances such as dentures or bridges.
Flow regulators designed to control the infusion rate through gravity intravenous administration infusi
regulators typically consist of a mechanism that regulates the flow using a calibrated dial that permits
rate in a given range (e.g., from a few to 250 ml/h); the regulators may also include a lateral clamp fo
interruption of the infusion or a check valve to permit parallel infusion. Dial-calibrated flow regulators
gravity infusion administration sets; some are available as an integral component of the gravity infusi
tubing set.

Solutions prepared for peritoneal dialysis for exchange of solutes below a certain molecular size (dete
threshold of the membrane material) across a semipermeable membrane (i.e., the peritoneum). The t
peritoneum differs from patient to patient.
Prefabricated self-standing columns that are designed to organize the utility services (e.g., electrical,
devices at the head of the patient's bed. These columns are usually factory-made, pre-wired and pre-
manufactured from a standard system of components. Most service columns have a rectangular cross
the need for individual installation of services and afford nearly 360-degree access to the patient. A t
oxygen, air, and vacuum station outlets; electrical power receptacles; provision for nurse call and code
jacks; physiologic monitor support brackets; and various types of lighting (ambient, reading, exam, n

Nasoenteral tubes designed to provide access to the small intestines for enteral feeding. These device
single- or dual-lumen plastic tube that has a diameter and length appropriate to reach the duodenum
inserted through the nose, down the throat, through the esophagus and stomach, and into the duoden
nasoenteral tubes are mainly used in patients who have intolerance for gastric feeding (gastroparesis
used occasionally to remove air and liquids from the stomach and/or duodenum.

Eye charts designed to be used in measuring visual acuity using a sheet of paper on which rows of sta
different sizes are printed. The symbols can be shaped letters (e.g. block letters, letter E), numbers, o
Visual acuity is measured by the smallest row of symbols a person standing at a certain distance can i
marked with a distance value). Projectors or monitor screens indicating the ophthalmic symbols are a
purpose. Visual acuity eye charts are used mainly for vision screening in healthcare facilities, at ophth
in the field.

Eye charts designed to be used in the detection of color blindness by means of a special chart on whic
dot patterns are depicted. The devices usually consist of a plate containing several symbols made of c
(e.g., numbers, letters, geometric shapes ) on a background of dots in randomly mixed colors (e.g., Ish
patterns are visible to those with normal vision and are invisible to those with color vision deficiency (
tritanopia, deuteranopia). Color discrimination eye charts are used mainly for vision screening in healt
ophthalmologist offices, and in the field.

Tubing and one-way valves designed to provide a flow of oxygen and/or air to ventilator patients initia
between controlled breaths. They are typically constructed of plastic and are used with older model v
built-in intermittent mandatory ventilation mode.
Surgical knives designed for cutting fibrous connective tissue (i.e., cartilage). These knives consist of
handheld instruments usually with a wide straight tubular handle and a long, flat, stiff cutting blade at
knives frequently have concave U-shaped guards. The handle may be finished in a perpendicular plate
to facilitate hitting with a mallet. Cartilage knives are mainly used in orthopedic procedures.

Devices designed to dispense liquids by combining several liquid components in a given ratio from a s
into a final product container. These compounders are frequently automated or semiautomated device
standardized source containers each attached with plastic tubes to the compounding device. The outp
device is, in turn, attached to the final liquid container; the compounder may also include a control pa
manual or bar-coded introduction of mixing and/or checking instructions. Compounders are mainly use
other healthcare facilities to dispense drugs according to specific medical prescriptions.
Instruments designed to measure and/or obtain preestablished concentrations of gases in liquids (e.g.
exposing samples to an ambient gas phase in such a way that each gas reaches equilibrium between
phase. These devices typically work using one of two techniques: (1) The thin-film technique use a hu
at a constant temperature (usually 37 degrees C/98.6 degrees F), a glass or plastic rotary cup fitted in
chamber, a timer, and controls; the cup rotates in short bursts while flushed with the humidified gas f
the liquid (e.g., blood) in the cup to form thin layers on the inside of the cup; (2) The bubble technique
syringe that allows gas to be introduced into and humidified through the plunger, a gas line, and a the
controlled heat block to keep the syringe at a constant temperature. A sample is loaded into the syrin
initiated from the gas line to the plunger; the gas bubbles through the blood in the syringe to the atm
tonometers are also used in research, to prepare blood samples for special tests that are not frequent
hospitals, and to prepare blood samples for quality control of devices (e.g., oxygen and carbon dioxide
measure blood gas samples.

Measuring instruments designed to determine intraocular pressure. These instruments may use sever
applanation, indentation, and noncontact (air puff) tonometry. Tonometers can be attached to a slit lam
handheld devices are also available. Ophthalmic tonometers are mainly intended for assessing ocular
(intraocular pressure between 10 and 24 mm Hg is considered normal), usually to screen patients for

Pitchers designed for the safe and easy handling of melted paraffin. These devices typically consist of
that is open at the top and a pouring pitcher appropriate for placement inside the thermal unit. The th
a cylindrical double-wall metallic (typically stainless steel) jacket enclosing an internal chamber, as we
element coiled between the walls to ensure even temperature distribution. It also includes a thermost
paraffin at the desired viscosity, a handle, and rubber legs at the bottom. The pouring pitcher is made
metal and a visible volume scale. Paraffin pitchers are used mainly in clinical laboratories for embeddi
amounts of paraffin (typically to perform histological studies) while maintaining a complete control of

Combinations of preassembled disposable devices designed to process blood in apheresis units. These
tubing, needles, and collection bags; they may also include the solutions used in the procedure (e.g.,
Blood pheresis sets are available as closed sets with all components and products preattached or as o
do not include the solutions needed for the process.
Blood-collection and centrifugation tubes designed to remove fibrin from the serum portion of blood s
typically are glass or more frequently shatter-resistant plastic tubes that have filtering capabilities, su
or gels applied to the internal walls to provide a barrier that separates fibrin and other particulates fro
separation tubes are intended to avoid second centrifugation and secondary sample preparation and/
tubes are available for use in angle-head or horizontal-head centrifuges. They permit direct sampling
laboratory devices from primary collection tubes.

Laboratory urine analyzers used to detect bacteria and estimate their concentration in urine specimen
detection analyzers use a luminometer to measure light emitted in certain biochemical reactions. As
proportional to the amount of bacteria in the sample, the luminometer reading indicates the concentr
results are usually expressed in relative light units (RLU). These analyzers provide rapid screening for
performing lengthy and expensive culturing procedures. Urine bacteriuria analyzers are used to asses
disease in the kidneys, the urinary bladder, or the urinary tract, which is one of the most common typ
Timers designed to measure the duration of each step of cleaning and disinfection of the hands and a
scrub station. These timers consist of time measuring instruments that may use mechanical, electrom
technologies and audible signal generators (e.g., buzzers) to indicate that the time needed for a partic
operation has elapsed; some timers may include outputs to the control circuits that operate the water
lamps, or other station devices. Scrub station timers are frequently an integral part of the station.

Nonrefrigerated low-speed tabletop centrifuges designed to automatically wash, decant, mix, and rew
from a blood sample with little or no sample preparation. These centrifuges are used before an antiglo
standardized blood bank assay for detecting most antibodies that are implicated in transfusion proble

Temperature recorders designed for continuous measurement and recording of the temperature inside
laboratory equipment components and/or products undergoing in-vitro diagnostic tests. These recorde
local or remote central unit that stores the information for later review, and a set of sensors, transduc
intended to be placed inside laboratory equipment (e.g., refrigerators, freezers, ovens) and/or into liqu
semisolids undergoing testing and/or during storage. The probes and sensors may be wired or wireles
recording unit. A great variety of temperature sensors and probes intended for specific laboratory equ
are available.

Hematology blood-grouping analyzers used to perform blood-grouping tests, to process test data, and
interpretation of test results using computing programs. Some automated analyzers require previous c
samples to separate the red cells from the plasma. These analyzers use microplate- and/or cassette-b
most perform forward and reverse grouping for routine blood tests. Fully automated systems are used
centers, while modular semiautomated analyzers are used in smaller centers. Automated blood-group
the speed and accuracy of testing and minimize reagent use.

Laboratory electrolyte analyzers that measure ion activity potentiometrically, using an external refere
specific to each of the ions under analysis. The external reference electrode and the ISE are exposed
sample solution, and the potential difference between them is amplified and displayed as electrolyte c
in mmol/L (millimoles per liter).
Laboratory electrolyte analyzers that measure the electrolyte concentration by determining the amou
passing between two electrodes in an electrochemical cell, usually at a constant electric current. This
directly proportional to the amount of substance produced or consumed by the redox process at the e
displayed as electrolyte concentration in millimole per liter (mmol/L).

Laboratory plunger syringes designed for accurate measurement and display of the quantity of fluid d
These syringes may include a digital display that shows the volume of fluid delivered in milli- or micro
of accuracy (e.g., within 5%). These syringes are typically used for injection of liquid samples, prepara
instrument analysis, and/or calibration of instruments and detector systems.

Devices designed to cover syringe tips in order to prevent syringe content leakage and maintain steril
used. They are typically constructed of plastic or polypropylene and may come in multiple colors for c
medications. These caps may be designed to fit a specific type of syringe tip (e.g., luer slip, luer lock).
Prepackaged collections of the devices and supplies (either custom or standard kits) needed for provid
into the larynx and trachea. Items in these kits usually include a sterile, anatomically-curved plastic ca
vial injector, and a single-dose vial prefilled with a sterile aqueous solution of lidocaine hydrochloride.
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Laryngotracheal anesthesia kits and trays are intended for use in the block of laryngeal nerve roots du
therapeutic procedures.

Dry heat sterilizing units designed for total elimination of microorganisms from laboratory inoculating
These devices usually consist of a dedicated tabletop unit with a small open chamber (e.g., an open c
accommodate the needle or loop and a source of heat (e.g., infrared lamp, electric heaters) that provi
enough (815 degrees Celsius/1,500 degrees Fahrenheit) to incinerate the microorganisms in few secon
units are used in clinical laboratories to sterilize inoculating loops and needles, avoiding the risks of op

Light sources designed to provide light illumination at the distal end of a rigid endoscope (e.g., laparo
devices by delivering light through a fiberoptic cable attached to the proximal end of the device. Thes
consist of a lamp fixture that include one of a variety of light sources [e.g., xenon, halogen, incandesc
diodes (LED)] and a detachable fiberoptic cable; dedicated adapters are frequently necessary for part
endoscopes or other devices. Rigid Endoscope/multipurpose, light sources are used in endoscopic or i
procedures performed for diagnosis, therapy, or surgery.

Prepackaged collections of the devices and supplies (either custom or standard) needed for collecting
bone marrow cavity by suction through a fine needle attached to a syringe (i.e., performing a bone ma
biopsy). Items in these kits usually include povidone-iodine swab sticks, lidocaine hydrochloride, a sca
needle, Luer lock syringes, frosted slides, and needles; kits may also include towels, a fenestrated dra
bandages, specimen tubes, gauze pads, and an absorbent towel. The kits are frequently supplied in s
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Bone marrow aspira
kits and trays are intended for use during the removal of living tissue for microscopic (in-vitro) laborat
diagnose a variety of hematopoietic and non-hematopoietic diseases.

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
biopsy procedure. Items in these kits usually include a spinal needle, a biopsy gun, glass slides, sterile
surgical blade, and a disposable syringe with needle; they may also include a disposable cup filled wit
plastic container, cotton balls, a cotton applicator, and a suture scissor. The kits are frequently supplie
(i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery sup
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Renal b
and trays are intended for use during the removal of a small piece of kidney tissue for laboratory (in-v
diagnose and/or to determine the severity of a kidney disorder.
Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
procedure. Items in these kits usually include Luer lock syringes, needles, anesthetics, scalpel, specim
microscope slides, and a ruler; kits may also include gauze pads, towels, a fenestrated drape, and adh
kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed rec
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Soft tissue biopsy procedure kits and trays are intended for use during the removal of a sma
(e.g., skin, fat, muscle, tendon) for microscopic (in-vitro) laboratory examination.

Peripheral circulatory assist units designed for sequential compression. These units include a set of pn
stockings with several chambers. The cuffs or chambers inflate and deflate sequentially in a pattern th
chamber enclosing the foot or ankle and continuing to chambers around the calf and thigh. In some u
reaches the same pressure but at different times; other units apply greater pressure in the more dista
gradually lower pressures in each of the chambers higher on the leg. Sequential peripheral compressi
provide better circulatory assistance than conventional peripheral assist units.

Dental casting materials, whose main component is gypsum hemihydrate, designed to make a positiv
of the oral cavity, using a mold previously taken at the dentist's office. These dental casting materials
that is mixed with water and then poured into a mold which contains a hollow cavity of an appropriate
and/or oral tissue, allowed to solidify and then ejected or broken out of the mold to complete the proc
have considerable strength and may originally be white but are generally colored for identification pur
include various modifiers to regulate setting time and setting expansion. Dental stones are classified a
physical characteristics (e.g., strength) in Class I, II and III respectively. They are used in dental labora
and dies which in turn are used to make prostheses (e.g., gold crowns) and/or orthodontic appliances.

Dental materials designed for placement in the space between the denture base and the natural gum
fit. These dental materials consist of acrylic resins or silicone-based products that are added to the ba
surface of a denture as a permanent coating or lining. Denture reliners usually restore a proper fit to a
eliminating or lessening rubbing and sore spots; soft and hard denture reliners are available. They are
offices, dental laboratories, and at home.

Ultrasonic power meters designed to assess the peak power (to check cavitation) and the average pow
energy consumption) of ultrasonic cleaning systems. These devices are designed to measure at frequ
60 kHz; the results are commonly expressed in power/volume (e.g., W/g) units. These devices usually
(e.g., a microphone) that is immersed in the tank of the cleaning system and a measuring unit with a

Ultrasonic power meters designed to assess the output characteristics of ultrasound scanners and oth
equipment. These meters measure at frequencies between one and twenty MHz; the results are expre
units (W) or intensity (i.e., power/unit area, typically W/cm2) in a range of up to 10 W These meters us
appropriate sensor (target), which detects the ultrasonic pressure, coupled to a measuring unit that in
a mechanical balance, electronic load cell, or strain gauge, as well as an appropriate display.
Ultrasonic power meters designed to assess the output characteristics of ultrasonic physical therapy u
continuous- or pulsed-operation therapeutic ultrasound devices. These devices are typically designed
fixed frequencies (e.g., 1 and 3 MHz) or in a continuous range of frequencies from 0.5 to 5.0 MHz; the
in either power units (W) or intensity (i.e., power/area, typically W/cm2) in a range from 1 to 30 W.

Fluids (i.e., gases or liquids) intended for replacement of the aqueous and/or vitreous eye humors dur
procedures or for longer terms (e.g., several months). The use of the same fluid to substitute both hum
successful due to the different nature of the natural eye humors; but some saline solutions and gases
those purposes. The replacement media used for aqueous humor are low-density aqueous solutions (t
solution is usually substituted by the natural humor in a short period. The replacement for the vitreou
performed using gases (e.g., air, sulphahexafluoride gas) and liquids (e.g., silicone oil, perfluorocarbon
solutions such as hydroxypropylmethylcellulose (HPMC) and sodium hyaluronate are a better match to
characteristics of the natural vitreous humor.

Oxygen delivery units designed to supply oxygen to an individual patient. These units may consist of
gas canister, a regulator, and appropriate means to supply oxygen to the user (e.g., cannulae). Units u
(LOX) as the oxygen source consist of a container in which the lower reservoir contains LOX, a warmin
oxygen is converted into gas, and a smaller upper reservoir where the oxygen gas is stored. A valve th
of gaseous oxygen to the patient from the upper reservoir of the container due to the pressure gradie
gas and the atmosphere is also needed. When the upper reservoir falls below a certain pressure, addi
drawn up from the lower reservoir of the container, providing a constant flow to the patient. The use o
volume and weight of portable oxygen delivery units, facilitating its use by ambulatory patients.

Ports designed to infuse fluids, electrolytes, medications, or parenteral nutrition solutions; they can wi
hundred punctures (usually from 500 to 2,000). These ports include a reservoir that leads to a vascula
(e.g., silicone) septum for access to the reservoir. Injection/infusion ports are totally implanted; they a
with specially designed needles (e.g., Huber needles), which are deflected at the tip to prevent coring
(noncoring needles).

Laboratory monitors designed for continuous measuring and display of the carbon dioxide concentrati
closed environment, usually inside of a laboratory device (e.g. incubator, hood). These monitors typica
unit including electronic circuitry and a digital display, and carbon dioxide sensors located in the inter
device.
Boards designed for dissection of human body parts. These boards are typically constructed of a stain
resistant material (e.g., high-density polyethylene). To reduce the possibility of spreading infection, th
nonporous and appropriate for mechanical washing and autoclaving; the borders are typically shaped

Electrosurgical electrodes designed to deliver radiofrequency (RF) electric current to the body tissues
current effect is required. Electrosurgical electrodes may be intended to apply monopolar or bipolar cu
electrodes deliver the RF energy through insulated cables from an RF generator located in the electro
usually a component of a handpiece (for monopolar units) or the distal tips of instruments (e.g., forcep
manipulated by the surgeon for bipolar surgery. The current circulation is controlled using hand or foo
some active electrode handpieces include mechanisms for smoke evacuation. Active electrosurgical u
mostly used in procedures intended to cut tissues, stop bleeding, and/or for tissue fusion.
Biological bone grafts stored after stabilization by rapid freezing and dehydration under vacuum cond
lyophilization). These grafts are typically obtained from the body of another person (i.e., allografts, us
or, less frequently, from a different animal species (i.e., xenografts). Biological bone grafts are usually
using very-low-temperature freezers; they are used in reconstructive and/or plastic surgery to increas
provide mechanical support.

Radioimmunoassay analyzers that require the human manipulative effort (e.g., manual insertion of re
all steps of each test, including manual pipetting, control of incubation, separation, and counting. The
performed using manufacturer's kits, which include the unlabeled and radioactively labeled ligands, th
calibration standards. Most current manual radioimmunoassay analyzers include computerized data-p
reduction) devices.

Automated cytometers in which cells are dispersed in fluid suspension and flow one at a time through
light, typically from a laser. Each cell generates optical signals that are measured and analyzed. These
cell transportation system, a laser for cell illumination, photodetectors for signal detection, and a com
management system.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for c
from the fetal scalp intended for in-vitro tests. Items in these kits may include needles, a plastic cone,
cotton swabs, and disinfectant solutions. The kits are frequently supplied in supporting trays (i.e., proc
of a flat-bottomed receptacle with a border around the periphery supporting all the instruments and s
procedure; the trays are usually covered or wrapped. Fetal scalp blood sampling procedure kits and tr
during labor to determine if the baby is getting enough oxygen. They are used in maternity hospitals,
facilities.

Laboratory syringes designed to inject samples in the injection ports of gas and/or liquid chromatogra
devices typically consist of small-volume syringes that include either fixed needles (e.g., cemented), L
special tips. Gas/liquid chromatography syringes are available to inject the samples in a specific inject
split/splitless or the packed-column injection port; some syringes are manufactured for use only in dev
model or from a specific manufacturer .

Laboratory syringes designed to inject samples in the injection ports of high-pressure liquid chromatog
These devices typically consist in gas-/liquid-tight syringes and frequently include reinforced plungers
stainless steel) and with tips (e.g., Luer lock) that allow high-pressure injection (e.g., up to 200 to 500
inch) of liquids. HPLC syringes are available to inject the samples in a specific injection port, such as t
packed-column injection port; some syringes are manufactured for use only in devices of a particular m
specific manufacturer.

Small laboratory syringes designed to prepare and inject microliter samples (typically from a few to se
microliters) providing a high level of accuracy (typically about 1%). These syringes may include either
needles (e.g., cemented). Microsample syringes are mostly used to prepare, transfer, or inject sample
laboratory autosamplers; they may also be used in chromatography assays.

Testers designed to measure the electrical impedance between the surface of external electrocardiogr
the skin; most testers are also capable of measuring interference voltages that may be stored on elec
voltage) and/or detecting faulty lead wires or cables. Electrocardiographic impedance testers are used
ability of a set of surface (skin) electrodes to conduct bioelectric signals from the skin to the electrode
measure the impedance of the leads and cables from the electrodes to the measuring unit.
Electric conductors (e.g., wires) designed to conduct electrical biosignals from electrodes placed in or
and/or monitor equipment either directly or through pre-amplifiers. The leads may be also intended to
from an external stimulator to electrodes attached to or implanted into the body. These leads typically
wires that are completely isolated except at the electrode tip to prevent electric shock. A variety of lea
single and multiple-lead are available. Lead size, connector type, and other characteristics of the lead
with the equipment transmitting and or receiving the signal and/or the therapy prescribed. Dedicated
both external and implantable devices, such as cardiac pacemakers, defibrillators, evoked potential re
stimulators are also available.

Radiographic/tomographic systems in which the film and the x-ray tube are moved in parallel, straight
directions. In most of these systems, the tube rotates so that the central axis of the beam is directed
rotation throughout the exposure (planigraphy); in some other systems, the x-ray tube is moved in an
moved in a straight line (simplified Grossman system).
Radiographic/fluoroscopic (R/F) systems that consist of a combination of a patient support unit (usuall
movable tabletop), an under-table x-ray tube and holder, x-ray generators, a power-assisted spot-film
cassetteless or, alternatively, a photospot camera or digital photospot system), an image intensifier, r
Bucky film tray, an overhead x-ray tube and ceiling support for follow-up radiography, and a control pa
R/F technology is effective in performing diagnostic examinations, including many studies (e.g., arthro
gastrointestinal, biliary tree) amd other applications (e.g., locating ingested foreign materials) and, wh
media, in highlighting congenital anatomic abnormalities, diagnosing congestive heart failure, and ev

Laboratory analyzers that perform semiquantitative chemical analysis to determine the presence of ce
estimate their concentration in a urine sample. These analyzers use reflectance photometry methods
amount of light produced by a LED [light emitting diode] and reflected from a reagent-impregnated te
with the urine sample in measured, automatic microscopy) and/or other methods (e.g., electrical imp
instruments can detect bilirubin, glucose, ketones, pH, protein, leukocyte esterase, and other analytes
embedded dipsticks, but the results are less precise than those obtained with multianalyte chemical a
analyzers are used to help physicians in diagnosis and management of renal, urinary tract, and metab

Laboratory urine analyzers that perform the analysis, requiring the technicians to immerse the reagen
dipstick in each urine specimen and place the strip in the instrument, usually one specimen at a time.
usually interface with computers and include a final report, either displayed or printed.

Data tape recorders that include catheters (e.g., esophageal, biliary) and an electronic amplifier. There
recorders: real time and retrospective, according to the point at which analysis is performed. These re
used in ambulatory patients to correlate pH data (e.g., related to gastroesophageal reflux) to patient s

Fixed beds designed to provide a very soft, fluid-like surface for the patient. These beds typically cons
filter sheet that rests loosely atop a tank that contains tiny soda-lime glass or ceramic microspheres, w
suspended by a continuous flow of warm air. Air-fluidized fixed beds are intended for a variety of seve
particularly in treating patients with burns or decubitus ulcers.
Photo slide projectors designed for projection on a screen one slide from a set of positive images mou
film (i.e., eye charts) that are intended for visual function assessment. These projectors usually consis
equipment that includes a power supply, lights (e.g., halogen), lenses, electronic circuitry, controls (e.
screens, and sealed slide holders (e.g., discs) and/or carrousels carrying a set of multiple eye charts; t
include other attachments that permit the projection of the eye chart's images with the appropriate si
brightness adequate for visual assessment. Some projectors may include as a component the screen i
of the images. Eye chart projectors are used for screening and evaluation of a patient's visual function
other areas of healthcare facilities.

Gamma camera scanning systems that permit the bedside assessment of critically ill patients. Some s
with the detector, detector stand, and data-processing console integrated into a single-powered, whee
systems include the data-processing console in a separate unit, which is also mounted on wheels and
coaxial or fiberoptic cable to the detector unit. The operation and image acquisition process in the mo
similar to those in the stationary systems; most mobile systems can obtain only planar images, but so
emission capabilities. Mobile gamma camera scanning systems are used mostly for the assessment of
perfusion in patients with myocardial infarction and in other critically ill patients.

Gamma camera scanning systems that produce a two-dimensional image (i.e., planar image) of a rad
distribution within a patient's body. These systems scan the patient by moving either the patient or th
track-mounted movable detector that passes over the patient or a patient table that moves beneath a
They are used mostly for whole-body scanning.
Devices designed to terminate x-ray exposures when sufficient intensity of x-ray radiation has reache
provide acceptable film darkness. These devices are commonly known as automatic exposure control
usually included as an integral component of the Bucky system of a radiographic system table or plac
intensifier in a fluoroscopic system. The controllers signal the control system to stop the radiation from
the radiation intensity is appropriate, usually displaying the exposure time in milliseconds. Stand-alon
available to upgrade x-ray units and systems that do not have those capabilities; dedicated controller
radiographic units and mammographic equipment are also available. Stand-alone units are also used
calibration, and/or quality control of radiographic and/or fluoroscopic units and systems.

Pouches in which a battery-powered portable telecommunication transmitter attached to an ambulato


carried. These pouches are typically plastic or fabric containers with appropriate means of attachment
shoulder strap) to the patient. The transmitter in the pouch is connected to sensors (e.g., lead wires w
electrocardiography) on the patient's body and to a small antenna that transmits the signal to a remo
The antenna is linked to a central station monitor, where the patient's physiologic parameters are disp
pouches are used mainly in hospitals to facilitate physiologic parameter monitoring of patients who ar
condition but who require continuous monitoring.

Computed tomography scanning systems that use a magnetically rotating electron beam and stationa
rings rather than a standard x-ray tube to generate x-rays. Because there is no mechanical motion, th
very short, on the order of 50 ms each or less. These systems are mainly designed to allow transaxial
heart, but due to their very rapid image acquisition, they can also be used in quantification of coronar
and pericardial disease, as well as in uses in which motion could affect image acquisition (e.g., pediat
patients).
Blood flowmeters designed to measure blood flow using the Doppler principle applied to a laser beam
typically consist of a laser source (e.g., diode laser) and a fiberoptic cable to transmit the monochrom
that illuminates the tissue under testing. The light reflected by the tissue is sent back through a secon
photodetector in the measuring instrument; the light frequency shift is a measure of the blood flow ve
Laser flowmeters can measure perfusion in the superficial portion of any tissue or inside the tissue if a
inserted below the surface of the tissue. The instruments are available in single and dual-channel con
frequently used during surgical and endoscopic procedures.

Laboratory densitometers designed to determine the optical density of patterns found on the media (e
membranes) commonly used in biotechnology tests. These densitometers typically include a light sou
devices to provide sample motion or analysis over a given area, optical systems to direct and regulate
photodetector; some scanning densitometers include computer capabilities for the analysis of densito
Scanning light laboratory densitometers are used to assess the developed pattern or protein fractions
membranes after electrophoresis (electrophoretogram) as well as the results of thin-layer chromatogr

Patient transfer chairs designed for use in narrow stairs, hallways, and similar locations. These chairs
restraints and two pairs of carrying handles and can be folded for storage in small compartments.
Immunoassay analyzers that use a dedicated nephelometer, which measures particulates suspended
detection system. These analyzers can be used to monitor immunoassays that produce antigen-antibo
enzyme immunoassays) that are capable of scattering monochromatic light at a particular wavelength

Digitizers designed to convert transparent x-ray film images into a digital format according to the opti
image, mapping them into a two-dimensional digital matrix. These devices typically consist of a light
transmission system, and a light sensor; a mechanical film-transporting system; an analog-to-digital c
processor; and a computer interface. Some systems use a laser light source. Film digitizers facilitate r
transfer and manipulation through hospital information systems, printing of images using laser printer
archiving in magnetic and/or optical disks.

Steam sterilizing units designed for total inactivation of microorganisms that are or may be present on
culture media. These units usually include a pressurized (1.5 kg/cm2-15 psi is typical) treatment cham
heaters, a water circulation system for rapid cooling, and a compressor. Some units prepare the appro
from dehydrated culture media and water before sterilization. Agar culture media sterilization units ar
clinical laboratories for culture media that do not contain compounds that are affected by heat.

Standing wheeled frames designed to help users remain in a standing, upright position when they are
frames typically consist of a rigid, metal framework with the center of gravity low enough for stability;
bars for user support, bottom bars mounted on casters, and brakes. Mobile frames are available in a v
according to the intended purpose, such as help getting in and out of wheelchairs; some frames provi
belts, foot straps, knee pads) to help patients maintain a standing position. Mobile standing frames m
(e.g., pneumatic, electric) mechanisms used to move the frame with the user in a standing position or
patient. Frames with appropriate sizes for use by children and adults are available.
Controlled atmosphere glove boxes designed to provide an enclosure with a very low level of oxygen a
devices usually deliver a continuous gas (e.g., carbon dioxide) flow at a slightly high pressure to preve
humidity from entering the box; they also include transfer chambers to facilitate the introduction of m
with minimal compromise of the glove box atmosphere, inlet and outlet valves to establish and mainta
atmosphere, pressure monitors, and a vacuum pump for the transfer chamber. Some anaerobic glove
incubators either inside or attached to the main chamber to promote growth of cultured organisms. An
boxes are used for oxygen sensitive (anaerobic) tests, either using organic or biochemical materials.

Contraceptive devices intended to be inserted intra-vaginally against a woman's cervix. These sponge
prevent sperm from gaining access to the female reproductive tract by providing a physical barrier. Co
are soft, disk-shaped devices made of polyurethane foam that are approximately 2 inches in diameter
an inch thick. They are coated with spermicide that blocks or kills sperm. Contraceptive sponges are a
counter and they do not come in multiple sizes; it is intended that one size fits all women and so do n
a healthcare provider. A contraceptive sponge is inserted into the vagina to cover the cervix to preven
the uterus through the cervix and to release spermicide into the vagina. It has a small pull-strap to as

Power conversion kits designed for converting a mechanically operated bed into an electrically powere
typically include one or more electric motors with appropriate gears and controls for appropriate mani
usually to adjust the bed height, surface, and/or contour. Bed power conversion kits are used for conv
manual (mechanically operated) bed into a power-operated bed.

Ophthalmic perimeters that perform visual field assessment with little operator involvement. Currently
perimeters perform static perimetry, as well as simultaneous monitoring of the fixation of the eye. The
targets at predetermined locations in the visual field for patient detection, using one or more procedu
(i.e., threshold, supra threshold, threshold-related). Automated perimeters include a stimuli source (pr
emitting diodes) with automated background illumination and computing capabilities for test program
processing, recording, and display.

Ophthalmic perimeters that perform peripheral visual assessment with operator involvement in all the
Typically, the patient focuses one eye on a spot in the central portion of the perimeter, with the other
bandage. The target is passed in several meridians, typically at 15 intervals through the 360 degrees,
asked to signal whether he or she sees the target in each position. The results are manually recorded
coordinate chart showing the limits of the visual field.

Implantable prostheses designed to be affixed to the proximal humerus bone, replacing the head of th
prostheses provide a partial substitution of the shoulder articulation; they typically consist of a ball att
can be inserted in the humerus. Humeral component shoulder prostheses are made typically of metal
chromium alloys) or, less frequently, of ceramics, polymers, or a combination of materials; the prosthe
for implantation with or without bone cement. Humeral component shoulder joint prostheses are used
from osteoarthritis, rheumatoid arthritis, severe fracture of the humerus, or osteonecrosis.
Implantable prostheses designed to replace the cavity of the shoulder blade (i.e., the glenoid cavity) w
humerus articulates, providing a partial substitution for the shoulder articulation. These prostheses ar
parts: a metal tray with a long stem that is anchored directly in the bone and a plastic (e.g., very high
cup that forms the socket; they frequently include protrusions on the prostheses that are fitted into ho
surface. The prostheses may be intended for implantation with bone cement or without; prostheses us
cement include a fine mesh of holes on the surface where bone grows. Glenoid component shoulder jo
used in patients who suffer from osteoarthritis, rheumatoid arthritis, or osteonecrosis. Total shoulder jo
both the humeral component and the glenoid component.

Infusion pumps that are designed to deliver a predetermined amount of analgesic drug on demand, i.e
Infusion pumps designed to deliver a predetermined amount of analgesic drug on demand (i.e., when
patient) as well as delivering continuous pain control. To prevent tampering or diversion, PCA pumps t
of securing the controls and medication container, which is connected to a proprietary administration
set tubing is connected to an intravenous catheter or other infusion device (e.g., epidural catheter, su
injection/infusion port). Typically, PCA pumps are programmed to deliver in any one of the following m
demand dose plus continuous infusion, or continuous infusion only; the pumps can also be programm
doses (i.e., bolus or loading doses). PCA pumps are designed with specific safeguards that restrict the
can be requested and delivered over a specific period of time (e.g., 1 mg of drug every 6 minutes for
hour). PCA pumps allow narcotic analgesics (e.g., morphine, meperidine, hydromorphone) and fentany
as needed by the patient while keeping the amount within the prescribed limits and preventing unaut
medication. The software inherent in the PCA pump is typically capable of storing cumulative data reg
doses delivered, date/time of each dose delivered, number of requests received, and total volume of d
pumps are intended for patient control of pain by permitting self-administration of analgesics (i.e., pat
analgesic pumps) within pre-established limits; they are typically mounted on poles or used on tableto
ambulatory pumps are also available.

Holders designed to hold and protect a large number of microscope slides in an organized fashion in a
position. These slide holders can be made of metal, wood, plastic, or a combination of these materials
slots or sleeves for holding and storing standard slides that are used with light microscopes. Some mic
hold slides flat in a sleeve in book or binder format while others are in the shape of boxes or racks of s
slides in a vertical or upright position. Slide holders protect microscope slides from breakage, dirt, or d

Power supplies designed to deliver an almost steady, predetermined value of AC voltage (e.g., 120 V)
input line voltage variations (e.g., plus or minus 10%). These devices typically include an electronic lin
detect line voltage fluctuations and some electric or electronic stabilization circuit or device to compe
variations. Line voltage stabilizing power supplies are mostly used to maintain normal operation of ele
(e.g., motors, pumps, lights, refrigerators) under reduced-voltage conditions (brownouts).

Power supplies that receive alternating-current energy from a power line and deliver one or more regu
outputs. Regulated power supplies usually consist of a step-up or step-down transformer, a rectifier, a
electronic regulator that keeps the voltage, current, or power output stable over a broad range of load
Electric power systems designed to provide independent continuous electric power during a limited pe
minutes or a few hours), without delay or transients, when the line power supply has complete blacko
acceptably (e.g., momentary fluctuations or interruptions). These power systems are usually connecte
line; they include a battery charger, a battery, an inverter, and a transfer device (e.g., a static switch)
systems are used when a continuous supply of electric energy is needed (e.g., for computerized devic
temporary interruptions that usually occur when using the standard emergency or standby power sup

Physiologic respiratory monitors designed for continuous measurement and display of the partial pres
(PCO2) in an exhaled breath. These monitors are hard-wired to the patient at the bedside and/or in the
carbon dioxide respiratory monitors display the results as a maximum value of PCO2 (i.e., carbon diox
measured at the end of exhalation, known as end-tidal carbon dioxide concentration). These monitors
that usually measures with infrared spectroscopy, and attached sensors typically consisting of an infra
optical filter, reference and sample chambers, and a detector. The monitors measure PCO2 either by u
patient's breathing circuit (mainstream) or, more frequently, by sampling from the patient's airway (si
monitors use microstream (filter-line) technology. Carbon dioxide respiratory monitors are used to dete
check the placement of endotracheal tubes, and assess the pulmonary function or the adequacy of pe
cardiopulmonary resuscitation; they are also intended for intraoperative use in patients under genera

Surgical punches designed to excise a segment of tissue (typically in the form of a thin disc of several
diameter) from the spinal cord and/or associated tissue. These punches are typically handheld, manua
cutting mechanism (e.g., movable two-part) at the distal end and are operated by grasping an articula
cord punches may have distal ends designed for straight, downward, or upward cutting; dedicated spi
available to perform anterior cervical discectomy and/or laminectomy.

Laboratory analyzers used to measure the concentration of ionized calcium (Ca++), total calcium, or b
plasma, serum, and other body fluids. These analyzers typically use electrochemical (ion-selective ele
measure ionized calcium and fluorescence-quenching techniques for measuring total calcium. Many a
electrode for pH measurement or calculate the Ca++ content at a pH corrected value of 7.4, due its d
Dedicated calcium analyzers are used to determine low- and high- serum calcium concentrations relat
and the consumption of certain drugs and/or food. They are used in the course of some major surgical

Argon gas lasers designed for use in surgical procedures. These lasers typically emit energy at wavele
514 nm (blue-green); they are usually operated in continuous-wave mode. Surgical argon lasers are fr
treatment of vascular diseases, including the removal of vascular tumors.
Carbon dioxide lasers used mainly to create surgical incisions, to excise or vaporize deeper tissues (e.
and to coagulate small vessels. These lasers can be used for macroscopic surgery, for endoscopic and
procedures, and for microscopic surgery. Surgical carbon dioxide lasers can also be used in dermatolo
infectious, or inflammatory conditions, as well as malignant, premalignant, and benign tumors of the s

Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) lasers, usually operated in continuous-wave or


used mainly to cut, excise or vaporize, and coagulate deep tissues. Their laser energy penetrates dee
absorbed by a large volume of tissue, allowing photocoagulation of blood vessels at low-power densiti
tumors at high-power densities. These lasers are frequently used in laparoscopic and endoscopic surg
Argon lasers used to coagulate abnormal vascular tissue in the retina and to perform other photocoag
the eye. These lasers are typically coupled to a biomicroscope slit lamp or to an indirect ophthalmosco
fiberoptic cable.
Krypton lasers used to coagulate abnormal vascular tissue in the retina and to perform other photocoa
the eye. They are typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a
cable.
Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) lasers, usually Q-switched, used to cause a pho
the eye (e.g., posterior capsulotomy), forming a plasma and generating immense localized mechanica
(microexplosions) that, when highly focused, can destroy tissue. These lasers have built-in slit-lamp b
coupled to a slit-lamp or indirect ophthalmoscope by fixed mirrors.

Wheelchairs that are user propelled and/or attendant operated (i.e., nonpowered, mechanical, manua

Systems designed to recover silver from solutions by placing the solutions in a container and adding a
substance (e.g., trisodium salt) to separate the silver from the solution; the precipitant causes the silv
short period of time. Chemical precipitation silver recovery systems are a reliable method for recoveri
mainly in healthcare facilities to recover silver from solutions used during radiographic film processing

Equipment designed to recover silver from solutions using an electrolytic process consisting of electro
plating cell. The electrolytic plating cell acts as the cathode in the electrolytic process; the process ma
fixing tank or in a separate tank to facilitate collection of the used fixer. Silver is removed from the fix
controlled, direct electric current passes between the electrodes, causing the silver to plate onto the c
is 90 to 96 percent pure; the plated cathodes are periodically removed and the plated silver is strippe
Electrolytic plating cell systems are used mainly in healthcare facilities to recover silver from solutions
radiographic film processing.

Equipment designed to recover silver from solutions using a process in which a sealed cartridge filled
wool) undergoes an oxidation-reduction reaction with silver solutions (e.g., silver thiosulfate) to produ
metallic silver. Usually, two cartridges are placed in a series so that a secondary cartridge will collect t
one may miss in the event of a breakthrough. A typical system can recover about 95% of the silver in
usually recovered as sludge in the bottom of the cartridge (typically containing 30% of pure silver). Me
cartridge systems are used mainly in healthcare facilities to recover silver from solutions used during
processing.

Analgesia units that alleviate pain through patient inhalation of a gas or mixture of gases. These units
device that mixes nitrous oxide and oxygen from two gas cylinders in a previously selected proportion
patient using appropriate inhalers; the mixture must have not less than 20% to 30% oxygen content.
units help patients retain consciousness while pain sensations are subdued; they are mostly used in d
also been used for women in labor, in emergency care, and for minor surgery.

Electronic thermometers that measure body temperature by use of a fiberoptic probe that includes a s
temperature sensor, usually based on phosphor-fluorescence-decay time or other temperature-varying
(e.g., liquid crystal structure, polarization rotation). Fiberoptic thermometer probes are immune to ele
interference and are electrically and chemically passive. These thermometers are designed for cathe
measurements in the presence of electromagnetic fields.
Slide stainers that automate the Gram staining method of classification of gram-positive or -negative
inserts slides into a carrier and selects a time or programmed procedure. Linear transport slide stainer
that moves baskets of slides into and out of parallel reagent vessels. Robotic arm stainers allow the us
stainer to move the robotic arm carrying the slides to the desired bucket. Centrifugal stainers spray re
placed in a rotating carousel and use centrifugal force to remove excess reagents and dry the slides. T
stainer is controlled by a microprocessor that regulates the amount of stain and wash solution sprayed
centrifugation time and speed. Linear transport and triaxial arm stainers are microprocessor controlled
reagents by capillary action. Slides are placed in grooves on conveyor spirals and moved facedown alo

Implantable prostheses designed to replace the natural mandibular condylar head, providing an articu
mandibular fossa. These prostheses provide a partial substitution of the temporomandibular articulati
made of a combination of a (typically 45 to 55 mm) metal frame and plastic (e.g., polymethyl methac
combination of metal and polymeric materials. Mandibular condyle temporomandibular prostheses are
exclusively in combination with mandibular fossa components in total temporomandibular prostheses;
patients who suffer from osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms,
(e.g., fracture).

Video systems designed to display the output of the image intensifier of fluoroscopic systems, with ap
of image sharpness and contrast and minimum lag. These systems typically consist of a video camera
the output phosphor of the image intensifier of the fluoroscopic system, one or more standard or high
tube monitors, and video signal recording devices (e.g., VHS or super-VHS videotape recorders, digital
cameras used for general fluoroscopy typically include a conventional tube that operates based on the
photoconductivity (e.g., a vidicon tube); for fast motion studies and/or when a series of sequential ima
in angiography studies), tubes with better contrast preservation and less lag (e.g., Plumbicon, Saticon
cameras with charge-coupled devices (CCDs) instead of electron tubes are also used. Video systems f
fluoroscopic images to be viewed on video monitors inside the examination room and in remote locati

Bone grafts produced artificially (i.e., using synthetic materials) for replacement of a diseased or injur
consist mainly of porous and mesh ceramic materials that provide a framework for bone growth. Or th
harvested sea coral (mainly hydroxyapatite) that works as an additive, extender, or framework for bon
bone grafts are used for reconstructive and/or plastic surgery to increase body mass and provide mec
may also provide a framework for bone growth.

Cables designed to translate one form of energy to another (e.g., pressure, temperature, pulse) into a
communicate this signal to a device (e.g., monitor). Typically, these cables are designed to be compat
pressure transducers embedded in devices such as transducer tubing sets (e.g., used with central ven
catheters, intracranial catheters, and pulmonary artery catheters), pulse oximeter probes, noninvasive
temperature probes, and respiratory/electrocardiography electrodes and associated monitors (e.g., ph
transport monitors).
Radiotherapy systems that use cobalt-60 as a radiation source to produce gamma radiation at photon
and/or 1.33 MeV. The source is fitted into a treatment head that contains massive shielding (about one
mechanism for exposing or hiding the source, either by rotating it away from the collimator or by rota
shield the source. The gamma-ray beam is directed at the tumor to be treated via a set of collimators
treatment so that maximum radiation dose is delivered to the point at the center of the rotation, othe
less. Cobalt radiotherapy systems also include a control unit and appropriate filters and collimators. B
reaches its maximum dose about 0.5 cm below the skin surface, cobalt units are especially suited for
head, neck, and breast, as well as for tumors in other parts of the body located within 5 cm of the skin

Radiotherapy systems designed to emit x-ray beams produced by electric voltages, typically in the ran
These systems usually include an x-ray source, a manual or automated computerized control unit, filte
applicators; some systems also include displays and printer output. Orthovoltage systems, including
up to 150 or 200 kV, can perform superficial treatments (e.g., squamous cell carcinoma of the skin, Ka
equipment using tubes with higher voltages (e.g., 300 kV or more) can be used in radiation treatment
centimeters under the skin.

Video recorders designed to store video information in magneto-optical discs. These recorders usually
electromechanical device that includes external connectors to attach video cameras or other sources
signals; a magneto-optical writer (a device that de-magnetize a specific area of the disk while laser wr
controls; and a magneto-optical disk memory. The recorders may include an analog/digital converter a
Magnetic/optical disk recorders usually have playing capabilities (using a laser reader) both for video a
through integral amplifiers, displays, and loudspeakers (typical in portable video recorders) or providin
reproduction systems (e.g., monitors or television sets). Video recorders are available in tabletop, rac
portable versions.

Heart prostheses designed for implantation in the patient's chest that include a percutaneous connect
power source that supplies the driving power, such as a pneumatic machine or electric battery. These
consist of an implantable metallic and plastic mechanism that includes one or more pumps that work
pushing the blood from the inlet valve to the outlet valve and then trough the circulatory system; an e
external power source is connected to the implanted pumps through electrical wires or pneumatic driv
part of the patient's chest. Percutaneously powered heart prostheses include a battery and/or a pneum
permanently attached to the patient for power supply as well as for pumping rate and pressure contro
heart prosthesis. These prostheses are mainly used as a temporary solution ("bridge") until transplant

Exploratory probes designed for introduction into body articulations through arthroscopes that are inte
exploratory purposes. These probes typically consist of a slender flexible metal or plastic cylinder with
passing through the working channel of arthroscopes that may be attached to a handle at the proxima
flexible or rigid. The devices are intended to enhance visualization of the areas being explored to incre
the joint conditions thereby allowing a better evaluation. Arthroscopic exploratory probes help in the d
treatment of bone and tissue disorders in the articulations, such as osteochondrosis of the elbow and
instability, and meniscal tears.
Caloric stimulators that use a dry agent (i.e., air-fluidized solids) to transfer the heat to the patient, us
These devices consist of a bed of finely divided cellulose particles located in a container. A stream of w
38 to 48 degrees C) is forced through the particles in such a way that the particles become suspended
similar to a fluid, allowing patients to submerge and exercise body parts in them. These stimulators ar
physical therapy programs for desensitization of hypersensitive fingers and/or toes.

Laboratory analyzers used to determine the characteristics of human sperm cells (spermatozoa). Thes
measure the total sperm cell concentration and the morphology and motility of cells. Most of these an
devices (e.g., light sources, microscopes), computer processing capabilities, and monitors to display th

Automatic electronic sphygmomanometers that measure the change in blood volume taking place in a
these instruments use a cuff wrapped around a finger; the cuff detects minute arterial volume change
an inflatable bladder which exerts pressure (counterpressure) just sufficient to equal the arterial press

Carts designed for organized storage, transport, and facilitation of devices, supplies, and drugs neede
body temperature, usually as a consequence of general anesthesia (i.e., malignant hyperthermia). Th
include a working surface at the top of the cart, large wheels (e.g., 4 inch/10cm), and a closed stainles
drawer shelf or shelf/drawer cabinet-like structure. Hyperthermia carts may also include a small refrig
poles, ice packs, blood gas syringes, cold irrigation and intravenous solutions, and other medications.

Leads designed to conduct electrical pacing signals from the pulse-generating unit of an external card
electrodes placed on the outer surface of the heart (i.e., myocardial). Some leads may also conduct th
signals back to the unit. These leads typically consist of flexible wires that are completely isolated exc
that makes contact with the heart. Myocardial (also known as epicardial) leads are directly attached to
heart during open surgery. A variety of lead systems, including single- and multiple-lead is available. L
type, and other characteristics of the leads must be compatible with the pulse generator and the ther
Epicardial external cardiac pacemaker leads are used in temporary procedures (e.g., surgery, emergen

Electric beds designed to tilt the horizontal axis of the bed surface to a full or nearly full vertical positi
include manual controls to move the bed surface to the required tilting angle needed using the electri
Vertical tilt electric beds permit patients with severe back problems to have easy ingress and egress in
without bending their backs; they are also used in physical therapy and chiropractic treatments.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
intended for dialysis into the peritoneal cavity. Items in these kits usually include scalpels, scissors, di
needles, trocars, a peritoneal catheter, sponges, medicines, drapes, and sutures. The kits are frequen
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
dialysis catheterization procedure kits and trays are used to infuse and extract a dialysate (i.e., chemi
dialysis) into the peritoneal cavity; the dialysis procedure is used to correct an imbalance of fluid or of
blood or to remove toxins, drugs, or other wastes normally excreted by the kidney. The kits are used in
and in other healthcare facilities.
Telemedicine information systems used to electronically transmit and receive radiologic images (e.g.,
imaging or computed tomography scans) and consultative text to and from one or more remote sites.
telemedicine systems are mostly used by small remote hospitals and in emergency situations to trans
radiologist at a larger hospital for review, interpretation, and/or consultation.

Flexible endoscopes designed for examination of the inner lumen of vessels. They are usually introduc
system through peripheral vessels. Angioscopes usually consist of a fiberoptic lighting system surroun
sheath; they are usually available in sizes from 0.8 to 3 mm in diameter and are appropriately sized fo
renal, and coronary arteries. Large-diameter angioscopes often include an irrigation channel through w
is pumped to clear blood from obstructing the view. Angioscopes may be used to evaluate the results
procedures either in peripheral or in the coronary arteries, as well as to distinguish clots from plaque.

Prefabricated rails designed to organize the utility services (e.g., electrical, gas, vacuum) and devices
patient's bed. These systems consist of horizontal metal rails with raceways for gas an electrical powe
mounted in the corner of a room, across windows, or on wall surfaces. Service rails are frequently mo
modification; they eliminate the need for individual installation of services within a wall. A typical ser
oxygen, air, and vacuum station outlets; electrical power receptacles; provision for nurse call and code
jacks; physiological monitor support brackets; and various types of lighting (ambient, reading, exam,

Lenses designed to be mounted, usually in pairs, in frames that hold them in an appropriate position b
eyeglass frames) to assist vision. Lenses are usually made of glass or plastic (e.g., polycarbonate) and
teh visual acuity of the wearer, they may be configured as monofocal, bifocal, trifocal, or progressive.
used mainly as a vision aid, but some lenses are designed to protect the eye (e.g., sunglasses) or use
purposes.

Cameras designed to receive an optical image and transform it into an electronic signal (videosignal)
necessary information needed for storage or display. Video cameras may be used for many medical ap
surgical and endoscopic procedures.
Video cameras attached (either directly or by means of an adapter) to a flexible or rigid endoscope. Th
consist of a charge-coupled device (CCD). Endoscopic video cameras are used for picture documenta
findings or for instantaneous display to make possible the performance of real-time surgical procedur
endoscope.
Tubes designed to provide a pathway between the lacrimal sac and the nasal cavity. These devices typ
small single-lumen polymeric (e.g., silicon) tube. Lacrimal tubes are intended to provide lacrimal drain
when the canal is obstructed or does not exist; they are usually implanted after surgery (dacryocystos
create a surgical passage.
Small, round, thin patches impregnated with an antimicrobial substance (i.e., a substance known to ki
of one or more microorganisms) that are intended to be used to measure (e.g., by a disk-agar diffusio
broth elution technique) the in vitro susceptibility of most clinically important bacterial pathogens to a
These disks are typically used in the identification of bacteria.
Enriched culture media in the form of liquids, solids, or semisolids used as a medium capable of suppo
specific mycobacteria. These culture media consist of a base whose physiological mixture is enriched
nutritional components (e.g., blood, blood serum, vitamins, extracts of plant or animal tissues, hyaluro
support the growth of, identify, and study specific mycobacteria. The culture media usually include an
potassium penicillin G) in an amount effective to inhibit growth of contaminating microorganisms. Myc
culture media are used in the diagnosis of disease caused by pathogenic microorganisms.

Selective culture media in the form of liquids, solids, or semisolids used as a medium capable of supp
mycoplasma, while inhibiting the growth of other microorganisms. These selective culture media com
base usually containing peptones, serum (e.g. horse serum, swine serum), growth factors favoring the
mycoplasmas and an antibiotic mixture inhibiting the growth of most antagonistic associated bacteria
culture media are often used for the isolation and identification of mycoplasma in pharmaceutical prod
vaccines, cell banks, and virus cultures.

Microbiology reagents in the form of liquids, solids, or semisolids used as a selective medium capable
growth of certain types of bacteria, while inhibiting the growth of other microorganisms. These selecti
consist of particular substances including dyes (e.g., methylene blue, crystal violet) or high (e.g., 7%)
products that inhibit the growth of unwanted microorganisms, and allow the specified bacteria to be is
culture. Bacteria selective culture media are typically used in laboratories to ensure the survival or pro
with certain properties (e.g., antibiotic resistance, the ability to synthesize a certain metabolite).

Substances intended to detect and/or measure, in some cases producing or modifying other substanc
interest (e.g., enzymes, hormones). Substances used as reagents must be sufficiently pure to appropr
specific analytical test. Reagents are typically used in the clinical laboratory for clinical chemistry, imm
hematology, microbiology (e.g., culture), infectious immunology, and molecular biology (e.g., nucleic

Hematology reagents used in automated analyzers to count the number of red blood cells (RBCs or er
blood cells (WBCs or leucocytes), and platelets per unit volume in a sample of venous blood. Most rea
complete blood cell counts are intended for use in a particular model of hematology analyzer; usually
calculate the erythrocyte indexes ( mean corpuscular volume, mean corpuscular hemoglobin, and me
hemoglobin concentration).

Clinical chemistry reagents consisting of a substance intended to establish points of reference (i.e., ca
and/or enzymatic assays used in the determination of components in human specimens.

Hematology reagents consisting of a substance intended to establish points of reference (i.e., calibrat
determination of blood coagulation.
Reagents consisting of a substance intended to establish points of reference (i.e., calibrate) in cytolog
assays performed for analyses of human cells and tissues, particularly their structure, function, and pa

Serology reagents consisting of a substance intended to establish points of reference (i.e., calibrate);
performed for the determination of antigens and/or antibodies in human specimens due to infection b
microorganisms (e.g., viruses, bacteria, parasites).
Hematology reagents consisting of a substance intended to establish points of reference (i.e., calibrat
determination of the morphology of blood, its components, and blood forming tissues (i.e., hematolog
reagents include those used for calibration in blood cell counts.
Microbiology reagents intended to establish points of reference (i.e., calibrate) in a diverse range of bi
include cultivation and identification of microorganisms and/or determination of their susceptibility to

Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in immuno
to determine one or more of a group of drugs, such as acetaminophen, alcohol, and salicylates that ar
overdose, or other chemical agents that are accidentally or intentionally ingested.

Clinical chemistry reagents intended to establish points of reference (i.e., calibrate) in chemical and/o
used in the determination of analyte content (e.g., proteins, lipids) in a sample of urine.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate). They are u
performed for the determination of antigens and/or antibodies that cause infectious diseases in huma
pathogenic virus.
Reagents used in assays to separate mixtures of chemical compounds into individual components acc
rates at which they are retarded by a stationary material (stationary phase) as they pass over it. Thes
solvent mixture (i.e., the mobile phase, a gas or liquid) that carries the sample, the adsorbing materia
column), and other auxiliary reagents (e.g., solvents for elution). Chromatography reagents are mostly
laboratory to identify trace quantities of substances in body fluids.

Reagents intended for chromatography tests using a gas phase to carry the sample through the statio
or nitrogen is typically used as the mobile phase to carry the sample. Gas chromatography reagents a
the clinical laboratory to identify trace quantities of substances (e.g., therapeutic or toxic drugs) in bo

Reagents intended for chromatography tests using a liquid phase forced by high pressure to carry the
stationary material. Water or solvents are typically used as the mobile phase to carry the sample. High
chromatography reagents are frequently used in the clinical laboratory to identify trace quantities of s
therapeutic or toxic drugs) in body fluids.
Reagents intended for chromatography tests using a liquid phase to carry the sample through the stat
or solvents are typically used as the mobile phase to carry the sample. Liquid chromatography reagen
in the clinical laboratory to identify trace quantities of substances (e.g., therapeutic or toxic drugs) in

Reagents intended for chromatography tests using a thin layer of the support particles spread on a fla
the mobile phase travels up the plate by capillary action. Thin-layer chromatography reagents are freq
clinical laboratory to identify trace quantities of substances (e.g., therapeutic or toxic drugs) in body fl

Hematology reagents used in tests of the sequential process by which the multiple factors of the bloo
sample, resulting in the formation of an insoluble fibrin clot (coagulation).
Reagents used for decalcifying samples for cytology/histology examinations performed with an electro

Reagents used for decalcifying samples for cytology/histology examinations performed with a light mi

Reagents used in cytologic assays performed by flow cytometers. They include labels for cell membra
normalize instrument setup, cell count, and proliferation. These reagents are frequently available in ki
calibration, control, and standardization of flow cytometry analysis.
Clinical chemistry reagents consisting of samples of substances with known values used for quality co
enzymatic assays. Some control reagents are used in multianalyte assays, while others are specific fo
determination.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen. They are used for quality control in blood coagulation testing.

Reagents consisting of samples of substances with known values used for quality control in cytology a
performed for analyses of human cells and tissues, particularly their structure, function, and patholog

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen. They are used for quality control in a diverse range of sensitive
assays using immunochemical reactions (immunoassays) that are mostly used in the determination of
specimens. Reagents used for quality control may be either specific for some substance or more frequ
whole set of similar substances (e.g., proteins, lipids).

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen. They are used for quality control in hematology assays for the
morphology of blood, its components, and blood forming tissues (i.e., hematology assays). These reag
used for control in blood cell counts.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control in immunohematology assays
grouping (typing), antibody detection and identification, and/or compatibility testing.

Microbiology reagents consisting of samples of substances with known values; they are used for qual
range of biochemical assays that include cultivation and identification of microorganisms and/or dete
susceptibility to antimicrobial agents.
Reagents consisting of substances of known concentrations intended for quality control in a diverse ra
specific radioimmunoassay tests. Reagents used for radioimmunoassay quality control may be specific
more frequently, appropriate for quality control for a whole set of similar substances (e.g., proteins, lip
human specimens.
Reagents consisting of samples of substances with known values; they are used for quality control of i
performed for the determination of either one or more of a group of drugs such as acetaminophen, alc
that are toxic when taken in overdose or of other chemical agents that are accidentally or intentionally

Clinical chemistry reagents consisting of urine pooled from donors; control urine is used as a reagent f
assays performed in a sample of urine. Control urine is usually aseptically filtered and frozen or lyoph

Serology reagents consisting of samples of substances with known values; they are used for quality co
performed for the determination of antigens and/or antibodies in human specimens due to infection b
that cause infectious diseases.
Reagents used as a medium capable of surrounding and filling the spaces of a tissue so that thin secti
microtome for histologic examination. Most embedding media consist of paraffin, synthetic polymers,
both. These media may be specific for light and/or electron microscopy examinations.
Reagents used as an embedding media in cytology/histology examinations performed with an electron

Reagents used as an embedding media in cytology/histology examinations performed with a light mic

Immunoassay reagents used for quantitative or qualitative analysis to characterize tissues according t
histocompatibility of their antigens. These reagents are mostly used in tests (lymphocytotoxicity tests
total class I human leukocyte antigens (HLA) or total class II HLA. Some reagents for tissue typing are
degree of immune cellular stimulation of the recipient's T lymphocytes by donor cells (mixed lymphoc
culture that includes blood from both the donor and the recipient. Tests for tissue typing are mostly us
recipient tissues before transplants. Certain HLA types are associated to specific diseases (e.g., ankylo

Serology reagents intended to detect antibody titers or antigens to pathogenic viruses through in vitro
These viruses may cause infectious diseases in humans.
Electron microscopy reagents used to provide better contrast (e.g., by artificial coloration) to the cons
cells and the intercellular material when magnifying an image using an electron beam instead of light
typically consist of positive heavy metal particles (e.g., gold) or substances that attach around the spe
the specimen itself (i.e., negative stains) or by any other mean facilitating the differentiation of the ce
constituents or products. Electron microscopy stains are used in cytology and histology to identify and
microorganisms (e.g., bacteria, virus, fungi), and in other in-vitro clinical tests and/or for research.

Reagents used in hematology for artificial coloration of thin blood films for microscopic study (blood sm
morphologic examination of blood using a microscope. Stains used in hematology are formulated from
eosin, typically Romanovsky stains or its modifications, including Wright's and Giemsa stains.

Microbiology reagents used for artificial coloration of microorganisms such as bacteria and parasites, m
microscopic differentiation. Staining is typically performed using dyes. This procedure may be used to
groups of microorganisms or species in particular.
Projectors designed to project on a screen a series of images in quick succession at a frequency at wh
invisible (usually 24 frames per second), providing images that give the impression of movement (kno
images). Cine projectors usually consist of electric-powered equipment that includes a power supply;
lenses; electronic circuitry; a shutter (a device that interrupts the emitted light during the time the film
next frame); a film transport mechanism; controls (e.g., focus, brightness); and other attachments tha
of images with optical characteristics necessary for multiple viewers. Some projectors may include a
are very similar in their characteristics to cine cameras but usually do not include sound systems; Ded
intended only for use with 8, 16, or 35 mm. films are available.

Laboratory blood analyzers used to evaluate the deformation capabilities of red blood cells (erythrocy
instruments are based in measuring the flow of erythrocytes through a mechanical filter under known
the elongation of erythrocytes under induced shear force. The mechanical properties of the red blood
influence on blood flow is evident in a number of hematological pathologies.
Valves that usually connect an intracranial catheter to another catheter that drains the cerebrospinal
or the left atrium of the heart. The whole combination of the intracranial catheter, the peritoneal or at
and the valve is known as a ventriculoperitoneal or ventriculoatrial shunt, respectively. The shunt may
reservoir._x000D_
Reagents intended to perform qualitative and/or quantitative chemical analyses of body fluids such as
cerebrospinal fluid as well as of feces and tissue, using either manual or automated procedures.

Reagents used in qualitative and/or quantitative analyses of human cells and tissues, particularly thei
and pathology. These reagents include those used for staining, cleaning, fixing, control, and calibratio
appropriate media needed to perform cytology and/or histology procedures. Frequently, these reagent
that include all the necessary reagents for a particular test.

Reagents intended to perform qualitative and/or quantitative analyses of the morphology of the blood
blood-forming tissues. These reagents include those used for blood cell counts, coagulation testing, ot
control, and calibration.
Reagents intended for use in antigen-antibody reactions performed for red blood cell grouping (typing
and identification, and cross-matching of donor and recipient prior to blood component transfusion (kn
testing). These reagents are also intended for use in antigen-antibody reactions performed during eva
reactions to blood component transfusion and red blood cell autoimmunity (e.g., autoimmune hemoly
disease of the newborn).

Reagents used in biochemical assays for laboratory (in vitro) cultivation and identification of microorg
are used to determine the susceptibility of microorganisms to antimicrobial agents. Microbiology reage
media, stains, buffers, antibiotics, calibrators, controls, and standards. Most tests are based on bioche
(e.g., agglutination procedures, with detection either directly or using fluorescent techniques).

Surgical aspirators designed to remove fat deposits from particular areas of the body by means of vac
aspirators usually consist of a powered vacuum pump with a large vacuum capacity (> 700 mm Hg) a
liter/min); one or more collection canisters; plastic tubes connecting the components each other; an o
and/or bacteria filter; and the suction tubing (e.g., cannulae). Liposuction surgical aspirators are inten
specific areas of the body (e.g., abdomen, hips, thighs, arm, cheeks, and neck). They are mainly used
central vacuum system is not available or appropriate.

Detachable handle coverings (i.e., handgrips) usually connected at both ends to the middle section of
for grip on the crutch and keeping both the wrists and hands in natural position. These handgrips typi
cylinders; some are split to slide over the crosspiece attached to the shaft. They are usually made of s
as wood (e.g., walnut), plastic (e.g., rubber), or light metals (e.g., aluminum) or a combination of thes
frequently padded externally for comfort. Crutch handgrips are used in axillary, forearm and platform
intended to support the body weight and provide comfort to the user. They can easily be replaced whe
damaged.

Holders designed to hold surgical retractors in place during surgery and provide a mechanism for cont
retraction needed in the surgical field. Automatic surgical retractor holders typically have a sturdy me
articulating parts that can be locked into place) with clamps at one end which attach to the operating
structure and handles or clamps at the other end to hold one or more retractors in position above the
some type of adjustment mechanism that controls the position of the holder which in turn will adjust t
retractors and the amount of retraction in the surgical field.
Laboratory blood analyzers dedicated to measuring levels of glycohemoglobin (i.e., glycated hemoglo
glycosylated and glucosylated hemoglobin) in blood. These analyzers typically use a separation techn
charge differences (i.e., ion-exchange chromatography, high-pressure liquid chromatography, electrop
analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography,

Caloric stimulators that use moist air to transfer the heat to the patient. These devices consist of a mo
including a water tank, heaters, pumps, thermometers, and controls, and a treatment hood for applyin
the patient.
Cartridge syringes designed to inject dental anesthetics from a changeable, prefilled, disposable, seal
usually includes a needle attached to one end. These syringes are typically reusable devices with app
dimension for injection of anesthetics that are supplied in cartridges in the oral cavity.

Plunger syringes used in dentistry to inject and/or aspirate a volume of solution into the working area.
typically consist of small syringes (3 ml is typical) and are capable of aspirating the fluid and debris, p
extrusion beyond the apical confines of the tooth; some may also include thumb rings and/or swivel fi
control of the syringe. Most dental irrigation syringes may be attached to blunted needles for use in e
or to very fine needles to perform special procedures (e.g., root canal).

Dental attachments fabricated using special metal alloys under precise tolerances (i.e., high-precision
are designed to attach partial dentures (including overlay partial dentures) to receptacles that are con
abutment (e.g., tooth, dental implant, abutment crown). These attachments are typically two-compon
to each other with a high degree of precision; one component is fixed to an abutment or may be supp
second component is an integral part of the partial denture base. Precision dental attachments may b
degrees of resilience according to the torque transmitted to the abutment; they are available as intra-
devices according to the fixation site. Precision dental attachments usually distribute chewing forces b
better cosmetic results than conventional clasp attachments.

Dental prostheses designed to replace missing natural teeth. These devices resemble natural teeth in
functional capabilities; artificial teeth are typically made of ceramic, polymers, or resins. These prosth
available as sets of teeth of a variety of sizes, shapes, and colors that replace the different types of te
premolars, molars) for either the lower or upper arch. A single tooth may be replaced, or artificial teet
preformed dental plates to make new removable dentures or to repair existing dentures; artificial teet
an integral part of a fixed dental prosthesis are usually known as pontics.

External defibrillators that only require the user to apply the electrodes to the patient and follow the v
on-screen messages to operate the device; some require the user to activate the analysis function. Au
analyze the ECG rhythm to determine if a defibrillation shock is needed; if it is, the defibrillator warns
automatically charges and discharges. Most of these defibrillators use a single pair of disposable elect
ECG and deliver the defibrillator discharge, but some also incorporate ECG displays. The simple design
automated defibrillators requires very little training and operational skill.

Pads designed to provide thermal insulation to the myocardium during surgery. These pads are usuall
specially shaped plastic (e.g., polyethylene foam) devices; they may include notches for the vena cav
arteries. Cardiac insulation pads reduce undesired re-warming of the myocardium, helping in the prote
tissues during open-heart surgery procedures.
Electric programmable stimulators that are able to deliver precisely timed electrical impulses to the h
spontaneous and paced rhythms. These stimulators may be used in asynchronous or synchronous mo
variable strength and for pacing in a wide range of cycle lengths (typically from 150 to 1,500 msec). D
stimulators are used to perform physiologic cardiac tests, such as to determine the function of various
atrioventricular conduction, factors required for induction and termination of tachycardia, and to asses

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
determine the pH value and the levels of gases commonly present in blood (e.g., oxygen, carbon diox

Clinical chemistry reagents usually consisting of aqueous solutions with known pH and equilibrated wi
gases commonly present in blood (e.g., oxygen, carbon dioxide); they are used for quality control of a
and pH performed in a sample of blood.
Laboratory chambers designed to accommodate an analytical balance, isolated from the general labo
minimizing air drafts. These devices typically consist of a transparent plastic or glass chamber that fa
of an analytical balance by protecting it from the air flow and dust; preserving its accuracy even for ve
measurements. Analytical balance chambers are frequently available as an integral part of the balanc

Sack-like containers intended to hold the body of a deceased individual (e.g., a patient who has expire
transported to the morgue or other appropriate location, a body intended for dissection and study, etc
recovered from the scene of an accident/disaster). Cadaver bags are often included as a component o

Collectors designed to remove dust and other debris from the environment during surgical, postmorte
procedures involving bone cutting, sawing, and/or drilling. These collectors typically consist of a stand
that includes filters that entrap bone particles and other debris having a diameter in the order of one
low-noise motor that provides suction of the polluted air or a connection to a vacuum source; a collect
appropriate controls. Bone dust/debris collectors are used in orthopedic, plastic, and other surgeries in
procedures; they are also used during postmortem (e.g., autopsy) procedures. Surgical collectors conn
systems may be supplied as sterile disposable units; some dust collectors are an integral part of medi
saws and drilling machines.

Equipment designed to remove moisture, either in liquid or vapor state, from devices, films, fabrics, o
using a physical procedure (e.g., heat, centrifugal force, refrigeration, forced air, filtration), and/or nat
the exclusive use of chemical desiccating products. Dedicated dryers are used in healthcare facilities
laboratory slides and gels, laundry, small devices and/or utensils, forensic evidence, and x-ray films; t
dry the air in medical air systems.

Dryers designed to remove moisture from laboratory slides using heat (e.g., forced warm air). These d
of an electric warm-air generator with temperature controls, an enclosure that includes nozzles to inje
appropriate slide racks (typically two or three). Slide dryers are used to dry specimen slides immediat
other laboratory coating procedures.
Racks designed for temporarily holding and shelving cadaver trays or coffin plates inside a morgue re
typically consist of three major components: the post/bearing rail weldment, the rear bumper, and the
post/bearing rail is made of stainless steel wall tubing; each section is modular in construction and co
supporting; it may include adjustable leveling feet. The rear bumper bars and front tie bars are usually
stainless steel. Some of these are roller-type mortuary racks. Refrigerator morgue racks are mainly us
pathology, histology, and necropsy departments as well as in some mortuary homes.

Tables with an appropriate (e.g., stainless steel) top surface that is smooth and polished, with no crevi
and that has raised rims, rounded corners, and a flat surface. Some dissecting tables include drain ca
are typically smaller than autopsy tables and are designed to provide a working surface for examinati
organs and other anatomic parts, to facilitate cleaning and decontamination, and to prevent the accum
microorganisms. Dissecting tables are used mostly for postmortem pathologic investigations and for
purposes.

Upper-limb continuous passive motion exercisers designed to provide controlled flexion and extension
hand and/or wrist joints without the patient's muscular exertion. These exercisers are typically an elec
electromechanical mechanism that is attached to the patient's hand to provide periodic, rhythmic mov
range of motion. The exercisers are intended to prevent joint stiffness in the hand and/or wrist. They a
therapy and rehabilitation after illness, trauma, and/or surgical treatment.

Continuous passive motion exercisers designed to provide controlled movements (flexion, extension a
rotation) to the lower limb joints without muscular exertion. These exercisers typically consist of an ele
electromechanism that is attached to the lower limbs to provide periodic, rhythmic movements throug
Lower limb continuous passive motion exercisers are intended to prevent joint stiffness in the knee, hi
they are used for physical therapy and rehabilitation after illness, trauma, and/or surgical treatment. D
continuous passive motion exercisers for the hip, knee, ankle or foot are available.

Continuous passive motion exercisers designed to provide controlled movements (flexion, extension, a
and/or rotation) to the upper limb joints without muscular exertion. These exercisers typically consist o
controlled electromechanism that is attached to the upper limb to provide periodic, rhythmic moveme
motion. Upper limb continuous passive motion exercisers are intended to prevent joint stiffness in the
and/or wrist; they are used for physical therapy and rehabilitation after illness, trauma, and/or surgica
upper limb continuous passive motion exercisers for the shoulder, elbow, hand and/or wrist are availa

Analgesia units that alleviate pain by freezing body tissues. These units consist of a cryostat and a coo
also include a peripheral nerve block stimulator (nerve locator). A compressed gas (e.g., carbon dioxid
circulated through the probe, allowing expansion near the tip; frequently, some free-thaw cycles are p
analgesia application results in reversible, though prolonged (weeks or even months) peripheral nerve
postoperative and chronic intractable pain relief.

Pulmonary resuscitators designed to provide respiratory support to a patient using the air exhaled by
resuscitators consist of a mouthpiece, a nonrebreathing valve and/or filter to prevent rescuer's contac
from the patient,; and a device to deliver the air (e.g., mask, shield) to the patient airway. Exhaled- ai
resuscitators can be used either to provide gases through the mouth or nose; they are used as an alte
mouth resuscitation to reduce the risk or cross-contamination by physically separating the rescuer fro
Caps that are placed over the head of infants to help keep them warm. These caps are typically made
cotton material and universally sized to fit all infants, although special sizes (e.g., for premature infan
caps are used in both healthcare and home care settings.
Instrument cleaning brushes designed to remove debris from endoscopes during manual cleaning pro
usually include flexible plastic shafts with stiff bristles at one or both ends that are of a size that perm
endoscope channels; smaller brushes are available to clean the valves and heads of endoscopes. Som
antielectrostatic properties are specifically designed to clean endoscope lenses. Endoscope cleaning b
intended for single use or for reuse after sterilization.

Cystoscopes with a nonrigid (i.e., flexible) structure, capable of being manipulated and pointed in diffe
through the lumen of the curved path of the lower urinary tract. Flexible cystoscopes usually include a
and imaging system that facilitates the examination and performance of therapeutic procedures.

Cystoscopes with a nonflexible (i.e., rigid) structure that can only follow a straight path through the ur
include illumination and imaging systems, which enable the examination and treatment of the urethra
bladder.
Radiometers designed to measure the radiant flux (also known as radiant power) of a laser beam in a
spectral range. These instruments typically include a prefilter to filter out the light of a wavelength no
spectral range; a primary detector consisting of a temperature-stabilized, solid-state (e.g., selenium, i
arsenide) diode used to detect radiation; electronic circuits, including an amplifier; an electric meter;
battery); and a display showing the results in either analog or digital format. Laser beam radiometers
measuring radiant flux in different ranges of the spectrum (e.g., infrared, visible, ultraviolet) within a g
accuracy, and resolution; dedicated radiometers used to measure laser beam power in specific ranges
1,000 nm; from 1,000 to 1,700 nm) are also available. Power (i.e., electromagnetic radiation per unit t
measured in watts, and power density in watt/cm2.

Oximeters designed primarily for determining the relative amount of oxygenated and deoxygenated h
HHb, respectively) by measuring light absorbence changes resulting from arterial blood flow pulsation
results as percent saturation of hemoglobin in arterial blood (SpO2). These oximeters include red and
(typically LEDs of 660 and 940 nm), photodetectors, and probes that transmit light through a pulsatin
the finger tip, earlobe, or toe. Pulse oximeters are used in operating rooms, intensive care units, reco
sometimes in emergency vehicles or for patient respiratory care at home.

Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
products using electrolysis. The sterilizers work by electrolyzing a water-based solution containing a v
of a chemical that becomes a germicidal after electrolysis, such as a sodium chloride solution that pro
amount of sodium hypochlorite (a germicidal) after electrolysis. These devices typically include a steri
appropriate for the devices to be sterilized and the solution, an electric power source, electrodes place
container, the sterilization solution, and means to dispose the solution after use. Electrolytic sterilizati
for small devices; larger sterilizing units used for disinfection of water supplies and/or food products a
Dedicated electrolytic sterilizers intended for contact lenses have been used.
Isotope bone densitometers that use two sources to yield a dual-energy (two discrete line spectra) be
ray photons). In addition to the dual photon sources, these densitometers typically include a scanner,
analyzer, and a computer with appropriate software. Dual-photon densitometers are used to assess bo
the axial skeleton, usually by measuring the lumbar spine and the hip region, including the proximal f

Isotope bone densitometers that use a single source to yield an essentially monoenergetic (one discre
beam of gamma rays (x-ray photons). In addition to the single photon source, these densitometers typ
scanner, a single-channel analyzer, and a computer with appropriate software. Single-photon densitom
assess bone mineral content in the appendicular skeleton, usually by measuring the forearm (radius)

Densitometers intended to assess bone mineral content in the skeleton. The primary purpose of thes
measurements is to detect quantitative decreases in bone mass related to metabolic bone diseases su
and to help predict the risk of fracture.
Film radiographic systems designed to perform the most common (basic) radiographic procedures (e.g
orthopedic examinations) using minimum resources. These systems typically include a battery-powere
generator with a tube tension of 90 and 120 kV; limited exposure factors; a control panel that indicate
status before exposure and the chosen kV and mA values, and an integral protective screen; an x-ray
1 mm focal spot that can handle at least 20 kW for 0.1 second and 10 kW for 1.0 second; a rotating an
that matches beam size to film formats; an x-ray tube support and a cassette holder that firmly conne
and a rigid, x-ray-permeable patient support table with a 110 kg capacity. These systems may be des
common examinations (those not requiring fluoroscopy, tomography, or serial film changers) of the sk
head (e.g., trauma, infection), chest (e.g., tuberculosis, tumors), abdomen (e.g., intestinal obstruction
tissue. Basic radiographic systems are intended for use in small rural hospitals, large health centers a
medical practices, and as supplemental equipment in large hospitals.

Cardiac electrodes designed to attach to a patient's chest for transcutaneous delivery of pacing pulse
external pacemaker and/or pacemaker/defibrillator. The electrodes may be applied on the thorax surfa
anterior-posterior position (i.e., one electrode over the heart and one directly behind it) or in the anter
(i.e., one electrode near the apex of the heart and one on the right chest). These electrodes typically a
to 100 square cm), frequently pregelled, disposable pads; the electrode impedance may be high (e.g.
for electrodes used only for pacing or low for electrodes intended for external pacing and defibrillation
external pacemaker electrodes can deliver simultaneous stimuli to all chambers of the heart; they are
resuscitating patients, to correct arrhythmias, or for temporary pacing during surgical placement of im

Refrigerators designed for storage of drugs, pharmacy preparations, and other pharmaceutical produc
vaccines), typically at temperatures between 2 and 10 degrees Celsius (35 and 50 degrees Fahrenheit
typically consist of a chamber made with a corrosion-resistant (typically stainless steel) interior, minim
adulteration, contamination, and/or corrosion of contents; internal shelving appropriate for storage, ea
handling of pharmaceutical product containers; a compressor, condenser, evaporator, tubing, sensors
temperature recording chart, and alarms for dependable long-term storage following pharmacy standa
in upright, walk-in, and undercounter configurations. They may also be available with a small freezer a
Refrigerators designed to store laboratory products, cultures, and samples at temperatures typically b
degrees Celsius (35 and 50 degrees Fahrenheit). These refrigerators typically consist of a chamber ma
resistant (typically stainless steel) interior, minimizing the risk of adulteration, contamination, and/or c
internal shelving appropriate for storage, easy location, and handling of laboratory products; a compre
evaporator, and tubing; sensors, controls, and monitors; a temperature recording chart and alarms for
storage following laboratory standards; and an emergency power supply for both the refrigerator and
laboratory refrigerators are available with the capability to store flammable materials and to perform
Explosion-proof refrigerators are also available.

Laboratory refrigerators designed to be used to perform in chromatography tests, typically at tempera


10 degrees Celsius (34 and 50 degrees Fahrenheit). These refrigerators typically consist of a chamber
resistant (typically stainless steel) interior, minimizing the risk of adulteration, contamination, and/or c
glass door and internal shelving for easy setup of instrumentation and chromatography systems withi
providing full access to the chromatography equipment it contains; a compressor, condenser, evapora
Chromatography laboratory refrigerators include sensors, controls, monitors, forced-air circulation, a t
chart, and alarms for dependable performance of chromatography tests; they are usually available in
chamber, upright configurations.

Infusion pumps designed for use in the subcutaneous administration of insulin that are small enough t
by patients. These pumps are frequently battery-powered devices that use a syringe-driven mechanis
controller, and an internal low-volume (e.g., 3 ml) reservoir containing the insulin solution. The insulin
pump to a subcutaneous catheter typically inserted in the subcutaneous tissue of the abdomen. The p
or worn, typically in a case attached to the patient's belt. Many pumps have memory capabilities and
programming to account for daily patterns of insulin needs. Most pumps have an "automatic off" that
infusion if a button on the pump is not pushed within a preprogrammed period of time. Ambulatory in
infuse in micro volume pulses that mimic the function of a normal pancreas; the pump must be also a
or supplementary bolus doses of insulin when necessary. They are intended mainly for patients having
it is not possible to obtain appropriate results using other insulin administration methods.

Gas lasers with excited dimers (i.e., excimers) as the active medium. The most commonly used are ra
(e.g., argon fluoride [ArF], xenon chloride [XeCl]). Their principal emission wavelengths are in the ultra
depend on the monohalide used (e.g., 193 nm for ArF, 308 nm for XeCl). These lasers are operated in
modes and used in photoablative decomposition involving actual removal of tissue.

Aircraft (e.g., helicopters, airplanes) designed for transporting the sick or wounded that are equipped
devices and supplies to maintain or improve the clinical status of the patient during air transport.
Sets of tubing and auxiliary devices designed to connect a bag of dialysis solution to the proximal end
distal tip is located in a patient's abdomen, to perform ambulatory peritoneal dialysis. These sets typic
connectors, and a cap; some sets require a new cap each time the set is disconnected from the bag a
Typically, at the beginning of an exchange, the disposable cap is removed from the transfer set and th
Y-tube; the branches of the Y-tube connect to the drain bag and the bag of fresh dialysis solution. Afte
removed from the abdomen, the transfer set is clamped; some fresh solution is allowed to flow directl
and as a final step of the exchange, the peritoneal cavity is refilled with fresh dialysis solution from th

Skin, bone, or other tissue taken from an individual used to replace or regenerate diseased or injured
individual of the same species.
Radiographic units that consist of a stand-alone radiation safety cabinet and include an x-ray generato
collimator, an exposure timer, a specimen compartment, and a control panel. These units make it pos
resolution and contrast in tissue-sample imaging than those obtained in a standard patient radiograph
the use of a lower kilovoltage and a higher x-ray exposition. These units are used mainly in pathology
pathology radiography.

Equipment designed to recover silver from solutions by substituting ions in the solution for other ions
polymer molecule. The silver solution is passed through a packed resin cartridge (or column), and the
exchange ion for an ion of higher preference; in photographic (or x-ray) film processing, it can be the
complex. Once the ion-exchange cartridge is exhausted, an acid solution (typically low-concentrated s
through the resin, breaking down the silver thiosulfate complex that is held by the resin. A well-contro
remove silver to less than one part per million (ppm). Ion-exchange systems are used mainly in health
recover silver from solutions used during radiographic film processing. This technique is intended to tr
wash water; systems are usually used to achieve very low silver content in disposed water according t

Valves used in medical gas systems to control the flow of medical gases (such as oxygen or analgesics
patient's demand, or need, for the medical gases. The medical gas flow is controlled by the patient's r
deeper the inhalation, the greater the demand for the medicinal gases and the greater the flow. Durin
negative pressure is applied that opens the demand valve, thereby increasing flow of the medicinal ga
positive pressure is applied that closes the demand valve and shuts off the gas supply. Demand valve
and most other healthcare facilities with patients who need assisted breathing. They can be hand-held
medical gas cylinders, or with a central gas supply line. Dedicated demand valves used with the supp
analgesic gases are also available.

Masks used in conjunction with resuscitation devices. They are constructed of rubber or plastic materi
flexible rim to maintain an adequate seal around the nose and mouth during positive pressure ventila
masks may be reusable or disposable (i.e., single use); they are available in adult, pediatric, and infan

Motor vehicles designed for transporting the sick or wounded that are equipped with the necessary de
maintain or improve the clinical status of the patient during ground transport.
Laboratory analyzers used to determine the concentration of catecholamines (e.g., epinephrine, norep
and their metabolites in body fluids (e.g., plasma, urine). Most dedicated laboratory catecholamine an
high-pressure liquid chromatography (HPLC) using electrochemical detection or fluorimetric methods.
radioimmunoassay methods. The measurement of catecholamines are primarily used for the diagnos
secreting tumors (e.g., neuroblastomas). The excess of catecholamines is associated with stress, fall
congestive heart failure, and other diseases; their deficiency is seen in idiopathic postural hypotension

Radiographic systems used to perform diagnostic x-ray procedures by obtaining a latent image of the
the patient on film. This latent image is converted, usually in a separate device or system (e.g., a film
a visible image (i.e., a radiograph) reflecting the internal structure of the irradiated patient region. Th
a combination of a table, which includes a radiolucent tabletop with a longitudinal bin located underne
film tray and grid system; an integrated x-ray tubestand or overhead tube suspension; an x-ray tube a
x-ray generator; and a control panel. Most Bucky systems also include automatic exposure control de
provide acceptable film darkness and to avoid repeated examinations. These systems are used to per
diagnostic x-ray procedures provided by hospitals, clinics, physician offices, and urgent care centers, i
of the skull, respiratory organs, and skeletal system.

Data management information systems designed to process, organize, and store clinical and administ
related to radiology departments and imaging centers. These systems can be used for patient registra
film library management, order entry, patient tracking, patient scheduling, and other administrative ta
and accounting procedures.
Laboratory blood coagulation analyzers that require the manual addition of reagents and specimens, p
batches of specimens than automated analyzers. Most analyzers require previous centrifugation of the
plasma samples. Semiautomated blood coagulation analyzers include an incubation container (e.g., te
devices, a clot formation detector (e.g., using photometric, electrical impedance, or mechanical imped
some computerized capabilities for sample handling and data management. These analyzers are used
medium or light workloads where specimens are usually tested individually, although some semiautom
process several samples simultaneously.

Low-speed (typically up to 10,000 rpm) free-standing centrifuges designed to work at ambient temper
centrifuges are typically large stationary structures and consist of an electric motor, a shaft, a tachom
time controls; they also include a rotor on which one of several interchangeable heads is mounted. No
speed floor centrifuges are intended mainly for a variety of non-temperature-sensitive procedures suc
body fluids, reagents, and/or mixtures of both in preparation for analysis using other equipment.

Needles designed for injection or infusion of fluids through a subcutaneous implanted injection/infusio
typically consist of hollow, blunt-tip needles that inject the fluids through side holes near their tip, avo
noncoring needles).
Vascular catheters designed for elimination of areas of narrowing in blood vessels, thereby increasing
Angioplasty vascular catheters that dilate a stenotic artery by controlled inflation of a distensible ballo
usually consist of a double-lumen tube with a balloon in the distal tip and a side hole that is used for p
contrast material ejection. Typically, a guiding catheter is peripherally inserted and advanced into the
requiring dilatation; this catheter guides the dilating catheter into the stenotic arterial branch, where
across the stenosis to a predetermined maximal outer diameter, thereby enlarging the lumen. After b
catheter is withdrawn. These catheters are mostly used for the treatment of obstructions in the corona
aortocoronary saphenous vein bypass grafts, but they are also used in the treatment of other arterial
peripheral arteries) occlusive diseases.

Angioplasty catheters designed for direct laser ablation of atheroma without a significant thermal effe
may include either a single fiber (small and flexible, but that can debulk only very little amount of ma
densely packed optical fibers (typically of 50 to 61 micrometer in diameter) arranged concentrically ar
guide-wire lumen. These catheters are used for ablation of the atheromatous plaque inside the vessel
energy from a pulse laser (e.g., an excimer laser operating in the ultraviolet frequency range) to avoid
produced by continuous wave lasers. Laser angioplasty catheters are mostly used before balloon angi
of completely occluded vessels, for aortoostial stenoses, and for saphenous vein graft lesions; they ar
an adjuvant to balloon angioplasty to improve clinical success.

Speech assistive devices designed to deliver voice output, based either on the reproduction of previou
speech or on a synthesized voice following a pre-established set of pronunciation rules, or a combinat
devices typically consist of electronic units with keyboards and screens; the keyboards may include le
combination of both; some devices include dynamic screens to permit the user send complete messag
Voice synthesizer aids frequently are customized to the user's needs; they are used by patients with d
or totally impair voice capabilities, including users with chronic progressive diseases.

Cushions designed for strapping onto a bedrail. These cushions are usually made of padded soft plast
usually attached using ties or hook-and-loop straps that fit around the lateral bedrails. Bedrail cushion
prevent injuries to patients due to accidental bumping or slipping through the rail. They are mainly us
geriatric people and/or for patients undergoing rehabilitation or to facilitate injury prevention during tr
bedridden patients inside a healthcare facility.

Cardiac output units that determine the blood flow from the heart, measuring the changes in the frequ
reflected by red blood cells (Doppler effect) moving in the ascending aorta. These units consist of a p
piezoelectric crystals that transmit the ultrasonic wave and receive the reflected wave (echo) and an e
processes the data and displays the values of cardiac output and other hemodynamic parameters suc

Electrodes designed to be placed on the patient's skin to deliver electrical stimulus to reduce/eliminat
Radiographic/fluoroscopic systems that usually include 15 to 23 cm (6 to 9 in) image intensifiers, vide
using frame rates as high as 60 to 90 frames per second, display monitors, image recording devices (u
video recorders), and a patient table. Most cardiovascular systems also include digital recording devic
cine cameras, and digital acquisition and processing capability (e.g., digital subtraction). These system
one gantry arm (single-plane systems), or two orthogonal gantries (biplane systems), one of which is
mounted. Biplane systems provide simultaneous recording and viewing of images from two different
Cardiovascular systems are used to evaluate the anatomy and pathology of the heart (e.g., cardiac va
blood vessels (e.g., to detect coronary artery, aorta, and/or pulmonary vein diseases) and to perform t
using catheterization. The procedures are typically conducted in a special imaging suite (cardiac cath
containing the x-ray imaging system, a power injector for introducing contrast medium into the patien
physiologic monitoring equipment, and additional equipment to manage cardiovascular emergencies.

Bedside scales designed to weigh the patient by lifting him or her from the bed, similar to the way a p
scales consist of a sling (stretcher) that is positioned underneath the patient, hooks to lift the stretche
sidebraces, and a cart that includes the lift mechanism (e.g., hydraulic, electrical), weighing unit, cont
Activating the lift mechanism raises the sling and patient slightly off the bed, weighing nonambulatory
minimum discomfort.

Manometers designed to measure the pressure within a closed muscle compartment, typically in the f
frequently, in the forearm. Instruments for direct measurement of compartmental pressure typically c
desktop or handheld electronic manometer, a display, an extension tube set, an appropriate sensor/tr
port needle (or, less frequently, a straight needle or an axially cut slit catheter) that is introduced in th
compartment to be measured to inject liquid (typically saline solution) from an integral syringe until s
obtained with the tissue fluid pressure. Manometers intended to measure compartmental pressure usi
techniques, which are based on small infusion pumps, syringes, tubing, and pressure transducers, are
Compartmental pressure may be also measured indirectly by equipment using other techniques, such
nuclear magnetic resonance, and xenon scan.

Mass spectrometers (MS) designed to identify and quantify compounds in the microgram to nanogram
mass ranges between one and 4,000 atomic mass units (amu). These devices typically include magne
quadrupole mass analyzers. Laboratory mass spectrometers are frequently used coupled with a gas o
or in tandem with another MS. Such combined systems are used in clinical laboratories to determine s
fluids found in pathologic conditions (e.g., ketoacidosis, cancer), to verify results of screening immuno
identify drugs of abuse), and to identify other substances (e.g.., toxins, lipids, trace metals).

Devices that are inserted into the stomach in order to inflate within the stomach and thereby reduce t
devices are in the form of a balloon, inserted by catheter and remain until such time as the desired eff
The device is usually made of a polymer material. Certain types degrade over a period of time.
Data processors designed to acquire and process digital data obtained from ultrasonic scanning syste
typically consist of a computerized electronic unit that converts the ultrasonic echo signals in differen
according to their level (i.e., amplitude) and displays them as an image on a high-resolution monitor;
operator to optimize and/or magnify (i.e., zoom) the image and perform frame-by-frame examination;
magneto-optical disks for information storage; and software appropriate for the intended application (
obstetrics). Ultrasonic scanning data processors are usually a component of an ultrasonic scanning sy
are capable of transmitting the processed data to a workstation or an information system (e.g., a pictu
communication system [PACS]), frequently using American College of Radiology/National Electrical Ma
Association Digital Imaging and Communications in Medicine (DICOM) or other appropriate standards.

Warming/cooling units designed to warm or cool the patient by extracorporeal heat exchange with the
blood during heart-lung bypass procedures. These units consist of a central device including a cooling
household refrigerator), a heating element, and pumps for heating and circulating liquid to a heat exc
exchanger controls the blood and/or cardioplegic solution temperature during the entire cardiovascula
induces hypothermia, warms the blood). Some heart-lung bypass units incorporate both the heat exc
disposable) and the heating/cooling unit (i.e., the mixer) as integral parts.

View boxes equipped with visible light lamps and a translucent cover to provide appropriate dimensio
for the examination of microtiter plates in clinical laboratory tests.
Radiation survey meters designed to be sufficiently sensitive to detect a single ionization event. The
consist of a cylinder that is pressurized (typically from 70 to 200 mm Hg) and contains a mixture of he
and a quenching gas. A metal rod running through the center of the cylinder acts as an anode, and th
a cathode. Ionization radiation enters the chamber through a window on the front of the cylinder, prod
avalanche. Over a period of time (e.g., a minute), a pulse counter registers each ionization avalanche
pulse and displays the results on a meter. An audio speaker may be added to broadcast each ionizatio
cracking sound. Geiger-Muller survey meters are used to detect low-level radiation (less than 100 mill
are useful for detecting radioactive spills and contamination of work areas as well as in instrumentatio

Radiation survey meters designed to determine the amount, rate, and distribution of radiation emitted
ionizing radiation (dosimetry). These instruments typically consist of a gas-filled chamber containing t
conducting plates (anode and cathode). Ionization radiation from the environment enters the chambe
window typically constructed of plastic (e.g., polycarbonate, mylar, acrylic). This radiation ionizes the
electrons and positive ions that are attracted to the anode and cathode respectively, creating an elect
current is measured by an electrometer or charge digitizer, its value is proportional to the amount of i
present. Ionization chamber survey meters typically display exposure rates in units of roentgens per h
equivalent in sieverts per hour (Sv/hr); they can measure over wide ranges usually from 0.01mR/hr to
1microSv/hr to100Sv/hr; they are typically used to measure radiation intensity
and quantity (dose equivalents) for relatively high radiation intensities, such as the output of an x-ray
accelerator.
Intravenous (IV) fluid container hangers designed to directly attach to a wall fixture (mounting) or othe
and intended for overhead suspension of IV fluid containers (e.g., plastic bags, glass bottles). These h
metal structures with one or more hooks (e.g., ram's horn) appropriate to suspend IV containers; the h
to hang fluid containers during other patient procedures (e.g., irrigation, enteral feeding).

Leads designed to conduct electrical signals from the pulse generating unit of an electric stimulator in
electrodes (typically placed in the epidural space). These leads typically consist of flexible wires that a
except at the electrode tip that makes contact with the spine. Implantable spinal cord leads are direct
spine electrodes; the electrodes may be percutaneously inserted needle-type electrodes or, less frequ
(also known as mini laminectomy) electrodes. The other end of the lead is attached to the stimulator (
that is usually also implanted in the abdomen after a test period. The stimulators may use implantable
power through a radio system. A variety of single- and multiple-lead arrays is available; lead size, con
characteristics of the leads must be compatible with the pulse generator and the therapy prescribed.
is mainly used for analgesic purposes, but can be used for other purposes such as muscle control.

Chairs designed to assess the vestibulo-ocular reflex during head movements, by evaluating the rhyth
(nystagmus) and/or deviation of the eyes in response to the stimulation of the vestibular system by an
deceleration. These chairs are usually attached to a motor which provides precisely controlled rotatio
direction, velocity and acceleration of rotation) of the chair. Vestibulo-ocular rotating chairs are comp
includes other devices such as projectors and video cameras and computing capabilities.

Environmental monitors designed to measure and display the concentration of ethylene oxide. These
include an ethylene oxide sensor (e.g. solid state), a control unit and a display; they may also include
pre-fixed concentrations (e.g., 10, 20 ppm), recording capabilities, or a transmitter for remote central
oxide environmental monitors are used mostly for continuous or periodic monitoring in hospital steriliz

Recorders designed to read and store the alphanumeric information included in bar-code symbols. Bar
typically consist of a reader with a light scanner for scanning the bar-code symbols which then transdu
into a digital electric signal that is stored in an internal memory. Desktop and handheld recorders are
recorders include software to process the stored information. The recorder provides a digital output sig
introduced through a connector to a computer or other data-processing device.

Containers intended for use in mixing polymethylmethacrylate powder with methylmethacrylate mon
produce polymerising bone cement.
Computerized systems designed to receive, analyze, display, and distribute information within one he
among many healthcare facilities. Some systems are manufactured and configured with hardware and
appropriate for hospital clinical and/or administrative data management, either hospitalwide or for a p
or specialty; other systems (e.g., telemedicine systems) include capabilities to send or receive informa
locations, rather than use of local or wide area networks (LAN and WAN, respectively). A third type of
typically used in big hospitals, have higher (in the order of terabytes) image storage and retrieval cap
known as picture archiving and communication systems (PACS).
Data management information systems designed to provide clinical and administrative information a
These systems can automate or assist routine nursing tasks by acquiring, displaying, and reporting p
Bedside data management information systems can also provide real-time tracking of vital signs and
reporting of patients' condition and treatment, including drug dispensing, billing, and admission histor

Identification systems designed for patient and sample identification, improving the safety and speed
and reducing the likelihood of error in identifying and matching specimens. These systems vary acco
manufacturer; some use color coded numbers, other include bar-code bands, or a bracelet with an em
printing. They generally include a patient identification bracelet and a set of pre-numbered labels for
cross matching and charting purposes.

Devices that combine a compression cuff wrapped around an articulation (e.g., knee, shoulder, ankle)
fluid, either gas or liquid. The combination of cold with local compression is used in the treatment of p
sprains and in rehabilitation of the articulations.
Systems designed to remove and neutralize ethylene oxide (EtO) vapors. These systems may include
to convert EtO into less hazardous products and other chemical reactions that remove EtO from the ai
mainly is performed in sterilizers that use EtO and in other areas of healthcare facilities using EtO for

Inflatable cuffs designed to exert a pressure on the circumference of an extremity by means of a comp
devices typically include a bladder within the cuff that is inflated through tubes that run from the blad
source of compressed air located in the control unit of the tourniquet. The cuff is fastened to the extre
mechanisms (e.g., clips) and frequently secured with an external ribbon. Pneumatic tourniquet cuffs a
surgical procedures in the extremities enabling surgeons to perform delicate procedures in bloodless o
Dedicated cuffs with single- and double-bladder designs with different shapes and sizes that may be i
specific extremity areas (e.g., arm, thigh, wrist, ankle) are available.

Garments designed for general protection against environmental pollution agents (e.g., chemical part
and/or microorganisms that could be dangerous to human health. These garments include gowns, sho
eyewear or combinations of them, manufactured using appropriate materials and techniques. Protecti
characteristics and requirements vary according to the intended use; special garments are available f
limited personal protection of healthcare workers and/or other persons when treating infected/contam
emergency situations in contaminated areas, or while working for relatively long time periods in decon
cleaning procedures in areas with chemical, biological, or radioactive particle contamination.

Irrigation/distention systems used during endoscopic orthopedic procedures to keep the cavity of a joi
but also shoulder, elbow, hips and other joints) filled with pressurized distention solution. These syste
improving visualization and enlarging the surgical field. Typically a bolus of solution is pumped throug
and stays there, held in place by a closed stopcock or clamp on the outflow cannula, some systems in
(e.g., an automated pinch valve) in place of the manual stopcock or clamp.
Waste receptacles designed for the collection and storage of cytotoxic materials (e.g., chemotherapy/
These receptacles typically consist of a metal or hard plastic disposable structure, frequently with a di
plastic) liner and/or sealed leakproof bags, and usually separate or attached (e.g., hinged) covers that
final closure options. The receptacles usually include gaskets around the covers to prevent leakage an
with cytotoxic biohazard symbols) to identify their intended contents. Plastic bags are sometimes used
receptacles. Cytotoxic waste receptacles are used mainly in radiology and nuclear medicine departme
in clinical laboratories and pharmacies for temporary storage before final disposal.

Isolated electric power systems designed to supply electric power to several (e.g., eight) locations rou
radiographic units. These systems usually consist of a central unit with a single isolating transformer t
several power panels, an interlocking system that prevents the use of more than one circuit at a time,
system availability and individual alarms next to each power outlet. The system controls the selection
either with a switch next to each power outlet that automatically locks out all the other receptacles wh
through a central panel located in a convenient place (e.g., nurse station). Mobile radiographic unit iso
are used in operating rooms and other electric susceptible patient areas.

Neuromuscular electrical stimulators designed to apply electrical stimuli to stabilize or limit the progre
lateral curvature (scoliosis). These stimulators typically consist of a pulse generator and surface electr
spine; implantable devices linked to an external power source are less frequently used. The stimulatio
applied at nighttime while the patient is sleeping; the stimulators are used mainly in children and ado
idiopathic scoliosis.

Spinal cord electrical stimulators that apply stimuli to relieve pain (analgesia). Analgesic spinal cord st
treat acute and/or chronic intractable pain for which drug therapy is undesirable or no longer effective

Movable tilting platforms equipped with sensors that measure applied forces in any of the three dimen
data to a computer. Typically the patient stands on the platform while it moves to provoke destabilizin
Biomechanics platforms are commonly used as a part of neuromuscular function physiologic analyzers
and/or sense of equilibrium studies.
Surgical drapes designed to provide a bacteria-proof barrier between the unsterile surface of the laser
delivery system they cover and the sterile surgical field. These surgical drapes are configured to form
an emission barrier between the medical laser and the patient tissue to be removed. Laser-unit surgic
nonflammable material which is premoistened to prevent ignition; they can be reusable or disposable
are used in laser surgery procedures.

Patient surgical drapes designed to provide a bacteria-proof barrier between the unsterile skin of the p
surgical field while protecting the patient from laser radiation and potential ignition. These drapes con
non-metallic layers with an airspace in between. Laser-resistant patient surgical drapes harmlessly dis
misdirected laser beam which gives healthcare workers an opportunity to take corrective action before
ignite a fire. These patient surgical drapes are usually made of disposable materials, but reusable one
They are used in laser surgery procedures.
Synthetic sutures made of polybutester, a nonabsorbable (i.e., nonbiodegradable) copolymer of polyg
polytrimethylene terephthalate. These sutures are typically available in sterile monofilament uncoated
18, 30 in [45, 76 cm] long) attached to a single-use needle as an integral device; they are frequently c
identification during surgery. Polybutester sutures keep their tensile strength for very long periods of t
absorbed by tissues; their intended use includes surface closure of tissue.

Synthetic sutures made of polyglyconate, an absorbable (i.e., biodegradable) polymer. These sutures
in sterile monofilament uncoated thread sections (e.g., 18, 30 inches/45, 76 cm long) attached to a sin
integral device; they are frequently colored for easy identification during surgery. Polyglyconate absor
keep their tensile strength for two to several weeks, and complete absorption occurs in six to seven m
use includes general soft-tissue approximation (even in the presence of infection) and vessel ligation.

Absorbable (i.e., biodegradable) polymeric mesh made of polyglycolic acid. This mesh is used for tem
as a temporary scaffold for tissue regeneration (i.e., tissue engineering).
Syringes designed for volume calibration of spirometers and pulmonary function analyzers. These dev
plastic (e.g., acrylic) calibrated syringe with a volume of at least three liters. Most syringes include ap
that allow their use with a wide variety of spirometer sizes (e.g., from 1 to 1.5 inches).

Modular medical facilities mounted in self-propelled vehicles or trailers, facilitating movement from sit
components specially built to withstand the demands of a mobile environment. Most mobile medical f
own electric generator, so they do not need any external connection. These facilities are used for scre
mammography), for emergency conditions (e.g., natural disasters), to bring services to distant areas (
services among several hospitals, or in any other situation in which facilities are not intended to stay i
long time.

Drivers designed to insert wire loops intended to grip and shear atherosclerotic deposits from the lum
endarterectomy). These drivers are typically handheld, manual instruments that apply shearing action
endarterectomy loops are drawn through the artery; they usually include freely rotating handles that p
of torsion forces to the loops. A shear force gauge may be included to measure and limit the pulling fo
Endarterectomy loop drivers are used in endarterectomy procedures performed in the main arteries o
artery).

Batteries designed for use in nonimplantable hearing aids such as those placed on the external audito
batteries usually consist of a high-capacity low-weight cell (e.g., zinc-air); they should have a low cost
immediate and continuous use.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine quantitatively a particular (i.e., specific) immunoglobulin E antibody. These assays are m
a patient's abnormal hypersensitivity to one specific substance (i.e., an allergen), such as food (e.g.,
or inhalatory (e.g., cat hair, home dust, mite) allergens. IgE specific assays are performed when histo
provide conflicting information or skin tests can not be performed; they are also used when specific de
needed.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
determine the protein alpha-1-acid glycoprotein (AAG), also known as orosomucoid. AAG is a plasma p
concentration rises significantly during acute inflammatory processes (i.e., it is an acute-phase reacta
acute inflammatory responses include surgery, myocardial infarction, infections, and/or tumors. Increa
typically occur within 12 hours of the injury and decrease in 4 or 5 days.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (e.
determine the presence of protein alpha-1 Antitrypsin (AAT), also known as protease inhibitor. AAT is a
acts as the major inhibitor of trypsin and other proteolytic enzymes. Its concentration rises significant
inflammatory processes (i.e., it is an acute-phase reactant), including surgery, myocardial infarction, i
presence of tumors. Increased levels of AAT typically occur within 24 hours of the injury and decrease
Reduced levels or the absence of AAT is associated with increased risk of emphysema, especially in ch

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
determine the protein alpha-2 macroglobulin (A2MG), a high-molecular-weight protein whose major fu
oncotic pressure during protein loss and that inhibits protease in a different way than other inhibitors.
variety of enzymes, including trypsin, plasmin, thrombin, and elastase. Increased levels of A2MG in b
(hyperglobulinemia) are seen in nephrotic syndrome.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


maternal and fetal serum, amniotic fluid) to determine alpha-fetoprotein (AFP), a fetal glycoprotein se
pregnancy, initially by the fetal yolk sac and later by the fetal liver. Abnormally high levels of AFP in m
associated with many conditions, including fetal open neural tube defects such as anencephaly and sp
(meningomyelocele); low levels are found in conditions such as trisomy-21 (Down's syndrome) and tri
AFP is secreted after birth by neoplastic tumor cells (i.e., a tumor marker). High levels (typically greate
microgram/liter) are indicative of hepatocellular carcinoma; the level of AFP is used for prognosis and
hepatocellular carcinoma.

Microbiology reagents intended to identify bacteria that can multiply only in the absence of oxygen (i.
many anaerobic bacteria are part of the normal flora of the skin, mouth, colon, and vagina. Anaerobic
several pathologic species, such as Clostridium perfringens (causing gas gangrene) and C. tetani (etio
Anaerobic identification reagents may be specific for either manual or automated tests; reagents for id
particular species of anaerobes are available.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma, serum) to determine circulating antibodies against the cells of the walls of body cavities (i.e.,
[PCAs]). High levels of PCA, especially in diabetes type I patients, are associated with autoimmune ga
particularly to chronic atrophic gastritis and pernicious anemia.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine anti-smooth-muscle antibodies. These antibodies are frequently found in patients with ch

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies directed against thyroglobulin (i.e., antithyroglobulin antibodies), a large glycop
constituent of thyroid colloid. These antibodies are frequently found in a progressive autoimmune dise
gland with lymphocytic infiltration (Hashimoto's thyroiditis), in other autoimmune diseases of the thyr
disease), and in idiopathic myxedema (associated with primary hypothyroidism).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies associated with autoimmune diseases of the thyroid glands. Some of the antibo
autoimmune diseases are also found in other autoimmune diseases and in certain malignancies.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies directed against a protein component of thyroid cell microsomes (i.e., antimicros
These antibodies are found in almost all adult patients with a progressive autoimmune disease of the
lymphocytic infiltration (Hashimoto's thyroiditis), in more than 80% of patients with Grave's disease, a
idiopathic myxedema (associated with primary hypothyroidism).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine thyrotropin (also known as thyroid stimulating hormone) receptor antibodies (TRAb) that b
membranes at or near the thyrotropin receptor site. TRAbs are found in almost all adult patients with a
autoimmune disease of the thyroid gland with lymphocytic infiltration (Hashimoto's thyroiditis), in mo
with Grave's disease, and in patients with idiopathic myxedema (associated with primary hypothyroid

Serology reagents intended to detect antibodies to species of fungi of the genus Aspergillus, imperfec
Hyphomycetes. Aspergillus species (e.g., fumigatun, flavus) are opportunistic pathogens that cause as
characterized by inflammatory granulomatous lesions in the skin, lungs, and ears; they may also affec
meninges.
Serology reagents intended to detect antibodies to Bordetella pertussis, a gram-negative coccobacillu
cause pertussis (whooping cough).
Serology reagents intended to detect antibodies to species of Brucella, a genus of nonmotile bacteria
affiliation. Brucella bacteria of several species (e.g., B. abortus, B. suis) are pathologic in humans, cau
disease characterized by intermittent (i.e., undulant) fever.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine circulating C-reactive protein (CRP), a protein of the family of pentraxins secreted by the
variety of inflammatory cytokines. Levels of CRP increase rapidly in response to inflammation, infectio
decrease just as rapidly with the resolution of the condition. The levels are high in chronic inflammato
rheumatic, cardiovascular, and hepatic disorders.

Microbiology reagents intended to identify Candida albicans, a yeast-like species of imperfect fungi of
Cryptococcaceae. These fungi are part of the normal flora of the skin, mouth, intestinal tract, and vag
the Candida species that most frequently causes superficial infection of the moist cutaneous areas of
candidiasis). The fungi may also infect the blood stream (i.e., deep candidiasis), especially in immuno

Serology reagents intended to detect antibodies to Candida albicans, a yeast-like species of imperfect
Candida, family Cryptococcaceae. These fungi are part of the normal flora of the skin, mouth, intestina
they can cause superficial infection of the moist cutaneous areas of the body. The fungi may also infec
(i.e., deep candidiasis), frequently in immunocompromised patients.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine the oncofetal antigen human carcinoembryonic antigen (CEA), a family of related cell-su
secreted after birth by neoplastic tumor cells (i.e., a tumor marker). The level of CEA is elevated in ma
malignancies, especially in colorectal cancer, but also includes lung, gastric, breast, and pancreatic ca
is mostly used as an adjunct for clinical staging of cancer. CEA is also used for detecting metastasis of
monitoring cancer of several different organs. The family of CEA glycoproteins also includes CEACAM6
nonspecific cross-reacting antigen, or NCA) and CEACAM1 (also known as biliary glycoprotein or BGP)
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of a
sample to determine the total level of protein. Increased levels of protein in the cerebrospinal fluid are
the permeability of the blood-brain barrier is disrupted or whenprotein production in the brain or spina

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
(CER), the principal copper-containing protein in human plasma and one of the acute-phase reactants
ceruplasmin combined with increased copper concentration are associated with an inherited disease c
defect in the metabolism of copper (Wilson's disease, also called hepatolenticular degeneration). Incre
common in infections, trauma, biliary duct obstruction, and Hodgkin's disease.

Microbiology reagents intended to identify species of Chlamydia, a genus of intracellular bacteria of th


Chlamydiaceae, by detecting the target bacteria, usually through tests performed on cell-line cultures
cause a variety of diseases in humans, including trachoma, inclusion conjunctivitis, and a significant n
infections.
Microbiology reagents intended to identify Legionella pneumophila, an intracellular bacterium of the g
Legionellaceae. These bacteria cause legionellosis, a pneumonia-like disease in humans.
Serology reagents intended to detect antibody titers or antigens of Legionella pneumophila, an intrace
family Legionellaceae. These bacteria cause a pneumonia-like disease in humans (legionellosis).

Immunoassay reagents used in immunologic tests to determine human leukocyte antigens, a group of
that regulate the immune response and that are found on white blood cells and also in all nucleated c
tests are mostly used to match donor and recipient tissues before transplants (e.g., kidney, bone marr

Serology reagents intended to detect and/or identify antigens or serum antibody titers to measles viru
RNA enveloped virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is the etiologic a
acute, usually benign infection characterized by coryza, cervical lymphoid hyperplasia, conjunctivitis,
malaise, fever, and, finally, skin eruption (rash).
Serology reagents intended to detect antibodies to epidemic parotitis (mumps) virus, an RNA virus of
Paramyxovirus, family Paramyxoviridae. This virus is the etiologic agent of epidemic parotitis (also kno
infection characterized by swelling of one or both parotid glands that may also affect the pancreas, ca
the testes (orchitis), and affect the ovaries.
Microbiology reagents intended to identify Mycoplasma pneumoniae, a species of bacterium of the ge
family Mycoplasmataceae. These bacteria are the etiologic agent of primary atypical pneumonia (i.e.,
pneumonia) and other febrile upper-respiratory-tract infections.
Serology reagents used to detect antibodies to Mycoplasma pneumoniae bacteria. These bacteria are
primary atypical pneumonia (i.e., mycoplasmal pneumonia) and other febrile upper-respiratory-tract in

Microbiology reagents intended to identify Mycoplasma hominis and/or Ureaplasma urealyticum bacte
urethral or cervical sample, semen, infant cephalospinal fluid). These bacteria may cause infections in
reproductive tract; they are also associated with respiratory diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
cerebrospinal fluid) to determine myelin basic protein (MBP), the protein component of fatty myelin sh
in cerebrospinal fluid is probably an indicator of the activity of demyelination because its levels are re
or remission of multiple sclerosis.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
urine) to determine myoglobin, an oxygen binding protein found in small amounts in cardiac and skele
of liberated myoglobin increases, both in blood and in urine, soon after the occurrence of heart dama
of myocardial infarction) and before the increase of creatine kinase activity, permitting its use as an e
Myoglobin levels also increase due to injuries in skeletal muscles and/or after vigorous physical exerci

Microbiology reagents intended to identify species of Neisseria, a genus of bacteria of the family Neiss
Neisseria includes several pathologic species, such as N. gonorrhoeae (i.e., gonococci) and N. mening
identification reagents may be specific for either manual or automated tests; frequently, these tests a
to identify Haemophilus bacteria.
Microbiology reagents intended to identify Neisseria gonorrhoeae (also known as gonococcus). These
etiologic agent of gonorrhea, a disease that is usually transmitted sexually.
Microbiology reagents intended to identify Neisseria meningitidis (also known as meningococcus). The
etiologic agent of meningococcal meningitis.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
plasma) to determine plasminogen, a beta globulin that is one of the components of the fibrinolytic en
Plasminogen levels are decreased in several diseases including intravascular coagulation, fibrinogeno
diseases; congenital abnormalities are rare.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
plasminogen activators, a group of substances that convert plasminogen into plasmin. Plasminogen a
present in blood, vascular endothelium and other tissues, urine, and/or other body fluids. Several of th
therapeutic use in the treatment of thrombosis.
Serology reagents intended to detect antibodies to species of bacteria of the genus Chlamydia. These
variety of diseases in humans, including trachoma, inclusion conjunctivitis, and a significant number o
this test is typically used to detect systemic infections.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the presence of circulating immune complexes (CICs) in rheumatoid patients. CICs are hete
composition, and proinflammatory capacities and are associated with systemic inflammation processe
rheumatoid arthritis; they may be related to vascular inflammation and atherosclerosis, stroke, and ot
disorders.

Serology reagents intended to detect exotoxins from Clostridium difficile, a species of bacterium of the
Clostridium difficile bacteria are part of the normal colon flora in humans; they grow in large numbers
exotoxin in sufficient amounts to cause pseudomembranous enterocolitis in patients receiving certain
lincomycin) treatments.
Serology reagents intended to detect antibodies to Coccidioides immitis, a species of imperfect fungi
Moniliaceae. Coccidioides immitis is a pathogen of the respiratory tract, frequently causing allergic ma
fungi may also cause coccidiomycosis and/or fungal pneumonia.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
the level of one or more of a group (at least 20) of immunologically distinct proteins found in blood an
(complement components). These proteins are synthesized by the liver and are normally present in th
inactive molecules. Complement components of the classical and final pathway are numbered from C
and those of the alternative path are designated by single capitals (e.g., B, D), except C3, which is com
Lower-case suffixes (i.e., a, b, c) denote fragments into which a component has been split. In living org
components can interact with cell membranes to destroy viruses, bacteria, and cells; abnormal serum
components may be due to either inherited or acquired diseases.

Microbiology reagents intended to identify Cryptococcus neoformans, a yeast-like species of imperfec


Cryptococcaceae, which usually has a capsule. Cryptococcus neoformans is a pathogenic fungus that
(cryptococcosis) the brain membranes, the skin and the lungs, especially in immunocompromised pat

Serology reagents intended to detect antibodies to Cryptococcus neoformans, a yeast-like species of i


family Cryptococcaceae. Cryptococcus neoformans is a pathogenic fungus; infection may involve the
typically, brain membranes, especially in immunocompromised patients.

Serology reagents intended to detect antibodies to cytomegalovirus (CMV), a DNA virus of the family H
types of CMV may cause a variety of diseases (i.e., cytomegalic inclusion diseases, leukemia) dependi
status and age of the host; persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV), a


family Herpesviridae. Some types of CMV may cause a variety of diseases (i.e., cytomegalic inclusion
depending on the immune status and age of the host; persistence of the virus for the lifetime of the h

Serology reagents intended to detect antibodies to species of Entamoeba (amoeba) parasites, a genu
protozoa. Several species of Entamoeba are parasitic to humans, including E. coli and E. histolytica, ca
disorders and amebiasis.
Microbiology reagents intended to identify a family of interrelated gram-negative, non-spore-forming a
(Enterobacteriaceae); many of these bacteria are part of the normal flora of the large intestine in hum
vertebrates. Enterobacteriaceae family also includes some pathologic types of bacteria, such as Esche
typhi, and Shigella. These reagents may be specific for either manual or automated tests; reagents fo
particular genera, types, and/or subtypes (e.g., Salmonella, Salmonella typhi, Shigella dysenteriae) ar

Serology reagents intended to detect and/or identify antigens or serum antibody titers to Epstein-Barr
virus of the family Herpesviridae. EBV may cause infectious mononucleosis and is closely associated w
such as Burkitt's lymphoma and nasopharyngeal carcinoma.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV), a
family Herpesviridae. EBV may cause infectious mononucleosis and is closely associated with maligna
Burkitt's lymphoma and nasopharyngeal carcinoma.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the level of ferritin, an iron-apoferritin complex, one of the main forms of iron storage in
present in the blood in very low concentrations, but it usually reflects the variation in the total iron bo
levels of ferritin are found very early in the development of iron deficiency in otherwise healthy patien
ferritin are associated with chronic infections, rheumatoid arthritis, renal diseases, a variety of malign
and other diseases.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
determine fragments of varying sizes that result from the action of plasmin on fibrin or fibrinogen. Inc
these fragments are associated with diffuse intravascular coagulation (DIC) and fibrinolysis.

Serology reagents intended to detect antibodies to Francisella tularensis, a species of gram-negative b


bacteria cause tularemia, a disease characterized by malaise, fever, chills, and weakness; these bacte
transmitted by wild animals.
Microbiology stains used for coloration of bacteria, differentiating between two groups termed gram n
positive. This is usually the primary and most general classification performed on pathogenic bacteria
between gram-positive and gram-negative bacteria depends on the cell-wall thickness and structure o

Microbiology reagents intended to identify species of bacteria of the genus Haemophilus; many specie
family Pasteurellaceae; bacteria are part of the normal flora of the upper respiratory tract. Haemophilu
several pathologic species, such as H. influenzae (bacterial meningitis), H. parainfluenzae (bacterial e
aegyptius (purulent conjunctivitis). Haemophilus identification reagents may be specific for either man
tests; frequently, these tests are combined with tests to identify Neisseria bacteria.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
(HAP), a plasma glycoprotein that irreversibly binds to free hemoglobin. The hemoglobin/haptoglobin
the parenchymal cells of the liver, preventing loss of hemoglobin and conserving iron. Haptoglobin is o
reactants. Increased levels of HAP in plasma occur in extensive tissue damage and necrosis; low level
hemolytic anemia, transfusion reactions, and malaria.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
hemopexin, a plasma glycoprotein that irreversibly binds to free heme (a product of the breakdown of
and globin); the combined product is removed by the liver. Decreased levels of hemopexin are found i
hemolysis; as hemopexin is not a protein that reflects acute inflammation (i.e., it is not an acute-phas
determination is a better indicator of hemolysis when acute inflammation and hemolysis are concurre

Serology reagents intended to detect antibodies to hepatitis A viruses, RNA viruses of the genus Picor
Picornaviridae. These viruses may cause hepatitis, a disease characterized by jaundice and the increa
serum (e.g., aspartate aminotransferase); hepatitis A viruses are almost exclusively transmitted by th
contaminated food or water, although parenteral transmission is possible.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to hepatitis A viruses, typica
genus Picornavirus, family Picornaviridae. These viruses may cause hepatitis, a disease characterized
increase of some enzymes in serum (e.g., aspartate aminotransferase); hepatitis A viruses are almost
transmitted by the fecal-oral route or via contaminated food or water, although parenteral transmissio
Serology reagents intended to detect immunoglobulin antibodies (both IgG and IgM) to hepatitis B viru
antibodies typically appear in serum at the onset of disease, usually two or three months after exposu
are DNA viruses of the genus Hepadnavirus, family Hepadnaviridae. Hepatitis B virus may cause hepa
characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransfera
be transmitted percutaneously (e.g., via body piercing, tattooing), parenterally, from mother to child a
(e.g., sexual) contact.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to hepatitis B virus core anti
typically appear in serum at the onset of disease, usually two or three months after exposure, and are
high levels for five or more months. Hepatitis B viruses are DNA viruses of the genus Hepadnavirus, fa
These viruses may cause hepatitis, a disease characterized by jaundice and the increase of some enz
aspartate aminotransferase); these viruses may be transmitted percutaneously (e.g., via body piercin
parenterally, from mother to child at birth, or by intimate (e.g., sexual) contact.

Serology reagents intended to detect core antigens to hepatitis B viruses, DNA viruses of the genus H
Hepadnaviridae. Hepatitis B virus may cause hepatitis, a disease characterized by jaundice and the in
enzymes in serum (e.g., aspartate aminotransferase); these viruses may be transmitted percutaneous
piercing, tattooing), parenterally, from mother to child at birth, or by intimate (e.g., sexual) contact.

Serology reagents used to detect in a patient's sample either soluble antigens closely associated to su
hepatitis B or antibodies to those soluble antigens. These soluble antigens are known as Be (or early)

Serology reagents intended to detect antibodies to hepatitis B virus surface antigens. These antibodie
serum during the resolution and convalescent phases of the disease. Hepatitis B viruses are DNA virus
Hepadnavirus, family Hepadnaviridae. These viruses may cause hepatitis, a disease characterized by
increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruses may be transmi
(e.g., via body piercing, tattooing), parenterally, from mother to child at birth, or by intimate (e.g., sex

Serology reagents intended to detect antigens to the outer coat (i.e., surface) of hepatitis B viruses. T
appear in serum before any clinical sign of hepatitis and persist throughout the clinical course of the d
viruses are DNA viruses of the genus Hepadnavirus, family Hepadnaviridae. These viruses may cause
characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransfera
be transmitted percutaneously (e.g., via body piercing, tattooing), parenterally, from mother to child a
(e.g., sexual) contact.

Serology reagents used to corroborate (i.e., confirm) the results of a previous test for the presence of
surface antigens. Hepatitis B viruses are DNA viruses of the genus Hepadnavirus, family Hepadnavirid
cause hepatitis, a disease characterized by jaundice and the increase of some enzymes in serum (e.g.
aminotransferase); these viruses may be transmitted percutaneously (e.g., via body piercing, tattooin
mother to child at birth, or by intimate (e.g., sexual) contact. Confirmatory assays frequently use a diff
more specific methodology than the original test; they typically cost more and/or require more sophist
greater skill.
Microbiology reagents intended to identify Herpes simplex virus (HSV), a DNA virus of the family Herp
cause a variety of conditions, including gingivostomatitis, herpes labialis, genital herpes, neonatal her
conjunctivitis, skin eruptions, aseptic meningitis, and encephalitis. Activation of latent herpesvirus is a
malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect antibodies to Herpes simplex virus (HSV), a DNA virus of the fam
may cause a variety of conditions, including gingivostomatitis, herpes labialis, genital herpes, neonata
conjunctivitis, skin eruptions, aseptic meningitis, and encephalitis. Activation of latent herpesvirus is a
malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Herpes simplex virus (HSV
family Herpesviridae. HSV may cause a variety of conditions, including gingivostomatitis, herpes labia
neonatal herpes, keratitis, conjunctivitis, skin eruptions, aseptic meningitis, and encephalitis. Activatio
is associated with some malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect antibodies that nonspecifically react to different proteins and are
diagnosis of infectious mononucleosis. Mononucleosis is a viral infection causing fevers, sore throat, a
glands, especially in the neck. It is typically caused by the Epstein-Barr virus, but can also be caused b
such as cytomegalovirus. Both viruses are members of the herpesvirus family. Most patients (typically
a detectable Heterophile antibody level within three weeks of infection, but Heterophile antibodies are
infectious mononucleosis; they have been occasionally associated with disease states other than infec
(e.g., leukemia, cytomegalovirus, Burkitt's lymphoma, rheumatoid arthritis, viral hepatitis).

Serology reagents intended to detect antibodies to Histoplasma capsulatum, a yeast-like species of im


family Moniliaceae. Histoplasma capsulatum infection (histoplasmosis) is frequently asymptomatic, bu
influenza-like illness or pneumonia. These fungi can affect the lungs, meninges, heart, and other orga
immunocompromised patients.
Serology reagents intended to detect antibodies to human immunodeficiency virus serotype 1 (HIV-1)
genus Lentivirus, family Retroviridae. HIV-1 is the most common etiologic agent of acquired immunode
(AIDS).
Serology reagents used to detect antibodies to bacteria and/or fungi that may cause a respiratory hyp
when repeatedly inspired (i.e., hypersensitivity pneumonitis, also known as allergic alveolitis). These t
antibodies to any of several fungi (e.g., Aspergillus fumigatus, Aureobasidium pullulans) or bacteria (e
faeni, Thermoactinomyces vulgaris).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
determine immunoglobulin A (IgA), approximately 10% to 15% of total immunoglobulin in normal seru
secretory IgA (it includes two molecules of IgA) in tears, saliva, milk, and sweat. Increased levels of IgA
associated with respiratory, renal, and skin infections.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
determine immunoglobulin D (IgD), less than 1% of total immunoglobulin in normal serum. The prima
still unknown.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or bronchial secretion) to determine immunoglobulin E (IgE). IgE is usually found in very low levels in
normal people. Laboratory assays for total IgE are mostly used for allergic screening diagnosis, while s
used when history and skin (prick) tests provide conflicting information, or skin when tests cannot be

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
determine immunoglobulin G (IgG), approximately 70% to 75% of total immunoglobulin in normal seru
IgG in serum are associated with immune responses.
Immunoassay reagents intended to perform qualitative and/or quantitative analysis of body fluids (typ
determine immunoglobulin M (IgM), approximately 5% to 10% of total IgM in normal serum. Increased
associated with viral infections, primary biliary cirrhosis, and malaria.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
detect and/or measure levels of factor B, a proactivator of the C3 protein found in the alternative and
complement activation. Measurement of the levels of factor B is used in diagnosis of some diseases, i
diagnosis of Gram-negative bacteremic shock.
Microbiology reagents intended to identify Pseudomonas aeruginosa, a bacterium of the family Pseudo
bacteria are a major agent of nosocomial infection involving the urinary tract, wounds, abscesses, or t
especially in debilitated patients.
Immunoassay reagents used in rapid tests to detect Streptococcus, a species of coccoid bacteria, in a
Streptococcus is one of the most important bacterial pathogens of humans causing a wide range of su
(e.g., pharyngitis, otitis media, sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheum

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
binding protein (RBP), an alpha-globulin protein secreted by the liver that forms a complex with transt
binds and transports retinol (vitamin A) to the peripheral tissues. The level of RBP in plasma is a sensi
malnutrition or liver dysfunction due to their short half-life in healthy conditions; its level in serum also
renal diseases and decreases in protein malnutrition and during liver diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies against antigenic determinants frequently found in patients with rheu
rheumatoid factors). Determination of rheumatoid factors (RFs) is the most consistent prognostic of j
functional disabilities in early rheumatoid arthritis; its determination is frequently used in combination
determination of other autoimmune antibodies (e.g., cyclic citrullinated peptide antibodies) to increas
prediction.

Serology reagents intended to detect antibodies to species of Rickettsia, a genus of gram-negative ba


Rickettsiaceae. Rickettsia bacteria that are pathologic in humans are usually divided into three groups
relationships. The typhus group includes the species R. typhi and R. prowazekii. Spotted-fever-group s
several similar diseases that are widely distributed geographically (e.g., Rocky Mountain spotted fever
Siberian tick typhus), include R. rickettsii, R. conorii, and R. siberica. The group of species causing scru
tsutsugamushi.

Serology reagents intended to detect antibodies to rubella virus, an RNA virus of the genus Rubivirus,
Rubella virus is the cause of an acute, usually benign infection, often affecting children; the disease is
pink rash beginning on the head and spreading to become generalized. Transplacental infection of a fe
is also called German measles and, in French and Spanish, rubeola.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to rubella virus, an RNA viru
Rubivirus, family Togaviridae. Rubella virus is the cause of an acute, usually benign infection, often aff
disease is characterized by a pink rash beginning on the head and spreading to become generalized.
of a fetus may occur. Rubella is also called also German measles and, in French and Spanish, rubeola.

Serology reagents intended to detect antibodies to species of Salmonella bacteria. Salmonella bacteri
humans are classified based on their constituent antigens (serotypes) in three types: S. typhi, the cau
choleraesuis, associated with paratyphoid, gastroenteritis, and septicemia; and S. enteritidis (which in
serotypes except the first two), also associated with paratyphoid, gastroenteritis, and septicemia.

Microbiology reagents used for identification of Staphylococcus aureus, a coccoid bacterium. These ba
agent of serious suppurative infections.
Microbiology reagents intended to identify species of Streptococcus, a genus of coccoid bacteria of the
Streptococcaceae with a tendency to grow in pairs or chains; they are divided into many serogenic gro
cell wall (e.g., A, B, C). Streptococcus bacteria include many pathologic species, such as S. pneumonia
that cause a wide range of suppurative diseases (e.g., pharyngitis, otitis media, sinusitis, endocarditis
sequelae (e.g., acute rheumatic fever). These reagents may be specific for either manual or automate
identification of particular groups (e.g., A, B) of streptococci are available.

Microbiology reagents intended to identify group A Streptococcus (typically Streptococcus pyogenes),


bacteria of the family Streptococcacaea. Group A streptococci produce a wide array of serious infectio
pharyngitis, impetigo, endocarditis, meningitis, and arthritis.
Microbiology reagents intended to identify group B Streptococcus species (e.g., Streptococcus agalact
streptococci are associated with serious neonatal infections characterized by sepsis and meningitis, a
postpartum infections.
Serology reagents intended to detect antibody titers or antigens of Streptococcus pneumoniae (also k
pneumococcus) bacteria. These bacteria are the most common cause of lobar pneumonia; they can al
diseases (e.g., meningitis, septicemia, peritonitis).
Serology reagents intended to detect reagin, an antibody to the cardiolipin-lecithin complex, as a scre
of syphilis. These reagents are used in tests that are inexpensive and simple but that are subject to fa
presence of several other diseases such as hepatitis, herpes, and mononucleosis. Syphilis tests that d
used in monitoring the progress of syphilis and in determining the outcome of treatment.

Serology reagents intended to detect antibodies to teichoic acid, a polymer found in the cell wall and
bacteria. High levels of teichoic acid antibodies in serum indicate the possible presence of bacteria, es
Staphylococcus aureus infection.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine a glycoprotein known as the Tennessee antigen. Tennessee antigens are associated with
bladder, and gastrointestinal tract.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
serum) to determine thyroglobulin (Tg), a large glycoprotein (a prohormone) that is stored in the follic
thyroid gland and participates in the synthesis of triiodothyronine (T3) and thyroxin (T4). Increased le
associated to thyroid papillary and follicular carcinomas, thyroid adenoma, and other diseases of the t
determination is particularly useful in monitoring recurrence of thyroid carcinoma following surgical re
the level of thyroglobulin in serum samples is difficult if antithyroglobulin antibodies are present, as fr
thyroid cancer patients.

Serology reagents intended to detect antibodies to the Toxoplasma gondii parasite and/or rubella, cyto
herpes simplex viruses. Detection of any of these antibodies may indicate current, recent, or previous
these microorganisms.
Serology reagents intended to detect antibodies to Toxoplasma gondii, a species of obligate intracellu
parasite. These parasites cause toxoplasmosis, an acute or chronic disease transmitted by the feces o
cysts in infected meat. Most infections are mild and self-limited, but extensive damage (e.g., to the br
muscle) may occur, especially in immunocompromised patients or in fetuses infected by transplacent

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Toxoplasma gondii, a spec
intracellular coccidian protozoon parasite. These parasites cause toxoplasmosis, an acute or chronic d
the feces of cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but exte
the brain, eyes, cardiac muscle) may occur, especially in immunocompromised patients or in fetuses i
transplacental transmission.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
(also known as siderophilin), a beta-globulin protein that is the main plasma protein that binds and tra
Transferrin (TRF) is also capable of binding other metals, such as copper, calcium, zinc, and cobalt. Th
iron saturation of TRF is used as a differential diagnosis in anemia. High transferrin levels are associat
estrogen administration; low levels of TRF are found in the inherited disease atransferinemia, as well a
inflammation, and malignancies.

Serology reagents intended to detect antibodies to Trichinella spiralis, one of the smallest parasitic ne
parasites are the etiologic agent of trichinosis, a disease characterized in early stages by diarrhea, na
advanced stages produce stiffness, fever, pain, and swelling of muscles.
Microbiology reagents used to detect and/or identify one or more of the species of the genus Trichomo
species Trichomonas vaginalis that parasitize the human reproductive system. Trichomonas vaginalis i
pathological species, causing a profuse vaginal discharge in women; in men, infection is usually asym

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum, plasma) to determine either one or more of a group of drugs, such as acetaminophen, catecho
salicylates, that are the most common cause of human toxicities when taken in overdose and/or other
are accidentally or intentionally ingested. Toxicology determinations are also performed using chroma
can measure the level of many drugs simultaneously.

Rapid-test clinical chemistry reagents used to determine occult blood in a sample of feces in a short p
typically several minutes.
Bedside physiologic monitors designed for continuous measurement and display of information of the
the brain and the associated electroencephalogram (EEG) that can perform a computerized spectrum
wired to the patient at the bedside. These monitors include a central unit with electronic circuits that c
from electrodes that are usually placed on a patient's scalp and/or forehead. Spectral EEG monitors ty
computerized spectrum analysis that separates the spectrum into its sine and cosine components (i.e
The displayed signal may include bar graphs, a compressed spectral array (CSA), or a density spectra
electroencephalography monitors are used to facilitate the detection and evaluation of changes in the
monitors may be used as a component of a physiologic monitoring system that also includes a centra
auxiliary displays. Some intraoperative spectral analysis monitors can also perform a bispectral analys
technique that provides an index which correlates with the degree of awareness of anesthetized patie

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
spills/leaks of cytotoxic material (e.g., chemotherapeutic or antineoplastic agents). Items in these kits
absorbents, towelettes gloves, goggles, gowns, labels, disposal bags/containers, scoops/scrapers, and
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure. Cy
recovery kits are intended for absorbing and/or encapsulating cytotoxic material for removal and/or di
nuclear medicine laboratories, and other healthcare facilities.

Monitors designed to simultaneously and continuously sample, measure, and display the concentratio
anesthetic gases using a mass spectrograph during surgical procedures using general anesthesia (i.e.
monitors typically consist of a gas sampler, a mass spectrometer, electronic circuits, and a display.; tT
use of a disposable kit including tubes, adapters, and a filter for proper functioning. Mass spectrograp
respiratory/anesthetic gas monitors can identify and quantify simultaneously all common respiratory a
(e.g., oxygen, carbon dioxide, nitrous oxide, isoflurane, desflurane, and sevoflurane) and also nitrogen
quantification of nitrogen may aid in the diagnosis of intraoperative air embolism during surgery and i
integrity of the delivery system. Mass spectrography monitors can be used as a dedicated single-patie
of a computerized system for many patients in different operating rooms on a time-sharing basis.

Physiologic analyzers that assess human body composition. These analyzers may determine body com
fat/fat-free two-compartment models (also called fat/lean components) using indirect methods (e.g., d
absorptiometry, electrical conductivity, impedance), or a several-component method (typically four; i.
mineral, fat) using direct methods such as neutron-activation analysis.

Clinical chemistry reagents intended to determine the level of glucose in a sample of whole blood in a
typically several minutes (i.e., rapid tests). These reagents are impregnated in one or more areas of a
strip) that undergo a color change when reacted with specific substances. High levels of glucose (hype
typically caused by diabetes mellitus, a group of metabolic disorders of carbohydrate metabolism in w
underutilized; decreased levels of glucose (hypoglycemia) are found in several diseases in children an
Iontophoresis therapy units designed to introduce tap water and/or water solution (e.g., glycopyrrolate
ions into the sweat ducts to treat excessive perspiration (hyperhidrosis). These units typically consist
generator (some units also include alternating current output) and appropriate electrodes (e.g., axillar
palms and soles) connected to the generator by cords. Hyperhidrosis iontophoresis therapy units are u
palmoplantar sweating, but some units may be used to treat the axillae (armpit) area, the stump regio
other body areas. The mechanism of hyperhidrosis control is probably the development of hyperkerato
ducts.

Ultrasonic scanning systems that include an ultrasonic scanner, transducers, cardiac analysis software
(e.g., videocassette), and a printer. These systems usually produce sector images using mechanical or
configurations. Many cardiac ultrasonic scanning systems include additional transducers for improvin
increasing tissue penetration. Most cardiac ultrasonic scanners include continuous-wave and pulsed-w
capabilities for sensing the velocity and location of blood flow and can be operated in M mode and B m
and B-mode, color flow mapping, and triplex mode (simultaneous acquisition and display of 2-D gray-s
and color flow data). These systems are designed for real-time, noninvasive imaging of heart structure
diagnose congenital cardiac defects (e.g., patent ductus arteriosus), to determine the extent of myoca
detect other abnormal conditions, such as mitral and aortic stenosis and insufficiency.

Ventilators designed to provide support to patients who do not require complex critical care ventilator
positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an e
tracheostomy cannula, or a mask, typically when ventilation is needed only at night. These ventilators
system and alarms; some ventilators also include oxygen accumulators and heating and humidifying c
Portable/home care ventilators may use several methods of cycling (e.g., volume, time) and several v
including control, assist/control, and synchronized intermittent mandatory ventilation (SIMV) modes. P
supplied from a power line or from an internal or external battery (e.g., a car battery). These ventilato
lightweight, and easy to operate, should resist tipping over, and be easily mounted in different orienta
alarms should allow quick assessment and correction of the alarm condition. Portable/home care vent
long-term ventilatory support in extended care facilities and in the home; they may also be used in em

Aspirators/irrigators designed to provide irrigation and evacuate fluids (i.e., gases and liquids), tissue,
from a body cavity through an endoscope. These irrigators usually include pumps to deliver the liquid
debris, appropriate means (e.g., tubes, catheters) to irrigate the operatory or treatment field through
an endoscope, and controls for exterior regulation of the mode of operation (irrigation or suctioning )
the flush and vacuum applied. Endoscopic aspirators/irrigators are intended for a variety (e.g., gastric
procedures, each one using an appropriate delivery system.
Respiration monitors designed for continuous measurement and display of information on the gas pre
the ventilation artificial airway (e.g., inspiratory limb, Y-piece) that are hard-wired at the bedside. Thes
central unit with electronic circuits that can process data from pressure sensors attached to the artific
display. The monitors typically include high-pressure tubing, a transducer, and a cable. Airway pressur
provide real-time information on patients under assisted respiration at the bedside, helping to assess
mechanical ventilation or to ensure the maintenance of mechanical ventilation in clinically paralyzed p
monitors are sometimes integral components of ventilators or anesthesia units for intraoperative use.

Synthetic dressings made of synthetic polymers (typically polyurethane). These dressings are usually
coated with an adhesive that is permeable to water vapor and oxygen but impermeable to liquids and
film dressings do not absorb usually wound exudates; they are used mainly in wound management.

Ventilators designed for use in critical care settings; most use positive pressure to deliver gas to the lu
breathing rates and tidal volumes through an endotracheal tube or tracheostomy. These ventilators ty
flexible breathing circuit, a control system, monitors, and alarms. The gas is typically delivered to the
limb breathing circuit. The inhalation limb provides sites where the gas may be heated or humidified u
devices, and the exhalation limb includes an exhaust valve to release the gas to the ambient air. Inten
are usually connected to a wall gas (e.g., oxygen, air) supply. Intensive care ventilators are frequently
the variable used to terminate inspiration (e.g., volume, flow, pressure, time-cycled); they can be ope
modes, such as assist/control or synchronized patient triggered. Some intensive care ventilators can p
lungs at frequencies much higher than the normal breathing rates (100 or more times per minute is ty
pressure ventilators are also used in intensive care as an alternative to positive-pressure ventilators fo
patients.

Cleaning solutions formulated for loosing debris from contact lenses; most solutions require a gentle r
Specialized solutions are available according to the material of the contact lenses (e.g., soft, gas perm
solutions include chemical components to remove protein (enzymes) build-up and/or disinfection agen
Cleaning contact lenses typically require rinsing with water or a cleansing agent (e.g., saline solution)
cleaning solution. Contact lens cleaning solutions are used for manual daily cleaning of the lens.

Wetting solutions formulated for rewetting contact lenses. Specialized solutions are available accordin
contact lenses (e.g., soft, gas permeable, rigid). Wetting solutions are typically used after lens cleansi
the lens on the eyes. The use of contact lens wetting solutions facilitates lens wear and relieve from m
extending lens wearing time.
Incubators mounted on wheels. These incubators typically consist of a clear removable plastic hood w
caster; they also include some means to warm the infant and temperature controls that work automat
measuring the air temperature or through a temperature sensor attached to the infant skin. Most incu
humidity controls. Mobile infant incubators are used mainly to facilitate transportation inside a healthc
premature infants and other newborns that cannot regulate body temperature.
Infant radiant warming units designed to provide thermal stability to an infant while allowing its transp
typically consist of integral bassinet warming units mounted on casters, which may be equipped with
units have an infant weighing scale, resuscitation equipment (suctioning and oxygen delivery), and vi
equipment (e.g., SpO2, pulse, airway pressure, body temperature). Mobile infant radiant warming dev
for internal transportation of infants from one area of the hospital to another and for warming and sta
infant in the delivery room after birth.

Aspirators designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a body s
vacuum suction during autopsies and/or other postmortem procedures. These devices usually consist
pump, a pressure regulator and gauge, one or more large capacity collection canisters, and plastic tub
components to each other. Frequently these units are connected to an autopsy/dissection station, and
protection and/or a bacteria filter. The typical vacuum capability should be at least 400 mm Hg; free-fl
high as 35 liter/min or more. Autopsy aspirators may be portable or mobile and line- or battery-power
coupled to autopsy stations may include accessories to provide simultaneous irrigation. They are main
from a central vacuum system is not available or appropriate.

Thermistor/thermocouple electronic thermometers designed to measure temperatures in clinical labor


These thermometers typically consist of an electronic unit that processes and displays the temperatur
transducers (either thermistors or thermocouples) that convert temperature into electrical signals. Lab
thermistor/thermocouple electronic thermometers are usually used to verify that laboratory equipmen
heated cells, refrigerators) operate within prescribed temperature limits or that materials (e.g., liquids
have reached a desired temperature.

Irradiators designed to provide uniform and efficient irradiation of blood and blood products. These de
of a main unit containing a shielded radioactive source (e.g., cesium 137, cobalt 60), a canister chamb
and a detachable canister to manipulate the blood products. Irradiation of blood products is intended
division, decreasing the risk of graft-versus-host disease.

Laboratory light microscopes with two observation objectives and oculars that provide a three-dimens
under low magnification (usually no more than 60x) and configured for observation of samples using s
methods (e.g., dark field, phase contrast). Most stereo microscopes are manufactured with zooming ca
change in focus or working distance over a certain range. These microscopes are used for three-dimen
or living specimens.

Laboratory light microscopes configured with illumination at the top, the stage below, and optics on th
microscopic study of large specimens by transmitted light. Most inverted-stage microscopes are config
of samples using several contrast methods (e.g., phase contrast). These microscopes are used for exa
cultures in all types of culture vessels (e.g., petri dishes, culture bottles) and in microtest and microtit

Physiologic analyzers that determine male sexual arousal by measuring and evaluating erectile event
tumescence. These analyzers may consist of mechanical electroimpedance or ultrasound sensors for
circumferential volumetric, and/or blood-volume penile changes; they may collect data during diurnal
recording the nocturnal sleep erection cycle. Erection/Tumescence analyzers typically are used in the
dysfunction (impotence), especially in the differentiation between psychogenic versus organic impote
Physiologic monitors designed for the measurement and display of the partial pressure of both oxygen
dioxide (PCO2) in the respiratory circuit and are hard-wired at the bedside. These monitors measure g
by using a sensor in the patient's breathing circuit (mainstream) or by sampling from the patient's airw
monitors typically consist of a main unit which includes electronic circuits that can process the signals
for CO2 and O2 pressure detection, a display that shows the gas concentrations, and programmable a
can also display the CO2 waveform and the concentrations of oxygen (O2) and/or nitrous oxide (NO2).
dioxide/oxygen respiration monitors are used to monitor patients, detect ventilator failure, and to asse
function or the adequacy of perfusion during cardiopulmonary resuscitation; they may also be intende
use in patients under anesthesia.

Monitors designed to continuously and simultaneously sample, measure, and display data on respirato
gases administered during general anesthesia procedures in the operating room. These monitors disp
and expired concentrations of several respiratory gases (e.g., oxygen, carbon dioxide) and anesthetic
oxide, halothane, enflurane, isoflurane); some devices can assess particular gas concentrations from t
halogenated anesthetic gases. Respiration/anesthetic gas monitors perform a set of analyses based o
technologies to determine the concentrations of the gases (e.g., galvanic cells or paramagnetic senso
light spectrometers and/or piezoelectric for halogenated anesthetic agents and nitrous oxide). These m
computerized capabilities and alarms, as well as a display that shows the numerical values, waveform
concentrations of the gases. Anesthetic/respiration gas monitors provide information on the patient's
verify that appropriate levels of anesthetic gases are administered, and warn of problems of the gas d
may also be used also immediately after anesthetic procedures in recovery rooms. Dedicated monitor
and non-disper?sive infrared (DIR and NDIR, respectively) gas analysis and paramagnetic sensors to m
piezoelectric, mass spectrometry, and an infrared analyzer including a micro-optical rotor (MOR) with
filters and a detector to acquire the optical energy specific to the gases being analyzed are also availa

Stents designed for deployment into the trachea to provide support for and/or maintain patency of the
to provide respiration through the larynx. These devices may consist of a metallic (e.g., mesh-like wir
and they are available in several different shapes (e.g., straight, bent, T) to adapt to particular section
to prevent migration. The stent surface may be coated to give the stent special capabilities (e.g., wate
stents may be deployed using rigid or flexible bronchoscopes, according to their shape and physical c
stents are used to treat proximal or middle tracheal stenosis caused by benign diseases, injuries, or m
facilitate the flow of air into the lungs.

Dryers designed to remove moisture from breathing circuit components such as hoses and masks usin
warm air). These dryers typically consist of a warm-air generator, an enclosure that includes nozzles t
and appropriate holders to fix the breathing circuit components. Breathing circuit dryers are used to p
after the breathing circuits are washed.
Microbiology reagents in the form of liquids, solids, or semisolids that include additional nutritional com
enriched media) used as a medium capable of supporting the growth of specific bacteria. These cultur
relatively simple basal medium enriched by the addition of nutritional components (e.g., blood, blood
extracts, animal tissues) required to support the growth and identify of a wide variety of fastidious bac
having complex nutritional requirements. Enriched culture media are used in the identification and dia
caused by pathogenic microorganisms.

High-speed (usually up to 28,000 rpm) tabletop centrifuges designed to separate small sample volum
to 2.2 mL. These centrifuges are typically compact, stationary structures and consist of an electric mo
and time controls; they also include a rotor on which one fixed head is mounted. Most high-speed mod
capabilities; they include a compressor and other associated devices needed to keep the rotor chamb
facilitate performance of temperature-sensitive procedures. Microsample high-speed tabletop centrifu
microorganisms, cells, and precipitates from small samples (e.g., pediatric patient samples); they can
and cellular organelles.

Cardiac catheters designed for the percutaneous dilatation of a cardiac valve (i.e., atrioventricular, ao
trunk valves). Valvuloplasty cardiac catheters are mostly used for nonsurgical dilatation of commissur
mitral valves and annular, cuspal, and calcific nodular fractures; to improve cuspal mobility in adult ca
and for leaflet tearing in pulmonic valve stenosis. These catheters are also used for percutaneous bal
patients with recurrent pericardial effusion.

Physiologic analyzers that simultaneously measure, record, and interpret a variety of physiologic func
These analyzers typically perform evaluations of electroencephalography, electrocardiography, electro
electromyography, respiration, temperature, and pulse oximetry readings; usually, they also provide a
about the sleeping patient for behavioral analysis. Some analyzers also perform additional evaluation
study needs, such as gastroesophageal reflux, bedwetting (enuresis), or penile tumescence. Somnog
of electrodes and instruments that measure physiologic activities; a headbox that includes samplers,
and appropriate software for processing and patient reporting. These analyzers are used in the diagn
sleep and sleep-related disorders, such as difficulty falling asleep (insomnia), difficulty staying awake
and other sleep disorders associated with medical or psychiatric conditions.

Dedicated small refrigeration units designed to hold and quickly chill cold packs or compresses used o
consist of a box-like insulated structure (e.g., 27 inches L x 16 inches W x 33 inches H [69 cm x 41 cm
an outside door and interior shelves (some shelves may have cup-holders), an electrically-powered co
to hold and quickly chill the packs or compresses, and a drain valve for defrosting. Most cold pack chil
castors or wheels so they can be easily transported from room to room.

Polygraphs designed for graphic recording of physiologic parameters, such as electrocardiogram, elec
chest wall motion, airflow at both the nose and the mouth, eye movements, oxygen saturation and ele
the patient is asleep. Parameters may be added or omitted depending on the study being performed.
include multiple electrodes placed on the patient in specific areas, amplifiers, and filters. They are us
sleeping disorders (e.g., insomnia, snoring, sleep apnea).
Electrocardiography (ECG) electrodes designed for application to the surface of an infant's body to tra
signals from the heart to an electrocardiograph or intrapartum fetal monitor. These electrodes are usu
attached to a tape, foam, or cloth substrate that meet special pediatric size requirements; they are ty
conductive wet gel to provide instant electrical contact and to secure a gentle adhesion to the infant's
cardiac electrodes are intended to detect and transmit bioelectric heart signals for measuring, recordi
the cardiac rhythm. Reusable as well as disposable neonatal transcutaneous cardiac electrodes are av
neonatal electrodes applied to the fetal scalp intended for intrapartum use are also available.

Stents designed for deployment into the vessels to provide support for and/or maintain patency within
These devices typically consist of a metallic or synthetic scaffolding (e.g., mesh, coil, slotted tube) and
several different shapes (e.g., straight, bent, bifurcated) to adapt to particular sections of the vasculat
migration. Some metallic stents are either balloon expandable or self-expanding; their surface may be
capabilities to the stent (e.g., to reduce protein and/or platelet adhesion, to elute drugs). Vascular sten
reduce vascular recoil or narrowing (i.e., restenosis) of the vessels, especially in the coronary arteries.

Valves designed for use near the filter in tubing sets intended for external delivery of blood from a hea
a patient. These valves automatically prevent the buildup of excess vacuum pressure when blood is su
or the surgical field and/or in retrograde blood flow that may cause the entrainment of air at the cathe
and open vessels. These devices are typically valves with unidirectional flow properties (e.g., a duckbi
valve is typically configured to offer nominal resistance to blood being returned to the patient while bl
the patient to the heart-lung machine, preventing retrograde flow in the arterial line (more frequently
centrifugal pump). Heart-lung bypass automatic shut-off valves are used in tubing sets designed for u
procedures to help prevent inadvertent retrograde flow and delivery of air into the heart.

Synthetic sutures made of expanded polytetrafluoroethylene (ePTFE, also known as Teflon), a nonabso
nonbiodegradable) polymer. These sutures are typically available in sterile monofilament uncoated th
30 in [45, 76 cm] long) attached to a single-use needle as an integral device; they are frequently colo
identification during surgery. Polytetrafluoroethylene nonabsorbable synthetic sutures keep their tensi
long periods of time and are not absorbed by tissues; their intended use includes vessel and vessel-gr
other internal surgical procedures (e.g., hernia repair).

Intracorporeal lithotripters that use either a crystalline solid or an organic dye solution as their laser m
coherent monochromatic light energy. The energy is delivered through an optical fiber, which is place
stones. The laser energy typically causes stone fragmentation in one of two ways: in some cases, the
the laser is activated produces a plasma bubble that fragments the stone. In other cases, the laser en
the stone and causes the stone to vaporize and fragment. The stone fragments usually pass easily th
Stone fragments are sometimes removed using a stone basket or graspers.

Electrocardiography cable/leads including leads designed to produce a very small, almost negligible, a
passage of x-rays. These devices consist of a cable and several (e.g., 3, 5, 12) leads completely isolat
electrode end (known as patient leads); they are intended for connection between the patient electrod
electrocardiograph or cardiac monitor. Radiolucent electrocardiography cable/leads are mainly used fo
displaying in real time the waveforms (i.e., electrocardiograms) of the biologic electric signals from th
procedures (e.g., catheterization) that require real-time radiographic observation.
Synthetic sutures made of polyglactin, an absorbable (i.e., biodegradable) polymer. These sutures are
sterile braided multifilament coated (e.g., a copolymer of lactide and glycolide, polycraprolate) thread
in [45, 76 cm] long) attached to a single-use needle as an integral device; they are frequently colored
during surgery. Polyglactin absorbable synthetic sutures keep their tensile strength up to 2 weeks, and
occurs in 56 to 70 days; their intended use includes general soft-tissue approximation (even in the pre
vessel ligation.

Laboratory analyzers designed to determine the proportion of one or more constituents in a breath an
sample.
Point-of-care breath analyzers used to determine the alcohol (ethanol) content in a breath sample, usu
percentage of blood alcohol concentration.
Point-of-care breath analyzers designed to determine the hydrogen content in a breath sample, usuall
per million (ppm). These analyzers typically use electrochemical or gas chromatography measuring m
these analyzers can also determine methane and/or carbon dioxide content in the breath sample. Hy
analyzers are mostly used to determine carbohydrate bacteriological breakdown deficiencies and mal
intestine due to bacterial overgrowth.

Point-of-care breath analyzers designed to determine the methane content in a breath sample, usually
per million (ppm). These analyzers typically use electrochemical or gas chromatography measuring m
analyzers can also determine hydrogen and/or carbon dioxide content in the breath sample. Methane
mostly used to determine carbohydrate bacteriological breakdown deficiencies and malabsorption in t
to bacterial overgrowth.

Angiographic cardiac catheters that usually include distal tips formed into a circular curve (typical rad
an end hole and multiple side holes. These catheters are designed to pass through the interatrial sept
atrium to the left atrium with the aid of a special needle or a guide wire. Transseptal catheters are us
angiography of the left atrium and left ventricle.
Implantable prostheses designed for total replacement of the temporomandibular joint. These prosthe
both a mandibular fossa component (consisting of a plastic [e.g., polyethylene] fossa bearing that ma
mesh backing, also known as fossa eminence prosthesis [FEP]) and a mandibular condyle component
the mandibular condylar head and to articulate with the mandibular fossa component; they may inclu
disc as a separate component. Total temporomandibular joint prostheses are used in patients who suff
rheumatoid arthritis, congenital malformations, or neoplasms, as well as after trauma (e.g., fracture).

Clinical chemistry reagents intended to perform tests in a sample of urine in a short period of time, ty
(i.e., rapid tests). These reagents are typically in tablets or impregnated in one or more areas of a pap
that undergo a color change when reacted with specific substances. Usually, urinary rapid-test reagen
determination of constituents of urine and/or for sedimentation tests.

Dye lasers used to coagulate abnormal vascular tissue in the retina and to perform other photocoagul
eye. These lasers are typically coupled to a biomicroscope slit lamp or an indirect ophthalmoscope by
cable.
Tunable liquid lasers with organic compounds (i.e., dye) that have a strong absorption band used as th
During emission, the dye must be optically excited by another light source (e.g., another laser, flash la
wavelength may range from the ultraviolet to the near infrared (i.e., from 180 to 1,100 nm). These las
continuous-wave and pulsed modes.
Laboratory blood analyzers used to evaluate the adhesion of red cells (erythrocytes) to one another. E
aggregation analyzers typically determine aggregation indirectly by measuring the changes in light tr
photometer, while the flow velocity of a blood sample is adjusted over the range of interest. By apply
mechanical shear forces to the blood, high enough to cause total disaggregation, they make it possibl
difference between normal and pathological red cell aggregation. These analyzers are an alternative t
sedimentation rate analysis, with some potential advantages, such as a smaller blood sample and fas
disease risks (e.g., cardiovascular disease).

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for fe
Items in these kits usually include a bottle, and nipples; they may also include pacifiers, towelettes, an
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Infant oral feeding procedure kits and trays are intended for use to administer safe and suc
support to infants. They are used in maternity hospitals, homes, infant nurseries and other healthcare

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
spills/leaks of mercury. Items in these kits usually include gloves, goggles, labels, disposal bags/conta
documentation forms. Mercury spill recovery kits are intended for absorbing and/or encapsulating mer
storage/transport and disposal in hospitals, laboratories and other healthcare facilities.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
hazardous or potentially hazardous materials such as chemicals, mercury, infectious waste, or radioac
these kits usually include absorbents, towelettes, gloves, goggles, gowns, labels, disposal bags/contai
forms, and scoops/scrapers. Spill recovery kits are intended for use during immediate cleanup of fluid
laboratories, and other healthcare facilities.

Washers designed for automatic removal of dirt, stains, and/or biological debris (i.e., washing) from m
plates). These washers typically include an enclosure, a plate holder, pumps, hoses for connection to
to a vacuum source, and a programmable control unit (e.g., for controlling wash cycles, soak time, and
Microplate washers may perform several preestablished and/or customized cycles of operation, typica
washing, soaking and nonsoaking washes, and aspirate operations in any chosen order. They are suit
microplates used in many laboratory procedures, including fluorescence, chemiluminiscence, DNA pro
immunoassay.
Auditory evoked potential recorders designed for detecting, amplifying and recording the cochlear bio
the evoked potential [EP]) to auditory external stimuli. These recorders typically place the electrodes
method (passing a needle electrode through the tympanic membrane [i.e., transtympanic]) and restin
promontory. Or they are noninvasively place against the skin of the ear canal or the surface of the tym
extra-tympanic). Other components of the recorder are signal amplifiers; filters (to suppress interferen
electronic or optical/magnetic disc); and a display. The potentials usually recorded in an electrocochle
alternating current (AC) voltage that mirrors the waveform of the acoustic stimulus at low-moderate le
(i.e., cochlear microphonics); (2) a direct current that reflects the time-displacement pattern of the coc
response to the stimulus envelope (i.e., the cochlear summating potential; and (3) an AC potential th
summed response of the synchronous firing of several thousand auditory nerve fibers (i.e., the audito
Potential). Electrocochleographs may include capabilities to deliver external stimuli (e.g., clicks) appro
bioelectric response needed for recording. The recorders are used for diagnosis of specific types of dis
suffering from Meniere's disease and/or endolymphatic hydrops often display enlarged summating pot

Cardiac output units that determines cardiac output from measurements of the thoracic impedance ch
cardiac activity. These devices consist of electrodes appropriate to measure the thoracic impedance a
that processes the data and displays the cardiac output values.
Surgical retractors designed to temporarily separate and hold back the part of the head skin covered w
exposing and providing access to the bones of the skull. These retractors usually consist of manual ins
two blades that merge in a proximal-end rotating mechanism used to adjust the position of the blades
retention of the position once set (i.e., self-retained retractors). Scalp retractors that use scissors-like
retention at the proximal end are also available.

Connectors designed to allow intravenous (IV) delivery of medication by providing a reliable match be
needleless device and the Y-site of an IV administration set or a catheter port. IV connectors are inten
exposed needle after administration of medications. Dedicated connectors for needleless and recesse
available.
Equipment designed to cut molds used for manufacturing custom-made block shields used in radiothe
equipment typically consists of a cutting mechanism (e.g., a hot wire) that conforms the molding mate
to the appropriate shape needed for body protection (i.e., shielding) from unwanted radiation during t
procedure. It also includes appropriate controls for accurate cutting following a pre-established patter
computer assisted and manufacturing (i.e., CAD/CAM) procedure, cutting may be performed either ma
using equipment with computerized capabilities. This computerization allows the technician to use da
radiotherapy simulation systems and appropriate software. The molds produced by this equipment ar
manufacture radiotherapy block shields made of low-melting alloy materials in radiation therapy mold

Data management information systems designed to provide clinical and administrative information re
delivery. These systems include hardware and software capabilities to collect information from anesth
and other devices used in anesthesia administration; they can collect information both in real-time (e
physiologic monitors) and in delayed-time or off-line applications (e.g., preoperative evaluation data,
pharmacy data). Anesthesia data management information systems assist physicians in establishing t
of the patient and the parameters of the anesthesia machines and in managing the prognosis and trea
Incontinence neuromuscular electrical stimulators designed to apply external stimuli to the muscles o
stimulators typically consist of an electric pulse generator with electrodes attached to a plug or pessa
into the rectum or vagina respectively. Nonimplantable incontinence electrical stimulators are intende
and/or fecal continence.
Warming units designed for heating gel before use. These typically consist of a metallic box that inclu
to keep the box temperature close to the human body temperature; they can hold appropriately one o
(e.g., dispenser bottles) during warming. Some of these units include temperature control capabilities
are typically used to heat gels applied to the patient body for coupling ultrasonic transducers.

Printers designed to produce a permanent, monochromatic and/or color text or graphic copy (i.e., hard
other appropriate media (e.g., transparent film) from video data stored in a recorder or displayed by a
printers typically use thermal technology (e.g., thermal dye transfer also known as dye sublimation) to
on a dedicated film or on heat-sensitive paper with grayscale gradations; the printers may include a d
a frame grabber) to convert signals from analog video sources. Video printers are used in healthcare f
documentation of imaging procedures (e.g., endoscopic, ultrasound, radiographic), as well as to produ
files; video printers are not normally intended to produce images for diagnostic purposes.

Substances or materials capable of attracting or incorporating (i.e., absorbing) carbon dioxide. These
to be inserted in an anesthesia unit carbon dioxide absorber to remove carbon dioxide from the expire
the patient breathing circuit before they are recirculated back through the anesthesia system to the p
absorbent materials include soda lime (e.g., Sodasorb) and barium hydroxide lime (e.g., Baralyme).

External cardiac pacemaker invasive leads designed to conduct electrical pacing signals from the puls
external pacemaker through the esophagus and into the heart. Some leads may also conduct the bioe
back to the unit. These leads typically consist of flexible wires that are completely isolated except at t
Transesophageal pacemaker leads are configured according to the pacemaker characteristics and/or t
signal delivery to the heart. A variety of lead systems, including single- and multiple-lead is available.
type, and other characteristics of the leads must be compatible with the pulse generator and the ther
Endocardial external cardiac pacemaker leads are used in temporary procedures (e.g., surgery, emerg
electrophysiology studies).

Pacifiers designed to promote an infant's oral sucking action. These pacifiers typically consist of a nipp
mounted on a plastic shield that is designed to prevent the infant from swallowing the device; the shie
holes to circulate air and saliva to help protect the infant's skin from chafing. Oral infant pacifiers are
they are available in different sizes and shapes appropriate to fit the infant's mouth.

Devices designed to hold inserted nasogastric tubes in place in a patient's nasal passages, frequently
securing the tube throughout its use. Nasogastric tube holder designs vary; a typical example include
device that has a portion designed to be attached to the end of the patient's nose and a portion desig
around the part of the nasogastric tube that is immediately exterior to the nares. Another example inc
comprised of an adhesive strip that attaches to the end of the patient's nose and a connecting ring th
exterior of the nasogastric tube to lock it in place. Nasogastric tube holders come in adult and pediatr
Phototherapy units designed to irradiate newborns with visible light with a high component in the blue
480 nm wavelength) spectrum to treat hyperbilirubinemia (i.e., jaundice). The effect of this light is to
bilirubin to water-soluble photoproducts that are mostly excreted into bile. Hyperbilirubinemia phototh
available as overhead units that apply the radiation directly from the lamp to the newborn and as sep
deliver the light to the newborn through a fiberoptic cable and a transparent pad or blanket.

Brachytherapy systems designed for automated delivery of radioisotopes, usually cesium-137 or iridiu
cancerous tissue. These systems are typically radioisotope delivery units (i.e., afterload unit) with a so
(usually a computer-controlled stepper motor with drive rollers or belts), a shielded safe, applicators, a
computerized planning unit. Brachytherapy systems may include treatment planning modules, a moto
with three-dimensional (i.e., X, Y, and Z) movement, and x-ray imaging capabilities, completely integr
planning system for immediate update of dose distribution. Radiation isotopes are delivered using eith
for specific body cavities or disposable needles, tubes, or catheters for interstitial delivery. Remote aft
commonly used to treat a range of cancers, including endometrial, cervical, pancreatic, and endobron

Sources of radiation used in either manual or remote-afterloading brachytherapy treatments. These so


radioactive isotopes that may be either naturally occurring or accelerator/reactor produced. Brachythe
the radiation that is used to deliver either external or internal curative or palliative radiotherapy treatm
available in a variety of physical forms such as encapsulated (sealed), plated, foil, or imbedded; they
liquids, gels, other nonsolids, or gases. Radioactive isotopes commonly used in brachytherapy applica
paladium-103 (Pd-103), iridium-192 (Ir-192), and iodine-125 (I-125).

Angioplasty vascular catheters that permit the percutaneous transluminal removal of atherosclerotic p
arteries by mechanical means (e.g., cutting, drilling, pulverizing, shaving), resulting in a smooth vesse
residual stenosis. Some of these catheters make possible the extraction of the atheromatous material
the exterior.
Balloon angioplasty catheters designed to perform percutaneous transluminal coronary angioplasty pr
permitting transmission of blood to the distal coronary bed. In some of these catheters, blood enters t
through side holes proximal to the balloon, due to native coronary (aortic) pressure and exits beyond t
distal coronary artery (passive diffusion). Other perfusing catheters are large-lumen, over-the-wire-de
blood is pumped under pressure through the lumen to the distal tip (active diffusion). Active diffusion
tubes; the annular cavity between the tubes is the inflation channel, while the lumen of the inner tube
the guide wire, as well as for hemoperfusion. During the angioplasty procedure, blood is usually pump
artery using a piston pump. These catheters may be considered a tool for myocardial protection durin
procedures, for prevention of hemodynamic compromise in selected patients, and for prolonged balloo

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (ty
determine one or several of a group of proteins (apolipoproteins) usually synthesized in the liver and/o
Apolipoproteins are usually found surrounding polar lipids (phospholipids and cholesterol) forming a g
complexes in which lipids are transported in the blood. Apolipoproteins have been labeled and describ
from A to E according to their functions.
Cast saws driven by pneumatic power designed to cut casts. These saws are powered instruments wit
mechanism to drive the blade, and a hose connected to the pressurized gas source. Pneumatic cast sa
available as handheld instruments and, less frequently, as stationary tabletop devices; oscillating or r
used to cut casts without damaging the patient's body. Rotary saws are not appropriate for this use. P
are smaller and less noisy than electric saws but produce more debris; they are used to cut casts usin
fiberglass blades cast removal, creation of a hinged cast, or to open a window in the cast to view unde

Contact lens applied on the front surface of the eye for the purpose of protection, sealing of the anter
delivery, changing the corneal curvature or delivering specific treatment to the retina.
Water baths designed to conform plastic moldable splints. These baths typically consist of a temperat
electrical resistors, a thermometer, temperature controllers, and a timer. Some units include a pump
Temperature is usually adjustable from room temperature to 100 degrees Celsius (212 Fahrenheit). Sh
materials are introduced into the pan with the temperature adjusted according to the material and the
the desired splint.

Garment racks designed for temporarily holding aprons. These racks typically consist of an open heav
and/or plastic open framework with hooks or pegs on which aprons are hung; these racks can be wall-
steel racks with hooks/hangers. Apron racks are used in clinical laboratories, surgery and research cen
hospitals, surgery centers, and radiation laboratories and in other healthcare laboratories. Some apron
small wheels to facilitate placement.

Occupancy alarms designed to activate audible and/or visual signals when patients attempt to get out
wheelchairs. These alarms typically consist of pressure pad sensors placed on top of or beneath the se
wheelchair. These alarms are deployed to determine the patient's location and are connected to an el
some chair/wheelchair occupancy alarms can interface with nurse call systems providing remote alarm
occupancy alarms are used to alert caregivers that a patient has or is attempting to move. Chair/whee
alarms can help reduce the likelihood of falls and can promote speedy assistance to patients who hav
alerting caregivers that patients who should not get out of their chairs unassisted are doing so.

Portable fluoroscopic units that use a radiation isotope as the x-ray source instead of a conventional x
units typically are handheld and operated; they permit the observation of small parts of the body (e.g
Radioactive isotope fluoroscopic units are used to assess injured people before transport, in pediatric
remote places or emergency situations.
Ophthalmic devices designed for the diagnosis of binocular vision (e.g., strabismus, amblyopia, diplop
patient's perception of pictures. These devices include lenses, mirrors, a slide carrier of images, and a
permits the device to move in different directions (e.g., diverging, converging, vertical, horizontal, rota
presentation, a light source, and automatic or manual flashing controls to provide alternate illuminatio
used to assess three types of binocular vision: (1) simultaneous perception, (2) fusion, and (3) depth p
Synoptophores are used mainly in the diagnosis of binocular vision impairments such as strabismus, a

Reflecting stereoscopes that present to the two eyes two separate target images through two angled
between the two tubes can be adjusted horizontally and vertically. Therefore, convergence and diverg
measured, binocular vision can be measured or trained, and vision can be stimulated in the amblyopic
Autotransfusion units designed to collect and process blood lost by a patient to obtain red blood cells
reinfusion into the same patient (i.e., autotransfusion). These units typically include a disposable suct
blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., centr
separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate mic
reinfusion bag that stores the red blood cells suspended in saline. Blood processing autotransfusion un
during surgical procedures, but they may be also used during postoperative recovery and in emergen
units after trauma.

Autotransfusion units designed to collect blood lost by a patient for subsequent reinfusion into the sam
autotransfusion) without processing. These units typically include a suction mechanism to collect bloo
field, a mechanism to add anticoagulants, particulate microfilters, and a reservoir to store the blood. W
autotransfusion units are used mainly during surgical procedures, but they may be also used during p
and in emergency or intensive care units after trauma.

Bone densitometers that include an x-ray tube to produce the radiation that scans the body part to be
Measurements are based on the bone absorption of the x-rays and made by scintillation detectors.

Magnetic resonance imaging coils designed for use on the surface of the patient's body during magne
(MRI) studies. These devices typically are RF coils (antennas) in a shape matching the patient's anatom
electrically isolated housing. The coil housing may be either flexible or rigid. Surface coils are differen
specific anatomical regions (e.g., neck/head, spine, breast, extremity). Some coils may be an integral
(e.g., whole body coil, spine coils). Surface MRI coils are compatible with only one or a few specific MR
used to detect tissue abnormalities in MRI imaging studies in specific anatomical regions.

Patient surgical drapes are designed to provide a bacteria-proof barrier between the unsterile skin of t
sterile surgical field. Heat-loss prevention drapes are also designed to keep patients warm and preven
reflecting the body's radiant heat and eliminating convective heat loss. These patient surgical drapes
thermoplastics and aluminum; they can be reusable or disposable. Heat-loss prevention patient surgic
nonconductive, not subject to mechanical or electrical failure, and are also lightweight for patient com
operating rooms for surgical procedures.

Laboratory analyzers used to determine the concentration of lithium in body fluids (e.g., serum, plasm
laboratory lithium analyzers are based on emission photometry or atomic absorption spectrometry. So
selective electrodes for determining lithium concentration. Dedicated lithium analyzers are mostly us
lithium serum concentration (as an indicator of toxicity) in patients under lithium treatment for affecti

Mattresses with appropriate dimensions for use on stretchers in hospitals and/or ambulances. Most of
filled with foam; they are typically made of fire-retardant materials and are enclosed in waterproof ant
Some stretcher mattresses are designed in two or three sections to gatch in the typical positions of a
stretcher (e.g., Fowler).
Tracheal tubes designed to retard fire and reduce the risk of damage caused by laser radiation during
These tubes are typically made of metals (e.g., stainless steel) and/or combinations of metals and pla
polymers covered with aluminum). Laser-resistant tracheal tubes are used in surgical procedures that
on or around the head, neck, or throat. Dedicated tubes intended only to protect against a given rang
are also available.
Adjustable examination/treatment tables that usually include knee crutches, traction handles and hee
are designed to support the woman's body in appropriate positions during gynecologic examination an
may also be able to accommodate C-arm radiographic/fluoroscopic studies.

Combs that are used to locate and remove lice and their eggs from hair. These combs are typically fin
plastic or metal, and may be reusable or disposable.
Mattresses made completely with nonflammable materials (e.g., fireproof foam), not including externa
springs, or vents, to lessen the risk of injury to patients.
Caps that fit over a patient's head and have plastic electrode holders into which electrodes are plugge
need for glue or paste to attach electrodes directly to the scalp. These caps are typically made of an e
available in different sizes (e.g., infant, child, adult), and available in layouts that can hold 16, 32, 64,
electroencephalography electrodes. Caps may come with chin and/or ear straps that help to keep the

Mounts designed to fix or place a fluid-delivery system, typically an infusion pump and accessories, fo
use. These mounts typically consist of supports, backings, settings, clamps, and accessories that perm
fluid-delivery devices to independent stand-alone structures or furniture (e.g., poles, stands, beds, str
frequently, to a wall, ceiling, or other permanent element of a building. Dedicated mounts are availab
the structure on which the fluid delivery systems are fixed (e.g., special trays for mounting of infusion
poles); some mounts may be used also to place infusion controllers.

Radio-frequency (RF) therapy systems designed to deliver RF energy into the blood vessels to elimina
These systems include an RF generator and a delivery system with an appropriate catheter.

Speech valves designed for use by patients with an inserted tracheostomy tube after tracheostomy pr
devices typically consist of a one-way valve that is located in the hub of a tracheostomy tube allowing
out; the exhaled gas from the lungs goes through the natural breathing ducts including the vocal cord
making speech possible. Some valves may include air filters and/or humidifiers. Most speech tracheos
be used by patients who are under mechanical ventilation by placing the valve in the ventilator tube;
intended for placement in line between the tracheostomy and the ventilator tubes are also used.

Patient treatment chambers designed to prevent the entry of harmful airborne material. They protec
undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or
acquired condition. Reverse isolation chambers include fans and air filters which maintain an atmosph
pressure greater than the air pressure outside the enclosure.
Atherectomy angioplasty catheters that pulverize atheroma into fragments small enough to be aspira
through the reticuloendothelial system; they are not used in the removal of plaque. These catheters u
atherectomy device with a variable sized (1.25 to 6.0 mm) metal burr on the distal tip; the burrs are s
diamond chips that function as microblades. The burr rotates at 100,000 to 200,000 rpm and tracks a
wire, which must first traverse the lesion before rotational atherectomy can proceed. Certain catheter
that use atherectomy devices with a distal cam tip attached to a central drive shaft that revolves at h
100,000 rpm) and seeks the path of least resistance. Ablative atherectomy catheters are designed to
atheroma and diffusely stenotic lesions, including total occlusions if the central guide wire can travers
Thermal angioplasty catheters that use an electrical (e.g., radiofrequency) energy source to heat a me
cap typically encloses the distal tip of the catheter, while the metal band is placed around the cathete
thermal compression and ablation of the atheromatous plaque inside the vessels, except for heavily c
units do not deliver electric current to the tissues. Tip temperatures can exceed 400 degrees Celsius,
vaporized, melted, or otherwise reformed. Electrically heated thermal angioplasty catheters are used
occlusions or high-grade stenoses in peripheral arteries; they may also be used to facilitate balloon an
the assumption that thermal ablation improves clinical success and reduces the rate of complications

Devices used to measure the radius or curvature of hard contact lenses.


Endoscopic procedure needles designed to inject sclerosing solutions in the treatment of internal hem
esophageal varices. These needles usually include high-contrast optic tips for easy visualization; they
and lockable for better control and protection of the endoscope. Endoscopic sclerotherapy needles are
appropriate for use with colonoscopes and upper gastrointestinal tract endoscopes.

Units that help regulate a patient's temperature by adding heat. These units usually include a central
elements, controls, alarms, and some means (e.g., blankets) to deliver heat to the patient. Patient wa
patients for or protect patients from hypothermia; they are frequently used to help maintain normal b
during and after surgery.
Ultrasound therapy systems designed to heat solid tumors several degrees Celsius above core temper
42 degrees to 45 degrees C (108 degrees to 113 degrees F); these temperatures do not damage norm
systems consist of a radiofrequency generator, ultrasound transducers, a cooling system, temperature
computerized control unit. Ultrasound hyperthermia systems are used to treat solid malignant tumors
combination with ionizing radiation (thermoradiotherapy) or chemotherapy (thermochemotherapy); th
tumors near bone or air-filled cavities such as the lungs.

Trend graphic recorders used to record the patient's temperature.


Instruments designed to trap, retrieve, and/or manipulate stones for the treatment of conditions such
urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). These instruments typically compr
with a multiwire, self-expanding (typically nitinol) basket at the distal end and a handle at the proxima
and rotate the basket. These devices are intended to be used through the working channel of an endo
nephroscope or ureteroscope, during urological and related procedures.

Automated systems designed for partial percutaneous removal of a vertebral disk, particularly the nuc
the lumbar disks. These systems typically include a built-in flushing and aspirating system, they can r
nucleous pulposus in one step, eliminating the need for repeated insertion of the nucleotome.
Emergency kits designed for the preservation and transportation of a tooth that was knocked out (i.e.,
in anticipation of reimplantation. These kits consist of a prepackaged collection (custom or standard) o
supplies and devices needed for the preservation of an avulsed tooth, including a tooth preservative s
balanced salt solution) and a vial (typically a cup) with a plastic net inside to suspend the tooth in the
The kit may also include swabs, bandages, and other supplies to treat superficial mouth and/or other
out tooth must be suspended in the solution as soon as possible (within 30 minutes is ideal but no mo
avulsion); the preserved tooth may be reimplanted within a few days of preservation. Avulsed tooth pr
intended to be used to prevent the crushing and/or dehydration of tooth cells by immersing the tooth
solution compatible with periodontal cells; the kits are used mainly in the field in emergency situation
avulsion of teeth.

Testers designed to assess the performance of implantable cardioverter/defibrillators (ICDs). These tes
monitor, and/or record a set of implantable cardioverter/defibrillator parameters and/or waveforms, su
electrocardiographic signals from implanted ICD leads, the patient's defibrillation/cardioversion energy
display electric cardiac signals during arrhythmia induction. These testers are typically an electronic u
display, measuring (e.g., energy, voltage, time) devices, a pulse generator, and appropriate sensors. I
cardioverter/defibrillator testers are mainly used for electrophysiology laboratory tests, intraoperative
implantation procedures, and to evaluate ICDs before implantation.

Central venous catheter introducers that include an integral or detachable hemostasis valve. These in
consist of a sheath or hollow, single lumen large bore catheter (e.g., 3mm/9 French) and relatively sho
length intended for the percutaneous introduction into the subclavian or jugular veins, and that includ
hemostatic valve attached to the proximal end of the sheath. Catheter introducers which have a detac
valve that is screwed to the introducer sheath hub are also available. Some introducers also include a
intravenous tubing intended for administration of fluid therapy bonded to the valve. Hemostasis valve
introducers are used as a seal to prevent entry of air into the circulation as well as blood or fluid loss a
catheter when it is removed from the sheath. These catheters are mainly intended to obtain access fo
catheterization procedures (e.g., cardiac, angiograms) and for short-term central venous access in crit

Manual defibrillators that include an electrocardiograph, a microphone, a battery, a cellular telephone


consisting of a control panel, an ECG, and a display with recording facilities. These devices allow remo
diagnosis and defibrillation control of patients by physicians by means of a telephone connection.

Filters that are used before the heart-lung bypass unit is connected to the patient but after the bypass
(primed) with circulating fluid, usually a physiologic solution or blood substitute. The system is run, in
the filters serve to clean out any particles that might have been inadvertently left within the pumping
filters are then removed and the unit is connected to the patient.
Physiologic monitors designed for continuous measurement and display of parameters related to the a
neurological activity of the nerves, brain, and spinal cord. These units are hard-wired to the patient at
Neurophysiologic monitors typically consist of a main computerized electronic unit that process and d
detachable electrodes (e.g., cups, needles) appropriate to acquire the specific neuro-electrical signals
autonomous stimulators appropriate to provide the required stimuli. Bedside neurologic monitors are m
patients in intensive care (e.g., patients who are irresponsive or in coma).
Laparoscopic forceps designed to grasp a pledget swab at the distal end, obtain cytological samples o
dissection during gynecologic or other (e.g. cholecystectomy) procedures. These forceps are typically
with scissor-like handles that may include a ratchet mechanism; a long slender shaft; and strong jaws
inward facing tongs at the end of the jaws for security. Swab laparoscopic forceps are intended to per
backward wiping movements with the pledget swab for blunt dissection or to obtain cytologic samples
procedures.

Surgical tissue dissection spatulas designed to manipulate and/or dissect tissue during laparoscopic p
spatulas typically consist of a metallic (e.g., stainless steel) or plastic handheld instrument with a stra
flat, blunt distal tip. Some may have sharp edges to the working tip to aid in tissue dissection. They ar
introduced through a laparoscope to the surgical site and are used to dissect or manipulate tissue dur
laparoscopic surgical procedures.

Monitors designed to measure various physiologic parameters associated with a patient's condition wh
transported from one location to another (e.g., during interhospital or intrahospital transport). These m
include capabilities for monitoring of electrocardiogram, hemoglobin oxygen saturation percentage, n
pressure, and respiratory rate values; other monitoring capabilities (e.g., cardiac output, invasive bloo
blood pressure, end-tidal carbon dioxide) may also be included. Transport monitors are typically small
battery powered; intrahospital devices should be able to operate for several hours on battery power. T
include configured, configured/modular, or modular designs.

Manual pulmonary resuscitators designed for repeated use. These resuscitators are suitable for sterili
appropriate procedure (e.g., autoclave, ethylene oxide).
Manual pulmonary resuscitators designed either for single use or to be used more than once on a sing
patient use) and then discarded. These resuscitators are usually simpler in construction than reusable
are not generally suitable or recommended for sterilization.
Electric beds designed to provide a controlled-rate air loss from the mattress. These beds typically hav
consisting of interconnected synthetic fabric air-filled cushions that are inflated at regular intervals us
compressor. Inflation intervals are alternated with deflation intervals wherein the surface loses air thro
controlled rate. Low-air-loss electric beds are used to prevent patient skin breakdown or for use in pat
needs due to existing skin issues (e.g., burn patients, patients with decubitus ulcers, etc.).

Probes designed for use with a pulse oximeter to determine the oxygen saturation of hemoglobin (SpO
absorbance of a patient's arterial blood. These probes typically include two light emitting diodes (LED
and infrared light (e.g., wavelengths of 660 and 930 nm respectively) through the pulsating arterial b
photodetector that senses the light after it passes through the arterial bed and then sends the informa
to the oximeter for signal processing and display. Probes are manufactured in appropriate configuratio
the finger tips, earlobe, toe, or even the forehead (for reflectance pulse oximeters); they are typically
disposable adhesive wraps and/or clips. Some probes include a memory chip that contains the calibra
of the individual sensor. Oximeter probes are available in sizes for adult, pediatric, or newborn, either
or reusable.

Curved devices that fit over the teeth to protect them from damage during endotracheal intubation.
Ophthalmic surgery units designed for removal of cataractous lenses by the insertion of a probe that c
lenses using ultrasonic waves (phacoemulsification). These units consist of a hollow probe (i.e., a phac
an irrigation sleeve, an oscillating tip that converts electric energy into ultrasonic waves, and a chann
fragments; the units also include a vacuum pump and controls for the output levels, irrigation rate, an
Phacoemulsification units are used in ophthalmic offices for cataract extraction surgery.

Dental brushes designed for connection to a suction unit to facilitate simultaneous manual cleaning (i
teeth and removal of fluid and particles from the mouth. These brushes typically consist of a hollow-ha
that may be connected via a flexible tube to a healthcare facility vacuum outlet or to a dedicated port
Vacuum-supplemented manual brushes permit the removal of debris, plaque, bacteria, and fluid from
dental procedures; they are also used in people who are unable to swallow or have difficulty swallowin
and/or in emergency situations.

Filters used in heart-lung bypass to remove crystalloid particles from the priming solution and concent
blood before taking the patient off the bypass unit.
Implants obtained from biological sources or made of artificial (i.e., synthetic) materials to provide ost
tissue scaffolds (i.e., bone matrix). These matrix implants may be obtained from donor sites of the sam
autograft), from other individuals (i.e., allograph, typically from cadavers), and, less frequently, from a
xenograph); synthetic bone matrix implants are typically made of ceramics (e.g., tricalcium phosphate
less frequently, of bioactive glasses or biodegradable polymers. These implants are used to fill cystic d
fractures of the tibial plateau, and to extend autogenous bone grafts, as well as in dental procedures (
periodontal degeneration and gingival recession).

Auditory measuring instruments capable of both air conduction measurements and bone conduction m
devices are typically equipped with earphones and a headband, which provides pure tones of specifie
sound pressure levels, one ear at a time; they may also be equipped with a bone vibrator. For clinical
required, as well as means of generating calibrated masking noise. An external-input port is usually pr
to an external signal source. These devices are used to screen the auditory function of adult and pedia
capable to cooperate with the measurements.

Communication systems designed to transmit and receive electrical signals through telephone channe
typically include at the transmitting site an electronic device (e.g., a modem) that modifies signals fro
external, ambulatory, implanted) devices such as physiologic monitors or recorders and makes them t
telephone lines. At the receiving end, another electronic device (i.e., the receiver) processes the incom
provides an output signal appropriate for display on physiologic monitors (e.g., central station), recor
transmission and processing by healthcare information systems. Telephonic transmitter/receiver syste
to send signals from patients' homes or remote locations to hospital and other healthcare facilities usi
cellular telephone lines. Systems intended for transmission of multiple physiologic signals are availabl
used for specific signals (e.g., electrocardiography, electroencephalography) are also available.
Electric extension cords designed for temporarily powering several devices used at a distance beyond
power cords. These devices typically consist of a flexible cable with a plug for insertion in the main po
several sockets (female connectors) at the other end for insertion of the devices to be powered. Multio
extension cords may include safety conditions such as inclusion of fuses, polarized plugs and sockets,
circuit interrupters. The cords are available for indoor or for outdoor and wet conditions use.

Combinations of preassembled disposable devices designed to handle blood in the washing procedure
autotransfusion units. These sets typically include plastic tubing, filters (e.g., bacteria), connectors, an
cell, waste); some sets also include a disposable bowl for the processing solution (e.g., saline). Dispos
sets are used as a disposable component of an autotransfusion unit during surgery and/or treatment o
waste and improve the safety of autologous reinfused blood (autotransfusion).

Solutions designed to maintain temporary viability (usually from 7 to 14 days) of donated corneas out
until implant. Corneal preservation solutions usually contain sterilized water and other substances (e.g
polyoxyethylene/polyoxypropylene copolymers, chondroitin sulfate, insulin, cell nutrients, antibiotics,
preservatives) to maintain the life of the keratocytes in the cornea until it is needed for implant. They
banks.

Instruments designed to measure testicular volume. These instruments typically are manual, handhel
Prader orchidometers) that measure testicular volume by comparison with a string of calibrated plasti
beads in increasing volumes (typically from 1 to 25 mL). Punched-out (Takihara) orchidometers usually
16 punched-out ellipses of varying sizes that fit over the testis, calipers, and ultrasound devices are a
measuring testicular volume. Orchidometers are intended mainly for measurement of testicular volum
abnormal testicular volume in men due to genetic defects (e.g., primary or secondary hypogonadism)
or surgical procedures.

Denture reliner materials with a hard consistency designed for placement in the space between the de
natural gums to improve denture fit. These reliners are made of acrylic resins or silicone-based produc
hard product when added to the base or tissue-contacting surface of a denture conforming to the cont
Typically, the denture together with an accurate impression of the shape of the gums is sent to the lab
for replacement of the impression material with a hard (e.g., acrylic) denture reliner. Hard denture reli
laboratories to restore dentures, usually after removing some of the existing plastic from the inner por
base. Due to wear on dentures and/or changes in the users' gums, the process should be repeated pe
other year).

Denture reliner materials with a soft consistency designed for placement in the space between the de
natural gums to improve denture fit. These reliners are made of silicone-based products that become
consistency from waxy to hard rubber) material when added to the base or tissue-contacting surface o
conforming to the contours of the tissues. Soft denture reliners are used at dentists' offices and/or by
to facilitate a temporary (e.g., from one to two years) accommodation of the denture to the gums.
Angiographic cardiac catheters that include specific tip configurations to enter the cardiac chambers (
ventricle). Their distal tip may have an end hole and/or several side holes. Typical injection rates are m
to 65 mL/sec). Most of these catheters are introduced into either the femoral or the brachial artery; th
the left or right ventricle as necessary. Left ventriculography is needed more frequently and is used to
of functional impairment of the left ventricle, the presence of ventricular aneurysms or ventricular sep
assess the mitral valve. Right ventriculography is mostly used for assessing congenital heart disease.

Esophageal intubation detectors designed to determine the presence of exhaled carbon dioxide (i.e., e
dioxide) in intubated patients. Most detectors consist of a pH-sensitive device that changes color whe
with carbon dioxide. These detectors are used in healthcare facilities and in the field to detect esopha
prevents patient ventilation and may be fatal if not discovered in time.

Mechanical wheelchairs designed for temporary patient transport. These wheelchairs are usually ligh
also foldable. Patient-transfer wheelchairs are usually designed to be attendant operated.

Canes consisting of a single adjustable-length shaft and a standard C-handle (also known as crook han
provide additional support to the user while walking. These canes usually consist of a straight shaft di
sections with holes and pins to adjust the desired height, a standard handle at the proximal end, and a
distal end. The handle is typically curved which gives extra support and allows the patient to retain th
while performing other tasks. It also includes an easy-to-turn button/knob at its base with a mechanism
adjust the length of the cane to fit different heights. They are typically made of sturdy materials such
aluminum), plastics (e.g., acrylics), fiberglass, or a combination of these. Standard-handle adjustable-
mainly designed for use by patients with pain, one-sided weakness, and/or mobility disabilities; they a
hand straps/bands.

Canes using a single fixed-length shaft and a standard C-handle (also known as crook handle) designe
support to the user while walking. These canes usually consist of a one-piece straight shaft, a standar
at the proximal end, and a rubber tip at the distal end; They are mostly made of wood (e.g.; walnut).
length canes are mainly designed to provide minimal support to patients while walking; they are also
straps/bands.

Canes using a single adjustable-length shaft and an off-set handle designed to provide additional supp
walking. These canes usually consist of a straight shaft divided in several sections with holes and pins
height, an offset handle at the proximal end, and a rubber tip at the distal end. The offset handle prov
additional balance assistance (i.e., the hand rests directly over the shaft of the cane) and may also inc
button/knob at its base with a mechanism that is activated to adjust the length of the cane. They are
sturdy materials such as light metals (e.g., aluminum), plastics (e.g., acrylics), fiberglass, or a combin
handle adjustable-length canes are mainly designed to help provide balance for patients with mobility
Canes with a single fixed-length shaft and a supporting (pedestal) base designed to provide additiona
maximum stability to the user while walking. These canes usually consist of a one-piece straight shaft
the proximal end, and a pedestal base with metal/rubber pods at the distal end. The tips of the pods m
standing in order to provide maximum stability (e.g., tripod, quadripod). They are typically made of st
light metals (e.g., aluminum), plastics (e.g., acrylics), fiberglass, or a combination of these. Pedestal-b
available as fixed-length or adjustable-length. They are mainly designed to provide the user with supp
stability and to reduce the stress of impact on the user's hand.

Crutches supported under the arms that are designed to provide the user with additional support whi
crutches consist of a shaft that bifurcates partway up from the distal tip and is connected at the top a
crossbar; it also has a rubber tip at the distal end. The top cross bar is slightly concave in shape to fit
underarm) and is covered with a soft rubber pad used to brace the crutches against the body, the mid
and covered with a rubber grip that adjusts to hand level for gripping the crutches with the hands. The
by a rubber tip that contacts the floor. They are typically made of sturdy materials such as wood (e.g.,
(e.g., aluminum, titanium). Axillary crutches are commonly used in pairs to assist in weight bearing an
metal) have spring-loaded detents that facilitate adjustment of hand grip height and overall length.

Crutches supported by the forearms that are designed to provide the user with additional support whi
crutches consists of two pieces of light metal tubing that are telescoped one within the other to adjust
of the user, swivel-action arm cuffs that fit partially around the forearm; handgrips covered with a rub
tip at the distal end that meets the floor. Forearm crutches are designed to allow the user to slip his ar
thus hold the grip tightly. The cuff can be semi-circular or circular in shape, with a V-shaped opening o
the arm can be slid into the crutch. They are typically made of sturdy materials such as light metals (e
titanium), plastic (e.g., rubber), or a combination of these. Collapsible (i.e., folded/adjustable) forearm
available. Forearm crutches are intended to be used by individuals suffering from some sort of perma
disabilities.

Walkers designed with four-leg, rigid, nonwheeled frameworks. Standard walkers are typically a metal
hard plastics) structure that frames the front and sides of users at waist level; they usually include sup
the hands. Standard walkers are intended to help users stand and ambulate; they are intended for pe
disabled (e.g., infirm) patients and/or for use during rehabilitation.

Walkers designed with four- or five-leg, rigid, wheeled frameworks. Wheeled walkers are typically a m
hard plastics) structure that frames the front and sides of users at waist level; they usually include a s
wheels) and supports (i.e., grips) for the hands. Wheeled walkers are intended to facilitate users' amb
intended for permanent assistance of disabled (e.g., infirm) patients and/or for use during rehabilitatio

Walkers designed with two-leg frameworks to support one side of the user only. These walkers are typ
consisting of two frame pieces about a foot apart at the base that meet, forming the shape of an "A" o
form a single handle at the top. Single-side-support walkers are intended to help users who need more
and ambulating than that provided by canes and/or crutches but less support than that provided by st
are intended for permanent assistance of disabled (e.g., infirm) patients and/or for use during rehabili
Canes using a single shaft that can be adjusted in length designed to provide additional support to the
These canes usually consist of a straight shaft divided in several sections with holes and pins to adjus
the proximal end, and a rubber tip at the distal end. The handle typically includes an easy-to-turn butt
with a mechanism that is activated to adjust the length of the cane. They are typically made of sturdy
metals (e.g., aluminum), plastics (e.g., acrylics), fiberglass, or a combination of these. Adjustable-leng
designed for patients with mobility disabilities.

Surgical instruments designed for incision of urethra strictures and/or urinary bladder neck contractur
typically consist of a slender instrument, including several guide tips (e.g., filiforms) and one or more
knives), that is directly inserted into the urethra and a handle with a mechanism for external operation
knives. Urethrotomes do not permit direct visualization of the operative field._x000D_

Multitherapy infusion pumps designed to deliver from very small to large volumes of liquid medication
therapeutic solutions stored in bags, vials, bottles (or, with an adaptor, syringes) simultaneously throu
programmed flow rates with independent control of delivery for each channel. Multi-channel large-volu
deliver fluid through intravenous (IV) or epidural routes, although subcutaneous and peritoneal infusio
as well. These infusion pumps usually consist of a pumping mechanism to move fluid from the solution
IV set to the patient. Three common types are: (1) the linear peristaltic mechanism which uses fingerl
IV tubing successively in a rippling, wavelike motion; (2) the rotatory peristaltic mechanism that uses
silicone rubber tubing held taut around rollers mounted on a rotor; and (3) the cassette-type mechani
fills a compartment from the upstream side and empties to the downstream side. The pumps also incl
select the dose or volume to be infused, recording capabilities to register the actual infusion volume a
and/or visual alarms to indicate abnormal conditions. Many pumps can deliver secondary (piggyback)
two different solutions sequentially per pumping channel. Some pumps (known as "smart pumps") inc
of detecting medication administration errors (i.e., dose error reduction systems) are also available. M
volume multitherapy infusion pumps are usually intended for IV pole mounting; they are used mainly
healthcare facilities, and at home.

Devices used to adapt the connectors of an implantable pacemaker lead to a pacemaker for which the
originally designed to be connected. The adapters are implanted with the pacing system. devices use
pacemaker lead to another kind of pacemaker; the adapters are implanted with the pacing system.

Writing instruments (e.g., pencils) for marking bone tissue during surgery.
Testers designed to assess the performance of implantable pacemakers; they are usually intended to
display, and/or record a set of pacemaker parameters and/or visual waveforms, such as amplitude, pu
width of the pacing current signal. These testers typically consist of an electronic unit including a disp
(e.g., current, time), and pacer adapters. Typically, implantable pacemaker testers are used for the no
of implanted pacemakers through electrodes fixed on the patient's trunk.
Implantable pacemaker testers designed to perform the assessment/evaluation of pacemaker function
These testers include a transmitter that converts the pacemaker signal into a signal appropriate for tr
telephone line, a receiver at the monitoring point (e.g., physician's office) that records and decodes th
unit. Transtelephonic pacemaker testers typical transmit a complete electrocardiographic signal depic
activity in addition to the pacemaker performance data._x000D_

Implantable cardiac pacemaker testers designed to measure the minimum electrical stimulus needed
contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stim
thresholds, respectively). They can also measure other parameters of the lead/tissue interface and the
pulse rate and duration, voltage or current output). These testers typically consist of a portable unit th
devices for the bioelectrical signal, a pulse generator, controllers, and capabilities to test the characte
performance of the pulse generator in an implantable pacemaker; some testers include a display and/
Intraoperative implantable pacemaker testers are used at the time of pacemaker implantation, for inv
evaluation, and/or in electrophysiology diagnostic procedures.

Cannulae consisting of a rigid tube that is inserted percutaneously to remove fat deposits under the s
Radiosurgical frame-guided computer-aided stereotactic systems designed to aid in the performance o
from the exterior of the body using a single high dose of ionizing radiation provided by Cobalt-60 gam
These systems typically combine medical imaging, a rigid frame (e.g., a headframe) attached to the p
guidance, dedicated computer software, and a radiation delivery assembly with a patient table and a
guided radiosurgical linac stereotactic systems are mainly intended for use in neurosurgery (e.g., arte
malformations, neuromas, adenomas, and neoplasms).

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for d
vitreous humor replacement. Items in these kits usually include syringes, needles, anesthetics, and th
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure; th
covered or wrapped. Aqueous/vitreous humor replacement procedure kits and trays are intended for
for delivering the artificial fluid or semi-fluid substance used to replace the aqueous or vitreous humor
are used in hospitals, ophthalmological clinics, and other healthcare facilities.

Oxygenators designed to perform gas exchange by diffusing oxygen into the blood across of a gas-p
There are three main types of membrane oxygenators: plate, coil, and hollow fiber. Membrane oxygen
long-time procedures, they produce less emboli, are less likely to transport bubbles into the patient's
cause less blood damage than bubble oxygenators.

Arterial cannulae intended for the ostium of the coronary sinus in order to provide antegrade or retrog
perfusion/cardioplegia during cardiopulmonary bypass. They may be equipped with a self-inflating low
These cannulae are typically used for back-flushing the coronary vessels in the event of inadvertent c
embolization.
Physiologic analyzers that measure, record, and process the basal body temperature of women to det
infertile phases of the menstrual cycle. These analyzers are automatic, electronic, portable handheld
typically include a thermometer and a microprocessor programmed with a mathematical algorithm to
temperature shifts and their relation to fertility phases.
Circulating-liquid pumps designed to deliver a temperature-controlled flow of warmed liquid (e.g., wat
pads that have appropriate channels for liquid circulation. These pumps typically use an electric resis
purposes. Localized-heating pumps are used for therapeutic localized mild heating (i.e., warming at n
degrees C) of a patient's skin.
Units designed to warm a patient by circulating liquid. These units consist of a central device includin
and pumps for circulating liquid and a specially designed reusable or disposable blanket with appropri
circulation. Most warming units also include controls and alarms. Patient temperature is typically mo
thermometer. Circulating-liquid patient warming units are mostly used for rewarming patients in post

Implantable plastic devices (i.e., bands) designed to be placed around the upper stomach to reduce fo
treatment of morbid obesity. These devices typically consist of an adjustable silicone elastomer band
below the esophagogastric junction in an open surgical or, more frequently, laparoscopic procedure; s
inflatable inner shell and a buckle closure connected by tubing to an access port outside the abdomin
diameter of the band may be periodically adjusted by the addition or removal of saline through the ac
patient needs (i.e., the required rate of weight loss). Remotely (i.e., transcutaneously) adjustable band
programmer/tester to exchange information and power by means of an implantable antenna coupled
available. Gastroplasty bands are intended for use as a controllable and reversible method for achievi
bariatric patients.

Protective eyewear used during laser procedures containing filter glass that provides adequate visual
optical density (attenuation) for the specified laser wavelength with which they will be used.

Mechanical eye shields made of collagen that are placed on the eyes to protect the cornea. These shie
and permit clinical observation and partial patient vision during epithelial resurfacing of the cornea.

Paper sheets designed for placement on the surface of infant scales to provide a clean contact resting
These liners are typically made of lightweight tissue or absorbent crepe paper and are shaped to matc
the scale surface.
Duodenoscopes equipped with a television camera on the distal tip, typically in the form of a microchi
device [CCD]). The image is electronically transmitted through wires in the endoscope for external pro
recording of video images.
Clinical chemistry reagents intended to determine the total level of cholesterol in a sample of whole b
of time, typically several minutes (i.e., rapid tests). These reagents are impregnated in one or more ar
(reagent strip) that undergo a color change when reacted with specific substances. High levels of tota
(typically defined as more than 240 mg/dL) are associated with atherosclerosis and coronary artery di

Adhesive tapes made of metal fibers (e.g., aluminum, copper, steel) coated with acrylic adhesives. Th
long and narrow strips supplied in rolls. Metallic adhesive tapes are intended to be used in sealing and
ducts or other objects from moisture and are also used for packing or labeling purposes.
Patient transfer slings designed for use with and attached to a patient transfer lift. Typically these slin
fabric (e.g., canvas) or plastic seat that is attached to the swivel bar of a patient transfer lift. There is
available according to patient needs, such as cradle-like slings to support both the trunk and the legs
the perineal area free for toilet use; two-band slings with a band for the back and a separate band for
band slings with a band for the back and one for each leg.

Flexible bronchoscopes equipped with a television camera on the distal tip, typically in the form of a m
coupled device [CCD]). The image is electronically transmitted through wires in the endoscope for ext
display, and recording of video images.
Flexible gastroscopes equipped with a television camera on the distal tip, typically in the form of a mi
coupled device [CCD]). The image is electronically transmitted through wires in the endoscope for ext
display, and recording of video images.
Flexible sigmoidoscopes equipped with a television camera on the distal tip, typically in the form of a
coupled device [CCD]). The image is electronically transmitted through wires in the endoscope for ext
display, and recording of video images.
Colonoscopes that feature a television camera on the distal tip, typically in the form of a microchip (a
[CCD]). The image is electronically transmitted through wires in the endoscope for external processing
recording of video images.
Pulse oximeters in which all or a portion of the signal pathway is established through a radio link. Tele
are intended to promote the patient's freedom of movement, eliminating the need for cables connecte
monitor.
Radiographic units that include an x-ray generator, a collimator, a high-resolution image receptor, an
positioning features, and a control panel. Most of these units have an x-ray tube arm that swings and
for different projections (i.e., from full right to full left). Podiatric radiographic units may be wall- or floo
are mobile. These units are designed specifically for imaging the feet and are used mostly in podiatric

Films (e.g., oxidized regenerated cellulose, sodium hyaluronate/carboxymethylcellulose) designed to a


barrier inhibiting postsurgical adhesion between tissues and organs. These films are placed on the sur
organs at the end of surgery, before surgical close, and are typically resorbed by the body in a short p
days or weeks). Postsurgical adhesion inhibition films are mostly used in pelvic and gynecologic surge

Equipment designed for the automatic or semiautomatic washing (i.e., elimination of dirt and/or stains
physical decontamination) of organic debris (e.g., blood, fat, bone) from soiled devices. These units ty
corrosion-resistant chamber containing baskets or trays for the soiled devices; some can accommodat
and/or racks. Washers/decontamination units perform a cycle of operations that typically include wate
treatment, detergent wash, heated rinse, and drying; the process includes mechanical removal of con
physical decontamination) by water jets, and/or ultrasound energy and may include thermal disinfecti
from 60 to 95 degrees C [140 to 203 degrees F]). Dedicated units are available for surgical instrument
devices; simpler units that do not provide the same level of cleaning and physical decontamination ar
bedpans, containers, and other noncritical devices and utensils. This equipment may provide some lev
killing or inactivating several types of microorganisms.
Stents designed for deployment into the biliary ducts to provide support for and/or maintain patency w
tree. These devices may consist of a metallic (e.g., meshlike wire) or plastic tube, and they are availa
shapes (e.g., straight, bent, pigtail) and sizes to adapt to particular sections of the biliary tree and/or t
The stent surface may be coated to give the stent special capabilities (e.g., water repellant). Metallic s
balloon-expandable or self-expandable, and they may be deployed through endoscopic or percutaneo
procedures. Biliary stents are used mainly to open strictures of the ducts caused by malignant tumors
restoring the flow of bile.

Surgical instruments designed to bring anatomic structures into proximity or apposition (juxtaposition
procedures. These manual, handheld devices have physical dimensions and characteristics appropriat
they bring together (e.g., blood vessels, soft tissue, ribs, nerve tissue); they are manufactured with no
or components, differentiating them from other devices (e.g., hooks, clips, forceps) used to approxima
structures. Surgical approximators are frequently used in pairs to grasp torn or resected portions of a
structure.

Approximators designed to grasp torn or resected portions of a tendon, holding the tendon ends in an
position without tension for the purpose of reattaching one portion to the other (e.g., by suturing) in o
structure during a surgical procedure. These manual, handheld devices typically consist of a metallic f
atraumatic blades or clamps; they are frequently used in pairs.

Surgical approximators designed to grasp torn or resected portions of a vessel, holding the tissue in a
position without tension for the purpose of reattaching one portion to another to complete the structu
during a surgical procedure. These manual, handheld devices typically consist of a metallic frame with
clamps or blades with gripping surfaces; they are frequently used in pairs.

Systems designed for use during therapeutic procedures (mostly surgical) performed inside a cavity (e
cavity) to keep the cavity filled with pressurized distention solution. These systems should keep the m
necessary to distend the cavity without exceeding a safe maximum level. Irrigation/distention system
an electrically powered pump (manual pumps and gravity are also used), tubing from the pump to an
catheter placed in the cavity to be distended, and controls. Hysteroscopic and arthroscopic procedure
performed using these systems.

Irrigation/distention systems used during endoscopic procedures in the uterus (i.e., hysteroscopy) to k
filled with pressurized distention solution. These systems expand the uterus, improving visualization a
surgical field. Typically, a bolus of solution is pumped into and remains in the uterus during the proced
irrigation/distention systems are combined with gynecologic resectoscopes.

Devices used to produce high-resolution multi-format films directly from image data acquired during p
imaging (such as CT, MRI, ultrasound, digital radiography, and digital photospot fluoroscopy). Typical c
imaging system include a laser, a controlling computer, an optional film processor, and an interface to
host computer. Most laser imagers use standard wet film processing to develop the laser-sensitive film
emulsion of silver halide particles embedded in a gelatin matrix; some use special dry-processing met
permit diagnosis to be made from a hard copy rather than from an electronic image on a CRT screen,
digitize film images.
Blood gas monitors designed for extracorporeal quasi-continuous measurement and display of the par
gases (i.e., carbon dioxide, oxygen) and pH values in the arteries. These monitors are hard-wired to th
bedside. These monitors typically include a sensor cassette that is inserted in series with the arterial c
near the wrist. A bunch of three detectors that combine an optical fiber with a fluorescent dye (fluores
distal tip is placed inside the sensor cassette. Three optodes are needed: one sensitive to oxygen pres
sensitive to carbon dioxide pressure (pCO2), and a third sensitive to pH values. When the measureme
blood in the cassette and tubing is returned to the patient. Extracorporeal blood gas/pH monitors also
circuitry, a display, and programmable alarms. They are especially useful in patients with respiratory f
lung disease, severe asthma), in patients with severe pulmonary hypertension after cardiac surgery, a
who cannot tolerate multiple blood draws (e.g., neonates and infants).

Exercisers designed to guide, measure, and assess the performance of all major muscle groups in four
activity: passive (movement without exertion), isometric (exertion without movement), isokinetic (vari
constant rate of movement), and isotonic (constant exertion at a variable rate of movement). These e
exercise station that provides some form of resistance (e.g., hydraulic, electric, weights) to the muscu
the patient and a computerized unit that controls the sequence and duration of the exercise plan and
the patient's performance and progress. Computerized dynamometric exercisers are used for exercise
rehabilitation of weakened or injured muscles and for the assessment of muscle and or joint (e.g., kne
performance.

Catheters designed to be inserted into the bladder via the urethra for the purpose of draining urine fro
at various intervals as needed on a regular schedule (i.e., intermittent). These catheters are designed
unlike Foley urinary catheters (retained catheters), intermittent urinary drainage catheters are not int
bladder for an extended period and are removed from the bladder immediately after the urine is drain
males are usually curved and 20 to 40 cm (8 to 16 inches) in length, while catheters for female patien
smaller.

Vascular clip appliers designed to deliver small atraumatic vascular clips for blood vessel ligature duri
procedure (i.e., disposable clip appliers) to stop and/or prevent bleeding (i.e., hemostasis). These appl
mechanism for single or multiple insertions of clips. Dedicated disposable hemostatic clip appliers are
open surgery in specific anatomic sites (e.g., arteries, scalp vessels, aneurysms); they deliver disposa
are usually intended for temporary use during surgery.

Clip appliers designed to deliver atraumatic clips intended for temporary or permanent occlusion of bl
veins, frequently to stop and/or prevent bleeding (i.e., hemostasis). These appliers are typically a met
instrument with flat curved ends appropriate to hold and deliver the clips; some appliers may be used
bulldog-type) clamps. Vascular clip appliers are used mainly to deliver clips for temporary vessel occlu
arrest (i.e., hemostasis) during open surgical procedures; some clips may be used as permanent impla
as reusable devices or as disposable instruments intended for a single procedure (e.g., artery hemosta
occlusion).

An electrical conducting device used to measure the acid-base status of blood by determining its hydr
concentration.
Multichannel electrocardiographs (ECGs) designed for recording the variations of the electric potentia
electrical activity of the heart muscle. These variations are usually detected at the body surface from
simultaneously by averaging multiple cycles of the signal to reduce noise but which cannot perform a
ECG. These instruments include a computerized unit that can process and print the average of the EC
waveforms. Noninterpretive multichannel ECGs are used to diagnose cardiac abnormalities, determine
therapy, and reveal trends or changes in the heart function. Noninterpretive signal-averaging ECGs ar
real-time assessment of the electrocardiogram or other cardiac conditions.

Endoscopes designed for direct insertion into the urinary tract for visual examination, biopsy, removal
and treatment of lesions of the interior of the ureters and kidneys. Ureterorenoscopes usually consist
lighting system, and a working channel for catheters and operative devices; they are usually flexible.

Gas burners in which the gas is mixed with air before ignition in order to give complete oxidation.
Prepackaged collections of the devices and supplies (either custom or standard) needed for inserting u
operative procedure. Items in these kits usually include ureteral stents, deployment catheters, and gu
be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a b
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Ureteral stent delivery procedure kits and trays are intended to insert ureteral stents for preventing or
the upper urinary tract.

Instruments designed for use in the introduction of tracheal tubes through the mouth (i.e., orotrachea
instruments usually are very flexible stylet-like devices that are directly introduced in the trachea as a
of an endotracheal tube. Tracheal tube introducers (e.g., Eschmann introducers) are intended for use i
situations to facilitate difficult intubations, especially in the field or when other resources are not avail

Measuring instruments designed to measure and display the power density of the field (i.e., field stren
of frequencies (e.g., from a few Hertz to a few Giga Hertz). These instruments are typically portable de
an electronic unit with controls and filters that permit a selection of the range of frequencies to be me
circuits; an internal or external antenna; and a display that shows the power density (typically in micro
strength meters are used in health care facilities to determine possible electromagnetic radiation inte
device function and to help localize the source of interference.

Endodontic posts, either custom-made or preformed, designed for insertion into the root canal to retai
crown prostheses. These posts are typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy)
end appropriate to support the crown on top. The supporting post and crown are frequently available a
crown prostheses.
Physiologic analyzers designed to assess the volume, airflow (i.e., diffusion and distribution of tracking
parameters (e.g., airway compliance, resistance) through the respiratory tract from the nose to the lun
typically include a spirometer, a gas analyzer, and an electronic unit with computerized capabilities an
software. Respiratory function mechanics analyzers are intended for the evaluation of performance of
to determine a baseline ventilatory function and respiratory impairments; to screen for and/or diagnos
diseases. Dedicated analyzers are available for use with adults (including older children) and for neon
Respiratory function mechanics analyzers designed to assess lung and airway volume, flow, and mech
(including airway compliance and resistance) in young children and infants (including neonates). Thes
different from adult analyzers not only in absolute dimensions, but also in the special procedures requ
methods to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant rec
plethysmography, use of a pressure jacket to obtain forced exhalation); they also differ in their inabilit
parameters (e.g., vital capacity forced expiratory volume) due to their dependence on subject coopera
Neonatal/pediatric respiratory function mechanics analyzers are used for pulmonary function testing i
and for evaluation of diseases and chest deformities.

Intravenous administration sets with needles that, rather than being hollow, have the hole on the side
implantable injection/infusion ports.
Excimer lasers, usually Q-switched, used for corneal ablation (i.e., photorefractive keratectomy) and o
procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity)
incorporates a patient table, physician's chair, and computer system. Some systems have built-in slit

Sizers designed to measure and calibrate the annulus diameter and positioning (e.g., valve seating) o
determine the appropriate size of the replacement valve prosthesis (either mechanical or biological) t
a surgical procedure. These instruments typically consist of a set of sterile, reusable, handheld, manu
single or double working ends, usually with an integral calibrated cylinder or ring at one end to calibra
flanged end at the other extreme to calibrate the supra-annular placement and/or valve seating. Card
used in surgical procedures intended to replace stenotic or otherwise abnormal cardiac valves (e.g., a
sizers for use in minimally invasive surgery (typically for annuloplasty procedures) with a thickness of
inch) and that include a sizing portion for measuring the valve annulus and a coupling portion for atta
also available.

Multipurpose surgical scalpels designed with a blade that can be resistively (i.e., electrothermally) hea
scalpel handle using an external source of electric power. These scalpels consist of an electrothermall
appropriate handle with electrodes. The instrument is externally attached through cables to a dedicat
source that may include controls for the electric power supplied to the scalpel and also for the blade t
Electrothermal cautery scalpels are used to provide simultaneous hemostasis to the cutting action of t

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
spills/leaks of radioactive material (i.e., material that emit radioactive radiation). Items in these kits us
absorbent pads/towels, decontaminating solutions, brushes/sponges, radiation-shielding gloves, gogg
covers, labels, disposal bags/containers and documentation forms. Radioactive material spill recovery
use during procedures for cleanup and/or decontamination of affected areas before disposal. They are
laboratories and other healthcare facilities.
Treadmill exercisers designed for use partially immersed in water, utilizing the water for additional res
simultaneously alleviating stress on the joints in the reduced-gravity environment. These exercisers ty
continuous tread and an electric motor, controls for the belt speed and slope, and a display that show
characteristics and training information (e.g., speed, time, elevation, energy consumption). Most hydr
have front-mounted rails; some devices also include water jets and/or water temperature controls. Al
be water- and corrosion-resistant; electric components must satisfy appropriate electrical safety stand
treadmills are available as independent units that can be mounted in standard pools (including lap po
pools, or full-body hydrotherapy tanks. They are used in healthcare facilities, clinics, and at home for e
and/or rehabilitation.

Laminar air flow equipment designed to provide a clean environment at the surgical site in the operat
flow may be either vertical (e.g., from the ceiling down to and around the patient) or, less frequently,
surgical area; the laminar flow is distorted only by objects (e.g., surgical lamps) and staff in the flow p
to use appropriate clothing and follow a set of rules to work without affecting the air flow pattern. The
units are intended to provide a very low particle content environment and reduce airborne bacteria at
hospital operating rooms; they are frequently used for orthopedic surgery (e.g., hip transplant) and or
airborne particles are known to be associated with surgical site infections.

Laminar air flow clean rooms designed for use in clinical pharmacies. These clean rooms typically prov
content environment; class 100 or better (ISO 5 or less) are typical, which reduces airborne bacteria in
room. The laminar flow may be either vertical (e.g., from the ceiling down to and around the site of pr
medications) or, less frequently, horizontal at the preparation area, distorted only by objects (e.g., sur
in the flow pathway. The staff has to use appropriate clothing and follow a set of rules in order to work
air flow pattern. Medications are usually separated in different colored bins; wash stations and machin
rooms are used in the manufacturing of particular drugs. Pharmaceutical laminar air flow rooms are m
provide a low-pollutant level environment for storage, handling, and manufacturing of particular medi
total parenteral nutrition, and intravenous solutions including antibiotics and/or analgesics. They are a
antineoplastic or chemotherapeutic drugs.

Testers designed to check the performance of ventilators; they can usually measure, evaluate, display
ventilator parameters and/or waveforms, such as breath rate, inspiratory/expiratory ratio, tidal volume
pressure. For verifying and troubleshooting purposes, some testers can run tests for several hours. Ve
typically consist of an electronic unit including a display, measuring instruments, and appropriate sen
assess the most important ventilator parameters; these testers should be able to simulate the human
use an external human lung simulator in order to test several parameters (e.g., volume, flow). Most ve
capable of assessing infant, pediatric, and adult mechanical ventilators.
Imaging media (e.g., screens, plates) with appropriate frequency response to permit safe visualization
visible spectrum. These devices may consist of a phosphorous screen that emits light in the visible sp
red spectrum, 600-730 nm) when a laser beam in the near-infrared (e.g., diode, Nd:YAG) or visible spe
lower than 600 nm (e.g., argon, He:Ne, double-frequency Nd:YAG) impinges on the screen; the screen
persistence, allowing the observation of both continuous and pulsed laser beams. Devices configured
clip-on or tabletop-mounted units are available; similar devices intended for visualization of ultraviole
(e.g., excimer, nitrogen) are also available. Imaging media using other techniques are also available, i
that produce a real-time image of infrared laser beams using thermal-sensitive phosphorous plates an
glasses that convert UV or infrared light into visible light. Imaging media devices are used mainly as a
obtaining visual images of laser beams for alignment and/or checking purposes.

Prepackaged collections of the devices and supplies (either custom or standard) needed for collecting
cavity by suction through a fine needle attached to a syringe intended for in-vitro analysis (i.e., perfor
biopsy). Items in these kits usually include antiseptic swabs, anesthetics, a scalpel, a syringe with nee
frosted slides, and needles; the kits may also include towels, a drapes, adhesive strip, bandages, spec
pads. Aspiration kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Biopsy aspiration procedure kits and trays are intended for use
living tissue for microscopic (in-vitro) laboratory examination to diagnose a variety of diseases; dedica
marrow biopsy are available. Biopsy aspiration kits intended for use with ultrasound guidance are also

Stents designed for deployment into the main pancreatic duct to provide support for and/or maintain
duct. These devices may consist of a metallic (e.g., meshlike wire) or plastic tube, and they are availa
shapes and sizes and with various numbers of barbs or pigtails to adapt to particular sections of the d
migration. The stent surface may be coated to give the stent special capabilities (e.g., water repellant
be either balloon-expandable or self-expanding, and they may be deployed through endoscopic or per
transhepatic procedures. Pancreatic stents are used to open strictures of the ducts caused by maligna
diseases, restoring the flow of pancreatic juice to the duodenum.

Thin, gently curved sheets of radiolucent plastic used for external compression of the internal sperma
distal flow of a sclerosing agent. These devices are also used in compression of veins, bypass grafts,
angiographic procedures.
Examination light microscopes designed to magnify small structures of the skin and that are especiall
postoperative examination, and checkups that require high magnification or adjustable focusing. Thes
consist of a binocular microscope mounted in an articulated arm that is usually attached to an examin
to a wall or ceiling. Most dermatology examination microscopes are used in doctors' offices for diagno
wound exams, and frequently also for minor surgery procedures.
Testers designed to assess the performance of external pacemakers that use invasive (e.g., transthora
electrodes; they can usually measure, evaluate, display, and/or record a set of pacemaker parameters
such as amplitude, rate, and pulse width of the pacing current signals. These testers typically consist
including a display, measuring devices (e.g., current, time), and appropriate sensors; some testers can
electrocardiographic signal and arrhythmia waveform to verify the monitoring capabilities of pacemak
testers are sometimes used with manikins for training purposes.

Stress exercise physiologic monitoring systems designed to evaluate the cardiac response of a person
while the individual is performing exercise on a treadmill or a bicycle ergometer. These systems usual
machine, an electrocardiograph with appropriate electrodes, computing capabilities, a display, a recor
laser, Deskjet). Typically, the patient performs the test following a protocol that gradually increases hi
increasing the speed of a treadmill) while the electrocardiographic signal is monitored; the data is ana
printed. Some systems can automatically determine heart rate, analyze the ST-segment trend, and de
Cardiac stress exercise monitoring systems are used mostly to diagnose and monitor the course of cor

Stress exercise physiologic monitoring systems designed to evaluate the pulmonary response of a per
while the individual is performing exercise on a treadmill or a bicycle ergometer. These systems usual
machine, an oxygen analyzer (e.g., solid electrolyte sensor, spectrometer, paramagnet), a carbon diox
infrared), and a mouthpiece attached to tubing that is connected to the gas analyzers. Some systems
pyrometers to measure respiratory volumes and capacities (e.g., inspiratory, expiratory). Typically, the
test following a protocol that follows steady, incremental, or ramp workloads. Pulmonary stress exercis
are used to diagnose and monitor the course of pulmonary diseases.

Testers designed to assess the performance of the outlets in a medical gas system; they can measure
and/or record a set of gas output characteristics. These testers usually measure the static pressure wi
closed and the dynamic pressure with a preestablished test flow (e.g., 100 liters per minute), known a
pressure; they can also determine the gas type (e.g., medical air, oxygen, nitrogen, nitrous oxide) by m
concentration and comparing it to a set of internal values. Medical gas outlet testers include manome
electronic circuitry, a display, and recording capabilities; they are used to check medical gas systems
modification, or major repair.

Power line receptacle testers designed to measure and assess both the electrical characteristics of a r
mechanical holding force between the ground outlet in the wall receptacle and the male ground prong
simple testers include a prong that is plugged into the ground receptacle to measure tension and a dis
similar to those used in thermometers.
Physiologic analyzers designed to assess the functioning of normal or abnormal joints (e.g., knee); the
document the slackness and/or displacement in the motion of a joint (i.e., the joint laxity), usually by
motion, acceleration, or forces exerted by the joint. Some of these analyzers can also assess other cha
joints, such as the stability and/or anterior/posterior tibial displacement. Joint laxity evaluation physiol
used in joint function diagnoses and/or in reconstructive surgery to evaluate and control joint laxity an
and the length of reconstructed ligaments.
Data management information systems designed to provide clinical and administrative information in
These systems accumulate data on blood donor status; they may also include algorithms to process b
Most systems include specialized transfusion software, donor software, or both. Blood bank informatio
systems may perform additional tasks, such as autologous and direct unit tracking, cross-match result
management of bar-code information and patient history reports.

Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) frequency-doubled lasers, usually operated in c


pulsed modes, used in procedures requiring precise surgical excision, vaporization, or photocoagulatio
damage to surrounding tissue. The power density chosen for a given application determines the tissue
at the operative site.
Devices designed for either obstruction or closure of a body passway to the flow of fluids or other sub
that external stimuli get into the body senses . These devices are designed according to the nature an
passageway they are intended to close. Most occluders are used to close internal tubular structures of
blood vessels and fallopian tubes.
Occluders designed for restricting blood flow through vessels. These occluders may include devices ap
vasculature (e.g., clips) or devices inserted into the vessels, usually through syringes and/or catheters

Brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve them from,
the treatment site using automated procedures; automated brachytherapy applicators are usually con
directly or through a transfer tube), or are an integral part of, a remote afterloading system. These ap
include hollow needles, catheters, templates, and/or cannulae; they are frequently configured for use
treatment site, such as on the surface of the body (i.e., topical) or within the body (e.g., interstitial, in
applicators are configured for use only with a particular afterloading system. Automated brachytherap
typically used to treat malignant tumors.

Endoscopic automated suture units designed to repair lesions and/or muscle tears through arthroscop
of an external unit that controls the suturing parameters. The unit performs the suture through an ext
endoscope inserted in the interior of a joint and includes a suture punch system that places the numb
by the surgeon at the site of the lesion or tear.
Electrical safety electrosurgical monitors designed to assess the leakage current due to capacitive cou
the insulation of the active electrode of a monopolar electrosurgical unit (ESU) during laparoscopic sur
typically consist of a monitoring unit, a conductive shield for the active electrosurgical electrode, and
activated when the radio frequency (RF) current exceeds a predetermined value; usually the ESU is au
deactivated simultaneously.

Dental materials designed to roughen the surface of the tooth enamel (i.e., etching) to increase the ad
restorative materials. These dental materials consist of liquid acid solutions (30 to 50 percent of phosp
increase the viscosity of fillings; the etching material is usually placed in the tooth prior to using denta
and cavity sealants. Dental etching materials are typically supplied packed in syringe-like devices; the
offices.

Units designed to deliver argon gas for argon-enhanced coagulation. These delivery units are incorpor
and are connected to electrosurgical units, providing for a single control activation of both systems. A
is provided to permit simultaneous delivery of gas and electrical current.
Monopolar electrosurgical units (ESU's) that are equipped with a system (typically either housed in a s
incorporated into the ESU generator housing) for delivery of argon gas. The electrosurgical current fo
channel, or arc, within an argon gas stream that flows between the active electrode and the tissue sur
enhanced ESU can provide rapid, uniform coagulation over large bleeding surfaces such as capillary b

Laboratory analyzers designed to determine the morphology of the blood and blood-forming cells. The
to perform complete blood counts, determine hemoglobin concentration, evaluate the adhesion of cel
(aggregation), detect abnormalities in the process to complete normal blood clotting (coagulation), an
grouping and subgrouping, Rh and other red cell phenotyping, and antibody detection.

Hematology analyzers that require minimal involvement of technicians, with complete automation of
cell counting, and red blood cell index determination; some include closed-tube sampling to automatic
sample from the phlebotomy tube. Most of these analyzers are based on fluorescence quantification a
techniques or on electrical impedance (Coulter) techniques. Some automated hematology analyzers p
white blood cell differential count, while most provide a five-part count, differentiating all five types of
cells. Automated cell-counting hematology analyzers may include reticulocyte analysis capabilities.

Hematology analyzers that require the reduced involvement of a technician, using automation in som
procedures, such as sampling and dilution, cell counting, and red blood cell index determination. Most
hematology analyzers also perform a three-part white blood cell differential count.

Sound stimulators used to assess fetal well-being. These stimulators consist of a sound source (e.g., a
larynx) that is placed on the maternal abdomen over the fetal vertex to apply a vibroacoustic pulse st
seconds long. Sound stimulators are used to evaluate the condition of a fetus (e.g., heart-rate change
antepartum tests and/or during intrapartum monitoring.

Rectal catheters designed for measurement of pressure in the rectum and anal sphincter. These cathe
tubes that require infusion of water at a constant rate, with ports through which flow rate is changed a
sphincter contractions (hydraulic manometry); these changes are converted into electrical signals by
catheters include several miniature built-in pressure transducers, avoiding the need of water perfusion
catheters can evaluate the rectal musculature and anal sphincter functioning; they are mostly used in
incontinence and constipation.

Scanning systems that include an ultrasonic scanner, high-frequency (typically 20 and 30 MHz) miniat
mounted on the tip of a catheter, intravascular analysis package software, an image recorder (e.g., vid
printer. Some systems include color-flow mapping capabilities. Intravascular ultrasonic scanning syste
degree (cross-sectional) images of blood vessels for diagnostic and therapeutic applications, including
arterial plaque and vessel lesions, the measurement of vessel dimensions and stenosis, the monitorin
angioplasty and atherectomy procedures, and the deployment of intravascular stents.

X-ray bone densitometers that use a dual energy spectrum from an x-ray source, typically by applying
low and high kilovoltage to an x-ray tube or by applying a fixed voltage and separating the energy spe
energy bands using a filter. Dual-energy densitometers are used to assess bone mineral content in th
usually by measuring the lumbar spine and the hip region, including the proximal femur.
X-ray bone densitometers that use a single energy spectrum from an x-ray tube. Single-energy densi
assess bone mineral content in the appendicular skeleton, usually by measuring the forearm (radius)

Bone matrix implants made of artificial (i.e., synthetic) materials designed to provide osteoconductive
These implants are typically made of ceramics (e.g., tricalcium phosphate, hydroxyapatite) and, less f
glasses or biodegradable polymers. These implants are used to fill cystic defects, to repair fractures o
to extend autogenous bone grafts and in dental procedures (e.g., to treat periodontal degeneration an
Bone matrix implants combined with osteoconductive growth factors and osteogenic cells (i.e., compo
frequently used instead of autologous grafts and allografts.

Medication pill dispensers designed to store and deliver pills and/or other solid medications in the corr
for an individual patient. These dispensers usually consist of a container for unit-dose packaged pills o
are manually or automatically delivered in a single dose each time. They are commonly used at home
facilities.
Unit dose medication pill dispensers designed to store and deliver pills automatically in the correct sin
individual patient. These dispensers usually consist of a container with medication compartments to s
pills. They include a pre-established program with a reminder alarm to deliver the correct dosage of p
trays open and offer the unit-dose at the exact times and frequency set by the user. They are common
at healthcare facilities.

Unit dose medication pill dispensers designed to store and deliver pills and/or other solid (e.g., oral) m
the correct single dose needed for an individual patient. These dispensers consist of small containers
compartments containing a single dose each, allowing the patient to manually open the covers of the
dispense the dose. The containers are often labeled with the days of the week and the time of day tha
should be dispensed. They are commonly used at home and healthcare facilities.

Bone matrix implants consisting of biological materials that can provide osteoconductive bone tissue s
implants may be obtained from donor sites of the same person (i.e., autograft), from other individuals
typically from cadavers), or, less frequently, from animals (i.e., xenografts). Biological bone matrix imp
cystic defects and to repair bone fractures and in other orthopedic reconstructive and cosmetic proced

Mattress systems that include a mattress made of interconnected synthetic fabric air-filled cushions.
designed to lose air through the cushions at a controlled rate to prevent maceration of the patient's sk
systems are typically used in the care and management of patients who require special pressure relie
who have, or at risk for developing pressure/decubitus ulcers).

Electrical brain stimulators that apply stimuli to specific areas of a patient's brain (i.e., cerebrum, cere
psychiatric treatments. These stimulators typically consist of an external pulse generator and electro
pulses are applied via electrode arrays placed upon the cortex or through the electrode tips of very fin
deeply in the cerebellar nuclei. Psychiatric therapy stimulators are used to treat psychiatric disorders
anxiety, mania, and insomnia.

Adjustable examination/treatment tables that usually include knee and elbow rests and heel stirrups.
designed to support the patient's body in adequate position during perineal examination and procedu
Instruments designed to shape and enlarge holes in hard materials and/or tissues (e.g., bone, tooth) a
material from them during surgical or dental procedures. They are typically manual, handheld instrum
elongated, tapered, and serrated working end and a handle. Dedicated broaches are used in bone cav
endodontic procedures.
Information systems designed to manage clinical and/or administrative data in a healthcare facility. Th
hardware, including workstations (usually with digital computers) and peripheral devices (e.g., high-ca
devices, printers) that are typically connected as a local area network (LAN), as well as software, inclu
systems, a database management system, and application programs. Data management information
store, analyze, retrieve, display, and/or print information related to the whole facility (i.e., hospitalwid
clinical specialties or procedures. Dedicated systems intended for clinical applications (e.g., cardiology
administrative procedures (e.g., finances, reimbursement, materials management) are available, inclu
systems. Data management information systems that exchange information with medical imaging equ
digital radiology imagers) usually follow DICOM (Digital Imaging and Communications in Medicine), a s
medical informatics that ensures interoperability.

Physiologic analyzers that evaluate the interaction between the central nervous system and the perip
that activates the skeletal muscles (i.e., the basic units of the body movement). To make a complete
neuromuscular function, the system should include units capable of performing electrophysiologic tes
somatosensory evoked potentials, electromyography), diagnostic imaging (e.g., computed tomograph
imaging, ultrasound), and biomechanical studies (e.g., dynamometry, posturography, gait). These an
advanced diagnosis and research to assess structural and functional abnormalities of muscles, the ne
and the central nervous system, including the cortex, brain stem, and spinal motorneurons.

Detectors designed to magnify the sound of patient respiration by generating a whistle sound. These
proximal end of the tracheal or nasotracheal tube and accentuate the sound of air movement, enablin
easily localize the point of maximal air movement just above the cords. After intubation, the detector
positioning as the whistle is auscultated during both inspiration and expiration. Respiratory rate, depth
expiratory forces can be ascertained by noting the intensity, duration, and pitch of the whistle sound.

Cardiology data management information systems designed to record, process, and display informatio
clinical and administrative management of a patient's hemodynamic status. These systems include ha
to collect information from cardiac output units, monitors, and fluid administration devices. Hemodyna
systems help physicians establish baseline hemodynamics and manage the prognosis and treatment o
abnormal hemodynamic conditions, such as chronic congestive heart failure, hypertension, and during
or dialysis procedures. The systems may function as stand-alone systems or may be integrated in a ho
management information system network.

Erbium-doped yttrium-aluminum-garnet (Er:YAG) lasers used mainly to vaporize tissues. The combina
affinity and high-fluency pulses produces an exceptionally narrow zone of damage around the vaporiz
lasers are also used as a precision drill and saw for bone surgery.
Solid-state lasers, powered by a rod of yttrium-aluminum-garnet (YAG) crystal doped with holmium (H
element, as the active medium, designed for use in surgical procedures. These lasers typically emit en
of 2,100 nm (mid-infrared); they may be operated in continuous-wave, pulsed, and Q-switched modes
be delivered through a flexible optical glass fiber, and the laser can be operated in an aqueous enviro
lasers are used mainly to vaporize or ablate soft tissue with moderate hemostasis, little charring, and
they are frequently used in laparoscopic and endoscopic procedures.

Flexible soft loop devices designed to hold the heart suspended in an elevated position and improve e
coronary vessels during cardiothoracic surgery procedures. These devices usually consist of a mesh m
or other soft material that is suspended from an external frame. Cardiac slings are typically used durin
bypass surgery.
Argon/krypton lasers used to coagulate abnormal vascular tissue in the retina and to perform other ph
procedures in the eye. These lasers are typically coupled to a biomicroscope slit lamp or to an indirect
flexible fiberoptic cable.
Lasers that can produce either a neodymium-doped yttrium-aluminum-garnet (Nd:YAG) or a carbon di
beam. The combined device offers both the cutting capabilities of CO2 energy and the hemostatic cap
energy, allowing the surgeon to make bloodless incisions.
Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) lasers that double the frequency of the emitted
the energy through a crystal, typically of potassium titanyl phosphate (KTP), designed for use in surgic
lasers emit energy at a wavelength of 532 nm (green); they may be operated in continuous-wave or p
energy can be delivered through a flexible optical glass fiber. Frequency-doubled surgical Nd:YAG lase
variety of surgical applications.

Pumps designed to deliver a temperature-controlled flow of heated or cooled liquid through hoses into
appropriate channels for liquid circulation. These pumps usually include a reservoir for the liquid; a he
reservoir that warms the liquid; a pump that circulates the liquid in the pad; and temperature controls
pumps include a thermoelectric cooler. Circulating-liquid pumps are used for long-term localized mild
at no more than 43 degrees C) or cooling of patient's skin.

Circulating-liquid pumps designed to deliver a temperature-controlled flow of cooled liquid (e.g., wate
hoses into pads that have appropriate channels for liquid circulation. Some pumps use thermoelectric
circulating liquid with ice. Localized-cooling pumps are used for therapeutic localized cooling of a pati

Microbiology reagents used detect and/or identify one or more of the Cryptosporidium species that pa
intestines. Cryptosporidium parvum is the only known pathologic species, causing profuse, watery dia
several days. In immunocompromised patients the disease may persist indefinitely.

Microbiology reagents used for detection and/or identification of Giardia lamblia that parasitize human
lamblia causes giardiasis, a common infection of the small intestines.
Balloons used in conjunction with a manometer to assess function of rectal sphincter.
Neuromuscular electrical stimulators implanted in the abdomen to control incontinence. These stimula
electrodes placed in the bladder wall or in the pelvic floor and an external transmitter for sending the
transcutaneously to the implanted receiver.
Scanning systems that use a combination of near-infrared and red light sources to transilluminate the
the difference in attenuation, to aid in the evaluation of breast tissue (e.g., cyst, fat, tumors). These s
infrared light sources, fiberoptic cable and scanning heads, a video camera, electronic processors, and
systems are designed as an aid in the evaluation of breast diseases.

Adapters that are designed to be attached to a guiding catheter or balloon introducer hub to facilitate
angioplasty balloon. These devices provide a connection for pressure monitoring, dye delivery, and fl
dilatation catheters during transluminal coronary angioplasty procedures.
T-fasteners designed to appose the anterior gastric wall to the anterior abdominal wall. These fastene
bar, usually with a plastic (e.g., nylon) suture attached to it. These devices are typically positioned wit
slot in a needle; the needle with the suture is introduced into the gastric lumen. The T-bar is then mov
suture is pulled back against the stomach wall, and a cotton pledget anchors it outside the abdominal
gastrostomy T-fasteners are used to facilitate the insertion of gastrostomy tubes via gastropexy proce
the separation from the anterior abdominal wall in the event that the tube is dislodged.

Gastrostomy feeding tubes designed for insertion of the distal tip into the stomach using a percutaneo
procedure. Typically, an endoscope is introduced through the mouth and into the stomach, and a hollo
pushed through the abdominal wall (i.e., percutaneous) into the stomach; then the wire is grabbed wi
and pulled up through the mouth. The feeding tube is attached to the wire and pulled down into the s
through the opening in the abdominal wall. These tubes typically consist of a soft, clear, large bore (14
diameter is typical) silicone tube with a small rectangular crossbar called a bolster over it next to the
balloon or mushroom distal tip on the inside; they are commonly known as peri-epigastric tubes (PEG)
tubes are mostly used for feeding patients who require long-term enteral feeding but who are unable
oral intake (e.g., patients who have severe neurologic impairment; they are also used for patients who
mouth, larynx, or esophagus. Some of these tubes may be used to administer medications; dedicated
tubes with tips that are advanced into the jejunum for jejunal feeding are also available. PEGs may be
devices known as gastrostomy buttons for long-term feeding needs.

Jejunostomy tubes designed for insertion into the jejunum using a long (160 cm or more) gastroduode
remains in the jejunal lumen while the other catheter tip exits through a stab incision in the abdomina
usually consist of a large-bore (sizes from 14 to 28 French diameter are typical), thin-walled tube with
bumper. The insertion procedure may be performed in outpatients or at the bedside using minimal sed
endoscopic jejunostomy tubes are particularly suitable for long-term feeding in patients who are at inc
complications related to surgery; the catheters are of larger diameter and may be easier to place than
inserted by gastrostomy procedures.
Aerobic exercisers designed to simulate the motion of climbing stairs. These exercisers may consist of
staircases; more often, they are steppers (also known as climbers), consisting of footpedals or platform
drive system, side handrails, and/or front handlebars. These exercisers may be nonpowered or powere
exercisers usually include workout program modes to adjust resistance level; a monitor to display the
distance, speed, calories burned, and heart rate; and handlebars with grip pulse sensors or wireless h
may also have heart-rate controls to adjust the resistance level to suit the targeted heart rate. Climbin
are intended to increase cardiovascular endurance by keeping the heart and pulmonary rate elevated
period of time. Additionally, they provide strength and endurance to the muscles of the lower body (i.e
hamstrings, gluteus, hip flexors, calves) and the upper body (i.e., arms, shoulder, chest, back).

Pillows used while sitting or lying down that are shaped to conform to the natural curvature of the low
promotes correct posture and prevents or relieves lower back pain and fatigue. They can be shaped l
or can be larger to fit the entire back of a chair, with a base that curves out or inflates to support the l
back. There are also fully inflatable, gel-filled, and water-filled lumbar pillows.

Tracheal catheters designed for periodic tracheal and pharyngeal mucus removal and inflation of the l
from their distal tip. These catheters consist of either dual- or single-lumen tubes; dual-lumen cathete
suction and insufflation, and single-lumen catheters allow alternating suction and insufflation.

Devices that are used to burn off wax from an inlay mold and establish the proper condition and temp
investment to receive the molten casting alloy.
Biliary catheters used for measuring pressure in the biliary and/or pancreatic ducts, especially in the s
investing the associated bile and pancreatic passages as they traverse the wall of the duodenum (sph
devices usually consist of a triple-lumen 5 Fr catheter including two or three leads, either with micropr
located at their distal tip or with open-end, fluid-filled pressure catheters attached to an external strai
Most of them include openings for aspiration purposes. Manometric biliary catheters are frequently us
postcholecystectomy pain and for assessing sphincter of Oddi dysfunction.

Implants designed for repair and/or partial replacement of the pericardium, a double membranous, co
sac enclosing the heart and the roots of the great blood vessels. These implants are typically patches
grafts, available in a variety of shapes and sizes according to the intended site of implantation. Biolog
frequently xenograft patches made of glutaraldehyde-fixed (patches are also available using other fixi
pericardium; synthetic implants are also available.

Collimators designed for selective absorption of unwanted gamma rays, permitting the passage of rad
desired path. These collimators are made of heavy metals (e.g., lead); the basic types used in gamma
parallel hole, diverging, and converging collimators, each with specific uses. Gamma camera collimato
component of gamma cameras and single photon emission tomography scanning systems.

Exercisers designed to improve the range of motion around the jaw articulation by stretching the jaw m
exercisers provide repetitive passive motion of stretching jaws, operated by the user. The exercisers a
mouthpieces and press pads that provide the curved stretching force in the jaw. Users can adjust the s
distance of jaw-opening motions. The exercisers are designed to improve the flexibility and mobility o
joints and can also increase jaw muscle strength. The exercisers are used mainly for jaw treatment an
Materials capable of attracting or incorporating (i.e., absorbing) a liquid/semiliquid substance and des
immobilize/solidify liquid/semiliquid infectious waste (e.g., blood, urine, mucus, vomit) so that it can b
(i.e., for removal, storage, decontamination, and disposal). Infectious waste absorbents are typically u
liquid/semiliquid infectious waste has been spilled or has leaked from a container; these absorbents o
component of a spill cleanup kit. Infectious waste absorbents are also used to solidify liquid infectious
containers (e.g., suction canisters, infectious waste trash bags [i.e., red bags], urology bags).

Adapters (optical couplers) designed to connect a laser source to a fiber-optic laser delivery system. T
consist of an optical connector that collimates and focuses the energy supplied by the laser source int
delivery system. Some laser sources have a connector that makes possible direct coupling to the fiber
not need additional couplers; the couplers are especially necessary for diode lasers because the laser
diode is larger than that for other types of laser energy (e.g., up to 45? versus less than 15?).

Laser delivery systems consisting of flexible optic fibers used to deliver laser energy of visible and nea
wavelengths. These systems include a flexible fiberoptic cable with a silica core, an outer cladding an
and a handpiece; they are typically available in core sizes of 400, 600, and 1,000 micrometers. Tips ar
to the procedure to be performed (e.g., sculpted quartz for contact procedures, bare or side-firing for n
procedures); some systems permit the coupling of disposable laser fibers to the laser unit. Low-hydrox
numerical aperture is required by some systems for effective energy transmission.

Diode lasers, usually operated at low power and with gallium arsenide as the active medium at an 810
to coagulate abnormal vascular tissue in the retina and to perform other photocoagulation procedures
lasers can be coupled to a biomicroscope slit lamp or indirect ophthalmoscope by a flexible fiberoptic

Gloves designed to cover and protect wheelchair users' hands, providing protection against injury cau
wheelchair wheels with bare hands. These gloves are usually made of neoprene, spandex, Lycra, rubb
these; they are typically light, flexible, breathable, durable, and comfortable to wear for extended per
pushing gloves may also provide non-slip and/or water resistant capabilities to the user; some gloves
textured area built into the palm for added grip.

Shunts designed to provide an anastomosis (i.e., surgical connection) between the left subclavian arte
the aorta) and either the left or right pulmonary artery; they are intended mainly to shunt some of the
into the pulmonary circulation. These shunts typically consist of a synthetic (e.g., extended polytetrafl
(i.e., a vascular graft) with a thin wall and appropriate size (3 to 5 mm diameter and 2 to 5 cm length
configuration to facilitate the connection between the subclavian artery and the pulmonary artery (i.e
modified Blalock-Taussig procedure). Pulmonary artery shunts are used as implants in palliative surger
improvement of circulatory conditions of infants suffering from congenital heart defects, such as tetra
pulmonary atresia, pulmonary valve stenosis, and other congenital defects of the cardiopulmonary cir

Holders designed to hold vacuum blood collection tubes during blood collection from a patient. These
equipped with a blood collection needle or have the capacity to attach to a blood collection needle thr
one end of the tube. Blood collection tube holders are cylinders usually made of sturdy plastics and ar
Smaller blood collection tube holders can hold pediatric-sized blood collection tubes and needles.
Lasers designed for dermatologic therapy using a solid-state ruby rod as active medium. These lasers
wavelength of 694 nm (red) that is usually delivered using a flexible fiberoptic cable; they are typicall
and/or Q-switched modes. Ruby lasers are intended mainly for treatment of pigmented lesions, using
chemical dissociation by means of light (photothermolysis).
Wheelchair lifts designed to move a wheelchair-bound person between ground level outside a motor
vehicle. Most of these lifts consist of a platform onto which the patient wheels the wheelchair; then th
raise the wheelchair into the vehicle. Other lifts include a powered arm mounted in the vehicle that is
wheelchair to raise it. These lifts use electric or hydraulic power; some may be operated using the veh
motor-vehicle wheelchair lifts are permanently mounted in the vehicle.

Wheelchair lifts designed to carry person in a wheelchair along a staircase. These lifts typically include
mounted or free-standing in specially designed supports) that runs along the stairway and a platform
onto which the patient wheels the wheelchair. Some models fold against the wall, leaving the stairway
use. Stairway lifts are usually installed in existing stairways with minimum modifications; they may be
public places such as schools, libraries, and hospitals.

Patient transfer lifts designed to carry people along a staircase; they typically consist of a permanentl
attached to the wall that runs along the stairway and supports a rigid chair. These lifts include the foll
usually made of aluminum, a mounting system that attaches the track to the wall (sometimes free sta
designed supports), an electric motor or hydraulic mechanism, a seat, and a control box for lift movem
models fold against the wall leaving the stairway clear for pedestrian use. Stairway lifts are usually ins
stairways with minimum modifications; they are mostly used at home, but may be installed in public-u
schools, libraries, or hospitals.

Lifts designed to move a person in a wheelchair to a different height level. Wheelchair lifts are used to
persons to overcome vertical barriers. Wheelchair lifts are used in places such as hospitals, homes, offi
may be designed for vertical movement or to carry persons along a stairway. Special wheelchair lifts a
from motor vehicles or carry a person along a staircase.
Calibrators designed to test the accuracy of the volume delivered by pipettes, pipetters, and diluters.
typically use either colorimetric methods that use dedicated spectrophotometers and special reagents
methods based on analytic balances; other methods such as titration using digital titrators are also us
are used for periodic, regular checking of the performance of volumetric equipment.

Bronchial catheters designed with a balloon at or near the distal tip. These catheters are flexible synth
may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope in such a
reaches the bronchi, permitting the inflation of the balloon after introduction. Dedicated balloon bronc
available to treat benign stenosis and/or to control pulmonary bleeding (i.e., hemoptysis).

Powered devices that allow control of various motor vehicle functions (e.g., braking, acceleration) by a
means.
Mechanical devices designed to allow control of various motor vehicle functions (e.g., braking, acceler
nonconventional means.
Biopsy image-guided stereotactic computer-aided systems designed to aid in the performance of mini
(i.e., mammographic) biopsy procedures by combining medical imaging, dedicated computer software
instrument (e.g., needle wires) and tracking systems for guidance. The systems provide surgeons with
dimensional (3-D) positioning and orientation of instruments relative to the patient's anatomy on a vid
biopsy. Image-guided stereotactic systems provide medical images that show the location of the instru
during the biopsy. One or more imaging modalities, such as computed tomography (CT) and/or magne
(MRI), may be used in the procedure. Dedicated image-guided biopsy stereotactic systems intended fo
be mounted onto existing mammographic units are available.

Injection needles designed to penetrate the space that separates the spine's outermost membrane (d
enclosing vertebrae in the spinal cord. These devices typically consist of 14- to 20-gauge needles, 50
inches) in length, with appropriate tips (e.g., Tuohy, pencil, wave) to minimize cutting and/or lesion of
The needles may include permanent or removable wings and depth marks to facilitate accurate insert
are usually attached to catheters that are threaded through the needle for the external infusion of flui
then removed, and the epidural catheters are used to administer regional anesthesia during labor and
surgical procedures; they are also used to manage intractable pain and for steroid injections.

Ramps designed to be installed inside or outside of buildings or used with vehicles and intended to fac
people who use wheelchairs or scooters. Wheelchair ramps are usually constructed with standardized
maximum slopes, maximum lengths, weight-bearing capacity; the longer the ramp, the lesser the slop
Wheelchair ramps are usually made of aluminum, concrete, galvanized steel, or wood, and have non-s
ramps include hand rails.

Wheelchair ramps that are designed to be portable and that can be folded and moved to other locatio
needed. Portable ramps can be used inside or outside of buildings or with vehicles, such as vans or au
access for wheelchairs and their occupants. Wheelchair ramps are usually constructed with standardiz
maximum slopes, maximum lengths, weight-bearing capacity; the longer the ramp, the lesser the slop
Wheelchair ramps are usually made of aluminum, concrete, galvanized steel, or wood, and have non-s
ramps include hand rails. Some portable ramps can be powered by being connected to the vehicle's e

Wheelchair ramps that are designed to be stationary and intended to be installed permanently onto b
usually bolted or cemented in place. They are intended to facilitate access by people who use wheelch

Dental prostheses designed for partial or total replacement (i.e., restoration) of one or more teeth, wh
cemented) in place by the dentist and that the user cannot remove. These prostheses typically consis
custom-made devices with different shapes, such as an inlay, onlay, crown, or fixed partial denture (i.
made of cast metal alloys, synthetic (e.g., acrylic) resins, ceramic, or combinations of these materials.
prostheses are intended to replace missing teeth.
Devices that continuously or intermittently administer nitrous oxide or a mixture of nitrous oxide and a
produce conscious sedation during dental procedures. Unlike general anesthesia units, dental nitrous
are not used in conjunction with vaporizers because nitrous oxide is already in a gaseous state at norm
and pressures. Nitrous oxide anesthesia systems contain hardware that allows connection to a nitrous
central nitrous oxide gas system in a wall unit and usually connect to a breathing circuit (typically a fa
the anesthetic gas mixture is released. Flow regulators are used to regulate the amount of gas deliver
nitrous oxide anesthesia units deliver gases to the patient via a face mask, there is a possibility of lea
scavenging systems are an important part of the unit to help prevent the escape of exhaled gases. Als
rapidly diffused than nitrogen during desaturation, oxygen flush at the end of N2O administration is im
hypoxia. Some dental units are equipped with capability for the oxygen gas flush to the patient at the

Spectrophotometer calibrators designed for verification of the transmittance and/or absorbance scales
spectrophotometers. These calibrators typically consist of a set of filters (e.g., holmium oxide, didymiu
nominal transmittance values (e.g., 10, 20, 30%); each filter is calibrated stating the transmission valu
frequencies in the visible range (e.g., 440.0, 546.1, 635.0 nm).The filters are usually mounted in a cuv
facilitate calibration.

Liquid solutions designed to characterize the contact relationship of the occlusal surfaces between the
mandibular teeth. These solutions are typically a binary liquid system that includes a primary liquid co
partially absorbed by the teeth and a second liquid compound that may be either applied to the teeth
surfaces on the tooth itself or on a substrate that shows visible marks when the patient bites. Articula
used in a variety of dental tests, such as the determination of size, shape, and proper placement of pa
and to program and/or assess the progress of orthodontic treatments.

Dentures designed for replacement of one or more but not all the natural teeth in the upper (i.e., max
mandible) jaw. These devices are typically a removable, custom-made prosthesis with a cast metal fra
the alveolar ridge with porcelain or resin teeth attached. Partial dentures may be also intended to repl
(e.g., using an acrylic overlay) and adjacent parts of the maxilla or mandible.

Vascular catheters designed to facilitate intravascular access through their lumen to specific vessels (
coronary arteries). These catheters (also known as guiding sheaths) usually consist of a single-lumen
appropriate configuration, stiffness, and tip to access a particular section of the vasculature. Guiding v
used to insert other catheters, guide wires, balloons, occlusion devices, and stents, while performing i
catheterization procedures (e.g., angioplasty, atherectomy). Dedicated vascular guiding catheters are
of intravascular (e.g., peripheral, central venous) introducers and catheterization procedure kits and t

Microwave laboratory ovens designed for defrosting (i.e., thawing) frozen plasma. These ovens usually
box with a microwave generator that delivers an electromagnetic field with frequencies in the range o
(typically around 2.45 GHz); a chest-type chamber with an upper door or, less frequently, a conventio
intended for appropriate placing of frozen plasma bags; and accurate time and power controls that ma
programmed warming cycles. Plasma-thawing microwave ovens are used in blood banks, healthcare f
laboratories.
Biopsy instruments designed for the automatic extraction of core tissue samples (typically in the form
anatomic structure with minimal damage to the sample and surrounding tissue. Biopsy guns are typic
instruments with a spring-loaded mechanism for transcutaneous insertion of a biopsy needle to obtain
intended for laboratory examination and/or test (i.e. biopsy). Biopsy guns are used mainly to obtain la
tissue from internal organs, including the kidneys, prostate, pancreas, and liver, and the breast. The p
frequently performed under image guidance (e.g., radiographic, ultrasonic, magnetic resonance).

Filters designed to separate plasma from cellular components during manual or automated procedure
separate, collect, and reinfuse blood (i.e., pheresis procedures). These devices are typically a micropo
to 0.6-micrometer pores) membrane filter similar to those used in hemodialysis units. Pheresis filters a
manual procedures and/or in automated pheresis (e.g., plasmapheresis, leukapheresis) units used in h
and/or for therapeutic purposes (e.g., treatment of blood diseases and cancer). Dedicated filters inten
bacteria, microorganisms, and/or particles are also used in pheresis procedures.

Grafts obtained from a donor or produced artificially that are intended to replace, bypass, or shunt a p
injured blood vessel. Vascular grafts used in humans may be of biological origin, obtained mainly from
person (i.e., autograft) or from another person (i.e., allograft) or, less frequently, from a different spec
synthetic (usually made of Dacron or polytetrafluoroethylene). Bioengineered grafts are also available
(i.e., autografts) that are not processed in any way and usually reimplanted immediately during the sa
are not considered medical devices and are not included under any graft term. Biological grafts are in
replace small-diameter (less than 10 mm) vessels while synthetic grafts are best suited for large-diam
mm) high-flow vessel replacement. Vascular grafts are used in many vascular procedures (e.g., aortoil
axilloaxillary artery bypass) except those involving the coronary arteries.

Occlusal splints (also known as intraoral orthoses) designed to be placed inside the mouth for use dur
to treat obstructive sleep apnea (OSA) and help in avoiding inspiratory noise produced by vibration of
tissues (i.e., snoring). These splints usually consist of removable (e.g., plastic) devices that increase th
order to improve the patient's ability to exchange air, thus decreasing the air turbulence which is the
in snoring. There is a variety of occlusal splints used for the purpose of treating OSA and/or preventing
usually use one out of three main different techniques (i.e., mandibular repositioning, tongue retaining
combination of these. Dedicated OSA/anti-snoring splints using one or more of these techniques are a
usually positioned in dental offices.

Protein purified from skin, tendon, bone, cartilage and other connective tissue that is injected into pat
reconstructive purposes.
Breast implants that are prefilled with silicone gel. These implants typically consist of an outer shell (e
that may include a single or double (i.e., one shell inside the outer shell) lumen, silicone gel filler, and
shell once filled. Single-lumen implants are prefilled with a fixed volume of gel in the manufacturing p
implants have an inner lumen prefilled with silicone gel and an outer lumen ready for filling with saline
implantation or vice versa; some implants may allow adjustment of the saline content after implantati
implants are intended for breast reconstruction and/or augmentation.
Manual surgical saws designed to cut the cartilage structures of nose. These saws are small, handheld
typically with a thin serrated blade attached to a handle that may be in line or at a right angle to the b
cut the nasal cartilage. Manual nasal surgery saws are used in plastic (i.e., rhinoplasty) and reconstruc
nose.
Orthoses designed for external modification of the structural and/or functional characteristics of part o
limb, to provide immobilization and support. These orthoses consist of rigid or semi-rigid malleable me
stainless steel) structures (e.g., supports, restraints) that may be used for therapy (static therapy, dyn
or to improve the limb function (i.e., gait); some orthoses are externally powered. Lower-limb orthoses
for treatment of deformities and injuries after trauma. Dedicated prefabricated or custom-made lower
intended for a particular region of the limb (e.g., foot, ankle, leg, knee, thigh, hip), procedure (immobi
support, gait stabilization), and/or treatment (e.g., deformity, trauma, arthritis) are also available.

Tracheal tubes designed for one-lung isolation and/or to provide one-lung ventilation. One-lung ventila
using several different tubes and/or techniques, including conventional single-lumen tubes that may i
bronchial blocker, an isolated bronchial blocker, or a balloon at the tip to provide only one-lung endob
Dedicated double-lumen tracheal tubes that permit left-lung isolation and/or right-lung isolation are a
ventilation tracheal tubes are used mainly during thoracic surgery and/or intensive care procedures.

Mobile modular medical facilities that contain the equipment and supplies needed to function as an in
performing cardiac catheterization procedures (i.e., invasive medical procedures performed as a diagn
tool for heart and circulatory conditions). These facilities are typically divided into a patient treatment
that includes the operator console, and a room for auxiliary equipment (e.g., electric generator, air-co
Equipment found in these facilities typically includes a cardiovascular radiographic/fluoroscopic system
introducing contrast medium into the patient at high flow rates, physiologic monitoring equipment, an
equipment to manage cardiovascular emergencies.

Mobile modular medical facilities typically divided into a patient treatment area, an operator room tha
console, and an auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities in
(e.g., ultrasonic, electrohydraulic), a urological table, and endoscopic devices.
Mobile modular medical facilities typically divided into a patient treatment area, a magnet room, a con
the operator console, and an auxiliary equipment (e.g., electric generator, air conditioning) room. The
primary magnet, gradient magnets, a radio-frequency subsystem, a patient table, and a computer sub
software, display monitors, and a data-storage unit.
Mobile modular medical facilities typically divided into a radiographic area, a dressing room, a recepti
auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities include a high-fre
potential x-ray (usually from 20 to 35 kV) mammographic unit, patient positioning features (e.g., comp
an image recording system. Some facilities also include stereotactic biopsy capabilities and an x-ray fi

Laser delivery systems consisting of flexible or rigid hollow tubes (i.e., waveguides) appropriated for
energy from the laser source to the tissue, typically at infrared wavelengths,.
Multipurpose splints designed to be conformed to the appropriate shape (i.e., molded) at the point of
typically consist of a thin metallic (e.g., aluminum) and/or thermosetting plastic sheet that can be cut
according to the body part and the needs of the patient. Moldable splint orthoses are intended mainly
treatment of patients suffering fractures, sprains, dislocations, and/or other injuries of the limbs, neck
parts. Dedicated aluminum and plastic multipurpose moldable splints are available.

Vascular infusion catheters designed for local delivery of drugs (e.g., heparin) to the coronary vascula
typically consist of a double-lumen tube; a drug solution is infused into the arteries through a lumen a
wall, and a second lumen serves as a passage for a guide wire. Coronary artery infusion catheters are
drug delivery (e.g., heparin) and for the lysis of thrombus in the coronary vasculature.

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
providing immobilization and/or support. These orthoses consist of rigid or semi-rigid malleable metal
stainless steel) structures (e.g., supports, immobilizers) that provide assistance during use of the arm
intended mainly for rehabilitation after injuries or trauma (e.g., fractures).

Lower-limb orthoses designed for external modification of the structural and/or functional characterist
and foot, providing immobilization and support and/or intended for therapeutic or daily functional acti
orthoses may be classified according to the function of the orthoses (e.g., immobilizers, therapeutic, f
characteristics (e.g., shape, consistency), and/or the material used to make the orthosis (metal, plasti
these). Ankle-foot lower-limb orthoses frequently consist of soft or semi-rigid orthoses that can provide
during rehabilitation, therapeutic procedures, and during normal functional activities or practice of spo

Orthoses used to support, align, prevent, or correct deformities or to improve function of the knee.
Fluid implantable materials designed for mechanical reconstruction and/or improvement of physical a
devices typically consist of either biologic or synthetic fluid materials that are injected into the body. F
reconstructive materials are used in plastic surgery for cosmetic purposes and/or for reconstruction of
either of pathologic origin or after trauma; they are also used in other cosmetic procedures (e.g., treat
Available fluid reconstructive materials include either absorbable biologic fluids, such as injectable col
powder compounds mixed with blood, or more permanent fluids such as synthetic hyaluronic-acid-bas

Adult intensive care ventilators that deliver gas to the lungs by periodically applying and releasing an
pressure to the chest cavity. Some negative-pressure ventilators consist of a tight chamber (e.g., tank
the patient is enclosed from the neck down; then a vacuum pump creates a negative pressure around
to be sucked into the lungs. Others consist of a plastic or metallic shell (breastplate or cuirass) externa
patient chest and a vacuum pump that creates a negative pressure within the breastplate. Cuirass ne
ventilators that can control both inspiration and expiration either by providing a negative pressure dur
phase and a positive pressure during expiration or by intermittent swings of negative pressure (negat
ventilators) are also available. Adult negative-pressure ventilators typically operate at normal breathi
oscillatory type can reach respiratory rates up to several hundred cycles/minute.

Mobile modular medical facilities typically divided into an x-ray shielded radiographic scanning area, a
including the operator console, and an auxiliary equipment (e.g., electric generator, air conditioning) r
consist of a tomographic scanning subsystem, a patient table, and a computer subsystem including de
display monitors, and a data-storage unit.
Mobile modular medical facilities typically divided into an ultrasound examination area, a reception ar
equipment (e.g., electric generator, air conditioning) room. These facilities consist of an examination
general-purpose ultrasonic scanner, including transducers for several examinations (e.g., abdominal,

Systems designed for transmission (delivery) of laser energy from the laser generator to the tissue or
Laser delivery systems typically consist of fiber optics cables, waveguides, or hollow articulated arms

Defibrillator-pacemakers that generate electric impulses outside the body and deliver them to the hea
wall using paddles (or electrodes). These devices typically include an electrocardiographic monitor an
conductive, disposable adhesive electrodes that conduct the electrical stimuli through the skin and sk
heart. External defibrillator-pacemakers allow defibrillators to be used in the emergency temporary tre
severe bradycardia, implantable pacemaker failure, certain types of tachycardia, and sick sinus syndro

Batteries designed as a power source for implantable pacemakers, defibrillators, or pacemaker/defibri


batteries consist of nonrechargeable (e.g., lithium/iodine) cells. Implantable cardiac pacemaker batter
together with a pulse generator in a container; they are typically placed in a surgical pocket in the pat
abdomen.
Infrared electronic thermometers used to measure a patient's ear canal temperature. Most of these th
designed to estimate the internal ("core") temperature of the body by measurement of infrared radiat
auditory canal, while others claim to measure directly the infrared emissions from the tympanic memb
thermometers also usually display "corrected" offset values of oral and/or rectal temperature.

Electronic infrared thermometers used to estimate the temperature of a site on the skin (e.g., axilla, f
measurement of body infrared emissions at this particular point. The short interval between measure
thermometers provides a method to determine temperature patterns on the surface of the skin by me
locations in a small time (e.g., before performing an EMG).
Stents designed for deployment into the section of the urinary tract between the bladder and the ext
urethra), including the prostatic, membranous, bulbar, and penile sections of the urethra, to provide s
maintain patency within the duct. These devices typically include metallic self-expanding stents, eithe
stents that open by themselves as soon as they are released or shape-memory stents manufactured f
combining nickel and titanium (i.e., nitinol) that expands in response to body temperature. Some of th
radiopaque markers for accurate positioning. Urethral stents are typically deployed using endoscopic
used mainly to treat recurrent urethral strictures and prostatic obstructions caused by diseases such a
hyperplasia and prostatic carcinoma.

Dental condensers designed to pack filling materials into prepared root canals. Dental endodontic con
to condense root-canal fillings vertically into prepared root canals (i.e., vertical condensers or plugger
canal fillings horizontally against the wall of prepared root canals.

Devices used to mix orthopedic (or bone) cement. They typically consist of a mixing box, into which t
components are added, and a vacuum chamber. A vacuum is applied while the cement constituents a
with a spatula. This method of mixing may reduce porosity and enhance the strength of cement.

Devices (e.g., anchored straps) designed to secure an occupied wheelchair while it is in a motor vehic
typically anchored to the vehicle floor.
Oxygen/carbon dioxide metabolic rate physiologic analyzers combined with an ergonometer such as a
treadmill (i.e., a metabolic system) to measure metabolic energy expenditure as well as cardiovascula
function during exercise. These combined devices are used for periodic assess of patient progress in c
rehabilitation programs, for exercise and/or space physiology, to determine energy expenditure needs
applications (e.g., sport medicine).

Adapters designed for use with vials (small containers) to allow withdrawal of more than one dose (i.e
contents (e.g., medication, sterile saline flush solution). These adapters typically have a sharp, thin, p
allows the adapter to penetrate the stopper/cover of the vial, a venting pathway, and a fluid removal p
adapters also include an access port that supports the use of needleless systems.

Eye cannulae used for ocular surgery to provide simultaneous irrigation and aspiration. These cannula
automated irrigation/aspiration devices, phacoemulsifiers, and vitrectomy units or for manual procedu
bag and a syringe. These cannulae are used in many anterior-segment procedures, including cataract
aspiration of fluid from the eye, or use in a vacuum trephine for corneal tissue aspiration.

Recording systems designed for storage of speech (e.g., dictation), usually as digital signals, providing
transcription and revision of the recorded information. These systems typically consist of a specialized
including a CPU (central processing unit), an operating system, controllers, dictation and transcription
interfaces with the hospital information system. Digital dictation systems are typically used by physici
healthcare staff to dictate medical reports and/or other patient information; most systems permit rem
records (e.g., using a touchtone telephone) before, during, and/or after transcription, while some syste
capabilities. Digital dictation systems equipped with the appropriate software, particularly those with
capabilities, may be used to assist speech diagnosis and/or therapy.

Carts that include special structures designed for concealed transportation of a cadaver; they are also
storage of cadavers in the morgue. These carts may include special covers and/or a cadaver carrier un
cart. The cart resembles an empty stretcher while transporting the concealed body. Concealed cadave
move deceased patients throughout a healthcare facility without disturbing patients, personnel, or vis
appropriate to perform autopsies or other post-mortem procedures.

Pulmonary artery catheters dedicated to measure mixed venous oxygen saturation (SvO2); they usua
pulmonary artery wedge pressure. These catheters include a fiberoptic bundle and light-emitting diod
distal tips; the light emitted at two or three different wavelengths (e.g., red and near infrared) from th
reflected from the red blood cells varies according to the oxygen saturation level. The SvO2 is determ
optical module (reflectance spectrophotometry). Oximetry pulmonary artery catheters are used for co
hemodynamic monitoring of critically ill patients (e.g., acute respiratory failure and/or shock) and duri
medical procedures. Some of these catheters are used in monitoring jugular venous oxygen saturation
severe head injury.
Image digitization systems designed to acquire and digitize x-ray images from image storage phospho
imaging system consists of an imaging receptor (e.g., a cassette with an image plate), an image reade
console. The image is acquired on a photostimulatable substance (e.g., a phosphor plate), a reader/di
image and converts it into an electrical analog signal using a laser scanner; this signal is in turn ampli
digital signal, which is stored and processed by a computer. Dedicated systems are available for thora
conjunction with conventional radiographic table systems, and also for dental and mammography app
digitization systems can be used to upgrade exiting film based radiography systems.

Tissue ablation microwave therapy systems designed to ablate regions of the prostate. These system
microwave generator (e.g., 915 MHz frequency); an urethral catheter including a coaxial cable with a
and a temperature sensor located at its tip; a rectal probe with temperature sensors; and a temperatu
air cooling is frequently added to protect other tissues (e.g., rectum, external sphincter); in some syst
inserted into the patient's rectum with the antenna placed adjacent to the prostate gland. Prostatic a
systems are used for treating benign prostatic hyperplasia and cancer of the prostate.

Infusion pumps designed to deliver large volumes of blood, liquid medications, and/or other solutions
routes at pre-established accurate flow rates while warming the infusate. These infusion pumps usuall
mechanism to move fluid from the solution container through the IV set to the patient. They also inclu
attached warming unit to deliver the infusate at a temperature approximating that of the human body
include controls used to select the dose, temperature, or volume to be infused; recording capabilities
infusion temperature, volume and rate; and audible and/or visual alarms to indicate abnormal conditio
(known as "smart pumps") include software capable of detecting medication administration errors (i.e
systems) are also available. Warming blood/solution infusion pumps are usually intended for IV pole m
used mainly in hospitals, other healthcare facilities, and at home.

Systems that include a neuromuscular stimulator as an integral part of a therapeutic ultrasound unit.
used to produce a rhythmic contraction/release of injured muscles to promote the removal of metabol
applying ultrasound treatments. Neuromuscular stimulation combined with ultrasound therapy is use
formation in healing tissues and to help reduce spasms and pain.

Orthoses designed for external modification of the structural and/or functional characteristics of the sp
immobilization and support. These orthoses typically consist of rigid or semi-rigid (e.g., corsets, collar
with elastic fabric bands (e.g., thoracic, pelvic, lumbosacral) having appropriate physical characteristic
consistency) to encircle the body at a particular area of the spine. Spine orthoses are typically made o
combination of these. Dedicated spinal (prefabricated or custom-made) orthoses intended for a partic
(e.g., cervical, lumbosacral, sacroiliac), function (immobilization, alignment, support), and/or treatmen
trauma, osteoporosis) are available; dedicated spinal orthoses intended for therapeutic or daily activit
use are available.
Upper-limb orthoses designed for external modification of the structural and/or functional characterist
providing immobilization and/or support. These orthoses are usually classified according to the functio
immobilization, support, therapeutic, functional) and the physical characteristics (e.g., shape, consiste
used to make the orthosis (metal, plastics or a combination of these). Elbow upper-limb orthoses may
(e.g., a combination of cuffs, straps, and flexible mechanisms) that are intended to provide limited sup
or semi-rigid orthoses that can provide a high degree or total immobilization of the elbow joint. Elbow
are intended mainly to provide motion control of the elbow movements, for complete immobilization o
avoid pain after injuries or trauma. Dedicated elbow orthoses for immobilization, static and/or dynami
during normal daily (i.e., functional) use of the elbow are available.

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
providing controlled motions and/or immobilization and support. These orthoses are usually classified
function of the orthoses (e.g., immobilization, support, therapeutic, functional) and the physical chara
consistency) and/or material used to make the orthosis (metal, plastics or a combination of these). Wr
may consist of soft orthoses (e.g., a combination of cuffs, straps, and flexible mechanisms) that are in
limited support and stabilization or semi-rigid orthoses that can provide a high degree or total immobi
joint. Wrist upper-limb orthoses are intended mainly to provide motion control of the wrist movements
immobilization of the wrist joint, and to avoid pain after injuries or trauma. Dedicated wrist orthoses fo
dynamic therapy, and for use during normal daily activities (i.e., functional) are also available.

Neuromuscular electrical stimulators that apply stimuli to the nerves that control ejaculation. These s
consist of an electrode probe, typically inserted into a man's rectum and connected to the electrical p
devices are used in neurologically impaired males to obtain semen for assisted reproduction.

Devices that apply stimuli to specific areas of a patient's brain (e.g., cerebrum, cerebellum) to preven
Antiseizure brain stimulators may consist of an implanted lead/electrode system (attached to a passiv
which energy and/or signals are inductively coupled from outside the body, typically at radio frequenc
implantable self-contained stimulator (that carries its own energy source and has no inherent depende
devices, except for activation or change of stimulation settings). These stimulators are used to treat e
convulsive and movement disorders (e.g., cerebral palsy).

Serology reagents intended to detect antibodies to hepatitis C virus, an RNA virus of the genus Flavivi
Hepatitis C virus may cause hepatitis, a disease characterized by jaundice and the increase of some e
aspartate aminotransferase); this virus is transmitted frequently parenterally and possibly by intimate

Immunoassay analyzers that attach chemiluminescent substances (e.g., isoluminol, acridinium esters
particular wavelength during a chemical reaction, as a label to either an antigen or an antibody and th
concentration of the ligand (the substance being analyzed) in the specimen under analysis, using the
antibody reaction. These analyzers usually include an autosampler, a reagent dispenser, and a lumino
quantify photoelectrons. Chemiluminescent analyzers have better sensitivity than photometric or fluo
Columns designed to remove abnormal or pathogenic substances from the blood using immunoadsorp
automated apheresis procedures. These columns include adsorption products specific for a given appl
apolipoprotein B antibodies to reduce the concentration of low-density cholesterol; highly-purified stap
bound to an inert silica matrix to eliminate circulating immune complexes and platelet-specific auto-a
designed appropriately to remove the pathogenic substances responsible for a given disease. The aph
frequently involves extracorporeal separation of plasma from the cellular blood components and perfu
plasma over the adsorbent column. Immunoadsorption columns with a specific immunoadsorbent pro
particular treatment are available, including columns for reduction of low-density lipoproteins (LDL) an
pathogenic substances specifically responsible for a given disease.

Powered systems designed for bone and soft tissue resection during arthroscopic joint (e.g., knee, sho
procedures. These systems typically consist of a power supply unit (electric or pneumatic), a display o
characteristics, and dedicated software that provides optimal parameters for a procedure and/or store
one or more rotary handpieces with several speeds that can operate different sizes of a variety of bur
straight or curved) and other rotary instruments such as a sagittal saw. Smaller and lighter handpiece
for surgery in small joints (e.g., wrist, ankle). Arthroscopic shavers are used in combination with fibero
arthroscopes, irrigation systems, and other manual instruments. They are most commonly used to deb
cartilage (e.g., meniscus repair or meniscectomy) and remove the inflamed inner lining of the joint (sy

Molecular assay reagents consising of a nucleic acid probe with a DNA chemical structure. DNA probes
or nonradioactively (both enzymatic and nonenzymatic) labeled. DNA probes are used in tests to obta
the genetic characteristics of a sample; these procedures are generically known as nucleic acid assay
hybridization assays, amplification methods (e.g., polymerase chain reaction), and electrophoretic se

Molecular assay reagents consising of a nucleic acid probe with an RNA chemical structure. RNA probe
or nonradioactively (both enzymatic and nonenzymatic) labeled. RNA probes are used in tests to obta
the genetic characteristics of a sample; these procedures are generically known as nucleic acid assay
hybridization assays, amplification methods (e.g., polymerase chain reaction), and electrophoretic se

Monitors designed for continuous measurement and display of the frequency and intensity of uterus c
uterine activity) that are hard-wired to the mother at the bedside. These monitors consist of a main el
capable of acquiring and processing signals from sensors that detect the changes in the abdomen as t
and a display to show the uterine activity. Some devices include ultrasonic transducers to make possib
heart rate monitoring. Bedside uterine activity monitors with external sensors are used at home, in ph
sometimes in hospitals prior to childbirth (i.e., antepartum monitors). Monitors that use invasive cathe
transcervically to determine the frequency and duration of uterine contractions are usually intended f
childbirth (i.e., intrapartum). Fetal monitors (both antepartum and intrapartum) that can evaluate the
uterine activity of the mother are also available.
Scanning laser microscopes designed to obtain high-magnification cross-sectional (i.e., three-dimensio
scanning the sample with a focused point of laser light, restricting the illumination to a tiny, targeted
specimen, while eliminating out-of-focus light (i.e., confocal microscopy). The image data is detected,
digitized and displayed on a high-resolution (typically 1024 x 1024 pixels) monitor (and/or stored in th
computer). Most of these microscopes are mounted on conventional or specially designed light micros
inverted stage). These microscopes are used mainly for cell and molecular biology (e.g., cell cultures,
handheld microscopes intended mainly for in vivo skin histology assessments are also available. Dedi
instruments intended for use with endoscopes (e.g., gastrointestinal) are also available.

Catheters designed for the minimally invasive retrieval of embolized fragments in a blood vessel. Vasc
typically consist of tubes with end and/or side holes and long, flexible wires looped and inserted in the
variations are typical: In one model, the loop emerges from the distal tip of the catheter while both fre
emerge from the proximal end; in another model, one end of the wire is attached to the distal end of t
free end is passed through the lumen to emerge at the proximal end. Some catheters configure snare
the catheter to facilitate successful retrieval. The wire is usually made of a strong, stiff alloy (e.g., nick
catheters are very effective when used to entrap an embolized fragment that presents a free end.

Stents designed for deployment into the esophagus to provide support for and/or maintain patency of
These devices may consist of a metallic (e.g., meshlike wire) or plastic tube, and they are available in
shapes and sizes to adapt to particular sections of esophagus and/or to prevent migration; some inclu
The stent surface may be coated to give the stent special capabilities. These stents are typically deplo
procedures. Esophageal stents are used to bypass stenosis caused by benign diseases, injuries, or ma
provide relief from difficulties in swallowing (i.e., dysphagia) and facilitate normal feeding.

Neuromuscular function analyzers that measure and evaluate the movement of the human body or bo
these analyzers are automated optoelectronic devices that use pattern recognition and include marke
processors, and computers; others use video (normal or high-speed) or cine cameras employing manu
pattern-search algorithms. Analyzers consisting of electromagnetic devices that measure the position
sensors in space and are capable of measuring three-dimensional movements are also used for motio
segment analyzers are used to obtain a graphic image and biomechanical analysis of human body seg
(e.g., spinal analysis, joint function). These analyzers are used mostly to study the mechanisms of spo
and rehabilitation activities.

Orthoses used to support, align, prevent, or correct deformities or to improve function of the hip.
Liquid germicides, whose main component is glutaraldehyde, that are intended for killing and/or inact
microorganisms (e.g., viruses, bacteria, fungi). These liquid germicides typically consist of a colorless
ingredient. They are used in disinfecting units where a disinfecting process (typically by immersion) u
temperature, and concentration is performed. Liquid glutaraldehyde germicides usually require high c
elevated temperatures, and several hours of exposure time for sterilization purposes; therefore, they
disinfection rather than for sterilization purposes. Glutaraldehyde germicide is used mainly to disinfec
supplies that cannot be heat-sterilized (e.g., devices including plastic and/or rubber components). Glu
germicides may be used also for water treatment.
Circular devices used to facilitate the partitioning of a prosthetic cardiac valve sewing ring. These dev
commercially available and were custom made by the authors of the referenced study: see Health De
Accession No. M2282 dated April 10, 1992.
Springs that are fashioned by the surgeon from orthodontic wire that are implanted under the eyelid i
paralytic lagophthalmos. These devices are not commercially available and were custom made by the
Devices Alerts Implants Accession No. M2284 dated April 10, 1992).
Specialized hammers used in chiropractic procedures.
Tracheal tubes designed to provide short-duration pulses of gas under pressure into the airway (i.e., je
rate (more than 600 cycles per minute) for lung ventilation. These devices typically consist of a small-
frequently, plastic tube; tubes appropriate for introduction through a partially withdrawn endotrachea
removal are also available. Transtracheal jet-ventilation tubes allow endoscopic surgical access to the
ventilation tube may be placed either supraglottically (the tube may be attached to the endoscope) o
intubation via the nasal or the oral route). They are used mainly in patients who have acute airway pr

Devices that are used to check the performance of imaging equipment such as x-ray generators, x-ray
ray film processors, hard-copy cameras, film viewboxes, etc. QC devices will include kVp meters, time
spot test tools, sensitometers, densitometers, collimator test tools, spatial resolution test patterns, vid
etc.
Radiographic quality control devices designed to measure the parameters that control the x-ray dose
image quality from individual x-ray systems, determining if the system is faulty or has been set up inc
consist of instruments that can measure at minimum the charge released and energy imparted into th
(i.e., exposure and dose respectively), and the peak voltage in kilovolt applied between the electrodes
(kVp); the product of the tube current in miliampere and exposure time in seconds (mAs) can also be
usually required for routine quality control (QC). X-ray QC devices are available in a variety of shapes
contained units, incorporating all the needed control functions and radiation detectors in a single hous
separate units that should be combined to perform the measurements. Most x-ray QC devices are use
QC measurement on radiographic, fluoroscopic, and conventional mammographic equipment; some c
on dental, computed tomography and/or advanced mammographic equipment.

Data management information systems designed to provide clinical and administrative information re
and fetal status during pregnancy. These systems include hardware and software capabilities to collec
fetal heart rate, uterine activity, and maternal electrocardiograms from fetal and maternal monitors. O
management information systems assist physicians in managing the prognosis and treatment of both
during pregnancy and labor.

Transtracheal catheters designed for efficient direct delivery of oxygen into the lungs, improving comf
compliance (e.g., relief of apnea), and activity status when compared with nasal cannulas. These cath
a percutaneously introduced tube that has a long intratracheal portion with multiple fenestrations or a
that is surgically inserted under local or general anesthesia and usually includes a shorter intratrachea
supply is obtained from a stationary compressed-gas cylinder, a cryogenic liquid reservoir, or an ambi
portable systems are available for ambulatory patients. Oxygen-supply transtracheal catheters are us
oxygen therapy in patients with chronic oxygen-dependent respiratory failure (e.g., chronic obstructiv
interstitial fibrosis, diffusion defect).
Oximeters that non-invasively measure the regional oxygen saturation in the deep intracranial microv
which primarily represents cerebral venous saturation (SvO2). The technique used is similar to the filt
technique used in pulse oximeters, except that it does not require an arterial pulse. These oximeters
lens, a filter array (usually of several wavelengths in the near infrared spectrum), fiberoptic cables, a h
sensors and a computer unit that process the data and reduce them to relative oxygen concentrations
are used to monitor adults at risk of cerebral hypoxemia or ischemia in the operating room, intensive
units, and recovery rooms

Suction/irrigation tips that include a fiberoptic bunch to provide illumination at the distal end. These ti
wide, rigid tubes (either straight or bent) with one or two lumens that are attached to the distal end o
tubes or directly to a handpiece that is in turn connected to a high-level suction aspirator, an irrigator
source. Suction/irrigation tips are used mainly to clean and improve visualization of clinical or surgical
body cavities) when excellent illumination is needed; these tips are usually reusable devices. Dedicate
suction/irrigation tips are available for particular clinical and/or surgical procedures.

Reading-aid magnifiers that integrate a camera and lighting and that are used to project magnified im
monitor, a television screen, or a computer monitor and that are intended to be used as reading and v
usually mounted on a stand and the images or objects, such as labels on packages of food or medicin
maps, color photographs, or pictures, are placed under the video magnifier. Video magnifiers include a
such as magnification, brightness, text and background colors, and contrast levels. Some models inclu
capture and save an image. Handheld video magnifiers are also available.

Handpieces designed to operate surgical rotary instruments (e.g., drills, saws) used in surgical proced
bone and cartilage, such as orthopedic, middle ear, and cranial procedures. Most surgical handpieces
connection to a power source, typically a pneumatic system or an electric motor. Some surgical handp
powered.
Patient warming units designed to warm the patient by blowing warm air across the patient (i.e., conv
consist of a warming device with a thermostatically controlled fan heater (blower) heating and forcing
specially designed reusable or disposable blanket for the patient, and a flexible hose that attaches to
blanket. Usually these units also include controls and alarms. Forced-air patient warming units are m
rewarming patients in postanesthesia care units ( PACUs) and to help in the prevention of intraoperati
operating room.

Ring-shaped coverings that fit around the wheels of a wheelchair to absorb shock and to provide tract
vehicle and the surface upon which the wheelchair is being used. Wheelchair tires are made in variou
sized wheelchair wheels. Wheelchair tires can be made of solid polyurethane or foam; some may be h
pneumatic inner tubes with valves to add air as need to keep the tires inflated to a desired pressure.

Power conversion kits designed for converting a mechanically driven wheelchair into an electrically, b
wheelchair. These kits typically include one or more electric motor(s) with appropriate gears, controls
set of batteries that are appropriate for mounting on the wheelchair. Some kits also include a battery
power conversion kits are used for conversion of an otherwise manual (mechanically operated) wheel
operated wheelchair.
Handheld devices designed to engage rotary instruments (e.g., burs), controlling their speed and dire
are used to perform surgical and/or dental procedures, such as drilling and cleaning. Most handpiece
connection to a power source, usually either a pneumatic air system (air compressor) or an electric m
manually driven (intended for use with manual braces).
Hand drills designed to provide torque to integral or, more frequently, detachable components (e.g., d
surgical procedures. These devices consist of a manually propelled or powered (e.g., electric, pneuma
typically includes a chuck and other detachable components such as drill bits, reamers, and trephines
are used with special guides and/or over a guide wire. Some manual hand drills may include an integr
particular use; battery operated electric drills provide autonomous operation without connection to ex
Surgical hand drills are used for a variety of procedures, including orthopedic, dental/oral, ophthalmic,
procedures.

Mobile modular medical facilities typically divided into a patient treatment area, a reception area, and
equipment (e.g., electric generator, air conditioning) room. These facilities include a dental delivery u
examination lights, and a sterilizer. Some facilities also include a dental radiographic unit and an x-ray
mobile facilities are used for providing basic dental care.

Radiant warming units designed to provide thermal stability to infants while allowing direct observatio
can be operated either with the heating elements turning on and off according to the changes in the i
temperature (automated mode) or by setting the heater at a constant power level for a set period of t
These units are available in several different configurations, including freestanding and mounted on a
facilitate continuous thermal support for newborns and critically ill infants; they are also used for infan
treatment in a cool environment.

Stents designed for deployment into the bronchi to provide support for and/or maintain patency within
These devices may consist of a metallic (e.g., meshlike wire) or polymeric tube, and they are availabl
shapes (e.g., straight, bent) to adapt to particular sections of the bronchi and/or to prevent migration.
be coated to give the stent special capabilities (e.g., water-repellant). These stents may be deployed u
bronchoscopes, according their shape and physical characteristics. Bronchial stents are used mainly t
bronchial stenosis without carinal involvement caused either by benign diseases or malignant tumors
of air into the lungs.

Occlusion plugs designed to be inserted in the small drainage ducts in the corners of the eyes (lacrima
connect the eye to the nose for temporary or permanent occlusion. These plugs are usually made of s
biocompatible inert material; they are available in different sizes. Some occlusion plugs are intended f
dissolve upon contact with the punctum; others are permanent and do no dissolve, but can be remove
Lacrimal punctum occlusion plugs are intended to decrease or slow tear drainage; they are used main
of the condition generically known as "dry eye."

Copper vapor lasers used in the treatment of cutaneous vascular lesions (e.g., port wine stains, telang
diseases of the skin.
Information systems consisting of a communication network, including high-capacity computer-based
retrieval equipment (i.e., picture archiving and communication systems [PACS]); they can acquire, disp
and manipulate images in digital format from several diagnostic imaging modalities, including digital
cameras, and other imaging devices. These systems consist of image-acquisition devices, a host comp
devices, and display stations that are interconnected in a communication network. Each component o
a computer or processor to control image transmission, archiving devices, and networking capabilities
image transmission to any networked part of the hospital, direct access to stored images, simultaneou
several different physicians (e.g., surgeons and emergency room personnel), and centralized consulta
comparisons. Dedicated PACS intended for radiology and cardiology applications are available. PACS u
information with medical imaging equipment (such as digital cardiology and radiology imaging) device
(Digital Imaging and Communications in Medicine), a standard in the field of medical informatics that
interoperability.

Picture archiving and communication systems (PACS) designed to store and retrieve images from digit
other digital imaging systems that are used for endoscopic procedures. These systems consist of a ho
controls image capture and display, networking, storage, retrieval, and printer output, as well as imag
allow database management and include high-resolution displays and printers. Endoscopy PACS perm
to endoscopic images for surgeons, referring physicians, and emergency room personnel.

Backrests that are placed on the back portion of the commode, either to provide padding where there
support or to cover pipes and other commode hardware to prevent injury if the patient leans back or f

Leads designed to conduct electrical signals from the pulse-generating unit of an implantable defibrill
to the heart and also to conduct the bioelectric cardiac signals back to the unit. These leads typically
that are completely isolated except at the electrode tip that makes contact with the heart. The leads a
the surface of the heart during open surgery (i.e., epicardial leads) or threaded into the heart through
avoiding open-chest surgery. The other ends of the leads are attached through a connector to the puls
in the abdomen or chest. A variety of lead systems, including single- and multiple-lead, subcutaneous
available. The size, connector type, and other characteristics of the leads must be compatible with the
the therapy prescribed.

Gloves designed to provide hand and/or arm protection (i.e., safety) against extremely cold temperatu
cryogenic procedures. These gloves usually consist of several insulating layers made of natural rubbe
bonded together only at the edges of each piece. Cryogenic gloves should provide a maximum level o
against low temperatures (e.g., at least to -130 degrees Celsius/-202 degrees Fahrenheit) permitting a
and dexterity to the user; the gloves are usually light weight, flexible, durable, and comfortable to we
periods. Some gloves provide additional high tactile sensitivity and/or protection against chemical haz
gloves are used to manipulate cryogenic products in clinical laboratories and blood banks; they are als
cryogenic (e.g., dermal, surgical) procedures.
Thoracic support narrow flexible orthoses designed to encircle the thorax (i.e., belts) to provide suppo
sternum and associated muscles in appropriate position. These devices are usually made of narrow pi
plastic that may include hook-and-loop closures (e.g., Velcro) for adjustment of the size of the belts; th
reinforced with metallic stays for appropriate support of the muscles and sternum. Belt thoracic suppo
mainly to support and compress the sternum and/or thoracic muscles from traumatic injuries (e.g., bo
provide relief from pain and strain.

Injectors designed to inject viscous, radiopaque fluids (i.e., contrast media) into the arteries, veins, or
typically through a catheter. These injectors are usually automated devices powered using either elec
pneumatic mechanisms. Electromechanical injectors consist of an electric motor connected to a jacks
syringe piston into and out of the syringe barrel, they deliver a given volume of contrast medium at a
Pneumatic injectors develop and maintain a constant, preselected pressure and do not compensate fo
parameters that influence flow. Contrast media injectors are used to make vessels and/or particular tis
surrounding tissues in procedures such as angiography, computed tomography, and magnetic resonan

Contrast media injectors designed to inject the contrast media through a small catheter into the vascu
computed tomography (CT) procedures. These devices typically consist of automated electromechan
syringes that may be either reusable, disposable, or both; pneumatic mechanisms and peristaltic pum
used. CT contrast media injectors are capable of delivering contrast media with the pressure, flow ran
required for CT studies, some injectors can synchronize the delivery with the x-ray generator. They are
variety of diagnostic procedures (e.g., spine, head, vascular, gastrointestinal) using CT scanning.

Metallic tubing made of stainless steel alloy to provide corrosion-resistance capabilities. This tubing is
rigid, semirigid, or flexible cylinder designed for the transfer of materials, either liquids or gases, with
resistant capabilities. Stainless steel tubing is usually available in standardized lengths and in a variet
thicknesses (i.e., gauges) that permit the use of segments of different sizes appropriate for a given ap
healthcare facility; stainless steel is also used directly or as reinforcement for other tubing to deliver fl

Testers designed to assess the performance of laser radiation (i.e., laser beams); they can measure, d
some or all of the most critical laser beam characteristics, typically including peak intensity, centroid p
intensity profile, beam diameter, ellipticity, Gaussian fit analysis, and relative power/energy. These tes
a beam detector (e.g., charged-coupled device [CCD] camera, knife-edges), a computerized unit, appr
beam analysis, and a display. Laser beam testers are used for alignment, optimization, and quality con
delivered from continuous-wave and/or pulsed-laser medical devices.

Chairs for disabled patients, with an elevated seat used to raise a person from a sitting position to a s
These chairs may be operated either manually or powered (e.g., electrically). Most of these chairs inc
accessories for patient safety and comfort (e.g., movable arms).
Cushion-like devices designed to facilitate raise from a standard chair or sofa. These lifters typically co
two-part hinged structure with a mechanism that lifts the seating surface, raising the person close to a
Self-powered (e.g., using springs) and electrically powered lifters are available. Seat lifters are used to
have lost sufficient upper and/or lower body strength to get up unassisted.
Covers designed to wrap around the handgrips of walkers, canes, or crutches in order to provide comf
and irritation for a patient's hands, and to provide a better gripping surface. Handgrip covers are usua
(wool, sheepskin or polyester) or cloth-wrapped foam rubber and are attached to the handgrips by ho

Covers designed to wrap around the armrests of a chair, wheelchair, or a powered scooter in order to
moisture reduction, and relief from pain and irritation for a patient's arms. Armrest covers are usually
(sheepskin or polyester), foam rubber, or neoprene and are attached to the armrests by either ties or
fasteners.
Devices designed as a framework that combines a wheeled walker with an integral seat. These frame
metal (some also include hard plastics) structure that frames the front and sides of users at waist leve
three to five wheels; they usually include supports (i.e., grips, platforms) for the hands and a seat (wit
backrest) that allows a comfortable long-term sitting position. Wheeled walker/chairs may be foldable
height and/or width; they are intended for the permanent assistance of disabled (e.g., infirm) patients
rehabilitation by patients who need to rest often while walking.

Devices designed as a framework that combines a standard (nonwheeled) walker with an integral sea
are typically a metal (some also include hard plastics) structure that frames the front and sides of use
supported by three to five legs; they usually include supports (i.e., grips, platforms) for the hands and
a backrest) that allows a comfortable long-term sitting position. Nonwheeled walker/chairs may be fol
height and/or width; they are intended for the permanent assistance of disabled (e.g., infirm) patients
rehabilitation by patients who need to rest often while walking.

Frames designed to help users remain in a standing, upright position. These frames typically consist o
framework with the center of gravity low enough for stability; they include upper bars for user suppor
provide traction even when the floor is slippery. Standing frames are available in a variety of configura
intended purpose, such as help getting in and out of wheelchairs; some frames provide support (e.g.,
pads) to help patients maintain a standing position. They may include powered (e.g., pneumatic, elec
lower or raise the patient. Frames with appropriate sizes for use by children and adults are also availa
are not intended to facilitate a user's gait.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
spills/leaks of infectious waste (i.e., waste that may contain pathogens). Items in these kits usually inc
labels, disposal bags/containers and documentation forms. Infectious waste spill recovery kits are inte
encapsulating infectious waste for removal, decontamination, storage/transport, and disposal in hospi
laboratories and other healthcare facilities.

Speech valves designed for use by patients whose larynx (including the vocal cords) is completely rem
laryngectomy) and the trachea and esophagus are separated from each other. These devices typically
valve located in a surgical opening created between the trachea and the esophagus (tracheoesophage
valve permits air to pass from the lungs and through the trachea into the esophagus. By occluding the
air from the lungs can cause vibrations of the esophageal tissue producing a characteristic voice soun
tracheoesophageal speech).
Artificial airways designed for insertion through the mouth into the esophagus or trachea, permitting t
to the lungs while occluding the esophagus. These airways typically consist of a two-lumen tube that
through the mouth either into the esophagus or less frequently the trachea to keep airway patency wh
esophagus. The esophageal obturation lumen has a blocked distal end and perforations at the pharyn
lumen is open at both ends. A large oropharyngeal balloon seals mouth and nose, and a distal cuff occ
esophagus or trachea. Ventilation starts via the esophageal tube. If the tube is inserted in the esophag
pharynx via the perforations. If the tube is inside the trachea, the ventilation will be performed directl
tracheal tube. Esophageal obturation/tracheal airways are used in emergency situations by healthcare
minimal training to facilitate breathing and/or for resuscitation; single use (disposable) and reusable t

Systems incorporating a filter that separates motile sperm from nonmotile sperm and seminal fluid for
insemination and other forms of assisted reproduction techniques. In some systems, the semen is filt
Sephadex filter, a mechanical matrix filter.
Personal towelettes designed to apply an agent (e.g., antiseptic) that inhibits the growth and developm
microorganisms without necessarily killing them. These towelettes are usually presoaked with the ant
alcohol, benzalkonium chloride); some include agents that effectively kill pathogenic microorganisms
iodine or povidone-iodine (betadine). Personal antiseptic towelettes are mostly used to clean wounds
they are also used to avoid cross-contamination (e.g., by hand definition) when water is not available

Defibrillators-pacemakers that are permanently inserted (implanted) either abdominally or pectorally


the patient's heart through a set of epicardial and/or endocardial leads. These stimulators combine th
capabilities of implantable defibrillators and the pacing mode capabilities of implantable pacemakers
heart rhythms (bradycardia) or certain classes of cardiac arrhythmias.

Cannulae that are inserted percutaneously into the pleural space, usually used for placement of a tho

Instruments used for the intraosseous implantation of dental prostheses. These devices are used to in
implants or to attach abutment components to implants. Typical dental prosthesis implantation instru
drill bits, bone depth gauges, machine abutment tighteners, machine screwdrivers, machine-counter
manual-counter torque devices.
Detectors designed to elicit a visual or audible signal when penetration (strike-through) of a potential
body fluids, microorganisms) through an aseptic barrier, such as protective attire, is detected. Penetra
possible in several ways. Some detectors operate based on the simultaneous use of two gloves on eac
layer of gel that changes color with fluid contact, indicating outer glove protection failure. Other detec
and/or visual alarm when the glove fails (e.g., by tear, cut, perforation, or fluid saturation); they typica
detecting the flow of a very low electrical current when a closed electrical circuit is established due to
the patient and the healthcare professional (e.g., a surgeon). Aseptic barrier penetration detectors are
and other procedures that have high a risk of cross-contamination.
Bedside monitors designed to continuously measure the partial pressure of carbon dioxide (tcpCO2), o
at the skin surface. These monitors may use either two separate sensors or one combined tcPO2/tcPC
of a modified pH electrode, a single O2 cathode and heated reference electrode, a membrane, and an
a shielded container; some monitors include a third sensor to measure the pH in the blood. Monitorin
useful to avoid hyperoxemia and hypoxemia, to assess surgical patients, and for continuous evaluatio
metabolic status of patients.

Penile prostheses in the form of two inflatable tubes implanted in the penis to provide penile tumesce
contact. These prostheses include, in addition to the inflatable tubes, a fluid-filled reservoir implanted
subcutaneous manual pump implanted in the scrotum and connected to the tubes. Inflatable penile p
for patients who suffer from erectile dysfunction.

Penile prostheses in the form of one or more rods implanted in the penis to provide penile tumescence
contact. These prostheses typically consist of rigid or semirigid polymeric or silicone elastomer rods; s
reinforcements. Rod penile prostheses are intended for patients who suffer from erectile dysfunction.

Monitors designed for continuous measurement and display of the body movements (i.e., physical act
from a distant location through a point-to-point radio or other appropriate communication link (i.e., tel
monitors typically consist of a main unit attached to the patient (e.g., pocket, belt, wrist) which includ
that can process signals from movement-sensing probes (e.g., pedometers, accelerometers), and tran
also includes a receiver that is integral or associated to the central station where the information is di
activity monitors are used to assess patients with certain conditions (e.g., cardiac or pulmonary disord
(e.g., athletes) during their daily activities and/or while performing exercise. They may be also used to
wakefulness (sleep/awake cycle) during normal patient activity.

Ambulatory electrocardiography tape recorders that include two radionuclide detectors, one detector
iodide crystal) for detection of left ventricular activity, and another detector (usually of cadmium tellu
right lung to monitor background activity. The detectors are usually positioned using a gamma camera
plastic garment. These recorders are typically used to record left ventricular function for several hours
used to detect heart diseases, including silent ischemia.

Solutions designed to maintain temporal organ viability outside the human body, usually at cold temp
degrees Celsius (32 degrees Fahrenheit). These solutions consist of a variety of components mainly in
cells from swelling during cold ischemic storage and stimulate recovery of normal metabolism after re
solutions are available for organ preservation under cold storage, including those based on a combina
lactobionate, magnesium sulfate, adenosine, glutathione, and allopurinol among other ingredients (kn
Wisconsin solution). Modifications and/or simplifications of the original University of Wisconsin solution
Euro-Collins solutions, and other solutions based on polyethylene glycol and/or containing mannitol or
ketoglutarate (HTK) are also available. Organ preservation solutions include particular solution for pre
and pancreases for 72 hours and liver for 30 hours in a cold environment. Hearts may be preserved fo
(between 12 and 24 hours).
Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
immersion in germicidal solutions (e.g., formaldehyde, glutaraldehyde, phthaldehyde). These units us
treatment chamber with a container for the liquid germicide where trays with the devices to be steriliz
placed, usually after being cleaned of gross debris; means to introduce and/or circulate the liquid into
controls to regulate the time and temperature of the procedure, which depends on the germicide in us
sterilization cycle is complete the residual chemicals should be drained and the volatile compounds el
aeration or rinsing with filtered water). Liquid sterilizing units are available in a variety of shapes and
tabletop units. They are used for devices and supplies that are sensitive to high temperature and hum
including plastic and/or rubber components that are not damaged by the chemical product used for st

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
inject directly into a large bone marrow (i.e., intraosseous). Items in these kits usually include intraoss
syringes, intravenous (IV) tubing and solutions, povidone-iodine swabs, and tape. The kits are frequen
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
Intraosseous infusion procedure kits and trays are intended to provide fluids, blood, and medication us
is not available or cannot be used. They are used in the field and in emergency rooms and/or other are
facilities.

Backrests designed to be attached to the back of a wheelchair to provide support or comfort to the wh
providing posture support, lumbar support, spinal alignment, and lateral stability. Backrests are usuall
but can also be inflatable or gel-filled for adjustable support or based on wood or hard plastic for solid
made in different widths and heights to fit adult or pediatric wheelchairs.

Cardiac electrodes designed to attach to the chest for delivering an electric shock and/or pacing pulse
devices that combine defibrillation and pacing capabilities (i.e., an external defibrillator/pacemaker). T
applied on the thorax surface either in the anterior-posterior position (i.e., one electrode over the hea
behind it) or in the anterior-anterior position (i.e., one electrode near the apex of the heart and one on
These electrodes typically consist of large surface (80 to 100 square cm), frequently pre-gelled, single
the electrode impedance may be high (e.g., more than 500 Ohms) for electrodes used only for pacing
intended for external pacing and defibrillation. External defibrillator/pacemaker electrodes can deliver
to all chambers of the heart; they are intended to assist in resuscitating patients, to correct arrhythmi
pacing.

Mechanical shields worn over the hip area to prevent against hip fractures in the event of a patient fal
designed to transfer energy from the impact to the soft tissue and muscles anterior and posterior to th
diverting the force of the impact away from the greater trochanter.
Incubators designed to perform heating and cooling sequences (i.e., thermal cycling) on test samples.
contained and have a chamber to hold the samples. Water, aluminum blocks, and/or conductive fluids
heating and cooling; other incubators use the Peltier effect. Temperature cycling is typically used in ce
environmental tests of products and devices, and gene manipulation. Dedicated thermal cyclers inten
polymerase chain reaction replication (known as PCR thermal cyclers or thermocyclers) are also availa
Valves designed to provide speaking capabilities to patients after tracheostomy, complete laryngectom
breathing through a ventilator. Valves placed after tracheostomy or in patients under ventilation are u
tracheostomy tube or the ventilation tube, allowing air inspiration but redirecting the exhaled air throu
breathing ducts and the vocal cords. Speech valves intended for placement on a fistula between the e
breathing ducts are also in use; the air from the lungs goes inside of the valve (voice prosthesis) and t
creating a characteristic voice sound known as tracheo-esophageal speech.

Neutron-beam radiotherapy systems designed to deliver a beam of low-energy (epithermal) neutrons.


usually directed to a tumor site that was previously treated with boron-10 or other suitable neutron ca
penetrate the blood brain barrier, selectively target neoplastic cells, and persist therein for suitable pe
radiation (e.g., boron neutron capture therapy [BNCT]). The neutrons are captured by the boron and p
particles that are capable of damaging or destroying tumor tissue. Currently, this therapy is mostly us
gliomas.

Central venous infusion catheters designed for insertion in the peripheral vasculature (typically in the
veins) and that are long enough to advance and locate their distal tip in a central vein, usually the sup
cava. The length of these catheters is typically 22 to 60 cm (9 to 24 inches), and they are usually ma
elastomers (silastic) or polyurethane. They may be inserted using a variety of techniques (e.g., using
introducer, though over-the-needle catheters are provided with guide wires using the Seldinger techni
catheters are provided with guide wires to assist their insertion.

Blood flowmeters designed for non-invasive measurement of blood flow using nuclear magnetic reson
instrument typically senses magnetic resonance signals (typically at frequencies between a few MHz t
blood resulting from the application of a magnetic field; it measures blood flow volume through a cros
defined intervals. These flowmeters are available in two main types. One type has a cylindrical coil co
blood flow measurements through a cross-section of a limb and a second type, less frequently used, in
detectors that can measure blood flow at almost any surface of the body. Nuclear magnetic resonance
measure independently of vessel depth under overlying tissue, calcified arteries, or outer clothing. Th
of the instruments include quantifying the results of angioplasty, atherectomy, and bypass procedures
ischemia; helping to assess the results of diet, exercise, and medication therapy; and determining if li
has a vascular circulation origin.

Aerobic exercisers designed to simulate the motion of cross-country skiing, using forward-sliding leg a
motion. These exercisers typically consist of a pair of ski-like sliding footpads mounted on two rails an
rope-and-pulley device that simulates ski poles. They often include a monitor for displaying workout fe
speed, distance, calories burned, and heart rate. Cross-country skiing exercisers are intended to incre
endurance by keeping the heart and pulmonary rate elevated for a continuous period of time. Addition
strength and endurance to the muscles of the lower body (i.e., quadriceps, hamstrings, gluteus, hip fle
upper body (i.e., arms, shoulder, chest, back)._x000D_
forward-sliding motion opposite-leg - opposite-arm motion

Sacklike containers designed for collection and disposal of the products of emesis (i.e., vomit) from th
are usually treated paper or plastic, single-use or disposable, devices. Emesis bags are used for the hy
vomit.
Implantable prostheses designed to replace the mandibular (also known as glenoid) fossa of the temp
articulation surface for the mandibular condyle. These prostheses provide a partial substitution of the
articulation; they are typically made of metal or a combination of metal and polymeric materials (i.e.,
bearing may include a titanium mesh backing, known as fossa eminence prosthesis [FEP]). Mandibula
temporomandibular joint prostheses are used to treat adhesions, disc perforations, and ankylosis; they
component of total temporomandibular joint prostheses.

Implantable prostheses designed to replace the natural fibrocartilage disc attached to the mandibular
permitting rotation on the condyle during translational jaw movements. These prostheses provide a pa
the temporomandibular articulation; they are typically made of plastic (e.g., polymethyl methacrylate
materials. Intra-articular disc temporomandibular prostheses enable the sliding function of the tempor
are used in patients who suffer from osteoarthritis, rheumatoid arthritis, congenital malformations, or
after trauma (e.g., fracture).

A wheel is a circular component that is intended to rotate on an axial bearing and are used to support
means of moving the wheelchair. These wheels can be rotated manually by the user or power-assisted
Wheelchair wheels are typically between 22 to 26 inches (56 to 66 cm) in diameter. Smaller wheels, ty
8 inches (7 to 20 cm) in diameter and between 1 and 2 inches (2.5 to 5 cm) in width, are sometimes c
Wheelchairs typically have two sets of wheels, 2 larger ones and 2 smaller ones. The wheels can be p
middle, or rear of the wheelchair, depending upon its design.

Couplers designed to connect a laser delivery system (typically the articulating arm of a carbon dioxid
laparoscope, aligning the aiming beam and the treatment beam on the tissue. These couplers typicall
coupling device (lens housing), set of lenses, a laparoscope adapter, and a sleeve. The main coupling
the laser delivery system (e.g., articulating arm) at the proximal end; the laparoscope adapter at the d
sleeve is placed inside the working channel of the laparoscope to provide a path for the laser beam to
couplers include a joystick for adjusting the direction of the laser beam. Most couplers can also be use
(double-puncture) laparoscopes. Laser/laparoscope couplers are intended for laparoscopic procedures
using lasers with a wavelength that is not appropriate for fiberoptic cable transmission.

Total upper-limb orthoses designed to provide support and some degree of movement restriction to an
orthoses consist of a variety of devices that assist the support and positioning of the upper limb, and
person and/or attached to furniture, a structure, or wheelchair. Total upper-limb support orthoses are f
assist the limb by positioning it in an appropriate position; dedicated upper-limb supports (e.g., slings,
lapboards) are available.

Total lower-limb orthoses designed for lower-limb support and also to provide some degree of moveme
limb. These orthoses consist of a variety of devices that give support to the lower limb and are usually
structure, or a wheelchair. Total lower-limb supports are frequently used to keep the limb in an approp
rehabilitation after injuries or disease; dedicated lower-limb supports (e.g., slings, platforms) are also
Pads designed for enhancement of magnetic resonance images by improving the homogeneity of the
These pads typically consist of an externally sealed cover filled with a liquid (e.g., perfluorooctyl brom
Perflubron) that has the same magnetic susceptibility as human tissue. The pads are placed between
patient in such a way that they eliminate the air/tissue interfaces. MRI dedicated pads are usually con
places such as the neck, breast, ankle, and knee.

Image digitization systems designed to use fluoroscopic detection and imaging processing techniques
images in the verification of radiation treatment. Digital portal imaging systems typically incorporate
(usually mounted on the linear accelerator gantry), a computer system for image processing, and peri
printing and/or image storage. These systems provide an alternative to the traditional method of proc

Video image processors designed to acquire and process electronic images from a video endoscope or
the images to peripheral devices such as video monitors, VCRs, still-disk recorders, and printers. Thes
send images to computer systems for storage, retrieval, and manipulation. Some processors also hous
source and air, suction, and water pumps.
Video image processors designed to acquire and process electronic images from an operating microsc
images to peripheral devices such as video monitors, VCRs, still-disk recorders, and video printers. Th
send images to computer systems for storage, retrieval, and manipulation.
Image processors designed to acquire and process electronic images obtained from a separate device
transmit the images to peripheral devices such as video monitors, VCRs, still-disk recorders, and print
also send images to computer systems for storage, and retrieval, and manipulation.

Ophthalmic systems designed to objectively determine the configuration of the anterior corneal surfac
and the refractive power by projecting concentric circular rings on the cornea. The systems typically c
videokeratoscope that projects the illuminated rings onto the cornea and captures the reflected image
camera and the image-processing software system that analyzes the cornea topography data (e.g., cu
calculates the refraction power, and displays the data graphically. The devices are used mainly for pla
corneal surgery, fitting contact lenses, or diagnosing some corneal disorders.

Cloth gloves worn as liners underneath rubber, plastic or latex gloves (examination or surgical) to min
allergic reactions, rashes and other skin irritations or to reduce the risk of sharps injuries.
Medical-air dryers designed to remove moisture from the air using refrigeration (i.e., cold temperature
dryers typically consist of an air-to-air refrigerant heat exchanger, a mechanical condensate separator
drain trap. Refrigerating medical-air dryers may be equipped with filters for removing liquid oil aeroso
purifiers for removing solid and liquid particles and gaseous impurities such as carbon monoxide; thes
frequently included as an integral part of medical-air supply systems.

Medical-air dryers designed to remove moisture from the air using dynamic desiccant adsorption tech
typically include a set of desiccants (e.g., a bed of desiccant cores) in which the adsorption process is
the compressed air to be dried passes through a rotor while the desiccant removes water vapor direct
holds it while the wheel rotates. Desiccating medical-air dryers may be equipped with filters for remov
aerosols, and mists with purifiers for removing solid and liquid particles and gaseous impurities such a
these devices are frequently included as an integral part of medical-air supply systems.
Compressed-air monitors designed to measure and display the temperature at which water vapor con
some may also monitor the temperature at which water vapor condenses to form ice or frost (frost po
humidity. These monitors consist of either a dew (water vapor) sensor that detects changes in electric
characteristics (e.g., capacitance, voltage) with moisture or a direct dew-point sensor (e.g., chilled mir
sensor, and an electronic unit, including a display. Some monitors also include audible and/or visual al
prefixed values. Dew-point monitors are used to avoid condensation in the delivery system, preventin
components (e.g., carbonic acid) that corrode the parts of the air/gas system and could affect devices

Compressed air monitors designed to measure and display the concentration of carbon monoxide (CO
These monitors consist of CO sensor (e.g., oxide semiconductor) and an electronic unit including a dis
also include audio and/or visual alarms activated at prefixed CO concentrations (e.g., 10 or 20 ppm).

Impermeable covers that fit beneath standard pillow cases. These devices are typically used to reduce
infection control.
Isolation treatment chambers designed for administration of hazardous aerosols. These chambers typ
sealed rigid device, which encloses the patient's head and/or head and upper torso, with an exhaust s
the nearby environment by capturing airborne contaminants. The exhaust system usually includes ge
lights and several filters, such as carbon and/or high-efficiency particulate-air filters, permitting the re
back into the room. Hazardous aerosol treatment chambers are used for control of contaminated air d
hazardous aerosolized medication (e.g., treatment of Pneumocystis carinii using pentamidine therapy
induction._x000D_

Devices designed for the performance of surgery using ultrasound frequency energy; the heating effe
cutting and coagulation is provided by friction when tissue comes into contact with a vibrating blade.
include a high-frequency generator (frequencies of 23.5 and 55.5 kHz are typical), a handpiece in whi
transformed into mechanical ultrasonic vibration, and blades (e.g., shears) to apply the ultrasound en
tissue. Ultrasound surgical units are used mostly in laparoscopic surgery procedures (e.g., splenectom
tissue, providing proper hemostasis in vessels up to 3 mm in diameter without significant desiccation
units intended for dental treatments are also available.

Dryers designed to remove moisture from central healthcare facility medical-air systems; these dryers
as refrigeration, desiccant adsorption, and membrane filtration to remove water from the air. Water is
the medical-air system during the manufacturing process by the compression of ambient air, which m
Medical-air dryers may be equipped with filters for removing liquid oil aerosols and mists and with pur
solid and liquid particles and gaseous impurities such as carbon monoxide; these devices are frequent
integral part of medical-air supply systems.

Equipment designed to regulate the flow and application of a gaseous or liquid coolant (cryogen) to d
tissue by freezing (i.e, perform cryosurgery or cryoablation). Cryosurgical units induce freezing in targ
through direct application of liquid cryogen or indirectly through contact with a cryogen-cooled probe.
nitrogen, while others use nitric oxide (NO2 ) or carbon dioxide (CO2 ) as a refrigerating medium.
Ultrasonic scanning systems that include an ultrasonic scanner, transducers (frequencies of 7 to 12 M
because high-resolution and superficial imaging is needed), dedicated software, a recording subsystem
ultrasonic scanners include continuous-wave and pulsed-wave Doppler capabilities, including a spectr
systems are used for small (usually superficial) organ examinations, including bladder, thyroid, renal,
prostate examinations. Some of them also include capabilities for vascular peripheral and pediatric ex

Radiosurgical stereotactic systems that use a linear accelerator (linac) as the source of x-ray radiation
typically consist of a dedicated linac with a movable gantry and a single or multileaf collimator; stand
adapted for limited radiosurgery applications by the addition of stereotactic accessories. Linac-based
used for intracranial or neck procedures typically employ a metal head frame attached to the patient's
targeting of the radiation beam; other systems incorporate a miniature linac mounted on a flexible rob
image-guidance system that can track target location during treatment using fiducials as references w
invasive head frame. Systems that can be used in any location in the body and employ computer-cont
(known as Intensity Modulated Radiation Therapy [IMRT]) to conform the radiation dose to the shape o
lesion are also available, but those systems may not be as accurate in targeting and are used mainly
sessions (i.e., radiotherapy treatment systems) rather than as surgical systems. Most radiosurgical lin
computing capabilities and dedicated software appropriate for specific treatments. Radiosurgical linac
are used in neurosurgery (i.e., for brain, neck, and spinal tumors) and, less frequently, for radiosurger
tumors (e.g., to ablate abdominal tumors).

Data management information systems designed to record, process and display administrative inform
material management tasks of a hospital. These systems include hardware (e.g., a local network inclu
personal and/or laptop computers) and firmware and/or software to support the management of admi
provide reports for procedures such as purchasing, receiving and requisitioning supplies, controlling ce
invoicing, patient cost accounting, and capital assets control. Material management information syste
stand-alone systems or may be integrated in a hospitalwide data management information system ne

Digital radiographic systems usually designed for intraoral radiography. These systems include a conv
subsystem, either an imaging plate (computed radiography) or an intraoral detector (direct digital rad
imaging system with a workstation and a monitor. The x-ray tube is usually located in a cylindrical tub
articulating arm positioned according to the view desired. Most dental radiographic system x-ray tube
ranging from 50 to 100 kV and a current ranging from 1 to 20 mA. These systems perform image proc
multi-image viewing) and also save and retrieve images. Intraoral digital radiographic systems are use
and the upper third of the roots of the upper and lower teeth (bite-wing image), the full tooth structur
the masticating surface of premolars and molars (occlusal image).

Simulators designed to mimic the waveforms of the electrical activity of the brain; they usually includ
circuit generator or digitally recorded signals in their memory. When activated these simulators produ
electroencephalographic signals. They may also generate low- and high-frequency sine and multifrequ
simulators can also simulate evoked potential signals.
Physiologic/gas graphic recorders used for automatic recording and plotting data at specific intervals f
anesthetic gases and from physiologic monitoring devices. These recorders allow other data to be int
(e.g., drug dosages, laboratory data).
Devices designed to collect condensed moisture (i.e., condensate) that accumulates within a breathin
ventilator breathing circuit) during heated humidification. They are intended to be used to prevent the
blocking the breathing circuit and/or preventing the inhalation/ingestion of the condensate by the pat

Lifts designed to carry and transport carts filled with trash, laundry, or other hospital loads from one p
different heights. Most of these lifts can also tip/turn carts to dump their contents into large bins, incin
compactors, raising the cart out and over the receiving bins. Waste/laundry lifts are used to move hos
minimum human effort, avoiding contact of content by hospital personnel.
Intravenous (IV) line connectors designed to allow access to an IV infusion set or catheter port from a
These connectors may consist of one of several different configurations, including devices using a pre
blunt cannula; valve connectors; and capped Luer connectors with a manual clamp. Needleless IV line
intended to eliminate the use of needles for IV administration of medications.

Intravenous line connectors designed to allow access to the Y-site of either a primary set or an injectio
infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard s
fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or auto
moves the housing to protect the operator from the needle once the infusion is finished. Recessed-nee
intended to eliminate an exposed needle after administration of medications.

Syringe medication/vaccine injectors that include some mechanism (manually positioned or activated
blunt, or recess the needle after use, or by some other means lessen the possibility of contact of the h
with the needle. Some devices combine the injector, protective mechanism, and pre-filled syringe as a
unit.
Hypodermic syringes designed to provide needlestick protection (safety). These syringes include som
(manually positioned or activated) intended either to shield, blunt, or recess the needle after use or, b
to lessen the possibility of contact of the healthcare provider with a sharp needle.

Eyelid weights designed for implantation under the upper eyelid to provide additional weight. These d
metal (e.g., gold, platinum) weights in a range from 0.5 to 3.0 grams that are surgically implanted und
conforming to the curvature of the ocular sphere. Implantable eyelid weights are used in the treatmen
paralysis in which the eye cannot be completely closed (i.e., lagophthalmos); their use reduces the ris
and improves the appearance of the face.

Oxygen delivery units designed to halt the oxygen supply during a part of the respiratory cycle. These
the fact that that oxygen is needed only during the initial phase of inspiration, permitting the interrup
during the rest of the respiratory cycle. Most units either use a regulator to reduce the time of actual o
low flow and store oxygen during expiration that is then used as a bolus during inspiration; another ap
oxygen delivery is the use of a transtracheal catheter. Controlled oxygen delivery units are intended t
consumption (i.e., conserving oxygen), increasing the mobility of the patient because of the lower wei

Cartridge syringes designed to inject medicines from a prefilled, disposable, sealed cartridge with a bl
to one end. These syringes are mostly used for push intravenous delivery of drugs that are supplied in
Condoms intended to be inserted vaginally by women before engaging in coitus to prevent sperm from
female reproductive tract by providing a physical barrier between the penis and the vagina in order to
They can also be used to provide protection against sexually transmitted infections by preventing mic
being transmitted from one partner to another. Female condoms are sheaths with one closed end (pla
and one open end that stays outside of the vagina; each end has an encased flexible polyurethane rin
condom in place. They are usually approximately 15 centimeters in length and 7 centimeters in width
made of seamless polyurethane, nitrile, latex, or molded silicone; they are soft, thin, and transparent,
lubricated or lubrication can be added, as needed; female condoms can be used with spermicides. Som
medical-grade sponge at the closed end that can help with insertion and to help hold the condom in p

Condoms intended to be worn on a man's penis during coitus to prevent semen from gaining access t
reproductive tract by providing a physical barrier between the penis and the vagina in order to preven
also be used to provide protection against sexually transmitted infections by preventing microorganism
transmitted from one partner to another. Male condoms are sheaths with one closed end and one ope
sized approximately 2 inches in width and 7 inches in length. They are made of seamless latex, polyur
or lamb intestine; they are soft, thin, and transparent, and some come pre-lubricated.

Bathroom fixtures designed to deliver a water spray and/or a stream of dry air to bathe the external g
area. These fixtures typically resemble the shape and height of a toilet seat. Bidet function may be pe
attachments designed for the same purpose that are added to a standard toilet.

Spacers used to create and/or maintain space between teeth during dental/orthodontic treatments. Te
typically made of metal, plastic, or rubber and are removed once treatment is completed.
Devices designed to create and/or maintain space between two anatomic structures or their prostheti
may be removable (e.g., made of metal, rubber, or plastics) or absorbable (e.g., made of hydrogel).

Sequential peripheral circulatory assist units that synchronize the sequence of compression with the c
systems typically include a set of cuffs or boots that are wrapped around the patient calves, lower and
groins. The cuffs/boots are inflated in sequence from the calves to the buttocks during diastole, increa
blood returned to the heart through the veins. Synchronization of the sequence of compression with th
intended to provide a better peripheral circulatory assistance.

Instruments designed to measure and calibrate the dimensions (e.g., length, diameter) of anatomic pa
selection of the size of their replacements (i.e., grafts, implants, and/or prostheses) and/or the instrum
perform a procedure. These devices are typically manual, handheld instruments, including dedicated
rods, or other instruments, that permit fast and simple measuring intended for classification of sizes. S
for a very accurate measurement of anatomic parts but to facilitate the selection of the surgical instru
prostheses (e.g., heart valves), implants (e.g., breast, penile), and/or grafts (e.g., vascular) that best fi
from a series of preestablished sizes.
Gas germicides, whose main component is ethylene oxide, intended for killing and/or total inactivation
microorganisms (i.e., viruses, bacteria, fungi, and their spores). These gas germicides typically consist
ethylene oxide with other inactive components, such as carbon dioxide, nitrogen, or dichlorodifluorom
used in sterilizing units that include a closed chamber in which the time, temperature, and/or concent
during the sterilization process are controlled. The germicide is toxic and must be eliminated after the
complete. Ethylene oxide germicides are mainly used to sterilize surgical instruments, reusable suppli
products that cannot support conventional high temperature sterilization (e.g., devices that contain pl
components).

Electron microscopes designed to provide a topographical image of the surface of a specimen, useful
surface structure. Scanning electron microscopes (SEMs) consist of an electron gun and vacuum cham
electromagnetic imaging (lens) system, a scanning system, a specimen chamber, secondary and back
viewing chamber and fluorescent screen, and photographic and vacuum systems. The imaging system
beam with a fine focal spot that is deflected horizontally and vertically (i.e., scanning system); the ene
the electron beam and the sample yields electromagnetic radiation that is detected to produce an ima
observation, tissue samples must be fixed (including cryofixation for some dedicated instruments), pr
sectioned, mounted on a support stub, and usually coated (e.g., using a sputter coater) with a thin film
(e.g., gold). The clinical use of SEMs has yielded information on hematologic disorders and biological s
of the small intestines and serous cavities.

Electron microscopes designed to operate like light microscopes, except that that they use an electron
to magnify an image, allowing greater magnification and resolution than a light microscope. Transmiss
microscopes (TEMs) consist of an electron gun and vacuum chamber, an electromagnetic condenser a
electromagnetic (lens) systems, a specimen chamber, a viewing chamber and fluorescent screen, and
vacuum systems. Before observation, tissue samples must be fixed, processed, embedded, sectioned,
stub, and usually coated (e.g., using a sputter coater) with a thin film of a heavy metal (e.g., gold). TE
detailed (e.g., 500,000x magnification) visualization of tissue, individual cells, and cell structures; they
to identify types of microorganisms (viruses and bacteria) in medical specimens, as well as specific ce
samples.

Electron microscopes designed to combine the characteristics of transmission electron microscopes (T


electron microscopes (SEMs) in one instrument. These microscopes include an electron gun and vacuu
electromagnetic condenser and electromagnetic imaging (lens) systems, a specimen chamber, a view
fluorescent screen, photographic and vacuum systems, and a scanning system. Before observation, ti
prepared according to the technique to be performed (i.e., transmission or scanning), including fixatio
sectioning; additional preparation for scanning microscopy may be needed (e.g., gold coating of samp
of combined electron microscopes include visualization of tissue, individual cells, and cell structure; id
cells; diagnosing and differentiating types of renal diseases; and gathering information on hematologi
biological surfaces (e.g., small intestines, serous cavities).

Devices designed to interface with electrosurgical units to help manage high-frequency leakage curre
active electrodes used during laparoscopic procedures.
Respirators designed to prevent the wearer from inhaling airborne particles, gases, and/or vapors by fi
environmental air. These respirators typically consist of a filtering facepiece (e.g., mask) that includes
(e.g., filters, cartridges, canisters) that remove the contaminant before it reaches the user.

Electric signal generators designed to deliver video signals in a wide variety of test patterns according
(e.g., NTSC/PAL/SECAM); frequently, the generators can also deliver signals in high-definition format (i
generators are typically an electronic unit with front and/or remote controls that allow selection of tim
spaces, digital and/or high-definition output, and audio signal type and a display that shows the test p
chosen. Some generators include software that facilitates pattern control using a computer. Video test
are intended for assessing and testing video monitors and other video equipment (e.g., network video
video surveillance systems, video recorders) and/or their components.

Data management information systems designed to provide clinical and administrative information re
pathology laboratory. These systems automate activities such as specimen receiving and tracking, pa
coding, and case retrieval. Most anatomic pathology data management systems offer surgical patholo
cytology clinical packages, including tracking capabilities; they also offer other clinical and manageme
tumor registry, trend reports, bar coding, billing).

Ventilators designed to provide automated ventilatory support to patients during interhospital or intra
in emergency situations. The operation and control of these ventilators are intentionally simplified; the
lightweight (i.e., less than 5 kg), rugged devices. Most transport ventilators provide mandatory breath
(control mode), not allowing the patients to breathe spontaneously; operation in assist/control and/or
intermittent mandatory ventilation (SIMV) modes is available in some models. These ventilators usual
pressure monitor and low- and high-pressure alarms. Transport ventilators may be used in vehicles, am
hospitals for medium-term ventilation.

Detectors designed to determine when a tracheal tube has been incorrectly placed in the esophagus (
intubation) during tracheal intubation. These detectors typically consist of devices that either detect e
or apply a vacuum through a small-caliber tracheal tube inserted into the main tracheal tube used for
intubation detectors are used in healthcare facilities and in the field to detect esophageal intubation,
ventilation and may be fatal if not discovered in time._x000D_

Data management information systems designed to provide clinical and administrative information re
pharmacy procedures. These systems can automate pharmacy procedures such as prescription drug
reaction control; they can also manage patient information, medication administration records, and d
clinical pharmacy data management information systems can perform inpatient and outpatient funct
dedicated to one function or the other.

Data management information systems designed to provide clinical and administrative information re
providers such as private and group medical practices, clinics, and health maintenance organizations
include hardware and software that are appropriate for automating diagnosis recording and patient re
also assist in other administrative tasks, such as inventory monitoring and patient billing. Physician p
management information systems are also used to schedule the physician's time, both at the office a
hospital.
Ophthalmic instruments designed to measure aqueous flare (i.e., protein concentration) and the numb
aqueous humor. These instruments usually consist of light sources (e.g., lasers), a slit-lamp microscop
and dedicated software. Aqueous flare/cell meters measure the light scattered from the protein and ce
humor using a photo-multiplier and typically analyze the results using a personal computer; they are u
anterior chamber inflammation. Meters using lasers as light sources are used in current practice.

Ophthalmic implants designed to flatten the anterior corneal curvature without disturbing the visual a
surgically created (i.e., intrastomal) channel. These implants may consist of open-ended plastic rings
diameters of about 8 and 6.8 mm, respectively, or more frequently, of two separate, 150-degree, plas
inserts that can be implanted away from the radial incision to minimize complications and that are ava
(typically from 0.25 to 0.35 mm); the devices are inserted in holes made in the cornea using a diamon
Intracorneal rings and/or ring segments are intended to correct mild and moderate myopia; ring segm
the treatment of irregular astigmatism that is the result of keratoconus, especially in patients who can

Adapters designed to connect a camera (video or still image) to a non-video endoscope (rigid or flexib
Intrauterine catheters designed to obtain samples of the threadlike projections growing in the outermo
membrane (chorionic villi). These catheters consist of a soft (e.g., polyethylene) tube that usually incl
preshaped stylet. They are usually introduced under ultrasonographic guidance, and the suction for sa
an external syringe. Chorionic villus sampling catheters are used to aspirate a tissue sample for genet
trimester, typically between the 10th and 12th weeks of pregnancy.

Simulators designed to mimic the the characteristics of the blood pressure in the interior of the blood
venous pressure, intra-arterial pressure). These simulators usually include an internal mechanism to g
and/or time-varying testing pressures, electronic circuitry, controls, and/or manometers; some of thes
used to test the invasive blood pressure monitors as a complete set, including the frequency response

Simulators designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood p
measuring devices when the cuff is placed on a patient's arm. Typically, these devices can simulate no
neonatal blood pressure (e.g., systolic, diastolic, mean) and abnormal (e.g, hypertensive, hypotensive
simulators can perform static accuracy, leak, and overpressure tests. These simulators usually consist
generate the testing pressures, manometers, electronic circuitry, and a display. Noninvasive blood pre
used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers a
including the transducer. Some are also capable of simulations appropriate for testing auscultatory sp

Magnetic resonance imaging (MRI) scanning systems that allow imaging of all areas of the body, and w
usually range from 0.5 to 1.5 Tesla. The patient is accommodated in a long bore, typically 55 to 60 cm
diameter and 1.5 to 2.0 m (5.0 to 6.5 feet) long. Full-body MRI systems also include "open" or "access
cylindrical bore that is 75 cm (30 in) or greater in diameter or a rectangular bore that is 100 cm (40 in
may also incorporate a design with open sides.

Magnetic resonance imaging (MRI) scanning systems with small-bore diameter (typically 20 to 30 cm)
imaging of the extremities of the body (e.g., limb, joint) and whose magnetic fields usually range from
systems include specialized surface coils for the extremities (e.g., extremity, knee, head).
Magnetic resonance imaging (MRI) scanning systems dedicated to the imaging of the breast and who
typically in the order of 0.5 Tesla. These systems include a patient table designed to position the patie
imaging and specialized breast surface coils. Mammographic MRI scanning systems are used as an ad
mammography in mammograms that are difficult to interpret.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
that transmit energy between a pacemaker and/or defibrillator and the heart (i.e., pacemaker/defibrill
these kits usually include a stylet for locking at the distal tip of the lead and a sheath for separating a
The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed
border around the periphery supporting all the instruments and supplies needed for the procedure; th
covered or wrapped. Defibrillator/pacemaker lead extraction procedure kits and trays are intended fo
frequently in cases of lead malfunction, local infection or sepsis, or the presence of unnecessary leads
in hospitals' operating rooms and catheterization laboratories.

Devices designed to remove very fine particles from the air, typically 99.97% of particles bigger than
cleaners usually combine a low-efficiency prefilter and a high-efficiency particulate-air (HEPA) filter. HE
very-low-particulate environments in healthcare facilities (e.g., laboratories, isolation rooms) and remo
those causing tuberculosis) from the environment. HEPA cleaners can remove most aerosolized biolog
radioactive particles.

High efficiency particulate filter air cleaners mounted on wheeled platforms and specially designed fo
These cleaners are intended for movement from one location to another. In a healthcare facilities, mo
(both stationary and mobile), and in emergency shelters they may be used to protect from toxic indus
biological agents or radioactive particulates.
Particulate air cleaners designed to remove particles from the air by electrostatic attraction and captu
of the particles. Positively charged ions are attracted to airborne particles as they are drawn through t
charged particles are then precipitated from the air as they pass through a negatively charged panel o
The electrostatic charge should be supplied by an appropriate electrical power source.

Electrostatic precipitation filter air cleaners mounted on wheeled platforms and specially designed for
These cleaners are intended for movement from one location to another in a healthcare facility, they m
modular medical facilities (both stationary and mobile) and in emergency shelters.

Data management information systems designed to provide clinical and administrative information re
services provided to patients on an ambulatory (i.e., outpatient) basis rather than upon admission to a
These systems include hardware and software capabilities to collect information from measuring devic
sphygmomanometers), recorders (e.g., electrocardiographs), and other devices used during examinat
patients. Ambulatory care data management information systems assist physicians in managing the p
treatment of outpatients, including administrative tasks such as prescription drug recording and billing

Data management information systems designed to provide clinical and administrative information re
care services and facilities. These systems include hardware and software capabilities to collect inform
such as physiological monitors and fluid administration equipment; they can also keep records of drug
patient trends. Emergency care data management information systems assist the physician to manag
treatment of high-risk patients, typically during critical care treatment.
Data management information systems designed to provide administrative and clinical information re
and utilization of home healthcare services and facilities. These systems include hardware and softwa
in clinical activities, such as patient-visit- charting, care plans, and statistical reports; they can also as
tasks, including scheduling, accounting, billing, payroll, and inventory functions.

Data management information systems designed to record, process, and display clinical and administ
related to the cardiac status of patients. These systems include hardware and software to collect info
electrocardiogram waveforms) from monitors and defibrillators; they may obtain additional informatio
and cardiac catheterization studies, as well as from stress and electrophysiology tests. Cardiology info
physicians establish cardiac status and manage prognosis and treatment of patients during chronic ca
congestive heart failure) or intensive care treatments; they usually offer scheduling capabilities in add
administrative information. Dedicated systems, available for hemodynamics data, collect and process
cardiac output units and fluid administration devices; other dedicated systems are available to record
information related to electrocardiography signals. The systems may function as stand-alone systems
in a hospitalwide data management information system network.

Data management information systems designed to record, process, and display comprehensive finan
clinical, and/or patient data information related to the provision and utilization of hospitalwide service
Hospital information systems (HISs) typically include a combination of hardware (e.g., a local network
servers, and links) and firmware and/or software. Dedicated HISs intended to integrate all the informa
hospital (i.e., integrated hospital information systems or IHISs) are available; dedicated HISs that are o
master patient index or information regarding the admission, discharge, and transfer of patients throu
facility are also available.

Information systems designed to record, process, and display information related to risk management
These systems consist of hardware, including computerized workstations and peripheral devices (e.g.
devices) that are usually connected in a local area network (LAN), and software appropriate for autom
management procedures, such as incident reports, long-range problem detection, trending, and resolu
management information systems can also be used to monitor the effectiveness of risk and quality m
and corrective actions.

Transducer output simulators designed to mimic the electrical output of pulse oximetry monitor transd
performed at any preestablished heart rate values (e.g., 45, 60, 90 bpm) and at various saturation val
transducer simulators are mostly used to assess an oximetry monitor's ability to reproduce the calibra
absorption ratio curve (i.e., R curve) that the manufacturer designed into it. Some simulators include c
the electrical integrity of oximeters probe (e.g., short and open circuits).

Flexible endoscopes designed for direct insertion through the mouth in the upper gastrointestinal trac
examination, biopsy, and treatment of lesions of the interior of the small intestine. Enteroscopes usua
outer sheath, a lighting system, and a working channel for catheters and operative devices.

Enteroscopes that include a television camera on the distal tip, typically in the form of a microchip (a
[CCD]). The image is electronically transmitted through wires in the endoscope for external processing
recording of video images of the small intestine.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine the prostate-specific-antigen (PSA) enzyme, either total or free (fPSA); these reagents in
(typically monoclonal antibodies) with the capability of binding to this tumor marker. PSA level is used
of prostate carcinoma because it correlates with the stages of tumor extension and metastasis; the lev
PSA and the proportion of free to total PSA are also used in diagnosis of prostate carcinoma and its diff
benign prostatic hyperplasia.

Bottles that hold culture media for growing microbiological specimens.


Mills designed to grind whole bones or bone parts into fine particles. These mills typically consist of e
rotatory mechanism with a size and mechanical characteristics appropriate to grind bones of a variety
The size of the final particles depends on the pressure exerted on the bone and/or the duration of ope
mills may be manually or electrically powered; they are used to reduce bones (e.g., cortical bones) to
may be used as bone matrix or bone graft. Dedicated bone mills intended for use in dental implant pr
available.

Systems designed to create space in the abdominal cavity for laparoscopic procedures by mechanical
wall. These devices require minimal or no gas insufflation. These devices lift the abdominal wall by ins
sling, or subcutaneous wires and then provide lift with an external lifting system such as manual tract
clamped to the operating table, or a winch and framework.
Cup-like receptacles designed to be placed in the vagina in order to collect menstrual fluid.
Implantable devices intended to be used to join and transect excess structures, typically through the c
shaped components that are inserted into the ends of the segments to be attached. These devices m
biofragmentable.
Implantable devices intended to be used to join and transect excess tissue of gastrointestinal structur
the coupling of two ring-shaped components that are inserted into the ends of the segments to be att
may be permanent or biofragmentable.
Implantable devices intended to be used to join vascular structures typically through the coupling of t
components that are inserted into the ends of the vessels to be attached.
Telemedicine information systems designed for real-time consultation and diagnoses in remote sites u
may include other telecommunication equipment (e.g., fax). These systems typically consist of video
resolution displays, monitors, compression/decompression devices (CODECS), personal computer wo
microphones, and speakers; they can usually be interfaced with other telemedicine systems (e.g., tel
telepathology). Videoconferencing telemedicine systems are used to allow long-distance communicati
and with other healthcare specialists, including voice, data, and imaging interchange.

Chairs or carriages that contain three or four small wheels and handle(s) that allow the device to be p
an attendant for the purpose of transporting individuals with limited or no mobility. Strollers are typica
materials and collapsible.
Canopies designed to be attached to the back of a wheelchair or scooter and to be suspended over th
of the wheelchair or scooter, to protect the occupant from exposure to sun, rain, or snow. They are ma
fit adult or pediatric wheelchairs or scooters. Canopies are usually made of solid fabric and may come
observation panel, and can be vented with the addition of mesh material on the sides and back. Whee
distributed with mounting kits that are used to mount the canopies to the back of the wheelchair's or
mounting kits vary, based upon the model of the wheelchair or scooter. The canopies can be attached
slipping them in or out from the mounts.
Devices designed to facilitate the movement (i.e., closure) of the eyelids by providing additional weigh
typically a metal (e.g., tantalum, gold, platinum) device that may be attached externally by the patien
adhesive strips or implanted under the upper eyelid conforming to the curvature of the ocular sphere.
used in the treatment of partial facial paralysis in which the eye cannot be completely closed (i.e., lag
reduces the risk of ocular exposure and improves the appearance of the face.

Eyelid weights designed for external attachment to the eyelid to provide additional weight. These dev
(frequently tantalum) weights in a range from 0.5 to 2.0 grams that are externally fixed by the patient
the eyelid using disposable adhesive strips; they are available in a variety of colors to match patient's
weights are used in the temporary treatment of partial facial paralysis in which the eye cannot be com
lagophthalmos) or when the implantation of eyelid weights is not possible or desirable; their use redu
exposure and improves the appearance of the face.

Ultrasonic scanning systems that are designed to be small and lightweight, typically less than 23 kg (5
be carried by hand from location to location. Most of these systems support basic diagnostic techniqu
the optional advanced scanning capabilities that are found in larger general-purpose systems (e.g., Do
mapping). These systems are used in physician's offices, outpatient imaging centers, and small radiol
in hospitals for bedside scanning (e.g., abdominal small parts, obstetric/gynecologic) of patients who c
to the radiology department.

Laser scanning systems that use two or three laser beams to scan an object surface and convert the i
dimensional (3-D) computerized image. These devices can obtain topological images of parts or the w
are used in procedures such as planning and evaluating results of plastic surgery and determination o
outcome of prostheses.
Cardiac electrical stimulators designed to stimulate a muscle (e.g., latissimus dorsi) that has been wra
ventricles of the heart (myoplasty surgery) to augment the cardiac output. These stimulators typically
implanted two-channel synchronized pulse generator that combines the characteristics of cardiac pac
neuromuscular stimulators; they include pacemaker electrodes attached to the myocardium and musc
stimulate the wrapping muscle in synchrony with the heart muscle. Most stimulators include some pac
to pace the heart when the heart rate drops below a programmed value). Myoplasty cardiac stimulato
after a postoperative period of adaptation in patients who have ischemic or dilated cardiomyopathy.

Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
germicidal vapors or gases in a plasma state (a form of matter that includes electrons and positive ion
from the application of a strong electromagnetic [e.g., radio frequency] field). These units usually inclu
(frequently vacuum) chamber with shelves on which the devices to be sterilized are placed, usually af
gross debris and then packed; means to introduce the vapor (e.g., hydrogen peroxide, H2O2) into the
that are activated to convert the vapor to plasma; a radio-frequency generator; and controls to start/s
of the procedure. After the sterilization cycle is complete, an integral evacuation system to eliminate t
oxygen when using H2O2) is usually activated. Plasma sterilizing units are available in a variety of sha
stand-alone (bulk) and tabletop models; they are used for devices and supplies that are sensitive to h
humidity (e.g., devices and supplies that include plastic and/or rubber components).
Mattress systems that include a mattress made of multiple air cells, which are cyclically inflated and d
that the inflated sacks cells support the patient and the deflated ones give pressure relief to prevent
patient's skin. Control units connected to the mattress regulate the cycles of inflation and deflation. T
typically used in the care and management of patients at risk for, or who already have compromised s
burn patients, patients at risk for developing decubitus ulcers, patients with decubitus ulcers, etc.

Bar- or rail-like apparatus used to assist women with positioning and support during labor.
Nasal cannulae designed for simultaneous delivery of oxygen and sampling of exhaled gas for end-tid
monitoring. These cannulae are available in one-, two-, or four-prong configurations.
Testers which measure the ability of solid materials to resist plastic deformation or fracture when a for
them. Common types of hardness tests include scratch, indentation, and rebound hardness. Scratch h
of the resistance of a material to scratching of its surface. Scratch hardness testers usually consist of
indenter with a very hard tip (e.g., tungsten carbide, diamond), a load or applied force, and a scale to
applied by the load or force on the indenter to scratch the surface of a material. Scratch hardness is c
the Mohs scale. Indentation hardness is a measure of the resistance of a material to permanent plastic
constant compression load from a sharp object. Indentation hardness testers typically feature an inde
hard material (e.g., diamond, steel, tungsten carbide) to which a load or force is applied, a platform to
material to be tested, a load to apply the force to the indenter, and various measuring mechanisms to
indentation made in the test material by the indenter according to different hardness scales (e.g., Brin
Shore, Vickers, etc.). Rebound hardness, also known as dynamic hardness, measures the height of the
tipped hammer dropped from a fixed height onto a material. Rebound hardness testers usually have a
hammer and a measuring scale to measure the height of the bounce caused by the return energy of t
the hardness of the test material. Some hardness testers are interfaced with computers that aid in sel
parameters for the hardness test and in presenting results. Some hardness testers can be pocket-size
in hard to reach locations; many use electronic components to calculate hardness. Hardness testers th
indentations on delicate or brittle materials and use a microscope to make precision measurements of
(microhardness testers) are also available. Hardness testers are used in laboratories and sometimes in
the hardness of materials used in many different applications; they may have clinical applications in t
dental materials and other materials used in clinical engineering.

Devices designed to provide protection from laser radiation by attenuating, reflecting, and/or blocking
devices can be configured to cover a window or doorway or to partition an area of a room.
Individual laser shields designed to be placed either under or over the patient's eyelids in order to pro
injury during laser surgery.
Ultrasonic stimulators designed to apply energy to the bones to promote their growth (osteogenesis).
usually consist of a pulsed low-intensity ultrasound generator that includes a transducer probe and a r
alignment fixture for the probe. Ultrasonic bone growth stimulators are mainly used to promote healin
fractures; they are also used to speed the healing of fresh fractures.
Devices designed for minimum-access treatment of diseases by introduction of soluble drug ions (i.e.,
administration) into the body by means of electric current (i.e., iontophoresis). These units typically in
(DC) generator and two electrodes connected to the generator by cords. A pad saturated with the dru
placed on the skin, and a DC voltage is applied. Iontophoresis therapy units are used to administer a t
concentration to a limited area with minimal exposure to the rest of the body; dedicated units are use
by plugging the sweat ducts with tap water ions.

Systems designed to control the amount of contrast media that is actually supplied to the administrat
injector) in order to conserve the amount of contrast media used during a single procedure and preve

Intraoral devices designed to tightly overlay the occlusal surfaces of the upper or lower arch of the tee
splints). These splints usually consist of custom-designed soft or semi-rigid devices that are made of p
resins. Dedicated occlusal splints intended for dental treatment and management of mandibular posit
treatment of obstructive sleep apnea and snoring are available.

Contrast media injectors designed to inject the contrast media through a small catheter into the vascu
selectively alter the image of an anatomic region of interest in magnetic resonance imaging (MRI) pro
devices typically consist of automated electromechanical injectors with syringes that may be either re
both; pneumatic mechanisms and peristaltic pumps are less frequently used. MRI contrast media injec
delivering contrast media with the pressure, flow range, and volume required for MRI studies. They are
particular MRI procedures, such as those for enhancing lesions and vascular abnormalities.

Chemical agents intended for killing and/or total inactivation of microorganisms such as viruses, bacte
spores (i.e., germicides). Germicides typically consist of one or a mixture of gases or liquids typically u
that include a closed chamber in which the time, temperature, and/or concentration of the germicide
process are controlled. Germicides are usually toxic and must be eliminated after the sterilization cycl
residual chemicals should be drained and the volatile compounds eliminated (usually by aeration or ri
water). They are widely used to sterilize heat-sensitive surgical instruments and other reusable suppli
Gas germicides such as chlorine dioxide and ethylene oxide as well as liquid (e.g., glutaraldehyde) ge

Germicides intended for use in gas-phase for killing and/or total inactivation (i.e., sterilization) of micr
viruses, bacteria, fungi, and their spores). These germicides typically consist of one or a mixture of ga
units that include a closed chamber in which the time, temperature, and/or concentration of the germ
sterilization process are controlled. Gas germicides must be eliminated after the sterilization cycle is c
widely used to sterilize heat-sensitive surgical instruments and other reusable supplies including garm
Germicides intended for use in liquid-phase for killing and/or total inactivation of many microorganism
bacteria, fungi). These germicides typically consist of a non-corrosive chemical solution used in disinfe
units that include a closed chamber in which the time, temperature, and/or concentration of the germ
sterilization (typically by immersion) process are controlled. Liquid germicides usually require high co
temperatures, and several hours of exposure time for sterilization purposes. Therefore, they are mainl
rather than for sterilization purposes. Liquid germicides are used mainly to disinfect medical devices a
cannot be heat-sterilized due to their sensitivity to high temperatures (e.g., devices including plastic a
components). The most frequently used liquid germicides are glutaraldehyde, hydrogen peroxide, and

Gas germicides, whose main component is hydrogen peroxide, intended for killing and/or total inactiv
of microorganisms (i.e., viruses, bacteria, fungi, and their spores). These gas germicides typically cons
peroxide gas used in sterilizing units that include a closed chamber in which the time, temperature, an
the germicideal during the sterilization process are controlled. The germicide is toxic and must be elim
sterilization cycle is complete. Hydrogen peroxide gas germicides are mainly used to sterilize surgical
supplies, and pharmaceutical products that cannot support conventional high temperature sterilizatio
contain plastic or rubber components). The germicide is usually available as a liquid and vaporized by

Liquid germicides, whose main component is hydrogen peroxide, intended for killing and/or inactivatio
microorganisms (e.g., viruses, bacteria, fungi). These liquid germicides typically consist of colorless liq
active ingredient in disinfecting units where a disinfecting process (typically by immersion) under con
temperature, and concentration is performed. Hydrogen peroxide germicide is used mainly to disinfec
supplies that cannot be heat-sterilized due to their sensitivity to high temperatures. Liquid hydrogen p
can also be used in high concentrations for sterilization purposes.

Trial prostheses that are used to determine the prosthesis size of the acetabular component of the hip
Trial prostheses that are used to determine the prosthesis size of the femoral component of the hip joi
Implantable prostheses designed for total or partial replacement of the hip joint. Partial hip prostheses
either a femoral component (consisting of a metal stem inserted into the marrow cavity of the femora
neck where a metal ball component is attached, intended to replace the femoral head) or an acetabul
(consisting of a metal [e.g., cobalt-chromium alloy] or plastic cup-like component that is implanted int
Total hip joint prostheses typically consist of a combination of both femoral and acetabular componen
may be intended for implantation with or without bone cement; they are used mainly in patients who
abnormalities or who suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma.

Automation systems designed for use in healthcare facilities to dispense medications. They can usuall
medication orders and retrieve the correct medication, adjusting the inventory and/or the patient's bil
accommodate oral medicines (solid or liquid), ophthalmic drops, prefilled syringes, and topical prepara
interfaced with the pharmacy and/or the hospital information systems. Medication-dispensing automa
available either for a centralized distribution of medicines only in a central clinical pharmacy or throug
through computerized cabinets in patient care areas and/or nurse stations. All these systems are inten
safety and/or efficiency of dispensing medications; they are usually configured according to particular
requirements.
Automation systems designed for centralized preparation and distribution of medications (e.g., filling
unit-dose cassettes) in the clinical pharmacy. These systems can usually read patient's medication ord
correct medication, adjusting the inventory and/or the patient's bill. Most systems include a control m
that are used either to choose from prepacked medicines or for automated packaging and dispensing
from bulk containers. These systems can accommodate oral medicines (solid or liquid), ophthalmic dr
and topical preparations; they are usually interfaced with the pharmacy and/or the hospital informatio
pharmacy automation systems are intended to improve the safety and/or efficiency of dispensing med
usually configured according to particular hospital pharmacy requirements. Some systems can interac
information system with computerized medication cabinets located in patient care areas or nursing st

Automation systems designed to provide and control medicine distribution throughout a healthcare fa
typically consist of a combination of hardware and software that includes an appropriate server and a
medication-dispensing cabinets located in patient care areas and/or nurse stations. The systems can a
medicines (solid or liquid), ophthalmic drops, prefilled syringes, and topical preparations; they may be
pharmacy automation systems and/or with the hospital information system to provide complete medic
Some systems include a computerized device (e.g., a portable or handheld computer) with bar-code la
capabilities that reads information from the identification wristband and on the medication package, t
administered medications match provider orders (i.e., that it is the right patient, right drug, right dose
time). Medication-dispensing automation systems are intended to improve the safety and efficiency o
dispensing, providing better access, proper identification of patient and medicine, control of consump
inventory of medicines.

Automation systems designed to provide and control the distribution of supplies (material) throughout
They typically consist of a combination of hardware and software that includes an appropriate server a
computerized dispensing cabinets located mainly in areas of high-volume patient treatment, such as p
catheterization) and operating rooms and/or nurse stations. The systems can accommodate different
according to the intended use. Decentralized supplies-dispensing automation systems may include a h
management information system, either as an integral part or interfaced. These systems are intended
automated material management capabilities, improving the safety and efficiency of hospital supplies
providing better access, control of consumption, replenishing, and inventory of hospital supplies.

Devices intended to decelerate and stop the wheels of a nonpowered wheelchair. They may also be u
in place.
Devices intended to lock the wheels (typically the rear wheels) of a wheelchair in place in order to pre
(rolling).
Smoke-evacuation wands designed to clip on an electrosurgical active electrode.
Systems based on three-dimensional (3-D) arrangements and techniques that are designed to aid in t
minimally invasive procedures by combining medical imaging, dedicated computer software, and instr
systems for guidance. The systems provide the operator with real-time, three-dimensional positioning
probes and instruments relative to the patient's anatomy. Stereotactic systems may be based on real-
a video display (image-guided); guided by the position of devices relative to a rigid frame (i.e., frame-
not use any image as a guide (imageless) during the procedure. Dedicated image-guided, frame-guide
stereotactic systems intended for surgical, radiosurgical, biopsy, and/or other invasive procedures are
Stereotactic computer-aided surgical systems designed to aid in the performance of minimally invasiv
neurosurgical) procedures by combining medical imaging, dedicated computer software, and a rigid fr
headframe) attached to the patient body for guidance. The systems provide three-dimensional (3-D) p
orientation of instruments relative to the patient's anatomy and/or to the frame position during surger
an endoscope. Frame-guided intracranial stereotactic systems typically provide medical images that s
instruments relative to pre-operative images obtained from one or more imaging modalities such as c
(CT) and/or magnetic resonance imaging (MRI). Intracranial frame-guided stereotactic systems are use
surgical procedures, including craniotomies, resection of tumors and other lesions, removal of foreign
procedures, shunt placement, craniofacial procedures, skull and orbital cavity reconstruction. They ma
biopsies, puncture of abscesses, and deep brain stimulation.

Image-guided stereotactic computer-aided surgical systems designed to aid in the performance of min
neurosurgical intracranial procedures by combining medical imaging, dedicated computer software, an
tracking systems for guidance. The systems provide surgeons with real-time, three-dimensional (3-D)
orientation of surgical instruments relative to the patient's anatomy on a video display during the intr
without requiring the use of an endoscope. One or more imaging modalities, such as computed tomog
magnetic resonance imaging (MRI), may be used in the procedure. Intracranial neurosurgery image-gu
in a variety of surgical procedures, including craniotomies, resection of tumors and other lesions, remo
transnasal procedures, shunt placement, craniofacial procedures, skull and orbital cavity reconstructio
also for biopsies, puncture of abscesses, and deep brain stimulation.

Image-guided computer-aided stereotactic surgical systems designed to aid in the performance of min
procedures by combining medical imaging, dedicated computer software, and surgical instrument trac
guidance. The systems provide surgeons with real-time, three-dimensional (3-D) positioning and orien
instruments relative to the patient's anatomy on a video display during the biopsy without the use of
image-guided stereotactic systems provide medical images that show the location of the instruments
biopsy. One or more imaging modalities, such as computed tomography (CT) and/or magnetic resonan
be used in the procedure. Dedicated image-guided stereotactic systems intended for particular proced
bronchi, and prostate biopsies are available.

Diode lasers, usually operated in continuous-wave mode, typically at 810 or 980 nm wavelength, main
or vaporize and coagulate tissues. Their laser energy, especially at 980 nm wavelength, penetrates d
absorbed by a large volume of tissue, allowing photocoagulation of blood vessels at low power densiti
tumors at high power densities. These lasers are used in open, laparoscopic, and endoscopic surgery.

Electrical devices that clean by trapping small particles using a suction vacuum pump and appropriate
bags.
Vacuum cleaners employing a high-efficiency particulate-air (HEPA) filter and appropriate air-tight sea
to trap micrometric particles which cause upper-respiratory disorders and adversely affect allergy suff

Resectoscopes designed for removal or biopsy of lesions of the female genital tract (e.g., cauterization
removal of fibroid tumors); they typically include electric cautery and coagulating capabilities. Gyneco
usually consist of an outer sheath, a lighting system (e.g., fiberoptic), a wide-angle telescope, electros
a working channel for catheters and operative devices.
Resectoscopes designed for transurethral removal or biopsy of lesions of the bladder, prostate, or uret
include electric cautery and coagulating capabilities. Urinary tract resectoscopes usually consist of an
lighting system (e.g., fiberoptic), a wide-angle telescope, electrosurgical wire loops, and a working ch
operative devices. They may also include a television camera on the distal tip, typically in the form of
coupled device [CCD]). The image is electronically transmitted through wires in the endoscope for ext
display, and recording of video images.

Ureteroscopes designed with a nonrigid (i.e., flexible) structure, capable of being manipulated through
curved path of the upper urinary tract. The sheath is usually made of plastic.
Ureteroscopes designed with a nonflexible (i.e., rigid) structure that can only follow a straight path thr
The sheath is usually made of stainless steel, these endoscopes are less frequently used than flexible

Ophthalmoscopes that use a low-power laser beam for scanning horizontally and vertically across the
electronic image with depth resolution, which is particularly valuable in creating three-dimensional (to
the optic disc. Retinal conditions such as edemas, scars, and macular holes are assessed using this te

Optical coherence tomography (OCT) scanning systems designed to obtain cross-sectional images of e
tissues. These systems typically consist of a computerized unit that includes a light source, a photode
The light beam (usually in the infrared range) is divided into two beams, one directed towards the sam
towards a moving reference mirror. Tomographic images are then obtained by detecting the interferen
reflected by both beams. The images obtained can show tissue about two or three mm (0.08 to 0.12 in
provide axial and lateral resolution in the order of micrometers. The systems reveal the underlying str
observable (tomographic images) in an analogous way, but with higher image resolution than conven
ultrasound and magnetic resonance imaging. Systems that use light sources at different frequencies s
(spectral domain systems), rather than a mechanical movement of a mirror, are also available. OCT op
systems are used for a variety of clinical applications involving accurate retinal and intraretinal thickn

Ophthalmic instruments designed to measure aqueous flare (i.e., protein concentration) and the numb
aqueous humor. These instruments usually consist of a computerized unit with a low-power laser (e.g.
light source, a slit-lamp microscope, photo-multipliers, and dedicated software. Aqueous flare/cell met
scattered from the protein and cells in the aqueous humor using a photo-multiplier and typically analy
personal computer; they are used mainly to assess anterior chamber inflammation.

Endoscopes designed for direct insertion under the dermis for visual examination and treatment, espe
plastic surgery. Dermoscopes may include a lighting system and a working channel for operative dev

Dermoscopes designed for surgery beneath the facial skin (e.g., facial plastics, such as wrinkling of th
overhanging brow). These endoscopes are intended for decreasing the length of incisions and thus the
of standard surgical procedures.
Tunable solid-state lasers with a composition of chromium-doped BeAlO (a hard mineral known as alex
medium. Their emission wavelength ranges from 380 nm between 700 and 830 nm. These lasers are
continuous-wave, pulsed, and Q-switched modes.
Alexandrite lasers, usually Q-switched, used in the treatment of benign pigmented lesions, removal of
procedures related to the diagnosis and treatment of diseases of the skin.
Gas lasers with argon ion, as the active medium. Their principal emission wavelengths are 488 and 5
These lasers are operated in continuous-wave mode.
Argon gas lasers designed for use in dental procedures. These lasers typically emit energy at wavelen
nm (blue-green); they are usually operated in continuous-wave mode. Dental argon lasers are used in
gums and other soft tissue in the oral cavity.
Argon lasers used to treat cutaneous vascular lesions (e.g., facial telangiectasia) and other diseases o

Gas lasers with krypton ion as the active medium. Their principal emission wavelengths are 568 (yell
but are also used at 521 and 530 nm (green). These lasers are operated in continuous wave.
Krypton lasers used to treat small pigmented lesions and other diseases of the skin.
Gas lasers with mixed argon/krypton ions as the active medium. Their principal emission wavelengths
and krypton lasers. These lasers are operated in continuous-wave mode.
Gas lasers with carbon dioxide as the active medium. Their emission wavelength is 10,600 nm (far in
are operated in continuous-wave and pulsed modes. The laser energy can be delivered to the tissue t
through a rigid non-fiber-optic endoscope or adapted to an operating microscope.

Carbon dioxide gas lasers designed for use in dental procedures. These lasers typically emit energy at
nm (far infrared); the laser energy is usually delivered to the tissue through a handpiece. Dental carbo
be operated in continuous-wave or pulsed modes; they are used mainly to excise or vaporize soft tissu

Metal vapor lasers with copper vapor as the active medium. Their principal emission wavelengths are
nm (green). These lasers are operated in pulsed mode.
Dye lasers used in the treatment of pigmented lesions on the skin (e.g., hyperpigmentation, nevus of
diseases of the skin.
Dye lasers designed to deliver their energy to the surface of previously photosensitized tissues. The c
light, sensitizers, and tissue oxygen destroy tissue by a phototoxic effect (photodynamic therapy). Th
consist of a flash lamp of Nd:YAG pumped dye-laser generator and microlens or isotropic (spherical or
adapted to the absorption of the sensitizer. Photodynamic therapy dye lasers are used to ablate tissu
tumors) without significant thermal effect.

Metal vapor lasers with gold vapor as the active medium. Their principal emission wavelength is 628
lasers are operated in pulsed modes.
Gold vapor lasers that generate and deliver their energy to the surface of previously photosensitized t
effect of light, sensitizers, and tissue oxygen destroy tissue by a phototoxic effect (photodynamic ther
usually consist of gold vapor laser generator and microlens or isotropic (spherical or cylindrical) applic
absorption of the sensitizer. Photodynamic therapy gold vapor lasers are used to ablate tissue (e.g., m
without a significant thermal effect.

Solid-state lasers with a rod of yttrium-aluminum-garnet crystal doped with holmium, a rare earth elem
medium. Their emission wavelength is 2,100 nm (midinfrared). These lasers are operated in continuo
Q-switched modes. The laser energy can be delivered through a flexible optical glass fiber and can be
aqueous environment.
Ho:YAG lasers used for laser keratoplasty of hyperopia and other ophthalmic procedures in the eye. T
coupled to a biomicroscope slit lamp by a flexible fiberoptic cable.
Solid-state lasers, powered by a rod of yttrium-aluminum-garnet crystal doped with holmium, a rare-e
active medium, designed for use in dental procedures. These lasers typically emit energy at a wavelen
(midinfrared); they may be operated in continuous-wave, pulsed, and Q-switched modes. The laser en
through a flexible optical glass fiber that can be operated in an aqueous environment. Ho:YAG dental l
to excise or vaporize soft tissue (e.g., gums) in the oral cavity.

Solid-state lasers with a rod of yttrium-aluminum-garnet crystal doped with neodymium, a rare earth e
medium. Their emission wavelength is 1,064 nm (near infrared), although sometimes operated in oth
1,319 nm). These lasers are operated in continuous-wave, pulsed, Q-switched, and mode-locked mod
can be delivered through a flexible optical glass fiber.
Solid-state lasers, powered by a rod of yttrium-aluminum-garnet crystal doped with neodymium, a rar
active medium, designed for use in dental procedures. These lasers typically emit energy at a wavelen
infrared), although they are sometimes operated in other transitions (e.g., 1,319 nm). Nd:YAG dental l
in pulsed, Q-switched, and mode-locked modes; laser energy can be delivered through a flexible optic
dental lasers are used mainly to excise or vaporize soft tissue (e.g., gums) in the oral cavity.

Nd:YAG lasers used to photocoagulate both large diameter blood vessels and pigmented lesions found
well as in other diseases of the skin and in the treatment of tattoos.
Nd:YAG lasers in which passing the energy through a crystal, typically KPT (potassium titanyl phospha
frequency of the emitted laser light. Their emission wavelength is 532 nm (green). These lasers are o
wave, pulsed, and Q-switched modes. The laser energy can be delivered through a flexible optical gla

Nd:YAG frequency-doubled lasers, usually operated in pulsed modes, used to coagulate abnormal vasc
retina and other photocoagulation procedures in the eye. They are typically coupled to a biomicrosco
indirect ophthalmoscope.
Nd:YAG frequency-doubled lasers used in the treatment of pigmented superficial lesions on the skin (e
are usually operated in Q-switch mode.
Lasers with a solid-state rod of ruby, a precious stone that is red corundum (aluminum oxide), used as
Their emission wavelength is 694 nm (red). These lasers are operated in pulsed and Q-switched mode
can be delivered through a flexible optical glass fiber.
Lasers with a semiconductor diode as the active medium. Diode lasers transform electric energy to lig
principle as a light-emitting diode (LED), but with internal reflection capability, thus forming a resonat
light can reflect back and forth, allowing only a certain wavelength to be emitted. The emission of a g
fixed wavelength, determined by the active compound used (e.g., gallium arsenide crystals doped wit
indium). Typical wavelengths are 810, 1,060 and 1,300 nm. Semiconductor lasers are smaller and mu
conventional lasers. These lasers are operated in continuous-wave and pulsed modes.

Solid-state diode lasers designed for use in dental procedures. The emission of a given diode laser is o
determined by the active medium used (e.g., gallium arsenide crystals doped with aluminum or indium
wavelengths are 810, 1,060, and 1,300 nm. Diode lasers are smaller and much more efficient than co
may be are operated in continuous-wave and pulsed modes. Dental diode lasers are used mainly to ex
tissue (e.g., gums) in the oral cavity.

Diode lasers used to alter cellular behavior in the absence of significant heating, typically delivering 1
centimeter squared to treatment sites. These lasers have low output power, usually 10 to 90 mW. Dio
lasers are typically used to treat musculoskeletal injury, pain, and inflammation.
Solid-state lasers with a rod of yttrium-aluminum-garnet crystal doped with erbium, a rare earth elem
medium. Their emission wavelength is 2,940 nm (midinfrared). These lasers are operated in pulsed a
Their emitted wavelength is very near the peak absorption of light in water (2,900 nm). The laser en
through a flexible optical glass fiber and is highly absorbed by osseous minerals.

Er:YAG lasers, usually Q-switched, used to cause a photodisruptive effect in the eye (e.g., sclerotomy)
generating immense localized mechanical shock waves (microexplosions) that, when highly focused, c

Solid-state lasers, powered by a rod of yttrium-aluminum-garnet crystal doped with erbium, a rare-ear
active medium, designed for use in dental procedures. These lasers typically emit energy at a wavelen
(midinfrared), very close to the peak absorption of light in water (2,900 nm). They may be operated i
switched modes; the laser energy can be delivered through a flexible optical glass fiber and is highly a
minerals. Er:YAG dental lasers are used mainly to excise or vaporize hard tissue, usually in procedures
enamel and dentin.

Excited dimer (i.e., excimer) gas lasers designed for use in dental procedures. The most commonly us
rare gas monohalides (e.g., argon fluoride, xenon chloride); the emission wavelength is typically in the
depends on the monohalide used (e.g., 193 nm for ArF, 308 nm for Xe Cl). These lasers may be opera
switched modes. Dental excimer lasers are used mainly to excise or vaporize hard tissue, usually in pr
dental enamel and dentin.

Lasers that can produce an individual laser beam of either type. The excimer beam is used for photor
of mild to moderate myopia, while the Ho:YAG beam is used for the alteration of the corneal curvature
tissue in the treatment of hyperopia.
Gas lasers with mixed helium (He) and neon (Ne) as the active medium. Their principal emission wave
but they also operate at other visible and infrared wavelengths. Operated in continuous-wave and pul
typically used to assist with aiming other nonvisible lasers (e.g., carbon dioxide lasers) in biostimulatio
therapies.
Electrosurgical units in which the high-frequency electric current is delivered to the patient by an activ
and returns to unit through a return (dispersive) electrode.
Electrosurgical units in which two electrodes (generally the two tips of a pair of forceps or scissors) se
the active and dispersive leads in the monopolar mode. Bipolar electrosurgery is primarily used to co
(e.g., in neurosurgical, gynecologic, and ophthalmic procedures).
Electrosurgical units capable of both monopolar and bipolar functionality.
Electrosurgical units capable of both bipolar and argon-enhanced monopolar functionality.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for p
obtain images by detecting radiation from different parts of the body after a radioactive tracer materi
nuclear imaging). Items in these kits usually include a syringe, a needle, and imaging agent (e.g., mon
peptide), a shoulder support, a knee wedge, an acrylic arm support, and security straps. The kits are f
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
imaging procedure kits and trays are used to obtain nuclear images intended for assessing how organ
detect abnormal tissue conditions (e.g., neoplasms). They are used in nuclear medicine departments
healthcare facilities.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
monoclonal antibodies that are directed against specific molecular targets, followed by nuclear imagin
usually include a syringe, a needle, a monoclonal antibody as imaging agent, a shoulder support, a kn
arm support, and security straps. The kits are frequently supplied in supporting trays (i.e., procedure t
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Monoclonal antibody nuclear imaging procedure
intended for providing useful imaging characteristics for the evaluation of tumors and metastatic invo
used in nuclear medicine departments in hospitals and other healthcare facilities.

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for th
peptide agent directed against specific molecular targets, followed by nuclear imaging. Items in these
syringe, a needle, a peptide antibody as imaging agent, a shoulder support, a knee wedge, an acrylic
security straps. The kits are frequently supplied in supporting trays (i.e., procedure trays) consisting o
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Peptide agent nuclear imaging procedure kits and trays are int
procedures for providing useful imaging characteristics for the evaluation of tumors and metastatic in
used in nuclear medicine departments in hospitals and other healthcare facilities.

Vascular stents designed to be deployed into the coronary arteries. These stents are typically metallic
expandable or self-expanding. Some stents are uncoated (i.e., bare metal) while others are coated to
capabilities (e.g., to reduce protein and/or platelet adhesion, to elute drugs). Coronary vascular stents
treat coronary vessel disease; these devices form a scaffold that holds the arteries open without comp
of the vessel.

Vascular stents designed for deployment into one of the peripheral arteries, especially those that supp
extremities, such as the iliac, femoral, and popliteal arteries. These devices may consist of a metallic
or plastic tube, and they are available in several different shapes (e.g., straight, bent) to adapt to part
peripheral arteries and/or to prevent migration. Metallic stents may be either balloon-expandable or s
Peripheral vascular stents are designed to form a scaffold that holds the arteries open. Some of these
a specific peripheral artery (e.g., iliac, femoral, popliteal).

Self-expanding vascular stents designed with the appropriate size and configuration for deployment in
These stents typically consist of compressed metallic stents that open by themselves as soon as they
expanding stents are used mainly in stenotic lesions of the common or external iliac arteries, frequent
angioplastic procedures.
Prepackaged collections of needles and related supplies designed to be used for drawing blood. Typica
a blood drawing needle, tubing, and an adapter to allow connection to other devices typically used for
a vacutainer, a syringe, etc.
Blood collection needle sets that allow the blood-drawing needle to be retracted into or covered by a p
These needle sets are used for prevention of accidental needlesticks during blood collection procedure

Blood-collection needles designed to provide needlestick protection. These needles (or the attached b
include some manually positioned or activated mechanism intended either to shield, blunt, or recess t
by some other means, lessen the possibility of contact of the healthcare provider with the sharp need
Blood collection tube holders that are designed to hold vacuum blood collection tubes during blood co
incorporate a sheath that advances over the needle or covers a retracted needle. These devices may
protective blood collection needle, or have the capacity to attach to a protective blood collection need
some spring action that is activated when a needle is withdrawn from the patient or the blood collecti
the user after the last tube is removed from the holder. Protective blood collection tube holders are us
accidental needlesticks during blood collection procedures.

Blood collection tube holders that consist of a recessed needle holder that mates with a sampling site
tubing. These tube holders typically have a tubing access needle on one end that attaches to the don
as the blood collection needle and a tube-puncturing needle on the opposite end (recessed inside the
interfaces with the blood collection tube. The user attaches the tubing-access needle to the donor tub
blood collection tube inside the holder on the tube-puncturing needle to obtain samples. Some protec
tube holders have the donor collection tubing set attached to the holder's outer needle all as one irrem
protect against needlestick injuries to healthcare workers. Protective blood donor set tube holders are
are disposable. They are used in blood donation and collection settings for the collection of blood and
needlestick injuries.

Needle sets that include a large-bore (typically 16 G) winged needle. During use, the Luer fitting is att
hemodialysis pheresis set. Usually, two needle sets are used simultaneously per dialysis patient, with
a vein and the other inserted in an artery. Both needles are kept in the patient until the hemodialysis
completed.
Hemodialysis needle sets that allow the needle to be retracted into or covered by a protective sheath.
used for prevention of accidental needlesticks during hemodialysis.
Intracorporeal lithotripters that use a vibrating or oscillating probe to fragment stones. The probe is p
with the stone and the probe vibrations or oscillations cause the stone to fragment.
Systems that produce a mono-layer sample of the Papanicolaou smear using an automatic processor.
standardize the sample preparation technique and reduce the number of compromised cervical sampl
mucus, and inflammation, as well as errors due to the process of transferring the sample to a slide. T
obtained using a liquid collection method in which the sampling instrument is rinsed in a collection via
clinical laboratory for processing.

Computer-aided detection systems that analyze digital information (typically images) from Papanicola
slides taken from samples of cells of the female genital tract to detect abnormalities. They may either
information or use information provided by digital systems. These systems typically consist of a digitiz
import digital information, a computer capable of using appropriate algorithms, and a display and/or p
detected abnormalities in the genital tract cells. Some systems may include capabilities of archiving a
of view and annotated digital images of pathology scanned slides. Female genital tract Papanicolaou s
aid detection systems are used mainly in cytological screening or re-screening of a malignant and pre
the female genital tract.

Measuring instruments designed to measure the frequency of electric signals in one or more different
hertz to several gigahertz. These instruments usually consist of an electronic unit including controls, a
cables and probes appropriate to perform the measurement. The counters may also include computer
process the signals and outputs that permit recording, printing, and/or further processing of the result
are also used to measure time and/or the period of the signals as an inverse relationship to frequency.
Disposable surgical ports used as an adjunct to minimally invasive abdominal surgery (i.e., laparoscop
preserving peritoneum isolation and pneumoperitoneum. These ports are designed to permit the surg
into the abdominal cavity (e.g., using a pneumatic sleeve) through an incision smaller than normally r
open laparotomy. Surgical hand-access ports usually include an adhesive attachment to the skin to ke
components (e.g., retractors, blood/fluid absorbing materials). In this scenario, the port acts as a seal
surgeon to manually manipulate organs or instrumentation from within the abdominal cavity.

Grafts obtained from donors, which are intended to replace an area of a patient's diseased or injured s
obtained from the body of the same person (i.e., autograft), from another person (i.e., allograft, typica
less frequently, from a different species (i.e., xenografts, typically from pigs). Biological skin autograft
through a device (i.e., dermatome) that cuts slits in the graft allowing expansion to cover a larger area
intended for permanent use in the healing of extensive skin losses, including large wounds and burns.
xenografts are only intended for temporary use (e.g., a few days).

Grafts produced artificially (i.e., synthetically), which are intended to replace an area of a patient's dis
These grafts are typically a two-layer structure: an external layer strong enough to be sutured on the
as artificial epidermis), which consists of a silicone film intended to control wound moisture flux and b
an internal layer (i.e., the skin regeneration template, also known as artificial dermis) that includes typ
silicone layer is removed after 14 days and frequently replaced with a thin autograft or with an epider
laboratory from the patient's own epithelial cells when the internal layer has induced the synthesis of

Photometers in which the sample is aspirated into a flame, and the thermally excited atoms emit light
wavelengths. The intensity of the light emitted at one of these wavelengths is a measure of the amou
present. These instruments consist of a burner, a nebulizer, a narrow band-pass monochromator, and
Flame photometers are used for determining some metal ions, usually sodium, potassium, and lithium

Photometers that determine the absorbance or transmission of the light energy transmitted through a
fixed (typically, 40 nm) bandwidth. Their principal components are a stable light source, broadband fi
tubes for samples, a photodetector, appropriate electronics to process the detector signal, and a mea
results. These instruments have clinical applications primarily for the quantitative analysis of biologic
enzymes or drugs and their metabolites in specimens.

Filter photometers designed for automated assays, the most sophisticated of which are monochromat
performed in automatic colorimeters are based on simple colorimetry tests.
Filter photometers designed for manual assays. These instruments are used in handling a small numb
special diagnostic purposes. Manually operated, portable filter photometers are usually simpler and le
conventional filter photometers.
Filter photometers that use a light source that directs the light through a suspension (e.g., containing
photodetector positioned to measure the undeviated light from the suspension. These instruments ar
scattered light from reaching the photodetector. Usually, turbidimeters accept a larger band pass than
photometers.
Filter photometers that use a photomultiplier tube detector with a photon counter to detect and quant
emitted from a chemiluminescence or bioluminescence reaction. These instruments do not use a ligh
substance under analysis.
Hematology analyzers, most of them automated, that count the number of immature red blood cells (
blood sample. These dedicated analyzers are usually based on fluorescence quantification of reticuloc
cytometry techniques; automated reticulocyte analysis can also be performed using automated cell-c
analyzers based on nonfluorescent measurements. Automated methods improve the precision of retic
of these analyzers allow for semiquantitative assessment of reticulocyte RNA level and derivation of a
index (RMI). Some manual reticulocyte analyzers include an ocular disk (i.e., Miller disk) to facilitate co
high degree of inaccuracy in the manual reticulocyte count, owing to error and lack of reproducibility.

Floor centrifuges in which maximum speed is usually about 6,000 rpm (sometimes up to 10,000 rpm).
primarily used to centrifuge blood or precipitates; they cannot reach sufficient speed to adequately se
particles (e.g., viruses) or macromolecules or to perform density gradient centrifugation.

Floor centrifuges which usually operate at maximum speeds of 10,000 to 25,000 rpm and are refrigera
chamber. These centrifuges are mostly used to collect microorganisms, cells, cellular debris, and prec
effectively sediment viruses and cellular organelles.
Tabletop centrifuges in which maximum velocity is usually about 6,000 rpm (sometimes up to 10,000
centrifuges are used primarily to compact or collect small amounts of substances that sediment rapid
cells); they cannot reach sufficient speed to adequately separate ultrasmall particles (e.g., viruses) or
perform density gradient centrifugation.
Low-speed tabletop centrifuges which are refrigerated to cool the rotor chamber.
Nonrefrigerated low-speed tabletop centrifuges used to centrifuge solutions of suspended red blood c
agglutination and promoting the formation of packed cells at the bottom of the tube that remains duri
step of manual cell washing. Most blood bank centrifuges have a timer connected to the motor that a
mechanical or electric brakes; refrigeration is an available option in some models.

Nonrefrigerated low-speed tabletop centrifuges used to separate small sample volumes, usually from
samples from pediatric patients. These centrifuges can operate at up to 13,000 rpm and are used pri
blood or precipitates.
Nonrefrigerated low-speed tabletop centrifuges designed with a crank and gears to produce the requi
manual effort. These centrifuges are designed for field use or use in facilities where the electric suppl
driven centrifuges are used for basic laboratory tests.
Tabletop centrifuges which usually operate at maximum speeds of 10,000 to 25,000 rpm and are refri
rotor chamber. These centrifuges are mostly used to collect microorganisms, cells, cellular debris, and
also effectively sediment viruses and cellular organelles.
Tabletop centrifuges which usually operate at speeds of 30,000 to 120,000 rpm and relative centrifuga
over 800,000 gravities. Ultracentrifuges must be refrigerated because air friction created at ultrahigh
that could decompose the components being centrifuged. These devices are used for lipoprotein sepa
viruses, enzymes, and blood fractions for analysis and make possible the fractionation of DNA and RN
structures and functions within the cell.

Gas chromatography systems in which a nonvolatile liquid coating on the wall of the chromatographic
capillary column) is used as the stationary phase.
Gas chromatography systems in which a solid packed in a glass, plastic, or metal tube (i.e., a packed c
stationary phase.
Chromatography systems in which the separation process of the mixture of compounds is accomplishe
usually water or an organic solvent (i.e., the mobile phase) through a column of stationary phase. Sep
the relative solubility of the solutes in the two phases and their interaction with the stationary phase.
can be connected to these devices instead of a detector.
Liquid chromatography systems in which the stationary phase is a gel coated on a thin substrate (e.g.
systems include the plate or sheet holding the stationary phase, a closed container used to enclose th
mobile phase, a syringe or micropipette (i.e., spotting device) used to deliver a sample as a spot or st
visualization chamber, and a detector (usually a densitometer).

Liquid chromatography systems in which a solid packed in a glass, plastic, or metallic tube (i.e., a pac
the stationary phase.
High-pressure packed-column liquid chromatography systems in which the packing of the column is m
material, usually a resin. In these systems, the interactive solid has permanently bonded ionic sites an
electrostatic interaction.
High-pressure packed-column liquid chromatography systems in which the packing of the column is m
microparticulate silica gel. The functional groups of the stationary phase may be polar relative to thos
(i.e., normal bonded-phase chromatography) or, more usually, nonpolar (i.e., reverse bonded-phase ch

Chromatography columns fabricated by coating their inner walls with a thin film of liquid as the station
capillary columns use fused-silica, stainless steel, or glass tubes of 0.2 to 0.6 mm in inner diameter an
length. Capillary columns are very efficient but have a relatively low sample capacity. These columns
that use gas as the mobile phase (gas chromatography systems).

Chromatography columns filled with uncoated particles or particles (e.g., silica, alumina) that have be
stationary phase. Most packed columns use stainless steel or glass tubes of 10 to 40 mm in inner dia
length. These columns are used in both gas and liquid chromatography systems.

Packed chromatography columns in which the stationary phase is chemically bonded to the surface of
using a silica ester or a silicone polymeric linkage. Depending upon the relative polarities of the statio
phases, these columns are classified as normal bonded-phase chromatography columns and reverse b
chromatography columns. Most bonded-phase columns use stainless steel or glass-lined stainless ste
in inner diameter and 5 to 150 cm in length. These columns are used in high-pressure liquid chromat

Packed chromatography columns in which the stationary phase is made of a porous solid material, usu
either cationic or anionic groups are attached. Most ion-exchange columns are made of stainless stee
columns are used in high-pressure liquid chromatography systems.
Microscopes in which the specimen is viewed by being placed in a light path (which may be white ligh
visible wavelengths, ultraviolet light, or, less frequently, infrared light). These microscopes include a
objectives, condensers, and illumination systems.
Laboratory light microscopes that illuminate the object axially with white light so that the object appe
background. The great majority of microscopic specimens are stained, thin preparation sections, whos
details can be recognized using Brightfield microscopes. Depending on complexity, these microscope
the clinical (e.g., urinalysis, hematology), general, and/or research laboratories.
Laboratory light microscopes that illuminate the specimen only from oblique angles, so that it appears
background. Flagella, spirochetes, bacteria ,and similar specimens stand out clearly. Most Darkfield m
configured for Brightfield and/or phase-contrast observation. These microscopes are used in microbio

Laboratory light microscopes in which the use of polarized light enhances contrast and makes visible d
difficult to see, especially in the analysis of anisotropic or birefringent specimens. As a result of destru
contrast or color results, they can provide information on the condition and structure of the specimen.
microscopes can also be configured for Brightfield and/or phase-contrast observation. These microsco
microbiology (fungi are birefringent), cytology (wet mounts) and in urinalysis (birefringent crystals suc

Laboratory light microscopes that convert optical path differences in the object to intensity difference
may be accomplished by interference between light that passes through the object and light that follo
path. The most frequent method in current use (differential interference contrast of DIC) polarizes and
the source in two beams; these two beams, traveling in slightly different directions, pass through the
recombined. The optical path differences are then seen as differences in intensity and color (optical c
microscopes enable live specimens or unstained thin sections with very good contrast and are used in
hematology, and cytology.

Operating microscopes designed using combinations of couplers, objectives, lenses, and body tubes f
surgery. The illumination system of these microscopes usually includes special illuminators (e.g., slit,

Operating microscopes with high mobility and flexibility, designed using combinations of couplers, obj
body tubes for specific use in neurosurgery.
Operating microscopes with slim bodies designed using combinations of couplers, objectives, lenses, a
specific use in gynecologic (e.g., fallopian tubes) surgery. Gynecologic microscopes may have an inde
be attached to a gynecologic/obstetric table or chair.
Operating microscopes with high mobility and flexibility, designed using combinations of couplers, obj
body tubes for specific use in hand and plastic surgery.
Light microscopes used to magnify small structures and specially suited for diagnosis, postoperative e
check-ups that require high magnification or adjustable focusing. Examination microscopes typically c
microscope mounted in an articulated arm, usually attached to an examination chair or mounted to a
examination microscopes are used in doctor offices for dermatology, ophthalmic, otolaryngology, and
frequently in minor surgery procedures.

Microscopes with a monochromatic light source that is delivered from a scanning laser. The performan
microscopes is better in terms of optical resolution, depth contrast, and sensitivity of detection than c
microscopy. Scanning-laser microscope images are displayed on high-resolution video monitors. Two d
used in scanning laser microscopes: using ultrasound waves and using a focused point of laser light. M
microscopes are equipped with video capabilities and are computer controlled.

Mercury thermometers that have a long, thin bulb that is placed under the tongue. Oral thermometer
sensitive type of mercury thermometers used in patients. Oral mercury thermometers are used to tak
measurements as primary diagnostic indicators.
Mercury thermometers that have a large, pear-shaped bulb which helps keep them in place. These th
somewhat sturdier than the oral type and are less easy to damage. Rectal mercury thermometers are
temperature measurements as primary diagnostic indicators.
Mercury thermometers that have a short, stubby bulb and are considered safest with children, but are
considered accurate enough for adults. These thermometers are designed for use in the armpit, but m
mouth or rectum. Axillary thermometers usually require a longer time to record temperature than oth
thermometers. Axillary mercury thermometers are used to take periodic temperature measurements
indicators.

Mercury thermometers used in clinical laboratories. Most laboratory mercury thermometers are used
operate within the prescribed temperature limits (e.g., water baths, heated cells, refrigerators) or that
liquids, gases, semisolids) have reached a desired temperature.
Electronic thermometers that include sensors that convert changes in temperature in heavy metal oxi
electrical resistance variations, or sensors that convert variations of temperature at the junction of tw
(thermocouples) into electric voltage variations. The variations in resistance or voltage are in turn con
readings and displayed.
Laboratory monitors designed for continuous measuring and display of the internal temperature of lab
These monitors typically consist of an external central unit including electronic circuitry and a digital d
temperature-sensing probes located inside a clinical laboratory device (e.g. freezer, refrigerator, incub
immersed in liquids, semisolids, or gases while stored, or undergoing some physical or chemical proce
monitors include an additional probe to measure the environmental temperature, displaying both the
equipment and the ambient temperature continuously.

Thermometers designed to measure temperature using liquid crystal (typically esters of cholesterol) s
plastic strip. The strips are placed on an object; the heat of the object alters the molecular structure o
reversibly and in a reproducible way as a function of the temperature. Liquid crystal thermometers are
measure the temperature on the skin and/or on the surface of laboratory specimen containers.

Devices that are used to determine, by temporary insertion and trial reduction, the correct prosthesis
the permanent prosthesis. Trial prostheses are not implants.
Trial prostheses that are used to determine the prosthesis size of the femoral component of the knee j
Trial prostheses that are used to determine the prosthesis size of the patellar component of the knee j
Trial prostheses that are used to determine the prosthesis size of the tibial component of the knee join
Monitors designed to determine the patient absorption of irrigation liquid that are mainly used during
These monitors typically display fluid pressure setting, fluid deficit, and distension fluid loss; the moni
on non-invasive methods that measure the amount of delivered irrigation solution and compare it with
returned to the container (e.g., using a scale to measure the inflow and outflow volume). The devices
portable electromechanical monitoring device, typically mounted adjacent to the procedure main unit
hysteroscopic) on an intravenous pole. Fluid absorption monitors are typically used to protect the pati
absorption of irrigation fluid during large ablative surgical hysteroscopy procedures; some monitors ca
diagnostic and/or surgical cystoscopic and arthroscopic procedures.
Information systems designed to electronically transmit and receive images and consultative text betw
These systems typically consist of an image-capture station and a receiving station; the image-captur
personal computer (PC) with a high-speed modem, a high-resolution viewing monitor, and an image-c
the receiving station typically consists of a modem, a PC, and a high-resolution image monitor. Teleme
systems link hospital departments to other hospitals, physicians' homes, or clinics by means of teleph
networks, and microwave or satellite transmission; they facilitate rapid diagnosis and consultation by
storage capacity of these systems is typically fewer than 1,000 images. Telemedicine information syst
large storage systems and file controllers of picture archiving and communication systems.

Telemedicine information systems used to electronically transmit and receive images of microscopic p
and/or specimens and consultative text to and from one or more remote sites. Pathology telemedicine
used by small remote hospitals and in emergency situations to transmit cytology/histology images to
larger hospital or laboratory for review, interpretation, and/or consultation.

Mechanical eye shields that usually consist of a plastic or metallic eye cover attached to a tie tape fas
to facilitate their retention. These shields protect the eyes from light and injuries and are mostly used

Shields used for protection from laser radiation. These shields are used to attenuate, reflect or otherw
and are manufactured according to the wavelength of the laser radiation they are intended to shield.

Thyroid x-ray shields adjusted around the throat as a soft padded fabric. These shields are used by he
and/or the patients during x-ray examinations and procedures.
Thyroid x-ray shields that are wall, ceiling, or table mounted. Most of these units offer thyroid and eye
patient while performing C-arm, angiographic, and other x-ray procedures.
Shields used for protection from nuclear radiation (e.g., radioisotopes). These shields are intended to
radiation during nuclear medicine procedures.
Radiation shields designed for use on work benches in clinical laboratories. These shields are usually m
include a lead-glass transparent window. Work bench nuclear radiation shields are used to provide pro
handling radioactive materials.
Radiation shields that usually consist of a lead cylinder, sometimes with a lead-glass window, in which
radioisotopes are enclosed. These shields may include a lead-glass window for viewing the liquid leve
opening in the cover for the insertion of a syringe to withdraw the radioisotope.
Radiation shields that usually consist of a protective screen including a transparent lead-plastic sectio
shields are designed to provide visibility while protecting healthcare personnel from radiation nuclear
Nuclear radiation barrier shields may be a stand-alone fixed or mobile panel or be attached to a wall,
mounted articulated arm.
Nuclear radiation shields designed to protect normal oral tissue during oral cavity (e.g., tongue) tumo
Intra-oral radiation shields are molded for individual fit and made of resins and/or metals capable of a
These shields may also be used during neck or head radiation procedures
Shields used for thermal protection against the loss of heat by the patient's body.
Barriers (i.e., shields) designed to protect something (e.g., a healthcare worker, a patient) from flying
like substances (i.e., splashes, sprays) that may be harmful and/or pose a risk for contamination, such
hazardous chemicals. Various forms of shields are included in this category, such as moderate-size ba
worn over the face or smaller-size barriers that are designed to be attached to a particular device suc
endoscope. Garments intended to protect against splashes are not included in this category - see "Go
Protection."

Barriers (i.e., shields) designed to be attached to a syringe and used to protect against flying masses
substances (i.e., splashes, sprays) that may be harmful and/or pose a risk for contamination. These sh
protect the healthcare worker as well as the patient. Specific designs of syringe splash shields are ava
irrigation - these devices (e.g., protective domes that are fitted around the wound) are designed to pre
contamination from bacteria, etc., during wound irrigation/cleansing procedures.

Automatic electronic sphygmomanometers that measure by the use of sound and detection of blood s
(Korotkoff sounds).

Automatic electronic sphygmomanometers that measure by detecting and transducing both blood sou
(Korotkoff sounds) and air pressure fluctuations (i.e., auscultatory and oscillometric measurements). T
from the other for removing interferences from artifact signals.
Physiologic recorders designed to measure and record data and graphics of the physical and/or functio
the heart. Cardiographs are usually intended to record one or several of the following data and graphi
potential caused by the electrical activity of the heart muscle (e.g., electrocardiographs and vectorcar
biomagnetic field caused by the electrical activity of the heart muscle detected externally to the body
thoracic impedance due to heart activity (i.e., impedance cardiographs); (4) movements and forces ex
(e.g., ballistocardiographs); (5) ultrasonic signals reflected by the heart (i.e. echocardiographs); and (6
the heart movement (i.e., phonocardiographs). Cardiographs are intended for evaluation of recorded i
conditions, they are not intended for real-time assessment of those conditions. Cardiography monitors
systems (e.g., MRI, PET) are also used to evaluate heart conditions.

Multichannel electrocardiographs (ECGs) designed for recording the variations of the electric potentia
electrical activity of the heart muscle, usually detected at the body surface from two or more leads sim
cannot perform any interpretation of the results. The instrument usually records ECG signals automati
simultaneous diagnosis of several cardiac signals. Instruments that can perform the measuring of the
multiple cycles of the signal are also available. Non-interpretative multichannel ECGs are used to diag
abnormalities, determine the response to drug therapy, and reveal trends or changes in the heart func
electrocardiographs are not intended for a real-time assessment of the electrocardiogram or other car
Multichannel electrocardiographs (ECGs) designed for recording the variations of the electric potentia
electrical activity of the heart muscle, usually detected at the body surface from two or more leads sim
perform a computerized automated measuring and interpretation of the ECG by averaging multiple cy
reduce noise. These instruments include a computerized unit that can process the average of the ECG
those signals with an internal algorithm, and print out the ECG along with an interpretation that can b
tool by the cardiologist. Multichannel ECGs are used to diagnose cardiac abnormalities, determine the
therapy, and reveal trends or changes in the heart function; they provide an additional tool for identify
ventricular tachycardia. Multichannel signal-averaging electrocardiographs are not intended for a real
the electrocardiogram or other cardiac conditions.

Peripheral infusion vascular catheters that incorporate a plastic shielding mechanism that enables the
the introducer needle into the shield after withdrawing the needle from the vein; the shield locks over
protective catheters are used for accidental needlestick prevention during peripheral intravenous acce

Encephalographs designed for recording the variations of the very weak biomagnetic fields caused by
of the brain detected externally to the body. The magnetic field is typically picked up with supercondu
gradiometers) externally to the body and then detected with very sensitive sensors, such as an array
quantum interference devices (SQUIDs). The SQUIDs are housed in a cryogenic container (known as a
configured as a helmet and usually filled with liquid helium and where the patient places their head. A
signal-to-noise ratio the detected signals are amplified and displayed as magnetic field and/or electric
equipment also includes a computerized unit with dedicated software (a workstation) to process the m
magnetocardiographs should be used inside magnetic shielded locations. Magnetoencephalographs a
accurate localization of areas associated with brain disorders, such as epilepsy and schizophrenia and
are not intended for real-time assessment of the brain conditions.

Graphic recorders of the electrical activity from the smooth muscle of the stomach. These recorders i
placed internally through invasive procedures or externally on the skin and appropriate amplifiers. Ele
be used in the investigation of the physiology of the gastrointestinal tract and gastric disorders.

Evoked potential (EP) physiologic recorders designed for detecting, amplifying and recording the brain
to visual external stimuli. These recorders typically consist of detachable electrodes usually placed on
potentials originated in the cerebral cortex); signal amplifiers; filters (to suppress interference); memo
optical/magnetic disc); and a display. Visual EP recorders usually include capabilities to deliver externa
reversible checkerboard patterns, flashlights) at an appropriate repetitive level to elicit the bioelectric
recording. Visual EP recorders are mainly used in studies intended to diagnose ophthalmic diseases, u
the absence, attenuation, or increase in the time response (i.e., latency) of the peak response after th
Recorders with additional capabilities to perform specialized forms of visual EP responses (i.e., electro
electroretinography) are available; independent recorders intended only for these purposes are also a
Evoked potential (EP) physiologic recorders designed for detecting, amplifying and recording the bioel
central nervous system (brain and/or spine) in response to electric stimuli applied on or through the s
nerve fiber. These recorders typically include signal amplifiers; filters (to suppress interference); mem
optical/magnetic disc); a display; and detachable electrodes that are usually placed on appropriate loc
by anatomic landmarks (e.g., standard EEG positions on the head, midline of the spine). Cephalic bipo
relatively free from noise and are preferred for routine clinical use. EP recorders usually include capab
external or transdermal electrical stimuli appropriate to elicit the bioelectric response needed for reco
EP recorders are used in clinical studies of the spinal cord and upper and lower limb pathways and in a
status of comatose patients.

Plethysmographs designed for non-invasive measuring and recording of data and graphics (i.e., a plet
volume and variations in the volume of the brain due to the presence and flow of blood in the vascula
measurement of the volume waveform and amplitude. This technique is known as segmental plethysm
pulse volume recording (PVR) plethysmography, and pneumo plethysmography. These devices include
measuring in the scalp or neck. They are used in assessing diseases related to the cerebral blood circu

Plethysmographs designed for non-invasive measuring and recording data and graphics (i.e., a plethy
volume and variations in volume of the lower limbs due to the presence and flow of blood in the vascu
the measurement of the volume waveform and amplitude. This technique is also known as segmental
pulse volume recording (PVR) plethysmography, and pneumo plethysmography. These devices typical
measures, records, and displays the results (usually in graphic format) and compression cuffs, sensors
volume), transducers, and signal amplifiers. The sensors are applied to several points (e.g., thigh, calf
pressure changes in the bladder of the cuff wrapped around the limb. These changes reflect changes
which is a direct reflection of changes within the limb volume. Lower limb segmental plethysmographs
peripheral circulation and to assist in diagnosing diseases/disorders related to venous blood flow (e.g.
thrombosis).

Antepartum physiologic monitors designed for continuous measurement and display of information of
including the fetal heart rate (FHR); other fetal cardiac parameters; and, frequently, fetal movement a
mother's uterine contractions. These units are hard-wired to the mother at the bedside. These monito
central unit with electronic circuits that can process signals from the sensors (e.g., electrodes) placed
mother's abdomen using an indirect, noninvasive method. Bedside antepartum monitors are intended
offices, clinics, and at home prior to labor (i.e., antepartum); telemetric fetal monitors are also availab

Physiologic monitors designed for continuous measurement and display of information about the fetus
fetal heart rate (FHR), other fetal cardiac parameters, and frequently fetal movement and mother's ut
These units are hooked up to the fetus and/or mother at the bedside during childbirth. These monitors
central unit with electronic circuits that can process signals from the sensors (e.g., electrodes) placed
abdomen and/or directly on the fetal scalp (or other exposed fetal skin surface) and measure the chan
the uterus. Most intrapartum fetal monitors have additional capabilities, including fetal and maternal E
Intrapartum bedside fetal monitors are used during labor and delivery to assess the progress of labor
the mother and fetus.
Graphic recorders including sensors and amplifiers for measuring and recording two or more vital sign
electrocardiogram and blood pressure). These recorders are commonly used in patients to assess the

Physiologic graphical recorders designed to simultaneously collect and record several physiologic para
and/or noninvasive blood pressure, heart rate) during surgical procedures when general anesthesia is
typically consist of an electronic unit, amplifiers, and sensors appropriate for the parameters to be ass
physiologic graphical recorders are used for retrospective analysis and/or as evidence of the values an
physiologic parameters during surgical procedures.

Graphic recorders used for collecting and recording data of ventilation gases (e.g., oxygen, carbon dio
gaseous agents (e.g., nitrous dioxide, halothane). These recorders are used in the operating room for
surgical procedures using general anesthesia.
Graphic recorders used for collecting and recording data on carbon dioxide content during the inspirat
the form of a graph (a capnogram). These recorders usually display both the carbon dioxide waveform
data (e.g., end-tidal carbon dioxide, respiration rate).
Graphic recorders used to measure and store temperature. These recorders use a temperature senso
thermistor) to detect and transduce (into electric signals) the values of temperature.
Testers designed to determine the electrical conditions (state of charge and/or capacity of being charg
batteries (e.g., nickel-cadmium, lead-acid, lithium). These testers usually can identify battery defects,
and determine the charge energy required and the useful ampere-hours in the battery. Some battery t
automatically recognize the type of battery and analyze the battery accordingly using preprogrammed
current and/or voltage.

Devices designed both to determine the conditions (state of charge and/or capacity of being charged)
electrical charge to rechargeable batteries (e.g., nickel-cadmium, lead-acid, lithium). These devices
the capabilities of battery chargers and battery testers.
Devices designed to determine the electrical conditions (state of charge and/or capacity of being char
capacity of rechargeable batteries (e.g., nickel-cadmium, lead-acid, lithium). These devices restore the
rechargeable batteries using a controlled charge and/or discharge cycle, which reverses some chemic
battery, such as crystalline formation on the cell plates (memory) of nickel-cadmium batteries. Most te
battery defects, display deficiencies, and determine the charge energy required and the useful amper
Some battery testers/reconditioners can automatically recognize the type of battery and restore and/o
accordingly using preprogrammed values of electric current and/or voltage.

Audio recorders designed to store sound information on magnetic tapes. These recorders usually cons
electromechanical device that includes an integral microphone and/or external jacks to attach microph
controls, recording and erasing heads, and an attached open-reel tape memory or an external slot to p
recorders usually have playing capabilities, either through integral amplifiers and speakers or by prov
reproduction systems. Tape audio recorders are available in tabletop, rack mounted, and portable ver

Ambulatory electrocardiographic tape recorders where, instead of capturing every heartbeat, the reco
patient activated. These event recorders are typically used for a long period of time (i.e., one or two m
patient activities.
Audio recorders designed to store sound information in magneto-optical discs. These recorders usually
electromechanical device that includes an integral microphone and/or external jacks to attach microph
analog/digital converter; data processors; a magneto-optical writer (a device that de-magnetizes a sp
while laser writing); controls; and a magneto-optical disk memory. The recorders usually have playing
laser reader), either through integral amplifiers and speakers or by providing output to sound reprodu
Magnetic-optical audio recorders are available in tabletop, rack mounted, and portable versions.

Encephalographs (EEGs) designed for recording the variations of the electric potential (i.e., data and w
the electrical activity of the brain that include integral microcomputers and/or can interface with othe
systems. These recorders consist of a main unit that includes a large capacity memory (e.g., a magne
disk, electronic drive), signal processors, and appropriate connectors to the output of standard EEGs, o
EEG monitors, polysomnographs, sleep/awake recorders) or directly to a head box attached to a set of
recorder works with one or more dedicated software packages that can perform a variety of computer
brain mapping, sleep studies, and evoked potential responses according to the user needs. Some reco
video EEG capabilities. Computerized EEGs are mostly used to help in the diagnosis of neurological dis
sleep disorders) and to assist in localizing and assessing tumors and lesions inside the cranium.

Recorders designed to store large amounts of digital data, video, and/or audio signals in an optical dis
[DVD]). These recorders usually consist of an electromechanical device that includes external connect
video cameras or other sources of video, audio signals (e.g., cable boxes, camcorders) or data; an opt
a red light laser (typically 650nm wavelength); data processors; controls; and an slot to place a DVD. T
include an analog/digital converter and other accessories such as microphones. DVD recorders usually
capabilities (using a laser reader) both for video and audio signals, either through integral amplifiers,
loudspeakers (typical in portable players) or by providing output to video reproduction systems (e.g.,
sets). Most DVD recorders have capabilities to play audio and video optical compact discs (CDs). Som
output for high-definition television sets (i.e., up-conversion to 720 or 1080 lines). DVD recorders are a
rack mounted, and portable versions.

Electrocardiographs (ECGs) designed for recording the variations of the electric potential caused by th
the heart muscle in ambulatory patients, usually detected at the body surface and typically from three
simultaneously. The instrument usually records ECG signals automatically using an electronic storage
may be also used) worn by the patient that is usually attached to chest surface electrodes. Some amb
analyze the signals in an integral processor that includes dedicated software. Also available are ambu
that analyze the signal at the time that it is recorded, typically using microprocessors (i.e., real-time re
recorders that make the analysis when processing the recorded signal (i.e., retrospective recorders). A
usually worn by the patient for a period of 24 to 48 hours; they are used to detect transient cardiac pr
heat rate, arrhythmia), after myocardial infarction, or other problems of possible cardiac origin (e.g., d
Ambulatory ECGs are not intended for a real-time assessment of the electrocardiogram or other cardia
Ambulatory electrocardiographs (ECGs) designed for continuous recording of the variations of the elec
by the electrical activity of the heart muscle, usually detected at the body surface typically from three
simultaneously. The instrument usually records ECG signals automatically using an electronic storage
may be also used) worn by the patient in which the recording function is always active and includes d
surface electrodes. The recorded signals are analyzed in a processor that includes dedicated software
ambulatory ECGs that analyze the signal at the time that it is recorded, typically using microprocessor
recording), and recorders that make the analysis when processing the recorded signal (i.e., retrospect
Continuous ambulatory electrocardiographs are usually worn by the patient for a period of 24 to 48 ho
detect transient cardiac problems (e.g., variable heart rate, arrhythmia), after myocardial infarction, o
possible cardiac origin (e.g., dizziness, palpitations). Continuous ambulatory ECGs are not intended fo
assessment of the electrocardiogram or other cardiac conditions.

Ambulatory electrocardiographs (ECGs) designed for recording the variations of the electric potential
activity of the heart muscle, usually detected at the body surface typically from three to twelve leads
a cardiac event. The instrument usually records ECG signals using an electronic storage device (or tap
activated by the patient. The electronic storage device usually includes detachable chest surface elec
signals are analyzed in a processor that includes dedicated software. Event ambulatory ECGs are usua
for a period of several weeks during normal activities; they are used to detect transient cardiac proble
heart rate, arrhythmia), after myocardial infarction, or other problems of possible cardiac origin (e.g.,
Ambulatory event ECGs are not intended for a real-time assessment of the electrocardiogram or other

Ambulatory electrocardiographs (ECGs) designed for continuously recording the variations of the elect
the electrical activity of the heart muscle in ambulatory patients, usually detected at the body surface
detectors. The instrument records ECG activity automatically using one detector (usually a sodium iod
detection of left ventricular activity, and another detector (usually of cadmium telluride) placed over t
monitor background activity. These detectors are usually positioned using a gamma camera and held
garment. The recorded signals are analyzed in a processor that includes dedicated software. These ele
worn by the patient for several hours and are intended to assess the left ventricular function period du
order to help detect heart diseases, including silent ischemia. Ventricular function ambulatory ECGs a
real-time assessment of the electrocardiogram or other cardiac conditions.

Electronic data storage recorders that include a noninvasive sphygmomanometer (e.g., oscillometric,
recorders are commonly used in ambulatory patients for assessing blood pressure variations during no

Electroencephalographs (EEGs) designed for recording the variations of the electric potential caused b
of the brain, usually detected on the scalp in ambulatory patients. These instruments consist of a mai
electronic storage device (tape recorders may be also used) worn by the patient that automatically pr
cable that is connected at the distal tip to a set of electrodes fixed on the scalp in an array of standard
electrodes and leads transmit the bioelectrical signals to the recorder, usually through micro amplifier
capable of reproducing their characteristics in an amplitude versus time graph (i.e., an electroencepha
provide a spectral analysis of the signals. Ambulatory EEGs, known as AEEGs, are mainly used for peri
to confirm the diagnosis of epilepsy, assessment of seizures, and to record other neurological diseases
Electronic data storage recorders that include catheters (e.g., esophageal, biliary) and an electronic a
basic types of recorders: real time and retrospective, according to the point at which analysis is perfor
are commonly used in ambulatory patients to correlate pH data (e.g., data related to gastroesophagea
symptoms.
Electronic data storage recorders that include sensors and amplifiers for measuring and recording two
simultaneously (e.g., electrocardiogram and blood pressure). These recorders are commonly used in p
physical conditions.
Systems that use computing devices (e.g., computers, monitors, digital storage units) to display, proc
data usually obtained through an analog-to-digital converter from a TV camera or from a charge-coup
These systems are capable of processing the image data for hard-copy printing on a laser imager, arc
image (e.g., on an optical disk), and/or coupling to a hospital picture archiving and communication sys
Digital imaging systems are frequently used to add digital capabilities (upgrade) to existing imaging s
radiographic or fluoroscopic units and systems)._x000D_

Examination/treatment tables designed to maintain a fixed, nonadjustable, height and body position.
have a padded top surface covered with dirt and stain resistant material (e.g., vinyl) to facilitate clea
decontamination and to increase the useful life of the table. Fixed examination/treatment tables are u
(e.g., for outpatient examination), doctor's offices, and in other healthcare facilities for general, nonsp
and/or minor treatments.

Examination/treatment tables designed to allow changes in height and/or position (i.e., tables that are
adjustable examination/treatment tables are divided into three or more hinged sections (e.g. head, bo
designed to be raised and lowered by mechanical or hydraulic systems using manual or electric contro

Operating tables designed for performing arm and hand surgical procedures. Most of these tables inc
which permits simultaneous access to the operative site by several members of the surgical team. So
also include drain and/or prepping pans. Upper-extremities operating tables are usually portable or m
moved to the examining table in places such as emergency rooms.

Orthopedic operating tables designed for optimal patient positioning and surgical team access while p
surgical procedures. These tables usually include a base, pedestal, and an upper-body radiolucent rota
capabilities up to 360 degrees. The table allows intraoperative fluoroscopy. Spinal operating tables are
cervical spinal surgery, including surgical procedures for correction of deformities (e.g., osteotomies, l

Operating tables that include controls for horizontal slow speed adjustment of patient's position. Mos
clamps and other positioning aids. These tables are used in surgical procedures (e.g., neurologic, oph
performed under the microscope by means of handheld instruments.
Tables designed with a configuration and/or made of materials appropriate for performing patient ima
radiographic, ultrasonic). Most imaging tables are height and position adjustable using manual or pow
tables support the patient's body in adequate position during the imaging procedure.

Imaging tables fabricated with nonmagnetic materials in which vertical, lateral and longitudinal move
controlled either manually or automatically. Magnetic resonance imaging (MRI) tables facilitate the us
may include appropriate mechanisms for positioning (e.g., extension of the lumbar spine, rotation of t
These tables support the patient's body in adequate position during MRI procedures.
Imaging tables with cut-out, removable, or drop sections, specially designed for easy positioning of pa
unobstructed access to the body area (e.g., left thorax) to be scanned. These tables support the patie
ultrasound scanning procedures (e.g. echocardiography).
Instrument tables that include one or more fixed or removable top trays to accommodate surgical inst
are designed for use during surgical procedures, enabling surgeons to work from both sides of the ope
preventing tip over. In some multitray tables, trays can be rotated to stage the instruments as they a
specific procedure (e.g., neurologic, ophthalmic, cochlear).

Densitometers designed to assess bone density by delivering ultrasonic energy through a targeted bo
be used to obtain bone structural information. These densitometers typically determine bone density
speed and/or attenuation of ultrasound energy usually over frequencies from 0.2 to 0.6 MHz (known a
attenuation [BUA]). Bone ultrasound densitometers are used mainly to determine bone density in the
typically by measuring the heel (i.e., calcaneus) bone.

Electric beds designed to provide alternating pressure to the patient's body. These beds typically inclu
sacks that are cyclically inflated and deflated by an air compressor in such a way that the inflated sac
and the deflated ones give pressure relief to prevent maceration of the patient's skin. Alternating pres
mainly used for treating of patients with burns or decubitus ulcers.

Electric beds designed for periodic or constant turning (i.e., rotate) patients along the vertical axis of t
body alignment. These beds typically include a surface and restraints that are appropriate for use as a
the patient in a fixed position while rotating. Rotation electric beds are intended for unstable trauma p
those who have spinal cord injury; they also may be used for patients who have severe pulmonary dis
decubitus ulcers.

Electric beds designed to combine the capabilities of rocking and rotating beds. These beds can tilt pa
(e.g., 15 degrees) from the horizontal plane, placing them alternately in the Trendelenburg and revers
positions following a rocking motion or rotate patients along the vertical axis of the bed, keeping the b
Rotation/rocking electric beds are mainly intended for immobilized patients (e.g., patients who have u
severe pulmonary problems).

Hydraulic beds designed to permit women to assume more natural delivery positions and minimize th
discomfort and risks during birthing. These beds typically have three sections: backrest, seat, and foo
foot height, and bed height are adjustable, and the foot section can be removed to permit access to th
area. Hydraulic birthing beds lessen the lapse of time associated with transfers between beds, stretch
tables, often allowing the mother to remain in the same bed throughout labor and delivery.

Hydraulic beds designed to permit radiographic and/or fluoroscopic procedures on a patient. These be
radiolucent mattresses and supporting surfaces, raising and lowering mechanisms that do not interve
the radiation source and image intensifiers, and dimensions and clearances that facilitate placement o
under the bed. Radiography/fluoroscopy hydraulic beds are mainly used for bedside procedures using
fluoroscopic units.
Mechanical beds designed to permit women to assume more natural delivery positions and minimize t
discomfort and risks during birthing. These beds typically have three sections: backrest, seat, and foo
foot height, and bed height are adjustable, and the foot section can be removed to permit access to th
area. Mechanical birthing beds lessen the lapse of time associated with transfers between beds, stretc
labor/delivery tables, often allowing the mother to remain in the same bed throughout labor and deliv

Mechanical beds designed to provide a soft surface for the patient similar to that provided by floating
typically include a mattress filled with some appropriate substance, such as air, water, or gel; the mat
permeable to air and water vapor but not to liquids. Floatation therapy mechanical beds are used to tr
at moderate to high risk of developing decubitus ulcers and whose clinical status requires high head e
transfer, and/or ambulation.

Mechanical beds designed for periodic or constant turning (i.e., rotate) patients along the vertical axis
the body alignment. These beds typically include a surface and restraints that are appropriate for use
keep the patient in a fixed position while rotating. Rotation mechanical beds are intended for unstable
particularly those who have spinal cord injury; they also may be used for patients who have severe pu
and/or decubitus ulcers.

Mechanical beds designed to permit radiographic and/or fluoroscopic procedures on a patient. These b
radiolucent mattresses and supporting surfaces, raising and lowering mechanisms that do not interve
the radiation source and image intensifiers, and dimensions and clearances that facilitate placement o
under the bed. Radiography/fluoroscopy mechanical beds are mainly used for bedside procedures usin
or fluoroscopic units.

Cradle mechanical beds designed for child use. These beds have a size appropriate for children; they
configuration resembling a baby cradle, incorporating fixed endrails and movable and latchable sidera
framed canopy. Pediatric cradle mechanical beds restrain children passively, avoiding the risk of patie
easy access to the patient by the staff.
Mechanical beds designed for use by neonates. These beds typically include a plastic or stainless stee
surface that has a permanent, fixed height and contour that is used as the bed and a mechanism for c
newborns by mechanically tilting the bed. Neonatal beds are intended for intensive care (e.g., respirat
infants; some of these beds fit into infant incubators.

Beds designed with a support surface that has a permanent, fixed height and contour. These beds typ
standard mattress; some beds may include fixed, movable, and/or latchable siderails and endrails and
canopy. Beds are widely used in healthcare facilities, both in patient rooms and/or to perform special t
procedures. Dedicated fixed beds intended for pediatric patients and adults are also available.

Fixed beds designed to provide a soft surface for the patient similar to that provided by floating on a fl
typically include a mattress filled with some appropriate substance, such as air, water, or gel; the mat
permeable to air and water vapor but not to liquids. Floatation therapy fixed beds are used to treat pa
moderate to high risk of developing decubitus ulcers and whose clinical status requires high head elev
transfer, and/or ambulation.

Cradle fixed beds designed for adult use. These beds have a size appropriate for adults; they typically
resembling a baby cradle, incorporating fixed endrails and movable and latchable siderails and/or a fa
Adult cradle fixed beds restrain patients passively and avoid the risk of patient falls; they are used ma
severe physical and/or mental conditions.
Fixed beds designed for use by neonates. These beds typically consist of a plastic or stainless steel bo
surface that has a permanent, fixed height and contour. Neonatal beds are frequently attached to dres
trolleys; they may be used for a period up to a few weeks after birth in healthcare facilities, especially
neonate rooms.
Mattress systems that include a mattress consisting of air bladders which inflate and deflate to turn th
side. Control units connected to the mattress regulate the frequency and degree of rotation. These ma
typically used in the care and management of patients who require special pressure relief surfaces (e.
at risk for developing pressure/decubitus ulcers) as well as patients who have or are risk for developin
complications related to immobility.

Radiographic/fluoroscopic chairs with radiolucent headrests that make dental, maxillofacial, and crani
(e.g., pneumoencephalography) easier.
Radiographic/fluoroscopic chairs with radiolucent head- and backrest sections and positioning capabili
head and trunk x-ray procedures in patients with difficulty in swallowing (dysphagia), head and trunk
condition which requires these procedures.
Chairs, usually mobile, with lifting and rotating capabilities to facilitate x-ray and biopsy procedures in
These chairs provide an interface with mammography units and access for biopsy from all positions (e

Portable fixtures into which human waste is excreted and then disposed of via a removable commode
commodes typically consist of a framework (usually metal) that holds a commode pan and may come
capability to add/attach armrests, backrests, and/or a commode seat. Some portable commodes inclu
wheels and/or may be intended for use over fixed commodes. Portable commodes of an appropriate s
support the weight of obese and morbidly obese patients (e.g., bariatric commodes) are also available

Chairs designed to keep patients in an orthopedically correct position and comfortable during prolong
these chairs are reclinable and include footrests and casters. These chairs are used for patient recove
other medical procedures.
Rehabilitation chairs with an adjustable chest rest that permits the pulmonary (e.g., edema, emphyse
seated in a position of maximum comfort and relief.
Chairs designed to assist permanently disabled persons in performing long-term activities that the pe
difficult or impossible to do. Chairs for disabled patients are adjustable in height and may be operated
powered (e.g., electrically). Most of these chairs also include other accessories or restraints according
disabilities.
Mechanical wheelchairs designed for daily use by disabled people. These wheelchairs may include fo
wraparound, cut out) for patient use (e.g., dining, writing), restraints (e.g., safety belt), and other atta
the person's needs and comfort.
Mechanical wheelchairs for daily use by disabled obese patients. These wheelchairs are made with he
wide seats and with maximum capacity of at least 140 kg (300 lb). Some of these chairs also include
(e.g., wraparound, cut out) for patient use (e.g., dining, writing), and other accessories, or restraint, ac
disabilities and comfort.
Mechanical wheelchairs designed for daily use by disabled children. These wheelchairs may include f
wraparound, cut out), and other accessories or restraints according the patients' disabilities and comf
Powered wheelchairs (wheelchairs that are self-propelled, usually by an electric motor) designed for d
people. These wheelchairs may include foot rests, a table (e.g. wraparound, cut out) for patient use (
and restraints (e.g., safety belt), and other attachments according to the person's needs and comfort.

Small pads designed for absorption of milk secretions from the breast between nursing (i.e., breastfee
devices typically consist of small, round pads made of absorbing materials (e.g., cotton, or special pol
inside a brassiere. Nursing pads are intended to keep the breast and clothing dry; they may also provi
nipples and/or prevent brassiere friction on the breast. Nursing pads may be reusable or disposable.

Small pads designed for manual examination of breasts. These pads typically consist of two plastic sh
liquid (e.g., silicon) sealed in between. Breast examination pads are intended to reduce the friction be
and the breast; the pads are mainly used for women's self-examination of the breast (i.e., mammary g

Lithotripters that noninvasively disintegrate stones using focused external shock waves generated an
electromagnetic generators. These lithotripters typically consist of electromagnetic generators where
produced by an electric current conducted through a coil attached to a thin metallic membrane; when
repelled by the magnetic field, a shock wave is generated. Extracorporeal electromagnetic lithotripter
treatment of urolithiasis (i.e., kidney calculi also known as kidney stones).

Lithotripters that noninvasively disintegrate stones using focused external shock waves generated an
piezoelectric generators. These lithotripters typically consist of piezoelectric generators containing an
thousand of ceramic elements arranged on a spherical dish; when short, high-voltage pulses are appli
shock waves are generated at the focal point located at the center of the dish. Extracorporeal piezoele
intended for the treatment of urolithiasis (i.e., kidney calculi also known as kidney stones).

Lithotripters that noninvasively disintegrate stones using focused external shock waves generated an
electrostatic spark discharge (spark-gap) generators. These lithotripters typically consist of electrosta
generators that produce shock waves when an electrical discharge between two electrodes submerge
electrohydraulic) causes explosive vaporization. Extracorporeal spark-gap lithotripters are intended fo
urolithiasis (i.e., kidney calculi also known as kidney stones). Lithotripters using a variant of this meth
electrodes are submerged in a highly conductive solution rather than in water (known as electrocondu
also available.

Lithotripters used through a percutaneous or transurethral approach to locate, view, fragment, and re
devices typically include lithotripter probes, nephroscopes, ureteroscopes, and/or ureterorenoscopes,
pumps, and light sources.
Intracorporeal lithotripters that use a probe containing an oscillating metal end cap driven by an elect
to fragment stones. The probe is composed of an electrohydraulic electrode that is irrigated with salin
spring with a metal end cap and covered with a metal sheath. The probe is powered by an electrohyd
When the probe is discharged, the metal end cap rapidly and repeatedly extends beyond the metal sh
stone, causing it to fragment.

Intracorporeal lithotripters that use a probe driven by compressed air to fragment stones. The probe o
frequency of 12 cycles per second. The tip of the probe is placed directly on the stone, and the oscilla
to fragment.
Telephones designed to be used in patient room settings and to be discarded when the patient leaves
These telephones are usually mounted in special holders attached to the bed.
Point-of-care breath analyzers used to determine the increase in carbon isotope content (e.g., carbon-
usually expressed as a carbon isotope relation, such as the relation of carbon-13 to carbon-12, after a
carbon-13-labeled substrates. These analyzers typically use gas chromatography techniques. Carbon
analyzers are used to assess bacterial overgrowth and colonization in gastroenterology (e.g., determin
for detection of Helicobacter pylori), to measure organ function, and to evaluate digestion and absorp
lipids, and proteins.

Simulators designed for training in the performance of procedures in a beating heart. Beating heart si
of: (1) a movable platform mounted on a table that mimics the pericardial surface of the heart and a m
platform carrying projection wheels that intermittently elevate the platform simulating heartbeats or (
replica of the heart mainly made of plastic materials that include appropriate mechanisms to simulate
motion. Beating heart simulators are used to train surgeons in the performance of cardiac procedures
artery surgery, vascular anastomosis, and sewing of the heart membranes without the use of externa

Single-use sheaths designed as the outer component of a two-part flexible endoscope. These sheaths
working surfaces of the endoscope from contamination; they may include air, water, and suction/biop
parts. The reusable part of the endoscope contains the fiber optics and control devices appropriate for
(e.g., colonoscope, gastroscope, sigmoidoscope). Those sheaths not including channels may be used a
for most models of nasopharyngolaryngoscopes. Endoscope sheaths are disposed of after one use, mi
cleaning and eliminating disinfection during endoscopic reprocessing between procedures.

Chest radiographic units that include a storage magazine, a pair of intensifying screens, a receiving m
transport assembly. The x-ray films are loaded in bulk into the storage magazine, and the transport a
automatic film transport from the storage magazine to the exposure position and directly into a film-re
into a film processor after exposure. Some systems also automatically center between the x-ray beam
units increase patient throughput and minimize film-handling errors; they are mostly used in high-volu
departments.

Dental radiographic units for which the dental film is placed inside the patient's mouth. These units a
crowns and the upper third of the roots of both upper and lower teeth (bitewing image), the full tooth
image), or the masticating surface of the premolars and molars (occlusal image). In these units, the x
located in a cylindrical tube head mounted on an articulating arm positioned according to the view de

Dental radiographic units in which the dental film is placed in an external film cassette. These units a
imaging the maxillofacial region using a rotating x-ray beam (panoramic radiography), which produce
dental arch as a fixed elliptical shape; and/or to obtain images of the complete skull (cephalometric ra
region of interest from various angles. Some extraoral units can produce multilayered transverse ima
and mandibular jaws (cross-sectional tomography).

Chest radiographic units that include an x-ray film and a screen, that are held in a cassette that is ma
cassette holder. In these units, the transfer of the film from the cassette to the x-ray film processor is
the technician.
Systems that consist of a patient support unit (usually one or more tables), an x-ray tube and collimat
support for the x-ray tubes and image receptors (e.g., a cassette holder), and a control panel. These s
perform diagnostic x-ray procedures by obtaining a latent image of the irradiated portion of the patien
converted into a visible image (i.e., a radiograph) using a film or digital image processor. The interpre
by a physician contributes to a useful clinical diagnosis.

Radiographic systems designed to use a digital imaging system instead of conventional film. These sy
ray subsystem, a detector, a computer workstation and a monitor for digitally processing and displayi
appropriate software. The digital images can be printed to hardcopy, stored on an optical disk, or tran
computer network.
Digital radiographic systems designed for imaging of the thorax with the patient standing (i.e., in vert
systems consist of a chest (up-right) radiography unit including an image receptor (e.g., a phosphor, a
amorphous selenium image plate), and a computerized console. The radiographic image is usually dig
digital radiography systems are used for diagnosing lung disorders (e.g., tuberculosis, cancer), assess
function, identifying cardiac problems, indicating the need for additional diagnostic tests, and imaging
standard examination is performed at a long source-to-image distance, typically 182 cm (72 inches).

Digital radiographic systems designed for radiography of the breast (i.e., mammography). These syste
high-frequency, constant-potential x-ray generator (usually with a voltage ranging from 20 to 35 kV);
control device; filters; a collimator; patient positioning features (e.g., compression devices); and a dig
Typically, the digital imaging system consists of a phosphor imaging plate used to obtain a latent imag
with a laser and digitized in an analog-to-digital converter. Digital mammographic systems are specifi
imaging the breast; they are used for screening and/or assessment of breast lesions.

Units that include an x-ray source to irradiate the portion of the patient to be examined and a fluoresc
image is projected reflecting the internal structure of the irradiated patient region. Fluoroscopic units
real time; thus the organs can be seen in motion. Most current fluoroscopic units use electronic image
form the image on a television screen; this procedure eliminates irradiation of the operator and provid
than that seen on a fluoroscope screen. Fluoroscopic units do not include patient supports (e.g., table
additional devices for computerized image processing or transfer.

Fluoroscopic units that consist of a portable power supply and an x-ray source (e.g., an x-ray generato
tungsten x-ray tube and a screen in an attached examination device. Portable fluoroscopic units are d
injured people before transporting them and in remote places or emergency situations.

Scaled-down mobile radiographic/fluoroscopic units designed for extremity imaging of the feet, hands
ankles. These units have very small input phosphors, typically 6 to 15 cm (2.5 to 6 inches) in diamete
visualizing only a portion of three fingers simultaneously in one image. An optical magnifier can be us
phosphor in place of an electric monitor when line power is not available. These units are used incritic
operating room (especially in hand and foot surgery), in physician offices, and in remote places.

Systems that combine radiographic and fluoroscopic capabilities. These systems produce instantaneo
visual images (fluoroscopies), permanent x-ray film images (radiographs), and/or digital images for lat
for archiving.
General-purpose radiographic/fluoroscopic systems in which the image intensifier is located above the
table, x-ray tube, spot film, and image intensifier movement are located at the table or in the spot-film

General-purpose radiographic/fluoroscopic systems in which the image intensifier is located under the
operator console is used to fully control all table, x-ray tube, and image intensifier movements as well
functions.
Radiographic systems that can move the x-ray source and the film cassette in a coordinated way so th
structures in the plane of diagnostic interest (i.e., tomographic images) remain in focus, while images
become blurred. In most of these systems, the film and the x-ray tube move in parallel, straight lines
Radiographic/tomographic systems are mostly used for lung and chest studies, retrograde or intraven
middle-ear studies, as well as for the diagnosis of cervical-spine pathology, arthritis, joint trauma, and

Identification, tracking, and security systems designed for infant care and location. These systems inc
identification tag (e.g., ankle or wrist band, umbilical cord clamp) with a radio transmitter attached, a
(e.g., a reader), dedicated software, and a unit that displays information regarding the infant's location
wearing a tag is moved toward an off-limit area, a detector (e.g., receiver) picks up a signal from the t
information to an alerting and control unit to notify staff of the infant's movement. Control mechanism
door locks, may also be activated. These systems are used to prevent newborn and/or infant abductio
unauthorized movement of newborns, infants, and/or children within the facility; they may also alert w
does not match the mother's tag or when the tag is removed, preventing the tag from being cut to by
alarm.

Image digitization systems designed to convert analog images (e.g., from a television camera) to digit
permitting immediate viewing of digital radiographic and fluoroscopic images. The stored images can
through subtraction, black-and-white reversal, and edge enhancement, and hard-copy films can be pr
storage. These systems are frequently used to upgrade existing radiographic/fluoroscopic systems, re
cameras.

Computed tomography (CT) scanning systems in which the table moves the patient at a constant velo
and the x-ray tube rotates around the patient in such a way that the beam traces a spiral path, contin
imaging data from the region of interest. These systems obtain multiple images in each revolution and
alter some processing parameters after the scan, including, among other capabilities, "reslicing" data
different set of parameters without having to rescan the patient. Typical scanning time for each helix i
second, but faster scans are possible.

Gamma camera systems that produce cross-sectional slices of the in vivo distribution of an administe
radiopharmaceutical in the body, acquired at various angles around the patient and displayed as a co
tomographic image. These systems typically include a mechanical gantry to support and rotate the ca
collimators in a circular or elliptical orbit around the body. Systems with multiple camera heads and/or
capabilities are also available. Single photon emission tomography systems are mostly used for whole
brain perfusion studies, and cardiac imaging.
Scanning systems that use laser beams at one or more frequencies to generate an image of tissue in
the body. The light detected after passing across the tissue is analyzed to determine the absorption an
resulting in optical slices that are reconstructed to form a continuous image that can be viewed on a
These systems can be used in diagnostic procedures to differentiate tissues according their optical pro
measurements of tissue, detection of cancerous tissue).

Computed tomography (CT) scanning systems in which the table moves the patient into the gantry an
rotates around the patient in such a way that each revolution produces one slice. Axial CT scanners ar
to the geometry of the x-ray tube detector system in generations (e.g., first, second). Typical scanning
on the order of a few seconds. These systems are mostly used for diagnostic and examination purpose
diagnosis of injuries, lesions, and malignancies.

Laser scanning systems that use laser light at two different frequencies (e.g., 690 nm, 810 nm) to pro
the breast. The light is modulated and transmitted through the breast using optical fibers and typically
photomultiplier. The breast is scanned with both laser rays in tandem, making multiple passes and ob
that are processed and displayed to form a continuous image on a video optical display. These scannin
identify small cancerous lesions based on the fact that optical properties of cancerous tissue are signi
those of healthy tissue (e.g., angiogenesis associated with cancer).

Scanning systems designed to measure the distribution of a radiopharmaceutical within a patient's bo


camera as detector. These scanners typically consist of a single- or multiple-head gamma (scintillation
table, a computerized subsystem including appropriate imaging processing software, a graphical displ
storage unit, and an operator console. Both stationary and portable gamma camera scanning systems
dimension (planar) imaging are available; systems that produce cross-sectional slices that are recons
images (single-photon emission tomography [SPET]) are also available. These scanning systems are u
clinical evaluations, including nuclear cardiology studies, and imaging of cerebral blood flow.

Electronic balances designed for weighing with a high degree of accuracy and precision. These balanc
weighing range of up to 200 g (some are capable of measuring up to 300 or 400 g), with a readability
a reproducibility of 0.1 mg or better. Analytic electronic balances usually include an integrated or sepa
chamber, and some have motorized doors._x000D_
Electronic balances designed for general measurement in the clinical laboratory. These balances typic
capacities in different ranges from several hundred milligrams to about 30 kg, a readability of 1 to 10
reproducibility of 1 to 50 mg, according to the weighing range. Precision electronic balances typically
platform on their top for weighing (i.e., toploading balances).
Electronic balances designed to weigh, with a high degree of precision, substances with a very small m
typically register weights of between 5 and 20 grams with a readability and reproducibility of one mic
balances typically consist of an electronic unit that senses the deviation of the balance beam and app
electromagnetic force, processing and control circuits, and a digital display that shows the value of the
calibrated in units of weight. Balances usually incorporate automatic calibration, temperature change
taring capability for easy subtraction of the mass of the container. Microanalytical balances with integ
communicate with printers, computers, and data processing units are also available.
Mechanical balances designed for general measurement in the clinical laboratory. These balances typ
capacities ranging from several hundred milligrams to about 20 kg and readability of 0.1 to 1.0 g, acc
range. Precision mechanical balances may have one pan (single-pan balances) or two pans (double-pa
double-pan balances, one pan is located at each end of a beam that is poised on an agate knife-edge
hangs at the center of the beam. The object to be weighed is placed on one pan, and analytic weights
in the other pan until equilibrium (i.e., balance) is reached. With single-pan balances, a pan is located
shorter arm of the beam. The beam is balanced on a fulcrum by a larger arm that usually consists of t
beams to which weights are attached until the main beam returns to its null position.

Mechanical balances designed for weighing with a high degree of accuracy and precision. These balan
weighing range of up to 200 g, with a readability of 0.01 to 0.1 mg. Analytic mechanical balances usu
integrated weighing chamber.
Mechanical balances designed for weighing a very small mass with a high degree of accuracy and pre
typically have a weighing range of up to 5 to 20 g with a readability and reproducibility of 1 microgram

Scales designed to weigh adult patients. These scales are made with different configurations accordin
capabilities (e.g., ambulatory, bed-ridden, disabled) and/or the procedure or treatment (e.g., intensive
needed.
Patient scales that include a horizontal platform that is placed on the floor and a vertical column with
display capabilities. These scales may include measuring rods to determine patient height, handrails t
weak or unsteady ambulatory patients, and casters for easy movement. Some platform scales include
embedded into the floor to permit weighing of patients while they are standing or sitting on a chair or

Platform scales that typically include a balance beam mechanism with two poise bars. These scales us
capacity of up to 135 kg (300 lb) and a readability of 100 g (0.25 lb); some include a counterweight to
to 200 kg (450 lb). Mechanical platform scales are used in physician offices, hospitals, and nursing fac

Platform scales that include a sensor (e.g., strain gauge) and electronic circuitry to process the signal
weight. These scales usually have a weighing capacity of up to 270 kg (600 lb) and an accuracy of 100
have increased capacity to 400 kg (880 lb). Electronic platform scales are used in physicians offices, h
facilities.
Scales designed to weigh prone or supine patients by placing them on either a weighboard or a sling a
unit that includes the weighing mechanism. Bedside scales usually have a weighing capacity of up to
accuracy of 100 g (0.25 lb). These scales may use mechanical, electromechanical, or electronic techn
are portable, battery-powered units, and other models are line powered as well. Most of these scales a
weight assessment of bedridden patients.

Bedside scales designed to weigh the patient by lifting him or her from the bed. These scales consist o
board that the patient is rolled onto. The board is suspended by metal brackets from a cart that includ
(e.g., hydraulic, electrical), weighing unit, controls, and a display. Activating the lift mechanism raises
slightly off the bed, weighing nonambulatory patients with minimum discomfort.
Chair scales that include a precise and accurate weighing mechanism for measuring total weight, and
variations, during the dialysis procedure. These scales typically include a horizontal platform that is pl
chair for the patient, and a vertical column with measuring, control, and/or display capabilities; some
a weighing frame attached between the legs and the caster of a conventional dialysis chair, as well as
unit. Dialysis chair scales usually have a weighing capacity of up to 300 kg (660 lb) and an accuracy o
of them can measure and display changes in patient weight up to 5 kg (11 lb), with an accuracy of 10
negligible drift. These scales may use mechanical, electromechanical, or electronic weighing technolo
scales are used to monitor the weight of patients for several hours during dialysis procedures as an ad
accumulation or loss of fluids.

Patient scales that include separate (e.g., four) transducer units (cells or pods) connected to a central
electronic circuitry for weighing, the controls (e.g., for taring), and a display. The individual units with
under the legs of a bed, stretcher, crib, chair, or platform. These scales usually have a total weighing
to 600 kg (1,000 to 1,300 lb) and an accuracy of 100 g (0.25 lb) in patient weighing; most of them can
changes in patient weight up to several kilograms, with accuracy of 10 g (0.025 lb). Modular transduc
used to weigh patients when they are bedridden, disabled, weak, under dialysis procedures, or in othe
cannot stand on a conventional scale.

Infant scales designed for high-precision and high-accuracy weighing of infants while they are either i
incubator. These scales usually consist of a weighing platform with a transducer that is placed under t
separate electronic weighing module that includes the display; they may also include a tray and a ma
the warmer or incubator used. Most of these scales have a weighing capacity of up to 8 to 15 kg (18 t
accuracy of 5 g (0.0125 lb). Warmer/incubator infant scales are mostly used for continuous monitoring
care situations when highly accurate weighing is needed (e.g., water to monitor losses in low-birth-we
detect dehydration or overhydration during pediatric hemodialysis).

Scales designed for clinical use other than the direct measurement of patient weight. These scales inc
top surface or tray that is smooth and polished to permit easy cleaning and decontamination (e.g., sta
scales are used in hospitals, nurseries, and physician offices.
Scales designed for clinical use when high accuracy and sensitivity are needed. These scales typically
to 1 kg (2.2 lb), with an accuracy of 1 g (0.0025 lb); they include an appropriate top surface or tray to
and decontamination (e.g., stainless steel). Precision clinical scales are used for accurate weighing, su
for urine measurements in infants, sanitary pad weighing to determine blood loss in women, sponge w
operating room to determine blood loss, and dialysate-solution weighing during peritoneal dialysis pro

Stimulators that apply electrical stimuli (e.g., direct current, pulses of current) to a nerve, muscle, a di
central nervous system, or any other tissue. Electrical stimulators basically consist of an energy sourc
external) in electrical contact with target tissue via conductive lead wires, a controller or interrupter to
energies from damaging the tissues, and an enclosure to prevent the biological environment from dam
and vice versa.

Electrical stimulators that apply the stimulus to all or any part of the brain, such as the cerebellum or
(sometimes including the deep cerebral centers).
Electrical brain stimulators that apply the stimuli to specific areas of the deep brain (e.g., thalamus) to
Brain stimulators for tremor control consist of electrodes implanted in the brain using stereotactic surg
connected through leads to a pulse generator that is typically implanted near the collarbone. These s
control several tremors, such as those in people suffering from essential tremor or tremors associated
disease.

Electrical stimulators that apply the stimulus to all or any part of the spinal cord. These stimulators in
lead/electrode system located in the epidural spaces of the spinal cord, attached to either an implante
circuit into which energy and/or signals are inductively coupled from outside the body (typically at rad
totally implantable self-contained stimulator that carries its own energy source and has no inherent de
external devices. Spinal cord stimulators are used in analgesic treatments and also as adjuvant thera
vascular diseases and refractory angina pectoris.

Spinal cord electrical stimulators that apply stimuli to improve muscle coordination and power. Typica
placed in the upper back, and, after a testing period, the electric generator is implanted. Some move
stimulators may also improve bladder function. These stimulators are used to increase muscle control
patients who have enough muscle strength for daily activities.
Electrical stimulators designed to apply electrical stimuli to the peripheral nerves (i.e., the nerves out
spinal cord). These stimulators typically consist of an electric pulse generator and attached electrodes
generator and the electrodes may be implanted or applied externally to the limbs or trunk. Dedicated
intended for analgesia and acupuncture treatments and/or to asses block monitoring and evoke poten
available.

Peripheral nerve electrical stimulators designed to apply stimuli to alleviate pain (i.e., analgesic). Thes
consist of an electric pulse generator attached to electrodes that deliver the stimuli. Stimulators inclu
generator and electrodes that are placed on the skin to apply the stimuli transcutaneously (known as
nerve stimulators [TENS]) are available. Implantable stimulators, either completely implantable or us
inductive coupling with an external power source, with electrodes located around a peripheral nerve, a

Peripheral nerve electrical analgesic stimulators that apply the stimuli through electrodes placed arou
These stimulators usually consist of either an implanted lead/electrode system attached to a passive e
which energy is inductively coupled from outside the body, typically at radio frequencies, or a totally i
contained stimulator that carries its own energy source and has no inherent dependence upon externa
implantable analgesic stimulators are used to treat chronic severe intractable pain, where the use of d
undesirable or no longer effective.

Peripheral-nerve electrical stimulators that apply periodic stimuli to the vagus nerve with appropriate
intensity, frequency, pulse shape) to treat seizures. These stimulators consist of a pulse generator typ
anterior chest wall and lead wires that run subcutaneously to electrodes implanted around the left vag
stimulators can be programmed externally following implantation (e.g., using a programming wand, d
a standard personal computer). These stimulators are used in the treatment of epilepsy to eliminate s
seizure frequency and/or intensity.
Neuromuscular electrical stimulators that apply stimuli to the muscles that control the fingers and thu
consist of a two-channel (or more) generator and electrodes. Some grasp stimulators are completely
are used externally, including either surface or percutaneous electrodes. Depending on the particular
user controls the stimulation by movement (e.g., shoulder, wrist), voice, or other means. Some of the
capable of stimulating the muscles for elbow control, thus enabling the user to reach out in one or mo

Neuromuscular electrical stimulators that include dedicated surface electrode garments for easy setup
These stimulators are used to exercise and strengthen muscles weakened by inactivity. Muscle streng
may help increase muscle mass, but will not improve voluntary control to paralyzed muscle.

Neuromuscular electrical stimulators that apply stimuli to nerves in the lower extremities (e.g., perone
the muscles in the leg to contract, thus improving the gait in a patient with one or both paralyzed legs

Gait neuromuscular stimulators implanted in one or both of the lower extremities of the patient. Thes
consist of an implanted receiver, with electrodes placed around a nerve and an external transmitter fo
stimulating pulses transcutaneously to the implanted receiver. The external transmitter is typically ac
the heel of the patient's shoe.
Gait neuromuscular stimulators that apply transcutaneous fixed stimuli to the quadriceps to lock the k
and periodic alternative stimuli to the common peroneal nerve and quadriceps of each side to produce
steps. These devices consist of an external stimulator with four or more channels and electrodes that
External gait stimulators usually have patient-manipulated controls to regulate the magnitude and fre

Neuromuscular electrical stimulators that apply stimuli to the bladder wall or the pelvic floor to mainta
continence.
Electrical bone-growth stimulators that consist of external electrical generators and electrodes. These
include either a coil that is placed around the growth site to apply an electromagnetic field or two self
applied to the skin (usually on opposite sides of the cast), which are used to apply a capacitive couple

Electrical bone-growth stimulators that consist of an implanted electric generator and electrodes. The
include a cathode wire that is placed through surgically made holes in the bone and that is either thre
fracture or coiled and secured in the bone. They also include an anodic capsule placed under the skin
battery and electric circuitry needed to deliver constant current through the bone.

Electrical stimulators designed to apply electrical stimuli containing sound information to the inner ea
typically consist of partially implantable devices that include external sensors to obtain sound inform
into electric signals (e.g., microphones), processors to modify and/or amplify the signals, and implanta
electrodes at the distal end to deliver the signals to the internal ear structures. Auditory electrical stim
partially implantable devices; dedicated stimulators intended to apply electrical signals to the cochlea

Electrical stimulators designed to apply electrical stimuli to the heart. These stimulators typically cons
generator and attached electrodes; both the pulse generator and the electrodes may be implanted or
the chest. Dedicated cardiac stimulators intended for diagnostic and/or therapeutic purposes are avai
Stimulators that apply sound stimuli (e.g., clicks, sound bursts) to the patient. Sound stimulators basi
energy source, an electric-to-sound transducer, and a delivery system for the sound waves. Most of t
used to elicit a measurable response for diagnostic, monitoring, or experimental purposes.

Stimulators that apply signals with frequencies well above the upper limit of perception of the human
Ultrasonic stimulators basically consist of an electric energy source, an electric-to-ultrasound transduc
system for the ultrasonic waves. Most of these stimulators are used to elicit a measurable response fo
experimental purposes.
Stimulators that apply light stimuli (e.g., flashes of light) to the patient. Photic stimulators basically co
energy source and a phototransducer to deliver the light stimuli. Most of these stimulators are used t
response for diagnostic, monitoring, or experimental purposes.
Stimulators that apply heat stimuli (e.g., hot fluids) to the patient. Most of these stimulators are used
response for diagnostic, monitoring, or therapeutic purposes.
Caloric stimulators that apply the heat to the patient's skin to produce physiologic reactions in the tiss
stimulators are used in physical therapy programs to assist in reduction of pain and stiffness, to allevi
increase range of motion, and to improve tissue healing by increasing nutrient and blood flow to the a

Stimulators that apply mechanical stimuli (e.g., force, pressure) to the patient. Most of these stimulato
measurable response for diagnostic, monitoring, or therapeutic purposes.
Mechanical tactile stimulators that apply pressure stimuli, usually to the patient's great toe (hallux). T
consist of a handheld disc with protruding rods that differ in diameter (for patient discrimination of dia
sensitive nylon filaments mounted on an appropriate handle (for pressure sensibility measurements).
simple instruments typically used in the physician office for detecting peripheral neuropathy and/or th
or leprosy.

Tactile mechanical stimulators that apply vibration usually to the apex of the patient's great toe (hallu
increased until a vibratory perception threshold is determined. Vibration mechanical stimulators are m
detecting peripheral neuropathy, usually in diabetic patients.
Mechanical stimulators that apply the stimulus to some area (e.g., teeth, papillae, gingivae) in the ora

Mechanical stimulators used in dentistry for tooth position modification. These stimulators consist of
orthodontic appliance intended to elicit reflex-muscle activity, which in turn produces the desired toot

Stimulators used to regulate or substitute the normal rate at which a biologic center establishes the re
activity (rhythm) of an organ (e.g., heart, lungs). These stimulators control the pace by means of som
electric generator) stimuli. Pacemakers can be designed either for continuous use (usually implantab
temporary external use.
Pacemakers designed to apply a repetitive stimulus to regulate the rhythm of the breath. Respiratory
in patients in which an abnormally low amount of air enters the lungs (hypoventilation), usually cause
pulmonary injuries or diseases.
Cardiac pacemakers that generate impulses outside the body and deliver them to the heart through e
externally through the chest wall or invasively (e.g., through intravenous or transesophageal electrode
pacemakers are used for temporary pacing of the heart.
Defibrillators that generate electric impulses outside the body and deliver them to the heart through p
either directly during open heart surgery or externally through the chest wall. Most defibrillators inclu
paddles (e.g., chest paddles, smaller concave paddles for the exposed heart) or, alternatively, disposa
electrodes. The maximum output energy is limited to prevent injury to the heart muscle (i.e., 50 and 3
direct and external defibrillation, respectively).

External defibrillators that require the user tp apply the electrodes to the patient and activate the unit
analyzes the ECG rhythm to determine if a defibrillation shock is needed, activating on-screen messag
prompts to operate the device and to deliver the shock if needed. The simple design and ease of use
defibrillators requires little training and operational skill compared to conventional manual defibrillato

Cardiac electrical stimulators that apply brief high-voltage electroshocks to the heart that are intende
rhythm and contractile function in patients who are experiencing ventricular fibrillation or ventricular
accompanied by a palpable pulse (i.e., defibrillation) or (2) correct noncritical dysrhythmias (e.g., to su
tachycardia, ventricular reentrant tachycardia, atrial flutter and atrial fibrillation) by applying relativel
shocks synchronized to the patient's ECG (i.e., cardioversion).

Defibrillators/cardioverters that are permanently inserted (implanted) abdominally, pectorally, or subc


and abdominally implanted devices are connected to the patient's heart through a set of epicardial or
These defibrillators/cardioverters consist of a hermetically sealed container, including a lightweight ba
circuitry to sense cardiac activity and produce the electrical pulses (shocks), and electrode leads that
myocardial signals to the defibrillator and the electrical defibrillating pulses to the patient when neede
defibrillators/cardioverters are intended to:(1) restore normal rhythm and contractile function in patien
experiencing ventricular fibrillation or ventricular tachycardia that is not accompanied by a palpable p
or (2) correct noncritical dysrhythmias (e.g., to supraventricular tachycardia, ventricular reentrant tac
and atrial fibrillation) by applying relatively low-level stimuli shocks synchronized to the patient's ECG
Subcutaneous implanted defibrillator/cardioverters that are connected to leads and electrodes anchor
above but not touching the heart are also available.

Implantable defibrillator-cardioverters that can also analyze the cardiac rhythm and provide multitiere
antitachycardia and/or bradycardia pacing, low-energy synchronized cardioversion, and unsynchronize
of these stimulators have memory modules for storage and retrieval of the cardiac electrical activity a
capabilities.
Analyzers designed to be used at the point of patient care, wherever medical care is needed. Most of
used in places where a quick result is needed and where it is possible to perform the assay soon after
obtained, using samples taken directly from the patient, such as whole blood or urine, usually without
(e.g., centrifugation) before the introduction of the sample in to the analyzer. Some of these analyzer
computerized data management capabilities for storage and retrieval of test results and may also inco
programs (e.g., to calculate anticoagulant dosages). These analyzers are handheld portable or mobile
require permanent dedicated space. Point-of-care analyzers may be operated by healthcare providers
patients with a minimum of, or without, any previous training. Typical places for point-of-care analyze
care units, emergency departments, operating rooms, or at the bedside. Some point-of- care analyzer
home.
Devices used to remove obstructions from (i.e., restore the patency of) enteral nutrition feeding tubes
feeding tube can result from several causes, including inappropriate administration of medications, vi
flushing techniques, and aspiration of gastric or intestinal contents. The irrigation of chemical solution
devices is also used in declogging feeding tubes.
Helical fasteners designed for mesh fixation (fastening) using laparoscopic techniques. These fastene
springlike device, typically 4 mm in diameter and with a depth of penetration of 3.8 mm. Surgical me
threaded spirally to penetrate tissue and body structures using an appropriate instrument; they are u
herniorrhaphy procedures (e.g., to fix the mesh to the pubic bone) to prevent mesh migration.

Point-of-care analyzers that perform analysis using small samples of whole blood, usually allowing the
instead of venipuncture. Some of these analyzers can also use plasma or serum.
Point-of-care whole blood analyzers used to determine concentrations of clinically important analytes
glucose), electrolytes (e.g., sodium, potassium), and drugs of abuse; provide certain hematology value
concentrations); assay some therapeutic drugs (e.g., theophylline); and perform other clinical laborato
these analyzers currently perform analysis with minimal technician involvement and with complete au
process, providing a standardized method of obtaining accurate and reproducible chemical concentrat
Multianalyte point-of-care analyzers are used as primary instrumentation in intensive care units, emer
operating rooms, and animal research laboratories.

Point-of-care analyzers used for direct measurement of pH and partial pressure of carbon dioxide (PCO
whole blood specimens. Measurements are made using three different sets of electrodes. These anal
determine the patient's acid-base balance and oxygen-carbon dioxide exchange in diagnosis and regu

Point-of-care blood gas analyzers that can assess some metabolites as well as measure blood gas, pH,
These analyzers can directly measure pH and partial pressure of carbon dioxide (PCO2) and oxygen (P
concentrations of the most common ions (i.e., sodium [Na+], potassium [K+], chloride [Cl-] and bicarb
some metabolites such as calcium, magnesium, glucose, and lactate present in whole blood. These a
determination of metabolites and to assess abnormal electrolyte levels in the blood; they are also use
patient's acid-base balance and oxygen-carbon dioxide exchange.

Point-of-care analyzers dedicated to measuring lactate in whole blood. Some point-of-care lactate ana
measure lactate in plasma, serum, or cerebrospinal fluid. Most of these analyzers use amperometric m
current is measured through an electrochemical cell while a constant electric potential is applied to im
electrodes). These analyzers are used in critical care units and emergency rooms, for sports medicine
physiology, to determine lactate acidosis, and to assess other disorders such as cerebrovascular accid
liver perfusion.

Point-of-care analyzers dedicated to measuring red blood cells, white blood cells, and platelets in who
volumetric impedance technique or the light-scatter technique. Most of these analyzers can also mea
other values, such as mean corpuscular volume and hematocrit.
Point-of-care analyzers designed to determine the proportion of one or more constituents in a breath a
sample.
Point-of-care analyzers that perform semiquantitative chemical analysis to determine the presence of
estimate their concentrations in a urine sample. Most of these analyzers require the technician, to imm
portion of the dipstick in the urine specimen and place the strip in the instrument, usually one specim
care urine analyzers usually use reflectance photometry methods (typically, the amount of light produ
reflected from a reagent-impregnated test pad that has reacted with the urine sample is measured). T
detect one or more analytes such as bilirubin, glucose, ketones, or protein using reagent-embedded d
are less precise than those obtained with laboratory multianalyte chemical analyzers. These analyzer
physicians in diagnosing and managing renal, urinary tract, and metabolic diseases.

Structures housing all medical devices and other ancillary equipment or auxiliary systems needed for
performance of one or more medical procedures. Modular medical facilities are completely (or at least
degree) assembled at the manufacturer's premises, usually including the installation of the internal el
environmental systems. Most modular facilities are manufactured according the special consideration
climatic) required for proper and reliable use in the final destination, and/or are customized to the req
medical system manufacturer.

Mobile modular medical facilities typically divided into an ophthalmic examination area, a reception a
equipment (e.g., electric generator, air conditioning) room. These facilities include an ophthalmic exa
examination lights, ophthalmic instruments (e.g., ophthalmoscopes), and a sterilizer. Some dedicated
ophthalmic lasers (e.g., excimer) for some specialized procedures (e.g., corneal ablation for photorefra

Mobile modular medical facilities typically divided into a patient examination area, a reception area, a
equipment (e.g., electric generator, air conditioning) room. These facilities typically include several a
each including audiometers to measure and characterize hearing loss.
Mobile modular medical facilities typically divided into a patient treatment area, a reception area, and
equipment (e.g., electric generator, air conditioning) room. These facilities include an obstetric/gynec
examination lights, basic instruments (e.g., scales, sphygmomanometers), and a sterilizer. Some facili
specialized devices, such as ultrasound scanners, cardiotocographs (fetal monitors), and mammograp
Obstetrics/gynecology mobile medical facilities are used for prenatal care and may also be used for de

Mobile modular medical facilities typically divided into a laboratory room, a patient care area (typically
drawing chairs), a reception area, and an auxiliary equipment (e.g., electric generator, air conditioning
include basic clinical laboratory devices, such as balances, centrifuges, pH meters, filter photometers
sterilizers. Clinical laboratory mobile facilities permit patient specimen collection and limited laborator

Mobile modular medical facilities typically divided into an x-ray shielded radiographic area, an x-ray fi
storage room, and an auxiliary equipment (e.g., electric generator, air conditioning) room. These facil
general-purpose radiographic system or a chest radiographic unit.
Mobile modular medical facilities typically divided into a PET scanning area, a control room including t
and an auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities consist of
arranged in stationary rings around the patient, photomultiplier tubes, coincidence circuits, a patient t
subsystem including dedicated software, display monitors, and a data-storage unit.
Mobile modular medical facilities typically divided into a positron emission tomography (PET) scanning
including the operator console, and an auxiliary equipment (e.g., electric generator, air conditioning) r
consist of scintillation detectors arranged in stationary rings around the patient, photomultiplier tubes
patient table, and a computer subsystem including dedicated software, display monitors, and a data-s

Mobile modular medical facilities typically divided into a blood-drawing area, a reception area, a proce
area, and an auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities inclu
refrigerator, sterilizing units, examination tables, and blood-drawing chairs.
Mobile modular medical facilities typically divided into an operating room, a scrub room including a wa
sterilizer, and an auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities
anesthesia units, and physiological monitoring devices. They may also include electrosurgical units. S
surgical facilities include an area for postoperative recovery with appropriate beds and other devices (
electrocardiographs, resuscitators, ventilators).

Mobile modular medical facilities typically divided into a patient receiving area with easy access by am
room with a few mobile, adjustable-height stretchers; and an auxiliary equipment (e.g., electric gener
room. These facilities include all basic devices needed for emergency care, including resuscitators, el
defibrillators, emergency aspirators, sterilizing units, and surgical lights for minor surgery procedures.

Modular medical facilities designed to be transported completely (or at least to a substantial degree) a
manufacturer's premises to the final destination. Most stationary medical facilities are permanently lo
possible to relocate the facility if needed. Stationary modular medical facilities could need external co
electricity, water). These facilities are used for servicing distant or rural areas, for screening purposes
adding new capabilities to an existing hospital (e.g., magnetic resonnance imaging, catscan), and for
procedure or increasing the existing medical capabilities permanently or for long periods (e.g., severa
location .

Stationary modular medical facilities that are typically divided into a patient treatment area and recep
also include an auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities in
unit, a dental chair, examination lights, and a sterilizer. Some facilities also include a dental radiograp
film processor.
Stationary modular medical facilities that are typically divided into an ophthalmic examination area an
that could also include an auxiliary equipment (e.g., electric generator, air conditioning) room. These
ophthalmic examination chair, examination lights, ophthalmic instruments (e.g., ophthalmoscopes), a
dedicated facilities also include ophthalmic lasers (e.g., excimer) for some specialized procedures (e.g
photorefractive correction).

Stationary modular medical facilities that are typically divided into a patient examination area and a r
could also include an auxiliary equipment (e.g., electric generator, air conditioning) room. These facili
several audiometric booths, each including audiometers to measure and characterize hearing loss.

Stationary modular medical facilities that are typically divided into a patient treatment area and a rec
also include an auxiliary equipment (e.g., electric generator, air conditioning) room. These facilities in
obstetric/gynecologic table, examination lights, basic instruments (e.g., scales, sphygmomanometers)
facilities also include more specialized devices, such as ultrasound scanners, cardiotocographs (fetal m
mammographic units. Obstetrics/gynecology stationary medical facilities are used for prenatal care an
Stationary modular medical facilities that are typically divided into a patient treatment area and an op
a console) and could also include an auxiliary equipment (e.g., electric generator, air conditioning) roo
include a lithotripter (e.g., ultrasonic, electrohydraulic), a urological table, and endoscopic devices.

Stationary modular medical facilities that are typically divided into a laboratory room, a patient care a
blood-drawing chairs), and a reception area and could also include an auxiliary equipment (e.g., elect
conditioning) room. These facilities include basic clinical laboratory devices, such as balances, centrifu
photometers (colorimeters), and sterilizers. Clinical-laboratory stationary facilities permit patient spec
limited laboratory testing.

Stationary modular medical facilities that are typically divided into an x-ray shielded radiographic area
processing and storage room and could also include an auxiliary equipment (e.g., electric generator, a
These facilities typically include a general-purpose radiographic system or a chest radiographic unit.

Stationary modular medical facilities that are typically divided into a radiographic area, a dressing roo
area and could also include an auxiliary equipment (e.g., electric generator, air conditioning) room. Th
high-frequency or constant potential x-ray (usually from 20 to 35 kV) mammographic unit, patient pos
compression devices), and an image recording system. Some facilities also include stereotactic biopsy
ray film processor.

Stationary modular medical facilities that are typically divided into an x-ray shielded radiographic scan
control room, including the operator console, and could also include an auxiliary equipment (e.g., elec
conditioning) room. These facilities consist of a tomographic scanning subsystem, a patient table, and
subsystem including dedicated software, display monitors, and a data-storage unit.

Freestanding stationary modular medical facilities that contain the equipment and supplies needed to
integrated unit for performing cardiac catheterization procedures (i.e., invasive medical procedures as
therapeutic tool for heart and circulatory conditions). These facilities are typically divided into a patien
control room, including the operator console, and could also include a room for auxiliary equipment (e
air-conditioning unit). Equipment in these facilities typically includes a cardiovascular radiographic/flu
power injector for introducing contrast medium into the patient at high flow rates, physiologic monitor
additional equipment to manage cardiovascular emergencies.

Stationary modular medical facilities that are typically divided into a single photon emission computed
scanning area and a control room, including the operator console, and could also include an auxiliary
electric generator, air conditioning) room. These facilities consist of a gamma (scintillation) camera us
patient table, and a computer subsystem, including dedicated software, display monitors, and a data-

Stationary modular medical facilities that are typically divided into a positron emission tomography (P
a control room, including the operator console, and that could also include an auxiliary equipment (e.g
air conditioning) room. These facilities consist of scintillation detectors arranged in stationary rings aro
photomultiplier tubes, coincidence circuits, a patient table, and a computer subsystem, including dedi
monitors, and a data- storage unit.
Stationary modular medical facilities that are typically divided into a patient treatment area, a magne
room, including the operator console, and could also include an auxiliary equipment (e.g., electric gen
conditioning) room. These facilities include a primary magnet, gradient magnets, a radio-frequency su
table, and a computer subsystem including software, display monitors, and a data-storage unit.

Stationary modular medical facilities that are typically divided into a blood-drawing area, a reception a
and storage area and could also include an auxiliary equipment (e.g., electric generator, air conditioni
facilities include a blood-bank refrigerator, sterilizing units, examination tables, and blood-drawing cha

Stationary modular medical facilities that are typically divided into an operating room and scrub room
heater and sterilizer, and could also include an auxiliary equipment (e.g., electric generator, air condit
facilities include surgical lights, anesthesia units, and physiological monitoring devices, and they may
electrosurgical units. Some modular surgical facilities include an area for postoperative recovery with
other devices (e.g., electrocardiographs, resuscitators, ventilators).

Stationary modular medical facilities that are typically divided into a patient receiving area with easy
patients and a room with a few mobile adjustable-height stretchers; these facilities could also include
(e.g., electric generator, air conditioning) room. These facilities also include all basic devices needed f
including resuscitators, electrocardiographs, defibrillators, emergency aspirators, sterilizing units, and
minor surgical procedures.

Electrophoresis systems designed to perform the electrophoresis procedure in a small-bore (25- to 100
silica capillary column (sometimes included in a capillary cassette); sample volumes are typically sma
picoliter samples). These systems typically include high-voltage sources and may include different typ
optical, conductivity, electrochemical, mass spectroscopy). They have a wide application range, inclu
of capillary zone electrophoresis, capillary gel electrophoresis, and capillary isoelectric focusing; most
perform some techniques unique to capillary electrophoresis systems, such as micellar electrokinetic
separate neutral as well as charged solutes) and capillary electrochromatography, which combines the
chromatography and capillary electrophoresis. Capillary electrophoresis systems are used for separati
as amino acids, vitamins, peptides, proteins, DNA restriction fragments; whole cells; and virus particle

Chambers designed to perform the migration and separation of mixtures of ionic solutes by applying a
(electrophoresis). These chambers typically consist of a nonconducting material (e.g., glass, acrylic) th
separate buffer tanks; a supporting medium for electrophoresis (e.g., agarose gel, cellulose acetate) p
tanks, so that one end of the membrane contacts the buffer on each side of the chamber; and an elec
graphite) in each tank connected to a power supply. A sample is applied to the support, and electroph
a determined length of time, typically using constant voltage, current, or power. Some electrophoresis
power supply as an integral part. Systems including electrophoresis chambers and power supplies and
include other devices such as densitometers, temperature controllers, and/or computerized data proce
used for the separation of many solutes of interest in clinical chemistry, including proteins in serum, p
cerebrospinal fluid.
Electrophoresis chambers with the supporting media set in a horizontal position. These chambers incl
of supporting media usually supported on the bottom; the upper surface may be exposed to the air, in
evaporation may be a problem. Some chambers include covers to saturate the air and reduce evapor
chambers, the support is submerged in the buffer (submarine electrophoresis), cooling the support an
evaporation but drawing more current from the source.

Electrophoresis chambers with the supporting media set in a vertical position. These chambers includ
supporting media that are held between sheets of glass or acrylic unless they are strong enough to be
chambers can perform electrophoresis using vertical cylinders (columns).

Tubes covered with supporting media that are used to separate an ionic mixture of solutes into its com
differences in migration rate when an electric field is applied (electrophoresis). These columns are usu
plastic (e.g., acrylic) tubes; they are usually mounted vertically, with both ends placed into buffer well
electrical connection between the columns and the electrodes. Typically, several columns are run simu
electrophoretic system.

Electrophoresis columns used in electrophoresis capillary systems. These columns usually consist of fu
tubes (e.g., 25, 50, 75 micrometer) with lengths from 30 to 100 cm that are coated with the support (e
mounted in a capillary cassette for use.
Solid-state lasers with a rod of yttrium-lithium- fluoride (YLF) garnet crystal doped with neodymium, a
an active medium. Their emission wavelength is typically 1,053 nm (near infrared). These lasers can
continuous, pulsed, Q-switched, and mode-locked modes; they allow the generation of pulses of short
Nd:YAG lasers. The laser energy may be delivered through a flexible optical glass fiber or through a se
optical system of a microscope).

Batteries designed to provide power to devices that support the working environment (e.g., temperatu
chemicals) inside the human body. Implantable batteries are usually nonrechargeable and lightweight
batteries, although zinc/mercury-oxide batteries are also used. Implantable batteries are used as a so
for long-term implantable devices such as cardiac pacemakers, defibrillators, and stimulators.

Nd:YLF lasers usually consisting of a two-stage device (oscillator plus amplifier); they are operated in
locked modes, generating pulses of a few picoseconds. These lasers are designed to cause a photodis
eye by forming a plasma and generating immense localized mechanical shock waves (microexplosion
focused, can destroy tissue (e.g., creation of corneal flaps as a microkeratome); they can be focused t
size (typical spot size is less than 7 micrometers). Nd:YLF ophthalmic lasers usually include built-in slit
are coupled to them by mirrors.

Batteries designed for use as a power source in external defibrillators. These batteries typically consis
capacity and high-efficiency cells; they are usually rechargeable (e.g., sealed nickel-cadmium, lead ac
disposable nonrechargeable batteries (e.g., lithium) are sometimes used. Most external defibrillator ba
portable defibrillators or to ensure that equipment is serviceable if there is a failure of the main power

Any source of electric power, such as a power line or a battery. Batteries, direct-current electronic regu
line power supply systems (including isolated and uninterruptible systems), and transformers are the
the field of medicine to deliver electric power to electric and electronic medical devices in hospitals an
also used as power supplies for implantable medical devices.
High-capacity batteries designed to deliver energy to a direct-current motor used for wheelchair propu
typically consist of a stack of several sealed lead-acid (e.g., gel-type) or nickel-cadmium rechargeable
batteries are usually mounted into a battery box, which is placed on the wheelchair (e.g., under the se
include an integral battery charger.
Regulated power supplies that receive alternating-current energy from a power line and deliver one or
current outputs. Electrophoresis regulated power supplies usually consist of a step-up or step-down tra
filter, and an electronic regulator that keeps the voltage, current, or power output constant over a bro
input voltages. They are used in clinical laboratories either attached to or as an integral part of electro

Power systems designed to provide energy to equipment, devices, and/or instruments in a given area
Power systems may be intended to provide electric power under special conditions (e.g., isolated syst
rooms), as alternative sources of energy (e.g., solar panels), or when a line power supply is not availab
emergency systems for blackout periods). Other power systems are intended to provide electrical, me
form of energy (e.g., ultrasonic, pneumatic) for particular applications such as surgical, orthopedic, or

Electric power systems designed to automatically supply independent, continuous, reliable electric po
(e.g., operating room, critical care devices) after a pre-established time delay (e.g., 10 or 60 seconds)
supply has complete blackouts or does not perform acceptably . These systems should supply electric
period of time (usually several hours or a few days) without being refueled. Emergency power system
rotary energy converter, including its accessories (e.g., starting, cooling, and control systems) and oth
transfer switches, needed to ensure proper operation.

Electric devices that consist of two or more coils usually wound around a magnetic core and that are c
induction. Most transformers are used to change the voltage of an alternating current (e.g., step-up an
transformers). The ratio of the voltage on each coil is proportional to the number of turns, while the ra
inverse to the number of turns. Some transformers are used for other purposes, such as isolation betw
primary and secondary windings) or for impedance transform.

Transformers designed to isolate the secondary winding from the primary winding in such a way that n
secondary terminals is grounded. Typically the ratio of primary to secondary windings is one to one, so
secondary winding is the same as the input voltage of the primary. Isolation transformers are used to
currents of a particular device to levels low enough (e.g., less than or equal to 500 microampere) to m
electrical safety standards. These transformers may be included as an integral part of electric and ele
equipment or provided as accessory devices.

Orthoses designed for external modification of the structural and/or functional characteristics of the h
may be classified according to the physical characteristics (e.g., shape, consistency) and/or the mater
orthosis (metal, plastics, carbon fiber or a combination of these). Head orthoses are mainly intended f
(e.g., to correct cranial deformities); some dedicated orthoses may also provide immobilization and/or
immobilizers for the head and cervical spine are also available.
Microscopes that can image and measure the surface of a sample in all three dimensions (i.e., topogra
typical resolution of a few nanometers. These microscopes consist of a scanning system, a probe, and
have computer capabilities for microscope operation and to process and display the image informatio
microscopes employ one or more techniques to measure surface characteristics, including scanning tu
(STM), using a very sharp conducting tip for scanning on a conducting surface while measuring variati
and atomic force microscopy (AFM), which applies a force in the range of the interatomic forces that h
cantilever either in contact with or at a fixed distance from the sample surface while measuring its dis
to the topography of the surface, some scanning probe microscopes can measure other sample surfac
as magnetic force, electric field, and temperature gradients. Scanning probe microscopes are used to
samples in air, vacuum, or liquid environments without previous preparation (e.g., staining, coating), i
structures, cellular movement, and the interaction of bacteria with biomaterials.

Systems designed to detect, identify, track, and locate people (e.g., staff, patients, visitors, infants), a
instruments), and/or pharmaceuticals. These systems can monitor movement within a particular locat
into and exit from a facility. The basic elements of the system are an identification tag that is attached
by the person, a tag-detection device (e.g., a reader), dedicated software, and a unit that displays info
identification/tracking/security systems use radiofrequency (RF) signals, but systems based on ultraso
well as hybrid systems (e.g., RF and IR) are available; some dedicated systems are specialized for trac
assets, infants, surgical instruments, or pharmaceuticals.

Identification, tracking, and security systems designed for patient care and/or staff location within a h
track entry into and exit from the facility. These systems include an identification tag, usually in the fo
wrist band, or badge, typically with a radio transmitter attached (active tag) or that works with the en
location device (passive tag); a tag-detection device (e.g., a reader); dedicated software; and a unit th
regarding the individual's location. The systems are used to locate healthcare staff and patients; they
prevent mentally disoriented, cognitively impaired patients from wandering into off-limit areas of the
leaving the facility (elopement) without authorization. Systems intended for mentally disoriented patie
include capabilities to detect when a patient wearing a tag moves toward an off-limit area; a detector
up the signal from the patient's tag and sends the information to the alerting and control unit to notify
movement. Control mechanisms, such as magnetic door locks, may also be activated.

Solutions that have viscous and some elastic properties formulated in appropriate concentrations for i
procedures. These solutions typically consist of aqueous mixtures usually containing as main compone
hyaluronate, a purified sodium salt of hyaluronic acid (a glycosaminoglycan, [GAG]). Intraarticular visc
usually supplied in sterilized pre-filled syringes or vials; the solution is typically injected into the synov
articulation. They are intended for treatment of osteoarthritis and/or after arthroscopic surgery.
Computerized systems designed to perform a specialized procedure (e.g., laboratory testing, minimal
medication dispensing) either following a preestablished program with minimal human intervention, t
interface, or a combination of both. These systems typically consist of a combination of software used
procedure and appropriate hardware to perform the necessary mechanical operations. All hardware us
should share the same information protocol. Most systems are capable of information (e.g., data, imag
hospital information systems (e.g., radiology, anatomic pathology, material management). Automatio
to improve the ergonomy, safety, and/or efficiency of healthcare procedures; they are usually configur
particular hospital requirements.

Automation systems used in clinical laboratories to prepare, analyze, and evaluate samples. These sy
of several modules for specimen handling and processing that work as a network connected by a tran
under software control; they can perform tasks in sequence with minimal operator intervention. The s
modules for sample preparation (preanalytic modules), analysis of samples (e.g., hematology, clinical
immunoassay), and recompilation and evaluation of results (postanalytic modules). Each module typic
units (e.g., decappers, sorters, centrifuges, analyzers, refrigerators) that may be either standard clinic
equipment or, more frequently, specially designed units for the automation system. Laboratory autom
intended to improve the safety and/or efficiency of laboratory procedures; they are frequently configu
particular laboratory requirements. Most of these systems can interact with laboratory and/or hospital

Stents-grafts designed for deployment in blood vessels (i.e., endoprostheses) to bypass injured or dise
while maintaining patency within the vasculature. These devices typically consist of one or more meta
covered with a synthetic (e.g., polyurethane, Dacron) or biomaterial (e.g., native vein) graft. They are
different shapes (e.g., straight, bifurcated) to adapt to particular sections of the vasculature and to pre
stents may be either balloon-expandable or self-expanding. Vascular stent-grafts are used mainly to tr
to repair vessel perforations or ruptures; some are used to keep strictures of the vessels open and/or t
narrowing (i.e., restenosis) after angioplastic procedures.

Delivery Units designed to administer nitric oxide (NO) into the respiratory system, some may include
capabilities. These units may synchronize the delivery of NO with patient respiration (inhalation) to m
spontaneous reaction of NO with oxygen to form potentially toxic oxides (e.g., NO2). Nitric oxide deliv
dilate the pulmonary vasculature in the treatment of neonates with hypoxic respiratory failure; they m
adults for treatment of primary pulmonary hypertension (PPH) and/or acute respiratory distress syndro

Alarm systems designed to activate audible and/or visual signals when a patient attempts to move fro
such as a chair, wheelchair, bed, or room. These alarms are typically comprised of sensors deployed t
patient's location and connected to an electronic control unit. Specific occupancy alarms for beds and
available with pressure pads designed to fit on or beneath mattresses or wheelchair seats. Other occu
floor mats, clothing clips, and motion detectors are also available and can be used with beds, wheelch
Occupancy alarms have several possible configurations and sometimes several sensors can be used t
occupancy alarm system. Some occupancy alarms can interface with nurse call systems providing rem
Occupancy alarms are used to alert caregivers that a patient has or is attempting to move. Occupancy
reduce the likelihood of falls and can promote speedy assistance to patients who have already fallen b
that a patient who should not get up unassisted is doing so.
Solid-state lasers with a rod of yttrium-scandium-gallium garnet (YSGG) crystal doped with erbium, a r
the active medium. Their emission wavelength is typically 2,790 nm (midinfrared). Er:YSGG lasers are
pulsed modes; their energy can be delivered through a flexible optical fiber.
Solid-state lasers with a rod of yttrium-scandium-gallium garnet (YSGG) crystal doped with erbium, a r
chromium as the active medium. Their emission wavelength is typically 2,760 nm (midinfrared). ErCr:
operated in pulsed modes; their energy can be delivered through a flexible optical fiber.

ErCr:YSGG lasers used in the treatment of hard dental tissue (e.g., enamel, dentin) and soft dental tiss
appropriate for dental procedures because of the high absorption of their midinfrared (i.e., frequencie
micrometers) energy by both tissue water and hydroxyapatite and because the energy can be deliver
fiber. The subsurface expansion of water is accepted as the primary mechanism responsible for exfolia
the enamel mineral at temperatures below the melting point of teeth (around 1200 degrees Celcius).
used in oral surgery and for high-efficiency ablation of hard dental tissue, with relatively small therma
add a water spray to the laser irradiation to create a combined interaction of laser energy with atomiz
(called hydrokinetic energy), increasing the ablation depth with minimal injury to the surrounding tissu

ErCr:YSGG lasers used in the treatment of a variety of skin diseases, including scars, discoloration, an
lasers are appropriate for dermal procedures due to the high absorption of its midinfrared (i.e., freque
energy by tissue water. Some devices combine the effect of an air or water spray with the laser delive
thermal effects on the skin.
Feeding tube patency restorers that use mechanical forces to remove obstructions of occluded feeding
usually consist of a soft threaded mechanism that can be introduced into the tube and then rotated to
are available in a range from 10 to 24 Fr diameter and 20 to 40 cm (8 to 16 inches) in length. Other de
endoscopically inserted cytology brush. Mechanical patency restorers are used to remove obstructions
gastrostomy-jejunal feeding tubes.

Feeding tube patency restorers that flush liquid to remove obstructions to occluded feeding tubes. The
include a catheter of appropriate diameter and length (e.g., a 5 Fr catheter up to 1.40 m in length), an
syringe for flushing the clog with water or another solution (e.g., saline). Some devices include a prefi
administration of declogging solution before flushing. Flushing patency restorers are used to remove o
gastrostomy and gastrostomy-jejunal feeding tubes; they can also be used to restore patency in nasog
feeding tubes.

Neuromuscular electrodes designed as garments that cover the entire treatment area. These electrod
conductive cloth (e.g., socks, gloves, sleeves) made of woven fabrics such as nylon or Dacron and me
silver); they are connected to steady or pulsed electric stimulators that deliver very small currents, us
microamperes. Conductive garment electrodes are used in treatments intended to provide mild pain r
and/or increase blood circulation.

Diagnostic instruments designed as a combination of a direct ophthalmoscope and an otoscope. Thes


ophthalmoscope and otoscope heads and a handle with an internal battery that can be used either wi
or the otoscope head; they are usually available in cases. The handle frequently includes a battery ch
ophthalmoscope/otoscope sets are used for primary care or emergency diagnosis, but some devices c
surgery.
Alarms designed to activate audible (i.e., sound) and/or visual signals when cellular telephones, walki
radio-frequency transmitters are operated in the vicinity (e.g., inside the same room) of electrical or m
devices vulnerable to radio-frequency signals (i.e., electromagnetic interference). These devices inclu
sensors to detect the radiated electromagnetic field, typically from 400 to 2,000 MHz), electronic circu
light sources as alarms. Cellular-telephone detection alarms are used to alert users and healthcare pe
operation of cell telephones inside a healthcare facility near vulnerable or potentially vulnerable medi
defibrillators, ventilators).

Dental units designed to cut tooth structure or remove deposits from teeth by applying abrasive micro
aluminum oxide) by air blast, acting like a sandblaster. These instruments consist of a built-in air comp
controllers, and handpieces that typically use interchangeable nozzles; several nozzle angles (e.g., 45
available. Most units also include filtering modules for particle and gas evacuation (e.g., aluminum ox
odors). Some dental procedures can be performed with less noise, heat, and vibration than when usin
trauma and often eliminating the need for anesthetics. Dental air abrasion units are used for cavity pr
amalgam and composite materials; for tooth surface (enamel) treatment either, for removal of residue
surface for bonding of orthodontic appliances; in cosmetic dentistry; and in other dental procedures.

Systems designed for handling objects without physical contact of a human operator with the manipu
as "robotic" systems). Most systems are based on control (i.e., master) arms operated by a person and
manipulators that guide a set of instruments to perform the intended task (master-slave system). The
consist of robotic arms used as manipulators; a workstation including the control arms, computerized
visual displays; visual, auditory, and tactile transducers; and appropriate links between the manipulat
workstation. Telemanipulation systems are mostly used to move hazardous (e.g., radioactive) materia
difficult access places; they are also used for surgical purposes.

Telemanipulation systems designed to perform surgery without physical contact of the surgeon with th
instruments (i.e., remote surgery), either in a contiguous operating room or at a distant place. These s
consist of a surgeon's workstation, including a high-resolution stereoscopic video display, instruments
operating field, and an electronic control module; a remote patient unit including robotic arms that ma
instruments that actually perform the surgery; and links (e.g., coaxial cable) that connect the patient
These systems are intended to allow surgeons to remotely treat injured patients during emergencies (
cholecystectomies, hemorrhage control, gastrostomies) for auxiliary tasks during surgical procedures
devices (e.g., a laparoscopic camera) steadier than an assistant can; to perform precise microsurgery,
hand movements and filtering out the hand tremor; and/or for other general and minimally invasive su

Telemanipulation systems designed for planning, training, and/or performing minimally invasive surgic
systems usually consist of robotic arms that replicate the surgeon's hand movements but filter out the
guiding system, and a workstation that includes a computerized processor, displays showing a three-d
simulation, and the control units operated by the surgeon. Minimally invasive surgery telemanipulatio
for use in abdominal (e.g., appendectomy, cholecystectomy) and thoracic (e.g., cardiac surgery) proce
Telemanipulation systems designed to handle objects in hazardous (e.g., radioactive, vacuum, contam
These systems typically consist of robotic arms that replicate the operator's hand movements; a work
include a video display, control arms similar to those that perform the actual manipulation, and an ele
and links (e.g., coaxial cable) that connect the remote robotic arms to the workstation. Hazardous-env
telemanipulation systems are used in closed rooms or cabinets that may be an environmental risk for

Absorbent/cotton swabs designed for vaginal procedures. These swabs typically consist of a sterilized
material that can absorb sufficient solution (e.g., prepping solution) for vaginal procedures attached to
10 in) long wood or plastic stick. Vaginal swabs are used mainly in therapeutic abortions, curettage, an

Absorbent/cotton swabs consisting of a sterilized wad and a 40 to 45 cm (15 to 18 in) extra-length wo


with a diameter appropriate for use with proctoscopes, sigmoidoscopes, and anoscopes.
Swabs that include tips (e.g., cotton, foam) presoaked with a medication. They are mostly used to app
on the skin or in the body cavities.
Specimen-collection swabs that include a sterile wad suited for good specimen recovery (e.g, rayon, c
attached to one end of a very thin (typically 0.6 to 1.0 mm) reusable metallic (e.g., aluminum, nickel-s
Ultrathin specimen-collection applicators are mostly used for sample collection in ophthalmology, ped
venereal disease screening in the urethra.
Swabs that include a sterile wad (e.g., rayon, calcium alginate, polyurethane foam) suited for good sp
firmly attached to one end of a plastic or wooden stick; they are combined with a tube (e.g., polypropy
sample contamination and to facilitate protected transportation. In some models, the swab is secured
Specimen collection/transportation swabs are used to collect samples (e.g., nose, throat, vagina speci
microbiological examination and/or culture.

Stereotactic image-guided computer-aided systems designed to provide the capability to map the thre
anatomy of the heart. They are also designed to determine the electrophysiologic data at any given m
design the ablation strategy, and then return accurately to the desired site to aid in the performance t
These systems typically consist of a cardiac catheter with electrodes and miniaturized coils at the tip,
generator located underneath the patient, a computerized unit to process the currents induced in the
catheter is moved, and a graphical display on which images are a real-time representation of the 3-D
chamber, color-coded with relevant electrophysiologic information. Cardiac mapping/ablation image-g
systems are used to improve the safety of mapping and ablation procedures through accurate localiza
structures (e.g., His bundle, atrioventricular node), allowing better definition of the mechanisms of arr
ablation strategies, and guided catheter ablation.

Tissue ablation radiofrequency therapy systems designed to ablate (i.e., produce a therapeutic lesion)
tissue that give rise to or support cardiac arrhythmia. These systems typically consist of a radiofreque
(frequencies below 500 kHz are usual), a multipolar catheter 2 to 4 mm long with distal surface or nee
and a neutral electrode that is placed on the body surface. Some systems include thermocouples at th
for temperature-controlled mode capability.
Cardiac catheters designed for mapping the three-dimensional anatomy of the heart, acquiring electro
any given mapped point; they are also used to perform cardiac ablation procedures. Mapping/ablation
typically consist of a 7 or 8 French catheter with tip and/or ring electrodes; the catheters also include
induction coils activated by external magnetic fields) that permit their external localization and naviga
procedure. Mapping/ablation cardiac catheters are components of stereotactic systems used for mapp
through accurate localization of critical cardiac structures (e.g., His bundle, atrioventricular node) and
cardiac tissue by delivering of ablation energy (e.g., radio frequency) through the electrodes.

Devices designed for the local immobilization of a portion of the cardiac wall with a minimum comprom
function during beating-heart surgical procedures. These stabilizers typically consist of a mechanism
the movement of the cardiac wall; some stabilizers include paddles with malleable suction domes tha
adjustment to the cardiac surface. Cardiac wall stabilizers are used in open or minimally invasive surg
perform coronary artery bypass grafting and other delicate procedures on the coronary arteries or on
without using cardiopulmonary bypass or interrupting the native coronary blood flow.

Instruments to separate or break up any whole into its parts, to find out their nature, proportion, func
Most analyzers are used in the clinical field for in vitro analysis in the laboratory and/or at the point of
capable of physiologic or technical parameter analysis. These instruments are not designed to take c
monitor) of the parameters that are measured or determined in their analysis.

Analyzers that are designed to be used for in vitro analysis in a central clinical laboratory, operated by
and usually permanently located on a workbench or dedicated floor space. Some laboratory analyzer
satellite laboratories and/or can be moved to other locations using a cart (e.g., blood gas analyzers).

Dedicated laboratory analyzers that perform a particular analysis using samples of body fluids (e.g., p
cerebrospinal fluid). Most laboratory body-fluid chemical analyzers require some processing before th
sample in the analyzer (e.g., centrifugation).
Laboratory analyzers that determine analyte concentrations in samples of plasma, serum, or less freq
they include analyzers used for blood gas and pH determinations. Most dedicated laboratory blood ch
require centrifugation before the introduction of the sample in the analyzer.

Laboratory blood analyzers that measure the concentration of bilirubin in serum, plasma, and/or whol
analyzers use spectrophotometric methods for measurements. Some of them can measure total biliru
insoluble) bilirubin. For neonates, direct spectrophotometric determinations can be made because no
not begun to accumulate; in other patients it is needed to add appropriate reagents to the samples be
test. These analyzers are used to determine pathologic or physiologic high bilirubin levels in neonate
concentration in children and adults to assess hepatic metabolic disorders.

Laboratory blood analyzers that measure the molar ratio of zinc protoporphyrin (ZPP) to heme (a chela
usually using a sample of whole blood. The results may be obtained directly in micromole of ZPP to m
analyzers are usually portable, dedicated hematofluorometers and are mostly used as screening devic
particularly for chronic lead disease. Analyses that determine the free erythrocyte porphyrin (ZEP) us
extraction techniques are more definitive in assessing porphyrin. ZEP and ZPP measurements are not
good correlation.
Laboratory analyzers that measure concentrations of gases in samples of plasma, serum, or whole blo
are used for measuring partial pressure of carbon dioxide (PCO2) and oxygen (PO2), usually in arterial
specimens, using two different sets of electrodes. Some laboratory blood gas analyzers also calculate
such as oxygen total content (ctO2) and bicarbonate (HCO3-). They may also perform electrolyte and/
determinations (e.g., hematocrit). Blood gas analyzers are used to determine oxygen/carbon dioxide e
diagnosis and regulation of therapy.

Laboratory blood gas analyzers which combine the capacities of both the blood gas/pH analyzers and
analyzers used in the laboratory. These analyzers can directly measure pH and partial pressure of carb
Oxygen (PO2), as well as the most common ions (i.e., sodium [Na+], potassium [K+], chloride [Cl-], bi
present in whole blood. These analyzers are used to determine a patient's acid-base balance and oxy
exchange and also to assess abnormal electrolyte levels in the blood.

Laboratory blood gas analyzers designed to be used to assess some metabolites in addition to measu
blood gas, pH, and electrolytes. These analyzers can directly measure pH and partial pressure of carbo
oxygen (PO2), the most common ions (i.e. sodium [Na+], potassium [K+], chloride [Cl-], bicarbonate [
metabolites such as calcium, magnesium, glucose, and lactate present in whole blood.

Laboratory analyzers used to perform complete blood counts, including white blood cell, red blood cel
determine hemoglobin concentration; and also to determine the red cell blood indices (mean cell hem
hemoglobin concentration, and mean cell volume). Some also include white cell differential counts. H
use several measuring methods (e.g., electrical impedance, photometric, radiofrequency conductivity
them. Some of these analyzers also determine other parameters, such as red blood cell distribution w
volume. These analyzers are used to determine abnormalities in red cell blood count (anemia and po
count (indicating infections), or platelet count (related to blood clotting). The differential count of the
population is useful in diagnosing infections and as additional information for diagnosing such disease
rheumatoid disorders.

Laboratory blood coagulation analyzers that require the human manipulative effort (e.g., manual inse
samples) in all the steps of each test; most analyzers require previous centrifugation of the sample to
samples. These analyzers include an incubation cuvette or test tube, a heating block, a manual pipet
a clot formation detector (e.g., photometric); some analyzers may be connected to printers, recorders
processing devices. Manual blood coagulation analyzers are used as primary instrumentation for sma
backups for automated or semiautomated coagulation analyzers.

Laboratory blood-grouping analyzers used to perform blood-grouping tests and process test data; they
interpretation of test results using computing programs. These analyzers are usually modular and per
reduced involvement of technicians, using automation in some discrete steps of the procedures (e.g.,
microplate reader, autosampler). These analyzers are typically used in small transfusion centers. Se
grouping analyzers increase the speed and accuracy of testing and minimize reagent use when compa
analyzers.

Laboratory breath analyzers used to determine the nitrogen (N2) content in a breath sample. These a
gas-chromatography or spectroscopy techniques. Nitrogen analyzers are mostly used to determine th
(e.g., anatomic dead space, functional residual capacity, mixing efficiency) during pulmonary function
Laboratory breath analyzers used to determine the hydrogen content in a breath sample, usually expr
million (ppm). These analyzers typically use electrochemical or gas-chromatography measuring meth
analyzers can also determine methane and/or carbon dioxide content in the breath sample. Hydrogen
mostly used to determine carbohydrate bacteriological breakdown deficiencies and malabsorption in t
to bacterial overgrowth.

Laboratory analyzers used to identify and quantify specific substances, typically using an antibody (e.
a reagent to detect the substance (i.e., antigen, hapten) of interest. A label attached to the antibody o
detection of the binding compound. The specificity and high affinity of antibodies for specific antigens
antibodies to cross-link antigens enable the identification and quantification of substances using a wid
Dedicated immunoassay analyzers are usually used for heterogeneous immunoassay analysis, while h
immunoassay analysis can be performed either in clinical chemistry laboratory analyzers or in dedicat
analyzers. Typical assays include antiarrhythmic, antibiotic, anticonvulsant, or cardiac glycoside drug
determination; endocrine hormone testing; and protein, viral, or bacterial toxin determinations.

Immunoassay analyzers that use a dedication filter photometer or spectrophotometer as a detection s


analyzers usually include an autosampler, a reagent dispenser, a washer, a filter photometer or spect
detector, and, typically, computerized data processing devices. Photometric immunoassay analyzers c
immunoassays that produce compounds that absorb monochromatic light.

Photometric immunoassay analyzers that use enzyme-labeled antigens or antibodies and a solid-phas
(e.g., beads, microtiter plates) to detect and/or quantitate the substance of interest. These analyzers c
sample dispensers, washers, and photometric readers in a single instrument. Antigen detection may b
several methods, including competitive binding, "sandwich" technique, and antibody inhibition. ELISA
immunosorbent assays) can detect nano- and picogram quantities of analytes. These analyzers are us
the quantity of antigen or antibodies associated with most infectious viral diseases (e.g., measles, her
nonviral applications (e.g., mycoplasma pneumoniae), as well as many parasitic and fungal infections

Microbiology laboratory analyzers designed to test, process, and interpret data from microbiological b
culture analyzers are available that use a variety of techniques, including detection of carbon dioxide
infrared spectrophotometry and detection of microbial activity using photometric or fluorometric meas
analyzers use microcalorimetry, pH, electrical impedance, or flow cytometry techniques. Manual analy
hospital laboratories; automatic blood culture analyzers are used mainly in laboratories that perform l
Some analyzers can detect microbial growth in body fluids.

Microbiology laboratory blood culture analyzers that require the human manipulative effort in all steps
inoculation, incubation, and examination for the presence of bacteria by either enumerating using a d
photometric, fluorimetric) or measuring a bacterial end product such as carbon dioxide. Manual blood
used in laboratories that perform a small or medium quantity of tests.

Microbiology laboratory blood culture analyzers that can detect growth and test for susceptibility of M
(e.g., the microorganisms that causes tuberculosis) using blood and/or other body fluid (e.g., sputum)
Mycobacteria species analyzers are automated dedicated analyzers with particular characteristics for
of slow-growing organisms.
Laboratory chemical analyzers that measure and characterize cells and cellular constituents.
Automated cytometers that measure the change in electrical impedance introduced by a suspension o
liquid when passing through an orifice. These cytometers include one electrode submerged in the cel
submerged in the aperture tube. The change in the impedance of the electrical path as the cells pass
pulses, which can be electronically counted and sized according to the number and volume of the cell

Refractometers used for determining the specific gravity and the amount of solute in a solution by me
refraction. These instruments usually include a monochromatic light source. Laboratory refractomet
the field of medicine to measure the concentration of analytes, such as total proteins in plasma and to
Some laboratory refractometers include temperature-compensation chambers to make corrections in
according to the room temperature.

Dedicated laboratory refractometers that usually directly indicate the refractive index, the specific gra
plasma protein contained in the urine sample.
Oximeters designed for determination of only a small number of critical parameters (e.g., oxygen satu
hemoglobin) at the point of Care. These oximeters use smaller whole-blood samples and are simpler
laboratory oximeters, while producing fast and reasonably accurate results. Point-of-care oximeters a
surgical suites, cardiac catheterizations areas, critical care rooms, and the patient's bedside.

Catheters designed for insertion within the blood vessels. These catheters are usually long with dista
tapered and with curved proximal ends bonded to hubs or connecting devices. Their distal tips can be
balloons or sensing devices or by placement of holes for injection of fluids (e.g., drugs, contrast mater
may be stiff or flexible and ideally would be nonthrombogenic, strong, flexible, and bio-compatible. Th
their preshaped tip configuration (i.e., have memory) and permit torque control. Most vascular cathet
polymers (e.g., silicone elastomer, polyurethane) and may also include metals (e.g., stainless steel). V
used in therapeutic (e.g., drug infusion, angioplasty) and diagnostic (e.g., angiography, pH and cardia
measurement) procedures.

Vascular catheters used to infuse blood, fluids, electrolytes, medications or parenteral nutrition solutio
also used to monitor arterial blood gases or central venous pressure and to withdraw blood samples.
be located for permanent use (i.e., indwelling catheters), during short periods (several days), or speci
term (weeks, months, or even years) use.
Infusion catheters designed for insertion in the peripheral vasculature (typically in the basilic or cepha
enough to advance and locate their distal tip in the proximal portion of the extremity (e.g., upper arm
is not needed. The length of these catheters is typically 10 to 20 cm (4 to 8 inches), and they are usu
elastomers (silastics) or polyurethane. These catheters may be inserted using a variety of techniques
breakaway needle introducer, through an over-the-needle catheter, or over a guidewire using the Seld
Midline infusion catheters are usually used for several-week-long (typically two to four weeks) indwell
also be used for short terms. They are used for peripheral therapies needing greater hemodilution, us
near-isoosmotic solutions.
Central venous infusion catheters that are usually inserted into the external jugular or cephalic vein v
or more frequently by a percutaneous approach using the Seldinger technique. The catheter is tunne
entry site or tunneled away from the insertion site, depending on the type of catheter used. The inse
closed and the catheter is anchored in a place at the exit site with a suture, so it has a protruding seg
of the chest. The length of these catheters is typically 55 to 90 cm (22 to 35 inches), and they usually
elastomer (silastic) or polyurethane radiopaque tube of 0.22 to 0.32 mm diameter that includes one o
about 30 cm (12 inches) from the hub and a Luer lock at their proximal end. Tunneled central venous
long-term (weeks, months, or even years) hyperalimentation and fluid administration in patients with
disease, intestinal malabsorption syndrome) or any other conditions that prevent them from taking in
nutrients to maintain life. They are also used for administration of chemotherapy, antibiotics, transfus
patients who need prolonged intravenous support.

Central venous infusion catheters designed for direct insertion into the selected vein (typically, the su
jugular veins are used). The distal tip is usually advanced to the superior vena cava. The length of the
typically 20 cm (8 inches) for adult use, but may be 15 cm (6 inches) for smaller adults and even sma
Some 30 cm (12 inch) versions are used for left subclavian insertions and for larger adults. The Seldi
technique is the most common insertion method used. These catheters are used for short-term period
needs.

Perfusion vascular catheters designed for retrograde cerebral perfusion with oxygenated cold blood. T
typically consist of a 9 Fr two-lumen tube with several side holes and a balloon attached at its tip. The
into the internal jugular vein (IJV) via a puncture in such a way that the holes remain in the IJV so they
jugular-subclavian junction. The catheter is advanced until the inflation of the balloon at its tip occlud
(superior vena cava and azygos vein). These catheters are used for brain protection during profound
circulatory arrest during aortic surgery. Other techniques employing transatrial vena caval cannulae a
perfusion.

Vascular catheters that allow both blood perfusion through the central conduit and simultaneous fluid
infusion through and independent lumen. These catheters are used for extended local drug delivery i
patients while avoiding organ ischemia.
Infusion/perfusion catheters designed for local delivery of drugs (e.g., heparin) to the coronary vascula
simultaneous distal perfusion. These catheters typically consist of a triple-lumen shaft, including a no
inflation coil at their distal end, wrapped around a short (typically 2 cm) tubular sheath. One lumen se
port for the coils. When inflated, the coils expand against the vessel wall, opening the inner tubular s
creating a passage for blood flow. The coils form a series of closed compartments that are isolated fro
bordered by the vessel wall, the coils, and the tubular sheath. A drug solution is infused into these co
second lumen and bathes the vessel wall. A third lumen serves as a passage for a guide wire. These
used for extended (e.g., 30 minutes) local drug delivery (e.g., heparin) into the coronary vasculature
angioplasty with potential beneficial impact on both platelet deposition and smooth muscle cell prolife
used in the lysis of thrombus.
Atherectomy angioplasty catheters that cut or shave atheroma and directly remove the excised mater
using a collection chamber or suction port. These catheters typically consist either of a semiflexible c
a cup-shaped cutter that slices atheroma at the center of a nonflexible housing, and an opposing dilat
the plaque through a window into the metal housing during each cut (directional atherectomy); or of a
controlled, hollow catheter that includes an introducer sheath over a central guide wire for proper alig
atherosclerotic lesion, a rotating cone-shaped cutter in a housing unit to shave the plaque, and a colle
situated at the proximal end of the catheter (transluminal extraction catheters). Extirpative atherecto
mostly used for treating short, discrete, eccentrically placed atheroma, including calcific eccentric ste
amenable to balloon dilatation.

Balloon angioplasty catheters designed for percutaneous transluminal coronary angioplasty that are c
of drugs either before, during, or after dilatation of the lesion. These catheters may deliver the drugs
techniques, including: (1) porous balloons with laser-drilled holes to deliver the drugs; (2) two-balloon
the segment of the lesion permitting its filling with the drug; (3) injection of nanoparticles loaded with
of drug-coated balloons (also known as drug-eluting balloons). Drug delivery coronary balloon cathete
administration of concentrated drugs directly to the site of arterial injury during coronary angioplasty

Balloon angioplasty catheters that include an ultrasonic transducer mounted proximal to balloon for im
combine the capabilities of balloon angioplasty catheters and ultrasonic image vascular catheters. Th
supplied in a standard 5.5 Fr model and also in a lower profile version of 3.5 Fr; both over-the-wire and
available. Combined balloon angioplasty/ultrasound image catheters permit ultrasound guided angiop
catheter, avoiding repeated exchanges after each successive balloon inflation. These catheters are m
percutaneous transluminal coronary angioplasty to modify the dilatation strategy by obtaining intrava
quantitative information (e.g., lesion calcification, eccentricity, accurate lumen dimension) compleme
from angioplasty; they can also quantify the true degree of residual stenosis and plaque burden after
have important implications for restenosis.

Angioplasty catheters that use energy (e.g., laser, radiofrequency [RF], microwave) to heat a metal ca
tip of the catheter and/or a metal band around the catheter. They are used for thermal compression a
atheromatous plaque inside the vessels, except for heavily calcified plaque. Tip temperatures can exc
Celsius, allowing plaque to be vaporized, melted, or otherwise reformed. Thermal angioplasty cathete
open total occlusions or high-grade stenoses in peripheral arteries; they may also be used to facilitate
based on the assumption that RF ablation improves clinical success and reduces the rate of complicat

Hot-tip angioplasty catheters that usually include either a metal cap enclosing the distal tip, with prov
guide wire, or a band around the catheter. The catheter receives laser energy from a laser generator
attached to the catheter's proximal tip.
Angioplasty catheters that use ultrasonic energy for ablation of atheroma. These catheters typically c
7 to 9 Fr tube that includes a 1.5 to 2.6 Fr solid-wire ball-tipped probe with an ultrasonic transducer at
irrigation channel to cool the ultrasound probe. Ultrasonic angioplasty catheters may be used to open
high-grade stenosis in arteries, including calcified arteries; they may also be used to facilitate balloon
Vascular catheters designed to perform embolectomy/thrombectomy procedures using an inflatable b
tips. They are introduced into a vessel (i.e., artery, vein) and passed as far as possible through the em
thrombus; the balloon is inflated and then withdrawn, bringing out the clot with it. Balloon embolectom
catheters typically consist of a 2 to 7 French single-lumen silicone tube with a rounded distal tip that i
balloon; some catheters include a second lumen for drug (e.g., heparin, dye) injection proximal to the

Balloon embolectomy/thrombectomy catheters designed for use in the arteries. These catheters usua
distal tip to facilitate arterial insertion and minimize trauma and arteriopuncture. They are not design
venous valves. Arterial balloon embolectomy/thrombectomy catheters are used for retrograde extrac
and big diameter arteries, including aorta and iliac arteries.

Embolectomy/thrombectomy double-lumen catheters that inject a high-velocity liquid (e.g., saline solu
distal tip, creating a hydrodynamic vortex. As a consequence of the pressure reduction (Venturi effect
embolus is sucked, fragmented, and removed, typically into a collection bag. These catheters are des
thrombus and/or embolus material, thereby reducing the risk of embolization, restoring the flow, and
visualization of the disease area. There are several versions of the hydrolysis catheters, including 6 Fr
and 7 Fr for use in peripheral arteries, bypass grafts, and dialysis shunts.

Embolectomy/thrombectomy catheters designed to pulverize (i.e., fragment) a clot into particles. The
include an external handheld motor drive that spins a rotating device (e.g., an expandable open-wire
located at or near the distal tip of the catheter. The resultant slurry may be aspirated through the cath
dissolved using a thrombolytic agent.
Embolectomy/thrombectomy catheters that aspirate and liquefy the thrombus and recirculate the par
to that of a blender, progressively reducing the size of the particles (typically to less than 13 um). The
an impeller at their distal tip, mounted on a drive shaft in a metal housing that has sideports for recirc
is driven by an external motor at high speed (typically 150,000 rpm). Blending embolectomy/thrombe
well in cases of recent thrombosis, particularly in polytetrafluoroethylene grafts.

Occlusion vascular catheters designed to interrupt the blood flow in an artery during a limited period o
some minutes to several hours. These catheters typically consist of a double-lumen tube with a diste
distal tip and side holes that are used for pressure recording and drug injection. Some of these cathet
balloons (one for guiding and the other for occlusion) and several lumens to increase their capabilities
pressure, inject pharmacologic agents). Occlusion catheters are mostly used for temporarily fast inter
flow during emergencies (e.g., aneurysm rupture); in some radiographic, fluoroscopic, or surgical proc
resection; or in carotid occlusion for determination of cerebral blood flow.

Occlusion vascular catheters designed to interrupt blood flow in a vessel (i.e., embolization of an arter
These catheters occlude the vessels by introduction of occlusion devices, such as detachable balloon
or embolization microspheres. Permanent occlusion catheters are used in the treatment of spinal, cer
peripheral vascular lesions (e.g., inferior vena cava occlusion); they are also used for embolization of t
treatments such as arteriovenous malformations, carcinomas, ectopic pregnancy, and fibroid tumors.
Angiographic vascular catheters designed to inject contrast media in the great vessels of the neck and
arteries. These catheters usually have three separate curves and variations in the distal curve are ne
of the appropriate vessel; their distal tip may include a taper. Thin, flexible catheters with balloon tips
extremely selective angiography; in some cases, microballoons that follow blood flow are used in sma
Cerebral angiographic vascular catheters are used in the diagnosis of both extracranial and intracrani
diseases.

Angiographic vascular catheters designed to inject contrast media in branch vessels originating from t
these catheters have three curves: a primary curve convex in one direction, a secondary curve convex
direction, and a short tip angled in the same direction as the primary curve. This configuration is inten
positioning the catheter into a branch vessel originating from the aorta (e.g., superior mesenteric arte
different angles. These catheters must have very good torque control and memory to facilitate their m
Visceral angiographic vascular catheters are used in diagnosis of the abdominal organs and also in m
examinations or treatments (e.g., chemotherapy) by selective introduction into secondary or tertiary b
vessels.

Angiographic vascular catheters designed to inject a large bolus of contrast media into the aorta, min
injection. Typically, these catheters include a long, tapered pigtail configuration to reduce the flow of
the end hole; they have several side holes near the tip for even dispersion of the contrast medium. P
catheters are used to visualize the distal aorta, the iliac and femoral arteries, and other secondary ves
circulation in the lower limbs.

Vascular catheters designed to inject contrast medium into the biliary (sometimes also into the pancre
radiographic examination purposes (cholangiography). These catheters usually consist of a 6 or 7 Fr t
needle that is advanced through its lumen. The catheters are usually introduced through the jugular v
inferior vena cava, and into the hepatic veins; the contrast medium is introduced into the bile tree by
wall of the hepatic vein. Cholangiography vascular catheters are used as an alternative to percutaneo
patients with abnormal blood clotting or massive ascites.

Vascular catheters designed for the removal of tissue from the lumen or walls of a vessel through the
These catheters typically consist of an 8 or 9 Fr tube with surgical forceps on the proximal end affixed
within the catheter shaft to permit opening and closing of a pair of jaws at the distal tip. They are typ
through the jugular vein (e.g., pulmonary artery biopsy) or the femoral arteries (e.g., vena cava, iliac
vascular catheters are mostly used for differential diagnosis of purely intraluminal masses (e.g., to diff
thrombus). These catheters are also used frequently for retrieval of foreign objects.

Vascular catheters designed for the removal of tissue from the liver through the vascular system. The
consist of a 9 Fr plastic tube with a biopsy needle that is advanced through its lumen; the needle frequ
hollow stylet within it to prevent aspiration of the sample into the syringe. They are usually introduce
vein, advanced to the inferior vena cava, and to the hepatic veins; the needle is plunged into the liver
continuous motion while suction is maintained with a syringe. Contrast medium should be injected af
attempt to check for liver capsule perforation. Liver biopsy catheters through the vascular system are
to percutaneous biopsy in patients with abnormal blood clotting or massive ascites.
Hemodialysis catheters designed for direct insertion into a central vein, using surgical procedures. Th
consist of a silicone rubber (silastic) tube with several lateral holes; they are inserted and advanced to
a central vein, typically the superior vena cava or the right atrium (through the subclavian or internal
punctures), or less frequently in the inferior vena cava (through femoral insertion). Central venous ca
temporarily in the case of temporary but reversible access difficulties, acute renal failure, plasmapher
dialysis treatment for acute poisoning. They are also permanently implanted for regular hemodialysis
when the peripheral vasculature may be or become unsuitable, or when the arteriovenous fistula is no
preexisting cardiovascular diseases).

Central venous hemodialysis catheters that consist of two (usually parallel) lumen tubes. These cathe
inserted via the subclavian route and advanced to the superior vena cava, but sometimes the jugular
as an alternative.
Umbilical vascular catheters designed for insertion in an umbilical vein and are long enough to advanc
distal tip in a central vein, usually the inferior vena cava or the inferior vena cava right-atrial junction.
typically consist of a silicone elastomer (silastic) or polyurethane single- or double-lumen tube about 3
length and 5 Fr in diameter. Central venous umbilical catheters are used for quick central venous acc
neonates for emergency infusions, exchange transfusions, or central venous pressure monitoring.

Umbilical vascular catheters designed for insertion in the umbilical artery and are advanced to locate
thoracic aorta or, less frequently, in the abdominal aorta (usually in a high-level location T5 to T12 or
to L5). These catheters typically consist of a single-lumen tube or 5 Fr for large infants and 3.5 Fr for s
arterial catheters are used for blood gas monitoring (e.g., blood oxygen), infusion of liquids (e.g., gluc
and blood sampling; they are sometimes also used for blood transfusion, parenteral nutrition, and hyp

Vascular catheters designed for invasive measurement of blood pressure (BP) by means of a fluid-fille
connected to an external fluid system, which includes a pressure transducer. The electric signal from t
processed and the values of the maximum and minimum BP (i.e., systolic and diastolic pressures) are
monitor also displays the BP waveform (i.e., variation of pressure with time) and the mean pressure va
algorithm. Hydraulic BP vascular catheters are used mainly during intensive care and surgical procedu

Blood pressure vascular catheters that consist of a tube with a miniature pressure transducer at its dis
sends the electrical signal to a monitor that displays the maximum and minimum blood pressure value
diastolic pressures); most also display a mean pressure value calculated from the measured values us

Vascular catheters designed for continuous in vivo measurement of arterial blood gases and pH witho
These catheters include an optical fiber that conducts light and interacts with the indicator (either is a
causes fluorescence); the magnitude of the change in the light characteristics depends on the concen
the substance being measured. Blood-gas/pH-monitoring catheters use a detector that combines an o
fluorescent dye; the detector may be used either on the distal tip of the catheter as an intraarterial ga
extraarterial system within a sensor cassette that is inserted in series with the arterial catheter tubing
patient's wrist. Three detectors are needed for pH, PO2, and PCO2 measurements. These catheters m
continuous arterial monitoring of blood gases and pH to improve management and treatment in critica
Catheters designed to measure the temperature and light reflectance in arterial blood after a cold dye
indocyanine green) is injected into the right atrium using a dye-dilution cardiac catheter. These cathe
a 4 Fr tube including a fiberoptic (to detect reflected and scattered light at the catheter tip) and that a
near its distal tip; they are usually placed in the aorta via a femoral artery. Fiberoptic-thermistor cathe
bedside determination of intravascular volume (e.g. cardiac output, intrathoracic blood volume) after
critically ill patients.

Vascular catheters that include ultrasound transducers at or near their distal tips. These catheters are
intravascular images of the vasculature or to determine the flow velocity according to the Doppler freq
some of them have been used in angioplasty procedures. Catheters that combine ultrasound capabili
techniques (balloon angioplasty, atherectomy) are also used, most of them in coronary catheterization

Ultrasound vascular catheters designed for intravascular imaging of blood vessels (e.g., coronary arte
arteries). These devices usually include an ultrasonic phased-array transducer, typically operating at
30 MHz, mounted on or near the distal tip of a thin-lumen catheter (e.g., 5 Fr). More rigid catheters in
employing a mechanical transducer rotation of the ultrasound beam are also used. Ultrasound image
used for in vivo qualitative and quantitative assessment and measuring luminal dimensions of vessels
to characterize the thickness of plaque and, to some extent, the plaque composition (i.e., atheroma, c
media) in atherosclerotic vessels.

Ultrasound vascular catheters designed to determine blood-flow velocity by measuring the ultrasound
between the transmitted and reflected signals (i.e., Doppler principle). These catheters typically cons
with a ceramic crystal that is capable of transmitting and receiving ultrasound signals (20 MHz freque
attached at or near the distal tip. Two wires attached to the crystal are connected at the proximal end
flowmeter. These catheters usually include an infusion lumen and/or an additional lumen for a guide w
ultrasound catheters are used mainly to measure coronary hemodynamics (e.g., blood mean and peak
coronary catheterization.

Guiding vascular catheters designed to facilitate access to the coronary arteries. These catheters (also
cardiovascular guiding sheaths) usually consist of a 6 to 9 Fr thin plastic (e.g., polyurethane) tube that
nontapered tips with radiopaque extensions. Catheters of 7 to 9 Fr diameter are usually introduced us
approach; 6 Fr diameter catheters may be introduced through an upper limb (e.g., transradial or trans
Coronary artery guiding catheters are used for percutaneous coronary and/or graft angioplasty, to pla
to introduce devices for other interventional coronary procedures (e.g., atherectomy). Dedicated coron
guiding catheters are also used in a variety of intravascular (e.g., peripheral, central venous) introduc
procedure kits and trays.

Vascular catheters designed to retrieve foreign bodies (e.g., catheter tips, guide-wire fragments, stent
debris) from the central or peripheral vessels or from the heart. Several different catheters are used f
foreign objects, including loop snare, helical basket, hooked, pigtail, grasping forceps, and modified m
catheters. These catheters are used for recuperation of foreign bodies using percutaneous techniques
surgical removal.

Vascular retrieval catheters that consist of end-hole catheters, which include a core wire. A set of four
are joined at their distal tip and attached to the core wire, forming a flexible basket-like structure. The
mostly used in children and in smaller vessels because of their small outside diameter; the embolized
present a free end for effective ensnarement.
Vascular retrieval catheters that include forceps for grasping and removal of foreign objects. These ca
flexible forceps mounted on a small-lumen (e.g., 3 Fr) stainless steel shaft; single-tooth (rat tooth) and
(alligator type) forceps are available. Grasping retrieval catheters can grab an object any place along
the middle portion, eliminating the need for repositioning of the object as an initial stage to the proce
catheter immediately adjacent to the foreign body before exposing the forceps is recommended to mi
vascular injury.

Cardiac ablation catheters that use radio-frequency (e.g., 482 or 500 kHz) energy to destroy target en
catheters typically consist of a 7 Fr multipolar (e.g., quadripolar) catheter with a distal electrode lengt
neutral electrode is placed on the body surface. Some of these catheters are operated in power contro
catheters may include a thermocouple in their tip for temperature-controlled mode capability or an irr
continuous cooling of the tip. Radio-frequency ablation catheters are mostly used for treatment of atri
reentrant tachycardia, accessory pathways, and atrioventricular junction ablation.

Cardiac catheters designed to allow contrast material to be flushed, hand injected, or power injected w
volume to opacify cardiac and/or coronary artery structures during fluoroscopy and radiography. Thes
available in a multitude of tip configurations, from simple straight tips with a single end hole to compl
numerous side holes. Angiographic cardiac catheters are used in combined hemodynamic and angiog
undertaken for diagnostic purposes (cardiac catheterization), to confirm the presence of a clinically su
to define the anatomic and physiological severity of the condition.

Angiographic cardiac catheters available in two basic curve designs (i.e., right and left coronary artery
sizes to accommodate variations in the size of the aorta. These catheters include specific tip configur
coronary arteries and usually have an end hole and few side holes. Typical injection rates are low (e.g
of these catheters are introduced through either the femoral or the brachial artery. Coronary artery an
are used for coronary angiography and for saphenous vein or internal mammary artery bypass graft a
angiography is indicated for coronary atherosclerosis assessment, to confirm the presence of congenit
anomalous origin of the coronary arteries), and in patients with chest pain of uncertain cause.

Angiographic cardiac catheters available in several designs (e.g., pigtail, Gensini) that usually include
multiple side holes for the release of contrast material at high injection rates (e.g., 60 mL/sec). These
designed for the nonselective opacification of cardiac chambers and large vessels. High-flow angiogra
used to perform pulmonary angiography via the brachial or femoral approach or to opacify the aorta,
the vessels that arise from the aorta (aortography).

Cardiac catheters designed for catheterization of small-lumen (typically of less than 1 mm) cardiac va
catheters typically consist of 1.5 or 1.8 French tubes that are directed using the cardiac venous system
vasculature. Some of these catheters include hydrophilic coating for easy movement, as well as mini
distal tip. These catheters are used for electrophysiologic studies and in the diagnosis and/or treatme
tachycardia.

Septostomy cardiac catheters that perform the opening by the repeated jerking of a controlled inflate
through the interatrial septum. These catheters usually consist of a single- or double-lumen (for blood
of contrast medium) tube with a tough balloon affixed in their distal tip.

Septostomy cardiac catheters used to enlarge the interatrial defect when the balloon septostomy cath
big enough. These catheters include a retractable surgical blade attached to their distal tip and actua
wire.
Valvuloplasty cardiac catheters designed for use in procedures such as nonsurgical dilation of stenotic
catheters are typically constructed with a coaxial double-lumen tube with a manually controlled inflata
(typically 22 to 26 mm circular section diameter) balloon in their distal tip; the second lumen is usuall
and/or for pressure measurement.
Valvuloplasty cardiac catheters that usually consist of a coaxial double-lumen tube with a manually co
elliptic balloon (typically 15 to 25 mm section diameter) on their distal tip. Typically, two guide wires
heart (e.g., left atrium). Then, one valvuloplasty catheter is advanced over one of the guide wires and
valve (e.g., mitral valve); a second valvuloplasty catheter is then passed parallel to the first catheter,
wire. The two valvuloplasty catheters are then inflated simultaneously, until the indentation of the ba
stenotic valve disappears. Double-balloon valvuloplasty is mostly used for nonsurgical dilation of sten

Valvuloplasty cardiac catheters that usually consist of a tube carrying two side-by-side balloons (bifoil
cm long, that can be inflated separately or at the same time and include a pigtail tip. Typically, a guid
inserted and advanced into the heart (e.g., left atrium). Then, the bifoil-balloon catheter is advanced
and directed across the stenotic valve; both balloons are inflated quickly to a predetermined maximal
thereby enlarging the valve orifice. Bifoil-balloon valvuloplasty catheters are mostly used for nonsurg
mitral valves.

Cardiac catheters designed for intracardial recording of the electrical activity of the heart (i.e., cardiac
These catheters usually consist of a 7 or 8 Fr flexible plastic tube including a multielectrode distal tip;
variety of curve types, spacings, and numbers of electrodes. Electrophysiology cardiac catheters are
symptoms (e.g., complex arrhythmias), assess risks, and design treatments.

Cardiac catheters designed for the removal of tissue from the heart through the vascular system (e.g.
biopsy). These catheters typically consist of a 7 or 8 Fr tube with surgical forceps on the proximal end
wire within the catheter shaft to permit opening and closing of a pair of jaws at the distal tip. They ar
through the jugular vein (right ventricle biopsy) or the femoral arteries (left ventricular biopsy). Biops
mostly used for the detection of, and evaluation of response to treatment of, rejection after cardiac tra
also used in patients with other suspected cardiomyopathies (e.g., suspected myocarditis, primary car
chemically induced myocardiopathy). These catheters are also frequently used for retrieval of foreign

Catheters designed for use within the spinal column (i.e., columna vertebralis), particularly to infuse a
or steroid substances. These devices are typically large-bore silicone rubber catheters. Most spinal ca
management of intractable pain or spasticity and in regional anesthesia for labor, delivery, and during
procedures.
Spinal catheters introduced into the subarachnoid space through the membranes (sheath or "theca")
cord. These catheters are introduced using special needles, and their distal tip is advanced into the s
the desired spinal segment (e.g., lumbar). Intrathecal spinal catheters may be tunneled, using either
hub or a subcutaneous port for bolus administration or infusion via an external pump; these systems a
procedures (e.g., surgery, delivery) or in patients whose life expectancy is very short. Otherwise, the
attached to subcutaneous implanted infusion pumps for continuous infusion in relatively long-term pro
treatments of spasticity (using antispasmodic drugs such as baclofen) in spinal injured patients, or op
administration to cancer patients with long life expectancy. Intrathecal catheters usually employ sma
epidural catheters.

Intrathecal spinal catheters used for continuous or repeated injection of local anesthetics into the sub
anesthetize sensory nerves from the lower limbs, pelvis, or abdomen. These catheters are used in su
sometimes may also be used for diagnostic or temporary relief of chronic pain of the limbs, pelvis, abd
spine.
Intrathecal spinal catheters designed for introduction into the part of the spine between the thorax an
lumbus).
Intrathecal lumbar catheters designed to drain cerebrospinal fluid (CSF) from the lumbar subarachnoid
catheters are usually small-internal-diameter (e.g., 0.7 mm) silicone elastomer tubes; they are availab
(intended to reduce the risk of migration) or straight tubes. Lumbar hydrocephalic catheters are typic
a valve and/or a reservoir to another catheter that drains the CSF in the peritoneum; these devices as
lumboperitoneal shunts. These catheters are used as part of a lumboperitoneal shunt in treating child
obstruction of the CSF pathways, accompanied by an accumulation of CSF within the skull (hydroceph
benign intracranial hypertension treatment.

Catheters designed for introduction into the body case containing the brain (cranium), excluding the i
the bones of the face.
Peritoneal catheters designed for nonsurgical percutaneous drainage of abdominal abscesses and fluid
noninfected) collections. Many different catheter and catheter/trocar drainage assemblies have been
use; their utility for specific clinical application depends on the size of the collection, the nature of the
of safety of the access route. These catheters are mostly used for drainage of liver, subphrenic, subh
abscesses and fluids.

Percutaneous drainage peritoneal catheters which include a second-sump lumen that permits ingress
allow the use of positive suction and prevents adherence of the side holes to the wall of the abscess; m
additional lumens (e.g., for simultaneous irrigation). The main lumen usually consists of a large bore
facilitate complete aspiration of the cavity content and large side-hole apertures that assure ready flo
material. Multiple-lumen peritoneal catheters are mostly used for drainage of clinically evident pus w
volume of the collection is large (e.g., more than 100 ml).

Percutaneous drainage peritoneal catheters with a relatively small internal lumen (e.g., 10 Fr) and side
catheters are very flexible and easy to insert; they are used to drain nonviscous fluids, such as loculat
(ascites) and encapsulated bile (bilomas), from the abdominal cavity. Some even smaller caliber (e.g.
length catheters may be useful for limited drainage using a trocar-puncture technique when collection
less than 100 ml, or as secondary catheters placed with a multiple-lumen sump catheter.
Peritoneal catheters designed to visualize the peritoneal cavity, especially the pelvic peritoneal cavity
typically consist of a 5.5 Fr small rigid tube including a bundle of optic fibers; they are attached at the
light source and an eyepiece, which can be connected to a video camera and monitoring system. Opt
catheters can be used for outpatient laparoscopic diagnosis in office settings; they are mostly used in
gynecologic diagnosis procedures.

Biliary catheters designed to drain bile, usually from obstructed biliary ducts. These catheters typical
relatively small internal lumen (e.g., 10 Fr) silicone tube. Typically, suction is applied through the cath
drainage.
Drainage biliary catheters that are introduced into the biliary ducts, usually though a curved-tip guide
using a needle and/or sheath. Typically, the needle/sheath is advanced under fluoroscopic guidance t
(percutaneously), liver capsule, and parenchyma before entry into the intrahepatic biliary ducts.

Percutaneous drainage biliary catheters that are connected to an external drainage bag, permanently
are frequently used until internal drainage using a stent, endoprosthesis, or surgical procedure is acco
combining these catheters with percutaneous endoscopic gastrostomy has been used to drain bile int

Percutaneous drainage biliary catheters that include multiple side holes in the catheter proximal and d
allowing internal drainage of bile through the catheter into the duodenum. Some of these catheters h
configuration on their distal tip to anchor them to the duodenum and prevent withdrawal. Typically, a
percutaneous catheterization, external drainage is established (e.g., for 24 hours). Internal drainage i
by closing the stopcock to the outside so that bile can flow through the internal catheter to the duode
obstruction.

Biliary catheters designed to retrieve foreign bodies (e.g., catheter tips, guide wire fragments, stents,
gallstones from the biliary tree or pancreatic ducts. Several different catheters are used for retrieval,
helical basket, hooked, grasping forceps, and balloon tipped. These catheters are used for recuperatio
and gallstones using percutaneous techniques that obviate the need for surgical removal.

Retrieval biliary catheters designed for extraction of calculi from the biliary tree. These catheters incl
tip that incorporates a balloon; typically, they are 2 mm in diameter when the balloon in uninflated mo
diameter at maximum inflation. Gallstone extraction catheters are introduced into the common bile d
and/or the major hepatic biliary radicles (e.g., through a choledochostomy) and advanced past any ca
duct. The balloon is then inflated and gently withdrawn, bringing the stones with it. Gallstone extract
mostly used for extraction of intrahepatic duct stones; they may also be used for retrieval of foreign b
tree.

Cholangiography catheters that are introduced through the lumen of a duodenoscope. These cathete
lumen (e.g., 5 Fr); they are mostly used in endoscopic retrograde cholangiopancreatography (ERCP) pr
demonstrate all portions of the biliary tree.
Biliary catheters designed for elimination of areas of narrowing (i.e., strictures) in biliary ducts, thereb
Some stricturoplasty catheters consist of multilumen tubes that may allow cannulation, guide wire ad
of contrast, and balloon dilatation.
Stricturoplasty biliary catheters that are introduced into the biliary ducts through a curved-tip guide w
using a needle and/or sheath. Typically, the needle/sheath is advanced under fluoroscopic guidance t
(percutaneously), liver capsule, and parenchyma before entry into the intrahepatic biliary ducts.
Percutaneous stricturoplasty biliary catheters that include molded, plastic, tapered tips. These cathet
small or moderate biliary stricture dilatations; further dilatations require the use of balloon catheters.

Percutaneous stricturoplasty biliary catheters that include a balloon that can be inflated with air, wate
or near their distal tip. The procedure is generally started with a small-caliber balloon (e.g., 4 to 6 mm
progresses up to an 8 to 12 mm ballon, depending on the bile duct diameter. These catheters are mo
benign strictures of the biliary tree; their use is frequently followed by placing of stents.

Stricturoplasty biliary catheters that are introduced into the biliary ducts through the lumen of a duod

Percutaneous stricturoplasty biliary catheters that include molded, plastic, tapered tips. These cathet
small or moderate biliary stricture dilatation; further dilatations require the use of balloon catheters.

Percutaneous stricturoplasty biliary catheters that include a balloon that can be inflated with air, wate
or near their distal tip. The procedure is generally started with a small-caliber balloon (e.g., 4 to 6 mm
progresses up to an 8 to 12 mm ballon, depending on the bile duct diameter. These catheters are mo
benign strictures of the biliary tree; their use is frequently followed by placing of stents.

Biliary catheters designed to determine the length of stenting and for stent insertion. These catheters
6 Fr diameter Teflon tube of more than 200 cm in length that includes radiopaque bands at regular int
tip. Guiding biliary catheters are also used for drainage in benign and malignant strictures of the bilia
ducts.
Catheters designed to be introduced into the nostrils that are long enough to keep the distal tip inside
including the nasal sinuses. These devices are typically a soft plastic or rubber tube that may include
its distal tip. Dedicated nasal catheters are available to control nose bleeding, to supply oxygen, and t
passages (usually introduced through nasal endoscopes).
Nasal catheters designed to control nose bleeding (epistaxis). These catheters usually consist of a sin
with a balloon attached near its distal tip. Some of these catheters include a sponge and an integral a
patient breath while the catheter is in place. Some other nasal hemostatic catheters consist of a doub
a balloon attached to each distal end to be used simultaneously in both nasal cavities. Double-balloon
catheters have also been used for stabilization of zygomatic arch fractures.

Nasopharyngeal catheters designed for delivery of oxygen into the pharynx. These catheters typically
plastic or rubber tube with an internal diameter of 2 to 4 mm that usually has end and side holes. Ox
catheters are mostly used for short-term oxygen administration (e.g., in the immediate post-operative
ill patients).
Catheters designed for insertion into the biliary tree while their proximal tip is externally brought out t
These catheters are usually inserted through the lumen of a duodenoscope over a guide wire and adv
ducts, where they are held in position usually by means of their pigtail distal tips. The catheter is then
feeding tube previously inserted through a nasal passage and brought out through the mouth; the fee
withdrawn, leaving the nasobiliary catheter in position. Nasobiliary catheters may be used for drainag
attaching their external tip to biliary drainage bag systems, which function by gravity, to inject contra
biliary ducts (sometimes also into the pancreatic ducts) for radiographic examination purposes (chola
after stricture dilatation.
Catheters designed for insertion through the nose into the upper gastrointestinal tract. The proximal
their distal tip is advanced into the esophagus, stomach, or duodenum. Nasogastric catheters are use
drugs, contrast medium), injection, and irrigation; they can also be used for biopsy by passing a biops
lumen.
Nasogastric catheters used for the injection of liquids (e.g., drugs) into the small bowel. These cathet
a 13 Fr diameter tube with several side holes and a closed, rounded distal end, with or without a ballo
enough to advance and locate their distal tip into the duodenum. Enteroclysis nasogastric catheters a
introduce barium directly into the small bowel for radiographic examinations; they may be also used f
medicines or nutrients.

Nasogastric catheters designed for injection into bleeding lesions in upper gastrointestinal locations (i
stomach, duodenum). These catheters usually include a retractable needle with several-millimeter ex
are inserted through a standard diagnostic endoscope. Injection nasogastric catheters are used for ad
sclerosing solutions (e.g., polidocanol) and vasoconstrictors (e.g., adrenaline) in the treatment of esop
peptic ulcers.

Nasogastric catheters designed to introduce nondrug fluids into the esophagus or stomach. These ca
of a single-lumen tube with end and/or side holes at their distal port; the proximal port is connected th
syringe or water pumping system. Irrigation nasogastric catheters are used for stomach lavage proce

Nasogastric catheters designed for both injection of bleeding lesions in and irrigation of the upper gas
These catheters consist of a double-lumen tube, typically 160 cm in length and 2.3 to 2.7 mm in diam
contains a retractable needle with several-millimeter extrusion capability; irrigation is delivered via a
Injection/irrigation nasogastric catheters are used for administration of sclerosing solutions (e.g., polid
vasoconstrictors (e.g., adrenaline) in the treatment of esophageal varices and peptic ulcers.

Nasogastric catheters designed for indirect measurement (i.e., tonometry) of the partial pressure of ca
the internal gastric mucosa. These catheters consist of a gas-impermeable sampling tube (usually wit
a gas-permeable balloon attached at its distal end. The gas-permeable balloon is withdrawn after pres
reached, then its content is externally measured with a blood-gas analyzer. Some catheters designed
monitoring allow for periodic extraction of gas samples. The intramucosal pH may be also calculated
PCO2 value and the bicarbonate concentration in a contemporary sample of arterial blood. Tonometry
are used to facilitate assessment of gastrointestinal perfusion during some surgical procedures and in
unstable, critically ill patients.

Catheters designed for insertion into the nose or mouth that are advanced thorough the larynx and ph
distal tip in the trachea.
Catheters that are designed for percutaneous or surgical insertion into the trachea to the lung bronch
catheters usually consist of a thin tube (5 Fr mm in diameter) with an end hole; they are introduced in
a puncture wound between two of its upper rings using a needle and a guide wire. Transtracheal cath
speech, cough, and expectoration.
Catheters designed for introduction through the mouth or nose and that are long enough to make pos
their distal tip into the bronchi through the tracheobronchial tree.
Bronchial catheters designed to take protected specimens of bacteria (e.g., those causing nosocomial
the lungs. These catheters typically consist of a coaxial double-lumen protected catheter; one lumen i
aspiration and the second lumen includes a balloon with a diaphragm at its tip to prevent contaminati
bacteria catheters are intended for introduction into the bronchi through the mouth or nose, usually th
tube or a bronchoscope; the catheter is long enough to make possible the advance of its distal tip into
the tracheobronchial tree. The catheters are used mainly to diagnose pneumonia in mechanically ven
patients.

Balloon bronchial catheters designed for airway dilatation. These catheters consist of a flexible tube l
the stenosis; the balloon needs to be long enough to protrude from each end of the stenosis (typical b
15 mm; typical length is 2.5 to 4 cm). These catheters are introduced directly under fluoroscopic guid
flexible (fiberoptic) bronchoscope. Dilatation balloon bronchial catheters are used for treatment of be
stenosis, which can be of medical, surgical, or congenital origin.

Balloon bronchial catheters designed to reduce bronchial tamponade. These catheters are usually int
working channel of a flexible fiberoptic bronchoscope or through a guide wire under bronchoscopic ob
balloon bronchial catheters are used to control pulmonary bleeding (hemoptysis) as a result of illness,
artery perforation during surgical procedures.
Catheters designed for introduction into the mouth or nose and through the trachea that are long eno
the advance of their distal tips into the esophagus. These catheters typically consist of a plastic hollow
characteristics according to the procedure to be performed. Dedicated esophageal catheters intended
pressure (i.e., manometric) and/or pH value inside the esophagus are available; catheters used for bra
of the esophageal wall and to dilate esophageal strictures are also available.

Esophageal catheters designed to measure the pressure in the esophagus. These catheters usually co
with several recording ports or pressure transducers; the catheter is introduced, either through the mo
advanced until its distal tip is about five cm from the lower esophageal sphincter. Some of these cath
for recording pH in the lower esophagus. Manometric esophageal catheters are attached to a recorde
graphic showing the pressures from the upper and lower esophageal sphincters and from several poin
esophagus.

Manometric esophageal catheters that require infusion of water at a constant rate. These catheters in
flow rate is changed according to the esophageal contractions; these changes are converted into elec
external sensors. Hydraulic manometric esophageal catheters are used for short-term measurements
esophageal pressures and muscular events (e.g., peristalsis) with the patient in the supine position.

Manometric esophageal catheters with built-in pressure transducers. These catheters include several
electrical-signal transducers, avoiding the need of water perfusion. Pressure-transducer manometric e
usually include a pH sensor; they are suitable for continuous recording (e.g., 24 hours) of pressure, mo
catheters are frequently used in ambulatory esophageal monitoring during gastroesophageal reflux di
Esophageal catheters designed to measure pH, typically near (3 to 5 cm) the lower esophageal sphinc
usually consist of a thin (5 or 6 Fr) ruled single-lumen plastic (PVC, silicon rubber) tube that includes e
for pH measurements; some multilumen catheters with several sets of intermittent electrodes are des
measurements in different sections along the esophagus and/or the pharynx. Catheters for pH monito
through the nostril or less frequently through the mouth; they are externally connected to a recorder.
catheters are appropriate for pH measurements in the stomach and/or duodenum. Catheters for pH m
used to assess gastroesophageal reflux in the pharynx, larynx, and tracheobronchial tree.

Rectal catheters designed for indirect measurement of the partial pressure (i.e., tonometry) of carbon
internal mucosa of the sigmoid colon. These catheters typically consist of a 7 Fr gas-impermeable sam
with length markers and including a gas-permeable balloon attached at its distal tip. PCO2 in the salin
balloon is measured with a blood-gas analyzer after equilibrium. Then, the intramucosal pH (pHim) is
measured PCO2 value and the bicarbonate concentration in a contemporary sample of arterial blood.
catheters are used in the determination of intramucosal acidosis in the sigmoid colon (e.g., after abdo

Urethral catheters designed to drain urine from the bladder into an external collection device. These
a variety of applications, including the treatment of permanent or temporary urinary retention, postsu
bladder function, measurement of urinary output, and incontinence management.

Urethral catheters designed for elimination of areas of narrowing (i.e., strictures) in the urethra, thereb
These catheters typically consist of a 16 Fr soft (e.g., red rubber) tube; catheters including hydraulic b
diameter are also used. Dilatation urethral catheters are mostly used for clean intermittent self-cathe
an adjuvant in the management of urethral patency.

Urinary catheters designed for introduction directly into the bladder through a percutaneous incision a
(i.e., suprapubic). Several techniques are used to place the catheters, including over the needle and t
previously inserted using a trocar.
Ureteral catheters designed to drain urine or other fluids from the upper urinary tract. These catheter
of applications, including the extraction of urine samples from the ureter or renal pelvis and as part of
system for perfusion chemolysis treatment of stones simultaneously using another catheter for irrigat

Ureteral catheters designed for infusion of fluids into the upper urinary tract. They are used for remov
surgical or endoscopic procedures; they are also used as part of a double catheter system for perfusio
treatment of stones simultaneously using another catheter for drainage.
Ureteral catheters designed for endoscopic incision (ablation) of strictures in the proximal and distal u
ureteropelvic junction. These catheters typically consist of a 10 Fr tube with radioopaque markers tha
near its distal tip to define the area of stenosis, and a monopolar electrocautery cutting wire with a sm
(typically 2.8 cm length); the procedure is usually performed under fluoroscopic guidance. Ablation ur
used for the treatment of ureteral obstructions (endoureterotomy) and ureteropelvic junction obstruct

Ureteral catheters designed to infuse a contrast medium into a ureter. These catheters usually consis
flexible tube with graduate markings and one or two openings at its distal tip. Urography ureteral cat
urograms, showing the intrarenal collecting structures, the pelvis, and ureters.
Ureteral catheters designed to retrieve stones and foreign bodies (e.g., catheter tips, stents, other deb
urinary tract. Several different catheters are used for vascular retrieval, including loop snare and helic
them may be used for stone fragmentation before retrieval.
Nephrostomy catheters designed for elimination of areas of narrowing (i.e., strictures) in the ureters, t
lumen. These catheters typically consist of a flexible 7 Fr plastic tube including a hydraulic balloon at
to 12 to 26 Fr. These catheters are mostly used for treatment of benign strictures in the upper urinary

Intrauterine catheters designed for injection of opaque material into the uterus. These catheters usua
attached on or near their distal tip (some include two balloons) and a central lumen for injection of the
Radiography intrauterine catheters are used for the radiography of the uterus (salpingography) or ute
simultaneously (hysterosalpingography).
Intrauterine catheters designed for infusion of saline into the uterus to enhance the transvaginal ultra
These catheters usually include a balloon (rounded or elliptic) on or near their distal tip to be placed in
a central lumen for injection of the saline solution during the ultrasonic image procedure (hysterosono
enough (e.g., 5 to 7 Fr) to allow placement next to ultrasound probes. Some of these catheters may al
opaque medium for radiographic purposes. Hysterosonographic procedures are mostly used to assist
establishment of a specific diagnosis when endometrial thickness exist (e.g., detection of polyps).

Intrauterine catheters designed to eliminate (i.e., cannulation or recanalization) fallopian tube obstruc
usually consist of a 3 Fr Teflon tube; catheters tapered to 3 Fr to 2.2 Fr are sometimes used for obstruc
than 2 cm from the tubal ostium or for acute angles in the fallopian tube. They are introduced using s
methods, including special sets, rigid hysteroscopes, and coaxial passage through double-balloon cath
cannulation and radiography. Fallopian tube cannulation catheters are used for treatment of infertility

Intrauterine catheters designed to perform endometrial irrigation (lavage) to recover preimplanted ov


typically consist of a dual-lumen 11 Fr Teflon tube with a solid bullet-shaped distal tip; the internal coa
and the external lumen is for outflow. The lavage fluid is injected into the endometrial cavity over thr
using a syringe; the outflow is facilitated by a negative pressure pump. Ovum recuperation catheters
recover fertilized ova from fertile women to be nonsurgically transferred to infertile women.

Intrauterine catheters designed to obtain samples from the inner mucous membrane of the uterus (en
different catheters have been used, including single-, double-,and triple-lumen catheters; most of them
sampling collection. These catheters are used to determine the bacterial specimens of the uterine ca
contamination with the lower genital tract microflora; they are mostly used in women with postpartum

Intrauterine catheters designed to destroy the inner mucous membrane of the uterus (endometrium).
mostly used for control of excessive uterine bleeding occurring at regular intervals (i.e., hypermenorrh
the absence of malignancy.
Endometrial-blation intrauterine catheters that include a thermically controlled latex balloon. These c
consist of a 9 Fr plastic tube with a balloon attached on or near its tip; they usually include two lumen
connections and one as the temperature transducer (e.g., thermistor); the proximal end of the cathete
pressure, time, and thermal control.
Intrauterine catheters designed for direct measurement of the pressure generated by the muscular co
(myometrium). These catheters usually include a micropressure transducer located at their distal tip;
filled pressure catheters attached to an external strain gauge transducer are still in use. Manometric
provide diagnostic information to assess the pressure generated by the myometrium and in following
fetus during labor and delivery; they permit evaluation of uterine contraction frequency, duration, and
resting uterine tonus.

Intrauterine catheters designed for the injection of washed sperm and/or fluid containing embryos into
These catheters consist of a thin (e.g., 5 Fr), flexible, or semirigid tube (typically 18 to 30 cm long) tha
the uterus while minimizing trauma to the cervix, endometrium, and uterine walls. Some of these cat
marls to allow the physician to predetermine the depth of placement of the sperm. They are used in t
infertility (e.g., male or cervical factor infertility).

Catheters designed for introduction into an otherwise closed wound. These catheters typically consist
flexible plastic tube with end and/or side perforations at or near the distal end. Dedicated wound cath
drainage of blood and/or other fluids are available; wound catheters used for irrigation from external p
available.
Wound catheters designed to drain liquids and/or semisolids from a wound. These catheters consist o
plastic) perforated tube. Sometimes a larger superficial drain catheter is used in addition to a deep d
catheters are mostly used to remove blood and other fluids from surgical wounds during a few postop
intent of preventing formation of a hematoma and promoting wound healing.

Wound drainage catheters designed for aspiration of drain liquids and/or semisolids from an otherwise
catheters typically consist of a multiperforated rigid plastic tube externally attached through a large-d
to a strong negative-pressure collection jar. These catheters are used for wound drainage after surgic
mediastinal infections after cardiac operations, neck wounds after cancer surgery, and wounds after o
hip) surgery.

Wound catheters designed for infusion of fluids (e.g., povidone-iodine solution) into an otherwise close
catheters usually consist of a single-lumen tube with end and/or side holes at their distal port. The pr
connected through a Luer lock to a string or water pumping system, which infuses the solution at a pr
100 ml/hour). Wound irrigation catheters are used for continuous irrigation of infected wounds (e.g., m

Femoral cannulae designed for use in cardiopulmonary bypass procedures. These cannulae are usual
an end hole (some may include side holes); they are short enough to keep the distal tip inside the fem
artery or femoral vein). Cardiac bypass femoral cannulae are used for diverting the patient's blood to
tubing and an arterial pump, bypassing the heart and lungs completely; aortic and vena caval cannula
purpose.

Aortic cannulae designed for cardiopulmonary bypass procedures to deliver antegrade cardioplegia. T
consist of a 17 Fr (12 to 18 G) silicone tube with an end hole (some may include side holes). Cardiac b
can return blood from external tubing into the aorta, bypassing the heart and lungs completely; they a
cardiac surgery and also in some cardioplasty procedures.
Cannulae designed for cardiopulmonary bypass procedures. These cannulae typically consist of a 20
with an end hole (some include side holes); they are usually inserted via the left femoral vein. Cardia
cannulae can divert blood from the vena cava into external tubing and a pump, bypassing the heart a
they are mostly used in cardiac surgery and in some cardioplasty procedures.

Nasal cannulae designed for plugging the posterior nares to control nosebleed (epistaxis).
Sacklike containers designed to collect urine, typically via the proximal end of a catheter, which has a
urinary bladder. These devices are typically flexible plastic bags or pouches that are located externally
attached to the bed or a pole) or patient worn (e.g., fixed on a leg) for ambulatory use. Indwelling cath
bags usually include drainage capabilities to other containers or to dispose of the urine (e.g., into the
temporarily during surgical procedures and in acute care units; patient-worn bags are also used to tre
urinary incontinence.

Injection/infusion ports that are surgically inserted (implanted) under local anesthesia in the operating
technique similar to the one used for placing tunneled catheters. The vein to be catheterized, usually
cephalic, is surgically isolated, and the catheter is advanced through a subcutaneous tunnel into the v
catheter tip is in the superior vena cava; the port is then sutured into a subcutaneous pocket typically
infraclavicular fossa. These devices also may be placed through the saphenous vein and advanced in
cava, with the port placed on top of the thigh or on the lower rib cage.

Injection/infusion ports that are surgically implanted in the upper limbs so that the catheter is inserted
cephalic, or axillary vein, with the port placed in the inner aspect of the forearm or in the upper arm.
placed using angiography or using a sensor wire/catheter tracking system, the latter of which eliminat
fluoroscopy.
Small disposable absorbent cloths (e.g., cotton, nonwoven material), typically presoaked with an appr
according to the intended use (e.g., cleansing, disinfection, medication). Towelettes are mostly used t
skin or an equipment surface that needs cleaning or disinfection.
Towelettes designed for external application of cleansing, antiseptic, or medicated agents to humans.
Personal towelettes designed to clean the skin or other external part of the human body. These towel
presoaked with cleansing agents; they may also be presoaked with moisturizers, deodorants, and/or p
include mild antiseptics or antiadhesive agents.
Personal towelettes designed for external administration of medication. These towelettes are presoak
appropriate medicine. Medicated personal towelettes are used to apply medicine to the affected area
wiping; some of them release medicated vapors that the patient can breathe into the airways.

Medicated personal towelettes designed for administration of medication (e.g., witch hazel, pramoxine
anorectal, vaginal, and perianal areas. Perianal medicated towelettes are used for the temporary trea
and/or rectal or vaginal itching, pain, or irritation.
Medicated personal towelettes designed to release medicated vapors (e.g., menthol, camphor) that th
into the airways through the nose. These towelettes are held under the nose for temporary relief of b
the nose and upper airways.
Towelettes designed for cleansing nonporous surfaces. These towelettes may be dry or presoaked wit
deodorants, and/or perfumes. Surface cleansing towelettes can be used for cleansing, spill removal, a
nonporous surfaces of medical equipment and instruments, such as electrodes, glassware, and micros
in laboratories, radiology departments, general wards, and other hospital areas.

Surface cleansing towelettes made of materials or including products that have antistatic properties.
be used for cleaning transparent surfaces and to prevent the accumulation of dust particles in mamm
computer screens, and eyeglasses; those used to clean eyeglasses may also include antifog agents.

Towelettes used to apply an agent (disinfectant) to nonporous surfaces to reduce or eliminate infectio
towelettes are usually presoaked with the disinfectant; some include agents (germicides) that effectiv
microorganisms most commonly found in hospital environments. Disinfecting surface towelettes are u
radiographic, dental, and laboratory instruments and equipment to avoid cross-contamination.

Analyzers designed to assess one or more characteristics related to the processes and/or functions of
body (i.e., physiology). These analyzers are typically used for in vivo determination of a patient's or re
characteristics, performing analysis based on physiology rather than chemical evaluations. Dedicated
are available to assess a variety of body physiology characteristics, including body composition; aural
and neuromuscular functions; metabolic rate; and peristaltic motility. Dedicated animal physiologic an
not be used for human tests, are also available.

Physiologic analyzers that determine fat/fat-free (fat/lean) tissue ratio in human body composition by
subject's weight both out of water and submerged in water. These systems typically consist of a wate
the patient kneels during water immersion and that include the weighing gauges, some means to det
volume during immersion, and computing capabilities for data processing and recording. Hydrostatic
considered an accurate method for fat/fat-free body determinations in research and for use in healthy

Physiologic analyzers that determine the peristaltic smooth movement of some part of the digestive t
stomach, small intestine, colon) and the intraluminal pressure exerted in its content. Some of these a
motility in several areas of the intestinal tract using interchangeable dedicated catheters. These anal
catheters that either use a manometric sensor in the tip to measure the pressure directly (nonperfusio
connected to extracorporeal pressure transducers to measure the pressure indirectly (perfusion cathe
analyzers usually have multichannel capabilities for measuring pressure at several points simultaneou
additional sensors to perform other measurements of interest (e.g., pH); they may also include compu
data processing and recording.

Peristaltic motility analyzers that determine the motility of the colon (colon motility studies) and/or the
rectum and the internal and external sphincter (anorectal motility studies). These analyzers typically
balloons and pressure sensors; some include computer capabilities for recording and data processing.
analyzers are mostly used in the assessment of fecal incontinence.
Neuromuscular function analyzers that evaluate muscle strength. These analyzers include dedicated
and accessories for positioning the joints at specific angles, so they can perform measurements at con
resistance or speed (isometric, isotonic, and isokinetic measurements, respectively). Most of these an
mechanized and may also include computing capabilities for data processing and recording. Dynamo
used for upper- and lower-extremity analysis in several positions (e.g., supine, prone, sitting, standing
for trunk muscle evaluations.

Physiologic analyzers that evaluate upright posture, balance, and sense of equilibrium. These analyze
movable, tilting platform; a pressure transducer; and computing capabilities for data processing and r
these analyzers include electromyographic devices. For static posturography, the patient stands on a
to determine his/her center of gravity and to provoke destabilizing perturbations; in dynamic posturog
somatosensory, and vestibular inputs are applied to the patient during postural control efforts. Postur
used to evaluate equilibrium disorders and other diseases of the nervous system; they may be used t
weight distribution of manual wheelchairs.

Middle-ear physiologic analyzers that measure the absorption of acoustic energy by the tympanic mem
(tympanic membrane compliance) as a function of the air pressure in the external ear canal; the grap
membrane compliance is referred to as a tympanogram. These analyzers consist of an external instru
impedance bridge) connected to a probe that is hermetically sealed in the external auditory canal. Th
fixed-frequency audio tone into the ear canal and monitors the sound-pressure level using a micropho
to an external pump-manometer that varies the air pressure variations and performs measurements.

Middle-ear physiologic analyzers that measure the amplitude of the sound waves reflected off the tym
function of the distance from a sound source; the results are usually shown in a display and/or recorde
analyzers include a pulsed sound source and a microphone that picks up the sum of the emitted soun
reflected back, the higher the x, the higher the nullification or reinforcement of the sound waves.

Otoscopes designed for determination of the movement (compliance) of the tympanic membrane whe
moderate-pressure air current. The motion of the membrane is visually evaluated (subjectively) by th
instruments include a closed system for air delivery. Pneumatic otoscopes are used for determining m
otitis media), particularly in children.
Ophthalmic instruments designed to measure and evaluate the area (visual field) within which stimuli
surface will produce the sensation of sight with the eyes in a straight-ahead position. These devices ca
central and peripheral visual field and, usually, the areas of lost or depressed vision (scotomas). The d
establishes separately each eye's capability to see white test objects. Ophthalmic perimeters may use
fixed luminosity (kinetic perimeters) or fixed targets (static perimeters). The results are usually record
include a continuous curve that represents the boundary of the visual field on a polar-coordinates grap
are used to detect and evaluate pathologies that cause constriction of the peripheral vision (e.g., retin
retinitis pigmentosa) or that affect both peripheral and central vision, such as intracranial pathologies
automated ophthalmic perimeters are available.

Stools, including seats that are fixed in height. These stools are either metallic, typically with an upho
wood or plastic; some may include armrests and/or a backrest. Fixed stools are used to provide seatin
staff during clinicalor dental procedures (e.g. examination, treatment) .
Height-adjustable stools that do not have armrests but typically include an adjustable backrest comfo
term work in a clinical laboratory. These stools usually include a four-leg base without casters; the sea
typically higher (e.g., from 50 to 90 cm) than in a standard stool.
Height-adjustable stools that also include an adjustable backrest comfortable enough for long surgica
armrests that can be appropriately placed and adjusted (e.g., swing forward, up, and down) for perfor
accurate surgical procedures (e.g., microsurgery). Some of these stools include a five- or six-caster ba
and/or foot-controlled mechanisms to help in keeping the operating field sterile. Microsurgery adjusta
the surgeon and also by the assistant; the assistant stool usually includes a longer armrest.

Footstools that include a tubular metallic structure, typically with the shape of an inverted U (handrail
patient equilibrium while standing on the footstool. The handrail height is typically more than 75 cm (
footstools are used for patient safety (e.g., to help patient get off crutches and get into bed); sometim
as support for exercise.
Intensive care ventilators designed for adult ventilation and/or respiratory support. These ventilators
breathing system that applies pressure and volume and that includes a flexible tubing adequate for ad
also include continuous positive airway pressure (CPAP) and positive end-expiratory pressure (PEEP) c
care ventilators are used in critically ill patients with respiratory failure.

Neonatal/pediatric intensive care ventilators that use positive pressure to deliver breaths at frequenci
the normal breathing rate (100 or more times per minute is typical) and at a reduced tidal volume. Th
techniques used are high-frequency oscillation ventilation and high-frequency jet ventilation; typical o
operate at frequencies of 400 to 2400 cycles/minute, while jet ventilators operate from 100 to 600 cyc
ventilators are designed to reduce pressured-induced lung damage (i.e, barotrauma) and to reduce th
improve ventilation when air leaks previously existed.

Neonatal/pediatric intensive care ventilators designed to deliver gas to the lungs of newborns and infa
applying and releasing an external negative-pressure to the chest cavity. Some negative pressure ven
tight-chamber (e.g., tank or iron lung) where the patient is enclosed from the neck down; then a vacu
negative pressure around the body causing air to be sucked into the lungs. Others consist of a plastic
(breast-plate or cuirass) externally attached to the infant chest and a vacuum pump that creates a ne
the breastplate. Cuirass negative-pressure ventilators that can control both inspiration and expiration
negative pressure during the inspiratory phase and a positive pressure during expiration or by intermi
negative pressure (negative-pressure oscillatory ventilators) are also available. Neonatal/pediatric ne
ventilators typically operate at normal breathing rates, but the oscillatory type can reach respiratory r
cycles/minute.

Fasteners that consist of a helical, springlike device that can be threaded spirally (comparable to a scr
appropriate tool; they are typically used to fix implants to tissue.
Exhaled-air pulmonary resuscitators that include a mask to deliver the gases to the patient airways. T
typically include a nonrebreathing valve or filter in an adapter that has an outlet appropriate to fit any
mm in diameter) or attach to an endotracheal or tracheostomy tube (15 mm in diameter). Many mask
oxygen inlets. Both include reusable mask and a disposable valve.
Exhaled-air pulmonary resuscitators that include a face shield (made of polymeric material) to deliver
patient airways. The face shield includes a nonrebreathing valve or filter in the center. These resusci
only as disposable units.
Systems designed for the minimally invasive treatment of diseases by applying electromagnetic energ
frequency range from 10 kHz to several megahertz. These systems typically consist of a radio-frequen
delivery system that may include applicators, cables, electrodes, and/or catheters; the power and freq
and the configuration of the delivery system depend on the intended use.

Angioplastic radio-frequency (RF) therapy systems designed to eliminate areas of narrowing in blood v
RF energy directly to treated tissue through electrodes. These systems consist of an RF generator (ty
200 kHz to 2 MHz), a cable, and an appropriate catheter with electrodes (e.g., a ring) at its tip for dire

Radio-frequency (RF) therapy systems used for selective ablation (therapeutic lesions) of nerve pain fi
usually consist of a generator in the lower end of the RF spectrum (500 kHz or less is typical) and nee
electrodes, usually with a length from 9 to 30 cm (3.5 to 12 inches) and a diameter from 12 to 22 G th
for the tip. Selective ablation of pain fibers is possible because they are small and do not have a lipid
(unmyelinated), making them less resistant to heat than motor and tactile nerve fibers. Pain nerve fib
systems are used to treat some chronic facial pains (e.g., trigeminal neuralgia) and other intractable p
patients, usually by ablation in the spinal cord (cervical cordotomy) or in the brain (cingulotomy).

Tissue ablation radio-frequency (RF) therapy systems designed to ablate regions of the prostate. Thes
an RF generator; a catheter to be introduced into the prostatic urethra or rectum, sometimes with cap
needlelike electrodes from its tip; sleeves to prevent the exposure of untargeted tissue; thermocouple
and prosthetic temperature; and a neutral electrode that is placed on the body surface. Prostatic abla
used for treating benign prostatic hyperplasia and cancer of the prostate.

Tissue ablation radio-frequency (RF) therapy systems designed to ablate the inner mucous membrane
uterus. These systems consist of an RFgenerator (typical frequency is 27.12 MHz); a large-diameter (
catheter to be introduced into the uterus; guards to protect the vagina, especially anteriorly; thermoc
temperature; and a neutral electrode that is placed on the body surface (e.g., wrapped around the wa
not use fluids and do not work under direct hysteroscopic vision, unlike ablation performed using stan
units with rollerball or wire loop electrodes mounted on a resectoscope. Endometrial ablation RF thera
to treat excessive or dysfunctional uterine bleeding (menorrhagia).

Tissue-ablation radiofrequency (RF) therapy systems designed to ablate regions in the joints during ar
These systems consist of an RF generator; an applicator (e.g., a catheter), typically with needlelike ele
be introduced into the joint; and thermocouples to record tissue temperature. Some systems include t
The electrode configuration may be bipolar or monopolar, including a neutral electrode that is placed
Intra-articular ablation RF systems are used for cutting and coagulation of tissue during minimally inva
procedures (e.g., meniscectomy, ligament resection).
Tissue ablation radio-frequency (RF) therapy systems designed to ablate regions of solid organs (e.g.,
consist of an RF generator; interstitial or intracavitary arrays of electrodes, temperature sensors, and
power control; and computed tomography, ultrasound, or magnetic resonance guidance. Interstitial ti
are mostly used for coagulation necrosis of unresectable tumors at temperatures between 60 and 10

Hyperthermia radio-frequency (RF) therapy systems designed for localized heating of malignant tumo
three) centimeters deep. These systems consist of an RF generator (frequencies from 10 to 30 MHz a
either to two electrode plates (capacitive coupled systems) or to a coil (inductive coupled systems).

Hyperthermia radio-frequency (RF) therapy systems used for heating of deep-seated tumors. These s
generator, interstitial or intracavitary arrays of implanted electrodes, a temperature sensor, and a fee
power control. Interstitial hyperthermia systems are capable of applying energy inside a tumor, makin
uniform heating than with external applicators. Interstitial hyperthermia systems are commonly used
localized radiation therapy (thermobrachytherapy).

Radio-frequency (RF) therapy systems designed to shrink (occlude) veins by heating the vein walls. T
an RF generator and a catheter with collapsible electrodes. The electrodes are expanded against the
energy is applied so that the vein shortens and contracts as the catheter is moved back through the v
therapy systems is intended as a minimally invasive procedure to replace vein stripping in the treatm
limb venous diseases (e.g., varicose vein).

Systems designed for minimum access treatment of diseases by applying electromagnetic energy, us
range from 300 MHz to 300 GHz. These systems typically consist of a microwave generator and an ap
system that usually includes cables, antennas, applicators, and/or catheters, according to the intende

Microwave therapy systems that deliver energy into the vessels to eliminate areas of narrowing (i.e., a
systems consist of a microwave generator and an intravascular delivery system; the power and freque
and the configuration of the delivery system depend on the intended use.

Angioplastic microwave therapy systems designed to eliminate areas of narrowing in blood vessels by
energy directly to treated tissue through an antenna. These systems consist of a microwave generato
is typical), a low-loss coaxial cable, and an antenna (e.g., whip); the coaxial cable with the antenna on
the vessels through the lumen of a vascular catheter designed for balloon angioplasty.

Microwave therapy systems designed for thermal ablation of tissue. These systems typically consist o
generator, a coaxial cable, and an antenna. The radiating antenna is placed on or near the tissue volu
using an applicator or catheter; the higher frequency of microwave energy has the potential for a grea
than radio-frequency. The primary mechanism for tissue heating at microwave frequencies is vibratio
of water molecules) in the tissues at the frequency of the electrical field; ablation is produced by coag
temperatures over 60 degrees C and/or water vaporization over 100 degrees C.

Tissue-ablation microwave therapy systems designed to ablate regions of endocardial tissue that give
cardiac arrhythmia. These systems consist of a microwave generator, a catheter that includes a coax
antenna on its distal tip, and controls. Microwave energy is delivered through the antenna to the regi
the target endocardial tissue is destroyed.
Tissue-ablation microwave therapy systems designed to ablate the inner mucous membrane (endome
These systems consist of both a unit including a microwave generator, typically at a frequency of 9.2
temperature monitor which shows endometrial temperatures, and an applicator that includes a wave-
delivery system with a graduated scale, active dielectric tip, and temperature sensors. The probe is m
endometrial surface to produce ablation. Endometrial-ablation microwave therapy systems are used t
dysfunctional uterine bleeding (menorrhagia).

Tissue-ablation microwave therapy systems designed to ablate regions of solid organs (e.g. liver). The
a microwave (2.45 GHz) generator, interstitial needle-like applicators as antennas, and a temperature
tomography, ultrasound, or magnetic resonance guidance is used to locate the applicator and sometim
ablation. Interstitial tissue-ablation systems are mostly used for percutaneous coagulation necrosis of
at temperatures over 60 degrees C, but less than 100 degrees C.

Microwave therapy systems designed to heat solid tumors several degrees Celsius above core temper
degrees to 45 degrees C (108 degrees to 113 degrees F); these temperatures do not damage normal
include a microwave generator, appropriate delivery systems (e.g., coaxial cable), and antennas for se
maintaining the tumors at elevated temperatures. Hyperthermia microwave systems are used to trea
tumors, frequently in combination with ionizing radiation (thermoradiotherapy) or chemotherapy (ther
The procedure typically lasts from 30 to 60 minutes; it is usually repeated several times (e.g., every o

Hyperthermia microwave therapy systems designed for localized heating of malignant tumors up to a
centimeters deep. These systems typically include a microwave generator (e.g., 430 MHz frequency)

Hyperthermia microwave therapy systems used for heating of deep-seated tumors. These systems co
generator, interstitial or intracavitary applicators including antennas, a temperature sensor, and a fee
microwave power control; interstitial hyperthermia systems are capable of applying energy inside the
possible a more uniform heating than with external applicators. Conventional applicators are used for
balloon applicators (catheters) make it possible to treat larger tumors. Interstitial hyperthermia syste
in combination with localized radiation therapy (thermobrachytherapy).

Systems designed for minimum-access treatment of diseases by applying energy at frequencies over
audible limit (about 20 kHz) and up to several megahertz. These systems typically consist of a radio-f
and an appropriate delivery system that includes cables and/or catheters and electrical to ultrasonic t
and frequency of the generator and the configuration of the delivery system and transducers depend

Ultrasound therapy systems that deliver energy into the vessels to eliminate areas of narrowing (i.e.,
systems include a radio-frequency generator (frequency of 20 kHz is typical), ultrasonic transducers, a
systems include a ball-tipped wire that act as an acoustic wave guide, transmitting the energy to the t
artery; other systems use small ultrasonic transducers on the distal tip of a catheter that are excited t
ultrasonic waves. Ultrasound angioplasty systems are mostly used in total occlusion and calcified pla
balloon angioplasty.
Ultrasound therapy systems usually designed for thermal ablation of tissue. These systems typically c
frequency generator (frequency typically from 0.5 to 4.5 MHz), electroacoustical transducers (e.g., pie
a delivery system. Some systems use ultrasound or magnetic resonance guidance to control and/or e
The high-intensity focused ultrasound mechanical energy is absorbed by tissue; ablation is mostly pro
necrosis at temperatures over 60 degrees C. Most of these systems are used for focused noninvasive
tissues not blocked by bone (e.g., breast, bladder).

Tissue-ablation ultrasound therapy systems designed to ablate regions of the prostate. These system
frequency generator and an applicator including an ultrasonic transducer; some systems combine tiss
ultrasound imaging in a single piezoelectric crystal. The applicators are inserted into the patient's rec
adjacent to the prostate gland. Prostatic-ablation ultrasound systems are used for treating benign pro
cancer of the prostate.

Hyperthermia ultrasound therapy systems used for externally localized heating of malignant tumors u
centimeters deep. These systems typically include a radio-frequency generator and planar transduce
multiple nonfocused or scanned focused ultrasound transducers are typically used for treatments dee
centimeters.
Hyperthermia ultrasound therapy systems designed for heating of deep-seated tumors. These system
frequency generator and interstitial or intracavitary applicators including appropriate ultrasound trans
sensor, and a feedback system for controlling the power delivery. Interstitial hyperthermia systems ar
energy inside the tumors, making possible more uniform heating than with external applicators. Som
used simultaneously with localized radiation therapy (thermobrachytherapy); but other systems using
can only apply hyperthermia and radiation sequentially.

Hydrothermal ablation systems designed to produce coagulation necrosis in the inner mucous membr
(endometrium) by circulating a hot-water solution (e.g., saline) at a temperature close to 90 degrees C
Fahrenheit) during several minutes (typically 10) either directly within the uterus or in a flexible (e.g.,
placed into the uterus. Endometrial hydrothermal ablation systems are used to treat excessive or dys
bleeding (menorrhagia).

Endometrial hydrothermal ablation systems designed to produce coagulation necrosis in the endomet
of a thermal balloon designed to conform to the uterine cavity. These systems usually consist of a con
including temperature, pressure, and time controls and a two-line catheter for electrical connection an
heating solution (e.g., dextrose) into the balloon. In some systems, the distal end of the catheter form
the balloon, inside of which there is a heating element and a thermistor, surrounded by a perforated h

Nd:YAG lasers designed to deliver their energy into the vessels to eliminate areas of narrowing (i.e., a
lasers consist of an Nd:YAG laser generator and a delivery system including optical fibers and a cathet
performed by direct laser ablation; but some devices ablate the thrombotic tissue thermically by heat
enclosing the distal tip of a vascular catheter. Angioplasty Nd:YAG lasers are mostly used in periphera

Argon lasers designed to deliver their energy into the vessels to eliminate areas of narrowing (i.e., ang
lasers usually consist of an argon laser generator and a delivery system that includes fiber optics and
usually performed by direct laser ablation, but some devices ablate the thrombic tissue thermically by
enclosing the distal tip of a vascular catheter. Angioplasty argon lasers are mostly used in peripheral
Excimer lasers designed to deliver their energy into the vessels to eliminate areas of narrowing (i.e., a
lasers consist of a pulsed excimer laser generator and a delivery system including optical fibers and a
coronary devices include a steerable guide wire with an array of optical fibers; they combine the mech
the guide wire with the laser energy to facilitate the ablation of areas of total occlusion. Angioplasty e
mostly used in laser-assisted angioplasty of totally occluded coronary arteries; some are also used in t
occlusions in the peripheral vessels.

Ho:YAG lasers designed to deliver their energy into the vessels to eliminate areas of narrowing (i.e., an
lasers consist of a pulsed Ho:YAG laser generator and a delivery system including optical fibers and a
laser-energy from its distal tip. Angioplasty Ho:YAG lasers are mostly used in laser assisted angioplast
coronary arteries, especially in the presence of thrombus; some are also used in the treatment of tota
peripheral vessels.

Diode lasers that generate and deliver their energy to the surface of previously photosensitized tissue
effect of light, sensitizers, and tissue oxygen destroy tissue by a phototoxic effect (photodynamic ther
usually consist of a diode laser generator (633 nm wavelength is typical) and microlens or isotropic (s
applicators adapted to the absorption of the sensitizers. Photodynamic therapy diode lasers are used
malignant tumors) without a significant thermal effect.

Nd:YAG lasers designed for thermal ablation of subcutaneous or deeper tissue; they usually include a
100 to 120 W) generator and applicators that are inserted into the tissue to be ablated. Laser energy
directly, using either a bare fiber or special diffuser tips (e.g., ring mode or isotropic) as applicators. In
thermotherapy Nd:YAG lasers are mostly used for percutaneous ablation of deep-seated tumors by co
temperatures over 60 degrees C; some systems use magnetic resonance imaging as guidance to loca
also to evaluate the thermal results. Other systems include thermal sensors and a computer programm
energy to keep the tissue temperature (e.g., tumor) within a prespecified range. Some of these lasers
hyperthermia procedures at temperatures from 42 degrees to 45 degrees C (108 to 113 degrees F) in
malignant tumors; most procedures combine hyperthermia with ionizing radiation (thermoradiotherap
[thermochemotherapy])

Diode lasers designed for thermal ablation of subcutaneous or deeper tissue; they usually include a hi
to 60 W at a wavelength from 800 to 1,000 nm) diode laser generator and applicators that are inserte
ablated (e.g., tumor). Laser energy may be applied directly using either a bare fiber or a special diffu
or isotropic) as an applicator. Interstitial thermotherapy diode lasers are mostly used for percutaneou
seated tumors by coagulation necrosis at temperatures over 60 degrees C. Some systems use magne
as a guide to locate the applicator and to evaluate the thermal results; other systems include thermal
computer programmed to regulate laser energy to keep the tissue temperature (e.g., tumor) within a
Some of these lasers may also be used for hyperthermia procedures at temperatures from 42 to 45 de
degrees F) to treat solid malignant tumors; most procedures combine hyperthermia with ionizing radia
(thermoradiotherapy) or chemotherapy (thermochemotherapy).

Er:YAG lasers used in the treatment of fine superficial (e.g., epidermal nevi) or deeper papular tumors
hyperplasia) on the skin. These lasers are particularly appropriate for dermatologic procedures due to
by tissue water in the midinfrared.
Devices designed to perform surgery using a microwave frequency (typically 2.45 GHz) energy; the he
causes tissue coagulation is provided by tissue resistance to the high-frequency radiation. These unit
generator and appropriate applicators. The microwave energy delivered by the microwave surgical un
cut tissues, because they depend on mechanical action for cutting (e.g., scalpel). Microwave surgical
surgery of highly vascularized organs, such as the spleen and the liver because the thick eschars prod
deep penetration of microwave fields is very effective in stopping hemorrhage.

Microwave surgical units that use needle-like antennas for energy radiation. These units include a mic
typically of 100-watt energy and 2.45 GHz frequency, a coaxial cable to transmit the energy, and need
antennas). The needles are positioned surrounding the tissue to be resected (e.g., tumor), power is a
each needle creating a continuous boundary of coagulated tissue surrounding the tumor; hemostasis
in diameter is possible. The tumor is removed using a scalpel or an electrosurgical unit. Needle micro
units are used in open surgery of the liver and spleen; they are also used in endoscopic and laparosco
applications (e.g., to control bleeding in the digestive tract).

Microwave surgical units that use a device linking a microwave radiator to a scalpel. These units cons
generator typically of 150-to-200 watt energy and 2.45 GHz frequency, a coaxial cable to transmit the
of the scalpel and a surgical scalpel that includes a small-loop antenna in the blade. Scalpel microwav
used in surgery of the liver and spleen.
Electrothermal cautery units designed to coagulate tissue by applying an electric current to a high-res
through the working channel of an endoscope (e.g., resectoscope) intended to control bleeding (i.e., h
Electrothermal cautery units do not deliver electric current to the tissue; the high-resistance tip becom
electric current is passed through it. These units typically consist of a power source (e.g., radiofrequen
delivers the electric current, appropriate controls, a probe with heating elements that may also includ
appropriate connectors and/or adapters to attach the generator to the probe. Endoscopic electrotherm
usually monitor temperature and impedance and automatically control energy delivery.

Densitometers used in the clinical laboratory. Laboratory densitometers are usually dedicated instrum
density and/or specific gravity of liquids, gases, and semisolids. Other laboratory densitometers are u
optical density of films and slides.
Laboratory densitometers used to determine the density of liquids. These densitometers are mostly u
density of body fluids (e.g., blood, urine) and for other clinical laboratory determinations (e.g., protein
they may include digital displays and programming capabilities. Some laboratory liquid densitometer
specific gravity and/or gas density.
Bone densitometers in which one or more beams of gamma rays (x-ray photons) emitted in the decay
scanned across the body part to be measured. The measures are based on the bone absorption of the

Warming units designed to store and warm contrast-media vials before administration. These units in
appropriate shelves capable of warming many (e.g., 10 to 40) vials simultaneously; the temperature r
room temperature to 60 degrees C (140 degrees F). Contrast-media warming units are used to reduce
viscous contrast agents such as those with high iodine concentration.
Devices that use a refrigerating or other cooling mechanism (e.g., ice, solid state thermoelectric syste
to remove heat from a substance, material, fluid, or another device that dissipates heat. Cooling units
device, pumps to circulate air or other fluids, and programmable controls and displays for temperature
rate; some feature alarms to sounds alerts when system functions do not meet set parameters. Some
portable, and some may be specifically configured to cool certain pieces of equipment (e.g., laser coo
cooling units that help lower a patient's body temperature or cool operating room personnel by coupli
blankets or garments.

Devices that combine warming and cooling capabilities in one unit. These units include a heating elem
refrigerating system; they are designed to add or remove heat from a substance, material, fluid, or ot
warm or cool). Some warming/cooling units are used to help regulate a patient's temperature.

Patient warming/cooling units designed to warm or cool the patient by blowing air across the patient (
These units consist of a warming/cooling system with a thermostatically controlled fan (blower) for he
then forcing the air circulation; a specially designed reusable or disposable blanket; controls; and alarm
warming/cooling units are used for rewarming patients in postanesthesia care units (PACUs), to help in
intraoperative hypothermia or to induce hypothermia in the operating room, and to cool feverish patie

Blankets usually made of plastic material that include channels for blowing air over the patient (i.e., c
transfer). These blankets are attached to a central unit that delivers the heating or cooling to the blan
many different configurations and sizes, and may be reusable or disposable. Forced-air blankets are u
adequate heating and cooling to the patient's body in the operating room for recovery, in hypothermia
treatment, and in cardiac and pediatric procedures.

Point-of-care analyzers designed to measure and/or assess blood gas, pH, electrolytes, and some meta
specimens. These analyzers can directly measure pH, partial pressure of carbon dioxide (PCO2) and ox
concentrations of the most common ions (i.e., sodium [Na+], potassium [K+], chloride [Cl-], bicarbona
metabolites such as calcium, magnesium, glucose, and lactate. These point-of-care analyzers are used
abnormal metabolite and/or electrolyte levels in blood; they are also used to determine the patient's a
levels of oxygen/carbon dioxide exchange.

Tubes designed for insertion through a surgical opening into the jejunum; the distal tip usually remain
tubes typically consist of a soft, clear silicone tube with a small plastic attachment (e.g., a Dacron ring
secured by a bumper (e.g., wings) on the inside; they may be placed by open surgery or by using fluo
laparoscopic, or percutaneous endoscopic procedures. Jejunostomy tubes are used mainly for feeding
children) who require medium- or long-term enteral feeding but who are unable to maintain sufficient
patients who have severe neurologic impairment; patients who have tumors of the mouth, larynx, or e
tubes are also used for decompression, administration of medications, and/or for drainage.

Surgical smoke evacuation systems that integrate all functional elements (i.e., user interface, filters, s
exhaust) in a single, stand-alone unit, small enough to be either carried (i.e., portable) or wheeled (i.e
Mobile/portable systems can be transported from operating room to operating room as needed.
Surgical smoke evacuation systems in which most components are installed outside the operating roo
physical plant. The evacuation modules of these systems may be installed in one of several different
central designs with most components being used in common by several operating rooms, local syste
components for each operating room, or hybrid combinations of both). Stationary smoke evacuation s
permanently installed during building construction or major renovations.

Devices that combine the thermal capabilities of mobile infant incubators with the access advantages
warming units. These devices provide a centralized control and monitoring system for both the incub
unit; typically, they can be automatically converted from a closed incubator to an open-bed radiant wa
versa with little effort in a few seconds. Incubator/radiant warming units are used to maintain a stable
infants, avoiding the need for transfer between incubators and radiant warming units.

Diode lasers used in the treatment of a variety of skin diseases, including vascular and pigmented les
telangiectasia, angiomas, spider veins, and port wine stains. These lasers typically consist of a portab
generator and a set of specialized handpieces appropriate for laser delivery to the skin lesion.

Devices used to produce high-resolution multiformat films directly from image data acquired during di
procedures (e.g., computed tomography, magnetic resonance imaging, ultrasound, digital radiography
fluoroscopy), using dry-processing imaging. Typically, dry-processing imagers are used during a proce
require a ribbon (i.e., thermal recording process). The imagers include a thermal head, heat-responsiv
with dye precursors, and a developer; when heat is applied, the developer passes through the microca
with the dye precursor to form a dye that creates an image on film or paper. Dry-processing imagers a
made from a hard copy rather than from an electronic image on a monitor screen. They are not intend
images.

Data management information systems designed to allow physicians and other health care providers
medications, diagnostic tests, and other orders (e.g., wound care, special diets) using a desktop, mob
computer rather than through handwritten or oral orders. These systems typically consist of networke
(workstations) implemented over a local area network (LAN) or a wide area network (WAN). The syste
data repository, which is typically part of the main hospital-wide information system. These systems a
provider to enter all patient orders, check the status of patient orders, and retrieve other patient recor
(e.g., radiology exams, laboratory tests). Provider order entry information systems are used for accur
patient orders, including a record of the prescription and administration of medications, and reducing
care. Error reduction is achieved through the use of safety alerts and clinical decision support at the ti
entered. They also achieve error reduction by eliminating transcription errors that result from misinter
handwritten orders.The systems are used throughout a healthcare facility, including in emergency car
and outpatient physician's offices, and in nursing facilities.

Open magnetic resonance imaging (MRI) scanning systems dedicated to the imaging of the brain. The
magnetic poles of the scanner is designed to accommodate the patient's head; the open side design p
the patient head from two or more sides. Neurosurgical MRI scanning systems are intraoperative syst
neurosurgery for visualization, providing real-time guidance for the neurosurgeon. The 3-D capabilities
be useful in planning and performing stereotactic procedures.
Devices designed for non-invasive, automated assist in removing secretions from the lower respirator
secretion clearance from the airways); some units are also intended for treating incomplete expansion
atelectasis). These units may use one or more of different techniques, including the application of pos
airways opening, high-frequency oscillation (HFO) of the air column in the conducting airways, and ex
compression to the chest wall. Airway clearance units are frequently used in acute or chronically ill pa
and/or in addition to traditional procedures, such as postural drainage, manual percussion, or mechan
airways.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
determine the level of proteins that have catalytic properties (i.e., enzymes); frequently, a reagent is
particular form of the various structurally related forms of the enzyme (i.e., an isoenzyme) that may h
physical, or immunological characteristics. Assays for determination of enzymes/isoenzymes may mea
measuring the enzyme itself, or indirectly, such as measuring the enzymatic activity. The characteriza
activity is a diagnostic tool in many diseases, including myocardial infarction, hepatitis, and cancer.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme 5'ribonucleotide phosphohydrolase (abbreviated as 5'NT
increased two- to sixfold in hepatobiliary diseases in which there is interference with the secretion of b
the bile duct is obstructed by stones or tumors or with biliary cirrhosis.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine total content of the enzyme acid phosphatase (ACP), including both prostatic and
Total ACP concentration in serum may be elevated in Paget's disease, hyperparathyroidism, cancer me
and other diseases.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the prostatic form of the enzyme acid phosphatase (ACP). The measu
phosphatase in serum is used in the diagnosis and monitoring of carcinoma of the prostate.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme alanine transferase (ALT), also known as alanine aminotr
serum is typically increased in liver diseases associated with hepatic necrosis, such as viral hepatitis a
mononucleosis with involvement of the liver.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme aldolase (ALD). Aldolase in serum increases in a variety
assays are mostly performed to determine primary diseases of skeletal muscle (e.g., Duchenne muscu

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme alkaline phosphatase. Alkaline phosphatase is present in
forms according to its origin (e.g., liver, bones, intestine); its level is increased in a variety of diseases

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the relative levels of the isoenzymes of alkaline phosphatase in bones, liver, and
measurements are used in the differential diagnosis of several diseases.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
urine, pleural fluid) to determine the level of the enzyme amylase. Amylase levels are transiently raise
pancreatitis, both in serum and in urine; they are also used to assess the development of complication
effusion) following acute pancreatitis and in other diseases (e.g., some tumors of the lungs).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses on a
determine the presence of angiotensin converting enzyme (peptidyl-dipeptidase). This enzyme, usual
surface of the lungs, converts angiotensin I into activated angiotensin II, a powerful vasoconstrictor. A
stimulates the zona glomerulosa to produce aldosterone as part of renal metabolism.

Clinical chemistry reagents intended to perform qualitative and/or quantitative analyses on a body flu
blood, erythrocyte hemolysates) to determine vitamin B6 status by measuring the enzyme aspartate a
(AST); this enzyme is typically measured indirectly (i.e., measuring the pyridoxal-5-phosphate (PLP)-d
the enzyme aspartate aminotransferase). Decreased levels of vitamin B6 are associated with epilepti
young patients, dermatitis with cheilosis and glossitis, some types of chronic anemias, and encephalo

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme cholinesterase. Cholinesterase levels in serum are used
organophosphate poisoning and evaluate liver function.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme chymotrypsin, particularly chymotrypsin II, the more com
of chymotrypsin in blood. Chymotrypsin levels in serum are mostly determined to assess pancreatic d
pancreatitis) and renal failures in adults; elevated levels may be present in cord blood of infants with

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the total content of the enzyme creatine kinase (CK). CK levels are typically incr
disease or injury of all types of muscle, including skeletal muscles and the heart.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the content of one or more of the creatine kinase isoenzymes, known as brain-b
muscle-muscle (MM). Creatine kinase isoenzyme levels in serum are mostly determined to differentiat
of several diseases (e.g., cardiac, cerebral, muscular, hepatic).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the creatine kinase muscle-brain (MB) isoenzyme; this isoenzyme is
indirectly (i.e., the MB isoenzyme activity). Creatine kinase MB isoenzyme activity increases in respon
injury or necrosis, cardiac infarction, and other cardiac trauma, including surgery.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme gamma glutamyltransferase (GGT). GGT in serum typica
diseases; it is more sensitive and its levels elevate earlier than those of other enzymes in cases of obs
cholangitis, and cholecystitis; the level of GGT is highest in biliary obstructions.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme glutamate dehydrogenase (GLD). GLD in serum typically
damaging diseases, such as chronic hepatitis; it also increases in response to hepatotoxic agents.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of enzyme 2-hydroxybutyrate dehydrogenase. The level of 2-hydroxybu
is typically measured as an alternative to determination of levels of lactate dehydrogenase isoenzyme
used to assess myocardial infarction and liver diseases.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme lactate dehydrogenase; this enzyme is typically measur
enzyme "activity"). Methods used for lactate dehydrogenase determination may use either the forwar
oxidation of L-lactate to pyruvate) or the reverse reaction (i.e., the reduction of pyruvate to L-lactate).
dehydrogenase activity is typically increased in myocardial infarction, in liver diseases (especially toxi
jaundice), and in some malignant diseases.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the content of one or more of the isoenzymes of lactate dehydrogenase. At least
lactate dehydrogenase have been characterized, usually named LD-1 to LD-5 (LD-6 is an immunoglob
isoenzyme ratios are used to determine disease or injury, such as cardiac or pulmonary infarcts.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme arylamidase (also known as leucine aminopeptidase). Th
is increased in several diseases, such as hepatic tumors, and in diseases of the common duct, includin
and pancreatic carcinoma.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
plasma, ascitic fluid) to determine the level of the enzyme lipase. Lipase level is typically measured to
disorders, including both acute and chronic pancreatitis; in some cases, serum lipase is also increased
renal diseases.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme lysosyme (also known as muramidase and mucopeptide
level of lysosyme in serum is increased in several diseases, including monomyelocytic leukemia and g
inflammation.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme malate dehydrogenase. The level of malate dehydrogena
increased in several diseases, including myocardial infarction, hepatic necrosis, neoplastic diseases, a
anemia.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the levels of the isoenzymes of beta-N-acetylhexosaminidase (i.e., hexosaminida
deficiency of the enzyme hexosaminidase A is the cause of Tay-Sachs disease, a rare, genetically tran
disease characterized by a progressive destruction of nerve cells in the first years of life.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme pepsin. Increased pepsin levels are found in patients wit
gastrinomas, duodenal ulcers, and superficial gastritis; decreased levels are found in patients with atr
carcinoma, and Addison's disease.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme glucose phosphate isomerase (also known as phosphohe
deficiency of the enzyme glucose phosphate isomerase is the cause of hemolytic anemia, a genetical
metabolic disease.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme sorbitol dehydrogenase (also known as L-iditol 2-dehydro
of the enzyme sorbitol dehydrogenase is used as an indicator of parenchymal liver cell damage.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum) to determine the level of the enzyme trypsin. Trypsin level is measured in gastrointestinal secr
pancreatic function and to diagnose chronic pancreatitis and cystofibrosis.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
bone marrow aspirates and peripheral blood) to determine the level of the enzyme terminal deoxynuc
The level of this enzyme is an adjunct in determining types of leukemia (e.g., acute lymphoblastic leu

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
sample of serum, urine, or cerebrospinal fluid) to determine the level of one or more proteins. The clin
protein levels depends on the protein and body fluid chosen for analysis.

Clinical chemistry reagents intended to perform qualitative chemical analysis of body fluids (typically
the level of the protein albumin. Increased albumin levels (hyperalbuminemia) are of little diagnostic
dehydration, while decreased levels (hypoalbuminemia) are found in many disorders affecting liver fu
damage, and/or protein loss in urine and /or feces, such as diabetes, burns, neoplasms, or kidney dise

Clinical chemistry reagents intended to perform semiquantitative chemical analysis of body fluids (typ
determine albumin levels greater than normal, but less that the levels than can be detected in routine
Urinary albumin excretion is a marker of microvascular disease, and it precedes and is highly predictiv
nephropathy and end-stage renal disease.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bl
level of sugar residues that are added to proteins as the result of an irreversible nonenzymatic reactio
level of glycated proteins in blood (e.g., hemoglobin) is a measure of the integrated values for glucose
is free from daily fluctuations of glucose level, and provides additional criteria for glucose control.

Clinical chemistry reagents intended to be used in the performance of qualitative and/or quantitative
body fluids (typically human whole blood samples) to determine the level of HbA1c (glycated hemogl
significant interference from other hemoglobin (abnormal) variants such as HbC, HbS, HbE, or labile H
glycated hemoglobin in blood is a measure of the integrated values for glucose over a period of two to
level is free from daily fluctuations of glucose, and provides additional criteria for glucose control.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum or plasma) to determine the level of fructosamine, a generic name for plasma protein ketoamin
is a measure of the average concentration of blood glucose for a period of three to four weeks. It is no
of diabetes mellitus but it does provide additional criteria for glucose control.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
sample of serum, urine, or cerebrospinal fluid) to determine the total level of protein. The clinical sign
levels depends on the protein and body fluid chosen for analysis.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of a
determine the total level of protein. Total protein level in serum is usually high (i.e., hyperproteinemia
patients, with the concentrations of all the individual proteins increased to the same degree; in patien
intake or severe water loss caused by vomiting or diarrhea; and in patients with certain diseases (e.g.
The level is low (i.e., hypoproteinemia) in cases of increased plasma water volume as the result of int
retention diseases, or a long period in a recumbent position. Hyperproteinemia may also occur as a re
diseases. Low levels of albumin are a frequent cause of hypoproteinemia.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of an
determine the total level of protein. Increased levels of protein in urine (i.e., proteinuria) have several
common and serious is kidney injury, common to several diseases (e.g., diabetes, systemic lupus eryt

Multipurpose surgical scalpels designed to provide sharp protection (safety). Protective scalpels includ
(manually positioned or activated) intended either to shield or recess the blade after use or, by some
the possibility of contact of the healthcare provider with a sharp blade. Most protective scalpels use re
sheath mechanisms.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
sample of serum) to determine the level of one or more lipids. The clinical significance of lipid levels d
and body fluid chosen for analysis.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis to d
level of cholesterol in serum. Cholesterol is a lipid included in the core of lipoproteins and found in hig
density lipoproteins. High levels of total cholesterol in serum (typically defined as greater than 240 mg
with atherosclerosis and coronary artery diseases
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis to d
high-density lipoprotein cholesterol (HDL-C) in serum. High levels of HDL-C in serum (typically defined
mg/dL) are associated with low risk of atherosclerosis and coronary artery diseases; the absence of HD
a cerebrovascular disorder known as Tangier disease.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis to d
low-density lipoprotein cholesterol (LDL-C) in serum. High levels of LDL-C in serum (typically defined a
mg/dL) are associated with atherosclerosis and coronary artery diseases.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
amniotic fluid) to determine the level of lecithin (phosphatidylcholine), a lipid. The most frequently de
component is disaturated phosphatidylcholine (DSPC), the main surface active component of the lung
represents 85% of all lecithins. The levels of lecithin (or DSPC) in an amniotic-fluid sample are conside
lung maturity.

Clinical chemistry reagents intended to perform quantitative chemical analyses of body fluids (typical
determine the ratio of lipid lecithin (phosphatidylcholine) to sphingomyelin (L/S ratio). Sphingomyelin
nonlung sources that is used as a marker against which lecithin is measured. An L/S ratio of 2.0 or gre
fluid sample is considered a measure of fetus lung maturity.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
plasma or serum) to measure the level of fatty acid in plasma not bound to lipid esters (free fatty acid
of FFA in blood has been found in diabetic patients under acute stress; it is also associated with arrhyt
have suffered a myocardial infarction.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
plasma) to determine the level of phospholipids, the major part of pulmonary surfactant lipids; phosp
mostly of lecithin (phosphatidylcholine). Determination of total phospholipids in serum is of very limite

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses to d
triglycerides, the major lipid fraction of chylomicrons in serum. Increased levels of triglycerides are as
of atherosclerosis and coronary artery diseases; extremely high levels of triglycerides are present in a
characterized by recurrent abdominal pain and pancreatitis.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
feces) to determine the total level of lipids. Fecal lipids are usually composed of triglycerols, fatty acid
glycolipids, and sterols; most are dietary fats, but a significant part is derived from intestinal bacteria
cells. The level of fecal lipids is determined in metabolic and fat-balance studies to assess pancreatic
and to determine excessive amounts of fat in feces (steatorrhea). Determination of total lipids in serum
clinical use.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to determine the total level of lipoproteins and/or to measure particular lipids (e.g., high-, inte
density lipoproteins; triglycerides). High levels of total lipoproteins and/or of one or several lipids are a
atherosclerosis, coronary artery disease (CAD), and sometimes with pancreatitis; low levels may be re
mental retardation, and increased or decreased risk of CAD.

Clinical chemistry reagents intended to perform qualitative chemical analysis of body fluids (typically
determine the level of one or more of the metals that are essential for human life. The role of each me
Frequently, the accurate determination of metals in biological samples presents particular difficulties a
precautions.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses of b
serum or plasma) to determine the level of copper. The role of copper in adult humans is not yet well

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bl
to determine the level of iron. An increase in iron concentration (hemochromatosis) is a disorder that m
excessive absorption of iron from the diet or from an inborn, genetically determined overabsorption of
of iron are implicated in diabetes, arthritis, cardiac arrhythmias, and hepatic cirrhosis. Low levels of iro
by dietary deficiency, by chronic blood loss, or by a group of disorders known as sideroblastic anemia

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bl
to determine the maximum concentration of iron that serum proteins (mostly transferrin) can bind. To
capacity usually increases in patients with iron deficiency and decreases in patients with malignancies
disorders, or hemochromatosis.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum or plasma) to determine levels of zinc. Low levels of zinc in blood are associated with growth re
and adolescents, mild dermatitis, delayed wound healing, mental lethargy, alopecia, and diarrhea. Zin
associated with genetic disorders such as acrodermatitis enteropathica and inherited sickle cell anem

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine or serum) to determine the level of saccharides, mostly of monosaccharides. Abnormal levels of
particularly glucose, are characteristic of several diseases (e.g., diabetes).
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine or serum) to determine the level of fructose, a monosaccharide. The presence of fructose in urin
the presence of fructose in blood is called fructosemia. Fructosuria may be caused by fructose intolera
disorder characterized by hypoglycemia that, if left untreated, may cause death.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to determine the level of galactose, a monosaccharide. The presence of galactose in blood (ga
by defective galactose metabolism. Galactosemia includes several hereditary disorders characterized
disease, and mental retardation; classic galactosemia is often fatal in neonates.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum or plasma) to determine the level of glucose, a monosaccharide. High levels of glucose (hyperg
caused by diabetes mellitus, a group of metabolic disorders of carbohydrate metabolism in which gluc
decreased levels of glucose (hypoglycemia) are found in several diseases in children and adults.

Clinical chemistry reagents intended to perform qualitative chemical analysis of body fluids (e.g., bloo
to determine the level of one or more of the most typically found alcohols, such as ethanol, methanol,
acetone (a metabolite of isopropanol). Alcohols are considered toxic substances.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to determine the level of one or more substances metabolized and/or secreted by the liver (e.g
Measurement of the level of liver-secreted substances is useful in the diagnosis and treatment of seve

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to measure the level of a single bile acid or total bile acid. Measurement of the level of bile ac
determine ileal dysfunction; increased levels in blood are common in disturbances of the hepatic excr
other liver diseases (e.g., cirrhosis).
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to determine the total level of bilirubin, including both direct (conjugated) bilirubin and indire
bilirubin. The level of bilirubinin blood is commonly increased (i.e., hyperbilirubinemia) in newborns (p
and in patients with hepatic disorders that usually produce jaundice; the level is low in other diseases
syndrome).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to determine the level of direct (conjugated) bilirubin. Direct bilirubin is composed of both mon
bilirubin and the delta fraction tightly bound to albumin. The level of bilirubin in blood is commonly in
hyperbilirubinemia) in several biliary-tree and hepatic disorders that usually produce jaundice.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine) to measure the total level of porphyrin. Analysis may include a profile of porphyrin components
coproporphyrin). Measurement of the total level of porphyrins is used in the diagnosis and manageme
metabolic disorders, either inherited or acquired, usually known as porphyrias; measurement of the po
urine is used to characterize several specific diseases, such as porphyria cutanea tarda, that are assoc
presence of isocoproporphyrin. Some specific porphyrin analyses in whole blood are performed for scr
as zinc protoporphyrin for iron-deficiency anemia and free erythrocyteporphyrin determination for lead

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine) to measure the level of one or more of the products (e.g., porphobilinogen) that are necessary t
porphyrin. The presence of porphyrin precursors in urine is associated with porphyrin disorders (porph
of porphyrin precursor levels is used to differentiate among several types of porphyrias and other con
clinically similar to porphyrias (e.g., lead poisoning).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine) to determine the level of 5-aminolevulinic acid (ALA), a porphyrin precursor. A high level of ALA
during episodes of the neurological forms of porphyrin disorders (i.e., porphyrias), both inherited and
measurement of the levels of both ALA and porphobilinogen (PBG), another porphyrin precursor, is us
among several types of porphyrias and other conditions that are clinically similar to porphyrias (e.g., l
characterized by high levels of ALA but normal PBG).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine) to measure the level of porphobilinogen (PBG), a porphyrin precursor. Measurement of the leve
primary assay performed when an acute neurological porphyria is suspected. The measurement of the
and delta-aminolevulinic acid (ALA), another porphyrin precursor, is used to differentiate among sever
and other conditions that are clinically similar to porphyrias (e.g., lead poisoning, characterized by hig
normal PBG).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum and urine) to determine the level of nonprotein nitrogen metabolites (e.g., urea, creatinine). Inc
nitrogen metabolites are associated with several liver and renal diseases and with metabolic disorders

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
blood or serum) to determine the level of urea in blood, usually referred to as blood urea nitrogen (BU
is referred as azotemia, typically caused by renal failure.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum and urine) to determine the level of creatinine. Measurement of creatinine in both blood and u
permits the determination of creatinine clearance, a measure of the glomerular filtration rate of the ki
monitor renal function.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum) to determine the level of uric acid. A high level of uric acid is associated with several diseases
gout, organic aciduria, and genetic disorders; hyperuricemia also occurs after administration of some
or as a product of intoxication (e.g., lead poisoning).
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
serum and urine) to determine the level of D-xylose. The measure of D-xylose recovered in both sam
a specific time after its oral administration permits the determination of D-xylose clearance, which is a
mucosal absorption ability of the small intestine. Low absorption of D-xylose is usual in intestine mala
malabsorption is due to pancreatic insufficiency; low absorption of D-xylose also occurs in other disea
disease, pellagra, AIDS).

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
blood, serum) to determine the level of lactates and/or lactic acid, an intermediary in carbohydrate m
levels of lactate in serum are found in hypoxic states such as shock, hypovolemia, and cardiac failure
such as neoplasia and diabetes mellitus.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
blood) to determine the level of pyruvate, the end product of glycolysis. There are only a few clinical s
the determination of pyruvate level in blood.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis of bo
urine) to determine the level of oxalates. The presence of oxalic acid and oxalates in urine characteriz
disorder (oxalosis) that causes calcium deposits and stones in the kidneys.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum or plasma) to determine the level of substances that dissociate into ions capable of c
(i.e., electrolytes). The most common electrolytes measured in clinical chemistry assays are sodium (N
chloride (Cl-), and bicarbonate (HCO3-), but other electrolytes, such as magnesium (Mg++), are also f

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically plasma or serum) to determine the level of ammonia (NH3), which is usually in a pH-depend
the ammonium electrolyte (NH4+) in blood. A high level of ammonia (i.e., hyperammonemia) causes
central nervous system, and may be caused by inherited metabolic diseases (e.g., deficiency of urea c
children) or by acquired diseases, such as hepatic encephalopathy in cirrhotic patients.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically plasma or serum) to determine the level of bicarbonate electrolyte (HCO3-), conventionally
plasma bicarbonate, carbonate, and carbon dioxide (CO2) bound in plasma carbamino compounds. Th
dissolved in plasma ,together with the pH and the values of other gases contained in blood, is used to
base imbalance. A high level of bicarbonate is found in metabolic alkalosis and respiratory acidosis; a
with metabolic acidosis, respiratory alkalosis, and several disorders such as diarrhea and dehydration

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum, but plasma can be used) to determine the level of free calcium electrolyte (Ca++), a
the total calcium content in blood. A high level of calcium in serum (i.e., hypercalcemia) is mostly cau
hyperparathyroidism and/or malignancies.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum, urine, or sweat) to determine the chloride electrolyte (Cl-) level. A high level of chlor
(hyperchloremia) is associated with dehydration, renal tubular disease, diabetes insipidus and several
level (hypochloremia) is associated with chronic pyelonephritis, Addison's disease, and metabolic acid
determination of the concentration of chloride and sodium in sweat is used as a diagnostic test for cys
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum, plasma, or urine) to determine the lithium electrolyte (Li+) level. Lithium is administ
treatment of manic-depressive diseases.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum, plasma, or urine) to determine the magnesium electrolyte (Mg++) level. A low level
serum or plasma (i.e., hypomagnesemia) is associated with impairment of the neuromuscular function
cardiac arrhythmias) but is not a reliable marker of magnesium deficiency by itself.

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum or plasma) to determine the levels of both monovalent (H2PO4-) and divalent (HPO4-
phosphate, the free phosphate electrolytes in blood. High levels of phosphates in blood (hyperphosph
with renal failure to excrete phosphates and with some diseases such as acromegaly and leukemia; lo
(hypophosphatemia) are associated with some renal diseases, decreased intestinal absorption, and in

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum, plasma, or urine) to determine the potassium electrolyte (K+) level. High levels of po
(hyperkalemia) are associated with renal diseases; low levels (hypokalemia) are associated with alkalo
chronic starvation, and the use of diuretic drugs.
Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analysis in a
(typically serum or plasma) to determine the sodium electrolyte (Na+) level. High levels of sodium in
are associated with excessive loss of fluids caused by vomiting, diarrhea, or excessive sweating; some
and several diseases (e.g., cardiac failure). Low levels of sodium in blood (hyponatremia) are associate
intake of sodium and metabolic acidosis. The determination of the concentration of chloride and sodiu
diagnostic test for cystic fibrosis.

Clinical chemistry reagents consisting of samples of substances with known values used for quality co
performed to determine the enzyme (e.g., aldolase, creatine kinase) content in a sample of a body flu

Analyzers designed to take samples and measure and display the concentration of one or more gases
monoxide, nitrogen dioxide, ethylene oxide, halogenated anesthetics) in a gas mixture. These analyze
portable units operated either by line power or batteries; they include gas sensors (e.g., optical, elect
built-in sampling pump, electronic circuitry, and a display. These units may also include recording cap
Environmental/gas system analyzers are used to measure the concentration of gases in healthcare fa
(e.g., operating rooms, intensive care units, laboratories), at a sampling point of a compressed medica
and/or in other medical devices used for respiratory therapy or anesthesia.

Clinical chemistry reagents consisting of serum pooled from donors; control serum is used for quality c
performed in a sample of body fluids. Control serum is usually aseptically filtered and frozen or lyophi

Clinical chemistry reagents consisting of serum pooled from normal donors (i.e., with approximately n
constituents); normal serum control reagents are used for quality control of assays performed in a sam
Clinical chemistry reagents consisting of serum pooled either from disease-state donors with above-no
specific metabolites or, less frequently, obtained by extracting some components from normal donor s
serum); abnormal serum control reagents are mostly used for quality control of specific clinical chemis
in a sample of a body fluid.
Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of enzym
state donors with above-normal concentrations of specific enzymes; less frequently they are obtained
enzymes from normal donor serum (i.e., enzyme-deficient serum). Enzyme control reagents are mostl
control of specific enzyme assays performed in a sample of a body fluid.

Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of lipids
donors with above-normal concentrations of total lipoproteins or of some specific lipids; less frequent
by extracting some lipids from normal donor serum (i.e., lipid-deficient serum). Lipid control reagents
quality control of specific lipid assays performed in a sample of a body fluid.

Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of lipopro
state donors with above-normal concentrations of total lipoproteins or of some specific lipoproteins; le
obtained by extracting some lipoproteins from normal donor serum (i.e., lipoprotein-deficient serum).
reagents are mostly used for quality control of specific lipoprotein assays performed in a sample of a

Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of bilirub
state donors with above-normal concentrations of bilirubin. Bilirubin control reagents are mostly used
bilirubin assays performed in a sample of a body fluid.
Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of protei
state donors with above-normal concentrations of total proteins or of some specific proteins; less freq
obtained by extracting some proteins from normal donor serum (i.e., protein-deficient serum). Protein
mostly used for quality control of specific lipoprotein assays performed in a sample of a body fluid.

Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of album
state donors with above-normal concentrations of albumin; less frequently, they are obtained by extra
normal donor serum (i.e., albumin-deficient serum). These control reagents are mostly used for quality
assays performed in a sample of serum or plasma.
Clinical chemistry reagents consisting of serum pooled either from donors with normal levels of triglyc
state donors with above-normal concentrations of triglycerides; less frequently, as they are obtained b
triglycerides from normal donor serum (i.e., triglyceride-deficient serum). Triglyceride control reagents
quality control of albumin assays performed in a sample of serum or plasma.

Calibrators designed to detect and measure the total amount of ionization produced by a radiopharma
radionuclide activity) in either curies (Ci) or becquerels (Bq). The measured radiopharmaceuticals are
vials, or capsules. These calibrators typically consist of a power supply, a detector (e.g., an ionization
holders, amplifiers, an electrometer, and a display; they usually include controls to adjust for different
Cs-137). Radioisotope calibrators are used in nuclear medicine studies to prepare radiopharmaceutica
concentrations, to measure their activity before administration, and to determine the activity of radion
Mo-99). Some calibrators include appropriate measuring ranges and characteristics (e.g., holders) to c
energy gamma and beta nuclides, high-dose brachytherapy, and/or PET isotopes.
Clinical chemistry reagents consisting of cerebrospinal fluid (CSF) pooled from donors; stabilized CSF
for quality control of assays (e.g., glucose, protein) performed in a sample of CSF.
Clinical chemistry reagents consisting of cerebrospinal fluid (CSF) pooled from normal donors (i.e., don
normal levels of CSF constituents); they are used as reagents for quality control of assays (e.g., glucos
in a sample of CSF.
Clinical chemistry reagents consisting of cerebrospinal fluid (CSF) pooled either from disease-state do
normal concentrations of specific metabolites or, less frequently, obtained by extracting some compon
donor CSF (i.e., deficient CSF); they are used as reagents for quality control of specific assays (e.g., g
performed in a sample of CSF.
Clinical chemistry reagents intended to establish points of reference (i.e., calibrate) in chemical and/o
used in the determination of enzyme (e.g., aldolase, creatine kinase) content in a sample of a body flu

Clinical chemistry reagents intended to establish points of reference (i.e., calibrate) in chemical and/o
used in the determination of electrolyte (e.g., sodium, potassium, chloride) content in a sample of a b

Clinical chemistry reagents intended to establish points of reference (i.e., calibrate) in chemical and/o
used in the determination of analyte content (e.g., proteins, lipids) in a sample of serum.
Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for a
content of solutions during processes intended to recover silver. Items in these kits usually include an
measure, and display the silver content of the solution (e.g., a handheld colorimeter), pipettes with ap
reagents, flasks, and an instruction manual. Silver recovery test kits are intended to evaluate the silve
recovering procedures performed both for financial and environmental reasons. These kits are mainly
facilities to test solutions during silver recovery from discarded x-ray films and/or solutions used in pro

Reagents intended to establish points of reference (i.e., calibrate) in clinical chemistry assays used in
pH and gas content (e.g., carbon dioxide) in a sample of blood.
Clinical chemistry reagents intended to establish points of reference (i.e., calibrate) in chemical and/o
used in the determination of analyte content (e.g., proteins, lipids) in a sample of cerebrospinal fluid.

Clinical chemistry reagents consisting of a substance (e.g., a solution) that is established as a norm (s
similar reagents used in chemical or enzymatic assays are compared. These standards may be used to
or performance of clinical chemistry reagents.
Clinical chemistry reagents consisting of a substance (e.g., a solution) that is established as a norm (s
similar reagents used in clinical chemistry assays are compared to determine the enzyme (e.g., aldola
content in a sample of a body fluid. These standards may be used to determine the purity or perform
chemistry reagents used in enzyme determination.
Clinical chemistry reagents consisting of a substance (e.g., a solution) that is established as a norm to
used in clinical chemistry assays are compared to determine the electrolyte (e.g., sodium, potassium,
sample of a body fluid. These standards may be used to determine the purity or performance of clinic
used in electrolyte determination.
Clinical chemistry reagents used to resist changes in the concentration of substances during a clinical
performed to determine a product (e.g., enzymes, substrates, electrolytes) in body fluids, usually keep
solution as constant as possible.
Clinical chemistry reagents used as buffers in assays performed to determine enzyme (e.g., aldolase,
content in body fluids, usually keeping the pH of the solution as constant as possible.
Clinical chemistry reagents used as buffers in assays performed to determine the electrolyte (e.g., sod
chloride) content in body fluids, usually keeping the pH of the solution as constant as possible.
Clinical chemistry reagents designed to perform tests in a short period of time (rapid tests), typically
reagents are mostly used in laboratory and point-of-care analysis, but some may be used in self-tests

Clinical chemistry reagents used to perform tests in a sample of whole blood in a short period of time,
minutes (i.e., rapid tests). Frequently, these reagents are impregnated in one or more areas of a pape
that undergo a color change when reacted with specific substances. They are typically used to determ
glucose, and/or lactate.
Clinical chemistry reagents intended to determine the level of glucose in a sample of whole blood in a
typically several minutes (i.e., rapid tests). High levels of glucose (hyperglycemia) are typically caused
a group of metabolic disorders of carbohydrate metabolism in which glucose is underutilized; decreas
(hypoglycemia) are found in several diseases in children and adults.

Clinical chemistry reagents consisting of samples of substances with known values used for quality co
performed to determine the electrolyte (e.g., sodium, potassium, chloride) content in a sample of a bo

Clinical chemistry reagents intended to determine the total level of cholesterol in a sample of whole b
of time, typically several minutes (i.e., rapid tests). High levels of total cholesterol in serum (typically
240 mg/dL) are associated with atherosclerosis and coronary artery diseases.
Clinical chemistry reagents intended to determine the level of high-density lipoprotein cholesterol (HD
whole blood in a short period of time, typically several minutes (i.e., rapid tests). High levels of HDL-C
defined as more than 35 mg/dL) are associated with low risk of atherosclerosis and coronary artery dis
HDL-C is characteristic of a cerebrovascular disorder known as Tangier disease.

Clinical chemistry reagents intended to determine the level of high-density lipoprotein cholesterol (HD
whole blood in a short period of time, typically several minutes (i.e., rapid tests). These reagents are i
more areas of a paper strip (reagent strip) that undergo a color change when reacted with specific sub
HDL-C in blood (typically defined as more than 35 mg/dL) are associated with low risk of atheroscleros
diseases; the absence of HDL-C is characteristic of a cerebrovascular disorder known as Tangier diseas

Clinical chemistry reagents intended to determine the level of lactate in a sample of whole blood in a
typically several minutes (i.e., rapid tests). Increased levels of lactate in serum are found in hypoxic st
decreased tissue oxygenation), as in shock, hypovolemia, and cardiac failure, and in metabolic states,
such as neoplasias and diabetes mellitus.
Clinical chemistry reagents intended to determine the level of lactate in a sample of whole blood in a
typically several minutes (i.e., rapid tests). These reagents are impregnated in one or more areas of a
strip) that typically undergo a color change when reacted with specific substances. Increased levels of
found in hypoxic states (associated with decreased tissue oxygenation), as in shock, hypovolemia, and
metabolic states, usually in diseases such as neoplasias and diabetes mellitus.

Clinical chemistry reagents intended to determine the level of ethanol in a sample of whole blood in a
typically several minutes (i.e., rapid tests). Ethanol has a pharmacological action as depressor of the c
High levels in blood result in disorientation and lack of coordination; increased levels may result in com
Clinical chemistry reagents used to perform tests in a short period of time, typically several minutes (
determine several constituents in a sample of whole blood. These reagents may be impregnated in on
paper strip (reagent strip) that undergo a color change when reacted with specific substances. Whole
multianalytic reagents are mostly used for simultaneous determination of two or more of the most im
substances in blood (e.g., glucose, cholesterol, lactates).

Clinical chemistry reagents used to perform tests in a short period of time, typically several minutes (
determine pH and/or a specific chemical constituent in a sample of urine. These reagents are typicall
impregnated in one or more areas of a paper strip (reagent strip) that undergo a color change when re
substances. Urinary rapid-test reagents are mostly used for determination of protein, albumin, glucos
occult blood, bilirubin, or urobilinogen.

Serology reagents intended to detect antibody titers or antigens of Treponema pallidum, a bacterium
Spirochaetaceae. These bacteria cause syphilis, a disease that is usually transmitted sexually or acqu

Clinical chemistry reagents available in tablets that are used to perform tests in a short period of time
minutes (i.e., rapid tests), to determine pH and/or a particular chemical constituent in a sample of uri
reagent tablets are mostly used for determination of protein, albumin, glucose, ketone bodies, occult
urobilinogen.
Clinical chemistry reagents used to determine several components in a sample of urine in a short peri
several minutes (i.e., rapid tests). These reagents may be impregnated in one or more areas of a pape
that undergo a color change when reacted with specific substances. Urinary rapid-test multianalyte re
for simultaneous determination of two or more of the most important clinical substances in urine (e.g
glucose, ketone bodies, occult blood, bilirubin, urobilinogen).

Clinical chemistry reagents impregnated in one or more areas of a paper strip (reagent strip) used to
sample of urine in a short period of time, typically several minutes (i.e., rapid tests), to determine sev
simultaneously. Urinary rapid-test reagent strips are mostly used for determination of protein, albumi
bodies, occult blood, bilirubin, and urobilinogen.
Clinical chemistry reagents used to perform tests in a sample of urine in a short period of time, typica
(i.e., rapid tests), to determine specific chemical constituents in the urine sediment. Urinary sedimen
are usually available in kits and are mostly used for determination of cells (e.g., erythrocytes, leukocy
genitourinary tract), aggregates of material deposited in renal tubules (i.e., casts), and crystals (e.g., o

Rapid-test clinical chemistry reagents used to perform tests in a sample of feces in a short period of ti
minutes. Some of these reagents are impregnated in one or more areas of a paper strip (reagent strip
change when reacted with specific substances. Most of these reagents are used for determination of o

Serology reagents used to detect total antibodies to Treponema pallidum bacteria in a patient's sampl
bacteria cause syphilis, a disease that is mostly transmitted sexually or acquired in utero.

Clinical chemistry reagents impregnated in one or more areas of a paper strip (reagent strips) used to
blood in a sample of feces in a short period of time, typically several minutes (i.e., rapid tests).
Sacroiliac spinal orthoses designed to provide therapeutic traction to the lower spine (sacroiliac area i
area) that consist of a sling. These orthoses typically consist of a padded loop-shaped device designed
and some degree of movement restriction to the pelvis (sacroiliac area) by holding the pelvis suspend
by attachments to an orthopedic bed and/or other self-standing structure; traction is provided by an e
that usually includes a pulley and a set of weights. Traction slings are used mainly for treatment of low
trauma and in other orthopedic treatments.

Large flexible soft support devices (also known as slings) that are designed to support the whole body
lifting and transfer over small distances. Typically, these devices consist of large flexible fabric (e.g., c
patients are placed, either by themselves or with partial or total help by caregivers. The slings usually
wrapped around or attached to the patient's hips, back, thighs, or buttocks to lessen the risk of accide
transfer. Patient transfer slings may be either handled directly by the attendants or attached to the sw
transfer lift; they are used mainly to move the patients for a short distance, reducing the risk of injury
the patient.

Patient transfer slings designed for patient handling by attendants. Typically these slings consist of a fl
canvas) band that gives the caregiver an extension, providing extra leverage and a better grip around
back, or buttocks. Only one caregiver is needed if the patient is capable of supporting at least part of
For completely disabled patients the sling can be used by two caregivers to lift the patient as if he or s
chair.

Flat, usually rectangular, pieces of material (e.g., wood, plastic) that have appropriate physical charac
strength) and dimensions for a particular clinical use.
Boards designed to facilitate patient transfer between two close surfaces, providing a bridge on which
These boards are available in a variety of shapes and sizes. The most common are rectangular with di
cm x 20 to 25 cm (20 to 30 inches x 8 to 10 inches); most of them are made of wood or plastic, have t
include cutouts or notches to facilitate placing and removal. Patient transfer boards are used to transf
and from wheelchairs, beds, stretchers, commodes, and bathtubs.

Patient transfer lifts that consist of a permanently mounted overhead track supporting a suspended se
These lifts include the following: a track usually mounted on the ceiling, but that may be wall-mounte
mounting system that attaches the track to the ceiling; a console containing the motor and pulleys; a
including the seat; and a control box for lift movement regulation. Track-mounted patient transfer lifts
move patients between rooms (e.g., bathrooms, x-ray cabinets) in healthcare facilities.

Patient transfer aids designed to laterally transfer patients without lifting the patient. A variety of dev
lateral transfer including mats that are inserted under the patient or strapped to the patient, and then
patient; metallic rollers covered with plastic that are placed beneath the drawsheet, permitting the at
patient across the roller onto another surface; and devices that permit wrapping the draw sheet to a t
the patient laterally, using a powered mechanism. Horizontal patient transfer aids are used to move p
contiguous surfaces, such as bed and stretcher tops, that are at similar height.

Bed mattresses filled with gel to provide a pressure-relief surface to the patient. These mattresses are
foundation (e.g., foam) with several sections of gel bladders. Gel mattresses are used to reduce the pr
the mattress surface to the patient's skin (e.g., for the prevention of pressure sores [decubitus ulcers]
Bed mattresses filled with air to provide a pressure-relief surface to the patient. These mattresses are
several interconnected sections of air cells enclosed in a strong plastic casing (e.g., vinyl). Static-air m
to be inflated using an air pump; they are used to reduce the pressure on patients' skin (e.g., for the p
sores). Most mattresses include a safety valve to deflate the mattress quickly in an emergency (e.g., t
cardiopulmonary resuscitation).

Mobile hospital stretchers designed with a fixed-height patient platform; some permit a variety of plat
Trendelenburg, Fowler). These stretchers are generally lighter, less complex, less expensive, and simp
adjustable-height stretchers. Fixed-height hospital stretchers are used in hospitals when transfer surfa
or when costs and/or maintenance are major factors.
Mobile hospital stretchers that include an adjustable-height (e.g., mechanical, hydraulic, electrical) pa
also permit a variety of platform positions (e.g., Trendelenburg, Fowler). Adjustable-height hospital str
matching their platform to another surface level, such as examination and radiology tables that have
heights, providing easier and safer patient transfer; they are also appropriate to use during treatment
platform height levels.

Portable stretchers that consist of two poles (e.g., aluminum, wood) and a canvas, plastic (e.g., vinyl-c
body. These stretchers are very simple, inexpensive, and can be stored in a very small place; they are
in emergencies, such as natural disasters, accidents, and fires, or when no other stretcher is available

Stretchers that can be converted from stretcher to chair and back to stretchers, usually without transf
them.
Mobile hospital stretchers that can be converted from stretcher to chair (i.e., wheeled chairs) and back
transferring the patient. Typically these devices can take several positions between a stretcher (horizo
chair with a fully vertical back section; most of them permit vertical height adjustment when used as
Stretcher/chairs are used to decrease patient handling, avoiding patient transfer from reception or to
treatment, surgery, and discharge, reducing the possibility of injuries to both patients and staff.

Portable stretchers that can be converted from stretcher to chair and back to stretchers; some may in
these stretchers can be folded or hinged for compact storage and/or include two or four wheels to fac
transportation. Portable stretcher/chairs are used for patient transportation in places of difficult access
not enough for stretcher handling, such as stairs and elevators.
Simulators designed to mimic some characteristics (e.g., electrical, mechanical, sound) of normal or a
the human heart.
Training simulators that produce images imitating the mechanical movement of actual heartbeats. In
heartbeat pulsations, the simulators can mimic partial images showing only the movement of several
structures. Some of these simulators can provide three dimensional images of the heartbeat by taking
of a healthy person or a cardiac patient. Cardiac heartbeat simulators are mainly used for learning and
interpretation of the complex mechanical movements associated with cardiac pulsation.

Respiration simulators designed to mimic a set of several baseline impedances (e.g., 500, 1000 ohms
impedance variations (e.g., 0.2, 0.5 ohm) of the human thorax during the respiration cycle at different
20, 30, 60, 100 bpm). They may also simulate apnea for short periods (e.g., 12 or 32 seconds) or cont
simulators are used to verify the performance and/or calibrate respiration and apnea monitors that wo
in thoracic impedance.
Respiration simulators designed to mimic the normal or abnormal sounds of breathing, either using sim
an analog circuit generator and/or digitally recorded signals stored in their memory from a real patien
of the sounds can be altered in a certain range, such as respiration rate from 10 to 100 bpm and inspi
Abnormal sounds can be added in any part of the respiratory cycle. Breathing sound simulators are m
purposes.

Simulators designed to mimic the bioelectrical signals of human organs (e.g., heart, brain) and/or the
transducers that detect patient vital signs (e.g., blood pressure, temperature). These simulators mimic
signals, typically including the bioelectric signal of the heart; the thorax impedance baseline and its v
respiration; and the output of invasive blood pressure, cardiac output, and temperature transducers. T
typically consist of a signal generator, a display, and appropriate cables/leads to match with the units
include computer capabilities. Multiparameter simulators are used to test the performance of single a
physiologic monitors and other recording and measuring devices of physiologic parameters.

Simulators designed to mimic the electrical signals at the output of transducers used for conversion o
(e.g., pressure, temperature, cardiac output) into an electrical signal. These simulators typically includ
electronic circuitry, controls, and a display; they generate signals that can be processed and displayed
device in the same way as the output of their own transducers (e.g., as a numerical value and/or wave
physiologic variable). Transducer output simulators are mostly used for testing and/or calibration of m
measuring devices, excluding the transducer of the device being tested.

Transducer output simulators designed to mimic the electrical signals at the output of a pressure trans
range of simulated pressures varies in a wide range (e.g., from -500 to +500 mm Hg); either static pre
(i.e., dynamic) pressures can be simulated. Pressure transducer simulators are mostly used for testing
trend, and alarm values of electronic pressure monitors (e.g., arterial and venous blood pressure, intra
esophageal pressures) excluding the transducer of the device being tested.

Transducer output simulators designed to mimic the electrical output of an invasive blood pressure tra
venous pressure, intra-arterial pressure). These simulators include an electronic generator that simul
output of the transducer, typically equivalent to wide a range of pressure variation (e.g., from -50 to +
static pressures or time-varying (i.e., dynamic) pressures can be simulated. Invasive blood pressure tr
simulators are used to test invasive blood pressure monitors excluding the monitor transducer.

Transducer output simulators designed to mimic the electrical signals at the output of a cardiac outpu
simulating a particular catheter system (e.g., Edwards and Baxter), at several possible combinations o
(e.g., 3, 5, 7 liter/minute), blood temperatures (e.g., 36 degrees, 37 degrees, and 38 degrees C), and i
(e.g., 2 degrees and 20 degrees C). These simulators are used to test cardiac output monitors excludin
transducer.

Transducer output simulators designed to mimic the electrical signal at the output of a temperature tr
thermistor probe. The range of temperatures simulated usually varies in a wide range (e.g., from -40 d
degrees C). Temperature transducer output simulators are mostly used for testing the performance an
electronic thermometers, temperature monitors, and recorders excluding the transducer of the device
Bags designed as a gas reservoir that mimics the pulmonary mechanics by taking in air and then expe
consist of an elastomeric (e.g., rubber) bag with appropriate volume (e.g., one-liter capacity) and incl
capabilities to couple with the device under test but do not include measuring devices or allow any se
are typically used as part of a test set-up (e.g., attached to a ventilator tester) to test devices such as
resuscitators, and anesthesia machines.

Serology reagents used in rapid tests to detect antibodies in a patient's sample to gram-negative bact
unknown origin. Typically, these reagents include either antigens (e.g., Salmonella O and H, Brucella a
OX-19) to detect antibodies caused by typhoid fever, brucellosis, and tularemia and/or other Proteus a
OX2 and OX-K) to detect antibodies to Rickettsia diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies directed against nuclear antigens (i.e., antinuclear antibodies [ANA]). Increased
are associated with autoimmune connective-tissue diseases, such as systemic lupus erythematosus, s
rheumatoid arthritis.
Serology reagents intended to detect antibodies to hyaluronidase (i.e., Antihyaluronidase, [AHT]) prod
group A (typically Streptococcus pyogenes), a spherical bacterium of the family Streptococcaceae. S.
most important bacterial human pathogens, causing a wide range of suppurative diseases (e.g., phary
sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheumatic fever). AHT antibodies ar
autoimmune diseases, including rheumatoid arthritis and osteoarthritis.

Reagents used in tests (i.e., serologic tests) to measure serum antibody titers, antigens, or toxins due
microorganisms (e.g., bacteria, viruses, parasites) through in vitro reactions of immune sera (e.g., agg
complement fixation, precipitin).
Serology reagents intended to detect antibody titers, antigens, or toxins of pathogenic bacteria throug
These reagents are typically performed on immune sera (e.g., agglutination, complement fixation, pre

Serology reagents intended to detect toxins from or antigens or antibodies to Escherichia coli, the prin
genus Escherichia, family Enterobacteriaceae. E. coli is a common inhabitant of the large intestine in h
pathogenic strains cause diarrhea and may cause urinary tract infections, conjunctivitis, and septicem

Serology reagents intended to detect antibody titers or antigens of Neisseria gonorrhoeae (i.e., gonoc
species of bacterium of the family Neisseriaceae. These bacteria cause gonorrhea, a disease that is us
sexually; these bacteria are found primarily in purulent venereal diseases.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci group specific antigens), a species of bacterium of the family Neisseriaceae. These
meningococcemia and/or meningococcal meningitis.
Serology reagents intended to detect antibody titers or antigens of Helicobacter (formerly Campyloba
of bacteria of the family Spirillaceae. These bacteria cause chronic gastritis and pyloric ulcer and coul
for gastric cancer.
Serology reagents intended to detect antibody titers or antigens of Borrelia burgdorferi, a species of in
of the family Spirochaetaceae. These bacteria cause Lyme disease (i.e., Lyme borreliosis), acrodermat
atrophicans, and erythema chronicum migrans; they are typically transmitted by a parasitic tick of the
Serology reagents intended to detect antibody titers or antigens of species of Mycobacterium, a genu
bacteria of the family Mycobacteriaceae. Mycobacteria are etiologic agents of several diseases and in
Mycobacterium tuberculosis, which causes tuberculosis in humans.
Serology reagents intended to detect antibody titers or antigens of species of Mycoplasma, a genus of
Mycoplasmataceae. Mycoplasma bacteria are etiologic agents of several diseases. The species Mycop
causes primary atypical pneumonia (i.e., mycoplasmal pneumonia).
Serology reagents intended to detect antibody titers or antigens of species of Streptococcus, a genus
the family Streptococcaceae. Streptococci tend to grow in pairs or chains and are divided into many se
according to their cell wall (e.g., groups A, B, C). Streptococci that are pathologic to humans include S
(pneumococcus), a major respiratory tract pathogen and the most common cause of pneumonia, and
one of the most important bacterial human pathogens, causing a wide range of suppurative diseases
media, sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheumatic fever).

Serology reagents intended to detect antibody titers, antigens, or toxins of species of Staphylococcus,
bacteria of the family Micrococcaceae. Staphylococci grow singly, in pairs, or in irregular clusters; spec
to humans include, S. aureus, S. epidermidis, and S. saprophyticus. The most important species is S. a
ability to cause serious suppurative infections, especially in immunosuppressed patients, neonates, an
damaged skin or in viral infections of the lungs.

Serology reagents intended to detect antibody titers or antigens of Listeria monocytogenes, a species
resembling bacteria of the family Corynebacteriaceae. Listeria monocytogenes bacteria are the cause
infection can result in abortion, stillbirth, or premature birth; infection acquired during birth can cause
distress, diarrhea, vomiting, and meningitis; and infection in adults can produce meningitis, endocardi
granulomatous lesions.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
Campylobacter, family Spirillaceae. Campylobacter bacteria of some species cause diarrhea and acute
bacteria may also cause proctitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to rubella virus, an RNA virus
Rubivirus, family Togaviridae. Rubella virus is the cause of an acute, usually benign infection, often aff
disease is characterized by a pink rash beginning on the head and spreading to become generalized.
of a fetus may occur. Rubella is also called German measles and, in French and Spanish, rubeola.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to varicella-zos
of the genus Varicellavirus, family Herpesviridae. These viruses cause chickenpox (varicella), an infect
transmitted by direct contact or through the respiratory route and characterized by the appearance of
the skin and mucous membranes. Activation of varicella-zoster virus from a previous chickenpox (vari
to cause herpes zoster (also called shingles), a self-limited infection that affects ganglia and their area
producing severe neuralgic pain and vesicles on the skin.
Serology reagents intended to detect and/or identify antigens or serum antibody titers to Enterovirus,
stranded viruses of the family Picornaviridae that includes polio and nonpolio (e.g., coxsackieviruses,
enteroviruses. Enteroviruses typically inhabit the intestinal tract, and most infections are subclinical;
cause a wide range of diseases, including poliomyelitis (the etiologic agents are wild type polioviruses
and encephalitis (caused by several types of coxsackieviruses and echoviruses), and chronic meningo
by several types of echoviruses).

Serology reagents intended to detect antibodies to Influenza virus, a single-stranded RNA virus of the
Orthomyxoviridae. Human influenza viruses are usually divided into three serogenic types: A, B, and C
this virus are the etiologic agents of influenza, a disease characterized by sudden onset of high fever,
severe malaise, nonproductive cough, sore throat, and rhinitis.
Serology reagents intended to detect antibodies to Parainfluenza viruses, a group of single-stranded R
family Paramyxoviridae. Parainfluenza viruses affecting humans are classified into the genera Paramy
human Parainfluenza virus types 1 and 3) and Rubulavirus (includes human Parainfluenza virus types
are the etiologic agent of parainfluenza and several upper respiratory tract infections (e.g., bronchitis,
severity. Dedicated reagents are available to identify particular types of Parainfluenza viruses.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to respiratory s
an enveloped RNA species of the genus Pneumovirus, family Paramyxovirus. Several types of RSV are
lower respiratory tract infections; they are the most common cause of bronchiolitis and pneumonia am

Serology reagents intended to detect antigens to Rotavirus, a genus of nonenveloped double-stranded


wheel-like appearance, of the family Reoviridae. Several types of Rotavirus may cause diseases in hum
gastroenteritis and diarrhea; it is the most common cause of severe diarrhea among children.

Serology reagents intended to detect early soluble antigens (i.e., Be antigens), closely associated with
hepatitis B viruses. These antigens typically appear in serum shortly after appearance of the surface a
disappear shortly after disappearance of surface antigens. Hepatitis B viruses are DNA viruses of the g
family Hepadnaviridae. These viruses may cause hepatitis, a disease characterized by jaundice and th
enzymes in serum (e.g., aspartate aminotransferase); these viruses may be transmitted percutaneous
piercing, tattooing), parenterally, from mother to child at birth, or by intimate (e.g., sexual) contact.

Serology reagents intended to detect antibodies to early soluble antigens (i.e., Be antigens), closely a
antigens of hepatitis B viruses. These antibodies typically appear in serum after Be antigens disappea
indefinitely. Hepatitis B viruses are DNA viruses of the genus Hepadnavirus, family Hepadnaviridae. Th
hepatitis, a disease characterized by jaundice and the increase of some enzymes in serum (e.g., aspa
aminotransferase); these viruses may be transmitted percutaneously (e.g., via body piercing, tattooin
mother to child at birth, or by intimate (e.g., sexual) contact.

Serology reagents intended to detect core antigens to hepatitis C virus, an RNA virus of the genus Fla
Flaviviridae. Hepatitis C virus may cause hepatitis, a disease characterized by jaundice and the increa
serum (e.g., aspartate aminotransferase); this virus is transmitted frequently parenterally and possibl
sexual) contact. Tests using these reagents currently are not widely utilized; tests using these reagent
clinical usefulness, and easier or less expensive tests are available.
Serology reagents intended to detect antigens to hepatitis D virus, an unclassified defective RNA virus
requires the presence of hepatitis B virus (HBV) for viral replication to occur. Hepatitis D virus may occ
acute hepatitis infection or may be superimposed on a case of chronic HBV. Hepatitis is a disease char
and the increase of some enzymes in serum (e.g., aspartate aminotransferase). Hepatitis D viruses ar
parenterally and possibly by intimate (e.g., sexual) contact.

Serology reagents intended to detect antibodies to hepatitis E virus, an RNA virus of the genus Caliciv
Caliciviridae. Hepatitis is a disease characterized by jaundice and the increase of some enzymes in se
aminotransferase). Hepatitis E viruses are transmitted by the fecal-oral route or via contaminated food
endemic in some geographic areas. Hepatitis E virus is especially dangerous for pregnant women.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to viruses of th
The subfamilies of pathogenic retroviruses are Oncovirinae, Spumavirinae, and Lentivirinae; lentivirus
acquired immunodeficiency syndrome (AIDS); oncoviruses are associated with human T-cell lymphom
spumaviruses are considered nonpathogenic to humans.

Serology reagents intended to detect antigens to human immunodeficiency virus serotype 1 (HIV-1), a
genus Lentivirus, family Retroviridae. HIV-1 is the most common etiologic agent of acquired immunode
(AIDS).
Serology reagents intended to detect antigens to human immunodeficiency virus serotype 2 (HIV-2), a
genus Lentivirus, family Retroviridae. HIV-2 is the etiologic agent of acquired immunodeficiency syndr
these reagents are not widely utilized; these reagents may have questionable clinical usefulness, and
expensive tests may be available.
Serology reagents intended to detect antibodies to human immunodeficiency virus serotype 2 (HIV-2)
genus Lentivirus, family Retroviridae. HIV-2 is an etiologic agent of acquired immunodeficiency syndro

Serology reagents intended to detect antigens to human immunodeficiency virus serotype 1 (HIV-1) a
2). Human immunodeficiency viruses are retroviruses of the genus Lentivirus, family Retroviridae, tha
immunodeficiency syndrome (AIDS). Tests using these reagents are not widely utilized; these regents
clinical usefulness, and easier or less expensive tests may be available.

Serology reagents intended to detect antibodies to human immunodeficiency virus serotype 1 (HIV-1)
both. Human immunodeficiency viruses are retrovirus of the genus Lentivirus, family Retroviridae; the
agent of acquired immunodeficiency syndrome (AIDS).
Serology reagents intended to detect antibodies to human T-cell lymphotropic virus (also called huma
leukemia/lymphoma virus) type I (HTLV-I). HTLV-I retrovirus is a tumor-producing RNA virus of the subf
may cause chronic infection, T-cell leukemia, and tropical paraparesis (chronic progressive myelopathy
reagents are not widely utilized; these reagents may have questionable clinical usefulness, and easier
tests may be available.

Serology reagents intended to detect antibodies to human T-cell lymphotropic virus (also called huma
leukemia/lymphoma virus) type II (HTLV-II). HTLV-II retrovirus is a tumor-producing RNA virus of the sub
that may cause leukemia and other hematological diseases. Tests using these reagents are not widely
these reagents may have questionable clinical usefulness, and other tests may be easier or less expe
Serology reagents intended to detect antibodies to human T-cell lymphotropic virus (also called huma
leukemia/lymphoma virus) type I (HTLV-I) and/or type 2 (HTLV-II). Human T-cell lymphotropic retrovirus
producing RNA viruses of the subfamily Oncovirinae that may cause chronic infection, T-cell leukemia,
(chronic progressive myelopathy), and other hematological diseases.
Serology reagents intended to measure serum antibody titers or antigens in human body fluids due to
pathogenic fungi including molds and monocellular fungi (yeasts). Frequently, these tests provide sup
for the diagnosis of mycotic infections and, in some instances, they provide the only means of diagnos

Serology reagents intended to detect antibodies to species of fungi of the genus Blastomyces, imperfe
Hyphomycetes. Some species of Blastomyces may cause self-limited or localized pulmonary lesions (b
immunocompromised patients may develop a chronically progressive illness in the skin and/or organs
genitourinary tract, central nervous system).
Serology reagents used to detect antibody titers or antigens present in human blood due to pathogen
parasitic to humans.
Serology reagents intended to detect antibodies to species of Cryptosporidium, a genus of parasites o
Cryptosporidium parvum is the only known pathological species, causing a profuse, watery diarrhea th
indefinitely in immunocompromised patients.
Serology reagents intended to detect antigens that permit the identification of strains of Giardia lamb
protozoon characterized by the presence of a large sucking disk in the ventral surface, that parasitize
The species Giardia lamblia causes giardiasis, a common infection of the small intestines characterize
nausea.
Serology reagents intended to detect antibodies to Leishmania, a genus of protozoa of the suborder Tr
characteristics of Leishmania parasite infections (leishmaniasis) depend on the species or subspecies.
classified according to their effects as cutaneous, mucocutaneous, and visceral. These parasites are u
sand flies.
Serology reagents intended to detect antibodies to species of Schistosoma, a genus of trematode para
class of Platyhelminthes (flat worms). Schistosoma of several species (e.g., haematobium, indicum, ja
pathogenic to humans; the parasites typically enter through the skin of humans who come in contact
The adult worms are usually found in the veins, causing hematuria, dysentery, and bladder irritation.

Serology reagents consisting of samples of substances with known values; they are used for quality co
performed for the determination of antigens and/or antibodies in human specimens due to infection b
microorganisms (e.g., viruses, bacteria, parasites).
Serology reagents consisting of a substance (e.g., a solution) that is established as a norm with which
in tests performed to determine antigens and/or antibodies in human specimens due to infection by p
microorganisms (e.g., viruses, bacteria, parasites) are compared. These standards may be used to det
performance of immunoassay reagents used in infection tests.
Serology reagents designed to perform tests in a short period of time, typically several minutes, to de
antibodies, and/or toxins due to pathogenic bacteria in a patient's sample.
Serology reagents designed to perform tests in a short period of time, typically several minutes, to de
antibodies in a patient's sample to viruses that may cause infections in humans.
Reagents intended for use in a diverse range of sensitive and specific clinical assays using immunoch
(immunoassays). The specificity and high affinity of antibodies for specific antigens, coupled with the
cross-link antigens, allows the identification and quantification of specific substances using a variety o
these reagents are available in kits that include an antibody or antigen, calibrators, and other specific
activator). Immunoassay reagents may be specific for one or many different types of assays, such as
nephelometry, or microtiter assays. They are used in a variety of tests to determine levels of proteins,
abuse, and many other substances, facilitating the diagnosis of allergies, autoimmune diseases, tumo
conditions.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on body fluids to
presence of one or more of a variety of specific complexes of nitrogenous polymer complexes formed
amino acids (i.e., protein/polypeptides).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (e.
cervicovaginal exudates) to determine fibronectin, an adhesive glycoprotein that circulates in plasma
cell surfaces. Fibronectin is related to the aggregation of platelets. Fibronectin levels are decreased in
diseases; low levels in plasma of chronic diabetic patients are associated with hyperglycemia complica
cervicovaginal fetal fibronectin in pregnant women is associated with an increased risk of preterm del
the oncofetal isoform of fibronectin from neoplastic tissues is a marker for angiogenesis, such as in int
meningiomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum, but also in urine) to determine kappa light chains, as fragments of monoclonal immunoglobulin
presence of kappa light chains Ig in serum is used in the diagnosis of some malignant neoplasms, suc
plasmacytoma, and amyloid disease.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum, but also in urine) to determine lambda light chains as fragments of monoclonal immunoglobul
presence of lambda light chain Ig in serum is used in the diagnosis of some malignant neoplasms, suc
myeloma, plasmacytoma, and amyloid disease.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
associated with the total complement activity. These proteins are synthesized by the liver and are nor
blood as functionally inactive molecules. The values are usually expressed as hemolytic complement u
(known as CH50), representing the reciprocal of the dilution of serum required to lyse 50% of a stand
erythrocytes previously coated with erythrocyte antibodies. This test is typically used for screening pu
serum levels of complement components may be due to either inherited or acquired diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids to
presence of one or more of a group of plasma proteins that are usually bound to other substances, typ
hormones of low solubility,thus providing a transport system for them (transport or binding proteins).
be bound to a particular hormone (typically thyroid and steroid hormones) or to any low-soluble subst

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


plasma) to determine substances (i.e., cardiac markers) liberated from the myocardium into the plasm
of liberated substances (typically proteins or enzymes) are used in the diagnosis of the occurrence an
damage, mostly as the result of myocardial infarction.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of se
determine the creatine kinase isoenzyme MB (i.e., muscle-brain isoenzyme, CKMB) level. This isoenzy
cardiac muscle. The level of CKMB is used in the diagnosis of heart damage as the result of myocardia
pericarditis, or myocardial ischemia and also after cardiac surgery.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a serum or pla
determine Troponin T, the circulating tropomyosin-binding subunit of cardiac troponin (cTnT). Troponin
globular muscle proteins that inhibits contraction by blocking the interaction of actin and myosin; it is
tropomyosin. The level of liberated cTnT is a highly specific marker of the occurrence of ischemic hear
of myocardial infarction).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine either one or more in the group of glycoproteins that are normally attached to mast cells
E) or the vasoactive amines (e.g., histamines) that are released by mast cells when an antigen (allerg
attached IgE molecules; the presence of specific Immunoglobulin G subtypes may also be tested. The
used to characterize a patient's abnormal hypersensitivity to substances that are ordinarily harmless (
reagents may be used to determine allergy mediators (e.g., leukotrienes, tryptase).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


substances present in or secreted by neoplastic tumor cells (i.e., tumor markers). Tumor markers inc
as enzymes, hormones, and oncofetal antigens that may be found in cells, tissues, or body fluids. Idea
should be specific for a given type of cancer, sensitive for screening and/or early diagnosis, and propo
thus permitting the assessment of the response to treatment and monitoring for recurrence of cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


secretions) to determine enzymes secreted by neoplastic tumor cells (i.e., tumor markers); these reag
antibodies with the capability of binding to the tumor marker enzyme. Enzyme tumor markers include
phosphatase (PAP), prostate-specific antigen (PSA), neuron-specific enolase, and thymidine kinase.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine hormones secreted by neoplastic tumor cells (i.e., tumor markers), either as a result of a
the endocrine tissue that normally produces the hormone or as a product of nonendocrine tissues that
produce the hormone. Hormone tumor markers include adenocorticotropic hormone (ACTH), calcitonin
human chorionic gonadotropin (HCG).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine proteins normally produced during fetal life (oncofetal antigens); the reappearance of th
in cancer patients demonstrate that a malignant transformation of cells has reactivated one or more g
antigens are used as tumor markers; they include carcinoembryonic antigen (CEA), alpha-fetoprotein
carcinoma (SCC) antigen, and tissue polypeptide antigen (TPA).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine the placenta-like alkaline phosphatase (PLAP) enzyme, an enzyme synthesized by the tro
typically found in high levels in serum of pregnant women. High levels of PLAP are also found in serum
several malignancies, such as ovarian, lung, and gastrointestinal cancer as well as in Hodgkin's diseas
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine carbohydrate-related, high-molecular-weight mucin antigens present on the surface or s
tumor cells (i.e., tumor markers); these reagents include antibodies (typically monoclonal antibodies)
binding to these tumor markers. Carbohydrate antigen tumor markers are usually more tumor-specific
than hormones and enzymes.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine CA 15, a carbohydrate-related antigen tumor marker. The detection of the tumor marke
in monitoring therapy and disease progression in metastatic breast cancer, but not to diagnose prima
levels of CA 15 are also found in pancreatic, ovarian, colorectal, and hepatic malignancies.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine CA 19-9, a blood-group carbohydrate-related tumor marker. The detection of the tumor
mostly in diagnosis and monitoring of colorectal and pancreatic carcinomas; this assay has also been
cholangiocarcinoma.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine CA 125, a carbohydrate-related tumor marker. The detection of the tumor marker CA 125
prognosis of endometrial carcinoma; the level of CA 125 is also used for monitoring ovarian carcinoma
correlation with tumor size and staging. The level of CA 125 may also be used for differentiation of a m
a benign disease in patients with palpable ovarian masses and for diagnosis and monitoring of primar
carcinoma. CA 125 is not useful for screening for ovarian cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


secretions) to determine specific proteins secreted by neoplastic tumor cells (i.e., tumor markers). Pro
include beta-2-microglobuline, ferritin, and monoclonal immunoglobulins.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses in tissue prepara
molecular structures (i.e., receptors) within or on the surface of the cells (typically some specific prote
selective binding with high affinity and great specificity to particular substances (e.g., hormones, such
progesterone). These reagents are mostly used in monoclonal antibodies-based assays that act on dir
recognition.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses in tissue prepara
cellular regulatory protein that binds estrogenic hormones (i.e., cytoplasmic estrogen receptors). Thes
especially found in estrogen sensitive tissues (e.g., breast and uterus tissues). The assays are perform
removed samples, and determination of the level of estrogen receptors is used as a marker of the resp
therapy in diseases such as breast carcinoma.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine one or more of the group of hormones secreted by the thyroid gland, including th
triiodothyronine (T3); their precursors, monoiodotyrosine (MIT) and iodotyrosine (DIT); and the biologi
triiodothyronine (RT3). These reagents include antibodies (typically monoclonal antibodies) with the c
the specific thyroid hormone.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
serum) to determine triiodothyronine (3,5,3'-L- triiodothyronine), commonly known as T3, one of the t
secreted by normal thyroid glands. These assays determine the total circulating T3 in blood, an equilib
protein bound and free (typically 0.03% of total T3) hormone, either using isotopic or automated nonis
Measuring of T3 is useful to confirm hyperthyroidism in cases in which the level of thyroxin (T4) is onl

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine the hormone thyroxin (3,5,3',5'-L- tetraiodothyronine), commonly known as T4, t
secreted by normal thyroid glands. These assays determine the total circulating T4 in blood, an equilib
protein bound and free (typically 0.03% of total T4) hormone, either using isotopic or nonisotopic imm
Determination of T4 is a useful test to assess thyroid hormone production, but the level of T4 may be
thyroid disease because of changes in serum binding proteins.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine the free component of thyroxin (FT4), one of the two main hormones secreted by
These assays are very sensitive and permit direct measurement of FT4 (typically only 0.03% of the tot
blood) in undiluted serum after ultra filtration. The determination of FT4, the only fraction of T4 that is
is more indicative of the clinical state of the thyroid than the total level of T4; thus, FT4 determination
establish both hyperthyroidism and hypothyroidism.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses or a sample or bo


serum) to determine the total thyroid binding proteins (TBP), a group of proteins (albumin, prealbumin
binds both thyroxin (T4) and triiodothyronine (T3); individual TBPs are typically determined using elec
of TBPs is mostly determined in patients with normal thyroid hormones (i.e., euthyroid patients) to diff
abnormalities in the concentration of normal T4 binding proteins (either congenital or drug induced) fr
proteins that have altered affinity for T4 (e.g., congenital variants of albumin).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine one or more of the group of hormones that are vital for the human reproduction (
as testosterone and androstenedione, estrogens such as estradiol, progesterone). Hormones related t
mostly secreted by the ovaries, testes, and adrenal glands under control of the hypothalamus and pitu

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum or plasma) to determine dehydroepiandrosterone (DHEA) and/or its sulfated conjugate dehydro
sulfate (DHEA-S). Both hormones are mainly secreted by the adrenal glands and constitute the main a
women. Immunoassay analysis of DHEA is usually more difficult than DHEA-S and requires pretreatme
samples due to the lower concentration of DHEA in relation to DHEA-S (typically 1000-fold lower). High
found in patients with polycystic ovary diseases, in congenital adrenal hyperplasia, in adrenal tumors,
children; some contraceptives reduce DHEA-S levels. Decreased DHEA levels are also found during pre
estrogen therapy.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
serum) to determine estradiol (E2), the most potent natural estrogen, derived mainly from the ovaries
and bound fractions are measured. Estradiol is a sex steroid vital for human reproduction. Its level var
menstrual cycle. Estradiol determination is used to evaluate the ovarian function. Levels of estradiol m
gynecomastia and cirrhosis.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum or urine) to determine follicle stimulating hormone (FSH), one of the hormones that control the
the gonads (i.e., gonadotropins). FSH is vital for human reproduction, stimulates the growth of ovarian
contributes to ovum ripening in females, and stimulates spermatogenesis in males. The level of FSH is
with polycystic ovary disease or hypothalamic dysfunction. Decreased FSH levels are also found in hyp
hypogonadism, anorexia, and in some cancers of the testes, ovaries, or adrenal glands.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum or urine) to determine luteinizing hormone (LH), one of the hormones that control the functiona
(i.e., gonadotropins). In females, LH causes release of the ovum from the ovarian follicle and, following
transformation of the ruptured follicle into the corpus luteum (luteinization). In males LH is frequently
hormone or interstitial cell stimulating hormone because it stimulates testosterone production. High le
are found in primary amenorrhea, ovariectomy, polycystic ovarian diseases, pituitary or hypothalamic
administration of oral contraceptives. High levels in men are caused by primary testicular failure and t
syndrome. LH is vital for human reproduction.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine progesterone, a female sex hormone that in conjunction with estrogen regulates
during the menstrual cycle. Progesterone is essential for maintaining pregnancy and human reproduct
and bound fractions of progesterone are measured. Progesterone levels are associated with preparatio
pregnancy. Its level varies during the menstrual cycle and throughout pregnancy.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine prolactin (PRL), a hormone secreted by the anterior lobe of the pituitary gland th
sustains lactation. High levels of prolactin (also known as lactogen) are found in pregnant women and
minor alterations of fertility, such as absence of ovulation with or without menstrual irregularity or abn
milk (galactorrhea). The level of prolactin also increases in some diseases, including pituitary adenom
administration of some drugs (e.g., tricyclic antidepressants).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine dihydrotestosterone (DHT) and/or total testosterone, the two main circulating androgens
testosterone and DHT circulate in plasma either freely (typically less than 3%) or bound to plasma pro
bound to sex hormone binding globulin, weakly bound to albumin). Testosterone is a sex steroid vital f
reproduction; lack or low levels of testosterone during fetal, prepubertal, and postpubertal life affect t
reproductive function, producing diseases such as male infertility and growth of glandular breast tissu
male adults.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample or bo
serum) to determine one or more of the group of hormones (either steroid or protein hormones) that a
detection, evaluation, and monitoring of human pregnancy; the hormones related to pregnancy are m
ovaries and adrenal glands, usually under control from the hypothalamus and pituitary glands.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


urine) to determine the total steroid hormone estriol (E3), produced mostly by the placenta in pregnan
are high during pregnancy. Measurement of E3 is used, combined with other markers, to improve the
abnormalities such as Down's syndrome in the second trimester of pregnancy. Low levels or a drop of
distress.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


the glycoprotein hormone human chorionic gonadotropin (HCG), composed of two glycoprotein subun
beta. This hormone is produced mostly by the placenta in pregnant women. Qualitative tests for HCG
urine are used for the confirmation of pregnancy. Quantitative determination of HCG levels in serum a
estimates of fetal age, to determine abnormalities in pregnancy, and to diagnose and monitor neoplas
trophoblastic neoplasms); these tests are also useful in detecting ectopic pregnancies.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


urine) to determine the beta subunit (free and/or core fragment) of the glycoprotein hormone human
(beta-HCG). Quantitative tests for beta-HCG in serum are used to establish estimates of fetal age, and
abnormalities in pregnancy (e.g., ectopic pregnancy, uncertain outcome of abortion, molar pregnancy
with other markers to improve the detection of fetal abnormalities such as Down's syndrome.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum) to determine one or more of the group of hormones and other substances (e.g., C-peptide, glu
the regulation of glucose concentration in blood.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
urine) to determine C-peptide, a connecting (C) peptide chain that is removed when pro-insulin is clea
peptide levels are better indicators of the beta cells function of the islets of Langerhans in the pancre
concentration because it is not extracted by the liver. C-peptide provides a useful index of insulin secr
insulin cannot be measured or is difficult to measure due to the presence of insulin antibodies. C-pept
also used to monitor patients with surgical resectomy of the pancreas and/or after pancreas transplan
is a better indicator of beta-cell function than peripheral insulin concentration; C-peptide tests do not
insulin and do not cross-react with insulin antibodies. These tests are not used as general diagnosis c
mellitus.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum or urine) to determine insulin, a protein hormone produced by the beta cells of the islets of Lan
pancreas. Insulin stimulates the uptake of glucose into fat and muscle, inhibits glucose production by
protein breakdown, and promotes the conversion of glucose to glycogen or fat for storage. Both isotop
methods are used for insulin determinations. Insulin tests are primarily used in the evaluation of patie
hypoglycemia, but not for the general diagnosis of diabetes mellitus.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
serum or urine) to determine one or more of the group of hormones (e.g., aldosterone) and/or other p
produced or degraded by the kidneys (e.g., renin); these reagents are mostly used in testing the funct
the kidneys and/or related diseases (e.g., hypertension).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
urine) to determine the level of aldosterone, the major mineralocorticoid hormone secreted by the adr
secretion is stimulated by angiotensin II. Very high levels of aldosterone (i.e., aldosteronism) are assoc
volume expansion, hypertension, and edema; they may occur due to overproduction of aldosterone (e
or secondary due to extra adrenal diseases such as nephrotic syndrome or congestive heart failure.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


urine ) to determine the level of cortisol, the major natural glucocorticoid synthesized in the zona fasc
cortex. Cortisol is transported in plasma mostly bound to transcortin and albumin (about 90%); the bio
form typically excreted by the kidneys is only about 10% of the total. Decreased values of free cortiso
patients with renal diseases, and high levels are typically found during pregnancy. Determination of co
diagnosis of Cushing's syndrome due to adrenal hyperplasia or adrenal tumors.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses or a sample or bo


serum or urine) to determine either one or more of the group of hormones and/or their metabolites th
bone metabolism. These assays are mostly used in testing bone diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


to determine the parathyroid hormone (PTH), the final product in the biosynthesis from a 115 amino a
PTH. PTH is synthesized and secreted by the parathyroid glands; its secretion is primarily regulated by
calcium in plasma or extracellular fluid.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
plasma, urine) to determine one or more of a group of protein hormones (e.g., adenocortiotropic, hum
that are typically secreted by a specialized gland (i.e., an endocrine gland) in one location and directly
plasma or lymph to exert their specific effects in other organs. Most immunoassays of endocrine horm
using nonisotopic labels and labeled-monoclonal antibodies (immunometric) assays. Radioimmunoass
some determinations.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


serum or urine) to determine one or more of a group of hormones that consist of biogenic amines atta
bearing two hydroxyl groups (i.e., catecholamines). Catecholamines are mostly produced in the brain,
the adrenal medulla, and the sympathetic neurons. The main catecholamines are epinephrine, norepin
as adrenalin and noradrenalin, respectively), and dopamine. Increased levels of catecholamines (most
assays measure active, free catecholamines) are associated with thyroid hormone deficiency, low bloo
heart failure, and arrhythmias; low levels are associated with idiopathic postural hypotension. Measure
catecholamines and their metabolites are also used for the diagnosis of catecholamine-secreting tumo
Reagents, Immunoassay, Anemia Test: Immunoassay reagents intended to perform qualitative and/or
on a body fluid sample (e.g., serum, plasma, urine) to determine one or more of a group of substances
(e.g., erythropoietin, serum ferritin, folate) whose levels are usually changed in individuals with decre
and/or hemoglobin level (i.e., anemia).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine the level of erythropoietin, a polypeptide hormone produced in the kidneys that
production of red blood cells (erythrocytes) in the bone marrow. Erythropoietin level is increased in mo
but decreased in chronic anemias due to renal diseases. Determination of erythropoietin levels are als
differentiate disorders marked by overproduction of erythrocytes (polycythemias).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bl


to determine the level of iron bound to serum transferrin, but not the iron contained in serum as free h
of iron in serum are found in many but not all patients with iron deficiency anemia caused by dietary d
blood loss, or by a group of disorders known as sideroblastic anemia. Decreased levels of iron are also
chronic infection and cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the maximum concentration of iron that serum proteins (mostly transferrin) can bind. To
capacity usually increases in iron deficiency anemia and decreases in malignancies, inflammatory diso
hemochromatosis.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine one or more of a group of organic compounds (frequently described as coenzymes
required in trace amounts (microgram or milligram) in the daily diet for health, growth, and reproduct
classified in groups using capital letters (e.g., A, B, C), frequently followed by an Arabic number subsc
identified by common chemical names (e.g., folacin).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine vitamin B12, the generic descriptor of a group of biologically active substances kn
Vitamin B12 is frequently identified with cobalamins that have similar biological activity as cyanocoba
levels of vitamin B12 are associated with pernicious anemia. Deficiency of vitamin B12 may cause neu
as pain and loss of sensation of the limbs, weakness, paralysis, and even dementia that may occur wi
hematologic changes.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine 25-hydroxyvitamin D (25-OH-D), a metabolite of both vitamin D2 and D3. These assays are
differentiate between D2 and D3 metabolites; a large number of bone and mineral metabolism disord
abnormal levels of 25-OH-D, including hypocalcaemia and osteomalacia

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine 1,25-dihydroxyvitamin D, also known as 1,25-(OH)2-D, a metabolite of both vitamin D2 and
not designed to differentiate between D2 and D3 metabolites. Decreased levels of this metabolite are
failure, hypercalcemia, or malignancy and other diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine one or more of a family of compounds (folates) generically known as folacin vita
related to the pteroyl glutamic acid. Their principal form in human serum and other body fluids is N5-m
Folate levels are decreased in anemia characterized by the presence of megaloblasts in the bone mar
anemia), in some psychiatric disorders, and during pregnancy. Simultaneous low levels of folate and ir
malnourished people.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
and/or measure the levels of one or more of a group of chemical compounds administered to humans
treatment, or prevention of a disease or other abnormal condition or for the relief of pain (i.e., therape
the sample. These reagents are used in tests intended to monitor therapeutic drugs such as antibiotic
cardiovascular and nervous systems, antiasthmatic drugs, antineoplastic drugs, immunosuppressants

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels and/or otherwise analyze one or more of a group of therapeutic drugs known as cardiovascular
intended to affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume.
mainly used in tests intended to measure the cardiovascular drug levels in patients undergoing treatm
determine the adequacy of drug treatment or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of digoxin (a cardiotonic glycoside that has positive inotropic and negative chronotropic activity
ventricular rate in atrial fibrillation as well as in the management of congestive heart failure) present i
reagents are used in tests intended to measure digoxin drug levels in patients undergoing treatment t
adequacy of digoxin dosages or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of lidocaine (a local anesthetic and cardiac depressant typically used as an antiarrhythmia agen
sample. These reagents are used in tests to monitor lidocaine drug levels in patients undergoine treat
adequacy of therapy and to diagnose drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
to measure levels of one or more of a group of therapeutic drugs known as "anticonvulsants" (i.e., dru
seizures [clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive,
discharge of brain cells] or reduce their severity, or to treat related central nervous system disorders)
These reagents are mostly used to measure drug levels in patients undergoing treatment with anticon
determine the adequacy of drug treatment or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of total carbamazepine, an anticonvulsant and antineuralgic drug mostly used in the treatment
partial seizures typical of epilepsy and in pain associated to trigeminal neuralgia. Carbamazepine in b
(about 76%) to proteins in plasma, but only free carbamazepine and its metabolite carbamazepine-10
bioactive. Reagents for measuring levels of total carbamazepine are intended to monitor therapeutic d
diagnose a drug overdose or drug-related toxicity.
Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of phenobarbital (a barbituric acid derivative that acts as a nonselective central nervous system
in the sample. Reagents for mesuring levels of phenobarbital are used to monitor the drug levels in pa
treatment, either to determine the adequacy of treatment or to diagnose a drug overdose or a drug-re

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of total phenytoin (an anticonvulsant agent that is used in a wide variety of seizures; it is also a
a muscle relaxant) present in the sample. Reagents for measuring levels of total phenytoin are used t
patients undergoing treatment, either to determine the adequacy of treatment or to diagnose a drug o
related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
the levels of one or more of a group of therapeutic drugs that have the capacity to inhibit the growth o
microorganisms (i.e., antibiotics) present in the sample. Antibiotics (e.g., amikacin, gentamicin) suffici
host are administered to humans for treatment of infectious diseases typically caused by bacteria. The
typically used in tests intended to measure the drug levels in patients undergoing treatment, either to
adequacy of drug treatment or diagnose a drug overdose or antibiotic-related toxicity. Samples drawn
administration interval, e.g., immediately prior to the next dose (known as a "trough" sample) and/or
set interval based on the known half-life of the drug (e.g., within 1 hour) following the administration o
"peak" sample) are typically used when measuring therapeutic levels of antibiotic drugs in the blood.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of gentamicin, an aminoglycoside bactericidal agent, present in the sample. Gentamicin is used
wide variety of aerobic gram-negative bacteria and also for some gram-positive bacteria. Reagents fo
measurement are used to monitor drug levels in patients undergoing treatment, either to determine t
treatment or to diagnose a drug overdose or drug-related toxicity. Typical reference levels in blood, in
milliliter, are peak 5 to 8, predose (trough) 1 to 2, and toxic more than 10.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of tobramycin, an aminoglycoside bactericidal agent. Tobramycin is used in the treatment of a w
gram-negative bacteria and also for some gram-positive bacteria. Reagents for tobramycin level meas
monitor the drug levels in patients undergoing treatment, either to determine the adequacy of drug tr
diagnose a drug overdose or drug-related toxicity. Typical reference levels in blood, in micrograms per
8, predose (trough) 1 to 2, and toxic more than 10.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of vancomycin, a tricyclic glycopeptide bactericidal agent, present in the sample. Vancomycin is
of gram-positive bacteria and some gram-negative cocci; vancomycin is used in the treatment of seve
infections resistant to other antibiotics. Reagents for vancomycin drug level measurement are used to
patients undergoing treatment, either to determine the adequacy of drug treatment or to diagnose a d
related toxicity. Typical reference levels in blood, in micrograms per milliliter, are peak 20 to 30, predo
toxic more than 50.
Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
the levels of one or more of a group of therapeutic drugs known as antiasthma agents (i.e., drugs adm
for treatment and/or alleviation of patients with asthma [a form of bronchial disorder associated with a
marked by recurrent attacks of paroxysmal dyspnea, with wheezing due to spasmodic contraction of t
reagents are used to monitor the antiasthmatic drug (e.g., theophylline) levels in the blood of patients
treatment, either to determine the adequacy of drug treatment or to diagnose a drug overdose or dru

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
and/or measure levels of theophylline (a drug that relaxes bronchial smooth muscles to relieve or prev
aminophylline (a drug combination that contains theophylline and ethylenediamine), present in the sa
theophylline/aminophylline determination are used to monitor the therapeutic drug level in patients u
to determine the adequacy of drug treatment, or to diagnose a drug overdose or drug-related toxicity.
inhibitor of apnea, is a minor metabolite of theophylline in adults, but its long half-life in neonates ma
concurrent determination of theophylline and caffeine in those patients.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of caffeine, a drug that relaxes bronchial smooth muscles to relieve or prevent asthma. Caffeine
treatment of neonatal apnea. Caffeine drug level reagents are typically used to monitor the therapeut
blood of patients undergoing treatment to determine the adequacy of drug treatment, to identify drug
toxicity. Caffeine is a minor metabolite of theophylline in adults, but its long half-life in neonates make
concurrent determination of theophylline and caffeine in infants treated with theophylline.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels or otherwise analzye one or more antineoplastic agents (substances that inhibit or prevent the
neoplasms) and/or their metabolites present in the sample. These reagents are used to measure the l
antineoplastic agent levels in patients undergoing treatment to determine the adequacy the therapy,
overdosing/drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels and/or otherwise analyze methotrexate (Aan antineoplastic antimetabolite with immunosuppres
Reagents for measuring methotrexate levels are used to monitor the drug levels in patients undergoin
to avoid overdose and/or drug-related toxicity (e.g., unwanted cytotoxic effects).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
but also serum, and plasma) to determine one or more of a group of drugs that either are illegal or are
excess for nonmedical purposes (i.e., drugs with a high potential of abuse); they include amphetamine
cocaine, and morphine. Immunoassays for drugs of abuse are mainly used for initial screening; they m
the tested drug (pseudoephedrine may result in a positive test for amphetamine and methamphetam
confirm the results are usually performed using selective ion monitoring with gas chromatography/ma
(GC/MS) techniques.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine amphetamine, a central nervous drug stimulant with little therapeutic use (e.g., treating
Amphetamine produces an initial state of euphoria that creates a high potential for abuse. Reagents f
determination are used to identify those who have recently taken the drug; they cannot differentiate c
drug abuse, degree of impairment, exact time of use, or dose of drug taken. Immunoassays for amphe
cross-reactivity with other sympathomimetic amines (e.g., ephedrine, pseudoephedrine), so confirmat
are mandatory.

Immunoassay reagents intended to perform quantitative analyses of a sample of body fluids, (typicall
methamphetamine, a central nervous drug stimulant with little therapeutic use (e.g., treating narcolep
Methamphetamine produces an initial state of euphoria that creates a high potential for abuse. Reage
methamphetamine determination are used to identify patients that have recently taken the drug; they
casual use from chronic drug abuse, degree of impairment, exact time of use, or dose of drug taken. M
metabolizes partially as amphetamine; thus, a concurrent assay for amphetamines typically shows a c
that is approximately 10% that of methamphetamine. Immunoassays for methamphetamine have var
with other sympathomimetic amines (e.g., ephedrine, pseudoephedrine), so confirmation of positive r

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine barbiturates, central nervous system neuronal activity suppressor drugs with little therap
sedative, hypnotic). Barbiturates (e.g., phenobarbital) have largely been replaced by benzodiazepines
hypnotic purposes. Reagents for determination of barbiturates are used in tests intended to monitor d
as a result of either an induced therapeutic coma (anesthetic doses) or to diagnose and manage barb
caused by intentional or, less frequently, accidental ingestion.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine benzodiazepines, a group of minor tranquilizers (e.g., diazepam) with similar m
pharmacological effects (i.e., sedative, hypnotic, muscle relaxant); they are used as tranquilizers, for m
convulsions. Benzodiazepines, frequently in combination with alcohol, produce an initial state of euph
potential for abuse. Reagents for benzodoazepine determination are used in tests intended to diagnos
benzodiazepine intoxication caused by intentional or, less frequently, accidental ingestion.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine cannabinoids, a group of compounds found in the plant species cannabis sativa, and/or c
metabolites; the main psychoactive cannabinoid is delta-9-tetrahydrocannabinol (TTH). Cannabinoids
system drug stimulants with little or no therapeutic use that produce an initial state of euphoria, relax
creating a high potential for abuse. Cannabinoids are mostly consumed by smoking marijuana (usually
leaves and flowers) or hashish (the dry resinous secretion of the plant). Reagents designed to screen u
cannabinoids usually measure cannabinoid metabolites, typically THC-COOH; due to the cross-reactivi
metabolites, the measurement is greater than the actual concentration of the metabolite. Thus, the re
expressed as THC-COOH equivalent. Cannabinoid metabolites can be detected in urine samples for se
use; habitual smokers may remain positive for more than a month.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine cocaine, an alkaloid found in the leaves of the coca plant, and/or cocaine metabolites. Co
central nervous system stimulator that has therapeutic use as a local anesthetic and vasoconstrictor;
euphoria and alertness creating a high potential for abuse. Cocaine is mostly consumed by nasal insu
cocaine hydrochloride; it may also be smoked as a free base (crack). Reagents designed to screen uri
usually measure inactive cocaine metabolites, typically benzoylecgonine or ecgonine methyl ester, sin
of cocaine are excreted in the urine. Cocaine metabolites can be detected in urine samples for one to
use; habitual users may remain positive for more than a month.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine natural or semisynthetic alkaloids derived from the unripe seeds of the poppy plant (i.e.,
therapeutically useful due to their potent analgesic properties; they produce a state of sedation and/o
high potential for abuse. Reagents for opiate determination (mostly their derivatives, such as morphin
samples can detect drug metabolites up to four days after use. The presence of morphine in urine du
of ethylmorphine as an antitussive drug should be considered; poppy seeds can also create false-posi

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine acetaminophen, a drug commonly administered with analgesic and antipyretic use. Acet
known as paracetamol) may cause severe hepatic toxicity or death when consumed in overdose quan
determine acetaminophen concentration in serum are used to assess the severity of overdose and to
appropriate therapy, due that the initial clinical findings of acetaminophen toxicity are mild and nonsp

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma, urine) to determine ethanol, the most often used and abused chemical substance. Immunoas
determine ethanol may have some interference from other alcohols, particularly from isopropanol, me
glycol. Reagents used to determine ethanol concentration in blood can establish the degree of alcoho
frequently as legal supporting evidence. Inclusion of additional tests for other alcohols such as methan
acetone as a metabolite of isopropanol are sometimes needed for evaluation of intoxicated patients.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma, urine) to determine salycilate, a product of the hydrolysis of aspirin (acetylsalicylic acid). Salic
pharmacological agent of the action of aspirin (e.g., analgesic, antipyretic, anti-inflammatory), with th
inhibition. Reagents for determination of salicylate concentration are used to assess the severity of ov
The therapeutic level of salicylate in serum is lower than 60 mg/L for analgesic and/or antipyretic use
for anti-inflammatory purposes; toxic effects are frequent when the level exceeds 300 mg/L.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine, cerebrospinal fluid) to determine agents (e.g., antigens, antibodies) developed by the organism
response against its own tissue constituents (I.e., autoimmune diseases). Autoimmune diseases may b
erythematosus, rheumatism) or specific against a particular organ (e.g., thyroid gland).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies commonly found in diabetic patients.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies associated with autoimmune connective-tissue diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to extractable nuclear antigens (ENA). Increased ENA antibodies levels are assoc
autoimmune connective-tissue diseases such as rheumatoid arthritis. ENA determination is a screenin

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies associated with autoimmune diseases of the central nervous system.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine antibodies to one or more of a group of glycosphingolipids (gangliosides) that occur pred
tissues of the central nervous system (e.g., GM-1, GM-2, GQ1b, GD1b gangliosides). Antiganglioside a
associated with neuropathies; they may be a marker for the diagnosis of cerebral involvement in conn
autoimmune diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies associated with autoimmune diseases characterized by inflammation and degen
connective tissues (i.e., rheumatic diseases), especially the joints and related structures (e.g., muscle

Serology reagents intended to detect antibodies to species of Streptococcus, a genus of spherical bac
Streptococcaceae. Streptococci tend to grow in pairs or chains and are divided into many serogenic ty
cell wall (e.g., groups A, B, and C). Streptococci that are pathogenic in humans include many species,
(pneumococcus), a major respiratory tract pathogen and the most common cause of pneumonia, and
causes a wide range of suppurative diseases (e.g., pharyngitis, otitis media, sinusitis, endocarditis) an
sequelae (e.g., acute rheumatic fever).

Serology reagents intended to detect antibodies to deoxyribonuclease B (Dnase B antibodies) that dev
as the result of a preceding Streptococcal infection; streptococcus is a genus of spherical bacteria of t
Streptococcaceae. Streptococci that are pathologic to humans include S. pneumoniae (pneumococcus
tract pathogen and the most common cause of pneumonia, and S. pyogenes, which is one of the mos
human pathogens, causing a wide range of suppurative diseases (e.g., pharyngitis, otitis media, sinus
nonsuppurative sequelae (e.g., acute rheumatic fever). Dnase B antibodies are associated with some
including rheumatic disorders (e.g., poststreptococcal reactive arthritis).

Serology reagents intended to detect antibodies to deoxyribonuclease streptolysin (both type S and O
exotoxin produced mostly by certain strains of group A streptococci. These antibodies develop in resp
of a preceding streptococcal infection and are associated with some autoimmune diseases such as rhe
Tourette's syndrome.
Serology reagents intended to detect antibodies to exotoxins produced by several antigenically distinc
Streptococcus group A (typically Streptococcus pyogenes), spherical bacteria of the family Streptococ
one of the most important bacterial human pathogens, causing a wide range of suppurative diseases
media, sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheumatic fever). These antib
with some rheumatic autoimmune diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating immunoglobulin antibodies (e.g., antitissue transgluminase, antiendomysial, an
an autoimmune disease characterized by a malabsorption syndrome (i.e., celiac disease) affecting bo
this disease is promoted by ingestion of foods containing gluten, such as cereals. The antibodies dete
immunoglobulin A and G (IgA and IgG, respectively), indicating a nonallergic immune response to glut
the antibodies present in celiac autoimmune diseases are also found in patients with other autoimmun
certain malignancies.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies (e.g., anti-smooth muscle, liver/kidney microsomal) associated to aut
hepatitis, a disease characterized by a chronic inflammatory reaction directed against the hepatocyte
against the bile ducts. Autoimmune hepatitis is a syndrome that affects mainly women, and its histolo
indistinguishable from chronic viral hepatitis, but there is an absence of viral serologic markers. Some
present in this autoimmune disease are also found in patients with other autoimmune diseases and/or

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against the striated muscles (SMAs). High levels of SMA are frequently found in
generalized fatigue and exhaustion of the muscular system (i.e., myasthenia gravis); these antibodies
patients with rheumatic fever and other cardiac diseases (e.g., myocardial infarction).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against cytoplasmic constituents of neutrophil granulocytes (i.e., antineutrophil
[ANCA]), such as proteinase 3 (PR3-ANCA), myeloperoxidase (MPO-ANCA), lactoferrin (LF-ANCA), and
circulating levels of ANCA are mostly associated with autoimmune systemic necrotizing vasculitis.

Immunology reagents used for classification (i.e., typing) of human cells involved in humoral and/or ce
responses, frequently by determining the antigens (e.g., proteins) that are expressed on the cell surfa
to differentiate leukocytes from other cells, identify and quantify subsets of lymphocytes and monocyt
classify malignant cells for proper identification of neoplasms.

Immunology reagents used in immunologic tests to identify cell surface markers expressed by leukoc
distinguish cell lineages, developmental stages, and functional subsets. Such markers are named clus
antigens and numbered CD1, CD2, etc. These reagents include chemical and immunological homogen
(monoclonal antibodies) produced by the fusion of normal lymphocytes and tumor cells (hybridomas).
antibodies are used to tag monoclonal cells so that they can be counted (e.g., using flow cytometers).
typically found in lymphoid neoplasms (i.e., lymphocytic leukemia and lymphoma), which are the pro
transformed lymphocyte. They are also found in some myeloid neoplasms.
Immunology reagents including monoclonal antibodies that are used in immunologic tests for typing T
identifying their antigens (e.g., CD2, CD3, CD4, CD8). Frequently cells bearing the CD4+ receptor are
and those with the CD8+ receptor are termed suppressor T cells. T-lymphocytes are typically associat
immunity and are also involved in humoral immunity. These tests permit the differentiation between p
and monoclonal neoplasms and also contribute in the classification among different types of lymphoid
of CD4+/CD8+ is used in the diagnosis and monitoring of AIDS; an increase in this ratio is also conside
in the diagnosis of transplanted organ rejection.

Immunology reagents including monoclonal antibodies that are used in immunologic tests for typing B
identifying their antigens (e.g., CD19, CD20, CD23 antigens). B-lymphocytes are typically associated w
These tests permit the differentiation between polyclonal processes and monoclonal neoplasms and a
classification among different types of lymphoid neoplasms.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo


urine, but also serum and plasma) to determine in a short period of time, typically several minutes, on
of drugs that have a high potential of abuse, including amphetamines, barbiturates, cocaine, morphin
Reagents for rapid determination of drugs of abuse are especially useful in emergency situations. Fore
the results are usually performed using selective ion monitoring with gas chromatography/mass spect
techniques.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
plasma) to determine in a short period of time, typically several minutes, one or more of a group of dr
when taken in overdose (e.g., alcohol, acetaminophen, salicylates). They are also used to determined
that may be accidentally or intentionally ingested. Rapid tests for toxic drug determination are mostly
situations.

Reagents intended to establish points of reference (i.e., calibrate) in a diverse range of sensitive and s
using immunochemical reactions (immunoassays) that are mostly used to determine substances in hu
Reagents used for calibration may be either specific for some particular substance or more frequently
calibrate a whole set of similar substances (e.g, proteins, lipids).

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory. These substances are established as a norm with wh
used in a diverse range of sensitive and specific immunochemical clinical assays (e.g., immunoassays
usually to determine the purity or performance of those substances.

Microbiology reagents used to induce the propagation (culture) and identification of bacteria and/or de
susceptibility to antimicrobial agents under laboratory conditions (in vitro); these reagents include buff
and the laboratory media capable of supporting bacteria growth.
Microbiology reagents intended to identify of one or more of the unicellular prokaryotic microorganism
division (e.g., bacteria); the cell of a bacterium is typically contained within a wall. These reagents are
performed on bacteria cultures and include additives, solutions, and selective media that promote the
species of bacteria while inhibiting the growth of others.

Microbiology reagents intended to identify species of Campylobacter, family Spirillaceae, by detecting


usually through tests performed on bacteria cultures. Some species of Campylobacter bacteria may ca
acute gastroenteritis; these bacteria may also cause proctitis.
Microbiology reagents intended to identify Escherichia coli (E. coli), the principal species of the genus
Enterobacteriaceae. These bacteria are a common inhabitant of the large intestine of humans, but pat
diarrhea and may cause infections in the urinary tract, as well as conjunctivitis and septicemia.

Microbiology reagents intended to identify Helicobacter (formerly Campylobacter) pylori, a bacterium


Helicobacter, family Spirillaceae. These bacteria cause chronic gastritis and pyloric ulcer and could be
gastric cancer.
Microbiology reagents intended to identify bacteria that do not ferment sugars (i.e., nonfermentative)
specified conditions; these bacteria are typically gram-negative; many of them are part of the normal
membranes in humans and animals. Nonfermenting bacteria also include bacteria that may become p
certain conditions, including Pseudomonas (e.g., Pseudomonas aeruginosa) and some genera (e.g., M
Neisseriaceae. These reagents may be specific for either manual or automated tests; reagents for iden
genera, types, and/or subtypes (e.g., P. aeruginosa) are available.

Microbiology reagents intended to identify Treponema pallidum, a bacterium of the family Spirochaeta
pallidum bacteria are the etiologic agent of syphilis, a disease transmitted sexually or acquired in uter

Microbiology reagents intended to identify species of Staphylococcus, a genus of coccoid bacteria of t


Micrococcaceae: Staphylococci bacteria grow in pairs or irregular clusters and include several patholo
aureus, S. epidermidis, and S. saprophyticus; the most important is S. aureus because of its ability to
suppurative infections especially in immunodepressed patients, neomates, and the elderly. Bacteria id
may be specific for either manual or automated tests; reagents for identification of particular species
S. aureus) are available.

Microbiology reagents intended to identify species of Leptospira, a genus of finely coiled, motile bacte
Leptospiraceae. Leptospira interrogans bacteria are the pathogenic species to humans causing leptosp
acquired by direct contact with the urine or tissue of an infected animal (e.g., rodents, dogs) or indirec
contaminated water, soil, or vegetation.
Microbiology reagents intended to identify species of bacteria of the genus Mycoplasma, family Mycop
Mycoplasma bacteria are etiologic agents of several diseases, especially the species Mycoplasma pne
primary atypical pneumonia (i.e., mycoplasmal pneumonia).
Microbiology reagents intended to identify species of Mycobacterium, a genus of slow-growing bacteri
Mycobacteriaceae, including the highly pathogenic organisms that cause tuberculosis and leprosy (M.
leprae, respectively).
Microbiology reagents intended to identify Mycobacterium tuberculosis, a species of slow-growing bac
Mycobacteriaceae. These bacteria are highly pathogenic microorganisms that may cause pulmonary t
frequently, nonpulmonary tuberculosis.
Microbiology reagents intended to identify species of Rickettsia, a genus of gram-negative bacteria of
Rickettsiaceae. Rickettsia bacteria that are pathologic to humans are usually divided into three groups
antigenic relationships. The typhus group includes the species R. typhi and R. prowazekii. Spotted-fev
cause several similar diseases widely distributed geographically (e.g., Rocky Mountain spotted fever, K
Siberian tick typhus), include R. rickettsii, R. conorii, and R. siberica. The group that causes scrub feve
tsutsugamushi.
Microbiology reagents intended to identify species of Yersinia, a genus of intracellular, ovoid-shaped b
Enterobacteriaceae. Yersinia bacteria species that are pathologic to humans include Y. pestis, which ca
Y. enterocolitica, which causes acute gastroenteritis and mesenteric lymphadenitis; and Y. pseudotube
mesenteric lymphadenitis without gastroenteritis.
Microbiology reagents intended to detect and identify bacteria in the genitourinary tract (e.g., cervix,
tests may detect one or more of the most frequently found bacteria in the tract, including the species

Microbiology reagents used to assess the susceptibility of bacteria to antibacterial agents (e.g., antibi
susceptibility tests are based on the determination of the inhibition of bacterial growth due to antibiot
or in the determination of the minimum concentration of antibiotic at which there is no visible growth
(minimum inhibitory concentration [MIC]) in a dilution. These reagents may be specific either for man
procedures.

Microbiology reagents used to assess the susceptibility of bacteria to antibacterial agents (e.g., antibi
procedures. Manual susceptibility tests are based on the determination of the inhibition of bacteria gro
impregnated disks or the minimum concentration at which there is no visible growth of the bacteria (m
concentration) in a dilution.
Microbiology reagents used in manual tests to assess the susceptibility of mycobacteria to antibacteri
antibiotics). Mycobacteria susceptibility tests are based on the determination of the inhibition of bacte
either direct methods (i.e., using the patient's sample) or indirect methods (i.e., using organisms isola
specimen).
Microbiology reagents used to assess the susceptibility of mycobacteria to antibacterial agents (e.g., a
Mycobacteria susceptibility tests are based on the determination of the inhibition of bacteria growth, u
methods (i.e., esting a patient's sample) or indirect methods (i.e., testing organisms isolated from the
These reagents may be specific either for manual tests or for automated analyzers with slow-growing

Microbiology reagents used to induce the propagation and identification in tissue or serum culture me
group of minute microorganisms (e.g., viruses) characteristically consisting of a core of a single type o
RNA or DNA) and that multiply only within living host cells. Most of these reagents are used for identi
viruses.
Microbiology reagents that permit the explantation of cells and/or tissues from living organisms into a
basal media. They include all major ions, sugars, amino acids, and other substances needed for cellula
tissue cultures differ from cell cultures in the level of organization maintained in the explanted culture
cultures are mostly used for isolation and identification of viruses that cannot replicate apart from livin

Microbiology reagents intended to identify unicellular microorganisms that are not resolved in light mi
characterized by the lack of an independent metabolism, replicating only within living cells (i.e., viruse
typically used to identify a virus, typically in a serum or tissue culture; they include additives, solution
that promote the growth of specific viruses.
Microbiology reagents used to induce the propagation (culture) and identification of any of the eukary
as parasites or feed on dead or decaying organic matter and reproduce either sexually or asexually (fu
and monocellular fungi (yeasts); some reagents are used to determine fungi susceptibility to antimicro
laboratory conditions (in vitro). Fungi/yeast reagents include buffers, stains, controls, and the laborato
supporting fungi growth. Most fungi known as pathogenic to man belong to the group, Deuteromycotin
Microbiology reagents intended to identify fungi, including molds and monocellular fungi (yeasts). Mos
pathogenic to man belong to a group known as Deuteromycotina.
Microbiology reagents intended to identify species of fungi of Blastomyces, a species of imperfect fun
Hyphomycetes. Some species of Blastomyces may cause self-limited or localized pulmonary lesions (b
immunocompromised patients may develop a chronically progressive illness in the skin and/or organs
genitourinary tract, central nervous system).
Microbiology reagents intended to identify Sporothrix schenckii, a species of imperfect fungi of the fam
Sporothrix schenckii causes a chronic fungal infection (sporotrichosis) that may remain localized as no
and/or subcutaneous tissues or may be disseminated by the blood stream to other organs (e.g., viscer
membranes, musculoskeletal tissues).
Microbiology reagents used to detect and identify parasitic microorganisms and multicellular animals
Protozoa (e.g., Entamoeba), helminthes (e.g., Ascaris lumbricoides), and Arthropods (either true paras
vectors) in humans. Reagents used for parasite detection and/or identification include preservatives, a

Microbiology reagents used to assess the susceptibility of parasites to antimicrobial agents. These rea
either for manual or automated procedures.
Microbiology reagents in the form of liquids, solids, or semisolids used as a prepared medium capable
growth of microorganisms (e.g., coliforms) that are present in the clinical environment and that are av
slides or glass containers. These media are used to assess the level of contamination in places such a

Microbiology stains used for artificial coloration of bacteria, mostly for direct visual or microscopic iden
typically performed using dyes that permit the classification of bacteria in big groups (i.e., differentia
Gram's and acid-fast stains) or to identify species in particular
Microbiology stains used for artificial coloration of cultured cells, typically using direct or indirect immu
virus identification is characterized by the presence of dark staining under light microscopes (enzyma
fluorescence using a fluorescence microscope (immunofluorescence).

Microbiology stains used for artificial coloration of fungi and/or yeasts, mostly for direct visual or micro
Staining is typically performed using dyes that permit the classification of bacteria in big groups (e.g
or to identify species in particular (e.g., toluidine blue)
Microbiology stains used for artificial coloration of parasites, mostly for direct visual or microscopic ide
typically performed using dyes that permit the identification of a particular species of parasite (e.g., a
hematoxylin, P. carinii using toluidine blue).
Microbiology reagents used to prevent marked changes in the pH and/or in the concentration of a part
substance during a microbiology test (i.e, buffers). These reagents are typically available in solutions,
solutions, or powders in ready-to-use packs.
Microbiology reagents that are established as a norm to compare similar substances used in biochemi
cultivation and identification of microorganisms and/or determination of their susceptibility to antimi

Immunoassay reagents designed to perform tests in a short period of time to detect microorganisms i
Methods using biochemistry assays to determine microorganisms (e.g., bacteria, fungi) are only relativ
tests to determine pathogenic microorganisms are based on immunoassays.
Reagents designed for use in a diverse range of sensitive and specific clinical assays primarily based o
chemistry and structure of nucleic acid molecules. These assays rely on a thorough knowledge of the
sequences relevant to each diagnostic system. Molecular reagents are used in one or more of many d
manipulate nucleic acids (e.g., nucleic acid hybridization), using either amplification (e.g., polymerase
sustained replication) or nonamplification (e.g., Southern blotting of DNA, restriction fragment-length
techniques. Molecular reagents are mostly used in assays to detect infectious agents (e.g., bacteria, v
identify genetic disorders either inborn or acquired (e.g., tumor markers). Frequently, these reagents a
that include the nucleic acid probe (e.g., cloned, oligonucleotide, genomic) and all other reagents (e.g
salts, denaturants) needed to perform the assay.

Molecular assay reagents intended to identify pathogenic microorganisms (e.g., bacteria, viruses, para
specific genetic information (e.g., ribosomal RNA, plasmids, specific DNA sequences) of the target mic
tests are typically used when an in vitro culture is not possible or useful.
Molecular assay reagents intended to identify bacteria by detecting specific genetic information of the
usually detect either deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or ribosomal ribonucleic acid
bacteria. Infection bacteria are the etiologic agent of, are the cause of, or are associated with human o
diseases.
Molecular assay reagents intended to identify species of Chlamydia, a genus of intracellular bacteria o
Chlamydiaceae, by detecting specific genetic information of the ribonucleic acid of the target bacteria
cause a variety of diseases in humans, including trachoma, inclusion conjunctivitis, and a variety of ur

Molecular assay reagents intended to identify species of Mycobacterium, a genus of slow-growing bac
Mycobacteriaceae, by detecting specific genetic information of the nucleic acid of the target bacteria.
etiologic agents of several diseases and include the species Mycobacterium tuberculosis and Mycobac
cause human tuberculosis and leprosy respectively; other species may cause human infections, includ
children and systemic illness in immunocompromised people (e.g., AIDS patients).

Molecular assay reagents intended to identify species of Mycoplasma, a genus of bacteria of the famil
by detecting specific genetic information of the nucleic acid of the target bacteria. Species of these ba
agents of several diseases (mycoplasmosis); the species Mycoplasma pneumoniae causes primary aty
mycoplasmal pneumonia).
Molecular assay reagents intended to identify viruses by detecting specific nucleic-acid sequences inf
RNA, rRNA sequences) of the target virus. Pathogenic viruses are the etiologic agent of or are associat
animal diseases.
Molecular assay reagents intended to identify hepatitis B virus, a DNA virus of the genus Hepadnaviru
Hepadnaviridae, by detecting the nucleic acid of the target virus. Hepatitis B virus may cause hepatiti
characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransfera
be transmitted percutaneously (e.g., via body piercing, tattooing), parenterally, from mother to child a
(e.g., sexual) contact.

Molecular assay reagents intended to identify hepatitis C virus, an RNA virus of the genus Flavivirus, f
detecting specific genetic information of the target virus. Hepatitis C virus may cause hepatitis, a dise
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruse
frequently parenterally and possibly by intimate (e.g., sexual) contact.
Molecular assay reagents intended to identify human immunodeficiency virus (HIV), a retrovirus of the
family Retroviridae, by detecting the nucleic acid of the target virus. HIV is the etiologic agent of acqu
syndrome (AIDS).
Molecular assay reagents intended to identify Cytomegalovirus (CMV), a DNA virus of the family Herpe
the nucleic acid of the target virus. CMV may cause a variety of diseases (e.g., cytomegalic inclusion d
depending on the immune status and age of the host; persistence of the virus for the lifetime of the h

Molecular assay reagents intended to identify Herpes simplex virus (HSV), a DNA virus of the family H
detecting the nucleic acid of the target virus. HSV may cause a variety of conditions, including gingivo
labialis, genital herpes, neonatal herpes, keratitis, conjunctivitis, skin eruptions, aseptic meningitis, an
Activation of latent herpesvirus is associated with some malignancies. Persistence of the virus for the
common.

Molecular assay reagents intended to identify Epstein-Barr virus (EBV), a DNA virus of the family Herp
the nucleic acid of the target virus. EBV may cause infectious mononucleosis and is closely associated
diseases such as Burkitt's lymphoma and nasopharyngeal carcinoma.
Molecular assay reagents intended to identify human papilloma virus (HPV), a member of the family P
detecting the nucleic acid of the target virus. Some HPV genotypes cause mucosal infections (especia
and are associated with malignancy; other genotypes may cause cutaneous infections. Dedicated rea
DNA of specific genotypes of HPV (e.g., 6/11, 16/18).

Molecular assay reagents intended to identify varicella-zoster virus, a DNA virus of the genus Varicella
Herpesviridae, by detecting the nucleic acid of the target virus. Varicella-zoster viruses cause chicken
infectious disease typically transmitted by direct contact or through the respiratory route and characte
appearance of vesicular lesions on the skin and mucous membranes. Activation of varicella-zoster viru
chickenpox (varicella) infection may cause herpes zoster (also called shingles), a self-limited infection
and their areas of innervation, producing severe neuralgic pain and vesicles on the skin.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) in one or mor
chromosomes (46 in human beings, including the pair that determines the sex) included in the human
chromosome translocation is a rearrangement between nonhomologous (e.g., 9, 22) chromosomes; de
translocations may be used as tumor markers.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
(e.g., involving exchanges and/or fusion of genes). This translocation is present in patients with chron
and in some patients with acute lymphoblastic leukemia and acute myeloid leukemia. In detection ma
marker.
Molecular assay reagents intended for use in identifying stable and irreversible exchanges (i.e., transl
chromosomes 14 and 18, usually involving the exchange of the BCL2 gene with the joining region of t
heavy chain of chromosome 14. The detection of these translocations may be used as a tumor marker
present in most patients with follicular lymphomas and in some patients with acute lymphoblastic leu

Molecular assay reagents intended for use in identifying stable and irreversible exchanges (i.e., transl
chromosomes 12 and 15. The detection of these translocations (e.g., involving the genes ETV6 and NT
a tumor marker. The translocation is associated with infantile fibrosarcoma and is found in a subset of
myeloma.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
The detection of these translocations (e.g., a fusion gene from the PML gene from chromosome 15 and
receptor alpha gene from chromosome 17) may be used as a tumor marker. The translocation is assoc
promyelocytic leukemia and found in a subset of patients with multiple myeloma.

Molecular assay reagents intended for use in identifying stable and irreversible rearrangements in the
inversion) of one of the normal chromosomes (46 in human beings, including the pair that determines
is a chromosome rearrangement in which a segment of a chromosome is reversed end to end.

Molecular assay reagents intended for use in identifying stable and irreversible rearrangements in the
inversion) of chromosome 16 [inv(16)(p13q22)]. This inversion is often present in patients with a subg
leukemias that have a favorable prognosis. In these cases, the inversion is usually the result of the fus
MYH11 genes.
Molecular assay reagents used in immunology tests to determine human leukocyte antigens (HLAs); t
and/or locations (loci), such as A, DR. These reagents are also capable of determining slightly different
protein (i.e., allotypes) that may be located in each loci (alleles) and that are characterized by antige
for tissue typing are mostly used to match donor and recipient tissues before transplants. Several alle
with specific immune diseases.

Hematology reagents used to count the number of red blood cells (RBCs or erythrocytes), white blood
leucocytes), and platelets per unit volume in a sample of venous blood. Reagents used in blood cell co
either for manual use or for automated hematology analyzers.
Hematology reagents used in the qualitative and quantitative determination of the conjugated protein
responsible for the transport of oxygen (i.e., hemoglobin [Hb]). These reagents may be intended for d
total Hb concentration in the blood. Hb subtypes, also known as Hb variants, such as HbA (adult hemo
hemoglobin), HbC (abnormal hemoglobin), and HbS (Hb related to sickle-cell anemia) are mostly dete
electrophoresis analysis.

Hematology reagents used in the most general (e.g., screening) tests of the process of coagulation, ty
the thrombin clotting time, the prothrombin clotting time, or the activated partial thromboplastin time
used to monitor therapy.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
plasma) to determine one of the factors involved in a series of reactions that results in the formation o
of a visible coagulum). Coagulation factors are designated by Roman numerals, but frequently they ar
descriptive names such as fibrinogen (factor I), prothrombin (factor II), and thromboplastin (factor III);
the factors are designated by adding a letter "a" to the factor (e.g., XIIa).

Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
plasma) to determine fibrinogen (i.e., coagulation factor I), a plasma protein that is converted into fibr
pathway of coagulation. Deficiency of fibrinogen causes afibronogenemia or hypofibronogenemia, and
inherited disorders, the presence of thrombin inhibitors, or with fibrin polymerization.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
plasma) to determine the antihemophilic factor (coagulation factor VIII), a trace protein involved in the
coagulation. Hereditary deficiency of factor VIII is associated with hemophilia A and von Willebrand's
may also be caused by antibodies to factor VIII.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
plasma) to determine the plasma thromboplastin component (factor IX), a proenzyme involved in the
coagulation. Hereditary deficiency of factor IX is associated with hemophilia B.

Hematology reagents intended to perform qualitative and/or quantitative analyses of a sample of bod
plasma) for the simultaneous determination of several coagulation factors (e.g., II/V/VII/IX, VIII/IX/XI/XI
are based in the determination of prothrombin time using specific factor-deficient plasmas instead of a
serum. Factor activity is determined by the amount of correction detected when patient plasma is add
deficient plasma.

Hematology reagents used for qualitative and/or quantitative determination in plasma of substances t
coagulation process. Coagulation inhibitors include antithrombin III, proteins C and S, and lupus antico

Hematology reagents used for qualitative and/or quantitative determination in plasma of antithrombin
protein that inhibits coagulation. AT-III inactivates thrombin and several other coagulation factors, incl
IXa, and kallikrein.
Hematology reagents used for qualitative and/or quantitative determination in plasma of protein C, a
plasma protein that inhibits coagulation. Protein C is likely to inactivate the active forms of the coagul

Hematology reagents used for qualitative and/or quantitative determination in plasma of protein S, a
plasma protein that apparently inhibits coagulation by serving as a necessary cofactor for the action o

Hematology reagents used for qualitative and/or quantitative determination in plasma of coagulation
type, consisting of immunoglobulins of either the IgG or IgM class. These inhibitors inhibit various coa
involved in the intrinsic and common paths; they are not only present in systemic lupus erythematosu
groups of disorders, including rheumatoid arthritis, valvular heart disease, and benign prostatic hyper

Hematology reagents used for determination of the presence and/or concentration of one or more of t
plasma that may indicate a tendency for thrombosis (thrombophilia markers).
Hematology reagents used to obtain aggregation patterns that are typically analyzed photometrically
aggregometer. These reagents usually include collagen, adenosine diphosphate (ADP), epinephrine, a
aggregation assays are mostly used to classify hereditary and acquired platelet disorders. Increased v
aggregation may indicate thrombosis (i.e., it is considered a thrombophilia marker).

Hematology reagents intended to perform qualitative and/or quantitative analyses of a sample of bod
plasma) to determine one of the components of the fibrinolytic enzyme system. The fibrinolytic enzym
inert plasma proenzyme (plasminogen) into a proteolytic enzyme (plasmin) which is associated with th
This system in blood includes plasminogen and plasmin, together with activators and inhibitors.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
to determine D-dimer, an intermediate product in the process of degradation of fibrin or fibrinogen un
plasmin. The level of D-dimer in blood is associated with the activation of the fibrinolytic system.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory, and that are established as a norm with which simila
assays for the determination of the morphology of blood, its components, and blood forming tissues (i
assays) are compared (i.e., standardized).
Hematology reagents designed to perform tests in a short period of time, typically several minutes, to
required to form a fibrin clot (blood coagulation) when plasma is added to a thromboplastin-calcium m
used for rapid screening of coagulation disorders and for therapeutic monitoring of both hemorrhagic
diseases.
Hematology reagents designed to perform tests in a short period of time, typically several minutes, to
required to form a fibrin clot (i.e., blood coagulation) when calcium chloride, partial thromboplastin, an
added to the plasma. This assay is a measure of possible factor deficiencies of the intrinsic and comm
coagulation, and is also used to monitor heparin therapy.

Immunohematology reagents used for antigen detection on human red blood cells that permit its char
different types (i.e., typing or blood grouping). The most important blood groups are ABO and Rh; othe
less clinical significance include Lewis, Lutheran, MN, and Ss groups. Blood grouping is frequently perf
patients in the process of selecting red cells for transfusion.

Immunohematology reagents used to characterize human blood in types A, B, AB, or O. There are two
grouping: The forward grouping test in which cells from a person of an unknown group are reacted wit
anti-B sera and the reverse test (confirmatory) that involves testing the reaction of serum of the unk
known A and B reactivity.
Immunohematology reagents used to characterize human blood according to a complex group of imm
known as Rhesus antigens. Rhesus antigens are classified according to either the genetic constituent
E) or numbered following the order of discovery (Rh1, Rh2, and so on). The major Rhesus antigen is R
immunogenic antigen that is the only Rh antigen matched in routine transfusion practice.

Immunohematology reagents used for detection and/or identification of antibodies in the blood (typica
individual that react with antigens on the red blood cells of another person (alloantibodies). Usually, th
antibodies of clinical significance in immunohematology are those that shorten the survival of transfus
associated with the hemolytic disease of the newborn (HDN). Antibody detection reagents are mostly
testing and in prenatal testing to evaluate the likelihood of HDN.

Immunohematology reagents available as a panel of vials (i.e., cell panels) used for identification of a
antigens. These panels are group O erythrocytes with known antigen composition in each cell panel;
drawn from different individuals for each panel cell. The pattern of positive and negative reactions in t
permit identification of the most frequently found antibodies of clinical significance. Cell-panel tests a
in which antibodies have been detected during screening.

Immunohematology reagents, including antiglobulin serum (e.g., polyspecific antihuman serum), that
alloantibodies bound to the red cells under test. Antiglobulin serum is obtained either by the injection
human globulin or through hybridoma technology. Antiglobulin reagents used for detection and/or ide
antibodies in blood may be specific to detect gamma globulin (monospecific), or for detection of both
antibodies and complement components (polyspecific).
Hematology reagents used for determination of acquired plasma circulating antibodies specific to a c
these antibodies directly inhibit the coagulation factor activity. Most of these antibodies are specific to
VIII or IX; acquired antibodies to other coagulation factors are not frequently found.

Control reagents that consist of immunoglobuli-G-coated cells that are added after negative antiglob
verification that the antiglobulin reagent (i.e., antihuman globulin) was functional.
Reagents, usually liquids, used as a medium capable of supporting the primary culture of cells, usually
blood and/or bone marrow; amniotic fluid and/or chorionic villi cells are also used in cytologic diagnos
reagents are typically supplied in kits containing all necessary substances for chromosome diagnostic

Reagents used as a medium for mounting and long-term preservation of previously stained slides. The
optical and physical properties to avoid tissue alterations that cause image distortion or color fading
optical or microscopic examination. Mounting media frequently consist of synthetic resins.

Reagents used in cytology and/or histology assays to remove all calcium (i.e., decalcify) from samples
bone, cartilage). These reagents are mostly used in calcified tissues before microscopic examination;
may be specific for use either in light or electron microscopy.
Reagents used for coagulation and/or precipitation of protoplasmatic substances (i.e., fixation), makin
further changes either from the reagents to which they are subjected or from autolysis and putrefactio
sections can be prepared. Several substances are used as fixatives, including formaldehyde, mercury
glutaraldehyde solutions; some include decalcifier additives.
Reagents used for artificial coloration of the constituent parts of the cells and the intercellular materia
of natural or artificial dyes. Most cytology and histology stains are used for visual or microscopic differ
parts of the cell (e.g., nucleus, cytoplasm) and/or to differentiate between the different types of cells a

Immunoassay reagents that include serum containing one or more antibodies. Serum containing seve
for more than one antigen or antigenic epitope is termed polyclonal antiserum; serum that contains o
antibody specific for one antigen or antigenic epitope is known as monoclonal antiserum.

Reagents used in assays to separate ionic solutes based on differences in their rates of migration in
the influence of an electric field (i.e., electrophoresis assays). These reagents typically include a porou
(e.g., agarose gel film, cellulose acetate sheet), buffers, stains, and other auxiliary reagents. Electroph
mostly used in clinical laboratories to separate proteins and lipoproteins in body fluids such as serum,
cerebrospinal fluid; these assays are also used to separate proteins in tissues and erythrocites.

Reagents available as a set (kit) that permits the determination of one or more analytes of interest in
fluids, typically whole blood, urine, or feces. These kits are designed for rapid testing (typically a few m
performed at home by the patient or other non-healthcare provider with minimum training. Many reag
for home use may be available without prescription. They permit patients to check and/or control the
(e.g., glucose) that characterize a specific illness, to follow the progress of medical treatments, or to id
conditions (e.g., pregnancy) .
Reagents available as a home-test kits that permit the rapid determination (typically a few minutes) o
of interest in a sample of whole blood. Whole blood kits for home use permit patients to check and/or
substances (e.g., glucose) that characterize a specific illness (e.g., diabetes) or to follow the progress
(e.g., lowering of cholesterol). Frequently these kits include a paper strip (reagent strip) that changes
with a particular analyte.

Reagents available as home-test kits that permit the rapid determination (typically a few minutes) of c
of whole blood. Cholesterol determination kits for home use permit patients to check the level of chole

Reagents available as home-test kits that permit the determination of glucose in a sample of whole bl
determination kits for home use permit diabetic patients to check and/or control their level of glucose
medical treatments.
Reagents available as home-test kits that permit the determination of glycated hemoglobin, a result o
nonenzymatic addition of glucose residues to hemoglobin, in a sample of whole blood. Glycated hemo
kits permit patients to check the integrated values for glucose over a period of several weeks, free fro
glucose level, providing additional criteria for glucose control.
Reagents available as home-test kits that permit the semiquantitative determination of ketones in a s
Ketone determination kits for home use permit patients to check the level of ketones in their blood; in
concentration of ketones (ketonemia) is associated with diabetes mellitus, alcohol consumption, frequ
starvation. Semiquantitative determination of ketones in blood is reportedly more accurate than test m
specimens.

Reagents available as home-test kits that permit the rapid determination (typically in few minutes) of
of interest in a sample of urine. Most urine test kits for home use may be available without prescriptio
to check and/or control the levels of substances (e.g., bilirubin) that characterize a specific illness (e.g
to follow the progress of medical treatments. Frequently these kits include a paper strip (reagent strip
when reacting with a particular analyte.

Reagents available as home-test kits that permit the determination in a sample of urine of one or mor
hormones that are related to the detection of human pregnancy, typically human chorionic gonadotro
hormone determination (hCG hormone determination) kits for home use permit women to determine i

Reagents available as home-test kits that permit the determination in a sample of urine of one or mor
that either are illegal or are frequently taken in excess for nonmedical purposes (i.e., have a high pote
include amphetamines, barbiturates, cocaine, and morphine. Drug-of-abuse determination kits for hom
family members or healthcare providers to determine the presence/check the level of these drugs in t

Reagents available as home-test kits that permit the determination of several analytes (e.g., glucose a
sample of urine. Multianalyte determination kits for home use permit patients to simultaneously check
level of several urine analytes during illness and/or medical treatments.

Reagents available as home-test kits that permit the rapid determination (typically a few minutes) of o
interest and/or occult blood in a sample of feces.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against the cytochrome P450 2D6, specifically against the linear and conformati
CYP2D6 protein. These antibodies are generically known as liver/kidney microsomal antibodies type 1
frequently found in patients with chronic hepatitis.
Devices designed to divide solid tissue (e.g., tumors, the uterus) into pieces, followed by removal of th
(morcellation). Morcellators may consist either of a system combining an electrically powered unit and
needed for this procedure or a set of appropriate manually operated instruments (e.g., scissors, blade
instruments).
Morcellators consisting of a system that combines an electrically powered unit, a handpiece, an endos
blades, brushes, and extractors. These devices perform the morcellation through the endoscope using
surgery (e.g., laparoscopic) procedures, usually in less time than conventional manual procedures. Mo
used for dissection of the large tissue masses typically found in gynecological procedures, such as in
uterus or benign tumors (myomas).

Scanning systems designed to record and display as images the difference in flow of electricity throug
difference in their electrical impedance.
Electrical impedance scanning systems used to produce real-time images of the breast. These system
voltage electrical source (typically 1 to 2.5 V), an electrode attached to the source which is placed on
second electrode included in a probe to be placed against the breast, and an electronic unit that recor
signal as an image. Cytological and histological changes in cancerous tissue cause a significant chang
impedance, showing cancers as bright spots on a gray background. Mammographic electrical impedan
are used as an adjunct test for ambiguous mammograms to facilitate early diagnostics and reduce the

Wands used to capture the plume during a surgical procedure, allowing surgical smoke to be evacuate
origin.
Smoke-evacuation wands designed to clip on a surgical laser handpiece.
Active electrosurgical electrodes controlled by a hand switch designed to deliver radiofrequency (RF) e
body tissues. These units also include a suction wand that captures the smoke plume during the surgi
electrodes deliver the RF energy received through insulated cables from a RF generator located in the
they are usually a component of a handpiece or surgical instrument (for monopolar and bipolar units r
manipulated by the surgeon; the handpiece also includes a hand switch that allows its operation by th
evacuation active electrosurgical electrodes may apply monopolar or bipolar current; they are mostly
intended to cut tissues, stop bleeding, and/or for tissue fusion.

Active electrosurgical electrodes controlled by a foot switch that are designed to deliver radiofrequenc
to the body tissues. These units also include a suction wand that captures the smoke plume during th
These electrodes deliver the RF energy received through insulated cables from an RF generator locate
unit. They are usually a component of a handpiece or surgical instrument (for monopolar and bipolar u
is manipulated by the surgeon and also include a foot-pedal that works as an electric power switch. Sm
controlled active electrosurgical electrodes may apply monopolar or bipolar current. They are mostly u
intended to cut tissues, stop bleeding, and/or for tissue fusion.

Serology reagents intended to detect antibodies to deoxyribonuclease streptolysin O, an antigenic hem


mostly by group A streptococci but also by some group C and G streptococci. These antibodies develo
the result of a preceding streptococcal infection and are associated with some autoimmune diseases s
rheumatic fever, Tourette's syndrome, and post-streptococcal glomerulonephritis.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against small, sphere-shaped components found in the cytoplasm of cells (i.e., m
generically known as antimitochondrial antibodies (AMAs). Reagents for determination of AMAs in seru
diagnostics of primary biliary cirrhosis, an organ-specific, cholestatic autoimmune disease characteriz
progressive destruction of bile ducts, portal inflammation, and, ultimately, fibrosis. This disease predo
women.

Immunoassay reagents used in laboratory analysis of the cellular and humoral immune function (i.e.,
immunology). They can determine substances that constitute a challenge for the human body (antige
result of the response of the body to such substances (antibodies). These reagents are used in tests to
(i.e, tissue typing) and neoplastic cells (i.e., cell typing) and/or to determine proteins that regulate the
of an immune response (i.e., cytokines). Immunologic reagents are frequently available in kits that in
antigen, calibrators, and other appropriate reagents (e.g., activators). Some immunologic reagents ma
immunoelectrophoresis or immunofixation electrophoresis tests.

Microbiology reagents used to assess the susceptibility of bacteria to antibacterial agents (e.g., antibi
analyzers. There are two types of automated susceptibility tests available: the minimum inhibitory con
based on the determination of the minimum concentration at which there is no visible growth of the b
and the break-point tests that differentiate between the categories of susceptible, moderately suscep

Microbiology reagents used for rapid and qualitative determination (screening) of bacteria in urine sam
are frequently included in strips that can provide simultaneous information about the urine chemistry
glucose). Reagents for urine screening of bacteria (bacteriuria determination) could be appropriate eit
procedures using visual evaluation, for automated analyzers, or for both.

Reagents available as home-test kits that permit the determination in a sample of urine of one or mor
hormones that are released prior to human ovulation, typically luteinizing hormone (LH). Ovulation pre
determination) kits for home use may improve the chance of conception.
Serology reagents intended to detect antibody titers or antigens species of Chlamydia, a genus of intr
the family Chlamydiaceae. Chlamydia bacteria cause a variety of diseases in humans, including trach
conjunctivitis, and a significant number of genital infections.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
the genus Chlamydia. Chlamydia bacteria cause a variety of diseases in humans, including trachoma,
conjunctivitis, and a significant number of genital infections; this test is typically used to detect nonsy
trachoma).
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of bacteria of the
These bacteria cause a variety of diseases in humans, including trachoma, inclusion conjunctivitis, an
of genital infections; this test is typically used to detect systemic infections.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of bacteria of the
These bacteria cause a variety of diseases in humans, including trachoma, inclusion conjunctivitis, an
of genital infections; this test is typically used to detect systemic infections.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
principal species of the genus Escherichia, family Enterobacteriaceae. E. coli is a common inhabitant
humans, but pathogenic strains cause diarrhea and may cause urinary tract infections, conjunctivitis,

Serology reagents intended to detect toxins produced by Escherichia coli. E. coli is a common inhabita
intestine in humans, but pathogenic strains cause diarrhea and may cause urinary tract infections, co
septicemia.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., gonococci), a spherical species of bacterium of the family Neisseriaceae. These bacteria cause g
that is usually transmitted sexually.
Serology reagents used to detect antibodies to Neisseria gonorrhoeae (i.e., gonococci), a spherical spe
the family Neisseriaceae. These bacteria cause gonorrhea, a disease that is usually transmitted sexua

Serology reagents intended to detect serum antibody titers or antigens of Neisseria meningitidis (i.e.,
species of bacterium of the family Neisseriaceae. Meningococci are frequently found in the nasophary
carriers; their dissemination from the nasopharynx may cause meningococcemia and/or meningococc

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Treponema pallidum, a ba


Spirochaetaceae. These bacteria cause syphilis, a disease that is usually transmitted sexually or acqu

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Treponema pallidum, a ba


Spirochaetaceae. These bacteria cause syphilis, a disease that is usually transmitted sexually or acqu

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
bacteria. These bacteria cause chronic gastritis and pyloric ulcer and could be an etiologic agent for g

Serology reagents intended to detect antibodies to Helicobacter pylori bacteria. These bacteria cause
pyloric ulcer and could be an etiologic agent for gastric cancer.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Helicobacter pylori bacteri
cause chronic gastritis and pyloric ulcer and could be an etiologic agent for gastric cancer.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Helicobacter pylori bacter
cause chronic gastritis and pyloric ulcer and could be an etiologic agent for gastric cancer.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Helicobacter pylori bacter
cause chronic gastritis and pyloric ulcer and could be an etiologic agent for gastric cancer.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
pneumophila bacteria. These bacteria cause a pneumonia-like disease in humans (legionellosis).
Serology reagents intended to detect antibodies to Legionella pneumophila bacteria. These bacteria c
disease in humans (legionellosis).
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Legionella bact
cause a pneumonia-like disease in humans (legionellosis).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Legionella bact
cause a pneumonia-like disease in humans (legionellosis).
Serology reagents intended to detect antibodies to Borrelia burgdorferi, a species of intracellular bact
Spirochaetaceae. These bacteria cause Lyme disease (i.e., Lyme borreliosis), acrodermatitis chronica a
erythema chronicum migrans; they are typically transmitted by a parasitic tick of the genus Ixodes.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Borrelia burgdorferi, a spe
bacterium of the family Spirochaetaceae. These bacteria cause Lyme disease (i.e., Lyme borreliosis), a
atrophicans, and erythema chronicum migrans; they are typically transmitted by a parasitic tick of the

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Borrelia burgdorferi, a spe
bacterium of the family Spirochaetaceae. These bacteria cause Lyme disease (i.e., Lyme borreliosis), a
atrophicans, and erythema chronicum migrans; they are typically transmitted by a parasitic tick of the

Serology reagents intended to detect antibodies to species of Mycoplasma bacteria. Mycoplasma bact
agents of several diseases. The species Mycoplasma pneumoniae causes primary atypical pneumonia
pneumonia) and other febrile upper-respiratory-tract infections.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Mycoplasma ba
bacteria are etiologic agents of several diseases. The species Mycoplasma pneumoniae causes primar
(i.e., mycoplasmal pneumonia) and other febrile upper-respiratory-tract infections.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Mycoplasma ba


bacteria are etiologic agents of several diseases. The species Mycoplasma pneumoniae causes primar
(i.e., mycoplasmal pneumonia) and other febrile upper-respiratory-tract infections.

Serology reagents intended to detect antibody titers or antigens of Mycoplasma pneumoniae, a specie
family Mycoplasmataceae. M. pneumoniae is the etiologic agent of primary atypical pneumonia (i.e., m
pneumonia) and other febrile upper-respiratory-tract infections.
Serology reagents intended to detect antibody titers or antigens of species of Salmonella, a genus of m
peritrichous flagella of the family Enterobacteriaceae. Salmonella bacteria that are pathologic to huma
the cause of typhoid fever, and S. choleraesuis, an etiologic agent of paratyphoid, gastroenteritis, and

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
bacteria; some reagents may detect surface antigens external to the cell wall (capsular antigens). Sal
are pathologic to humans are classified based on their constituent antigens (serotypes) in three types
typhoid fever; S. choleraesuis, associated with paratyphoid, gastroenteritis, and septicemia; and S. en
includes all other serotypes except the first two), also associated with paratyphoid, gastroenteritis, an

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
genus of spherical bacteria of the family Streptococcaceae. Streptococci that are pathologic in human
pneumoniae (pneumococcus), a major respiratory tract pathogen and the most common cause of pne
pyogenes, which is one of the most important bacterial human pathogens, causing a wide range of su
(e.g., pharyngitis, otitis media, sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheum

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
pneumoniae bacteria. These bacteria are the most common cause of lobar pneumonia; they can also
diseases (e.g., meningitis, septicemia, peritonitis).
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
Staphylococcus a genus of coccoid bacteria of the family Micrococcaceae. Staphylococci that are path
include S. aureus, S. epidermidis, and S. saprophyticus. The most important species is S. aureus becau
cause serious suppurative infections, especially in immunosuppressed patients, neonates, and the eld
skin or in viral infections of the lungs. These reagents are used mostly in epidemiology tests.

Serology reagents intended to detect exotoxins (staphylotoxins) produced by species of Staphylococcu


bacteria, family Micrococcaceae. Staphylococci that are pathologic humans include S. aureus, S. epide
saprophyticus. The most important is S. aureus because of its ability to cause serious suppurative infe
immunosuppressed patients, neonates, and the elderly,through damaged skin or in viral infections of
reagents are used mostly in epidemiology tests.

Serology reagents intended to detect antibodies to Listeria monocytogenes, a species of bacterium clo
bacteria of the family Corynebacteriaceae. Listeria monocytogenes bacteria are the cause of listeriosi
result in abortion, stillbirth, or premature birth; infection acquired during birth can cause cardiorespira
vomiting, and meningitis; and infection in adults can produce meningitis, endocarditis, and dissemina
lesions.

Serology reagents intended to detect antibodies to Coxiella burnetii, a bacterium of the family Rickett
causes an acute infection (i.e., Q fever), characterized by fever and chills, that is frequently complicat
hepatitis, and endocarditis; in humans it is typically acquired by inhalation of airborne organisms deriv
animals.
Serology reagents intended to detect antibodies to species of Leptospira, a genus of finely coiled, mot
family Leptospiraceae. Leptospira interrogans is typically the species that is pathologic to humans, ca
Leptospirosis is acquired directly by contact with the urine or tissue of infected animals (e.g., rodents,
contact with contaminated water, soil, or vegetation.
Serology reagents intended to detect antibodies to species of Yersinia, a genus of ovoid-shaped bacte
Enterobacteriaceae. Yersinia species that are pathologic to humans include Y. pestis, which causes bub
enterocolitica, which causes acute gastroenteritis and mesenteric lymphadenitis; and Y. pseudotuberc
mesenteric lymphadenitis without gastroenteritis.
Serology reagents intended to detect and/or identify antigens or serum antibody titers to rubella virus
genus Rubivirus, family Togaviridae. Rubella virus is the cause of an acute, usually benign infection, of
the disease is characterized by a pink rash beginning on the head and spreading to become generaliz
infection of a fetus may occur. Rubella is also called German measles and, in French and Spanish, rube

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to measles virus, a single-str
virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is the etiologic agent of measles
benign infection characterized by coryza, cervical lymphoid hyperplasia, conjunctivitis, harassing coug
finally, skin eruption (rash).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to measles virus, a single-st
virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is the etiologic agent of measles
benign infection characterized by coryza, cervical lymphoid hyperplasia, conjunctivitis, harassing coug
finally, skin eruption (rash).
Serology reagents intended to detect and/or identify antigens or serum antibody titers to cytomegalov
virus of the family Herpesviridae. Some types of CMV may cause a variety of diseases (i.e., cytomega
leukemia) depending on the immune status and age of the host; persistence of the virus for the lifetim
common.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV), a
Herpesviridae. Some types of CMV may cause a variety of diseases (i.e., cytomegalic inclusion disease
depending on the immune status and age of the host; persistence of the virus for the lifetime of the h

Serology reagents intended to detect and/or identify antigens or serum antibody titers to Herpes simp
virus of the family Herpesviridae. HSV may cause a variety of conditions including gingivostomatitis, h
herpes, neonatal herpes, keratitis, conjunctivitis, skin eruptions, aseptic meningitis, and encephalitis.
herpesvirus is associated with some malignancies. Persistence of the virus for the lifetime of the host

Serology reagents intended to detect antigens to Herpes simplex virus (HSV), a DNA virus of the famil
may cause a variety of conditions, including gingivostomatitis, herpes labialis, genital herpes, neonata
conjunctivitis, skin eruptions, aseptic meningitis, and encephalitis. Activation of latent herpesvirus is a
malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpes simplex virus (HSV
family Herpesviridae. HSV may cause a variety of conditions, including gingivostomatitis, herpes labia
neonatal herpes, keratitis, conjunctivitis, skin eruptions, aseptic meningitis, and encephalitis. Activatio
is associated with some malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV), a
family Herpesviridae. EBV may cause infectious mononucleosis and is closely associated with maligna
Burkitt's lymphoma and nasopharyngeal carcinoma.
Serology reagents used to detect antigens of varicella-zoster virus. These viruses cause chickenpox (
varicella-zoster virus from a previous chickenpox (varicella) infection is likely to cause herpes zoster (a

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to varicella-zoster virus, a DN


Varicellavirus, family Herpesviridae. These viruses cause chickenpox (varicella), an infectious disease
by direct contact or through the respiratory route and characterized by the appearance of vesicular le
mucous membranes. Activation of varicella-zoster virus from a previous chickenpox (varicella) infectio
herpes zoster (also called shingles), a self-limited infection that affects ganglia and their areas of inne
severe neuralgic pain and vesicles on the skin.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to varicella-zoster virus, a D


Varicellavirus, family Herpesviridae. These viruses cause chickenpox (varicella), an infectious disease
by direct contact or through the respiratory route and characterized by the appearance of vesicular le
mucous membranes. Activation of varicella-zoster virus from a previous chickenpox (varicella) infectio
herpes zoster (also called shingles), a self-limited infection that affects ganglia and their areas of inne
severe neuralgic pain and vesicles on the skin.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to adenovirus,
family Adenoviridae. Some species of these viruses may cause acute respiratory, gastrointestinal, and
adenoviruses also cause latent infections of the tonsils and adenoids in children. Many species are like
malignancies.
Serology reagents intended to detect antigens to adenovirus, a DNA virus of the family Adenoviridae.
viruses may cause acute respiratory, gastrointestinal, and urinary tract diseases; adenoviruses also ca
the tonsils and adenoids in children. Many species are likely to induce malignancies.

Serology reagents intended to detect antigens to Enterovirus, a genus of single-stranded viruses of th


that includes polio and nonpolio (e.g., coxsackieviruses, echoviruses) enteroviruses. Enteroviruses typ
intestinal tract, and most infections are subclinical; but some types may cause a wide range of diseas
poliomyelitis (the etiologic agents are wild type polioviruses), aseptic meningitis and encephalitis (cau
of coxsackieviruses and echoviruses), and chronic meningoencephalitis (caused by several types of ec

Serology reagents intended to detect and/or identify antigens or serum antibody titers to Influenza vir
RNA virus of the family Orthomyxoviridae. Human influenza viruses are usually divided into three sero
C. Some subtypes of this virus are the etiologic agents of influenza, a disease characterized by sudde
myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis.

Serology reagents intended to detect antibodies to Influenza virus type A, a single-stranded RNA virus
Orthomyxoviridae. Influenza A viruses may cause human influenza, a disease characterized by sudden
myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis. Known subtypes o
affect humans are H1N1, H1N2, and H3N2; other subtypes such as H5 and H7 (i.e., avian influenza) aff
occasionally affect humans.

Serology reagents intended to detect antibodies to Influenza virus type B, a single-stranded RNA virus
Orthomyxoviridae. Influenza type B virus is an etiologic agent of influenza, a disease characterized by
fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to Parainfluenz
single-stranded RNA viruses of the family Paramyxoviridae. Parainfluenza viruses affecting humans ar
genera Paramyxovirus (including human Parainfluenza virus types 1 and 3) and Rubulavirus (includes
virus types 2 and 4). These viruses are the etiologic agent of parainfluenza and several upper respirat
(e.g., bronchitis, pneumonia) of varying severity. Dedicated reagents are available to identify particula
Parainfluenza viruses.

Serology reagents intended to detect antigens to respiratory syncytial virus (RSV), an enveloped RNA
Pneumovirus, family Paramyxovirus. Several types of RSV are etiologic agents of lower respiratory tra
the most common cause of bronchiolitis and pneumonia among infants.
Serology reagents intended to detect antibodies to respiratory syncytial virus (RSV), an enveloped RN
Pneumovirus, family Paramyxovirus. Several types of RSV are etiologic agents of lower respiratory tra
the most common cause of bronchiolitis and pneumonia among infants.
Serology reagents intended to detect and/or identify antigens or serum antibody titers to epidemic pa
an RNA virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is the etiologic agent of e
known as mumps), an infection characterized by swelling of one or both parotid glands that may also
cause inflammation of the testes (orchitis), and affect the ovaries.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis vir
common viruses that cause hepatitis belong to the families Picornaviridae (hepatitis A), Hepadnavirida
Flaviviridae (hepatitis C). These viruses cause hepatitis, a disease characterized by jaundice and the i
enzymes in serum (e.g., aspartate aminotransferase).
Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis A v
viruses of the genus Picornavirus, family Picornaviridae. These viruses may cause hepatitis, a disease
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase); hepatitis A v
exclusively transmitted by the fecal-oral route or via contaminated food or water, although parenteral
possible.

Serology reagents intended to detect antigens to hepatitis A viruses, typically RNA viruses of the genu
Picornaviridae. These viruses may cause hepatitis, a disease characterized by jaundice and the increa
serum (e.g., aspartate aminotransferase); hepatitis A viruses are almost exclusively transmitted by th
contaminated food or water, although parenteral transmission is possible. Tests using these reagents
utilized; easier or less expensive tests are available, and tests using the reagent may have questionab

Serology reagents intended to corroborate (i.e., confirm) the results of a previous test for the presence
antigens. Hepatitis A virus may cause hepatitis, a disease characterized by jaundice and the increase
serum (e.g., aspartate aminotransferase). Confirmatory assays frequently use a different approach or
methodology than the original test; they typically cost more and/or require more sophisticated device
using these reagents currently are not widely utilized; easier or less expensive tests may be available
may have questionable clinical usefulness.

Serology reagents used to detect immunoglobulin G (IgG) antibodies to hepatitis A viruses in a patie
antibodies are produced in the late phase of infection and may persist indefinitely in patients.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis B v
the genus Hepadnavirus, family Hepadnaviridae. Hepatitis B virus may cause hepatitis, a disease char
and the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruses may be
percutaneously (e.g., via body piercing, tattooing), parenterally, from mother to child at birth, or by in
contact.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to hepatitis B virus core antig
typically appear in serum at the onset of disease, usually two or three months after exposure. Hepatit
viruses of the genus Hepadnavirus, family Hepadnaviridae. Hepatitis B virus may cause hepatitis, a di
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruse
percutaneously (e.g., via body piercing, tattooing), parenterally, from mother to child at birth, or by in
contact.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis B v
Hepatitis B viruses are DNA viruses of the genus Hepadnavirus, family Hepadnaviridae; the X protein
the life cycle of Hepadnaviruses and in the carcinogenic process related to them. Hepatitis B virus ma
disease characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate amino
viruses may be transmitted percutaneously (e.g., via body piercing, tattooing), parenterally, from mot
by intimate (e.g., sexual) contact.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis C v
the genus Flavivirus family Flaviviridae. Hepatitis C virus may cause hepatitis, a disease characterized
increase of some enzymes in serum (e.g., aspartate aminotransferase); this virus is transmitted frequ
possibly by intimate (e.g., sexual) contact.
Serology reagents intended to corroborate (i.e., confirm) the results of a previous test for the presence
antibodies. Hepatitis C virus may cause hepatitis, a disease characterized by jaundice and the increas
serum (e.g., aspartate aminotransferase); this virus is transmitted frequently parenterally and possibl
sexual) contact. Confirmatory assays usually use a different approach or a more specific methodology
they typically cost more and/or require more sophisticated devices or greater skill.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis D v
defective RNA virus (delta agent) that requires the presence of hepatitis B virus (HBV) for viral replica
D virus may occur as a simultaneous acute hepatitis infection or may be superimposed on a case of ch
a disease characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate amin
Hepatitis D viruses are transmitted parenterally and possibly by intimate (e.g., sexual) contact.

Serology reagents intended to detect antibodies to hepatitis D virus, an unclassified defective RNA vir
requires the presence of hepatitis B virus (HBV) for viral replication to occur. Hepatitis D virus may occ
acute hepatitis infection or may be superimposed on a case of chronic HBV. Hepatitis is a disease char
and the increase of some enzymes in serum (e.g., aspartate aminotransferase). Hepatitis D viruses ar
parenterally and possibly by intimate (e.g., sexual) contact.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to hepatitis D virus, an uncla
virus (delta agent) that requires the presence of hepatitis B virus (HBV) for viral replication to occur. H
occur as a simultaneous acute hepatitis infection or may be superimposed on a case of chronic HBV. H
characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransfera
viruses are transmitted parenterally and possibly by intimate (e.g., sexual) contact.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis E v
the genus Calicivirus, family Caliciviridae. Hepatitis is a disease characterized by jaundice and the inc
in serum (e.g., aspartate aminotransferase). Hepatitis E viruses are transmitted by the fecal-oral route
food or water; this virus is endemic in some geographic areas. Hepatitis E virus is especially dangerou

Serology reagents intended to detect antigens to hepatitis E virus, an RNA virus of the genus Caliciviru
Hepatitis is a disease characterized by jaundice and the increase of some enzymes in serum (e.g., asp
aminotransferase). Hepatitis E viruses are transmitted by the fecal-oral route or via contaminated food
endemic in some geographic areas. Hepatitis E virus is especially dangerous for pregnant women.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to hepatitis E virus, an RNA v
Calicivirus, family Caliciviridae. Hepatitis is a disease characterized by jaundice and the increase of so
(e.g., aspartate aminotransferase). Hepatitis E viruses are transmitted by the fecal-oral route or via co
water; this virus is endemic in some geographic areas. Hepatitis E virus is especially dangerous for pre

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to hepatitis E virus, an RNA
Calicivirus, family Caliciviridae. Hepatitis is a disease characterized by jaundice and the increase of so
(e.g., aspartate aminotransferase). Hepatitis E viruses are transmitted by the fecal-oral route or via co
water; this virus is endemic in some geographic areas. Hepatitis E virus is especially dangerous for pre
Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis G v
the family Flaviviridae. Hepatitis G viruses may cause acute and chronic hepatitis, a disease character
the increase of some enzymes in serum (e.g., aspartate aminotransferase). The virus can be transmitt
perinatally, and by intimate (e.g., sexual) contact.
Serology reagents intended to detect and/or identify antigens or serum antibody titers to hepatitis-ass
single-stranded DNA virus of the family Circoviridae. TT viruses are associated with liver injury but are
cause of hepatitis of unknown origin.
Serology reagents intended to detect and/or identify antigens or serum antibody titers to human imm
serotype 1 (HIV-1), a retrovirus of the genus Lentivirus, family Retroviridae. HIV-1 is the most common
acquired immunodeficiency syndrome (AIDS).
Serology reagents intended to corroborate (i.e., confirm) the results of a previous test for the presence
immunodeficiency virus serotype 1 (HIV-1) antigens. HIV-1 is retrovirus of the genus Lentivirus, family
cause acquired immunodeficiency syndrome (AIDS). Confirmatory assays frequently use a different ap
specific methodology than the original test; they typically cost more and/or require more sophisticated
skills. Tests using these reagents are not widely utilized; these reagents may have questionable clinica
easier or less expensive tests may be available.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to human immunodeficiency


1), a retrovirus of the genus Lentivirus, family Retroviridae. HIV-1 is the most common etiologic agent
immunodeficiency syndrome (AIDS).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to human immunodeficiency
1), a retrovirus of the genus Lentivirus, family Retroviridae. HIV-1 is the most common etiologic agent
immunodeficiency syndrome (AIDS).
Serology reagents intended to corroborate (i.e., confirm) the results of a previous test for the presence
immunodeficiency virus serotype 1 (HIV-1) antibodies. HIV-1 is retrovirus of the genus Lentivirus, fami
may cause acquired immunodeficiency syndrome (AIDS). Confirmatory assays frequently use a differe
specific methodology than the original test; they typically cost more and/or require more sophisticated
skills.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to human imm
serotype 2 (HIV-2), a retrovirus of the genus Lentivirus, family Retroviridae. HIV-2 is an etiologic agent
immunodeficiency syndrome (AIDS).
Serology reagents intended to corroborate (i.e., confirm) the results of a previous test for the presence
immunodeficiency virus serotype 2 (HIV-2) antibodies. HIV-2 is a retrovirus of the genus Lentivirus, fam
may cause acquired immunodeficiency syndrome (AIDS). Confirmatory assays frequently use a differe
specific methodology than the original test; they typically cost more and/or require more sophisticated
skills.

Serology reagents intended to detect antigens to a specific protein with a molecular weight 24 (i.e., P2
surface of the human immunodeficiency virus (HIV), a retrovirus of the family Retroviridae. Tests to de
protein P24 are useful in the first period (usually between one and three weeks) after infection, before
present in blood. HIV is the etiologic agent of acquired immunodeficiency syndrome (AIDS).
Serology reagents intended to detect antibodies to a specific protein with a molecular weight 24 (i.e.,
surface of the human immunodeficiency virus (HIV), a retrovirus of the family Retroviridae. Antibodies
usually the earliest to appear in blood after infection, but they tend to decrease or become undetecta
progression of clinical symptoms. HIV is the etiologic agent of acquired immunodeficiency syndrome (

Serology reagents intended to detect and/or identify antigens or serum antibody titers to human imm
serotype 1 (HIV-1), and/or serotype 2 (HIV-2). Human immunodeficiency viruses are retroviruses of the
family Retroviridae; they are the etiologic agent of acquired immunodeficiency syndrome (AIDS).

Serology reagents intended to corroborate (i.e., confirm) the results of a previous test for the presence
human immunodeficiency virus serotype 1 (HIV-1) and/or serotype 2 (HIV-2). Human immunodeficienc
retroviruses of the genus Lentivirus, family Retroviridae, that may cause acquired immunodeficiency s
Confirmatory assays frequently use a different approach or a more specific methodology than the orig
cost more and/or require more sophisticated devices or greater skills.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to human T-cel
(also called human T-cell leukemia/lymphoma virus) type I (HTLV-I). HTLV-I retrovirus is a tumor-produc
subfamily Oncovirinae; it may cause chronic infection, T-cell leukemia, and tropical paraparesis (chron
myelopathy). Tests using these reagents are not widely utilized; these reagents may have questionabl
and easier or less expensive tests may be available.

Serology reagents intended to detect antigens to human T-cell lymphotropic virus (also called human
leukemia/lymphoma virus) type I (HTLV-I). HTLV-I retrovirus is a tumor-producing RNA virus of the subf
may cause chronic infection, T-cell leukemia, and tropical paraparesis (chronic progressive myelopathy
reagents are not widely utilized; these reagents may have questionable clinical usefulness, and easier
tests may be available.

Serology reagents used to corroborate (i.e., confirm) the results of a previous test for the presence of
cell lymphotropic virus (also called human T-cell leukemia/lymphoma virus) type I (HTLV-I). HTLV-1 retr
producing RNA virus of the subfamily oncavirinae; it may cause chronic infection, T-cell leukemai, and
(chronic progressive myelopathy). Confirmatory assays frequently use a different approach or a more
than the original test; they typically cost more and/or require more sophisticated devices or greater sk

Serology reagents intended to detect and/or identify antigens or serum antibody titers to human T-cel
(also called human T-cell leukemia/lymphoma virus) type II (HTLV-II). HTLV-II retrovirus is a tumor-prod
subfamily Oncovirinae that may cause leukemia and other hematological diseases. Tests using these r
utilized; these reagents may have questionable clinical usefulness, and easier or less expensive tests

Serology reagents intended to detect antigens to human T-cell lymphotropic virus (also called human
leukemia/lymphoma virus) type II (HTLV-II). HTLV-II retrovirus is a tumor-producing RNA virus of the sub
that may cause leukemia and other hematological diseases. Tests using these reagents are not widely
reagents may have questionable clinical usefulness, and easier or less expensive tests may be availab
Serology reagents intended to corroborate (i.e., confirm) the results of a previous test to detect huma
virus (also called human T-cell leukemia/lymphoma virus) type II (HTLV-II) antibodies. HTLV-II retrovirus
RNA virus of the subfamily Oncovirinae that may cause leukemia and other hematological diseases. C
frequently use a different approach or a more specific methodology than the original test; they typical
require more sophisticated devices or greater skills. Tests using these reagents are not widely utilized
have questionable clinical usefulness, and easier or less expensive tests may be available.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to human T-cel
(also called human T-cell leukemia/lymphoma virus) type I (HTLV-I) and/or type 2 (HTLV-II). Human T-ce
retroviruses are tumor-producing RNA viruses of the subfamily Oncovirinae that may cause chronic inf
tropical paraparesis (chronic progressive myelopathy), and other hematological diseases.

Serology reagents intended to detect serum antibody titers or antigens to Candida albicans, a yeast-li
fungi of the family Cryptococcaceae. These fungi are part of the normal flora of the skin, mouth, intes
they can cause superficial infection of the moist cutaneous areas of the body. The fungi may also infec
(i.e., deep candidiasis), frequently in immunocompromised patients.

Serology reagents intended to detect antibody titers or antigens to species of fungi of the genus Aspe
of the class Hyphomycetes. Aspergillus species (e.g., fumigatun, flavus) are opportunistic pathogens t
a disease characterized by inflammatory granulomatous lesions in the skin, lungs, and ears; they may
and meninges.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of fungi of the gen
imperfect fungi of the class Hyphomycetes. Aspergillus species (e.g., fumigatun, flavus) are opportuni
cause aspergillosis, a disease characterized by inflammatory granulomatous lesions in the skin, lungs
also affect the bones and meninges.
Serology reagents intended to detect serum antibody titers or antigens to Coccidioides immitis, a spe
of the family Moniliaceae. Coccidioides immitis is a pathogen of the respiratory tract, frequently causi
manifestations; these fungi may also cause coccidiomycosis and/or fungal pneumonia.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Coccidioides immitis, a sp


fungi of the family Moniliaceae. Coccidioides immitis is a pathogen of the respiratory tract, frequently
manifestations; these fungi may also cause coccidiomycosis and/or fungal pneumonia.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Coccidioides immitis, a sp


fungi of the family Moniliaceae. Coccidioides immitis is a pathogen of the respiratory tract, frequently
manifestations; these fungi may also cause coccidiomycosis and/or fungal pneumonia.

Serology reagents used to detect soluble cell-free antigens (exoantigens) extracted from cultures of C
species of imperfect fungi of the family Moniliaceae. Coccidioides immitis is a pathogen of the respirat
causing allergic manifestations; these fungi may also cause coccidiomycosis and/or fungal pneumonia

Serology reagents intended to detect antibody titers or antigens to Cryptococcus neoformans, a yeast
imperfect fungi of the family Cryptococcaceae. Cryptococcus neoformans is a pathogenic fungus; infe
skin, lungs, and, more typically, brain membranes, especially in immunocompromised patients.
Serology reagents intended to detect antigens to identify strains of Cryptococcus neoformans, a yeast
imperfect fungi of the family Cryptococcaceae. Cryptococcus neoformans is a pathogenic fungus; infe
skin, lungs, and, more typically, brain membranes, especially in immunocompromised patients.

Serology reagents intended to detect antibody titers or antigens to Histoplasma capsulatum, a yeast-l
imperfect fungi of the family Moniliaceae. Histoplasma capsulatum is a pathogenic fungus, and infecti
frequently asymptomatic but can cause an influenza-like illness or pneumonia. These fungi can affect
heart, and other organs in immunocompromised patients.
Serology reagents intended to detect antigens to strains of Histoplasma capsulatum, a yeast-like spec
of the family Moniliaceae. Histoplasma capsulatum infection (histoplasmosis) is frequently asymptoma
influenza-like illness or pneumonia. These fungi can affect the lungs, meninges, heart, and other orga
immunocompromised patients.
Serology reagents intended to detect antibody titers or antigens of Toxoplasma gondii, a species of ob
coccidian protozoon parasite. These parasites cause toxoplasmosis, an acute or chronic disease transm
cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but extensive dama
eyes, cardiac muscle) may occur, especially in immunocompromised patients or in fetuses infected by
transmission.

Serology reagents used to detect immunoglobulin G (IgG) antibodies to Toxoplasma gondii parasites, a
intracellular coccidian protozoon parasite. These parasites cause toxoplasmosis, an acute or chronic d
the feces of cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but exte
the brain, eyes, cardiac muscle) may occur, especially in immunocompromised patients or in fetuses i
transplacental transmission.

Serology reagents intended to detect serum antibodies to Trypanosoma cruzi, a species of protozoon o
Trypanosomatina. Trypanosoma cruzi causes Chagas' disease (American trypanosomiasis) in humans,
erythematous nodule (i.e., chagoma) appearing within a few days at the site of the inoculation. These
transmitted to humans by insects from other humans or from animals (e.g., cats, dogs, rodents).

Serology reagents intended to detect antibody titers or antigens of species of Cryptosporidium, a genu
human intestines. Cryptosporidium parvum is the only known pathologic species, causing a profuse, w
to several days; in immunocompromised patients the disease may persist indefinitely.

Serology reagents intended to detect antigens that permit the identification of strains of Cryptosporid
parasites of human intestines. Cryptosporidium parvum is the only known pathological species, causin
diarrhea that may persist indefinitely in immunocompromised patients.
Serology reagents intended to detect antibodies to Taenia solium (pork tapeworm), a large tapeworm
Taeniidae. Taenia solium is the most frequent cause of cysticercosis; taenia parasites live in adult form
and in larval form (forming cysts) in the muscles and the central nervous system, causing cysticercosi
usually transmitted to humans via inadequately cooked pork.

Serology reagents used in tests to measure serum antibody titers of Echinococcus parasites (small tap
the family Taeniidae. These parasites are pathogenic in humans (e.g., Echinococcus granulosus), caus
organs such as the liver, lungs, and kidneys (i.e., echinococciasis); they are transmitted by ingestion o
Serology reagents intended to detect antigens that permit the identification of strains of species of Tri
flagellated protozoa. The only known human pathologic species of the genus is Trichomonas vaginalis
and the prostate. This parasite causes trichomoniasis, profuse vaginal discharge in females and urethr
enlargement in males.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate); they are u
performed for the determination of antigens and/or antibodies in human specimens due to pathogenic
infectious diseases.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate); they are u
performed for the determination of antibodies in human specimens due to pathogenic parasites that c
diseases.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of serologic tests performed fo
antigens and/or antibodies in human specimens due to infection by pathogenic bacteria that cause inf

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of serologic tests performed fo
antigens and/or antibodies in human specimens due to infection by pathogenic parasites that cause in

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm with which simila
serologic tests performed to determine antigens and/or antibodies in human specimens due to infectio
bacteria are compared. These standards may be used to determine the purity or performance of immu
used in infection tests to determine bacteria.

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm with which simila
serologic tests performed to determine antigens and/or antibodies in human specimens due to infectio
virus are compared. These standards may be used to determine the purity or performance of immuno
infection tests to determine viruses.

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm with which simila
serologic tests performed to determine antibodies in human specimens due to infection by pathogenic
compared. These standards may be used to determine the purity or performance of immunoassay rea
tests to determine parasites.

Serology reagents designed to perform tests in a short period of time, typically several minutes, to de
antibodies, and/or toxins due to pathogenic microorganisms (e.g., bacteria, viruses, parasites) in a pat

Immunoassay reagents used in rapid tests to detect Chlamydia, a genus of intracellular bacteria, in a
Chlamydia causes a variety of diseases in humans, including trachoma, inclusion conjunctivitis, and a
of genital infections.
Serology reagents used in rapid tests to detect Helicobacter (formerly Campylobacter) pylori bacteria
Helicobacter pylori bacteria causes chronic gastritis, pyloric ulcer, and could be an etiological agent fo
Serology reagents used in rapid tests to detect Streptococcus class A (Streptococcus pyogenes), a spe
bacteria, in a patient's sample. Streptococcus pyogenes is one of the most important bacterial pathog
causing a wide range of suppurative diseases (e.g., pharyngitis, otitis media, sinusitis, endocarditis) a
sequelae (e.g., acute rheumatic fever).
Serology reagents used in rapid tests to detect Streptococcus class B (Streptococcus agalactiae), a sp
bacteria, in a patient's sample. Streptococcus agalactiae is a bacterial pathogen of humans causing u
infections and also otitis media.
Serology reagents used in rapid tests to detect Treponema pallidum, a genus of bacteria of the family
patient's sample. Treponema pallidum bacteria cause syphilis, a disease that is mostly transmitted sex
uterus.
Immunoassay reagents used in rapid tests to detect viruses that cause hepatitis infection; hepatitis is
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase).
Serology reagents used in rapid tests to detect antigens in a patient's sample identified as the outer c
hepatitis B viruses. Hepatitis B surface antigens typically appear in serum before any clinical signal of
throughout the clinical course of the disease.
Serology reagents used in rapid tests to detect antibodies in a patient's sample to hepatitis type C vir
viruses are transmitted parenterally and probably also by intimate contact (e.g., sexual contact).
Serology reagents used in rapid tests to detect antigens or antibodies in a patient's sample to viruses
family Retroviridae. The most common subfamilies of pathogenic retroviruses are Oncovirinae, Spuma
Lentivirinae. Lentiviruses are the cause of acquired immunodeficiency syndrome (AIDS), and oncoviru
human T-Cell lymphomas and leukemia.
Serology reagents used in rapid tests to detect antigens or antibodies in a patient's sample to human
virus serotype 1 (HIV-1). HIV is the cause (etiologic agent) of the acquired immunodeficiency syndrom

Serology reagents used in rapid tests to detect antigens or antibodies in a patient's sample to human
virus serotype 2 (HIV-2). HIV is the cause (etiologic agent) of the acquired immunodeficiency syndrom
common than the serotype 1 (HIV-1).
Serology reagents used in rapid tests to detect antigens or antibodies in a patient's sample to human
viruses of either serotype 1 (HIV-1), serotype 2 (HIV-2), or both. HIV is the cause (etiologic agent) of t
immunodeficiency syndrome (AIDS).
Serology reagents used in rapid tests to detect antibodies to cytomegalovirus (CMV) in a patient's sam
cause a variety of diseases (i.e., cytomegalic inclusion diseases) depending on the immune status an
persistence of the virus for the lifetime of the host is common.
Microbiology reagents in the form of liquids, solids, or semisolids used as a medium capable of suppor
bacteria. These culture media are used for the isolation and identification of bacteria and also in assay
susceptibility to antimicrobial agents.
Bacteria culture media with a very low content of water (typically less than 2%). These media are usu
powders that must be prepared by adding a preestablished quantity of water and/or other liquid addit

Bacteria culture media that are available either as liquid or semisolids in ready-to-use tubes. Some of
supplementation with other reagents before use.
Bacteria culture media that are available in liquid state (e.g., broth) in ready-to-use tubes. Some of th
supplementation with other reagents before use.
Bacteria culture media that include a solidifying agent derived from red seaweeds (e.g., agar) and tha
ready-to-use tubes. Some of these media may need supplementation with other reagents before use

Bacteria culture media that are available in ready-to-use tubes specially designed to transport the sam
laboratory, avoiding contamination and/or leakage.
Bacteria culture media that are available in ready-to-use bottles. These media may need supplementa
reagents (e.g., enrichment) before use.
Bacteria culture media that include a solidifying agent derived from red seaweeds (i.e., agar) and that
to-use bottles. These media may need supplementation with other reagents before use.
Bacteria culture media reagents in liquid state (e.g., broth) that are available in ready-to-use bottles. T
supplementation with other reagents before use.
Culture media reagents that are available in ready-to-use plates. These media may need supplementa
reagents before use.
Microbiology reagents, either in liquids or in plates, used as a medium capable of supporting the grow
particularly bacteria that may be present in the circulating blood. These media typically contain formu
enhancing the growth of a particular type of bacteria, the basic components include a nutrient broth a
blood culture media may be specific either for manual or automated tests.

Blood culture media that are appropriate for use in manual assays; some media include only basic com
broth and an anticoagulant. More elaborate media used in manual tests may include other componen
peptone), but they usually do not include osmotic additives that make visual evaluation more difficult

Blood culture media used in manual assays that include only a nutrient broth and an anticoagulant. Th
available in bottles that are appropriate for the volume of the sample and level of bacteremia found e
children.
Blood culture media used in manual assays consisting of a bottle that contains an agar slant partially
(biphasic media). These media, with appropriate ventilation, are also used for fungi cultures.

Blood culture media that are appropriate for use in automated assays; some media include only basic
broth and an anticoagulant. More elaborate media, usually supplied in ready-to-use bottles, include ot
supplemented peptone) and osmotic additives (i.e., hypertonic media). These media are frequently us
too.
Blood culture media that are available in ready-to-use bottles. Most blood culture bottles contain trypt
heart infusion agar, supplemented peptone, or thioglycolate broth. These media are available in bottle
for the volume of the sample and level of bacteremia found either in adults or in children; they may n
of some other reagents before use.
Microbiology reagents intended to identify species of Salmonella, a genus of motile bacteria with petri
family Enterobacteriaceae. Salmonella bacteria that are pathologic to humans include S. typhi, the ca
and S. choleraesuis, an etiologic agent of paratyphoid, gastroenteritis, and septicemia.

Microbiology reagents intended to identify Listeria monocytogenes, a bacterium of the genus Listeria.
monocytogenes bacteria are the cause of listeriosis and in utero infections resulting in abortion, stillbi
birth. Infections acquired during birth cause cardiorespiratory distress, diarrhea, vomiting, and mening
produces meningitis, endocarditis, and disseminated granulomatous lesions.
Microbiology reagents intended to identify Clostridium difficile, a bacterium of the family Bacillaceae.
bacteria are part of the normal colon flora in humans; they grow in large numbers and produce a prote
sufficient amounts to cause pseudomembranous enterocolitis in patients receiving certain antibiotic (e
treatments.
Microbiology reagents intended to identify Francisella tularensis, a species of gram-negative bacterium
cause tularemia, a disease characterized by malaise, fever, chills, and weakness; these bacteria are ty
wild animals.
Microbiology reagents used in manual analyses to assess the susceptibility of bacteria to antibacterial
antibiotics) by determining the minimum inhibitory concentration (MIC) of antibacterial agents in a so
broth) at which there is no visible growth of the bacteria.
Microbiology reagents used in manual tests to determine the susceptibility of bacteria to antibacterial
antibiotics) by determining the zones of inhibition around antibiotic-containing disks applied to agar p
standardized suspension of bacteria after several hours. The inhibition zone diameters are classified a
moderately susceptible (also known as indeterminate), or resistant.
Microbiology reagents used in automated analyzers to assess the susceptibility of bacteria to antibact
antibiotics) by determining the minimum inhibitory concentration (MIC) of antibacterial in a solution (e
which there is no visible growth of the bacteria.
Microbiology reagents used in automated analyzers to assess the susceptibility of bacteria to antibact
antibiotics) by differentiating between the categories of susceptible, moderately susceptible, or resista
tests).
Microbiology reagents intended to identify varicella-zoster virus, a DNA virus of the genus Varicelloviru
Herpesviridae. These viruses cause chickenpox (varicella), an infectious disease typically transmitted
through the respiratory route and characterized by the appearance of vesicular lesions on the skin and
Activation of varicella-zoster virus from a previous chickenpox (varicella) infection may cause herpes z
shingles), a self-limited infection that affects ganglia and their areas of innervation, producing severe
vesicles on the skin.

Microbiology reagents intended to identify respiratory syncytial virus, an enveloped RNA species of vir
Paramyxovirus. Several types of this virus are the etiologic agents of lower respiratory tract infections
common cause of bronchiolitis and pneumonia among infants.
Microbiology reagents intended to identify the serogenic types (i.e., A, B, C) of the human Influenza vi
RNA viruses of the family Orthomyxoviridae. Some types of this virus are the etiologic agent of influen
characterized by sudden onset of high fever, myalgia, headache, severe malaise, nonproductive coug
rhinitis; these viruses may be transmitted through the air or from one human to another.

Microbiology reagents intended to identify the serogenic types (i.e., 1, 2, 3) of the human Parainfluenz
these RNA viruses belong to the genus Paramyxovirus. Some types of this virus are the etiologic agen
several upper respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Microbiology reagents intended to identify Rotavirus, a genus of nonenveloped double-stranded RNA v


appearance of the family Reoviridae. Several types of Rotavirus may cause diseases in humans, includ
diarrhea; it is the most common cause of severe diarrhea among children.

Microbiology reagents used to identify Cytomegalovirus (CMV), a DNA virus of the family Herpesvirida
a variety of diseases (i.e., cytomegalic inclusion diseases) depending on the immune status and age
of the virus for the lifetime of the host is common.
Microbiology reagents in the form of liquids, solids, or semisolids used as media capable of supporting
multicellular and monocellular fungi (yeast). These culture media are used for the isolation and identifi
yeasts and also in assays to determine their susceptibility to antimicrobial agents.

Fungi/yeast culture media with a very low content of water (typically less than 2%) that are usually av
must be prepared by adding water and/or other liquid additives in a pre-established quantity before u

Fungi/yeast culture media that are available either as liquid or semisolids in ready-to-use tubes. Some
need supplementation of some other reagents before use.
Fungi/yeast culture media that are available in ready-to-use bottles. These media may need suppleme
reagents (e.g., enrichment) before use.
Fungi/yeast culture media reagents that are available in ready-to-use plates. These media may need s
other reagents before use.
Fungi/yeast culture media that are available as a component of ready-to-use slides.
Microbiology reagents intended to identify species of fungi of the genus Aspergillus, imperfect fungi o
Hyphomycetes. Aspergillus species (e.g., fumigatun, flavus) are opportunistic pathogens causing aspe
characterized by inflammatory granulomatosis, lesions in the skin, lungs, and ears; these fungi may a
and meninges.
Microbiology reagents intended to identify Coccidioides immitis, a species of imperfect fungi of the fam
Coccidioides immitis is a pathogen of the respiratory tract, frequently causing allergic manifestations;
cause coccidiomycosis and/or fungal pneumonia.
Microbiology reagents intended to identify Histoplasma capsulatum, a species of imperfect fungi of th
Histoplasma capsulatum infection (histoplasmosis) is frequently asymptomatic, but may cause influen
pneumonia. These fungi can affect the lungs, meninges, heart, and other organs of immunocompromi

Microbiology reagents used to assess the susceptibility of fungi and/or yeast to antifungal agents (e.g
antibiotics). Most susceptibility tests are based on the determination of the minimum concentration at
visible growth of the fungi (i.e., minimum inhibitory concentration [MIC]) in a dilution. Tests for fungi/y
similar to those performed to determine bacteria susceptibility.

Microbiology reagents used detect and/or identify unicellular organisms of the subkingdom protozoa t
These parasites include Entamoeba histolytica, Giardia lamblia, Cryptosporidium parvum, and various
(e.g., P. vivax, P. falciparum) that may be found in the blood, tissue, intestines, or urogenital system of

Microbiology reagents used to detect and/or identify one or more of the species of Plasmodium that pa
Plasmodium is the etiological cause of malaria; the most common species that infect humans are P. vi
but P. malariae and P. ovale also infect humans.
Microbiology reagents used to detect and/or identify one or more of the Amoebae species that parasit
Entamoeba histolytica is the only known pathological species of Amoebae, causing amebiasis.

Microbiology reagents used to detect and identify species of protozoa of the genus Leishmania, subord
Leishmania parasite infection (leishmaniasis) characteristics depend on the species or subspecies. The
according to their effects as cutaneous, mucocutaneous, and visceral. These parasites are usually tra
flies.
Microbiology reagents used to detect and/or identify worms that parasitize humans. Helminthes includ
flukes), cestodes (e.g., tapeworms), roundworms, and filariae that parasitize the intestines. They are t
detection of larvae or eggs in feces.
Microbiology reagents used to prevent marked changes in the pH and/or the concentration of a particu
substance in a culture media, either for bacteria, fungi, or tissue culture. These reagents are typically
concentrated solutions, or powders in ready-to- use packs.
Microbiology reagents used to prevent marked changes in the pH and/or the concentration of a particu
substance during a bacteria identification or susceptibility test (i.e., buffers). These reagents are typic
solutions, concentrated solutions, or powders in ready-to-use packs.
Microbiology reagents used to prevent marked changes in the pH and/or the concentration of a particu
substance during a virus identification test (i.e., buffers). These reagents are typically available in solu
solutions, or powders in ready-to-use packs.
Microbiology reagents used to prevent marked changes in the pH and/or the concentration of a particu
substance during a fungi and/or yeast identification or susceptibility test (i.e., buffers). These reagent
in solutions, concentrated solutions, or powders in ready-to-use packs.
Microbiology reagents used to prevent marked changes in the pH and/or the concentration of a particu
substance during a parasite identification or susceptibility test (i.e., buffers). These reagents are typic
solutions, concentrated solutions, or powders in ready-to- use packs.
Reagents intended to establish points of reference (i.e., calibrate) of a group of liquids, solids, or semi
medium capable of supporting the growth of microorganisms (e.g., bacteria); these calibrators may be
manual or automated tests.
Reagents intended to establish points of reference (i.e., calibrate) of a liquid medium capable of suppo
microorganisms, particularly bacteria that may be present in the circulating blood; these calibrators m
for manual or automated tests.
Reagents intended to establish points of reference (i.e., calibrate) in a diverse range of biochemical as
of bacteria and/or determination of their susceptibility to antibacterial agents (e.g., antibiotics); these
specific either for manual or automated tests.
Reagents intended to establish points of reference (i.e., calibrate) in a diverse range of biochemical as
of viruses; these calibrators may be specific either for manual or automated tests.
Reagents intended to establish points of reference (i.e., calibrate) of a group of liquids, solids, or semi
medium capable of supporting the growth of tissue; these calibrators may be specific either for manua

Reagents intended to establish points of reference (i.e., calibrate) in a diverse range of biochemical as
of fungi and yeasts and/or determination of their susceptibility to antifungicidal agents (e.g., antibioti
may be specific either for manual or automated tests.
Reagents intended to establish points of reference (i.e., calibrate) in a diverse range of biochemical as
of parasites and/or determination of their susceptibility to treatment agents (e.g., chloroquine).

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of a group of liquids, solids, or
medium capable of supporting the growth of bacteria; these controls may be specific either for manua
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of a liquid medium capable of
of microorganisms, particularly bacteria that may be present in the circulating blood; these controls m
for manual or automated tests.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control in a diverse range of biochemi
identification of bacteria and/or determination of their susceptibility to antibacterial agents (e.g., anti
may be specific either for manual or automated tests.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control in a diverse range of biochemi
identification of viruses; these controls may be specific either for manual or automated tests.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of a group of liquids, solids, or
medium capable of supporting the growth of tissue; these controls may be specific either for manual o

Microbiology reagents consisting of samples of substances with known values; they are used for qualit
range of biochemical assays for identification of fungi and yeasts and/or determination of their suscep
antifungicidal agents (e.g., antibiotics); these controls may be specific either for manual or automated

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control in a diverse range of biochemi
identification of parasites and/or determination of their susceptibility to treatment agents (e.g., chloro

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
media capable of supporting the growth of bacteria.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
liquid media capable of supporting the growth of microorganisms, particularly bacteria that may be pr
blood.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
diverse range of microbiology assays for identification of bacteria and/or determination of their susce
agents (e.g., antibiotics).
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
diverse range of microbiology assays for identification of viruses.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
media capable of supporting the growth of tissue.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
diverse range of microbiology assays for identification of fungi and yeasts and/or determination of the
antifungicidal agents (e.g., antibiotics).
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm to compare simila
diverse range of microbiology assays for identification of parasites and/or determination of their susc
agents (e.g., chloroquine).
Microbiology reagents used for rapid and qualitative determination (screening) of bacteria in urine sam
analyzers. The reagents may be liquid or included in sticks (e.g., dip sticks) that frequently can provid
information about the urine chemistry (e.g., bilirubin, ketone, glucose) and the presence of pus (pyuri

Microbiology reagents used for rapid and qualitative determination (i.e., screening) of bacteria in urine
manual procedures. The reagents may be liquid or included in sticks (e.g., dip sticks) that frequently c
simultaneous information about the urine chemistry (e.g., bilirubin, ketone, glucose) and the presence

Molecular assay reagents intended to identify bacteria of the species Neisseria gonorrhoeae (also kno
detecting specific genetic information of the nucleic acid of the target bacteria. These bacteria cause
that is usually transmitted sexually.
Molecular assay reagents intended to identify Treponema pallidum, a bacterium of the family Spirocha
specific genetic information of the nucleic acid of the target bacteria. These bacteria cause syphilis, a
transmitted sexually or acquired in utero.
Molecular assay reagents intended to identify Helicobacter (formerly Campylobacter) pylori, a bacteriu
Spirillaceae, by detecting specific genetic information of the nucleic acid of the target bacteria. Helico
cause chronic gastritis and pyloric ulcer and could be an etiologic agent for gastric cancer.

Molecular assay reagents intended to identify species of Legionella, a genus of intracellular bacteria o
Legionellaceae, by detecting specific nucleic-acid information of the target bacteria. Some species of
may cause pneumonia-like diseases (i.e., legionellosis) in humans, either as a serious illness (Legionn
milder form (Pontiac fever).
Molecular assay reagents intended to identify Borrelia burgdorferi, an intracellular bacterium of the fa
by detecting specific genetic information of the target bacteria. Borrelia burgdorferi bacteria cause Lym
borreliosis), acrodermatitis chronica atrophicans, and erythema chronicum migrans. These bacteria ar
by a parasitic tick of the genus Ixodes.
Molecular assay reagents intended to identify Mycobacterium tuberculosis, a species of slow-growing
Mycobacterium, family Mycobacteriaceae, by detecting specific genetic information of the nucleic acid
These bacteria are the etiologic agent of human tuberculosis.
Molecular assay reagents intended to identify species of Salmonella, a genus of motile bacteria with p
the family Enterobacteriaceae, by detecting specific nucleic-acid information of the target bacteria. Sa
are pathologic to humans include S. typhi, the cause of typhoid fever and S. choleraesuis, an etiologic
gastroenteritis, and septicemia.
Molecular assay reagents intended to identify species of Streptococcus, a genus of spherical bacteria
Streptococcaceae, by detecting specific nucleic-acid information of the target bacteria. Streptococci te
chains and are divided into serogenic types according to their cell wall (e.g., groups A, B, C). Streptoco
to humans include S. pneumoniae, a major respiratory tract pathogen and the most common cause of
pyogenes, which one of the most important bacterial human pathogens and causes a wide range of su
(e.g., pharyngitis, otitis media, sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheum
Molecular assay reagents intended to identify species of Staphylococcus, a genus of coccoid bacteria
Micrococcaceae, by detecting specific nucleic-acid information of the target bacteria. Staphylococci gr
clusters and include several pathologic species such as S. aureus, S. epidermidis, S. saprophyticus; th
aureus because of its ability to cause serious suppurative infections, especially in immunodepressed p
the elderly, through damaged skin or in viral infections of the lungs.

Molecular assay reagents intended to identify Listeria monocytogenes, a bacterium closely resembling
Corynebacteriaceae, by detecting specific genetic information of the nucleic acid of the target bacteri
monocytogenes bacteria are the cause of listeriosis, which may cause in utero infections that can resu
or premature birth; infections acquired during birth can cause cardiorespiratory distress, diarrhea, vom
Infection in adults produces meningitis, endocarditis, and disseminated granulomatous lesions.

Molecular assay reagents intended to identify Pseudomonas aeruginosa, a bacterium of the family Pse
detecting specific genetic information of the nucleic acid of the target bacteria. These bacteria are a m
acquired (i.e., nosocomial) infections, mostly those occurring in the urinary tract and in wounds, espec
immunodepressed or debilitated patients.
Molecular assay reagents intended to identify Escherichia coli, the principal species of the genus Esch
Enterobacteriaceae, by detecting specific genetic information of the nucleic acid of the target bacteria
strain). Escherichia coli bacteria commonly inhabit the large intestine of humans, but pathogenic strai
may cause infections in the urinary tract, conjunctivitis, and septicemia.

Molecular assay reagents intended to identify species of bacterium of the genus Campylobacter, fami
detecting specific genetic information of the nucleic acid of the target bacteria. Some species of Camp
cause diarrhea and acute gastroenteritis; they may also cause proctitis.
Molecular assay reagents intended to identify group A Streptococcus (typically Streptococcus pyogene
coccoid bacterium, by detecting specific nucleic-acid information of the target bacteria. S. pyogenes is
important bacterial pathogens for humans, causing a wide range of suppurative diseases (e.g., pharyn
sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheumatic fever).

Molecular assay reagents intended to identify group B Streptococcus (typically Streptococcus agalacti
coccoid bacterium, by detecting specific nucleic-acid information of the target bacteria. Streptococcus
bacterial pathogen in humans, causing urinary tract and wound infections and otitis media.

Molecular assay reagents intended to identify Streptococcus pneumoniae (also known as pneumococc
of the genus Streptococcus, by detecting specific genetic information of the nucleic acid of the target
bacteria are the most common cause of lobar pneumonia and can also cause other serious diseases (e
septicemia, peritonitis).
Molecular assay reagents intended to identify species of Enterococcus, a genus of spherical-to-ovoid b
family Streptococcaceae, by detecting specific nucleic-acid information of the target bacteria. Some s
Enterococcus genus are part of the common flora of the intestinal tract of humans, but some (e.g., E.
urinary tract infections, endocarditis, and bacteremia.
Molecular assay reagents intended to identify hepatitis viruses by detecting the nucleic acid of the tar
common viruses that cause hepatitis belong to the families Picornaviridae (hepatitis A virus), Hepadna
virus), and Flaviviridae (hepatitis C virus). These viruses may cause hepatitis, a disease characterized
increase of some enzymes in serum (e.g., aspartate aminotransferase).

Molecular assay reagents intended to identify hepatitis B virus, a DNA virus of the genus Hepadnaviru
Hepadnaviridae, by detecting the core of the target virus. Hepatitis B virus may cause hepatitis, a dise
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruse
percutaneously (e.g., via body piercing, tattooing), parenterally, from mother to child at birth, or by in
contact.

Molecular assay reagents intended to identify hepatitis D virus, an unclassified defective RNA virus (d
requires the presence of hepatitis B virus (HBV) for viral replication to occur, by detecting the nucleic
Hepatitis D virus may occur as a simultaneous acute hepatitis infection or may be superimposed upon
Hepatitis is a disease characterized by jaundice and the increase of some enzymes in serum (e.g., asp
aminotransferase).

Molecular assay reagents intended to identify hepatitis E virus, an RNA virus of the genus Calicivirus,
detecting the nucleic acid of the target virus. Hepatitis E virus may cause hepatitis, a disease characte
the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruses are transmit
route or via contaminated food or water and are endemic in some geographic areas. Hepatitis E virus
dangerous for pregnant women.

Molecular assay reagents intended to identify hepatitis G virus, an RNA virus of the family Flaviviridae
nucleic acid of the target virus. Hepatitis G virus may cause both acute and chronic hepatitis, diseases
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruse
parenterally, perinatally, or by intimate (e.g., sexual) contact.

Molecular assay reagents intended to identify viruses of the family Retroviridae by detecting the nucle
virus. The subfamilies of pathogenic retroviruses are Oncovirinae, Spumavirinae, and Lentivirinae; len
of acquired immunodeficiency syndrome (AIDS); oncoviruses are associated with human T-cell lympho
and viruses of the genus Spumaviruses are considered nonpathogenic to humans.

Molecular assay reagents intended to identify human immunodeficiency virus (HIV), a retrovirus of the
family Retroviridae, by detecting the nucleic acid of the target virus. HIV is the etiologic agent of acqu
syndrome (AIDS).
Molecular assay reagents intended to identify human immunodeficiency virus serotype 2 (HIV-2), a ret
Lentivirus, by detecting the nucleic acid of the target virus. HIV-2 is an etiologic agent of acquired imm
syndrome (AIDS).
Molecular assay reagents intended to identify human immunodeficiency virus serotype 1 and/or serot
nucleic acid of the target virus. Human immunodeficiency viruses belong to the genus Lentivirus; thes
etiologic agents of acquired immunodeficiency syndrome (AIDS).
Molecular assay reagents intended to identify human T-cell lymphotropic virus (HTLV; also called huma
leukemia/lymphoma virus) by detecting the nucleic acid of the target virus. HTLV is a tumor-producing
subfamily Oncovirinae, family Retroviridae; it may cause chronic infection, adult leukemia, tropical par
hematological diseases.
Molecular assay reagents intended to identify human T-cell lymphotropic virus, also called human T-ce
virus type I (HTLV-I), by detecting the nucleic acid of the target virus. HTLV-I retrovirus is a tumor-prod
subfamily Oncovirinae; it may cause chronic infection, T-cell leukemia, and tropical paraparesis.

Molecular assay reagents intended to identify human T-cell lymphotropic virus, also called human T-ce
virus type II (HTLV-II), by detecting the nucleic acid of the target virus. HTLV-II retrovirus is a tumor-pro
the subfamily Oncovirinae; it may cause leukemia and other hematological diseases.

Molecular assay reagents intended to identify rubella virus, an RNA virus of the family Togaviridae, by
acid of the target virus. Rubella virus is the cause of an acute, usually benign infection, often affecting
Transplacental infection of the fetus may occur. Called also German measles and, in French and Spanis

Molecular assay reagents intended to identify fungi or yeast by detecting specific nucleic-acid informa
RNA, DNA sequences) of pathogenic fungi including molds and monocellular fungi (yeasts). These test
supplemental information for the diagnosis of mycotic infections and, in some instances, provide the o
diagnosis.
Molecular assay reagents intended to identify Candida albicans, a species of a yeast-like species of im
family Cryptococcaceae, by detecting specific genetic information of nucleic acids of the target microo
are part of the normal flora of the skin, mouth, intestinal tract, and vagina; they can cause superficial
cutaneous areas of the body. The fungi may also infect the blood stream (i.e., deep candidiasis), espec
immunocompromised patients.

Molecular assay reagents intended to identify Coccidioides immitis, a species of imperfect fungi of the
detecting specific nucleic-acid information (e.g., DNA, RNA) of the target microorganism. These fungi m
coccidiomycosis, a mycotic infection of the respiratory tract characterized by allergic manifestations; i
virulent, severe, chronic granulomatous disease involving tissue, viscera, and the central nervous syst
immunocompromised patients.

Molecular assay reagents intended to identify Cryptococcus neoformans, a yeast-like species of imper
Cryptococcaceae, by detecting specific nucleic-acid information (e.g., DNA, RNA) of the target microor
may cause cryptococcosis, a mycotic infection of the brain and meninges, which may also involve oth
skin and lungs. The disease may progress by invading the central nervous system, lungs, liver, and sp
immunocompromised patients.

Molecular assay reagents intended to identify Histoplasma capsulatum, a yeast-like species of imperfe
Moniliaceae, by detecting specific nucleic-acid information (e.g., DNA, RNA) of the target microorganis
capsulatum fungi may cause histoplasmosis, a mycotic influenza-like infection or pneumonia; the dise
invading the lungs, meninges, heart, and peritoneum of immunocompromised patients.

Molecular assay reagents intended to identify Blastomyces dermatitidis, a species of imperfect fungi o
Moniliaceae, by detecting specific genetic information of the nucleic acids of the target microorganism
cause self-limited or localized pulmonary lesions; immunocompromised patients may develop chronica
illnesses affecting the skin or organs (e.g., lungs, genitourinary tract, central nervous system).
Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
patient sample (e.g., fetal cells from amniotic fluid), rather than the normal two (i.e., trisomy). Congen
typically characterized by physical and developmental disorders. The most common congenital trisom
chromosome 21 (i.e., Down syndrome), chromosome 18 (i.e., Edwards' syndrome), and chromosome 1
syndrome); but trisomies may occur in other chromosomes (e.g., 8, 11, 22).

Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
21 in a patient sample (e.g., fetal cells from amniotic fluid), rather than the normal two (i.e., trisomy 2
Down syndrome. Molecular tests for Down syndrome are typically used for prenatal diagnosis in pregn

Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
18 in a patient sample (e.g., fetal cells from amniotic fluid), rather than the normal two (i.e., trisomy 1
Edwards' syndrome. Molecular tests for Edwards' syndrome are typically used for prenatal diagnosis in

Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
13 in a patient sample (e.g., fetal cells from amniotic fluid), rather than the normal two (i.e., trisomy 1
Patau's syndrome. Molecular tests for Patau's syndrome are typically used for prenatal diagnosis in pre

Molecular assay reagents intended for use in identifying the presence of atypical sex chromosomes, s
number of sex chromosomes in a patient sample resulting in abnormalities in sexual differentiation an
physical and/or mental abnormalities. Some common sexual chromosome disorders are Klinefelter and

Molecular assay reagents intended for use in identifying the presence of two or more X chromosomes
one Y chromosome in a male patient sample, rather than the normal XY combination. Variants include
XXXY, XXXXY, and mosaic patterns. These chromosomal aberrations cause Klinefelter syndrome, in wh
males have small testes, may be developmentally disabled, and tend to be tall with long legs.

Molecular assay reagents intended for use in identifying the absence of the second sexual chromosom
sample (i.e., XO rather than the normal XX). Variants may include mosaic combinations such as XO/XX
chromosome aberrations cause Turner syndrome, in which phenotype women are usually sterile with s
pubic hair, webbing of the neck, and sexual infantilism.
Molecular assay reagents intended to identify mutations in the tumor protein p53 (TP53) gene, located
17p13.1, that encodes for a protein that acts as a tumor suppressor and induces cellular apoptosis. Th
mutation has been identified in patients with many types of cancers
Molecular assay reagents intended to identify mutations in the Kirsten (K-ras) oncogene; these mutati
detected in malignancies of the pancreas (up to 95% of patients), colon, and lung.
Molecular assay reagents intended to identify mutations in the neuroblastoma RAS viral (v-ras) oncoge
gene, located at chromosome 1p13.2, which encodes for a membrane-linked protein that moves betw
apparatus and the plasma membrane. The protein is a small GTPase. Mutations at this locus have bee
with juvenile myleomonocytic leukemia (JMML), colorectal cancer, thyroid cancer, and follicular cancer
Molecular assay reagents intended to identify mutations in the rearranged during transfection (RET) g
chromosome 10q11.2, which encodes for a receptor tyrosine kinase that transduces signals for cell gr
differentiation. It is essential for the development of several kinds of nerve cells, kidney development,
These genetic mutations have been identified in patients with several diseases, including multiple end
2 (MEN2), both type II A (MEN 2A, Sipple's syndrome) and type II B (MEN 2B), and Hirschsprung's disea

Molecular assay reagents intended to identify mutations in the v-myc myelocytomatosis viral oncogen
also known as c-Myc) gene, located at chromosome 8q24, which encodes for a multifunctional, nuclea
is involved in cell cycle progression, apoptosis, and cellular transformation. It functions as a transcript
regulates transcription of specific target genes. Mutations at this locus have been identified in patient
tumors, leukemias, and lymphomas, including Burkitt's lymphoma.

Molecular assay reagents intended to identify mutations in the human epidermal growth factor recept
(also known as ERBB2), located at chromosome 17q11.2-q12, which encodes for growth factor recepto
locus have been identified in patients with breast cancer; they are also associated with other cancer t
primary lung tumors and non-small cell lung cancer (adenocarcinomas) and gastric, ovarian, brain, an

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
These translocations usually involve the MYC oncogene on chromosome 8 and the immunoglobulin loc
This translocation is present in most patients with Burkitt's cell leukemia or Burkitt's lymphoma. Its de
a tumor marker.
Molecular assay reagents intended for use in identifying stable and irreversible exchanges (i.e., transl
chromosomes 4 and 11. The translocation is found in most children with T-cell acute lymphoblastic leu
may be used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
This translocation typically leads to an apparent deregulation of FGFR3 and WHSC1/MMSET genes. Thi
typically found in patients with congenital fibrosarcoma, plasma cell leukemia, or multiple myeloma. It
used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
The translocation is most frequently found in children with acute lymphoblastic leukemia. Its detection
tumor marker.
Reagents used in cytologic diagnostic procedures as a specific medium capable of supporting the cult
amniotic fluid, and/or chorionic villi cells for fragile X chromosome evaluation. Disorders in the long ar
cause fragile X syndrome, a disease characterized by mental retardation, enlarged testes, high forehe
in males, and mild mental retardation in females

Reagents for use in staining during cytologic and/or histologic procedures and are available as powder
prepared adding water and/or other liquid additives in a preestablished quantity before use.
Reagents available as ready-to-use solutions (e.g., aqueous, alcoholic) for use in staining during cytolo
procedures.
Reagents available as ready-to-use solutions (e.g., hematoxylin) for use in staining gynecologic (e.g. v
gynecologic (e.g., prostatic) exfoliated cells using the Papanicolaou technique, allowing examination o
cytoplasmic components.
Immunoassay reagents that include antibodies specific for one antigen or antigenic epitope (i.e., mon
are usually the result of a single clone or plasma cell line and are typically produced as the secretion o
by the fusion of lymphocytes and tumor cells (i.e., hybridomas) in a laboratory culture. Monovalent an
used in cell typing.
Immunoassay reagents that include antibodies specific for two or more antigens or antigenic epitopes
antisera). They are usually the result of the response of an animal host to immunogen administration.
frequently used in immunoassays in the clinical laboratory, particularly in the determination of plasma
concentrations.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory, and that are established as a norm with which simila
cytology and/or histology assays are compared (i.e., standardized).
Immunoassay reagents used in immunologic tests to determine class I human leukocyte antigens, a g
proteins coded in three different locations (loci) named A, B, and C of the major histocompatibility com
These tests are mostly used to match donor and recipient tissues before transplants (e.g., kidney, bon

Immunoassay reagents used in immunologic tests to determine class II human leukocyte antigens, a g
proteins of the D region coded in three different locations (loci) named DR, DQ, and DP of the major hi
complex class II genes. These tests are mostly used to match donor and recipient tissues before trans
bone marrow).
Immunoassay reagents used in immunologic tests to determine antibodies to either class I, class II, or
human leukocyte antigens (HLA), a group of cell surface proteins that regulate the immune response a
white blood cells and in all nucleated cells of the body. These tests may be used in conjunction with H
matching donor and recipient tissues before transplants (e.g., kidney, bone marrow).

Immunology reagents including monoclonal antibodies that are used in immunologic tests which contr
monocytes, a type of cell of the mononuclear phagocyte system of bone marrow origin, by identifying
CD13, CD14, CD33). Monocytes migrate from the blood into various tissues and transform in macroph
antigens of both types of cells are usually similar. These tests are used to differentiate among a hetero
neoplasms.

Immunology reagents including monoclonal antibodies that are used in immunologic tests which contr
macrophages, a type of cell of the mononuclear phagocyte system of bone marrow origin, by identifyi
CD13, CD14, CD15, CD33). Macrophages are the result of the migration of the monocytes from the blo
tissues, thus the antigens of both types of cells are similar. These tests are used to differentiate amon
group of neoplasm.

Immunology reagents including monoclonal antibodies that contribute to typing lymphocytes capable
without prior exposure to them (natural killer cells). They identify the presence of some antigens (e.g.
lack of other antigens on their surface, particularly CD3, CD4, and CD8. These tests are used to differe
heterogeneous group of neoplasms having phenotypes resembling NK cells from other lymphomas.

Immunology reagents including monoclonal antibodies that are used in tests for differentiation of leuk
cells, usually by identifying the leukocyte common antigen (CD45) that is present in all leukocytes.

Reagents used in immunologic immunoassays as a liquid medium with appropriate components, addit
cell separation. These media facilitate the classification of cells in different groups (i.e., cell typing).
Reagents used in immunologic immunoassays as a liquid medium that includes components and add
separation and differentiation of groups of mononuclear cells (e.g., lymphocytes, monocytes) from wh

Reagents used in immunologic immunoassays as a liquid medium that includes components and add
separation and differentiation of groups of mononuclear cells (e.g., lymphocytes, monocytes) from wh

Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests of a sam
(typically serum) to determine messenger proteins (i.e., cytokines) produced by the cells that regulate
duration of the immune response. These regulator proteins are named lymphokines when produced b
groups of cytokines are the interleukins; the interferons, which play an important role in the enhancem
response; and tumor necrosis factors, which have cytotoxic activity against tumor and virally infected
determination reagents are frequently available in kits.

Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests of a sam
(typically serum) to determine one or more of a group of cytokines known as interleukins (literally "be
named IL-1, IL-2). At least 15 interleukins have been identified. Interleukins are produced by hematop
primarily on leukocytes; many of them are related to inflammatory responses and/or to lymphocyte gr
differentiation.

Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests of a sam
(typically serum) to determine one or more of a family of substances (interleukin receptors, abbreviat
more of the interleukins. ILR's are involved with the activation of the immunologic response.

Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests on a bo


serum) to determine the presence of one or more low-molecular-weight cytokines known as interferon
interfere with viral replication). Interferons are grouped into three classes: alpha, beta, and gamma, a
source and function.
Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests of a sam
(typically serum) to determine either one of two different cytokines known as tumor necrosis factors (
They conduct cytotoxic activity against tumors and virally infected cells. TNF alpha is secreted by mac
beta is produced by both CD4 and CD9 lymphocytes.
Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests of a sam
(typically serum) to determine one or more of a family of substances (tumor necrosis factor receptors,
that bind one or more of the cytokine tumor necrosis factors and other clinically significative ligands.
apoptosis, cell proliferation, or both.
Immunoassay reagents intended to perform qualitative and/or quantitative immunologic tests of a sam
(typically serum) to determine one or more of a group of cytokines known as colony stimulating factor
mostly derived from lymphocytes or stromal cells. CSF cytokines stimulate hematopoiesis.

Molecular assay reagents used in laboratory analysis of the cellular and humoral immune function (i.e
immunology). They can determine substances that constitute a challenge for the human body (i.e., a
result of the response of the body to such substances (i.e., antibodies). These reagents are used in m
tests to characterize tissues (i.e., tissue typing), frequently to match donor and recipient in transplant
Molecular assay reagents used in immunological tests to determine human leukocyte antigens (HLAs)
surface proteins that regulate the immune response found on the white blood cells and on all other nu
tests are mostly used to match donor and recipient tissues before transplants (e.g., kidney, bone marr

Molecular assay reagents used in immunological tests to determine class I human leukocyte antigens,
proteins coded in three different locations (loci), named A, B, and C, of the major histocompatibility co
These tests are mostly used to match donor and recipient tissues before transplants (e.g., kidney, bon

Molecular assay reagents used in immunological tests to determine one or more of the slightly differe
surface proteins coded in the locus A of the class I genes of the major histocompatibility complex. The
used to match donor and recipient tissues before transplants (e.g., kidney, bone marrow).

Molecular assay reagents used in immunological tests to determine one or more of the slightly differe
surface proteins coded in the locus B of the class I genes of the major histocompatibility complex. The
used to match donor and recipient tissues before transplants (e.g., kidney, bone marrow). Several alle
associated with immune diseases.
Molecular assay reagents used in immunological tests to determine the allele B27 coded in the locus B
the major histocompatibility complex. The presence of the allele B27 is strongly associated to ankylos
inflammatory disease of the vertebral column.
Molecular assay reagents used in immunological tests to determine one or more of the slightly differe
surface proteins coded in the locus C of the class I genes of the major histocompatibility complex. The
used to match donor and recipient tissues before transplants (e.g., kidney, bone marrow).

Molecular assay reagents used in immunological tests to determine class II human leukocyte antigens
surface proteins of the D region coded in three different loci, named DR, DQ, and DP, of the major hist
class II genes. These tests are mostly used to match donor and recipient tissues before transplants (e.
marrow).
Molecular assay reagents used in immunological tests to determine one or more of the alleles of the c
coded in the locus DR of the class II genes of the major histocompatibility complex. These tests are m
donor and recipient tissues before transplants (e.g., kidney, bone marrow). Several alleles (e.g., DR3,
with immune diseases.
Molecular assay reagents used in immunological tests to determine one or more of the alleles of the c
coded in the locus DQ of the class II genes of the major histocompatibility complex. These tests are m
donor and recipient tissues before transplants (e.g., kidney, medulla). Several alleles (e.g., DQ7) are a
diseases.
Molecular assay reagents used in immunological tests to determine one or more of the alleles of the c
(alleles) coded in the locus DP of the class II genes of the major histocompatibility complex. These tes
match donor and recipient tissues before transplants (e.g., kidney, medulla).
Molecular assay reagents consisting of a known fragment of nucleic acid, typically labeled with a tag.
classified according to their chemical structure as DNA or RNA probes, strandedness as double- or sin
ss, respectively), and origin as cloned (recombinant), genomic, or synthesized (oligonucleotides). Prob
radioactively or nonradioactively (both enzymatic and nonenzymatic) labeled. Nucleic acid probes are
information about the genetic characteristics of a sample; these procedures are generically known as
and include hybridization assays, amplification methods (e.g., polymerase chain reaction), and electr
Reagents used in electrophoresis assays to carry the applied current and to prevent marked changes i
process is carried out. They determine the kind of electrical charge on the solute and the extent of its
frequently used buffers in electrophoresis are the barbital and Tris-boric-EDTA buffers.

Reagents used in electrophoresis for artificial coloration of the separate fractions, permitting their visu
Stains used in electrophoresis are frequently chosen according to the application (e.g., naphthol blue
for proteins).
Reagents used in electrophoresis as porous supporting media for the migration of the charged particle
agarose gel films, cellulose acetate sheets, and cellulose paper.
Supporting media consisting of gels (e.g., agarose gel) that are used in electrophoresis for supporting
charged particles.
Reagents available as home-test kits that permit the determination of high-density lipoprotein cholest
sample of whole blood. HDL-C determination kits for home use permit patients to check the level of H
blood.
Reagents available as home-test kits that permit the determination of fructosamine, a generic name f
ketoamines, in a sample of whole blood. Fructosamine determination kits for home use permit patient
integrated values for glucose over a period of several weeks, free from daily fluctuations of glucose le
additional criteria for glucose control.
Reagents available as home-test kits that permit the determination of triglycerides, the major lipid fra
in a sample of whole blood. Triglycerides determination kits for home use permit patients to check and
triglycerides in their blood.
Reagents available as home-test kits that permit the determination of several analytes (e.g., glucose a
sample of whole blood. Multianalyte determination kits for home use permit patients to simultaneousl
several blood analytes.
Reagents available as home-test kits that permit the determination of bilirubin in a sample of urine. B
kits for home use permit patients to check the level of bilirubin during illness and/or medical treatmen
disorders).
Reagents available as home-test kits that permit the determination of chlorides in a sample of urine. C
kits for home use permit patients to check and/or control the level of chloride during illness (e.g., adre
medical treatments (e.g., diets).
Reagents available as home-test kits that permit the determination of creatinine in a sample of urine.
determination kits for home use permit patients to check and/or control on a routine basis the level of
urine, frequently during clinical treatment.
Reagents available as home-test kits that permit the determination of glucose in a sample of urine. Gl
kits for home use provide diabetic patients and/or care providers with a semiquantitative method to c
Glucose tests using urine samples are less accurate than tests using whole blood samples.

Reagents available as home-test kits that permit the determination of ketones in a sample of urine. Ke
kits for home use permit patients to check the level of ketones in their urine. Ketones tests using urine
accurate than tests using whole blood samples.
Reagents available as home-test kits that permit the determination of nitrates in a sample of urine. Ni
kits for home use permit patients to check the levels of nitrates in their urine. They are used during so
treatments.
Reagents available as home-test kits that permit the determination of occult blood (i.e., blood that can
the naked eyes) in a sample of urine. Occult blood determination kits for home use are used to check
intact erythrocytes (hematuria) and/or free hemoglobin (hemoglobinuria).
Reagents available as home-test kits that permit the determination of the chemical potential of the hy
sample of urine. Home-test kits for the determination of pH permit patients to check the pH during illn
acidosis or alkalosis) and/or during medical treatments.
Reagents available as home-test kits that permit the determination of proteins in a sample of urine. Pr
kits for home use permit patients to check the level of proteins in urine during several illnesses (e.g.,
pyelonephritis) or after exposure to toxic agents (e.g., cadmium).
Reagents available as home-test kits that permit the determination of urobilinogen in a sample of urin
determination kits for home use permit patients to check the level of urobilinogen (a marker of biliary
during hepatic illness, medical treatments for liver diseases, or after exposure to toxic agents.

Reagents available as home-test kits that permit the determination of catalase in a sample of urine. C
kits for home use permit patients to check the level of catalase in urine, an indicator of the presence o
may provide patients with an early detection of urinary tract infection .
Clinical chemistry reagents intended for semiquantitative determination of ketones in in a sample of
period of time, typically several minutes (i.e., rapid tests). Increased blood concentration of ketones (k
associated with diabetes mellitus, alcohol comsumption, frequent vomiting, and/or starvation. Semi-q
determination of ketones in blood is more accurate than their determination in urine.

Reagents available as home-test kits that permit the determination of occult blood (i.e., blood that can
the naked eyes) in a sample of feces. Occult blood determination kits for home use are used to check
gastrointestinal tract and are particularly used for early detection of colon cancer.

Cell/tissue culture media, including blood serum (e.g., from fetal bovine origin) and supplements capa
cellular survival and growth, and that are appropriate for virus propagation. These cultures are mostly
identification of viruses because a virus cannot replicate apart from living cells.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a serum or pla
determine Troponin I, the circulating inhibiting subunit of cardiac troponin (cTnI) that prevents actin-m
is a complex of globular muscle proteins that inhibits contraction by blocking the interaction of actin a
bound to tropomyosin. The level of liberated cTnI is a highly specific marker of the occurrence of ische
the result of myocardial infarction)

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood or urine) to determine in a short period of time, typically several minutes, one or more of the gr
(either steroid or protein hormones) that are related to the detection, evaluation, and monitoring of hu

Hematology reagents used in screening tests to determine the time required to form a fibrin clot whe
partial thromboplastin, and an activator (to ensure maximal activation of factor XII) are added to a sam
assay is a measure of possible factor deficiencies of the intrinsic and a common pathway of coagulatio
monitor heparin therapy.
Hematology reagents used in screening tests to determine the time required to form a fibrin clot when
added to a thromboplastin-calcium mixture. Prothrombin time (PT) and the derived international norm
measures of possible factor deficiencies of the extrinsic pathway of coagulation; the reagents are used
the clotting tendency of blood, vitamin K status, and to regulate warfarin dose.

Computer aided detection systems designed to detect and classify areas in mammograms with abnor
indicative of breast cancer, such as micro calcifications, spiculated lesions, and other abnormal masse
digitize film mammograms or use digital images from fully digital mammographic systems. These sys
of a film digitizer or a means to import digital information, a computer capable of using appropriate al
display/and or printer that provides an image that shows the detected abnormalities in the mammogr

Clinical chemistry reagents impregnated in one or more areas of a paper strip (i.e., a reagent strip) th
urine samples and present results in a short period of time, typically a few minutes. The tests are usua
determine pH and/or one of the constituents in a urine sample, such as glucose, ketone bodies, occult
urobilinogen.
Immunoassay reagents to determine a group of glycoproteins normally found in serum that are synthe
by plasma cells (immunoglobulins [Ig]); these reagents include antigens with the capability of binding
immunoglobulins. Immunoglobulins are classified in five general classes designated as IgG, IgM, IgA, I
all immunoglobulins are present in serum (IgE that is found normally only in trace amounts). Increased
are associated with immune responses and infections. Low levels of Ig in serum are typically found in
diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
albumin, the most abundant protein in human plasma. Albumin stores and transports various ligands
aldosterone), maintains oncotic pressure, and serves as a source of endogenous amino acids. Increase
(hyperalbuminemia) are of little diagnostic value except in dehydration, while decreased levels (hypoa
found in many diseases related to liver function, tissue damage, and/or protein loss in urine and/or fec
burns, neoplasms, or kidney diseases

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine one or more of a group of lipid-protein complexes (micellar structures) in which lipids are
blood. Lipoproteins usually include an outer monolayer of protein (apolipoprotein) surrounding polar li
and cholesterol).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine apolipoprotein A-I, a component of a group of lipid-protein complexes in which HDLs are
blood. Apolipoproteins A-I and A-II are nearly 90% of the high-density lipid protein complexes in plasm
I level is typically three times the level of apolipoprotein A-II. Levels of apolipoproteins in plasma are a
atherosclerosis and risk of coronary artery diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to detect and identify proteins released from the myocardial tissue into the plasma (i.e., card
and level of proteins (typically enzymes) are used in the diagnosis of the occurrence and extent of hea
the result of ischemia/myocardial infarction.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine alkaline phosphatase (AP), an enzyme secreted by neoplastic tumor cells (i.e., a tumor mar
biliary tract. High levels of AP are found in primary or secondary liver cancer. They are correlated to th
bone metastasis (e.g., prostatic cancer with bone metastasis).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine human chorionic gonadotropin (hCG), a hormone normally secreted by the placenta, as a tu
highest levels of hCG are caused by trophoblastic tumors; high levels of hCG are also found in germ ce
nonseminomatous testicular carcinoma). The levels of hCG are mostly useful in monitoring the progre
tumors; its presence in cerebrospinal fluid may indicate brain metastasis. Elevated levels of hCG are n
pregnancy.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine metabolites of hormones secreted by neoplastic tumor cells (i.e., tumor markers), either
excess production by the endocrine tissue that normally produces the hormone or produced by nonen
normally do not produce the hormone.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine immunoglobulin (Ig) molecules with identical structures as a product of a single clone of
monoclonal immunoglobulins, also called paraproteins). They may be polymers, monomers, or fragme
molecules. The presence of monoclonal immunoglobulins in serum is used to diagnose some maligna
multiple myeloma or plasmacytoma; high levels of them are also found in patients with lymphomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analysis on a body fluid sa
but also urine) to determine light chain (either kappa or lambda) fragments of monoclonal immunoglo
light chain Ig in serum is used to diagnose some malignant neoplasms such as multiple myeloma, pla
amyloid disease.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses in tissue prepara
presence of a cellular regulatory protein that binds progesterone hormones (i.e., cytoplasmic progeste
receptors are especially found in progesterone-sensitive tissues (e.g., breast, uterus, pituitary gland).
performed in surgically removed samples; determination of the level of progesterone receptors is used
the response to endocrine therapy (i.e., it is a marker) in diseases such as breast cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood) to determine the level of glycated hemoglobin, a result of an irreversible nonenzymatic additio
to hemoglobin. The level of glycated hemoglobin in blood is a measure of the integrated values for glu
several weeks, free from daily fluctuations of glucose level, providing additional information about glu
hemoglobin tests are not used for the general diagnosis of diabetes mellitus. Liquid chromatography
widely used for determination of glycated hemoglobin than immunoassays.

Hematology reagents used in manual procedures to count the number of red blood cells (RBCs or eryt
cells (WBCs or leucocytes), and platelets per unit volume in a sample of venous blood.

Hematology reagents used in manual procedures to count the number of immature red blood cells con
cytoplasmic ribonucleic acid and organelles (i.e., reticulocytes).
Hematology reagents used in automated analyzers to count the number of immature red blood cells c
cytoplasmic ribonucleic acid and organelles (i.e., reticulocytes).
Hematology reagents used to maintain blood samples in appropriate conditions (e.g., avoiding clotting
from blood drawing to laboratory analysis, including transport if necessary.
Hematology reagents used to prevent clotting of blood samples for laboratory analysis by inhibiting b
also maintain cell viability. Most of these anticoagulants act by making calcium unavailable for the clo
include citrates, oxalates, and ethylene-diamine-tetraacetic-acid (EDTA). Heparin is also used for this p
clotting by inactivating thrombin and/or other coagulation factors. Anticoagulants are frequently avail
internal coating.

Hematology reagents (e.g., heparin, citrate) packaged in blood collection tubes; these reagents are de
prevent clotting of the blood samples that have been obtained for laboratory analysis.
Hematology reagents used in the determination of enzymes that enter in serum or plasma from the ce
consequence either of cell membrane deterioration and possible death or to altered rates of enzyme p
increase of the level of enzymes may reflect cellular damage due to chemicals and drugs, physical ag
mechanisms, genetic defects, or nutritional disorders.
Hematology reagents used in screening tests to determine the time required for thrombin to convert
insoluble fibrin clot. Fibrin formation is triggered by the addition of thrombin to the specimen, therefor
in the coagulation cascade. This test does not measure deficiencies in the intrinsic or extrinsic pathwa
test is only intended to qualitatively measure the level of fibrinogen and/or circulating anticoagulants
plasmin).

Hematology reagents used to determine the time required for thrombin to convert fibrinogen to an in
fibrin formation is triggered by the addition of reptilase (a snake venom enzyme) to the specimen, th
steps in the coagulation cascade. This test does not measure deficiencies in the intrinsic or extrinsic p
coagulation; the test is only intended to measure levels of fibrinogen. The reptilase time is not affecte
slightly affected by fibrinogen degradation products.

Hematology reagents used to determine the time required for thrombin to convert fibrinogen to an ins
fibrin formation is triggered by the addition of ecarin (a snake venom) to the specimen. This test does
deficiencies in the intrinsic or extrinsic pathways of coagulation; the test is only intended to measure
recombinant hirudin (lepirudin), a direct thrombin inhibitor anticoagulant that is frequently used in car
general antithrombotic agent.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine prothrombin (i.e., coagulation factor II), a plasma protein that is the precursor of thrombi
in the common pathway of coagulation. Two-stage assays for prothrombin and prothrombin consumpt
accurate and specific tests, but are elaborate and time consuming. Deficiency of this factor is associat
hypoprothrombinemia.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine thrombin, the result of the calcium-dependent activation of prothrombin. Thrombin is ca
coagulation factor II (factor IIa).
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine proaccelerin (coagulation factor V), a plasma protein that is involved in the activation of
common pathway of coagulation. Hereditary deficiency of factor V is associated with a rare hemorrhag
Owren's disease.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine proconvertin (coagulation factor VII), a proenzyme that functions together with thrombop
extrinsic pathway of coagulation. Hereditary or acquired deficiency of factor VII is associated with hem
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine the activated form of factor VII (i.e., factor VIIa), the result of an enzymatic cleavage of a
VII with the formation of a two-chain protease.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine coagulation factor X, a proenzyme essential for the formation of prothrombinase in the c
coagulation. Hereditary deficiency of factor X is associated with systemic coagulation disorders.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine coagulation factor XI, a proenzyme essential in the intrinsic pathway of coagulation. Defi
associated with a systemic blood-clotting defect called Hemophilia C or Rosenthal's syndrome.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine coagulation factor XII, a proenzyme important in the intrinsic pathway of coagulation. D
is associated with prolonged in vitro clotting, but not likely with clinical disorders.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine the activated form of coagulation factor XII (i.e., factor XIIa) as the result of a calcium-de
under physiologic conditions.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine coagulation factor XIII, a proenzyme that polymerizes fibrin monometers, enabling it to f
XIII is involved in the common pathway of coagulation.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine the activated form of coagulation factor XIII (i.e., factor XIIIa) as the result of the combin
and calcium in the final stage of the clotting cascade.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine the coagulation factor known as high- molecular-weight kininogen (HMWK, estimated mo
110,000). The predominant version of kininogen in blood has lower molecular weight and is probably n
coagulation.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine a protein required for normal platelet adhesion that is aberrant or deficient in a disorder
Willebrand's disease. It is involved in the intrinsic pathway of coagulation. This protein forms with the
the so-called factor VIII von Willebrand complex.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine both of two similar forms of the proenzyme prekallikrein (pre-K) present in plasma that a
intrinsic pathway of coagulation.
Hematology reagents used for determination of acquired plasma circulating antibodies specific to the
These antibodies directly inhibit coagulation factor activity. Coagulation factor VIII antibodies are foun
severely affected with hemophilia type A; they are also associated with inflammatory diseases (e.g., r
elderly persons, and drug reactions.
Hematology reagents used for determination of acquired plasma circulating antibodies specific to coa
these antibodies directly inhibit coagulation factor activity. Coagulation factor IX antibodies are mostly
hemophilia type B and rarely in previously normal persons.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine one or both of the antigens to the subunits of the coagulation factor XIII. The subunits a
(subunit S is also known as subunit B); the level of the factor XIII subunit A antigen is associated to the
vascular disease and Crohn's disease.
Hematology reagents used for qualitative and/or quantitative determination in plasma of heparin, a m
that acts as a potent anticoagulant by enhancing the activity of antithrombin III and from inhibition of
anticoagulant factors. Heparin is released by the mast cells and by basophils of the blood and presen
Heparin is frequently used as a therapeutic drug to prevent thrombosis; heparin therapy is frequently
partial thromboplastin time tests.

Hematology reagents used for qualitative and/or quantitative determination in plasma of heparin cofa
plasma antiprotease that resembles antithrombin III (AT-III). HCF-II inactivates thrombin and several ot
including factor IXa, but, unlike AT-III, is only a weak inhibitor of factor Xa.
Hematology reagents used for qualitative and/or quantitative determination in plasma of hirudin and/
a potent anticoagulant that acts as direct thrombin inhibitor; hirudin has the same active principle as
secretion of leeches. Hirudin is used as a therapeutic drug to prevent thrombosis .

Hematology reagents used for qualitative and/or quantitative determination in plasma of platelet fact
platelet-specific protein that is usually released simultaneously with thromboglobulin. Platelet factor 4
increased levels in blood may indicate the occurrence of thrombosis (i.e., it is considered a thrombop

Hematology reagents used for qualitative and/or quantitative determination in plasma of prostacyclin,
synthesized by the vascular endothelial cells. Prostacyclin is a powerful vasodilator and inhibitor of pla
increased levels in blood may indicate the occurrence of thrombosis (i.e., it is considered a thrombop
Prostacyclin is also used as a therapeutic drug.
Hematology reagents used for qualitative and/or quantitative determination in plasma of thromboxane
product of the enzymatic conversion in platelets of prostaglandin G2, is a powerful vasoconstrictor an
aggregation; it is very unstable undergoing nonenzymatic hydrolysis to thromboxane B2, which is inac
of thromboxane in blood may indicate the occurrence of thrombosis (i.e., it is considered a thromboph

Hematology reagents used for qualitative and/or quantitative determination in plasma of thromboglob
protein that is usually released simultaneously with platelet factor 4. Beta-thromboglobulin binds and
and blocks the release of prostacyclin; increased levels in blood may indicate the occurrence of throm
considered a thrombophilia marker).
Hematology reagents intended to perform qualitative and/or quantitative analyses of a sample of bod
plasma) to determine the resistance to activated protein C (APC), usually defined as a low normalized
(e.g., lower than 0.84 in functional testing). The most frequent cause by far of activated protein C resi
presence of a mutated coagulation factor V (known as factor V Leiden) that is resistant to degradation
C. APCR is a major risk factor for venous thrombosis and the most common known genetic cause of th
may also occur in some diseases (e.g., cancer, diabetes, AIDS) and temporarily during pregnancy.
Hematology reagents intended to perform qualitative and/or quantitative analyses of a sample of bod
blood) to determine one of the substances that are present before thrombin is biologically available in
levels of these substances are used as molecular markers of thrombosis; they are present in disorder
thrombosis, disseminated intravascular coagulation, and pulmonary emboli. Thrombosis markers can
for early diagnosis and management of coagulation disorders.

Hematology reagents intended to perform qualitative and/or quantitative analyses on a sample of bod
blood) to determine fibrinopeptide A, a product of the conversion of fibrinogen to fibrin monometer in
coagulation. Increased levels of fibrinopeptide A are used as markers of thrombosis; they provide spec
diagnosis and management of coagulation disorders.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
determine the prothrombin fragment 1+2, a small inactive peptide resulting from the conversion of pr
Increased levels of prothrombin fragment 1+2 are used as a marker of thrombosis, in particular, disse
coagulation.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
determine the thrombin-antithrombin III complex, a bimolecular complex that is cleared rapidly from c
hepatic cells. Increased levels of this complex are used as a marker of thrombosis

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
determine fibrin monometer, a product of fibrinogen in the process of coagulation. Fibrin monometer i
venous thromboembolism; it is used to rule out deep venous thrombosis and pulmonary embolism on

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine plasmin, a proteolytic enzyme that is one of the components of the fibrinolytic enzyme s
that has strong affinity for fibrin. Plasmin levels are increased in several diseases, including fibrinogen
diseases; congenital abnormalities are rare.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine plasmin inhibitors, a group of serine protease inhibitors (serpins) that include alpha2-an
macroglobulin. Plasmin inhibitors limit the action of plasmin to the area of fibrin deposition, avoiding t
fibrinogen in blood.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
to determine plasmin-alpha2-antiplasmin, a complex that results from the binding of the alpha2 plasm
lysine binding site on plasmin. The level of these complexes in blood is associated with the activation
system.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
tissue-type plasminogen activators, a type of plasminogen activator that likely originates in the endo
in normal plasma, but only in trace amounts. Tissue-type plasminogen activators are present in signifi
the vascular endothelium, small veins, and the renal vasculature; they are also present in urine, tears

Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
urokinase, a plasminogen activator. Urokinase is present in urine and in many tissues, including the va
and renal cells; it is present in normal plasma in trace amounts.
Hematology reagents intended to perform qualitative and/or quantitative analyses on a body fluid sam
plasminogen activator inhibitor 1 (PAI-1), a member of the family of serine protease inhibitors (serpins
activity of urokinase and tissue plasminogen activators; it can be isolated from vascular endothelium,
tissues.
Hematology reagents consisting of samples with known values either of normal or abnormal (e.g. defi
these reagents usually include other appropriate substances (e.g., buffers and stabilizers); they are us
in hematology assays of whole blood.
Hematology reagents consisting of samples of plasma with known values of hemoglobin and usually in
appropriate substances (e.g., buffers and stabilizers). They are used for quality control in hematology
determination of hemoglobin.
Hematology reagents consisting of plasma pooled from normal donors (i.e., with approximately norma
constituents) and including other appropriate substances (e.g., buffers, stabilizers); these reagents are
control in blood coagulation testing. Some plasma control reagents may include above or below norma
specific metabolites (i.e., abnormal plasma controls)
Hematology reagents consisting of a substance intended to establish points of reference (i.e., calibrat
assays of whole blood.
Hematology reagents consisting of a substance intended to establish points of reference (i.e., calibrat
determination of hemoglobin.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm with which simila
hematology assays of whole blood are compared (i.e., standardized).
Hematology reagents consisting of samples of human plasma with known values of hemoglobin and u
appropriate substances (e.g., buffers and stabilizers); they are established as a norm with which simila
hematology assays for determination of hemoglobin are compared (i.e., standardized)

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm with which simila
blood coagulation testing are compared (i.e., standardized).
Hematology reagents consisting of plasma pooled from normal donors (i.e., with approximately norma
constituents) and other appropriate substances (e.g., buffers, stabilizers) that are established as a nor
used in blood coagulation testing is compared (i.e., standardized). Plasma coagulation standard reage
assayed and matched to international standards.
Reagents used to resist changes in the concentration of substances during analyses performed to dete
morphology of the blood, its components, and blood-forming tissues, usually keeping the pH of the so
possible.
Reagents used to resist changes in the concentration of substances during analyses performed to dete
coagulation, usually keeping the pH of the solution as constant as possible.
Hematology reagents designed to perform tests in a short period of time, typically several minutes. Th
mostly in coagulation tests performed at the point of care, operating rooms, or, less frequently, at hom
providers.
Immunohematology reagents used in ABO blood grouping that consist of known anti-A and/or anti-B s
person of an unknown group are reacted with known sera. Cells agglutinated only with anti-A serum a
agglutinating only with anti-B serum are group B, and those agglutinating with both antiserum are AB
agglutinate with either antiserum are group O. Monoclonal antibodies of human or mouse origin are fr
grouping. These sera may be used either in manual or automated tests.

Immunohematology reagents used in ABO blood grouping that consist of red blood cells of known A an
from a person of an unknown group is reacted with red cells of known A and B reactivity. Cells with A a
agglutinated by serum of group B persons and cells with B antigens are agglutinated by serum of grou
serum of group AB persons fails to agglutinate both A and B cells. Serum of type O agglutinates both
cells may be used either in manual or automated tests as reversed (confirmatory) tests.

Immunohematology reagents used to characterize human blood according to the presence of the D a
antigen (also called Rh1) of the Rhesus group. D antigen is highly immunogenic and is the only Rh ant
routine transfusion practice; red blood cells that possess this antigen are frequently termed Rh positiv
be polyclonal, monoclonal, or a blend of each.
Immunohematology reagents available as a two-vial set (i.e., two-cell test) that are used for detection
red cell antigens. These reagents are group O red blood cells, either from a single source when used in
from pooled sources when used in donor testing. Red blood cells used for screening must express the
with the most clinically relevant antibodies, such as those related to the Rh (e.g., C, D, E), Kell, Duffy,

Immunohematology reagents available as a three-vial set (i.e., three-cell test) that are used for detect
red cell antigens. These reagents are group O red blood cells, either from a single source when used in
from pooled sources when used in donor testing. Red blood cells used for screening must express the
with the most clinically relevant antibodies, such as those related to the Rh (e.g., C, D, E), Kell, Duffy,

Immunohematology reagents including antiglobulin serum (i.e., monospecific antihuman serum) that
immunoglobulin G (IgG) specific alloantibodies bound to the red blood cells being tested. Monospecific
mostly obtained through hybridoma technology. Tests performed with monospecific reagents avoid in
antibodies that are not usually of clinical significance (e.g., cold reactive antibodies).

Immunohematology reagents including antiglobulin serum with both antihuman immunoglobulin G an


activity (i.e., polyspecific antihuman serum). Polyspecific antiglobulin serum is obtained either by the
with human globulin or through hybridoma technology. These reagents, unlike monospecific antiglobu
may detect antibodies that bind complements to the red blood cells being tested.

Reagents that consist of substances that facilitate the antigen antibody reactions (i.e., enhancement m
antibody detection and identification immunohematologic assays. These reagents may potentiate the
point) reactions, shorten the period of incubation, and/or change the electric charge of the red cells. E
include low ionic strength saline (LISS) media, polyethylene glycol (PEG), and several proteolytic enz

Reagents that consist of low ionic strength saline (LISS) solutions that iare used as enhancing media in
reactions that occur in immunohematologic alloantibody detection assays. LISS solutions increase the
association when volume proportions are correct.
Reagents that consist of polyethylene glycol (PEG), a water-soluble linear polymer that is used as enh
antigen-antibody reactions that occur in alloantibody detection assays. PEG solutions remove water, t
around the red blood cell and thereby concentrating antibody, promoting antibody uptake, and enhan

Immunohematology reagents that consist of proteolytic enzymes that act as enhancing media in antig
that occur in alloantibody detection assays. These enzymes typically act by removing sialic acid from
thus diminishing its negative charge. Enhancement media enzymes include trypsin, papain, ficin, and

Reagents consisting of a substance intended to establish points of reference (i.e., calibrate) in immun
performed for blood grouping (typing), antibody detection and identification, and/or compatibility test

Reagents consisting of substances of known composition. The value of which is established by an ana
different from that used in the clinical laboratory and that are established as a norm (I.e., standardized
similar reagents used in immunohematology assays performed for blood grouping (typing), antibody d
immunohematology analyses.
Immunoassay reagents intended to perform qualitative and/or quantitative analysis on a body fluid sa
to determine subdivisions (i.e., subclasses) of immunoglobulin A (IgA), based on structural and antige
heavy chains. Two subclasses of IgA are currently determined, denoted by numerical subindexes as Ig

Immunoassay reagents intended to perform qualitative and/or quantitative analysis on a body fluid sa
to determine subgroups (subclasses) of immunoglobulin G (IgG), based on structural and antigenic diff
chains. Five subclasses of IgG are currently determined, denoted by numerical subindexes from IgG1 t

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the q fragment of the C1 protein (C1q) found in the classic pathway of the complement c
found in blood and other body fluids. C1q binds to IgG or IgM and initiates the classic pathway of com
C1q level determination is used in diagnosis of immunocomplex diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma is possible) to detect and/or measure levels of alpha-2-globulin, an esterase inhibitor of the C
classic pathway of the complement components proteins. The absence of this inhibitor is associated w
disease (i.e., angioedema) that causes localized subcutaneous and visceral edema.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the C3 protein and its activation product fragment c (i.e., C3c). C3 is found in both the a
classic pathway of the complement components proteins. Determination of the levels of C3 and/orC3c
diseases such as lupus erythematosus, shunt nephritis, and Gram-positive bacteremia; C3-deficient in
recurrent bacterial infections and manifest immune complex diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the protein C4 found in the classic pathway of complement activation. Determination of
diagnosis of diseases such as lupus erythematosus, shunt nephritis, and Gram-positive bacteremia.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to detect and/or measure levels of C5a, a potent anaphylatoxin product of the complement componen
final complement pathway. Complement component C5a causes the release of histamine (edema); it i
infected tissues. C5 deficiency is associated with systemic Neisseria species; the presence of C5a is as
inflammatory diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to detect and/or measure levels of one or more of the proteins C5 to C9 found in the final complement
of complement components C5 to C9 are associated with several diseases, especially recurrent neisse

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
lactoferrin (Lf), a plasma glycoprotein that irreversibly binds to iron. Its action-making activity prevent
to iron. Lactoferrin levels are useful in determining pancreatic function; they may be also associated t
and to the stage of AIDS patients.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
transthyretin (also known as prealbumin), an alpha-globulin protein secreted by the liver that forms a
binding protein; this complex binds and transports retinol (vitamin A). Transthyretin also binds to the h
and triidothyroxine but is not the principal carrier of them. The level of transthyretin in plasma is a sen
protein malnutrition or liver dysfunction; its level in serum decreases in inflammation, malignancy, an

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
transcobalamin II (TC II), a beta-globulin protein that is the main plasma protein that binds and transp
Decreased levels of TC II are associated with megaloblastic anemia.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum, urine, amniotic fluid) to determine the protein alpha-1-microglobulin (A1MG), a low-molecular-
Increased ratios of alpha-1-microglobulin/creatinine in urine are associated with kidney tubule and/or
especially in children. High levels of placental A1MG in the serum of pregnant woman may be conside
intrauterine diseases (e.g., intrauterine hypoxia).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the beta-2-microglobulin (B2M) protein. High levels of B2M in serum is associated with diso
immune function, multiple myeloma, chronic lymphocytic leukemia, B-cell lymphoma, and neuroendo

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine pancreatic elastase, a serine endopeptidase. There are two types of elastase: elastase I, wh
elastase II, which is cationic. The level of elastase 1 in serum is a specific indicator of pancreatitis; hig
associated with carcinoma of the pancreas. Measurements of elastase 1 in feces is also used for asses
pancreatic function in cystic fibrosis patients.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or feces) to determine the serine proteinase trypsin. There are two types of trypsin: trypsin I, which is
serum either as its precursor trypsinogen or in complexed forms, and trypsin II, which is anionic and i
people as its precursor trypsinogen II. Trypsin is used as an indicator of the type and severity of pancr
trypsin in feces and duodenal content is used as an aid in the diagnosis of chronic pancreatitis and cy
and children.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine apolipoprotein A; this apolipoprotein is the main protein in high-density lipids (HDLs), for
protein complexes in which HDLs are transported in the blood. Apolipoprotein A is found in at least fou
A-IV; the major components are apolipoprotein A-I and A-II. Apolipoprotein A-III was formerly known as
levels of apolipoproteins in plasma are associated with the risk of atherosclerosis and coronary artery

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine apolipoprotein B, the major protein in low-density lipids (LDLs) and present in large amo
4%) in both very-low-density lipids (VLDLs) and chylomicrons. Apolipoprotein B is found in at least two
100) synthesized in the liver, and B-48 (Apo B-48), probably synthesized in the intestines. Levels of ap
plasma are associated with the risk of atherosclerosis and coronary artery diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine apolipoprotein C, a protein of very-low-density lipids (VLDLs), intermediate-density lipop
chylomicrons; apolipoprotein C is also a minor protein constituent of high- and low-density lipids (HDL
respectively). Apolipoprotein C is a low-molecular-weight apolipoprotein found in at least three forms,
III, differing from each other in their quantity of amino acids.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine apolipoprotein E, a protein of very-low-density lipoproteins (VLDLs), intermediate-density
and chylomicrons. Apolipoprotein E is a glycoprotein found in at least four isoforms, named E-I to E-IV,
another by one charge only. Levels of apolipoproteins in plasma are associated with risk of atheroscler
artery diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine a protein known as "a" or "Lp(a);" this particle is usually attached to the apolipoprotein B
synthesized in the liver. Lp(a) exists in many different isoforms; the smaller form is found in higher con

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a serum or pla
determine atrial natriuretic peptide (ANP), a protein typically liberated from the myocardium into the b
atrial dilation or increased vascular fluid volume. ANP normalizes blood pressure and circulating blood
the volume and the excretion of sodium in the urine (i.e., diuresis and natriuresis, respectively) and by
concentrations of some hormones in blood (e.g., aldosterone, antidiuretic hormone). The level of liber
diagnosis of congestive heart failure.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine the fatty-acid-binding protein (FABP), sometimes named heart FABP. The level of li
increases, both in blood and in urine, soon after the occurrence of heart damage (e.g., as the result o
or cardiac surgery) and before the increase of creatine kinase activity, permitting its use as an early a
marker.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a serum or pla
determine the glycogen phosphorylase isoenzyme GPBB (i.e., brain-brain isoenzyme). GPBB release in
fluids follows ischemia-induced structural alterations of the myocardium. The level of liberated GBPP i
of the occurrence and extension of ischemic heart injuries, mostly as the result of myocardial infarctio
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a serum or pla
determine myosin light chain (MLC). The level of liberated MLC, in addition to evaluation with other ca
in the diagnosis of the occurrence of heart damage, mostly as the result of myocardial infarction

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or bronchial secretion) to determine the amine beta-imidazolylethylamine (histamine). Histamine is a
causing a drop in blood pressure and constriction of the bronchial smooth muscles of the lungs. The d
histamines is mostly used to characterize a patient's abnormal hypersensitivity to substances that are
(allergens).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine a group of biologically active substances mostly found in leukocytes (i.e., leukotrienes) that
other smooth muscle contractions. Leukotrienes are identified by letters from A to E, followed by num
quantity of double bounds in the molecule. Some leukotrienes (e.g., LTC4, LTD4, LTE4) are considered
constriction and allergic reactions (e.g., allergic rhinitis, asthma). Reagents for leukotriene determinat
provocation tests (e.g., determination of LTC4 in nasal secretions after inhaling allergens); these reage
for monitoring severity and improvements in asthma attacks (e.g., LTE4 in urine) and to determine LTC
(e.g., hymenoptera venom) allergy diagnosis.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the prostatic acid phosphatase (PAP) enzyme, an enzyme secreted by neoplastic tumor ce
marker) of the prostate. Use of PAP as a tumor marker is being replaced by the determination of prost
(PSA). But, PAP is still used because its level is associated with metastasis of prostate carcinomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the neuron-specific enolase (NSE) enzyme (also known as phosphopyruvate hydratase) as
level of NSE is associated with tumors of neuroendocrine origin. It may be used as a moderately sensi
marker for monitoring pediatric neuroblastoma, hemophagocytic lymphohistiocytosis, and small cell lu

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the thymidine kinase (TK) enzyme as a tumor marker. A high level of TK is associated with
and small cell lung cancer.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
tumor tissue extracts) to determine one or more of the cathepsin aspartate proteinases (i.e., cathepsi
of enzymes secreted by some specific cells (e.g., mucous neck cells, pyloric gland cells). Cathepsins a
processes of tumor growth, revascularization, and metastasis. They are used in the prognostic and mo
types of malignancies, including breast, lung, colorectal, brain, and head and neck cancers.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
tumor tissue extracts) to determine the cathepsin-D aspartate proteinase, an enzyme. Cathepsin-D is
marker in breast cancer; its overexpression is used as a predictor of breast cancer metastasis (e.g., ly
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine calcitonin, a hormone normally secreted by the C cells of the thyroid, as a tumor marker. Ca
secreted to decrease the calcium release from bone, thus lowering the calcium level in serum. High le
associated with medullar carcinoma of the thyroid; their level in serum correlates with tumor progress
Determination of the level of calcitonin is also used for screening of inherited familial medullar carcino
High levels of calcitonin are also found in other malignancies (e.g., lung, breast, and renal cancer) and
nonmalignant diseases (e.g., pancreatitis, pernicious anemia).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine metanephrines, both normetanephrine and metanephrine, products from the metaboliza
norepinephrine and epinephrine, respectively. Increased levels of urinary metanephrines are found in
catecholamine-secreting tumors.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine 5-hydroxyindoleacetic acid (5-HIAA), the most significant metabolite of the hormone sero
hydroxytryptamine, or 5HT). High levels of 5-HIAA are found in the urine from the secretion of carcino
according to the tissue of the tumor. The highest levels occur in tumors from mid-gut cells (e.g., ileal c
levels of 5-HIAA are also detected in the urine from bronchial, pancreatic, duodenal, and biliary cance
measurement of very small quantities, liquid chromatography methods are preferred.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
respiratory secretions) to determine the oncofetal squamous cell carcinoma (SCC) antigen, a glycopro
neoplastic tumor cells (i.e., a tumor marker). Measurement of the SCC antigen level is used in the mon
and progression of malignancy in several squamous cell carcinomas, such as lung, cervix, skin, neck,
gastrointestinal; it is also used for prediction of recurrence.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
bronchoalveolar lavage) to determine oncofetal soft keratin (i.e., cytokeratin) antigens, referred to as
antigens (TPAs). They are frequently found in the serum of patients with malignant tumors. These reag
antibodies (either monoclonal or polyclonal) capable of binding to cytokeratins 8, 18, and 19. The det
(tumor markers) level is used in treatment monitoring and prognosis evaluation of several types of ma
lung, breast, and colorectal cancer; the level of TPA can also be used to differentiate cholangiocarcino
hepatocellular carcinomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
bronchoalveolar lavage) to determine an oncofetal soft keratin (i.e., cytokeratin) fragment 18 antigen,
polypeptide specific (TPS) antigen, frequently found in the serum of patients with malignant tumors.
the level of the TPS marker (cytokeratin 18) is used in treatment monitoring and prognosis evaluation
malignancies, including bladder and thyroid cancer; the level of TPS can also be used to differentiate c
from hepatocellular carcinomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the oncofetal antigen soft keratin (i.e., cytokeratin) fragment 19, referred to as CYFRA 21-1
serum of patients with malignant tumors. The detection of the tumor marker CYFRA 21-1 (cytokeratin
monitoring of non-small cell lung cancer and squamous cell carcinomas; its presence in pleural effusio
for discriminating benign from malignant diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine CA 27.29, a carbohydrate-related tumor marker. The detection of the tumor marker CA 27.2
monitoring therapy and disease progression in metastatic breast cancer, but not to diagnose primary

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine CA 50, a carbohydrate-related tumor marker. The detection of the tumor marker CA 50 is m
monitoring of colorectal and pancreatic carcinomas.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine CA 72-4, a carbohydrate-related tumor marker. The detection of the tumor marker CA 72-4
diagnosis and monitoring of ovarian and/or gastrointestinal tract (e.g., gastric, colorectal) cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine CA 195, a blood group carbohydrate-related tumor marker. The detection of the tumor mar
used in diagnosis and monitoring of colorectal and pancreatic carcinomas.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine CA 242, a blood group carbohydrate-related tumor marker. The detection of the tumor mar
used in diagnosis and monitoring of colorectal and pancreatic carcinomas; this assay has been also us
cholangiocarcinoma.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine CA-549, a carbohydrate-related tumor marker. The detection of the tumor marker CA 549 i
monitoring therapy, disease progression, recurrence, and metastases of breast cancer, but not to diag
cancer.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine MCA (i.e., mucinlike carcinoma-associated antigen), a carbohydrate-related tumor marker.
tumor marker MCA is mostly used in monitoring therapy and disease progression in metastatic breast
diagnose primary breast cancer. The levels of MCA typically correlate to those of the CA 15-3 tumor m

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine Du-pan-2, a carbohydrate-related tumor marker. The detection of the tumor marker Du-pa
diagnosis of pancreatic cancer. It is also detected in many patients with biliary tract and hepatocellula

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
but also urine) to determine heavy chain (alpha, gamma, or mu) fragments of monoclonal immunoglo
Heavy-chain related diseases are less frequent than light chain diseases. They are associated with lym
causing severe malabsorption in the intestines.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
but also urine) to determine alpha heavy chain fragments of monoclonal immunoglobulins (paraprotei
diseases are associated with lymphoid infiltration, typically causing severe malabsorption in the intest

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
but also urine) to determine gamma heavy chain fragments of monoclonal immunoglobulins (paraprot
chain diseases are associated with lymphoid infiltrations.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
but also urine) to determine mu heavy chain fragments of monoclonal immunoglobulins (paraproteins
diseases are associated with lymphoid infiltration, typically causing severe malabsorption in the intest

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine laminin, an adhesive glycoprotein. The determination of laminin is associated with invasive
cervical cancer); its level in serum is used in the prediction of metastasis.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine chromogranin A (CgA), a soluble protein secreted by the adrenal medulla. CgA is a sensitive
marker for various types of neuroendocrine tumors, its determination is mostly used as a general tum
carcinoid and endocrine pancreatic tumors without clinical hormone-related symptoms (i.e., nonfunct
determination of the CgA level is also used as a serum marker for diagnosis and therapeutic monitori
neuroendocrine tumors.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine nuclear mitotic apparatus protein (NMP), a protein that makes up the internal structure o
nuclear matrix protein) and is usually known as NMP22. Increased levels of NMP22 are found in urine
transitional cell carcinoma of the urinary tract.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine proteins. The presence or level of these proteins is altered by activation or mutation of gen
malignancies, either hematologic (e.g., leukemia) or with solid tumors. The determination of these pro
Abl, bcl-2) may be used for diagnosis, assessment of progress, monitoring of treatment, or differentia
larynx, prostatic adenocarcinoma). Unlike other tumor markers oncogenes and their encoded protein p
identified with specific biological processes regulating cell growth, such as cell cycle, angiogenesis, ap
adhesion.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine substances present in or secreted by neoplastic urinary bladder tumor cells (i.e., tumor m
reagents include antibodies capable of binding to the urinary bladder tumor associated antigens such
H related protein, fragments of cytokeratines 8 and 18, or nuclear mitotic apparatus protein NMP22. T
to obtain information on tumor grade and clinical stage of urothelial carcinomas of the bladder.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine fragments of cytokeratins 8 and 18 secreted by neoplastic urinary bladder tumor cells (i.
These reagents are used in assays known as urinary bladder cancer (UBC) antigen determination assa
information on tumor grade and clinical stage of urothelial carcinomas of the bladder.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a urine sampl
complement factor H related protein, a protein secreted by neoplastic urinary bladder tumor cells (i.e.
These assays (typically known as bladder tumor antigen or BTA assays) are used to obtain information
clinical stage of urothelial carcinomas of the bladder.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a feces sampl
presence of hidden (occult) blood. Occult blood in feces is a marker of a bleeding ulcer or malignant d
gastrointestinal tract; tests for occult test in feces are mostly used for screening patients for colorecta
Immunological tests reduce the false positive rate with respect to chemical test for occult blood in fec
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the free component of triiodothyronine (FT3), one of the two main hormones secreted b
glands. These assays are very sensitive and permit direct measurement of FT3 (typically only 0.3% of
in blood) in undiluted serum after ultrafiltration. The determination of FT3, the only fraction of T3 that
is useful for adjusting the total T3 for variations in binding proteins.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the biologically inactive reverse triiodothyronine (3, 3', 5' triiodothyronine), commonly k
hormone secreted by normal thyroid glands. The level of rT3 is mostly determined to differentiate bet
and sick patients with normal thyroid (euthyroid patients) if the question cannot be solved with thyroid
(TSH) evaluation assays. High levels of rT3 are commonly found in serum in hyperthyroidism, hepatic
and in malnutrition or starvation.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the unsaturated thyroid hormone (either triiodothyronine (T3) or thyroxin (T4)), binding c
number of unoccupied thyroid hormone binding sites on serum proteins). Usually these values (i.e. the
determined in relation to values in serum from patients with normal thyroid hormones (i.e., euthyroid
determinations of the relative free fraction of T3 or T4 are known as the thyroid hormone binding ratio

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine thyrotropin, also known as thyroid stimulating hormone (TSH). Thyrotropin is a hormone
released by the pituitary thyrotropes under the action of the thyrotropin-releasing hormone (TRH) secr
hypothalamus. Both isotopic and nonisotopic methods (e.g., enzymatic) are used. High levels of thyro
patients with primary hypothyroidism either inherited or acquired (i.e., when the thyroid gland is dam
thyrotropin and high levels of the free component of thyroxin (FT4) are usually an indication of hypert
Determination of thyrotropin is also used in the early identification (screening tests) in newborns for c
hypothyroidism, typically after the determination of an abnormal level of thyroxin (T4).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine thyroxin-binding globulin (TBG), a protein that binds both thyroxin (T4) and triiodothyron
levels of TBG are found due to inherited diseases (e.g., congenital variants of albumin that have altere
some nonthyroidal diseases (e.g., hepatitis, HIV), or as a consequence of drug use (e.g., estrogens, or

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine androstenedione, an androgen mainly secreted by the adrenal glands that is an immedia
testosterone. Androstenedione is a sex steroid vital for human reproduction. High levels of circulating
found in diseases such as polycystic ovaries, congenital adrenal hyperplasia, and adrenal tumors.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
saliva, whole blood) to determine 17-hydroxyprogesterone, a precursor of cortisol and aldosterone. De
levels of 17-hydroxyprogesterone are useful in the evaluation of women with infertility and/or excessiv
hair (hirsutism). Measurements in plasma are also used for the diagnosis and monitoring of therapy of
hyperplasia (CAH) in newborns.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine free testosterone (typically less than 3% of total testosterone), including both free testos
dihydrotestosterone (DHT). Sometimes these assays include the determination of the active testostero
testosterone), including both the free testosterone and testosterone weakly bound to albumin, but not
bound to sex hormone binding globulin. Testosterone is a sex steroid vital for human reproduction; lac
testosterone during fetal, prepubertal, and postpubertal life affect the normal male reproductive funct
diseases such as male infertility and growth of glandular breast tissue (gynecomastia) in male adults.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum) to determine sex hormone binding globulin (SHBG), a protein that closely resembles serum glo
and dihydrotestosterone circulate mainly bound to SHBG in men; steroids bound to SHBG are biologica
of SHBG in serum is useful for interpreting blood levels of its tightly bound testosterone, a sex steroid
reproduction. Lack or low levels of testosterone during fetal, prepubertal, and postpubertal life affect t
reproductive function, producing diseases such as male infertility and growth of glandular breast tissu
male adults.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the steroid hormone estriol (E3), produced mostly by the placenta in pregnant women, b
(i.e., conjugated) by the liver as glucoronides and sulfates. Maternal serum concentrations of unconjug
probably a better indicator of fetoplacental function than total estriol.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine the total steroid hormone estrone (E1). Estrone determinations are used to identif
dysfunctions caused by extra glandular estrone production and may be useful in the diagnosis of post

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine a oligosaccharide variant of the glycoprotein hormone human chorionic gonadotr
hyperglycosilated hCG), also known as invasive trophoblast antigen (ITA). This test is specifically used
determination of Down syndrome during the second trimester of pregnancy, either by itself or combin
(e.g., serum alpha-fetoprotein levels).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the polypeptide hormone human placental lactogen (hPL), very similar to growth hormone.
produced mostly by the placenta in pregnant women. The level of hPL in serum increases with gestati
correlated with the mass of placental tissue. The use of hPL levels to determine general fetal well-bein
used in routine practice.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine pregnancy-associated plasma protein A (PAPP-A), a protein mostly produced by the placent
PAPP-A levels are elevated in maternal serum in trisomy 21 (Down syndrome) pregnancies and in dege
development of fertilized ova (i.e., molar pregnancy); a low level in the second trimester of pregnanc
trisomy 18.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the pregnancy specific beta-1-glycoprotein (SP-1 or PSG-1), also known as Schwangerschaf
levels in maternal serum are elevated in the second trimester of trisomy 21 (Down syndrome) pregna
or abnormal development of fertilized ova (i.e., molar pregnancy), and in other abnormal pregnancies
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine glucagon, a polypeptide secreted by the alpha-cells of the pancreas. Glucagon stim
of glucose and the oxidation of fatty acids in the liver. Increased levels of glucagon are present in pati
mellitus, and in other diseases such as cirrhosis and renal failure; high levels of glucagon (typically mo
also found in patients with pancreatic alpha-cell tumors (i.e., glucagonoma).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine the level of proinsulin, an amino acid polypeptide with low biological activity tha
form of insulin. Increased levels of proinsulin may be sufficient to produce hypoglycemia; high levels o
found in patients with chronic renal failure, cirrhosis, hyperthyroidism, or beta-cell tumors in the pancr

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the level of one or both of the vasopressor hormones angiotensin I and/or angiotensin II. An
decapeptide, is produced in the blood by the hydrolization of angiotensinogen (previously produced in
is rapidly converted into angiotensin II, an octapeptide, by a circulating angiotensin-converting enzym
powerful vasoconstrictor that also stimulates the cells of the zona glomerulosa to produce aldosterone

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine plasma renin in terms of its enzymatic activity, known as plasma renin activity (PRA). PRA i
to the generation of angiotensin I. Renin activity is increased during salt-losing nephropathies, renin-s
adrenocortical insufficiency. Low levels are associated with adrenal carcinomas and primary aldosteron

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine plasma renin in terms of its enzymatic activity, known as plasma renin activity (PRA). PRA i
to the generation of angiotensin I. Renin activity is increased during salt-losing nephropathies, renin-s
adrenocortical insufficiency. Low levels are associated with adrenal carcinomas and primary aldosteron

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the presence of calcitonin, an amino acid peptide secreted by the parafollicular or C cells o
Calcitonin secretion is primarily regulated by the level of ionized calcium in plasma; calcitonin lowers
Elevated calcitonin levels are found in patients with hypercalcemia, pulmonary diseases, and thyroida
carcinomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the 84 amino acid intact parathyroid hormone (PTH). Intact PTH is synthesized and secrete
glands. The level of PTH in serum is used to determine the cause of hypercalcemia and hypocalcemia
parathyroid function in disorders of bone and mineral metabolism and renal failure. Secretion of intact
hypocalcemia and reduced or absent in hypercalcemia. Two-site labeled antibody immunoassays for in
specific assays for PTH determinations; they are preferred over the assays used to determine fractions
terminal, N-terminal).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the inactive carboxyl-terminal fragment (amino acid sequence 53 to 84) of the parathyroid
terminal PTH fragment). The level of C-terminal PTH in serum is useful in determining the cause of hyp
hypocalcemia and the parathyroid function status in disorders such as bone and mineral metabolism a
Secretion of C-terminal PTH fragments persist even in hypercalcemia.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the active first third terminal fragment (amino acid sequence 1 to 34) of the parathyroid ho
terminal PTH fragment). The level of N-terminal PTH in serum has been used to determine the cause o
hypocalcemia and he parathyroid function status in disorders such as bone and mineral metabolism a
assays are not useful to measure PTH in normal people.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the mid-region inactive fragment (amino acid sequence 44 to 68) of the parathyroid hormo
Region PTH fragment). The level of M-region PTH in serum is used to determine the cause of hypercalc
hypocalcemia and the parathyroid function status in disorders such as bone and mineral metabolism a
Secretion of M-region PTH fragments persist even in hypercalcemia.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine peptides produced by some tumors that have the ability to bind to the parathyroid hormon
parathyroid hormone related peptide [PTHrP]). The presence of PTHrPs is associated with abnormal bo
metabolism; its determination in serum is used to diagnose hypercalcemia produced by a malignant t
(frequently from squamous carcinomas) that causes resorption of bone distal to the site of the tumor.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine one or more of the group of substances that are indicators of bone turnover (i.e
markers), either bone formation (osteoblast activity) or bone resorption (osteoclast activity). These re
in testing bone diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the isoenzymes of alkaline phosphatase (AP) produced by the osteoblasts in the bones. The
provide the specificity and sensitivity needed to differentiate bone AP isoenzymes from the AP produc
kidneys. An increased level of AP bone isoenzymes in serum reflects increased osteoblast activity or b
bone isoenzymes are a marker of bone formation); abnormal high levels are frequently found in disea
inadequate or delayed mineralization of bone, such as rickets disease in children, osteomalacia in adu
and osteitis deformans (a disease characterized by increased bone resorption followed by excessive a

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine the protein osteocalcin (also known as bone GLA protein), the major noncollagenous protei
Osteocalcin is synthesized in the skeleton by the osteoblasts; it binds both free calcium and hydroxya
of osteocalcin in serum reflect increased osteoblast activity or bone formation (osteocalcin is a marker
abnormal high levels are frequently found in diseases such as high-turnover osteoporosis, hyperthyro
hyperparathyroidism.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine free or protein-bound pyridinoline (hydroxylysylpyridinoline), a nonreducible cross-link th
mature collagen chains within the extracellular matrix; it is found in bone, in hard connective tissues,
Increased levels of pyridinoline in urine occur during bone resorption and/or cartilage degradation (py
of bone resorption).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample on a


(typically urine) to determine free or protein-bound deoxypyridinoline (lysylpyridinoline), a nonreducib
stabilizes the mature collagen chains within the extracellular matrix. It is found in bone and dentine. I
deoxypyridinoline in urine occur during bone resorption (pyridinoline is a marker of bone resorption); t
with high-turnover osteoporosis, hypercalcemia due to malignancy, and other diseases with high bone
Deoxypyridinoline in urine is a more specific marker of bone degradation than pyridinoline.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine cyclic adenosin monophosphate (cAMP), a cyclic nucleotide that mediates the action of s
as parathyroid hormone (PTH). Decreased levels of cAMP in urine are found in most patients with hype
exception of humoral hypercalcemia due to malignant tumors. The level of cAMP in urine is infrequent
PTH secretion; it is not considered a specific marker of bone metabolism.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the extension (either amino- or carboxy- terminal) peptides of collagen type I, II, or III . P
extensions are cleaved from collagen during fiber formation and circulate in blood. The level of procol
is not specific to bone formation, thus they are not considered specific markers of bone formation.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the carboxyterminal (C) extension peptides of type I collagen (PICP). The level of PICP in
bone formation, thus the PICP level is only used as an index of total bone-forming activity and not as a
bone formation.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the amino (N) extension peptides of type I collagen (PINP). The level of PINP in blood is n
formation, thus the PINP level is only used as an index of total bone-forming activity and not as a spec
formation.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the carboxyterminal telopeptide that originates from one of the two intermolecular sites
cross-linking with type I collagen (also known as I-C telopeptide [ICTP]). Increased levels of ICTP are p
normal bone resorption; they are associated with bone resorption in diseases such as osteoporosis.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine a fraction (known as CTx) of the carboxyterminal telopeptide that originates from one of
sites of the pyridinoline cross-linking with type I collagen. Increased levels of CTx are associated with
is a bone-resorption marker) in osteoporosis and other bone diseases. Some immunoassays are capab
independently the nonisomerized CTx (i.e., alpha-CTx) and isomerized CTx (i.e., beta-CTx) in urine; th
components seems to be useful in the characterization of some bone diseases, such as Paget's diseas
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine a fraction (known as NTx) of the amino-terminal telopeptide that originates from one of t
sites of the pyridinoline cross-linking with type I collagen. Increased levels of NTx are strongly associ
resorption (NTx is a sensitive bone resorption marker) in osteoporosis and other bone diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine either one or more of the group of substances (e.g., caffeine) that are safely an
metabolized by the liver. These assays are mostly used in testing the function of the liver, either in th
disease or to assess liver donors and candidates for liver transplantation.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine monoethylglycinexylidide (MEGX), a lidocaine metabolite that has nearly identical toxic equ
Determination of MEGX in serum after lidocaine injection is used in assessing hepatic function; high le
indicate good liver function. These assays are used either in the screening for liver disease or to asses
candidates for liver transplantation.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the endocrine hormone adrenocorticotropin (ACTH), also known as corticotropin. ACTH is
anterior lobe of the pituitary gland. Its concentration in plasma is usually very low following a circadia
concentrations of ACTH are found in diseases such as congenital adrenal hyperplasia, Addison's disea
tumors, and hypoglycemia. Determination of the ACTH level is also useful in differentiating primary fro
insufficiency.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine the endocrine growth hormone (GH), also known as somatotropin. GH is a hete
single-chain polypeptide hormone isoforms secreted by the anterior lobe of the pituitary gland. The m
promote growth in many soft tissues, in cartilage, and in bone. Decreased levels of GH are found in un
(dwarfism), in patients with acute or chronic protein or caloric deprivation, and in adults with large pit
increased levels are characteristic in gigantism and acromegaly. GH determination may be performed
nonisotopic immunoassays.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or plasma) to determine the endocrine insulin-like growth factor I (IGF-I) hormone, also known generic
IGF-I, the major insulin-like growth factor hormone, it is a peptide secreted by the anterior lobe of the
structural similarities to insulin. The main effects of IGF-I are cartilage growth promotion and insulin-lik
tissues. Increased levels of IGF-I are associated with excessive growth (e.g., acromegaly); low levels a
with growth hormone deficiency or with acute or chronic protein or calorie deprivation. IGF-I determina
performed using either isotopic or nonisotopic immunoassays.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or plasma) to determine the endocrine insulin-like growth factor II (IGD-II hormone), also known gener
IGF-II is a peptide secreted by the anterior lobe of the pituitary gland with structural similarities to insu
of IGF-II are cartilage growth promotion and insulin-like activity in some tissues. Increased levels of IG
excessive growth (e.g., acromegaly); low levels are found in patients with growth hormone deficiency
chronic protein or calorie deprivation. IGF-II determination is mostly used as a complement of IGF-I ass
performed using either isotopic or nonisotopic immunoassays.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine the antidiuretic hormone (ADH), also known as vasopressin or arginine vasopre
synthesized in the neurohypophyseal system and stored and secreted by the posterior lobe of the pitu
physiological effects of ADH are on the reabsorption of water and concentration of urine by the kidney
generalized vasoconstriction with a rise of blood pressure. Measurement of the levels of ADH are usef
central diabetes insipidous, nephrogenic diabetes insipidous, and syndrome of inappropriate antidiure
(SIADH). ADH may be determined using either isotopic or nonisotopic immunoassays.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the gonadotropin hormone releasing hormone (GHRH), a polypeptide hormone secreted
GHRH directly induces the release of gonadotropin hormones, both luteinizing and follicle-stimulating
FSH, respectively), by the anterior lobe of the pituitary gland. Low levels of GHRH are associated with
males (e.g., Kallmann's syndrome) and with other diseases related to abnormal levels of LH and FSH.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine oxytocin, a hormone that is synthesized in the neurophypophyseal system and
the posterior lobe of the pituitary gland. The major physiological effects of oxytocin are uterine contra
of milk ejection; the primary stimulus for its release is the stimulation of the tactile receptors around t
Oxytocin determination may be performed using either isotopic or nonisotopic immunoassays.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or plasma) to determine melatonin, an amine secreted by the pineal gland that acts on the hypothala
gonadotropin and growth hormone release, thus inducing sleep. Melatonin is also associated with the
and ovarian cycles. Its secretion is induced by the exposure to light.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine epinephrine (also known as adrenaline), a secondary amine hormone in the ca
Epinephrine is the major substance produced by the adrenal medulla, it is a potent stimulator of the n
powerful cardiac stimulant; epinephrine also influences metabolic processes. Increased epinephrine le
measure active, free epinephrine) are associated with thyroid hormone deficiency, low blood pressure
failure, and arrhythmias. Measurements of epinephrine and its metabolites (e.g., urinary metanephrin
acid) are also used for diagnosis of some catecholamine- secreting tumors (e.g., pheochromocytoma).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine norepinephrine (also known as noradrenaline), a primary amine hormone in the
Norepinephrine is the major substance liberated by the postganglionic sympathetic nerves; it is also t
catecholamine secreted in fetal life. Norepinephrine is an important neurotransmitter within the centr
also has a marked influence on the vascular system. Increased norepinephrine levels (most assays me
norepinephrine) are associated with thyroid hormone deficiency, low blood pressure, congestive heart
arrhythmias; low levels are associated with idiopathic postural hypotension and depression. Measurem
and its metabolites (e.g., urinary metanephrines, vanillylmandelic acid) are also used for diagnosis of
secreting tumors, including neuroblastomas and pheochromocytomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine dopamine, a primary amine hormone in the catecholamine group. Dopamine is
neurotransmitter within the central nervous system; it also has a marked influence on the vascular sy
dopamine levels (most assays measure active, free dopamine) are associated with thyroid hormone d
pressure, congestive heart failure, and arrhythmias; low levels are associated with idiopathic postural
depression. Measurements of dopamine and its metabolites (e.g., homovanillic acid) are also used for
catecholamine-secreting tumors, particularly neuroblastomas.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine serotonin, a hormone that is a derivative of the amino acid tryptophan; it is transported
platelets. Serotonin (5-hydroxytryptamine [5-HT]) is a neuron transmitter within the brain, with a mark
pain perception, social behavior, and depression. Low levels of serotonin are associated with some de
serotonin-deficient patients). High-pressure liquid chromatography assays are most widely used for de
serotonin.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine the absorption of serotonin (also known as 5-hydroxytryptamine, [5-HT]) by bloo
platelet serotonin uptake). The results are frequently expressed as maximal velocity uptake (Vmax) or
of platelet serotonin uptake (Km); results can also be expressed as platelet uptake index which is the
5-HT and plasma 5-HT levels. Abnormal values of serotonin uptake are associated with depression, alc
neuropsychiatric diseases.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or plasma) to determine insulin-like growth factor binding protein 1 (IGFBP-1), a plasma protein that is
like growth factors. Measurement of the levels of IGFBP-1 in circulation are useful in the determinatio
deficiency.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or plasma) to determine insulin-like growth factor binding protein 3 (IGFBP-3), a plasma protein that is
like growth factors. IGFBP-3 is the major carrier of insulin-like growth factor hormones in circulation; it
useful in the determination of growth hormone deficiency.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or plasma) to determine either one or more of a group of hormones (e.g., bombesin, neurotensin) secr
and released into extracellular space.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine bombesin, a peptide hormone produced in the gastrointestinal tract and also in the brain
stimulates the release of various hormones, smooth muscle contractions, and changes in cardiovascu
Increased levels of bombesin are found in certain pulmonary and thyroid tumors.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or cerebrospinal fluid) to determine beta-endorphin, an opioid peptide hormone that originates from th
(proopiomelanocortin [POMC]) as adrenocorticotropin (ACTH). Beta-endorphin is a potent analgesic; it
sedation, increase of pain threshold, and autonomic regulation of respiration, heart rate, and blood pre
endorphin are very low in normal people. Increased levels in plasma are associated with some disease
abnormal levels in cerebrospinal fluid are present in depression, schizophrenia, and chronic pain.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine alpha-melanocyte stimulating hormone (MSH), a neuroendocrine hormone. This hormone
be secreted by the middle lobe of the pituitary gland; it is identical to some residues of the adrenocor
(ACTH). High levels of MSH are found in patients with abnormal adrenocortical activity (e.g., Addison's
dispersion of pigment granules and darkening of the skin.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the neuroendocrine hormone neurotensin, a peptide secreted by the endocrine glands o
tract and also by the brain. Neurotensin acts in the brain as a neurotransmitter; its action includes gas
contraction, hypotension, and increased vascular permeability.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the neuroendocrine hormone substance P (SP), a peptide secreted by the endocrine glan
gastrointestinal tract and also by the brain. Substance P acts as a neurotransmitter and analgesic; its
gastrointestinal contraction, promotion of salivation, and release of histamine.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the neuroendocrine hormone somatostatin, also known as growth hormone inhibiting ho
an amino acid peptide secreted by the hypothalamus and by the endocrine glands of the gastrointesti
inhibitor of endocrine hormones such as growth hormone, insulin, glucogen, and neurotensin. The cor
effects of somatostatin include gastric emptying, inhibition of gallbladder contraction, secretion of bile
enzymes, and hypotension.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine vasoactive intestinal peptide (VIP), a neuropeptide hormone present throughout the bod
nervous system and gastrointestinal tract. VIP is a regulator of embryonic brain growth and developm
in menstrual cycle regulation, in hypothalamo-pituitary-adrenal axis secretion, and in pancreatic horm
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine cortisol metabolites, including 17-hydroxycorticosteroids (17-OHCS) and 17-ketosteroid g
Other cortisol metabolites include tetrahydro metabolites (e.g. tetrahydrocortisone), hexahydro metab
beta cortols, cortolones), and 11-oxygenated ketosteroids (e.g., 11-ketoandrosterone). Determination
in urine are used in tests of adrenal diseases such as nodular adrenocortical diseases and secondary a
The assays for determination of cortisol, both in urine and blood, have decreased the use of tests for c
urine.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine 17-hydroxycorticosteroid (17-OHCS), a cortisol metabolite. Determination of 17-OHCS in
of congenital adrenal hyperplasia, secondary adrenal insufficiency, and other adrenal diseases. The as
of cortisol, both in urine and blood, have decreased the use of urine cortisol metabolite testing.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma, urine) to determine either one or more of a group of protein hormones (e.g., vasoactive intest
are mostly secreted by the endocrine cells found throughout the gut mucosa. Gastrointestinal hormon
secretion, digestion, and absorption in the gut; many of these hormones are also present in the centra

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine gastrin, a generic name for a group of polypeptide hormones secreted by the endocrine
gastrointestinal tract and also by the brain. Gastrin stimulates gastric acid and pepsinogen secretion;
three molecular forms: big gastrin (G-34), little gastrin (G-17), and mini gastrin (G-14). All of these circ
or nonsulfated forms. Immunoassays for gastrin are typically specific for the C-terminal of gastrin; the
gastrin molecules either in sulfated or nonsulfated forms. Highly increased levels of gastrin in serum a
pancreatic and duodenal endocrine tumors (i.e., gastrinomas). High levels are found in patients with c
and other diseases, such as pernicious anemia, chronic renal failure, and rheumatoid arthritis.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine gastric inhibitory polypeptide (GIP), a hormone secreted by the K cells of the duodenal a
hormone is related to the stimulation of insulin secretion, the reduction of intestinal motility, and also
inhibition. Increased levels of GIP are found in GIP-dependent Cushing's syndrome, renal failure, and i
patients.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine one or more of a group enzymes that are secreted in the gastrointestinal tract, including
proteinases (i.e., the pepsinogens) and two other aspartate proteinases, cathepsin D and E. These enz
determined using isotopic and nonisotopic immunoassays.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine a group of proteolytic enzyme precursors (proenzymes) known as pepsinogens, usually f
mucosa; pepsinogens are converted by acid in the active enzyme (pepsin). There are two groups of pe
to their immunological characteristics; they are classified as group 1 pepsinogens and group II pepsin
can be determined using isotopic and nonisotopic immunoassays.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
or urine) to determine a group (at least five) of proteolytic enzyme precursors with similar immunolog
classified as group I pepsinogens. Group I pepsinogens are only found in the chief and mucous neck ce
glands. Increased levels of pepsinogen group I are found in diseases associated with increased gastric
increased parietal mass, as well as in gastrinomas, duodenal ulcers, and superficial gastritis. Decrease
with decreased chief cell mass, gastric carcinoma, atrophic gastritis, pernicious anemia, and Addison's
pepsinogens can be found in urine (i.e., uropepsinogen)

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine a group (at least two) of proteolytic enzyme precursors with similar immunologic charact
pepsinogens. Group II pepsinogens are found in the chief and mucous neck cells of the oxyntic glands
the cardiac and pyloric glands and in the Brunner's glands in the duodenum. Increased levels of pepsi
found in diseases associated with superficial gastritis and indicate a high risk of gastric ulcer; group II

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
juice, serum) to determine the enzyme pancreatic elastase, a serine endopeptidase. There are two typ
elastase I, which is anionic and is found in serum either free or as a complex with alpha-1-antitrypsin,
is cationic. Both free elastase and the elastase-alpha-1-antitrypsin complex may be determined using
immunoassay procedure. The level of elastase 1 in serum is a specific indicator of pancreatitis; high le
associated with carcinoma of the pancreas. Measurements of elastase 1 in feces are also used for asse
pancreatic function in cystic fibrosis patients.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
unsaturated fatty acids containing a cyclopentane ring known generically as prostaglandin (PG). Prost
designated by a capital letter (A, B, E, F, G, H, and I), followed by a number; the F series is also divide
alpha and beta.
Immunoassay reagents designed to perform tests on a body fluid sample, usually whole blood, in a sh
rapid tests), typically several minutes. These reagents are mostly used in point-of-care assays or less
performed at home by healthcare providers; some of them are available in kits that include an antibod
calibrator, and other specific (e.g., activator) reagents.
Immunoassay reagents intended to perform qualitative and/or quantitative analysis on a body fluid sa
blood) in a short period of time, typically several minutes, to determine the presence of one or more o
proteins and/or polypeptides.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid s
blood) in a short period of time, typically several minutes, to determine substances liberated from the
plasma (i.e., cardiac markers). The type and level of liberated substances (typically proteins or enzym
diagnoses of the occurrence and extension of heart damage, mostly as the result of myocardial infarc

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood) in a short period of time, typically several minutes, to determine the presence and/or level of c
isoenzyme MB (i.e., muscle-brain isoenzyme). The level of MB isoenzyme is used in the diagnosis of h
of myocardial infarction, pericarditis, myocardial ischemia, and after cardiac surgery.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood and/or urine) in a short period of time, typically several minutes, to determine myoglobin and ox
The level of liberated myoglobin increases soon after the occurrence of heart damage (e.g., as the res
infarction) both in blood and in urine before the increase of creatine kinase activity, permitting its use
marker. Myoglobin levels also increase due to injuries in skeletal muscles and/or after vigorous physica

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood) in a short period of time, typically several minutes, to determine the circulating inhibiting subu
(cTnI). The level of liberated troponin I is used as a highly specific marker of ischemic heart injuries (e
myocardial infarction).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood) to determine in a short period of time, typically several minutes, the circulating tropomyosin-bi
troponin (cTnT). The level of liberated troponin T is used as a highly specific marker of ischemic heart
result of myocardial infarction).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood, secretions) to determine in a short period of time (typically several minutes) substances presen
neoplastic tumor cells (i.e., tumor markers). Tumor markers include substances such as enzymes, hor
antigens that may be found in cells, tissues, or body fluids.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood) to determine in a short period of time (typically several minutes) the prostate specific antigen (
total or free (fPSA). Measurements of PSA level are used in monitoring treatment of prostate carcinom
with the stages of tumor extension and metastasis and indicates success of treatment. The level of to
and the proportion of free to total PSA can be used to help differentiate benign prostatic hyperplasia a

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine in a short period of time (typically several minutes) substances present in or secreted by
bladder tumor cells (i.e., tumor markers). These reagents include antibodies with the capability of bind
associated with urinary bladder tumor, such as complement H-related protein, fragments of cytokerat
nuclear mitotic apparatus protein NMP22. Urinary bladder tumor marker assays are used to obtain info
grade and clinical stage of urothelial carcinomas of the bladder; they are also used to determine tumo

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine in a short period of time (typically several minutes) fragments of the cytokeratins 8 and 18
present in neoplastic urinary bladder tumor cells. These assays (usually known as urinary bladder can
assays) are used to obtain information in tumor grade and clinical stage of urothelial carcinomas of th

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine in a short period of time (typically several minutes) the human complement factor H relate
secreted by neoplastic urinary bladder tumor cells (i.e., tumor markers). These assays (usually known
antigen [BTA] assays) are used to obtain information in tumor grade and clinical stage of urothelial ca
bladder.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood) to determine in a short period of time, typically several minutes, one or more of the group of ho
for human reproduction (e.g., androgens such as testosterone and androstenedione, estrogens such a
progesterone); the hormones related to fertility function are mainly secreted by the ovaries, testes, an
under control of the hypothalamus and pituitary gland.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood or urine) to determine in a short period of time (typically several minutes) the follicle-stimulatin
is one of the hormones that control the functional activity of the gonads (i.e., gonadotropins). The leve
women with polycystic ovary disease or hypothalamic dysfunction; decreased FSH levels are also foun
hypogonadism, anorexia, and in some cancers of the testes, ovaries, or adrenal glands.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood or urine) to determine in a short period of time, typically several minutes, the luteinizing hormo
release of the ovum from the ovarian follicle and, following ovulation, the transformation of the ruptur
corpus luteum (luteinization). Rapid tests for LH are typically performed to determine ovulation for con

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood or urine) to determine in a short period of time, typically several minutes, the glycoprotein horm
gonadotropin (hCG). Qualitative tests for hCG either in blood or urine are used for the confirmation of

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a cervicovagin


determine in a short period of time (typically several minutes) the insulin-like growth factor binding pr
determination of the presence of IGFBP-1 in the vagina (typically using a dipstick) is used to detect pr
fetal membranes in symptomatic or asymptomatic women due to its higher concentration in amniotic
cervical mucous, urine, and seminal plasma.

Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of a variety of proteins and/or polypeptides. These reagents may be either specific for a protein
appropriate to calibrate a whole set of similar proteins (e.g., immunoglobulins, transport proteins).

Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of a group of lipid-protein complexes in which lipids are transported in the blood. These reagents
for calibration of a lipoprotein or, more frequently, appropriate to calibrate a whole set of similar lipop

Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
liberated from the myocardium into the plasma (i.e., cardiac markers). These reagents may be either
of a cardiac marker, or more frequently, appropriate to calibrate a whole set of similar cardiac marker

Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
immunoglobulin E (IgE) or histamines released by mast cells when an antigen (allergen) cross-links tw
molecules. These reagents may either be specific for calibration of an allergy-related substance or mo
appropriate to calibrate a whole set of similar allergy-related substances.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
present in or secreted by neoplastic tumor cells (i.e., tumor markers) that may be found in cells, tissu
These reagents may be either specific for calibration of a tumor marker or, more frequently, appropria
set of similar tumor markers.
Immunoassay reagents intended to establish points of reference (i.e., calibrate) in tests performed to
of the group of hormones secreted by the thyroid gland , such as thyroxine (T4) and triiodothyronine (
may be either specific for calibration of a thyroid hormone or, more frequently, appropriate to calibrat
thyroid hormones.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of the group of hormones that are vital for human reproduction. These reagents may be either s
a fertility hormone or, more frequently, appropriate to calibrate a whole set of similar fertility hormone

Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of the group of hormones related to the detection, evaluation, and monitoring of human pregnan
may be either specific for calibration of a pregnancy hormone or, more frequently, appropriate to calib
similar pregnancy hormones.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of the group of hormones (e.g., insulin, C-peptide, glucogen) that modulate the regulation of the
glucose in the blood. These reagents may be either specific for calibration of a diabetes test hormone
appropriate to calibrate a whole set of similar diabetes test hormones.

Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of the group of hormones that are produced or degraded by the kidneys (e.g., renin, aldosterone
be either specific for calibration of a renal metabolism hormone or, more frequently, appropriate to ca
similar renal metabolism hormones.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
or more of the group of hormones (and/or their metabolites) that regulate the mineral and bone meta
substances that are indicators of bone turnover. These reagents may be either specific for calibration
substance, or more frequently, appropriate to calibrate a whole set of similar bone metabolism substa

Reagents intended to establish points of reference in immunoassay tests performed to determine eith
group of substances that are safely and almost completely metabolized by the liver. These reagents m
for calibration of a liver metabolic product or, more frequently, appropriate to calibrate a whole set of
products.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
more of a group of endocrine hormones (e.g., human growth hormone, adenocortiotropic). These reag
specific for calibration of an endocrine hormone or, more frequently, appropriate to calibrate a whole
hormones.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
or more of a group of neuroendocrine hormones (e.g., bombesin, neurotensin). These reagents may e
calibration of a neuroendocrine hormone or more frequently appropriate to calibrate a whole set of sim
hormones.
Reagents intended to establish points of reference (i.e., calibrate) in immunoassay tests performed to
or more of a group of gastrointestinal hormones (e.g., vasoactive intestinal polypeptide). These reage
specific for calibration of a gastrointestinal hormone or, more frequently, appropriate to calibrate a wh
gastrointestinal hormones.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in immuno
to determine one or more of a group of derivatives of fatty acids known as prostaglandins. These reag
specific for calibration of a prostaglandin or, more frequently, appropriate to calibrate a whole set of s

Reagents intended to establish points of reference (i.e., calibrate) in a diverse range of sensitive and s
using radioimmunoassay tests. Reagents used for radioimmunoassay calibration may be specific for a
frequently, appropriate to calibrate a whole set of similar substances (e.g., proteins, lipids) that are fo
specimens.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of proteins and/or polypeptides. These reagents may be either specific for quality contr
frequently, appropriate for control of a whole set of similar proteins.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of a group of lipid-protein complexes in which lipids are transported in th
reagents may be either specific for quality control of a lipoprotein or, more frequently, appropriate for
of similar lipoproteins.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of substances (i.e., cardiac markers) liberated from the myocardium into the plasma. Th
either specific for quality control of a cardiac marker or, more frequently, appropriate for control of a w
cardiac markers.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more in a group of immunoglobulin E (IgE) proteins or histamines released by
antigen (allergen) cross-links two attached IgE molecules. These reagents may be either specific for q
allergy-related substance or, more frequently, appropriate for control of a whole set of similar allergy-r

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of substances present in or secreted by neoplastic tumor cells (i.e. tumor markers) tha
tissues, or body fluids. These reagents may be either specific for quality control of a tumor marker or,
appropriate for control of a whole set of similar tumor markers (e.g., enzymes, hormones, carbohydrat

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of the group of hormones secreted by the thyroid gland, such as thyroxi
triiodothyronine (T3). These reagents may be either specific for quality control of a thyroid hormone o
appropriate for control of a whole set of similar thyroid hormones.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of the group of hormones that are vital for human reproduction. These r
specific for quality control of a fertility hormone or, more frequently, appropriate for control of a whole
hormones.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of the group of hormones related to the detection, evaluation, and moni
pregnancy. These reagents may be either specific for quality control of a pregnancy hormone or, more
appropriate for control of a whole set of similar pregnancy hormones.

Reagents consisting of samples of substances with known values that resemble the unknown specime
quality control of immunoassay tests performed for the determination of one or more of the group of h
C-peptide, glucogen) that modulate the regulation of the concentration of glucose in the blood. These
either specific for quality control of a diabetes test hormone or, more frequently, appropriate for contr
similar diabetes test hormones.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of the group of hormones that are produced or degraded by the kidneys
aldosterone). These reagents may be either specific for quality control of a renal metabolism hormone
appropriate for control of a whole set of similar renal metabolism hormones.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of either one or more of the group of hormones (and/or their metabolites) that regulate
metabolism or of substances that are indicators of bone turnover. These reagents may be either speci
a bone metabolism substance, or more frequently, appropriate for control of a whole set of similar bon
substances.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of either one or more of the group of substances that are safely and almost completely
liver. These reagents may be either specific for quality control of a liver metabolic product or, more fre
for control of a whole set of similar liver metabolic products.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of a group of endocrine hormones (e.g., adenocorticotropic, human grow
reagents may be either specific for quality control of an endocrine hormone or, more frequently, appro
whole set of similar endocrine hormones.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of either one or more of a group of neuroendocrine hormones (e.g., bombesin, neuroten
may be either specific for quality control of a neuroendocrine hormone or, more frequently, appropriat
set of similar endocrine hormones.
Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of either one or more of a group of gastrointestinal hormones (e.g., vasoactive intestina
reagents may be either specific for quality control of a gastrointestinal hormone or, more frequently, a
of a whole set of similar gastrointestinal hormones.

Reagents consisting of substances of known concentrations that are assayed by the usual clinical labo
that resemble the unknown specimen; they are used for quality control of immunoassay tests perform
determination of one or more of a group of derivatives of fatty acids known as prostaglandins. These
specific for quality control of a prostaglandin or, more frequently, appropriate for control of a whole se
prostaglandins.

Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory. These substances are established as a norm and com
substances used in a diverse range of sensitive and specific immunochemical clinical assays (i.e., imm
determine the purity or performance of those substances.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory, that are established as a norm and compared with s
immunoassay tests performed for the determination of lipoproteins.
Reagents consisting of substances of known composition, the value of which is established by an ana
different from that used in the clinical laboratory, that are established as a norm and compared with s
immunoassay tests performed for the determination of substances liberated from the myocardium int
cardiac markers).
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of substances present in or secreted by neoplast
tumor markers).
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a normand compared with similar rea
immunoassay tests performed for the determination of one or more of the group of hormones secrete

Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of hormones that are
reproduction.
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of hormones that are
pregnancy.
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of hormones (e.g., in
glucogen) that modulate the regulation of the concentration of glucose in the blood.
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of hormones that are
by the kidneys (e.g., renin, aldosterone).
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of hormones that reg
bone metabolism.
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of substances that ar
turnover (i.e., bone metabolism markers).
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of the group of substances that ar
completely metabolized by the liver.
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of a group of protein hormones th
secreted by an endocrine gland.
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of a group of hormones secreted a
neuroendocrine hormones).
Reagents consisting of substances of known composition, the value of which is established by an anal
from that used in the clinical laboratory, that are established as a norm and compared with similar rea
immunoassay tests performed for the determination of one or more of a group of gastrointestinal horm

Clinical chemistry reagents intended to perform qualitative and/or quantitative chemical analyses on a
(typically urine) to determine the level of catecholamine metabolites (e.g., vanillylmandelic and/or ho
Increases levels of catecholamine metabolites in urine are associated with catecholamine secreting tu
catecholamine metabolites is frequently performed using high-pressure liquid chromatography techni

Clinical chemistry reagents intended to perform qualitative and/or quantitative analyses on a body flu
urine) to determine vanillylmandelic acid, a catecholamine metabolite derived from the hormone epin
norepinephrine. Increased levels of urinary vanillylmandelic acid is found in patients with catecholami
Determination of vanillylmandelic acid is frequently performed using high-pressure liquid chromatogra

Clinical chemistry reagents intended to perform qualitative and/or quantitative analyses on a body flu
urine) to determine homovanillic acid (HVA), a catecholamine metabolite from the hormone dopamine
urinary HVA are found in patients with catecholamine-secreting tumors, particularly neuroblastomas. D
vanillylmandelic acid is frequently performed using high-pressure liquid chromatography techniques.
Clinical chemistry reagents intended to perform qualitative and/or quantitative analyses on a body flu
urine) to determine dehydroepiandrosterone (DHEA) and/or DHEA-sulfate metabolites, including 17-ke
17-ketosteroid glucoronides (17-KS-G). Determination of DHEA metabolites in urine is used to assess
patients (both physical and mental), especially under stress conditions.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine 17-ketosteroid sulfate (17-KS-S), a metabolite of dehydroepiandrosterone (DHEA)-sulfate
DHEA metabolites in urine is used to assess the health status of patients (both physical and mental), e
conditions. Most of these assays also include the simultaneous determination of the cortisol metabolit
hydroxycorticosteroid (17-OHCS); the ratio of 17-KS-S to 17-OHCS seems to be a good indicator of the

Reagents that include labeled antibody substances intended for use as specific probes for protein and
These reagents permit the examination of single cells for specific markers to identify cell lines and/or
synthetic capability. Labels may be either fluorescent or enzymatic; enzymatic labels make possible th
embedded in paraffin. Light microscopy is usually employed to identify labeled features, but electron
in some methods. Immunocytochemistry reagents are widely used to determine substances (e.g., pro
various tissue samples (e.g., frozen tissue, paraffin-embedded tissue, fine-needle aspirations), especia
cells.

Immunocytochemistry/immunohistochemistry reagents intended to perform qualitative and/or quantit


the expression of antigens (e.g., proteins) characteristic of neoplastic tumor cells (i.e., tumor markers)
Immunocytochemistry/immunohistochemistry analysis to assess the expression of tumor markers may
wide diversity of tissue sample types, including frozen tissue, paraffin-embedded tissue, and fine-need

Immunocytochemistry reagents intended to perform qualitative and/or quantitative analyses on a tiss


paraffin embedded) to determine the protein p53, a nuclear phosphoprotein codified by the p53 tumo
accumulation of p53 protein, a consequence of suppressor gene p53 inactivation, is considered a poor
invasive breast cancer. The expression of protein p53 is also associated with poor survival in patients
squamous cell carcinoma or with moderately differentiated, early stage, or residual epithelial ovarian
p53 protein is a marker of progression in classic Kaposi's sarcoma.

Immunocytochemistry reagents intended to perform qualitative and/or quantitative analyses on tissue


determine molecular structures (i.e., receptors) within or on the surface of the cells (typically some sp
permit selective binding with high affinity and great specificity to particular substances (e.g., hormone
and progesterone). These reagents are mostly used in monoclonal antibody based assays that act on
recognition.

Immunocytochemistry reagents intended to perform qualitative and/or quantitative analyses on tissue


determine a cellular regulatory protein that binds estrogenic hormones (i.e., cytoplasmic estrogen rec
receptors are especially found in estrogen-sensitive tissues (e.g., breast and uterus tissues). The assa
surgically removed samples. Determination of the level of estrogen receptors is used as a marker of th
endocrine therapy in diseases such as breast carcinoma.
Immunocytochemistry/immunohistochemistry reagents intended to perform qualitative and/or quantit
the expression of the progesterone receptor (PR). Analysis of PR expression may be used to character
particular, PR expression levels aid in determining whether patients in whom breast cancer has been d
for treatment with endocrine therapy.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine the level of serum transferrin receptor (sTfR), a protein associated with the cellular upta
Levels of sTfR in serum are considered a sensitive and specific index of iron depletion, as sTfR levels
deficiency anemia but not in chronic inflammatory diseases. They may be used also to differentiate be
anemia.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine thiamine (vitamin B1), a pyrimidyl-substituted thiazole, and/or some of its metabo
some metabolites) are excreted into the urine by the renal tubules. Measurement of thiamine levels is
vitamin B1 deficiency (a disease called beriberi), typically found in diets poor in thiamine, chronic alco
metabolic diseases. The functional status of thiamine is usually determined by measuring the vitamin
the enzyme transketolase (TK).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine riboflavin (vitamin B2), a yellow compound that is an integral part of numerous na
flavins. Riboflavin and some of its metabolites are excreted into the urine. Decreased levels of vitamin
by the presence of sore throat, hyperemia, stomatitis, and edema of the oral and pharyngeal membra
riboflavin may also cause seborrheic dermatitis and some types of anemias. The functional status of r
determined by measuring the vitamin-dependent activity of the enzyme glutathione reductase (GTR).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine) to determine vitamin B6, its metabolites, and/or pyridoxal-5'-phosphate (PLP), the coenzyme fo
B6-dependent reactions. Vitamin B6 is a group of three natural forms: pyridoxine, pyridoxamine, and p
levels of vitamin B6 are associated with epileptic-like convulsions in young patients, dermatitis with ch
some types of chronic anemias, and encephalographic abnormalities. The functional status of vitamin
determined by measuring the vitamin-dependent activity of the enzyme aspartate aminotransferase (
be also measured using high-pressure liquid chromatography.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine two families of secosteroids (known as Vitamin D), the ergocalciferols and cholecalciferols (
respectively). Cholecalciferols are produced naturally in humans, while ergocalciferols are ingested fro
by irradiation of ergosterol produced by yeasts. Regardless of the slight chemical differences, it is likel
the same biological effects. A large number of bone and mineral metabolism disorders are associated
of vitamin D and/or its metabolites.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine metabolites of vitamin D, both of vitamin D2 (ergocalciferol) or D3 (cholecalciferol). These
designed to differentiate between D2 and D3 metabolites because both produce dihydroxylated meta
equal biological activity. Determination of circulating vitamin D metabolites (e.g., 25-hydroxyvitamin D
dihydroxyvitamin D) is easier and likely reflects the vitamin D status better than the assays of vitamin
number of bone and mineral metabolism disorders are associated with abnormal levels of vitamin D a
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine both folate and vitamin B12. Folate levels are decreased in megaloblastic anem
disorders, and during pregnancy. Decreased levels of vitamin B12 are associated with pernicious anem
disorders, and dementia. The simultaneous determination of folates and vitamin B12 is important bec
either one or both cause megaloblastic anemia, and an inappropriate treatment of B12 deficiency with
irreversible nerve degeneration.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of digitoxin (a cardiac glycoside sometimes used in place of digoxin; digitoxin is a digitalis medi
be used to improve the strength and efficiency of the heart or as an antiarrhythmic agent to control th
the heartbeat) present in the sample. These reagents are used to measure digitoxin levels in patients
to monitor the adequacy of therapy, and to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of disopyramide (a class I antiarrhythmic agent [one that interferes directly with the depolarizat
membrane and thus serves as a membrane-stabilizing agent] with a depressant action on the heart si
guanidine) present in the sample. These reagents are used in tests intended to monitor disopyramide
patients undergoing treatment to determine the adequacy of therapy, and to diagnose drug overdose
toxicity.

Immunoassay reagents intended to perform quantitative analyses on body fluid samples (e.g., serum,
levels of N-acetylprocainamide (NAPA) (also known as acecainide; NAPA is a metabolite of the antiarrh
procainamide) in the samples. These reagents are used to measure NAPA levels for therapeutic drug m
diagnose a drug overdose or drug-related toxicity. NAPA level analysis is typically performed simultane
of levels of procainamide.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of procainamide (an antiarrhythmic drug used in the treatment of premature ventricular contrac
ventricular tachycardia, and atrial fibrillation) in a sample. These reagents are used in tests to monitor
in patients undergoing treatment to determine the adequacy of therapy and to diagnose drug overdos
toxicity. Procainamide levels are typically measured in conjunction with levels of the procainamide me
acetylprocainamide (NAPA).

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of propanolol (a non-cardioselective beta-adrenergic antagonist used in the treatment or preven
including acute myocardial infarction, arrhythmias, angina pectoris, hypertension, hypertensive emerg
hyperthyroidism, migraine, pheochromocytoma, menopause, and anxiety) in the sample. Propanolol d
used for therapeutic drug monitoring because there is no close correlation between blood concentrati
and drug effects; these reagents are more often used to diagnose a drug overdose or drug-related tox

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of nadolol (a non-selective beta-adrenergic antagonist used in cardiovascular disease to treat a
pectoris, and hypertension, as well as migraine disorders and tremors) in the sample. Nadolol levels a
therapeutic drug monitoring as there is no close correlation between drug levels found in the blood an
reagents are more typically used in the diagnosis of drug overdoses or drug-related toxicity.
Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
the level of quinidine, an optical isomer of quinine, present in the sample. Quinidine dampens the exc
skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs c
and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission
tests are used in the treatment/monitoring of certain cardiovascular conditions (e.g., atrial premature
tachycardia). Quinidine is available either as quinidine sulfate or quinidine gluconate. These reagents
quinidine levels in patients, e.g., to determine the adequacy of therapy, and in the diagnosis of a drug
related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of verapamil (a calcium channel blocker/class IV antiarrhythmia agent) in the sample. These rea
intended to measure verapamil levels in patients undergoing treatment to determine the adequacy of
diagnose a drug overdose or drug-related toxicity.
Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of mexiletine (an antiarrhythmia agent similar in structure and action to lidocaine that is typical
treatment of ventricular arrhythmias, such as life-threatening ventricular tachycardias) present in the
reagents are used in tests intended to monitor mexiletine drug levels in patients undergoing treatmen
adequacy of therapy or to diagnose a drug-overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of amiodarone, an antiarrhythmic used to control supraventricular and ventricular tachyarrhyth
sample. These reagents are used to measure amiodarone levels in patients undergoing treatment, to
of therapy, and to establish the likelihood of drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of propafenone, an antiarrhythmic drug, in the sample. These reagents are used to monitor pro
patients undergoing treatment to determine the adequacy of therapy or to diagnose a drug overdose

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of tocainide (an antiarrhythmic agent which exerts a potential- and frequency-dependent block
the sample. These reagents are used to measure tocainide drug levels in patients undergoing treatme
adequacy of therapy or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (typically se
of free carbamazepine, the bioactive component of carbamazepine, in the patient sample. Carbamaze
anticonvulsant and antineuralgic drug, but only free carbamazepine and its metabolite carbamazepine
bioactive. Reagents for measuring levels of free carbamazepine can be used in tests intended to mon
patients under treatment, either to determine the adequacy of drug treatment or diagnose a drug ove
toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of ethosuximide (a drug used in the treatment of a form of epilepsy known as petit mal) presen
Reagents for measuring levels of ethosuximide are mostly used to monitor the adequacy of drug treat
frequently to diagnose a drug overdose or drug-related toxicity.
Immunoassay reagents intended to perform quantitative analyses of a sample of human serum or pla
of free phenytoin (the bioactive component of phenytoin in blood) present in the sample. Reagents for
free phenytoin are used to monitor the drug levels in patients undergoing treatment, either to determ
drug treatment or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of primidone (an antiepileptic agent related to the barbiturates; it is partly metabolized to phen
and owes some of its actions to this metabolite) present in the blood. Reagents for measuring levels o
monitor the drug levels in patients undergoing treatment, either to determine the adequacy of drug tr
diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of total valproic acid (a fatty acid used in the treatment of epilepsy and bipolar disorders) prese
Valproic acid is highly bound (about 93%) to proteins in plasma, but only free valproic acid is bioactive
measuring total valproic acid are used to monitor the drug levels in patients undergoing treatment, ei
adequacy of drug treatment or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (typically se
of free valproic acid, the bioactive component of valproic acid, present in the sample. Reagents for me
acid are used to monitor the drug levels in patients undergoing treatment, either to determine the ade
treatment or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of clonazepam (a benzodiazepine with a chemical structure closely related to diazepam that is u
of seizures and infantile spasms) present in the sample. Reagents for measuring levels of clonazepam
the drug levels in patients undergoing treatment, either to determine the adequacy of drug treatment
overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of amikacin, a semisynthetic aminoglycoside bactericidal agent present in the sample. Amikacin
treatment of a wide variety of aerobic gram-negative bacteria and also for some gram-positive bacter
measuring amikacin levels are used monitor the therapeutic drug levels in patients undergoing treatm
determine the adequacy of drug treatment or to diagnose a drug overdose or antibiotic-related toxicit
levels in blood, in micrograms per milliliter, are peak 20 to 25, predose (trough) 5 to 10, and toxic mor

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of kanamycin, an aminoglycoside bactericidal agent. Kanamycin is used in the treatment of a w
gram-negative bacteria and also for some gram-positive bacteria including mycobacteria. Reagents fo
measurement are used to monitor the therapeutic drug level in patients undergoing treatment, either
adequacy of drug treatment or to diagnose a drug overdose or drug-related toxicity. Typical reference
microgram per milliliter, are: peak 20 to 25, predose (trough) 5 to 10, and toxic more than 35.
Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of netilmycin, a semisynthetic aminoglycoside bactericidal agent, present in the sample. Netilm
treatment of a wide variety of gram-negative bacteria and also for some gram-positive bacteria. Reag
drug level measurement are used to monitor therapeutic drug levels in patients undergoing treatmen
the adequacy of drug treatment or to diagnose a drug overdose or drug-related toxicity. A prolonged n
than 16 micrograms per milliliter in blood is considered toxic.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of chloramphenicol, an antibiotic that acts by interfering with bacterial protein synthesis and is
Chloramphenicol is used in the treatment of a wide range of gram-negative and gram-positive bacteri
in the treatment of typhus and other rickettsial infections. Reagents for chloramphenicol drug level de
able to differentiate between the pro-drug forms (i.e., chloramphenicol palmitate or succinate) and the
chloramphenicol. These reagents are used to monitor the drug levels in patients undergoing treatmen
a therapeutic drug level exists, or to diagnose a drug overdose or drug-related toxicity. Typical referen
micrograms per milliliter, are peak 20 to 30, predose (trough) 10, and toxic more than 50.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
levels of one or more immunosuppressive agents (i.e., agents that suppress immune function by one o
of action) in the sample. These reagents are used to measure the immunosuppressant levels in patien
treatment to determine the adequacy of drug treatment (i.e., therapeutic drug monitoring) or to diagn
drug-related toxicity. Therapeutic drug monitoring plays a key role in helping clinicians maintain immu
therapeutic ranges in blood due to the narrow therapeutic index unique to each patient and to the var
distribution, and elimination that is characteristic of these agents.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (typically wh
levels of cyclosporine (immunosupressive agents with a specific action on T-lymphocytes that are typi
prophylaxis of graft rejection in organ and tissue transplantation) and/or its metabolitesin the sample.
measuring cyclosporine levels are intended to be used to measure drug concentrations in patients un
monitor the efficacy of drug treatment or to diagnose a drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (typically wh
levels of tacrolimus (a macrolide isolated from the culture broth of a strain of Streptomyces tsukubaen
immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antige
stimulation in vitro) in the sample. Reagents for measuring levels of tacrolimus (also known as FK 506
to monitor the drug levels in patients undergoing treatment to determine the adequacy of drug treatm
drug overdose or drug-related toxicity.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (typically wh
levels of sirolimus (also known as rapamycin), an immunosuppressive agent that possesses both antif
antineoplastic properties, in the sample. These reagents are designed for the selective measurement
specific reagents), but cross-reactivity with sirolimus metabolites may occur. Reagents for sirolimus dr
are used to monitor the drug levels in patients undergoing treatment to determine the adequacy of dr
diagnose a drug overdose or drug-related toxicity.
Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (typically wh
levels of mycophenolic acid, the active metabolite of mycophenolate mofetil (MMF), in the sample. My
antibiotic substance derived from Penicillium stoloniferum, and related species that blocks de novo bio
nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase. Mycophenolic acid h
the immune system and prevents the proliferation of T-cells, lymphocytes, and the formation of antibo
also may inhibit recruitment of leukocytes to inflammatory sites. Reagents for measuring mycophenol
to monitor the drug levels in patients under treatment to determine the adequacy of drug treatment o
overdose or drug-related toxicity.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum, saliva) to determine cotinine, the most frequently measured metabolite of nicotine. Cotinine i
that smoke or consume other tobacco-related products; it may be also present in nonsmokers as a con
smoking. Both cotinine and another major metabolite of nicotine, trans-3-hydroxycotinine (THOC) may
chromatographic methods.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
serum) to determine lysergic acid diethylamide (LSD), a synthetic hallucinogenic drug prepared from t
fungus. LSD produces mood changes, sensory distortions, hallucinations, delusions, and depersonaliza
physiological dependence on LSD is rare. Both LSD and its metabolite 2-oxohydroxy-LSD (O-H-LSD), w
metabolite and present for a longer time than LSD, can also be measured using chromatographic met
determination are used to diagnose intoxication caused by intentional or, less frequently, accidental in

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine methaqualone, a quinazoline derivative. Methaqualone has therapeutic use as a
drug; it can produce drug dependence and therefore has the potential for being abused. Acute overdo
and convulsions, followed by coma and death. Reagents for methaqualone determination are used in
diagnose and manage intoxication caused by intentional or, less frequently, accidental ingestion

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine phencyclidine (PCP), a drug formerly used as a surgical anesthetic and that is still used i
PCP has potent hallucinogenic properties, and it produces a state of euphoria, creating a high potentia
for PCP determination in urine samples can detect drug metabolites for several days (typically more th
users.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine one or more of a group of drugs that stimulates the mood of a depressed patient (i.e., antid
frequently administered antidepressants contain three fused rings in their chemical structure (i.e., tric
They include amitryptiline, desipramine, doxepin, imipramine, and nortriptyline. Some tetracyclic drug
antidepressants. Reagents used to determine antidepressant concentration in blood differentiate ther
(typically very low) from toxic levels due to overdose. Tricyclic antidepressant concentration in serum
therapeutic response, with the exception of nortriptyline which has a specific therapeutic window (typ
nanograms/milliliter). The metabolism of tricyclic antidepressants, especially their hydroxylation, resu
active metabolites, which contribute to both the therapeutic and the adverse effects of these compou
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine amitriptyline, an antidepressant tricyclic drug that also has sedative effects. Am
produces physiologically active metabolites (e.g., secondary tricyclic amines with antidepressant activ
nortriptyline); these metabolites should be measured simultaneously. Reagents used to determine am
concentration in blood differentiate therapeutic levels (typically very low) from toxic levels due to ove

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine desipramine, an antidepressant secondary tricyclic amine drug that is administe
capsules as desipramine hydrochloride. Reagents used to determine antidepressant concentration in b
therapeutic levels (typically very low) from toxic levels due to overdose.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine doxepin and/or its metabolites. Doxepin is an tertiary tricyclic amine drug admin
doxepin hydrochloride. It has therapeutic use as an antidepressant and topically as an antipruritic age
doxepin is highly conditioned to the production of active metabolites, including secondary tricyclic am
antidepressant activity, such as nordoxepin, and other metabolites such as E- and Z-N-desmethyldoxe
metabolites must be measured too. Reagents used to determine antidepressant concentration in bloo
therapeutic levels (typically very low) from toxic levels due to overdose.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine imipramine, a tertiary tricyclic amine drug with therapeutic use as an antidepre
Imipramine is administered as imipramine hydrochloride for attention deficit disorder, enuresis, chron
bulimia. Imipramine metabolism produces physiologically active metabolites (e.g., secondary tricyclic
antidepressant activity such as desipramine), these metabolites should be measured simultaneously.
determine antidepressant concentration in blood differentiate therapeutic levels (typically very low) fr
overdose.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine nortriptyline, a secondary tricyclic amine drug of the dibenzocycloheptadiene cl
of amitriptyline. Nortriptyline has therapeutic use as an antidepressant and analgesic. It is administer
hydrochloride to treat symptoms of depression and chronic pain. Reagents used to determine nortript
blood differentiate therapeutic levels (typically very low) from toxic levels due to overdose.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma) to determine protriptyline, an antidepressant secondary tricyclic amine drug. Protriptyline is a
protriptyline hydrochloride to treat symptoms of depression, attention deficit disorder, and cataplexy a
narcolepsy. Reagents used to determine antidepressant concentration in blood differentiate therapeu
very low) from toxic levels due to overdose.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine one or more of a group of substances, such as carbohydrate-deficient transferrin (CDT) and
glutamyltransferase (GGT), which are considered markers of long-time high alcohol consumption (i.e.,
markers). The sensitivity and specificity of these markers are likely related to patient age, sex, and he
are used as part of a group of tests for screening or monitoring of alcoholism.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine carbohydrate-deficient transferrin (CDT). CDT is a highly sensitive and specific marker for l
consumption in men over 40 years, but it is not a good marker in young men and women. Generally C
than gamma-glutamyltransferase (GGT) in the identification of alcohol abuse among patients with alco
liver diseases. The sensitivity of the test can be enhanced using CDT and GGT combined.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine gamma-glutamyltransferase (GGT). GGT is a moderately sensitive and specific marker for l
consumption. In general, GGT is a worse marker than carbohydrate-deficient transferrin (CDT). The se
be enhanced using CDT and GGT combined.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine metabolites of aromatic hydrocarbons. These metabolites are usually synthesized in the
the urine. Some metabolites of interest and their main sources are phenol from benzene; hippuric acid
toluene; o-, m-, and p-methylhippuric acids from xylene; and mandelic acid and phenylglyoxylic acid f
ethylbenzene. Reagents used to determine the concentration of these metabolites in urine are mostly
degree of intoxication due to the exposure to aromatic hydrocarbons, frequently as the result of occup

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine hippuric acid, a crystallizable acid synthesized in the liver (e.g., from benzoic acid) and e
Hippuric acid is the main human metabolite from toluene, an aromatic hydrocarbon of widespread use
automotive, shoemaking, and speaker manufacturing industries. Reagents used to determine hippuric
urine can establish the degree of intoxication with toluene, frequently as the result of occupational ex
the results should consider the dietary sources of the affected patients because they may include food
contain benzoic acid, increasing the level of hippuric acid in urine not related to toluene.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
to determine phenol (also known as carbolic acid) and/or one or more of a group of phenol-derivated c
generic name of phenols characterized by a hydroxyl group directly attached to an aromatic ring. The
metabolized in the liver and excreted in the urine. Reagents used to determine phenol/phenol compou
cresol) concentration in urine are used to establish the degree of intoxication with phenol, cresol, and
hydrocarbons (e.g., toluene), frequently as the result of occupational exposure. It may also occur by a
ingestion of phenol, creosol, or other related product. Phenol itself is considered a specific indicator of

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine, bile, feces) to determine porphyrin derivatives (commonly abbreviated as porphyrins). There ar
porphyrins, but only three (uroporphyrin, coproporphyrin, and protoporphyrin) are clinically important
protoporphyrin IX containing iron is known as heme; uroporphyrin and coproporphyrin type III isomers
contribute to heme synthesis. High levels of porphyrins are found in toxic (acquired) porphyrias cause
group of toxic agents (e.g., ethanol, hydrogenated hydrocarbons). Some dietary products, metabolic d
hereditary deficiencies (i.e., inherited porphyrias) may also cause abnormal porphyrin levels.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
blood, bile, feces) to determine protoporphyrin IX, a porphyrin derivative that is usually called heme w
Protoporphyrin is not water soluble and is not excreted in urine. Its determination usually requires who
erythrocyte assays; analysis of protoporphyrin in feces also has diagnostic capabilities. High levels of
found in toxic (acquired) porphyrias caused by one or more of a group of toxic agents (e.g., lead, alum
Some dietary products, metabolic diseases, and hereditary deficiencies (i.e., inherited porphyrias) ma
protoporphyrin levels.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine uroporphyrin, a porphyrin derivative. Uroporphyrin is the most water soluble of all porphyri
excreted in urine. High levels of uroporphyrin are found in toxic (acquired) porphyrias caused by one o
toxic agents (e.g., lead). Some dietary products, diseases (e.g., chronic renal failure), and hereditary d
inherited porphyrias) may also cause abnormal protoporphyrin levels.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
feces) to determine coproporphyrin, a porphyrin derivative. Coproporphyrin is moderately water solub
both in feces and in urine. High levels of coproporphyrin are found in toxic (acquired) porphyrias cause
group of toxic agents (e.g., chronic ethanol exposure, lead, mercury, arsenic). Some dietary products,
malignancies), and hereditary deficiencies (i.e., inherited porphyrias) may also cause abnormal coprop

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine insulin autoantibodies (IAAs), which are commonly found in diabetic patients treated with e
pig) insulin. These antibodies are found in patients during the development of diabetes mellitus cause
destruction of pancreatic beta-cell.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine cytoplasmic islet cell antibodies (ICAs). These antibodies are found in patients during the d
diabetes mellitus caused by autoimmune destruction of pancreatic beta-cell. Measurement of ICA leve
as a preclinical screening test to predict the development of diabetes in close relatives of patients wit
dependent) diabetes.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antiglutamic acid decarboxylase (GAD) antibodies. GAD antibodies are found in patients du
of diabetes mellitus caused by autoimmune destruction of pancreatic beta-cell. Measurement of anti-G
mostly used as a preclinical screening test to predict the development of diabetes in close relatives of
(i.e., insulin dependent) diabetes.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine protein tyrosine phosphatase antibodies (IA-2). These antibodies are found in patients durin
diabetes mellitus caused by autoimmune destruction of pancreatic beta-cell. Measurement of IA-2 ant
used as a preclinical screen test to predict the development of diabetes in close relatives of patients w
dependent) diabetes.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antinuclear antibodies to centromere proteins (CENP). Increased circulating levels of CENP
variant scleroderma and in some patients with Raynaud's disease and other autoimmune diseases (e.
systemic lupus erythematosus).
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine double-stranded DNA (ds-DNA) antibodies. Increased ds-DNA antibody circulating levels are
autoimmune connective tissue diseases, such as systemic lupus erythematosus (SLE). These reagents
assays intended for detection, diagnosis, and monitoring of SLE patients.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine single- stranded DNA (ss-DNA) antibodies. Increased ss-DNA antibody circulating levels are
autoimmune connective-tissue and inflammatory rheumatic diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine Jo-1 antibodies to (histidyl transfer RNA synthetase). Circulating Jo-1 antibodies are present
connective-tissue diseases, particularly in polymyositis, a chronic, progressive inflammatory disease o
polymyositis frequently occurs with inflammatory skin changes (i.e., dermatomyositis). Patients suffer
have associated interstitial lung disease.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to polymyositis-scleroderma (PM-Scl) overlap syndrome antigens. Increased leve
are associated to scleroderma overlap syndromes, such as mixed connective-tissue disease.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine Scleroderma-70 ([Scl-70], DNA topoisomerase I) antibodies. Circulating Scl-70 antibodies a
autoimmune connective-tissue diseases, particularly in scleroderma and progressive systemic scleros

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine Smith (Sm) antibodies, a part of a small nuclear RNA protein complex known as snRNA. Sm
of several proteins; circulating Sm antibodies are sometimes present in autoimmune connective-tissue

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to ribonucleic proteins (anti-RNPs), one of the extractable nuclear antigens. The
in autoimmune connective-tissue diseases, including systemic lupus erythematosus.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies (termed SS-A or SS-A/ro) to an RNA/protein complex (an extractable nuclear ant
antibodies are present in autoimmune connective-tissue diseases, particularly in Sjogren's syndrome w
by keratoconjunctivitis and xerostomia.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies (termed SS-B or SS-B/La) to an RNA/protein complex (an extractable nuclear ant
antibodies are present in autoimmune connective-tissue diseases, particularly in Sjogren's syndrome w
by keratoconjunctivitis and xerostomia.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to part of a small RNA protein complex known as snRNA (U1-snRNP antibodies).
antibodies are present in autoimmune connective-tissue diseases, particularly in systemic lupus eryth
related diseases.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine total antiganglioside antibodies (e.g., anti-GM1, anti-GD1b). Total antiganglioside antibodie
neuropathies, such as Guillain-Barre syndrome and chronic inflammatory demyelinating polyneuropat

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to the Asialo ganglioside-monosialic acid GM1 (i.e., anti-GM1 antibodies). These
associated with neuropathies, such as Guillain-Barre syndrome, its variant called Miller-Fisher syndrom
idiopathic neuropathy.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to the ganglioside GM2 (i.e., anti-GM2 antibodies). These antibodies are associa
such as Guillain-Barre syndrome (GBS); they are frequently present in the serum from GBS patients wi
infection with cytomegalovirus; antibodies to a rare form (i.e., variant B1) of GM2 gangliosides are as
neurodegenerative disorders such as speech, gait, and seizures in children.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluids s
determine antibodies to the Asialo ganglioside-monosialic acid (Asialo- GM1). These antibodies are as
neuropathies, especially with multifocal motor neuropathies.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of bo
to determine antibodies to the disialoganglioside acid (GD1b antibodies). These antibodies are associa
particularly to chronic sensory ataxic neuropathy.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antimyelin antibodies (e.g., antimyelin associated glycoprotein antibodies) in which activity
peripheral nerve antigens. These antibodies are mostly found in neuropathies.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antimyelin-associated glycoprotein antibodies (anti-MAG antibodies) in which activity is dire
peripheral nerve antigens. These antibodies are mostly found in chronic demyelinating or inflammator

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antisulfated 3-glucuronyl paragloboside antibodies (anti-SGPG antibodies) in which activity
peripheral nerve antigens. These antibodies are mostly found in demyelinating neuropathies.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to one or more of several retinal proteins found in patients with cancer-associat
CAR antibodies). This retinopathy is a rare disease characterized by retinal degeneration and a progre
association with cancer in the absence of metastatic, infectious, or metabolic complications (i.e., a pa
neurological disease). Reagents to determine anti-CAR antibodies are mainly used in assays intended
cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies to recoverin, a 23 kDalton retinal photoreceptor protein. These antibodies are fo
cancer-associated retinopathy (CAR), a rare disease characterized by retinal degeneration and a progr
association with cancer, in the absence of metastatic, infectious, or metabolic complications (i.e., a pa
neurologic disease). Reagents used to determine recoverin are mainly used in assays intended for ear
frequently when only visual symptoms are present.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine anti-Hu antibodies. These antibodies are found in patients with diseases characterized by a
neurological disorders and cancer in the absence of metastatic, infectious, or metabolic complications
neurological diseases). Reagents to determine anti-Hu antibodies may be used in assays intended for
cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine anti-Yo antibodies; these antibodies are found in patients with diseases characterized by an
neurological disorders and cancer in the absence of metastatic, infectious, or metabolic complications
neurological diseases). Reagents to determine anti-Yo antibodies may be used in assays intended for
cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine anti-Ri antibodies; these antibodies are found in patients with diseases characterized by an
neurological disorders and cancer in the absence of metastatic, infectious, or metabolic complications
neurological diseases). Reagents to determine anti-Ri antibodies may be used in assays intended for e
cancer.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies directed against thyroid peroxidase (TPO), the main and possibly only antigenic
thyroid epithelial cells. Antibodies against TPO (i.e., anti-TPO antibodies) provide a high sensitivity and
microsomal antibodies of thyroid epithelial cells; anti-TPO antibodies are found in almost all adult patie
autoimmune disease of the thyroid gland with lymphocytic infiltration (Hashimoto's thyroiditis), in mo
with Grave's disease, and in patients with idiopathic myxedema (associated with primary hypothyroid
TPO are used for detecting, confirming, and monitoring autoimmune thyroid disorders.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies directed toward the A2hnRNP core protein, known as anti-RA33 antib
anti-RA33 antibodies, combined with the determination of rheumatoid factor antibodies, may be used
patients at risk of erosive arthritis, especially those patients who suffer from systemic lupus erythema

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies directed toward keratin (stratum corneum). Antikeratin antibodies (A
with erosive polyarthritis; its determination, frequently combined with the determination of rheumatoi
used in the diagnostic and therapeutic strategies for early rheumatoid arthritis.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies against perinuclear antigens (i.e., antiperinuclear factor [APF)S. APFs
but less specific in the determination of rheumatoid arthritis. Determination of APF may be used in com
determination of rheumatoid factor antibodies in the prognosis of early rheumatoid arthritis.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies against streptokinase (i.e., antistreptokinase antibodies) produced by
pyogens. These antibodies are developed in response to, or as the result of, a preceding streptococca
streptokinase administration in patients who had suffered from myocardial infarction. Antistreptokinas
associated with some autoimmune diseases, including rheumatism.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies against gliadin (GA), a protein found in wheat and rye gluten. Antibod
found in patients suffering from an autoimmune disease characterized by a malabsorption syndrome (
affecting both children and adults; this disease is promoted by ingestion of foods containing gluten, su

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies against the sheath that surrounds muscular fibers (I.e., endomesium)
highly specific and sensitive for an autoimmune disease characterized by a malabsorption syndrome (
affecting both children and adults; this disease is promoted by ingestion of foods containing gluten, su

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine circulating antibodies against the enzyme tissue transglutaminase (TG). These antibodies a
sensitive for an autoimmune disease characterized by a malabsorption syndrome (i.e., celiac disease)
and adults; this disease is promoted by ingestion of foods containing gluten, such as cereals.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antinuclear histone proteins (e.g., H1, H2A, H2B, H3, H4) antibodies. Increased circulating l
with autoimmune connective tissue (e.g., systemic lupus erythematosus), chronic hepatitis, and inflam
diseases. High levels of histones are also found in response to long treatments with some therapeutic
procainamide, hydralazine).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against phospholipids (e.g., cardiolipin, phosphatidylserine) and/or their comple
proteins. Increased levels of antiphospholipid antibodies are found in some patients in a large spectru
diseases, including connective tissue diseases, rheumatoid arthritis, and in an antiphospholipid syndro
systemic lupus erythematosus.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against cardiolipin (i.e., anti-CL antibodies), an anionic phospholipid present in m
bacterial membranes. Increased levels of anti-CL antibodies are found in some patients in a large spec
diseases, including connective tissue diseases, rheumatoid arthritis, and systemic lupus erythematosu
(particularly, some specific monoclonal antibodies) are also present in the serum of patients with the a
syndrome; they are associated with increased risks of thrombosis and coronary and cerebral ischemic

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
urine, cerebrospinal fluid) to determine neopterin, a low-molecular-mass pteridine mostly produced by
monocytes. Increased concentrations of neopterin in serum and urine are associated with activation o
system; they are found in patients with viral infections, malignant diseases, chronic infections, and oth
diseases; determination of neopterin levels are also used for differential diagnosis of acute viral and b
for monitoring the progress of autoimmune diseases (e.g., lupus erythematosus).

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against the glomerular and alveolar basement membranes (i.e., Goodpasture an
against the globular domain of type IV collagen. Reagents for determination of these antibodies in ser
diagnostic of Goodpasture disease, an autoimmune disorder characterized by progressive glomerulon
frequently, pulmonary hemorrhage.
Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antibodies against nuclear substructures known as nuclear dots (ND10) that contain severa
Sp100, promyelocytic leukemia protein, NDP52). These antibodies are associated to autoimmune dise
biliary cirrhosis, promyelocytic leukemia, other forms of neoplasias, and some viral infections.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
plasma, serum) to determine antibodies to the sperm surface (antisperm antibodies [ASAs]), these an
sperm agglutinating and/or immobilizing activities, block sperm-egg interaction, or prevent implantati
directed against antigens (e.g., rSMP-B, calpastin, HED-2) produced by different cells of the reproducti
and characteristics associated with one or more ASAs in men or women are associated with the fertiliz
spermatozoa (immunologic infertility); increased levels of ASA are found in men with sperm pathologi
vasectomy and also in prepubertal boys with testicular failures.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine antineutrophil cytoplasmic antibodies to proteinase 3 (PR3-ANCA). Increased circulating lev
used in the diagnostic of systemic vasculitis, they are also associated with extra-renal organ involvem
respiratory involvements), autoimmune connective tissue diseases, and Wegener's granulomatosis. M
with cytoplasmic-ANCA using indirect immunofluorescence, a less specific method, have antibodies to

Immunoassay reagents intended to perform qualitative and/or quantitative analyses on a body fluid sa
determine myeloperoxidase-antineutrophil cytoplasmic antibodies (MPO-ANCA). Increased circulating
associated with chronic lesions and slow deterioration of renal function; they are also found in autoimm
diseases. Many patients identified with perinuclear-ANCA using indirect immunofluorescence, a less sp
antibodies to MPO-ANCA.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
amphetamines in a short period of time, typically several minutes. Reagents for rapid determination o
used in tests intended to monitor the drug levels in patients as a result of a fairly recent drug use; the
casual use from chronic drug abuse, degree of impairment, exact time of use, or dose of drug taken. I
amphetamine have variable cross-reactivity with other sympathomimetic amines (e.g. ephedrine, pse
confirmation of positive results is mandatory.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically seru
barbiturates in a short period of time, typically several minutes. Reagents for rapid determination of b
tests intended to monitor drug levels in patients as a result of either an induced therapeutic coma (an
diagnose and manage barbiturate intoxication caused by intentional, or less frequently, accidental ing
emergency situations.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically seru
determine benzodiazepines and/or their metabolites in a short period of time, typically several minute
determination of benzodoazepines are used in tests intended to diagnose and manage benzodiazepin
by intentional or, less frequently, accidental ingestion, especially in emergency situations.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
cannabinoid levels and/or cannabinoid metabolite levels in a short period of time, typically several mi
Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
cocaine and/or cocaine metabolites in a short period of time, typically several minutes. Cocaine is mo
insufflation (snorting) as cocaine hydrochloride; it may also be smoked as a free base (crack). Immun
designed for rapid screening of urine samples for cocaine usually measure inactive cocaine metabolite
benzoylecgonine, because only small amounts of cocaine are excreted in the urine. These tests are m
emergency situations, especially before administration of anesthetics (e.g., during labor), due to the i
cocaine and anesthetic products.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
presence/concentration of opiates in that sample within a short period of time, typically several minut

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
morphine levels in the sample within a short period of time, typically several minutes.
Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
codeine in a short period of time, typically several minutes. Codeine, an alkaloid from opium or prepar
some analgesic properties because about 10% is converted into morphine, has therapeutic use as ana
prevent cough. Codeine can cause drug dependence and therefore has the potential to be abused. Fo
ingestion, both codeine and morphine can be detected in the urine. Codeine can be also detected afte
codeine is a common contaminant of heroin. Reagents for codeine determination in urine samples ca
to four days after use. The consumption of foods that include poppy seeds, such as cakes, muffins, an
urine excretion of codeine.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
propoxyphen levels in that sample within a short period of time, typically several minutes.
Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
methadone in a short period of time, typically several minutes. Methadone, a synthetic agent with mo
is a long-lasting opiate that has therapeutic use as an analgesic and in withdrawal from morphine add
administered orally as methadone hydrochloride, but can be also administered intramuscularly or sub
Methadone produces a state of sedation and euphoria similar to, but less intensive than, natural opiat
potential for abuse. Reagents for methadone determination in urine samples can detect methadone m
one to four days after use.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
meperidine in a short period of time, typically several minutes. Meperidine, a synthetic agent with mo
has therapeutic use as a short-term analgesic. It is administered orally as meperidine hydrochloride. M
state of sedation and euphoria similar, but less intense than, natural opiates, creating a high potentia
for meperidine determination in urine samples can detect its use typically for one to four days after us
useful in emergency situations.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (typically urin
phencyclidine in a short period of time, typically several minutes. Phencyclidine is a drug formerly use
anesthetic and that is still used in veterinary medicine. Reagents for rapid determination of phencyclid
can detect its use for several days (typically more than seven) after its last use in frequent consumers
useful in emergency situations.
Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (e.g., serum)
period of time, typically several minutes, one or more of a group of drugs that stimulates the mood of
(I.e., antidepressants). Reagents used for rapid determination of antidepressant concentration in blood
therapeutic levels (typically very low) from toxic levels due to overdose when these drugs are ingeste
intentionally. Rapid tests for antidepressant determination are mostly used in emergency situations.

Immunoassay reagents intended to perform qualitative analyses on a body fluid sample (e.g., serum)
period of time (typically several minutes), one or more of a group of tricyclic antidepressant drugs, inc
desipramine, doxepin, imipramine, and nortriptyline. Reagents used for rapid determination of tricycli
concentration in blood differentiate therapeutic levels (typically very low) from toxic levels due to ove
drugs are ingested either accidentally or intentionally. The active metabolites of these antidepressant
therapeutic and adverse effects of these compounds. Rapid tests for tricyclic antidepressant determin
in emergency situations.

Immunoassay reagents intended to perform quantitative analyses on a body fluid sample (e.g., serum
short period of time, typically several minutes, the parathyroid hormone (PTH) level. Intraoperative te
determination of PTH in plasma provides angiographers with almost immediate feedback, facilitating a
adenoma localization and confirming complete removal in operations performed for management of p
hyperparathyroidism.

Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in tests pe
one or more of a group of substances present in the blood (e.g., erythropoietin, serum ferritin) of whic
characterize anemia disorders.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in immuno
to determine some vitamins, including vitamin B12 and folate.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in immuno
to identify and/or measure levels (i.e., in a serum, plasma or whole blood specimen) of one or more of
drugs that include pain relievers, antibiotics, and cardiovascular, nervous system, antiasthmatic, antin
immunosuppressive agents.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in immuno
to determine one or more of a group of drugs that have a high potential of abuse, including amphetam
cocaine, and marijuana.
Reagents consisting of substances intended to establish points of reference (i.e., calibrate) in immuno
to determine agents developed by the organism that cause an immune response against its own tissu
autoimmune diseases).
Reagents consisting of samples of substances with known values; they are used for quality control of i
performed for the determination of one or more of a group of substances present in the blood (e.g., e
ferritin) in which the level may be used to characterize anemia disorders.
Reagents consisting of samples of substances with known values; they are used for quality control of i
performed to determine one or more of a group vitamins (e.g., vitamin B12, folate).
Reagents consisting of samples of substances with known values; they are used for quality control of i
performed to measure levels of one or more of a group of therapeutic drugs in a specimen (e.g., serum
blood) collected from a patient.
Reagents consisting of samples of substances with known values; they are used for quality control of t
determine one or more of a group of drugs that have a high potential of abuse, including amphetamin
cocaine, and marijuana.
Reagents consisting of samples of substances with known values; they are used for quality control of i
performed to determine agents developed by the organism that cause an immune response against it
constituents (I.e., autoimmune diseases).
Reagents consisting of a substance that is established as a norm with which similar reagents used in i
performed for the determination of one or more of a group of substances, which may be used to chara
disorders present in the blood (e.g., erythropoietin, serum ferritin, folate), are compared. Standard rea
determine the purity or performance of the reagents used in those tests.

Reagents consisting of a substance that is established as a norm and compared with similar reagents
tests performed for the determination of one or more of a group of vitamins (e.g., vitamin B12, folate)
may be used to determine the purity or performance of the reagents used in those tests.

Immunoassay reagents consisting of a substance that is established as a norm and compared with sim
immunoassay tests performed to measure levels of one or more of a group of therapeutic drugs in a s
plasma, whole blood) collected from a patient. Standard reagents may be used to determine the purit
the reagents used in those tests.
Reagents consisting of a substance that is established as a norm and compared with similar reagents
tests performed to determine one or more of a group of drugs that have a high potential of abuse. Sta
used to determine the purity or performance of the reagents used in those tests.

Reagents consisting of a substance that is established as a norm and compared with similar reagents
tests performed for the determination of one or more of a group of drugs that are toxic when taken in
reagents may be used to determine the purity or performance of the reagents used in these tests.

Reagents consisting of a substance that is established as a norm and compared with similar reagents
tests performed to determine agents developed by the organism that causes an immune response ag
constituents (autoimmune diseases). Standard reagents may be used to determine the purity or perfo
reagents used in these tests.
Clinical chemistry reagents intended to perform qualitative and/or quantitative analyses on a body flu
blood, erythrocyte hemolysates) to determine the riboflavin (vitamin B2) status by measuring the enz
reductase; this enzyme is typically measured indirectly (i.e., measuring the flavin adenine dinucleotid
the enzyme glutathione reductase). Decreased levels of vitamin B2 are characterized by the presence
hyperemia, stomatitis, and edema of the oral and pharyngeal membranes; deficiency of riboflavin ma
dermatitis and some types of anemias.

Clinical chemistry reagents intended to perform qualitative and/or quantitative analyses on a body flu
blood, erythrocyte hemolysates) to determine the thiamine (vitamin B1) status by measuring the enzy
this enzyme is typically measured indirectly (i.e., measuring the thiamine-dependent activity of the en
Decreased levels of thiamine are used for diagnosis of vitamin B1 deficiency (a disease called beriber
found in diets low in thiamine, chronic alcoholism, or some inborn metabolic diseases.
Serology reagents intended to detect antibodies to the M protein produced by Streptococcus group A
Streptococcus pyogenes), a spherical bacteria of the family Streptococcaceae. Streptococcus pyogen
important bacterial human pathogens, causing a wide range of suppurative diseases (e.g., pharyngitis
endocarditis) and nonsuppurative sequelae (e.g., acute rheumatic fever). These antibodies identify sp
may be associated with some autoimmune diseases (such as acute rheumatic fever) idiopathic mitral
poststreptococcal glomerulonephritis.

Cytology/histology reagents intended to establish points of reference (i.e., calibrate) for assays using
techniques. These reagents typically consist of fluorescent labeled latex microspheres; they are usual
calibration kits.
Cytology/histology reagents intended for quality control for assays using flow cytometry techniques. T
consist of fluorescent labeled monoclonal antibodies of known values; they are usually available as co

Testers designed to measure the opposition to an electric current circulation by a material or device w
alternating voltage is applied to it (i.e., impedance). Impedance testers usually include measuring inst
the appropriate range of impedance as well as accessory devices designed to perform the assessmen
physical characteristics and configuration of the material or device under test.

Impedance testers designed to measure the impedance between the biopotential surface electrodes t
electroencephalography and the skin; most testers are also capable of measuring the interference vol
stored in the electrodes (offset voltage) and detecting faulty lead wires and/or cables. Electroencepha
impedance testers are used to assess the ability of a large set (e.g., 20 or more) of surface electroenc
electrodes to conduct the brain bioelectric signals from the skin to the electrodes, and/or through the
measuring unit.

Physiologic electroencephalography (EEG) monitors designed for continuous intraoperative measurem


activity and the translation and display of its value as a numerical index (i.e., the level of consciousne
process and display EEG waveforms and/or density spectral arrays. These monitors include a central c
with electronic circuits that can process the signal, a display, and a patient cable with disposable EEG
consciousness monitors are mostly intended to help in the evaluation of the brain state changes (e.g.,
in response to drug dose during surgery; their use may reduce the quantity of anesthetic agents requ
release of patients from the post anesthesia care units.

Scanning systems designed to combine computed tomography (CT) and positron emission tomograph
These systems may consist either of CT and PET scanners mounted in a common mechanical support
or of open-design CT and PET scanners that permit the use of CT and PET as stand-alone scanning sys
include common tables, workstations, monitors, and appropriate software to align the CT and PET ima
be used when needed for separate CT and PET studies without loss of technical performance. The sys
(i.e., integration) of anatomic images provided by CT slices and the functional (metabolic) images from
the same session with the patient in treatment position. CT/PET combined systems are intended to fac
accurate evaluations; they are mostly used for the diagnosis, treatment planning, and evaluation of th
patients, characterizing the disease by both its anatomic and biological features.
Testers designed to check the performance of pulse oximeters; these testers deliver optical signals thr
interface (e.g., an optomechanical finger) to the oximeter probe. Tests may be performed at preestabl
various saturation values (e.g., 45 beats per minute [bpm], 60 bpm, 90 bpm). Pulse oximeter testers a
assess the pulse oximeter's ability to reproduce the calibration ratio of the absorption ratio curve (i.e.,
the manufacturer; some testers include capabilities for testing the electrical integrity of the probes (e
circuits).

Testers that combine the capabilities of electrical safety testers and multiparameter medical device si
instruments that measure electrical variables and parameters such as leakage electric current and res
evaluate the safety of electrical devices, including line power receptacles and line interruption monito
include pulse generators designed to simulate the bioelectrical signals of human organs (e.g., heart, b
electrical output of transducers that detect patient vital signs (e.g., blood pressure, temperature) and
into electrical signals. Electrical safety/medical device performance testers are typically used for auto
the safety of electrically powered medical equipment and other electrical devices (e.g., line power rec
fault circuit interrupters); they are also used to check the performance of single- and multiparameter
and other devices that record and measure physiologic parameters.

Instruments designed to measure the quantity of energy per unit of time (i.e., power), usually in watts
typically include detectors, electronic circuitry, and displays with characteristics appropriate to measu
energy (e.g., direct-current, alternating-current, and/or radio-frequency electric power; ultrasonic pow
power values. Power meters are typically used to measure the power output of medical devices (e.g.,
warmers, ultrasonic physiotherapy units) or to determine the strength of radiation at a given point.

Power meters designed to measure the power output of devices that radiate electromagnetic energy i
frequencies used for radio transmission (i.e., radio-frequencies), typically from 3 to 30 MHz. Radio-freq
usually measure in watts; the measurements are typically performed on a reference resistor of known

Ultrasonic power meters designed to characterize the size, shape, and energy of the shock-wave field
within the focal region; it requires a wide frequency response (up to 100 MHz) with appropriate lineari
typically consist of a main unit with electronic circuitry and a display, as well as a remote submersible
wave sensor (e.g., a disposable piezoelectric material membrane). Shock-wave ultrasonic power mete
and assess the output characteristics of shock-wave ultrasonic therapeutic units such as extracorpore
lithotripters.

Auditory function screening devices designed to detect hearing loss in new borns. Tests are based on
manual or automated) of the response of the hearing pathway from the ear to the cochlea by detectin
emissions (OAE); from the ear to the brainstem by detecting the auditory brainstem response (ABR); o
typically consist of an audio frequency generator, earphones, sensors, cables, a computerized process
and/or printer.
Bedside monitors designed to acquire, measure, display, monitor, record/store, and in some cases ana
related to one or more physiologic parameters reflecting a patient's clinical condition. These monitors
circuits or other technology designed to acquire and/or process the signal from one or more physiolog
electrodes, catheters, probes, pressure transducer sets). Physiologic bedside monitors are designed to
connected via cables/leads to the appropriate sensors (e.g., electrodes, catheters, probes, transducer
inserted in the patient. Physiologic bedside monitors, when used as part of a patient monitoring syste
change or add monitored parameters for an individual patient without having to employ other monito
monitoring of other parameters.

Bedside physiologic monitors that are designed to be customized using one or more individual and/or
physiologic monitor modules (e.g., electrocardiographic, respiratory, blood pressure, cardiac output). T
a dedicated location (e.g., "slot") or are designed to be used with a module rack; the module "slot" or
accepting one or more modules.
Bedside physiologic monitors that are designed to monitor a predetermined number and type of param
electrocardiographic, respiratory, blood pressure, temperature, oximetry). The number of parameters
the manufacturer, model and/or the specific needs of the healthcare facility.

Bedside physiologic monitors designed to measure and display a predetermined number and type of p
parameters) such as electrocardiographic and blood pressure, as well as additional capabilities determ
or more physiologic monitor modules.
Monitors designed for continuous or intermittent measurement and display of the values of the cardia
of blood pumped out by the ventricles in a given period of time) that are hard-wired to the patient at t
monitors include a central unit with electronic circuits and a display that can process a signal from one
sensors (e.g., catheter/pressure transducer sets) using a software algorithm. Cardiac output monitors
display the cardiac output values and curve(s), cardiac output index, blood temperature, stroke volum
vascular resistance. Some cardiac output monitors may provide hemodynamic monitoring data and/or
cardiopulmonary functions, such as measurement of venous oxygen saturation.

Neurological bedside physiological monitors designed to continuously measure and display the intrins
generated by muscle fibers. These units are hard-wired to the patient at the bedside. These monitors
electrodes (e.g., Nichrome wires) that are inserted into the muscles using a hypodermic needle; an ele
amplifier that boosts and transmits the bioelectric potentials; and a display that shows the action pote
Electromyographic bedside neurological monitors can be used to display the electric potentials from a
extraocular, facial, laryngeal, lingual) or from several muscles simultaneously.

Physiologic monitors designed for intravascular continuous measurement and display of the partial pr
(i.e., carbon dioxide, oxygen) and pH values in the arteries. These monitors are hard-wired to the patie
These monitors include a vascular catheter equipped with three detectors that combine an optical fibe
dye sensor (e.g., fluorescent optodes) at its distal tip; three optodes are needed: one sensitive to oxyg
another sensitive to carbon dioxide pressure (pCO2), and a third sensitive to pH values. Intravascular
also include electronic circuitry, a display, and programmable alarms. They are especially useful in pa
failure (e.g., obstructive lung disease, severe asthma) and in patients with severe pulmonary hyperten
surgery. Some monitors may be used during surgical procedures.
Monitors designed to simultaneously and continuously sample, measure, and display the concentratio
anesthetic gases, such as nitrogen oxide (N2O), and halogenated agents (e.g., halothane, enflurane, a
administered to a patient during surgical procedures using general anesthesia. Some monitors are als
determining the concentrations of the anesthetic gases using the principle that different gases absorb
different wavelengths (IR spectrometry). Other monitors use the change of resonant frequency in a qu
increases when a special coating absorbs the anesthetic agent. Still other monitors combine different
the measurements. Anesthetic gas monitors are used during anesthetic administration to ensure that
these agents are administered to patients.

Monitors designed for continuous and simultaneous measure and display data on respiratory and adm
gases and also on several additional physiologic parameters during general peri-operative and anesth
procedures (intraoperative). These monitors consist of a computerized unit as well as a display that sh
values, waveforms, and trends of the concentrations of the gases and other measured parameters, at
alarms. They can sample, measure, and display simultaneously data on inspired and expired concentr
(e.g., oxygen, carbon dioxide) and anesthetic gases (nitrogen oxide, enflurane, isoflurane) and severa
parameters such as invasive pressure, electrocardiography, pulse oximetry, and temperature.

Monitors designed to be positioned in a central location, usually at a nurses' station; they typically con
(e.g., audible and visual alarms) from individual bedsides and/or telemetry monitors. These monitors u
electrocardiogram for each patient being monitored; they include computing capabilities and addition
trend information; some also include full-disclosure capabilities. Central station monitors are used for
of patients in one or more areas of a healthcare facility; however, they do not replace bedside monitor

Monitors designed for continuous measurement and display of the frequency and intensity of uterus c
uterine activity) from a distant location through a point-to-point radio or other appropriate communica
telemetric). These monitors typically consist of a main unit clipped to the patient's gown (or carried in
includes electronic circuits that can process signals from external sensors, a transducer, a display, and
alarms that are triggered when the uterine contractions are below (or exceed) preset limits. The moni
receiver that is integral or associated to the central station where the information is displayed. Teleme
monitors are used at home, in physician's offices and sometimes in hospitals. Fetal monitors that can
status and the uterine activity of the mother are also available.

Monitors designed for continuous measurement and display at a central station monitor of the cerebro
pressure inside the skull and/or the meningeal membranes taken from a distant location through a po
other appropriate communication link (i.e., telemetric). These monitors typically consist of a main unit
patient's gown (or carried in a pouch) and includes electronic circuits that can process signals from inv
pressure transducers) placed in the skull and/or spine and a pocket-sized, battery-powered transmitte
includes a receiver that is integral or associated to the central station where the information is display
telemetric pressure monitors are used after cranial trauma or surgery and for continuous checking of
also used to facilitate the evaluation of malfunction or obstruction in hydrocephaly shunts.
Physiologic self-monitoring (i.e., personal) monitors designed for continuous or near continuous measu
a patient's glucose level. These monitors consist of a small main electronic unit that is worn by the pa
around the wrist, carried in a pouch) that includes electronic circuits, an LCD display, and attached glu
be inserted in the subcutaneous tissue (typically in the abdomen), or noninvasively (usually by measu
extracted from the skin). Personal glucose monitors are intended to improve the patient's self-manage
record glucose level variations in diabetic patients, permitting better therapy planning by identifying p
fluctuation of glucose level (i.e., glucose profile).

Physiologic self-monitoring (i.e., personal) monitors designed for continuous or near continuous measu
a patient's glucose level using an implantable sensor. These monitors consist of a small main electron
the patient (e.g., belt, pocket, carried in a pouch) that includes electronic circuits, an LCD display, and
sensors that are usually inserted in the subcutaneous tissue (typically in the abdomen). The monitors
hypoglycemia alarm. Personal glucose monitors are intended to improve the patient's self-manageme
record glucose level variations in diabetic patients that can be downloaded to a personal computer, pe
therapy planning by identifying patterns in the fluctuation of glucose level (i.e., glucose profile).

Physiologic self-monitoring (i.e., personal) monitors designed for continuous or near continuous measu
a patient's glucose level using external sensors. These monitors consist of a small main electronic uni
patient (typically around the wrist) that includes electronic circuits, an LCD display, and attached noni
sensors. The sensors typically measure using electro-osmotic (iontophoresis) or laser-based procedure
interstitial fluid; the fluid is then absorbed by a small pad placed on the skin and the value is determin
electrochemical technique. Personal glucose monitors are intended to improve the patient's self-mana
record glucose level variations in diabetic patients that can be downloaded to a personal computer, pe
therapy planning by identifying patterns in the fluctuation of glucose level (i.e., glucose profile).

Monitors designed for continuous measurement and display of the number of rhythmic expansions (pu
per minute (i.e., pulse rate in beats per minute) that are intended for personal use. These monitors co
electronic unit that is worn by the patient (e.g., placed around the wrist, carried in a pouch) that includ
a display; and appropriate sensors for measuring the required physiologic parameters. The monitor m
and/or visual alarms that are triggered when the patient's pulse rate drops below or exceeds preset lim
rate monitors are used for personal self-monitoring during daily activities and/or when performing exe
Monitors designed primarily for continuous or quasi-continuous real-time measuring and display of nu
waveforms of the conditions and elements that made of the surroundings (environment) and to which
exposed in the health care facilities. These monitors are intended to assess natural conditions (e.g., te
pressure), concentrations of natural gases (e.g., oxygen, nitrogen), hazardous substances (e.g., toxic g
biological agents), and/or other physical conditions in the environment (e.g., ionizing radiation, high p
These devices usually consist of a tabletop electronic unit that includes a display showing the charact
under observation; the monitor may be connected to the line and/or powered by internal batteries. Th
include appropriate attached probes and sensors that make possible sequential and/or simultaneous m
parameters. The monitors may also record the parameters of the event and alarm when one or more o
under observation reach a value outside from a pre-established range. _x000D_
Most environmental monitors used in healthcare are intended to measure the conditions in closed env
monitors are available for use in particular areas of healthcare facilities such as clinical laboratories, s
surgical areas.

Environmental monitors designed to display the concentration of nitrogen oxide and/or nitrogen dioxid
typically include appropriate sensors (e.g., electrochemical), a control unit, and a display; they may al
activated at several prefixed concentrations, recording capabilities, and/or a transmitter for remote ce
Nitrogen oxide/dioxide monitors are typically used to detect the presence of NO and NO2 in rooms wh
improving the safety of healthcare personnel.

Monitors designed for continuous measuring and display gas concentration, humidity content and/or d
content in compressed air and/or medical gases. These monitors can measure and display the concen
gases or contaminants; some include alarms (e.g. audio, visual) that can be activated at pre-fixed con
Compressed air/gas monitors are hooked up at a sampling point of a compressed medical air or gas sy

Compressed air monitors designed to measure and display simultaneously several gas concentrations
typically include sensors (e.g solid state, electrochemical, infra-red), electronic circuitry, and a display
alarms, recording capabilities, and/or a transmitter for remote central monitoring. Multigas compresse
for continuous measuring the concentration of gases (e.g. oxygen, carbon monoxide, nitrogen oxide, n

Monitors designed to continuously measure and display data on one or more electrical variables (e.g.,
parameters (e.g., impedance) that may cause a hazardous condition when their value is not in a prede
Most of these monitors include measuring devices, displays, and alarms.
Electrical safety monitors designed to continuously measure the characteristics of electrical power de
and/or the integrity of the electrical delivery circuit between the electrosurgical unit and the patient d

Laboratory monitors designed for continuous measuring and display of the resistivity and/or conductiv
units may be also capable of measuring total organic carbon (TOC) content. These monitors usually co
measuring unit and threaded in-line sensors attached to the water pipe and connected to the measuri
monitors are used for assessing the quality of water in low and/or high purity laboratory water supplie
monitor TOC are used to assess the level of dissolved organic compounds in very high purity water sy
pressure liquid chromatography water supplies).
Systems designed to continuously acquire, measure, process, and display biologic, technical, environm
from one or more patients, devices, or other targets. These systems typically consist of a central stati
receives, consolidates, and displays information from a set of monitors and/or appropriate sensors (e.g
pressure) that are deployed throughout a healthcare area; cables and/or wireless links; computerized
display monitors. Dedicated monitoring systems are typically used in healthcare facilities to monitor p
laboratory parameters; other monitoring systems may be used to monitor technical and safety charac
levels, presence of pathogens), and environmental data.

Electronic storage data recorders designed to measure and record body movements (i.e., physical act
typically include electronic circuits that can process body part movement data, including timing and c
external acceleration sensors that are typically attached to a patient's wrist or to the ankle of young c
movements. The devices can store information for later computer analysis; some recorders allow the
sample period (time on, time off, number of recording days). Physical activity recorders are used to as
certain conditions (e.g., cardiac or pulmonary disorders) or healthy people (e.g., athletes) during their
while performing exercise; they are also used to record sleep and wakefulness (sleep/awake cycle) du
activity for prolonged periods (e.g., a month).

Electronic storage data recorders designed to measure and record the amount, type, and timing of sle
overnight or in 24-hour periods. These recorders usually consist of a small portable unit worn on the b
parameter (e.g., electrooculograph, electromyograph) sensor electrodes attached to the patient's bod
information analogous to that obtained in polysomnography studies, but for a limited set of paramete
electronic storage recorders are used for ambulatory and/or home assessment of sleep disorders, such
somnambulism.

Point-of-care breath analyzers designed to measure the amount of carbon monoxide (CO) present in a
expressed as parts per million (ppm). These analyzers typically use electrochemical sensors to determ
present; analyzers may display the CO value or the equivalent carboxyhemoglobin estimated value us
algorithms. Carbon monoxide breath analyzers are typically used to measure CO concentrations prese
samples following accidental exposure to CO and/or in the clinical care of patients with conditions ass
tobacco (e.g., asthma, COPD); they are also used as an indirect method to determine red blood cell lif
management of patients with sickle cell disease).

Needles designed for intradermal, subcutaneous, intramuscular, or intravenous injection and/or infusi
and semisolids, either directly or through other medical devices (e.g., catheters, infusion ports). Inject
consist of hollow, sharply pointed, metallic devices with the opposite end finished in a connector (e.g.
Luer lock) that can be easily attached to a syringe or other infusion device.

Hypodermic needles designed for injection of fluids into the soft tissues of the oral cavity. These devic
small-diameter (27 to 30 gauge is typical) needles with a Luer lock tip to provide adequate grip on de

Hypodermic needles designed for injection of fluids into eye tissues. These devices typically consist of
diameter (20 gauge tapered to 30 gauge is typical) needles, either straight or curved. Ophthalmic inje
in specific regions of the eye, such as subretinal or vitreoretinal injections, are available.
Injection needles designed for percutaneous fluid injection into the muscular layer beneath the dermis
typically consist of hollow, sharply pointed, metallic devices with the opposite end finished in a conne
slip or Luer lock) that can be easily attached to a syringe. Intramuscular needles are typically of a larg
26 gauge) and longer (typically from 1 to 2 inches [25 to 51 mm]) than hypodermic needles.

Needles designed for percutaneous transhepatic injection of fluids and/or percutaneous drainage of th
devices typically consist of very fine, long, flexible needles that can reach the biliary tree and the com
needles are mostly used for percutaneous drainage of bile; they may also be used to inject contrast m

Needles designed for injection of fluids into fibrous connective tissues (I.e., ligaments), such as those
articulations (e.g., knee) and teeth. These needles are used to inject anesthetics and other drugs.

Needles designed for injection of fluids in the fibrous connective tissue (i.e., ligament) that surrounds
intraligamentary) and separates it from the alveolar bone. These needles are mostly used to inject the
anesthetize a single tooth, providing rapid diffusion of the anesthetic.
Needles designed for injection into the bones (i.e., intraosseus). These devices usually consist of relat
(e.g., 30 gauge), short-length needles that can penetrate directly into the bone without bending or bre
Intraosseous needles frequently include a stainless steel sliding sheath to provide the necessary stabi
needles are used frequently in emergency situations to inject medication and other fluids into the bon

Dental needles designed for intraosseus injection into the oral cavity. These devices usually consist of
diameter (e.g., 30 gauge), short-length needles that can penetrate directly into the bone without bend
injection. Dental intraosseous needles frequently include a stainless steel sliding sheath to provide the
Dental intraosseus needles are mostly used to inject anesthesia into the bone for single-tooth procedu

Aspiration needles designed for percutaneous puncture of the pericardial cavity for aspiration of fluids
pericardiocentesis). These devices typically consist of long (typically from 4 to 7 inches [10 to 18 cm])
bevel at the tip. Cardiac aspiration needles are sharp and stiff enough to perforate the pericardium.

Aspiration needles designed for aspiration of fluids from the eyes. These devices typically consist of st
hooked needles that may be tapered at the tip, typically of 20 gauge tapered to 30 gauge. There are s
available for aspiration from different areas of the eye, including the midperiphery, subretinal fluids th
retinotomy, the region anterior to the equator, and the macular hole.
Aspiration needles designed for aspiration of the uterine cavity content. These devices usually consist
hollow, large-lumen (e.g., 19 gauge), blunt, noncoring needle that may be attached to a vacuum line a

Single-lumen aspiration needles designed for retrieval and collection of ova. These devices usually co
large-lumen (17 gauge is typical), noncoring needle, 24 to 32 cm (9 to 13 inches) in length. Ovum-col
include marks that can be easily visualized using both ultrasonic imaging equipment and a vacuum lin
proximal end.
Needles designed for either aspiration or injection of gases, liquids, and semisolids in body tissues or
or through other medical devices (e.g., catheter introducers, infusion ports). These needles typically c
metallic devices with the proximal end finished in a connector (e.g., female Luer slip or Luer lock) that
to a syringe or other infusion/withdrawal device. Some injection needles may have blunt or noncoring
Needles designed for injection and/or aspiration inside the brain tissue. These devices typically consis
insertion lengths of 15 cm (6 inches) or more and blunt tips to minimize the risk of brain tissue damag
injection/aspiration needles are mostly used during neurosurgery for drainage of hematomas and cyst
for abscess drainages; they may also be used in aspiration biopsies and as guides in some minimally i

Needles designed for aspirating fluids from and/or irrigating body cavities. These devices may consist
needles for simultaneous aspiration and irrigation or single-lumen needles to perform irrigation and as

Needles designed for aspirating fluids from and/or irrigating the uterine cavity. These devices may con
needles for simultaneous aspiration and irrigation or single-lumen needles to perform irrigation and as

Double-lumen aspiration/irrigation needles designed for simultaneous irrigation of follicles and retriev
in the uterine cavity.
Aspiration/irrigation needles designed for dental procedures, especially in endodontics (e.g., root-cana
devices typically consist of fine, blunted needles that permit both the irrigation of solutions in the wor
aspiration of fluids and debris.
Aspiration/irrigation needles designed for ophthalmic procedures, such as subretinal surgery. These de
of hollow tapered needles (e.g., 20-gauge needles that taper to 30 gauge at the tip) that may be conn
units; some dual-bore needles are used for simultaneous irrigation and aspiration of subretinal fluid.

Needles designed to pass a suture filament or fine wire underneath a blood vessel or to other tissues
tumor pedicle) to tie, bind, or partially strangulate it. These devices consist of a slender steel needle w
a curved end with an eye and a sharp or blunt tip appropriate to handle the ligatures. Ligature needle
right and left handed surgeons. Stronger ligatures with a bigger diameter are usually manipulated usi
(also known as ligature carriers).

Needles designed to penetrate the body and infuse anesthetics in the proximity of the nerves in which
cut off. These devices typically consist of thin-wall needles with appropriately beveled tips to minimize
of tissues and nerves; some needles have blunt tips to deflect rather than transfix neural structures. L
used either for short-term procedures that require a regional block or for continuous regional blocks. T
usually attached to catheters.

Local block needles designed to inject anesthetics into the region of the tuberosity of the ischium to b
nerves. These devices typically consist of 18- to 20-gauge needles, available in lengths of 125 to 150

Local block needles designed to inject anesthetics into the region posterior to the eyeball (i.e., retrobu
nerves of the eyes during surgery (e.g., cataract surgery). These devices typically consist of 25-gauge
length needles (typically from 35 to 40 mm [1 1/4 to 1-5/8 inch]); the smaller needles avoid damage t

Local block needles designed for injection of anesthetics to block the conductivity of the nerves of the
typically consist of 19- to 25-gauge needles that are typically available in lengths from 25 to 150 mm.
needles may be used for either an upper- or lower-limb nerve block.
Peripheral block needles designed with an isolated body, except for the tip. These needles typically in
stimulation wire and an attached injection catheter and Luer adaptor for connection to an electrical st
source, respectively. Insulated peripheral block needles are designed both to localize the nerves of the
location, and for injection of anesthetics to cut off their conductivity.
Needles designed for particular procedures performed in the oral cavity, such as delivery of impressio
filling; they are also used in root canals and other endodontic and exodontic special procedures. Most
attached to hypodermic syringes, cartridge syringes, or other reusable and/or disposable syringes spe
use in dentistry.
Needles designed to deliver impression and/or filling materials under high pressure during dental proc
typically consist of a blunt needle with a threaded hub to attach the needle to an appropriate plunger
The needles are used either in permanent teeth and in retrograde root-canal filling procedures or to ob
(i.e., impression) of dental or related structures (e.g., dental arch).

Needles designed for particular procedures performed in the eyes, such as hemostasis, membrane ide
dissection, and lacrimal duct cannulation. Most of these devices are hollow, blunt, stainless steel need
tapered, or curved. Some of these needles are specialized for procedures in specific areas of the eye,
space or the macular hole.
Needles designed for withdrawal and reinfusion of blood from the peripheral circulatory system after p
external hemodialysis machine. These devices typically consist of thin-walled needles of appropriate d
to 19 gauge) and length to be introduced in arteries and veins and connected to the blood line of a dia
Hemodialysis needles are available either with a single lumen for alternating flow procedures or with t
simultaneous withdrawal/infusion procedures; they may be used for periodical long-term treatments o
emergency procedures.

Hemodialysis needles designed for withdrawal and reinfusion of blood from an arteriovenous (AV) fistu
procedures. These needles typically consist of a thin-walled, small-length (e.g., 25 to 32 mm [1 to 1.25
cannula (typically 14 to 17 gauge) for introduction into the AV fistula and fixed or rotational wings tha
insertion and add protection to inadvertent pull-out; they usually also include a tube (e.g., 15 to 30 cm
connected to the blood line of a dialysis machine.

Needles designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-cont
endoscopic procedures. Endoscopic needles are available for many applications, including injection, a
biopsy, puncture, and other procedures performed through the working channel of endoscopes.

Endoscopic procedure needles used for bronchial lesion aspiration through a bronchoscope. These nee
attached to clear catheters to identify bloody aspirates. They are available either in stiffer or flexible v
central or peripheral lesions, respectively.
Endoscopic procedure needles designed to make punctures in the myocardial tissue through the veno
typically consist of a thin, flexible outer cannula (typically 56 to 71 cm) and an inner sharp, curved ne
gauge) that protrudes several millimeters from the tip of the cannula. Cardiac endoscopic procedure
used to allow left atrial access from the right atrium through the atrial septum during fluoroscopically-
procedures.

Needles designed for accurate placement of small radioactive sources (seeds) directly into tissues (i.e
procedures). Brachytherapy needles usually include marks (e.g., 0.5 cm apart) and tips that can be ea
ultrasonic imaging equipment (i.e., echogenic tips) to facilitate the procedure. These needles are used
percutaneous procedures to treat cancer tumors, such as prostate, tongue base, and neck cancers.
Biopsy needles designed to take soft tissue and/or organ samples for laboratory analysis. These devic
inner needle with a sharp tip, marks (e.g., 0.5 cm apart), notches that are positioned for harvesting sa
predetermined size (e.g., 9.5 or 19 mm), and an outer needle (cannula) to cut and capture the tissue
notch. Biopsy needles are used to obtain histologic information for diagnosis and characterization of s
lesions in the breast, lungs, and other soft tissues and organs.

Biopsy needles designed to take a sample of breast tissue for laboratory analysis. These devices may
conventional soft-tissue biopsy device that includes two concentric needles to take a sample (i.e., core
more frequently, a very fine needle used for aspiration of cells (i.e., fine-needle aspiration biopsy). Som
are part of systems that perform mammographic stereotactic biopsies.

Biopsy needles designed to obtain tissue samples from the brain. These needles typically include an in
attached to an external aspiration syringe and an outer needle (cannula) to cut the aspirated tissue th
pulling out the inner needle. Brain biopsy needles are used to perform biopsies of cystic lesions and su
Needles that can be used in stereotactic procedures, either under radiographic or magnetic resonance
available.

Biopsy needles designed for percutaneous transabdominal puncture of the uterus to obtain samples o
devices typically consist of 20- or 22-gauge needles of 90 to 150 mm (3-1/2 to 6 inches) in length, w
minimize damage to the uterus and/or fetus. The needles are usually attached to external devices (e.g
external aspiration of the amniotic fluid; some needles include depth marks to facilitate accurate inse

Biopsy needles designed to obtain samples of tissues inside bones (i.e., intraosseous). These needles
passage through bone and cortex and sample retention as the needle is withdrawn.
Intraosseous biopsy needles designed to obtain bone marrow samples, typically from the manubrium
devices typically consist of a long (e.g., 2 or 3 inches), 16- to 22-gauge needle with appropriate tips (e
separate the fibers of the dura with minimum damage and fluid seepage. Bone marrow biopsy needle
with Luer-lock or Luer-slip hubs for syringe attachment. They are usually locked to a handle to ensure
secure placement.

Needles designed for localization of lesions, especially tumors. These devices typically consist of a hol
to facilitate accurate depth placement. Some needles include a strong, flexible localization wire that c
repositioned; other devices consist of a puncture needle and an anchor at the tip. Lesion-localization n
used for tumor localization in moving organs (e.g., lung) and/or in the thoracic breast tissue.

Needles designed for localization of lesions, especially tumors, in thoracic breast tissue. These device
20-gauge, hollow needles with marks to facilitate accurate depth placement. Most needles include a
localization wire that can be retracted and repositioned; they may also include a locking mechanism t
migration during breast compression or patient transport. Breast lesion localization needles are availa
(e.g., 3, 5, 12.5 cm). Some needles include tips that can be easily visualized using ultrasonic imaging
echogenic tips) to facilitate the procedure.
Needles designed for the initial percutaneous insertion of a catheter. These needles typically consist o
tapered cannula with a sharp obturator inside. Catheter-insertion needles may be used to introduce dr
wounds, for initial introduction of spinal catheters, for initial introduction of peritoneal catheters for dia
infusion, and, more frequently, for the insertion of percutaneous venous and/or arterial catheters follo
technique. Dedicated catheter introduction needles are also used in a variety of intravascular introduc
midline, central venous) and also in catheterization procedure kits and trays (e.g., peritoneal dialysis,
angiography, intravascular).

Suture needles designed to close surgical and/or traumatic wounds, including the skin. Surgical sutur
opposite cutting edges that cut tissue (i.e., cutting needles), tapered tips that pierce tissue without cu
needles), or blunt tips. Surgical suture needles are available for general surgical use and also for spec
in tissues and/or organs, such as the intestines, tonsils, fistula, and kidneys.

Surgical suture needles with sharp cutting edges at their distal tip which permit ease of penetration in
skin and fascia.
Surgical suture needles with a tapered distal tip which permit easy penetration without tearing of deli
intestine and peritoneum tissues.
Suture needles with a tip that is not as sharp (i.e., more blunt) as the tip of a conventional tapered sut
still penetrate tissues for suturing, but the blunt needle does not easily penetrate tough tissues, such
needles are typically used for suturing kidney and liver tissues; they are also used in general surgery
tapered-point needles to lessen the possibility that accidental contact with the needle tip will result in
The use of blunt suture needles for some procedures requires changes in the surgical technique for su
appropriate for skin-closure applications.

Suture needles designed with appropriate shape and size to thread sutures through the eye tissues to
traumatic wounds. These devices typically consist of high-quality, stainless steel, curved needles with
extreme for insertion of the suture and a sharp tip at the other end. Ophthalmic suture needles may h
edges that cut tissue (i.e., cutting needles) or tapered tips that pierce tissue without cutting (i.e., tape

Ophthalmic suture needles that include sharp cutting edges in their distal tip, permitting ease of pene
tissues.
Ophthalmic suture needles that include a tapered distal tip, permitting easy penetration without tearin
inside the eyes.
Suture needles designed with appropriate shape and size to thread sutures through the oral tissues, in
(e.g., ligaments) around the teeth, to close surgical or traumatic wounds. These devices typically con
stainless steel, curved or, less frequently, straight needles with an eye in one extreme for insertion of
tip at the other end. Dental suture needles usually have opposite cutting edges that cut tissue (i.e., cu

Dental suture needles with sharp cutting edges in their distal tip, permitting ease of penetration in tou

Needles designed for threading sutures in cadaver tissues. These devices typically consist of half-curv
frequently, double-curved stainless steel needles with an eye in one extreme for insertion of the sutur
at the other end; most suture needles have cutting edges.
Syringes consisting of a hollow transparent cylinder (barrel) that is typically graduated (e.g., cubic cen
show its content, as well as a movable plunger (piston) within the cylinder. When the piston is withdra
to flow into the cylinder and, when pressed, to be ejected from the cylinder. The barrel may include ei
male connector to attach a hollow needle through which the fluid flows into or out of the cylinder. Plun
for intramuscular or intravenous (either directly or through catheters) injection and/or infusion of liqui
syringes (i.e., hypodermic syringes) are designed for subcutaneous injection, especially of tuberculin a
plunger syringes are designed for other applications (e.g., irrigation) and/or particular procedures, suc
and chromatographic assays.

Plunger syringes with a male tapering fitting (tip) that are designed to connect the syringe with other
as a needle using only compression to secure the connection. The tapered Luer tip (i.e., Luer slip) allo
tapered fittings to slip-fit into each other in a liquid-leakproof and mechanically secure manner that st
be readily separated.
Protective plunger syringes with a Luer-slip tip that are designed to provide needlestick protection (sa
include some mechanism (manually positioned or activated) intended either to shield, blunt, or recess
or, by some other means, lessen the possibility of contact of the healthcare provider with the sharp ne
slip allows connection of the syringe with other medical devices, such as a needle using only compres
connection.

Plunger syringes with a male fitting (tip) that are designed to provide a locked, secure connection betw
other medical devices such as a needle. Luer-lock tapers include an internally threaded skirt or other s
taper, adding additional strength to the connection with a female Luer taper for a short time and low-p
a liquid-leakproof and mechanically secure manner.
Plunger syringes with a needle preattached to their Luer-lock tip that are designed to provide needles
These syringes include some mechanism (manually positioned or activated) intended either to shield,
needle after use or, by some other means, lessen the possibility of contact of the healthcare provider
Luer-lock tapers include an internally threaded skirt or other structure around the taper, adding additi
connection with a female Luer taper for a short time and low-pressure applications.

Plunger syringes supplied with a needle permanently attached to their tip (e.g., cemented into glass s
plastic syringes). The needles are frequently fixed at a point that corresponds to the zero graduation m

Plunger syringes supplied with a needle permanently attached to their tip (e.g., cemented into glass s
plastic syringes) that are designed to provide needlestick protection (safety). These syringes include s
(manually positioned or activated) intended either to shield, blunt, or recess the needle after use or, b
lessen the possibility of contact of the healthcare provider with the sharp needle. The needles are freq
that corresponds to the zero graduation mark.

Plunger syringes designed with a nonconcentric (i.e., eccentric) Luer-slip male tapering fitting (tip). Th
connection with other medical devices, typically a needle, that is almost flush with the side of the barr

Plunger syringes with an eccentric Luer-slip tip that are designed to provide needlestick protection (sa
include some mechanism (manually positioned or activated) intended either to shield, blunt, or recess
or, by some other means, lessen the possibility of contact of the healthcare provider with a sharp nee
provides a connection with other medical devices, typically a needle, that is almost flush with the side
Plunger syringes designed with a nonconcentric (i.e., eccentric) Luer-lock male fitting (tip). These syrin
connection with other medical devices, typically a needle, that is almost flush with the side of the barr

Plunger syringes with an eccentric Luer-lock tip that are designed to provide needlestick protection (sa
include some mechanism (manually positioned or activated) intended either to shield, blunt, or recess
or, by some other means, to lessen the possibility of contact of the healthcare provider with a sharp n
provides a connection with other medical devices, typically a needle, that is almost flush with the side

Plunger syringes supplied with a needle permanently attached to their tip (e.g., cemented into glass s
plastic syringes) that is not concentric (i.e., eccentric) with the barrel. These syringes provide a conne
medical devices, typically a needle, that is almost flush with the side of the barrel.

Plunger syringes supplied with a needle permanently attached to their tip (e.g., cemented into glass s
plastic syringes) that is not concentric (i.e., eccentric) with the barrel and that are designed to provide
(safety). These syringes include some mechanism (manually positioned or activated) intended either
recess the needle after use or, by some other means, to lessen the possibility of contact of the health
sharp needle.

Catheter-tip plunger syringes designed for irrigation and aspiration of fluids through catheters. These
include an integral or detachable tube to infuse and/or withdraw the fluid and a blunt catheter tip; som
rings and/or swivel finger bars to improve control of the syringe. Catheter-tip aspiration/irrigation syrin
or withdraw fluid from a body cavity or wound and in aspiration and/or irrigation procedures performe
gastrointestinal and/or genitourinary tract, such as urinary bladder and urethra irrigation. These syring
inflate urinary tract catheters during cystoscopy, gastric sampling, blood-clot evacuation, and irrigatio
catheters.

Insulin syringes, including a male tapering fitting (Luer slip), designed to connect the syringe with a ne
compression to secure the connection. The tapered Luer slip allows the two mating tapered fittings sli
a liquid-leakproof and mechanically secure manner that still permits the parts to be readily separated

Insulin syringes with a Luer-slip tip designed to provide needlestick protection (safety). These syringes
mechanism (manually positioned or activated) intended either to shield, blunt, or recess the needle af
other means, to lessen the possibility of contact of the healthcare provider with a sharp needle. The ta
Luer slip) allows the two mating tapered fittings to slip-fit into each other in a liquid-leakproof and me
manner that still permits the parts to be readily separated.

Insulin syringes, including a male fitting (Luer lock), designed to provide a locked, secure connection w
tapers include an internally threaded skirt or other structure around the taper, adding additional stren
with a female Luer taper.
Insulin syringes, usually with a preattached needle to their Luer-lock tip, that are designed to provide
(safety). These syringes include some mechanism (manually positioned or activated) intended either
recess the needle after use or, by some other means, to lessen the possibility of contact of the health
sharp needle. Luer-lock tapers include an internally threaded skirt or other structure around the taper,
strength to the connection with a female Luer taper.
Insulin syringes supplied with a needle permanently attached to their tip (e.g., cemented into glass sy
syringes). The needles are frequently fixed at a point that corresponds to the zero graduation mark.

Insulin syringes with a fixed needle that are designed to provide needlestick protection (safety). These
some mechanism (manually positioned or activated) intended either to shield, blunt, or recess the nee
some other means, to lessen the possibility of contact of the health care provider with a sharp needle

Tuberculin/allergy syringes including a male tapering fitting (Luer slip) designed to connect the syringe
only compression to secure the connection. The tapered Luer slip allows the two mating tapered fitting
other in a liquid-leakproof and mechanically secure manner permits the parts to be readily separated.

Tuberculin/allergy syringes that still includes a needle preattached to their Luer slip tip, that are desig
stick protection (safety). These syringes include some mechanism (manually positioned or activated)
shield, blunt, or recess the needle after use or, by some other means, to lessen the possibility of conta
provider with a sharp needle. The tapered Luer tip (i.e., Luer slip) allows the two mating tapered fitting
other while yet permitting the parts to be readily separated.

Tuberculin/allergy syringes including a male fitting (Luer lock) designed to provide a locked, secure co
Luer-lock tapers include an internally threaded skirt or other structure around the taper, adding additi
connection with a female Luer taper.
Tuberculin/allergy syringes with a needle preattached to their Luer-lock tip that are designed to provid
protection (safety). These syringes include some mechanism (manually positioned or activated) intend
blunt, or recess the needle after use or, by some other means, to lessen the possibility of contact of th
with a sharp needle. Luer-lock tapers include an internally threaded skirt or other structure around the
additional strength to the connection with a female Luer taper.

Tuberculin/allergy syringes supplied with a needle permanently attached to their tip (e.g., cemented in
glued in plastic syringes). The needles are frequently fixed at a point that corresponds to the zero grad

Tuberculin/allergy syringes with a fixed needle permanently attached to their tip (e.g., cemented into
plastic syringes) that are designed to provide needlestick protection (safety). These syringes include s
(manually positioned or activated) intended either to shield, blunt, or recess the needle after use or, b
to lessen the possibility of contact of the healthcare provider with sharp needle.

Blood-sampling syringes with a male fitting (Luer lock) designed to provide a locked, secure connectio
and a needle. Luer-lock tapers include an internally threaded skirt or other structure around the taper,
strength to the connection with a female Luer taper.
Blood-sampling plunger syringes usually with a needle preattached to their Luer-lock tip that are desig
needlestick protection (safety). These syringes include some mechanism (manually positioned or activ
to shield, blunt, or recess the needle after use or, by some other means, to lessen the possibility of co
provider with a sharp needle. Luer-lock tapers include an internally threaded skirt or other structure ar
additional strength to the connection with a female Luer taper.
Blood-sampling syringes with a male tapering fitting (Luer slip) designed to connect the syringe with a
compression to secure the connection. The tapered Luer tip (i.e., Luer slip) allows the two mating tape
into each other in a liquid-leakproof and mechanically secure manner while permitting the parts to be

Blood-sampling plunger syringes usually with a needle preattached to their Luer slip tip that are desig
needlestick protection (safety). These syringes include some mechanism (manually positioned or activ
to shield, blunt, or recess the needle after use or, by some other means, to lessen the possibility of co
provider with a sharp needle. The tapered Luer tip (i.e., Luer slip) allows the two mating tapered fitting
other while permitting the parts to be readily separated.

Plunger syringes designed to inject contrast media, typically into arteries or veins, for imaging proced
radiographic angiography, computed tomography (CT), magnetic resonance imaging (MRI), or some u
Most of these syringes are incorporated into automated contrast-media injectors; usually, an electrom
moves the piston in and out of the syringe barrel. Contrast-media syringes are frequently designed for
specific model of injector or for injectors from a particular manufacturer.

Plunger syringes designed for irrigation, aspiration, and injection of impression, filling, and/or other re
the oral cavity. Plunger dental syringes may include either fixed needles or appropriate tips (e.g., Luer
needles to perform dental procedures.
Plunger syringes designed to introduce filling materials (e.g., sealants, cements) under high pressure
procedures. These devices typically consist of a barrel (e.g., octagon shaped), a screw-type plunger, a
attach a blunt needle; some other syringes are all-plastic disposables. Dental filling syringes are mos
teeth and in retrograde root-canal filling procedures.
Plunger syringes supplied with fluid in their barrel (i.e., prefilled), typically ready for single-dose inject
usually contain a medication and/or other fluid for some particular procedure (e.g., catheter flushing).
include a fixed needle, a Luer-lock tip (with or without a needle attached), or a blunt cannula; they are
sterile disposable devices that do not require the use of a cartridge syringe holder.

Prefilled syringes supplied with a predetermined medication, such as atropine, epinephrine, or furosem
are intended for administering medications and minimizing errors and contamination by supplying pre
they are usually supplied as sterile disposable devices that do not require the use of a cartridge syring

Prefilled medication syringes supplied with a specific prefilled medication (e.g., epinephrine) and a Lue
These syringes may either be used for push intravenous medications or attached to a needle for intra

Prefilled medication syringes ended in a Luer-lock tip and that include some mechanism (manually po
intended either to shield, blunt, or recess the needle after use or, by some other means, to lessen the
of the healthcare provider with the sharp needle.
Prefilled medication syringes that end in a blunt cannula. These syringes are generally used for push i
medications.
Prefilled syringes supplied with a predetermined amount of solution (e.g., saline or heparin compound
concentration for catheter flush. These syringes are intended for needlestick prevention and to minim
contamination by supplying pre-measured unit doses. They are usually supplied as sterile disposable d
require the use of a cartridge syringe holder.
Prefilled syringes supplied with a specific catheter-flush solution (e.g., saline or heparin compounds) th
tip. These syringes are intended to avoid the use of needles, thus providing needlestick prevention, as
errors and contamination by supplying premeasured unit doses of the solutions.

Prefilled syringes supplied with a specific catheter-flush solution (e.g., saline, heparin) and that end in
syringes are intended to avoid the use of needles, thus providing needlestick prevention, as well as to
contamination by supplying premeasured unit doses of the solutions.

Plunger syringes designed for precision fluid (both gas and liquid) handling in the clinical laboratory. T
consist of plastic or glass syringes; some incorporate metallic (e.g., stainless steel) plungers. Many diff
laboratory syringes are available for special purposes, including air- and/or liquid-tight syringes, samp
rate syringes, and specialized syringes to inject samples in chromatography system ports.

Laboratory plunger syringes designed for sample preparation and injection. These syringes typically c
(from a few to several hundred milliliters) plastic or glass plunger syringes that may include Luer-lock
They are used in procedures such as pipetting, as well as to prepare, transfer, and/or inject samples in
laboratory autosamplers; some are used in chromatography assays.

Laboratory plunger syringes designed for sample preparation and filtration. These syringes typically c
(from microliters to some milliliters) plastic or glass plunger syringes that include either Luer-lock tips
may also include a filter holder and a disposable membrane filter. Filters are available either to isolate
(i.e., ultrafiltration) or with a larger pore size to remove particulates from a sample or the moving pha
(i.e., microfiltration). Some sampling syringes are manufactured only to inject samples in a particular

Laboratory syringes designed to inject samples into chromatography system ports. These devices typ
volume (usually in the range of microliters) gas- and/or liquid-tight syringes that include either Luer lo
Laboratory chromatography syringes are available for use in thin-layer, gas, liquid, and high-pressure
(HPLC).
Laboratory syringes designed to inject samples in the injection ports of thin-layer chromatography (TL
devices typically consist of low-volume syringes that include fixed needles (e.g., cemented), Luer-lock
tips. Some TLC syringes are manufactured for use only in devices of a particular model or from a spec

Plunger syringes designed for calibration of reservoirs and/or instruments. These devices consist of la
calibrated syringes, typically including plastic (e.g., acrylic) barrels and plastic or aluminum plungers.
are used for the calibration of spirometers and pulmonary function physiologic analyzers; they are als
sampling and to prepare gas mixtures.
Cartridge syringes designed to inject medicines from a prefilled, disposable, sealed cartridge that incl
intended to connect the syringe with other medical devices, such as a needle or a catheter Luer lock.
include an internally threaded skirt or other structure around the taper, adding additional strength to
female Luer taper. These syringes may be used either for intramuscular injections or for push intraven
that are supplied in cartridges
Luer-lock cartridge syringes designed to provide needlestick protection. These syringes include a prefi
cartridge and a male Luer lock with a preattached needle; a mechanism (manually positioned or activ
shield, blunt, or recess the needle after use (e.g., aspirating medication from a vial) or, by some other
possibility that the healthcare provider will contact the sharp needle.

Cartridge syringes designed for injection of anesthetics and/or impression, filling, and/or other restora
oral cavity tissues.
Cartridge syringes designed to inject dental anesthetics from a changeable, prefilled, disposable, seal
includes a needle attached to one end. These syringes include some mechanism (manually positioned
either to shield, blunt, or recess the needle after use or, by some other means, to lessen the possibilit
healthcare provider with the sharp needle.
Cartridge dental syringes designed to introduce impression and/or filling materials under high pressur
procedures. Dental impression/filling syringes are used either in permanent teeth and in retrograde ro
procedures and/or to obtain a negative copy (i.e., impression) of dental or related structures (e.g., den
construction or assembly of a fixed restoration or denture.
Cartridge syringes designed to inject insulin from a changeable, prefilled, disposable, sealed cartridge
fine (e.g., 30- or 31-gauge) needle attached to one end. These syringes are usually reusable devices
and dimensions for accurate injection of insulin supplied in cartridges, typically of 3 to 5 mL capacity.

Cartridge syringes that are designed to resemble a standard ball-point pen and are used to inject insu
disposable cartridges (e.g., 1 to 3 mL capacity). These syringes are typically reusable metallic devices
accurate selection of the appropriate dose and a button for injection.
Syringes consisting of a hollow rubber bulb tapered to a small tip. These syringes are mostly used for
aspiration.
Syringes consisting of a hollow rubber bulb attached to one end of a plastic or glass barrel; the other
include a male tapering fitting (tip) designed to connect the syringe to a blunt needle. These syringes
and/or aspiration in otolaryngology procedures and/or external wounds; some bulb/barrel syringes are
aspiration/irrigation through catheters (e.g., urinary tract catheters).

Syringes designed to deliver air from a pressurized air tank. These syringes consist of a tapered air ba
attached and a tube or hose for connection with the compressed air supply. Air-system syringes are us
procedures and in some laboratory applications.
Air-system syringes designed for use during dental procedures. These syringes typically include a fine
and a pressure-regulating valve; they may also include a clamp for attachment of a spray bottle. The
connected to the compressed-air tank of the dental delivery unit using a hose or tube. Dental air syrin
dry tooth cavities and/or to blow debris from cavities in preparing teeth for restoration.

Medication/vaccine injectors that include a syringe-like mechanism and are designed for injection of in
typically consist of a prefilled, disposable device with appropriate shape and size to facilitate handling
read dose-selector scales. Insulin injectors are intended to make insulin injection easier and more accu
conventional syringes, especially for the elderly.
Instruments designed for mechanical fastening of tissues (e.g., closing of wounds, joining organs, bon
delivering staples into the tissues. These devices usually consist of a mechanism for delivering staples
disposable cartridge containing the staples; the mechanisms are frequently reloadable but for single-p
are available in many different types and sizes, including surgical staplers for internal organs and ana
structures and skin staplers for skin wound closure. Bone staples are usually delivered using staple dr

Staplers designed to deliver staples to join internal tissues of the body during surgical procedures. The
deliver U-shaped staples that are conformed into a B shape as they are driven through the tissue; the
delivered one at a time or simultaneously, typically as a set of double staggered rows either following
pattern. Surgical staplers are mostly used to close internal organs, for anastomosis in gastrointestinal
procedures, for biopsy or wedge resection of the lung, and in other thoracic surgical procedures.

Surgical staplers designed to deliver staples in one or two double staggered rows following a linear pa
may include parallel closing jaws, either U- or V-shaped (placing a double staggered row of staples), o
(placing two double staggered rows of staples). Some linear staplers include articulating and/or flexibl
between the body and jaws to facilitate positioning in difficult operative places. Processed biological ti
pericardium) may be used as a buttressing material for reinforcement of the stapled tissues to preven
staple-hole enlargement. Linear staplers are available for use in gastrointestinal and thoracic surgery,
procedures. Most staplers are reloadable, single-use devices.

Linear staplers designed to deliver staples (e.g., made of titanium) in resection, transection, and anas
performed on the gastrointestinal tract and/or other thoracic surgery procedures. These staplers are a
tissues with the characteristic thickness of the gastrointestinal tract (typically from 1 to 2.5 mm); they
several sizes to adapt their use to different tissue thicknesses. Linear gastrointestinal staplers can cre
different lengths (e.g., 30, 60, 90 mm). Some staplers are disposable but may be reloaded during a sin

Surgical linear stapplers/cutters designed to deliver two or more double staggered rows of staples to t
tract tissue that include a knife for simultaneous cutting of the tissue between the two double rows. T
usually staplers/cutters of the forked type; some staplers are disposable but may be reloaded during a
linear staplers/cutters are mainly used to create anastomosis of two segments of the GI tract; they ma
transection and resection of organs such as the liver.

Linear staplers designed to deliver staples (e.g., made of titanium) in resection, transection, and anas
performed on the vessels. These staplers are appropriate for use in tissues with the characteristic thic
vasculature, typically tissues that can be compressed to 1 mm or less in thickness. Vascular staplers a
sizes to adapt their use to different tissue thicknesses; the staplers can create stapling lines of differe
mm, 60 mm). Some staplers are disposable but may be reloaded during a single procedure.

Surgical staplers designed for intraluminal delivery of double staggered rows of staples following a cir
staplers include a detachable head assembly, a firing handle, a locking spring, a staple housing, and t
appropriate for use in gastrointestinal tissues (typically from 1 to 2.5 mm thickness). Usually a circular
simultaneously to staple driving through the tissues. Circular staplers are available in several sizes to
different diameters of the lumen. They are mostly used in anastomosis throughout the gastrointestina
Surgical staplers designed to excise enlarged prolapsed anal mucose (hemorrhoids). These devices ty
circular staplers of at least 1.25-inch (33 mm) diameter. The device is introduced through the anus int
prolapsed tissue is pulled into the stapler and removed, while the remaining hemorrhoidal tissue is sta
its original normal position. Hemorrhoid circular staplers are frequently used together with anal dilator
anoscopes.

Staplers designed to deliver staples one at a time across cut skin edges to close the incision. These st
U-shaped staples that approximate and evert the edges of the tissue as the staples are driven through
conformed into a rectangular shape. The rectangular configuration of the staples resist rotation while
of the skin, resulting in easy removal with good cosmetic results. Skin staplers are intended to close th
traumatic wounds with less pain and better results than obtained with standard sutures; they are avai
disposable devices and also as reusable devices with disposable cartridges..

Staples designed to produce compression and rigid fixation across cancellous bone surfaces. These de
two-leg, mechanically adjusted staples or one-piece staples that are reshaped to apply compression u
electrical current after its implantation. Compression bone staples are used in fracture fixation, fixatio
knee, shoulder) with proliferation of bone cells (i.e., arthrodesis), bone fusion sites, and in other ortho

Compression bone staples consisting of two separated pieces (legs) that can be adjusted as a staple t
using a mechanical threaded mechanism. These staples apply a compression force that is effective to
after tibial osteotomy; they are also used as an aid in procedures involving fixation of the joints with p
cells (i.e., arthrodesis), including the knee, shoulder, and ankle joints.

Compression bone staples that can be reconformed to their original shape after being delivered into th
heated electric current through them. These staples apply a compression force across bone fractures
deflecting their prongs; they are made of special shape-memory metal alloys (e.g., nitinol). Heat resha
available in several sizes and shapes; they are intended to accelerate the healing response of bones.
procedures such as general fracture fixation; skull, maxillofacial, and other oral fractures; and ligamen

Staples made of heavy-gauge metal and long legs appropriate for accommodating the thick gastric an
tissues. These staples are usually U-shaped metallic wires that are conformed into a B shape as they a
tissue; they are typically delivered by staplers in one or two double staggered rows, following either a
pattern. Gastrointestinal/internal organ staples are mostly used to close internal organs in procedures
wedge resection of the lung, for anastomosis of the gastrointestinal tract, and in other thoracic surgica
fixation of hernia suturing mesh).

Staples made of fine-gauge metal and short legs appropriate for accommodating the thin vascular tis
usually U-shaped metallic wires that are conformed into a B shape as they are driven through the tissu
delivered by staplers in one or two double staggered rows following a linear pattern. Vascular staples
anastomosis of the arteries and veins.
Staples designed to join cut skin edges. These staples are usually U-shaped metallic wires that are con
rectangular shape as they are driven into the tissue to properly approximate and evert the border of t
easy removal. Skin staples are typically delivered by staplers one at a time, following a very different
in internal surgery and avoiding tissue compression for better cosmetic results; they are usually availa
regular and wide (3.5 mm and 4.2 mm width, respectively).
Regulated power supplies designed to deliver a heat-controlled current through a special shape-memo
nitinol) bone staple to reconform it to its original shape, producing a compression force. The current is
staple has been placed into the bones. These units consist of an electronic-current source with control
appropriate connector to match the staples. Orthopedic procedures using heat-reshaped staples are in
the healing response of bones; the procedures include general fracture fixation; skull, maxillofacial, an
and ligament reattachment. These procedures are typically performed using a set of manual instrume
in addition to the staple and power supply unit.

Pacemakers designed to apply a repetitive electrical stimulus to the nerves in the stomach wall to reg
gastric contractions. These devices consist of a battery-powered implantable electrical stimulator and
electrodes to connect the stimulator to the stomach muscles; they usually permit noninvasive reprogr
parameters following implantation using an external programmer. The stimulator is implanted beneath
subcutaneous pocket, using either laparoscopic or open-surgery procedures. Gastric pacemakers are m
disorders characterized by slow food movement through the stomach (i.e., gastroparesis), alleviating
vomiting associated with the illness.

Devices designed for testing and/or changing the characteristics (i.e., programming) of implanted pro
Programmer/testers typically consist of a computerized unit with programming, testing, and recording
interact with the stimulator to read information previously stored, perform diagnostic tests, generate p
reprogram the stimulator; they are mostly used to test and/or change the characteristics of implanted
(e.g., pacemakers) and infusion pumps.

Programmer/testers designed for noninvasively testing and/or changing the electrical characteristics (
implanted gastric pacemakers. These devices typically consist of a computerized unit with programmi
recording capabilities that can interact with the implanted pacemaker to read information previously s
printed reports, and/or reprogram the pacemaker. Implantable gastric pacemaker programmer/testers
change the pacing conditions of implanted gastric pacemakers during patient checkup; they are usual
a particular set of implantable pacemakers.

Devices designed for bathing. The water is sprayed on the bather from a showerhead, usually secured
are used in healthcare for bathing of patients and healthcare workers; some are specifically designed
emergency situations (e.g., contamination from chemicals).
Emergency showers that can be easily installed on-site, either in a healthcare facility or in the field. Th
reusable or disposable showerhead and controls for effective use of water; some may include pumps a
structure with curtains for patient privacy. These showers can be installed either using standard water
water tanks. Portable emergency showers are used for patient decontamination and/or by emergency
an emergency, such as industrial disasters and chemical or biological spills.

Tables with a smooth and polished flat-top surface that frequently have raised rims and rounded corne
slope toward a table sink; they are available either fixed, mobile, or portable. They usually include a w
tables facilitate collection and disposal of bloodborne pathogens and hazardous materials from contam
healthcare facilities (e.g., hospitals, nursing homes), contributing to contamination control. Decontam
for patients suffering from traumas, burns, wounds, and other diseases with potential for contaminatio
in emergency situations involving contaminated patients.
Decontamination tables consisting of a lightweight plastic frame (e.g., polyvinyl chloride) and a polish
raised rims and rounded corners; the surface usually slopes toward a table sink. They usually include
These tables facilitate collection and disposal of bloodborne pathogens and hazardous materials that c
contamination control in prehospital care. Portable decontamination tables are used in emergency for
traumas, burns, or wounds and/or potentially contaminated with bloodborne pathogens, chemicals, or
substances.

Stationary modular medical facilities designed for massive decontamination of people from chemical a
mustard (H agent), nerve agents such as VX and the G series (including tabun [GA] and Sarin [GB]), to
materials, and some biological agents. These facilities typically include a module with a showerhead a
effective use of water, a water pump, and additional modules for removal of potentially contaminated
redressing with clean clothes (e.g., gowns); the facilities frequently include water-heating capacity, de
injectors, and a climate-controlled environment with appropriate chemical and biological protection. S
facilities used for showering and decontamination of peoples can be installed either using standard wa
water tanks; some include a transparent plastic wall with reach-in glove arms to permit healthcare pe
cleaning while keeping a protective barrier. The facilities provide a rapid solution in the event of mass
situations (e.g., chemical or other biohazardous spills) involving individuals potentially contaminated w
pathogens, chemicals, or other biohazardous substances.

Mobile medical facilities designed for decontamination of people from chemical agents, including mus
agents such as VX and the G series (including tabun [GA] and sarin [GB]), toxic industrial materials, an
agents. These facilities typically include separate areas for disposal of contaminated clothes, washing
may include several showerheads, water-heating capacity, decontamination-solution injectors, and a c
environment. Mobile medical facilities for decontamination provide a rapid solution in the event of ma
situations (e.g., chemical or other biohazardous spills) involving individuals potentially contaminated w
pathogens, chemicals, or other biohazardous substances.

Protection garments designed for personal protection during decontamination and/or cleaning procedu
typically consist of a body coverall made of a vapor permeable plastic laminate, a surgical mask, glov
covers. Decontamination/cleaning personal protection garments may be used for temporary (typically
days) and limited protection while working in areas slightly contaminated with chemical, biological, or
most of these garments are disposable. Decontamination/ cleaning protection garments do not offer a
for rescuer's use in potentially contaminated areas.

Protection garment designed for personal protection of rescuers in contaminated areas. These garmen
body coverall made of a vapor permeable plastic laminate (e.g., polypropylene) that can repel drips, s
safety eyeglasses or a hood to cover the face and/or head; special gloves; and boots. Contamination e
garments are used for temporary (typically some hours or a few days), limited protection in areas with
contamination with chemical, biological, or radioactive particles; most of these garments are disposab
protection from radiation.
Protection garment designed to facilitate potentially contaminated clothes changing (i.e., redressing)
decontamination of affected persons. These garments typically consist of disposable clothes including
allows patients to change clothes while maintaining privacy, fabric boots, a valuables bag, and a cloth
may also include towels. Re-dressing personal protection garments are mostly used for field decontam
contaminated areas and patient transport during massive emergency situations; they do not offer any
person or rescuer in potentially contaminated areas.

Gloves designed for hand protection against chemicals or chemically contaminated objects. These glo
of thick plastics (e.g., nitrile, neoprene) or butyl rubber; some are made of combined layers of latex an
long-wearing and resistant to a wide range of chemicals. Most gloves include skidproof treads to provi
Chemically resistant gloves are used by healthcare personnel for protection during handling and trans
cleaning, decontamination, and transport of patients and objects contaminated with chemicals or othe
substances.

Shoe covers designed for foot protection against chemicals or chemically contaminated objects. These
made of thick plastics (e.g., polypropylene, polyethylene) or butyl rubber; they are waterproof, resista
chemicals, and intended for long wear. Most shoe covers include a skidproof covering for better tractio
shoe coverings are for healthcare personnel to use over their shoes or boots for protection during han
chemicals or for cleaning, decontamination, and transportation of patients and objects contaminated
biohazardous substances.

Cardboard, metal, or plastic markers used for object (e.g., medical device, container with clinical samp
(e.g., health emergency patients, accident victims) identification and/or classification.
Tags designed to identify and classify individuals according to a priority status based on the severity o
These tags usually include a standard color code (e.g., separate-color tags, colored tear-offs) for patie
sequential code for identification. The severity of injuries is determined using an established procedur
triage and rapid treatment (START) system, which is based on the respiration, pulse, and mental (rpm
classification color code is red for individuals who need immediate care; yellow when delayed care is p
individuals with minor injuries, who can leave the affected area by themselves (I.e., walking wounded
dead/dying victims. Triage tags are attached to the victim's body (e.g., tied to their neck or limbs); the
mass-casualty incidents (typically more than 10 victims), including bus accidents, factory explosions,
train and airplane crashes, and chemical, biological, and radiation (I.e., hazardous materials) incidents

Tags designed for personnel identification to control access to actual or programmed evacuated areas
These tags usually include color code (e.g., separate-color tags, colored tear-offs) for appropriate class
personnel, according their needs (e.g., officials, rescuers, press, residents). These tags are usually issu
to the area, attached to the person's clothing, and collected when the person leaves the area.

Tags designed for identification and/or recording of the main data regarding dead human bodies (i.e.
are usually attached to the left great toe of the cadaver using a string; a copy may be attached to the
kept for recording. Cadaver tags are mostly used in the morgue for identification of cadavers during a
studies.
Alarms designed to activate a visual or more frequently audible (i.e., sound) signal when a fluid conta
infusions is nearly empty. These alarms typically consist of a portable battery-operated electronic unit
that senses the weight of the fluid bag, operating visual (e.g., LED ) and/or sound alarms when pre-es
weights (e.g., 150 g) are reached. The units typically include a clamp for attachment to any vertical in
Gravity infusion alarms can also be used to indicate the completion of bolus infusions and to help in th
introduction into the infusion line.

Systems designed to perform radiotherapy by administering a radioisotope directly into tissue (e.g., tu
prevent or reduce tissue proliferation. These systems typically include a radiation delivery unit, a sour
and controls. Brachytherapy systems (e.g., remote afterloading systems) are used to treat cancer and
abnormal proliferative tissue (e.g., intravascular restenosis), minimizing the radiation dose to surround
avoiding hospital staff exposure to radiation.

Brachytherapy systems designed to deliver radiation (e.g., beta, gamma) to tissue inside the vessels
peripheral arteries). These systems typically consist of a radioisotope source delivery unit and a cathe
for application of the intravascular radiation. The most common isotope for gamma irradiation is Iridiu
irradiation, Phosporous-32, Rhenium-188, Yttrium-90, Strontium-90, and their compounds are used. In
brachytherapy systems are mainly intended to prevent and/or treat excessive intimal proliferation of t
progressively obstructs the arterial lumen (i.e., restenosis) of arteries after angioplasty procedures, fre
implanted stents.

Vascular catheters designed to deliver radiation to a predetermined area inside a vessel and/or into a
inserted into the vessel. These devices typically consist of double-lumen catheters that center the rad
metallic wire, liquid containers) within a closed lumen, while allowing side and distal perfusion through
Vascular catheters for brachytherapy procedures are mostly intended to prevent and/or treat restenos
angioplastic procedures, including restenosis in the inner part of stents (i.e., in-stent restenosis); they
component of intravascular brachytherapy systems that also include a unit for delivery and retrieval o

Computerized systems that analyze digital information (typically images) to detect abnormalities; the
the original information or use information provided by digital systems. These systems typically consis
means to import digital information, a computer capable of using appropriate algorithms, and a displa
show the detected abnormalities for further analysis. Some systems may include capabilities of archiv
communication of view and annotated digital images of pathology scanned slides. Dedicated systems
analysis both of in-vivo images (e.g., breast, pulmonary) and from tissue (pathology) slides (e.g., Pap
available.

Computer aided detection systems designed to detect and classify areas in thoracic radiographies wit
nodules) that may be indicative of lung cancer. These systems typically consist of a film digitizer, a co
using appropriate algorithms for nodule detection and evaluation, and a display/and or printer that pro
showing regions of interest (ROI) in the chest radiography, including lung and mediastinum.

Monitors designed to continuously measure and display one or several parameters such as gas concen
temperature within an enclosure (e.g., hood) or equipment (e.g., incubator, warmer, bath) of a clinical
monitors may be externally attached to or placed near the device or process that they are monitoring
place of the laboratory using telemetric sensors. Some laboratory monitors include alarms. Laboratory
connection with a central station that receives, consolidates, and displays the information from severa
equipment (i.e., laboratory monitors may be a component of a laboratory monitoring system).
Devices designed to provide respiratory protection. They may prevent the device wearer from inhaling
gases, and/or vapors from the environment. Respirators may be designed to remove particles (e.g., du
bacteria), gases/vapors, or both; typically, the user can attach the respirator to his/her face without h
person. Some devices filter the ambient air before it reaches the respirator user; others supply clean a
source different than the surrounding air. Respirators are mostly used in emergency situations to prote
inhalation of bacteria, contaminated particulates, and gases and/or vapors from chemical spills.

Air-purifying respirators designed to prevent the wearer from inhaling airborne particulates, including
and some bacteria (e.g., Mycobacterium tuberculosis). These respirators typically consist of a filtering
of multilayer filter material. Disposable respirators or the filters in reusable units should be replaced w
becomes difficult. Particulate air-purifying respirators do not protect against inhalation of gases and va

Air-purifying respirators designed to prevent the wearer from inhaling specific gases and/or vapors. Th
typically consist of a filtering facepiece (e.g., a mask) that includes disposable filters (e.g., cartridges
be replaced when their absorbing capacity is depleted. Gas air-purifying respirators do not protect ag
airborne particles.
Air-purifying respirators designed to prevent the wearer from inhaling airborne particulates and gases
environment. These respirators typically consist of a filtering facepiece (e.g., a mask) that includes bo
particulate filter that should be replaced when breathing becomes difficult and a disposable filter that
when its absorbing capacity is depleted.
Respirators designed to prevent the wearer from inhaling airborne particulates, gases, and/or vapors f
by supplying air from a source other than the surrounding air to the user. Air-supplying respirators typ
hoses, and a source of air; they are available either as self-contained devices that include the source o
should be connected to a stationary source of compressed air. Air-supplying respirators must supply a
requirements, such as grade D air, as defined by the Compressed Gas Association.

Air-supplying respirators designed to prevent the wearer from inhaling airborne particles, gases, and/o
environment by supplying air from a stationary source of compressed air. These respirators usually inc
long hose that should be connected to a nonportable, high-capacity compressed air source. Stationary
limit the range of mobility of the user, they are intended for use for extended periods in an environme
but not immediately dangerous to life or health (e.g., in the neighborhood of hazardous chemical spill

Air-supplying respirators designed to prevent the wearer from inhaling airborne particles, gases, and/o
environment by supplying air from a self-contained air container. These respirators usually include a m
portable air container that may be attached to the user. Self-contained source respirators do not limit
the user. They are available in two configurations: open-circuit type (intended for short-term use, usua
and closed-circuit type respirators that filter and recycle the air and that may be used for up to a few
intended to enter and escape from an environment that is or may be immediately dangerous to life or
rooms with contaminated particles or hazardous chemical spills).
Air-Supplying respirators designed to prevent the wearer from inhaling airborne particles, gases, and/o
environment by supplying air either from a stationary source of compressed air or from a low-capacity
contained air container. These respirators usually include a mask, a portable air container that may be
and a long hose that should be connected to a high-capacity compressed air source. Combined station
container respirators are intended for use for extended periods in an environment that is or may be im
to life or health for the user (e.g., closed rooms with contaminated particles or hazardous chemical sp
supplementary air supply that is enough to escape in emergency.

Physiologic respiratory monitors designed for continuous measurement and display of the partial pres
(FiO2) in a gas mixture and are hard-wired to the patient at the bedside and/or in the operating room.
of a main electronic unit that can measure using a galvanic cell whose voltage changes with the conce
a polarographic cell whose current varies with the oxygen concentration, sensors, and a display that s
voltage or current as percent of oxygen concentration. Most of these monitors include alarms for dang
concentrations. Oxygen respiratory monitors are intended for use with critical air ventilators and othe
administration equipment; they are also used to check the accuracy of ventilator settings and the pur
oxygen and air; intraoperative use of inspired oxygen monitors during administration of anesthetic ga

Surgical units designed to perform surgery using jets of high-pressure water or water solutions (e.g., s
typically consist of a central console for pressurizing the liquid which includes controls and an operatin
footpedal); a liquid-delivery system, including a pump, tubes, high-pressure nozzles, and a liquid cont
handpieces (usually disposable) to apply the jet. Some units include a collecting system to capture the
surgical units perform resection without warming; they can also cut apart (i.e., dissect) certain tissues
liver tissue from vessels and muscle from fat. Water-jet surgical units can provide the desired tissue d
immersed in irrigation fluid or in air; some units are specialized for endoscopic and/or dermal procedu

Water-jet surgical units designed to perform endoscopic surgery in the articulations (i.e., arthroscopic)
include an electrically powered central console for pressurizing the liquid (e.g., up to 30,000 psi) and a
footpedal) to control the operation; a liquid-delivery system, including a pump, tubes, high-pressure n
container; a waste hose for collecting the liquid and debris (e.g., excised tissue); and a set of specializ
are used for direct delivery of the jet; other tools (e.g., burs) use the high-pressure liquid as a power s
driven mechanisms. Arthroscopic water-jet surgical units can cut, shape, and remove soft and hard tis
burring; they are used in a variety of arthroscopic procedures in small and large articulations.

Devices designed to deliver eye drops into the eyes from appropriate medication containers (e.g., spe
aids typically include a triggering mechanism (e.g., button) to release the drops, an eye cup to deliver
eyes, and some means for coupling with the medication container. Eye-drop delivery aids are intended
self-administration of medicines (e.g., for glaucoma treatment) into the eyes; they are usually reusabl
medication container when empty.

Embolization microspheres designed to give large local radiation (e.g., beta rays) to tumors with little
neighboring healthy tissues. These devices typically consist of glass or ceramic microspheres that incl
radiopharmaceutical isotope (e.g., Yttrium-90) either bound to their surface or forming part of the mic
Radioactive embolization microspheres are mostly used for local radiotherapy (i.e., brachytherapy) of
simultaneous embolization of the vasculature (e.g., the hepatic artery for liver cancer) nourishing the
Gel (e.g., carbohydrate polymer) designed to act as a temporary barrier inhibiting postsurgical adhesi
and organs. This gel is applied to the surface of tissues and organs at the end of surgery, before surgi
typically resorbed by the body in a short period (e.g., several days or weeks). Postsurgical adhesion in
used as an adhesion barrier following spinal surgery (e.g., laminectomy) or tendon and peipheral nerv
adhesion inhibition gels are inteneded for use in pelvic, gynecological, abdominal, or implant surgery

Solutions designed to act as a temporary barrier inhibiting postsurgical adhesion between tissues and
solutions are applied to the surface of tissues and organs at the end of surgery, before surgical closure
resorbed by the body in a short period (e.g., several days). Postsurgical adhesion inhibition solutions a
pelvic and gynecological surgery, both in open and laparoscopic procedures.

Implantable pacemakers that can also deliver simultaneous biventricular stimulations to synchronize v
contractions. Typically, the device (a dedicated pulse generator) is combined with a set of leads that in
leads placed in both the right atrium and the right ventricle and a third unipolar-electrode lead that is
coronary vein (i.e., transvenously) that overlies the left ventricle. These devices add the capability of
synchronization) of the left and right ventricles to obtain better pumping action. They are used for res
in patients with advanced heart failures (e.g., dilated cardiomyopathy) and/or serious heart-rhythm pr
ventricular dysynchrony).

Defibrillator/cardioverter/pacemakers that can also deliver simultaneous biventricular stimulations to


contractions. Typically, the device (a dedicated pulse generator) is combined with a set of leads that in
leads placed in both the right atrium and right ventricle and a third unipolar-electrode lead that is usu
coronary vein (i.e., transvenously) that overlies the left ventricle. These devices add the capability of
synchronization) of the left and right ventricles to obtain better pumping action. They are used for res
in patients with advanced heart failures (e.g., dilated cardiomyopathy) and/or serious heart-rhythm pr
ventricular dysynchrony).

Implantable cardiac pacemaker and/or defibrillator/cardiac pacemakers leads used for sensing cardiac
delivering electrical stimuli to synchronize ventricular contractions. These leads are connected to imp
pacemakers or defibrillator/cardioverter/pacemakers for resynchronization therapy in patients with ad
(e.g., dilated cardiomyopathy) and/or serious heart-rhythm problems such as delayed ventricular activ
(i.e., ventricular dysynchrony).

Ultrasonic scanning systems designed for endoscopic imaging. Some systems include a processor att
ultrasonic endoscope, while other systems attach the processor either to an ultrasonic probe that can
working channel of standard endoscopes (e.g., gastroscopes, colonoscopes) or to rigid probes (e.g., re
ultrasonic system probes include ultrasonic transducers up to 20 MHz frequency to obtain high-resolut
monitored, recorded, post-processed, and/or used for further studies. Endoscopic ultrasonic scanning
obtain additional information to endoscopic imaging, especially in colon, rectal, and upper gastrointes
are also used in some special ultrasonic procedures (e.g., ultrasonic-guided needle biopsy).
Carbon dioxide pulsed lasers designed to deliver their energy using an articulated arm and a handpiec
myocardium, producing temporary myocardial channels. They usually include a helium neon aiming la
induce real mechanisms of revascularization (e.g., temporary perfusion through the laser channels, m
angiogenesis), other mechanisms (e.g., myocardial denervation, myocardial fibrosis), and/or placebo e
are available with handpieces for open or minimally invasive surgery. Transmyocardial revascularizatio
for palliative treatment of stable angina; they may also improve blood perfusion to the myocardium.

Holmium:yttrium aluminum garnet (Ho:YAG) pulsed lasers designed to deliver their energy using a fib
through the myocardium, producing temporary myocardial channels. These lasers may induce real me
revascularization (e.g., temporary perfusion through the laser channels, myocardial angiogenesis), oth
myocardial denervation, myocardial fibrosis), and/or placebo effects. These laser systems may be use
minimally invasive. Transmyocardial revascularization lasers are intended for palliative treatment of st
also improve blood perfusion to the myocardium.

Holmium:yttrium aluminum garnet (Ho:YAG) pulsed lasers designed to deliver their energy into the m
fiberoptic catheters (typically a few millimeters deep but not through all the cardiac muscle), producin
myocardial channels. These lasers may induce mechanisms of revascularization (e.g., myocardial ang
mechanisms (e.g., myocardial denervation, myocardial fibrosis), and/or placebo effects. The laser deli
fiberoptic catheters for percutaneous delivery (i.e., percutaneous myocardial revascularization) throug
Percutaneous revascularization lasers are intended for palliative treatment of stable angina; they may
perfusion to the myocardium.

Cardiac catheters designed for fiberoptic delivery of laser energy to the myocardium using percutaneo
producing temporary myocardial channels. These devices typically consist of single-use, 6 Fr diameter
length fiberoptic catheters with a 9 Fr sheath. Laser energy may induce real mechanisms of revascula
myocardial angiogenesis), other mechanisms (e.g., myocardial denervation, myocardial fibrosis), and/
Percutaneous revascularization catheters are intended for palliative treatment of stable angina; they m
perfusion to the myocardium.

Balloon-expandable coronary stents that include a drug on their surface (e.g., immunosuppressors suc
tacrolimus, cytostatics such as taxol and its derivative, paclitaxel) that is released into the surrounding
(typically several weeks). The drug is usually placed on the stent surface using a polymeric coating or
sleeve. Drug-eluting coronary stents are intended to slow down the growth of unwanted cells (resteno
the endothelialization of the inner layer (i.e., intima) of the artery.

Balloon-expandable coronary stents that include a stable, nonlixiviation (nonleaching) bioactive drug,
phosphorylcholine, on their surface. Bioactive-coated coronary stents are intended to reduce the risk o
associated with stent implantation by inhibiting coagulation mechanisms related to thrombin formatio
activation.
Point-of-care whole blood analyzers dedicated to measuring the concentration of glycated hemoglobin
glycohemoglobin, in a sample of capillary blood. These analyzers may use several measuring techniqu
photometry and immunoassay. The amount of GHB in blood represents the integrated values for gluco
three month period. GHB point-of-care analyzers are mostly used in physician's offices for assessing g
Multianalyte point-of-care analyzers designed to determine the concentration of analytes in the blood
appropriate for diabetes disease management. The most frequently measured analytes are glycated h
known as glycohemoglobin, in whole blood, and urine creatinine and albumin. The amount of GHB in b
integrated values for glucose for the previous three months; the value of the albumin/creatinine ratio
microalbuminuria. These devices typically consist of a portable analyzer that includes a reagent cartri
assess the samples; they may use several measuring techniques, including photometry and immunoa
analyzers for diabetes management are used in clinics and physician's offices to obtain criteria in asse
and/or to find early signs of possible diabetes-related nephropathy.

Image-guided computer-aided stereotactic surgical systems designed to aid in the performance of min
otorhinolaryngology procedures by combining medical imaging, dedicated computer software, and sur
tracking systems for guidance. The systems provide surgeons with real-time, three-dimensional (3-D)
orientation of surgical instruments (e.g., trephines, drills) relative to the patient's anatomy on a video
without the use of an endoscope. These surgical systems typically use electromagnetic techniques or
LEDs) for three-dimensional real-time tracking of the anatomic structures and positioning of instrumen
anatomic landmarks and/or and pre-established fiducials. One or more imaging modalities, such as co
(CT) and/or magnetic resonance imaging (MRI), may also be used in the procedure. Otolaryngology im
systems are used in several procedures, including skull base procedures, nasal sinus surgery, and oth
middle ear procedures.

Automation systems designed to control multiple operating-room devices via a common interface. The
consist of a combination of hardware and software that includes a networked computerized control sy
information and images can be directed, a user interface (e.g., touchscreens, voice control) to perform
issuing commands, routing data and video), surgical and ancillary devices (e.g., electrosurgical units,
devices) that share a common communication protocol and that are integrated into the system, and lo
operating-room video systems. Some systems only network devices located within the operating room
systems); other systems can communicate with information and image systems outside the operating
and/or radiology information systems). Operating-room automation systems are intended to improve t
and efficiency of surgical procedures, particularly during minimally invasive surgery; they are usually
particular surgical requirements.

Endoscopic video systems that include a microchip camera consisting of an array of silicon circuits tha
capacitors (i.e., charge-coupled devices [CCDs]) for image detection of the interior of body cavities. Th
consist of an endoscope that includes a CCD camera attached to its distal tip, an image processor, and
source (e.g., xenon lamp). Chip-camera endoscopic video systems also include monitors and recording
systems provide accessories such as insufflators and irrigation and suction pumps; frequently, the sys
a cart. Video endoscopy systems are used for diagnostic and therapeutic procedures, such as gastroin
laparoscopy, and arthroscopy.
Endoscopic video systems including an external adapter that can be attached to the eyepiece of a fibe
a camera (also called camera head) for image detection of the interior of body cavities. These system
adapter that can be combined with rigid and/or flexible endoscopes, a camera, and an image processo
monitors and recording devices. Most systems provide accessories such as insufflators and irrigation a
typically, the system is mounted in a cart. Video endoscopy systems are used for diagnostic and thera
such as gastrointestinal endoscopy, laparoscopy, and arthroscopy. Some systems include an additiona
possible the image detection from operating microscopes.

Video systems designed to examine various points along the intestinal tract using images captured wi
video camera. These systems typically consist of three components: a disposable ingestible camera p
swallowed by the patient and that transmits video images as it passes through the gastrointestinal tra
the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera
appropriate for processing, displaying, and recording the images from the recorder. Ingestible camera
systems are used to detect abnormalities in the gastrointestinal tract (e.g., cancer lesions, telangiecta
areas of the small intestine that are difficult or impossible to reach using endoscopes. They are also us
esophagus to diagnose and evaluate esophageal diseases (e.g., gastroesophageal reflux disease, esop
esophagus, esophageal ulcers, esophageal varices).

Video cameras designed as a tiny, disposable-image pill that is swallowed by the patient and transmit
from various locations along the gastrointestinal tract. These devices include a number of component
camera, lights, a transmitter, an antenna, and appropriate batteries; the camera pills/capsules are usu
that includes a recorder worn by the patient and a computerized unit to process and display the image
swallows the pill/capsule, which then travels along the gastrointestinal tract by natural movement (i.e
eventually excreted. Endoscopic camera pills/capsules are used to detect abnormalities in the gastroin
cancer lesions, telangiectasia), especially in areas of the small intestine that are difficult or impossible
endoscopes. They are also used to view the esophagus in the diagnosis and evaluation of esophageal
gastroesophageal reflux disease, esophagitis, Barrett's esophagus, esophageal ulcer, esophageal vari

Information systems designed to provide clinical and administrative information related to the periope
including preoperative evaluations and documentation, intraoperative documentation, and postoperat
assessment and pain surveillance. These systems include hardware and software that are appropriate
surgical scheduling, supply management, comprehensive reporting on activities, and information on p
patient status, billing, and costs. Some systems are modular and include specialized units for every ta
nursing, operating room, anesthesia, record transcription).
Therapeutic systems designed to treat open wounds by locally warming them to temperatures close t
normothermic) or slightly higher than body values, typically close to 38 degC (100 degF), without mak
wound. These systems usually consist of a noncontact wound cover, a warming card, and an electroni
unit. The noncontact cover consists of a gas-vapor-permeable plastic (e.g., polyurethane) film that ma
humidity environment and absorbs wound exudates; it also includes a transparent window to view the
are available in a range of sizes to accommodate different wound sizes and/or body sites. The warmin
heating element; they are inserted into a pocket of the noncontact cover to deliver temperature-contr
the wound. The cards are typically multiuse, single-patient devices. The temperature-control unit con
regulator for monitoring and controlling the temperature; it may be line and/or battery operated. Nonc
wound-therapy systems are used for continuous protection and treatment of chronic wounds (which c
bedridden, diabetic, and venous-insufficient patients); the treatment typically consists of several one-
daily. They are intended to promote healing in wounds that are difficult to heal using conventional trea

Therapeutic systems designed to treat open wounds by locally applying negative pressure to the wou
consist of dressings, an evacuation tube, a collection canister, and a computer-controlled vacuum pum
usually include a foam (e.g., black polyurethane, polyvinyl alcohol) dressing with an evacuation tube e
transparent film dressing that is applied over the foam package to seal the foam and the tube. The ot
connected to a fluid-collection canister, which, in turn, is attached to the vacuum pump. The compute
pump applies either continuous or intermittent negative pressure through the tube to the foam dressi
of interstitial fluids from the wound. Negative-pressure wound-therapy systems decompress the capill
vessels, thus improving blood flow to the wound and reestablishing normal circulation of interstitial flu
to promote healing of wounds (e.g., chronic wounds, burns) that are difficult to heal using conventiona

Heart prostheses designed for implantation in the chest that include an implantable short-term power
battery). These devices typically consist of a metallic (e.g., titanium) and plastic mechanism with seve
hydraulic pump that creates the force needed for blood circulation, and valves that open and close to
one compartment of the prosthesis to another and then to the circulatory system. The mechanism is e
to other implantable components, including a rechargeable battery that permits limited (e.g., 30 minu
functioning of the prosthesis, an electronic controller that monitors and controls the pumping speed, a
pumping mechanism is implanted in the chest and is attached to remnants of the left and right atria o
to the aorta and pulmonary arteries after removing the heart ventricles. A coil, an electronic control, a
implanted in the abdomen. The internal battery is recharged by induction across--but without piercing
transcutaneously) using a magnetically coupled circuit between the implanted coil and an external co
transcutaneous energy transmission power system). The external coil usually takes the energy from a
patient (e.g., attached to the waist). Transcutaneously powered heart prostheses are intended for use
replacement for the natural heart, although they may be used as a temporary solution ("bridge") until
Lightweight, hollow beads (i.e., microspheres) of micro- or nanometric diameter, typically of less than
These devices are usually manufactured from ceramics, glass, or polymeric materials; some are obtain
occurring by-product of the burning process of coal. Microspheres made of appropriate materials and u
used in healthcare for vessel embolization (e.g., venous malformations, tumor treatment), local radiot
brachytherapy), and controlled local drug delivery; they are also used for blood-flow measurement, la
microscopes) calibration, and other clinical laboratory uses.

Microspheres designed for vessel occlusion. These microspheres may be manufactured either from ce
or starch; they are available in diameters from 30 to 1,200 microns according to the intended applicat
usually administered through a syringe or catheter that is placed in the arteries; the blood then transp
selected vasculature. Embolization microspheres are mostly used for occlusion of venous malformatio
peripheral (i.e., close to the tumor) vasculature nourishing hypervascularized cancer tumors (e.g., the
cancer); microspheres are also used for uterine fibroid embolization.

Plunger syringes designed to provide needlestick protection (safety). These syringes include some me
positioned or activated) intended to shield, blunt, or recess the needle after use or by some other mea
possibility of contact of the healthcare provider with the needle.
Embolization microspheres designed to locally heat tumors with little warming of the neighboring hea
devices typically consist of ferromagnetic ceramic microspheres that raise the temperature of the tum
degrees C when subjected to an external alternating magnetic field. Hyperthermia embolization micro
used for local overheating (i.e., hyperthermia) of cancer tumors with simultaneous embolization of the
nourishing the tumors.

Embolization microspheres designed for local delivery of pharmaceutical agents into tissues. These de
of a polymeric matrix microsphere that releases a drug (e.g., chemotherapeutic agents such as doxoru
tissues, either by diffusion of the drug from the matrix or, more frequently, by degradation of the poly
microspheres provide a combination of both mechanisms. Drug-delivery embolization microspheres ar
destroy cancer tumors by embolization of the vasculature nourishing the tumors and simultaneous loc
at therapeutic levels for extended periods without systemic exposure and with little effect on healthy

Microspheres that are radio or fluorescent labeled to facilitate their detection; they are typically 10 to
diameter. These microspheres are injected into the arteries that supply blood to a specific organ or tis
blood flow (i.e., regional perfusion) is determined by measuring the quantity of microspheres that reac
using either scintigraphy techniques for radio-labeled microspheres or other appropriate detection me
labeled microspheres (e.g., histologic methods). Regional blood-flow measurement microspheres are m
determine blood flow in the vasculature of the heart, lung, kidney, and pancreas.

Microspheres manufactured within a very narrow diameter distribution from the nominal value. These
typically made of ceramic, glass, or polymers; they are available in a wide range of nominal diameter
calibration/laboratory microspheres are appropriate to calibrate laboratory instruments, such as flow c
electronic microscopes, they are also used in a variety of clinical laboratory applications (e.g., chroma
Paramagnetic microspheres coated with specific nuclear antibodies are part of some separation cell im
Gowns designed for protection against fine particulates and chemical splashes. These gowns are typic
breathable multilayer plastic material (e.g., polyethylene); they may consist either of an open-back ga
protection or jacketlike gowns with full protection to the upper body. Most of these gowns include a sn
wrists. Splash-protection gowns are appropriate for clinical laboratories and general hospital use; they
handling hazardous materials or for decontamination of patients and/or objects.

Programmer/testers designed for noninvasively testing and/or changing the electrical characteristics (
implanted incontinence (e.g., urinary) stimulators. These devices typically consist of both a computeri
programming, testing, and recording capabilities and a programming head that can interact with the i
sending information to the stimulator and/or receiving information previously stored from it. Implantab
stimulator programmer/testers are used during patient checkup to test and/or change the intensity an
characteristics of the electrical stimulus applied by the implanted stimulator; they are usually appropr
particular set of implantable pacemakers.

Programmer/testers designed for noninvasively testing and/or changing (i.e., programming) the drug-
implanted infusion pumps. These devices typically consist of a computerized unit, including a program
interact with the implanted infusion pump, sending programming signals to the pump and receiving s
it. Implantable infusion pump programmer/testers are used during patient checkup to test and/or chan
rate of the implanted pump (e.g., intrathecal delivery pumps); they are usually appropriate only for a
implantable infusion pumps.

Intravascular occluders consisting of microparticles appropriate for vascular embolization. These occlu
of absorbable gelatin-sponge segments and polyvinyl alcohol granules. Particulate intravascular embo
mostly used for occlusion of venous malformations and lesions in spinal and cerebral vessels (e.g., an
used in peripheral (close to the tumor) occlusion of selected vasculature-nourishing hypervascularized

Occluders designed to be inserted in the anterior sacrum bone to control hemorrhage in presacral ven
occluders typically consist of small (e.g., 7, 10, 12 mm) metallic pins that may include either smooth o
shafts; special applicators may be used to hold the pin during insertion. Presacral bleeding occluders
emergency surgery involving surgical mobilization of the rectum.
Occluders designed for closure of atrial or ventricular cardiac septal defects using percutaneous trans
These occluders typically consist of a button, umbrella, double umbrella, or double-disk devices; they
metals, plastic fabrics (e.g., polyester), or a combination of both. The occluders are usually deployed
system that includes a sheath, a dilator, a loading device, and a cable. Cardiac septal occluders are us
many atrial or ventricular defects, including the fetal aperture between the atria (i.e., patent foramen
sinus septal defects, provided that the defects have good rims all around and are separated from imp
They are frequently used for occlusion of large (typically 4 mm or larger) patent ductus arteriosus.

Occluders designed to close the slender tubes that connect the uterus with the ovaries (i.e., fallopian
sperm from reaching the ovum. These occluders may consist either of devices applied externally to th
bands) or devices inserted into the tubes (e.g., plugs, valves). Fallopian-tube occluders are used for pe
conception (contraception), but some devices may be successfully explanted.

Occluders designed to close the blood vessels in the umbilical cord of newborns. These occluders may
ligatures, string, or other device appropriate for permanent occlusion of the vessels.
Devices designed to attenuate high-level noise, typically more than 80 to 90 decibels. These devices t
padded headband and multiposition, lightweight ear cups. Ear muffs may prevent ear damage, and th
remove and replace than ear plugs for intermittent applications.
Biliary stents manufactured from polymeric materials such as polyethylene, silicone, Teflon, or silastic
several different sizes to adapt to particular sections of the duct and/or to prevent migration. These st
inserted using either percutaneous or endoscopic procedures. Polymeric biliary stents are removable d
treat stenosis caused by benign diseases (e.g., stones, strictures).

Biliary stents manufactured from metallic alloys, such as stainless steel, platinum, or nickel titanium a
typically consist of a metallic (e.g., meshlike wire) tube, and some include a plastic cover. Pancreatic m
either balloon expandable or self-expanding; they may be deployed using endoscopic or percutaneous
stents are permanent devices mostly used to treat stenosis of the biliary ducts caused by malignant tu

Biliary metallic stents designed to be expanded using a high-pressure balloon after delivery through a
delivery system, applying a constant radial pressure to the artery walls. These stents are usually mad
platinum, and some are radiopaque or include radiopaque markers for accurate positioning. Balloon-e
stents are used to open biliary-tree strictures (e.g., malignant strictures) without compromising the fle

Biliary metallic stents that are designed to open (i.e., expand) automatically (i.e., self-expanding) (ver
dilatation or other method) after deployment in the structure through an appropriate stent-delivery sy
consist either of compressed metallic stents that open by themselves as soon as they are released or
stents manufactured from an alloy combining nickel and titanium (i.e., nitinol) that expands in respon
temperature. Some stents include radiopaque markers for accurate stent positioning. Self-expandable
to open biliary-tree strictures (e.g., palliation of malignant strictures) without compromising the flexibi

Coronary vascular stents designed to be expanded, applying a constant radial pressure to the artery w
pressure balloon after delivery through an appropriate stent delivery system. These stents are usually
stainless steel, platinum), and some are radiopaque or include radiopaque markers for accurate positi
expandable coronary stents are intended to form a scaffold that holds the coronary arteries open to p
caused by vessel recoil and/or remodeling.

Coronary vascular stents that expand by themselves after deployment through an appropriate stent d
applying a constant radial pressure to the artery walls. These devices consist either of compressed me
by themselves as soon as they are released or of shape-memory stents manufactured from an alloy co
titanium (i.e., nitinol) that expands in response to body temperature. Some stents include radiopaque
stent positioning. Self-expandable coronary stents are intended to form a scaffold that holds the coron
prevent restenosis caused by vessel recoil and/or remodeling.

Vascular stents designed for deployment into the carotid arteries to provide support and/or to maintai
artery. These stents typically consist of a metallic, very flexible meshlike tube either of uniform section
vascular stents are designed to form a scaffold that holds the arteries open, preventing restenosis cau
and/or remodeling.
Carotid vascular stents that expand by themselves after deployment through an appropriate stent del
a constant radial pressure to the artery walls. These devices consist either of compressed metallic ste
themselves as soon as they are released or of shape-memory stents manufactured from an alloy comb
titanium (i.e., nitinol) that expands in response to body temperature. Some stents include radiopaque
stent positioning. Self-expandable carotid stents are intended to form a scaffold that holds the carotid
prevent restenosis caused by vessel recoil and/or remodeling.

Vascular stents designed for deployment into the renal arteries to provide support and/or to maintain
artery; they typically consist of a metallic, very flexible balloon-expandable meshlike tube. These sten
wall in the ostial part to obtain a high radial strength and a thin wall with a bent tip in the distal part t
flexibility, allowing easier access to the renal artery.
Peripheral vascular stents designed to be expanded using a high-pressure balloon after delivery throu
stent-delivery system, applying a constant radial pressure to the duct walls. These stents are usually m
steel, platinum), and some are radiopaque or include radiopaque markers for accurate positioning into
arteries. Balloon-expandable peripheral stents are used to form a scaffold that holds the arteries open
caused by vessel recoil and/or remodeling.

Peripheral vascular stents that expand by themselves after deployment through an appropriate stent-
applying a constant radial pressure to the artery walls. These devices consist either of compressed me
by themselves as soon as they are released or of shape-memory stents manufactured from an alloy co
titanium (i.e., nitinol) that expands in response to body temperature. Some stents include radiopaque
stent positioning. Self-expanding peripheral stents are used to form a scaffold that holds the arteries o
restenosis caused by vessel recoil and/or remodeling.

Bronchial stents manufactured from polymeric materials such as silicone or silastics. These devices m
project into the bronchial wall to help anchor the stent in place. Polymeric bronchial stents are mostly
stem bronchial stenosis without carinal involvement caused either by benign diseases or malignant tu
flow of air into the lungs. They are usually inserted under general anesthesia using rigid bronchoscope
be used for long periods and extracted if needed.

Small bronchial stents manufactured from metallic alloys, such as stainless steel, platinum, or nickel t
nitinol). These devices typically consist of a metallic (e.g., meshlike wire) tube, and some include a pl
metallic stents may be either balloon expandable or self-expandable; they are typically deployed unde
using flexible bronchoscopes. These stents are permanent devices mostly used to treat stenosis cause
tumors.

Metallic bronchial stents designed to be expanded using a high-pressure balloon after delivery, applyi
pressure to the bronchial walls. Some of these stents are radiopaque or include radiopaque markers fo
Balloon-expandable bronchial stents are typically deployed under local anesthetics using flexible bron
mostly used to treat stenosis caused by malignant tumors.

Metallic bronchial stents that expand by themselves after deployment, applying a constant radial pres
walls. These devices consist either of compressed metallic stents that open by themselves as soon as
shape-memory stents manufactured from an alloy combining nickel and titanium (i.e., nitinol) that exp
body temperature. Some stents include radiopaque markers for accurate stent positioning. Self-expan
are typically deployed under local anesthetics using flexible bronchoscopes; they are mostly used to t
malignant tumors
Tracheal stents manufactured from polymeric materials such as silicone or silastics. These devices ma
project into the bronchial wall to help anchor the stent in place; they may be straight or T-shaped. Poly
are used to treat upper- or middle-tracheal lesions caused by either injuries, benign diseases, or malig
facilitating the flow of air into the lungs. These stents are usually inserted under general anesthesia u
bronchoscopes; some plastic tracheal stents (e.g., T-tubes) require permanent tracheotomy. They can
periods and extracted if needed

Polymeric tracheal stents with a long center lumen and a smaller lumen projecting from the side of th
degrees or 75 degrees angle (i.e., configured as a T) that are permanently inserted to maintain patenc
airway. These stents typically consist of a silicone or slapstick tube inserted using a tracheostomy proc
tracheostomy technique used to open the airways in emergency. The side lumen extends through the
shaped polymeric tracheal stents are used to bypass tracheal stenosis situated between the thoracic
usually when surgery of the tracheal obstruction is not possible.

Tracheal stents manufactured from metallic alloys, such as stainless steel, platinum, or nickel titanium
These devices typically consist of a metallic (e.g., meshlike wire) tube, and some include a plastic cov
stents may be either balloon expandable or self-expandable. They are permanent devices typically de
anesthetics using flexible bronchoscopes; they are used to treat stenosis caused by injuries, benign di
tumors.

Metallic tracheal stents designed to be expanded after delivery using a high-pressure balloon, applyin
pressure to the bronchial walls. Some of these stents are radiopaque or include radiopaque markers fo
Balloon-expandable tracheal stents are typically deployed under local anesthetics using flexible bronc
mostly used to treat stenosis caused by injuries, benign diseases, or malignant tumors.

Metallic tracheal stents that expand by themselves after deployment, applying a constant radial press
walls. These devices consist either of compressed metallic stents that open by themselves as soon as
shape-memory stents manufactured from an alloy combining nickel and titanium (i.e., nitinol) that exp
body temperature. Some stents include radiopaque markers for accurate stent positioning. Self-expan
are typically deployed under local anesthetics using flexible bronchoscopes; they are mostly used to t
injuries, benign diseases, or malignant tumors

Stents designed for deployment into the trachea and the main stems of the bronchi, to provide suppo
patency of the respiratory airways, facilitating the flow of air into the lungs. These devices typically co
silicone) bifurcated tube (Y-shape). The bifurcated tracheobronchial stents fit snugly into the distal tra
the proximal bronchi. The stent surface may be coated to add special capabilities to the stent (e.g., w
are usually deployed using a catheter and a rigid bronchoscope. Tracheobronchial stents are used to t
trachea, carina, and/or main stems of the bronchi caused either by benign diseases, injuries, or malign

Stents designed for deployment into the larynx to provide support and/or to maintain patency of the a
typically consist of a plastic tube that conforms to the inner contour of the larynx, providing support b
stent retains its position by adherence to the laryngeal contour; some include straps for additional anc
stents are used for posttraumatic support after laryngotracheal reconstruction. They are also used to
glottis, subglottis) stenosis. These stents are usually removed endoscopically after laryngeal healing.
Esophageal stents manufactured from synthetic plastic materials, such as silicone or silastics. These d
anchors that project into the esophageal wall to prevent stent migration. Polymeric bronchial stents ar
strictures and/or lesions caused either by injuries or benign diseases; they are not appropriate for poo
These stents are usually inserted under local or general anesthesia using endoscopic procedures. Poly
used for long periods and extracted if needed.

Esophageal stents manufactured from metallic alloys, such as stainless steel, platinum, or nickel titan
nitinol). These devices typically consist of a metallic (e.g., meshlike wire) tube. Most stents include a
resist tumor ingrowth and/or to seal esophageal fistula. Metallic stents used in the esophagus are usu
local anesthetics using endoscopic procedures (i.e., esophagoscopy). Metallic esophageal stents are p
mostly used to treat stenosis caused by malignant tumors. They could also be used for injuries and/o

Metallic esophageal stents that expand by themselves after deployment, applying a constant radial pr
esophageal walls. These devices consist either of compressed metallic stents that open by themselve
released or of shape-memory stents manufactured from an alloy combining nickel and titanium (i.e.,
response to body temperature. Some stents include radiopaque markers for accurate stent positioning
esophageal stents are typically deployed under local anesthetics using endoscopic procedures; they a
stenosis caused by malignant tumors. The stents could also be used for injuries and/or benign diseas

Pancreatic stents manufactured from polymeric materials such as polyethylene, silicone, Teflon, or sila
available in several different sizes to adapt to particular sections of the duct and/or to prevent migrati
usually inserted using either percutaneous or endoscopic procedures. Polymeric pancreatic stents are
stenosis of the main pancreatic duct caused either by benign diseases (e.g., stones, papillary stenosis
malignant tumors, facilitating the flow of pancreatic juice into the duodenum.

Pancreatic stents manufactured from metallic alloys, such as stainless steel, platinum, or nickel titani
These devices typically consist of a metallic (e.g., meshlike wire) tube, and some include a cover. Panc
may be either balloon expandable or self-expanding; they are typically deployed using endoscopic pro
are mostly used to treat stenosis of the main pancreatic duct caused by malignant tumors.

Metallic pancreatic stents designed to be expanded after delivery using a high-pressure balloon, apply
pressure to the pancreatic duct walls. Balloon-expandable pancreatic stents are typically deployed usi
procedures. They are mostly used to treat stenosis of the main pancreatic duct caused by malignant

Pancreatic metallic stents that expand by themselves after deployment, applying a constant radial pre
duct walls. These devices consist either of compressed metallic stents that open by themselves as soo
or of shape-memory stents manufactured from an alloy combining nickel and titanium (i.e., nitinol) th
to body temperature. Some stents include radiopaque markers for accurate stent positioning. Self-exp
stents are typically deployed using endoscopic procedures; they are mostly used to treat stenosis of th
duct caused by malignant tumors.
Stents designed for deployment into the colon or the proximal rectum to provide support and/or to ma
the lower digestive tract. These devices typically consist of metallic self-expanding stents, either comp
that open by themselves as soon as they are released or shape-memory stents manufactured from an
and titanium (i.e., nitinol) that expands in response to body temperature. Some stents include radiopa
accurate stent positioning. Colonic stents are typically deployed using endoscopic procedures; they ar
strictures caused by carcinomas in patients with high operative risk and/or advanced disease. Some o
used in other sections of the digestive tract (e.g., duodenum).

Stents designed for temporary use during dental procedures and/or maxillary surgery. Dental stents a
shapes, and most are especially designed for different applications, including control of hemorrhage, t
eruption (pedodontic), for proper location of tooth implants, and as a surgical guide in maxillofacial su
stents consist of direct impressions of the mouth and/or oral structures; they are made of stent mass o
compounds.

Slender tubular devices designed to functionally replace injured or diseased sections of the body's tub
blood vessels) while maintaining patency. These devices typically consist of one or more open mesh m
balloon expandable or self-expanding) covered with either a synthetic (e.g., Dacron) or, less frequentl
tube. Stent/grafts are usually placed endoscopically, via a percutaneous approach (e.g., via the femor
surgical approaches.

Stent/grafts designed for percutaneous deployment into the coronary arteries. These devices typicall
(e.g., balloon expandable) meshlike stent covered with a synthetic graft such as Dacron or polytetraflu
Some devices consist of a layer of expanded PTFE placed between two stainless steel stents. Coronary
intended for emergency treatment of perforations in native coronary arteries and/or saphenous vein b

Stent/grafts designed for percutaneous deployment into the aorta. These devices typically consist of
supporting frame (e.g., a set of self-expanding stents) covered with a graft (e.g., made from a synthet
Dacron). Most aortic stent/grafts are used to bypass lower abdominal (under the renal artery) aortic an
stent/grafts are introduced within the aneurysm through the femoral arteries in the groin area. Aortic
flow of blood away from the aneurysm wall, excluding the aneurysm from circulation. The procedure d
aneurysm but allows it to shrink over time.

Stent/grafts designed for percutaneous deployment into the aorta and proximal sections of the iliac ar
are available in several shapes and materials. Some devices consist of an integral bifurcated (Y-shape
its ends that includes a larger-diameter section for the aorta and two limbs for the iliac arteries. Othe
systems with self-expanding stents that are inserted by parts - first, one part of the graft stent, includi
and one iliac limb, is introduced through a femoral artery, then the contralateral limb is inserted from
attached to the previously inserted part. Most aortoiliac stent/grafts are used to bypass lower abdomin
artery) aortic aneurysms without a distal neck, usually also affecting the iliac arteries. Aortic stent/gra
blood away from the aneurysm wall, excluding the aneurysm from circulation. The procedure does not
but allows it to shrink over time.
Vascular stent/grafts designed for deployment into one of the peripheral arteries, especially those tha
lower extremities, such as the iliac, femoral, and popliteal arteries. These devices typically consist of a
self-expanding stent covered with a synthetic (e.g., polyurethane, Dacron) graft; they are available in
shapes (e.g., straight, bend) to adapt to particular sections of the peripheral arteries and/or to preven
vascular stent/grafts are mostly used to treat aneurysms or pseudoaneurysms and/or to repair vessel
ruptures. Some are used to keep open strictures of the vessels and/or to reduce vascular narrowing (i
angioplastic procedures.

Subcutaneous-port needles designed to provide needlestick protection. These needles typically includ
positioned or activated mechanism intended either to shield, blunt, or recess the needle after use or,
lessen the possibility of contact of the healthcare provider with the sharp needle.

Airway clearance units designed to apply low-frequency cycles of a gradually increasing positive press
H20) to the airways followed by a rapid change to a negative pressure (typically negative 30 to negat
exhausting the lungs and reproducing in the bronchial tree the effects of a vigorous cough. These dev
a portable electric unit that provides the positive and negative pressures and that includes automated
controls and timers to perform the inspiratory and expiratory cycles; and a patient breathing circuit th
filter, breathing tubes; and a patient interface (e.g., a mask, mouthpiece, tracheostomy tube adapter)
Insufflation/exsufflation units are intended to palliate respiratory deficiency in patients with debilitated
and/or other disorders that affect the respiratory function, such as spinal cord injuries, muscular dystr
lateral sclerosis, and poliomyelitis.

Serology reagents used in rapid tests to detect influenza virus (either type A, B, or both) antigens or in
activity. Influenza viruses are the etiologic agent of influenza, an acute infection of the respiratory trac

Insulin syringes designed to provide needlestick protection (safety). These syringes include some mec
positioned or activated) intended to shield, blunt, or recess the needle after use or by some other mea
possibility of contact of the healthcare provider with the needle.
Devices designed to convert information (e.g., data, images) to digital format. These devices may tak
a document, film, or other external sources that provide information in analog format. The most chara
a digitizer is an analog-to-digital converter. Digitizers are mostly used in the clinical field to digitize ra
medical reports, and/or analog signals from imaging systems (e.g., ultrasound and video systems).

Digitizers designed to convert information in paper form (print documents, color and monochromatic p
signatures) into digital format using either an optical scanner or a camera that captures the specified
devices typically include light sources, a mechanical document-transporting system, an analog-to-digi
electronic processor, and a computer interface. Document digitizers are used to create backup and pa
files; some are capable of capturing bar codes and/or high-resolution photos.
Digitizers designed to convert analog video signals from external devices (e.g., video cameras) into di
way that the images can be displayed using computers and processed through digital information sys
usually digitize one frame at a time (frame grabbers). These devices typically consist of video-input m
signals (e.g., composite video, S-video format), an analog-to-digital converter, electronic processors, a
and appropriate software. Some of these devices are bidirectional, also allowing conversion from digit
Video digitizers permit video-image transfer and manipulation through hospital information systems, p
using laser printers, and permanent archiving in magnetic and/or optical disks.

Devices that combine the capabilities of video digitizers and high-capacity (e.g., magnetic disk) record
typically obtain (capture) and digitize images from an external video source, such as a charge-coupled
video-cassette recorder and then store them on a high-capacity internal hard disk drive. They may inc
rewritable compact-disc driver (burner). Video digitizer/recorders permit the storage of several thousa
and/or several hours of motion video. The stored information may be transferred, processed, and man
hospital information systems; printed using laser printers; and transmitted to remote places using a st
browser.

Aprons designed for safe evacuation of infants. These aprons are typically made of heavy-duty fabrics
retardant) that include several pouches in the front and in the back, with appropriate fasteners to hold
They are typically finished in bright colors (e.g., yellow) for easy recognition during emergency situati
include pouches for newborns and other models are appropriate for older infants. Infant-evacuation ap
multiple evacuation of infants (typically up to four or five babies) by only one person during emergenc
environmental contamination, fires, and floods.

Plunger syringes designed for subcutaneous injection of precise low-volume doses (typically 0.25 to 2
and/or sensitivity (allergy) tests; they may also be used for other subcutaneous injections (e.g., rubell
syringes typically have a small-diameter, low-volume cylinder, usually 1 mL in size, that is accurately
of milliliter or cubic centimeter using permanent lines on its barrel. Tuberculin/allergy syringes usually
short-length, very-small-gauge needles (25 to 28 gauge is typical) attached or fixed to their tip that m
or eccentric with the syringe barrel.

Tuberculin/allergy syringes designed to provide needlestick protection (safety). These syringes include
(manually positioned or activated) intended to shield, blunt, or recess the needle after use or by some
the possibility of contact of the healthcare provider with the needle.
Plunger syringes designed to administer an accurate dosage of oral liquid medication. These syringes
plastic barrel marked with 0.5 mL graduations (and/or with teaspoon fractions), ended in a hollow blun
capacity is usually 0.5 to 20 mL, although syringes with higher capacities (e.g., 60 mL) are available. O
syringes should not be capable of connecting to needles, intravenous tubing, stopcocks, or injection p
for pediatric administration may have long soft tips and/or child-resistant caps.

Plunger syringes designed to withdraw arterial blood samples. These devices typically consist of a 3 t
syringe internally covered with heparin or heparin-based compounds (e.g., dry lithium heparin, sodium
coagulation. The syringes are impenetrable by air and liquids to avoid blood and/or gas loss while tran
some include filters for air-bubble removal. Blood-sampling syringes are used to obtain samples for lab
including pH, blood gases (e.g., O2, CO2), electrolytes (e.g., calcium, magnesium, potassium, chloride
such as lactate and glucose.
Arterial blood sampling plunger syringes designed to provide needlestick protection (safety). These sy
mechanism (manually positioned or activated) intended to shield, blunt, or recess the needle after use
means lessen the possibility of contact of the healthcare provider with the needle

Cartridge syringes designed to provide needlestick protection (safety). These syringes include some m
positioned or activated) intended to shield, blunt, or recess the needle after use or by some other mea
possibility of contact of the healthcare provider with the needle.
Cartridge dental syringes designed to inject anesthetic in the fibrous connective tissue (ligament) tha
a tooth and separates it from the alveolar bone (i.e., intraligamentary tissue). These syringes are used
required to anesthetize a single tooth, providing rapid diffusion of the anesthetic.

Syringes designed to deliver air, water, or a combination mist into the mouth (e.g., onto the teeth). Th
consist of a handle with two different conduits for air and water with individual controls to deliver the
Air/water syringes are used by the dentist or a dental assistant for oral prophylaxis.

Instruments designed to access, examine, diagnose, and/or treat internal tissues and/or organs of the
inaccessible through natural canals or body cavities. These instruments usually consist of an outer she
(e.g., fiberoptic), and a working channel to introduce catheters and operative devices. Endoscopes ma
using plastic or metallic (e.g. stainless steel) outer sheaths; some include a video camera to display im
the endoscope. Most endoscopes are specialized for the area where they operate and/or the procedur
they are named accordingly.

Endoscopes designed for direct insertion in the respiratory tract for visual examination, biopsy, retriev
and treatment of lesions in all or most of the tract, including the nasal cavity, pharynx, larynx, and bro

Endoscopes designed for insertion in the gastrointestinal tract for visual examination, biopsy, retrieva
treatment of lesions in the tract. Gastrointestinal-tract endoscopes for visualization of the upper gastr
typically are inserted through the mouth; those intended for the lower gastrointestinal tract are insert

Gastrointestinal-tract endoscopes designed to access, examine, diagnose, and/or treat the upper gast
These devices are used mainly for biopsy, retrieval of foreign objects, and treatment of lesions in all o
including the esophagus, stomach, and parts of the small intestine (e.g., the duodenum). These endos
inserted through the mouth.
Endoscopes designed for insertion in the gastrointestinal tract for visual examination, biopsy, retrieva
treatment of lesions in areas of the tract such as the anal canal, rectum, colon, and/or the large intest
are inserted through the rectum.
Choledochoscopes designed for percutaneous insertion in the biliary tract for visual examination, biop
crushing of stones, and treatment of lesions in the interior of the tract, especially the common bile du

Choledochoscopes designed for percutaneous insertion in the biliary tract during laparoscopic procedu
cholecystectomy) for visual examination, biopsy, removal or crushing of stones, and treatment of lesio
the tract, especially the common bile duct.
Choledochoscopes designed for insertion through the duodenum, typically using the working channel
These choledochoscopes are used for visual examination, biopsy, removal or crushing of stones, and t
the interior of the tract, especially the common bile duct.
Endoscopes designed for insertion in the urinary tract for visual examination, biopsy, removal or crush
treatment of lesions in all or most of the tract, including the urethra, bladder, ureters, and renal pelvis
endoscopes may be inserted either directly in the tract through the urethra or percutaneously through
renal pelvis.
Laparoscopes designed for viewing the organs of the abdominal cavity; their diameter typically range
although some small-diameter laparoscopes about 2 mm in diameter (microlaparoscopes) are frequen
procedures. These instruments may be rigid or flexible; they do not have instrument channels. Diagn
used to visualize gynecologic conditions, determine the causes of infertility and chronic abdominal pa
condition of diseased livers, including the performance of biopsies.

Laparoscopes designed to perform surgery, including laser and electrosurgery procedures, through the
their diameter typically ranges from 8 to 12 mm. These instruments incorporate prisms or mirrors tha
light to and from the tissue through one or two bends to the eyepiece, which is offset from the laparos
surgical instrument can be inserted through a separate instrument channel in the shaft and manipulat
laparoscopes are used with other specialized surgical instruments to perform minimally invasive surgi
cholecystectomy (removal of the gallbladder), appendectomy, and hysterectomy.

Encephaloscopes with a nonflexible (i.e., rigid) structure that can follow only a straight path into the c
thin (e.g., 4 mm diameter) endoscopes that are available with different directions of view (e.g., 30 or 1
direct examination of the cerebral ventricles (i.e., ventriculoscopy) and inspection of cystic tumors.

Encephaloscopes with a nonrigid (i.e., flexible) structure that are capable of being manipulated in curv
cranium; they are used for the removal of tumors and cysts and the performance of other endosurgica
treatment of bleeding and catheter implantation. Flexible encephaloscopes may include an attached v
the performance of procedures under direct video observation.

Endoscopes designed for insertion through the natural orifice or through a surgical opening into the sa
examination, biopsy, and removal or crushing of stones. Sialoendoscopes consist of an outer sheath a
surgical units to introduce forceps, stone baskets, graspers, and other miniature instruments typically
diameter.
Specula designed to expand the distal opening of the oral cavity for examination and/or treatment of
specula typically consist of a metallic instrument comprising a hollow cylinder and a solid handle that
and depresses the tongue at the same time. Pharyngeal specula may be of many different sizes and s
stainless steel and reusable.
Prostheses designed to assist and/or substitute for one ventricle of a damaged or weakened heart in o
they may substitute for either the left ventricle or, less frequently, the right ventricle. These devices
implantable metallic and plastic mechanism that includes one pump, which works as an artificial vent
blood from the inlet to the outlet and then through the circulatory system.
Cardiac-ventricle prostheses that include an implantable pumping mechanism with a percutaneous co
power source (either electrical or pneumatic) that supplies the driving power. These devices typically
implantable pump that works as an artificial ventricle by pushing the blood from the inlet valve to the
through the circulatory system and an electrical or pneumatic external power system that is connecte
pump through electrical wires or pneumatic drive lines that enter the left part of the patient's chest. B
continuous-flow pump systems are available. Percutaneously powered heart prostheses include a batt
console that is permanently attached to the patient for power supply and control of the pumping rate
implanted prosthesis. These prostheses are used mainly as a temporary bridge to transplantation, but
units may be capable of long-term use.

Cardiac-ventricle prostheses designed for implantation in the chest that use a power source (e.g., a ba
typically consist of a metallic (e.g., titanium) and plastic mechanism with a sealed chamber and a hyd
pulsatile or continuous) that creates the force needed for blood circulation; they may also include valv
to let the blood flow in and out through the circulatory system. These mechanisms are electrically con
implantable components, including a rechargeable battery that permits limited autonomous functionin
(e.g., 30 min), an electronic controller that monitors and controls the pumping speed, and an internal
pumping mechanism is implanted in the chest; one end is attached either to the left or, less commonl
ventricle, and the other end is attached to the aorta or pulmonary artery. The internal coil, an electron
battery are implanted in the abdomen. The internal battery is recharged by induction across--but with
(i.e., transcutaneously) using a magnetically coupled circuit between the implanted coil and an extern
known as a transcutaneous energy transmission power system). The external coil usually takes the en
worn by the patient (e.g., attached to the waist). Transcutaneously powered cardiac-ventricle prosthes
permanent assistance of the heart, although they may be used as a temporary bridge to transplantati

Devices designed primarily for automated discovery and/or ascertainment of the presence or existenc
some physical, chemical, physiologic, or technical condition. Detectors are not intended for accurate m
display of the numerical values of the conditions that are detected, although they can provide rough e
conditions and/or indicate when predetermined values have been reached or exceeded. These device
recorders and/or alarms. Most detectors are used in healthcare applications to indicate life-threatening
occur in medical device operation (e.g., bubble detection during intravenous infusion), to localize met
(especially in the eyes), or to determine the presence of certain physiologic vital signs (e.g., respiratio
detectors can indicate the presence of hazardous environmental conditions (e.g., toxic agents, ionizin
biological agents).

Detectors designed for automated discovery and/or ascertainment of the presence of some physical, c
conditions and elements in the environment to which individuals may be exposed. These detectors m
and have capabilities to process information. Environmental detectors are used mainly to determine t
abnormal concentrations of gases (e.g., oxygen, carbon dioxide), hazardous substances (e.g., toxic ga
biological agents), and/or other physical conditions in the environment (e.g., high or low temperatures
high particle concentration). Many environmental detectors warn of a hazardous condition when prede
concentrations have been reached or exceeded.
Environmental detectors designed for automated detection of chemicals that may kill or seriously inju
chemical agents), such as industrial toxic chemicals (e.g., ammonia, nitric acid, phosgene, formaldehy
(e.g., tabun, sarin, VX), and blister (vesicant) agents (e.g., mustard, lewisite). Some can also detect no
lacrimator) agents. The sample is typically taken from the atmosphere, but sometimes liquid and/or p
used. Some of these detectors are computerized and detect, identify, and warn of a hazardous conditi
predetermined values of the chemical agent have been reached or exceeded. Chemical agent environ
available mainly as portable or handheld units and less frequently as stand-alone or mobile devices; t
healthcare personnel, rescuers, firefighters, and military personnel in accidentally and/or intentionally
potentially contaminated areas.

Chemical agent environmental detectors designed for automated detection and identification of comp
biological effects by inhibition of the enzyme acetylcholinesterase (nerve agents), such as tabun (GA)
(GD), and VX. The effects of these agents may be produced while in vapor (if inhaled) or in liquid state
transcutaneously). Some devices can also detect agents that act when absorbed into the blood (i.e., b
cyanide salts (either solid or liquid), cyanogen chloride (CK), and hydrogen cyanide (AC). These detect
several different technologies, including surface acoustic waves, induced fluorescence, and spectrosco
spectroscopy). The sample is typically taken from the atmosphere, but water and/or particle samples a
Most detectors warn of a hazardous condition when predetermined values of the nerve agent have be
exceeded. Nerve agent environmental detectors are available mainly as portable or handheld units an
stand-alone or mobile devices. They are used by healthcare workers, rescuers, firefighters, and militar
accidentally and/or intentionally contaminated or potentially contaminated areas.

Chemical agent environmental detectors designed for automated detection and identification of comp
biological effects by producing blisters (i.e., vesicants) such as impure or distilled mustard (H and HD,
phosgene oxime (CX), and lewisite (L). The effects of these agents may be produced while in vapor (if
state ( if absorbed transcutaneously). These detectors may use one or several different technologies,
acoustic waves, induced fluorescence, chromatography, and spectroscopy. The sample can be taken f
but water and/or particle samples are sometimes used. Most detectors warn of a hazardous condition
values of the blister agent have been reached or exceeded. Blister agent environmental detectors are
handheld, or stand-alone units and less frequently as mobile devices. They are used by healthcare wo
firefighters, and military personnel in accidentally and/or intentionally contaminated or potentially con
Chemical agent environmental detectors designed for automated detection and identification of indus
as toxic industrial materials, or TIM) that produce highly toxic effects, such as nitric acid (HNO3), amm
formaldehyde, and hydrochloric acid (HCl). The effects of these agents may be produced while in vapo
liquid state (if absorbed transcutaneously). Some devices can also detect agents that produce choking
such as phosgene and chlorine. These detectors may use one or several different technologies, includ
and spectroscopy. The sample is typically taken from the atmosphere (gases and aerosols), but liquid
are sometimes used. Most detectors warn of a hazardous condition when predetermined values of the
been reached or exceeded. These detectors are available mainly as portable or handheld units and les
alone or mobile devices. They are used by healthcare workers, rescuers, firefighters, and military pers
and/or intentionally contaminated or potentially contaminated areas.

Chemical agent environmental detectors designed for automated detection and identification of hazar
(e.g., nerve and/or blister agents) using a sensor with long-range capabilities. These detectors typical
automated-scanning infrared sensor that can recognize agent clouds up to a line-of-sight range of 5 km
systems work by comparing the background spectrum obtained by the detector with the information s
Remote-sensing hazardous chemical detectors have a sensitivity in the order of 100 mg/cubic meter f
500 mg/cubic meter for blister agents; they are used in civil defense and military applications.

Chemical agent environmental detectors designed for automated detection and/or identification of ha
agents (e.g., nerve and/or blister agents) using a sensor that is connected via a hardwired, radio, or sa
more remote stations. They usually warn when predetermined values of the chemical agent have bee
These detectors may use one or several different technologies, including surface acoustic waves and
Telemetric chemical agent environmental monitors can be placed in hospital wards or at victim collect
contamination and prevent personnel from entering a contaminated area.

Telemetric chemical agent detectors designed for automated detection and/or identification of hazard
(e.g., nerve and/or blister agents, toxic industrial agents) using a sensor that is attached to a sonde th
from an aircraft. These detectors may use one or more technologies, including surface acoustic waves
the information through a VHF or UHF link. Chemical agent detection air-drop sondes are used to pro
and/or advanced warning of the risk of chemical contamination of the environment in an operational a
rescue, or military personnel are deployed. Most detectors can provide additional information about th
atmospheric conditions.

Environmental detectors designed for automated detection of bacteria and virus pathogens and/or tox
seriously injure human beings (i.e., biological agents). The sample is usually taken from the atmosphe
particle samples are sometimes used. These detectors may use one or several different technologies
clinical laboratory analyzers (e.g., immunoassay, molecular assay). Some of these detectors are comp
and warn of a hazardous condition when a biological agent has been detected. Biological agent enviro
available mainly as portable or handheld units and less frequently as stand-alone or mobile devices. T
healthcare workers, rescuers, firefighters, and military personnel in accidentally and/or intentionally c
potentially contaminated areas.
Biological agent environmental detectors designed for automated detection and discrimination betwe
that may include hazardous agents (e.g., bacterial and/or virus pathogens) and nonbiological aerosols
sensor with long-range capabilities; the sensors typically consist of passive automated-scanning infrar
devices that can recognize distant (typically at ranges of one mile or more) agent clouds. The system
the background spectrum obtained by the detector with the information stored in a computer. Remote
agent detectors are used in civil defense and military applications.

Chemical agent environmental detectors designed for automated detection and/or identification of bio
generic and/or specific types of bacteria, viruses, spores, and/or toxins) using a sensor that is connect
radio, or satellite link to one or more remote stations. They usually warn when predetermined concent
agents have been reached or exceeded. These detectors may use one or several different technologie
and/or optical detection. Telemetric biological agent environmental monitors can be placed in hospital
collection sites to detect contamination and to prevent personnel from entering a contaminated area.

Telemetric biological agent detectors designed for automated detection and/or identification of hazard
(e.g., generic and/or specific types of bacteria, viruses, spores, and/or toxins) using a sensor that is at
can be dropped from an aircraft. These detectors may use one or several different technologies, includ
chemistry and fluorescence detection; they usually transmit information through a VHF or UHF link. B
detection air-drop sondes are used to provide a characterization and/or advanced warning of the risk o
contamination of the environment in an operational area before healthcare rescue, or military personn
detectors can provide additional information about the meteorological conditions in the atmosphere.

Environmental detectors designed for automated discovery and/or ascertainment (i.e., detection) of io
usually in the form of gamma rays and/or alpha or beta particles. The sample is typically taken from th
water and/or particle samples are sometimes used. Ionizing radiation environmental detectors are ava
portable, handheld, or individually worn units; some detectors are computerized and detect, identify,
hazardous condition when predetermined values of radiation are reached or exceeded. These devices
personnel, rescuers, and firefighters in radioactive or potentially radioactive contaminated areas.

Ionizing radiation detectors designed for automated discovery and/or ascertainment of the presence o
to 500 or 1,000 miliroentgen/ hour) ionizing radiation levels that are not a short-term hazard to huma
may use one or several different sensing devices, including Geiger tubes and/or other ionizing chamb
include visual and/or sound indicators to show that ionizing radiation is present (e.g., flashing lights an
for each radiation event) but do not include displays showing the radiation level. Low-level detectors o
used mainly in areas where a radiation leakage has or may have occurred, to check low-level contami
water, and to evaluate the results of decontamination procedures. Many low-level detectors become s
exposed to high radiation levels (e.g., more than one roentgen/hour), making them useless to detect d
lethal) ionizing radiation levels that are present in some nuclear emergencies. Low-level ionizing radia
detectors are used by healthcare personnel, rescuers, and firefighters in radioactive or potentially rad
areas.
Ionizing radiation detectors designed for automated detection of high levels (typically up to 100 roent
ionizing radiation that are an immediate hazard to humans. These detectors may use one or several d
(e.g., scintillation). The detectors typically include visual and/or sound indicators that show when dang
are present; some permit a rough estimate of the radiation levels. These detectors do not include disp
radiation rate. High-level ionizing radiation detectors are used mainly by healthcare personnel, rescue
military personnel in highly contaminated or potentially highly contaminated radioactive areas, as a re
plant leakage, nuclear explosion, or any other event involving high-energy ionizing radiation sources.

Environmental detectors designed for automated discovery and/or ascertainment (i.e., detection) of tr
(e.g., group A explosives such as TNT and TNB; group B explosives such as RDX, H, and C4; compound
that may be used in explosives). The sample is typically taken from the atmosphere (by using an air c
particles and vapors from an individual's clothing, luggage, and packages), but samples may also be o
suspected items. Some detectors are computerized and detect, identify, and warn when traces of exp
found. These detectors are usually available as stand-alone or mobile devices and less frequently as
Explosive trace environmental detectors permit localization of concealed explosives and/or evidence o
they are used by healthcare personnel, rescuers, firefighters, and military personnel in public-access b
airports and healthcare facilities.

Environmental detectors designed for automated discovery and/or ascertainment (i.e., detection) of tr
drugs of abuse such as cocaine, heroin, and ecstasy). The sample is typically taken from the atmosph
current to dislodge particles and vapors from an individual's clothing, luggage, and packages), but sam
obtained by wiping the suspected items. Some detectors are computerized and detect, identify, and w
narcotics are found. These detectors are usually available as stand-alone or mobile devices and less f
units. Narcotic-trace environmental detectors permit the localization of concealed narcotics and/or evi
manipulation; they are used by healthcare personnel, rescuers, firefighters, and military personnel in
such as airports and healthcare facilities.

Environmental detectors designed for automated discovery and/or ascertainment (i.e., detection) of tr
(e.g., TNT, RDXX, Semtex, nitrates, HMX) and/or narcotics (e.g., drugs of abuse such as cocaine, heroi
sample is typically taken from the atmosphere (by using an air current to dislodge particles and vapor
clothing, luggage, and packages), but samples may be obtained by wiping the suspected items. Som
computerized and detect, identify, and warn when traces of explosives or narcotics are found. These
available as stand-alone or mobile devices and less frequently as portable units. Explosive/narcotic tra
detectors permit the localization of concealed explosives and narcotics and/or evidence of their manip
by healthcare personnel, rescuers, firefighters, and military personnel in public-access buildings such
healthcare facilities.

Rapid-test clinical chemistry reagents that consist of paper strips treated with dyes that change color
concentration in a liquid media; the color of the paper is an indicator of a solution's pH. These reagent
determine the acid/base status and/or for semiquantitative pH measurement of solutions in clinical lab
including urinalysis. Both wide-range (e.g., 1 to 14) and short-range, more specific (e.g., 6.0 to 8.5) re
available. The reagents are available either as individual strips or in rolls.
Rapid-test clinical chemistry reagents to detect and identify hazardous liquid and/or aerosol chemicals
such as nerve and blister agents. These reagents typically consist of several (e.g., three) indicator dye
cellulose fibers (i.e., a paper matrix). Some paper matrixes change to only one color in the presence o
(e.g., M9 paper), while other reagents (e.g., M8 and three-way paper) change color according to the a
identification (they work in a manner similar to that of pH paper strips). Typically, nerve agents of the
papers yellow, VX nerve agents turn them dark green, and blister agents turn them red. These paper-
available either in booklets containing many (e.g., 25) perforated sheets of a small size (e.g., 5 x 7.5
rolls; roll papers (e.g., M9 paper) and some booklet papers (e.g., three-way papers) include adhesive b
procedure is to expose the paper to a surface suspected of contamination or to the agent itself by wip
some detection papers can be attached to a surface that may be exposed in the future (e.g., clothing,
test chemical agent reagent results should be verified because the papers also change color when con
such as sodium hydroxide and petroleum products (e.g., brake fluid, antirepellents).

Kits designed primarily for discovery and/or ascertainment (i.e., detection) of some physical, chemica
technical condition. These kits are not usually intended for accurate measurement and/or to display th
the conditions that are detected, although they can identify and provide rough estimates of the values
predetermined values have been reached or exceeded. Detection kits are used in healthcare applicati
situations to indicate the presence of toxic materials, industrial contaminants, chemical or biological a
radiation-contaminated objects.

Detection kits designed to detect and identify chemical agents, mainly nervous and/or blister liquids a
method used is typically an enzymatic substrate-based reaction; the presence of agents is indicated b
change. Chemical agent detection kits are very sensitive tools to detect nerve agents (e.g., VX and G
and sarin) and blister agents including mustard and lewisite. Some kits can also detect blood agents,
products such as hydrogen cyanide and cyanogen chloride. These kits are very useful in determining a
Most kits are based either on chemical agent strip detection reagents or colorimetric tubes; kits specia
detection and identification of chemical agents in treated and/or untreated water samples are also ava
detection kits are used by healthcare workers, rescuers, firefighters, and military personnel for rapid d
contaminated or potentially contaminated areas.

Chemical agent detection kits based on strip detection reagents that change color in the presence of a
permitting agent identification. These kits typically include a disposable plastic vapor sampler, one bo
agent detection strips (typically M8 paper), and instruction cards with laboratory filter paper test spot
agents. The method typically used is an enzymatic substrate-based reaction; the presence of agents i
specific color change. Chemical agent detection kits are very sensitive tools to detect nerve agents (e
such as tabun and sarin), blister agents such as mustard and lewisite, and blood agents, including cya
hydrogen cyanide and cyanogen chloride. These kits are very useful in determining areas of contamin
detect chemical agents in water. They are used by healthcare workers, rescuers, firefighters, and milit
detection in contaminated or potentially contaminated areas.
Chemical agent detection kits that use enzymatic techniques and colorimetric tubes to identify chemi
usually include a hand pump that draws a sample into a specific tube to determine the presence of th
signified by a change in color. They are very sensitive tools to detect nerve agents (e.g., VX and G ser
sarin) and blister agents such as mustard and lewisite. Some kits can also detect blood agents, includ
such as hydrogen cyanide and cyanogen chloride. More than 100 substance-specific reagent tubes are
include an optical device to facilitate identification. The method typically used is an enzymatic substra
presence of agents is indicated by a specific color change. The kits are an inexpensive, fast, and simp
chemical agents, but some knowledge is required of the agent that is likely to be present in the enviro
agent detection kits are used by healthcare workers, rescuers, firefighters, and other personnel for rap
contaminated or potentially contaminated areas.

Chemical agent detection kits designed to test natural and/or processed water. These kits usually inclu
reagents, an instruction booklet or cards, tube holders, and a plastic container. They are used to detec
or VX) agents and/or blister agents, including mustard and lewisite. Some can also detect blood agent
products such as hydrogen cyanide and cyanogen chloride. Typically, patches are wetted with water s
determination and test containers are filled with water samples for blister and/or cyanide agent determ
agents is usually performed using colorimetric techniques. Chemical agent detection kits are used by
rescuers, and other personnel to determine whether a water supply is potable (i.e., drinkable).

Detection kits designed to detect and identify biological agents, such as bacteria and virus pathogens
kits are based on technologies similar to those of clinical laboratory analyzers (e.g., immunoassays pe
strips with antibodies to specific agents). Typically, a sample is obtained with a swab and mixed with
dropped in the test device that displays the results (either positive or negative) within a few minutes.T
common biothreats are available, including anthrax, ricin, plague (Yersinia pestis), botulinum toxin, tu
tularensis), and brucella. Biological agent detection kits permit in situ screening for unknown biologica
results should be verified with further laboratory tests. They are used by healthcare workers, rescuers
military personnel for rapid detection in contaminated or potentially contaminated areas.

Detection kits designed to detect and identify traces of explosives (e.g., group A explosives such as TN
explosives such as RDX, H, and C4; compounds containing nitrates that may be used in explosives). T
consist of a set of reagents (e.g., sprays), detecting papers and/or pads, verification pads, and other m
be needed for proper explosive identification. Explosive trace detection kits permit in situ screening fo
explosives; they are also useful as a pre- and/or postblast analytical tool. They are used by emergency
investigative, forensic, and law-enforcement personnel.
Environmental monitors designed for automated detection and continuous numerical and/or graphic d
concentration of chemicals that may kill or seriously injure human beings (i.e., chemical agents), such
chemicals (e.g., ammonia, nitric acid, phosgene, formaldehyde), nerve agents (e.g., tabun, sarin, VX),
agents (e.g., mustard, lewisite). These monitors may use one or several different technologies, includi
ion-mobility spectroscopy). They typically are computerized and detect, identify, measure, and display
chemical agents. Some monitors provide warning signals (e.g., alarms) that operate when predetermi
chemical agent and/or the recording capabilities of the monitor have been reached or exceeded. Chem
environmental monitors are available as portable, handheld, stand-alone, or mobile units. They are us
personnel, rescuers, firefighters, and military personnel for continuous observation of contaminated o
contaminated areas.

Chemical agent environmental monitors designed for automated detection and continuous numerical
of the concentration of compounds that exert their biological effects either by inhibition of the enzyme
(i.e., nerve agents such as tabun [GA], sarin [GB], soman [GD], or VX) or by producing blisters (i.e., b
mustard, phosgene, and lewisite). Some devices can detect nonlethal, irritant compounds such as Mac
The effects of these agents may be produced while in vapor (if inhaled) or liquid state (if absorbed tra
monitors provide warning signals (e.g., alarms) that operate when predetermined values of the chemi
recording capabilities of the monitor have been reached or exceeded. Chemical agent environmental
as portable, handheld, stand-alone, or mobile units. They are used by healthcare personnel, rescuers,
military personnel for continuous observation of contaminated or potentially contaminated areas.

Chemical agent environmental monitors designed for automated detection and continuous numerical
of the concentration of industrial chemicals that produce highly toxic effects, such as nitric acid (HNO3
oxide, formaldehyde, and hydrochloric acid (HCl). The effects of these agents may be produced while
in liquid state (if absorbed transcutaneously). Some devices can also detect agents that produce chok
inhaled, such as phosgene and chlorine. These monitors may use one or several different technologie
electrochemistry and spectroscopy. Most monitors warn of a hazardous condition when predetermined
agent have been reached or exceeded. Toxic industrial environmental monitors are available as portab
alone, or mobile units. They are used by healthcare personnel, rescuers, firefighters, and other person
observation of contaminated or potentially contaminated areas.

Simulators designed to mimic detectors and/or monitors of environmental agents that are dangerous
dangerous to humans. These simulators typically closely replicate the physical and/or functional chara
detectors or monitors but use techniques that avoid the use of hazardous agents. They may or may n
other simulants of the substances to be detected or monitored. There are simulators available for dete
of hazardous chemicals such as industrial toxic gases and chemical-warfare agents (e.g., nerve and bl
as for detectors and/or monitors used for ionizing radiation. Some simulators are computerized and ke
testing conditions and/or the operator's performance during the test. Environmental detector simulato
personnel on tests for environmental detection and/or monitoring of hazardous agents, replicating rea
possible without using the real contaminants.
Simulators designed to mimic detectors and/or monitors of environmental chemical agents such as in
(e.g., ammonia, nitric acid, phosgene, formaldehyde), nerve agents (e.g., tabun, sarin, VX), and/or blis
(e.g., mustard, lewisite). Some of these simulators have recording systems that can store error messa
use by the operator or other abnormal situations. These simulators are used to simulate chemical dete
during training, both for contamination detection and decontamination procedures, without using the

Chemical agent detector and/or monitor simulators designed to detect a nonhazardous chemical simu
characteristics similar to the hazardous agent. Chemical agent simulators may detect and/or monitor
simulants. The simulants can be mixed to produce simulant contaminants of different consistencies (e
technologies are used for this purpose (e.g., fluorescence). These simulators are used to simulate che
monitors during training, both for contamination detection and decontamination procedures, without u
contaminants.

Chemical agent detector and/or monitor simulators designed to mimic the detection of a hazardous ch
using a chemical simulant. These devices may use different technologies to simulate the chemical con
procedure, such as ultrasound (US) (e.g., US transmitters and receivers) or magnetic systems (e.g., m
tags). They are used to simulate chemical detectors and/or monitors during training, both for contami
detection/monitoring and decontamination procedures without using the real contaminants.

Simulators designed to mimic detectors and/or monitors of environmental hazardous biological agents
virus pathogens and/or toxins that may kill or seriously injure human beings (i.e., biological agents). S
simulators detect simulants with characteristics similar to those of the real biological agent. Biological
detector/monitor simulators may have recording systems that can store error messages showing incor
operator or other abnormal situations. They are used to simulate biological detectors and/or monitors
for contamination detection/monitoring and decontamination procedures, without using the real conta

Simulators designed to mimic detectors and/or monitors of ionizing radiation, such as alpha and/or be
and gamma radiation detectors. These devices use different technologies to simulate the ionizing rad
procedure. They may also include simulated gamma and/or alpha/beta radiation sources.

Simulators designed to mimic detectors and/or monitors of gamma radiation. These simulators may u
technologies to simulate the gamma detection procedure, such as ultrasound (US) (i.e., US transmitte
inclusion of nonhazardous simulated gamma sources permits simulation of various patterns of radioac
directional, circular). These simulators allow simultaneous deployment of various simulated sources. G
detector/monitors simulators are used for training in safe-area demarcation, instrument operation, an
shielding without ionizing radiation sources.

Simulators designed to mimic detectors and/or monitors of alpha and/or beta radiation. These simulat
technologies to simulate the ionizing radiation detection procedure; they frequently use nonhazardous
that can be located anywhere without radiation risks. Some simulators include a simulation probe that
the real detector and responds to the simulation sources as if it were detecting the real radioactive co
Alpha/beta particle radiation detector/monitor simulators are used for training in safe-area demarcatio
operation, and appropriate use of shielding without ionizing radiation sources.
Mobile modular medical facilities that are capable of biological and/or chemical agent detection (i.e., a
These facilities are typically equipped with all the devices required for sampling, detection, and analys
nerve, blister, toxic industrial compounds) and/or biological agents (e.g., pathogens such as bacteria,
These facilities may also have electric generators, air conditioners, meteorological stations, and comp
communication systems. Chemical/biological agent mobile facilities are used by disaster response age
emergency teams, environmental technicians, and civil defense and military personnel. Some facilitie
overpressure protection system that permits working in contaminated areas.

Devices designed to obtain a small quantity (i.e., a sample) of a substance. These devices may take s
liquids, and/or solids, including particulates. Samples are usually taken for analysis of their content. B
manual tests and completely automated samplers are used in clinical laboratories; automated sample
obtain samples of substances that are present in the environment.
Samplers used in the clinical laboratory to take samples of body fluids and/or other substances for ana
samplers may consist of either very simple devices that are intended for use by technicians (especiall
while performing manual tests or devices designed to automatically obtain samples and deliver them
and/or other laboratory equipment.
Laboratory samplers designed to take samples using manual methods usually for testing procedures.
consist of tubes with some mechanism (e.g., a check valve) to prevent accidental spills and/or loss of
are configured to obtain samples of particulate materials. Samplers manufactured especially for manip
acids, viscous liquids, and other uses are also available. Manual samplers are available either as dispo
or reusable devices (which are typically made of stainless steel); some are supplied sterile. Specially d
ladles, spatulas, and other devices are also used to obtain samples in the clinical laboratory.

Laboratory samplers designed for sequentially aspirating aliquots of liquid samples and delivering the
chemical analyzers or other laboratory equipment. These devices typically use robotic arms and/or oth
mechanisms to sample serum or other body fluids directly from primary collection tubes and/or from t
body fluids transferred from the original collection tube. The cups or tubes are automatically covered
before the specimen is analyzed to avoid evaporation. The samples are then transferred, usually at a
a holding zone (which may be refrigerated) or directly to the loading zone of an analyzer or other piec
equipment. Automated samplers are intended for use as independent units, as a part of a laboratory a
for both purposes.

Samplers designed for obtaining small quantities of one of the components of the surroundings (envir
individuals may be exposed. Environmental samplers may be designed especially to take samples from
drinking or sewage), and/or soil. Environmental samplers are used mainly to take samples for analysis
abnormal concentrations of gases (e.g., oxygen, carbon dioxide), hazardous substances (e.g., toxic ga
biological agents), and/or physical conditions (e.g., high or low temperatures, ionizing radiation, high p
are present in the environment.
Air samplers designed to obtain samples of biological agents that are present in the air, usually in the
particles. These devices can capture small (e.g., from 2 to 10 microns) aerosol particles of biopathoge
viruses, fungi, and toxins for laboratory analysis. The samplers typically include blowers, which provid
and permit rapid biological sample collection in a short period (e.g., a few minutes), either in indoor o
environments. Both dry systems that use special filters and wet systems that collect the samples in a
available; some wet-system samplers include pumps for sample transfer to the detectors. Biological a
intended to monitor for infectious diseases in clinical wards, workplaces (e.g., mail rooms), and airpor
used to detect biological pathogens in agricultural products and livestock.

Environmental samplers designed especially to obtain samples of water, either potable (drinkable) or
these devices are designed for manual collection of water samples (e.g., long tubes with sampling bot
automatically collect samples using computerized controllers that permit either on-call or periodic coll
be subsequently analyzed or inserted in special detectors to determine the presence of toxic industria
chemical or biological agents. Water samplers are used to collect samples from healthcare facilities, w
places where water is or may be polluted and/or contaminated. They are also used in emergency situa
rescuers to characterize the water in contaminated environments.

Prepackaged collections of the devices and supplies (either custom or standard) designed to collect sa
potentially hazardous materials, including toxic industrial chemicals and chemical and biological agen
appropriate to collect gas, liquid, and solid samples from a contaminated area. Items in these kits usu
needed to collect the samples, including a set of manual samplers (e.g., special tubes, scoops, knives
containers, and operating instructions, usually packaged in a sturdy plastic case. The kits may be sup
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Hazard
kits are used by emergency teams, forensic and law enforcement personnel, and other civil and milita
characterize contaminated environments.

Injection needles typically consisting of a solid thin metallic rod approximately 50 to 75 mm (2 to 3 inc
diameter, with one end flattened and formed into two sharp prongs (similar to a small two-prong fork)
a plastic hub to facilitate manipulation. The size and shape of the two-prong end is appropriate to hold
dose volume of reconstituted liquid vaccine by capillary action when it is dipped into a vial containing
preestablished concentration. The vaccine is then delivered into the superficial layers of the skin by p
scarification) using a series of repetitive strokes (typically 15) with the bifurcated needle. Bifurcated n
specialized devices designed for massive smallpox vaccination; they are usually disposable, but sterili
using autoclaves or dry-heat sterilizers).

Bifurcated injection needles designed to provide needlestick protection during vaccination (typically s
These needles usually include some manually positioned or activated mechanism intended to shield o
lessen the possibility of contact of the healthcare provider with the needle. Some needles are mounte
base to provide a support for the protective mechanism and to facilitate manipulation of the needle.
Prepackaged collections of the necessary devices and supplies (either custom or standard) designed f
vaccination. Items in these kits usually include a sterile package with a lyophilized dry-vaccine vial an
(e.g., a prefilled syringe), transfer needles for use during liquid-vaccine reconstitution, and bifurcated
(scarification). These kits may be supplied in supporting trays (i.e., procedure trays) consisting of a fla
with a border around the periphery supporting all the instruments and supplies needed for the proced
usually covered or wrapped. Smallpox vaccination procedure kits and trays include enough vaccine an
disposable bifurcated needles to immunize 100 or more individuals.

Radiotherapy systems designed to deliver a beam of neutrons. These systems include a source of neu
one of several technologies (e.g., cyclotrons, linear accelerators), a control unit, and appropriate filter
Neutron-beam radiotherapy systems are designed to emit high-energy fast neutrons, a low-energy flu
neutrons)--usually for boron neutron capture therapy (BNCT)--or a combination of both types of radiat
currently used in some selected clinical applications

Neutron-beam radiotherapy systems designed to deliver a high-energy fast-neutron beam. These syst
of fast neutrons (e.g., cyclotrons, linear accelerators), a control unit, and appropriate filters and collim
radiotherapy is used in selected clinical indications, such as inoperable sarcomas of bone and soft tiss
salivary gland tumors.
Radiotherapy systems designed to deliver a beam of protons. These systems include a particle accele
synchrotron), a delivery system, range modulators, fixed beamlines and/or isocentric gantries, patient
and a computerized control unit. The use of protons provides a more defined range and less lateral sc
conventional radiation therapy (e.g., photon, x-ray, gamma ray, electron), permitting the use of highly
shaped for the tumor) radiotherapy techniques to minimize the doses to critical anatomic structures. L
(60 to 100 MeV) are used to treat superficial disorders, while higher-energy protons (above 150 MeV)
deep-seated tumors. Specialized proton-beam radiotherapy systems are available for treatment of eye
certain skull-based or spinal tumors (e.g., chordomas); high-energy systems may be used for treatmen
chest and/or abdomen.

Radiotherapy simulation systems that perform radiographic and/or fluoroscopic imaging to determine,
externally mark the area to be treated. These systems combine technologies from both therapeutic an
they consist of a radiographic/fluoroscopic simulator that includes an x-ray system and a mechanical s
gantry, table, controls) that mimics the movement of a linear accelerator and/or a cobalt unit.

Radiotherapy simulation systems that use a computed tomography (CT) scanner with specialized hard
radiotherapy simulation and treatment-field delineation. These systems can delineate the tumor in CT
target volume using a treatment-planning computer, select the treatment field, and mark the patient
in a single session. CT-based systems are also used for verification of tumor margins, tracking of tumo
three-dimensional image analysis for multileaf collimators and conformal radiotherapy.
Catheters designed for percutaneous insertion into a potential space (known as the pleural cavity) enc
membrane completely investing the lungs and also lining the thoracic cavity (i.e., the pleura). These d
small-caliber catheters (e.g., 8 to 10 Fr) and have particular characteristics according their clinical use
available for intrapleural instillation of drugs (e.g., urokinase), to treat simple and/or tension pneumot
(e.g., hemathorax), and for permanent indwelling use in the long-term drainage of pleural effusions. P
frequently included in kits such as pneumothorax, thoracocentesis, and drainage kits.

Pleural catheters designed for long-term drainage of abnormal fluid accumulation (e.g., pleural effusio
usually consist of a plastic (e.g., silicone) catheter that is partially implanted (i.e., tunneled) in the che
multihole distal end inserted in the pleural cavity and typically including a cuff near the proximal end.
includes a one-way valve that is kept closed until it is opened by a specially designed drainage line. T
usually attached to a vacuum bottle or other vacuum source during drainage. Drainage pleural cathet
outpatient, long-term, intermittent aspiration of recurrent malignant or nonmalignant pleural effusions
other treatments. Pleural catheters may be used also for continuous drainage.

Prepackaged collection (either custom or standard) of equipment and supplies designed for long-term
fluid accumulation (e.g., effusions) from the pleural cavity. These kits typically consist of a catheter int
drainage that is partially implanted (i.e., tunneled) in the chest cavity and that includes an external va
especially designed to open the drainage catheter valve during drainage; dressings and supplies for c
dressing; and a vacuum source (typically a vacuum bottle) that is used to drain the fluid from the pleu
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Pleural drainage kits are used mainly for long-term, intermittent drainage of recurrent pleural effusion
patients.

Substances (i.e., decontamination agents) intended to destroy, physically remove, or reduce to accep
contaminants such as chemical agents, radioactive materials, and toxic industrial material. Some deco
effective against biological agents (i.e., agents with germicidal capabilities). Decontaminants typically
removing (i.e., physical decontaminants) or neutralizing (i.e., chemical decontaminants) the contamin
products can be used to decontaminate individuals (especially the skin), equipment, and/or installatio

Decontaminants intended for physical removal of contaminants from the surface of individuals (i.e., sk
garments, and/or equipment (including vehicles and/or installations). Physical-removal decontaminant
common products (e.g., water, air, soap, flour) either at room temperature or hot; fluids (e.g., gases, w
delivered at high pressure. Some decontaminants consist of products specifically designed for that pu
absorbent resins, viscous solutions). Physical decontaminants generally do not neutralize chemical or
making it necessary to use additional chemical decontamination to achieve complete decontaminatio

Physical-removal decontaminants consisting of a nonplastic form of kaolin (clay) containing an alumin


silicate. The fine-crushed product is best suited for skin and/or personal-gear decontamination. Nonpla
are used for gross decontamination or when a more specific product for decontamination is not availa
not neutralize chemical or biological agents, making it necessary to subsequently neutralize skin or ge
decontaminant (also known as Fuller's earth) is easily available due to its use as kitty litter, a spill abs
medium.
Decontaminants intended for chemical neutralization of chemical and/or, less frequently, biological ag
decontaminants typically consist of reactives that readily react with the chemical contaminant withou
shaking (i.e., reactive chemicals). Chemical-neutralization decontaminants include oxidizing agents (e
hypochlorite [NaOCl]), strong bases (e.g., potassium hydroxide [KOH]), aqueous foams, catalytic enzy
compounds with low solubility in water (microemulsions).

Chemical-neutralization decontaminants consisting of powerful oxidizing agents. These decontaminan


oxidizing agents or products especially designed for decontamination. Common oxidizing agents used
include calcium hypochlorite (Ca[OCl]2), sodium hypochlorite (NaOCl) (i.e., laundry bleach), potassium
aqueous solutions of chloramine-B. Some oxidants especially formulated for decontamination are avai
hyperchlorinated bleaches such as a mixture of Ca(OCl)2 and calcium oxide ([CaO], known as supertro
and Oxone (a mixture of several potassium salts). Oxidizing decontaminants are used mainly for deco
agents of VX and the G series (e.g., tabun [GA], sarin [GB]) and/or chemical agents such as mustard (H

Oxidizing decontaminants consisting of a biodegradable aqueous foam. Typically one or more liquid re
with water at the site of application to produce a water-based foam that readily neutralizes chemical a
biological contaminants. Foam-oxidizing decontaminants are intended for decontamination from nerve
and VX, mustard (HD), biological agents, and/or radioactive material contamination.

Foam-oxidizing decontaminants consisting of a binary mixture of surfactants and mild oxidizers intend
chemical agents into nontoxic substances; they may also be effective in killing bacteria, spores, and v
foam decontaminants are usually supplied as a twin liquid sprayer device. The simultaneous delivery
to form a foam that expands to many (e.g., 100) times its liquid volume; the foam collapses back as a
liquid form in a few hours. They are intended for decontamination from nerve agents of the G series a
and biological agents such as anthrax.

Oxidizing decontaminants typically consisting of an aqueous solution of an oxidant (e.g., Oxone, perox
gelling agent such as alumina or amorphous (fumed) silica. The gel can be liquified by stirring and the
conventional sprayers (e.g., painting sprayers); it will solidify again after application and adhere to sur
ceilings). Gel oxidizing decontaminants transform the chemical agents into nontoxic substances; the o
also effective in killing bacteria, including spores. They are intended for decontamination from nerve a
and VX, mustard (HD), and biological agents. These decontaminants usually are nontoxic and noncorr
damage painted surfaces; they are used mainly for equipment and facility decontamination in civilian

Chemical neutralization decontamination products including strong bases as active components. Thes
be either common bases or products specially designed for decontamination. Common strong bases u
decontamination include calcium hydroxide (Ca[OH]2), potassium hydroxide ([KOH], caustic soda), an
(NaOH). Strong base decontaminants are effective for decontamination from nerve agents of the G se
mustard (HD).
Strong base chemical neutralization decontaminants (known as decontamination solution number 2 [D
combination of a strong base dissolved into an organic solvent. Their composition typically consists of
(NaOH) dissolved into 70% diethylenetriamine (DETA) and 28% 2-methoxyethanol (also known as ethy
monomethyl ether [EGME]). Propylene glycol monomethyl ether is sometimes used as a substitute for
this composition is known as DS2P. DS2 reacts instantly with nerve agents of the G series and VX, as
(HD) at ambient temperatures; it is generally noncorrosive and has long-term storage stability but can
plastics, and rubber materials. DS2 is very effective for neutralization of chemical agents and many bi
should be rinsed off with water after 30 minutes to minimize the damage on paints, plastics, and rubb

Chemical-neutralization decontamination products consisting of thermodynamically stable mixtures of


and cosurfactants that appear macroscopically as homogenous phase (i.e., microemulsions). These de
specially designed to combine several products with different decontamination properties in a variety
Microemulsification decontaminants are intended to provide faster decontamination by increasing the
chemical contamination agents (e.g., nerve gases) that have a limited solubility in water.

Microemulsion chemical-neutralization decontaminants (known as C8 decontaminants) that consist of


weight, of 15% tetrachloroethylene (C2Cl2), 76% water, 1% surfactant, and 8% calcium hypochlorite (
emulsion in particularly effective in the decontamination of nerve agents of the G series and VX, as w
can also dissolve chemical agents embedded inside painted surfaces without paint damage; C8 can b
water after decontamination.

Chemical-neutralization decontamination products consisting of a mixture of catalytic enzymes such a


hydrolase or organophosphorous acid anhydrolase and other natural products. The catalytic property o
them to decontaminate many times their own weight of agent in a short time (either seconds or a few
with different properties and specificities can be mixed together in a single formulation, making them
a variety of chemical agents (e.g., G-type and/or VX nerve agents, sulfur mustard) and also against bi
bacterial cells, anthrax spores).

Physical-removal and chemical-neutralization decontamination products consisting of a reactive and a


resin is typically a mixture of a carbonaceous adsorbent, a polystyrene polymeric compound, and an i
mixture is usually impregnated on pads or mitts and packaged in kits containing a set of pads and oth
products to facilitate its application. These resins are used for skin and/or personal-gear decontaminat
and/or biological agents.

Physical-removal and chemical-neutralization decontamination products consisting of a reactive visco


lotion is supplied either impregnated on sealed pads for individual use or as a liquid that can be poure
affected site. Viscous lotion decontaminants are used to decontaminate the skin and personal gear fro
biological agents by wiping the affected area.
Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
skin and/or personal gear either by physical removal, chemical decontamination, or a combination of
kits typically include a ready-to-use and properly sealed decontamination agent and a set of applicato
that permit quick and easy preliminary self-decontamination. The kits may be supplied in supporting t
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Decontamination kits an
used by civil rescuers, firefighters, and military personnel; they are intended for decontamination from
warfare or toxic industrial) agents and radiation contaminated materials, and less frequently from biol

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
skin either by physical removal, chemical decontamination, or a combination of both. Items in these k
ready-to-use and properly sealed decontamination agent and a set of applicators (e.g., pads, mitts) th
easy preliminary self-decontamination. The kits may be supplied in supporting trays (i.e., procedure tr
flat-bottomed receptacle with a border around the periphery supporting all the instruments and suppl
procedure; the trays are usually covered or wrapped. Skin decontamination kits and trays are usually
decontamination below hazardous levels for the individual from chemical (either warfare or toxic indu
radiation contaminated materials, and less frequently from biological agents. All products used for ski
should be safe for individual health; the kits are mainly used by civil rescuers, firefighters, and military

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
skin by neutralizing chemical agents, toxic industrial materials, and/or radiation-contaminated materia
typically include a ready-to-use and properly sealed decontamination agent and a set of applicators (e
permit quick and easy preliminary self-decontamination. The kits may be supplied in supporting trays
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Chemical neutralization skin dec
trays are usually intended for decontamination below hazardous levels for the individual from chemica
toxic industrial) agents and radiation contaminated materials, and less frequently from biological agen
for skin decontamination should be safe for individual health; the kits are mainly used by civil rescuer
military personnel.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
personal gear (e.g., garments, personal protection devices) either by physical removal or reduction, ch
decontamination, or a combination of both. Items in these kits typically include a ready-to-use and pro
decontamination agent and a set of applicators (e.g., pads, mitts) that permit quick and easy prelimin
The kits may be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed recep
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Personal gear decontamination kits and trays are mainly used by civil rescuers, firefighters,
they are intended for decontamination from chemical (either warfare or toxic industrial) agents and ra
materials, and less frequently from biological agents.
Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
personal gear (e.g., garments, personal protection devices) by destruction, reduction, or neutralization
toxic industrial materials, and/or radioactive materials; they are also effective for decontamination fro
Items in these kits typically include a set (usually four) of wipe-down mitts enclosed in separated prot
mitt is impregnated with a reactive and absorbent black resin. The resin is usually a mixture of a carbo
polystyrene polymeric compound, and an ion-exchange resin. The kits may be supplied in supporting
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. The decontamination is
opening the packet and scrubbing the contaminated device with the impregnated mitt; the contamina
absorbed by the resin and the mitt. Personal gear decontamination removal/neutralization resin kits a
used by civil rescuers, firefighters, and military personnel.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
skin and/or personal gear either by physical removal, chemical decontamination, or a combination of
kits typically include a ready-to-use and properly sealed decontamination agent and a set of applicato
that permit quick and easy preliminary decontamination. The kits may be supplied in supporting trays
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Skin/personal gear decontaminat
usually intended for decontamination below hazardous levels for the individual from chemical (either
industrial) agents and radiation contaminated materials, and less frequently from biological agents. A
skin and personal gear decontamination should be safe for individual health; the kits are mainly used
firefighters, and military personnel.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
skin and/or personal gear either by physical removal and a sorbent technology using non-plastic kaoli
typically include a sealed plastic bag containing several (e.g., four) pads filled with non-plastic kaolin a
magnesium silicate (known as Fuller's earth); some kits also include a dispenser with additional kaolin
accomplished by rubbing the contaminated skin or gear (e.g., mask, boots); the user should wear glov
decontamination procedure and properly dispose the contaminated pads. The kits may be supplied in
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered or wrapped. Non-plastic kaolin s
decontamination kits and trays are usually intended for decontamination below hazardous levels for t
chemical (either warfare or toxic industrial) agents and radiation contaminated materials, and less fre
agents. The kits are mainly used by civil rescuers, firefighters, and military personnel.
Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
decontamination kits during training but without having any decontamination capabilities. Items in th
include a set of applicators (e.g., a pad, mitts), similar to those used in real decontamination kits, and
(e.g., liquid, powder) that is similar in physical characteristics to a decontaminant but without deconta
The kits may be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed recep
around the periphery supporting all the instruments and supplies needed for the procedure; the trays
wrapped. Training decontamination kits and trays are used to save costs and risks during training of c
military personnel; they are appropriately colored and labeled to differentiate them from actual decon

Towelettes intended for decontamination of chemical agents from the surface of the skin and persona
masks, gloves, protective garments) chemical neutralization. These towelettes are usually impregnat
oxidation of chemical agents, including mustard agents (e.g., H agents), nerve agents such as VX and
Tabun [GA], sarin [GB]), and lewisite (L). Typically, the towelettes are supplied in a set of sealed pouc
gas. Gloves are worn when opening the pouches; the towelette solution is wiped on the contaminated
off with a new, clean towelette. Chemical-agent decontamination towelettes are not intended for use
eyes or mouth. Decontamination towelettes are typically used by civil rescuers, firefighters, and milita

Devices designed for decontamination by physical removal, chemical decontamination, or both. These
intended for decontamination of chemical-warfare agents, toxic industrial materials, radiation-contam
and/or biological agents. The units typically include decontaminant-agent delivery system, decontami
controls (e.g., temperature, pressure); they may also include mixers, hoses, and other auxiliary device
type of decontamination performed. Decontamination units are mainly intended to decontaminate eq
units can be used for personnel decontamination.

Decontamination units designed to physically (e.g., through mechanical means) remove contaminants
biological agents and toxic industrial materials from the equipment surface. Some units are also used
personal-gear decontamination. Physical-removal decontamination units that employ high-pressure w
pressure gases, particulates, and ultrasound are available.
Decontamination units that employ hot or cold high-pressure water for physical removal of chemical a
materials, and, less frequently, biological agents from the surface of equipment. These units typically
pressure-water delivery device and one or more hoses, nozzles, pressure gauges, and filters. High-pre
decontamination units are used for surface decontamination of outdoor equipment and vehicles. A sec
cycle using chemical-neutralization agents is usually necessary.

Decontamination units that employ high-pressure gas (typically carbon dioxide) for physical removal
toxic industrial materials, and, less frequently, biological agents from the surface of equipment. These
of a portable high-pressure-gas delivery device and one or more hoses, nozzles, pressure gauges, and
include a handgun-like device to deliver frozen carbon dioxide particles (i.e., dry ice) at supersonic spe
interior of sensitive equipment. Some units also use plastic and/or glass beads for more aggressive su
High-pressure-gas decontamination units can remove micrometric particles and hydrocarbon contamin
destruction and/or abrasion of the equipment surface. Some devices may be used for skin decontamin
Decontamination units designed for chemical neutralization of chemical and/or, less frequently, biolog
equipment. These units typically include a delivery system (e.g., a spray system) that applies a chemi
agent that readily reacts with the chemical contaminant (e.g., sodium hypochlorite [NaOCl], decontam
2, microemulsion C8). Chemical-decontamination units are intended mainly for external decontaminat
equipment and vehicles.

Decontamination units that generate and deliver calcium hypochlorite (e.g., C8 decontaminant) and/o
emulsions for neutralization of chemical agents, including mustard (H/HD agent), and nerve agents su
series (e.g., tabun [GA], sarin [GB]), and/or biological agents on the surface of vehicles and outdoor eq
are typically powered devices that include a mixer/applicator, which produces a continuous online em
other accessories. Emulsion-application decontamination units are used to provide noncorrosive decon
ambulances and other vehicles and outdoor equipment. They are also used to decontaminate the exte
aircraft.

Decontamination units that generate and deliver a controlled spray of a decontamination product (typ
decontaminant) for neutralization and physical removal of chemical and biological agents. These devi
portable unit that includes a pressurized tank of the decontaminating solution, a mounting bracket, a
safety valve; they also include spare parts and tools to facilitate operation and maintenance by the op
decontamination units may be used with different decontamination solutions; they are frequently inte
solution of 2% sodium hydroxide dissolved into 70% diethylenetriamine and 28% 2-methoxyethanol (a
glycol monomethylether [EGME]), a product known as decontamination solution number 2, DS2. The s
neutralizing mustard (HD agent), nerve agents such as VX and the G series (e.g., tabun, sarin), and bi
surfaces of vehicles and outdoor equipment). The units should be filled and operated by users wearing
protective clothing.

Decontamination units designed for both physical (i.e., mechanical) removal and chemical neutralizat
less frequently, biological contaminants on equipment. These units may use one of several technologi
(e.g., hot soapy water solution, ultrasound, hot air) and a chemical substance (e.g., decontaminant so
neutralization of the contaminants. These units are used mainly for decontamination of sensitive (e.g.
equipment.

Decontamination units designed for both physical (i.e., mechanical) removal and chemical neutralizat
less frequently, biological contaminants on contaminated equipment. These units include several tank
five) that provide a cycle of washing, rinsing, chemical decontamination, and drying; several steps are
ultrasound energy and/or other heat sources. Ultrasonic decontamination units are used for cleaning a
sensitive equipment, including precision cleaning at the microscopic level.

Systems designed for decontamination of chemical agents, including mustard (H agent), nerve agents
series (e.g., tabun [GA], sarin [GB]), and toxic industrial materials; biological agents; and/or nuclear m
These systems usually consist of several separate but interacting units (e.g., pumps, applicators, heat
deliver appropriate products (e.g., water, gases, decontaminants, steam). They perform decontaminat
removal and/or chemical neutralization of contaminants from the surface of equipment. Decontamina
mainly used for decontamination of large outdoor equipment and vehicles; specialized systems that d
garments and personal gear or the effects of dispersive (blast) contaminant artifacts are also available
Decontamination systems designed to remove and/or neutralize chemical agents, toxic industrial mat
agents from the surface of outdoor equipment, vehicles, and/or facilities. These systems usually includ
modules) to provide high-pressure water, hot-water, steam, and chemical-decontaminant delivery. De
usually performed in several steps. First, preliminary removal of the contaminant is performed using a
agent (e.g., hot gas, high-pressure water, steam). Then, chemical neutralization (e.g., using decontam
microemulsions) occurs. The last step consists of residue removal and drying. In addition, steam may
decontamination. Some systems are also intended for terrain and/or personal-gear decontamination. M
available.

Decontamination systems designed to remove and/or neutralize chemical agents, toxic industrial mat
agents from contaminated garments and/or personal gear. These systems usually include units that p
decontamination (e.g., using high-pressure water, or hot gas) and chemical decontamination and/or d
chemical spray, hot water, steam); some systems also include laundry equipment and ironing capabili
garment/personal-gear decontamination systems can perform simultaneous decontamination and/or d
protective garments and gear for multiple people, such as a rescue team or military platoon.

Decontamination systems designed to lessen the escape of chemical and/or biological agents associa
explosive devices (e.g., withless than 1 kg of explosive) and/or dispersive devices. These systems typ
multilayer, explosion-resistant, flexible enclosure to place the suspected device inside; a mechanism t
decontaminant antidispersive product (usually foam) inside the enclosure and surround the hazardous
hoses, and containers to store and deliver the decontaminant. Antidispersive/blast-foam decontamina
mitigate the effects of small explosive devices (e.g., briefcase-size bombs) by performing a controlled
preventing the escape of warfare agents from dispersive devices. They are inside buildings or outdoor
or military personnel to protect people and/or equipment and facilities.

Chambers designed to decontaminate equipment from chemical agents including mustard (H agent),
VX and the G series (e.g., tabun [GA], and sarin [GB]), and toxic industrial materials; biological agents
material contaminants. These chambers usually include appropriate devices (e.g., pumps, applicators
perform mechanical or, less frequently, chemical decontamination. Decontamination is typically perfo
high-pressure water spray or steam over contaminated equipment placed inside the chamber. Some c
systems for delivery of decontamination chemical solutions. Decontamination chambers are used mai
decontamination of the surface of equipment (e.g., hand tools) that is not sensitive to heat and water.

Decontamination chambers that employ high-pressure gas (typically carbon dioxide) for physical remo
including mustard (H agent), nerve agents such as VX and the G series (e.g., tabun [GA], sarin [GB]), f
equipment. These chambers typically include a handgun-like device that delivers frozen carbon dioxid
pellets) at supersonic speeds to clean the interior of sensitive equipment and a mobile stand (e.g., a t
equipment around the dry-ice-particulate delivering device for full decontamination of all equipment s
chambers are used for decontamination of very sensitive devices.

Cabinets designed to store instruments, medicine, and supplies that are used frequently in healthcare
cabinets are constructed of metal, glass, plastic, wood, or a combination of these materials. Storage c
alone, wall-mounted, undercounter, or countertop units; they usually include drawers, shelves, and do
storage cabinets are distributed among the healthcare facility and located in areas such as nursing sta
rooms, patient rooms, and clinical laboratories.
Medicine storage cabinets that include computerized capabilities to automatically keep track of users
transaction; some cabinets include mechanisms to render the cabinet unusable for unauthorized user
medicine storage cabinets frequently maintain a database that allows either the display or printing of
information such as the name of the current user, the history of previous users, and both withdrawal a
each transaction. These cabinets may provide data to hospital information systems and/or be used as
medication-dispensing automated systems designed to provide safe and orderly control of medicine d
healthcare facility (i.e., decentralized medication management systems).

Narcotics-control storage cabinets that are designed for use inside a refrigerator. These devices consis
(e.g., similar to a box) that is specifically manufactured to be securely attached to an integral part insi
that the cabinet cannot be removed when locked. Refrigerator narcotics-control cabinets are used for
require refrigeration during storage.
Instrument storage cabinets of the appropriate size and design to be either recessed or wall mounted
manufactured using stainless steel to avoid corrosion and permit ease of cleaning and sterilization. Th
consist of multiple drawers, shelves, or a drawer/shelf combination. Some cabinets include special co
supplies. Wall-mounted instrument cabinets may include sliding or hinged glass or solid doors; some a
locks. They are used mainly in operating and procedure rooms, including dental and ophthalmologic c

Instrument storage cabinets of the appropriate size and design for freestanding use; they are typically
stainless steel to avoid corrosion and permit ease of cleaning and sterilization. These cabinets consist
shelves, or a drawer/shelf combinations. Some include special compartments for supplies. Stand-alone
may include sliding or hinged glass or solid doors; some also include security locks. They are used ma
procedure rooms, including dental and ophthalmologic clinics and offices.

Cabinets designed for organized storage and display of cleaned endoscopes (e.g., bronchoscopes, gas
colonoscopes). These cabinets are typically manufactured using materials (e.g., stainless steel, polypr
permit ease of cleaning; they include endoscope holders and may also include special soft-plastic brac
endoscope heads. Endoscope cabinets should have proper vents to keep the devices dry. Some cabin
using a high-efficiency particulate-air filter, exhausting the air back into the room through an activate
Endoscope storage cabinets are used to keep endoscopes clean for the next procedure after they are
all removable parts are detached. Endoscopes should not be stored in their carrying cases.

Cabinets designed for organized storage, and display of catheters and for easy device access. These c
manufactured using materials (e.g., steel, polypropylene) that permit ease of cleaning; most cabinets
hangers and/or pegboard backs. They may also include drawers and shelves for supplies. Catheter sto
available in stand-alone and wall-mounted configurations; the cabinets are used mainly in cardiac cat
laboratories, invasive radiology suites, and operating rooms.
Catheter storage cabinets that include a computerized unit to automatically keep track of users and th
transaction. These computerized systems include a set of safety features to facilitate orderly control o
cabinet access; some systems include mechanisms to render the cabinet unusable for unauthorized u
controlled catheter storage cabinets maintain a database that allows either the display or printing of d
information related to catheterization laboratory activities, such as the name of the current user, the h
use, both withdrawal and return time for each transaction, and costs. Computerized catheter storage
data to hospital information systems and a continuous inventory of catheters.

Desiccating storage cabinets that prevent moisture by circulating an inert gas (e.g., nitrogen). These c
airtight seals and gas distribution systems; most include hygrometers. Inert-atmosphere cabinets typi
plastic (e.g., acrylic, polystyrene) enclosure that may be colored (e.g., amber, smoke-tinted) to protec
materials.
Cabinets designed for storage of acids and/or other corrosive products, such as bases. These cabinets
thick plastic (e.g., high-density polyethylene), protected wood (e.g., epoxy-painted or polypropylene li
density plywood), protected metal (e.g., resin-covered steel), or a combination of these. They are avai
wall-mounted, and under-the-counter models. Some cabinets include several plastic shelves, trays, an
cabinets offer protection against drips and spills (e.g., leakproof sills), and some include special comp
concentrated strong-acid (e.g., nitric acid) storage.

Storage cabinets designed to resist strong-acid vapors and spills. These cabinets are typically made co
plastic (e.g., polyethylene), including their internal shelves, compartments, doors, and appropriate ve
storage cabinets are suitable for storage of very strong and/or fuming acid, such as hydrochloric, sulfu

Cabinets designed for storage of flammable liquids (e.g., alcohol, gasoline, paint). These cabinets typi
welded-steel double wall that acts as a thermal barrier and include vents with flame arrestors to provi
some cabinets are made of wood. Flammable-liquid storage cabinets are available in stand-alone, wal
counter, and stackable configurations. Some cabinets include automated self-closing degrees capabil
temperature reaches a preestablished value (e.g., 70 degrees Celsius/160 degrees Fahrenheit).

Flammable-liquid storage cabinets designed for organized storage of flammable paint and ink. These
include appropriate shelves to store paint and/or ink containers (frequently one-gallon cans). They are
the features of standard flammable-liquid cabinets.
Flammable-liquid storage cabinets designed for storage of large drums (typically 55-gallon) containing
These cabinets usually include appropriate shelves to store one or more drums horizontally or vertical
cabinets include additional accessories, such as funnels, pumps, drum supports, drum dollies, and ram
provide additional shelves for small containers and accessories. Horizontal-drum storage, frequently u
particularly appropriate for fuel, solvent, lubricant, and cleaner bulk dispensing. Many drum storage c
weather-resistant exterior finish and/or chemical-resistant interior lining for outdoor storage.

Storage cabinets designed to accommodate and protect medical gas (e.g., oxygen) cylinders. These c
consist of either a metallic (e.g., steel, aluminum) mesh or a solid metal or wood structure. Medical ga
cabinets are available to store from a few to 20 or more cylinders, horizontally or vertically. Most cabin
to withstand weathering for outdoor use, and they may have padlocks to prevent unauthorized access
accessories for maximum stability and security.
Storage cabinets designed to accommodate one or more bedpans and/or urinals. These cabinets are t
metal (e.g., stainless steel, aluminum) to avoid corrosion and permit ease of cleaning and sterilization
enough internal open space to allow air circulation. Bedpan/urinal cabinets are typically mounted on t
recessed or surface mounted. Each bedpan or urinal is usually stored in an individual compartment in

Cabinets designed for safe storage of radioisotopes during a relatively short period of time, protecting
and patients from harmful radiation. These cabinets typically consist of a lead-lined (e.g., 6 mm/0.25 i
structure that may include dose storage and decay drawers (with leaded fronts) and compartments fo
Some cabinets also have a thicker lined (e.g., two-inch) lead-lined compartment to storage high-energ
including syringes for isotope infusion. Isotope storage cabinets are used mainly in nuclear medicine l
nuclear medicine treatment units.

Cabinets designed to provide space to storage the plastic (e.g., polycarbonate, acrylic) trays used in r
treatments (i.e., blocking trays). These cabinets typically consist of a set of compartments for placing
separate bin. The cabinets are typically made of metal, wood, particle board, or a combination of thes
intended for wall mounting. They are available in several sizes depending on hospital needs. Blocking
used in radiology and nuclear medicine departments.

Storage cabinets designed to accommodate and protect fire extinguishers. These cabinets may consis
recessed wall-mounted unit and are typically made of metal (e.g., steel, aluminum), plastic, fiberglass
cabinets include a glass or transparent-plastic front door to make the extinguisher visible. Some cabin
provide access to the extinguisher only when the glass door is broken; they usually include a hammer
extinguisher cabinets are available in several sizes to accommodate different types of fire extinguishe
common 2.25/4.5 kg (5/10 lb) dry chemical extinguishers to heavier (e.g., 14 kg/[30 lb]) units. Cabine
those manufactured specifically for outdoor use or deck mounting are also available.

Storage cabinets designed to accommodate and facilitate the rapid release of folded or rolled blanket
fiber (e.g., fiberglass, treated wool) that are large enough to completely wrap around a person. These
wall-mounted units, usually with the blankets easily visible through a window or opening. Fire-blanket
conveniently located throughout a healthcare facility, permitting use of the blankets to extinguish a fi
to provide protection during escape from fire, or to rescue nonambulatory patients during fire-emerge

Heavy-duty cabinets designed for organized storage of tools. These cabinets are typically wide, multid
bearing sliders and locking systems. They typically include 1 m (40 in) wide or larger drawers with a w
of 100 kg (220 lb) or more each. Most tool storage cabinets are made of metal (e.g., steel, aluminum)
coating (e.g., epoxy) that can resist acids and/or solvents, frequently including holders to keep tools in
are available with a working surface on which hand tools (e.g., drills) can be mounted. Others include
chest on the top to facilitate tool transport. Tool storage cabinets are used in healthcare facilities for p
and/or repair of medical devices and other equipment.

Cabinets designed for organized storage of small components (e.g., mechanical, electric, electronic) a
cabinets typically consists of several drawers and/or shelves with multiple compartments to classify d
with removable plastic bins are also available. Most cabinets are made of metal or plastic some used
electronic parts are designed to avoid static electric charges. These cabinets are used in healthcare fa
components and/or supplies for preventive maintenance and/or repair of medical devices and other eq
Cabinets designed for organized storage of keys. These cabinets typically consist of wall-mounted me
plastic units with hooks or other appropriate means to hold one or more keys and/or with identifying n
key cabinets include several panels (or trays) that support key hooks. They may include sliding trays,
and/or other locking mechanisms. Key storage cabinets are available in many different sizes to store f
even thousands of keys.

Key storage cabinets that include a computerized unit to automatically keep track of users and the tim
involving stored keys. These computerized systems include a set of safety features to facilitate orderly
and access (e.g., vehicles, restricted areas); some systems include mechanisms to render the cabinet
unauthorized users. Computer-controlled key storage cabinets frequently maintain a database that all
printing of data logs with information such as the name of the current user, the history of previous use
withdrawal and return time for each transaction.

Cabinets designed to store, display, and provide ready access to small equipment, instruments, labwa
they may also include a working surface (e.g., the top of the cabinet) for laboratory procedures. They
wood, laminate, metal (including stainless steel), or a combination of theese, permitting ease of clean
These cabinets typically consist of multiple drawers, shelves, or a drawer/shelf combination. Some inc
compartments for corrosive chemicals. Laboratory cabinets are available in multiple configurations (e.
mounted) and usually include sliding or hinged glass or solid doors; some also include security locks. L
used mainly in clinical laboratories, but they may be used to store and/or manipulate chemical produc
and in dental and ophthalmologic clinics.

Laboratory cabinets designed to provide a vented space to store tissue specimens for pathologic anal
typically consist of a set of perforated shelves to accommodate containers with a preservative liquid (
which pathology samples are immersed. Some cabinets are capable attaching to the laboratory ventil
include a wheeled shelf that can be removed from the cabinet and used for tissue transport. Pathology
are used for short- and long-term storage of specimens.

Cabinets designed to store food products and/or kitchen utensils. These cabinets consist of metallic, w
with surfaces that facilitate ease of cleaning. They may include drawers, shelves, and/or doors. Some
used for long-term storage of products that do not need refrigeration (e.g., canned products) or staple
sugar). Kitchen cabinets are used in healthcare facilities, nursing centers, and homes.

Cabinets designed for short-term storage and display of prepared, ready-to-eat food products at room
relative protection from the external environment. This furniture consists of metallic, wooden, or plast
surfaces appropriate for easy cleaning and may include drawers, shelves, and/or doors. Food storage
in configurations and/or with characteristics appropriate for short-term storage of food products that d
refrigeration or heating, such as bread, pastries, and fruit. The cabinets should be installed in cool, dry
appliances that produce heat. Food cabinets are used in hospitals, nursing centers, and other healthca
Cabinets designed for storage of miscellaneous products in a healthcare facility. This furniture typicall
wooden, or plastic cabinet that may include shelves, drawers, compartments, and/or doors; all surface
appropriate finishes or coatings to facilitate easy cleaning. Healthcare facility storage cabinets are ava
sizes and configurations (e.g., upright, wall mounted, above or under the counter) and they are used i
nonclinical areas of healthcare facilities to store a variety of products that do not have any particular s
special requirements for long-term time preservation.

General-purpose storage cabinets with appropriate size and characteristics for freestanding use. This
consists of metallic or plastic cabinets that may include shelves, drawers, compartments, and/or doors
have appropriate finishes or coatings to facilitate easy cleaning. Healthcare facility freestanding stora
available in a variety of sizes and are used in clinical and nonclinical areas of health facilities to store
that do not have any particular storage and/or other special requirements for long-term preservation.

General-purpose storage cabinets with appropriate size and characteristics to be either recessed in or
This furniture typically consists of metallic or plastic cabinets that may include shelves, drawers, comp
doors; all surfaces should have appropriate finishes or coatings to facilitate easy cleaning. Healthcare
storage cabinets are available in a variety of sizes and are used in clinical and nonclinical areas of hea
variety of products that do not have any particular storage and/or other special requirements for long-

General-purpose storage cabinets with appropriate size and characteristics to be installed beneath a c
furniture typically consists of metallic or plastic cabinets that may have shelves, drawers, compartmen
surfaces should include appropriate finishes or coatings to facilitate easy cleaning. Healthcare facility
cabinets are available in a variety of sizes and are used in clinical and nonclinical areas of health facili
of products that do not have any particular storage and/or other special requirements for long-term pr

Storage cabinets with appropriate size and characteristics to be attached to intravenous solution cont
(i.e., holding poles). These cabinets typically consist of a small metallic or plastic box that may include
compartments; all surfaces have appropriate finishes or coatings to facilitate easy cleaning. Some cab
compartments that may be locked to provide limited access to bags being used for large-volume infus
medications. Pole-mounted intravenous solution storage cabinets are used in clinical areas of healthca
variety of supplies that are frequently used in acute care and do not have any particular storage and/o
requirements for long-term preservation.

General-purpose cabinets that combine multipurpose and garment storage capabilities. These cabinet
stand-alone metallic, plastic, or wooden structure with a vertical compartment that includes a clothes
additional compartments to store miscellaneous materials. Storage/wardrobe cabinets are intended m
by healthcare workers (e.g., maintenance and/or service personnel).
Cabinets designed to store, display, and provide ready access to small equipment, instruments, and m
medical treatment and other medical procedures. This furniture typically consists of stand-alone multi
-shelf/drawer cabinets with a working surface (e.g., the top of the cabinet) appropriate for use while p
treatment. The cabinets usually have hinged or sliding (either glass or solid) doors; some cabinets als
grounded outlets, security locks, and/or small wheels for easy movement. Treatment cabinets are use
treatments in emergency situations or in the field. Some are specially designed to perform particular p
anesthesia, dentistry, ophthalmology, and otorhinolaryngolog..

Cabinets designed to store, display, and provide ready access to instruments, devices, and materials (
used in ear, nose, and throat diagnoses and treatment; they usually have a working surface (e.g., the
intended to facilitate the procedure. This furniture typically consists of a stand-alone, multiple drawer
cabinet, it may have hinged or sliding (either glass or solid) doors. Otolaryngology cabinets may inclu
otoscope sets; they may also include attachments for suction and pressure pumps, electrosurgical uni
sources, built-in grounded electrical outlets, security locks, and/or small wheels for easy movement. T
hospitals and physician's offices.

Cabinets designed to store, display, and provide ready access to instruments, devices, and materials (
used in ophthalmic diagnoses and treatment; they usually have a working surface (e.g., the top of the
facilitate the procedure. This furniture typically consists of stand-alone, multiple-drawer, -shelf, or -she
hinged or sliding (either glass or solid) doors. Ophthalmologic storage/treatment cabinets usually inclu
ophthalmoscopes and/or ophthalmoscope sets. They may also include attachments for electrosurgical
sources, built-in grounded electrical outlets, security locks, and/or small wheels for easy movement. T
hospitals and physician offices.

Cabinets designed to file medical and/or administrative documents or other media used in a healthcar
typically consists of freestanding or (less frequently) under- or over-the-counter mounted cabinets; the
constructed of metal (e.g., steel), wood, plastic, or combinations of them. Filing cabinets are available
configurations and sizes. Many cabinets are manufactured to store some particular type of document
or legal paper, cards (e.g., medical records, library), or larger documents (e.g., blueprints); others are
a particular store medium (e.g., hanging folders, audio or video cassettes, compact discs). Filing cabin
throughout hospitals and other healthcare facilities.

Filing cabinets designed to store files and/or file folders upright and perpendicular to the front of the c
filing). These cabinets typically consist of a metallic or wooden stand-alone structure, including one or
accommodate letter-, A4-, and/or legal-size documents; they may include side-to-side rails to hang file
cabinets frequently include locking systems and/or mechanisms that allow only one drawer to open at
tipping; they are available in many different configurations and sizes.
Lateral filing cabinets designed with appropriate insulation to provide resistance against fire. Some ca
insulation for each drawer, making them fireproof individually. These cabinets are available in several
the protection that they offer against external temperature for a predetermined time (e.g., 927 degree
degrees Fahrenheit or 1,093 degrees Celsius/2,000 degrees Fahrenheit for one, two, three, or four hou
internal temperature at an appropriate value to preserve paper documents (typically below 176 degre
Fahrenheit). These cabinets frequently offer additional protection against dropping up to a maximum h
feet) and/or include sealed gaskets to protect against water penetration. Fire safety lateral filing cabin
many different configurations and sizes.

Filing cabinets designed to store files and/or file folders upright and parallel to the front of the cabinet
These cabinets typically consist of a metallic or wooden stand-alone structure, including one or more d
accommodate letter-, A4-, and/or legal-size documents; they may include front-to-back rails to hang fi
cabinets frequently include locking systems (e.g., thumb-latch), wire follower to keep files upright, and
allow only one drawer to open at a time to avoid tipping; they are available in many different configur

Vertical filing cabinets designed with appropriate insulation to provide resistance against fire. Some ca
separate insulation for each drawer, making them fireproof individually. These cabinets are available i
according the protection that they offer against external temperature for a predetermined time (e.g.,
Celsius/1,700 degrees Fahrenheit or 1,093 degrees Celsius/2,000 degrees Fahrenheit for one, two, thre
keeping the internal temperature at an appropriate value to preserve paper documents (typically belo
Celsius/350 degrees Fahrenheit). These cabinets frequently offer additional protection against droppin
height (e.g., 9.1 m/30 feet) and/or include sealed gaskets to protect against water penetration. Fire sa
cabinets are available in many different configurations and sizes.

Small filing cabinets designed to store files and/or file folders upright, either parallel or, less frequentl
front of the cabinet. These cabinets typically consist of a metallic or wooden stand-alone structure, inc
drawers that can accommodate letter-, A4-, and/or legal-size documents; they may include rails to han
be easily suspended or placed at a side or under a working desk. Pedestal cabinets are usually design
and are available in many different configurations and sizes. Some pedestal cabinets include casters w

Pedestal cabinets designed with appropriate insulation to provide resistance against fire. These cabine
several classes according to the protection that they offer against external temperature for a predeter
degrees Celsius/1,700 degrees Fahrenheit or 1,093 degrees Celsius/2,000 degrees Fahrenheit for one,
hours), keeping the internal temperature at an appropriate value to preserve paper documents (typica
Celsius/350 degrees Fahrenheit). These cabinets frequently offer additional protection against droppin
height (e.g., 9.1 m/30 feet) and/or include sealed gaskets to protect against water penetration. Fire sa
are available in many different configurations and sizes.
Filing cabinets designed to store cards upright and either perpendicular or parallel to the front of the c
vertical filing, respectively). These cabinets typically consist of a metallic or wooden stand-alone struc
more drawers that can accommodate cards of one or more size (e.g., 6 x 9 inch, 5 x 8 inch); they may
store several rows of cards in each drawer. Many card filing cabinets include locking systems and/or m
only one drawer to open at a time to avoid tipping; they are available in many different configurations
cabinets are used to store many different types of information in healthcare facilities, including medic
results, device status, and library and financial information and/or inventories.

Card filing cabinets designed with appropriate insulation to provide resistance against fire. Some cabin
insulation for each drawer, making them fireproof individually. These cabinets are available in several
the protection that they offer against external temperature for a predetermined time (e.g., 927 degree
degrees Farenheit or 1,093 degrees Celsius/2,000 degrees Farenheit for one, two, three, or four hours)
temperature at an appropriate value to preserve paper documents (typically below 176 degrees Celsiu
Farenheit). These cabinets frequently offer additional protection against dropping up to a maximum he
feet) and/or include sealed gaskets to protect against water penetration. Fire safety card filing cabinet
different configurations and sizes.

Small filing cabinets designed to provide personal storage of medical charts (e.g., one or more ring bin
convenient writing surface. This furniture usually consists of slim, lockable cabinets that may include a
other documents; usually the door can be positioned to provide a flat surface to write on. Medical cha
place on the walls of halls, nurse stations, intensive care units, and other places in healthcare facilities
convenient working place near the patient.

Filing cabinets designed to store information media in several different formats such as audio cassette
(VHS), compact discs (CDs), floppy disks, optical disks, digital versatile disks (DVDs), and 4 and 8 mm
Some cabinets can also accommodate long plays, laser disks, and cards. These cabinets typically cons
steel) enclosures with doors to provide electromagnetic shielding and prevent electrostatic charges; th
lateral or vertical filing type. They typically include several shelves (e.g., fixed, roll-out) and drawers, i
may be adjustable to accommodate different types of media within the same unit. Multimedia filing ca
many configurations and sizes according to the capabilities required and type of media to be stored.

Multimedia filing cabinets designed with appropriate insulation to provide resistance against fire. Som
separate insulation for each drawer, making them fireproof individually. These cabinets are available i
according to the protection that they offer against external temperature for a predetermined time (e.g
Celsius/1,700 degree Farenheit or 1,093 degree Celsius/2,000 degree Farenheit for one, two, three, or
the internal temperature at an appropriate value to preserve multimedia devices (typically below 52 t
Celsius/125 to 150 degree Farenheit) These cabinets frequently offer additional protection against dro
maximum height (e.g., 9.1 m/30 feet) and/or include sealed gaskets to protect against water penetrat
multimedia filing cabinets are available in many different configurations and sizes.

Filing cabinets designed to store audiocassettes. These cabinets typically consist of a metallic, plastic,
that may include drawers and/or doors. They typically include several shelves (e.g., fixed, roll-out) and
dividers that may be adjustable to accommodate the audiocassettes. Audiocassette filing cabinets are
configurations and sizes according to the capabilities required. Metallic units that provide electromagn
prevent electrostatic charges are preferred to store important information.
Filing cabinets designed to store compact discs. These cabinets typically consist of a metallic, plastic,
that may include drawers and/or doors. They typically include several shelves (e.g., fixed, roll-out) and
that may be adjustable to accommodate the compact discs; some can also store digital versatile disks
filing cabinets are available in many configurations and sizes according to the capabilities required.

Filing cabinets designed to store videocassettes, usually in VHS format. These cabinets, typically cons
plastic, or wooden structurewith drawers and/or doors. They typically include several shelves (e.g., fix
drawers, including dividers that may be adjustable to accommodate the videocassettes. Videocassette
available in many configurations and sizes according to the capabilities required. Metallic units that pr
shielding and prevent electrostatic charges are preferred to store important information.

Filing cabinets designed to store digital versatile disks (DVDs). These cabinets typically consist of a me
wooden structure with drawers and/or doors. They typically include several shelves (e.g., fixed, roll-ou
dividers that may be adjustable to accommodate the DVDs; some can also store compact discs (CDs).
available in many configurations and sizes according to the capabilities required.

Cabinets designed to store a large number (typically from a few hundred to several thousand) of slide
mountings or racks. These cabinets are manufactured in different configurations that permit either ho
filing; they are available in freestanding and over-the-counter configurations. The slides are usually st
full visibility and easy searching, mounting, and removal; they are frequently protected using transluc
storage cabinets are used mainly for microscope glass slides and 35 mm projection slides; some cabin
appropriate to hold histologic cassettes.

Cabinets designed to store blocks of either tissue-embedding rings or cassettes. Typically the cabinets
number (a few hundred to several thousand) of rings and/or cassettes. These cabinets are manufactur
configurations that permit either horizontal or vertical filing; they are available in freestanding and in
configurations. The blocks are usually placed in drawers to provide permanent storage and include ap
easy identification.

Filing cabinets designed to store documents larger than the standard letter or legal size. These cabine
blueprints, large x-ray films, and drawings without requiring folding. Large-document storage cabinet
metallic or wooden structures, including appropriate drawers, vertical clamps, or compartments. They
radiology departments and in the administrative areas of healthcare facilities.

Filing cabinets designed for flat (horizontal) storage of large documents. These cabinets typically cons
frequently, wooden structures with horizontal drawers for storage of several large flat-sheet documen
frequently include handles and hold-downs to prevent curling of documents. Large-document flat-stor
typically used to store blueprints, maps, artwork, and large radiographic (i.e., x-ray) films.

Filing cabinets designed for vertical storage of large documents. These cabinets typically consist of m
frequently, wooden structures that have drawers with hanging clamps and/or folders for storage of se
documents. Large-document vertical hanging filing cabinets are typically used to store documents larg
letter or legal size, such as computer drawings (e.g., 11 x 17 inch/28 x 43 cm), blueprints (usually up
45 cm), maps, artwork, and large radiographic (i.e., x-ray) films.
Filing cabinets designed for storage of large, rolled documents. These cabinets typically consist of me
structures with square vertical compartments for storage of several large, rolled documents; the comp
frequently arranged in different heights to facilitate insertion and removal of materials. Large-docume
cabinets are typically used to store blueprints, maps, artwork, and charts.

Cabinets that combine the capabilities of a general-purpose storage cabinet (e.g., a unit with internal
with those of a lateral filing unit. These cabinets include one or more drawers. Storage/lateral filing ca
many different configurations and sizes; they are frequently used for personal storage.

Biological safety cabinets designed to protect the operator and the environment from low- and moder
agents. These cabinets typically consist of an enclosure with an open front for handling of products. Th
produce an inward flow of room air into the hood front and an exhaust system with a high-efficiency p
filter that exhausts the air through the top rear directly to the outside or, less frequently, into the labo
microbiological safety cabinets can provide biological safety for operation of devices such as blenders
materials may be handled inside these cabinets if inlet air release gloves are added and the gases are
outside environment. Since the incoming air is not filtered, these cabinets are not appropriate for han
susceptible to airborne contamination.

Biological safety cabinets designed to protect the operator, the environment, and the samples inside t
and moderate-risk biological agents (e.g., human pathogens). These cabinets typically consist of an e
front for handling of products. They include blowers to produce an inward vertical laminar flow of room
an exhaust system; both the inward vertical laminar airflow system and the exhaust-air system includ
particulate-air (HEPA) filters (for product and environmental protection, respectively). Class II cabinets
for most clinical laboratories for handling of cell cultures and human pathogens (e.g., bacteria, viruses
culture and tumor virus work, and for handling extremely toxic agents (e.g., chemotherapy drugs). Cla
safety cabinets are further classified in types A (exhaust of air to the room environment through HEPA
ducted to the outdoor environment, exhaust of air through HEPA filter). The construction and the airflo
patterns of type A cabinets make them suitable for microbiological use but not for handling volatile or
radionuclides, while the characteristics of class B cabinets permit their use with toxic chemicals and ra

Biological safety cabinets designed to offer the highest degree of protection to the operator and the e
protect samples inside the cabinet from contamination caused by practically all known biologically ha
cabinets typically consist of a ventilated, gastight total enclosure made of stainless steel; all operation
are performed under negative-pressure conditions and through attached armlength gloves. They inclu
an inward vertical flow of room air into the hood and an exhaust system; the inward vertical laminar a
high-efficiency particulate-air (HEPA) filter and the exhaust-air system includes two HEPA filters in seri
followed by incineration before outside exhaustion. Access into the cabinet should be allowed only thr
double-door pass-through box, which may include an autoclave. All devices needed for the working pr
centrifuges, incubators) must be integral to the cabinet. Class III biological safety cabinets are used to
hazardous microbiological agents, including infection aerosols.
Structures designed to provide an opening between two contiguous rooms, usually to transfer product
throughs may consist of either open or enclosed structures. Open pass-throughs provide free passage
two rooms; enclosed structures include doors on two (usually opposite) sides to permit access to both
room from the other and/or providing a contamination-free environment while performing the transfer

Enclosed pass-throughs designed for contamination-free transfer of materials in and out of a clean roo
throughs typically consist of a chemical resistant metallic, plastic (e.g., polypropylene, PVC), or stainle
may include a safety sprinkler, an air shower, and a high-efficiency particulate-air (HEPA) filter. During
shower, the clean-side door of the cabinet cannot be opened. The air is exhausted to the outer side (i.
the objects are introduced into the clean room. Clean-room enclosed pass-throughs are frequently wa
mounted units are available to allow carts to be wheeled into the room.

Enclosed pass-throughs designed for contamination-free passage of personnel into a clean room. Thes
typically consist of a metallic and/or plastic structure with two opposite or right-angle-located doors. P
cabinets usually include a high-efficiency particulate-air (HEPA) filter; they may also include an autom
is actuated upon entry and permits opening of the exit door only after a predetermined time of functio
interlock. After the air shower finishes, the air is exhausted to the outer side (i.e., the dirty room), and
enter the clean room. Most personnel clean room pass-throughs are also used to transfer materials int
room, frequently in wheeled devices (e.g., carts).

Enclosed pass-throughs designed to pass samples from the patient area into the clinical laboratory. Th
a wall-mounted, stainless-steel, or, less frequently, plastic structure; they may include either doors on
revolving plate by which the samples are moved into the laboratory.
Pass-throughs typically consisting of four rigid, upright plastic or metallic sections connected at right a
around a central upright pivot. These pass-throughs are usually mounted either in a wall common to t
or on the floor. They permit access between two contiguous rooms preventing the passage of air, light
or other environmental agents. Revolving pass-throughs are typically used in healthcare facilities to p
restroom to the clinical laboratory and to transfer x-ray film cassettes into and out of darkrooms.

Pass-throughs consisting of open structures located between two contiguous rooms. These pass-throu
shelves to hold the products that are being transferred (e.g., medicine containers, food trays). Open p
in healthcare facilities in places such as the clinical pharmacy to dispense medicines and the kitchen t

Warming units designed for temporary food storage at temperatures below the water boiling point (ty
80 to 85 degrees Celsius/176 to 185 degrees Farenheit). These units usually consist of cabinet-like str
usually available in stand-alone or under counter configurations. They may include forced-air circulat
and temperature controls, and alarms in addition to the heaters. Food warming units are used to keep
for a short time before its distribution; units including racks that can accommodate roll-in baking pans
food containing flour mixtures (i.e., proofing units) are also available.
Controllers designed to regulate high-pressure (e.g., up to several hundred psi/several thousand kPa)
nitrogen gas lines from a single point. These controllers typically include one or more pressure gauges
valves, and a diameter indexed safety system (DISS) outlet, all enclosed in a cabinet-like container. An
control knobs for the valves and pressure is attached to the container. The whole controller is either re
on a wall. Air/nitrogen pressure controllers are used for remote control of turbine-driven surgical tools
equipment (e.g., gas tracks, columns) in surgical rooms. They permit the user to make and break equi
zero level pressure.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed t
skin either by physical removal, chemical decontamination, or a combination of both. Items in these k
set of packets (usually two pockets with three packets each) containing a nonwoven decontamination
a reactive and absorbent black resin. The most commonly used resin is a mixture of a carbonaceous a
polystyrene polymeric compound, and an ion-exchange resin. Decontamination is accomplished by op
scrubbing the skin with the impregnated pad that is both adsorbent and reactive. The kits may be sup
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Remov
decontamination kits and trays used on the skin are usually intended for decontamination below haza
individual from chemical (either warfare or toxic industrial) agents and radiation contaminated materi
from biological agents. All products used for skin decontamination should be safe for individual health
intended for decontamination of wounds or for use near the eyes or mouth. The kits are mainly used
firefighters, and military personnel.

Hematology analyzers designed to measure total blood and/or some of its components (e.g., plasma a
a person's circulatory system; the devices can also determine the normal quantity of blood that an ind
according to his/her body size. The measurements are based on the time rate of disappearance of a ra
iodine isotope 131, I131) that is typically attached to albumin (the most abundant blood protein). A sm
injected through an intravenous line using a special, pre-filled, small, and calibrated syringe. Typically
collected using a standard blood collection setup in five- to six-minute intervals after an initial waiting
minutes. Blood/component volume measuring analyzers are intended for use after sudden blood loss
surgery); they may be used also for blood donors and in patients suffering from renal and/or heart fail

Pre-filled, small (e.g., 1 mL), and calibrated syringes that end in a Luer lock tip and that are supplied fi
solution containing a specific blood albumin tracer (e.g., iodine isotope 131, I131). These syringes are
(sometimes with a stop cock instead of a plunger) to inject an accurate dose of several microcuries (ty
through an intravenous line; they are used for blood and blood component (e.g., red cells, plasma) vo
blood samples taken after the tracer injection using a semi-automated or automated analyzer.
Nucleic acid processors designed for purification (e.g., filtration and centrifugation) of nucleic acid (e.g
samples, usually obtained from body fluid specimens, such as whole blood, serum, plasma, cephalo-sp
cell samples. These purifiers consist of a set of devices (typically including pipettes, samplers, reactiv
eluting devices) that are integrated into a unit, which by following computerized protocols and using a
kits, isolate the required nucleic acids without cross-contamination. The purification may be performed
technologies such as magnetic beads. Nucleic acid purifiers are used in clinical laboratories to isolate
viral nucleic acids) for further procedures, such as replication (e.g., polymerase chain reaction, PCR), e
diagnostic tool or for research.

Nucleic acid processors designed to increase nucleic acid (e.g., DNA, RNA, mRNA) samples in a repetit
replication) that multiplies the number of samples in each cycle. The procedure is directly applicable t
samples usually require a reverse transcription procedure. The nucleic acid samples are typically obta
specimens such as whole blood, serum, plasma, cerebrospinal fluid, and/or other cell samples. This eq
the replication (amplification) either at constant temperature or through a thermal cycle. Some device
techniques to extend the length and provide higher fidelity of the sequence that could be amplified (e
thermostable polymerase and/or a proofreading polymerase) and/or introducing molecular tags (e.g.,
possible the detection and quantification of minute amount of pathogens. Nucleic acid replicators are
laboratories to obtain appropriate samples for analysis from previously purified nucleic acids either fo

Laboratory analyzers designed for automated performing, processing, displaying, and reporting the re
assays. These analyzers integrate all the steps of the analysis, including sample (i.e., nucleic acid) pre
amplification, and detection. The analyzers may use one or more of several technologies, such as poly
(PCR), reverse transcriptase PCR (RT-PCR), fluorescent in situ hybridization (FISH), and nucleic acid seq
amplification (NASBA) or branched DNA signal amplification (bDNA). They perform the detection eithe
fluorimeter or luminometer, melting curve analysis) from a sample that was previously replicated in a
include a nucleic acid replication processor (e.g., a thermal cycler) that amplifies a previously purified
Molecular assay analyzers are used clinically to detect, identify, and/or quantify molecules of microorg
virus, fungus) and/or genetic abnormalities based in the characteristics of the patient's nucleic acids (
mRNA).

Immunoassay reagents intended to perform quantitative analyses on amniotic fluid samples obtained
to determine the ratio of phospholipids (i.e., surfactants) to albumin. These tests are typically used to
maturity and to assess the associated risk of respiratory distress syndrome if birth occurs. The predict
than 40mg/g for immature lungs and more than 70mg/g for mature lungs, but values may change as p

Pipette fillers designed for safe use of pipettes when handling potentially hazardous liquids. These fille
or plastic bulb with a small bulb derivation and several valves. The operation of the pipette includes s
and the aspiration (A) valve simultaneously to produce a vacuum; squeezing the suction (S) valve unt
desired level; and squeezing the expel (E) valve allowing the liquid to flow out the pipette.
Ophthalmic implants designed to repair the floor of the bony cavity that contains the eyeball and its a
vessels, and nerves (i.e., the orbital floor). These implants may consist of flexible mesh made of eithe
alloplastics (e.g., polyglactin, silastics), biologically absorbable materials (e.g., polyglicolic acid), or me
some consist of pre-punched solid alloplastics (e.g., expanded polytetrafluoroethylene also known as e
several shapes (e.g., triangular, round, square) and sizes. Orbital floor implants are mainly used to tre
(e.g., blow-out fractures); they are also used to correct other traumatic or non-traumatic volume defic
floor. These implants are frequently used for reconstruction of orbital wall defects.

Air pressure units (i.e., generators) designed for treatment of excess fluid volume and pressure in the
Meniere's disease). These devices consist of a low-pressure generator that delivers low-frequency, low
pulses to the middle ear through a ventilation tube that was previously implanted into the patient's ea
external canal and the middle ear. The device administers automatically controlled pulses of air to inc
within the middle ear, reducing fluid pressure in the inner ear. Middle ear pressure therapy units are u
symptoms of Meniere's disease when other clinical treatments (e.g., administration of drugs) have fai

Implantable liquid substances intended to be injected into specific gastrointestinal tissue (e.g., the reg
esophageal sphincter) and allowed to precipitate as a solid permanent implant. These substances typ
organic material or a biocompatible copolymer (e.g., ethylene-vinyl alcohol), a radio opaque marker (e
liquid solvent (e.g., dimethyl sulfoxide). The substance is typically injected into gastrointestinal tissue
deep submucosal layers of the LES (immediately adjacent to and surrounding the cardiac opening of t
needle attached to a catheter that is introduced through an endoscope under fluoroscopic visualizatio
tissue bulking agents are available for the treatment of specific disorders (e.g., esophageal sphincter

Prepackaged collections of the devices and supplies (either custom or standard) needed for injection o
specific gastrointestinal tissue (e.g., the region of the lower esophageal sphincter) and allowed to prec
permanent implant increasing tissue bulk. Items in these kits usually include two containers with the i
(e.g., a biocompatible copolymer and a radio opaque marker) and a liquid solvent respectively, a cath
needle, a syringe, and a hypodermic needle. These kits may be supplied in supporting trays (i.e., proc
of a flat-bottomed receptacle with a border around the periphery supporting all the instruments and s
procedure; the trays are usually covered or wrapped. Gastrointestinal bulking agent injection procedu
intended for the treatment of specific disorders (e.g., esophageal sphincter reflux).

Signs intended to allow visual identification of healthcare facility areas and/or rooms. These signals ty
boards or placards with legends such as "Patient Rooms 300-320", "Nuclear Medicine", "Nursing Statio
"Clinical Laboratory." Identification signs are placed throughout healthcare facilities to facilitate area id
patients, and visitors.
Protective plunger syringes designed for injection of radiopharmaceuticals; allowing conventional radi
prevention while offering needlestick protection. These syringes usually include the safety mechanism
typically the syringes can be operated with a radiation shield properly positioned to prevent exposure
radiopharmaceutical. Radiopharmaceutical protective syringes are used in nuclear medicine and othe
radiographic) procedures that may require injection of radiopharmaceuticals.
Needles designed for the initial percutaneous insertion of a catheter, with means of protection against
during and after use. These devices usually include some manually positioned or activated mechanism
retract the needle or by some other means decrease the possibility of contact between the needle and
provider. These needles typically consist of a hollow, blunt, tapered catheter with a sharp obturator in
needles may be used for introduction of drainage catheters into wounds, initial introduction of spinal c
introduction of peritoneal catheters for dialysis and/or drug infusion, and, most frequently, insertion of
and/or arterial catheters.

Reverse osmosis (RO) water purification systems designed to deliver water pure enough for hemodialy
systems typically consist of a container with a central semi-permeable membrane separating the cont
the purified water. Hydrostatic pressure high enough to exceed the osmotic pressure is then applied to
water section. The membrane is permeable to water but impermeable to the solutes thus providing pu
other side of the membrane. RO systems used in hemodialysis remove salts, metal ions, and particula
than standard RO systems. Water obtained after the procedure should be tested periodically due to th
that patients are exposed to during hemodialysis in which even trace quantities of contaminants (e.g.
dangerous. The elimination of chloramines (e.g., using a carbon bed) present in tap water is also esse
reverse osmosis is usually performed after filtration to eliminate particulates from the incoming water
ultrafiltration, and/or disinfection with ultraviolet radiation may be needed after reverse osmosis if the
contaminants is high due to the fact that RO removes percentages (e.g., 95 to 99 percent) rather than
contaminants. Portable hemodialysis RO systems are also available.

Hemodialysis reverse osmosis (RO) water purification systems designed to deliver water pure enough
procedures that can be transported on wheels or that are compact and lightweight enough to permit m
wearing by one person (i.e., portable). These systems typically consist of a small container with a cen
membrane separating the contaminated water from the purified water. Hydrostatic pressure high enou
osmotic pressure is then applied to the contaminated water section. The membrane is permeable to w
to the solutes thus providing purified water on the other side of the membrane. Appropriate tubing (e.
the system to the water supply and the hemodialysis unit respectively is also needed. RO systems use
remove salts, bacteria, metal ions, and particulates to a greater degree than standard RO systems. Wa
procedure should be tested periodically due to the high volume of water that patients are exposed to
which even trace quantities of contaminants (e.g., aluminum) may be dangerous. The elimination of c
a carbon bed) present in tap water is also essential. Reverse osmosis systems may be used after filtr
water is performed, especially if the water is highly contaminated with particulates. Deionization, ultra
disinfection with ultraviolet radiation may be needed after reverse osmosis if the presence of contami
the fact that RO removes percentages (e.g., 95 to 99 percent) rather than fixed quantities of contamin

Occluders designed to close the slender tubes that connect the uterus with the ovaries (i.e., fallopian
sperm from reaching the ovum. These occluders may consist either of devices applied externally to th
bands) or devices inserted into the tubes (e.g., plugs, valves). Fallopian tube occluders are used for pe
conception (contraception), but some devices may be successfully explanted.
Manual brachytherapy applicators designed to deliver radioactive liquids to, retrieve them from, and/o
interstices or cavities (often surgically created) of the body. These applicators usually include one or m
balloon at the tip, as well as anchoring clips, noncoring needles, an infusion set with appropriate syrin
supplies. The balloon is left in the surgical cavity (e.g., after extraction of a tumor). After surgery, the
source is introduced into the balloon to allow radiation treatment very close to the tissue adjacent to t
Liquid radioisotope brachytherapy applicators are typically used to treat to malignant brain tumors.

Intracranial catheters designed for liquid brachytherapy treatment in the brain, usually in the cavity re
resection. These catheters typically consist of a single-lumen radiopaque catheter with a double balloo
an infusion port in the proximal end that is fixed on top of the skull. A few days after surgery, the inne
filled (typically using a prefilled syringe) with a radioactive liquid that irradiates the tissue surrounding
the outer safety balloon is possible if necessary. Both the catheter and the radioactive source are rem
(three to seven is typical) of continuous treatment. Liquid radioisotope brachytherapy intracranial cath
brain tumors, especially when these tumors recur.

Prostheses designed for total or partial replacement of the natural disk between two spinal vertebrae
disk). These prostheses typically consist of a set of components available in different configurations an
metallic, polymeric, or combinations of them). Intervertebral disk prostheses are used mainly in patien
disk disease (DDD), frequently as an alternative to spinal fusion surgery.

Prostheses designed for total (i.e., the fibrous ring or annulus and the pulpy center or nucleus) replace
intervertebral disk. These prostheses are available in several different configurations and materials; p
either mechanical (e.g., a combination of a polyethylene spacer and two separate metal endplates, a
socket secure with screws to the vertebrae) or hydraulic (based on a fluid absorbent gel core that exp
the disc space) mechanism. Total intervertebral disk prostheses are implanted mainly in patients with
degenerative disk disease (DDD) following an open surgical procedure known as arthroplasty, frequen
spinal fusion surgery.

Prostheses designed for partial replacement of the intervertebral disk, typically to replace the pulpy c
the disk. These prostheses are available in several different configurations and materials, according to
replacement to be performed. Partial intervertebral disk prostheses are used mainly in early or interm
disk disease (DDD), frequently as an alternative to spinal fusion surgery. Some partial prostheses may
minimally invasive surgery (i.e., endoscopic procedures).

Powered wheelchairs with the capability of climbing curbs and stairs and/or allow the occupant to ope
while lifted in a balanced seated position to the eye-level of a standing person. They may have additio
as displacement on uneven surfaces (e.g., gravel, sand, grass) and operation under remote control wh
sitting on the wheelchair. These wheelchairs typically consist of a seating structure including a seat, a
footrests, and other components and/or accessories; a power system including a motor, a battery, and
computerized unit for easy and reliable operation of the wheelchair; and a control unit operated by th
Climbing/lifting powered wheelchairs (as typical for powered wheelchairs) are customized for each pat
usually appropriate for indoor and outdoor use.
Immunoassay reagents intended to perform quantitative analyses on a serum, plasma, or whole blood
brain natriuretic peptide (BNP) or pro-PNB (a PNB precursor). PNB is a protein typically liberated from t
the blood as a result of regional wall stress in the ventricles. Circulating BNP is associated with advers
remodeling and as an indicator of poor prognosis. The level of liberated BNP is used mainly in the diag
responsiveness of congestive heart failure.

Physiologic analyzers designed to measure the rate at which a person burns calories either at rest (i.e
rate, RMR), during normal activities, and/or during exercise (e.g., stress exercise). These devices typic
calorimetry methods to calculate the metabolic rate; they may include gas analyzers, airflow measure
controls, and a computerized system that integrates the measurements and brings the result in energ
physiologic analyzers are used to assess patient status in ICU and CCU units and for other medical app
medicine, nutritional support, spatial and military physiology).

Metabolic rate physiologic analyzers designed to measure oxygen consumption (VO2) and estimate t
person burns calories, usually at rest (i.e., resting metabolic rate, RMR). These devices calculate the R
calorimetry methods, performing algorithms based only on oxygen consumption rather that the comb
consumption and carbon dioxide production; making them simpler than conventional metabolic analy
analyzers are portable or handheld devices that include a mouthpiece with unidirectional breathing va
computerized capabilities; all integrated as a single unit. Oxygen based physiologic analyzers are ma
hospitals and/or doctor's offices for nutritional assessment; usually to determine oxygen uptake and th
requirements of patients (e.g., weight management, burn and/or parenterally fed patients, patients at

Data management information systems based in codes consisting of a group of printed and variously
spaces (i.e., bar codes); these codes are designed to be scanned and read into computer systems to id
objects. Bar-code information systems are used in healthcare facilities to increase the accuracy and s
management, especially in activities where manipulation of patient-related data may represent a high
such as administration of medication or blood products, specimen handling for laboratory analysis, an
inventory in the clinical pharmacy.

Bar-coded data management information systems designed to build safeguards in medicine administr
the point of care that administered medications match provider orders. These information systems inc
device (e.g., a portable or handheld computer) with bar-coded label reading capabilities; the device ca
other (e.g., hospital, clinical pharmacy, provider order entry) information systems in the healthcare fa
coded label on the patient's identification wristband and the one on the medication packaging are sca
coded medication administration (BCMA) system confirms that the administered medications match p
that it is the right patient, right drug, right dose, right route, and right time). Systems specifically des
the correct drug and concentration are entered into infusion pumps and that the pump's initial progra
provider's orders for a specific patient (i.e., automated infusion pump programming/verification system
Medication administration bar-coded systems are intended to improve accuracy and safety in medicat
minimizing errors.
Bar-code enabled data management information systems designed to build safeguards in clinical labo
collection at the point of care by verifying patient and healthcare professional identification and that t
specimen container is used; they also print the correct specimen label. These information systems inc
device (e.g., a portable or handheld computer) with bar-coded label reading and printing capabilities;
interact with other (e.g., hospital, laboratory, provider order entry) information systems in the healthc
the bar-coded label on the patient's identification wristband and the one on the specimen container ar
bar-coded specimen collection system confirms that the collected specimens match provider orders (i
patient, right health-care professional, right specimen container, right order of draw, and right time). S
bar-coded systems are intended to improve accuracy and safety of specimen collection for laboratory
errors.

Protection garments designed for personal protection against chemical and/or biological agent contam
offer protection at least for 24 hours after external contamination occurs. The garments are typically m
tightly woven or laminate vapor-permeable outer layer and an inner layer (e.g., charcoal-impregnated
technology) that absorbs and/or neutralizes the liquid or vapor agent. Some garments are made of a m
that is permeable to perspiration while providing protection against chemical and biological agents. Th
consist either of a full coverall (i.e., overgarment) or a hip-length coat and trousers with appropriate fa
also includes chemical resistant gloves, boots, and masks or hoods to cover the face and/or head. Che
protection garments are used by civil rescuers in massive contamination events and by military perso
protection from radiation.

Chemical and biological protection garments designed for use under the standard cloth (i.e., undergar
undergarment typically consist of a two-piece (jacket and underpants) made of a fabric that provides
biological agent protection. They are typically configured with an integral form-fitting hood and detach
fire-resistant socks. Chemical and biological agent protection undergarment are frequently used unde
rescuer, or military uniforms.

Masks designed to protect the face, eyes, and respiratory tract from gases and/or aerosols containing
biological agents. The masks usually prevent the agent from reaching the respiratory mucosa by phys
agent and/or by chemically destroying it. Some masks can also protect against toxins and/or breathing
alpha, beta) particulates; they do not offer protection from radiation. These masks typically consist of
one (e.g., a molded silicone film for maximum seal) that is fitted tightly against the face and an extern
butyl rubber) for maximum protection; two ridged eye lenses; appropriate means to avoid lens foggin
canisters or cartridges. Some masks include a drinking system consisting of internal and external drin
communication systems both for face-to-face and radio telephone communication; they may also incl
nosecup. The masks are available in several sizes; they may provide additional features for special us
that interface with aircraft communication systems). The combination of chemical and biological agen
with appropriate cartridge or canister filters and hoods for additional protection of the head and neck
and biological protection respirator.

Air-purifying respirators designed to prevent the wearer from inhaling chemical and/or biological agen
materials from the environment, either as airborne particulates, gases, or vapors. They do not offer pr
radiation. These respirators typically include a mask that includes two appropriate disposable filtering
particulates and another to absorb and/or neutralize the chemical or biological agent. Chemical and b
respirators are intended for long-term (e.g., 24 hours or more) use in highly contaminated areas.
Testers designed to check the leakage of protective masks and/or respirators that are used against co
chemical, biological, toxic industrial) agents. These testers are either stand-alone units or portable pa
compare the numerical value of particles in the environment with the particles in the air inside the we
a result a ratio (i.e., a protection factor) which value should be greater than a pre-established value (e
testers employ aerosol generators as an integral part to perform the leakage test. The leakage test e
the proper size for the individual wearer and that there are no critical leaks in the mask or respirator. S
check the functioning of the outlet valve and the drink tube system.

Facilities that can be easily transported and rapidly deployed to offer protection from the environmen
housing to people after natural disasters, industrial accidents, or otherwise affected areas. Shelters wi
protection can be used also to protect victims of chemical, biological, or radiological disasters outside
areas. Shelters typically include a soft canvas with supporting columns, an electric power unit, and an
heating, ventilation) control unit.

Shelters that can be easily transported and rapidly deployed to provide temporary housing and protec
and/or chemical agents and from breathing of radioactive particulates; they do not offer protection fro
shelters typically consist of a soft impermeable canvas with supporting columns, an electric power un
that provides heating, cooling, ventilation, and filtration of contaminating (e.g., chemical, biological) a
radioactive particles. Chemical/biological protection shelters are usually over pressured to prevent any
from entering.

Equipment designed to control the environmental characteristics of a closed space. This equipment us
exchange unit, a control panel, heating devices, filters, and a compressor. Environmental control units
the temperature and humidity and also to reduce (i.e., filter out) airborne particles in the environment
control units include special filters to eliminate bacteria.
Environmental control units designed to protect the environment of a closed space (e.g., a shelter) fro
biological agents and from breathing of radioactive particulates; they do not offer protection from radi
typically provide heating, cooling, ventilation, and filtration of contaminating (e.g., chemical, biologica
radioactive particles; they usually provide a pressurized air protection of the internal environment. Th
includes a standby electric power plant, a heat exchange unit, a compressor, filters, and a control dev
Chemical/biological agent protection environmental control units are used mainly to protect the enviro
other installations in a contaminated area.

Air cleaners designed to remove particulates (e.g., smoke, biological aerosols) from the room air. Thes
include a combination of filters (e.g., a coarse pre-filter and a very fine particle filter), intake and exha
blower assembly, and a control panel that includes an airflow speed control, a manometer to measure
the filter and/or a filter-change indicator. Some devices remove the particles by electrostatic attraction
electrostatic precipitation) of the particles instead of filtering. Particulate air cleaners are used in healt
reduce the concentration of biological airborne infections and allergens.

Air cleaners designed to cleanse room air by removing particulates and gas/vapors from the air and th
cleansed air. These cleaners typically include a set of filters to remove particulates and gas/vapors; de
characteristics and efficiency of the filter(s) they can remove airborne particulates (aerosols) such as a
biological agent particulates, or radioactive particles; and/or gases and vapors including toxic industri
chemical and biological agents. Particulate and gas/vapor air cleaners are used in healthcare facilities
rooms, and emergency shelters.
Particulate/gas/vapor air cleaners designed to remove very fine particulate from the air, typically 99.9
than 0.3 micron, and also toxic industrial contaminants (TIC's) in gas or vapor phase from the air strea
usually include a combination of a low-efficiency pre-filter, a high efficiency particulate air (HEPA) filte
sorbent filters according to the expected industrial contaminants and the prevalent conditions (e.g., c
concentration, molecular weight and size, temperature). TIC air cleaners are used in air cleaning syste
permanent facilities and/or in temporary emergency shelters during industrial accidents.

Particulate/gas/vapor air cleaners designed to remove very fine particulate from the air, typically 99.9
than 0.3 micron, and also chemical agents (e.g., nerve, blister) in gas or vapor phase from the air stre
usually include a combination of a low-efficiency pre-filter, a high efficiency particulate air (HEPA) filte
sorbent filters according to the expected chemical agent and the prevalent conditions (e.g., contamin
molecular weight and size, temperature). Chemical agent air cleaners are used in air cleaning system
permanent facilities and/or in temporary emergency shelters in areas contaminated and/or potentially
chemical agents.

Air filters that are intended to remove either solid or liquid particulates (i.e., aerosols) from the air stre
perform either mechanical or electrostatically enhanced filtration. Mechanical filters are typically com
cotton, fiberglass, polyester) woven together tightly; the particles are caught as the air passes throug
to the woven material. Electrostatic filtration uses electrostatically enhanced (i.e., polarized) fibers tha
particulates. Special filters intended to remove very fine particles and droplets are available; they are
and cleaning systems to remove airborne pathogens and to obtain a clean environment (e.g., clean ro
air flow conditions.

Particulate air filters designed to remove coarse particulate from the air, typically 90 to 95% of particl
micron. These filters usually consist of pleats of a filter medium separated by rigid sheets of corrugate
foil. Low-efficiency air filters remove most common air contaminants such as dust, pollen, spores, toba
bacteria from the environment; they are not effective for removing sub micrometer particles. Low-effic
filters are used mainly in home air filtration systems and as prefilters to protect the mechanical compo
filtration/cleaning systems in healthcare facilities.

Particulate air filters designed to remove very fine particulate from the air, typically 99.97% of particle
micron. These filters usually consist of pleats of filter medium separated by rigid sheets of corrugated
foil; most high efficiency particulate air (HEPA) filters direct the flow of air in a uniform parallel pattern
filters are used to obtain very low particulate environments in places such as clean rooms, patient isol
laminar air hoods; they are also used in high efficiency air cleaners. High-efficiency particulate air filte
aerosolized biological agents and radioactive particles.

Particulate air filters designed to remove ultra fine particulate from the air. These filters usually consis
medium separated by rigid sheets of corrugated paper or aluminum foil; most ultra low penetration ai
the flow of air in a uniform parallel pattern (laminar flow). ULPA filters are similar in construction and a
efficiency particulate (HEPA) filters but with a filtering medium with higher retention of the smaller mi
typically remove 99.999 of particles bigger than 0.12 micron. ULPA filters are used to obtain the maxim
cleanliness (minimum particulate environment) that characterize classes 1 and 10 (i.e., less than 1 an
cubic foot respectively) clean rooms.
Particulate filters consisting of small cartridges containing materials that remove particulates (e.g., sm
aerosols, radioactive particulates) from the air as they pass through. They do not offer protection from
filters usually consist of a set of fibers (e.g., cotton, fiberglass, polyester) woven together tightly; the p
the air passes through (i.e., perpendicular) to the woven material. Particulate filtration cartridges are i
masks and/or personal respirators.

Air filters designed to remove gas and vapors from the air stream. These filters use either physical ads
chemisorption for gas and vapor removal. They are typically composed of highly porous materials (e.g
that may be either chemically active (e.g., using strong oxidizers) or not. Some air gas/vapor filters co
layered sorbents to permit the removal of a broad range of contaminants. Gas/vapor filters are used to
common gaseous contaminants in healthcare facilities; specialized filters can be used to remove toxic
and/or chemical agents.

Gas/vapor air filters designed to remove toxic industrial contaminants (TIC's) from the air stream. The
sorbents according to the expected contaminants and the prevalent conditions (e.g., contaminant con
weight and size, temperature); typically activated carbon, zeolites, alumina, or polymer sorbents are u
agent gas/vapor filters are used in air cleaning systems designed for permanent facilities and/or temp
shelters during industrial accidents.

Gas/vapor filters consisting of small cartridges containing substances (e.g., activated carbon) that can
toxic industrial contaminants (e.g., chlorine dioxide, ammonia) in gaseous or aerosol form from the air
These cartridges are disposable devices intended for protection against a limited number of exposure
agents. Toxic industrial material protection cartridges are used in respirators and masks to prevent the
reaching the respiratory mucosa, the eyes, and the face of the user.

Gas/vapor air filters designed to remove chemical agents from the air stream. These filters use gas so
expected agent (e.g., nerve, blister) and the prevalent conditions (e.g., contaminant concentration, m
size, temperature); currently copper-silver-zinc-molybdenum-triethylenediamine (ASZM-TEDA) is consi
appropriate sorbent for chemical agents. Chemical agent gas/vapor filters are used in air cleaning sys
permanent facilities and/or temporary emergency shelters.

Gas/vapor filters consisting of small cartridges containing substances (e.g., copper-silver-zinc-molybde


triethylenediamine, ASZM-TEDA) that can absorb and/or destroy chemical (e.g., cyanogens chloride, p
in gaseous or aerosol form from the air as they pass through. These cartridge filters are disposable de
protection against a limited number of exposures to contaminating agents. Chemical agent protection
respirators and masks to prevent the chemical agent from reaching the respiratory mucosa, the eyes,
user.

Prepackaged collections of the devices and supplies (either custom or standard) needed for facilitating
orientation, signaling, and communication in the event of a real or potential chemical, biological, or ra
environmental contamination._x000D_
Items in these kits usually include appropriate garments to cover the whole body including the feet; d
face and respiratory tract (e.g., masks or hoods with appropriate filters); means for orientation (e.g., c
signaling (e.g., whistles, lights); and communication (e.g., radio receivers, speakers).The kits may be s
trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around the peripher
instruments and supplies needed for the procedure; the trays are usually covered or wrapped. Chemic
emergency procedure kits and trays are intended for long-term storage (e.g., 10 years) in a ready-to-u
intended for emergency teams, rescuers, and/or the general population.
Prepackaged collections of the devices and supplies (either custom or standard) needed for facilitating
orientation, signaling, and communication in the event of a real or potential chemical, biological, or ra
environmental contamination that are intended for adult use. Items in these kits usually include a pro
overgarment that protects against chemical and biological agents and also against most toxic industri
contaminations; a mask with canister filters that absorb and/or neutralize the contamination agents; c
gloves and overboots; and duct tape to seal the garment. The kits also include devices to facilitate ori
(e.g., flashlights, compass), signaling devices such as whistles and sirens, communication means (e.g
speakers). They may also include a booklet with instructions for emergency situations and supplies fo
emergency kits including protection for several adults are also available. The kits may be supplied in s
procedure trays) consisting of a flat-bottomed receptacle with a border around the periphery supportin
and supplies needed for the procedure; the trays are usually covered by a sterile wrap. Adult chemica
emergency procedure kits and trays may be stored for a long time (e.g., 10 years) in ready-to-use con
intended for emergency teams, rescuers, and the general population.

Prepackaged collections of the necessary devices and supplies (either custom or standard) intended f
babies, toddlers). Items in these kits usually include a baby carrying frame with adjustable straps to h
transparent hood; canister filters that absorb and/or neutralize the contamination agents; and a feedin
bottle; some kits include a battery-powered blower to circulate the air in and out of the hood. The kits
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
chemical/ biological agent emergency procedure kits and trays are provided for long-term storage (e.g
to-use condition; they are intended for emergency teams, rescuers, and/or the general population.

Liquid substances intended to be injected into a target tissue to increase tissue bulk after their solidifi
implant. These substances may consist of an organic material or more frequently a biocompatible cop
vinyl alcohol) and a solvent; they are usually injected using endoscopic procedures. Dedicated tissue b
available for the treatment of specific disorders (e.g., esophageal sphincter reflux, vesicoureteral reflu

Implantable liquid substances intended to be injected into urinary structure/tissues such as the urethr
ureter wall close to the ureterovesical junction, periurethral tissue). These substances typically consist
(e.g., autologous chondrocytes) or more frequently of a biocompatible copolymer (e.g., dextranomer-h
liquid solvent. The agent is frequently delivered using a needle attached to a catheter that is introduc
endoscope. Urological tissue bulking agents are available for the treatment of specific disorders (e.g.,
incontinence).

Measuring instruments designed for direct evaluation and display of the carbon dioxide content either
gas, in body cavities, and/or in body tissues. Capnometers are used to check the correct placement of
assess the pulmonary function or the adequacy of perfusion during cardiopulmonary resuscitation, an
checking the status of critically ill patients; they can also detect ventilator failure.
Capnometers designed for measuring the partial pressure of carbon dioxide (PCO2) in an exhaled brea
measure PCO2 either by using a sensor in the patient breathing circuit (mainstream) or by sampling fr
airway (sidestream). The sensor usually consists of an infrared light source, an optical filter, reference
chambers, and a detector. Most capnometers display the results as a maximum value of PCO2 (i.e., CO
measured at the end of exhalation, known as end-tidal carbon dioxide concentration or ETCO2). Capno
check the correct placement of endotracheal tubes, to assess the pulmonary function or the adequacy
cardiopulmonary resuscitation, and in diagnostics and checking the status of critically ill patients; they
ventilator failure.

Capnometers designed to measure the partial pressure of carbon dioxide (PCO2) in the sublingual tiss
devices typically consist of a measuring unit (i.e., the capnometer) that measures and displays the Ps
connected through a cable to a single-use transducer that is placed in contact with the sublingual tiss
the tongue). Sublingual tissue capnometers are used mainly in diagnostics and evaluation of critically
be useful for assessing tissue perfusion.

Carbon dioxide monitors designed for continuous evaluation and display of the partial pressure of carb
the gastrointestinal tissue (PgCO2) that are hard-wired to the patient at the bedside. These devices ty
external monitoring instrument that periodically displays (e.g., every 10 minutes) the values of PgCO2
which have been automatically withdrawn from a nasogastric catheter. The monitoring unit is frequen
module of a physiologic monitor. Gastrointestinal tissue carbon dioxide monitors are used mainly to as
perfusion in hemodynamically unstable, critically ill patients.

Probes designed for use with a dedicated capnometer for measuring the partial pressure of carbon dio
tissue (PslCO2). These devices are typically single used probes including a transducer that are placed
sublingual tissue (e.g., placed under the tongue). The probes are connected via cabling to a dedicated
displays the PslCO2 values.
Airway clearance units designed to generate positive airway pressure in the airways (typically 10 to 2
as the patient exhales through a resistance. Positive expiratory pressure (PEP) devices include one of
orifice resistors that only generates pressure when the expiratory flow is high enough to generate bac
orifice. PEP units typically include a soft, transparent, hand ventilation mask or mouthpiece, a T assem
valve, and a manometer. The mask is applied tightly but comfortably over the mouth and nose. A mou
used, but only if the patient can maintain a reasonable seal and not release air through the nose durin
airway clearance units are mainly used to help remove pulmonary secretions.

Airway clearance units designed to apply forces at the airway opening to perform a simultaneous deliv
expiratory pressure and a high-frequency oscillation (HFO) of the air column in the conducting airways
one of several different techniques to create the airflow oscillation, including metallic ball vibrations a
counterweighted plug and a magnet. Oscillatory positive expiratory pressure units are used for preven
closure by stabilization of the airways with positive expiratory pressure (PEP) and to aid in mucus mob
expectoration in patients suffering from chronic obstructive pulmonary diseases.
Handheld oscillatory positive expiratory pressure units consisting of a pipe-like device that includes a
cone (i.e., the pipe bowl) that is loosely covered by a perforated cap. The weight of the ball provides p
(close to 10cm of H20) during expiration (i.e., positive expiratory pressure, PEP), and the ball moveme
generates oscillations with a changing frequency ranging from 2 to 30 Hz (typically about 15 Hz) acco
position. Flutter valve devices are intended to shear mucus from the airway wall by oscillatory forces,
airway closure by stabilization of the airways with PEP, changes in mucus rheology, and to aid in mucu
expectoration. They are intended mainly for use in patients with chronic obstructive pulmonary diseas

Handheld oscillatory positive expiratory pressure units consisting of a counterweighted lever and a ma
passes through the cone which is intermittently occluded by a plug attached to the lever, producing a
knob located at the distal end of the device adjusts the distance between the magnet and counterwei
adjusting the frequency, amplitude, and mean positive expiratory pressure (PEP). These units are avai
intended for patients with an expiratory flow capacity smaller or greater than 15 liter/minute respectiv
devices are intended to shear mucus from the airway wall by oscillatory forces, prevention of early air
stabilization of the airways with PEP, and to aid in mucus mobilization and expectoration. They are int
patients with chronic obstructive pulmonary diseases.

Airway clearance units designed to perform high-frequency airway oscillation of the air column in the
applying high-flow mini-bursts (similar to those provided by high-frequency ventilators) to the airway
inhalation and exhalation. During these percussive bursts of gas a continuous positive airway pressure
while the pulsatile percussive airway pressure increases. These units typically consist of a pneumatic
provides the positive pressure and connecting tubes, controls, adapters, sputum cups, and attachmen
masks) for intermittent deliver of gas to the patient. The oscillation frequency and pressure are usuall
30 Hz and 10 to 20 cm of H20 respectively. Oscillatory intrapulmonary percussion units make no attem
patient, the oscillatory pressure is layered on top of the patient normal breathing. Most units include o
nebulizers and to oral or endotracheal suction equipment. They are intended to shear mucus from the
oscillatory forces, to aid in mucus mobilization and expectoration, for treatment of atelectasis, and fre
nebulized medications.

Airway clearance units designed to apply automated mechanical oscillation to the chest wall to obtain
oscillation (HFO) of the air column in the conducting airways. These devices may use one of several te
the oscillation, including external percussion on the chest wall, intermittent compression by a patient-
of positive and negative pressure compression provided by a cuirass around the patient chest. High-fr
oscillation units are intended to shear mucus from the airway wall by oscillatory forces and to aid in m
expectoration; some units are capable of providing mechanical ventilation of patients. Devices that pe
oscillation using a cuirass may also act as mechanical ventilators.

Airway clearance units designed to apply automated external percussion to the chest to obtain a high
(HFO) of the air column in the conducting airways. These units are usually pneumatic powered; the pe
the chest typically at frequencies between 13 and 15 Hz (close to the natural harmonic frequency of t
are used mainly to facilitate secretion removal in vulnerable patients, especially those suffering from c
pulmonary, neuromuscular, or neurological disorders that affect normal secretion of mucous from the
Airway clearance units designed to applied non-invasive, high-frequency oscillation (i.e., compression
using a vest. These devices typically consist of large-volume variable-frequency air-pulse delivery unit
stretchable inflatable vest worn by the patient and that extends over the entire torso. The pressure (in
mm of H20) is applied by the vest either during all the respiratory cycle or only during expiration, in p
is controlled by the patient typically in a range from 5 to 25 Hz. Vest units are intended for self-admini
mucus clearance and sputum induction in patients with chronic obstructive pulmonary diseases.

Airway clearance units designed to applied high-frequency oscillation (i.e., compression) to the chest
flexible chest enclosure (a cuirass, similar to those used in negative pressure ventilators), delivering n
(i.e., cycles of positive and negative pressure) to the airways and lungs. These devices typically inclu
powered oscillator that is controlled using a microprocessor. The expiratory pressure may be positive,
negative, permitting ventilation above, at, or below the patient normal residual capacity; frequency m
controlled in the range of -70 to +70 cm of water and pressure from 8 to several hundred oscillations/
clearance units are intended for administration of therapy for mucus clearance and sputum induction;
to provide mechanical ventilation to some patients.

Devices designed to apply positive air pressure to the airways of patients that are performing spontan
Positive air pressure (PAP) units may apply positive pressure during inspiration, expiration, or both; po
applied continuously either at the same level or at two different levels (typically one level during inspi
level during expiration), or by pulses (i.e., pulsatile). These units are intended to provide noninvasive
breathing assistance therapy through a mask (either nasal or oronasal), a mouthpiece, and/or a lipsea
intended for continuous breathing support. Some PAP units include or may be connected to nebulizers
suction devices.

Devices designed to apply positive airway pressure at two different separately adjustable levels (i.e., b
each breathing cycle, providing independent pressures during inhalation and exhalation while the pat
spontaneous breathing. These units are used to assist spontaneous respiratory efforts and supplemen
patient inspires into the lungs. Some bi-level units additionally include a time back-up feature (known
or S/T) to ensure that the appropriate amount of air is provided when it detects that a patient has sto
breathing. Bi-level PAP units are intended to provide noninvasive (i.e., through a nasal or oronasal mas
lipseal) positive pressure breathing assistance therapy; they are frequently used in patients suffering
thoracic disorders (e.g., muscular dystrophy, amyotrophic lateral sclerosis), severe chronic obstructive
(COPD), central sleep apnea, or obstructive sleep apnea (OSA). They are not intended for continuous b

Devices designed to apply positive airway pressure only during expiration; sub-atmospheric pressures
inspiration. Expiratory positive airway pressure (EPAP) units typically consist of a pressurized circuit in
valve that allows gas to enter the airway on inspiration and directs exhaled gas through a threshold re
underwater seals or weighted balls. A threshold resistor is a device that exerts a predictable, quantifia
at the expiratory limb, creating a threshold pressure (typically of 5 to 20 cm of H20) that must be exce
thorough the valve. EPAP units do not require a high-flow gas source. These units are intended to prov
positive pressure breathing assistance therapy through a mask (either nasal or oronasal), a mouthpiec
treat central sleep or obstructive apnea disorders. They are not intended for continuous breathing sup
Devices designed to provide positive air pressure to nonintubated patients or to artificial airways, eith
assistance or intermittent positive pressure breathing (IPPB). These devices consist of an electric or m
pneumatic powered unit that provides the positive pressure; they typically include a volume measurin
held spirometer), connecting tubes, controls, adapters, sputum cups, and attachments (e.g., mouthpi
intermittent delivery of gas to the patient. Units are available either for re-use in multiple patients or f
multiple uses. Most units include or may be connected to nebulizers, humidifiers, and to oral or endot
equipment. These units are used for augmenting lung expansion and to deliver aerosol medication. Th
mechanical ventilators in emergency situations but are not intended for continuous breathing support

Ventilators designed for noninvasive support ventilation (e.g., through a mask or mouthpiece) in spon
insufficiently breathing patients, typically in the home care environment. Noninvasive positive pressur
ventilators may use one or more of several positive pressure techniques, including continuous positive
(CPAP), bi-level continuous positive airway pressure (Bi-level PAP), or volume- or pressure-targeted ve
ventilators typically consist of a unit that delivers the positive pressure and a breathing circuit includin
or oronasal) or a mouthpiece for external delivery of the pressurized gas to the patient; they may also
gas source and a manometer. NPPB ventilators are intended for patients suffering from restrictive thor
muscular dystrophy, amyotrophic lateral sclerosis), severe chronic obstructive pulmonary disease (CO
apnea, or obstructive sleep apnea (OSA); they are frequently used only during the night. Some intens
include capabilities that allow their use also for noninvasive ventilation.

Peripheral-nerve electrical stimulators that apply stimuli to the vagus nerve. These stimulators typica
implantable electrical generator and lead wires that run subcutaneously to electrodes implanted aroun
they usually can be programmed externally following implantation. Vagus nerve stimulators are inten
seizures and/or other neurological disorders such as sleep apnea, depression, migraine, and dementia

Detectors designed to discover air bubbles and/or foam in the blood that is returned to the body throu
the extracorporeal blood circuit of an apheresis unit. These devices detect the air bubbles and foam ty
sensors that detect changes in acoustic density. Apheresis unit air bubble/foam detectors usually trigg
automated mechanisms to stop the infusion.
Detectors designed to discover abnormally low or high levels of liquid in medical device reservoirs. Th
detect liquid level using float switches, or photoelectric, capacitive, or ultrasonic (either contact or no
Liquid level detectors are mainly used in extracorporeal perfusion machines used to deliver blood and
solutions into the vascular system (e.g., infusion pumps) and/or to provide temporary either total or p
circulation for therapeutic or other purposes, such as heart-lung bypass, hemodialysis, and apheresis
used also to detect liquid levels in other medical devices.

Detectors that combine the capabilities of bubble, foam, and level detectors; they typically consist of
non-contact ultrasonic sensors. These detectors are intended to detect when blood has abnormally low
there are air bubbles or foam in the blood that is returned to the body through a venipuncture. Air bub
detectors are used mainly in extracorporeal circulation devices such as heart-lung bypass, hemodialys
They usually trigger alarms and activate automated mechanisms to turn off the blood flow when an ab
occurs.
Detectors designed to sense blood leaks in the dialyzer of hemodialysis machines. These detectors ty
devices that sense the presence of hemoglobin in the spent dialysate, usually indicating a leak in the
leaks in the dialyzer not only prevent from blood losses but also the pass of toxins from the dialysate i
leakage detectors are used mainly in the dialysate path or dialyzer of hemodialysis units; they usually
blood pumps, shut arterial and venous clamps, and set ultrafiltration rate to a minimum.

Detectors designed to sense strain in lenses mounted on eyeglasses. These detectors typically include
source and two polarized lenses; the amount of light visible in the lens and the pattern of the light sho
of strain in the lenses. Eyeglass lens strain detectors can determine both excessive strain on the lense
stress has been placed on the lens to keep it from wobbling or being accidentally dislodged from the f
can be used also to verify that the lenses have been appropriately heat-treated for impact resistance.

Detectors designed to evaluate blood flow using transcutaneous, noninvasive methods. These detecto
several techniques, including ultrasound and electromagnetic waves. Blood flow detectors can sense b
outside the skull and thorax (i.e., not blocked by bone or air), determining the extent of peripheral vas
restrictions (e.g., clots, stenosis), but they do not measure any characteristic of the flow. They are use
atherosclerosis, varicose veins, and venous thrombosis and in the diagnosis of the vascular state of th

Esophageal intubation detectors designed to apply vacuum (using either a plunger syringe or a self-in
piece of small caliber tubing introduced into a tracheal tube that has been inserted into the patient's a
are disposable; pediatric models with smaller size are also available. These devices utilize the anatom
the trachea and the esophagus; when the detector bulb or syringe is depressed (i.e., vacuum is applie
the intubation is tracheal, and fails to fill if the intubation is esophageal (the esophagus collapses arou

Detectors designed to identify carious tissue in a tooth. These detectors are based on one of several t
induced light fluorescence (either using a conventional lamp or a laser), electrical resistance, digital ra
reflection of acoustic or laser waves. Dental caries detectors are intended for early identification of ca
caries) and/or to differentiate between carious tissue and tissue that is stained but appropriate to left

Dental caries detectors designed to determine the changes in the fluorescence of teeth enamel and d
loss. These devices consist of a light source (typically a laser) that elicits fluorescence in teeth and a u
altered fluorescence of the infected tooth tissue (i.e., caries). Induced fluorescence dental caries detec
diagnosis of early stage caries and to monitor the progress of tooth caries.

Dental caries detectors designed to determine the changes in electrical impedance as the result of mi
developed in teeth. These devices typically consist of a sensor with an electric conductive strip that is
circulate a small electrical current through it; and a unit which measures the changes in impedance an
an indicator of tooth decay. Electrical resistance dental caries detectors are intended mainly for diagn
caries.

Dental materials designed to aid in the identification of bacterially infected dentin (i.e., caries), so tha
effectively removed. These dental materials consist of staining solutions (i.e., dyes such as propylene
organic matrix of less mineralized dentin to produce visible contrast that will assist the dentist in the r
caries; they do not stain the bacteria. Caries detection dyes are available in a variety of colors; they a
offices.
Voltmeters designed for measuring surface potentials (i.e., voltage) due to electric charge unbalance
conducting surface. These instruments typically determine the presence, magnitude, and polarity of e
Typical electrostatic voltmeters consist of an electronic unit including amplifiers, an oscillator, a power
and an attached non-contact sensing probe (e.g., using a Kelvin vibrating capacitive sensor). There ar
electrostatic voltmeters such as DC- and AC-feedback instruments. Electrostatic voltmeters are usuall
brought near to potentially charged surfaces.

Embolization microspheres designed for occlusion (embolotherapy) of the uterine arteries. The device
resorbable elastic microspheres with a hydrophilic surface; they are manufactured using acrylic polym
gelatin. The microspheres are available in diameters from 40 to 1,200 microns either in sterile vials or
saline solution. They are usually administered using a syringe through a catheter that is introduced in
advanced into the uterine arteries in a fluoroscopic guided procedure. Uterine artery embolization mic
several procedures such as arteriovenous malformations, hypervascular tumors, and ectopic pregnanc
intended for uterine fibroid embolization should be of 500 microns or greater.

Prefilled syringes that contain vascular embolization material (e.g., microspheres) in their barrel. Thes
available with different capacities (e.g., 1, 2, 5 mL); they are filled with similarly sized embolization m
microspheres of 40 to 120, 100 to 300, 700 to 900 microns, etc.) suspended in a sterile solution (e.g.,
syringes are typically used in the treatment of vascular lesions (e.g., arteriovenous malformations) an
pregnancy, and uterine fibroid tumors.

Dictation systems designed for automated digital recording of speech input (e.g., dictation) and transl
information into text output. These systems typically consist of a personal computer (PC), a microphon
with the speech recognition system and the PC sound board, a speaker and/or headphone, a printer, a
software (e.g., general and medical terminology dictionaries and a word processing program). Typical
recognition systems include dictation and editing of clinical findings and related reports, frequently wi
a transcriptionist or need for hard copy. Speech recognition systems equipped with the appropriate so
used as a component of speech therapy/diagnosis interventions.

Image storage plates designed for temporary storage of a latent image after exposure to radiation fro
(radiography) diagnostic unit. These plates typically consist of a thin sheet of a radiolucent material c
a layer of a suspension of long-term storage phosphor. The plates are usually housed in cassettes sim
screen-film systems to facilitate their use and transport and to protect them from environmental light.
plate is typically transferred to a reading device that produces a digital image from the latent image. R
storage plates can be used in computed radiography (digital) systems or as a substitute for conventio

Radiography cassettes designed for holding a plate storing latent images that are captured when the
radiation from an x-ray (radiography) diagnostic unit. These cassettes are typically placed in an x-ray
a component of the radiography unit. After x-ray exposure, the image plate is transferred to a reading
a digital image from the latent image. Radiography image storage plate cassettes are typically used in
radiography (digital) systems or as a substitute for conventional screen-film cassettes.
Image digitization systems designed to acquire and digitize computed mammography images for view
printing. The image digitization system typically consists of an exposure unit with an imaging recepto
and a computer console. The image is acquired on a photostimulatable substance (e.g., a phosphor pl
reads the latent image and converts it into an electrical analog signal using a laser scanner; this signa
amplified and converted to a digital signal, which may be stored and processed by a computer. Compu
mammography image digitization systems are typically installed as upgrades to existing film-based
radiography/mammography systems.

X-ray detectors designed to be placed temporarily in the mouth (i.e., intraoral) to sense the absorption
radiation from a dental radiographic unit. The detector acquires the data and then transmits it to a co
workstation. These detectors typically consist of a small device including an x-ray-sensitive sensor, alo
digital converter and means for connection to the workstation. Intraoral x-ray detectors are typically u
conventional intraoral films used in dental radiography; the systems including the intraoral detector a
workstation process the information as digital data.

Image digitization systems designed to acquire and digitize dental (typically intraoral) x-ray images fo
printing. The digital imaging system typically consists of an imaging receptor (e.g., a packet with an i
reader, and a control console. The image is acquired on a photostimulable substance (e.g., a phospho
reader/digitizer then reads the latent image and converts it into an electrical analog signal using a las
is then amplified and converted to a digital signal, which is stored and processed by a computer. Dent
radiography image digitization systems are typically installed as an upgrade to film-based dental radio

Component devices ("modules") designed to be used with physiologic monitors and related devices to
display, monitor, record/store, and in some cases analyze information related to one or more physiolo
reflecting a patient's clinical condition. These modules contain electronic circuits or other technology d
and/or process the signal from one or more physiologic sensors (e.g., electrodes, catheters, probes, pr
sets) and transmit it to the physiologic monitor, which contains the software designed to support the m
function(s). Physiologic monitor modules are designed to be inserted in a dedicated location (e.g., "slo
monitor (e.g., modular or modular/configured bedside or transport monitor) or related device (e.g., mo
externally connected via cables/leads to the appropriate sensors (e.g., electrodes, catheters, probes, t
attached to or inserted in the patient. Physiologic monitor modules, when used as part of a patient mo
users to change or add monitored parameters for an individual patient without having to employ othe
the monitoring of other parameters

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of continuously monitoring the electrical activity of the heart and
electrocardiogram (ECG). These modules contain electronic circuits or other technology designed to a
the signal from one or more physiologic sensors (e.g., electrodes) and transmit it to the physiologic m
the software designed to support the module's intended function(s). Electrocardiography modules mu
dedicated location (e.g., "slot") within a physiologic monitor (e.g., modular or modular/configured bed
monitor) or related device (e.g., module rack) in order to support the desired function(s). Typical funct
electrocardiography module, when used with a physiologic monitor, include continuous 3-, 5-, and/or 6
heart rate numeric and ECG waveform(s) display; arrhythmia detection; ST-segment analysis; and app
visual/audible alarms. Some modules provide additional functions, such as 12-lead ECG monitoring an
interpretation.
Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purposes of intermittently measuring and/or continuously monitoring inva
arterial blood pressure, intracranial pressure, central venous pressure, pulmonary artery pressure). Th
electronic circuits or other technology designed to acquire and/or process the signal from one or more
(e.g., electrodes, catheter/pressure transducer sets) and transmit it to the physiologic monitor, which
designed to support the module's intended function(s). Invasive pressure modules must be inserted in
(e.g., "slot") within a physiologic monitor (e.g., modular or modular/configured bedside or transport m
device (e.g., a module rack) in order to support the desired function(s). Typical functions of an invasiv
when used with a physiologic monitor, include continuous monitoring of arterial blood (systolic, diasto
pressure, central venous pressure, pulmonary artery (systolic, diastolic, and mean) and capillary wedg
intracranial and cerebral perfusion pressures. Various waveform and alphanumeric displays, along wit
are typically supported. Some modules may provide additional hemodynamic monitoring functions or
other invasive pressures, such as intra-abdominal pressure, when used with the appropropriate senso
devices.

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of intermittently monitoring systemic blood pressure (systolic, dia
noninvasive methods. These modules contain electronic circuits or other technology designed to acqu
signal from a transducer located inside tubing attached to a pneumatic cuff wrapped around the patie
transducer detects blood pressure fluctuations (oscillometric method) and transmits this information t
monitor, which contains the software designed to support the module's intended function(s). Noninvas
monitor modules must be inserted in a dedicated location (e.g., "slot") within a physiologic monitor (e
modular/configured bedside or transport monitor) or related device (e.g., module rack) in order to sup
function(s). Typical functions of a noninvasive blood pressure module, when used with a physiologic m
intermittent measurement and display of systolic, diastolic, and mean systemic blood pressure, along
initiation of visual/audible alarms; typically, the module also allows the clinician to configure/change t
settings (e.g., automatic/manual measurement, measurement time intervals).

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purposes of intermittently measuring and/or continuously monitoring card
of blood pumped out by the ventricles in a given period of time). These modules contain electronic cir
technology designed to acquire and/or process a signal from one or more physiologic sensors (e.g., ca
transducer sets) and transmit it to the physiologic monitor, which contains software to support the mo
function. Cardiac output modules must be inserted in a dedicated location (e.g., "slot") within a physio
modular or modular/configured bedside or transport monitor) or related device (e.g., module rack) in o
desired function. Typical functions of a cardiac output module, when used with a physiologic monitor,
measurement and/or calculation and display of the cardiac output curve(s), cardiac output index, bloo
volume, and systemic vascular resistance. Some modules may provide continuous cardiac output mon
additional intermittent or continuous hemodynamic monitoring features, or other functions, such as m
oxygen saturation.
Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purposes of continuously monitoring the respiratory rate and detecting the
breathing (apnea). These modules contain electronic circuits or other technology designed to acquire
(e.g., changes in electric impedance of the thoracic cavity or other physical variations) from one or mo
(e.g., electrodes, thermistors) and transmit it to the physiologic monitor, which contains the software
the module's intended function(s). Respiratory rate/apnea modules must be inserted in a dedicated lo
within a physiologic monitor (e.g., modular or modular/configured bedside or transport monitor) or rel
module rack) in order to support the desired function(s). Typical functions of a respiratory rate/apnea m
with a physiologic monitor, include continuous monitoring of respiratory rate, display of the respirator
numeric rate value, detection of apnea, and appropriate initiation of visual/audible alarms.

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of intermittently or continuously monitoring the partial pressure o
exhaled breath. These modules contain electronic circuits or other technology designed to acquire and
from one or more physiologic sensors and transmit it to the physiologic monitor, which contains the so
support the module's intended function(s). Carbon dioxide monitor modules must be inserted in a ded
"slot") within a physiologic monitor (e.g., modular or modular/configured bedside or transport monitor
(e.g., module rack) in order to support the desired function(s). There are several methods for monitori
carbon dioxide in an exhaled breath, including mainstream sampling, which uses a sensor placed dire
circuit or nasal/oral airway cannula, or sidestream sampling, which uses a sensor placed in a remote s
to the breathing circuit or nasal/oral airway cannula; one module may offer a combination of methods
single method. Typical functions of exhaled carbon dioxide monitor modules, when used with a physio
display of waveform(s) and numeric values for the concentration of carbon dioxide in an exhaled brea
carbon dioxide concentration) and appropriate initiation of audible/visual alarms.

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of intermittently or continuously monitoring the fraction of inspire
modules contain electronic circuits or other technology designed to acquire and/or process the signal
physiologic sensors (e.g., a galvanic cell whose voltage changes with the oxygen concentration a pola
current changes with the oxygen concentration) and transmit it to the physiologic monitor, which cont
designed to support the module's intended function(s). Inspired oxygen monitor modules must be inse
location (e.g., "slot") within a physiologic monitor (e.g., modular or modular/configured bedside or tran
related device (e.g., module rack) in order to support the desired function(s). Typical functions of an in
module, when used with a physiologic monitor, include display of waveform(s) and numeric/trends for
and appropriate initiation of visual/audible alarms.
Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purposes of continuously and, in some cases, simultaneously monitoring t
anesthetic gases such as nitrous oxide, halothane, enflurane, sevoflurane, desflurane, and isoflurane v
some modules can also process information on the inspired and expired concentrations of several resp
carbon dioxide) gases and related physiologic parameters. These modules contain electronic circuits o
designed to acquire/process the signal from a set of sensors (e.g., infrared light spectrometry probes)
physiologic monitor, which contains the software designed to support the module's intended function(
monitoring modules must be inserted in a dedicated location (e.g., "slot") within a physiologic monitor
modular/configured monitor) or related device (e.g., module rack) in order to support the desired func
can also be used with dedicated anesthesia units. Typical functions of an anesthetic gas monitor modu
physiologic monitor or anesthesia unit, include display of waveforms and numeric/trends for anestheti
(and in some cases, related physiologic parameters) and appropriate initiation of visual/audible alarm

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of continuously monitoring the temperature of the internal region
temperature) and/or the skin and subcutaneous regions (shell temperature). These modules contain e
other technology designed to acquire and/or process a signal from one or more physiologic sensors (e
and transmit it to the physiologic monitor, which contains the software designed to support the modul
function(s). Temperature monitor modules must be inserted in a dedicated location (e.g., "slot") within
(e.g., modular or modular/configured bedside or transport monitor) or related device (e.g., module rac
the desired function(s). Typically, temperature measurements/changes can be monitored on a range o
rectal, nasal, esophageal, arterial, and venous sites; module functions include display of numeric valu
temperature readings in Celsius or Fahrenheit and appropriate initiation of visual/audible alarms.

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of continuously, noninvasively monitoring the partial pressure (co
dioxide (tcpCO2) and/or oxygen (tcpO2) in the blood through skin-surface (i.e., transcutaneous) measu
tcpCO2/tcpO2 measurements correlate with arterial partial pressure, providing a noninvasive means o
monitoring blood gas. These modules contain electronic circuits or other technology designed to acqu
signal from two separate sensors or a combined tcpCO2/tcpO2 sensor applied to the patient's skin and
the physiologic monitor, which contains software to support the module's intended function. Transcuta
monitor modules must be inserted in a dedicated location (e.g., "slot") within a physiologic monitor (e
modular/configured bedside or transport monitor) or related device (e.g., module rack) in order to sup
function. Typical functions of a transcutaneous blood gas monitor module, when used with a physiolog
display of waveforms and numeric/trends for tcpCO2 and/or tcpO2 and appropriate initiation of visual/
modules also support measurement and display of information related to the pH of the blood. Transcu
monitor modules are typically used in the neonatal intensive care unit.
Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of continuously, noninvasively monitoring the percent of oxygen s
hemoglobin in arterial blood; oxygen saturation values indicate whether the patient's blood is carrying
These modules contain electronic circuits or other technology designed to acquire and/or process a sig
physiologic sensors (e.g., probes) and transmit it to the physiologic monitor, which contains the softwa
the module's intended function(s). Pulse oximetry probes typically have red and infrared light sources
through a pulsating arterial bed (e.g., in the patient's fingertip or earlobe), along with photodetectors
that passes through the arterial bed. Oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin
absorb the two wavelengths of light differently. Based on the relative absorption of the wavelengths, t
module determines the relative amount of O2Hb and HHb in the blood and calculates and displays the
oximetry monitor modules must be inserted in a dedicated location (e.g., "slot") within a physiologic m
or modular/configured bedside or transport monitor) or related device (e.g., module rack) in order to s
function(s). Typical functions include display of numeric values/trends for SpO2, display of the plethys
and appropriate initiation of visual/audible alarms. Many modules also allow for monitoring and displa
rate (e.g., with a numeric value in beats per minute).

Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of continuously monitoring mixed venous oxygen saturation level
saturation level is a measure of the oxygen delivered minus the oxygen consumed; clinically significan
saturation changes can be used as an early indicator of physiologic instability. These modules contain
other technology designed to acquire and/or process a signal from one or more physiologic sensors (e
catheter/transducer sets) and transmit it to the physiologic monitor, which contains the software desig
module's intended function(s). Intravascular oximetry monitor modules must be inserted in a dedicate
within a physiologic monitor (e.g., modular or modular/configured bedside or transport monitor) or rel
module rack) in order to support the desired function(s). Typical functions include display of numeric v
venous oxygen saturation level and appropriate initiation of visual/audible alarms. Many modules also
oxygen saturation level along with the oxygen saturation of hemoglobin in arterial blood and display r
plethysmogram waveforms, numeric values).
Modules designed to be used as a component of a physiologic monitor, along with related devices, to
process information for the purpose of continuously monitoring electrical signals generated by the bra
electroencephalogram (EEG). These modules contain electronic circuits or other technology designed
process a signal from one or more physiologic sensors (e.g., electrodes) and transmit it to the physiolo
contains the software designed to support the module's intended function(s). Electroencephalography
be inserted in a dedicated location (e.g., "slot") within a physiologic monitor (e.g., modular or modular
transport monitor) or related device (e.g., module rack) in order to support the desired function(s). Typ
measurements/trends are monitored via electrodes placed on a patient's scalp and/or forehead; intrac
epidural) and nasopharyngeal sites are sometimes used. Electroencephalography module functions in
numeric values/trends for EEG measurements and associated waveforms and appropriate initiation of
Electroencephalography modules may support a variety of signal-processing and display techniques (
spectral array, density spectral array, bispectral analysis), depending on the application (e.g., monitor
patients, level-of-consciousness monitoring of anesthetized patients). An example of a specialized tec
consciousness monitoring is bispectral analysis, a signal-processing technique that quantifies the deg
between the sinusoidal components of the EEG signal and produces an index from EEG data to correla
awareness of anesthetized patients.

Component devices ("modules") designed to be used with physiologic monitors and related devices to
display, monitor, record/store, and in some cases analyze information related to two or more physiolog
reflecting a patient's clinical condition. These modules contain electronic circuits or other technology d
and/or process the signal from one or more physiologic sensors (e.g., electrodes, catheters, probes, pr
sets) and transmit it to the physiologic monitor, which contains the software designed to support the m
function(s). Physiologic monitor modules are designed to be inserted in a dedicated location (e.g., "sl
physiologic monitor (e.g., modular or modular/configured bedside or transport monitor) or related dev
and externally connected via cables/leads to the appropriate sensors (e.g., electrodes, catheters, prob
attached to or inserted in the patient. Physiologic monitor modules, when used as part of a patient mo
users to change or add monitored parameters for an individual patient without having to employ othe
the monitoring of other parameters. Examples of multiparameter modules include modules that comb
and, electrocardiogram, respiratory rate, and noninvasive blood pressure monitoring; modules that ar
several invasive pressure parameters (e.g., pulmonary artery pressure, central venous pressure, intra
modules that are designed to monitor several parameters commonly used when monitoring patients u

Cassettes designed for holding a radiographic image receptor (e.g., an x-ray film, a phosphor image s
exposure to radiation by an x-ray (radiography) diagnostic unit. The cassettes are usually placed in an
in the radiography unit. These devices typically consist of a metal or plastic housing with appropriate
transportation of the film or image plate and to protect the cassette and its contents from environmen
cassettes are typically available for use with radiography film units/systems or with computed radiogr
Radiography cassettes designed for holding a plate storing latent images that are captured when the
radiation from a mammography unit; typically, they are designed to be placed in an x-ray cassette ho
mammography unit. These cassettes are typically available in the size and configuration needed for c
mammography units. After x-ray exposure, the image plate is transferred to a reading device that pro
from the latent image. Image storage plate cassettes are typically used as a substitute for convention
cassettes.

Dedicated plates designed for temporary storage of latent images. These devices typically consist of a
translucent plastic material covered with an excitable compound (e.g., storage phosphor) used for sto
following exposure of the material to some type of radiation (e.g., x-ray, light). After exposure, the pla
reading devices that retrieve the information from the latent image and convert it to a digital signal.

Radiography image storage plates including an x-ray-sensitive component (e.g., phosphor) that are de
storage of a latent image after exposure to radiation from a mammography diagnostic unit. The plates
to provide the definition needed for breast imaging and are sized to fit in cassettes designed to facilita
transport and to protect them from environmental light. After exposure, the plate is transferred to a re
produces a digital image from the latent image. Mammography image storage plates are typically use
conventional mammography films.

X-ray detectors designed to sense the absorption pattern of x-ray radiation from a diagnostic radiogra
send this information to a computerized workstation. These detectors typically consist of a device incl
sensitive sensor, along with an analog-to-digital signal converter and means for connection to a radiog
Digital radiography detectors can be used as a substitute for conventional films used in radiography; t
the detector and the computerized workstation are designed to process the information as digital data

X-Ray detectors designed to sense the absorption pattern of x-ray radiation from a diagnostic mammo
transmit these data to a computerized workstation. These detectors typically consist of a device inclu
sensor (e.g., a charge coupled device or CCD, amorphous silicon), an analog-to-digital signal converte
a mammography workstation. Digital mammography detectors designed for full-field mammography c
screening as a substitute to conventional film based systems.

Digital radiography systems designed with an incorporated table component to support imaging imag
they are lying in horizontal position. These systems typically consist of an x-ray generator; a table wit
for computed systems or an electronic detector for direct digital systems and attached accessories (e.
clamps); an operator console; a plate reader (for computed systems); and a workstation with a monito
devices to process the digital data and image. Table digital radiography systems are typically used for
examinations, as well as specific examinations of the skull, respiratory organs, and the skeletal system

Image plate reader/digitizers designed to read a latent image that has been captured on a radiograph
an x-ray energy storage phosphor plate), usually by scanning the plate with a laser beam, and then co
digital format. These devices typically consist of a laser, a light guide, a photomultiplier tube to produ
signal from the image plate, and an analog to digital signal converter designed to digitize the image in
plate readers are available for single (either portable or stationary) plate reading or multiple plate rea
information is usually transmitted automatically to the workstation of a digital imaging system for pro
and/or display.
Image plate reader/digitizers designed to read the latent image on a mammography image plate (typi
storage phosphor plate), usually by scanning the plate with a laser beam, and then convert the signal
These devices typically consist of a laser, a light guide, a photomultiplier tube to produce an analog e
image plate, and an analog to digital signal converter designed to digitize the image information. The
usually transmitted automatically to the workstation of a digital imaging system for processing, storag

Workstations designed to process digital data and images acquired by radiography units and systems.
typically obtain the digital radiography data directly from the digital radiography systems or through d
radiography films or image plates. Digital radiography workstations typically consist of a high-speed d
optical/magnetic disks, input and output devices, and processors; they usually follow the instructions
for radiographic image processing. Digital radiography workstations are frequently installed as a comp
with radiography and/or hospital information systems (e.g., radiology information systems).

Digital radiography workstations designed to process digital data and images acquired by dental radio
systems. These workstations typically obtain the data directly from digital dental radiographic system
scans of radiography films or image plates. Dental radiography workstations typically consist of a high
computer, optical/magnetic disks, input and output devices, and processors; a workstation usually foll
specialized software for dental image processing.

Digital radiography workstations designed to process digital data and images acquired by mammogra
These workstations typically obtain the data directly from digital mammographic systems or through d
radiographic films or image plates. Digital mammography workstations typically consist of a high-spee
optical/magnetic disks, input and output devices, and processors; they usually follow the instructions
for mammography image processing. The workstations are frequently installed as a component of or i
radiography (e.g., radiology information systems) and/or hospital information systems.

Workstations designed to process digital data and images acquired by radiotherapy and/or radiothera
These workstations typically obtain the information directly from the radiotherapy units and/or system
accelerators, automated brachytherapy systems). Radiotherapy workstations typically consist of a hig
computer, high-definition printers, optical/magnetic disks, input and output devices, and processors; t
instructions of specialized software for radiotherapy image processing. The workstations are frequentl
component of or interact with radiotherapy and/or hospital information systems, including picture arch
communication systems.
Oncology data management information systems designed to record, process, and display clinical and
information related to radiotherapy treatment delivery, simulation, and planning, providing quality con
during the procedures. These systems typically consist of computerized workstations with appropriate
radiotherapy delivery systems (e.g., linear accelerators) and/or radiotherapy simulation systems; the
system workstations usually include a computer, high-resolution color monitors, and a printer. The sys
dedicated workstations for administrative and data management functions (e.g., patient registration,
summary reports). Radiotherapy information systems can be used to verify treatment setup paramete
record treatment delivery, and manage patient and treatment data; the systems include warnings and
prevent errors in treatment delivery. The software for the station includes capabilities such as automa
simulated treatment fields, recall of patient treatment simulations, and review of port films and data o
radiation dose. Radiotherapy information systems are used mainly to manage and document treatme
related diseases; they may function as stand-alone systems or may be integrated into an oncology da
system network.

Devices designed to deposit small and accurate volumes (e.g., picoliters) of chemicals (typically nucle
fragments, such as oligonucleotides) in predetermined spots of prepared surfaces (e.g., glass slides, n
obtain molecular assay microarrays. These devices may consist of either equipment that uses spotting
chemicals from microtiter plates to the solid substrates (including ink-jet printers) or dedicated equipm
oligonucleotides in situ using well-developed photolithographic technologies. Microarray arrayers are a
and/or custom production of molecular assay microarrays for research and/or clinical use.

Molecular diagnostic laboratory analyzers designed to use nucleic acid diagnostic techniques to identi
specific molecules belonging or related to microorganisms (e.g., bacteria, viruses, fungi) that infect hu
perform appropriate sequential cycles of incubation, replication (amplification), washing, and detectio
thermal cycle (e.g., polymerase chain reaction), but others use an isothermal process. Infectious disea
diagnostic laboratory analyzers are used in the detection of bacteria (e.g., Chlamydia trachomatis, Ne
mycobacteria (e.g., Mycobacterium tuberculosis), and viruses (e.g., human immunodeficiency, hepatit

Molecular assay laboratory analyzers designed to identify mutations within a gene or chromosome alt
analyzers typically perform some or all of the processes of separation, hybridization genetic diseases
phase), replication (e.g., polymerase chain reaction), and detection; they use a fragment of nucleic ac
a variety of reporter groups (i.e., a nucleic acid probe) and appropriate reagents. Genetic analyzers ar
of inherited genetic diseases (e.g., cystic fibrosis, hemophilia) or acquired genetic diseases (e.g., neop
chromosomal disorders (e.g., Down syndrome) and for detection of single nucleotide polymorphisms;
human leukocyte antigen typing to test histocompatibility before transplants and for forensic and pate
Molecular assay analyzers designed for data acquisition, display, and analysis from either wet or dry s
typically based on a glass or silicon substrate or less frequently on nylon membranes, mirrored slides,
These analyzers typically include a microarray scanner (i.e., reader/digitizer), a dedicated configured c
display, printing and recording capabilities, and appropriate software to process the information. Micro
used to process information and provide useful results (e.g., for characterization, diagnostic, and/or tr
microarrays that include spotted molecular samples of cDNA, oligonucleotide, protein, and/or tissues.
characterize the expression of many genes in a single experiment, permitting the genetic characteriza
acids and their variations due to inherited or acquired diseases (e.g., tumor cells). Microarray analyzer
partial or total genomic characteristics of pathologic microorganisms (e.g., bacteria, virus, fungus).

Readers designed for determining the fluorescence spot intensities of a two-dimensional array of dots
microarray (i.e., a biochip), usually on the standard microscopic slide format. They typically consist of
includes an either confocal or non-confocal laser scanning microscope (using at least two different wa
excitation, and an image detection unit (e.g., charged coupled devices, photo-multiplier tube) for sign
emitted from the dyes is passed through a series of filters, mirrors, and lenses; the light is then conve
signal and digitized. Some devices include software appropriate for processing the information using a
computer with an appropriate display; they may also include automated loading accessories to read b
include patient, sample, and processing information. Microarray readers are used to obtain informatio
oligonucleotide, protein, SNP, and other types of microarrays used in molecular assays.

Laboratory incubators designed to provide the heating and/or cooling sequences required for DNA hyb
using microarrays. These incubators typically include a removable, frequently rotating rack with variou
a wide temperature control range (e.g., 5 to 90 degrees Celcius). Some incubators include racks that s
chambers designed to encase the microarrays in an air- or watertight environment.

Chambers designed to hold and encase microarray slides, providing a constant humidity environment
procedures performed in either hybridization incubators or less frequently in water baths. These devic
reusable metallic (e.g., stainless steel) or plastic chamber with capacity for one or more slides (e.g., 1
include a chamber top and a chamber bottom; the chamber also may include single-use consumables
septa, and gaskets (e.g., O-rings). Microarray hybridization chambers are available for use in hybridiza
(airtight) or in water baths (water-tight).

Automated equipment designed to process high-molecular-weight nucleotide polymers (i.e., nucleic a


characteristic components of which are DNA and RNA. These processors can perform one or more of a
processes on nucleic acids, such as purifying nucleic acids (e.g., DNA, RNA, mRNA), the samples of wh
obtained from body fluid specimens; combining the building block base pairs in a "cocktail mix" to ma
synthesizing); recombining two complementary strands (i.e., hybridization); increasing the number of
repetitive cycles (replication or amplification, such as polymerase chain reaction); and determining th
pairs in the amplified chain (i.e., sequencing).
Nucleic acid processors designed for the automated determination of the precise sequence of the bas
thymine, cytosine, and guanine for DNA) in a sample of nucleic acid. These devices typically process s
molecules (labeled with multiple fluorescent dyes) that are loaded onto a gel. Usually, the samples are
using capillary electrophoresis; samples are illuminated and detected using a scanning laser beam, an
processed using computer analysis. Electrophoretic separation can be displayed in real time; the sequ
the whole sample (e.g., read lengths as long as several hundred base pairs) is printed after computeri

Nucleic acid replication processors that perform nucleic amplification following a process typically ada
replication scheme of retroviruses. These replicators perform all reactions at the same temperature, c
the reactant to allow for accumulation of the nucleic acid product (DNA or RNA).

Nucleic acid replication processors that perform nucleic amplification (replication) following a thermal
commonly used procedure is polymerase chain reaction, which is performed in a vial containing the te
DNA or RNA to be copied) and two primer molecules to start the copying process. The primers are sho
different chemical components that make up any strand of genetic material. In the first part of the pro
chains in the double helix are separated at about 90 degrees Celcius (C) (195 degrees Farenheit (F)). T
degrees C (131 degrees F) to bind (anneal) the primers to the end of the DNA strands. In the final step
complete copy of the templates is made at around 75 degrees C (158 degrees F). The three steps take
minutes. At the end of the cycle, each piece of DNA in the vial has been duplicated. Repeating the pro
may yield more than one billion copies.

Nucleic acid processors designed for combining the building block base pairs of nucleic acids (e.g., arg
cytosine, and guanine for DNA) in a "cocktail" mix to make a complete chain. These devices typically
following a cycle that includes the addition of nucleosides in solution to nucleosides immobilized on a
an internucleotide linkage. This cycle is conducted until the chain is completed; then, the crude nucle
the support, purified, and quantified. Synthesis nucleic acid processors include a chemical processing
computerized system with appropriate software.

Automated equipment designed to process the amino acids in a protein or peptide sample. These proc
one or more of a variety of processes on proteins and/or peptides such as determining the order of the
sample (i.e., sequencing) and putting protected amino acids together to form proteins or peptides (i.e
Dedicated devices are available for sequencing and synthesizing proteins and/or peptides.

Protein/peptide processors designed for automated: determination of the precise sequence of the ami
that make up a protein or peptide. These instruments typically include a chemical module to perform
chemical degradation of the protein; a module for phenylthiohydantoin (PTH) identification; and a com
setting and control of sequencing runs and collect the resulting data using specialized software.
Protein/peptide processors designed for automated synthesis of peptides and/or proteins from protect
instruments typically perform a three-step cyclic process that includes removing the protecting group
at the end of the peptide chain (deprotection), converting the next amino acid to be added to an activ
and forming an amide bond between the active ester and the deprotected alpha-amino group (couplin
complete, the synthesized peptide is removed. These processors frequently perform synthesis in reag
the instrument and peptide synthesis columns that include solid resins; the processors also include co
with appropriate software.

Small solid plates (e.g., glass, silicon, nylon) on which densely packed samples (up to one million or m
microarray) of known sequences of nucleic acid nucleotides (e.g., DNA fragments known as oligonucle
predetermined array are either synthesized using photolithographic procedures or deposited using pin
(e.g., with ink-jet printers). Typically, the microarray is washed with a labeled (e.g., fluorescent) sampl
sequence. The immobilized microarray spots mate with the sample sequences according to their comp
resulting fluorescence pattern permits the identification of the sample sequence using an appropriate
and/or data processing using a molecular array analyzer. Dedicated molecular microarrays are used fo
to detect variations in gene copies, and to detect gene mutations/polymorphisms.

Microarrays designed to determine the level (i.e., volume) at which a certain gene is expressed. The p
microarray spots typically consist of immobilized complementary DNA (cDNA) nucleotides (e.g., DNA f
oligonucleotides) derived from the messenger RNA (mRNA) of known genes (or proteins that are overe
only with certain disease states). DNA-labeled samples from normal and diseased tissues are hybridize
intensity of the fluorescence on different spots generates an expression pattern that can be compared
pattern of a known disease. Expression analysis molecular microarrays can be used in the identificatio
specific diseases, to follow the progress of diseases (e.g., cancer tumors), and in evaluation of drug eff

Microarrays designed to detect genomic gains or losses or changes in the number of copies of a partic
with a disease. The packet samples on the microarray spots consist of large immobilized pieces of DN
chromosomal location for each spot. DNA-labeled samples from normal and diseased tissues are hybri
expression pattern with more bright spots indicates that the number of genes involved in the disease
Expression pattern comparative genomic molecular microarrays can be used to determine the extent
progress of particular diseases (e.g., cancer tumors).

Microarrays designed to detect mutations or polymorphisms in a gene sequence. The packet samples
spots typically consist of immobilized DNA from a single gene; the sequence placed on any given spot
differs from that on other spots by only one or a few specific nucleotides. A sequence that is frequentl
single genetic variations that can occur within a human DNA sequence, known as single nucleotide po
Samples of labeled DNA from a person's normal tissue are hybridized to the array; the sample DNA wi
greater frequency to SNPs particular to that person. If the sample SNP pattern is coincident to the kno
disease, the person has, or is at risk of having, the disease. Mutation/polymorphism molecular microa
screen for inherited or acquired genetic susceptibility to a particular illness and/or other genetic chara
metabolism).
Polymorphism detection microarrays designed to detect genetic variations in the genes 2D6 and 2C19
P450 pathway when used with a molecular assay analyzer. These microarrays can typically detect 29
in the CYP2D6 gene, including gene duplication and deletion, resulting in the identification of 33 uniqu
also permit the detection of two major polymorphisms in gene CYP2C19. These tests are used to chara
phenotype, permitting a classification of the patient metabolic characteristics (e.g., poor, intermediate
metabolizers).

Laboratory analyzers designed to perform tests using clinical chemistry or immunoassay techniques. T
examine samples of either compounds or mixtures to determine the nature or the proportion of their c
separate them in their constituent substances by means of chemical reagents (e.g., clinical chemistry
and quantify specific substances using an antibody (e.g., immunoglobulin) as a reagent to detect the
antigen, hapten) of interest (i.e., immunoassay). Combined clinical chemistry/immunoassay analyzers
determination of the concentration of metabolites, electrolytes, proteins, and drugs in body fluids (e.g
urine, cerebrospinal fluid); they are also used for endocrine hormone testing and protein, viral, or bact
determinations.

Transcutaneous electrical stimulators designed to provide pain relief and biophysical stimulation to the
typically consist of an external electrical stimulator and electrodes placed on the skin for transcutaneo
predetermined electrical stimuli (usually in the form of pulses) directly to the affected articulation. De
electrical stimulators intended for knee stimulation (usually the most affected joint) that include a bat
stimulator; electrode pads to be placed on the knee and thigh, respectively; and an elastic strap to be
knee to hold the electrodes in place are available; they are intended to relieve the pain associated wit

Leads designed to conduct electrical pacing signals from the pulse generating unit of an implantable c
the heart and conduct the bioelectric cardiac signals back to the unit. These leads typically consist of
completely isolated except at the electrode tip that makes contact with the heart. Implantable cardiac
be directly attached to the myocardial tissue using open surgery (i.e., epicardial leads) or threaded int
the vascular system; the other end of the leads is attached to the pulse generator implanted in the ab
variety of lead systems, including single and multiple lead, subcutaneous array, and patch is available
type, and other characteristics of the leads must be compatible with the pulse generator and the ther

Electrothermal cautery units designed to coagulate and/or destroy tissue by applying an electric curre
element to perform angioplasty through a catheter that is percutaneously inserted into the blood vess
These units typically consist of a power source (e.g., radiofrequency or microwave generator) that del
current, appropriate controls, a catheter, and appropriate connectors and/or adapters to attach the ca
Electrothermal cautery units do not deliver electric current to the tissues; the high-resistance tip beco
electric current is passed through it. The unit usually controls temperature and energy delivery autom
electrothermal cautery units can be used to eliminate areas of narrowing in blood vessels by performi
compression and ablation of atheromatous plaque; they are used mainly to open total occlusions or hi
peripheral arteries.
Electrothermal cautery units designed to coagulate and/or destroy tissue by applying an electric curre
element through a catheter. These units typically consist of power source (e.g., radiofrequency or mic
delivers the electric current, appropriate controls, one or more dedicated catheters, and appropriate c
adapters to attach the catheter to the unit. The unit usually controls temperature and energy delivery
catheter is percutaneously inserted into vessels (e.g., arteries) and/or naturally or surgically created c
electrocautery. Dedicated transcatheter electrothermal cautery units are used in specialized procedur
and intradiscal electrothermal annuloplasty.

Electrothermal cautery units designed to perform annuloplasty by applying heat (usually up to 90 deg
F]) through a catheter that is percutaneously inserted into an intervertebral disc wall. Electrothermal c
deliver electric current to the tissue; the high-resistance tip becomes heated when an electric current
These units typically consist of a power source (e.g., radiofrequency generator), a catheter that includ
heating element at the tip, and appropriate connectors and/or adapters to attach the catheter to the u
transcatheter units usually monitor temperature and impedance and automatically control energy del
intended for thermal contraction and thickening of collagen and for coagulation of nerve endings in th
procedure known as intradiscal electrothermal therapy or intradiscal electrothermal annuloplasty). Th
outpatient procedures to treat chronic, long-term discogenic pain.

Spinal catheters designed for introduction into an intervertebral disc to perform thermal cauterization
electric current to the tissues. These catheters consist of a flexible wire (typically 30 cm long) with a 5
heating element at the tip and a thermocouple to monitor the temperature. The catheter is passed thr
previously inserted percutaneously in the disc, and is then maneuvered around the outer edge of the
disc. Power is supplied to the catheter from an electrical (e.g., radiofrequency) generator in an electro
specially designed for use with the catheter. Electrothermal cautery intervertebral disc catheters are u
procedures to treat chronic, long-term discogenic pain.

Spinal catheters designed for introduction into an intervertebral disk to perform ablation by delivering
current through the tissues. These catheters include a needle electrode at the distal tip to deliver the
electrode located externally on the patient's skin (i.e., monopolar systems). The catheter is usually int
hollow needle previously inserted percutaneously in the disc and is then maneuvered around the oute
nucleus of the disc. Power is supplied to the catheter from an RF generator that includes connectors a
specially designed for use with the catheter. RF ablation intervertebral disc catheters are used in outp
treat chronic, long-term discogenic pain.

Probes designed to apply heat to a body part, either directly to the surface of a tissue or an organ or i
do not deliver electrical current to tissue. These probes typically consist of a high-resistance element
to a handle that is electrically connected to an electric power-supply unit (a generator) through a cord
an electrical current delivered by the generator; the heat transferred from the tip of the probe by cond
coagulates the tissue depending on the type of probe used. Two main types of electrothermal cautery
which the heating component is uncovered (these are typically used for cutting and/or coagulation) an
heating wire is coated with a nonstick covering (these are used mainly for coagulation and/or control o
probes include an internal irrigation system and/or temperature sensors.
Electrothermal cautery probes in which the heating component (e.g., a high-resistance wire) is encase
They do not deliver electrical current to tissue. The cover is usually made of a nonstick material to fac
and prevent it from pulling away coagulated tissue when retracted. Covered electrocautery probes are
coagulation and/or control of bleeding during minor surgical procedures.

Covered electrothermal cautery probes that have irrigation capabilities. These probes have conducts t
and nozzles at their tips. They clean and/or cool the operation field while coagulating and/or controllin
minor surgical procedures.
Electrothermal cautery probes in which the heating component (e.g., a high-resistance wire) is formed
shape and left exposed to contact the tissue directly. They do not deliver electrical current to tissue. U
electrocautery probes are used mainly for cutting and/or coagulation during surgical procedures. In so
the heating element is attached to a scalpel blade, making them hemostatic scalpels.

Devices designed to provide electrical energy at one or more frequencies in the range between 10 kH
radiofrequency [RF]); RF generators used in clinical applications usually provide output energy at seve
waveforms in a frequency range of 10 kHz to less than 100 MHz. These devices typically consist of ele
convert the input energy either from the power line (typically at 50 or 60 Hz) or, less frequently, from
signal; the generators are typically an integral part of specialized equipment. Dedicated RF generator
equipment that either directly delivers RF energy to the body (e.g., electrosurgical units, RF therapy s
energy into another form of energy (using an appropriate transducer), such as ultrasound (e.g., ultras
ultrasonic lithotripters) and heat (e.g., electrothermal cautery units, thermal angioplasty). Some gene
appropriate connectors and/or couplers can be used for several of these tasks. RF generators are also
independent units for device testing, communication services, and other ancillary tasks.

Synthetic sutures made of polyglecaprone, an absorbable (i.e., biodegradable) polymer prepared from
glycolide epsilon caprolactone. These sutures are typically available in sterile monofilament uncoated
18, 30 in [45, 76 cm] long) attached to a single-use needle as an integral device; they are frequently c
identification during surgery. Polyglecaprone absorbable synthetic sutures keep their tensile strength
and complete absorption occurs in 90 days; their intended use includes general soft tissue approxima
cardiovascular or neurologic tissues) and vessel ligation.

Portable devices designed to extinguish a fire, often in an emergency situation. These devices consist
container of fire-suppressing material (e.g., dry chemical compounds, water, deionized water mist, ca
when discharged, can extinguish a fire. Various types of portable fire extinguishers are used in healthc
be categorized by an accepted class rating based on the types of fires they are designed to extinguish
and multiclass) or by the fire-suppressing material used to extinguish the fire (e.g., water, dry chemic
hydrochlorofluorocarbon, foam, carbon dioxide). Various sizes of portable fire extinguishers are typical
lb [1.13 kg], 5 lb [2.27 kg], 10 lb [4.53 kg], 20 lb [9.07 kg]). Some portable fire extinguishers are desig
healthcare environments (e.g., magnetic resonance imaging [MRI]-compatible fire extinguishers, whic
steel and can be safely used in an MRI suite). The type of extinguisher used in a particular healthcare
selected based on of the fire risks present in the area to be protected.
Devices designed to deliver therapeutic radioactive sources to, retrieve them from, and/or hold them
brachytherapy applicators typically include components such as hollow needles, tubes, catheters, hold
These applicators may be configured for manual or automated approaches (i.e., connected to a remot
brachytherapy system) and may be placed using endoscopic or image-guided techniques. Brachyther
typically used to treat malignant tumors on the surface of the body (i.e., topical) or within the body (e
intracavitary, intraluminal). Dedicated applicators are available for use on a specific treatment site or
afterloading system; some brachytherapy applicators are designed specifically to treat intravascular r

Brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve them from,
the treatment site using manual procedures, without any connection to an automated afterloading sys
typically include hollow needles, catheters, templates, and/or cannulae; and are frequently configured
the treatment site, such as on the surface of the body (i.e., topical) or within the body (e.g., interstitia
Manual brachytherapy applicators are typically used to treat malignant tumors.

Manual brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve the
them on the surface of the body. These applicators typically include special holders and templates and
configured for use according to the treatment site (e.g., neck, eyes). Topical manual brachytherapy ap
used to treat malignant tumors on or close to the skin or other external surface of the body.

Manual brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve the
them inside tissue (i.e., interstitial) and/or natural or surgically created body cavities (i.e., intracavitar
typically include hollow needles, catheters, and/or cannulae and are frequently configured for use acc
site within the body (e.g., brain, bladder, biliary ducts, breast). Some applicators include a catheter wi
that is left in a surgical cavity for introduction of solid radioactive sources (i.e., seeds) after surgery. In
manual brachytherapy applicators are typically used to treat malignant tumors in internal tissue and/o

Automated brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve
them on the surface of the body. The radioactive source is delivered by a remote afterloading system.
typically include special holders and templates and are frequently configured for use according to the
neck, eyes). Topical automated brachytherapy applicators are typically used to treat malignant tumors
skin.

Automated brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve
them in (natural or surgically created) interstices or cavities of the body. These applicators typically in
catheters, and/or cannulae and are frequently configured for use according to the treatment site withi
bladder, biliary ducts, breast). Some applicators include a catheter with a balloon at the tip that is left
(e.g., after extraction of a breast lump); several treatments are performed after surgery by introducing
(i.e., seed) into the balloon through a catheter for a predetermined period of time. The radioactive sou
remote afterloading brachytherapy system. Interstitial/intracavitary automated brachytherapy applica
to treat malignant tumors in internal tissue (e.g., sarcoma) and/or organs.
Automated brachytherapy applicators designed to deliver therapeutic radioactive sources to, retrieve
them in the uterine cavity. The applicator consists of a hollow metal tube (i.e., tandem), which tempor
radioactive source, and two semioval, cuplike structures (i.e., ovoids) placed on either side of the cerv
the radioactive source during treatment and includes tiny shields to reduce the radiation dose to the r
The tandem is fixed inside a hollow plastic tube (i.e., Smitt sleeve) previously inserted into the uterine
interstitial/intracavitary applicators are used to treat cervical cancer.

Automated brachytherapy applicators designed to deliver a therapeutic radiactive source (e.g., metal
container), retrieve it from, and/or hold it in a predetermined area inside a vessel and/or a stent previo
vessel. These applicators usually include a double-lumen catheter that locates the radioactive source;
or are an integral part of, an intravascular automated brachytherapy system. Intravascular automated
applicators are intended to prevent and/or treat restenosis in arteries and/or vascular stents.

Prepackaged collections of the devices and supplies (either custom or standard) needed for obtaining
intended for biopsy from the breast milk ducts by suction through a fine needle. Items in these kits us
aspirator (e.g., a transparent port attached to a syringe) to identify the nipple ducts, very thin dilators
cannulation, a blunt catheter to infuse and collect fluid to and from the breast ducts, and a vial to coll
cells for cytological analysis in the laboratory (in a manner similar to the way a Pap smear is performe
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Breast ductal cell procedure kits and trays are intended for use in healthcare facilities (e.g., hospitals,
obtaining and preparing breast ductal smears of women at high risk for developing breast cancer.

Predrilled plates with holes that are used to guide the insertion of catheters, needles, or other hollow
pattern (e.g., rectangles, concentric circles) to cover the tumor volume during brachytherapy treatme
used during brachytherapy procedures at internal sites.
Brachytherapy templates made of metal or rigid synthetic material. These templates are usually clam
table during the procedure. They are typically used to insert radioactive sources (i.e., seeds) during lo
procedures at internal sites such as the prostate and the brain.
Brachytherapy templates made of flexible plastic or rubber. These templates are usually attached (e.g
treatment area once the catheters or needles are properly positioned. They are typically used during h
brachytherapy procedures at internal sites such as the prostate gland.
Examination/treatment gloves designed to provide additional protection to both the patient and health
of allergic reactions to latex. These gloves are usually made of synthetic (e.g., polyisoprene, styrene-e
styrene) polymers; hypoallergenic gloves should fit comfortably but remain watertight and be strong e
tears or holes. Hypoallergenic examination/treatment gloves are used in healthcare facilities to preven
healthcare staff and patients.

Intracranial catheters designed for brachytherapy treatment in the brain, usually in the cavity ramaini
resection. Typically, several catheters are used simultaneously; they are frequently introduced using a
that is fixed to the skull. The external ends of the catheters are connected via external tubes to an aut
afterloading brachytherapy system that delivers the high-dose radioactive source (e.g., seeds) throug
area close to the tumor site. The catheters are removed after several days of treatment. Brachytherap
catheters are used in the treatment of brain tumors.
Catheters designed for introduction into the breast. These catheters are designed for introduction eith
or into a surgical cavity after tumor resection. Dedicated breast catheters are available for cytology an
treatment.
Catheters designed to be inserted into the breast ducts to obtain cells for cytologic testing. These cath
of a flexible, small-diameter tube. Typically, a small amount of anesthetic is infused through the cathe
then fluid is introduced into the duct and aspired to rinse the duct (ductal lavage) using a syringe. The
together with epithelial cells are collected in a vial for laboratory cytologic analysis. The procedure is t
women who are at high risk for developing breast cancer.

Breast catheters designed for introduction into and around a surgically created cavity within the breas
brachytherapy treatments, usually after tumor resection (lumpectomy). These catheters are typically
tubes that are introduced through needles that were placed under ultrasound guidance. Frequently, 1
inserted into the breast, encompassing the surgical cavity plus a few centimeters in all directions. Eac
the automated introduction of a radioactive source (seed) from a remote-afterloading brachytherapy s
for a predetermined time. The treatment is used to facilitate the control or cure of breast cancer, or to
breast cancer.

Breast catheters with a balloon at the distal tip and a cap that sticks out of the skin on the proximal en
intended for brachytherapy treatment. The balloon attached to the catheter is either left in the surgica
extraction of a breast lump) or introduced after surgery. Several treatments are performed after surge
single high-dose radioactive source (a "seed" attached to a wire) into the balloon through the catheter
period of time. The radioactive source is delivered by a remote-afterloading brachytherapy system. Th
facilitate the control or cure of breast cancer or to relieve symptoms of breast cancer.

Bronchial catheters designed for brachytherapy treatment of major bronchi. These catheters are usua
radiopaque design and are inserted through the working channel of a flexible bronchoscope into the a
catheter is left in position and (after the extraction of the bronchoscope) connected via an external tu
afterloading brachytherapy system that delivers the high-dose radioactive source through the cathete
tumor. The source (e.g., iridium 192) is usually welded to a stainless steel wire that is advanced into th
steps called dwell positions. Frequently, several catheters are used simultaneously in each treatment.
bronchial catheters are used to treat malignant tumors in bronchi but not those in the pulmonary tissu

Biliary catheters designed for brachytherapy treatment of the biliary duct walls and gallbladder. These
of a radiopaque single-lumen design; the catheter is inserted into the biliary ducts until its distal tip is
area. The catheter is left in position and connected via an external tube to a remote-afterloading brac
delivers the radioisotope through the catheter to the treatment site. The source (e.g., iridium 192) is u
stainless steel wire that is advanced into the catheter in fixed steps called dwell positions. Brachyther
catheters are used for high-dose treatment of malignant tumors.
Esophageal catheters designed for brachytherapy treatment of the esophageal wall. These catheters
single-lumen (typically about 1 cm diameter) tubes; the catheter is inserted through the mouth and ad
tip is close to the area to be treated. The catheters are left in position and connected through an exter
afterloading brachytherapy system that delivers the radioisotope into the catheter. The source (e.g., ir
welded to a stainless steel wire that is advanced into the catheter following fixed steps called dwell po
esophageal catheters are intended to be used for high-dose treatment of malignant tumors.

Automation systems designed to provide and control medicine distribution at a smaller scale than typ
hospital-based installations (i.e., clinical pharmacy automated medication dispensing systems). Medic
these systems will typically be via individual containers for use in outpatient or ambulatory care settin
typically consist of a combination of hardware and software that includes a cabinet-like or enclosed sh
perform all or most of the operations of counting, packaging, bar-coding, labeling, and dispensing soli
medications (e.g., tablets, pills, capsules) of different sizes and shapes, recording the individual delive
an inventory of the stored drugs. Most systems can exchange data with automated pharmacy and/or a
other information systems.

Implantable prostheses designed for total replacement of the ankle joint. These prostheses may consi
combination of a tibial component and talus component prostheses or, more frequently, of advanced d
three or more components. Several total ankle joint prostheses are available with different shapes and
semiconstrained three-component mobile-bearing prosthesis requires resurfacing of the superior ankl
semiconstrained cemented prosthesis requires the conversion of the three-bone ankle joint into a two
fusing the fibrous union at the distal ends of the tibia and fibula (i.e., tibiofibularis syndesmosis). Total
are used in patients who suffer from osteoarthritis or rheumatoid arthritis, as well as after trauma.

Miniature optical scanning laser microscopes designed to be used for endoscopic procedures. These m
high-magnification (typically up to 1000x) cross-sectional (i.e., three dimensional) images by scanning
point of laser light, restricting the illumination to a tiny, targeted section of the specimen while elimin
(i.e., confocal microscopy). The instruments typically include a miniature microscope (usually with a d
millimeters) and a fiberoptic cable; the system also includes an external image data processor, record
microscopes are used mainly to observe the structure of living normal and cancer cells, resulting in in
diagnosis without performing biopsies, especially in the gastrointestinal tract. Endoscopic optical scan
be separate components intended to be used through the working channel or as an integral part of vid

Systems that convert an input image taken from a microscope into a digital signal that is then convert
(e.g., still pictures, video) for display on a monitor or on other computerized imaging systems. These s
include a charge-coupled device or video camera that is inserted in the optical path of the microscope
converter, a digital memory, a digital storage device (e.g., optical disk), and a controlling computer. M
digitization systems are used to perform a variety of computer-assisted image acquisition, processing
both from clinical laboratory and surgical microscopes. Dedicated systems are also available for use w
confocal microscopes.
Systems designed to process, display, and store images taken by a confocal scanning laser microscop
typically consist of a laser light source, an image display, and a computerized processor that controls
image processing, and the display monitor. The system is usually attached to a confocal laser optical m
be used externally (i.e., on the skin) or in endoscopic procedures, either as an integral component of a
operating through the working channel of a video endoscope. Endoscopic confocal scanning laser mic
are used mainly to observe the structure of both normal and living cancer cells and may assist in in-vi
(e.g., of the gastrointestinal tract) without the need for biopsy.

Prepackaged collections of materials/supplies designed to be used to create a carbon dioxide enriched


for the performance of anaerobic procedures (usually for the culture of anaerobic bacteria) by either in
dioxide content, reducing the oxygen content, or both. These kits typically include a flexible container
with integral reagent sachets containing the atmosphere modifying chemical products, liquid activatin
the atmosphere development, and carbon dioxide concentration indicator strips. Products available in
intended to provide the appropriate atmosphere in a sealed jar by placing them after opening in the ja
pouches (e.g., transparent pouches that permit the observation of bacterial growth) typically permit th
perform small culture processes (usually a few bacteria inoculated Petri dishes). Dedicated kits with p
are available to perform cultures with enriched atmospheres of carbon dioxide, carbon dioxide plus hy
plus hydrogen with reduced oxygen (microaerophilic environment), and carbon dioxide plus hydrogen
catalyst strip.

Approximators designed to bring nerve edges into proximity during surgical procedures. These approx
manual, handheld instruments with two arms mounted on a mechanical frame; one arm is fixed at one
while the other arm can slide along the metallic frame to approach or to separate from the fixed one.
needles on the distal end of the arms to pierce the center of the nerve sections without damaging the
permits adjustment and/or locking of the distance between the arms. Nerve approximators are typical
intended to reattach one nerve portion to another.

Approximators designed to bring rib edges into proximity during surgical procedures. These approxima
manual, handheld instruments with two arms pivoted at the center; the distal ends are configured to h
anatomically correct position. The proximal ends are configured as handles to manipulate the approxim
approximators are typically used in procedures intended to reattach one rib portion to another in orde
structure.

Approximators designed to temporarily bring the edges of a skin wound into proximity or contact with
surgical procedures; they are manufactured with nonconventional shapes or components. These manu
instruments may consist of two hinged sections with free ends that move toward and away from each
have barbed arms that are inserted into the skin at opposite sides of a wound; the hinged arms pivot
the sections toward each other. The pivoting movement causes skin edges extending along the wound
before they move into abutment with one another. Other dedicated skin approximators consist of a se
fixed rod. Skin approximators are used during surgical procedures to bring together the edges of a sk
they are not intended for use for permanent wound closure.
Approximators designed to bring the sternal bone edges into proximity during surgical procedures, us
of holding the bone edges in place so that they can be securely sutured. These manual, handheld dev
fixed blade located at one end of the instrument and a second blade that can be displaced in steps alo
grasp the resected portions of the sternum. Sternum approximators are used during procedures intend
portion to the other to complete the structure. Sternal approximators are frequently used in pairs.

Vessel approximators designed to grasp torn or resected portions of small-diameter vessels, holding th
anatomically correct position without tension for the purpose of reattaching one portion to another to
during microsurgical procedures. These manual, handheld devices typically consist of a very small me
sliding atraumatic clamps or blades with gripping surfaces; they are frequently used in pairs. They are
microsurgical repair of very thin vessels (i.e., microanastomosis).

Awls designed for marking the surface of or piercing small holes in bony tissue and/or exploring or init
cortical bones. They are typically handheld, manual instruments with a slender, straight or curved and
working blade and a sturdy handle that is an integral part or attached to the working blade. Dedicated
oral, plastic, and orthopedic surgery to make small dents (i.e., to mark) and/or holes to prepare bones
prosthesis attachment, as well as to explore small bone cavities.

Awls designed for piercing small holes in cartilage. They are typically handheld, manual instruments w
or curved, and frequently grooved working blade with a very sharp point and a handle that is an integ
the working blade. Cartilage awls are usually smaller and more slender than bone awls. These awls ar
surgery (e.g., facial reconstruction) and oral surgery procedures; dedicated cartilage awls are also ava
procedures (e.g., to fix nasal deformities, for lip augmentation).

Awls designed to make small dents (i.e., to mark) or pierce small holes in the lower jaw bone (i.e., the
typically handheld, manual instruments with a slender, usually curved working blade and a sturdy han
integral part of the instrument. Mandible awls are used in plastic and oral surgery procedures to mark
mandible for prosthesis attachment.
Awls designed for piercing small holes on the sternum. They are typically handheld, manual instrumen
straight or curved, and frequently grooved working blade and a sturdy handle that is an integral part o
working blade. Sternum awls are used mainly to make appropriate holes for sternum closure (e.g., sut

Awls designed for piercing small holes in bone to facilitate the placement of a wire around the zygoma
facial bone formed by the temporal process of the zygomatic bone and the zygomatic process of the t
typically consist of handheld, manual instruments with a slender, slightly curved working blade with a
sturdy handle as an integral part. Zygomatic arch awls are used in orthopedic procedures to treat oral
fractures.

Bone awls designed for piercing the slightly thickened layer of bone that underlies and supports the a
end of long bones (i.e., the subchondral bone) for the purpose of producing microfractures to promote
regeneration. The area of cartilage damage is debrided, and the awl is used to produce holes (e.g., ev
depth of 3 to 4 mm) in the bone at the base of a cartilage defect, causing formation of a superclot. Th
stage arthroscopic surgery that is intended for smaller and localized chondral defects in the knee. Sub
are available with different shaft calibers and curvatures at their working end (e.g., 30, 45, or 90 degr
used to mark intended drill sites during anterior and/or posterior cruciate ligament procedures.
Cartilage awls designed for piercing the nasal cartilage and surrounding tissue. They are typically han
instruments with a slender, very delicate, slightly curved grooved blade with a very sharp point and a
integral part or attached to the working blade. Nasal cartilage awls are available in shapes and sizes a
the nasal cartilage so that damage to the cartilage and surrounding tissue is minimized; they are used
surgery procedures.

Bougies designed to be inserted through the working channel of a rigid or flexible bronchoscope and u
bronchi. These manual, handheld devices are typically hollow metal or plastic cylinders with a tapered
Bronchial bougies are used to produce stricture dilation to improve ventilation and prevent atelectasis
are also used prior to stent implantation. Dedicated bronchoscopy dilators with an inflatable balloon a
bronchial stricture dilatation.

Bougies designed for probing and/or dilating the conducts of the ear canal and/or the eustachian tube
handheld devices are typically hollow metallic or plastic cylinders with a tapered working end. Ear can
bougies are mainly used during surgical procedures involving the middle ear, the nasal cavity, and/or

Esophageal bougies filled with mercury (a metal that is liquid at room temperature) that are designed
area in the esophagus. These bougies are typically strong-walled rubber or latex tubes filled with merc
flexible weight, either with a round, blunt tip (Hurst type) or a fine tip tapered to full diameter over se
the tip (Maloney type). Mercury-filled esophageal bougies are available in sets that include bougies wi
diameters; they are intended to treat cardiospasm, esophagitis, and stenosis.

Esophageal bougies filled with tungsten (a metal that is solid at room temperature) that are designed
area in the esophagus. These bougies are typically strong-walled polyvinyl chloride or silicone tubes fi
powder suspended in a gel to provide weight, either with a round, blunt tip (Hurst type) or a fine tip ta
over several centimeters from the tip (Maloney type). They are used with the same techniques as mer
Tungsten-filled esophageal bougies are available in sets that include bougies with a variety of diamete
to treat cardiospasm, esophagitis, and stenosis. Tungsten-filled bougies (i.e., mercury-free bougies) ar
alternative to mercury-filled bougies to avoid the hazards of mercury manipulation.

Bougies designed to calibrate esophageal strictures and/or dilate the esophagus using a set of olive-s
manual, handheld devices typically consist of a set of perforated olive-shaped tips that are inserted in
increasing order of diameter via a swallowed string, frequently using a spring mechanism. Olive-tip bo
intended to treat esophageal strictures in children and adults.
Extremely slender esophageal bougies designed to explore and/or dilate the esophagus. These manua
are typically solid metallic or plastic tapered tubes; some devices include an olive-shaped tip at the di
bougie may be introduced directly or via an appropriate esophageal catheter; the device may also be
attaching it to the distal end of a larger-diameter bougie. They are used mainly to treat minute cicatric

Extremely slender urethral bougies designed to explore and/or dilate the urethra. These manual, hand
typically metallic or plastic, thread-shaped, tapered, slender solid tubes; some devices include an oliv
distal end. A filiform bougie may be introduced directly or via an appropriately threaded urethral cathe
device may also be used as a guide by attaching it to the distal end of a larger-diameter bougie.
Broaches designed to shape and enlarge holes in bone and/or to remove material from bone during su
They are typically manual, handheld instruments with an elongated, tapered, and serrated working en
broaches are used in bone cavity preparation for prosthesis insertion; dedicated broaches are availabl
intramedullary canal.
Bone surgical broaches designed to shape and enlarge holes in the intramedullary canal. These broac
manual, handheld instruments with an elongated, tapered, and serrated working end and a handle. In
broaches are used mainly for cavity preparation before prosthesis insertion.
Broaches designed to shape and enlarge dental cavities (e.g., root canal) and/or to remove dental tiss
are typically manual, handheld instruments with an elongated, tapered, and serrated working end and
dental broaches are used mainly in endodontic procedures to remove intact pulp tissue.

Dental instruments designed to shape or cut materials used in dental restorations and/or dental prost
Dental carvers are typically slender, single- or double-ended, handheld, manual instruments that are a
shapes and sizes. A variety of configurations (e.g., discoid carvers, cleoid carvers, discoid-cleoid carve
Hollenback/Hollenbach carvers, Roach carvers) are available. Some dental carvers are designed as de
intended for carving specific substances (e.g., dental amalgam, dental wax, composite dental fillings)
are double-ended instruments with different designs at each end, intended to carve more than one su
amalgam, dental wax, carious dentin).

Dental amalgam carvers designed to shape or cut amalgam on the occlusal tooth surface. These carv
slender, double-ended, handheld, manual instruments with sharp cutting edges configured to carve th
occlusal tooth surface (e.g., discoid carvers, cleoid carvers [some are also known as acorn carvers]). D
are used after the amalgam is condensed into the tooth cavity.
Dental amalgam carvers designed to shape or cut amalgam on the interproximal tooth surface. These
slender, double-ended, handheld, manual instruments with sharp cutting edges and are configured to
the proximal tooth surface. They are used after the amalgam is condensed into the tooth cavity.

Dental carvers designed to shape or cut composite filling restorations in tooth to approximate the orig
removing excess filling. These carvers are typically slender, single- or double-ended, handheld, manua
sharp cutting edges. Dedicated carvers are available for carving along specific tooth surfaces (e.g., th
surface); some double-ended instruments have one end configured to carve along the right side of the
end to carve along the left side. Composite filling carvers are used after the filling material is filled and
cavity.

Chisels designed to shape teeth, remove bone, and/or to split teeth during dental procedures. These c
of a handheld, manual instrument including a flat blade with a cutting edge that is beveled on one sid
an integral handle. Small dental chisels are available to split tooth enamel, to smooth tooth-cavity wa
cavity preparations in operative dentistry; surgical chisels are also available to remove bone and/or sp
surgery.

Dental chisels designed to shape teeth during the restorative treatment of defects in tooth enamel an
operative procedures). These chisels are typically a handheld, manual instrument with a very small fla
cutting edge that is beveled on one side at the distal end and an integral handle. Dental operative chi
split tooth enamel, to smooth cavity walls, and to sharpen cavity preparations. Dedicated operative de
available for the anterior teeth (straight or monoangle chisels) and for difficult-to-access tooth structu
angle chisels).
Dental chisels designed to cut bone and teeth during surgical procedures in the oral cavity. These chis
a handheld, manual instrument with a flat blade including a cutting edge that is beveled on one side a
integral handle with a proximal end appropriate for mallet impact; dental/oral surgery chisels are large
chisels used in restorative dentistry. They are used mainly to split teeth and/or to reduce alveolar bon

Chisels designed to cut and shape bone during procedures (e.g., autopsy, dissection) performed on th
(i.e., postmortem procedures). These chisels are typically a sturdy handheld, manual flat-blade instrum
edge that is beveled on one side at the distal end and an integral straight or, less frequently, cross ha
chisels are used mainly during autopsy and cadaver dissection. Dedicated postmortem chisels are ava
open cadaver skulls.

Postmortem chisels designed to crack or otherwise open the skull bones (e.g., separate the cranium fr
the cranial lines or previous cuts made with a saw) during postmortem procedures. These chisels typic
sturdy, handheld, manual flat-blade instrument with a cutting edge that is beveled on one side at the
handle. Skull chisels are used mainly during autopsy and cadaver dissection, including the separation
the lower skull.

Chisels designed to cut and shape hard tissue (e.g., bone, cartilage) during surgical procedures. These
consist of a handheld, manual flat-blade instrument with a cutting edge that is beveled on one side at
handle. Dedicated surgical chisels are available in a variety of shapes and sizes according to the proce
they are used in orthopedic, plastic, middle-ear, and other surgical procedures.

Surgical chisels designed to cut and shape bone during surgical procedures. These chisels typically co
handheld, manual flat-blade instrument with a cutting edge that is beveled on one side at the distal e
Dedicated surgical chisels are available in a variety of shapes and sizes according to the procedure to
are used in orthopedic and plastic surgery, neurosurgery, and other surgical procedures.

Surgical chisels designed to cut the elongated, flattened bone forming the middle part of the thorax (i
These chisels typically consist of a sturdy handheld, manual instrument including a flat blade with a c
beveled on one side (either rectangular or rounded) that is conformed at a right angle with the shaft o
an integral straight or cross handle. Sternum chisels are used mainly during thoracic (e.g., pulmonary
thoracic cavity.

Bone surgical chisels designed to excise bone outgrowths (i.e., osteophytes). These chisels typically c
manual instrument including a straight or slightly curved flat blade with a very sharp cutting edge tha
side. Dedicated bone-outgrowth surgical chisels are used mainly in delicate neurosurgical procedures,
opening and spinal discectomy; other dedicated chisels are available for use in microsurgical procedu

Bone surgical chisels designed to excise bone outgrowths (i.e., osteophytes) during microsurgical proc
are typically a small handheld, manual instrument including a straight or slightly curved flat blade wit
cutting edge and a knurled handle. Bone outgrowth microsurgical chisels are mainly used in delicate n
procedures of the spine, including lumbar discectomy.
Orthopedic surgical chisels designed to create a cavity or slot (usually rectangular) into which prosthe
chisels are typically a sturdy handheld, manual instrument including a straight or slightly curved flat b
edge that is beveled on one or, more frequently, two sides and a handle. Mortising bone chisels are us
procedures intended to attach a prosthesis to a bone.
Surgical chisels designed to open the sellar (i.e., sella turcica) floor to access the pituitary gland. Thes
consist of a handheld, manual instrument including a flat blade with a cutting edge that is beveled on
markings at the distal end and an integral handle. Pituitary gland (hypophysis) chisels are used mainly
intended to excise pituitary tumors.
Middle-ear surgical chisels designed to fenestrate and/or cut pieces from the flat oval plate of bone on
stapes or foot plate) that fits into the oval window of the middle ear. These chisels typically consist of
handheld, manual instrument including a narrow flat blade with a cutting edge that is beveled on one
a straight or angled semirigid shaft, and an integral handle. Foot-plate surgical chisels are used during
procedures; very small foot-plate chisels are available for microsurgical procedures.

Middle-ear surgical chisels designed for cutting and shaping bone, cartilage, and associated tissue of
procedures performed under a microscope (i.e., microsurgery). These chisels are typically a very smal
flat-blade instrument with a cutting edge that is beveled on one side at the distal end and an integral
handle. Microsurgical middle-ear chisels with a great variety of shapes are available; they are usually
intended for particular procedures such as stapes surgery (stapedectomy) and otologic microsurgery.

Nasal surgical chisels designed to cut and shape cartilage of the nose during plastic surgery procedure
These chisels are typically a handheld, manual, flat-blade instrument with a cutting edge that is ribbe
beveled on one side at the distal end and an integral cross (T-shaped) handle. The flat part of the instr
distal and proximal end is frequently serrated to provide good finger grip. A variety of rhinoplasty chis
and shapes are available, including chisels to remove the bony dorsal hump.

Nasal surgical chisels designed to cut (resect) the nasal septum during surgical procedures. These chi
a handheld, manual instrument with a wide, flat blade and a cutting edge that is beveled on one side
an integral straight handle. Nasal septum surgical chisels are used in procedures intended for resectio
resection) of the nasal septum.
Surgical chisels designed to cut and shape bone, cartilage, and associated tissue of the spinal cord. Th
consist of a handheld, manual flat-blade instrument with a cutting edge that is beveled on one side at
integral handle. Middle spine surgery chisels of many different sizes and shapes are available, includin
lumbosacral spinal fusion, sturdy chisels for laminectomy, and shouldered chisels for cervical discecto

Spine surgical chisels designed to perform anterior cervical discectomy. These chisels typically consist
instrument with a beveled cutting end that is shouldered in a wider blade that prevents chisel slipping
rounded surface of the vertebrae. Cervical discectomy chisels are available in several sizes for use ac
anatomic characteristics
Spine surgical chisels designed for excision of the posterior arch of a vertebra (i.e., laminectomy). The
consist of a sturdy handheld, manual instrument with a wide blade including a beveled cutting edge a
handle. Laminectomy chisels are available in several sizes for use according to patient's anatomic cha

Silicone sheets designed to treat dermal wounds, preventing hypertrophic scar tissue and keloids whe
occlusive or semi-occlusive covering to the wound. These sheets typically consist of a soft, thin, and s
of silicone that may also include other compounds (e.g., corticosteroids, vitamins) that are also intend
healing. Scar/keloid inhibition silicone sheets are available in a variety of sizes and shapes (e.g., strips
they are used, typically after surgery, as dressings in patients with dermal wounds, burns, or other wo
Foam sheets with a silicone-gel surface designed to treat dermal wounds, preventing hypertrophic sca
when applied as a wound covering, facilitating uniform compression on the wound edges. These shee
soft, thick (typically about 13 cm/0.5 inch) layer of foam with a slightly adherent covering of silicone g
to the wound. Scar/keloid inhibition silicone-gel-foam sheets are usually available in large sizes (e.g., 2
inch); they are used, typically after surgery, as dressings in patients with dermal wounds, burns, or oth
gel-foam sheets provide a gentle adherent patient interface and a consistent compression distribution
inflammation and edema when compression garments are applied, especially after surgical procedure

Silicone gels designed to treat dermal wounds, preventing hypertrophic scar tissue and keloids when a
or semi-occlusive covering to the wounds. These gels usually consist of a soft silicone ointment (i.e., a
the skin to improve wound healing. Scar/keloid inhibition gels are usually available in tubes for manua
may be used as dressings in patients with dermal scars, typically after surgery, burns, or other wound

Cleansers designed to clean silicone sheets used on wounds to prevent hypertrophic scars and keloids
typically consist of a mild, low-foaming, odorless soap. The cleanser is intended for patient self-care o
with silicone sheets.
Electromechanical moving belts designed for automated movement of objects (and/or people), usually
inclined plane. These conveyors typically consist of a moving belt, a powered mechanism, and control
movement and/or speed of the belt. Conveyors are used in healthcare facilities to move objects such
equipment, devices, and supplies; dedicated conveyors are used to move food trays and laundry.

Conveyors designed for automated transport of laundry, either in bulk or in bags. These conveyors typ
moving belt with stationary siderails, a powered mechanism, and controls to regulate the movement a
belt. Laundry conveyors can accommodate and transport laundry towards washers, dryers, pressers, o
they are available in many sizes, and in horizontal or inclined configurations.

Dryers designed to remove moisture from laundry (e.g., sheets, towels, cloth) using heat (e.g., forced,
centrifugal force. These dryers typically consist of a heat generator, an enclosure that can usually rota
force, hoses for venting, and appropriate controls of the drying cycle. Laundry dryers are used to dry l
areas (e.g., operating rooms) and/or patient and staff personal clothing; they are used after the laund

Medical-air dryers designed to remove moisture from the air using membrane-filtration techniques. Ty
compressed air to be dried passes through a set of hollow-fiber membranes, in which the water vapor
membranes, drying the compressed air. Simultaneously a small portion of the dry air is redirected alon
fibers to sweep out the water vapor that has permeated the membrane; then the moisture-laden swee
atmosphere while dry air is supplied to the distribution system. Membrane medical-air dryers may be
for removing liquid oil aerosols and mists, and purifiers for removing solid and liquid particles and gas
carbon monoxide; these devices are frequently included as an integral part of medical-air supply syste

Dryers designed to remove moisture from laboratory gels using heat or heat combined with vacuum. T
consist of a container with a transparent cover and electric heating elements, a vacuum port, appropr
polyethylene), and temperature and time controls to establish appropriate drying conditions for differe
dryers are used to dry large gels and/or a combination of smaller gels intended for preservation or for
electrophoresis, densitometry, and/or other laboratory procedures.
Dryers designed to remove moisture from forensic evidence (e.g., cloth, shoes, underwear, masks, tow
ensure that the samples are dry. These dryers typically consist of a large (typically from 55 to 440 cub
feet]), freestanding cabinet-like enclosure with a forced-air source and appropriate corrosion-proof hol
evidence; some dryers include electric heating elements. The devices also include air intake and exha
HEPA), carbon filters, time and temperature controls, and alarms. Forensic evidence dryers are intende
(e.g., of sexual assault) before further processing, reducing the risk of cross-contamination.

Forensic evidence dryers designed to remove moisture from swabs containing forensic evidence (e.g.,
using forced air to ensure that the samples are dry. These dryers typically consist of a small tabletop o
enclosure (typically of less than 55 cubic dm [2 cubic feet]) with a forced-air source (usually a fan) and
may be independent from the enclosure. The devices also include air intake and exhaustion filters (e.g
Swab dryers are intended to dry wetevidence (e.g., of sexual assault) samples (typically swabs impre
fluids) before further processing, reducing the risk of cross-contamination.

Dryers designed to remove moisture from x-ray film after it has been developed, fixed, and washed us
static or forced) air. These dryers typically consist of a plastic or metal enclosure with a hinged lid or w
heating elements, appropriate hangers for the film, a ventilator to produce the air, and temperature c

X-ray film dryers designed to remove moisture using an automated heated unit from an x-ray film afte
developed, fixed, and washed. These dryers typically consist of a unit with an internal drum in which t
electrical heating source, and temperature and speed controls. Automated film dryers are frequently i
part of x-ray film processors that perform all x-ray film processing functions (i.e., developing, fixing, w

Ovens designed for clinical laboratory procedures (e.g., baking, drying, desiccating, sterilizing of glass
cultures, or samples); they operate at temperatures typically from ambient to a maximum of between
Celsius (392 to 620 degrees Fahrenheit) with the chamber temperature accuracy, resolution, and unifo
clinical laboratory work. These ovens usually consist of a thermal isolated chamber made of corrosion
frequently, a large glass window; they also include time-and-temperature sensors and controls (either
automated), temperature protection, and alarms. Laboratory ovens are available in many different cap
27 to 135 cubic dm [1 to 5 cubic feet]) and configurations (e.g., tabletop, upright, undercounter). Ded
provide gravity and/or forced-air capabilities; some can provide a vacuum environment in the working

Laboratory ovens designed to provide forced-air convection in the working chamber, increasing the un
They usually operate (frequently using a computer program) at temperatures in a range from ambient
between 200 and 300 degrees Celsius (392 to 572 degrees Fahrenheit). These ovens typically consist
chamber made of corrosion-proof materials and, frequently, a big glass window, a blower that circulat
the chamber. and air intake and exhaust ports. The ovens also include time-and-temperature sensors
manual or automated), temperature protection, and alarms. Forced-air laboratory ovens are used mai
conditioning, sterilizing, quality control) involving cultures and samples when accurately controlled un
required. They are available in many different capacities (typically from 27 to 135 cubic dm/1 to 5 cub
configurations (e.g., tabletop, upright, undercounter). Tabletop units intended for thawing and/or warm
other related products (e.g., whole blood, erythrocytes) are also available.
Laboratory ovens designed to provide the relatively low-vacuum environment in the working chamber
laboratory procedures. They usually operate (frequently using a computer program) at temperatures r
to a maximum of between 200 and 300 degrees Celsius (392 to 572 degrees Fahrenheit). These ovens
thermal isolated chamber made of corrosion-proof materials and, frequently, thick walls and a glass w
closing purge and vacuum valves and ports; time-and-temperature sensors and controls (either manu
temperature protection, and alarms. Some vacuum ovens permit operation with an inert gas environm
chamber. Vacuum laboratory ovens are used mainly in procedures such as desiccating, moisture testin
vacuum embedding. They are available in many different capacities (typically from 14 to 54 cubic dm
and configurations (e.g., tabletop, upright, undercounter).

Equipment designed for automated pressing (i.e., ironing) and smoothing cloth and other fabrics. This
includes a set of moving bands intended to press the laundry, a heating system (e.g., steam, electrica
adjust the temperature and the band speed according with the material and the humidity content of t
presses are available in many sizes and using several configurations.

Equipment designed for the automatic folding of fabrics after ironing. This equipment typically consist
belts, heat sources, suction devices, and controls. Folding laundry units can typically perform one to fo
up to three cross-folds; they are frequently linked to a stacker cabinet by a conveyor. Dedicated units
sheets, towels, and/or tablecloths are available.
Dental instruments designed to pack and condense restorative material inside a tooth cavity. These in
slender, handheld, usually curved devices with a smooth or serrated hammer-like working end; dental
frequently double-ended instruments. Dedicated condensers are available for a variety of restorative
amalgam, packable resin composites, gold, and endodontic (root canal) fillings.

Dental amalgam condensers designed to pack amalgam into the tooth cavity by manual operation. Th
handheld manual instruments with a handle and smooth or serrated hammer-like working ends large
the soft amalgam without sinking into it; manual dental amalgam condensers may also be used for co
packable) resin composites.
Dental amalgam condensers designed to pack amalgam into the tooth cavity by repeated impact, usin
vibration or ultrasonic energy. The amalgam is usually packed from the center toward the walls of the
the fine-point working end of a bit attached to the power unit.
Dental condensers designed to pack filling materials vertically into prepared root canals. These conde
single-ended manual instruments with a handle and a cylinder-shaped, contra-angled working end wit
condensers include serrations at intervals (e.g., 5 mm) to evaluate the penetration depth. Vertical den
also known as dental pluggers.
Dental condensers designed to pack filling materials horizontally (i.e., spread) against the wall of prep
These condensers are typically single-ended manual instruments with a handle and contra-angled wo
a point. Dental condensers that apply filling materials horizontally are also known as dental spreaders

Cytology brushes designed to scrape and collect cells from the biliary and/or pancreatic tract through
cannula/sphincterotome or the working channel of a choledochoscope or duodenoscope. These brushe
cluster of bristles attached to a wire, possibly surrounded by a plastic sleeve, that runs back to a hand
manipulation. The characteristics of endoscopic biliary brushes, including diameter and length, should
models of endoscopes; these brushes may be intended for reuse or, more frequently, for single use.
Cytology brushes designed to scrape and collect cells from the bronchi through the working channel o
bronchoscope. These brushes usually consist of a cluster of bristles attached to a wire, possibly surrou
sleeve, that runs back to a handle for external brush manipulation. The characteristics of endoscopic b
including diameter and length, should match one or more models of bronchoscopes; these brushes m
reuse or, more frequently, for single use.

Cytology brushes designed to scrape and collect cells from the upper esophagus using nonendoscopic
brushes usually consist of manual, handheld devices with a cluster of bristles attached to a wire, poss
plastic sleeve, that runs back to a handle for external brush manipulation. Some brushes are introduce
through another device, such as a nasogastric tube.
Cytology brushes designed to scrape and collect cells from the upper gastrointestinal tract, from the e
frequently, from the stomach, through the working channel of a flexible gastroscope. These brushes u
cluster of bristles attached to a wire, possibly surrounded by a plastic sleeve, that runs back to a hand
manipulation. The characteristics of endoscopic esophageal and/or gastric brushes, including diamete
match one or more models of gastroscopes; these brushes may be intended for reuse or, more freque

Cytology brushes designed to scrape and collect cells from the lower gastrointestinal tract, usually fro
the working channel of a flexible colonoscope. These brushes usually consist of a cluster of bristles att
possibly surrounded by a plastic sleeve, that runs back to a handle for external brush manipulation. Th
endoscopic colon brushes, including diameter and length, should match one or more models of colono
may be intended for reuse or, more frequently, for single use.

Cytology brushes designed to scrape and collect cells from the urinary tract or bladder through the wo
flexible cystoscope. These brushes usually consist of a cluster of plastic or metallic bristles attached to
surrounded by a plastic sleeve, that runs back to a handle for external brush manipulation. The charac
tract/bladder brushes, including diameter and length, should match one or more models of cystoscope
be intended for reuse or, more frequently, for single use.

Cytology brushes designed to scrape and collect cells from the cervix and/or uterine endometrium (i.e
endocervical/ectocervical cell samples). These brushes usually consist of a cluster of stiff metallic or p
distal tip attached to a handle for direct manipulation. Cervical/uterine cytology brushes are available
configurations (e.g., with fibers perpendicular to the handle for endocervical sampling, with parallel fib
handle for simultaneous ectocervical and endocervical sampling, with two brushes arranged at right a
design, with shorter peripheral fibers). These brushes are used to obtain samples for Pap smears (both
monolayer) and/or to detect bacteria in the cervix (e.g., chlamydia).

Cytology brushes designed to scrape and collect cells from each of the three layers (i.e., basal, interm
of the oral mucosa, usually in the space between the cheek and gum, along the roof of the mouth, and
These brushes typically include a cluster of stiff plastic fibers at the distal tip attached to a handle for
Oral cytology brushes are also available in particular configurations (e.g., with two scraping surfaces,
end of the brush and another circular at one border of the brush). These brushes are used to obtain sa
detect abnormalities in oral tissue (e.g., malignancies).
Cytology brushes designed to scrape and collect cells from the eye surface (conjunctiva). These brush
very small cluster of soft plastic bristles at the distal tip attached to a handle for direct manipulation. E
cytology brushes are available with flat or round distal tips. These brushes are used to obtain samples
abnormalities in conjunctiva tissue by analyzing the presence of keratinized cells, nonkeratinized cells
inflammatory cells. Eye-cytology brushes are used to collect samples for the diagnosis of several eye
eye).

Brushes designed for use during surgical procedures. These brushes typically include a set of tufts of b
materials at the distal tip and a handle for proper manipulation. Dedicated surgical brushes are used i
procedures, including cleaning and debridement of bone canals in orthopedic surgery, dermabrasion i
dermatologic surgery, and wiping of the cornea during ophthalmic surgery.

Surgical brushes designed for use during procedures performed on bone. These brushes typically cons
twisted, metallic (e.g., stainless steel) wire with bristles (e.g., nylon) radiating from the shaft; the wire
handle or conformed for direct manual manipulation or use with a manual or powered handpiece at th
Dedicated bone brushes are used mainly in orthopedic surgery to prepare (i.e., clean and debride) a b
before cement application during prosthetic procedures.

Bone surgery brushes designed to prepare (i.e., clean and debride) the large cavity of the coxa, where
articulates (i.e., the acetabulum), for application of bone cement. These brushes typically consist of a
metallic (e.g., stainless steel) wire with bristles (e.g., nylon) radiating from a shaft that is conformed a
end; the wire is attached to a handle or, more frequently, conformed for use with a manual or powere
proximal end. Acetabular brushes are typically used with simultaneous application of irrigation after b
the cavity; they are used mainly in prosthetic orthopedic procedures (e.g., hip replacement).

Bone surgery brushes designed to prepare (i.e., clean and debride) a narrow (usually 0.5 inch [1.27 cm
for application of cement. These brushes typically consist of a disposable (single use) flexible, twisted
stainless steel) wire with bristles (e.g., nylon) radiating from the shaft at the distal end; the wire is con
appropriate for handling at the proximal end. Narrow-canal bone brushes are typically used after broa
canal; they are used in total arthroplastic hip replacement and other orthopedic procedures.

Bone surgery brushes designed to prepare (i.e., clean and debride) the femoral canal for application o
brushes typically consist of a disposable (single-use) flexible, twisted, metallic (e.g., stainless steel) w
nylon) radiating from the shaft at the distal end; the wire is conformed as a loop appropriate for handl
end. Femoral canal brushes are typically used with simultaneous application of irrigation after broachi
canal; they are used in prosthetic orthopedic procedures (e.g., hip replacement).

Brushes designed to apply materials (e.g., resins) and to remove deposits (e.g., calculi) and/or debris
surrounding tissue during dental procedures. These brushes typically include a set of tufts of bristles o
materials at the distal tip and a handle for proper manipulation or an appropriate configuration to be a
handpiece. Dental brushes are used in dental offices. Dedicated brushes are available for resin applica
application of antiseptic, medicine, and fluoride on the tooth surface; tooth prophylaxis; and removal o
tissue.

Brushes designed for topical application of liquid medication (e.g., antiseptic, medicine) and/or protec
fluoride) to the tooth surface. These brushes are typically disposable and include a handle with tapere
tip. Topical application dental brushes are used mainly in preventive, prophylactic, and/or cosmetic de
Brushes designed for dental resin application, especially in associated etching and bonding procedure
typically disposable and include a handle with bristles in a round configuration at the working end; dis
attached to a reusable handle are less frequently used.
Brushes designed to remove debris from the surface of devices, instruments, and/or working areas. Th
include a set of tufts of bristles or other flexible materials that are mounted along a single plane at the
or radiate from a central shaft for proper manipulation. Dedicated cleaning brushes of the appropriate
materials are available for cleaning devices and instruments (e.g., burs, dilators, endoscopes), prosthe
hearing aids), and labware and for general surface cleaning (including housekeeping) in healthcare fa

Cleaning brushes designed to remove debris from instruments as part of preparation for a clinical proc
routine maintenance. These brushes typically include a set of tufts of bristles or other flexible materia
along a single plane at the distal end of a handle or radiate from a central shaft for proper manipulatio
cleaning brushes can be used to clean the surfaces and crevices of a variety of instruments; dedicated
appropriate shape, size, and materials are available for cleaning specific instruments and parts (e.g., b
endoscopes).

Endoscope cleaning brushes designed to remove debris from endoscope channels (e.g., biopsy, suctio
typically include a long (e.g., 48 to 96 inch, 120 to 240 cm,) flexible plastic (e.g., polypropylene), textu
(e.g., nylon) radiating from the shaft at one or both ends; they may include a soft, ball tip (to avoid da
endoscope) and round plastic handles. Some brushes have tiered or tapered bristles to adapt to most
channel sizes. Endoscope channel cleaning brushes are available in several diameters and lengths, ac
size of the particular endoscope (e.g., cystoscope, gastroscope) to be cleaned, some endoscopes requ
brushes for water/air channels and suction/biopsy channels. Endoscope channel cleaning brushes may
use or for reuse after sterilization.

Endoscope cleaning brushes designed to remove debris from the valves, biopsy ports, and heads of en
brushes typically include a small (e.g., 2 inch [5 cm]), rigid plastic (e.g., polypropylene), textured shaf
nylon) radiating from the shaft at the working end. Endoscope valve/head cleaning brushes may be in
or, more frequently, for reuse after sterilization.
Instrument cleaning brushes designed to remove debris from the lumen of esophageal stricture dilato
typically include a very thin (e.g., 2 or 3 mm), long (e.g., 40 inch [100 cm]), flexible shaft with short st
working end. Esophageal dilator cleaning brushes are used in manual cleaning procedures and are typ
sterilization.
Instrument cleaning brushes designed to remove debris from a reusable inner cannula that is used ins
tracheostomy tubes (small tubes inserted into the tracheostomy to keep the stoma clear). These brus
round handle and a small, thin, curved plastic (e.g., polypropylene) shaft with bristles (e.g., nylon) tha
at the working end and are of the appropriate size for cleaning the cannula lumen.

Brushes designed to remove debris from the surfaces and crevices of manual instruments (e.g., surgic
preparation for a clinical procedure or during routine maintenance. These brushes typically include a s
other flexible materials that are mounted along a single plane at the distal end of a handle or radiate
proper manipulation. Multiuse instrument cleaning brushes are available in a variety of sizes, configur
(usually plastic or nylon) appropriate for general cleaning of surgical and/or dental instruments.

Denture cleaning brushes designed especially for patients with limited manual dexterity. The shape an
brushes permit partially disabled patients to clean their own dentures.
Cleaning brushes designed to remove debris from the microphone opening of a hearing aid. These bru
a small flat brushing surface with bristles (e.g., nylon) and a semirigid plastic handle resembling a too
appropriate size and shape to facilitate hearing-aid cleaning. Hearing-aid cleaning brushes are also av
hearing-aid maintenance kits.
Brushes designed to remove debris from clinical laboratory labware. These brushes typically include a
or other flexible materials that are mounted along a single plane at the distal end of a handle or radia
for proper manipulation. Labware cleaning brushes can be used in a variety of devices; dedicated labw
appropriate shape, size, and materials are available for cleaning beakers, bottles, test tubes, jars, and

Toothbrushes designed for cleaning teeth with electrically powered bristles. These toothbrushes emplo
(e.g., back-and-forth, circular, elliptical) when manually placed on the teeth by the user. Electrical toot
include a set of bristles arranged in a rectangular or circular array and a handle that includes the elec
batteries. Electric toothbrushes are usually battery-powered devices; some may include rechargeable
for battery recharging.

Toothbrushes designed for mechanically cleaning the teeth. They typically consist of a small flat head
surface 1.0 to 1.25 inches (2.5 to 3 cm) long and 5/16 to 3/8 inches (0.8 to 1cm) wide with a rigid plas
are usually made of nylon or hog-bristle (natural bristle), and may be grouped in separate tufts (typica
four rows or evenly distributed. Manual toothbrushes are intended mainly for personal hygiene at hom

Manual toothbrushes designed for mechanically cleaning the gingiva, the spaces between the teeth (i
and/or the spaces between the teeth and periodontal pockets; they are also used to deliver cleaning a
sites. These brushes typically have outer and inner V-shaped portions forming working surfaces with i
distal ends from the spines, and bristles extending from the intersections that are intended to clean th
the subgingival region between the teeth and gums. Gingiva/interproximal toothbrushes frequently in
least one of the working surfaces to deliver irrigation fluid, medicating (e.g., antibacterial), or other cle
product is then guided by the bristles to the subgingival region.

Toothbrushes designed to perform mechanical and ultrasonic cleaning of teeth. These toothbrushes cl
simultaneous mechanical motion (e.g., back-and-forth, circular, elliptical) and an ultrasonic wave actio
placed on the teeth by the user. Ultrasonic toothbrushes typically include a set of bristles arranged in
circular array, an ultrasound transducer, and a handle that includes an electric motor and batteries. U
are usually reusable battery-powered devices.

Dental applicators designed to transport and place resins and cements. These instruments are typical
metallic or plastic, double-ended devices; they are available with a variety of working ends from smal
padded-like shapes. Resin/cement dental applicators can also be used to apply temporary, insulating,
materials; dedicated dental brushes are also used for resin application, especially in etching and bond

Dental applicators designed to hold cotton or other absorbent material fibers for the application of liqu
These applicators are typically slender flexible instruments with a rough, round cross section tapered
can hold the cotton fibers without slipping. Endodontic dental applicators are used mainly to clean, ap
and/or sterilize the empty root canal.
Visual function physiologic analyzers designed to assess degenerative effects on the macula (i.e., mac
analyzers typically consist of an electrically powered device intended to produce two conical, brushlike
touching (known as Haidinger's brushes). The observation of image characteristics through a Nicole p
evaluation of visual function, particularly macular integrity.
Washers designed for automatic removal of dirt and/or stains (i.e., washing) from laboratory glass or q
cells). These washers typically include a plastic enclosure, a filtering flask, and a hose for connection t
Cuvette washers perform a cycle of operations typically including a cleaning spray washing, rinsing, a
for drying the cuvette; frequently a final wash with acetone is used to eliminate any water droplets. Th
laboratories to clean cuvettes (cells) before reuse.

Washer/decontamination units designed for automatic or semiautomatic washing (i.e., eliminating dirt
physical removal (i.e., physical decontamination) of organic debris such as blood, fat, bone from surgi
reusable respiratory devices (e.g., anesthesia sets), and other critical devices. These units typically co
resistant chamber containing baskets or trays for the soiled instruments; some can accommodate inst
dedicated racks. The equipment performs a cycle of operations typically including water prewash, enz
detergent wash, heated rinse, and drying; the process includes mechanical removal of contaminants b
ultrasound energy and may include thermal disinfection (usually using water from 60 to 95 degrees C
degrees Fahrenheit]). Surgical instrument washer/decontamination units are frequently used as an ad
cleaning of surgical instruments before sterilization; they provide some level of disinfection by killing o
types of microorganisms. They are available in stand-alone and wall-recessed configurations, typically
supplies departments of healthcare facilities.

Washer/sterilizing units designed for automatic or semiautomatic washing (i.e., eliminating dirt and/or
organic debris (e.g., blood, fat, bone), and killing all microorganisms including spore-forming bacteria
present in very high numbers), providing a high level of disinfection that is nearly sterile for surgical in
critical utensils. These units typically consist of one or two corrosion-resistant chambers containing ba
soiled instruments; some can accommodate instrument trays and/or racks. Surgical instrument washe
perform a cycle of operations typically including water prewash, enzyme treatment, detergent wash, h
sterilization (usually using steam from 121 to 140 degrees Celsius [250 to 284 degrees Fahrenheit]), a
usually includes mechanical removal of contaminants by water jets or previous manual scrubbing. Wa
are used in the central supply area of a healthcare facility; their function is frequently replaced by the
washer/decontamination unit and a dedicated sterilizing unit.

Washer/Sterilizing units designed for automatic or semiautomatic washing (i.e., eliminating dirt and/or
organic debris (e.g., blood, fat, bone), and killing all microorganisms including spore-forming bacteria
present in very high numbers), providing a high level of disinfection that is nearly sterile for surgical in
central supply carts. These units typically consist of one or two corrosion-resistant chambers with fron
models) or front-and-back doors that permit pass through of carts (i.e., tunnel type); a control panel, a
jets (booms) and other accessories needed to perform the washing and sterilizing cycles on the soiled
washer/sterilizing units perform a cycle of operations typically including mechanical removal of contam
detergent wash, and germicide application (usually performed using high-pressure booms), and therm
used mainly in the central supply area of a healthcare facility. Dedicated units for open-top carts and f
are available.

Clamps designed to compress anatomic structures and/or to bring together several isolated objects by
or binding them firmly during dental procedures. They are typically handheld, manual instruments inc
pivoted at the center, finished in blunt (i.e., atraumatic) distal ends. Dedicated dental clamps are used
and gingival tissue.
Dental clamps designed for retracting gingival tissue during operative procedures. These clamps are t
handheld, manual instruments with an unbalanced spring; they provide a good working field without i
operative procedures, reducing blood and/or tissue contamination while inserting restorative material
cavity after removal of dental caries. Gingiva dental clamps are used in procedures in which access is
operative procedures prolonged; they were originally intended for gold foil insertion in restorative den
longer frequently performed in dental practice.

Clamps designed to compress anatomic structures and/or to bring together several isolated objects an
pressing, fastening, or binding them firmly during surgical procedures. Surgical clamps are typically ha
instruments including two parts pivoted at the center with blunt (i.e., atraumatic) distal ends. Dedicat
used for directly performing operative procedures directly or for holding ancillary devices in orthopedi
vascular, and other surgical procedures.

Bone surgical clamps designed to grasp and manipulate bones for open reduction of fractures. These
manual instruments typically with one or two flexible, blunt, curved distal jaws, fixed or adjustable in s
reduction devices combine two flexible clamps attached to a mechanism (known as extension clamps

Bone surgical clamps designed to hold small bones or bone fragments, usually during delicate proced
repositioning of fractured or dislocated bones. These clamps are typically handheld, small manual inst
parts pivoted at the center; each part has a blunt curved (rounded) distal end and a proximal end con
most devices include ratchet mechanisms. They are also used to hold small bones (e.g., fingers, toes)
other instruments (e.g., cutting forceps).

Bone surgical clamps designed to provide a firm grip on the crescent-shape disks of fibrocartilage (i.e.
to the bones (e.g., tibia). These clamps are typically handheld, small manual instruments including tw
center with a curved shank and a set of sharp pins in one jaw and matching holes in the other jaw tha
especially appropriate to grip the meniscus. Meniscus clamps are used for meniscus dissection and re

Bone surgical clamps designed to grasp, stabilize, and center bone plates firmly in position. These cla
manual instruments typically with two straight or angled blunt curved distal jaws; one jaw end is curv
and the other is especially conformed to hold the plate. Some clamps include a drill guide to maintain
fracture site and drill a screw hole simultaneously. Bone plate holding clamps are used to apply bone p
fracture fragments.

Surgical clamps designed to hold, grasp, and/or manipulate fibrous connective tissue (i.e., cartilage). T
are handheld, manual instruments with two straight or curved distal jaws. Cartilage clamps are mainl
procedures.
Eye (ophthalmic) surgical clamps designed to temporarily and atraumatically grasp the eyelid edge an
hemostasis. These devices are typically small, handheld, manual instruments resembling small tweez
distal ends; one of the ends is solid and the other resembles a ring that can be locked using a threade
surgical clamps are used in procedures intended to treat eyelid cysts and other abnormalities (e.g., ho
Eye (ophthalmic) surgical clamps designed to temporarily and atraumatically grasp the orbital muscle
the inner lining of the upper eyelid during ophthalmic surgery. These clamps are typically handheld, m
instruments with two long distal ends that can be locked together and a handle; they frequently includ
mechanism that is turned until the tissues are firmly secured. The tissues within the clamp are then ex
appropriate blade. Muscle eye clamps are used to correct abnormal upper eyelid margin (ptosis) and i
upper eyelid (i.e., blepharoplasty).

Surgical clamps designed to temporarily and atraumatically grasp the fallopian tubes during gynecolo
clamps are typically small snap-on instruments that are applied using special forceps. Fallopian tube c
gynecological microsurgical procedures, including midtubal and uterotubal anastomosis.

Intestinal surgical clamps designed for the atraumatic grasping or compression of a portion of the colo
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
appropriate for the manipulation of the colon in the deep abdomen or pelvis; the instruments include
straight, angled, or curved distal blades and appropriate handles. Dedicated intestinal clamps are ava
and/or anastomosis (end-to-end and lateral) of the colon, frequently including a locking mechanism; o
are intended for colostomy.

Intestinal surgical clamps designed with the appropriate size for the atraumatic grasping or compressi
colon. These clamps are typically handheld, manual instruments with two rectangular blades hinged a
in locking mechanism at the other end. Locking colon clamps are used to facilitate end-to-end, lateral
anastomosis, preventing bleeding; they are also used in the excision of colon diverticula.

Intestinal surgical clamps designed for the atraumatic grasping or compression of a portion of the sma
open-surgery procedures. These clamps are typically handheld, manual instruments including two par
center with a size appropriate for the manipulation of the small intestine in the deep abdomen; the in
include smooth or serrated, straight, angled, or curved distal blades and appropriate handles. Dedicat
clamps are available for resection and/or anastomosis (end-to-end and lateral) of specific segments of
(i.e., duodenum, jejunum, ileum), frequently including a locking mechanism; other dedicated devices
ostomy procedures.

Intestinal surgical clamps designed with the appropriate size for the atraumatic grasping or compressi
small intestine, providing a locking mechanism. These clamps are typically handheld, manual instrum
parts that have rectangular distal blades and a built-in locking mechanism at the other end. Dedicated
intestine (i.e., duodenum, jejunum, ileum) clamps are used to facilitate end-to-end, lateral, and end-to
preventing bleeding.

Surgical clamps designed for the atraumatic grasping and manipulation of the kidney during open-sur
clamps are typically handheld, manual instruments including two parts pivoted at the center with curv
blades at the working end and appropriate ratchet handles. Kidney clamps can be used in the transve
oblique axis of the kidney, permitting a dry field during resection while preserving perfusion of the rem
organ.

Surgical clamps designed for the atraumatic grasping and/or compression of the kidney pedicle during
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
or right-angled distal blades and appropriate ratchet handles; some clamps include interlocking longit
prevent slipping. Kidney pedicle clamps are used mainly to control the blood supply to the kidney duri
procedures.
Surgical clamps designed to atraumatically grasp the liver during open-surgery procedures. These cla
handheld, manual instruments including two parts pivoted at the center with very long and slightly cu
handles that include a ratchet mechanism. Some clamps have a locking device at the distal end. Dedi
available for liver transplant and/or for resection of portions of the liver.

Surgical clamps designed for the atraumatic grasping or compression of a portion of the stomach duri
procedures. These clamps are typically handheld, manual instruments with flat, long-nosed parallel ja
(e.g., threaded) to a U-shape handle. Dedicated gastric clamps are available according to the characte
areas that they are intended to compress or separate (e.g., proximal and/or distal region, pylorus) and
performed (e.g., resection); some gastric clamps include a twin clamping mechanism or a mechanism
together.

Stomach (gastric) surgical clamps designed for the atraumatic grasping or compression of the canal b
and the duodenum (i.e., pylorus) during open-surgery procedures. These clamps are typically handhel
with flat, long-nosed parallel jaws that are articulated (e.g., threaded) to a U-shape handle. Pylorus cla
gastrointestinal procedures involving the pyloric sphincter.
Surgical clamps designed for the atraumatic grasping or compression of a portion of the lungs during
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
serrated, distal blades and appropriate handles. Dedicated pulmonary clamps are available for wedge
of a lung; some lung clamps can be also used as bronchus clamps and/or to occlude the pulmonary ar

Middle-ear surgical clamps designed for holding the ossicles. These clamps are typically handheld, ma
two strips of metal joined at one end (i.e., resembling thumb forceps) with a threaded mechanism to p
temporary grasp of the ossicles.
Surgical clamps designed to compress the foreskin of the penis during circumcision of a male infant. T
usually handheld, manual, single-use (i.e., disposable) plastic devices that are placed over the penis,
degrees of protection (or none at all) to the glans according to the design. Typically, the whole clamp o
components are left on the penis for several days until they drop off or are detached.

Surgical clamps designed to compress the foreskin of the penis during circumcision of a male infant. T
typically handheld, reusable, manual, metallic instruments that include a post, a bell, and a plate; the
placed over the glans (for its protection); the foreskin is pulled over the outside of the bell, clamped b
the plate, and excised with a surgical knife that is run around the bell. A variety of different devices ar
different degrees of protection (or none at all) to the glans.

Surgical clamps designed to grasp and/or compress the muscles of the neck, particularly those of the
hyoid bone. These clamps are typically handheld, manual instruments including two parts pivoted at t
blade that includes teeth, another blade with a coupling longitudinal serration, and a handle with a ra
Strap muscle clamps are used in conjunction with a thyroid dissector for division of the thyroid muscle
thyroidectomy.

Surgical clamps designed for the atraumatic grasping of the isthmus of the thyroid gland during open-
These clamps are typically handheld, manual instruments including two parts pivoted at the center wi
serrated distal blades and appropriate handles with ratchet mechanisms. Thyroid surgical clamps are
intended to resect the thyroid gland and/or associated malignant tumors.
Surgical clamps designed for the atraumatic grasping and/or compression of the meatus and polypoid
caruncles) in the urinary membrane of the meatus in women. These clamps are typically handheld, m
including two parts pivoted at the center with two straight, tapering, distal jaws and a ratchet handle.
meatus/caruncle surgical clamps are used in meatotomy and in the excision of caruncles.

Surgical clamps designed for the atraumatic grasping, compression, and/or manipulation of the ureter
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
working ends having opposite rows of noncrushing teeth to facilitate the lateral strip of the ureter and
the lower ureter in congenital dilatation ureters (megaloureter). Several clamps are usually needed in
procedures intended to repair and/or modify the ureter.

Surgical clamps designed for the atraumatic grasping of the cervix (e.g., the anterior lip), to facilitate
manipulation of the uterus. These clamps are typically handheld, very thin manual instruments includ
at the center each with specially shaped, blunt distal blades. Cervical uterine clamps are used in a var
such as rotation of the uterus into its normal position, vagina mobilization from the rectum and the pe
foreign bodies (e.g., intrauterine device fragments), and to facilitate catheter insertion.

Uterine surgical clamps designed to atraumatically cut off the uterine blood supply while excising fibro
myomectomy). These clamps are typically handheld, manual instruments including two parts pivoted
a specially shaped, wide, blunt distal blade; they may include a four-hole handle for easy manipulation
are used to control blood flow to and from the uterus, providing a bloodless operative field.

Uterine surgical clamps designed for the atraumatic grasping of the parametrium tissue with minimal
These clamps are typically handheld, manual instruments including two parts pivoted at the center ea
that may be smooth or serrated; several jaw designs (e.g., S-shaped) are available to minimize the pr
holding the tissue; these clamps usually include a handle with a ratchet mechanism with variable sett
clamps are used during vaginal or abdominal excision of the uterus (i.e., hysterectomy).

Aorta vascular surgical clamps designed for the atraumatic compression of the aorta during vascular a
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
long distal blades that are usually serrated and curved in a semicircular shape; other aorta anastomos
mechanism that operates two semicylindrical distal ends that hold and compress the artery. Anastomo
clamps are used in procedures such as anastomosis of the aorta to the pulmonary artery.

Aorta vascular surgical clamps designed for the atraumatic compression of the neck of aortic aneurysm
surgery procedures, usually to cause complete temporary occlusion of the aneurysm. These clamps ar
manual instruments including two parts pivoted at the center with serrated, slightly curved, distal bla
locking mechanism.
Vascular surgical clamps designed for the gradual atraumatic compression of the pulmonary artery du
procedures, usually to cause total or partial temporary occlusion (i.e., coarctation). These clamps are t
manual instruments with two movable prongs at the distal end that are operated by rotation of the ha
mechanism. Dedicated pulmonary artery clamps are available for controlled gradual occlusion and/or
artery.
Vascular surgical (i.e., bulldog) clamps designed for the atraumatic compression of an artery to arrest
during microsurgical procedures. These clamps are typically handheld, manual instruments with two m
conformed at the distal end as tiny, straight or curved blades and at the proximal end as flat handles
with the thumb and fingers), connected by a locking spring; the two parts are joined by a swivel pin at
microsurgical spring clamps have a cross-action mechanism instead of a spring and a swivel pin. Dedi
spring artery clamps are available in a variety of shapes and sizes appropriate for specific blood vesse
coronary artery, intracranial).

Vascular surgical clamps designed for the atraumatic compression of veins or arteries during microsur
usually to cause total or partial occlusion (i.e., coarctation). These clamps are typically small, handhel
actuated, centrally pivoted, snap-on instruments with straight or curved distal blades; they are usually
such as testicular implantation. Microsurgery vascular clamps are also used in the restoration of the v
vasectomy (i.e., vasovasostomy). Some clamps are used in pairs attached to a vice.

Vascular surgical clamps designed for the atraumatic compression of veins or arteries during microsur
procedures in infants/neonates, usually to cause total or partial occlusion (i.e., coarctation). These clam
handheld, manual instruments including two parts pivoted at the center; dedicated microclamps of ap
configurations are available for performing specific surgical procedures on infants.

Vascular surgical clamps designed for the total or partial occlusion (i.e., coarctation) of the vena cava
procedures. These clamps are typically handheld, manual instruments including two parts pivoted at t
or curved distal blades and ring handles. The serrated region has a central, nonserrated trough runnin
trauma to the enclosed vessel. Vena cava clamps are mainly used during open thoracic surgery; dedic
include an indwelling cannula are also available.

Vascular surgical clamps designed for occlusion of the vena cava during surgical procedures, permittin
an indwelling cannula (or catheter). These clamps are typically manual, ring-handled instruments inc
pivoted at the center with straight or curved serrated distal blades. The serrated region has a central
permits flow through the cannula while occluding the vein. Vena cava indwelling cannula clamps are m
cardiopulmonary bypass procedures.

Vascular surgical clamps designed for the atraumatic compression of one of the appendages (i.e., auri
atrium (either right or left) during open-surgery procedures, usually to cause total or partial temporary
clamps are typically handheld, manual instruments including two parts pivoted at the center with serr
blades and a ratchet locking mechanism. Dedicated auricle clamps are available in several sizes and c
the patient's anatomy and the intended surgical procedure.

Surgical clamps designed to atraumatically grasp the ductus (vas) deferens during vasectomy procedu
typically handheld, manual instruments including two parts pivoted at the center; dedicated vasectom
with small teeth that are relatively atraumatic to the scrotum and permit ductus exposure and with bl
to transfix the vas for injecting anesthesia.
Clamps designed to compress anatomic structures and/or to bring together several isolated objects an
pressing, fastening, or binding them firmly during postmortem procedures (e.g., autopsy, dissection).
typically handheld, manual instruments including two parts pivoted at the center with blunt distal end
stronger than surgical clamps and may cause some degree of trauma to tissues. Dedicated postmorte
anatomic instruments or to hold ancillary devices in autopsies and dissection procedures.
Clamps designed for external (i.e., noninvasive) atraumatic compression of anatomic structures to pro
occlusion of a natural duct. These clamps are handheld, manual, instruments including two parts pivo
with spring-operated mechanisms, usually with padded distal ends. Dedicated external occlusion clam
suppress urine circulation through the penis or to interrupt breathing through the nose.

Clamps designed to hold and manipulate towels without damaging them. These clamps are available
configurations; they are frequently a manual instrument with two blades that are either crossed at the
permitting manipulation in a cross-action or joined at their midportion resembling forceps or scissors.
have blunt ends; they are designed to temporarily attach or hold towels during surgical and/or other m

Tubing clamps designed to grasp and compress an infusion line (e.g., peripheral, central venous, hem
damaging it. These clamps are available in several sizes and configurations according to the infusion l
the procedure performed; they frequently include a mechanism (e.g., a roller) that partially or comple
Infusion line clamps are used to close the line to any substance that is or may be infused and/or draw
system.

Tubing clamps designed to grasp and compress a suction line without damaging it. These clamps are t
including two parts pivoted at the center, with distal blades that are serrated and straight or curved. S
used for partially or completely obstructing a suction line.
Tubing clamps designed to hold rigid or flexible tubing during clinical laboratory procedures. These cla
variety of materials, shapes, and sizes according to the tubing diameter and thickness and/or the proc
performed; some clamps can be adjusted (e.g., threaded) to regulate flow through flexible tubes. Ded
tubing clamps are available that resist heat (e.g., up to more than 220 degrees Celsius/430 degrees Fa
chemicals (e.g., salts, solvents, acids).

Clamps designed to hold beakers and/or flasks during clinical laboratory procedures. These clamps are
of materials, shapes, and sizes according to the beaker/flask size and/or the procedure to be performe
laboratory beaker/flask clamps are available that resist heat (e.g., up to more than 220 degrees Celsiu
Fahrenheit]) and/or chemicals (e.g., salts, solvents, acids).
Clamps designed to hold one or more test tubes during clinical laboratory procedures. These clamps a
variety of materials, shapes, and sizes according to the test tube diameter and/or the procedure to be
frequently corrosion-protected spring wires and/or threaded metallic devices. Dedicated laboratory tes
available that resist heat (e.g., up to more than 220 degrees Celsius [430 degrees Fahrenheit]) and/or
solvents, acids).

Clamps designed to fix attachments to examination and/or operating tables. These clamps typically ar
that include a mechanism for fixing to the table (e.g., on the rails) and that can hold small instrument
some table clamps include locking capabilities. Examination/operating table clamps are used to add c
tables by incorporating accessories such as foot supports, intravenous tube poles, and instrument hol

Clip appliers designed to deliver small implantable clips for external occlusion of the fallopian tubes w
tube. These appliers may include a mechanism for single or multiple insertions of clips. Dedicated fall
are available for open and/or laparoscopic surgical procedures; they are mainly intended for applying
occlusion of the tubes, usually for sterilization purposes.
Clip appliers designed to deliver small atraumatic implantable clips for external occlusion of the fallop
laparoscopic procedures. These appliers may include a mechanism for single or multiple insertions of
fallopian tube clip appliers are used for applying clips for permanent occlusion of the tubes, usually fo

Clip appliers designed to deliver small atraumatic implantable clips in the upper and/or the lower gast
walls through the working channel of an endoscope. These appliers typically include a fixing device w
mechanism for direct orientation of the clips. Clips are loaded into the applier and drawn into a sheath
out of the sheath at the lesion site, oriented with a rotational handle, and then deployed. Multiple-use
use devices are available. GI tract clip appliers are used for treatment of bleeding in diseases such as
angiectasis, and gastric tumors; they are frequently used following sphincterotomy and biopsy in the u
appliers can also be used for surgical procedures in the lower GI tract, such as diverticula and rectal u
polypectomy and biopsy.

Clip appliers designed for the application of small clips with sharp points that can grasp the edges of a
minimum trauma. Manually operated, forceps-like devices are available with appropriate jaws and me
insertions of suture clips in the skin edges as fast as the edges can be approximated. These instrumen
close wounds; the applied clips are made of nondegradable materials requiring removal after healing
(absorbable) materials.

Disposable vascular clip appliers designed for application of atraumatic vascular microclips intended f
of blood veins or arteries in the scalp during a single surgical procedure to stop and/or prevent bleedin
These appliers are available in a variety of shapes and sizes; some appliers include a mechanism for m
clips. Disposable (single use) scalp clip appliers are typically made of plastic; they are mainly used in
procedures.

Reusable vascular clip appliers designed for application of atraumatic microvascular clips usually inten
blood veins or arteries in the scalp, to stop and/or prevent bleeding (i.e., hemostasis). These appliers
variety of shapes and sizes; some appliers include a mechanism for multiple insertions of clips. Reusa
are typically metal; they are mainly used in neurosurgical procedures. The applied clips are usually int
use during surgery.

Reusable vascular aneurysm clip appliers designed for application of atraumatic microclips for total or
ligature of intracranial aneurysms to stop and/or prevent bleeding (i.e., hemostasis). These appliers ar
of shapes and sizes; they frequently include a mechanism for multiple insertions of intracranial clips. I
clip appliers are used to apply clips to the neck of an aneurysm; the applied clips may be intended for
neurosurgical procedures or as permanent implants.

Small metallic clips designed to be implanted for blood vessel and/or other anatomic tubular structure
permanent suture of internal wounds, or to fix tissues together. Implantable clips are frequently applie
instruments (e.g., clip appliers). They are implanted during vascular, ophthalmologic, contraceptive, g
other surgical procedures.
Implantable clips designed to bring together tissues or to occlude small blood vessels in the eye. Thes
small, metal (typically tantalum) devices that are implanted using dedicated appliers. Implantable oph
intended to approximate the edges of a wound and/or for hemostasis of small blood vessels in the eye
Eye (ophthalmic) implantable clips designed to approximate the edges of an eye wound. These clips a
U-shaped, metal (e.g., tantalum) devices with ends that close around the wound edges. Wound ophth
facilitate wound healing and/or to prevent bleeding from small blood vessels.

Eye (ophthalmic) implantable clips designed to secure the overlapped ends of an implantable ophthal
These clips are typically very tiny, U-shaped, metal (e.g., tantalum) devices with ends that close aroun
Iris-implantable clips are used in the scleral buckling technique, a surgical procedure intended for retin

Implantable clips designed for occlusion of the cystic duct, either in open surgery or during laparoscop
clips are typically small metal devices. One clip is applied to the cystic duct near its junction with the
additional clips are placed near the point where the cystic duct joins the common bile duct. Implantab
intended to close the duct in surgical procedures to excise the gall bladder.

Implantable clips designed for attaching to the lining of the stomach or intestinal tract, typically using
procedures. These clips are typically small metallic (e.g., titanium) devices that are applied using dedi
Implantable gastrointestinal clips are mainly used for hemostasis (e.g., in mucosal defects, bleeding u
anchoring of jejunal feeding tubes, endoscopic marking, and closing of perforations.

Implantable vascular clips designed for extravascular occlusion of intracranial vessels. These clips are
devices that are externally applied to the vessels using dedicated appliers. Implantable intracranial cl
to prevent and/or control bleeding (i.e., hemostasis); dedicated devices are available for occlusion of i

Intracranial implantable vascular clips designed for extravascular occlusion of aneurysms in the vascu
cranium. These clips are typically small metal devices that are externally applied to the aneurysm usin
Aneurysm implantable intracranial blood vessel clips are used mainly to prevent and/or control bleedi
during and after neurosurgical procedures.
Implantable vascular clips designed for extravascular occlusion of the scalp vasculature. These clips a
metallic devices that are externally applied to the vessels using dedicated appliers. Implantable scalp
intended mainly for hemostasis during neurosurgical procedures.
Implantable vascular clips designed for extravascular occlusion of small peripheral veins or arteries. T
small metallic devices that are externally applied to the vessels using dedicated appliers. Implantable
vessel clips are intended mainly for surgical hemostasis.
Clips designed for external occlusion of the umbilical cord of a newborn. These clips are typically smal
instruments with two blades that are closed to compress the vasculature of the umbilical cord. Umbilic
disposable (i.e., single-use) devices; they may be manually delivered and discarded or self-discarded a

Clips designed for temporary atraumatic (i.e., without intentionally piercing) attachment or occlusion
(e.g., blood vessels, fallopian tubes) and/or small ancillary devices (e.g., towels, drapes, bandages) du
procedures. These clips are typically small (usually metal) instruments with two blades joined at the m
from a single alpha-shaped part and permit only a small jaw opening, have a normally closed resting s
include a handle or other proximal attachment. They can be delivered manually or with an instrument
forceps. Surgical clips are used for skin and internal suturing, vascular hemostasis, and temporary occ
anatomic ducts and can hold surgical instruments and/or other small ancillary devices.
Surgical clips designed for the temporary atraumatic occlusion of blood vessels during surgical proced
typically small, usually metal instruments with two blades joined at the midportion or made from a sin
Vascular clips are usually applied manually; they do not include a handle or other proximal attachmen
They are used mainly for hemostasis and/or to facilitate surgical procedures by temporarily interruptin
particular site of the body.

Vascular surgical clips designed for the temporary atraumatic occlusion of blood vessel aneurysms du
procedures. These clips are typically small, usually metal (e.g., cobalt, titanium alloy) instruments with
the midportion or made from a single alpha-shaped part. Aneurysm surgical clips are usually applied m
include a handle or other proximal attachment for manipulation. Aneurysm clips are used mainly for h
facilitate surgical procedures by temporarily interrupting of blood circulation into a vessel aneurysm.

Vascular surgical clips designed for the atraumatic compression of veins or arteries during microsurgic
to cause total or partial temporary occlusion. These clips are typically small cross-action snap-on instr
vascular clips are typically used in vascular procedures such as testicular implantation; they are also u
of the vas deferens after vasectomy (i.e., vasovasostomy).

Curettes designed to remove a sample of tissue intended for laboratory examination and/or test (i.e.,
anatomic structure of the body. These curettes are typically manual, handheld, or endoscopic instrum
fenestrated (e.g., a ring, loop) working end that resembles a spoon with sharp or blunt edges and a ha
Biopsy curettes are used to collect tissue specimens from the uterus (endometrium), bronchium, and
devices are especially designed for endoscopic use.

Biopsy curettes designed to remove superficial tissue from the internal wall of the bronchial tree throu
bronchoscope), usually under imaging (e.g., fluoroscopic, helical computed tomography) guidance. Th
typically manual instruments with a long shaft and a distal working end that resembles a solid or ring-
appropriate for introduction through the working channel of the bronchoscope and a proximal end with
permits manipulation (e.g., flexion, rotation) of the working end. Bronchoscopic biopsy curettes are av
flexible (e.g., double-hinged curettes) or rigid endoscopes; they are typically used to obtain samples o
and/or tumors.

Endoscopic biopsy curettes designed to remove superficial tissue from the internal wall of the bronchi
flexible endoscope (i.e., bronchoscope), usually under imaging (e.g., fluoroscopic, helical computed to
These curettes are typically disposable manual instruments with a long flexible (e.g., double-hinged) s
end that resembles a very narrow solid spoon with sharp edges and a size appropriate (typically less t
for introduction through the working channel of a flexible bronchoscope; and a proximal end with a me
manipulation (e.g., flexion, rotation) of the working end. Flexible bronchoscopic biopsy curettes are ty
samples of large- or fine-diameter bronchial tissue and/or tumors.

Endoscopic biopsy curettes designed to remove superficial tissue from the internal wall of the bronchi
endoscope (i.e., bronchoscope), usually under imaging (e.g., fluoroscopic, helical computed tomograp
curettes are typically manual instruments with a long stiff shaft; a distal working end that resembles a
spoon with sharp edges and a size (typically less than 2 mm diameter) appropriate for introduction th
channel of a rigid bronchoscope; and a proximal end with a mechanism that permits manipulation (e.g
the working end. Rigid bronchoscopic biopsy curettes are typically used to obtain samples of large-dia
and/or tumors.
Biopsy curettes designed to remove nasal mucosal cells for laboratory examination and/or test, usuall
the surface of the inferior turbinate. These curettes are typically single-use, plastic, handheld, manual
spoonlike working end of about 1.5 mm diameter and 0.5 mm depth and a flexible handle. Nasal biop
collect samples for testing to determine the respiratory epithelial response to air pollutants and for as
(e.g., in cystic fibrosis patients).

Biopsy curettes designed to remove superficial tissue from the uterine endometrium (either from the b
from the cervical canal) for laboratory examination and/or test. These curettes are typically handheld,
with a rounded, ring-like, working end that may be also serrated; a shaft that is frequently malleable;
single-use devices that include a semi-rigid tapered cannula with sharp slots for better sampling from
endometrial cavity are also available.

Uterine endometrium biopsy curettes designed to remove tissue from the internal lining of the cervica
are typically single-use synthetic (e.g., nylon), handheld, manual instruments that can remove superfi
damage to the tissue. Uterine cervix biopsy curettes are used to obtain histologic tissue samples from
for early detection of endocervical carcinoma (e.g., cervical cancer screening tests).

Uterine curettes designed for scraping and suctioning the uterine lining (i.e., endometrium) and/or the
uterus. These curettes are usually metal, straight or angled, handheld manual instruments, with blunt
end and one or more openings to allow the passage of aspirate. The curette is attached to a uterine su
evacuate fluids, tissue from the uterine lining, and/or contents of the uterus. Biopsy/surgical suction u
used to obtain tissue samples (some devices attach a single-use strainer to collect the sample); they a
remove the contents of the uterus after incomplete miscarriages or in abortion procedures (e.g., uteri
procedures).

Curettes designed to scrape and/or remove superficial tissue from an anatomic cavity, surface, or stru
procedures. These curettes typically consist of handheld, manual instruments with a working end that
ring-like spoon with sharp or blunt edges and a handle at the other end; some surgical curettes have w
extremes. Dedicated surgical curettes are available for use in a variety of tissue (e.g., bone, skin, ear,
procedures (i.e., gynecologic, orthopedic, otolaryngology, ophthalmic, spinal surgery). Some surgical c
designed for endoscopic use.

Curettes designed to remove tissue and/or materials from the teeth and/or adjacent tissue during den
curettes are typically handheld, manual instruments with a working end that resembles a solid or ring
or blunt edges and a handle at the other end. Dedicated dental curettes are available for endodontic (
procedures, for excising tissues (i.e., periodontic) around the teeth, and for removal of subgingival cal

Dental curettes designed for scraping and/or excising tissue surrounding the teeth. These curettes are
manual instruments with a working end that resembles a solid or ring-like spoon with sharp edges and
end. Dedicated periodontal curettes are available for subgingival calculus removal, root planing, and r
from periodontal pockets; larger and heavier devices are also available for periodontal surgery.

Periodontal curettes designed for scraping and/or excising tissue surrounding the teeth during operati
procedures. These curettes typically consist of handheld, manual instruments with a working end that
ring-like spoon with sharp edges and a handle at the other end; these devices are usually larger and h
used for routine scaling. Periodontal operative curettes are used mainly to remove granulation, fibrous
remove subgingival calculus deposits.
Periodontal curettes designed for subgingival calculus removal (i.e., scaling). These curettes are typica
instruments with a working end that resembles a solid or ring-like spoon with sharp edges and a hand
Periodontal curettes with two cutting edges on each blade (i.e., universal curettes) that adapt to most
and devices designed with only one cutting edge that is angled according to a particular area of the d
specific curettes) are available. Scaling periodontal curettes are also used for root planing and to remo
periodontal pockets.

Periodontal curettes designed to adapt to most areas of the dentition for subgingival calculus removal
two cutting edges. These curettes are typically handheld, manual instruments with a working end tha
spoon with two cutting edges on either side of the face and a handle at the other end. Two-cutting-edg
(known as universal curettes) can adapt to most areas of the dentition by modifying the hand position
They may be also used, with some limitations, for root planing and to remove soft tissue from periodo

Periodontal curettes designed to adapt to a particular area of the dentition for subgingival calculus rem
using a single cutting edge. These curettes are typically handheld, manual instruments with a working
a specific area of the dentition and that resembles a solid spoon and a handle at the other end; they in
edge. Single-cutting-edge periodontal curettes (known as area-specific curettes) are available in a var
angulations, and contra-angulations of the shank. Single-cutting-edge periodontal curettes are the bes
curettes for root planing and for removing soft tissue from periodontal pockets.

Dental curettes designed for excising tissue, usually to clean out debris from infected cavities in bone
during surgical procedures in the oral cavity. These curettes are typically handheld, manual instrumen
that resembles a solid spoon with sharp edges and a handle at the other end. Oral surgery/dental cure
many sizes, with straight or angled shapes according to the nature and location of the bone cavity or

Surgical curettes designed for scraping and/or excising tissue from bones. These curettes are typically
handheld, manual instruments with a sharp, oval or round cup at the distal end and a straight, curved
attached to or finished in a sturdy handle as an integral part of the instrument. Bone curettes are mai
bones in orthopedic procedures (e.g., prostheses implantation); dedicated bone curettes are also avai
orthopedic surgical procedures including spinal surgery and/or microsurgery.

Bone surgical curettes designed for microsurgical removal of bony, calcified, or other hard tissue. Thes
typically very slender, handheld, manual instruments with a bayonet shape and a straight or angled (e
shaft. Microsurgical bone curettes are mainly used to thin bone before removal, frequently combined w

Bone surgical curettes designed for scraping and/or excising bone tissue from the spine. These curette
metallic, handheld, manual instruments with a sharp, round cup-like working end and a long straight s
or finished in a sturdy handle as an integral part of the instrument. Spinal bone curettes are used in o
procedures performed in the spine, such as lumbosacral fusion; dedicated curettes are available for su
performed in the spinal discs (e.g., discectomy).

Spinal surgical curettes designed for scraping and/or excising bone tissue from the spinal discs. These
handheld, manual instruments including a shaft with a straight, backward-, or forward-angled spoon-li
attached to a sturdy handle. Spinal disc curettes are available in several sizes and shapes appropriate
and/or cervical discectomy; some curettes may be used under a microscope to perform microdiscecto
Surgical curettes designed to remove tissue by scraping the skin. These curettes are typically slender,
manual instruments with an oval or round blade at the distal (straight, curved, or angled) end that is a
Skin curettes are used mainly to remove growths (such as warts or basal cell carcinomas) after a biop
another means; these devices are less commonly used for diagnosis (i.e., biopsy) because they may p
sample (i.e., they break the specimen into pieces), which sometimes precludes microscopic evaluation
that are helpful in diagnosis.

Surgical curettes designed to remove tissue by scraping within the external ear and/or ear canal. Thes
slender, metal, handheld, manual instruments with a serrated or blunt loop at the distal (straight, slig
end. These devices are used mainly to remove tissue from the ear canal; some dedicated instruments
used to extract difficult-to-remove ear wax from the ear canal.

Surgical curettes designed to remove tissue by scraping or excising the eye and/or eyelid surface. The
typically slender, metallic, handheld, manual instruments with a serrated, round, or oval cup at the dis
curved) end. Dedicated surgical ophthalmic curettes are available for corneal scraping, capsule polish
treatment of eyelid inflammation masses (i.e., chalazion).
Eye surgical curettes designed for excising eyelid inflammation masses (i.e., chalazion). These curette
handheld, manual instruments with a serrated, round cup at the distal (straight or angled) end with an
1 to 3 mm diameter). Chalazion curettes are used in surgical procedures of the eyelids.

Eye surgical curettes designed for scraping the cornea. These curettes are typically metal, handheld, m
with a serrated, round or oval cup at the distal (straight or angled) end with an appropriate size (e.g.,
Corneal curettes are used in ophthalmic surgical procedures; they are frequently used to remove forei
cornea surface.
Surgical curettes designed for debridement of tissue during open joint surgery and/or arthroscopic pro
curettes are typically slender, metallic, manual, handheld or endoscopic instruments with solid spoon-
edge working ends, a straight shaft, and a fine handle (a triangular shape is typical). Dedicated joint c
debridement of cartilage in open orthopedic surgical procedures, such as the insertion of a patch in pa
defects; joint curettes intended to perform orthopedic procedures through endoscopes (i.e., arthrosco

Surgical curettes designed for shaping bone and/or cartilage during endoscopic procedures in the join
These curettes are typically slender, manual, metal instruments with a cup-like or ring-like sharp-edge
(frequently faceted to facilitate insertion), a straight flexible shaft, and a fine handle appropriate to m
end. Endoscopic joint surgical curettes are used in a variety of arthroscopic procedures, including hip a
repair of indentation and depressions in bones (also known as notchplasties).

Surgical curettes designed to remove tissue from middle-ear structures (including the ossicles) by scra
These curettes are typically slender, metallic, handheld, manual instruments with a serrated, round, o
the distal end; a straight or slightly curved shaft, and a fine handle. Dedicated middle-ear (i.e., endau
are available in a variety of shapes and sizes according to the procedure to be performed; dedicated c
procedures include curettes to remove the superior bony rim in stapedectomy, to remove the mastoid
mastoidectomy, to scrape sinus tissue, and to remove necrotic mucosa from the antrum.
Middle-ear curettes used in surgical procedures performed under the microscope. These curettes are t
handheld, manual instruments with sharp 1 to 2 mm diameter edges at the working end, straight or c
fine handle. Dedicated microsurgical middle-ear curettes are available in single- and double-ended co
stapedectomy, tympanoplasty, and myringoplasty microsurgical procedures.

Surgical curettes designed to remove tissue by excising and or scraping within the nose or related tiss
typically slender, metal, handheld, manual instruments with the distal end finished in an appropriate s
spoon-like) according to the procedure to be performed. Nasal curettes are available in a variety of sh
specialized instruments are available for the adenoids, ethmoid bone, and paranasal sinuses.

Surgical curettes designed to remove tissue by excising the adenoid glands (i.e., adenoidectomy). The
typically slender, metal, handheld, manual instruments with a wide handle and a distal concave inner
convexity of the posterior pharyngeal wall to facilitate the removal of lymphoid tissue, avoiding injury
muscles. Adenoid curettes are the instruments most commonly used to excise the adenoids; adenoids
excised using more elaborate instruments known as adenotomes.

Surgical curettes designed to remove tissue by excising the ethmoid cells or a portion of the ethmoid
ethmoidectomy). These curettes are typically slender, metallic, handheld, manual instruments with on
ends that are usually sharp on both sides.
Surgical curettes designed for scraping and/or excising tissue from one of the paranasal sinuses. Thes
slender, metal, handheld, manual instruments with the distal end finished in an appropriate shape (e.
spoonlike) according to the procedure to be performed. Paranasal sinus curettes are available in a var
sizes; dedicated instruments are available with appropriate characteristics (e.g., sharp, blunt, single- o
each of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary).

Surgical curettes designed for scraping and/or excising tissue from the pituitary gland. These curettes
metallic, handheld, manual instruments with a sharp cup end, angled or bayonet-like shaft, and a fine
surgical curettes are used in partial or total excision of the gland (i.e., hypophysectomy).

Surgical curettes designed for scraping and/or excising tissue from the uterine lining or the uterus con
are usually plastic or metallic, straight or curved, handheld, manual instruments with sharp edges; so
one or more openings to allow the passage of aspirate by suctioning. Dedicated uterine surgical curet
excise tissue from the uterine cervix, the uterus, and/or the placenta and ovum in pregnant women.

Uterine surgical curettes designed for scraping the uterine lining to remove tissue and the uterus cont
women (i.e., placenta and fetus). These curettes are typically metal, handheld, manual instruments w
blunt loop at the distal end, a straight or curved shaft, and a sturdy handle. These curettes are availab
malleable versions. Uterine placenta and ovum curettes are used mainly after incomplete miscarriage
procedures.
Burs designed to be held and rotated by a surgical handpiece (manual, electrical, or pneumatic) to ex
tissue during surgical procedures. These burs typically consist of a shank made of steel or tungsten ca
differentiated working head in a variety of sizes and shapes (e.g., round, cylinder, inverted cone, pear
tapered, notched, or elongated proximal end to fit into the rotary device; and a neck that connects the
part. Dedicated surgical burs are available for many different types of procedures, including orthopedi
oral, ophthalmic, podiatric and plastic surgery. They are usually intended for reuse after sterilization, b
use) surgical burs are also available.

Surgical burs designed to excavate, perforate, reshape, and/or excise fragments of bone usually durin
procedures, including podiatric surgery. These burs typically consist of a shank made of steel or tungs
differentiated working head (sometimes with bound diamond chips) in a variety of sizes and shapes (e
inverted cone, pear) on the distal end; a tapered, notched, or elongated proximal end to fit into the ro
that connects the shank to the working part. Dedicated bone burs are available for many different use
bones for prosthetic procedures and cranial perforation before intracranial surgery and/or biopsy. They
after sterilization but disposable (single use burs are also available).

Bone surgical burs designed to excavate, cut, polish, shape, and/or remove bone and/or cartilage duri
(endaural) procedures. These burs typically consist of a shank made of steel or tungsten carbide with
working head in a variety of sizes and shapes (e.g., round, cylinder, conical) on the distal end; a taper
elongated proximal end to fit into the rotary device; and a neck that connects the shank to the workin
middle-ear surgical burs are available for incision of the mastoid bone and for polishing or cutting the
structures. Middle-ear burs are usually intended for reuse after sterilization, but disposable (single use
available.

Middle-ear surgical burs designed for cutting and removal of tissue. These burs typically consist of a s
tungsten carbide with a well-differentiated working head with an appropriate shape (e.g., cone, tapere
the distal end; a tapered, notched, or elongated proximal end to fit into the rotary device; and a neck
shank to the working part. Cutting middle-ear burs are used in a variety of procedures (e.g., repair of
stapedectomy); they are usually intended for reuse after sterilization, but disposable (single use) devi

Middle-ear surgical burs designed for removal of the mastoid bone. These burs typically consist of a sh
tungsten carbide with a well-differentiated working head with an appropriate shape (e.g., cone) and si
tapered, notched, or elongated proximal end to fit into the rotary device; and a neck that connects the
part. Mastoid burs are mainly used in the removal of bone from the mastoid process (mastoidectomy)
procedures intended for dissection of the facial nerve through the mastoid.

Middle-ear surgical burs designed to excavate, cut, polish, shape, and/or remove bone and/or cartilage
(endaural) procedures manually performed under microscope visualization (i.e., microsurgery). These
of a small shank made of steel or tungsten carbide with a well-differentiated working head in a variety
(e.g., round, cylinder, conical) on the distal end; a tapered, notched, or elongated proximal end to fit i
device; and a neck that connects the shank to the working part. Dedicated middle-ear surgical burs ar
of the mastoid bone and for polishing or cutting middle-ear bony structures. Middle-ear burs are usual
after sterilization, but disposable (single use) devices are available.
Middle-ear surgical burs designed for polishing and shaping of bone tissue. These burs typically consis
steel or tungsten carbide with a well-differentiated working head (frequently with a diamond coating)
shape (e.g., round) and size on the distal end; a tapered, notched, or elongated proximal end to fit int
and a neck that connects the shank to the working part. Polishing middle-ear burs are used in a variet
repair of middle-ear ossicles); they are usually intended for reuse after sterilization, but disposable (si
also available.

Surgical burs designed for excavation, incision, or removing of hard tissue (e.g., cartilage) during nasa
burs typically consist of a shank made of steel or tungsten carbide with a well-differentiated working h
size and shape (a rounded end is typical) on the distal end; a tapered, notched, or elongated proximal
rotary device; and a neck that connects the shank to the working part. Dedicated nasal surgical burs a
incision of the nasal septum and/or the ethmoid antrum and also for polishing or cutting nasal cartilag
Dedicated nasal burs are used in anterior maxillary osteotomy, plastic surgery (rhinoplasty), and othe
procedures; they are usually intended for reuse after sterilization, but disposable (single use) devices

Nasal surgical burs designed for removal of hard tissue (either bone or cartilage) to eliminate nasal se
burs typically consist of a long, curved shank made of steel or tungsten carbide; a well-differentiated w
usually includes suction through a cannula on the working end; a proximal end to fit into the rotary de
connects the shank to the working part. Septum nasal burs are used in nasal surgery procedures to co
nasal septum, to improve breathing or for aesthetic purposes (septorhinoplasty).

Surgical burs designed for gentle abrasion and/or removal of foreign objects from the eyes. These bur
shank made of steel or tungsten carbide with a well-differentiated working head in appropriate sizes a
rounded, cylinder, cone) on the distal end; a small, thin proximal end to fit into an ophthalmic slow-sp
and a neck that connects the shank to the working part. Dedicated eye surgery burs are available for
(e.g., corneal abrasion and/or rust-ring removal); they are used to polish small scratches, remove fore
eye surface, and to remove rust stains from the cornea. Eye burs are intended for reuse after steriliza
of after a single use.

Surgical burs designed for abrasion of the cornea. They typically consist of a shank of steel or other ha
differentiated diamond sphere at its working tip, a proximal end to fit into the rotary device, and a nec
shank to the working part. Corneal abrasion burs are used to polish corneal scratches and/or the ptery
surgical removal and/or abrasion of lid margin lesions. These burs are intended for use with a special s
electrically powered ophthalmic device (e.g., an ophthalmic electric spud).

Corneal abrasion burs designed for gentle removal ("brushing") of rust stains (rust rings) from the corn
of a ferrous foreign object. They typically consist of a shank of steel or other hard metal with a well-diff
working tip and a proximal end to fit into a rotary handpiece, typically a slow-rotation electrically powe
(e.g., an ophthalmic electric spud).
Surgical burs designed for excavation, incision, or removal of bone and hard tissue during neurosurgic
procedures of the spine. These burs typically consist of a long shank made of steel or tungsten carbid
differentiated working head in appropriate sizes and shapes (e.g., round, cylinder, cone) on the distal
notched, or elongated proximal end to fit into the rotary handpiece; and a long neck that connects the
part. Dedicated spine surgery burs are available for specific applications (e.g., graft harvesting, impac
procedures such as the application of prosthetic plates to the cervical vertebrae (i.e., cervical plating)
usually intended for reuse after sterilization, but disposable (single use) devices are available.

Surgical burs designed for excavation, incision, or removal of bone and hard tissue during microsurgic
spine performed under microscope visualization (i.e., microsurgery). These burs typically consist of a s
steel or tungsten carbide with a well-differentiated working head in a variety of sizes and shapes (e.g.
the distal end; a tapered, notched, or elongated proximal end to fit into a very small surgical rotary de
connects the shank to the working part. Dedicated spinal microsurgical burs are available for a variety
including microlumbar discectomy; they are usually intended for reuse after sterilization, but disposab
are available.

Burs designed to be held and spun by a rotary device (e.g., handpiece, drilling machine) for gentle rem
excavation of soft or hard foot tissue in foot care procedures (i.e., podiatric nonsurgical procedures). T
consist of a shank of steel or other hard metal with a well-differentiated working head of various shap
inverted cone, pear) and materials (e.g., diamond, metal carbide) on the distal end; a tapered, notche
proximal end to fit into a rotary device; and a neck that connects the shank to the working part. Dedic
available for use in podiatrist offices to debride excrescences and to handle heavy nails and/or plantar
heat and minimum dust. Conventional orthopedic burs are used in podiatric surgery.

Instruments designed to hold, manipulate, deposit, and/or transport materials, substances, or small de
application during healthcare procedures or for cleaning the internal, hard-to-reach components of spe
such as endoscopes. These carriers are typically a handheld, manual device with a working end to hol
device being manipulated and a handle at the proximal end. Dedicated carriers are available to hold a
cleaning pads (e.g., cotton, gauze), filling materials during dental procedures, and sponges and/or swa
procedures. Powered endodontic carriers and carriers intended for endoscopic use are also available.

Carriers designed to hold and manipulate materials and products for manual cleaning of the internal c
working channels) of specific medical devices before they undergo processing (e.g., disinfection, steri
These carriers are typically a slender instrument with a working end appropriate for mechanical and/o

Carriers designed to hold a cotton or gauze pad at the distal tip for cleaning the internal components
devices. These carriers are typically a long, slender instrument with a distal end appropriate to hold th
handle for its manipulation. Cotton/gauze cleaning carriers are used for direct mechanical cleaning an
impregnated with cleaning products (e.g., detergent) for chemical cleaning of a medical device before
disinfection. Dedicated cotton/gauze pad carriers are available to remove debris from endoscopes and
structures of certain medical devices.

Cotton/gauze pad carriers designed to clean the internal working channels of endoscopes. These carri
slender instrument with a distal end appropriate to hold a pad of cotton or gauze and an integral hand
facilitate its manipulation. Endoscope cleaning carriers are used to remove debris from the working ch
before they undergo disinfection.
Carriers designed to hold, manipulate, and/or transport dental filling materials (e.g., amalgam, cemen
to a root canal during dental restorations and endodontic procedures. These carriers are available in s
sizes, including dedicated dental carriers for amalgam restorations and cement/paste application to fi
root canals (i.e., for endodontic procedures). Dental carriers are available as manual or powered devic
are typically used in endodontic procedures.

Carriers designed to hold, transport, and deposit cement and/or paste into the finished root canal befo
percha master cone. These carriers are typically small, manual or powered, handheld devices with a lo
working end and a latch handle. These carriers are commonly known as lentulo spirals.

Carriers designed to hold, transport, and deposit cement and/or or paste into the finished root canal b
percha master cone. These carriers are typically a small, powered device with a long spiral spring at it
separate powered handpiece. These carriers are commonly known as powered lentulo spirals.

Carriers designed to hold and transport small pieces of cleaning/absorbing materials and/or suturing fi
surgical procedures. These carriers are typically slender, manual, handheld instruments with a workin
carry fabric pads (e.g., cotton, gauze) or suturing ligatures and/or wires. Dedicated surgical carriers ar
fluids and other liquids during surgical (e.g., endoscopic, microsurgical) procedures.

Carriers designed to carry a sponge or a small pad (e.g., a swab) of cotton or other absorbent materia
clean and/or absorb body fluids (e.g., blood, mucus) during surgical procedures. These carriers are typ
manual, handheld instruments that include grasping claws at the working end, a long shaft, and a han
end to manipulate the grasping end. Sponge/swab surgical carriers are used mainly in surgical sites th
directly (e.g., the nasal cavities, the throat, the ear canal).

Sponge/swab carriers designed to carry a sponge or a small pad (e.g., a swab) of cotton or other abso
working tip to clean and/or absorb body fluids (e.g., blood, mucus) through the working channel of an
endoscopic surgical procedures. These carriers are typically long, slender, manual, flexible instrument
claws at the working end, a long shaft, and a handle at the proximal end to manipulate the grasping e
sponge/swab endoscopic surgical carriers are available in sizes (i.e., length and diameter) appropriate
endoscopes.

Sponge/swab carriers designed to carry a very small sponge or pad (e.g., a swab) of cotton or other ab
the working tip to clean and/or absorb body fluids (e.g., blood, mucus) during microsurgical procedure
typically long, slender, manual, handheld instruments that include grasping claws or a small loop at th
shaft, and a handle at the proximal end to manipulate the sponge/swab. Microsurgery sponge/swab ca
in laryngeal procedures.

Surgical instruments designed to manipulate (i.e., pass) ligatures and/or wires through or around tissu
surgical procedures. These instruments are typically manual, handheld, flexible or rigid, slender devic
hold the ligature and a proximal end with a handle appropriate to manipulate the ligature. Dedicated l
available in a variety of shapes (e.g., rods, scissors-like) and sizes to pass ligatures and/or wires throu
sites.
Passers designed to manipulate ligatures through or around tissues during surgical procedures. These
manual, handheld, flexible or rigid, slender instruments with an operating end to hold the ligature and
handle appropriate to manipulate the ligature. Dedicated ligature passers are available in a variety of
scissors-like) and sizes to pass ligatures around particular anatomic structures (e.g., bone, vasculature

Ligature passers designed to carry and manipulate ligatures through tissue and cartilage and/or aroun
passers are typically manual, handheld instruments including a rod with a straight or curved distal end
configuration (e.g., U-shaped, loop) to hold the ligature. Bone ligature passers are used mainly to fix li
during orthopedic procedures.
Ligature passers designed to carry and manipulate ligatures through tissue and around blood vessels.
typically manual, handheld instruments including a rod with a straight or curved distal end and with a
configuration (e.g., U-shaped, loop) to hold the ligature and a handle to manipulate the ligature. Vascu
are used mainly to fix ligatures around deep vessels; dedicated carriers are available for particular art
and/or veins.

Vascular ligature passers designed to carry and manipulate ligatures around the aorta. These passers
handheld, scissors-like instruments with strongly curved serrated distal blades appropriate to hold liga
manipulation. Aorta vascular ligature passers are used for hemostasis of the aorta or aorta aneurysms
surgery.
Passers designed to manipulate wires through or around hard tissue (bone and/or cartilage). These pa
manual, handheld flexible or rigid, slender instruments with an operating end to hold the wire and a p
handle appropriate to manipulate the wire. Dedicated wire passers are available in a variety of shapes
at the tip) and sizes to pass wires around particular anatomic structures (e.g., bone cerclage); they are
orthopedic procedures.

Wire passers designed to manipulate wires to encircle bone and easily draw the wire back around the
passers are typically slender, manual, handheld, rigid instruments with an operating single or double
hold the wire and a proximal end with a handle appropriate to manipulate the wire. Bone cerclage wire
facilitate wire placement and tightening for a secure fixation of bone fragments, minimizing surgical tr
passers are available to accommodate one or more of the wire gauges commonly used in surgery.

Surgical instruments designed to push knot loops onto a body structure for a secure tie, usually with n
These passers are typically long, slender, manual, handheld instruments with the operative end config
moving curved hooks; the instruments may also include a dissecting tip at the proximal end to clear t
site. Ligature passer/knot tier instruments are used mainly for placing a ligature around a vessel or ov
procedures in which manipulative space is limited.

Ligature passer/knot tiers designed to push knot loops onto a body structure for a secure tie, usually w
pressure, during endoscopic procedures. Passer/knot tiers are typically long, slender, manual instrume
end configured as a moving curved hook, a shaft appropriate for introduction into the working channe
a handle at the proximal end with a mechanism to manipulate and tie the ligature. Endoscopic ligature
frequently used to suture internal wounds and/or to ligate polyps.

Molecular assay reagents intended to identify species of Aeromonas, a genus of bacteria of the family
detecting specific nucleic-acid information of the target bacteria. Some species of these bacteria may
infections, including furunculosis and/or ulcer disease.
Molecular assay reagents intended to identify Aeromonas salmonicida, a rod-shaped bacterium of the
by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Th
cause furunculosis and/or ulcer disease.
Molecular assay reagents intended to identify species of Bartonella, a genus of bacteria of the family B
detecting specific nucleic-acid information of the target bacteria. Some species of these bacteria may
infections, including benign lymphoreticulosis (cat-scratch disease); they are also associated with end

Molecular assay reagents intended to identify species of Bartonella, a genus of rod-shaped bacteria of
Bartonellaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the tar
species of these bacteria may cause human infections, including benign lymphoreticulosis (cat-scratch
also associated with endocarditis.
Molecular assay reagents intended to identify Bartonella henselae, a rod-shaped bacterium of the fam
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These
benign lymphoreticulosis (cat-scratch disease) and regional lymphadenitis.

Molecular assay reagents intended to identify Bartonella quintana, a rod-shaped bacterium of the fam
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. This b
trench fever and is associated with endocarditis.
Molecular assay reagents intended to identify species of Bordetella, a genus of gram-negative coccob
detecting specific nucleic-acid information of the target bacteria. Some species of these bacteria may
human respiratory tract, including whooping cough.
Molecular assay reagents intended to identify species of Bordetella, a genus of gram-negative coccob
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Some
bacteria may cause infections in the human respiratory tract, including whooping cough.

Molecular assay reagents intended to identify Bordetella parapertussis, a gram-negative coccobacillus


detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These
etiologic agent of whooping cough.
Molecular assay reagents intended to identify Bordetella pertussis, a gram-negative coccobacillus bac
specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria
agent of whooping cough.
Molecular assay reagents intended to identify species of Borrelia, a genus of bacteria of the family Spi
detecting specific nucleic-acid information of the target bacteria. A species of these bacteria is the eti
disease; these bacteria may also cause other human infections.
Molecular assay reagents intended to identify Borrelia burgdorferi, an intracellular bacterium of the fa
by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Bo
bacteria cause Lyme disease (i.e., Lyme borreliosis), acrodermatitis chronica atrophicans, and erythem
These bacteria are typically transmitted by a parasitic tick of the genus Ixodes.

Molecular assay reagents intended to identify species of Brucella, a genus of nonmotile coccobacillus
family affiliation, by detecting specific nucleic-acid information of the target bacteria. Some species of
etiologic agent, a disease characterized by intermittant (i.e., undulant) fever of brucellosis; they may
tract infections in humans.
Molecular assay reagents intended to identify species of Brucella, a genus of nonmotile coccobacillus
family affiliation, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
species of these bacteria are the etiologic agent of brucellosis, a disease characterized by intermittan
they may also cause respiratory tract infections in humans.

Molecular assay reagents intended to identify species of Brucella, a genus of nonmotile coccobacillus
family affiliation, by detecting specific genetic information of the ribonucleic acid (RNA) of the target b
of these bacteria are the etiologic agent of brucellosis, a disease characterized by intermittant (i.e., un
may also cause respiratory tract infections in humans.

Molecular assay reagents intended to identify Brucella abortus, a coccobacillus bacterium, by detectin
information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria are an etiologic a
disease characterized by intermittent (i.e., undulant) fever.
Molecular assay reagents intended to identify Brucella melitensis, a coccobacillus bacterium, by detec
information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria are an etiologic a
disease characterized by intermittent (i.e., undulant) fever.
Molecular assay reagents intended to identify Brucella suis, a coccobacillus bacterium, by detecting sp
information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria are an etiologic a
disease characterized by intermittent (i.e., undulant) fever.
Molecular assay reagents intended to identify species of Campylobacter, a genus of rod-shaped bacte
Spirillaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the t
bacteria species may cause diarrhea, bacteremia in immunocompromised patients, urinary tract infec
arthritis, and prosthetic-joint infections.
Molecular assay reagents intended to identify Campylobacter coli, a rod-shaped bacterium of the fami
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
cause diarrhea and acute gastroenteritis.
Molecular assay reagents intended to identify Campylobacter jejuni, a rod-shaped bacterium of the fa
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
cause diarrhea and acute gastroenteritis.
Molecular assay reagents intended to identify Campylobacter lari, a rod-shaped bacterium of the fami
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
cause diarrhea, bacteremia in immunocompromised patients, urinary tract infections, reactive arthriti
infections.
Molecular assay reagents intended to identify species of Chlamydia, a genus of intracellular bacteria o
Chlamydiaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
bacteria species may cause a variety of diseases in humans, including trachoma, conjunctivitis, atypic
encephalomyelitis, and a variety of urogenital infections.
Molecular assay reagents intended to identify Chlamydia trachomatis, an intracellular bacterium of th
Chlamydiaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
bacteria may cause a variety of diseases in humans, including trachoma, inclusion conjunctivitis, and
infections.
Molecular assay reagents intended to identify Chlamydia trachomatis, an intracellular bacterium of th
Chlamydiaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of t
These bacteria may cause a variety of diseases in humans, including trachoma, inclusion conjunctiviti
urogenital infections.
Molecular assay reagents intended to identify Chlamydia trachomatis and/or Neisseria gonorrhoeae ba
specific genetic information of the deoxyribonucleic acid (DNA) of one of the target bacteria. These ba
variety of diseases in humans, including trachoma, lymphogranuloma venereum, and gonorrhea.

Molecular assay reagents intended to identify species of Chlamydophila, a genus of intracellular bacte
Chlamydiaceae, by detecting specific genetic information of the ribonucleic acid of the target bacteria
cause respiratory infections, mild atypical pneumonia, and/or psittacosis.
Molecular assay reagents intended to identify Chlamydophila pneumoniae, an intracellular bacterium
Chlamydiaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
bacteria may cause respiratory infections and mild atypical pneumonia.
Molecular assay reagents intended to identify Chlamydophila pneumoniae, a bacterium of the family C
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
cause respiratory infections and mild atypical pneumonia.
Molecular assay reagents intended to identify Chlamydophila pneumoniae and/or Chlamydophila psitt
the family Chlamydiaceae, by detecting specific genetic information of the DNA of one of the target ba
may cause respiratory infections, mild atypical pneumonia, and/or psittacosis.

Molecular assay reagents intended to identify Chlamydophila psittaci, a bacterium of the family Chlam
specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria
psittacosis.
Molecular assay reagents intended to identify species of Coxiella, a genus of bacteria of the family Ric
detecting specific nucleic-acid information of the target bacteria. A species of these bacteria is the eti
an acute infection characterized by fever and chills and frequently complicated by pneumonitis, hepat
in humans.
Molecular assay reagents intended to identify Coxiella burnetii, a bacterium of the family Rickettsiace
specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria
of Q fever, an acute infection characterized by fever and chills and frequently complicated by pneumo
endocarditis; in humans, it is typically acquired by inhalation of airborne organisms derived from infec

Molecular assay reagents intended to identify species of Ehrlichia, a genus of bacteria of the family Ri
detecting specific nucleic-acid information of the target bacteria. Some species of these bacteria are e
monocytic ehrlichiosis in humans (i.e., they attack monocytes, a type of white blood cell).

Molecular assay reagents intended to identify Ehrlichia canis, a bacterium of the family Rickettsiaceae
genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria are an e
human disease with symptoms similar to spotted fever (these bacteria are also the etiologic agent of

Molecular assay reagents intended to identify Ehrlichia chaffeensis, a bacterium of the family Ricketts
specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria
of monocytic ehrlichiosis in humans (i.e., they attack monocytes, a type of white blood cell).

Molecular assay reagents intended to identify Enterococcus, a genus of spherical-to-ovoid bacteria (co
Streptococcaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the
species of the Enterococcus genus are part of the common flora of the intestinal tract of humans, but
can cause urinary tract infections, endocarditis, and bacteremia.
Molecular assay reagents intended to identify Enterococcus, a genus of spherical-to-ovoid bacteria (co
Streptococcaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) o
Some species of the Enterococcus genus are part of the common flora of the intestinal tract of human
faecalis) can cause urinary tract infections, endocarditis, and bacteremia.

Molecular assay reagents intended to identify species of Francisella, a genus of gram-negative coccoid
detecting specific information of the nucleic acid of the target bacteria. Some species of these bacteri
agents of tularemia, a disease characterized by malaise, fever, chills, and weakness; these bacteria ar
by wild animals.
Molecular assay reagents intended to identify Francisella tularensis, a gram-negative coccoid or rodlik
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. This b
etiologic agent of tularemia (type A strains frequently result in pulmonary tularemia), a disease charac
fever, chills, and weakness; these bacteria are typically transmitted by wild animals.

Molecular assay reagents intended to identify Francisella tularensis, a gram-negative coccoid or rodlik
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
etiologic agent of tularemia (type A strains frequently results in pulmonary tularemia), a disease chara
fever, chills, and weakness; these bacteria are typically transmitted by wild animals.

Molecular assay reagents intended to identify Gardnerella vaginalis, a gram-negative rod-shaped bact
of the genus Gardnerella, family Rickettsiaceae, by detecting specific nucleic-acid information of the t
bacteria may cause genital tract bacteremia (vaginitis) in females.
Molecular assay reagents intended to identify Gardnerella vaginalis, a gram-negative rod-shaped bact
of the genus Gardnerella, family Rickettsiaceae, by detecting specific genetic information of the deoxy
of the target bacteria. These bacteria may cause genital tract bacteremia (vaginitis) in females.

Molecular assay reagents intended to identify Gardnerella vaginalis, a gram-negative rod-shaped bact
of the genus Gardnerella, family Rickettsiaceae, by detecting specific genetic information of the riboso
(rRNA) of the target bacteria. These bacteria may cause genital tract bacteremia (vaginitis) in females
Units designed to cool and/or rewarm a patient by circulating liquid (e.g., saline) through an intravasc
controlling the patient's core temperature (typically from 32 to 37 degrees Celsius [90 to 99 degrees F
exchange between the blood and the saline solution through the wall of a balloon, without perfusion o
or drawing blood. These devices typically consist of a central console that includes a cooling and heat
coils, and/or tubes for circulation and delivery of the liquid to intravascular catheters; and electronic c
to monitor and show patient and equipment data (e.g., patient core and saline temperature, rate of ch
temperature). The units typically provide automatic adjustment of the circulating solution temperature
core temperature at the desired level according to the temperature sensor included in the catheter. D
catheters with appropriate closed-loop liquid circulation, heat-exchange balloons, and temperature se
short-term (e.g., a few hours) or longer-term (e.g., a week) patient temperature control; some cathete
lumens and can be used also as standard central venous catheters. Intravascular patient warming/coo
to induce hypothermia, maintain normothermia, and rewarm patients; they may be used during surge
preserve cerebral function in patients with brain injuries, after cardiac arrest, in the care of patients w
other intensive care procedures.

Molecular assay reagents intended to identify species of Haemophilus, a genus of bacteria of the fami
detecting specific nucleic-acid information of the target bacteria. Some species of these bacteria are n
human upper respiratory tract, but some may cause bacteremia, acute bacterial meningitis, cellulitis,
infections, and bacterial pneumonia.
Molecular assay reagents intended to identify Haemophilus ducreyi, a bacterium of the family Pasteur
specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These bacteria
or chancres in the genitals.
Molecular assay reagents intended to identify Haemophilus influenzae, a bacterium of the family Paste
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
an inflammatory response that causes diseases. Encapsulated (polysaccharide) organisms of Haemop
cause bacteremia and acute bacterial meningitis; occasionally, they may cause epiglottitis (obstructiv
osteomyelitis, joint infections, and bacterial pneumonia in children.

Molecular assay reagents intended to identify Haemophilus influenzae type A, a bacterium of the fami
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These
an inflammatory response that causes diseases.
Molecular assay reagents intended to identify Haemophilus influenzae type B, a bacterium of the fami
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These
inflammatory response that causes diseases. Encapsulated (polysaccharide) organisms of Haemophilu
cause bacteremia and acute bacterial meningitis; occasionally they may also cause epiglottitis (obstru
cellulitis, osteomyelitis, joint infections, and bacterial pneumonia in children.

Molecular assay reagents intended to identify species of Helicobacter, a genus of bacteria of the famil
detecting specific genetic information of the nucleic acid of the target bacteria. Some species of Helic
proctitis, chronic gastritis, and pyloric ulcer and could be an etiologic agent for gastric cancer.
Molecular assay reagents intended to identify Helicobacter (formerly Campylobacter) pylori, a bacteriu
Spirillaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target
pylori bacteria cause chronic gastritis and pyloric ulcer and could be an etiologic agent for gastric can

Molecular assay reagents intended to identify Anaplasma phagocytophilum (formerly Ehrlichia phagoc
bacterium of the genus Anaplasmataceae, family Rickettsiaceae, by detecting specific genetic informa
deoxyribonucleic acid (DNA) of the target bacteria. These bacteria are an etiologic agent of granulocy
humans (i.e., they attack the granulocytes, a type of white blood cell).
Molecular assay reagents intended to identify species of Legionella, a genus of intracellular bacteria o
Legionellaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the tar
species of Legionella bacteria may cause pneumonia-like diseases (i.e., legionellosis) in humans, eithe
(Legionnaire's disease) or in a milder form (Pontiac fever).
Molecular assay reagents intended to identify species of Legionella, a genus of intracellular bacteria o
Legionellaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of th
Some species of Legionella bacteria may cause pneumonia-like diseases (i.e., legionellosis) in humans
illness (Legionnaire's disease) or in a milder form (Pontiac fever).

Molecular assay reagents intended to identify Legionella pneumophila, a bacterium of the family Legio
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Legio
bacteria cause pneumonia-like disease (i.e., legionellosis) in humans, either as a serious illness (Legio
a milder form (Pontiac fever).
Molecular assay reagents intended to identify Legionella pneumophila, a bacterium of the family Legio
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. L
bacteria cause pneumonia-like disease (i.e., legionellosis) in humans, either as a serious illness (Legio
a milder form (Pontiac fever).
Molecular assay reagents intended to identify species of Leptospira, a genus of finely coiled, motile ba
Leptospiraceae, by detecting specific nucleic-acid information of the target bacteria. Some species of
etiologic agents of leptospirosis, a disease acquired directly by contact with the urine or tissue of an in
rodents, dogs) or indirectly by contact with contaminated water, soil, or vegetation.

Molecular assay reagents intended to identify species of Leptospira, a genus of finely coiled, motile ba
Leptospiraceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
species of these bacteria are the etiologic agents of leptospirosis, a disease acquired directly by conta
tissue of an infected animal (e.g., rodents, dogs) or indirectly by contact with contaminated water, soi

Molecular assay reagents intended to identify species of Listeria, a genus of bacteria that closely rese
family Corynebacteriaceae, by detecting specific nucleic-acid information of the target bacteria. A spe
Listeria monocytogenes) is the cause of listeriosis, which may cause in utero infections that can result
or premature birth; infections acquired during birth can cause cardiorespiratory distress, diarrhea, vom
Infection in adults can produce meningitis, endocarditis, and disseminated granulomatous lesions.
Molecular assay reagents intended to identify Listeria monocytogenes, a bacterium closely resembling
Corynebacteriaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA
These bacteria are the etiologic agent of listeriosis, which may cause in utero infections that can resul
or premature birth; infections acquired during birth can cause cardiorespiratory distress, diarrhea, vom
Infection in adults can produce meningitis, endocarditis, and disseminated granulomatous lesions.

Molecular assay reagents intended to identify species of Mycobacterium, a genus of slow-growing bac
Mycobacteriaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the
species of these bacteria are the etiologic agents of human tuberculosis and leprosy; other species ma
diseases, lymphadenitis in children, and systemic illness in immunocompromised people (e.g., AIDS p

Molecular assay reagents intended to identify species of Mycobacterium, a genus of slow-growing bac
Mycobacteriaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) o
Some species of these bacteria are the etiologic agents of human tuberculosis and leprosy; other spec
pulmonary diseases, lymphadenitis in children, and systemic illness in immunocompromised people (e

Molecular assay reagents intended to identify Mycobacterium avium complex, a group of slow-growing
avium, M. intracellulare) of the family Mycobacteriaceae, by detecting specific genetic information of
acid (DNA) of the target bacteria. These bacteria may cause pulmonary diseases, lymphadenitis in chi
illness in immunocompromised people (e.g., AIDS patients).

Molecular assay reagents intended to identify Mycobacterium avium complex, a group of slow-growing
but not limited to, M. avium and M. intracellulare) of the family Mycobacteriaceae, by detecting specifi
of the ribosomal ribonucleic acid (rRNA) of the target bacteria. These bacteria may cause pulmonary d
in children, and systemic illness in immunocompromised people (e.g., AIDS patients).

Molecular assay reagents intended to identify Mycobacterium intracellulare, a species of slow-growing


family Mycobacteriaceae, by detecting specific nucleic-acid information of the target bacteria. These b
pulmonary diseases with symptoms similar to those of tuberculosis, but requiring different treatments

Molecular assay reagents intended to identify Mycobacterium tuberculosis, a species of slow-growing


Mycobacteriaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the
bacteria are the etiologic agent of human tuberculosis.
Molecular assay reagents intended to identify Mycobacterium tuberculosis, a species of slow-growing
Mycobacteriaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) o
These bacteria are the etiologic agent of human tuberculosis.
Molecular assay reagents intended to identify Mycobacterium tuberculosis strains that have develope
resistance (e.g., to rifampin, a semisynthetic antibiotic derivative of rifamycin), by detecting specific g
the deoxyribonucleic acid (DNA) of the particular strain of the target bacteria. These bacteria are the e
antimicrobial-resistant human tuberculosis.
Molecular assay reagents intended to identify species of Mycoplasma, a genus of bacteria of the famil
by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Sp
are the etiologic agents of several diseases (mycoplasmosis).
Molecular assay reagents intended to identify Mycoplasma pneumoniae, a species of bacterium of the
family Mycoplasmataceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA
bacteria. These bacteria are the etiologic agent of mycoplasmosis, primary atypical pneumonia (i.e., m
pneumonia), and other febrile upper-respiratory-tract infections.
Molecular assay reagents intended to identify Mycoplasma pneumoniae, a species of bacterium of the
family Mycoplasmataceae, by detecting specific genetic information of the ribosomal ribonucleic acid
bacteria. These bacteria are the etiologic agent of mycoplasmosis, primary atypical pneumonia (i.e., m
pneumonia), and other febrile upper-respiratory-tract infections.

Molecular assay reagents intended to identify species of Neisseria, a genus of bacteria of the family N
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Speci
the cause of meningococcal meningitis and gonorrhea.
Molecular assay reagents intended to identify Neisseria gonorrhoeae, a gram-negative bacterium of th
Neisseriaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the targ
bacteria are the etiologic agents of gonorrhea, a disease that is usually transmitted sexually.

Molecular assay reagents intended to identify Neisseria gonorrhoeae, a gram-negative bacterium of th


Neisseriaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of th
These bacteria are the etiologic agents of gonorrhea, a disease that is usually transmitted sexually.

Molecular assay reagents intended to identify Neisseria meningitidis, a gram-negative bacterium of th


by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteri
the etiologic agents of meningococcal meningitis.
Molecular assay reagents intended to identify species of Pasteurella, a genus of rod-shaped bacteria o
Pasteurellaceae, by detecting specific nucleic-acid information of the target bacteria. Some species of
cause human infections, including pneumonia, meningitis, and septicemia; these bacteria are typically
and dog bites.
Molecular assay reagents intended to identify species of Pasteurella, a genus of rod-shaped bacteria o
Pasteurellaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
species of these bacteria may cause human infections, including pneumonia, meningitis, and septicem
typically transmitted by cat and dog bites.
Molecular assay reagents intended to identify Pasteurella multocida, a rod-shaped bacterium of the fa
by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. Th
cause pneumonia, meningitis, and septicemia and are transmitted typically by cat and dog bites.

Molecular assay reagents intended to identify species of Pseudomonas, a genus of bacteria of the fam
Pseudomonadaceae, by detecting specific genetic information of the nucleic acid of the target bacteri
these bacteria are a major agent of hospital-acquired (i.e., nosocomial) infections, mostly those occurr
and in wounds, especially in immunodepressed or debilitated patients.
Molecular assay reagents intended to identify species of Pseudomonas, a genus of bacteria of the fam
Pseudomonadaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of th
Some species of these bacteria are an etiologic agent of hospital-acquired (i.e., nosocomial) infections
occurring in the urinary tract and in wounds, especially in immunodepressed or debilitated patients.
Molecular assay reagents intended to identify species of Rickettsia, a genus of gram-negative bacteria
Rickettsiaceae, by detecting specific nucleic-acid information of the target bacteria. Some species of t
etiologic agent of epidemic typhus; they may also cause recrudescent (latent) typhus and spotted fev

Molecular assay reagents intended to identify species of Rickettsia, a genus of gram-negative bacteria
Rickettsiaceae, by detecting specific genetic information of the ribonucleic acid (RNA) of the target ba
these bacteria are the etiologic agent of epidemic typhus; they may also cause recrudescent (latent) t
fever.
Molecular assay reagents intended to identify Rickettsia prowazekii, a gram-negative bacterium of the
by detecting specific genetic information of the ribonucleic acid (RNA) of the target bacteria. These ba
agent of epidemic typhus; they may also cause recrudescent (latent) typhus.

Molecular assay reagents intended to identify Rickettsia rickettsii, a gram-negative, obligate, intracellu
family Rickettsiaceae, by detecting specific genetic information of the ribonucleic acid (RNA) of the ta
bacteria are an etiologic agent of spotted fever (e.g., Rocky Mountain spotted fever).

Molecular assay reagents intended to identify species of Salmonella, a genus of motile bacteria with p
the family Enterobacteriaceae, by detecting specific genetic information of the deoxyribonucleic acid
bacteria. Species of Salmonella are the etiologic agents of typhoid fever, paratyphoid, gastroenteritis,
bacterial diseases.
Molecular assay reagents intended to identify species of Staphylococcus, a genus of coccoid bacteria
Micrococcaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
Staphylococci grow in pairs or irregular clusters and include several pathologic species; the most impo
because of its ability to cause serious suppurative infections, especially in immunodepressed patients
elderly through damaged skin or in viral infections of the lungs.

Molecular assay reagents intended to identify species of Staphylococcus, a genus of coccoid bacteria
Micrococcaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of t
Staphylococci bacteria grow in pairs or irregular clusters and include several pathologic species; the m
is S. aureus because of its ability to cause serious suppurative infections, especially in immunodepres
and the elderly through damaged skin or in viral infections of the lungs.

Molecular assay reagents intended to identify Staphylococcus aureus, a gram-positive bacterium of th


Micrococcaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of t
These bacteria may cause serious suppurative infections, especially in immunodepressed patients, ne
elderly, through damaged skin or in viral infections of the lungs.

Molecular assay reagents intended to identify Staphylococcus aureus, a gram-positive bacterium of th


Micrococcaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the ta
bacteria may cause serious suppurative infections, especially in immunodepressed patients, neonates
through damaged skin or in viral infections of the lungs.
Molecular assay reagents intended to identify Staphylococcus aureus strains that have developed a hi
resistance (e.g., to methicillin, a semisynthetic antibiotic), by detecting specific genetic information of
acid (DNA) of the target bacteria. These bacteria may cause serious suppurative infections, especially
patients, neonates, and the elderly, through damaged skin or in viral infections of the lungs.

Molecular assay reagents intended to identify group A Streptococcus (typically Streptococcus pyogene
coccoid bacterium, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) o
S. pyogenes is one of the most important bacterial pathogens in humans, causing a wide range of sup
(e.g., pharyngitis, otitis media, sinusitis, endocarditis) and nonsuppurative sequelae (e.g., acute rheum

Molecular assay reagents intended to identify Streptococcus group B (Streptococcus agalactiae), a spe
bacterium, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the ta
bacteria may cause urinary tract and wound infections and otitis media.
Molecular assay reagents intended to identify group C Streptococcus (e.g., S. equisimilis, S. zooepidem
a species of coccoid bacterium by detecting specific nucleic-acid information of the target bacteria. Gr
may cause endocarditis, bacteremia, pneumonia, meningitis, and mild upper respiratory tract infectio
most common group C bacterial pathogen in humans, but other group C species such as S. zooepidem
dysgalactiae may also cause infections.

Molecular assay reagents intended to identify group D Streptococcus (e.g., S. faecalis, S. faecium, S. d
S. bovis) a species of coccoid bacterium by detecting specific nucleic-acid information of the target ba
S. faecium are the most common bacterial pathogens in humans in this group; group D streptococci m
and biliary or urinary tract infections.
Molecular assay reagents intended to identify group F Streptococcus (e.g., S. anginosus, also known a
of coccoid bacterium, by detecting specific nucleic-acid information of the target group of bacteria. Gr
bacterial pathogens in humans that may cause subcutaneous or organ abscesses, endocarditis, and m
tract infections.
Molecular assay reagents intended to identify group G Streptococcus, a heterogeneous collection of co
colony beta-hemolytic and minute beta-hemolytic colony group G strains) by detecting specific nuclei
the target group of bacteria. Group G Streptococci are bacterial pathogens in humans that are associa
skin and soft tissue infections, septicemia, endocarditis, and arthritis.

Molecular assay reagents intended to identify Streptococcus pneumoniae, a bacterium of the family S
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target bacteria. T
most common cause of lobar pneumonia and can also cause other serious diseases (e.g., meningitis,

Devices designed to produce text and/or graphic images on paper or other appropriate media (e.g., tr
stored in electronic format. Printers may use a variety of technologies to print documents, including in
liquid ink-jet printers), toner-based (typically laser printers), thermal transference (e.g., solid-ink printe
dot matrix printers). Printers are intended mainly for use as computer peripherals and/or to provide ha
network users; other dedicated printers, usually with limited capabilities and intended for specific app
and/or bar-code printing and to print graphic strips intended to store information (i.e., printer/recorder
Molecular assay reagents intended to identify species of Treponema, a genus of bacteria of the family
detecting specific genetic information of the nucleic acid of the target bacteria. Some species of these
syphilis; others may cause oral infections or pinta (carate).
Molecular assay reagents intended to identify species of Tropheryma, a genus of gram-positive bacter
Cellulomonadaceae, by detecting specific genetic information of the nucleic acid of the target bacteria
bacteria causes intestinal lipodystrophy (Whipple's disease).
Molecular assay reagents intended to identify Tropheryma whippelii, a gram-positive bacterium of the
Cellulomonadaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of th
These bacteria cause intestinal lipodystrophy (Whipple's disease).
Molecular assay reagents intended to identify species of Yersinia, a genus of intracellular, ovoid=shap
family Enterobacteriaceae, by detecting specific nucleic-acid information of the target bacteria. A spec
the etiologic agent of bubonic and pneumonic plagues; other species may cause gastroenteritis and ly
humans.
Molecular assay reagents intended to Yetsinia pestis, an intracellular bacterium of the family Enteroba
detecting specific genetic information of the nucleic acid of the target bacteria. These bacteria are the
bubonic and pneumonic plagues.
Molecular assay reagents intended to identify Yersinia pestis, an intracellular bacterium of the family E
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target bacteria. These
etiologic agent of bubonic and pneumonic plagues.
Microbiology reagents intended to identify Aeromonas, a genus of bacteria of the family Vibrionaceae,
target bacteria, usually through tests performed on bacteria cultures. Some species of these bacteria
causing furunculosis or ulcer disease.
Microbiology reagents intended to identify species of Bartonella, a rod-shaped bacterium of the family
detecting the target bacteria, usually through tests performed on bacteria cultures. Some species of t
human infections, including benign lymphoreticulosis (cat-scratch disease); they are also associated w

Microbiology reagents intended to identify species of Bordetella, a genus of gram-negative coccobacil


detecting the target bacteria, usually through tests performed on bacteria cultures. Some species of t
cause infections in the human respiratory tract, including whooping cough.
Microbiology reagents intended to identify species of Borrelia, a genus of bacteria of the family Spiroc
detecting the target bacteria, usually through tests performed on bacteria cultures. A species of these
etiologic agent of Lyme disease; these bacteria may also cause other human infections.

Microbiology reagents intended to identify species of Brucella, a genus of coccobacillus bacteria, by d


bacteria, usually through tests performed on bacteria cultures. A species of these bacteria is the etiolo
brucellosis; these bacteria may also cause respiratory tract infections in humans.

Microbiology reagents intended to identify species of Enterococcus, a spherical-to-ovoid coccus of the


Streptococcaceae, by detecting the target bacteria, usually through tests performed on bacteria cultu
the Enterococcus genus are part of the normal flora of the intestinal tract of humans, but some (e.g., E
urinary tract infections, endocarditis, and bacteremia.
Microbiology reagents intended to identify antimicrobial-resistant species of Enterococcus, a spherical
family Streptococcaceae, by detecting the target bacteria, usually through tests performed on bacteri
members of the Enterococcus genus are part of the common flora of the intestinal tract of humans, bu
faecalis) can cause urinary tract infections, endocarditis, and bacteremia.

Microbiology reagents intended to identify Gardnerella vaginalis, the only species of a genus of bacter
Rickettsiaceae, by detecting the target bacteria, usually through tests performed on bacteria cultures.
cause genital tract bacteremia (vaginitis) in females.
Microbiology reagents intended to identify Haemophilus ducreyi, a bacterium of the family Pasteurella
target bacteria, usually through tests performed on bacteria cultures. These bacteria may cause chan
the genitals.
Microbiology reagents intended to identify species of Legionella, a genus of intracellular bacteria of th
Legionellaceae, by detecting the target bacteria, usually through tests performed on bacteria cultures
cause legionellosis, a pneumonia-like disease in humans.
Microbiology reagents intended to identify species of Listeria, a genus of bacteria closely resemble ba
Corynebacteriaceae, by detecting the target bacteria, usually through tests performed on bacteria cul
these bacteria (i.e., Listeria monocytogenes) is the cause of listeriosis and in utero infections; infection
birth cause cardiorespiratory distress, diarrhea, vomiting, and meningitis. Infection in adults produces
endocarditis, and disseminated granulomatous lesions.

Microbiology reagents intended to identify Mycobacterium avium complex, a group of slow-growing ba


not limited to, M. avium and M. intracellulare) of the family Mycobacteriaceae. These bacteria may ca
diseases, lymphadenitis in children, and systemic illness in immunocompromised people (e.g., AIDS p

Microbiology reagents intended to identify antimicrobial-resistant strains of Mycobacterium tuberculos


bacterium of the family Mycobacteriaceae. These bacteria are highly pathogenic microorganisms that
tuberculosis or, less frequently, nonpulmonary tuberculosis.
Microbiology reagents intended to identify species of Vibrio, a genus of rod-shaped bacteria of the fam
detecting the target bacteria, usually through tests performed on bacteria cultures. Some species of t
cause human infections; these species include V. cholerae, which causes Asiatic cholera, and several s
diarrhea.
Microbiology reagents intended to identify Yersinia pestis, an ovoid-shaped bacterium of the family En
Yersinia pestis is the etiologic agent of bubonic and pneumonic plague in humans.
Serology reagents intended to detect antibodies to Bartonella bacilliformis, a species of bacterium of t
family Bartonellaceae. These bacteria may cause a type of bartonellosis known as Carrion's disease, c
acute anemic stage (Oraya fever) followed by chronic benign skin eruption (verruga peruana).

Serology reagents intended to detect antibodies to Bartonella elizabethae, a species of bacterium of t


family Bartonellaceae. These bacteria may cause bacterial endocarditis.
Serology reagents intended to detect antibodies to Bartonella henselae, a rod-shaped bacterium of th
Bartonellaceae. These bacteria may cause benign lymphoreticulosis (cat-scratch disease) and regiona

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Bartonella henselae, a rod
the family Bartonellaceae. These bacteria may cause benign lymphoreticulosis (cat-scratch disease) a
lymphadenitis.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Bartonella henselae, a rod
the family Bartonellaceae. These bacteria may cause benign lymphoreticulosis (cat-scratch disease) a
lymphadenitis.
Serology reagents intended to detect antibodies to Bartonella quintana, a rod-shaped bacterium of the
Bartonellaceae. These bacteria may cause trench fever and are associated with endocarditis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Bartonella quintana, a rod
the family Bartonellaceae. These bacteria may cause trench fever and are associated with endocarditi

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Bartonella quintana, a rod
the family Bartonellaceae. These bacteria may cause trench fever and are associated with endocarditi

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
parapertussis, a gram-negative coccobacillus bacterium. These bacteria are an etiologic agent of who

Serology reagents intended to detect antibodies to Bordetella parapertussis, a gram-negative coccoba


These bacteria are an etiologic agent of whooping cough.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Bordetella pertussis, a gra
coccobacillus. These bacteria may cause pertussis (whooping cough).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Bordetella pertussis, a gra
coccobacillus. These bacteria may cause pertussis (whooping cough).
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Brucella, a gen
bacteria of uncertain family affiliation. Brucella bacteria of several species (e.g., B. abortus, B. suis) ar
humans, causing brucellosis, a disease characterized by intermittent (i.e., undulant) fever.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Brucella, a gen
bacteria of uncertain family affiliation. Brucella bacteria of several species (e.g., B. abortus, B. suis) ar
humans, causing brucellosis, a disease characterized by intermittent (i.e., undulant) fever.

Serology reagents intended to detect antibodies to Brucella abortus, a coccobacillus bacterium. These
etiologic agent of brucellosis, a disease characterized by intermittent (i.e., undulant) fever.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Brucella abortus, a coccob
These bacteria are an etiologic agent of brucellosis, a disease characterized by intermittent (i.e., undu

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Brucella abortus, a coccob
These bacteria are an etiologic agent of brucellosis, a disease characterized by intermittent (i.e., undu

Serology reagents intended to detect antibodies to Brucella melitensis, a coccobacillus bacterium. The
etiologic agent of brucellosis, a disease characterized by intermittent (i.e., undulant) fever.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Brucella melitensis, a cocc
These bacteria are an etiologic agent of brucellosis, a disease characterized by intermittent (i.e., undu

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Brucella melitensis, a coc
These bacteria are an etiologic agent of brucellosis, a disease characterized by intermittent (i.e., undu
Serology reagents intended to detect antibodies to Brucella suis, a coccobacillus bacterium. These ba
agent of brucellosis, a disease characterized by intermittent (i.e., undulant) fever.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Chlamydia trachomatis, an
bacterium of the family Chlamydiaceae. These bacteria are an etiologic agent of trachoma, a disease
chronic infection of the conjunctiva and cornea; they are also associated with genital infections.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Chlamydia trachomatis, a


bacterium of the family Chlamydiaceae. These bacteria are an etiologic agent of trachoma, a disease
chronic infection of the conjunctiva and cornea; they are also associated with genital infections.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Chlamydia trachomatis, a


bacterium of the family Chlamydiaceae. These bacteria are an etiologic agent of trachoma, a disease
chronic infection of the conjunctiva and cornea; they are also associated with genital infections.

Serology reagents intended to detect antibodies to Chlamydophila pneumoniae, an intracellular bacte


Chlamydiaceae. These bacteria may cause respiratory infections and mild atypical pneumonia.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Chlamydophila pneumonia
bacterium of the family Chlamydiaceae. These bacteria may cause respiratory infections and mild aty

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Chlamydophila pneumonia


bacterium of the family Chlamydiaceae. These bacteria may cause respiratory infections and mild aty

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Chlamydophila pneumoni


bacterium of the family Chlamydiaceae. These bacteria may cause respiratory infections and mild aty

Serology reagents intended to detect antibodies to Chlamydophila psittaci, a bacterium of the family C
bacteria may cause human psittacosis.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Chlamydophila psittaci, a b
Chlamydiaceae. These bacteria may cause human psittacosis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Chlamydophila psittaci, a
Chlamydiaceae. These bacteria may cause human psittacosis.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Chlamydophila psittaci, a
family Chlamydiaceae. These bacteria may cause human psittacosis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
psittaci, a bacterium of the family Chlamydiaceae. These bacteria may cause human psittacosis.

Serology reagents intended to detect toxins from or antigens or antibodies to species of Clostridium, a
the family Bacillaceae. These bacteria are part of the normal colon flora in humans; some species may
numbers and produce a protein exotoxin in sufficient amounts to cause gas gangrene and/or necrotizi

Serology reagents intended to detect toxins from Clostridium botulinum, a species of bacteria of the fa
Clostridium botulinum bacteria produce a neurotoxin in sufficient amounts to cause poisoning (i.e., bo
Serology reagents intended to detect toxins from or antigens or antibodies to Clostridium difficile, a sp
the family Bacillaceae. Clostridium difficile bacteria are part of the normal colon flora in humans; they
and produce a protein exotoxin in sufficient amounts to cause pseudomembranous enterocolitis in pat
antibiotic (e.g., lincomycin) treatments.
Serology reagents intended to detect exotoxins from Clostridium perfringens, a species of bacterium o
Bacillaceae. Clostridium perfringens bacteria grow in large numbers and produce a protein exotoxin in
cause gas gangrene and/or necrotizing colitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Coxiella burnetii, a bacter
Rickettsiaceae. C. burnetii causes an acute infection (i.e., Q fever), characterized by fever and chills, t
complicated by pneumonitis, hepatitis, and endocarditis; in humans it is typically acquired by inhalatio
organisms derived from infected animals.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Coxiella burnetii, a bacter
Rickettsiaceae. C. burnetii causes an acute infection (i.e., Q fever), characterized by fever and chills, t
complicated by pneumonitis, hepatitis, and endocarditis; in humans it is typically acquired by inhalatio
organisms derived from infected animals.
Serology reagents intended to detect antibodies to species of Ehrlichia, a genus of bacteria of the fam
Some species of these bacteria are an etiologic agent of monocytic ehrlichiosis in humans (they attac
type of white blood cell).
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Ehrlichia, a gen
family Rickettsiaceae. Some species of these bacteria are an etiologic agent of monocytic ehrlichiosis
the monocytes, a type of white blood cell).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Ehrlichia, a gen
family Rickettsiaceae. Some species of these bacteria are an etiologic agent of monocytic ehrlichiosis
the monocytes, a type of white blood cell).
Serology reagents intended to detect antibodies to Ehrlichia chaffeensis, a bacterium of the family Ric
bacteria are an etiologic agent of monocytic ehrlichiosis in humans (they attack the monocytes, a type

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Ehrlichia chaffeensis, a ba


Rickettsiaceae. These bacteria are an etiologic agent of monocytic ehrlichiosis in humans (they attack
of white blood cell).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Ehrlichia chaffeensis, a ba
Rickettsiaceae. These bacteria are an etiologic agent of monocytic ehrlichiosis in humans (they attack
of white blood cell).
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Francisella tularensis, a sp
bacterium. These bacteria cause tularemia, a disease characterized by malaise, fever, chills, and wea
are typically transmitted by wild animals.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Francisella tularensis, a sp
bacterium. These bacteria cause tularemia, a disease characterized by malaise, fever, chills, and wea
are typically transmitted by wild animals.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Francisella tularensis, a sp
negative bacterium. These bacteria cause tularemia, a disease characterized by malaise, fever, chills,
bacteria are typically transmitted by wild animals.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Haemophilus influenzae, a
family Pasteurellaceae. These bacteria induce an inflammatory response that causes diseases. Encaps
(polysaccharide) organisms of Haemophilus influenzae type B cause bacteremia and acute bacterial m
occasionally cause other diseases (e.g., obstructive laryngitis, cellulitis, osteomyelitis, bacterial pneum

Serology reagents intended to detect antibodies to Haemophilus influenzae type B, a bacterium of the
Pasteurellaceae. These bacteria induce an inflammatory response that causes diseases. Encapsulated
organisms of Haemophilus influenzae type B cause bacteremia and acute bacterial meningitis; they m
epiglottitis (obstructive laryngitis), cellulitis, osteomyelitis, joint infections, and bacterial pneumonia in

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Haemophilus influenzae ty


the family Pasteurellaceae. These bacteria induce an inflammatory response that causes diseases. En
(polysaccharide) organisms of Haemophilus influenzae type B cause bacteremia and acute bacterial m
occasionally cause epiglottitis (obstructive laryngitis), cellulitis, osteomyelitis, joint infections, and bac
children.

Serology reagents intended to detect antibodies to Anaplasma phagocytophilum (formerly Ehrlichia ph


bacterium of the genus Anaplasmataceae, family Rickettsiaceae. These bacteria may cause human gr
a disease characterized by the attack on granulocytes, a type of white blood cell.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Anaplasma phagocytophil


phagocytophilum), a bacterium of the genus Anaplasmataceae, family Rickettsiaceae. These bacteria
granulocytic ehrlichiosis, a disease characterized by the attack on granulocytes, a type of white blood

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Anaplasma phagocytophi


phagocytophilum), a bacterium of the genus Anaplasmataceae, family Rickettsiaceae. These bacteria
granulocytic ehrlichiosis, a disease characterized by the attack on granulocytes, a type of white blood

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Leptospira, a ge


motile bacteria of the family Leptospiraceae. Leptospira interrogans is typically the species that is pat
causing leptospirosis. Leptospirosis is acquired directly by contact with the urine or tissue of infected a
dogs) or indirectly by contact with contaminated water, soil, or vegetation.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Leptospira, a g


motile bacteria of the family Leptospiraceae. Leptospira interrogans is typically the species that is pat
causing leptospirosis. Leptospirosis is acquired directly by contact with the urine or tissue of infected a
dogs) or indirectly by contact with contaminated water, soil, or vegetation.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
finely coiled, motile bacteria of the family Leptospiraceae. Leptospira interrogans is typically the speci
humans, causing leptospirosis. Leptospirosis is acquired directly by contact with the urine or tissue of
rodents, dogs) or indirectly by contact with contaminated water, soil, or vegetation.
Serology reagents intended to detect antibodies to species of Listeria, a genus of bacteria closely rese
family Corynebacteriaceae. A species of these bacteria (i.e., Listeria monocytogenes) is the etiologic a
which causes in utero infection that can cause abortion, stillbirth, or premature birth; infections acquir
cause cardiorespiratory distress, diarrhea, vomiting, and meningitis. Infection in adults can produce m
and disseminated granulomatous lesions.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Listeria monocytogenes, a


closely resembling bacteria of the family Corynebacteriaceae. Listeria monocytogenes bacteria are th
listeriosis, which may cause in utero infections, that can result in abortion, stillbirth, or premature birt
during birth can cause cardiorespiratory distress, diarrhea, vomiting, and meningitis. Infection in adult
meningitis, endocarditis, and disseminated granulomatous lesions.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Listeria monocytogenes, a


closely resembling bacteria of the family Corynebacteriaceae. Listeria monocytogenes bacteria are th
utero infection can result in abortion, stillbirth, or premature birth; infection acquired during birth can
cardiorespiratory distress, diarrhea, vomiting, and meningitis; and infection in adults can produce men
and disseminated granulomatous lesions.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
complex (Mycobacterium avium and Mycobacterium intracellulare, based on antigenic specificity), a g
bacteria of the family Mycobacteriaceae. These bacteria may cause pulmonary diseases, lymphadenit
systemic illness in immunocompromised people (e.g., AIDS patients).

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Mycoplasma pneumoniae


bacteria are the etiologic agent of primary atypical pneumonia (i.e., mycoplasmal pneumonia) and oth
respiratory-tract infections.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae
bacteria are the etiologic agent of primary atypical pneumonia (i.e., mycoplasmal pneumonia) and oth
respiratory-tract infections.
Serology reagents intended to detect antibodies to Neisseria meningitidis (i.e., meningococci), a speci
family Neisseriaceae. These bacteria may cause meningococcemia and/or meningococcal meningitis.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci) type A, a species of bacterium of the family Neisseriaceae. These bacteria may ca
and/or meningococcal meningitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Neisseria meningitidis (i.e
species of bacterium of the family Neisseriaceae. These bacteria may cause meningococcemia and/or
meningitis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci) type B, a species of bacterium of the family Neisseriaceae. These bacteria may ca
and/or meningococcal meningitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Neisseria meningitidis (i.e
C, a species of bacterium of the family Neisseriaceae. These bacteria may cause meningococcemia an
meningitis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci) type C, a species of bacteria of the family Neisseriaceae. These bacterium may ca
and/or meningococcal meningitis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci) type Y, a species of bacterium of the family Neisseriaceae. These bacteria may ca
and/or meningococcal meningitis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci) type Y, a species of bacterium of the family Neisseriaceae. These bacteria may ca
and/or meningococcal meningitis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., meningococci) type W135, a species of bacterium of the family Neisseriaceae. These bacteria ma
meningococcemia and/or meningococcal meningitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Neisseria meningitidis (i.e
W135, a species of bacterium of the family Neisseriaceae. These bacteria may cause meningococcem
meningococcal meningitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Rickettsia, a ge
bacteria of the family Rickettsiaceae. Rickettsia bacteria that are pathologic to humans are usually div
based on antigenic relationships. The typhus group includes the species R. typhi and R. prowazekii. Sp
species, which cause several similar diseases that are widely distributed geographically (e.g., Rocky M
Kenya tick typhus, Siberian tick typhus), include R. rickettsii, R. conorii, and R. siberica. The group of s
fever includes R. tsutsugamushi.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Rickettsia, a ge


bacteria of the family Rickettsiaceae. Rickettsia bacteria that are pathologic to humans are usually div
based on antigenic relationships. The typhus group includes the species R. typhi and R. prowazekii. Sp
species, which cause several similar diseases that are widely distributed geographically (e.g., Rocky M
Kenya tick typhus, Siberian tick typhus), include R. rickettsii, R. conorii, and R. siberica. The group of s
fever includes R. tsutsugamushi.

Serology reagents intended to detect antibodies to Rickettsia prowazekii, a gram-negative bacterium


Rickettsiaceae. These bacteria are an etiologic agent of epidemic typhus; they may also cause recrude

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Rickettsia prowazekii, a gr


bacterium of the family Rickettsiaceae. These bacteria are an etiologic agent of epidemic typhus; they
recrudescent (latent) typhus.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Rickettsia prowazekii, a g
bacterium of the family Rickettsiaceae. These bacteria are an etiologic agent of epidemic typhus; they
recrudescent (latent) typhus.
Serology reagents intended to detect antibodies to Rickettsia rickettsii, a gram-negative bacterium of
Rickettsiaceae. These bacteria are an etiologic agent of Rocky Mountain spotted fever, transmitted by
dogs, and foxes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Rickettsia rickettsii, a gram
of the family Rickettsiaceae. These bacteria are an etiologic agent of Rocky Mountain spotted fever, tr
from rodents, dogs, and foxes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Rickettsia rickettsii, a gra
of the family Rickettsiaceae. These bacteria are an etiologic agent of Rocky Mountain spotted fever, tr
from rodents, dogs, and foxes.
Serology reagents intended to detect antibodies to species of the typhus group of Rickettsia (including
prowazekii), a genus of gram-negative bacteria of the family Rickettsiaceae. These bacteria are an eti
epidemic typhus, usually transmitted through fleas and lice from rats and other mammals; they may a
recrudescent (latent) typhus.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of the typhus grou
(including R. typhi and R. prowazekii), a genus of gram-negative bacteria of the family Rickettsiaceae.
etiologic agent of epidemic typhus, usually transmitted through fleas and lice from rats and other mam
cause recrudescent (latent) typhus.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of the typhus grou
(including R. typhi and R. prowazekii), a genus of gram-negative bacteria of the family Rickettsiaceae.
etiologic agent of epidemic typhus, usually transmitted through fleas and lice from rats and other mam
cause recrudescent (latent) typhus.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
aureus, a bacterium of the family Micrococcaceae. These bacteria may cause serious suppurative infe
immunosuppressed patients, neonates, and the elderly, through damaged skin or in viral infections of

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(typically Streptococcus pyogenes), spherical bacteria of the family Streptococcaceae. St. pyogenes i
important bacterial human pathogens, causing a wide range of suppurative diseases (e.g., pharyngitis
endocarditis) and nonsuppurative sequelae (e.g., acute rheumatic fever). These antigens are associat
autoimmune diseases, including rheumatoid arthritis and osteoarthritis.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., Streptococcus agalactiae), spherical bacteria of the family Streptococcaceae. S. agalactiae is a b
humans causing urinary tract and wound infections and otitis media.These antigens are associated wi
diseases, including rheumatoid arthritis and osteoarthritis.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(including S. equisimilis, S. zooepidemicus, and S. dysgalactiae), spherical bacteria of the family Strep
Streptococcus group C bacteria may cause endocarditis, bacteremia, pneumonia, meningitis, and mild
tract infections. S. equisimilis is the most common group C bacterial pathogen of humans, but other g
S. zooepidemicus and S. dysgalactiae may also cause infections.

Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(i.e., S. faecalis, S. faecium, S. durans, S. avium, S. bovis), spherical bacteria of the family Streptococc
faecium are the most common bacterial pathogens of humans in this group; group D streptococci may
and biliary or urinary tract infections.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
(e.g., Streptococcus anginosus, also known as Streptococcus milleri), spherical bacteria of the family S
Group F streptococci are bacterial pathogens of humans that may cause subcutaneous or organ absce
mild upper-respiratory-tract infections.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
G, a heterogeneous collection of microorganisms (that include, but are not limited to, the large-colony
the minute-colony beta-hemolytic group G strains of coccoid bacteria), spherical bacteria of the family
Streptococcus group G bacteria are associated with pharyngitis, skin and soft tissue infections, septice
arthritis.

Serology reagents intended to detect antibodies to species of Treponema, a genus of spiral gram-nega
family Spirochaetaceae. Species that are pathologic to humans include T. pallidum (causing syphilis),
yaws), and T. carateum (causing pinta).
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Treponema, a g
negative bacteria of the family Spirochaetaceae. Species that are pathologic to humans include T. pall
syphilis), T. pertenue (causing yaws), and T. carateum (causing pinta).
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Treponema, a g
negative bacteria of the family Spirochaetaceae. Species that are pathologic to humans include T. pall
syphilis), T. pertenue (causing yaws), and T. carateum (causing pinta).
Serology reagents intended to detect antibodies to species of Thermoactinomyces, a genus of thermo
family Micromonosporaceae. Species that are pathologic in humans include T. vulgaris, T. candidus, an
species of bacteria may cause hypersensitivity pneumonitis (farmer's lung disease).

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Thermoactinom


thermophilic bacteria of the family Micromonosporaceae. Species that are pathologic in humans includ
candidus, and T. sacchari; these species of bacteria may cause hypersensitivity pneumonitis (farmer's

Serology reagents intended to detect antibodies to Thermoactinomyces candidus, a thermophilic bact


Micromonosporaceae. These bacteria may cause hypersensitivity pneumonitis (farmer's lung disease)

Serology reagents intended to detect antibodies to Thermoactinomyces sacchari, a thermophilic bacte


Micromonosporaceae. These bacteria may cause hypersensitivity pneumonitis (farmer's lung disease)

Serology reagents intended to detect antibodies to Thermoactinomyces vulgaris, a thermophilic bacte


Micromonosporaceae. These bacteria may cause hypersensitivity pneumonitis (farmer's lung disease)

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Thermoactinomyces vulga


bacterium of the family Micromonosporaceae. These bacteria may cause hypersensitivity pneumonitis
disease).
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
genus of rod-shaped bacteria of the family Vibrionaceae. Some species of these bacteria may cause d
etiologic agent of human (Asiatic) cholera, an endemic acute enteritis infection that may be fatal.

Serology reagents intended to detect immunoglobulin A (IgA) antibodies to species of Yersinia, a genu
bacteria of the family Enterobacteriaceae. Yersinia species that are pathologic to humans include Y. pe
bubonic plague; Y. enterocolitica, which causes acute gastroenteritis and mesenteric lymphadenitis; a
pseudotuberculosis, which causes mesenteric lymphadenitis without gastroenteritis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Yersinia, a genu
bacteria of the family Enterobacteriaceae. Yersinia species that are pathologic to humans include Y. pe
bubonic plague; Y. enterocolitica, which causes acute gastroenteritis and mesenteric lymphadenitis; a
pseudotuberculosis, which causes mesenteric lymphadenitis without gastroenteritis.

Serology reagents intended to detect antibodies to Yersinia enterocolitica, an ovoid-shaped bacterium


Enterobacteriaceae. These bacteria may cause acute gastroenteritis and mesenteric lymphadenitis.

Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Yersinia enterocolitica, an


bacterium of the family Enterobacteriaceae. These bacteria may cause yersiniosis, characterized by a
and mesenteric lymphadenitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Yersinia enterocolitica, an
bacterium of the family Enterobacteriaceae. These bacteria may cause yersiniosis, characterized by a
and mesenteric lymphadenitis.
Serology reagents used in tests intended to detect antigens that permit the identification of strains of
ovoid-shaped bacterium of the family Enterobacteriaceae. These bacteria are the etiologic agent of bu
plague in humans.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Yersinia pseudotuberculos
bacterium of the family Enterobacteriaceae. These bacteria may cause acute gastroenteritis and mese

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Yersinia pseudotuberculos


bacterium of the family Enterobacteriaceae. These bacteria may cause acute gastroenteritis and mese

Instruments designed for bending metallic wires and/or plastic cords or tightening them to anatomic p
and implants during surgical and dental procedures. Some crimpers are used to manipulate flexible pi
crimpers are typically a dedicated forceps- or pliers-like, handheld, manual instrument with jaws spec
manipulate wires (and/or flexible pins or bands). Wire crimpers are used mainly in orthopedic, middle-
procedures.

Wire crimpers designed for bending or tightening metallic wires and/or plastic cords or bands to anato
prostheses and implants during surgical procedures. These crimpers are typically a forceps-like, handh
instrument with jaws conformed to manipulate wires and/or flexible pins or bands. Dedicated surgical
for use in orthopedic (e.g., cerclage), middle-ear, and nasal procedures.

Surgical wire crimpers designed for bending or tightening metallic and plastic wires to middle-ear ana
crimpers are typically a forceps-like handheld instrument with appropriate size and conformed jaws to
the ear canal. Middle-ear surgical wire crimpers are used mainly in procedures intended to repair or re
ossicles; they are also used in reconstructive and plastic-surgery procedures of the inner ear.

Surgical wire crimpers designed for bending or tightening metallic wires to bones during orthopedic pr
crimpers are typically a forceps-like handheld instrument with appropriate size and conformed jaws to
they frequently include attached pins protruding from the jaws to roll the wire. Orthopedic surgery wir
mainly in procedures intended to fix bones in open fractures of long bones; they are also used as an a
cerclage procedures.
Surgical wire crimpers designed for bending or tightening metallic wires to the maxilla and/or other or
crimpers are typically a pliers-like, sturdy, handheld instrument with appropriate size and conformed j
wires around the maxilla and/or in the oral cavity. Oral/maxillary surgery wire crimpers are used mainl
intended to fix bones in a fractured maxilla or to correct malpositions of the jaw bones (i.e., orthognat

Instruments designed to apply metal and/or plastic liners to seal tubes, bottles, and small containers (
medical procedures and/or laboratory tests, preventing fluid leakage. These crimpers are typically inst
mechanism at the working end that is operated by a two-part squeezable handle; forceps-like hand he
instruments with jaws conformed to manipulate crimp seals are less frequently used. Bench-mounted
semiautomatic manual or power (electric, pneumatic) machines are also available for facilities that pe
of bottle/vial capping, sealing, and/or crimping.

Instruments designed to remove crimp seals and caps from tubes, bottles, and small containers (i.e., v
procedures and/or laboratory tests. These decrimpers may be manual, automated electric, or pneuma
instruments. Manual instruments are intended for healthcare facilities with a low volume of operations
instruments are used in clinical pharmacies, laboratories, or any other area with a high-volume of dail

Crushers designed to squeeze and mix bone, cartilage, and/or fascia intended for implantation during
These crushers are typically benchtop instruments including a metallic solid base structure with a cav
manually compress bone, cartilage, and/or fascia. Bone/cartilage/fascia crushers are used in healthcar
implantable material before or while performing procedures such as plastic, orthopedic, ophthalmic, o
surgery.

Devices designed to reduce pills and caplets to a powder. These crushers are typically a tabletop unit
mechanism (e.g., a pressure level, twisting lid) to crush the pill and a detachable container (e.g., plast
the crushed pill. Pill crushers are used mainly in healthcare facilities and at home to facilitate the intak
vitamins), either directly or mixed with liquid or soft food.
Devices designed to split a pill in two halves. These devices are typically a tabletop plastic container w
typically, the lower part includes a holder for the pill and the upper part includes a manual cutting me
that cuts the pill when the lid is tightly compressed. Some devices include a storage compartment in t
pills. Pill splitters are used mainly to facilitate the administration of drugs (e.g., vitamins) or to provide
whole pill.

Waste-disposal units specially designed for destroying glassware (e.g., vials, bottles), either filled or e
they may also crush glass syringes (without needles). These units typically consist of a small cabinet w
glassware to be crushed and either a crank (manual operation) or a motor (automatic operation) to cr
finely crushed glass is then rinsed and disposed of for recycling, while the waste liquid is transferred i
container. Glass-crushing waste disposal units are typically constructed of stainless steel; dedicated, s
only for crushing syringe barrels during field use (e.g., immunization) are also available.

Devices designed for rendering hypodermic syringes and/or needles unusable and ready for disposal.
be manual devices that use mechanical action or electrical devices that use a burning unit to destroy
cutting unit to destroy the syringe. Some devices are capable of mechanically destroying both the nee
there is no electric power available. After destruction, the container debris and the unusable syringe r
disposal.
Devices designed for rendering hypodermic syringes and/or needles unusable using mechanical action
typically a small, tabletop unit with a base, a manually actuated mechanism with a hole to place the s
attached needle, and a container for the needle and/or needle and syringe connector debris. They are
of configurations, each with a different destruction mechanism, including devices with two handles tha
together to actuate two circular blades across each other, devices with hand-powered clipper action to
and devices with two blades that cut the syringe at the nozzle (hub), separating the needle from the s
syringe/needle destroyers are typically reusable; however, hub cutters are intended to store the cut n
unit is discarded when the container is full.

Needle and/or syringe destroyers especially designed for destroying needles attached to a hypodermi
temperature oxidation (i.e., burning). These devices are typically a container with an aperture for nee
includes two low-voltage electrodes; the current heats the needle to a high temperature (typically from
degrees Celsius), oxidizing the needle into metallic oxide ash in a few seconds. A sealed cartridge coll
remnants of the syringe without the needle and the ash cartridge (not sharp disposals) may be dispos
biohazard waste disposal unit. Needle-burning syringe/needle destroyers frequently include a mechan
for complete destruction of the syringe; some devices are capable of mechanically destroying both th
when there is no electric power available. These devices are typically reusable.

Hair clippers designed to cut the hair above the skin surface using a handheld, manually operated me
a two-blade clipping action to cut the hair above the skin surface. These hair clippers are used mainly
and grooming. Dedicated hair clippers intended for hair removal before surgical or other related clinic
catheterization, labor) are also available. Manual hair clippers are usually manipulated by an operator
to remove a patient's hair. Other manual instruments, such as scissors and razors, are also used to cu

Hair clippers designed to cut the hair above the skin surface using a handheld electrically powered me
a two-blade clipping action to cut the hair above the skin surface. Electric hair clippers are used mainl
and grooming. Dedicated hair clippers intended for hair removal before surgical or other related clinic
catheterization, labor) are also available. Electric hair clippers are usually manipulated by an operator
to remove a patient's hair.

Electric hair clippers designed to remove hair from the head or body before surgical or other clinical p
devices typically consist of a handheld, electrically (battery and/or line) powered mechanism with a na
performs a clipping action to cut the hair above but close to the skin surface. Preoperative electric hai
to remove hair, with minimum skin damage, before surgical or other related clinical procedures (e.g.,
Preoperative electric hair clippers are usually manipulated by a healthcare worker to remove a patient

Clippers designed for cutting the fingernails using a mechanism that performs a two-blade clipping ac
typically, small, manual, handheld instruments with two articulated metal pieces, used for personal hy
Nail clippers are usually manipulated by a person to trim his or her own nails. Dedicated clippers desig
disabled individuals (e.g., tabletop-mounted clippers) are also available. Other manual instruments th
action, such as scissors and nippers, are also used to cut fingernails.

Clippers designed for use by individuals with physical limitations (i.e., disabilities) for cutting their own
devices use a mechanism that performs a two-blade clipping action. These clippers are typically small
tabletop-mounted instruments with two articulated metal pieces, used for personal hygiene and groom
Clippers designed for cutting the toenails using a mechanism that performs a two-blade clipping actio
nail to prevent ingrowth. These clippers are typically strong manual, handheld instruments with two sm
pieces with straight cutting edges, used for personal hygiene and grooming. Toenail clippers are usual
person to trim his or her own nails. Dedicated clippers designed especially for disabled individuals (e.g
are also available. Other manual instruments that perform a shearing action, such as scissors and nipp
cut toenails for both grooming and podiatric procedures.

Clippers designed for use by individuals with physical limitations (i.e., disabilities) for cutting their own
devices use a mechanism that performs a two-blade clipping action to cut straight across the nail, pre
These clippers are typically strong, manual instruments with a far-reaching mechanism (e.g., pistol-gr
small articulated metal pieces with straight cutting edges, used for personal hygiene and grooming.

Surgical instruments designed to decapitate fetuses. These instruments typically include a wire saw b
end with a rubber sheath to prevent damage to the surrounding maternal tissues, handles at both end
to pass the wire saw behind the fetal head. Decapitation is performed by pulling the blade back and fo
neck. Fetal decapitators are typically used during obstetrical procedures when the fetus is not viable o
mother's life during difficult labor. Other instruments used for fetal decapitation include dedicated hoo
as wire-type manual saws.

Computers designed for use by an individual to store, retrieve, and process data, typically in digital fo
instructions of one or more programs stored internally, either temporarily or permanently (i.e., softwa
respectively). These computers typically consist of a microprocessor-based CPU (central processing un
simple well-defined functions; with input and output ports for connection to other devices including ke
devices such as a mouse, joystick, and trackball; data storage devices; and an electronic monitor for i
Additional peripheral devices, such as printers, plotters, and high-capacity data recorders, are frequen
computer to increase its capabilities. Personal computers are available in several configurations (e.g.,
are used in healthcare facilities, at physician offices for clinical and administrative data processing, an
data processing; workstations (e.g., radiology, ultrasound, MRI), or information/automation systems.

Personal computers designed to be used on a desk. These computers typically consist of a microproce
(central processing unit) that performs simple, well-defined functions; input and output ports for conn
including keyboards and pointing devices such as a mouse, joystick, and trackball; and data storage d
electronic monitor for image display. Additional peripheral devices, such as printers, plotters, and data
frequently attached to the computer to increase its capabilities. Desktop personal computers can stor
data, typically in digital form, following the instructions of one or more programs stored internally, eith
permanently (i.e., software and firmware, respectively). They are used in healthcare facilities, physicia
clinical and administrative data processing, as a component of data processing workstations (e.g., rad
MRI), or information/automation systems.
Computers designed as a single portable unit that integrates all the components needed for proper op
individual, including storage, retrieval, and the processing of digital data following the instructions of o
stored internally, either temporarily or permanently (i.e., software and firmware, respectively). These
consist of a foldable device that includes a microprocessor-based CPU (central processing unit), a keyb
devices, and an electronic display (screen); they also include a battery to permit operation in any loca
Additional peripheral devices, such as printers and plotters, are frequently connected to a laptop com
capabilities. Laptop computers are used in healthcare facilities, physician offices, and at home for clin
data processing; they may be used as a component of data processing workstations (e.g., radiology, u
information/automation systems.

Computers designed as a single handheld unit (i.e., palmtop) that integrates the components needed
individual, including storage, retrieval, and the capacity to process digital data, following the instructio
programs stored internally, typically in a read-only memory (ROM) chip or added later in the device's
memory (RAM). These computers typically consist of a small unit including a relatively simple micropr
memories, an LCD display, operating buttons, input-output ports, and a battery; some devices include
and/or a touchscreen. Basic handheld computers act as an electronic organizer known as a PDA (perso
capable of sharing and synchronizing information with a personal computer. Dedicated handheld comp
connected to the Internet, run multimedia software, and act as global positioning systems; handheld c
frequently combined with cell phones, multimedia players, and other communication devices.

Devices designed to acquire, process, and store data and/or images specific to a particular procedure
cardiology, ultrasound). The main component of a workstation is usually a high-capacity digital compu
typically obtain the data directly from the devices that perform the procedure (e.g., digital radiograph
cameras) or through digitized scans of printed or electronic images (e.g., films, image plates). They ty
high-speed digital computer with a powerful microprocessor, optical/magnetic disks, and input and ou
workstation usually follows the instructions of specialized software for data and/or image processing. W
frequently installed as a component of or interact with department and/or hospital information system
archiving and communication systems.

Radiotherapy workstations designed to verify that the proper radiotherapy treatment is being delivere
permanent record. These workstations include input and output devices for graphical and alphanume
keyboards, monitors, printers). They usually follow the instructions of software intended to reduce hum
monitoring the parameters of the radiotherapy unit (e.g., linear accelerator), patient information, and
before commencement of treatment. The information is entered into a patient's file and stored. Record
are usually interlocked with the radiotherapy unit to ensure that treatment is not permitted if any para
predetermined tolerances. They are used mainly in treatment of cancer and related diseases.
Radiotherapy workstations designed to optimize the calculation of the expected radiation energy (dos
patients from both external sources of radiation (teletherapy) and implanted sources (brachytherapy).
typically consist of a computer, software for dosage calculation, and input and output devices (e.g., ke
printers) for graphic and alphanumeric data. Radiotherapy planning workstations usually follow the in
appropriate software that enables clinicians to choose the best combination of radiation beams and m
eradicating tumors while reducing radiation-related complications in healthy tissue. They are used ma
cancer and related diseases.

Workstations designed to process and store digital data and images acquired by monitors and/or recor
catheterization laboratory, intended to locate and identify irregularities in the heart and its vasculatur
vena cava, as well as to define the size or severity of lesions. These workstations typically obtain the h
parameters or related physiologic data (e.g., valve areas, shunt flows, systolic ejection periods) direct
cardiac output units, and electrodes; they also obtain images from the catheterization system and/or p
devices. Catheterization laboratory workstations usually consist of a high-speed digital computer, high
optical/magnetic disks, input and output devices, and processors; they usually follow the instructions
to create reports related to hemodynamic data and images and include physician comments. They are
a component of or interact with cardiology information systems and/or cardiology picture archiving an
systems.

Workstations designed to process and store digital data and images acquired by monitors and/or recor
exercise laboratory, intended to evaluate the cardiac and/or pulmonary response of a person to physic
performing exercise on a treadmill or a bicycle ergometer. These workstations typically obtain the card
rate, ST-segment trend, arrhythmias) and respiratory function data (e.g., oxygen and carbon dioxide c
inspiratory and expiratory volumes) from monitors and recorders. Stress-exercise laboratory workstati
a high-speed digital computer, high-definition printers, optical/magnetic disks, input and output devic
they usually follow the instructions of specialized software to create reports that help diagnose and m
coronary artery and/or pulmonary diseases or to differentiate between them. Stress-exercise workstat
installed as a component of or interact with cardiology information systems and/or cardiology picture
communication systems.

Workstations designed to process digital data and images acquired by gamma camera scanning syste
single photon emission tomography (SPET) systems. These workstations typically obtain the anatomic
physiologic information directly from the gamma cameras. Gamma camera/SPET workstations typicall
speed digital computer, high-definition printers, optical/magnetic disks, input and output devices, and
processors). These workstations usually follow the instructions of specialized software to measure the
intensity of radiation emitted from radiopharmaceuticals; software specific for SPET scanning systems
reconstruction of transverse image slices taken through the patient's body. The workstations are frequ
component of or interact with hospital information systems, including radiology picture archiving and
systems.
Workstations designed to process and store digital data and images acquired by monitors, recorders, a
systems (e.g., computed tomography, magnetic resonance imaging) in real time used in three-dimens
surgery. These workstations typically process stored data from imaging systems before surgery and si
data and images in real time using electromagnetic techniques or optical devices (e.g., LEDs) for three
tracking of the anatomic structures and positioning of instruments, based on anatomic landmarks and
fiducials. Stereotactic surgery workstations typically consist of a high-speed digital computer, high-de
optical/magnetic disks, input and output devices, and processors; they usually follow the instructions
according to the procedure (e.g., cardiosurgery, cardiac ablation, neurosurgery). The workstations ma
information systems and/or cardiology picture archiving and communication systems.

Workstations designed to process and store digital images and data acquired by one or more diagnost
including computed radiography, computed tomography, magnetic resonance imaging, and ultrasoun
workstations typically consist of a high-speed digital computer, high-definition printers, very-high-cap
disks, input and output devices, and data/image processors; they usually follow the instructions of spe
manipulation of images from different sources, frequently permitting computer reconstruction of trans
taken through the patient's body. These workstations typically permit image processing and display an
image archiving capacity; they may be networked with other workstations and/or display devices conf
archiving and communication system. Dedicated workstations with capacity for three-dimensional pro
the images are also available.

Picture archiving and communication systems workstations designed to analyze, process, and store hi
volumetric digital images and data, providing three-dimensional (3-D) images and segmentation. Thes
process images from several different diagnostic imaging systems, including computed radiography, c
magnetic resonance imaging, and ultrasound scanners. Three-dimensional workstations typically cons
digital computer, high-definition printers, very-high-capacity optical/magnetic disks, input and output
data/image processors; they usually follow the instructions of specialized software for rapid and straig
of images. The main feature of the software is, in addition to the display of 3-D images, its capability f
measurement of tumors, lesions, and aneurysms using real-time multiplanar reformatting of the imag
permits the display of bone-free images facilitating the visualization of vessels and other soft tissue (e

Workstations designed to analyze, process, and store high-resolution volumetric digital images and da
different diagnostic imaging systems, providing three-dimensional (3-D) images and segmentation. Th
obtained from computed radiography (CR), computed tomography (CT), magnetic resonance imaging
(US) scanners using appropriate software. 3-D image workstations typically consist of a high-speed dig
definition printers, input and output devices, and data/image processors; they usually follow the instru
software for rapid and straightforward manipulation of images. The main feature of the software is, in
of 3-D images, its capability for segmentation and measurement of tumors, lesions, and aneurysms us
multiplanar reformatting of the images; these workstations can also provide bone-free images facilitat
vessels and other soft tissue (e.g., angiograms). Workstations with dedicated software intended for on
few applications (CR, CT, MRI, US, endoscopy) are also available.
Computerized devices designed to manage (allocate) network resources. These devices typically cons
computer and/or associated devices (e.g., modems, disc drives) intended to perform a particular set o
servers are available for processing database queries (i.e., a database server), storing files (i.e., a file
manage one or more printers (i.e., a print server). Network servers are used mainly in healthcare facil
LAN (local area network) resources of their digital information and/or communication systems.

Dental wire crimpers designed for bending or tightening metallic wires to teeth and surrounding struc
procedures. These crimpers are typically a pliers-like handheld instrument with appropriate size and c
manipulate wires in the oral cavity. Orthodontic wire crimpers are used mainly to temporarily repair br

Sack-like containers designed for transporting/holding medical devices or gas cylinders (e.g., oxygen c
devices incorporate shoulder straps or other mechanisms so that they can be worn by a healthcare wo
thereby supporting ambulatory use of the device as needed.
Orthopedic cement extraction systems designed for the breakage, removal, and extraction of orthope
(typically polymethyl methacrylate [PMMA]) from a previously implanted prosthesis using ultrasonic e
orthopedic procedures. These systems typically consist of a dedicated ultrasonic generator with appro
more ultrasound handpieces, and cement-removal probes that may be reusable or intended for single
also include irrigation devices, vacuum devices with appropriate suction tubes and filters to extract ce
accessories such as slap hammers, and endoscopic video systems. Ultrasonic orthopedic cement extr
used mainly to remove cement (e.g., mantle, plug) during the removal of prostheses in revision surge
of hip, knee, and other cemented orthopedic prostheses.

Orthopedic cement/bone cutting and extraction systems designed for breaking, cutting, removing, an
fragments and/or orthopedic acrylic cement (typically polymethyl methacrylate [PMMA]) from a previo
prosthesis using ultrasonic energy during orthopedic procedures. These systems typically consist of a
generator with appropriate controls, two or more handpieces (one handpiece is usually intended for cu
bone, and the other is intended for cement breakage and removal); and cement-removal probes that
intended for single use. The systems may also include vacuum devices with appropriate suction tubes
cement/bone fragments, irrigation devices, accessories such as slap hammers, ultrasonic powered ins
osteotomes), and endoscopic video systems. Ultrasonic orthopedic bone and cement cutting and extra
used to cut and remove bone fragments during orthopedic procedures (e.g., prosthesis implantation)
cement (e.g., mantle, plug) during the removal of old prostheses in revision surgery (e.g., replacemen
other cemented orthopedic prostheses.

Systems designed for cutting, removal, and extraction of bone and/or orthopedic acrylic cement (typic
methacrylate [PMMA]) from a previously implanted prosthesis using high-speed powered drills during
These systems typically consist of dedicated electric or pneumatic high-speed rotary handpieces with
and saws; they may also include irrigation devices and vacuum devices with appropriate suction tube
cement/bone fragments. Powered drilling orthopedic bone and cement cutting and extraction systems
remove bone fragments during orthopedic procedures (e.g., prosthesis implantation) and to remove c
plug) during the removal of old prostheses in revision surgery (e.g., replacement) of hip, knee, and oth
orthopedic prostheses.
Computerized video recorder systems designed to view, record, and analyze two-dimensional (i.e., ho
three-dimensional (i.e., horizontal, vertical, torsional) eye movements, usually during a set of standard
tests. These instruments typically consist of goggles or light masks, including an infrared (IR) light sou
for each eye, as well as a dedicated or standard computer with appropriate software to process, recor
the digital video signals obtained from the eye movements (including real-time observation of the act
and/or reports related to the eye-movement tests. The human eye cannot detect IR light signals, perm
of tests using invisible light without any additional disturbance. Videonystagmographs (VNG) may incl
video screens controlled by VNG software to display visual stimuli that may be followed by the patient
are mainly used to perform dedicated standard tests (e.g., caloric, positional, gaze, saccades, smooth
optokinetic) to detect vestibular conditions (e.g., balance, vertigo, dizziness); they may be used also t
of drugs as well as multiple sclerosis and other disorders characterized by involuntary eye movement

Manometers designed to measure the pressure inside a vascular aneurysm using a sensor/transducer
the aneurysm sac created by a stent-graft implanted to repair the aneurysm; the sac is excluded from
during the procedure. These devices typically consist of an implantable pressure transducer (e.g., rad
ultrasound) and an external console that reads the pressure from the transducer signal and displays th
aneurysm manometers are used during endovascular procedures intended to repair vascular aneurysm
aortic aneurysms); comparing aneurysm sac pressure values before and after the exclusion of the sac
aneurysm repair facilitates the detection of internal leaks (e.g., type I endoleaks).

Centrifugal blood cell processors designed for the automatic production of platelet-rich plasma (PRP) a
plasma from a small quantity of autologous blood. These devices typically consist of a dedicated porta
electronic controls, a display, and a kit of disposable items including a separation chamber, syringes,
Autologous platelet separation systems are designed for use at the point of care as well as in the clini
devices may typically be used during surgery to obtain PRP to mix with autograft and/or allograft bone
applications; the plasma and PRP obtained may also be used for diagnostic tests in the clinical laborat

Depressors designed to displace the tongue by compression, facilitating the examination of the surrou
cavity during examination. These instruments are typically handheld, slender and straight sticks or bla
mouth. Tongue examination depressors are usually disposable (i.e., single use) wooden or plastic stick
metal devices (blades) are available for repeated use after sterilization. Disposable sticks may also be
designed stick holders that facilitate their manipulation without directly touching the stick; those hold
ejecting mechanism.

Depressors designed to displace by compression tissue or organs, facilitating the performance of surg
depressors are typically handheld, manual reusable instruments in a variety of shapes and sizes that m
the organ or tissue for a long period of time during the surgical procedure. Surgical depressors are use
ophthalmic, orthopedic, and other procedures; some depressors may be used also to facilitate the eva
before surgery.
Surgical depressors designed to displace by compression (e.g., roll) the white outer coat of the eyebal
facilitating the examination of the surrounding tissue in the eye. These instruments a handheld, manu
with a loop or other appropriate tip at the working end and a handle or a thimble-like (either closed or
the proximal end. Scleral examination depressors permit surgeons to view the peripheral fundus while
the retinal surface and to see the peripheral retina using an ophthalmoscope; they are used to visualiz
and/or elevations before or during surgery. Dedicated pediatric scleral depressors permit the examina
for retinopathy of prematurity (ROP).

Surgical depressors designed for atraumatic compression of neurological brain tissue. These depresso
handheld, manual, metal, slender, flat instruments that may be concave at one or both working ends.
depressors are used for gentle compression and slight movement of brain tissue during neurosurgery,
pressure.
Surgical depressors designed to displace the uterus by compression, facilitating the excision of surrou
depressors are typically handheld, slender, metal instruments with single or double working ends con
Uterine surgical depressors are used to facilitate tumor excision and for other surgical procedures in th

Surgical depressors designed to displace the tongue by compression for a prolonged period of time, fa
of surrounding tissue in the oral cavity. Surgical tongue depressors are typically metal instruments wit
often serrated blades and a handle that is frequently at a right angle to the blade. Tongue surgical dep
intended for repeated use; they are used for oral and/or dental surgery.

Surgical depressors designed to displace by compression the humeral head; they are usually hooked a
of the glenoid rim to expose the glenoid fossa. These depressors are typically a handheld, manual, sle
instrument with one slightly curved open circular end, a flat shaft, and a smaller open opposite end fo
with the shaft. Humeral head depressors are used to facilitate total shoulder reconstruction and recon
procedures.

Laboratory refrigerators designed to store flammable products (typically liquids with a flash point belo
[100 degrees Fahrenheit]) at temperatures between 1 and 10 degrees Celsius (34 and 50 degrees Fah
the ignition of flammable vapors inside the storage compartment. These refrigerators' electrical comp
located outside the chamber, and the compressor is sealed or located at the top of the unit; they may
doors, magnetic door gaskets, and special inner-shell materials that limit the damage should a reactio
storage compartment. Flammable material laboratory refrigerators are usually available in upright and
configurations.
Laboratory refrigerators with a lead liner designed for temporary storage of low- or medium-level radi
radiopharmaceuticals, tagged biological materials) that require refrigeration, typically at temperatures
degrees Celsius (34 and 50 degrees Fahrenheit). These refrigerators typically consist of a chamber ma
resistant (typically stainless steel) interior, minimizing the risk of adulteration, contamination, and/or c
thin (typically 3 to 6 mm [0.125 to 0.25 inch]) lead liner, a key-locked door, and internal shelving appr
easy location, and handling of radioactive products; a compressor, condenser, evaporator, tubing, sen
dependable long-term storage following radioactive laboratory product storage standards. Cooling ele
placed inside the lead shielding to avoid heating problems. Lead-lined laboratory refrigerators are usu
undercounter or tabletop configurations. High-energy radioisotopes must be stored in lead-lined safes
mm [2 inches]) lead liner than in other refrigerators.

Refrigerators designed to be used to perform test procedures and/or to store laboratory products, cult
temperatures typically between 2 and 10 degrees Celsius (35 and 50 degrees Fahrenheit). These refri
consist of a chamber made with a corrosion-resistant (typically stainless steel) interior, minimizing the
contamination, and/or corrosion of contents; internal shelving (either fixed or detachable) appropriate
location, and handling of laboratory products; a compressor, condenser, evaporator, tubing, sensors, c
temperature recording chart, and alarms for dependable long-term storage following laboratory stand
an emergency power supply for the refrigerator and alarm. Refrigerators are available in upright, walk
configurations.

Multiuse laboratory refrigerators with a front-opening (upright) configuration designed to store laborat
samples, such as in vitro diagnosis reagents and laboratory samples (e.g., tissue, body fluid), at temp
and 10 degrees Celsius (35 and 50 degrees Fahrenheit). These refrigerators typically consist of a cham
corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulteration, contaminatio
contents; internal shelving appropriate for storage, easy location, and handling of laboratory products
condenser, evaporator, tubing, sensors, controls, monitors, a temperature recording chart, and alarms
term storage following laboratory standards. They may include an emergency power supply for the re

Small multiuse laboratory refrigerators with a configuration appropriate for use under laboratory coun
to store laboratory products and samples, such as in vitro diagnosis reagents and laboratory samples
fluid), at temperatures between 2 and 10 degrees Celsius (35 and 50 degrees Fahrenheit). These refri
consist of a chamber made with a corrosion-resistant (typically stainless steel) interior, minimizing the
contamination, and/or corrosion of contents; internal shelving appropriate for storage, easy location, a
laboratory products; a compressor, condenser, evaporator, tubing, sensors, controls, monitors, a temp
chart, and alarms for dependable long-term storage following laboratory standards.
Multiuse laboratory refrigerators with a cabinet-like storage compartment large enough to permit a pe
designed to store laboratory products and samples, such as in vitro diagnosis reagents and laboratory
body fluid), at temperatures between 2 and 10 degrees Celsius (35 and 50 degrees Fahrenheit); they
perform laboratory tests and experiments. These refrigerators typically consist of a chamber made wi
(typically stainless steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion
shelving appropriate for storage, easy location, and handling of laboratory products once the user is in
compressor, condenser, evaporator, tubing, sensors, controls, monitors, a temperature recording char
dependable long-term storage following laboratory standards. They usually include an emergency pow
refrigerator and alarms. Walk-in laboratory refrigerators are available completely assembled or as sep
elements (e.g., doors, panels, floors) and units (e.g., refrigeration system, condensing unit) for assem

Refrigerators with a front-opening (upright) configuration designed for storage of drugs, pharmacy pre
pharmaceutical products (e.g., live virus vaccines) typically at temperatures between 2 and 10 degree
degrees Fahrenheit). These refrigerators typically consist of a vertical chamber made with a corrosion-
stainless steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion of conten
appropriate for storage, easy location, and handling of pharmaceutical product containers; a compress
evaporator, tubing, sensors, controls, monitors, a temperature recording chart, and alarms for depend
following pharmacy standards.

Pharmacy refrigerators with a cabinet-like storage compartment large enough to permit a person to e
for storage of drugs, pharmacy preparations, and other pharmaceutical products (e.g., live virus vacci
temperatures between 2 and 10 degrees Celsius (35 and 50 degrees Fahrenheit). These refrigerators
chamber made with a corrosion-resistant (typically stainless steel) interior, minimizing the risk of adul
contamination, and/or corrosion of contents; internal shelving appropriate for storage, easy location, a
laboratory products once the user is inside the chamber; a compressor, condenser, evaporator, tubing
monitors, a temperature recording chart, and alarms for a dependable long-term storage following ph
Walk-in pharmacy refrigerators are available completely assembled or as separate structural elements
floors) and units (e.g., refrigeration system, condensing unit) for assembly at user facilities.

Morgue refrigerators with openings that permit the insertion of cadavers in a longitudinal (i.e., along t
body) position. These refrigerators are designed to slow decomposition of stored cadavers in the morg
procedures or until the cadaver is disposed of; the refrigerator usually operates at temperatures betw
Celsius (39 and 50 degrees Fahrenheit). They typically consist of one or more chambers madewith cor
(typically stainless steel) interiors, minimizing the risk of adulteration, contamination, and/or corrosion
(e.g., 54 x 70 cm [21 x 27.5 inch]) door, configured for appropriate storage and easy manipulation of c
compressor, condenser, evaporator, tubing, controls, and alarms for dependable long-term storage ac
procedures. When the door is opened and the tray is fully extended, the cadaver is displayed in a full
opening morgue refrigerators are available with a telescoping mechanism or a conveyor tray system p
inside the refrigerator; both mechanisms fully support the body tray and cadaver outside the refrigera
Morgue refrigerators with openings that permit the insertion of cadavers in a transversal (i.e., along th
body) position. These refrigerators are designed to slow decomposition of stored cadavers in the morg
procedures or until the cadaver is disposed of; the refrigerator usually operates at temperatures betw
Celsius (39 and 50 degrees Fahrenheit). They typically consist of one or more chambers made with co
(typically stainless steel) interiors, minimizing the risk of adulteration, contamination, and/or corrosion
(e.g., 54 x 215 cm [21 x 84 inch]) door, configured for appropriate storage and easy manipulation of c
condenser, evaporator, tubing, controls, and alarms for dependable long-term storage according to m
When the door is opened and the tray is fully extended, the cadaver is displayed in a full side view. Si
refrigerators are available with the telescoping mechanism or a conveyor tray system permanently loc
refrigerator; both mechanisms fully support the body tray and cadaver outside the refrigerator chamb

Refrigerators with a cabinet-like storage compartment large enough to permit a person to enter; they
decomposition of stored cadavers in the morgue during autopsy procedures or until the cadaver is dis
refrigerator usually operates at temperatures between 4 and 10 degrees Celsius (39 and 50 degrees F
refrigerators typically consist of a chamber made with a corrosion-resistant (typically stainless steel) i
risk of adulteration, contamination, and/or corrosion of contents; internal shelving appropriate for acco
location, and handling of many bodies (e.g., 10, 50); compressors, condensers, evaporators, and tubin
refrigerators also include sensors, controls, and monitors; they may include a temperature recording c
dependable long-term cadaver storage according to morgue procedures. Walk-in morgue refrigerators
completely assembled or as separate structural elements (e.g., doors, panels, floors) and units (e.g., r
condensing unit) for assembly at user facilities.

Refrigerators designed to store food at temperatures typically between 4 and 10 degrees Celsius (39 a
Fahrenheit). These refrigerators typically consist of a chamber made with a corrosion-resistant or corro
stainless steel) interior, minimizing the risk of adulteration and/or contamination of contents; internal
for storage, easy location, and handling of food products; a compressor, condenser, evaporator, tubing
sensors, controls, possibly a temperature recording chart, and alarms for dependable long-term storag
in upright, walk-in, and undercounter configurations. Small dedicated units intended to maintain infan
degrees Celsius (104 degrees Fahrenheit) are also available.

Food refrigerators with a front-opening (upright) configuration, designed to store laboratory products a
typically between 4 and 10 degrees Celsius (39 and 50 degrees Fahrenheit). These refrigerators typica
chamber made with a corrosion-resistant or corrosion-proof (typically stainless steel) interior, minimiz
adulteration and/or contamination of contents, internal shelving appropriate for storage, easy location
products; a compressor, condenser, evaporator, tubing, temperature sensors, and controls.

Small food refrigerators with a configuration appropriate for use under counters (e.g., in nurse station
are designed for storage of food products at temperatures typically between 4 and 10 degrees Celsius
Fahrenheit). Undercounter refrigerators typically consist of a chamber made with a corrosion-resistan
(typically stainless steel) interior, minimizing the risk of adulteration and/or contamination of contents
appropriate for storage, easy location, and handling of food products; a compressor, condenser, evapo
temperature sensors, and controls.
Combinations of devices (units), ancillary devices, and accessories designed to provide low temperatu
point of water (i.e., 0 degrees Celsius [32 degrees Fahrenheit]), typically from 2 to 10 degrees Celsius
Fahrenheit), to a walk-in enclosure (i.e., a chamber) especially designed for this purpose or conditione
healthcare facility room. This equipment typically consists of compressors, fans, evaporators, ducted-a
systems, thermometers, temperature controls, and warming systems to balance the temperature; it m
recording temperature chart and alarms for dependable long-term storage. The characteristics of the
the size, location, and intended use of the chamber (e.g., food storage, laboratory, morgue).

Freezers designed to store blood bank products and samples, such as plasma and red blood cells. The
made with a corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulteration,
corrosion of contents and internal shelving appropriate for storage and easy location of blood bank pro
bags). Blood bank freezers include automatic defrost capability, keeping the temperature in freezing c
preestablished limits during the process; they also include sensors, controls, monitors, chart recorders
dependable long-term storage according to blood storage standards. Typically, blood bank freezers are
different temperature ranges: standard, from 0 to -20 or -30 degrees Celsius (32 to -4 or -22 degrees F
from -40 to -90 degrees Celsius (-40 to -130 degrees Fahrenheit); and cryogenic, from -130 degrees Ce
Fahrenheit) or lower. Programmed (e.g., linear rate) or manual control of the freezing rate is possible i
freezers. A wide variety of capacities and freezer configurations, including upright, undercounter, and
available.

Blood bank freezers designed for long-term storage of blood bank products and samples at temperatu
Celsius (-82 degrees Fahrenheit); the freezer temperature is frequently set at values lower than minim
typically between -80 and -100 degrees Celsius (-112 and -148 degrees Fahrenheit). These freezers ar
corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulteration, contaminatio
contents; they usually provide linear and/or controlled rate capabilities for a controlled rate of freezing
effects of sudden cooling on the red blood cells (RBCs). Blood bank ultralow temperature freezers inclu
capability, keeping the temperature in all the freezing chambers within preestablished limits; they als
controls, monitors, chart recorders, and alarms for dependable long-term storage following the require
storage standards. The freezers are available in several sizes and configurations (e.g., upright, chest)
appropriate for blood bags. Programmed (e.g., linear rate) or manual control of the freezing rate is pos
temperature blood bank freezers. Ultralow temperature blood bank freezers permit the storage of bloo
extended periods (typically several years); they are frequently used for preservation of products such
cryoprotective agents such as glycerol at 40% or dimethyl sulfoxide and for long-term preservation of
Freezers with a low height, top-opening (chest) configuration, designed to store blood bank products a
temperatures below -65 degrees Celsius (-85 degrees Fahrenheit); the freezer temperature is frequent
than minimum requirements, typically between -80 and -100 degrees Celsius (-112 and -148 degrees
freezers are usually made with a corrosion-resistant (typically stainless steel) interior, minimizing the
contamination, and/or corrosion of contents; they typically provide linear and/or controlled rate capab
rate of freezing, minimizing the effects of sudden cooling on red blood cells (RBCs). Blood bank ultralo
freezers include automatic defrost capability, keeping the temperature in all the freezing chambers wi
limits during the prorcess; they also include sensors, controls, monitors, chart recorders, and alarms fo
term storage following the requirements of blood storage standards. Ultralow temperature blood bank
storage of blood bank products for extended periods (typically several years); they are frequently use
products such as RBCs with cryoprotective agents such as glycerol at 40% or dimethyl sulfoxide and fo
preservation of plasma.

Freezers with a front-opening (upright) configuration designed to store blood bank products and samp
below -65 degrees Celsius (-82 degrees Fahrenheit); the freezer temperature is frequently set at value
requirements, typically between -80 and -100 degrees Celsius (-112 and -148 degrees Fahrenheit). Th
usually made with a corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulte
and/or corrosion of contents; they typically provide linear and/or controlled rate capabilities for a cont
minimizing the effects of sudden cooling on red blood cells (RBCs). Blood bank ultralow temperature f
automatic defrost capability, keeping the temperature in all the freezing chambers within preestablish
process; they also include sensors, controls, monitors, chart recorders, and alarms for dependable lon
following blood storage standards. Ultralow temperature blood bank freezers permit the storage of blo
an extended period (typically several years); they are frequently used for preservation of products suc
cryoprotective agents such as glycerol at 40% or dimethyl sulfoxide and for long-term preservation of

Freezers designed to store blood bank products and samples at temperatures below the point at which
activity ceases (sometimes defined as the glass transition temperature of water) about -130 degrees C
Fahrenheit). These freezers typically use liquid nitrogen as the cooling agent; some specially designed
systems are also capable of cooling at these temperatures. Products may be stored either directly in li
provides a temperature of -180 degrees Celsius (-292 degrees Fahrenheit) or colder with minimal tem
or they may be stored at the vapor phase above liquid nitrogen at a temperature of about -140 degree
degrees Fahrenheit). Storage in the vapor phase decreases the risk of cross-contamination between st
blood cells (RBCs) preserved with a low concentration of a cryoprotective agent such as glycerol at 20
sulfoxide may be stored for long periods, typically up to 10 years. Cryogenic blood bank freezers are u
rare types of RBCs.

Blood bank cryogenic freezers designed to store red blood cells (RBCs) using conventional compressed
cooling. These devices typically include an enclosure to store the frozen products, an electrical gas co
valves for the refrigerating gas, and appropriate temperature sensors and controls. Electromechanical
typically perform a cascade two-cycle refrigeration process to lower the temperature in their chamber
degrees Celsius (-202 degrees Fahrenheit). RBCs preserved with a cryoprotective agent such as glycer
dimethyl sulfoxide may be stored for long periods, typically up to 10 years. Cryogenic blood bank free
store rare types at RBCs.
Blood bank cryogenic freezers designed to store blood bank products and samples using liquid nitroge
storage agent. Liquid nitrogen storage provides a temperature of -180 degrees Celsius (-292 degrees
with minimal temperature fluctuations. These freezers typically consist of a chamber with two vessels
vacuum space (the inner vessel for the cryogenic fluid and the outer vessel intended to insulate the c
the environment); automatic level and cryogenic temperature controls; an external container to replen
fluid; a pressure-relief device; and a pressure-controlling valve. Red blood cells (RBCs) and/or other blo
immersed in liquid nitrogen using appropriate sealed containers, but the use of large volumes (depth)
sealed glass create potential hazards: cross-contamination by virus pathogens via the liquid nitrogen
RBCs preserved with a cryoprotective agent such as glycerol at 40 percent or dimethyl sulfoxide may
periods, typically up to 10 years. Cryogenic blood bank freezers are mainly used to store rare types of
of time.

Blood bank cryogenic freezers designed to store blood bank products and samples using liquid nitroge
and vapor phase nitrogen for storage. Vapor phase nitrogen storage provides a temperature of -140 d
degrees Fahrenheit) that is not as low as the liquid nitrogen (-180 degrees Celsius [-292 degrees Fahre
the risk of cross-contamination between stored products compared to the use of liquid nitrogen immer
typically consist of a chamber with two vessels separated by a vacuum space (the inner vessel is for t
the outer vessel intended to insulate the cryogenic liquid from the environment); automatic level and
controls; an external container to replenish the cryogenic fluid; a pressure-relief device; and a pressur
blood cells (RBCs) are immersed using appropriate containers in the vapor atmosphere above the liqu
blood bank freezers are used mainly to store rare types of RBCs with a cryoprotective agent such as g
dimethyl sulfoxide for long periods, typically up to several years.

Freezers designed to store laboratory products and samples, such as in vitro diagnosis reagents and la
(e.g., tissue, body fluid samples) at temperatures from 0 to -20 or -30 degrees Celsius (32 to -4 or -22
These freezers are usually made with a corrosion-resistant (typically stainless steel) interior, minimizin
adulteration, contamination, and/or corrosion of contents; the internal shelving is of a size and configu
storage and easy location of laboratory products and samples. Multiuse laboratory freezers include au
capability, maintaining the temperature in the entire freezing chamber within preestablished limits du
also include sensors, controls, monitors, and alarms for dependable long-term storage following labora
standards. Programmed (e.g., linear rate) or manual control of the freezing rate is possible in most lab
wide variety of freezer capacities and configurations, including upright, undercounter, and walk-in mo
Multiuse laboratory freezers with a front-opening (upright) configuration, designed to store laboratory
such as in vitro diagnosis reagents and laboratory tissue and body fluid samples, at temperatures from
degrees Celsius (32 to -4 or -22 degrees Fahrenheit). These freezers are usually made with a corrosion
stainless steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion of conten
is appropriate for storage and easy localization of laboratory products and samples. Upright multiuse l
include automatic defrost capability, maintaining the temperature in the entire freezing chamber with
during the process; they also include sensors, controls, monitors, and alarms for dependable long-term
laboratory storage standards. Programmed (e.g., linear rate) or manual control of the freezing rate is p
upright laboratory freezers. A wide variety of freezer capacity and shelf configurations are available.

Small multiuse laboratory freezers with a configuration appropriate for use under laboratory counters,
laboratory products and samples, such as in vitro diagnosis reagents and laboratory tissue and body fl
temperatures from 0 to -20 or -30 degrees Celsius (32 to -4 or -22 degrees Fahrenheit). These freezers
a corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulteration, contaminat
contents; internal shelving is appropriate for storage and easy location of laboratory products and sam
multiuse laboratory freezers include automatic defrost capability, maintaining the temperature in the
chamber within preestablished limits during the process; they also include sensors, controls, monitors
dependable long-term storage following laboratory storage standards.

Multiuse laboratory freezers with a cabinet-like storage compartment large enough to permit a person
designed for storage of laboratory products and samples, such as in vitro diagnosis reagents and labo
tissue, body fluid) at temperatures from 0 to -20 or -30 degrees Celsius (32 to -4 or -22 degrees Fahre
are usually made with a corrosion-resistant (typically stainless steel) interior, minimizing the risk of ad
contamination, and/or corrosion of contents; the internal shelving is appropriate for storage and easy
products and samples. Walk-in multiuse laboratory freezers include automatic defrost capability, main
temperature in the entire freezing chamber within preestablished limits during the process; they also
controls, monitors, and alarms for dependable long-term storage following laboratory storage standar
freezer capacity and shelf configurations are available.

Laboratory freezers designed to store flammable products (typically liquids with a flash point below 38
degrees Fahrenheit]), at temperatures from 0 to -20 or -30 degrees Celsius (32 to -4 or -22 degrees Fa
the ignition of flammable vapors inside the storage compartment. These freezers typically have all ele
located outside the freezer chamber, and the compressor is sealed or located at the top of the unit; th
incorporate features such as self-closing doors, magnetic door gaskets, and special inner shell materia
damage if a reaction occurs within the storage compartment. Flammable material laboratory freezers
freezer is needed to store flammable liquids; they are available mainly in upright and undercounter co
Laboratory freezers designed to prevent ignition of flammable materials (vapors and/or gases) at tem
or -30 degrees Celsius (32 to -4 or -22 degrees Fahrenheit); flammable materials may be present in th
the freezer or the result of vapors leaking from improperly sealed containers inside the freezer. These
motors, switches, and thermostats that are insulated to prevent arcing that can ignite flammable air-v
insulation prevents explosions inside and/or outside of the unit. All explosion-proof freezers must be h
power source by rigid metal wires rather than connected by cord-and-plug assemblies. Explosion-proo
are used in rooms in which a flammable atmosphere may develop. They are mainly available in uprigh
configurations.

Freezers designed to store laboratory products and samples, such as in vitro diagnosis reagents and la
body fluid samples that require very low temperatures, usually from -40 to -90 degrees Celsius (-40 to
Fahrenheit). These freezers are usually made with a corrosion-resistant (typically stainless steel) interi
of adulteration, contamination, and/or corrosion of contents; the internal shelving is appropriate for st
location of laboratory products and samples. Multiuse laboratory freezers include automatic defrost ca
the temperature in the entire freezing chamber within preestablished limits during the process; they a
controls, monitors, and alarms for dependable long-term storage following laboratory storage standar
linear rate) or manual control of the freezing rate is possible in most laboratory freezers. A wide variet
temperature freezer capacities and configurations, including upright and chest models, is available.

Laboratory freezers with a front-opening (upright) configuration, designed for storage of products and
vitro diagnosis reagents and laboratory tissue and body fluid samples that require very low temperatu
to -90 degrees Celsius (-40 to -130 degrees Fahrenheit). These freezers are usually made with a corros
stainless steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion of conten
is appropriate for storage and easy location of laboratory products and samples. Ultralow laboratory fr
automatic defrost capability, maintaining the temperature in the entire freezing chamber within prees
the process; they also include sensors, controls, monitors, and alarms for dependable long-term storag
storage standards. Programmed (e.g., linear rate) or manual control of the freezing rate is possible in
laboratory freezers. A wide variety of ultralow temperature freezer capacities and configurations is av

Laboratory freezers with a low height, top-opening (chest) configuration, designed for storage of prod
as in vitro diagnosis reagents and laboratory tissue and body fluid samples that require very low temp
-40 to -90 degrees Celsius (-40 to -130 degrees Fahrenheit). These freezers are usually made with a co
(typically stainless steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion
usually include either no internal shelving or very simple shelving. Ultralow laboratory freezers include
capability, sensors, controls, monitors, and alarms for dependable long-term storage following laborat
A wide variety of ultralow temperature chest freezers with different sizes and capacities is available.
Laboratory freezers designed for tissue-sample storage (e.g., ovum, embryo) at temperatures below t
or all biological activity ceases (sometimes defined as the glass transition temperature of water), abou
(-202 degrees Fahrenheit). These freezers typically use liquid nitrogen as the cooling agent; some spe
electromechanical systems are also capable of cooling at these temperatures. The products may be st
nitrogen, which provides a temperature of -180 degrees Celsius (-292 degrees Fahrenheit) or colder w
temperature fluctuations; or they may be stored in the vapor phase above the liquid nitrogen at a tem
degrees Celsius (-220 degrees Fahrenheit). Storage in the vapor phase decreases the risk of cross-con
stored products. Tissue (e.g., ovum, embryo, bone, cornea) may be stored for extended periods, typic

Laboratory cryogenic freezers that use conventional compressed gas cycles for cooling. These freezer
enclosure to store the frozen products, an electrical gas compressor, tubes and valves for the refrigera
temperature sensors, and controls. Electromechanical cryogenic freezers typically perform a cascade
process to lower the temperature in their chambers at or below -130 degrees Celsius (-202 degrees Fa
Electromechanical cryogenic laboratory freezers are mainly used for cell and/or tissue (e.g., ovum, em
storage for extended periods (typically several years).

Freezers that use liquid nitrogen as the cooling and storage agent. Liquid nitrogen storage provides a
degrees Celsius (-292 degrees Fahrenheit) or colder with minimal temperature fluctuations. These free
of a chamber with two vessels separated by a vacuum space (the inner vessel for the cryogenic fluid a
intended to insulate the cryogenic liquid from the environment); automatic level and cryogenic tempe
external container to replenish the cryogenic fluid; a pressure-relief device; and a pressure-control val
immersed in the liquid nitrogen using appropriate sealed containers, but the use of large volumes (de
and sealed glass create potential hazards; cross-contamination by virus pathogens via the liquid nitrog
occurred. Liquid nitrogen cryogenic laboratory freezers are used mainly for cell or tissue (e.g., ovum, e
storage for extended periods (typically several years).

Freezers that use liquid nitrogen as the cooling agent and vapor phase nitrogen for storage. Vapor pha
provides a temperature of -140 degrees Celsius (-220 degrees Fahrenheit) that is not as low as liquid n
Celsius [-292 degrees Fahrenheit]), but decreases the risk of cross-contamination among the stored pr
freezers using liquid nitrogen immersion. These freezers typically consist of a chamber with two vesse
vacuum space (the inner vessel for the cryogenic fluid and the outer vessel intended to insulate the c
the environment); automatic level and cryogenic temperature controls; an external container to replen
fluid; a pressure-relief device; and a pressure-control valve. Cells and/or tissues are immersed in the v
above the liquid nitrogen in appropriate containers. Vapor phase nitrogen cryogenic laboratory freezer
cell and/or tissue (e.g., ovum, embryo, bone, cornea) storage for extended time periods (typically sev
Freezers designed to store drugs and other pharmaceutical products typically at temperatures from 0
Celsius (32 to -4 or -22 degrees Fahrenheit). These freezers are usually made with a corrosion-resistan
steel) interior, minimizing the risk of adulteration, contamination, and/or corrosion of contents; the int
size and configuration appropriate for storage and easy location of pharmaceutical product containers
frequently include automatic defrost capability and sensors, controls, monitors, recorders, and alarms
term storage. Pharmacy freezers are available in a variety of sizes, capacities, and configurations, incl
undercounter, and walk-in models.

Pharmacy freezers with front-opening (upright) configurations designed for storage of drugs and other
products at temperatures from 0 to -20 or -30 degrees Celsius (32 to -4 or -22 degrees Fahrenheit). Th
usually made with a corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulte
and/or corrosion of contents; the internal shelving is appropriate for storage and easy location of phar
containers. Upright pharmacy freezers include automatic defrost capability, maintaining the temperat
freezing chamber within preestablished limits during the process; they also include sensors, controls,
for dependable long-term storage following pharmacy standards. A wide variety of freezer capacities a
configurations is available.

Small pharmacy freezers with a configuration appropriate for use under pharmacy counters; they are
drugs and other pharmaceutical products at temperatures from 0 to -20 or -30 degrees Celsius (32 to
Fahrenheit). These freezers are usually made with a corrosion-resistant (typically stainless steel) interi
of adulteration, contamination, and/or corrosion of contents; the internal shelving is appropriate for st
location of pharmacy product containers. Undercounter pharmacy freezers include automatic defrost c
the temperature in the entire freezing chamber within preestablished limits during the process; they a
controls, monitors, and alarms for dependable long-term storage following pharmacy storage standard

Pharmacy freezers with a cabinet-like storage compartment large enough to permit a person to enter;
store drugs and other pharmaceutical products at temperatures from 0 to -20 or -30 degrees Celsius (
Fahrenheit). These freezers are usually made with a corrosion-resistant (typically stainless steel) interi
of adulteration, contamination, and/or corrosion of contents; the internal shelving is of a size and confi
for storage and easy location of pharmaceutical products. Walk-in multiuse pharmacy freezers include
capability, maintaining the temperature in the entire freezing chamber within preestablished limits du
also include sensors, controls, monitors, and alarms for dependable long-term storage following pharm
standards. A wide variety of freezer capacity and shelf configurations are available.
Freezers designed to store tissue and, less frequently, organs excised from cadavers during autopsy p
temperatures typically from 0 to -20 degrees Celsius (32 to -4 degrees Fahrenheit). These freezers are
corrosion-resistant (typically stainless steel) interior, minimizing the risk of adulteration, contaminatio
contents; the internal shelving is appropriate for storage and easy location of the tissue and/or organ
typically manufactured in a stand-alone, upright configuration, but some smaller units are available in
configuration. Postmortem freezers include automatic defrost capability, maintaining the temperature
chamber within preestablished limits during the process; they also include sensors, controls, monitors
dependable long-term storage following laboratory storage standards. Freezers frequently meet secur
forensic evidence valid for extended periods. They are used in autopsy rooms and in medical examine

Freezers designed to store food products at temperatures typically from 0 to -20 degrees Celsius (32 t
Fahrenheit). These freezers are usually made with a corrosion-resistant interior, minimizing the risk of
contamination, and/or corrosion of contents; the internal shelving is of a size and configuration approp
easy location of food. Food storage freezers usually include temperature sensors, controls, and alarms
term storage; they may also include automatic defrost capability. A wide variety of food freezer capac
are available, including upright, undercounter, chest, and walk-in models.

Food storage freezers with a front-opening (upright) configuration, designed to store food at temperat
-20 degrees Celsius (32 to -4 degrees Fahrenheit). These freezers are usually made with a corrosion-re
minimizing the risk of adulteration, contamination, and/or corrosion of contents; the internal shelving
configuration appropriate for storage and easy location of food. Upright food storage freezers usually
sensors, controls, and alarms for dependable long-term storage; they may also include automatic defr
variety of upright freezers with different capacities and shelf configurations are available.

Food storage freezers with a cabinet-like storage compartment large enough to permit a person to ent
to store food at temperatures typically from 0 to -20 degrees Celsius (32 to -4 degrees Fahrenheit). Th
usually made with a corrosion-resistant interior, minimizing the risk of adulteration, contamination, an
contents; internal shelving appropriate for storage and easy location of food; temperature sensors, co
dependable long-term storage; they may also include automatic defrost capability. A wide variety of w
different capacities and shelf configurations are available.

Food storage freezers with a low height, top-opening (chest) configuration, designed to store food at t
from 0 to -20 degrees Celsius (32 to -4 degrees Fahrenheit). These freezers are usually made with a co
interior, minimizing the risk of adulteration, contamination, and/or corrosion of contents; they usually
shelving or simple shelving. Chest food storage freezers usually include temperature sensors and con
long-term storage; they may also include automatic defrost capability. A wide variety of chest freezers
capacities and shelf configurations are available.
Combinations of units, ancillary devices, and accessories designed to provide temperatures below the
degrees Celsius [32 degrees Fahrenheit]) to a chamber (i.e., a walk-in enclosure) specially designed fo
conditioned from an existing healthcare facility room. This equipment typically consists of compressor
distribution systems, thermometers, insulation material, and temperature controls; it may also include
recording chart and alarms for dependable long-term storage. The characteristics of the equipment de
location, and intended use of the freezing chamber (e.g., food storage, laboratory, pharmacy).

Security systems designed to identify and track assets (e.g., equipment, instruments) within a healthc
entry into and exit from the facility. The basic elements of the system are an identification tag, typical
transmitter (active tag) or that works with the energy supplied by a location device (passive tag) that
asset, a tag-detection device (e.g., a reader); dedicated software; and a unit that displays information
location, facilitating the control of assets; some systems may also include or interface with audible ala
mechanisms to lock doors or disable elevators. Most asset identification/tracking/security systems use
signals, but systems based on ultrasonic and infrared (IR) technologies, as well as hybrid systems (e.g
available; some dedicated systems are intended for tracking surgical instruments.

Security systems designed to identify, track, monitor, and control the movement of individual surgical
operating room and sterilization department. The basic elements of the system are identification (e.g.
labels, laser-etched or engraved bar codes) for each instrument, a detection device (e.g., a scanning r
electronic unit that provides real-time location and relevant information (e.g., descriptor, manufacture
identification) on the instrument by linking the instrument code to a database. Surgical instrument ide
tracking systems may provide reports on the location, sterilization cycles, and usage for each instrum
status of the instruments, missing instruments, and instrument availability.

Security systems designed to identify, track, monitor, and locate people (e.g., staff, patients, visitors)
equipment, instruments) within a healthcare facility. These systems can monitor movement of person
particular location, as well as their entry into and exit from the facility. The basic elements of the syste
tag that is attached to the asset or worn by the person, with a radio transmitter (active tag) or that wo
supplied by the location device (passive tag); a tag-detection device (e.g., a reader; dedicated softwa
displays location and alerts. Some systems may include audible alarms and mechanisms to lock doors
Most identification/tracking/security systems use radiofrequency signals, but systems based on ultras
technologies are also available.

Identification, tracking, and security systems designed to monitor pharmaceutical container entry, exi
factories, distribution centers, healthcare facilities, and pharmacies, permitting the tracking of pharma
supply chain. The basic elements of the system are an identification tag, typically with a radio transm
tag) or that works with the energy supplied by the location device (passive tag), that is attached or fix
container; a tag-detection device (e.g., a reader); and a unit with dedicated software that displays info
shipment, receipt, and history of the pharmaceutical's path at any point of the distribution chain. Mos
identification/tracking/security systems may use radiofrequency signals, but systems using bar-coded
available.
Dermatomes designed to harvest large, uniform-thickness skin grafts using manual (mechanical) proc
dermatomes are manually operated, handheld frames with an attached cutting blade or, more frequen
oscillating blade that is manually operated as the drum rolls over the skin. Several models of manual
available, including Reese and Padgett-Hood drum dermatomes. Manual dermatomes are used mainly
from donor sites, but they are sometimes used in other procedures (e.g., to remove tattoos).

Dermatomes designed to harvest large, uniform-thickness skin grafts using electric power. These derm
handheld instruments that include an electric powered rapidly oscillating cutting blade that is manual
skin. Several dedicated electric dermatomes using this operating principle are available (e.g., Castrov
Hood, Brown, Davol-Simon, Zimmer). Electric dermatomes are mainly used to obtain skin grafts from d
sometimes used in other procedures (e.g., to remove tattoos).

Dermatomes designed to harvest large, uniform-thickness skin grafts using pneumatic power. These d
typically manual instruments that include a pneumatic-powered, rapidly oscillating cutting blade that
over the skin. Several dedicated electric dermatomes using this operating principle are available (e.g.
Padgett-Hood, Brown, Davol-Simon, Zimmer). Pneumatic dermatomes are mainly used to obtain skin g
but are sometimes used in other procedures (e.g., to remove tattoos).

Molecular assay reagents intended to identify parasites by detecting specific nucleic-acid information
These parasites are the etiologic agent of, or are associated with, human and/or animal diseases.

Molecular assay reagents intended to identify species of Babesia, a genus of hematozoan protozoa, by
nucleic-acid information of the target parasite. Some species of these parasites may cause babesiosis
disease characterized by malaria-like fever, chills, sweats, and myalgia. The parasite is typically trans
rodent ticks.
Molecular assay reagents intended to identify species of Babesia, a genus of hematozoan protozoa, by
information of the deoxyribonucleic acid (DNA) of the target parasite. Some species of these parasites
(piroplasmosis), a disease characterized by malaria-like fever, chills, sweats, and myalgia. The parasit
transmitted to humans by rodent ticks.
Molecular assay reagents intended to identify Babesia microti, a species of hematozoan protozoon, by
genetic information of the deoxyribonucleic acid (DNA) of the target parasite. These parasites may ca
(piroplasmosis), a disease characterized by malaria-like fever, chills, sweats, and myalgia. The parasit
transmitted to humans by rodent ticks.
Molecular assay reagents intended to identify Amoeboid protozoa, a genus of hematozoan protozoa, b
nucleic acid information of the target parasite. Some species of these parasites may cause amebiasis
intestines, but potentially extending to the liver and lungs); they are transmitted to humans through w
contaminated food.
Molecular assay reagents intended to identify Entamoeba histolytica, a species of the genus Amoeboi
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target parasite. These
amebiasis (typically in the intestines, but potentially extending to the liver and lungs); they are transm
cysts in contaminated food.
Molecular assay reagents intended to identify species of Giardia, a genus of flagellate intestinal protoz
specific nucleic acid information of the target parasite. Most species are nonpathogenic, but Giardia la
giardiasis in humans, a disease characterized by diarrhea and nausea.
Molecular assay reagents intended to identify species of Leishmania, protozoa of the suborder Trypano
detecting specific nucleic acid information of the target parasite. These parasites are the etiologic age
the characteristics of the disease depend on the species or subspecies. They are usually transmitted t
flies.
Molecular assay reagents intended to identify species of Leishmania, protozoa of the suborder Trypano
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target parasite. These
etiologic agent of leishmaniasis; the characteristics of the disease depend on the species or subspecie
transmitted to humans by sand flies.
Molecular assay reagents intended to identify species of Taenia, a large tapeworm parasite of the fam
detecting specific nucleic acid information of the target parasite and/or its eggs. Several species of Ta
the human intestines; Taenia solium and, less frequently, Taenia saginata, may cause cysticercosis; Ta
adult form in human intestines and in larval form (forming cysts) in the muscles and the central nervo
parasites are usually transmitted to humans via inadequately cooked pork or beef.

Molecular assay reagents intended to identify species of Taenia, a large tapeworm parasite of the fam
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target parasite and/or
species of Taenia are parasitic to the human intestines; T. solium and, less frequently, T. saginata may
Taenia parasites live in adult form in human intestines and in larval form (forming cysts) in the muscle
nervous system. These parasites are mostly transmitted to humans via inadequately cooked pork or b

Molecular assay reagents intended to identify Taenia saginata, a large tapeworm parasite of the family
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target parasite and/or
saginata may cause cysticercosis; these parasites live in adult form in human intestines and in larval f
the muscles and the central nervous system. Taenia saginata parasites are usually transmitted to hum
cooked beef.

Molecular assay reagents intended to identify Taenia solium, a large tapeworm parasite of the family T
specific genetic information of the deoxyribonucleic acid (DNA) of the target parasite and/or its eggs.
most frequent cause of cysticercosis; taenia parasites live in adult form in human intestines and in lar
cysts) in the muscles and the central nervous system. These parasites are usually transmitted to hum
cooked pork.

Molecular assay reagents intended to identify species of Toxoplasma, a genus of obligate intracellular
parasites, by detecting specific nucleic-acid information of the target parasite. Some species of these
toxoplasmosis, a mild and self-limited infection, but extensive damage (e.g., to the brain, eyes, cardia
mostly in immunocompromised patients or through transplacental transmission to a fetus.

Molecular assay reagents intended to identify species of Toxoplasma, a genus of obligate intracellular
parasites, by detecting genetic information of the deoxyribonucleic acid (DNA) of the target parasite.
parasites may cause toxoplasmosis, a mild and self-limited infection, but extensive damage (e.g., to th
muscle) may occur, mostly in immunocompromised patients or through transplacental transmission to
Molecular assay reagents intended to identify Toxoplasma gondii, a species of obligate intracellular co
parasite, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target pa
may cause toxoplasmosis, a mild and self-limited infection, but extensive damage (e.g., to the brain, e
may occur, mostly in immunocompromised patients or through transplacental transmission to a fetus.
usually transmitted via feces of cats or through tissue cysts in infected meat.

Molecular assay reagents intended to identify species of Trichinella, a genus of nematode parasites, b
nucleic acid information of the target parasite. Species of these parasites may cause intestinal infectio
species Trichinella spiralis is the etiologic agent of trichinosis, a disease characterized in early stages b
and colic that may progress to stiffness, fever, pain, and swelling of muscles.

Molecular assay reagents intended to identify species of Trichinella, a genus of nematode parasites, b
genetic information of the deoxyribonucleic acid (DNA) of the target parasite. Species of these parasit
intestinal infections in humans; the species Trichinella spiralis is the etiologic agent of trichinosis, a dis
early stages by diarrhea, nausea, and colic that may progress to stiffness, fever, pain, and swelling of

Molecular assay reagents intended to identify species of Trichomonas, a genus of flagellated protozoa
nucleic-acid information of the target parasite. Some species of these parasites may cause trichomon
discharges, in females and urethritis and/or prostate enlargement in males.
Molecular assay reagents intended to identify Trichomonas vaginalis, a species of flagellated protozoo
genetic information of the deoxyribonucleic acid (DNA) of the target parasite. These parasites may ca
profuse vaginal discharge, in females and urethritis and/or prostate enlargement in males.

Molecular assay reagents intended to identify Trichomonas vaginalis, a species of flagellated protozoo
genetic information of the ribosomal ribonucleic acid (rRNA) of the target parasite. These parasites ma
trichomoniasis, profuse vaginal discharge, in females and urethritis and/or prostate enlargement in m

Molecular assay reagents intended to identify species of Trypanosoma, a genus of flagellated protozoa
nucleic-acid information of the target parasite. Some species of these parasites are the etiologic agen
(sleeping sickness); they are transmitted to humans via the bites of tsetse flies.

Molecular assay reagents intended to identify Trypanosoma brucei, a species of flagellated protozoon,
genetic information of the deoxyribonucleic acid (DNA) of the target parasite. These parasites are the
trypanosomosis (sleeping sickness) and Chagas' disease; they are transmitted via the bites of tsetse fl

Molecular assay reagents intended to identify Trypanosoma cruzi, a species of protozoon of the subord
by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target parasite. Try
parasites cause Chagas' disease (American trypanosomiasis) in humans, characterized by an erythem
chagoma) appearing within a few days at the site of the inoculation. These parasites are transmitted t
either from other humans or from animals (e.g., cats, dogs, rodents).

Microbiology reagents intended to identify species of Giardia, a genus of flagellate intestinal protozoa
intestines. Some species of Giardia cause infection of the small intestines.
Microbiology reagents used to detect and/or identify Toxoplasma gondii, a species of obligate intracell
parasite. These parasites may cause toxoplasmosis, a mild and self-limited infection, but extensive da
brain, eyes, cardiac muscle) may occur, mostly in immunocompromised patients or through transplac
fetus. They are usually transmitted by the feces of cats or via tissue cysts in infected meat.

Microbiology reagents used to detect and/or identify one or more of the species of Trypanosoma, a ge
protozoa parasites. Some species of these parasites are the etiologic agent of trypanosomosis (sleepin
transmitted to humans via the bites of tsetse flies.
Serology reagents used to detect antibodies to Babesia microti, a hematozoan protozoon. These paras
babesiosis (piroplasmosis), a disease characterized by malaria-like fever, chills, sweats, and myalgia.
transmitted to humans by ticks.
Serology reagents used to detect immunoglobulin G (IgG) antibodies to Babesia microti, a hematozoan
parasites may cause babesiosis (piroplasmosis), a disease characterized by malaria-like fever, chills, s
The parasite is typically transmitted to humans by ticks.
Serology reagents used to detect immunoglobulin M (IgM) antibodies to Babesia microti, a hematozoa
parasites may cause babesiosis (piroplasmosis), a disease characterized by malaria-like fever, chills, s
The parasite is typically transmitted to humans by ticks.
Serology reagents used to detect antibodies to species of Babesia, a hematozoan protozoon. Several s
parasites may cause babesiosis (piroplasmosis), a disease characterized by malaria-like fever, chills,

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Leishmania, a genus of pr


Trypanosomatina. The characteristics of Leishmania parasite infections (leishmaniasis) depend on the
Infections are usually classified according to their effects as cutaneous, mucocutaneous, and visceral.
usually transmitted by sand flies.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Leishmania, a genus of pr
Trypanosomatina. The characteristics of Leishmania parasite infections (leishmaniasis) depend on the
Infections are usually classified according to their effects as cutaneous, mucocutaneous, and visceral.
usually transmitted by sand flies.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to K39 antigens of Leishman
a species of the genus Leishmania, a genus of protozoa of the suborder Trypanosomatina. These paras
(also known as kala-azar), an endemic visceral Leishmania disease usually transmitted by sand flies.

Serology reagents intended to detect antibodies to species of the genus Paragonimus, a trematode (i.
the lungs. Species of this parasite, and in particular Paragonimus westermani (Oriental lung fluke), ma
paragonimiasis and hemoptysis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Schistosoma, a
parasites (blood flukes), a class of Platyhelminthes. Schistosoma of several species (e.g., haematobium
are pathogenic to humans; the parasites typically enter through the skin of humans who come in cont
The adult worms are usually found in the veins, causing hematuria, dysentery, and bladder irritation.

Serology reagents intended to detect antibodies to Taenia saginata, a large tapeworm parasite of the
Taenia saginata may cause cysticercosis; these parasites live in adult form in human intestines and in
cysts) in the muscles and the central nervous system. These parasites are mostly transmitted to huma
cooked beef.
Serology reagents intended to detect antibodies to species of Taenia, large tapeworm parasites of the
Several species of Taenia parasitize human intestines; T. solium and, less frequently, T. saginata may c
Taenia parasites live in adult form in human intestines and in larval form (forming cysts) in the muscle
nervous system. These parasites are usually transmitted to humans via inadequately cooked pork or b

Serology reagents intended to detect antigens that permit the identification of strains of species of En
parasites, a genus of Amoeboid protozoa. Several species of Entamoeba are parasitic to humans, inclu
histolytica, causing intestinal disorders and amebiasis.
Serology reagents intended to detect antibodies to Entamoeba (ameba) histolytica parasites, a specie
Amoeboid protozoa. Entamoeba may cause amebiasis (typically in the intestines, but potentially exten
lungs); these parasites are transmitted via water or cysts in contaminated food.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Entamoeba (amoeba) hist
species of the genus Amoeboid protozoa. Entamoeba may cause amebiasis (typically in the intestines
extending to the liver and lungs); these parasites are transmitted via water or cysts in contaminated f

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Entamoeba (ameba) histo
species of the genus Amoeboid protozoa. Entamoeba may cause amebiasis (typically in the intestines
extending to the liver and lungs); these parasites are transmitted via water or cysts in contaminated f

Serology reagents intended to detect antigens that permit the identification of strains of Entamoeba (
parasites, a species of the genus Amoeboid protozoa. Entamoeba may cause amebiasis (typically in th
potentially extending to the liver and lungs); these parasites are transmitted via water or cysts in con

Serology reagents intended to detect antibodies to Fasciola hepatica, a species of trematode (i.e., fluk
ducts and the liver. Fasciola hepatica parasites may obstruct the biliary passages and affect the liver p

Serology reagents intended to detect antibodies to species of Giardia, a genus of flagellate protozoa, c
presence of a large sucking disk in the ventral surface, that parasitize human intestines. Most species
but Giardia lamblia may cause giardiasis in humans, a common infection of the small intestines chara
and nausea.
Serology reagents intended to detect antigens that permit the identification of strains of species of Gi
flagellated protozoa characterized by the presence of a large sucking disk in the ventral surface, that
intestines. The species Giardia lamblia causes giardiasis, a common infection of the small intestines c
diarrhea and nausea.
Serology reagents intended to detect antibodies to Giardia lamblia, a flagellated protozoon that paras
intestines. Giardia lamblia causes giardiasis, a common infection of the small intestines.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Giardia lamblia, a flagellat
parasitizes human intestines. Giardia lamblia causes giardiasis, a common infection of the small intes

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Giardia lamblia, a flagellat
parasitizes human intestines. Giardia lamblia causes giardiasis, a common infection of the small intes
diarrhea and nausea.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Giardia lamblia, a flagella
characterized by the presence of a large sucking disk in the ventral surface, that parasitizes human in
lamblia causes giardiasis, a common infection of the small intestines chracterized by diarrhea and nau

Serology reagents intended to detect antibodies to species of Toxoplasma, a genus of coccidian protoz
Eimeriina. Toxoplasma species (e.g., Toxoplasma gondii) cause toxoplasmosis, an acute or chronic dise
feces of cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but extensi
brain, eyes, cardiac muscle) may occur, usually in immunocompromised patients or in fetuses infected
transmission.

Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Toxoplasma gondii, a spec
intracellular coccidian protozoon parasite. These parasites cause toxoplasmosis, an acute or chronic d
the feces of cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but exte
the brain, eyes, cardiac muscle) may occur, especially in immunocompromised patients or in fetuses i
transplacental transmission.

Serology reagents intended to detect immunoglobulin E (IgE) antibodies to Toxoplasma gondii, a speci
intracellular coccidian protozoon parasite. These parasites cause toxoplasmosis, an acute or chronic d
the feces of cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but exte
the brain, eyes, cardiac muscle) may occur, especially in immunocompromised patients or in fetuses i
transplacental transmission.

Serology reagents intended to detect antibodies to species of Toxoplasma, a genus of coccidian protoz
Eimeriina. Toxoplasma species (e.g., Toxoplasma gondii) cause toxoplasmosis, an acute or chronic dise
feces of cats or via tissue cysts in infected meat. Most infections are mild and self-limited, but extensi
brain, eyes, cardiac muscle) may occur, usually in immunocompromised patients or in fetuses infected
transmission.

Serology reagents intended to detect immunoglobulin E (IgE) antibodies to species of Toxoplasma, a g


protozoa of the suborder Eimeriina. Toxoplasma species (e.g., Toxoplasma gondii) cause toxoplasmosis
disease transmitted by the feces of cats or via tissue cysts in infected meat. Most infections are mild a
extensive damage (e.g., to the brain, eyes, cardiac muscle) may occur, especially in immunocomprom
fetuses infected by transplacental transmission.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of Toxoplasma, a g


protozoa of the suborder Eimeriina. Toxoplasma species (e.g., Toxoplasma gondii) cause toxoplasmosis
disease transmitted by the feces of cats or via tissue cysts in infected meat. Most infections are mild a
extensive damage (e.g., to the brain, eyes, cardiac muscle) may occur, usually in immunocompromise
infected by transplacental transmission.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of Toxoplasma, a


protozoa of the suborder Eimeriina. Toxoplasma species (e.g., Toxoplasma gondii) cause toxoplasmosis
disease transmitted by the feces of cats or via tissue cysts in infected meat. Most infections are mild a
extensive damage (e.g., to the brain, eyes, cardiac muscle) may occur, usually in immunocompromise
infected by transplacental transmission.
Serology reagents intended to detect antibodies to species of Trichinella, a genus of nematode parasit
parasites may cause intestinal infections in humans; the species Trichinella spiralis is the etiologic age
disease characterized in early stages by diarrhea, nausea, and colic; advanced stages produce stiffnes
swelling of muscles.
Serology reagents intended to detect immunoglobulin E (IgE) antibodies to Trichinella spiralis, one of t
nematodes. These parasites are the etiologic agent of trichinosis, a disease characterized in early stag
nausea, and colic; advanced stages produce stiffness, fever, pain, and swelling of muscles.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Trichinella spiralis, one of
nematodes. These parasites are the etiologic agent of trichinosis, a disease characterized in early stag
nausea, and colic; advanced stages produce stiffness, fever, pain, and swelling of muscles.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Trichinella spiralis, one of
nematodes. These parasites are the etiologic agent of trichinosis, a disease characterized in early stag
nausea, and colic; advanced stages produce stiffness, fever, pain, and swelling of muscles.

Serology reagents intended to detect serum immunoglobulin G (IgG) antibodies to Trypanosoma cruzi
of the suborder Trypanosomatina. Trypanosoma cruzi causes Chagas' disease (American trypanosomia
characterized by an erythematous nodule (i.e., chagoma) appearing within a few days at the site of th
parasites are transmitted to humans by insects from other humans or from animals (e.g., cats, dogs, r

Serology reagents intended to detect serum immunoglobulin M (IgM) antibodies to Trypanosoma cruzi
protozoon of the suborder Trypanosomatina. Trypanosoma cruzi causes Chagas' disease (American try
humans, characterized by an erythematous nodule (i.e., chagoma) appearing within a few days at the
These parasites are transmitted to humans by insects from other humans or from animals (e.g., cats,

Laser printers designed to produce a standard and/or high-definition, permanent, monochromatic text
hard copy) on full-size (e.g., letter, legal) and/or nonstandard, large-format paper or other appropriate
black toner (fine particles of plastic powder mixed with a carbon black agent) to a light-sensitive print
source. The toner is transferred to the printing medium (usually common paper) using static electricit
fused to the paper using heat and pressure. These printers typically include a revolving photosensitive
(e.g., a laser diode), a toner cartridge, rollers that apply heat and pressure to the paper, a rubber blad
toner, controls, and paper trays. Monochromatic laser printers are intended mainly for use as compute
computer network users, providing high-definition hard copies at a high printing speed.

Laser printers designed to produce a standard and/or high-definition, permanent, color text or graphic
on full-size (e.g., letter, legal) and/or nonstandard, large-format paper or other appropriate media by a
(fine particles of plastic powder mixed with coloring agents, usually cyan, yellow, and magenta) to a li
drum using a laser source. The toner is transferred to the printing medium (usually common paper) us
and then the toner is fused to the paper using heat and pressure. These printers typically include a re
drum, a laser source (e.g., a laser diode), a toner cartridge, rollers that apply heat and pressure to the
to remove excess toner, controls, and paper trays. Color laser printers are intended mainly for use as
and/or by computer network users, providing high-definition color hard copies at a relatively high prin
Printers designed to produce a permanent monochromatic or color text or graphic copy (i.e., hard cop
letter, legal) and/or nonstandard, large-format paper or other appropriate media (e.g., transparency) f
computers or computer networks by spraying small amounts of ink on common paper. These printers
(i.e., bubble) technologies; but other technologies including piezoelectric and continuous ink-jet are al
printers typically include a cartridge with tiny chambers (with heating or piezoelectric elements used
nozzles that deliver the ink to the paper, roller mechanisms to move the paper, controls, and paper tr
intended mainly for use as computer peripherals and/or by computer network users, dedicated ink-jet
printers) that can produce high-quality color prints on photographic cards are also available.

Printers designed to produce a permanent monochromatic and, less frequently, color text or graphic c
full-size (e.g., letter, legal) and/or nonstandard, large-format paper or other appropriate media (e.g., t
stored in computers or computer networks by impact on a matrix of small pins that create dots on the
printers typically include a head that strikes the page, a soft, inked ribbon, roller mechanisms to move
and paper trays; the dot matrix print head strikes the ribbon against the paper, producing text in a va
graphic forms. Dot matrix printers have been used as computer peripherals and/or by computer netwo
application is currently less common; they are used mainly to produce multicopy documents (either ca
due to the impact mechanism.

Document scanners designed to provide bar-code data-entry capabilities to handheld computers (i.e.,
assistants [PDAs]). These scanners typically consist of a card and LED (light-emitting diode) sources th
slot of a handheld computer, providing automatic decoding of many common bar-code symbol system
(Universal Product Code) and EAN (European Article Number). Handheld computer bar-code document
perform tasks that require extensive mobile data collection from bar-coded labels or tags, such as dev
also for manipulation of laboratory sample data.

Molecular assay reagents intended to identify adenovirus, a DNA virus of the family Adenoviridae, by
acid of the target virus. Some species of these viruses may cause acute respiratory, gastrointestinal, a
diseases; adenoviruses also cause latent infections of the tonsils and adenoids in children. Many spec
malignancies.
Molecular assay reagents intended to identify adenovirus, a DNA virus of the family Adenoviridae, by
deoxyribonucleic acid (DNA) of the target virus. Some species of these viruses may cause acute respir
and urinary tract diseases; adenoviruses also cause latent infections of the tonsils and adenoids in chi

Molecular assay reagents intended to identify adenovirus, a DNA virus of the family Adenoviridae, by
ribosomal ribonucleic acid (rRNA) of the target virus. Some species of these viruses may cause acute
gastrointestinal, and urinary tract diseases; adenoviruses also cause latent infections of the tonsils an
Many species are likely to induce malignancies.
Molecular assay reagents intended to identify viruses of the genus Astrovirus, the sole genus of the fa
family of RNA viruses having a nonenveloped spherical virion, by detecting the nucleic acid of the targ
may cause gastroenteritis and mild watery diarrhea in children; the disease can be more serious in im
patients.
Molecular assay reagents intended to identify viruses of the genus Astrovirus, the sole genus of the fa
family of RNA viruses having a nonenveloped spherical virion, by detecting the ribonucleic acid (RNA)
These viruses may cause gastroenteritis and mild watery diarrhea in children; the disease can be mor
immunocompromised patients.
Molecular assay reagents intended to identify BK virus, a DNA virus of the subfamily Polyomavirinae, b
deoxyribonucleic acid (DNA) of the target virus. This virus may cause cystitis and nephritis in immuno
the virus is also associated with cancer tumors.
Molecular assay reagents intended to identify Coxsackievirus, a group of single-stranded RNA viruses
Enterovirus, family Picornaviridae, by detecting the nucleic acid of the target virus. These viruses may
resembling poliomyelitis, febrile illness, and/or aseptic meningitis.
Molecular assay reagents intended to identify Coxsackievirus group A, a single-stranded RNA virus of
genus Enterovirus, family Picornaviridae, by detecting the ribonucleic acid (RNA) of the target virus. T
diseases resembling poliomyelitis, febrile illness, and/or aseptic meningitis.

Molecular assay reagents intended to identify Coxsackievirus group A subtypes, single-stranded RNA v
of the genus Enterovirus, family Picornaviridae, by detecting ribonucleic acid (RNA) of the target virus
diseases resembling poliomyelitis, febrile illness, and/or aseptic meningitis.

Molecular assay reagents intended to identify Coxsackievirus group B, a single-stranded RNA virus of
genus Enterovirus, family Picornaviridae, by detecting the ribonucleic acid (RNA) of the target virus. T
diseases resembling poliomyelitis, febrile illness, and/or aseptic meningitis.

Molecular assay reagents intended to identify Coxsackievirus group B subtypes, single-stranded RNA v
of the genus Enterovirus, family Picornaviridae, by detecting specific genetic information of the ribonu
target virus. This virus may cause diseases resembling poliomyelitis, febrile illness, and/or aseptic me

Molecular assay reagents intended to identify Cytomegalovirus (CMV), a DNA virus of the family Herpe
the deoxyribonucleic acid (DNA) of the target virus. CMV may cause a variety of diseases (e.g., cytom
diseases, leukemia) depending on the immune status and age of the host; persistence of the virus for
is common.
Molecular assay reagents intended to identify dengue virus, a single-stranded RNA virus of the family
detecting the nucleic acid of the target virus. Several different types of this virus are the etiologic age
hemorrhagic dengue. Dengue is typically transmitted by the bite of infected mosquitoes of the genus

Molecular assay reagents intended to identify any of the four types of the dengue virus, a single-stran
family Flaviviridae, by detecting the ribonucleic acid (RNA) of the target virus. These viruses are the e
dengue and hemorrhagic dengue. Dengue is typically transmitted by the bite of infected mosquitoes o

Molecular assay reagents intended to identify eastern equine encephalitis virus, a virus of the genus A
Togaviridae, by detecting the nucleic acid of the target virus. This virus may cause subclinical infection
fever in humans; in some cases this fever may be followed by encephalitis, characterized by increasin
rigidity, confusion, paralysis, convulsions, and coma. The virus is typically transmitted by the bite of in
the genus Aedes.

Molecular assay reagents intended to identify eastern equine encephalitis virus, a virus of the genus A
Togaviridae, by detecting the ribonucleic acid (RNA) of the target virus. This virus may cause subclinic
low-grade fever in humans; in some cases this fever may be followed by encephalitis or and encephal
characterized by increasing drowsiness, neck rigidity, confusion, paralysis, convulsions, and coma. Th
transmitted by the bite of infected mosquitoes of the genus Aedes and other species (e.g., culex mosq
Molecular assay reagents intended to identify Ebola virus, a virus of the genus Filovirus, family Filoviri
ribonucleic acid (RNA) of the target virus. This virus is an etiologic agent of hemorrhagic fever, charac
anorexia, and myalgia, followed by a maculopapular rash and mucous membrane hemorrhage associa
in coagulation parameters.
Molecular assay reagents intended to identify echovirus, a group of viruses of the genus Enterovirus, f
by detecting the nucleic acid of the target virus. This virus may have a wide range of clinical presenta
cause acute febrile illness in infants and young children, echoviruses are also associated with rashes,
infections (e.g., sore throat, bronchitis), pericarditis, and aseptic meningitis.

Molecular assay reagents intended to identify echovirus, a group of viruses of the genus Enterovirus, f
by detecting the ribonucleic acid (RNA) of the target virus. This virus may have a wide range of clinica
Echoviruses may cause acute febrile illness in infants and young children; they are also associated wit
respiratory infections (e.g., sore throat, bronchitis), pericarditis, and aseptic meningitis.

Molecular assay reagents intended to identify subtypes of echovirus, a group of viruses of the genus E
Picornaviridae, by detecting the ribonucleic acid (RNA) of the target virus. Some subtypes of this virus
febrile illness in infants and young children, specific subtypes are associated with rashes, diarrhea, res
(e.g., sore throat, bronchitis), pericarditis, and/or aseptic meningitis.

Molecular assay reagents intended to identify Enterovirus, a genus of single-stranded RNA viruses of t
Picornaviridae that includes polio and nonpolio (e.g., coxsackieviruses and echoviruses) enteroviruses
ribonucleic acid (RNA) of the target virus. These viruses may cause a wide range of diseases, including
etiologic agents are wild type polioviruses), aseptic meningitis, and encephalitis (caused by several ty
coxsackieviruses and echoviruses), as well as chronic meningoencephalitis (caused by several types o

Molecular assay reagents intended to identify epidemic parotitis (mumps) virus, an RNA virus of the fa
by detecting the ribonucleic acid (RNA) of the target virus. This virus is the etiologic agent of epidemic
as mumps), an infection characterized by swelling of one or both parotid glands that may also affect t
inflammation of the testes (orchitis) and affect the ovaries.
Molecular assay reagents intended to identify Epstein-Barr virus (EBV), a DNA virus of the family Herp
the deoxyribonucleic acid (DNA) of the target virus. EBV may cause infectious mononucleosis and is cl
malignant diseases such as Burkitt's lymphoma and nasopharyngeal carcinoma.

Molecular assay reagents intended to identify Hantavirus, the only member of the Bunyaviridae family
transmitted, by detecting the nucleic acid of the target virus. Some particular strains of this virus (Han
Puumala) may cause hemorrhagic fever with renal syndrome; other strains (Sin Nombre, Bayou, Black
York) are the etiologic agents of Hantavirus pulmonary syndrome.
Molecular assay reagents intended to identify Hantavirus, the only member of the Bunyaviridae family
transmitted, by detecting the ribonucleic acid (RNA) of the target virus. Some particular strains of this
Dobrava, Puumala) may cause hemorrhagic fever with renal syndrome; other strains (Sin Nombre, Bay
New York) are the etiologic agents of Hantavirus pulmonary syndrome.
Molecular assay reagents intended to identify hepatitis A virus, a member of the family Picornaviridae
nucleic acid of the target virus. Hepatitis A virus may cause hepatitis, a disease characterized by jaun
of some enzymes in serum (e.g., aspartate aminotransferase); these viruses are almost exclusively tra
oral route or via contaminated food or water, although parenteral transmission is possible.

Molecular assay reagents intended to identify hepatitis A virus, a member of the family Picornaviridae
ribonucleic acid (RNA) of the target virus. Hepatitis A virus may cause hepatitis, a disease characterize
increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruses are almost exclu
the fecal-oral route or via contaminated food or water, although parenteral transmission is possible.

Molecular assay reagents intended to identify hepatitis B virus, a DNA virus of the genus Hepadnaviru
Hepadnaviridae, by detecting the deoxyribonucleic acid (DNA) of the target virus. Hepatitis B virus ma
disease characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate amino
viruses may be transmitted percutaneously (e.g., via body piercing, tattooing), parenterally, and from
birth, or by intimate (e.g., sexual) contact.

Molecular assay reagents intended to identify hepatitis B virus, a DNA virus of the genus Hepadnaviru
Hepadnaviridae, by detecting the specific genetic constitution (i.e., the genotype) of the target virus.
genotypes may cause hepatitis, a disease characterized by jaundice and the increase of some enzyme
aspartate aminotransferase); these viruses may be transmitted percutaneously (e.g., via body piercin
parenterally, from mother to child at birth, or by intimate (e.g., sexual) contact.

Molecular assay reagents intended to identify hepatitis B virus, a DNA virus of the genus Hepadnaviru
Hepadnaviridae, by detecting the ribosomal ribonucleic acid (rRNA) of the target virus. Hepatitis B viru
a disease characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate amin
viruses may be transmitted percutaneously (e.g., via body piercing, tattooing), parenterally, from mot
by intimate (e.g., sexual) contact.

Molecular assay reagents intended to identify hepatitis C virus, an RNA virus of the genus Flavivirus, f
detecting the specific genetic constitution (i.e., the genotype) of the target virus. Hepatitis C virus gen
hepatitis, a disease characterized by jaundice and the increase of some enzymes in serum (e.g., aspa
aminotransferase); these viruses are transmitted parenterally and possibly by intimate (e.g., sexual) c

Molecular assay reagents intended to identify hepatitis C virus, an RNA virus of the genus Flavivirus, f
detecting the ribonucleic acid (RNA) of the target virus. Hepatitis C virus may cause hepatitis, a diseas
jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransferase); these viruse
parenterally and possibly by intimate (e.g., sexual) contact.
Molecular assay reagents intended to identify hepatitis C virus, an RNA virus of the genus Flavivirus, f
detecting the ribosomal ribonucleic acid (rRNA) of the target virus. Hepatitis C virus may cause hepati
characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransfera
transmitted frequently parenterally and possibly by intimate (e.g., sexual) contact.

Molecular assay reagents intended to identify hepatitis D virus, an unclassified defective RNA virus (d
requires the presence of hepatitis B virus (HBV) for viral replication to occur, by detecting the ribonucl
target virus. Hepatitis D virus may occur as a simultaneous acute hepatitis infection or may be superim
chronic HBV. Hepatitis is a disease characterized by jaundice and the increase of some enzymes in ser
aminotransferase).
Molecular assay reagents intended to identify hepatitis G virus, an RNA virus of the family Flaviviridae
ribonucleic acid (RNA) of the target virus. Hepatitis G virus may cause both acute and chronic hepatiti
characterized by jaundice and the increase of some enzymes in serum (e.g., aspartate aminotransfera
be transmitted parenterally, perinatally, or by intimate (e.g., sexual) contact.

Molecular assay reagents intended to identify hepatitis-associated TT virus, a single-stranded DNA vir
Circoviridae, by detecting the deoxyribonucleic acid (DNA) of the target virus. TT viruses are associate
viruses. Liver injury is likely associated with TT virus infection but these viruses are not a main cause
origin.
Molecular assay reagents intended to identify Herpes simplex virus (HSV), a DNA virus of the family H
detecting the deoxyribonucleic acid (DNA) of the target virus. HSV may cause a variety of conditions,
gingivostomatitis, herpes labialis, genital herpes, neonatal herpes, keratitis, conjunctivitis, skin erupti
and encephalitis. Activation of latent herpesvirus is associated with some malignancies. Persistence o
lifetime of the host is common.

Molecular assay reagents intended to identify Herpes simplex virus type 1 (HSV1), a DNA virus of the
by detecting the deoxyribonucleic acid (DNA) of the target virus. HSV1 is transmitted mainly by infect
may cause a variety of diseases, typically nongenital infections, but it may be the cause of sexually tr
infections. Activation of latent HSV1 is associated with some malignancies. Persistence of the virus for
host is common.

Molecular assay reagents intended to identify Herpes simplex virus serotypes 1 and 2 (HSV1 and HSV
viruses of the family Herpesviridae, by detecting the deoxyribonucleic acid (DNA) of the target viruses
transmitted by infected saliva and causes nongenital infections; HSV2 is sexually transmitted and is th
of herpes genital infections. Activation of latent herpesvirus is associated with some malignancies. Pe
for the lifetime of the host is common.

Molecular assay reagents intended to identify Herpes simplex virus type 2 (HSV2), a DNA virus of the
by detecting the deoxyribonucleic acid (DNA) of the target virus. HSV2 acquired immunodeficiency sy
transmitted; it is an etiologic agent of a variety of diseases including genital infections. Activation of la
associated with some malignancies. Persistence of the virus for the lifetime of the host is common.

Molecular assay reagents intended to identify Herpes virus type 6, a beta-herpesvirus of the genus Ro
detecting the deoxyribonucleic acid (DNA) of the target virus. This virus may cause roseola infantum;
with bone marrow suppression, pneumonitis, encephalitis, encephalopathy, hepatitis, fever, and skin r
immunocompromised patients.
Molecular assay reagents intended to identify Herpes virus type 7, a beta-herpesvirus of the genus Ro
detecting the deoxyribonucleic acid (DNA) of the target virus. This virus is associated with roseola infa
useful in the diagnosis of chronic fatigue syndrome, especially when Herpes virus type 7 is acting sim
Herpes virus type 6.
Molecular assay reagents intended to identify Herpes virus type 8, a double-stranded DNA herpesviru
humans, by detecting the deoxyribonucleic acid (DNA) of the target virus. This virus is associated with
sarcoma (KS), including classic, endemic, post transplant, and acquired immunodeficiency syndrome-r
have identical histological features.
Molecular assay reagents intended to identify human metapneumovirus (hMPV), an RNA virus of the f
by detecting the ribonucleic acid (RNA) of the target virus. A wide spectrum of acute respiratory infect
pediatric patients, is associated with hMPV.
Molecular assay reagents intended to identify human papilloma virus (HPV), a member of the family P
detecting the deoxyribonucleic acid (DNA) of the target virus. Some HPV genotypes cause mucosal inf
anogenital diseases) and are associated with malignancy; other genotypes may cause cutaneous infe
reagents can identify the DNA of specific genotypes of HPV (e.g., 6/11, 16/18).

Molecular assay reagents intended to identify human papilloma virus (HPV), of the family Papovavirida
ribosomal ribonucleic acid (rRNA) of the target virus. Some HPV genotypes cause mucosal infections (
diseases) and are associated with malignancy; other genotypes may cause cutaneous infections. Ded
identify the rRNA of one or more specific genotypes of HPV (e.g., 6/11, 16/18).

Molecular assay reagents intended to identify high cancer risk types of human papilloma virus (HPV),
Papovaviridae, by detecting the deoxyribonucleic acid (DNA) of the target viruses. High-risk HPV types
anogenital tract epithelium, but they can also be found in the oral mucosa, conjunctiva, and respirator
common high-risk types include HPV types 16 and 18, but types 45 and 56 are usually included in this
genotypes cause mucosal infections and are associated with malignancy.

Molecular assay reagents intended to identify types 16 and/or 18 of human papilloma virus (HPV), of t
Papovaviridae, by detecting the deoxyribonucleic acid (DNA) of the target viruses. HPV types 16 and 1
common high cancer risk types and usually infect the anogenital tract epithelium causing mucosal inf
associated with malignancy.
Molecular assay reagents intended to identify intermediate cancer risk types of human papilloma viru
Papovaviridae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the targ
Intermediate-risk HPV types usually infect the anogenital tract epithelium, but they can also be found
conjunctiva, and respiratory tract; intermediate-risk types include HPV types 31, 33, and 35. These HP
mucosal infections and are occasionally associated with malignancy.

Molecular assay reagents intended to identify low cancer risk types of human papilloma virus (HPV), o
Papovaviridae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the targ
HPV types usually infect the skin (e.g., forehead, arms, soles of feet); the most common low-risk types
and 11, but types 42, 43, and 44 are usually included in this test. These HPV genotypes cause cutaneo
almost never associated with malignancy.

Molecular assay reagents intended to identify Influenza virus, a single-stranded RNA virus of the famil
detecting specific genetic information of the nucleic acid of the target virus. Some species of this virus
agent of influenza, a disease characterized by sudden onset of high fever, myalgia, headache, severe
nonproductive cough, sore throat, and rhinitis. Dedicated reagents can identify specific types and/or s
viruses (e.g., A, B, C).

Molecular assay reagents intended to identify Influenza virus type A, a single-stranded RNA virus of th
Orthomyxoviridae, by detecting the nucleic acid of the target virus. Influenza A virus may cause huma
characterized by sudden onset of high fever, myalgia, headaches, severe malaise, nonproductive coug
rhinitis. Subtypes of Influenza virus that known to affect humans are H1N1, H1N2, and H3N2; other su
and H7N2 (i.e., avian influenza) affect birds and may affect humans.
Molecular assay reagents intended to identify Influenza virus type A, a single-stranded RNA virus of th
Orthomyxoviridae, by detecting the ribonucleic acid (RNA) of the target virus. Influenza A virus may ca
a disease characterized by sudden onset of high fever, myalgia, headaches, severe malaise, nonprodu
throat, and rhinitis. The subtypes of influenza known to affect humans are H1N1, H1N2, and H3N2; oth
H5 and H7 (i.e., avian influenza) affect birds and may affect humans.

Molecular assay reagents intended to identify subtypes of Influenza virus type A (single-stranded RNA
Orthomyxoviridae) that affect birds, by detecting the ribonucleic acid (RNA) of the target virus. Influen
that cause avian influenza usually include the surface glycoproteins H5 or H7 (i.e., subtypes H5N1 and
may occasionally cause human influenza, a disease characterized by sudden onset of high fever, mya
malaise, nonproductive cough, sore throat, and rhinitis.

Molecular assay reagents intended to identify Influenza virus type A and/or type B, single-stranded RN
Orthomyxoviridae, by detecting the ribonucleic acid (RNA) of the target viruses. Influenza type A and
agents of influenza, a disease characterized by sudden onset of high fever, myalgia, headache, severe
nonproductive cough, sore throat, and rhinitis.
Molecular assay reagents intended to identify Influenza virus type B, a single-stranded RNA virus of th
Orthomyxoviridae, by detecting the ribonucleic acid (RNA) of the target virus. Influenza type B virus is
influenza, a disease characterized by sudden onset of high fever, myalgia, headache, severe malaise,
sore throat, and rhinitis.
Molecular assay reagents intended to identify Japanese encephalitis virus, a single-stranded RNA virus
Flaviviridae, by detecting the ribonucleic acid (RNA) of the target virus. This virus may cause encepha
encephalomyelitis; it is usually transmitted by the bite of infected mosquitoes.
Molecular assay reagents intended to identify JC (i.e., John Cunningham) virus, a double-stranded DNA
Polyomavirinae, by detecting the deoxyribonucleic acid (DNA) of the target virus. This virus may cause
leukoencephalopathy, a demyelinating disease of the human brain, especially in immunocompromised

Molecular assay reagents intended to identify La Crosse virus, a single-stranded with helical and enve
RNA virus of the family Bunyaviridae, by detecting the ribonucleic acid (RNA) of the target virus. This
encephalitis (California encephalitis) and encephalomyelitis; it is usually transmitted by the bite of inf

Molecular assay reagents intended to identify measles virus, a single-stranded RNA enveloped virus o
Paramyxoviridae, by detecting the nucleic acid of the target virus. This virus is the etiologic agent of m
usually benign infection characterized by coryza, cervical lymphoid hyperplasia, conjunctivitis, harass
fever, and, finally, skin eruption (rash).
Molecular assay reagents intended to identify measles virus, a single-stranded RNA enveloped virus o
Paramyxoviridae, by detecting the ribonucleic acid (RNA) of the target virus. This virus is the etiologic
acute, usually benign infection characterized by coryza, cervical lymphoid hyperplasia, conjunctivitis,
malaise, fever, and, finally, skin eruption (rash).
Molecular assay reagents intended to identify Norwalk and/or Norwalk-like viruses, human RNA nonen
genus Calicivirus, by detecting the ribonucleic acid (RNA) of the target virus. These viruses are the eti
self-limited gastroenteritis.
Molecular assay reagents intended to identify parainfluenza viruses, a group of single-stranded RNA v
Paramyxoviridae, by detecting specific nucleic-acid information of the target viruses. Parainfluenza vir
are classified into the genera Paramyxovirus (including human Parainfluenza virus types 1 and 3) and
human Parainfluenza virus types 2 and 4). These viruses are the etiologic agent of parainfluenza and
respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity. Dedicated molecular assa
available to identify specific types of Parainfluenza viruses.

Molecular assay reagents intended to identify Parainfluenza type 1 virus, a single-stranded RNA virus
Paramyxovirus, family Paramyxoviridae, by detecting the ribonucleic acid (RNA) of the target virus. Th
agent of parainfluenza and several upper respiratory tract infections (e.g., bronchitis, pneumonia) of v

Molecular assay reagents intended to identify Parainfluenza type 2 virus, a single-stranded RNA virus
Rubulavirus, family Paramyxoviridae, by detecting the ribonucleic acid (RNA) of the target virus. This v
agent of parainfluenza and several upper respiratory tract infections (e.g., bronchitis, pneumonia) of v

Molecular assay reagents intended to identify Parainfluenza type 3 virus, a single-stranded RNA virus
Paramyxovirus, family Paramyxoviridae, by detecting the ribonucleic acid (RNA) of the target virus. Th
agent of parainfluenza and several upper respiratory tract infections (e.g., bronchitis, pneumonia) of v

Molecular assay reagents intended to identify human parvovirus B19, a single-stranded DNA virus of t
by detecting the deoxyribonucleic acid (DNA) of the target virus. This virus may cause fifth disease (e
and chronic bone marrow failure in immunocompromised patients.
Molecular assay reagents intended to identify rabies virus, a bullet-shaped, single-stranded RNA virus
Lyssavirus, family Rhabdoviridae, by detecting the ribonucleic acid (RNA) of the target virus. This virus
of rabies, a disease characterized by the infection of the central nervous system, causing encephalopa
paralysis, and coma.
Molecular assay reagents intended to identify respiratory syncytial virus (RSV), an enveloped RNA spe
family Paramyxovirus, by detecting the ribonucleic acid (RNA) of the target virus. Several types of RSV
lower respiratory tract infections; they are the most common cause of bronchiolitis and pneumonia am

Molecular assay reagents intended to identify human immunodeficiency virus serotype 1 (HIV-1), a ret
Lentivirus, family Retroviridae, by detecting the nucleic acid of the target virus. HIV-1 virus is the mos
agent of acquired immunodeficiency syndrome (AIDS).
Molecular assay reagents intended to identify human immunodeficiency virus serotype 1 (HIV-1), a ret
Lentivirus, by detecting the ribonucleic acid (RNA) of the target virus. HIV-1 is the most common etiolo
immunodeficiency syndrome (AIDS).
Molecular assay reagents intended to identify the specific genetic constitution (i.e., genotype) of hum
virus serotype 1 (HIV-1), a retrovirus of the genus Lentivirus. HIV-1 virus genotypes are the most comm
acquired immunodeficiency syndrome (AIDS).
Molecular assay reagents intended to identify human immunodeficiency virus serotype 2 (HIV-2), a ret
Lentivirus, by detecting the deoxyribonucleic acid (DNA) of the target virus. HIV-2 an etiologic agent o
immunodeficiency syndrome (AIDS).
Molecular assay reagents intended to identify human T-cell lymphotropic virus, also called human T-ce
virus type I (HTLV-I), by detecting the deoxyribonucleic acid (DNA) of the target virus. HTLV-I retrovirus
RNA virus of the subfamily Oncovirinae; it may cause chronic infection, T-cell leukemia, and tropical pa

Molecular assay reagents intended to identify human T-cell lymphotropic virus, also called human T-ce
virus type II (HTLV-II), by detecting the deoxyribonucleic acid (DNA) of the target viruses. HTLV-II retrov
producing RNA virus of the subfamily Oncovirinae; it may cause chronic infection, T-cell leukemia, and

Molecular assay reagents intended to identify rhinovirus, a single-stranded RNA virus of the family Pic
detecting the ribonucleic acid (RNA) of the target virus. This virus is the etiologic agent of common co
acute otitis media and/or sinusitis.
Molecular assay reagents intended to identify Rotavirus, a genus of nonenveloped double-stranded RN
like appearance of the family Reoviridae, by detecting the ribonucleic acid (RNA) of the target virus. S
Rotavirus may cause diseases in humans, including gastroenteritis and diarrhea; it is the most commo
diarrhea among children.
Molecular assay reagents intended to identify rubella virus, an RNA virus of the family Togaviridae, by
ribonucleic acid (RNA) of the target virus. Rubella virus is the cause of an acute, usually benign infecti
children; the disease is characterized by a pink rash beginning on the head and spreading to become
Transplacental infection of the fetus may occur. Rubella is also called also German measles and, in Fre
rubeola.

Molecular assay reagents intended to identify Saint Louis Encephalitis virus, a single-stranded RNA vir
Flaviviridae, by detecting the ribonucleic acid (RNA) of the target virus. This virus may cause encepha
encephalomyelitis; it is usually transmitted by the bite of infected mosquitoes.
Molecular assay reagents intended to identify a coronavirus associated with severe acute respiratory s
associated Coronavirus), an RNA virus of the family Coronaviridae that is genetically and antigenically
human coronaviruses, by detecting the ribonucleic acid (RNA) of the target virus. This virus is the etio
and viral pneumonia.
Molecular assay reagents intended to identify vaccinia virus, a virus of the genus Orthopoxvirus that d
(being propagated only in the laboratory for use as an active vaccine against smallpox), by detecting
acid (DNA) of the target virus. Vaccinia viruses only cause mild reactions in healthy persons when use
inoculator against smallpox; vaccinia smallpox vaccine does not contain and cannot cause smallpox, b
in one million individuals will develop a acute (and even fatal) response to the vaccination.

Molecular assay reagents intended to identify varicella-zoster virus, a DNA virus of the genus Varicella
Herpesviridae, by detecting the deoxyribonucleic acid (DNA) of the target virus. Varicella-zoster viruse
(varicella), an infectious disease typically transmitted by direct contact or through the respiratory rout
the appearance of vesicular lesions on the skin and mucous membranes. Activation of varicella-zoster
chickenpox (varicella) infection may cause herpes zoster (also called shingles), a self-limited infection
and their areas of innervation, producing severe neuralgic pain and vesicles on the skin.

Molecular assay reagents intended to identify Venezuelan equine encephalitis virus, an Alphavirus of t
by detecting the ribonucleic acid (RNA) of the target virus. This virus may cause mild flu-like illness, e
encephalomyelitis; it is usually transmitted by the bite of infected mosquitoes.
Molecular assay reagents intended to identify West Nile virus, a single-stranded RNA virus of the famil
detecting the ribonucleic acid (RNA) of the target virus. This virus may cause encephalitis and enceph
transmitted by the bite of infected mosquitoes.
Molecular assay reagents intended to identify western equine encephalitis virus, an Alphavirus of the
detecting the ribonucleic acid (RNA) of the target virus. This virus may cause mild flu-like illness, ence
encephalomyelitis; it is usually transmitted by the bite of infected mosquitoes.
Molecular assay reagents intended to identify yellow fever virus, a single-stranded RNA arbovirus of th
family Flaviviridae, by detecting the ribonucleic acid (RNA) of the target virus. This virus causes yellow
infection, which in severe form is characterized by fever, liver damage and jaundice, hemorrhage, and
usually transmitted by the bite of infected mosquitoes.
Microbiology reagents intended to identify adenovirus, a DNA virus of the family Adenoviridae. Some t
may cause acute respiratory, gastrointestinal, and urinary tract diseases; adenoviruses also cause late
tonsils and adenoids in children. Many species are likely to induce malignancies.

Microbiology reagents intended to identify human papilloma virus (HPV), a member of the family Papo
genotypes cause mucosal infections (especially anogenital diseases) and are associated with maligna
may cause cutaneous infections.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to adenovirus, a DNA virus o
Adenoviridae. Some species of these viruses may cause acute respiratory, gastrointestinal, and urinar
adenoviruses also cause latent infections of the tonsils and adenoids in children. Many species are like
malignancies.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to adenovirus, a DNA virus o
Adenoviridae. Some species of these viruses may cause acute respiratory, gastrointestinal, and urinar
adenoviruses also cause latent infections of the tonsils and adenoids in children. Many species are like
malignancies.
Serology reagents intended to detect and/or identify antigens or serum antibody titers to Arenavirus,
single-stranded RNA viruses of the family Arenaviridae. Some types of this virus may cause acute hem
humans (e.g., Lassa, Machupo, Junin, Guanarito, Sabia); other types may rarely infect humans infrequ
diseases (e.g., Lymphocytic Choriomeningitis virus may cause aseptic meningitis or an influenza-like i
arenavirus is usually associated with a particular rodent species by which diseases are transmitted to

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Arenavirus, a genus of en


stranded RNA viruses of the family Arenaviridae. Some types of this virus may cause acute hemorrhag
Machupo, Junin, Guanarito, Sabia) in humans; other types may rarely infect humans, infrequently caus
(e.g., Lymphocytic Choriomeningitis virus may cause aseptic meningitis or an influenza-like illness). Ea
is usually associated with a specific rodent species by which the virus is transmitted to humans.

Serology reagents intended to detect antigens to Arenavirus, a genus of enveloped single-stranded RN


Arenaviridae. Some types of this virus may cause acute hemorrhagic fever (e.g., Lassa, Machupo, Juni
humans; other types may rarely infect humans, infrequently causing mild diseases (e.g., Lymphocytic
may cause aseptic meningitis or an influenza-like illness). Each type of Arenavirus is usually associate
species by which the virus is transmitted to humans.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Lassa fever virus, an enve
old world group of Arenaviruses (i.e., LCM/Lassa complex) of the family Arenaviridae. This virus may c
hemorrhagic fever in humans (known as Lassa fever); it is usually associated with multimammate rats
by which the virus is transmitted to humans.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Lassa fever virus, an enve
old world group of Arenaviruses (i.e., LCM/Lassa complex) of the family Arenaviridae. This virus may c
hemorrhagic fever in humans (known as Lassa fever); it is usually associated with multimammate rats
by which the virus is transmitted to humans.
Serology reagents intended to detect antigens to Lassa fever virus, an enveloped RNA virus of the old
Arenaviruses (i.e., LCM/Lassa complex) of the family Arenaviridae. This virus may cause acute hemorr
(known as Lassa fever); it is usually associated with multimammate rats (Mastomys natalensis) by wh
transmitted to humans.
Serology reagents intended to detect antibodies to Lymphocytic Choriomeningitis virus (LCV), an enve
old world group of Arenaviruses (i.e., LCM/Lassa complex) of the family Arenaviridae. This virus causes
aseptic meningitis, influenza-like illness); the virus may rarely cause hemorrhagic fever in humans, bu
to a fetus. LCV is usually transmitted to humans by rodents.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Arbovirus, a pathogenic cl


replicates in blood-feeding arthropods; they usually belong to the families Bunyaviridae, Flaviviridae,
Rhabdoviridae, or Togaviridae. Some types of this virus may cause encephalitis (e.g., Saint Louis ence
equine encephalitis, California encephalitis group, eastern equine encephalitis). The test is used as an
arboviral infection.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Arbovirus, a pathogenic c


replicates in blood-feeding arthropods; they usually belong to the families Bunyaviridae, Flaviviridae,
Rhabdoviridae, or Togaviridae. Some types of this virus may cause encephalitis (e.g., Saint Louis ence
equine encephalitis, California encephalitis group, eastern equine encephalitis). The test is used as an
arboviral infection.

Serology reagents intended to detect antigens to Astrovirus, the sole genus of the family Astroviridae,
nonenveloped spherical virion. These viruses may cause gastroenteritis and mild watery diarrhea in ch
can be more serious in immunocompromised patients.
Serology reagents intended to detect antibodies to BK virus, a DNA virus of the subfamily Polyomaviri
cause cystitis and nephritis in immunocompromised patients; the virus is also associated with cancer

Serology reagents intended to detect antibodies to Cache Valley virus, a pathogenic class of viruses th
feeding arthropods (i.e., an arbovirus), that belongs to the genus Bunyavirus, family Bunyaviridae. Th
congenital defects of the central nervous system (e.g., neural tube defects) and, rarely, encephalitis. T
transmitted to humans by mosquitoes.
Serology reagents intended to detect antibodies to California encephalitis virus, a pathogenic class of
California serogroup that replicates in blood-feeding arthropods (i.e., an arbovirus) and belongs to the
family Bunyaviridae. This virus may cause encephalitis; it is usually transmitted to humans by mosqui

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to California encephalitis viru
of viruses of the California serogroup that replicates in blood-feeding arthropods (i.e., an arbovirus) an
Bunyavirus, family Bunyaviridae. This virus may cause encephalitis; it is usually transmitted to human
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to California encephalitis vir
of viruses of the California serogroup that replicates in blood-feeding arthropods (i.e., an arbovirus) an
Bunyavirus, family Bunyaviridae. This virus may cause encephalitis; it is usually transmitted to human

Serology reagents intended to detect antibodies to coxsackievirus group A, a genus of single-stranded


family Picornaviridae. This virus may cause diseases resembling poliomyelitis, febrile illness, and/or as

Serology reagents intended to detect antibodies to Coxsackievirus group B, a single-stranded RNA viru
genus Enterovirus, family Picornaviridae. This virus may cause diseases resembling poliomyelitis, febr
aseptic meningitis.
Serology reagents intended to detect antibodies to dengue virus, a single-stranded RNA virus of the fa
Several different types of this virus are the etiologic agent of dengue and hemorrhagic dengue. Dengu
transmitted by the bite of infected mosquitoes of the genus Aedes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to dengue virus, a single-stra
family Flaviviridae. Several different types of this virus are the etiologic agent of dengue and hemorrh
is typically transmitted by the bite of infected mosquitoes of the genus Aedes.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to dengue virus, a single-str
family Flaviviridae. Several different types of this virus are the etiologic agent of dengue and hemorrh
is typically transmitted by the bite of infected mosquitoes of the genus Aedes.

Serology reagents intended to detect antibodies to eastern equine encephalitis virus, a virus of the ge
Togaviridae. This virus may cause subclinical infections in humans, with only a low-grade fever; in som
be followed by encephalitis, characterized by increasing drowsiness, neck rigidity, confusion, paralysis
coma. The virus is typically transmitted by the bite of infected mosquitoes of the genus Aedes.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to eastern equine encephalit
genus Alphavirus, family Togaviridae. This virus may cause subclinical infections in humans, with only
some cases this fever may be followed by encephalitis, characterized by increasing drowsiness, neck
paralysis, convulsions, and coma. The virus is typically transmitted by the bite of infected mosquitoes

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to eastern equine encephali
genus Alphavirus, family Togaviridae. This virus may cause subclinical infections in humans, with only
some cases this fever may be followed by encephalitis, characterized by increasing drowsiness, neck
paralysis, convulsions, and coma. The virus is typically transmitted by the bite of infected mosquitoes

Serology reagents intended to detect antibodies to Ebola virus, a virus of the genus Filovirus, family Fi
an etiologic agent of hemorrhagic fever, characterized by chills, anorexia, and myalgia followed by a m
mucous membrane hemorrhage associated with abnormalities in coagulation parameters.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Ebola virus, a virus of the
Filoviridae. This virus is an etiologic agent of hemorrhagic fever, characterized by chills, anorexia, and
maculopapular rash and mucous membrane hemorrhage associated with abnormalities in coagulation
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Ebola virus, a virus of the
Filoviridae. This virus is an etiologic agent of hemorrhagic fever, characterized by chills, anorexia, and
maculopapular rash and mucous membrane hemorrhage associated with abnormalities in coagulation

Serology reagents intended to detect antibodies to echovirus (enterocytopathic human orphan virus),
the genus Enterovirus, family Picornaviridae. These viruses may have a wide range of clinical presenta
may cause acute febrile illness in infants and young children, they are also associated with rashes, dia
infections (e.g., sore throat, bronchitis), pericarditis, and aseptic meningitis.

Serology reagents intended to detect antibodies to echovirus (enterocytopathic human orphan virus)
viruses of the genus Enterovirus, family Picornaviridae. Some particular subtypes of this virus (e.g., 4,
acute febrile illness in infants and young children; specific subtypes are associated with rashes, diarrh
infections (e.g., sore throat, bronchitis), pericarditis, and/or aseptic meningitis.

Serology reagents intended to detect antibodies to Enterovirus, a genus of single-stranded viruses of


Picornaviridae that includes polio and nonpolio (e.g., coxsackieviruses, echoviruses) enteroviruses. En
inhabit the intestinal tract, and most infections are subclinical; but some types may cause a wide rang
including poliomyelitis (the etiologic agents are wild type polioviruses), aseptic meningitis and enceph
several types of coxsackieviruses and echoviruses), and chronic meningoencephalitis (caused by seve
echoviruses).

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Enterovirus, a genus of si


of the family Picornaviridae that includes polio and nonpolio (e.g., coxsackieviruses, echoviruses) ente
Enteroviruses typically inhabit the intestinal tract, and most infections are subclinical; but some types
range of diseases, including poliomyelitis (the etiologic agents are wild type polioviruses), aseptic men
encephalitis (caused by several types of coxsackieviruses and echoviruses), and chronic meningoence
several types of echoviruses).

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to epidemic parotitis (mump
of the genus Paramyxovirus, family Paramyxoviridae. This virus is the etiologic agent of epidemic paro
mumps), an infection characterized by swelling of one or both parotid glands that may also affect the
inflammation of the testes (orchitis), and affect the ovaries.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to epidemic parotitis (mump
of the genus Paramyxovirus, family Paramyxoviridae. This virus is the etiologic agent of epidemic paro
mumps), an infection characterized by swelling of one or both parotid glands that may also affect the
inflammation of the testes (orchitis), and affect the ovaries.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) n
a DNA virus of the family Herpesviridae. EBV may cause infectious mononucleosis and is closely assoc
diseases such as Burkitt's lymphoma and nasopharyngeal carcinoma.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) n
EBV is a DNA virus of the family Herpesviridae. EBV may cause infectious mononucleosis and is closel
malignant diseases such as Burkitt's lymphoma and nasopharyngeal carcinoma.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV) n
EBV is a DNA virus of the family Herpesviridae. EBV may cause infectious mononucleosis and is closel
malignant diseases such as Burkitt's lymphoma and nasopharyngeal carcinoma.
Serology reagents intended to detect antibodies to Hantavirus, the only member of the Bunyaviridae
arthropod transmitted. Some particular strains of this virus (Hantaan, Dobrava, Puumala) may cause h
renal syndrome; other strains (Sin Nombre, Bayou, Black Creek Canal, and New York) are the etiologic
pulmonary syndrome. Rodents are the usual carriers of Hantavirus.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Hantavirus, the only mem
Bunyaviridae family that is not arthropod transmitted. Some particular strains of this virus (Hantaan, D
cause hemorrhagic fever with renal syndrome; other strains (Sin Nombre, Bayou, Black Creek Canal, a
etiologic agents of Hantavirus pulmonary syndrome. Rodents are the usual carriers of Hantavirus.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Hantavirus, the only mem
Bunyaviridae family that is not arthropod transmitted. Some particular strains of this virus (Hantaan, D
cause hemorrhagic fever with renal syndrome; other strains (Sin Nombre, Bayou, Black Creek Canal, N
etiologic agents of Hantavirus pulmonary syndrome. Rodents are the usual carriers of Hantavirus.

Serology reagents intended to detect antibodies to Herpes simplex virus serotype 1 (HSV1), a DNA vir
Herpesviridae. HSV1 is transmitted mainly by infected saliva. HSV1 causes a variety of diseases, typic
infections, but may cause sexually transmitted genital infections. Activation of latent herpesvirus is as
malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpes simplex virus sero
virus of the family Herpesviridae. HSV1 is mainly transmitted by infected saliva. HSV1 causes a variet
nongenital infections, but may cause sexually transmitted genital infections. Activation of latent herpe
with some malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Herpes simplex virus sero
virus of the family Herpesviridae. HSV1 is mainly transmitted by infected saliva. HSV1 causes a variet
nongenital infections, but may cause sexually transmitted genital infections. Activation of latent herpe
with some malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect antigens to Herpes simplex virus serotype 1 (HSV1), a DNA virus
Herpesviridae. HSV1 is mainly transmitted by infected saliva. HSV1 causes a variety of diseases, typic
infections, but may cause sexually transmitted genital infections. Activation of latent herpesvirus is as
malignancies. Persistence of the virus for the lifetime of the host is common.

Serology reagents intended to detect antibodies to Herpes simplex virus serotype 2 (HSV2), a DNA vir
Herpesviridae. HSV2 is mainly sexually transmitted; it is an etiologic agent of a variety of conditions in
infections. Activation of latent herpesvirus is associated with some malignancies. Persistence of the vi
the host is common.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpes simplex virus sero
virus of the family Herpesviridae. HSV2 is mainly sexually transmitted; it is an etiologic agent of a var
including genital infections. Activation of latent herpesvirus is associated with some malignancies. Per
for the lifetime of the host is common.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Herpes simplex virus sero
virus of the family Herpesviridae. HSV2 is mainly sexually transmitted; it is an etiologic agent of a var
including genital infections. Activation of latent herpesvirus is associated with some malignancies. Per
for the lifetime of the host is common.
Serology reagents intended to detect antigens to Herpes simplex virus serotype 2 (HSV2), a DNA virus
Herpesviridae. HSV2 is mainly sexually transmitted; it is an etiologic agent of a variety of conditions in
infections. Activation of latent herpesvirus is associated with some malignancies. Persistence of the vi
the host is common.
Serology reagents intended to detect antibodies to Herpes simplex virus serotypes 1 and 2 (HSV1 and
DNA viruses of the family Herpesviridae. HSV1 is transmitted mostly by infected saliva and typically c
infections; HSV2 is frequently sexually transmitted and is the main etiologic agent of herpes genital in
latent herpesvirus is associated with some malignancies. Persistence of the virus for the lifetime of th

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpes simplex virus sero
and HSV2, respectively), DNA viruses of the family Herpesviridae. HSV1 is transmitted mostly by infec
causes nongenital infections; HSV2 is frequently sexually transmitted and is the main etiologic agent
infections. Activation of latent herpesvirus is associated with some malignancies. Persistence of the vi
the host is common.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Herpes simplex virus sero
and HSV2, respectively), DNA viruses of the family Herpesviridae. HSV1 is transmitted mostly by infec
causes nongenital infections; HSV2 is frequently sexually transmitted and is the main etiologic agent
infections. Activation of latent herpesvirus is associated with some malignancies. Persistence of the vi
the host is common.

Serology reagents intended to detect antigens to Herpes simplex virus serotypes 1 and 2 (HSV1 and H
DNA viruses of the family Herpesviridae. HSV1 is mostly transmitted by infected saliva and typically c
infections; HSV2 is frequently sexually transmitted and is the main etiologic agent of herpes genital in
latent herpesvirus is associated with some malignancies. Persistence of the virus for the lifetime of th

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpesvirus 6, a beta-herp


Roseolovirus. This virus may cause roseola infantum; it is also associated with bone marrow suppressi
encephalitis, encephalopathy, hepatitis, fever, and skin rash in immunocompromised patients.

Serology reagents intended to detect immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibod
beta-herpesvirus of the genus Roseolovirus This virus may cause roseola infantum; it is also associate
suppression, pneumonitis, encephalitis, encephalopathy, hepatitis, fever, and skin rash in immunocom

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpesvirus 7, a beta-herp


Roseolovirus. This virus is associated with roseola infantum and may be useful in the diagnosis of chro
especially when it is acting simultaneously with Herpesvirus type 6.

Serology reagents intended to detect immunoglobulin M (IgM) and/or immunoglobulin M (IgM) antibod
beta-herpesvirus of the genus Roseolovirus. This virus is associated with roseola infantum and may be
diagnosis of chronic fatigue syndrome, especially when it is acting simultaneously with Herpesvirus ty
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Herpesvirus 8, a double-st
herpesvirus found only in humans. This virus is associated with all types of Kaposi's sarcoma (KS) (inc
endemic, post transplant, and AIDS-related KS), all of which have identical histological features.

Serology reagents intended to detect antibodies to human metapneumovirus (hMPV), an RNA virus of
Paramyxoviridae. A wide spectrum of acute respiratory infections, especially in pediatric patients, is a

Serology reagents intended to detect and/or identify antigens or serum antibody titers to Influenza vir
stranded RNA virus of the family Orthomyxoviridae. Influenza A viruses may cause human influenza, a
by sudden onset of high fever, myalgia, headache, severe malaise, nonproductive cough, sore throat,
subtypes of influenza that affect humans are H1N1, H1N2, and H3N2; other subtypes such as H5 and
influenza) affect birds but may affect occasionally humans.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Influenza virus type A, a s
virus of the family Orthomyxoviridae. Influenza A viruses may cause human influenza, a disease chara
onset of high fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis
influenza known to affect humans are H1N1, H1N2, and H3N2; other subtypes such as H5 and H7 (i.e.
birds but may occasionally affect humans.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Influenza virus type A, a s
virus of the family Orthomyxoviridae. Influenza A viruses may cause human influenza, a disease chara
onset of high fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis
influenza known to affect humans are H1N1, H1N2, and H3N2; other subtypes such as H5 and H7 (i.e.
birds but may occasionally affect humans.

Serology reagents intended to detect antigens to Influenza virus type A, a single-stranded RNA virus o
Orthomyxoviridae. Influenza A viruses may cause human influenza, a disease characterized by sudden
myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis. Subtypes of influen
humans are H1N1, H1N2, and H3N2; other subtypes such as H5 and H7 (i.e., avian influenza) affect bi
occasionally affect humans.

Serology reagents intended to detect and/or identify antigens or serum antibody titers to Influenza vir
stranded RNA virus of the family Orthomyxoviridae. Influenza type B virus is an etiologic agent of influ
characterized by sudden onset of high fever, myalgia, headache, severe malaise, nonproductive coug
rhinitis.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Influenza virus type B, a s
virus of the family Orthomyxoviridae. Influenza type B virus is an etiologic agent of influenza, a diseas
sudden onset of high fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Influenza virus type B, a s
virus of the family Orthomyxoviridae. Influenza type B virus is an etiologic agent of influenza, a diseas
sudden onset of high fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and
Serology reagents intended to detect antigens to Influenza virus type B, a single-stranded RNA virus o
Orthomyxoviridae. Influenza type B virus is an etiologic agent of influenza, a disease characterized by
fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Japanese encephalitis viru
RNA virus of the family Flaviviridae. This virus may cause encephalitis and encephalomyelitis; it is usu
bite of infected mosquitoes.
Serology reagents intended to detect antibodies to La Crosse virus, a single-stranded RNA virus of the
This virus may cause encephalitis (California encephalitis) and encephalomyelitis; it is usually transmi
infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to La Crosse virus, a single-s
the family Bunyaviridae. This virus may cause encephalitis (California encephalitis) and encephalomye
transmitted by the bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to La Crosse virus, a single-s
the family Bunyaviridae. This virus may cause encephalitis (California encephalitis) and encephalomye
transmitted by the bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Parainfluenza type 1 virus
virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is an etiologic agent of parainflu
respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Parainfluenza type 1 virus
RNA virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is an etiologic agent of para
upper respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Serology reagents intended to detect antigens that permit the identification of Parainfluenza type 1 vi
RNA virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is an etiologic agent of para
upper respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Parainfluenza type 2 virus
virus of the genus Rubulavirus, family Paramyxoviridae. This virus is an etiologic agent of parainfluenz
respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Parainfluenza type 2 virus
RNA virus of the genus Rubulavirus, family Paramyxoviridae. This virus is an etiologic agent of parainfl
upper respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Serology reagents intended to detect antigens to Parainfluenza type 2 virus, a single-stranded RNA vir
Rubulavirus, family Paramyxoviridae. This virus is an etiologic agent of parainfluenza and several uppe
infections (e.g., bronchitis, pneumonia) of varying severity.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Parainfluenza type 3 virus
virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is an etiologic agent of parainflu
respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Parainfluenza type 3 virus
RNA virus of the genus Paramyxovirus, family Paramyxoviridae. This virus is an etiologic agent of para
upper respiratory tract infections (e.g., bronchitis, pneumonia) of varying severity.

Serology reagents intended to detect antigens to Parainfluenza type 3 virus, a single-stranded RNA vir
Paramyxovirus, family Paramyxoviridae. This virus is an etiologic agent of parainfluenza and several u
infections (e.g., bronchitis, pneumonia) of varying severity.
Serology reagents intended to detect antibodies to human Parvovirus B19, a single-stranded DNA viru
Parvoviridae. This virus may cause fifth disease (erythema infectiosum) and chronic bone marrow failu
immunocompromised patients.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to human Parvovirus B19, a
virus of the family Parvoviridae. This virus may cause fifth disease (erythema infectiosum) and chronic
in immunocompromised patients.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to human Parvovirus B19, a
virus of the genus Parvovirus, family Parvoviridae. This virus may cause fifth disease (erythema infect
bone marrow failure in immunocompromised patients.
Serology reagents intended to detect antibodies to poliovirus, a species of viruses of the genus Entero
Picornaviridae. Some types of polioviruses are the most common cause of poliomyelitis and poliomyel
Poliomyelitis may be nonparalytic, characterized by fever, sore throat, headache, and sometimes stiffn
back; or paralytic, characterized by involvement of the central nervous system, stiffness, and paralysi
atrophy of several groups of muscles.

Serology reagents intended to detect antibodies to poliovirus type 1, a virus of the genus Enterovirus,
Poliovirus type 1 is the most common cause of poliomyelitis and poliomyelitis epidemics. Poliomyelitis
characterized by fever, sore throat, headache, and sometimes stiffness of the neck and back; or paral
involvement of the central nervous system.
Serology reagents intended to detect antibodies to poliovirus type 2, a virus of the genus Enterovirus,
Poliovirus type 2 may cause poliomyelitis and poliomyelitis epidemics. Poliomyelitis may be nonparaly
fever, sore throat, headache, sometimes stiffness of the neck and back; or paralytic, characterized by
central nervous system, stiffness, and paralysis with subsequent atrophy of several groups of muscles

Serology reagents intended to detect antibodies to poliovirus type 3, a virus of the genus Enterovirus,
Poliovirus type 3 may cause poliomyelitis and poliomyelitis epidemics. Poliomyelitis may be nonparaly
fever, sore throat, headache, sometimes stiffness of the neck and back; or paralytic, characterized by
central nervous system, stiffness, and paralysis with subsequent atrophy of several groups of muscles

Serology reagents intended to detect antibodies to rabies virus, a bullet-shaped RNA virus of the genu
Rhabdoviridae. This virus is the etiologic agent of rabies, a disease characterized by the infection of th
system, causing encephalopathy, convulsions, paralysis, and coma.
Serology reagents intended to detect antigens to rabies virus, a bullet-shaped RNA virus of the genus
Rhabdoviridae. This virus is the etiologic agent of rabies, a disease characterized by the infection of th
system, causing encephalopathy, convulsions, paralysis, and coma.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to respiratory syncytial virus
RNA species of the genus Pneumovirus, family Paramyxovirus. Several types of RSV are etiologic agen
tract infections; they are the most common cause of bronchiolitis and pneumonia among infants.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to respiratory syncytial virus
RNA species of the genus Pneumovirus, family Paramyxovirus. Several types of RSV are etiologic agen
tract infections; they are the most common cause of bronchiolitis and pneumonia among infants.

Serology reagents intended to detect antibodies to Saint Louis encephalitis virus, a single-stranded RN
Flaviviridae. This virus may cause encephalitis and encephalomyelitis; it is usually transmitted by the
mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Saint Louis encephalitis vi
RNA virus of the family Flaviviridae. This virus may cause encephalitis and encephalomyelitis; it is usu
bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Saint Louis encephalitis v
RNA virus of the family Flaviviridae. This virus may cause encephalitis and encephalomyelitis; it is usu
bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to identify severe acute resp
(SARS)-associated Coronavirus, an RNA Coronavirus of the family Coronaviridae that is genetically and
from other human coronaviruses. This virus is the etiologic agent of SARS and viral pneumonia.

Serology reagents intended to detect antibodies to vaccinia virus, a virus of the genus Orthopoxvirus
nature (it is propagated only in the laboratory for use as an active vaccine against smallpox). Vaccinia
reactions in healthy persons when used as a live-virus inoculator against smallpox; vaccinia smallpox
contain and cannot cause smallpox, but approximately one in one million individuals will develop an a
response to the vaccination.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to Venezuelan equine encep
Alphavirus of the family Togaviridae. This virus may cause mild flu-like illness, encephalitis, and encep
usually transmitted by the bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to Venezuelan equine encep
Alphavirus of the family Togaviridae. This virus may cause mild flu-like illness, encephalitis, and encep
usually transmitted by the bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to West Nile virus, a single-s
the family Flaviviridae. This virus may cause encephalitis and encephalomyelitis; it is usually transmit
infected mosquitoes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to West Nile virus, a single-s
the family Flaviviridae. This virus may cause encephalitis and encephalomyelitis; it is usually transmit
infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to western equine encephali
of the family Togaviridae. This virus may cause mild flu-like illness, encephalitis, and encephalomyeliti
transmitted by the bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to western equine encephali
of the family Togaviridae. This virus may cause mild flu-like illness, encephalitis, and encephalomyeliti
transmitted by the bite of infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to yellow fever virus, a single
Arbovirus of the genus Flavivirus, family Flaviviridae. This virus causes yellow fever, an acute infection
is characterized by fever, liver damage and jaundice, hemorrhage, and kidney damage; it is usually tr
of infected mosquitoes.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to yellow fever virus, a singl
Arbovirus of the genus Flavivirus, family Flaviviridae. This virus causes yellow fever, an acute infection
is characterized by fever, liver damage and jaundice, hemorrhage, and kidney damage; it is usually tr
of infected mosquitoes.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to the Toxoplasma gondii par
cytomegalovirus, or herpes simplex viruses. Detection of any of these antibodies may indicate current
exposure to any of these microorganisms.
Serology reagents intended to detect immunoglobulin M (IgM) antibodies to the Toxoplasma gondii pa
cytomegalovirus, or herpes simplex viruses. Detection of any of these antibodies may indicate current
exposure to any of these microorganisms.
Molecular assay reagents intended to identify Blastomyces dermatitidis, a species of imperfect fungi o
Moniliaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the t
These fungi may cause self-limited or localized pulmonary lesions; immunocompromised patients may
progressive illnesses affecting the skin or (e.g., lungs, genitourinary tract, central nervous system).

Molecular assay reagents intended to identify the genus Candida, a yeast-like species of imperfect fun
Cryptococcaceae, by detecting specific nucleic-acid information (e.g., DNA, RNA) of the target microor
of Candida may cause candidiasis, a superficial mycotic infection of the moist cutaneous areas of the
also infect the blood stream (i.e., deep candidiasis), especially in immunocompromised patients.

Molecular assay reagents intended to identify Candida albicans, a species of a yeast-like species of im
family Cryptococcaceae, by detecting specific genetic information of deoxyribonucleic acid (DNA) of t
microorganism. Candida albicans fungi are part of the normal flora of the skin, mouth, intestinal tract,
cause candidiasis, a mycotic superficial infection of the moist cutaneous areas of the body. The fungi m
blood stream (i.e., deep candidiasis), especially in immunocompromised patients.

Molecular assay reagents intended to identify species of the genus Candida, a yeast-like species of im
family Cryptococcaceae, by detecting specific genetic information of deoxyribonucleic acid (DNA) of t
microorganism. Candida fungi are part of the normal flora of the skin, mouth, intestinal tract, and vag
candidiasis, a mycotic superficial infection of the moist cutaneous areas of the body. The fungi may al
stream (i.e., deep candidiasis), especially in immunocompromised patients.

Molecular assay reagents intended to identify Coccidioides immitis, a species of imperfect fungi of the
detecting specific genetic information of the deoxyribonucleic acid (DNA) of the target microorganism
cause coccidiomycosis, a mycotic infection of the respiratory tract characterized by allergic manifesta
to a virulent, severe, chronic granulomatous disease involving tissue, viscera, and the central nervous
immunocompromised patients.

Molecular assay reagents intended to identify Coccidioides immitis, a species of imperfect fungi of the
detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the target microorga
cause coccidiomycosis, a mycotic infection of the respiratory tract characterized by allergic manifesta
to a virulent, severe, chronic granulomatous disease involving tissue, viscera, and the central nervous
immunocompromised patients.
Molecular assay reagents intended to identify Cryptococcus neoformans, a yeast-like species of imper
Cryptococcaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of
microorganism. These fungi may cause cryptococcosis, a mycotic infection of the brain and meninges
involve other organs such as the skin and lungs. The disease may progress by invading the central ne
liver, and spleen of immunocompromised patients.

Molecular assay reagents intended to identify Histoplasma capsulatum, a yeast-like species of imperfe
Moniliaceae, by detecting specific genetic information of the deoxyribonucleic acid (DNA) of the targe
Histoplasma capsulatum fungi may cause histoplasmosis, a mycotic influenza-like infection or pneumo
progress by invading the lungs, meninges, heart, and peritoneum of immunocompromised patients.

Molecular assay reagents intended to identify Histoplasma capsulatum, a yeast-like species of imperfe
Moniliaceae, by detecting specific genetic information of the ribosomal ribonucleic acid (rRNA) of the t
Histoplasma capsulatum fungi may cause histoplasmosis, a mycotic influenza-like infection or pneumo
progress by invading the lungs, meninges, heart, and peritoneum of immunocompromised patients.

Molecular assay reagents intended to identify Pneumocystis jiroveci (formerly known as Pneumocystis
yeast-like species of imperfect fungi of the family Pneumocystidaceae, by detecting specific nucleic-ac
DNA, RNA) of the target microorganism. P. jiroveci fungi are opportunistic pathogens of the respiratory
immunocompromised patients.
Molecular assay reagents intended to identify Pneumocystis jiroveci (formerly known as Pneumocystis
yeast-like species of imperfect fungi of the family Pneumocystidaceae, by detecting specific genetic in
deoxyribonucleic acid (DNA) of the target microorganism. P. jiroveci fungi are opportunistic pathogens
tract, especially in immunocompromised patients.
Microbiology reagents intended to identify Blastomyces dermatitidis, a species of imperfect fungi of th
Blastomyces dermatitidis may cause self-limited or localized pulmonary lesions (blastomycosis); affec
immunocompromised patients may develop a chronically progressive illness in the skin and/or organs
genitourinary tract, central nervous system).
Microbiology reagents intended to identify species of the genus Candida, a yeast-like species of imper
Cryptococcaceae. Candida species fungi are part of the normal flora of the skin, mouth, intestinal trac
species may cause superficial infection of the moist cutaneous areas of the body (i.e., candidiasis). Th
the blood stream (i.e., deep candidiasis), especially in immunocompromised patients.

Microbiology reagents intended identify species of the genus Pneumocystis, a yeast-like species of im
family Pneumocystidaceae. Pneumocystis jiroveci are opportunistic pathogens of the respiratory tract,
immunocompromised patients. Pneumocystis carinii is another species of this genus, but it is not belie
humans.
Microbiology reagents intended to identify Pneumocystis jiroveci (formerly known as Pneumocystis ca
yeast-like species of imperfect fungi of the family Pneumocystidaceae, that parasitize the human resp
is an opportunistic pathogen of the respiratory tract, especially in immunocompromised patients.

Microbiology reagents intended to identify fungi of more than one genera and/or species in clinical lab
can typically detect fungi of the genera Aspergillus, Blastomyces, Coccidioides, and Histoplasma.
Multifungi microbiology reagents intended to identify a variety of genera and/or species of fungi/yeast
tests using automated analyzers. The tests can typically detect fungi of the genera Aspergillus, Blasto
and Histoplasma.
Multifungi microbiology reagents intended to identify a variety of genera and/or species of fungi/yeast
tests using manual analyzers. The tests can typically detect fungi of the genera Aspergillus, Blastomy
Histoplasma.
Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of fungi of the gen
imperfect fungi of the class Hyphomycetes. Some species of Blastomyces may cause self-limited or lo
lesions (blastomycosis); affected immunocompromised patients may develop a chronically progressive
and/or organs (e.g., lungs, genitourinary tract, central nervous system).

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of fungi of the ge
imperfect fungi of the class Hyphomycetes. Some species of Blastomyces may cause self-limited or lo
lesions (blastomycosis); affected immunocompromised patients may develop a chronically progressive
and/or organs (e.g., lungs, genitourinary tract, central nervous system).

Serology reagents intended to detect antigens to strains of species of the genus Blastomyces, imperfe
Hyphomycetes. Some species of Blastomyces may cause self-limited or localized pulmonary lesions (b
immunocompromised patients may develop a chronically progressive illness in the skin and/or organs
genitourinary tract, central nervous system).
Serology reagents intended to detect toxins, antigens, or antibodies to species of the genus Candida,
fungi of the family Cryptococcaceae. Candida species fungi are part of the normal flora of the skin, mo
and vagina; some species may cause superficial infection of the moist cutaneous areas of the body (i.
fungi may also infect the blood stream (i.e., deep candidiasis), frequently in immunocompromised pat

Serology reagents intended to detect immunoglobulin A (IgA) antibodies to species of the genus Cand
imperfect fungi of the family Cryptococcaceae. Candida fungi are part of the normal flora of the skin, m
and vagina; some species may cause superficial infection of the moist cutaneous areas of the body (i.
fungi may also infect the blood stream (i.e., deep candidiasis), frequently in immunocompromised pat

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to species of the genus Cand
imperfect fungi of the family Cryptococcaceae. Candida fungi are part of the normal flora of the skin, m
and vagina; some species may cause superficial infection of the moist cutaneous areas of the body (i.
fungi may also infect the blood stream (i.e., deep candidiasis), frequently in immunocompromised pat

Serology reagents intended to detect immunoglobulin M (IgM) antibodies to species of the genus Cand
imperfect fungi of the family Cryptococcaceae. Candida fungi are part of the normal flora of the skin, m
and vagina; some species may cause superficial infection of the moist cutaneous areas of the body (i.
fungi may also infect the blood stream (i.e., deep candidiasis), frequently in immunocompromised pat

Serology reagents intended to detect antigens to strains of species of the genus Candida, yeast-like im
family Cryptococcaceae. Candida fungi are part of the normal flora of the skin, mouth, intestinal tract,
species may cause superficial infection of the moist cutaneous areas of the body (i.e., candidiasis). Th
the blood stream (i.e., deep candidiasis), frequently in immunocompromised patients.
Serology reagents intended to detect immunoglobulin A (IgA) antibodies to Coccidioides immitis, a spe
of the family Moniliaceae. Coccidioides immitis is a pathogen of the respiratory tract, frequently causi
manifestations; these fungi may also cause coccidiomycosis and/or fungal pneumonia.

Serology reagents intended to detect immunoglobulin E (IgE) antibodies to Coccidioides immitis, a spe
of the family Moniliaceae. Coccidioides immitis is a pathogen of the respiratory tract, frequently causi
manifestations; these fungi may also cause coccidiomycosis and/or fungal pneumonia.

Serology reagents intended to detect antigens or antibodies to species of the genus Cryptococcus, ye
of the family Cryptococcaceae. Some Cryptococcus species fungi are pathogenic; infection may involv
more typically, brain membranes, especially in immunocompromised patients.

Serology reagents intended to detect antibodies to species of the genus Cryptococcus, yeast-like impe
family Cryptococcaceae. Some Cryptococcus species fungi are pathogenic; infection may involve the s
typically, brain membranes, especially in immunocompromised patients.
Serology reagents intended to detect antigens to strains of species of the genus Cryptococcus, yeast-
the family Cryptococcaceae. Some Cryptococcus species fungi are pathogenic; infection may involve t
more typically, brain membranes, especially in immunocompromised patients.

Serology reagents intended to detect immunoglobulin G (IgG) antibodies to strains of Histoplasma cap
species of imperfect fungi of the family Moniliaceae. Histoplasma capsulatum infection (histoplasmosi
asymptomatic, but can cause an influenza-like illness or pneumonia. These fungi can affect the lungs,
other organs in immunocompromised patients.
Serology reagents intended to detect antibody titers or antigens to Pneumocystis jiroveci (formerly kn
carinii sp. hominis), yeast-like imperfect fungi of the family Pneumocystidaceae. P. jiroveci is an oppor
the respiratory tract, especially in immunocompromised patients.
Serology reagents intended to detect antigens to of Pneumocystis jiroveci (formerly known as Pneumo
hominis), yeast-like imperfect fungi of the family Pneumoncystidacae. P. jiroveci is an opportunistic pa
respiratory tract, especially in immunocompromised patients.
Systems designed for communication between staff members or staff and patients, as well as for the
healthcare facility. These systems consist of a central communication station with a power supply and
and means to interconnect individual devices (e.g., telephones, pagers, loudspeakers) for transmissio
voice, messages, and/or pictures. Hospital communication systems may transmit signals using wires o
using electromagnetism (e.g., radiofrequency, microwaves) through the air (i.e., wireless). Dedicated
patient/staff communication (e.g., nurse call systems, pagers), interstaff communication (e.g., telepho
and/or general public announcements (e.g., loudspeaker systems) are available.

Hospital communication systems designed to provide voice (i.e., telephonic) communication between
between staff and individual patients via wire or radiated electromagnetic (i.e., wireless) signals. Thes
consist of a central exchange console including a switching device that allows communication with ea
supplies, interconnecting wiring or electromagnetic (e.g., radiofrequency, microwave) signal transmiss
antennas and telephone sets. Hospital telephonic communication systems may have capabilities for s
visual displays); they are used to provide routine and emergency voice communication.
Hospital communication systems designed to provide voice (i.e., telephonic) communication between
between staff and individual patients through radiated electromagnetic (i.e., wireless) signals. These s
consist of a central exchange console including a switching device that allows communication with ea
supplies, electromagnetic (e.g., radiofrequency, microwave) signal transmission, and reception device
sets (e.g., handsets, badge-like devices) including appropriate antennas. Hospital telephonic commun
have capabilities for sending messages (e.g., visual displays); they are used to provide routine and em
communication.

Hospital communication systems designed to page, summon, or locate staff members via radiated ele
wireless) signals. These systems typically consist of a central transmission unit including a switching d
communication with each user, power supplies, electromagnetic (e.g., radiofrequency, microwave) sig
appropriate antennas and portable reception devices (i.e., pagers, badges) that are carried by membe
and that attract their attention with an audible, tactile, or visual signal. Hospital paging communicatio
used to deliver a brief message to the individuals carrying receivers; the systems include capability fo
emergency paging and/or confidential messaging to staff members.

Hospital communication systems designed to page, summon, or locate people and to provide voice (i.
communication between staff members and/or between staff and individual patients through radiated
wireless) signals. These systems typically consist of a central transmission unit including a switching d
communication with each user, power supplies, electromagnetic (e.g., radiofrequency, microwave) sig
appropriate antennas and reception devices such as telephone sets (e.g., handsets, badge-like device
capabilities. Hospital paging/wireless telephone communication systems may include visual displays t
messages and audible, tactile, or visual signals to attract the user's attention when a message is rece
routine and emergency voice communication and paging capabilities.

Cardiology data management information systems designed to record, process, and display informatio
clinical and administrative management of a patient based on electrocardiography (ECG) waveform st
include hardware and software to collect, process (e.g., waveform magnification and/or superposition,
integrate, and retrieve information from electrocardiographic signals that may be taken under differen
stress exercise testing, ambulatory data, pacemaker events), usually providing interpretative stateme
management information systems help physicians establish a comprehensive evaluation of a patient's
systems may function as stand-alone systems or may be integrated in a hospitalwide data manageme
network.

Data management information systems designed to record, process, and display comprehensive integ
management, financial, and clinical information related to the provision and utilization of hospitalwide
The systems are capable of producing clinical and financial reports, patient data, and/or customized re
These systems can support the management of a variety of administrative (e.g., materials manageme
cost accounting, billing reimbursement, human resources), patient data (e.g., medical records,
admission/discharge/transfer), and clinical (e.g., radiology, cardiology, pharmacy, laboratory) tasks of
Integrated hospital information systems (IHISs) are usually available as a combination of hardware (e.
including workstations, servers, and links) and firmware and/or software. IHISs may be installed as a c
assembled by integrating independent information systems already installed in the healthcare facility.
Hospital data management information systems designed to provide a common patient database for u
healthcare facility (i.e., a master patient index or MPI). These systems typically establish a patient rec
for each patient during the patient's first visit (regardless of the type of visit or admission). The comm
through the entire healthcare facility independent of any records created for a specific hospital depart
information systems include hardware (e.g., a local network including workstations, servers, and links
software; they may be operated as stand-alone systems or can be assembled into an integrated hospi
system.

Data management information systems designed to record, process, and display comprehensive infor
patient admission, discharge, and transfer throughout the healthcare facility. These systems typically
display information regarding the sequence of procedures performed on a patient from his/her admiss
independent of any particular record specific to a hospital department. Admission/discharge/transfer h
systems include hardware (e.g., a local network including workstations, servers, and links) and firmwa
they may be operated as stand-alone systems or can be assembled in an integrated hospitalwide info
network.

Data management information systems designed to record, process, and display financial data of a he
systems consist of hardware, including computerized workstations and peripheral devices (e.g., high-c
devices) that are usually connected as a local area network (LAN), as well as software specifically inte
collection, analysis, and budget strategy. These systems can automate procedures such as general an
accounting, invoice payments, leasing, and expense accounting. Financial data management informat
the analysis, planning, and forecasting of healthcare facility finances; dedicated systems and/or softw
manage accounts receivable/payable, financial analysis/planning, and ledgers are also available. Finan
systems may function as stand-alone systems or may be integrated in a hospitalwide data manageme
network.

Information systems designed to record, process, and display data related to the rules and terminolog
episode codes (i.e., coding) and the appropriate reimbursement calculations. These systems consist o
computerized workstations and peripheral devices such as high-capacity storage devices and printers
packages specifically intended for coding and filing reimbursement claims according to guidelines, rul
Coding/reimbursement data management information systems streamline and improve the accuracy o
billing (i.e., reimbursement). These information systems may function as stand-alone systems or may
hospitalwide data management information system network.

Information systems designed to record, process, and display data related to human resources, autom
as payroll, personnel performance, and/or compensation. These systems consist of hardware, includin
workstations and peripheral devices such as high-capacity storage devices and printers, as well as sof
specifically intended for administration and analysis of personnel benefits, payroll, recruiting, perform
compensation. Human resources data management information systems are intended to streamline a
accuracy of managing the core functions of human resources departments; they may function as stan
may be integrated in a hospitalwide data management information system network.
Information systems designed to manage scheduling and resource data of a healthcare facility. These
hardware, including computerized workstations and peripheral devices such as high-capacity storage
and software packages. The systems are specifically intended for scheduling all patient-related activit
facility, synchronizing patient, staff, procedures (e.g., laboratory, surgery), and resource (e.g., surgica
allocation at a given time, and providing appropriate reports. Centralized scheduling data managemen
are intended to streamline and improve coordination of patients, staff, and resources of a healthcare f
function as stand-alone systems or may be integrated in a hospitalwide data management information

Information systems designed to record, process, and display patient electronic health records at a he
(i.e., a longitudinal record); aggregating patient data from various departmental systems. These syste
hardware, including computerized workstations and peripheral devices such as high-capacity storage
and software packages. The systems are intended to automate the retrieval and review of clinical info
planning care, and documentation; they may also include decision support capabilities, drug database
(e.g., medication administration warnings), and the ability to capture practitioner's notes in several fo
departmental electronic medical records. Health record information systems are intended to provide u
patients, including activities performed in physician offices, hospital departments, and in other health
may function as stand-alone systems or may be integrated in hospitalwide data management informa

Information systems designed to record, process, and display clinical and administrative information r
(both data and images) of the treatment of cancer patients. These systems typically consist of hardwa
computerized workstations and peripheral devices such as high-capacity storage devices and printers
connected as a local area network (LAN), and software packages (e.g., radiology, surgery, chemothera
management systems can be used for patient registration, result reporting, film library management,
tracking, patient scheduling, and administrative tasks such as billing and accounting procedures; they
treatment history, test results, and previous reports. Oncology data management information systems
data from surgical, chemotherapy, and radiotherapy treatments and/or procedures; dedicated system
only radiotherapy information are available. The systems may function as stand-alone systems or may
hospitalwide data management information system network.

Picture archiving and communication systems (PACS) designed to store and retrieve digital images fro
catheterization laboratories and other cardiac digital imaging systems, including radiography, comput
magnetic resonance imaging, nuclear cardiology, and ultrasound (echocardiography). These systems
computer that controls image capture and display, networking, storage, retrieval, and printer output,
display workstations that allow database management, measurements, and quantification (e.g., steno
diameter) and include high-resolution displays and printers. Cardiology PACS permit simultaneous acc
images for surgeons, referring physicians, and emergency room personnel.
Workstations designed to acquire, process, and store digital data related to hemodialysis treatments a
workstations typically store and process patient and treatment data, send treatment parameters to th
machines, and provide complete patient prescription, treatment, and related data. Hemodialysis work
include a high-capacity digital computer, printers, input and output devices, and processors; they usu
instructions of specialized software intended for management of hemodialysis procedures. They are fr
component of or interact with hemodialysis machines and/or hospital information systems; some work
capabilities for management of peritoneal dialysis procedures.

Printers designed to produce monochromatic and, less frequently, color text and/or graphics on paper
self-adhesive) labels and/or cards; label printers may work as a computer-controlled peripheral. These
include a thermal head that may transfer ink from a ribbon to the label (thermal transfer printer) for a
perform temporary (up to a year) printing on heat-sensitive paper (direct thermal printer); label printe
special feeding mechanisms to manipulate multiple labels provided either in tear sheets or in rolls. La
healthcare facilities to mark laboratory samples, for patient and/or equipment identification, and for o
dedicated label printers intended to print bar-code labels are also available.

Epidural injection needles designed to provide needlestick protection during and following insertion an
needle in the space that separates the spine's outermost membrane (dura mater) from the enclosing
cord (i.e., epidural space). Protective epidural injection needles usually include some manually and/or
activated mechanism (e.g., a safety clip located in the hub of the catheter) intended to shield the nee
some other means, to reduce possibility of contact between the healthcare provider and the sharp ne

Bone Tamps with balloons designed to enlarge a hole into the bone cavity. Inflatable bone tamps are
in the cancellous bone in an orthopedic procedure (i.e. kyphoplasty). These instruments usually includ
balloon which is inserted into the intra-vertebral space and then is inflated to create a vertebral cavity
guidance. Then the balloon is removed and the cavity is filled with bone cement. Inflatable bone tamp
reduce the compression fractures (e.g., spinal fracture).

Plunger syringes designed to inject fluid (typically contrast media) to the balloon of a bone cavity dila
a bone tamp) to increase the volume of the balloon. These syringes usually consist of a plastic barrel,
pressure gauge or pressure markings used to measure the resistance of the bones to the expansion o
tamp inflation syringes are sterile and single use.
Drainage bags designed to collect, and in some cases, measure cerebrospinal fluid (CSF) that has bee
body. These devices usually consist of sterile plastic bags connected via sterile tubing to a catheter (e
catheter, lumbar catheter) that has been inserted into areas such as the lateral ventricles of the brain
subarachnoid space. CSF drainage bags are typically used in conjunction with other components of an
drainage system to drain CSF in various situations where drainage of CSF is warranted, for example, t
pressure (ICP) or cerebral perfusion pressure (CPP) following certain types of surgery, following an acu
manage certain conditions (e.g., hydrocephalus).

Floor mats designed to prevent people from slipping or sliding. These mats are usually flat synthetic o
non-slipping polymeric materials or with a non-slipping contact surface layer (e.g., by incorporating sm
cups) permanently attached at the bottom; the mats are typically oil and/or grease resistant. Antiskid
variety of uses including assisting in patient transfer and preventing slipping in bathtubs and vehicle fl
Strips designed to help to prevent people from slipping and falling in any area with smooth and slippe
devices usually include strips made of anti-skidding materials and backed with pressure sensitive adh
surfaces (e.g., floors, mats). They can usually resist grease, oil, and water. Antiskid strips may be insta
places, such as bathtubs, staircases, and kitchen floors.
Prepacked collection of materials and supplies needed to perform ophthalmic frontalis suspension surg
These kits typically include solid silicone rods (40 cm/16 inch in length and .80 mm/.032 inch in diame
suspension materials, steel needles attached to the rod, and silicone sleeves to secure the rods. Front
mainly used in frontalis suspension surgery to treat patients with ptosis and poor levator muscle (eyel

Leads designed to conduct electrical pacing signals from the pulse generating unit of an external card
heart; some leads may also transmit the bioelectric cardiac signals back to the unit. These leads typic
wires that are completely isolated except at the electrode tip. Pacemaker leads are configured accordi
characteristics and/or the technique used for signal delivery to the heart. Leads used with external pa
either invasive (typically transvenous or transesophageal); non-invasive which applies the electrodes
transcutaneous); or attached directly to the myocardium in open surgery procedures. A variety of lead
single- and multiple-lead, subcutaneous array, and patch is available. Lead size, connector type, and o
the leads must be compatible with the pulse generator and the therapy prescribed. External cardiac p
used in temporary procedures (e.g., surgery, emergency, electrophysiology studies).

Devices designed to assist people in putting on/adjusting their clothing when their reach, dexterity, or
limited or compromised due to medical condition/physical impairment. These aids come with different
the intended function. Dressing aids are used by people suffering from a variety of conditions includin
recent surgery, arthritis, and/or neuropathies. Dedicated dressing aids designed to help people to put
stockings and socks, or to button and zipper their clothes are available.

Rings designed to fit around laboratory glassware (e.g., flasks) for stabilization when the glassware is
These devices usually consist of rings made of lead and covered with vinyl or PVC to avoid scratching
rings can be open or closed loop devices; they are available in different sizes and weights according to
diameter and the intended use (e.g., water bath).
Prepackaged collections of the devices and supplies (either custom or standard) needed for draining t
that is made by the liver and stored in the gallbladder (i.e., bile). Items in these kits usually include a
dressing, gauze, alcohol swabs, gloves, and clamps; frequently the kits also include the appropriate ca
be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a b
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Typically one end of the drainage catheter is inserted into the biliary bladder or ducts to stay there an
connected to an external drainage bag permanently or temporarily. Biliary drainage procedure kits an
external drainage of bile.
Devices designed to match (i.e., adapt) the electric requirements of small, usually portable, equipmen
and/or frequency. These devices typically consist of an electric transformer and other electric and/or e
and one or more integral or detachable plugs that match the outlet standards in different areas (e.g.,
Continental Europe, Japan, Australia, and UK). Electric voltage and/or frequency adapters that switch f
another automatically by recognizing the line supply voltage (110/120 V or 220/240V) and frequency
manual adapters that have to be switched manually by the user are available. Dedicated adapters int
types of equipment (e.g., radio and TV receivers, shavers, hair clippers) are also available.

Thin, soft, absorbent sheets of paper that are suitable for use on/around the face, e.g., the nose, eyes
tissues are typically supplied in multiple-use dispenser packs of prefolded tissues, with each tissue de
sheet intended for single-use. They have a range of common applications, e.g., for capturing/absorbin
tears, etc.
Measuring instruments designed to measure the cohesive energy present at an interface; the instrum
measure the surface tension between a liquid and air and/or the interfacial tension between the boun
Other tensiometers are intended to measure the surface tension between a liquid and a solid (also kn
meters). There are several methods to measure the surface tension between a liquid and air and/or th
between two liquids; the most common techniques are: (1) force tensiometers, instruments that meas
submerged in the liquid from the liquid to the air or between the common surface of two liquids and m
needed to break through the surface (that is related to the surface tension). A variant of the method u
placed but not submerged in the liquid) is also available. Force tensiometers are mainly used to deter
tensions or substances such as oils, detergents, and other chemicals. (2) Instruments that are based i
between liquid heights in a capillary tube to the surface tension and (3) tensiometers intended to mea
tension between a liquid and a solid are based in the measurement of the angle between a liquid drop
usually employing optical techniques; they are mainly used to determine the wettability of surfaces w
surfactants, ink adhesion, and materials before coating. Some instruments employing other techniqu
pressure) are also used for these measurements.

Endoscope sleeves designed to cover and sterilize the endoscope in the operating field. These device
sleeve filled with sterile fluid into which the instrument is placed, with one end made of a thin membr
the endoscope. These devices are single use and disposable.
Caps designed to deliver shampoo to the hair without the need to rinse. These devices usually include
is pre-moistened with rinse-free shampoo and conditioner. Shampoo caps are mainly used when a wat
convenient (e.g., for a patient who is confined in bed).
Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
surgery. Items in these kits usually consist of surgical instruments (e.g., knives, forceps) appropriate to
procedure and/or technique; the kits may also include supplies (e.g., plastic and/or metal plates, screw
are frequently supplied in supporting trays (i.e., procedure trays) consisting of a metal or plastic flat-b
with a border around the periphery supporting all the instruments and supplies needed for the proced
usually covered or wrapped. Spinal surgery kits and trays are intended for spinal open or minimally in
hospital and outpatient facilities; dedicated kits are available for particular procedures such as surgery
diseases (e.g., herniated discs), kyphosis treatment, and spinal cord traumatic injuries.
Devices designed to provide an interface for delivering noninvasive ventilation (i.e., ventilations that a
invasively via endotracheal tubes or tracheostomy tubes) between the patient and the ventilator. The
consist of a transparent plastic shell that encloses the patient's head, two straps to hold the hood in p
preventing suffocation, and tubing ports for connecting the inspiratory and expiratory tubes, feeding t
These devices are available in different sizes. Ventilation hoods are mainly used to provide noninvasiv
the management of acute or chronic respiratory failure for patients in ICU, emergency department or

Reagents used in tests performed on the skin to identify substances that produce an allergic reaction
allergens). Typically, a small amount of the suspected allergy substance (i.e., the allergen or "test reag
skin (usually on the forearm or back) and introduced under the skin by scratching or pricking the skin
The skin is observed for about 20 minutes; the test is considered positive (probable allergy) if redness
swelling is present. These reagents may be also injected under the skin (intracutaneous), using a sma
the skin, usually mixed with a nonallergenic material in aluminum discs that are typically placed on th
covered with tape for longer periods (typically 48 hours) to determine allergic contact dermatitis (i.e.,
test reagents are used mainly to determine specific substances that cause respiratory (e.g., dust, poll
seafood) allergies, but they are also used to test for allergies to drugs (e.g., penicillin) or to products (

Vascular catheters designed to cool and/or rewarm a patient by circulating a liquid (e.g., saline) in a cl
through the catheter. These catheters control the patient's core temperature (typically from 32 to 37 d
99 degrees Fahrenheit]) by heat exchange between the blood and the saline through the wall of a ball
of fluids into the body or drawing blood. These catheters are usually inserted percutaneously through
the inferior vena cava. They usually include a balloon or other flexible heat-exchange element and tem
provide feedback appropriate to adjust the temperature of the cooling or warming solution that is circ
console. Dedicated catheters are available for short-term (e.g., a few hours) or longer-term (e.g., a we
temperature control; some catheters include several lumens and can also be used as standard centra
Cooling/warming vascular catheters are intended to induce hypothermia, maintain normothermia, and
are used during surgery and recovery to preserve cerebral function in patients with brain injuries, afte
care of patients with septicemia, and in other intensive care procedures.

Structures suspended from the ceiling, secured to the floor, or securely attached to the wall that are d
and support hospital utility services (e.g., electricity, gas) and medical devices. Structures that are sel
are also available. These booms typically consist of a ceiling-, wall-, or floor-mounted structure, or free
consists of a support system, a pendant head, and an equipment carrier; they may include medical ga
inlets, electric power outlets, communication systems, medical device support brackets, and attachme
canisters and intravenous solution hangers. Facility booms are usually installed in operating rooms, in
cardiac catheterization laboratories, interventional radiology suites, emergency rooms, and other hea
dedicated booms intended to support operating microscopes are also available.
Facility booms designed to be suspended from the ceiling and intended to organize and support hospi
electricity, gas) and medical devices. These booms typically consist of a ceiling fixture support system
movable arms, a pendant head, and an equipment carrier. Single support arms allow rotation of the pe
also allow vertical involvement; double movable arms extend the pendant's range. The booms may in
outlets, vacuum inlets, electric power outlets, communication systems, medical device support bracke
such as suction canisters and intravenous solution hangers. Ceiling-mounted facility booms are usuall
rooms, intensive care units, emergency rooms, and other healthcare areas; dedicated booms intended
microscopes are also available.

Facility booms designed to be suspended from a structure attached to the wall and intended to organi
utility services (e.g., electricity, gas) and medical devices. These systems typically consist of a structu
the floor and walls with minimal ceiling support and telescopic single or double supported arms; they
gas outlets, vacuum inlets, electric power outlets, communication systems, medical device support br
attachments such as suction canisters and intravenous solution hangers. The arms of the system can
wall when not in use to provide extra space in the room; the system provides enough flexibility to plac
convenient position in the room. Wall-mounted facility booms are usually installed in intensive care un
care units, emergency rooms, and other healthcare areas; dedicated systems intended for specific are
units) are available.

Video colonoscopes designed with integrated optical scanning laser microscopy capabilities. These co
the components of a standard video colonoscope (i.e., external sheath, fiberoptic cable, image detect
coupled device [CCD]) and an integrated confocal microscopy system that consists of a miniature mic
diameter of a few millimeters) located at the tip of the endoscope, a fiberoptic light cable to transmit
tissue, an external confocal image data processor with appropriate software, and a confocal monitor t
microscopic image. Confocal microscopy video colonoscopes are intended for high-resolution (typically
histology assessments of both the surface mucosa and horizontal slices below the surface of the colon
gastrointestinal tract sections; they can also perform all the other diagnostic and therapeutic function
colonoscopes.

Manometers designed to measure the pressure inside a vascular aneurysm using a radiofrequency (RF
implanted in the aneurysm sac created by a stent-graft implanted to repair the aneurysm; the sac is e
circulation during the procedure. The device consists of a portable or cart-mounted console, which inc
an antenna, electronic circuits, and a monitor; the console works with a sensor/transducer that is usua
aneurysm sac at the same time as the stent-graft. The console antenna transmits RF energy to the tra
variable resonant frequency according to the pressure in the aneurysm sac; the frequency of the feed
the transducer to the console is displayed as a value of pressure in the console monitor. RF vascular a
are used during endovascular procedures to repair vascular aneurysms (typically abdominal aortic ane
the aneurysm sac pressure values before and after the exclusion of the sac from circulation during an
facilitates the detection of internal leaks (e.g., type I endoleaks).
Manometers designed to measure the pressure inside a vascular aneurysm using an ultrasound transd
in the aneurysm sac. The transducer is fixed to the outside of the implantable stent-graft intended to
the sac is excluded from blood circulation during the procedure. The device consists of a portable cons
acoustic waves that provide energy to the transducer and receives the signal, which is displayed as a
the console screen, from the transducer. The implant is energized by the external acoustic waves from
converting the waves into electrical energy. Ultrasonic vascular aneurysm manometers are used durin
procedures to repair vascular aneurysms (typically abdominal aortic aneurysms); comparing the aneu
values before and after the exclusion of the sac from circulation during aneurysm repair facilitates the
leaks (e.g., type I endoleaks).

Transducers designed to measure the pressure inside a vascular aneurysm sac that is excluded from t
(usually in an area of thrombus) by a stent-graft implanted to repair the vascular aneurysm. These de
implantable transducers that convert pressure to radiofrequency or ultrasound signals; the transducer
external console that reads the pressure from the transducer and displays the results. Vascular aneury
measuring transducers, in combination with a matching external unit, are used during endovascular p
repair vascular aneurysms (typically abdominal aortic aneurysms); comparing the value of the pressu
before and after the exclusion of the sac from the blood circulation during the aneurysm repair proced
detection of internal leaks.

Transducers designed to convert pressure to radiofrequency (RF) energy to measure the pressure in a
excluded from the blood circulation (usually in an area of thrombus) by a stent-graft implanted to rep
aneurysm; the transducer works with an external unit including a handheld probe that makes contact
the pressure from the transducer signal. These transducers typically consist of a hermetically sealed e
without power sources and a micro membrane that translates pressure changes in the aneurysm sac i
changes in the transducer (usually changing the capacitance value in a capacitance-inductance reson
antenna transmits RF energy to the transducer; the frequency of the feedback signal sent by the trans
displayed as a value of pressure in the console monitor. RF vascular aneurysm pressure measuring tra
combination with a matching external unit, are used during endovascular procedures intended to repa
(typically abdominal aortic aneurysms); comparing the value of the pressure in the aneurysm sac befo
exclusion of the sac from the blood circulation during the aneurysm repair procedure facilitates the de
leaks.

Transducers designed to convert pressure to ultrasound energy to measure the pressure in an aneurys
from the blood circulation (usually in an area of thrombus) by a stent-graft implanted to repair the vas
transducer works with an external unit including a handheld probe that makes contact with the skin to
from the transducer signal. These transducers are typically a hermetically sealed device that is fixed t
stent-graft; the transducer includes a piezoelectric membrane that charges a capacitor when energize
from a handheld probe; once charged the transducer sends back an ultrasound signal to the external
according to the value of the pressure. Ultrasonic vascular aneurysm pressure measuring transducers
matching external unit, are used during endovascular procedures intended to repair vascular aneurys
abdominal aortic aneurysms); comparing the value of the pressure in the aneurysm sac before and af
sac from the blood circulation during the aneurysm repair procedure facilitates the detection of intern
Systems designed for the removal and extraction of orthopedic acrylic cement (typically polymethyl m
from a previously implanted prosthesis during orthopedic procedures. These systems typically consist
devices, such as electric or pneumatic handpieces and burs; or ultrasonic devices, handpieces, and pr
are based in the combined use of manual instruments such as dedicated chisels, slap-hammers, hook
drills, and osteotomes. The systems may also include vacuum devices with appropriate suction tubes
cement/bone fragments, irrigation devices, and endoscopic video systems. Orthopedic cement extrac
mainly to remove cement (e.g., mantle, plug) during the removal of prostheses in revision surgery (e.
knee, and other cemented orthopedic prostheses.

Orthopedic cement extraction systems designed for the breakage, removal, and extraction of orthope
(typically polymethyl methacrylate [PMMA]) from a previously implanted prosthesis using a combinati
instruments during orthopedic procedures. These systems typically include disposable (i.e., single use
cannulas, tubes, and syringes and reusable dedicated chisels, slap-hammers, hooks, low-speed manu
osteotomes; some systems mix new bone cement with the old cement and then extract the mixture. T
include vacuum devices with appropriate suction tubes and filters to extract cement/bone fragments,
endoscopic video systems. Manual orthopedic cement extraction systems are used mainly to remove
plug) during the removal of old prostheses in revision surgery (e.g., replacement) of hip, knee, and oth
orthopedic prostheses.

Systems designed for cutting, removal, and extraction of bone and/or orthopedic acrylic cement (typic
methacrylate [PMMA]) from a previously implanted prosthesis during orthopedic procedures. These sy
of dedicated powered devices such as electric or pneumatic handpieces and burs or ultrasonic device
probes either for cutting bones or breaking cement (e.g., plugs). The systems may also include irrigat
devices with appropriate suction tubes and filters to extract cement/bone fragments, and endoscopic
Orthopedic bone and cement cutting and extraction systems are used to cut and remove bone fragme
procedures (e.g., prosthesis implantation) and/or to remove cement (e.g., mantle, plug) during the rem
in revision surgery (e.g., replacement) of hip, knee, and other cemented orthopedic prostheses.

Sinks designed for cleaning food preparation and delivery utensils and/or washing dishes. These sinks
one or more large, deep stainless steel bowls with a seamless construction without crevices; several f
water supply; and appropriate tubing for drainage. Kitchen sinks are used in central food preparation
stations of healthcare facilities.
Sinks designed for cleaning utensils and supplies used for janitorial and housekeeping tasks. These sin
one or more large, deep metal and/or epoxy resin bowls; one or more faucets; a cold and hot water su
tubing for drainage. Janitor/housekeeping sinks are distributed among different departments and insta
facilities.
Trephines designed to cut and remove circular sections of tissue for histological examination (i.e., biop
are typically handheld, manual instruments consisting of hollow cylinders with a circular-saw-like serra
an integral, perpendicular handle for application of torque; some biopsy trephines include detachable
manually operated or powered (e.g., electric) surgical handpiece. The biopsy sample occupies the hol
trephine from which it can be removed after trephine extraction. Dedicated trephines are available for
bone marrow, and skin.
Biopsy trephines designed to cut and remove circular sections of bone tissue intended for laboratory e
with minimal sample and surrounding tissue damage. These trephines are typically handheld instrume
hollow cylinders with a circular-saw-like serrated working edge and an integral, perpendicular handle f
torque. Some biopsy trephines include detachable blades and a rotary powered (e.g., electric, pneuma
handpiece. Dedicated bone biopsy trephines are available for vertebral and medullar biopsy procedur

Biopsy trephines designed to cut and remove circular sections of bone marrow (a cone of bone and m
the hip bone (usually from the anterior superior iliac spine below the iliac crest) that are intended for l
and/or test with minimal sample and surrounding tissue damage. These trephines are typically handhe
instruments consisting of large (at least 5 to 7 mm) hollow cylinders with a circular-saw-like serrated w
to a handle; the procedure is frequently performed immediately after bone marrow aspiration using a
marrow samples can be obtained using bone marrow core needles. Bone marrow biopsy trephines are
histologic samples for morphological assessment of the marrow.

Biopsy trephines designed to cut and remove circular sections of skin tissue intended for laboratory ex
with minimal sample and surrounding tissue damage. These trephines are typically handheld, reusabl
consisting of hollow cylinders with a circular-saw-like working edge attached to a rotary manual or pow
handpiece; disposable (i.e., single use) trephines with ribbed plastic handles attached to stainless stee
blades are also available. Skin biopsy trephines with similar characteristics and/or with wider diamete
also used for excisional biopsy, a procedure mainly intended to excise neoplasms from the skin.

Trephines designed to cut and remove circular sections of tissue during surgical procedures. These tre
manual instruments consisting of a hollow cylinder with circular-saw-like edges and an integral perpen
application of torque; some surgical trephines have detachable blades and a rotary manually operated
electric) surgical handpiece. Dedicated surgical trephines are available for several ophthalmic, nasal
surgical procedures.

Surgical trephines designed to cut and remove circular sections of eye tissue. These trephines are han
consisting of a hollow cylinder with a circular-saw-like edge attached to an integral perpendicular hand
torque; some surgical trephines may have detachable blades and a rotary manually operated or powe
surgical handpiece. Dedicated eye surgery trephines are available for several ophthalmic procedures,
implantation and excision of chalazion or tissue in stenotic or occluded lacrimal ducts.

Eye (ophthalmic) surgery trephines designed to cut and remove circular sections of eyelid inflammatio
chalazions). These trephines are typically handheld, manual instruments consisting of sharp, beveled
different diameters (usually from 1 to 2.5 mm) with circular-saw-like working edges and double window
the trephine cuts. Eye surgery trephine components are usually attached to a manually operated com
ophthalmic surgery trephines are used to excise chalazions in surgical procedures of the eyelids.
Eye (ophthalmic) surgery trephines designed to cut and remove cylindrical sections of tissue from the
eye. These trephines are typically handheld, manual instruments consisting of a detachable, sharp, ho
with a beveled edge and a manually operated handle; they are available in a variety of diameters (usu
to a few millimeters), some include a coaxial center-point guide. Lacrimal trephines are used in minor
the eye intended to remove scar tissue from stenotic or totally occluded lacrimal ducts (i.e., canalicula
followed by stenting of the duct. Dedicated, very thin (typically less than 1 mm diameter) trephines ar
removing micro-cylindrical scars prior to stenting the stenotic lacrimal duct (i.e., canalicular lacrimal t

Surgical trephines designed to make a small hole in the nasal frontal sinus by cutting and removing cy
the front wall of the sinus through the eyebrows. These trephines are typically handheld, manual instr
detachable hollow cylinder with a circular-saw-like edge and a handle for application of torque. Frontal
trephines are used to facilitate drainage of infectious products and/or to locate an irrigation/drainage c
through the frontal wall hole.

Surgical trephines designed to percutaneously cut and remove (i.e., harvest) cylindrical sections of bo
These instruments typically consist of a hollow cylinder with a circular-saw-like edge, a centering poin
powered (e.g., electric) rotary surgical handpiece. Bone harvesting surgery trephines are used to obta
from donor sites (e.g., iliac crest, tibia, femur) used in autologous transplants for osseous reconstructi
as the repair of craniomaxillofacial bony defects.

Trephines designed to cut and remove circular sections of tissue during dental procedures. These instr
hollow, cylindrical, detachable blades with a circular-saw-like edge and a manua or, more frequently, p
rotory surgical handpiece. Dedicated dental trephines are available to facilitate the retrieval of broken
from root canals, for artificial tooth root implantation, and for removal of failed implants.

Dental trephines designed to cut and remove minimal circular sections of the tooth structure immedia
metal fragment of a broken file or silver point in a root canal, permitting the fragment to be grasped b
instruments are typically hollow cylinders with a very thin circular-saw-like edge and a powered (e.g.,
rotary surgical handpiece; endodontic trephines usually provide internal irrigation. Implant removal de
to facilitate the extraction of metal fragments from a root canal during endodontic procedures.

Dental trephines designed to cut and remove minimal circular sections of bone tissue around a failed
instruments are typically hollow cylinders a very thin circular-saw-like edge and a powered (e.g., elect
handpiece; dental trephines usually provide internal irrigation. Implant removal dental trephines are u
extraction of defective implants and placement of new implants once the failed one is removed.

Dental trephines designed to cut and remove cylindrical sections of gingival and alveolar bone tissue
implantation site, resulting in an implantation cavity. These instruments are typically detachable, hollo
very thin circular-saw-like edge and a powered (e.g., electric) rotary surgical handpiece; dental trephin
internal irrigation. Artificial tooth root implantation trephines are used to facilitate tooth implantation p
Biopsy punches designed to excise a segment (frequently in the form of a disc) of bone tissue intende
examination and/or test with minimal sample damage. These punches are typically handheld, manual
movable, sharp, hollow tube at one or both distal ends and a handle (sometimes configured for mallet
biopsy bone punches are available in several sizes and with a variety of working end shapes (e.g., rou
intended for specific bones or bone parts (e.g., femur neck).

Biopsy punches designed to excise a segment of tissue (frequently in the form of a thin disc) from the
laboratory examination and/or test (i.e., biopsy) with minimal sample or tissue damage. These punche
handheld, manual instruments with a cutting mechanism (e.g., two-part movable) at the distal end op
Larynx biopsy punches may also be used to perform biopsies of laryngeal tumors.

Biopsy punches designed to excise a segment of tissue (frequently in the form of a thin disc) from the
intended for laboratory examination and/or test (i.e., biopsy) with minimal sample or lung damage. Th
typically handheld, manual instruments with a cutting mechanism (e.g., a hollow tube with an interna
end operated by a handle. Pleural biopsy punches may also be used to perform biopsies of lung tumo

Biopsy punches designed to excise a segment of tissue (frequently in the form of a thin disc several m
from the skin intended for laboratory examination and/or test (i.e., biopsy) with minimal sample or sur
damage. These punches are typically handheld, manual instruments with a hollow sharpened tube at
handle. Skin biopsy punches are available in a variety of sizes and diameters, and as reusable or dispo
they are useful for performing biopsies of the full thickness of the skin.

Skin (dermal) biopsy punches designed to excise a segment of skin tissue (frequently in the form of a
millimeters in diameter) intended for laboratory examination and/or test (i.e., biopsy), with minimal sa
tissue damage. These punches are reusable after sterilization and/or sharpening. Reusable skin biopsy
handheld, manual instruments with a hollow metallic tube sharpened at the working end and a handle
are intended for use with a set of interchangeable cutting tips.

Skin (dermal) biopsy punches designed to excise a segment of skin tissue (frequently in the form of a
millimeters in diameter) intended for laboratory examination and/or test (i.e., biopsy) with minimal sa
tissue damage. These punches are intended for disposal after use (i.e., single use). Disposable skin bi
typically handheld, manual instruments with a hollow tube sharpened at the distal end and an integra
punches are available in a variety of sizes and diameters.

Biopsy punches designed to excise a segment of uterine cervix tissue (frequently in the form of a disc
examination and/or test (i.e., biopsy) with minimal sample damage. These punches are typically hand
instruments with two distal blades that work together as a jaw pivoted at the center and operated by

Punches designed to excise a segment (frequently in the form of a disc) of materials and/or prosthese
procedures. These devices are typically handheld, manual instruments with two distal ends with attac
and are articulated in the middle. Dedicated dental punches are available to make perforations in rub
in prosthetic materials such as dental plates and metal backings used to fix artificial teeth.
Dental punches designed to cut out pieces of dental prostheses (typically dental plates) or to perforat
pins used for fastening artificial teeth. These punches are typically manual, handheld instruments with
attached or integral to handles and articulated in the middle; one working end has a round punch plun
a hole opposite the punch plunger. The use of these instruments is no longer common in dental practi

Punches designed to cut round holes close to the distal end of urinary drainage catheters. These punc
manual, handheld instruments with a rotating cylinder mounted on a small frame that resembles a rot
micrometer; the instrument can open small holes (3 mm in diameter is typical) in urine drainage cath
size (e.g., 14 Fr or larger). These catheter punches are used mainly to open additional holes in urinary
urethral, suprapubic) used in percutaneous and/or endoscopic urinary catheterization procedures.

Punches designed to excise a segment of tissue (frequently in the form of a disc) from an anatomic st
graft during surgical procedures. These punches are typically handheld, manual instruments with a m
mechanism (e.g., tube, jaw) at the distal end operated by squeezing a ring-shaped, two-part handle. D
punches are available for specific anatomic structures and/or tissue, including bone, skin, blood vesse

Surgical punches designed to excise a segment (frequently in the form of a disc) of hard tissue from a
graft during surgical procedures. These punches are typically handheld, manual instruments with a m
tube at the distal end and a handle (sometimes configured for mallet striking). Dedicated surgical bon
available in several sizes and with a variety of distal end shapes (e.g., round, half round, oval) intende
and/or bone grafts; these punches are larger and sturdier than bone biopsy punches.

Bone surgical punches designed to excise a segment of bone tissue (frequently in the form of a disc),
insertion of bone prostheses (e.g., nails, pins) and/or bone grafts previously taken from a donor during
These devices are typically handheld, manual instruments with a movable, sharp, hollow tube at the d
(sometimes configured for mallet striking). Dedicated surgical bone grafting punches are available in
a variety of working end shapes (e.g., round, half round, oval) for the insertion of bone grafts and/or p
bones (e.g., femur) during orthopedic procedures.

Bone surgical punches designed to excise a segment of cranial bone tissue (frequently in the form of a
the insertion of probes and/or catheters during surgical procedures. These punches are typically hand
like instruments with a small indentation in one blade and a matching hole facing the indentation in th
that are operated by squeezing the handles.
Bone surgical punches designed to excise a segment of the sternal tissue (frequently in the form of a
during thoracic (e.g., cardiovascular) procedures. These devices are typically handheld, manual, force
with a strong, sharp distal blade and a matching cavity facing the sharp end on the other distal blade,
squeezing the handles.
Surgical punches designed to excise a segment (frequently in the form of a disc) of one of the two alm
tissue masses located on each side of the oropharynx (i.e., palatine tonsils). These punches are typica
instruments with two blades ending in sharp concentric rings that work together as a jaw at the distal
manipulating scissors-like ring handles configured at an angle (e.g., 60, 90 degrees) to the blades.
Surgical punches designed to excise a segment (frequently in the form of a disc) of the middle-ear tiss
ossicles (e.g., stapes, tympanum). These devices are typically handheld, manual instruments with two
concentric sharp rings or cups that work together as a jaw at the distal end and scissors-like ring hand
90 degrees) to the blades. Middle-ear punches are used in endaural surgical procedures including exc
stapedectomy) and opening of attic and/or the mastoid antrum of the middle ear (i.e., atticotomy and
respectively)

Surgical punches designed to excise a segment of tissue (frequently in the form of a disc), typically ca
and/or nearby anatomic structures through the nose. These punches are typically handheld, manual in
movable, sharp mechanism (e.g., tube, jaw) at the distal end, operated by squeezing a handle (i.e., rin
Dedicated nasal surgical punches are available for specific anatomic structures and/or procedures, suc
adenoids and the paranasal sinuses.

Nasal surgery punches designed to excise a segment (frequently in the form of a disc) from the hyper
in the nasopharynx (i.e., adenoids). These punches are typically handheld, manual instruments with tw
together as a jaw at the distal end operated by manipulating ring handles configured at an angle (e.g.
blades.
Nasal surgery punches designed to excise a segment of tissue (frequently in the form of a disc) from t
of the paranasal sinuses. These devices are typically handheld, manual instruments with a sliding, rot
mechanism at the working end, operated by squeezing a two-part handle configured at a right angle t
mechanism. Dedicated nasal punches are available with appropriate characteristics for perforating ea
sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary).

Nasal surgery punches designed to excise a segment of tissue (frequently in the form of a disc) from t
through the nose, usually to provide access to the paranasal ethmoid sinus. These punches are typica
instruments with a cutting mechanism (e.g., two-part, movable) at the distal end, operated by manipu
handle. Dedicated ethmoid bone punches are available with the working end designed for straight, do
cutting.

Surgical punches designed to open the sellar (i.e., sella turcica) floor to access the pituitary gland. The
typically handheld, manual instruments with a cutting mechanism (e.g., movable, two-part) at the dis
grasping an articulated handle configured at an angle (e.g., 60 degrees) to the mechanism. Sella turci
mainly in surgical procedures intended to excise pituitary tumors.
Surgical punches designed to excise a segment of eye tissue (frequently in the form of a disc) or from
donors. These punches are typically handheld, manual instruments with a sharp, hollow tip at the dist
mechanism that may be integral or attached and operated by squeezing a two-part handle. Eye surgic
mainly for ophthalmic graft implantation and to open a hole in the trabecular meshwork; they are less
obtain grafts from the sclera of cadaver donors.

Corneoscleral eye surgery punches designed to excise a segment (frequently in the form of a disc) fro
grafts previously taken from (cadaver) donors. These punches are typically sturdy bench-mounted stru
sliding mechanism that can be operated using a set of interchangeable cutting tips of different sizes a
punching mechanism) and a cutting block for the corneoscleral graft. Corneoscleral punching units are
graft implants to an appropriate size during or before surgery.

Eye (ophthalmic) surgery punches designed to excise a segment of tissue (frequently in the form of a
trabecular meshwork of the eye. These devices typically are handheld, manual instruments with an in
at the distal end, operated by squeezing a two-part handle. Trabecular mesh eye surgical punches are
remove a portion of the trabecular area to facilitate drainage of the aqueous humor in patients sufferi
Surgical punches designed to excise a segment of tissue (typically in the form of a thin disc several m
from the skin during surgical procedures. These devices are typically handheld, manual instruments w
sharpened at the distal end and a handle; some handles can be used with a set of interchangeable cu
punches are usually stronger and larger than skin punches used for biopsy; they are used mainly in pl
remove skin blemishes) and for removal of small dermal tumors.

Spinal surgery punches designed to excise small segments of tissue (typically in the form of a thin dis
diameter) from the cervical spine and/or posterior ligament. These punches are typically handheld, m
a cutting mechanism (e.g., movable, two-part) at the distal end with a size appropriate to perform the
operated by grasping an articulated handle. Cervical spinal punches may have distal ends designed fo
or upward cutting; they are used mainly to perform anterior cervical discectomy.

Spinal surgery punches designed to excise small segments of tissue (typically in the form of a thin dis
diameter) from the posterior arch of a vertebra (i.e., laminectomy). These punches are typically handh
instruments with a cutting mechanism (e.g., movable, two-part) at the distal end with a size appropria
procedure and are operated by grasping an articulated handle. Laminectomy punches are available w
designed for straight, downward, or upward cutting.

Punches designed for precise excision of vascular wall segments of pre-determined length during surg
punches are typically handheld, manual instruments with two blades including concentric matching sh
end that work together as a jaw, operated by manipulating pivoted ring handles configured at an angl
the blades. The jaws are frequently calibrated (e.g., in millimeters); vascular punches may be used for
artery segments, frequently during anastomosis procedures.

Biopsy guns designed for the automatic extraction of core tissue samples (typically in the form of a cy
anatomic structure of the body with minimal sample and surrounding tissue damage. Side-notch biops
include a reusable, spring-loaded mechanism that advances an inner disposable biopsy needle (trocar
released, the side notch of the inner needle fills with tissue, and a cut-core tissue biopsy sample is ext
cannula is triggered. Biopsy guns are used mainly to obtain samples of soft tissue from internal organ
kidneys, prostate, pancreas, and liver and the breast. The procedures are frequently performed under
radiographic, ultrasonic, magnetic resonance).

Biopsy guns designed for the automatic extraction of core tissue samples (typically in the form of a cy
anatomic structure of the body, by advancing an outer needle (i.e., a cutting cannula) into the tissue w
released, while the inner needle (trocar) remains stationary. The biopsy gun holds the sample within t
withdrawn from the patient and usually maintains a tight suction around the trocar. End-cut biopsy gu
reusable, spring-loaded mechanism and disposable biopsy needles; they are used mainly to obtain sa
from internal organs, including the kidneys, prostate, pancreas, and liver and the breast. The procedu
performed under image guidance (e.g., radiographic, ultrasonic, magnetic resonance).
Single-use end-cut biopsy guns designed for the automatic extraction of core tissue samples (typically
cylinder) from an anatomic structure of the body. End-cut disposable biopsy guns typically consist of a
loaded mechanism that advances the inner disposable biopsy needles, which work like a pair of pince
sample and retracting it in the cannula without suction. Biopsy guns are used mainly to obtain sample
internal organs, including the kidneys, prostate, pancreas, and liver and the breast. The procedures ar
under image guidance (e.g., radiographic, ultrasonic, magnetic resonance).

Saws designed to cut plaster and/or synthetic (e.g., fiberglass, polyester cloth impregnated with resin
available as handheld, manual instruments with a serrated blade and a handle or, less frequently, as s
(e.g., electric, pneumatic) instruments that can drive serrated blades. Cast saws are used to cut casts
plaster or fiberglass blades for cast removal, creation of a hinged cast, or to open a window in the cas
tissue.

Electric cast saws designed to cut casts using a serrated blade that oscillates at a very high speed per
of the machine without full rotation. These saws are handheld instruments with an electric motor; a m
blade; a detachable, toothed, circular or semicircular flat blade; and an electric cable. Oscillating elect
to cut casts using dedicated plaster or fiberglass blades for cast removal, creation of a hinged cast, or
the cast to view underlying tissue; they may also be used to cut plaster and/or fiberglass jackets, dres

Electric cast saws designed to cut casts with serrated blades that reciprocate alternately. These saws
instruments with an electric motor; a mechanism to drive the blades; one or two detachable, toothed,
blades; and an electric cable; some saws include a foot guide for the blades. Reciprocating electric sa
casts using dedicated plaster or fiberglass blades for cast removal especially from the thorax or pelvis
cast, or to open a window in the cast to view underlying tissue; saws using two parallel reciprocating b
of cast are also available.

Pneumatic cast saws designed to cut casts using a serrated blade that oscillates at a very high speed
axis of the machine without full rotation. These saws are handheld instruments with a pneumatic mot
drive the blade, and a hose connected to the pressurized gas source. Cast saws are usually handheld
available less frequently as tabletop stationary devices. Oscillating pneumatic cast saws are used to c
dedicated plaster or fiberglass blades for cast removal, creation of a hinged cast, or to open a window
underlying tissue; they may also be used to cut plaster and/or fiberglass jackets, dressings, and molds

Pneumatic cast saws designed to cut a strip of cast using serrated blades that reciprocate alternately.
handheld instruments with a pneumatic motor; a mechanism to drive the blades; one or two detachab
curved blades; and a hose connected to the pressurized gas source; some saws include a foot guide fo
Reciprocating pneumatic cast saws are used to cut casts using dedicated plaster or fiberglass blades f
especially from the thorax or pelvis, for creation of a hinged cast, or to open a window in the cast to v
saws using two parallel reciprocating blades that cut a strip of cast are also available.

Cast saws designed for cutting casts by manual operation. These saws are handheld, manual instrume
sturdy metal structure including a handle and an integral or detachable wide, serrated blade. Manual
for cast removal, creation of a hinged cast, or to open a window in the cast to view underlying tissue.
Saws designed to cut hard tissue during autopsy and dissection (i.e., postmortem) procedures, driven
or battery) power. These saws are typically waterproof (doubled-insulated), heavy-duty handheld pow
an electric motor, a mechanism to drive the blade, and an electric cable. Postmortem electric saws ar
(e.g., cranium) and other hard tissue; they are frequently provided with an extraction unit and a conta
bone/tissue debris.

Electric saws designed to cut hard tissue during autopsy and dissection (i.e., postmortem) procedures
that oscillates at a very high speed perpendicular to the axis of the machine without full rotation. The
(doubled-insulated), heavy-duty, handheld instruments with an electric motor; a mechanism to drive t
detachable, flat, circular or semicircular, toothed blade; and an electric cable. Special attachments, in
blades, double-bladed mechanisms, and dedicated trephines, are available for these saws. Oscillating
saws are used to cut bone (e.g., cranium) and other hard tissue; they are frequently provided with an
container for collecting bone/tissue debris.

Electric saws designed to cut tissue during autopsy and dissection (i.e., postmortem) procedures using
rotates at a very high speed. These saws are waterproof (doubled-insulated), heavy-duty, handheld in
electric motor; a mechanism to drive the blade; a detachable, toothed, circular flat blade; and an elec
mechanism that operates two parallel rotating blades are also available. Rotary electric postmortem s
tissue and/or bones not intended for subsequent examination or test; saws are frequently provided wi
and a container for collecting bone/tissue debris.

Saws designed to cut hard tissue (e.g., bone) during autopsy and dissection (i.e., postmortem) proced
typically handheld, manual instruments with a sturdy metal structure, a handle, and a detachable, str
serrated blade. Manual postmortem saws are intended to uniformly and accurately cut bones; dedicat
intended to cut spinal bone structures are also available.

Manual saws designed to cut the spinal cord during autopsy and dissection (i.e., postmortem) procedu
typically handheld, manual instruments with a sturdy metal structure; a handle; a detachable, curved
blade; and a guiding attachment. Spinal manual postmortem saws are intended to uniformly and accu
bones.
Saws designed to cut hard tissue during autopsy and dissection (i.e., postmortem) procedures, driven
These saws are heavy-duty, handheld or, less frequently, stationary, powered instruments with a pneu
mechanism to drive an oscillating blade, and a hose connected to the pressurized gas source. Postmo
are usually oscillating saws intended to cut bones (e.g., cranium) and other hard tissue; saws are freq
extraction unit and a container for collecting bone/tissue debris.

Saws designed to cut hard tissue during surgical (e.g., orthopedic, microsurgery) procedures. These sa
handheld, manual instruments with a serrated blade and a handle or, less frequently, tabletop powere
reciprocating, oscillating, or sagittal blade. Surgical saws are used mainly to cut bones with minimal d
surrounding tissue; dedicated manual surgical saws are available for amputation procedures. Small, th
delicate plastic surgery procedures are also available.

Surgical saws designed to cut bone and other hard tissue during total or partial amputation procedure
Dedicated amputation saws are usually handheld, manual instruments with a sturdy metal structure in
a detachable or integral wide, serrated blade. Amputation surgical saws are used mainly to cut bone w
the surrounding tissue; electric and pneumatic saws designed to cut bones during surgical procedures
amputation.
Surgical saws designed to completely or partially amputate a finger or toe. These saws are typically h
instruments (resembling a knife) with a metal structure including a handle and a detachable or integra
Finger/toe amputation manual saws are intended to totally or partially cut fingers (metacarpal) and/or
procedures.
Surgical saws designed to cut bone and other hard tissue with minimal damage to the surrounding tis
typically handheld, manual instruments with a metal structure and a detachable or integral serrated b
electric, pneumatic) instruments with a motor to drive an oscillating, reciprocating, or sagittal blade. B
used in orthopedic, cardiothoracic, and other procedures; dedicated manual wire (e.g., Gigli) saws inte
cranial cutting procedures are also available.

Surgical saws designed to cut bone and other hard tissue, driven by electric (either line or battery) po
typically small handheld, powered instruments with an electric motor to drive an oscillating, reciproca
Bone surgery electric saws are used in orthopedic, cardiothoracic, and other surgical procedures.

Electric surgical saws designed to cut bone and other hard tissue using a serrated blade that oscillate
perpendicular to the axis of the machine without full rotation. These saws are typically small, handhel
instruments with an electric motor to drive the blade, an electric cable, and a flat, detachable, circular
toothed blade. Electric bone surgical saws are used in orthopedic, cardiothoracic, and other surgical p
thyrotomy, laryngeal cartilage resection) to cut bone or cartilage with minimal damage to the surroun

Electric bone surgery saws designed to cut bone and other hard tissue using a serrated blade that rec
along the machine axis. These saws are typically small, handheld, powered instruments with an electr
blades, an electric cable, and a detachable, toothed, curved blade. Electric bone surgery saws are use
cardiothoracic, and other surgical procedures to cut bone with minimal damage to the surrounding tis

Electric bone surgery saws designed to cut bone and other hard tissue using a serrated blade that osc
speed in a plane that includes the axis of the machine (i.e., sagittal) without full rotation. These saws
handheld, powered instruments with an electric motor to drive the blade, an electric cable, and a deta
blade. Electric bone surgery saws are used in orthopedic, cardiothoracic, and other surgical procedure
minimal damage to the surrounding tissue.

Surgical saws designed to cut hard tissue during surgical (e.g., orthopedic, microsurgery) procedures.
typically handheld, manual instruments with a metal structure including a hinged back, a handle, and
blade. Manual bone surgical saws are used mainly in orthopedic procedures.
Manual surgical saws (commonly known as Gigli saws or Olivecrona wire saws, depending on the desi
bone with a wire blade using a back-and-forth movement. These saws typically consist of a spiral wire
wires conformed in a loop and finished in a small ring at each end; the saws are manipulated by using
that include a hook for insertion into each ring. Wire saws are frequently combined with a protector an
minimize damage to surrounding tissue; they are used in osteotomy procedures (e.g., knee, elbow), to
and to remove segments of the skull; manual wire saws are also used in postmortem procedures.
Pneumatic surgical saws designed to cut bone and other hard tissue using a serrated blade that oscilla
speed perpendicular to the axis of the machine without full rotation These saws are typically small, ha
instruments with a pneumatic motor to drive an oscillating blade and a hose connected to the pressur
Oscillating pneumatic-power bone surgical saws are smaller and less noisy than electric saws but prod
debris in the environment. They are used in orthopedic, cardiothoracic, and other surgical procedures.

Pneumatic surgical saws designed to cut bone and other hard tissue using a serrated blade that recipr
These saws are typically small, handheld, powered instruments with a pneumatic motor to drive a rec
hose connected to the pressurized gas source. Pneumatic-power bone surgery saws are smaller and le
saws but produce a larger amount of debris in the environment. They are used in orthopedic, cardioth
surgical procedures.

Reciprocating pneumatic bone surgery saws designed to cut the elongated flattened bone forming the
thorax (i.e., sternum). These saws are typically handheld, powered instruments with a pneumatic mot
reciprocating blade and a hose connected to the pressurized gas source. Pneumatic-power bone surge
and less noisy than electric saws but produce a larger amount of debris. The cut is performed by the b
alternately along the sternum. Pneumatic sternum bone surgery saws are usually more powerful and r
than standard reciprocating saws; they are used mainly in cardiothoracic procedures.

Pneumatic surgical saws designed to cut bone and other hard tissue using a toothed blade that oscilla
speed in a plane that includes the axis of the machine (i.e., sagittal) without full rotation. These saws
handheld, powered instruments with a pneumatic motor to drive a sagittal blade and a hose connecte
gas source. Pneumatic-power bone surgery saws are smaller and less noisy than electric saws but pro
of debris. They are used in orthopedic, cardiothoracic, and other surgical procedures.

Manual surgical saws designed to cut the structures of the middle ear, such as the ossicles. These saw
handheld manual instruments (resembling a file) with a long, serrated distal end appropriate to cut th
integrated handle. They are used in microsurgical procedures of the middle ear, especially to cut the l
stapes (i.e., crurotomy).
Electric saws designed to precisely cut laboratory samples of hard tissue (e.g., bone) with minimal dam
using a serrated blade that rotates at a variable speeds. These saws are typically heavy-duty bench-m
instruments with an electric motor; a mechanism to drive the blade; a flat, detachable, circular, toothe
sample holders; and an electric cable. Rotary electric laboratory saws are used to cut bone (including
original form or embedded in resin, usually to prepare thin sample sections.

Glove boxes designed to provide a confined atmosphere in which procedures maybe performed in isol
room environment, protecting materials and/or processes and the operator and the environment from
glove boxes consist of an air-tight enclosure that includes doors, a window, and gloves attached to po
Basic glove boxes usually do not include transfer chambers, inert gas circulation, pressure control, or
internal environment controls, although some boxes permit the attachment of one or more such acces
boxes are used in clinical laboratories and healthcare facilities to process substances, devices, and/or
contaminated or potentially contaminated but that do not require conditions of complete isolation and
internal high or low pressure). Dedicated basic glove boxes with characteristics (e.g., big doors, flexibl
appropriate to manage mail and packages are also available.
Basic glove boxes designed to provide a confined atmosphere in which mail may be opened and proce
opening of packages). These boxes typically include big, easy-open doors to pass large packages in an
include flexible diaphragms that permit the use of the gloves without changing the internal pressure i
processing glove boxes are used to facilitate the manipulation of contaminated or potentially contami
anthrax) mail; they may prevent the spread of contamination during the sorting and opening process
manipulation of mail sealed inside the glove box. These glove boxes are intended for use where mail i
in healthcare facilities.

Glove boxes designed to provide a confined atmosphere in which materials may be stored and/or proc
performed in such a way as to protect them from the operator and the environment. These boxes are
under low-level positive pressure, isolating the interior of the box from the external environment; som
are manufactured with special characteristics intended to prevent the influence of specific external co
humidity, temperature, and/or particles. Isolation glove boxes are used mainly to prevent environmen
the samples in clinical laboratory tests.

Glove boxes designed to provide an enclosure with a very low-leak, controlled environment (e.g., very
gas). These boxes typically include transfer chambers to facilitate the introduction of materials and/or
compromise of the glove box atmosphere, inlet and outlet valves to establish and maintain the contro
pressure monitors, and a vacuum pump for the transfer chamber. They may also include automatic pu
pressure controllers, oxygen and moisture removers, and alarms. Controlled atmosphere isolation glov
perform processes (e.g., laboratory tests) that require conditions such as very low levels of oxygen, m
they are also used to provide an environment consisting of only a specific gas (e.g., nitrogen, argon, h
of gases.

Glove boxes designed to provide a confined atmosphere in which materials may be stored and/or proc
such a way as to protect the operator and/or the environment. These boxes are typically operated und
which prevents leakage from the box. Containment glove boxes frequently include bag-in and/or bag-o
materials are packaged in a foil bag before they are inserted in or removed from the glove box for add
the operator and environment. Containment glove boxes are mostly intended to process hazardous pr
laboratories; some are manufactured especially for pharmaceutical, biological research, or radioisotop
applications.

Containment glove boxes designed to provide a confined atmosphere to protect the operator and the
highly toxic biohazardous materials inside. These boxes are typically made of stainless steel, one-piec
plastic with a stainless steel liner. They include more safety devices and mechanisms than standard co
boxes, such as a ventilation system with one or more high-efficiency particulate-air (HEPA) or ultra-low
filters both at the input and output of the box, and a secondary HEPA, ULPA, or carbon filter (for partic
contaminants, respectively) in the exhaust system. Most of these boxes include blowers to permit outs
required for a particular application and gloves and/or sleeves (e.g., neoprene, butyl, Hypalon) approp
being processed. Some boxes can accommodate an analytical balance for safe weighing of biohazardo
other equipment (e.g., moisture analyzers). Biohazardous material glove boxes are used in laboratorie
pharmacies to process dangerous or potentially dangerous products; special boxes are available for pr
materials, chemotherapy drugs, and low-level gaseous or particulate radioisotopes.
Glove boxes that combine the capabilities of isolation and containment glove boxes. These boxes typi
maintaining negative pressure to perform processes in which it is necessary to protect the operator an
as a containment glove box) from exposure to hazardous or toxic materials and positive pressure (i.e.,
box) to protect the processed product from the operator and/or the external environment. Isolation/co
have multiple applications in clinical laboratories and pharmacies (e.g., toxic drug manipulations, radi
handling).

Carts designed for safe storage, transportation, and use of computers and/or video monitors. These ca
heavy-duty metal and/or plastic, tubular angled frame that includes several shelves with a nonslip sur
compartments to hold the computer and its peripherals, such as the printer and keyboard; and an app
attachment to hold and facilitate observation of the monitor screen. Most computer carts include a se
15 or 20 cm [ 6 or 8 inch]) casters; some casters have mechanisms (e.g., pneumatic) to cushion trans
also include brakes, drawers, and electric power outlets; height-adjustable carts are also available.

Decision support systems designed to assist healthcare facilities in making financial decisions by effec
calculating, planning, and forecasting the performance of the healthcare facility financial data in an el
main focus of the financial decision support (FDS) systems is accountability with regards to the import
budgeting and cost, thus providing useful information to all involved in the decision making process. T
consist of a combination of hardware and software. The hardware typically includes dedicated network
computers. The software consists of a dedicated software package that is capable of processing inform
accountability with regard to the importance of flexible budgeting and cost. This can provide useful in
involved in the decision making process. Financial decision support systems allow facilities to make fin
focused on both the short-term and the long-term financial goals of the facility. They may function as
may be integrated in a hospital-wide data management information system network.

Decision support systems designed to assist healthcare facilities in making clinical decisions for enhan
These systems typically consist of a combination of hardware and software. The hardware typically inc
network servers and computers; the software consists of a dedicated software package that allows me
health data, including everything from simple facts to detailed health knowledge with clinical observa
may also utilize advanced information such as new medical knowledge from clinical research, includin
for patients in specific disease states. Clinical decision support systems (CDSS) are usually run in eithe
mode. In active mode, the CDSS will process information in the background and alert health professio
indicates a need for intervention. In passive mode, the system will advise only when it is requested by
specific inputs. Successful active and passive CDSS will interface with existing electronic medical reco
knowledge databases to provide the most detailed and accurate information.
Hospital data management information systems designed to manage the assignment and status of ca
as inpatient hospital beds, emergency department rooms or "hall beds," therapy bays in ancillary clini
infusion chairs used in ambulatory infusion centers (e.g., chemotherapy clinics). These systems typic
combination of hardware and software. The hardware typically includes dedicated network servers an
software consists of a dedicated software package (e.g., bed-tracking) that is able to monitor bed stat
tracking individual patient activity. This supportive documentation outlines the amount of time elapse
of the patient care process. It also provides immediate system notifications to housekeeping when a r
allowing sufficient time to prepare and clean the bed and/or patient room. Bed management systems
reports and real-time alerts, reduce patient wait times, and decrease emergency and/or other departm
allowing personnel to correctly match patients with the appropriate level of care. They may function a
or may be integrated in a hospital-wide data management information system network.

Data management information systems designed to permit healthcare organizations to handle more p
and provide better clinical advice in a timely manner. These systems typically consist of a combination
software. The hardware typically includes telephone receivers, dedicated network servers, and compu
consists of a dedicated software package that is capable of identifying emergencies through symptom
providing basic reference health information during the call management process. Telephone triage da
systems support nurse decision-making across the healthcare continuum; they may function as stand
be integrated in a hospital wide data management information system network.

Data management information systems designed to permit healthcare organizations to maintain a det
employee education and privileging information in terms of licensure, training, experience, and perfor
systems support the ability to centrally track compliance and requirements information. These system
combination of hardware and software. The hardware typically includes dedicated network servers an
software consists of a dedicated software package that can record and process education, training, lic
qualification data of each employee. Patient staff education/credentialing management systems ensur
is in compliance with all governmental regulatory (e.g., federal, state) and/or other organization (e.g.,
They may function as stand-alone systems or may be integrated in a hospital-wide data management
network.

Data management information systems designed to provide education on patient health. These syste
a combination of hardware and software. The hardware typically includes dedicated network servers a
computers, printers, and touch screens; the software consists of a dedicated software package that is
health knowledge, outlining discharge instructions, and providing patient surveys. Patient education d
systems enhance self-care during the recovery period without consuming staff resources; they are als
information on the patient health status and development of good health habits. They may function a
or may be integrated in a hospital-wide data management information system network.
Data management information systems designed to manage time and attendance of the healthcare fa
systems typically consist of a combination of hardware and software. The hardware typically includes
dedicated network servers, computers, scanners; the software consists of a dedicated software packa
software that processes employee data such as the complete history, competencies, licenses, and pay
benefits. The software package frequently encompasses the entire hire-to-retire process. Time/attenda
systems permit Human Resources departments to make appropriate decisions to reduce or eliminate
excessive overtime and overstaffing; they may function as stand-alone systems or may be integrated
financial data management information system network.

Data management information systems designed for collection, reporting, and workflow management
mammography procedures. These systems typically consist of a combination of hardware and softwar
typically includes dedicated network servers and workstations, computers, and printers; the software
software package that is capable of processing information from patient interviews, procedural reports
automated generation of reports. Mammography data management systems permit automated patien
logging, and utilization and marketing report generation; they may function as stand-alone systems o
a hospital-wide data management information system network.

Devices designed to be used in combination with a nasoenteral tube/stylet to enable visualization/det


location, thereby guiding the positioning/placement of the tube. These locators typically work by dete
(e.g., a low-level, high-frequency electromagnetic field or near infrared light) that is emitted via the tip
designed nasoenteral tube stylet. These devices are typically hand-held, reusable, and battery-powere
consist of several components, such as a detector/sensor unit and a stand-alone screen that allows vis
tip/stylet.

Punches designed to excise a segment of tissue from the liver of a cadaver without performing an aut
are typically handheld, manual instruments (resembling a stylet) that are appropriate for direct perfor
wall and dissection of a liver sample. Postmortem liver punches are used mainly for diagnosis of yellow
appropriate for biopsy of internal organs in living persons. The instruments also may be used to obtain
internal organs from cadavers.

High-intensity electromagnetic stimulators designed to apply electromagnetic flux density to the brain
transcranial magnetic stimulation [TMS]) and/or the spinal cord. These stimulators typically consist of
radiofrequency generator, a control panel, and a probe including an electromagnetic coil; the equipme
treatment chair as an integral component. Typically, the stimulator uses the principle of electromagne
induced currents in the brain and modulate cortical functions; the stimuli are applied in trains of multi
(i.e., repetitive TMS) with varying characteristics (e.g., single or paired pulses; frequency, strength, an
interval between pulses; mono- or biphasic waveforms). High-intensity electromagnetic stimulators ar
treatment of several neurologic (e.g., migraine) and behavioral (e.g., anxiety, depression) disorders; t
within the field of neurology and neurophysiology for diagnosis of nerve conduction and nerve velocity
degenerative nerve diseases.
Electromagnetic stimulators designed to apply low flux density (in the order of microtesla) pulsed sign
spinal cord below the nerve stimulation threshold, usually at a frequency below 1,000 Hz. These devic
stationary or portable electrically powered (e.g., battery) generator, transducers to be placed near the
a headset with coils placed above the ears at both sides of the head), and a wireless system or cable
from the generator to the transducer. The device may also include a handheld programmer to introdu
treatment parameters for a given patient. Brain/spinal cord electromagnetic stimulators, using a varie
waveforms, are intended for use in healthcare facilities or at home to help in the treatment of pain (i.e
and/or depression.

Bladder support implants made of synthetic materials, designed for stabilizing the urethrovesical junc
compression of the urethral lumen and support to the urinary bladder. These implants are typically so
shaped devices made of synthetic material (e.g., silicone elastomer, polyglactic acid, polyester, polyp
intended for urethral, pubovaginal placement during surgical (e.g., prepubic, transobturator, suprapub
devices are fixed to the posterior pubic bone by sharp-tipped bone anchors.

Devices with combined printing and graphic recording capabilities that permit the storage of a graphic
copy) of the waveform of a given variable (e.g., pulse oximetry, blood pressure). These devices usuall
printing capability; they typically use a thermal dot matrix technique to print. Printer/graphic recorde
healthcare facilities to store a graphic record of patient test results (e.g., pulse oximetry signal).

Physiologic monitor/computer data interface units designed to allow communication between a monit
and/or computer peripherals, providing data download capabilities and temporary storage of data from
(i.e., not in real time) numerical and/or graphical data processing in a computer. These devices typica
processing unit including memory circuits, appropriate software, and wireless or cable connections be
monitor and the input of a computer. Temporary storage monitor/computer data interface units are int
of digital data from bedside or personal monitors (e.g., pulse oximetry, blood pressure, heart rate, wei
direct downloading of data to a computer; use of the interface may reduce the size and weight of sma
monitors by limiting their activity to data collection and transferring the task of data and graphical pro
computer or workstation.

Data interface units designed to allow communication between a physiologic monitor and a computer
peripherals, providing data download capabilities to the monitor and permitting real-time numerical a
processing in the computer. These devices typically include an electronic processing unit and wireless
between the output of a monitor and the input of a computer or computerized network; they may also
software. Monitor/computer data interface units make possible the analysis of digital data from physio
pulse oximeter, blood pressure, heart rate, weight) and, less frequently, from other bedside devices (e
instruments, recorders) that do not allow direct downloading of data to a computer. The interface may
weight of small personal or bedside monitors by limiting their activity to data collection and transferri
graphical processing to a personal computer.
Monitors designed for continuous measurement and display of the percent saturation of hemoglobin in
that are intended for patient self-monitoring. The monitors usually determine the relative amount of o
deoxygenated hemoglobin (O2Hb and HHb, respectively) by measuring light absorbance changes resu
blood flow pulsations. These monitors consist of a small main electronic unit that is worn by the patien
the wrist, carried in a pouch) that includes electronic circuits, an LCD (liquid crystal display), red and i
(typically light emitting diodes [LEDs]), photodetectors, and probes. The monitor may include audible
that are triggered when the patient's SpO2 drops below preset limits. Personal pulse oximetry monitor
during daily activities and/or when performing exercises. Many multipurpose and cardiac physiologic m
measure pulse oximetry.

Enclosed cases and supports (i.e., housings) designed to hold physiologic monitor modules separate f
or other modular physiologic monitor and display units, without any data processing capabilities. Thes
consist of a metal or hard plastic structure with appropriate slots or racks to place the monitor module
typically include common power and ground circuits and cable connections to the main unit. Physiolog
housings are used to support the individual modules used in modular or modular/configured physiolog
configuration that is physically split in two or more parts while keeping all processing capabilities in th

Physiologic monitor module housings, designed to hold physiologic monitor modules separate from th
display units, that process signal data before sending them to the central monitor. These devices typic
or hard plastic structure with appropriate slots or racks to place the monitor modules, common power
electronic processing unit, and cable connections to the main unit. Physiologic monitor module proces
to support the individual modules used in modular or modular/configured physiologic monitors with a
physically split in two or more parts.

Computer/computerized system keypads designed for remote entry of data in a computer, workstatio
computerized equipment (e.g., physiologic monitoring system). These keypads typically consist of a m
electromechanical grid of keys arranged for efficient data entry that may include alphabetic, numeric,
and/or function keys and a remote wireless or cable connection with the equipment receiving the inpu
dedicated keypads are available according to the intended use; applications of remote keypads includ
data in medical devices such as monitors, recorders, and workstations.

Monitor/information system data interface units designed to allow communication between a physiolo
information system, matching monitor output data and the information system, and permitting real-tim
graphical data processing and information transmission through the system. These devices include an
unit and wireless or cable connections between the output of a bedside monitor or, less frequently, ot
(e.g., measuring instruments, recorders) and the input of an information system (e.g., cardiology). Phy
monitor/information system data interface units are intended for the appropriate transmission of digit
physiologic monitors.
Physiologic monitoring system alarms designed to generate remote audible and/or visual signals on a
away from the central station and/or patient room, when patient status triggers an alarm. These syste
electronic display screens and/or audio devices (e.g., loudspeakers); the devices may also provide add
such the reason for the alarm and/or the room number of the patient whose status triggered the alarm
monitoring system alarms are placed in hallways and/or multipatient rooms, providing healthcare staff
patient alarm information. Some alarms may be available as components of physiologic monitoring sy
installation and support. Physiologic system auxiliary displays intended to show the monitored data (i.
waveforms) as well as the alarm signals are also available.

Sutures made of natural raw materials derived from animal collagen (e.g., surgical gut sutures) or pro
or, less frequently, from vegetable fibers (e.g., cotton, linen). These sutures may be absorbable (i.e., b
typically made of surgical gut (collagen derived from sheep or beef intestinal mucosa), or nonabsorba
nonbiodegradable), made of silk, cotton, or linen. The type of natural suture used depends on the size
wound, the strength and period of use required, cosmetic effect desired, and/or other clinical or physic
sutures are typically available in sterile sections (e.g., 18, 30 in [45, 76 cm] long) attached to a single-
integral device; they are frequently colored for easy identification during surgery.

Natural surgical gut sutures treated with chromium salt solutions to resist body enzymes. These sutur
available in sterile thread sections (e.g., 18, 30 in [45, 76 cm] long) attached to a single-use needle as
they are frequently colored for easy identification during surgery. Natural chromium-treated surgical g
tensile strength for 10 to 21, days and complete absorption occurs in 90 or more days. Their intended
rapidly healing tissues, ligating superficial blood vessels, and suturing subcutaneous tissue, frequently
presence, of infection.

Natural sutures made of nonabsorbable (i.e., nonbiodegradable) materials not metabolized by the bod
typically consist of raw silk spun by silkworms (an animal protein) or, less frequently, products derived
(e.g., cotton, linen); they are typically available in sterile thread sections (e.g., 18, 30 in [45, 76 cm] lo
single-use needle as an integral device. The sutures are frequently colored for easy identification durin
Nonabsorbable natural sutures are frequently encapsulated by fibrous connective tissue; their intende
suturing of internal organs and tissues.

Sutures made of synthetic polymer fiber threads. These sutures may be made of absorbable (i.e., biod
nonabsorbable (i.e., non biodegradable) materials; typically, absorbable sutures are made of polyglyc
derivatives, lactic acid, or caprolactone, while nonabsorbable sutures are made of more common poly
polypropylene, polyester, nylon). The type of synthetic suture used depends on the size and location o
strength and period of use required, cosmetic effect desired, and/or other clinical or physical needs. S
usually have a smooth surface but some sutures are made of barbed threads. Barbed thread sutures a
suture without using knots (also known as knotless sutures); they can also be used for cosmetic proce
cosmetic breast lifting). Synthetic sutures are typically available in sterile sections (e.g., 18, 30 inches
attached to a single-use needle as an integral device; they are frequently colored for easy identificatio
Synthetic sutures made of absorbable (i.e., biodegradable) polymeric (e.g., polyglactin, polyglycolic ac
threads. These sutures are typically available in sterile (either monofilament or multifilament, frequen
sections (e.g., 18, 30 inches/45, 76 cm long) attached to a single-use needle as an integral device; the
colored for easy identification during surgery. Absorbable synthetic sutures typically keep their tensile
days to several weeks, and complete absorption occurs in less than six months; their intended use inc
suturing. The sutures usually have a smooth surface but some sutures are made of barbed threads. Ab
thread sutures are mainly used to suture without using knots (also known as knotless sutures); they ca
cosmetic procedures (e.g., face-lifting, cosmetic breast lifting).

Synthetic sutures made of nonabsorbable (i.e., nonbiodegradable) polymeric (e.g., polyester, polyprop
threads. These sutures are typically available in sterile (either monofilament or multifilament, frequen
sections (e.g., 18and 30 in [45 and 76 cm long] attached to a single-use needle as an integral device;
colored for easy identification during surgery. Nonabsorbable synthetic sutures keep their tensile stren
years, and complete absorption never occurs for most of these sutures; their intended use includes cl
wounds, vessel anastomosis, and prosthesis and implant fixation (anchoring). The sutures usually hav
some sutures are made of barbed threads. Nonabsorbable barbed thread sutures are mainly used to s
knots (also known as knotless sutures); they can also be used for cosmetic procedures (e.g., face-liftin
lifting).

Polyester synthetic sutures made of polyester, a nonabsorbable (i.e., nonbiodegradable) polymer. The
available in sterile monofilament uncoated thread sections (e.g., 18, 30 in [45, 76 cm] long) attached
as an integral device; they are frequently colored for easy identification during surgery. Monofilament
their tensile strength for very long periods of time and are not absorbed by tissues; their intended use
tissue approximation and tissue suturing in cardiovascular, ophthalmic, and neurologic procedures.

Polyester synthetic sutures made of polyester fibers, a nonabsorbable (i.e., nonbiodegradable) polyme
typically available in sterile uncoated or coated (e.g., with polybutilate, silicon) multifilament thread s
inches/45, 76 cm long) attached to a single-use needle as an integral device; they are frequently colo
identification during surgery. Braided multifilament polyester sutures keep their tensile strength for ve
and are not absorbed by tissues; their intended use includes vessel anastomosis and placement of pro
cardiac valves) and implants.

Synthetic sutures made of polyvinylidene fluoride homopolymer and polyvinylidene fluoride hexafluor
nonabsorbable (i.e., nonbiodegradable) polymers. The sutures are typically available in sterile monofil
thread sections (e.g., 18, 30 in [45, 76] cm long) attached to a single-use needle as an integral device
colored for easy identification during surgery. These synthetic nonabsorbable sutures keep their tensil
seven years and are not absorbed by tissues; their intended use includes vascular and/or cardiovascu
fine sutures are needed.

Synthetic sutures consisting of monofilament nylon fibers made from nonabsorbable (i.e., nonbiodegra
polyamide 6) polymer. These sutures are typically available in sterile coated thread sections (e.g., 18,
attached to a single-use needle as an integral device; they are frequently colored for easy identificatio
Nylon sutures keep their tensile strength for very long periods of time; nylon is not absorbed, but hydr
gradual loss of tensile strength over time. Nylon nonabsorbable sutures' intended use includes genera
approximation.
Synthetic sutures consisting of multifilament nylon fibers made from nonabsorbable (i.e., nonbiodegra
polymers. These sutures are typically available in sterile braided coated thread sections (e.g., 18, 30 i
attached to a single-use needle as an integral device; they are frequently colored for easy identificatio
Nylon sutures keep their tensile strength for very long periods of time; nylon is not absorbed, but hydr
gradual loss of tensile strength over time. Nylon nonabsorbable synthetic braided sutures are characte
excellent handling properties; their intended use includes suturing internal organs and tissues.

Sutures made of nonabsorbable (i.e., nonbiodegradable) metallic or/and metallic alloys. The type and
suture depends on the size and location of the wound, the strength and period of use required, cosme
and/or other clinical or physical needs. These sutures are typically available in sterile monofilament or
sections that may be attached to a single-use needle as an integral device; they usually keep their ten
long periods of time and are not absorbed by tissues. Stainless steel is by far the most used metallic s
(e.g., silver, titanium) may be occasionally used for particular procedures (e.g., to permit magnetic res
implants).

Stainless steel sutures usually made of single filaments (i.e., monofilament) of commercially pure titan
are typically available in sterile uncoated thread sections (e.g., 18, 30 inches/45, 76 cm long) that ma
single-use needle as an integral device. Titanium sutures keep their tensile strength for very long peri
absorbed by tissues; their intended use includes soft tissue approximation and/or ligation, including o
such as canthoplasty.

Scissors designed to cut tissue and/or prosthetic material during dental procedures. These scissors are
manual instruments with two metallic (e.g., stainless steel) blades with sharp edges that slide past ea
action). The blades are usually attached to handles with the proximal end conformed as a ring to facili
operating with the fingers; both parts are joined by a swivel pin in the center. Heavy-duty dental sciss
and/or trimming dental prosthetic materials such as plates, crowns, and collars; dental scissors with o
blades are also used in dental surgery to trim the gums and/or other soft tissues.

Dental scissors designed to cut and/or trim prosthetic material. These scissors are typically handheld,
instruments with two metallic (e.g., stainless steel) blades with sharp edges that slide past each other
The blades are usually attached to handles with the proximal end conformed as a ring to facilitate hol
with the fingers; both parts are joined by a swivel pin in the center. Prosthetic material dental scissors
and/or cut plates, collars, and crowns during dental prosthodontic procedures (including modeling plas

Scissors designed to cut and/or trim the gums and/or other soft tissue in the oral cavity during dental
These scissors are typically handheld, manual instruments with two metallic (e.g., stainless steel) blad
and one or both serrated to eliminate slippage. The blades are attached to long, curved handles with
conformed as a ring to facilitate holding and operating with the fingers; both parts are joined by a swi
Scissors designed to cut tissue and/or material during surgical procedures. These scissors are typically
instruments with two metallic (e.g., stainless steel) blades with sharp edges that slide past each other
The blades are usually attached to handles with the proximal end conformed as a ring to facilitate hol
with the fingers; both parts are joined by a swivel pin in the center. Some surgical scissors intended f
(e.g., ophthalmic, neurosurgery, microsurgery) have flat handles with serrations to provide a safer grip
springs, avoiding uneven tension and providing a more uniform and/or sensitive manipulation. Small fi
blades are used to cut and dissect soft tissue; heavy-duty scissors are used for cutting stronger tissue
cartilage; dedicated surgical scissors with a variety of tips and blades are available for particular proce
ophthalmic, abdominal, arteriotomy, obstetric).

Devices designed to be placed on a person's abdomen to facilitate a maneuver (known as Heimlich m


generate a pressure to move and expel an obstructing foreign body in that person's airway (i.e., to rel
devices usually include a head with a central bulge to be placed against the upper abdomen and a rod
device is used by being pulled inward and upward to generate the desired expulsion pressure on the l

Surgical scissors designed to cut and/or dissect brain tissue. These scissors are typically handheld, ma
two metallic (e.g., stainless steel) angled or curved blades with sharp or blunt (e.g., pointed) tips and
slide past each other (i.e., shearing action). The blades are usually attached to handles with the proxim
a ring to facilitate holding and operating with the fingers; both parts are joined by a swivel pin in the c
scissors are used mainly for dissection of brain tissue during neurosurgical procedures.

Surgical scissors designed to incise the lens capsule (i.e., capsulotomy) during ophthalmic procedures
typically handheld, manual instruments with two metallic (e.g., stainless steel) blades with very thin a
past each other (i.e., shearing action). The blades are usually attached to serrated flat handles to prov
handles also have inserted flat springs to avoid uneven tension and that provide a more uniform and/o
manipulation. They are used in ophthalmic procedures such as cataract excision.

Eye (ophthalmic) surgery scissors designed to cut eyelid tissue during ophthalmic procedures. These s
very small handheld, manual instruments with two metallic (e.g., stainless steel) blades with slightly c
frequently serrated tips that slide past each other (i.e., shearing action). The blades are attached to h
proximal end conformed as a ring to facilitate holding and operating with the fingers and are joined by
center. Eyelid scissors are used in ophthalmic procedures intended to repair the eyelids and/or for cos
blepharoplasty).

Eye (ophthalmic) surgery scissors designed to cut the extraocular muscles during ophthalmic procedu
to correct strabismus. These scissors are typically very small handheld, manual instruments with two
steel) blades with straight or slightly curved sharp tips that slide past each other (i.e., shearing action
attached to handles with the proximal end conformed as a ring to facilitate holding and operating with
joined by a swivel pin in the center; scissors with larger finger rings and flat shanks to facilitate opera
are also available. Extraocular muscle/strabismus scissors are used to cut one or more of the six extra
provide motility to the eye, either in muscle recession or resection procedures intended to improve th
(i.e., correct strabismus).
Eye (ophthalmic) surgery scissors designed for partial excision of vitreous tissue. These scissors are ty
manual instruments with two metallic (e.g., stainless steel) blades with straight or angled (e.g., 60 de
slide past each other (i.e., shearing). The blades are attached to a serrated flat handle to provide a sa
scissors are used mainly to remove the front part of the vitreous tissue, to perform a pars plana (the t
ciliary disc) incision to remove vitreous membranes and/or opacities, and for removal of the content o

Eye (ophthalmic) surgery scissors designed to cut tissue (e.g., corneal, scleral) during ophthalmic mic
These scissors are typically very small handheld, manual instruments with two metallic (e.g., stainless
(frequently beveled) with straight or curved, either sharp or blunt tips that slide past each other (i.e.,
blades are usually attached to serrated flat handles to provide a safer grip; the handles also have inse
avoid uneven tension and to provide a more uniform and/or sensitive manipulation. Ophthalmic micro
used in procedures such as keratoplasty, keratectomy, corneal trephination during corneal transplants
other ophthalmic procedures involving the eye tissues, including pediatric patients.

Surgical scissors designed to cut middle-ear tissues during endaural procedures. These scissors are ty
manual instruments with two long metallic (e.g., stainless steel) blades with straight, angled, or curve
that slide past each other (i.e., shearing action). The blades are attached through long slender shanks
proximal end conformed as a ring to facilitate holding and operating with the fingers; both parts are jo
the center. Middle-ear surgery scissors are used to cut soft tissue in several procedures of the stapes a
membrane (e.g., tympanoplasty).

Surgical scissors designed to cut small caliber wires used in prosthesis of middle ear ossicular structur
typically light handheld, manual instruments with two metallic (e.g., stainless steel) and frequently se
straight, angled or curved sharp tips that slide past each other (i.e., shearing action). The blades are a
with the proximal end conformed as a ring to facilitate holding and operating with the fingers; both pa
swivel pin in the center. Ossicular cutting scissors are used in middle-ear surgery to cut wire used in o
the wire is placed as a long prosthesis linking the malleus to the oval window to keep the ossicular cha
stapedectomy procedures.

Middle-ear surgery scissors designed to dissect tissue during endaural microsurgical procedures. Thes
very small handheld, manual instruments with two long and very fine metallic (e.g., stainless steel) bl
angled sharp tips that slide past each other (i.e., shearing action). The blades are attached through lo
with the proximal end conformed as a ring to facilitate holding and operating with the fingers. Both pa
swivel pin in the center. Middle-ear surgery scissors are used to cut soft tissue in microsurgical proced
of the middle ear such as stapes and tympanic membrane surgery (i.e., tympanoplasty).

Surgical scissors designed to cut hard bony internal nasal structures, usually the turbinate (i.e., nasal
scissors are typically sturdy handheld, manual instruments with two long metallic (e.g., stainless steel
blades with straight blunt tips that slide past each other (i.e., shearing action). The blades are usually
handles with inserted flat springs to provide a safer grip and a more uniform and/or sensitive manipul
tension. Turbinate nasal scissors are used to perform plastic and/or reconstructive procedures of the n
Nasal surgery scissors designed to cut (resect) nasal septum tissue. These scissors are typically handh
instruments with two long metallic (e.g., stainless steel) blades with straight or angled sharp tips that
(i.e., shearing action). The blades are attached to handles with the proximal end conformed as a ring t
operating with the fingers; both parts are joined by a swivel pin in the center. Sturdier scissors with re
blades, and flat curved handles with inserted springs to provide a safer grip and a more uniform and/o
manipulation, avoiding uneven tension, are also available. Nasal septum surgery scissors are used to
reconstructive procedures of the nose (i.e. rhinoplasty).

Nasal surgical scissors designed to cut and/or excise tissue from one of the paranasal sinuses. These s
handheld, manual instruments with two small metallic (e.g., stainless steel) blades with straight or an
left) sharp tips that slide past each other (i.e., shearing action). The blades are at the distal end of a lo
attached, usually at a 90-degree angle, to handles with the proximal end conformed as a ring to facilit
operating with the fingers. Nasal sinus scissors are used mainly in procedures intended to excise abno
materials.

Surgical scissors designed to cut loose or redundant tissue from the facial skin, eliminating wrinkles (i
rhytidectomy, also known as facelift). These scissors are typically handheld, manual instruments with
stainless steel) straight or curved blades with blunt, strong, flat tips that slide past each other (i.e., sh
blades are usually attached to very long slender shanks that are pivoted (using a swivel pin) at the po
handles that are conformed at the proximal end as a ring to facilitate holding and operating with the fi
scissors include a slightly spread tip to facilitate undermining of the facial skin with a few strokes durin
procedures.

Surgical scissors designed to cut and/or dissect tissue from the larynx and associated structures. Thes
handheld, manual instruments with two long metallic (e.g., stainless steel) blades with straight or ang
slide past each other (i.e., shearing action). The blades are attached to handles with the proximal end
facilitate holding and operating with the fingers and are joined by a swivel pin in the center.

Larynx surgery scissors designed to cut tissues during laryngoscopic procedures. These scissors are ty
manual instruments with two small metallic (e.g., stainless steel) blades with straight or angled (to th
tips that slide past each other (i.e., shearing action). The blades are at the distal end of a long shaft th
at a 60- to 90- degree angle, to handles with the proximal end conformed as a ring to facilitate holding
the fingers. Sturdier laryngoscopic scissors with double-action lever mechanisms that permit more sta
fibrous tissue with less rotation are also available. Larynx surgery scissors are used in many procedure
excision of large masses (e.g., the pedicle of polyps) and to cut the epithelium in surgical procedures
pathologic structures of the vocal cords (phonosurgery). They are used frequently in microsurgery.

Surgical scissors designed to cut tissue in the bronchi through the working channel of a bronchoscope
typically handheld, manual instruments with two metallic (e.g., stainless steel), very thin blades with
flexible shank; usually, a movable blade slides toward a stationary blade (i.e., shearing action). The bl
through the shank to handles at the proximal end conformed as rings to facilitate holding and operatin
Bronchoscopic scissors are used to cut and excise tissue from the bronchi, typically to widen the lume
tumors.
Surgical scissors designed to cut pituitary tissue during procedures involving pituitary gland tissues. T
typically handheld, manual instruments with two small metallic (e.g., stainless steel) blades with strai
tips that slide past each other (i.e., shearing action). The blades are attached by a long shank (e.g., 36
to handles with the proximal end conformed as a ring to facilitate holding and operation with the finge
action). Pituitary surgery scissors are used in neurosurgical procedures for total or partial removal of t
hypophysectomy). They are used during microsurgery.

Surgical scissors designed for dissection of soft tissue in deep surgery procedures performed in the ab
thoracic cavities. These scissors are typically handheld, manual instruments with two metallic (e.g., st
angled, or curved blades with blunt tips that slide past each other (i.e., shearing action). The blades a
large, strong handles with the proximal end conformed as a ring to facilitate holding and operating wit
parts are joined by a swivel pin in the center. Abdominal/thoracic cavity tissue dissection surgery sciss
cut soft tissue from anatomic structures and organs, including the loose connective tissue forming the
an organ (i.e., adventitia).

Surgical scissors designed to cut cardiac tissue. These scissors are typically handheld, manual instrum
(e.g., stainless steel) sharp blades that slide past each other (i.e., shearing action). Typically, the blade
shanks, usually at an acute (e.g., 30, 45, 60 degrees) angle, finished in handles with the proximal end
to facilitate holding and operating with the fingers; both parts are joined by a swivel pin close to the b
scissors are used in emergency procedures on the heart and in other cardiac procedures that include h
valve transplants.

Heart (cardiac) surgical scissors designed to cut cardiac tissue in minimal-access procedures. These sc
handheld, manual instruments with two metallic (e.g., stainless steel) straight, razor-like, very sharp b
each other (i.e., shearing action), making possible smooth cutting even of calcified tissue. Typically, th
to very long and slender shanks, finished in handles with the proximal ends conformed as a ring to fac
operating with the fingers; both parts are joined by a swivel pin close to the blades. Minimally invasive
are used in minimal-access cardiothoracic procedures.

Heart (cardiac) surgical scissors designed to cut cardiac valve tissue (i.e., during valve replacement or
These scissors are typically handheld, manual instruments with two slender and flat metallic (e.g., sta
curved sharp blades that slide past each other (i.e., shearing action). Typically, the blades are attache
finished in handles, with the proximal ends conformed as a ring to facilitate holding and operating wit
parts are joined by a swivel pin close to the blades. Dedicated scissors designed for a particular heart
also available.

Surgical scissors designed to cut the abdominal wall. These scissors are typically sturdy, handheld, ma
two metallic (e.g., stainless steel blades), with straight or curved (sharp, blunt, or combined) tips that
(i.e., shearing action). The blades are attached to handles with the proximal end conformed as a ring t
operating with the fingers; both parts are joined by a swivel pin in the center. Abdominal wall surgical
open surgery procedures involving the abdominal organs.
Surgical scissors designed to cut tissue from the intestine (bowels). These scissors are typically handh
instruments with two metallic (e.g., stainless steel), straight or angled blades with long blunt tips that
(i.e., shearing action), and a long shank attached to handles with the proximal end conformed as a rin
and operating with the fingers; both parts are joined by a swivel pin in the center. Intestinal surgery sc
in surgical procedures for partial resection of the bowels after appropriate suture and/or in procedures
surgical openings of the intestines through the abdominal wall (i.e., enterotomy).

Surgical scissors designed to be used via a laparoscope to cut tissues encountered during laparoscopi
scissors are typically handheld, manual instruments with two metallic (e.g., stainless steel), very thin,
serrated blades with sharp tips that are slid past each other (i.e., shearing action). A long, flexible, and
(e.g., 360 degrees) shank is attached to the blades and to handles at the proximal end conformed as r
holding and operating by squeezing with the fingers. Laparoscopic scissors are used to cut and excise
abdomen during a variety of surgical (e.g., gynecologic, urinary tract, biliary tract) procedures; some a
cord and appropriate insulation to perform monopolar electrosurgery.

Laparoscopic surgical scissors designed to cut tissue using a hook-like nonslipping jaw during laparosc
scissors are typically handheld, manual instruments with two metallic (e.g., stainless steel), very thin
conformed as a hook to encircle the tissue. The blades slide past each other (i.e., shearing action) to c
blades are the integral part of a shank that is attached to a handle at the proximal end conformed as
holding and operating or are separate components that are used with a handle that is common to sev
instruments. Hooking jaw laparoscopic scissors are used mainly to cut secured ducts (e.g., cystic duct
cholangiography), arteries, and nerve bundles in neurectomy with no chance of slippage.

Surgical scissors designed to cut and/or dissect the gall bladder. These scissors are typically handheld
with two metallic (e.g., stainless steel) straight blades with sharp tips that slide past each other (i.e., s
long shank. The blades are attached to handles with the proximal end conformed as a ring to facilitate
with the fingers; both parts are joined by a swivel pin in the center. Gall bladder scissors are used in s
opening or complete dissection of the gall bladder.

Surgical scissors designed to cut biliary duct tissue. These scissors are typically handheld, manual ins
metallic (e.g., stainless steel) sharp blades that slide past each other (i.e., shearing action). The blade
shanks, usually conformed at a 60-degree angle; they also include handles with the proximal end conf
facilitate holding and operating with the fingers; both parts are joined by a swivel pin in the center. Bil
used in open surgery procedures involving the opening, dissection, and/or removing of the biliary duc

Surgical scissors designed to cut spinal tissue during surgical procedures. These scissors are typically
instruments with two small metallic (e.g., stainless steel) blades with straight sharp tips that slide pas
shearing action). The blades are attached by a turnable (e.g., 360 degrees) long shank to handles with
conformed as a ring to facilitate holding and operating with the fingers; both parts are joined by a swi
Spinal surgery scissors with larger finger rings; both parts are flat shanks (e.g., ribbon style) to facilita
available. Spinal surgery scissors are used in neurosurgical procedures of the spinal cord
Spinal surgery scissors designed to cut spinal (e.g., spinal disc) tissues during microsurgical procedure
typically handheld, manual instruments with two small metallic (e.g., stainless steel) blades with strai
slide past each other (i.e., shearing action). The blades are attached by a turnable (e.g., 360 degrees)
with the proximal end conformed as a ring (e.g., ribbon style) to facilitate holding and operating; with
are joined by a swivel pin in the center.

Surgical scissors designed to cut tissue in the urinary tract through the working channel of a cystosco
These scissors are typically handheld, manual instruments with two very thin metallic (e.g., stainless s
sharp tips and a long flexible shank; typically, a movable blade is slid toward a stationary blade (i.e., s
blades are attached through the shank to handles at the proximal end conformed as rings to facilitate
by squeezing with the fingers. Cystoscopic scissors are used to cut and excise tissues from the urinary
the lumen, to excise polyps).

Surgical scissors designed to cut and dissect tissues in the uterus and surrounding tissues. These scis
handheld manual instruments with two metallic (e.g., stainless steel) wide, straight, or curved blades
that slide past each other (i.e., shearing action). The blades are attached to handles with the proximal
ring to facilitate holding and operating with the fingers; both parts are joined by a swivel pin in the ce
scissors are used in procedures involving the uterus and surrounding tissues; dedicated scissors for cu
in radical vaginal hysterectomy are also available.

Uterine surgery scissors designed to cut the parametria. These scissors are typically handheld, manua
metallic (e.g., stainless steel) angled or curved blades with blunt tips that slide past each other (i.e., s
may include a ball. The blades are attached to handles with the proximal end conformed as a ring to f
operating with the fingers; both parts are joined by a swivel pin in the center. Parametrium uterine sur
to sever the parametrium tissue bundles with little trauma to surrounding tissue in radical vaginal hys

Surgical scissors designed for fetal decapitation. These scissors are typically handheld, manual instrum
(e.g., stainless steel) sturdy, curved, wide blades with blunt tips to prevent damage to the surrounding
attached shanks, and rounded blunt tips that are slid past each other (i.e., shearing action); the blade
handles with the proximal end conformed as a ring to facilitate holding and operating with the fingers
by a swivel pin in the center. Fetal decapitation scissors are used during obstetric procedures when th
to protect the mother during difficult labor.

Surgical scissors designed to perform an incision in the peritoneum and vagina during labor (i.e., episi
are typically handheld, manual instruments with two metallic (e.g., stainless steel), wide angled or cu
shanks, and rounded blunt tips that slide past each other (i.e., shearing action); usually one blade is lo
and has a serrated edge. The blades are attached to handles with the proximal end conformed as a rin
and operating with the fingers; both parts are joined by a swivel pin in the center. Scissors with larger
shanks to facilitate operation (e.g., ribbon style) are also available. Episiotomy scissors are used in ob
prevent traumatic tearing during delivery.
Scissors designed to cut and/or dissect blood vessel (vascular) tissues. These scissors are typically ha
instruments with two metallic (e.g., stainless steel) angled or curved (and frequently serrated) blades
slide past each other (i.e., shearing action). The blades are usually attached to handles, with the proxi
a ring to facilitate holding and operation with the fingers; both parts are joined by a swivel pin in the c
vascular scissors are available with many different shapes, sizes, and blade configurations according t
or the procedure to be performed (e.g., coronary artery bypass, peripheral vasculature dissection, ven
carotid endarterectomy).

Vascular surgical scissors designed for fine and sharp incision and/or dissection of arteries (i.e., arterio
are typically handheld manual instruments with two metallic (e.g., stainless steel) curved blades, a lon
sharp tips that slide past each other (i.e., shearing action). The blades are typically attached to handle
end conformed as a ring to facilitate holding and operating with the fingers; both parts are joined by a
center. Arterial surgery scissors are mainly used in vascular and cardiovascular procedures; smaller an
scissors are used in neurosurgical procedures (e.g., intracranial vasculature). Dedicated artery surgery
for incision of the coronary arteries and to trim and prepare the internal mammary artery or the saphe
anastomosis.

Vascular surgery scissors designed for fine and sharp incisions of the coronary arteries. These scissors
manual instruments with two metallic (e.g., stainless steel) either straight, curved, or bayonet-shaped
that slide past each other (i.e., shearing action); an angled bayonet handle offers improved visualizati
blades are typically attached to serrated flat or curved handles to provide a safer grip; the handles als
springs to avoid uneven tension and to provide a more uniform and/or sensitive manipulation. Corona
scissors are used in cardiovascular procedures involving the coronary arteries, including coronary ana

Vascular surgery scissors designed for fine and sharp incisions of the circumflex artery (i.e., a branch o
artery that curves back of the left ventricle in the coronary sulcus, supplying the left ventricle and the
scissors are typically handheld manual instruments with two metallic (e.g., stainless steel) small, strai
sharp tips that slide past each other (i.e., shearing action); the blades are usually mounted at a 90-de
shanks and are joined by a swivel pin in the center, located at the point of union with the shank. The s
the proximal end in handles conformed as a ring to facilitate holding and operation with the fingers; a
frequently located on the shanks between the union of the blades and the ring handles. Circumflex ar
are used in cardiovascular procedures involving the coronary arteries, including coronary anastomosis

Vascular surgery scissors designed for excision of the atheromatous tunica intima of the carotid arteri
endarterectomy). These scissors are typically handheld, manual instruments with two metallic (e.g., s
angled, or straight blades with very sharp tips that slide past each other (i.e., shearing action). The bl
attached to handles with the proximal end conformed as a ring to facilitate holding and operating with
are joined by a swivel pin in the center. Endarterectomy scissors are mainly used in vascular procedur
stenosis of the common carotid artery; they may be also used for endarterectomy of other main arteri
Vascular surgical scissors designed for fine and sharp dissection of blood vessels in microsurgical proc
are typically very small handheld, manual instruments with two straight or curved metallic (e.g., stain
frequently beveled blades with tips specially shaped to avoid vessel slipping and appropriate for rough
slide past each other (i.e., shearing action). The blades are usually attached to serrated flat handles to
grip; the handles also have inserted flat springs to avoid uneven tension and to provide a more uniform
manipulation. Vascular microsurgery scissors are mainly used in neurosurgery and plastic surgery.

Surgical scissors designed to cut fibrous connective tissue (i.e., cartilage). These scissors are typically
instruments with two metallic (e.g., stainless steel) straight or curved sturdy blades, frequently cutting
sharp pointed tips and long shanks that slide past each other (i.e., shearing action). The blades are us
handles with the proximal end conformed as a ring to facilitate holding and operating with the fingers
by a swivel pin in the center. Cartilage surgery scissors are used mainly for dissection of tissues during
plastic surgery procedures.

Surgical scissors designed to cut the outermost of the three membranes (meninges) covering the brai
(i.e., the dura mater). These scissors are typically handheld, manual instruments with two metallic (e.
angled or slightly curved blades with sharp or blunt (e.g., pointed) tips and very long shanks that slide
shearing action). The blades are usually attached to handles with the proximal end conformed as a rin
and operating with the fingers; both parts are joined by a swivel pin in the center. Dura mater surgery
neurosurgical procedures involving the brain and/or the spinal cord.

Surgical scissors designed to cut tissue during arthroscopic procedures. These scissors are typically ha
instruments with two metallic (e.g., stainless steel), very thin blades with a variety of tips and angles
other (i.e., shearing action). A long flexible and frequently rotating shank is attached to the blades and
proximal end conformed as rings to facilitate holding and operating with the fingers. Arthroscopic scis
and excise tissue from the joints (e.g., parts of the meniscus) during endoscopic procedures.

Surgical scissors designed for fine and sharp dissection of nerves. These scissors are typically handhe
with two metallic (e.g., stainless steel) straight or curved blades, a long shank, and inside sharp and o
that slide past each other (i.e., shearing action). The blades are usually attached to long handles with
conformed as a ring to facilitate holding and operating with the fingers; both parts are joined by a swi
Nerve cutting and dissection surgery scissors are mainly used in delicate neurosurgical procedures.

Surgical scissors designed to cut a tendon (i.e., tenotomy). These scissors are typically handheld, man
two metallic (e.g., stainless steel) blades with blunt tips that slide past each other (i.e., shearing actio
usually attached to large, strong handles with the proximal end conformed as a ring to facilitate holdin
the fingers; both parts are joined together by a swivel pin in the center. Tendon surgery scissors are m
tendons in neurosurgical procedures; they are also used to cut tendons that attach the ophthalmic orb
procedures intended to correct strabismus.
Surgical scissors designed to cut small-caliber suturing wires. These scissors are typically sturdy hand
instruments with two metallic (e.g., stainless steel) and frequently serrated blades with straight, angle
that slide past each other (i.e., shearing action); a blade may include a notch to facilitate rapid pickup
blades are attached to handles, with the proximal end conformed as a ring to facilitate holding and op
fingers; both parts are joined by a swivel pin in the center. Wire-cutting scissors are used to cut wire s
orthopedic surgery; many wire cutting scissors are also used to cut metallic mesh used in surgical pro
Smaller dedicated wire cutting scissors are available to cut wire ossicle prosthesis.

Scissors designed to cut the umbilical cord after delivery. These scissors are typically handheld, manu
metallic (e.g., stainless steel), thin, very wide blades with large, rounded, blunt tips that slide past eac
action). The blades are attached to handles with the proximal end conformed as a ring to facilitate hol
with the fingers; both parts are joined by a swivel pin in the center. Umbilical cord scissors are used in
procedures to cut the umbilical cord after the cord is appropriately clamped.

Scissors designed to cut and excise foreign material and/or damaged or contaminated tissue from or a
scissors are typically handheld, manual instruments with two metallic (e.g., stainless steel) sharp or se
tips that slide past each other (i.e., shearing action). The blades are attached to long, straight, or curv
handles at the proximal end conformed as a ring to facilitate holding and operating with the fingers; b
a swivel pin in the center.

Scissors designed to cut and dissect tissue during postmortem procedures (e.g., autopsy, dissection).
typically handheld, manual, heavy-duty instruments with two metallic (e.g., stainless steel) blades wit
that slide past each other (i.e., shearing action) conformed according to the tissues to be dissected. T
attached to handles with the proximal end conformed as a ring to facilitate holding and operating with
are joined by a swivel pin in the center. Scissors with sharp and blunt blade tips are available; dedicat
scissors (e.g., with probe tips for the coronary arteries, ball ends for anatomic ducts) are also available

Scissors designed to cut plaster cast. These scissors are typically strong, handheld, manual instrumen
(e.g., stainless steel) curved or angled blades, with sharp and frequently serrated edges that slide pas
shearing action); usually one blade is longer than the other and is finished in a narrow blunt tip, while
a wider, rounded tip. The blades are usually attached to handles with the proximal end conformed as
holding and operating with the fingers; both parts are joined by a swivel pin in the center.

Scissors designed to cut and/or trim fingernails and/or cuticles. These scissors are typically handheld,
with two thin, curved metallic (e.g., stainless steel) blades with sharp edges that slide past each other
The blades are usually attached to handles with the proximal end conformed as a ring to facilitate hol
with the fingers; both parts are joined by a swivel pin in the center. Fingernail scissors are usually ope
trim his/her own nails; they are used mainly for personal hygiene or grooming. Dedicated smaller scis
only intended to trim cuticles are also available.

Scissors designed to cut and/or trim the toenails and/or toe cuticle. These scissors are typically handh
instruments with two thin, straight metallic (e.g., stainless steel) blades with sharp edges that slide pa
shearing action). The blades are usually attached to handles, with the proximal end conformed as a rin
and operating with the fingers; both parts are joined by a swivel pin in the center. Toenail scissors may
person to trim his/her own nails for personal hygiene or grooming; they are also used in podiatric proc
ingrown toenails).
Probes primarily designed to detect targeted gamma radiation emissions from the human body after t
injection of a radiopharmaceutical tracer (i.e., radioactive drug). These probes typically include a sens
shielding from radiation outside the intended target. Gamma radiation detection probes may be inten
imaging and/or nonimaging gamma radiation detectors; dedicated probes intended for specific areas
head, thorax) and/or to perform lymphatic mapping are available. The probes may be used externally
including during laparoscopic procedures; some probes may be also used to detect radiation from a lo
emitting device or from radioactive material.

Gamma radiation detection probes designed to detect the level of radiation in lymphatic nodes around
prior ingestion or injection of a radiopharmaceutical tracer (i.e., radioactive drug). These probes typica
detector, a collimator, and shielding from radiation outside the intended target; they are used with no
radiation devices that display the count rate corresponding to each node. Lymphatic mapping gamma
used to detect high-radiation points (hot spots), facilitating to find the lymph node to which the tumor
SN), helping the pathologist to identify lymph node metastasis status.

Gamma radiation detection probes designed to detect the level of radiation in the superficial area of t
around a cancer tumor after prior ingestion or injection of a radiopharmaceutical tracer (i.e., radioacti
typically consist of a detector, a collimator, and shielding from radiation outside the intended target; t
imaging or non-imaging gamma radiation devices that display the count rate corresponding to each ti
gamma radiation probes are intended to detect high-radiation points (hot spots), facilitating to find th
the tumor drains (sentinel node, SN), helping in the diagnosis and prognosis of cancer tumors and also
operatively detection of oral, head, thyroid gland, and/or neck carcinomas during procedures.

Gamma radiation detection probes designed to detect the level of radiation in the abdominal cavity ar
after prior ingestion or injection of a radiopharmaceutical tracer (i.e., radioactive drug). These probes
detector, a collimator, and shielding from radiation outside the intended target; they are used with im
gamma radiation devices that display the count rate corresponding to each tissue. Abdominal gamma
intended to detect high-radiation points (hot spots), facilitating to find the lymph node to which the tu
node, SN), helping in the diagnosis and prognosis and detection of small cancer tumors and also in pro
identify small malignant (e.g., gastrointestinal, prostatic) lesions intra-operatively during open and lap

Gamma radiation detection probes designed to detect the level of radiation in the thoracic cavity arou
after prior ingestion or injection of a radiopharmaceutical tracer (i.e., radioactive drug). These probes
detector, a collimator, and shielding from radiation outside the intended target; they are used with im
gamma radiation devices that display the count rate corresponding to each tissue. Thoracic gamma ra
intended to detect high-radiation points (hot spots), facilitating to find the lymph node to which the tu
node, SN), helping in the diagnosis and prognosis of small cancer tumors and also in procedures used
malignant (e.g., breast, lung) lesions intra-operatively during open and laparoscopic surgery.

Devices designed to separate blood into plasma and cell components by centrifugation. These device
dedicated portable centrifuge with electronic controls, a display, a separation chamber, and appropria
is mixed with an anticoagulant and centrifuged to separate plasma from other blood components such
white blood cells, and platelets. Centrifugal blood cell processors are used in blood banks and clinical
isolated blood components.
Centrifugal blood cell processors designed for the automatic addition of glycerol to red blood cells (RB
prevent the disruption of the RBC membranes (i.e., hemolysis) and/or to wash the RBCs (reducing the
minimum) after blood thawing for posterior reinfusion. These devices typically consist of a dedicated p
with electronic controls, a display, and a glycerization and deglycerization (usually disposable) set; the
recording devices and/or printers. Frozen blood cell processors provide a closed system that permits fr
RBCs; the processors are intended to extend postthaw storage (up to several days) longer than manua
the devices may be used to facilitate the frozen storage of rare blood types, to ease emergency blood
manage autologous blood for autotransfusion.

Printers designed to produce a permanent, monochromatic text or graphic copy (i.e., hard copy) on pa
appropriate media (e.g., transparent film) from video data stored in a recorder or displayed by a moni
typically use a thermal technology to produce a hard copy with grayscale (typically 256 tones) gradat
paper or, less frequently, on dedicated film; the printers may include a digitizer (also known as a fram
signals from analog video sources. Monochromatic video printers are used in healthcare facilities for d
imaging procedures (e.g., ultrasound, radiographic) when a color picture is not required or possible, as
images for patient files; video printers are not normally intended to produce images for diagnostic pur

Handheld surgical instruments designed to hold vein grafts during surgical vein anastomosis and hold
the vein graft to prevent catching of the opposite vein wall during suturing. These holders are typicall
stylus (made of radiopaque sturdy plastic) with a tapered concave distal tip containing a stainless stee
the underside of the vein graft. The vein graft holding instrument holds the vein in place during suture
graft's circumference.

Endoscopic automated suture units designed for mounting on an endoscope used to suture the tissue
esophageal sphincter during endoluminal gastroplication procedures. The devices typically consist of
mechanism, frequently including a capsule chamber that contains needles, a suture-carrier accessory
manipulate the equipment and control the suture delivery. The devices place the stitches and create
esophageal sphincter. Lower esophageal sphincter endoscopic suture units are mainly used to tighten
sphincter to reduce acid reflux for patients with gastroesophageal reflux disease.

Printers designed to produce a permanent, color text or graphic copy (i.e., hard copy) on paper or othe
(e.g., transparent film) from video data stored in a recorder or displayed by a monitor. These printers t
transfer technology (e.g., thermal dye transfer, also known as dye sublimation) to produce a hard cop
of color tones on a dedicated film; the printers may include a digitizer (also known as a frame grabber
from analog video sources. Color video printers are used in healthcare facilities for documentation of i
(e.g., endoscopic, ultrasound, nuclear medicine), as well as to produce images for patient files; video
normally intended to produce images for diagnostic purposes.
Printers designed to produce a standard and/or high-definition, permanent text or graphic copy (i.e., h
(e.g., letter, legal) and/or nonstandard, large-format paper or other appropriate media (e.g., transpare
in computers or computer networks. These printers may use a variety of technologies to print docume
spray (typically liquid ink-jet printers), toner-based (typically laser printers), thermal transference (e.g
and, less frequently, impact (e.g., dot matrix printers). Printers using other technologies intended for s
are also available. Computer/network printers are used mainly in healthcare facilities as peripherals o
workstations. They provide hard copies to computerized hospital information (e.g., imaging, laborator
system users.

Printers designed to produce a standard and/or high-definition, permanent, monochromatic or color te


hard copy) on full-size (e.g., letter, legal) and/or nonstandard, large-format paper or other appropriate
toner to a light-sensitive print drum using a laser source. The toner is transferred to the printing medi
paper) using static electricity, and then the toner is fused to the paper using heat and pressure. These
include a revolving photosensitive drum, a laser source (e.g., a laser diode), a toner cartridge, rollers t
pressure to the paper, a rubber blade to remove excess toner, controls, and paper trays. Laser printer
for use as computer peripherals and/or by computer network users, providing high-definition hard cop
speed.

Label printers designed to produce monochromatic bar-coded graphics on paper or plastic (frequently
tags; they may work as a computer-controlled peripheral. These printers typically include a thermal he
ink from a ribbon to the tag (thermal transfer printer) for a permanent print or perform temporary (up
heat-sensitive tag (direct thermal printer); bar-code printers usually include special feeding mechanism
multiple tags provided either in tear sheets or in rolls. Bar-code printers are used in healthcare facilitie
samples, for patient and/or equipment identification, and for inventories and other administrative pur
frequently used as components of hospital bar-coded information systems.

Syringe assemblies designed as reusable components of angiographic kits used with contrast media in
assemblies typically include a syringe and a contrast medium bottle, permitting the performance of se
maintaining sterility. The assembly may also include a handpiece that facilitates the operator's contro
flow of the injection. Reusable syringe assembly angiographic kits are intended to reduce the contrast
during injection and to reduce time between procedures.

Manifold assemblies designed as a disposable (i.e., single use) component of angiographic kits used w
injectors. These assemblies typically include a manifold and low-pressure tubing required for dispensin
may also include a disposable pressure transducer. Disposable manifold assemblies and reusable syri
reduce the contrast media discarded during injection and time between procedures.

Syringe/manifold assemblies consist of a combine reusable syringe and a disposable manifold assemb
used as components of angiographic kits used in conjunction with contrast media injectors. The assem
reusable syringe assembly which includes a contrast media bottle; a handpiece to facilitate operator c
and flow of the injection; and a manifold assembly that includes low-pressure tubing to dispense salin
syringe/disposable manifold assemblies are intended to reduce the amount of contrast media discarde
and to reduce the time between procedures.
Control assemblies designed as disposable components for manual control of the angiography kits use
injection systems. These assemblies typically consist of a disposable hand operated mechanical contr
high-pressure stopcocks; extension tubing for administration of the contrast media may be also attach
the control kit. Contrast media injection control assemblies are used for precise flow and volume admi
media during angiographic procedures.

Apheresis units primarily designed to automate the separation, collection, and reinfusion of blood com
plasma, platelets, and leukocytes from a healthy blood donor. Typically, one or more components are s
collected and the rest of the blood is automatically reinfused; with the use of automated methods, larg
components can be obtained from a single donor. Blood donor apheresis units usually consist of a disp
(i.e., a tubing set that connects the patient to the apheresis unit), pumps (e.g., rotary peristaltic pump
chamber, bowls, filters, clamps, controls (e.g., centrifuge and pump speed, volume of solution added)
detectors. The blood products collected depend on the needs of the blood center and the weight, tota
hematocrit of the donor. Dedicated apheresis units are available to collect only plasma or platelets (i.e
plasmapheresis or plateletpheresis, also called thrombocytapheresis).

Apheresis units designed to automate the separation and collection from and reinfusion of platelets to
(i.e. perform plateletpheresis). Typically, platelets are collected and the rest of the blood is automatica
use of automated methods, large quantities of platelets can be obtained from a single donor. Blood do
units usually consist of a disposable pheresis set (i.e., a tubing set that connects the patient to the ap
(e.g., rotary peristaltic pumps), a centrifugation chamber, bowls, filters, clamps, controls (e.g., centrifu
volume of solution added), alarms, and bubble detectors.

Apheresis units primarily designed to automate the separation and collection of plasma from a health
perform plasmapheresis). Typically, plasma is collected and the rest of the blood is automatically reinf
automated methods, large quantities of plasma can be obtained from a single donor. Blood donor plas
usually consist of a disposable pheresis set (i.e., a tubing set that connects the patient to the apheres
rotary peristaltic pumps), a centrifugation chamber, bowls, filters, clamps, controls (e.g., centrifuge an
of solution added), alarms, and bubble detectors. Blood donor plasmapheresis units may be used also
in some therapeutic procedures.

Apheresis units primarily designed to automate the removal of a pathologic component or toxin from t
and/or its exchange with a replacement fluid. Typically, one or more pathologic components (e.g., anti
and/or toxins are removed and the rest of the blood is automatically reinfused. These units usually con
pheresis set (i.e., a tubing set that connects the patient to the apheresis unit); pumps (e.g., rotary per
centrifugation chamber; bowls; filters; clamps; controls (e.g., centrifuge and pump speed, volume of s
and bubble detectors. Some therapeutic apheresis units use special affinity columns which contain ad
adsorbents selectively remove a pathogenic substance by chemical or antigen-antibody reactions as t
through the column rather than centrifugation.
Apheresis units designed to produce an immunosuppressant response in a patient using extracorporea
phototherapy) of leukocytes. These units typically separate the blood cell component to be treated (e
incorporate a photosensitive drug (e.g., 8-methoxypsoralen), and then photoactivate them using an a
(e.g., ultraviolet); the treatment may be tailored to the specific needs of a patient. Phototherapy aphe
the treatment (either curative or palliative) of several diseases, especially those related to T-cell disor
treatment of cutaneous effects of T-cell lymphoma, and organ transplant rejection).

Therapeutic apheresis units designed to remove low-density lipoprotein (LDL) cholesterol from the blo
includes a specialized filter that eliminates the LDL (including the very low-density [VLD]) cholesterol
blood and two intravenous lines; one line is used to draw blood from one arm and the other to return t
arm after LDL cholesterol filtration. LDL cholesterol removal apheresis units are used periodically (e.g.
when diet, exercise, and drugs do not provide an adequate treatment for high levels of cholesterol. Ot
such as triglycerides and fibrinogen are also lowered with this apheresis treatment.

Combinations of preassembled devices designed for use in blood cell washers. These sets typically inc
filters (e.g., clot, debris), connectors, and bags (e.g., red blood cell, waste); some sets also include a d
processing solution (e.g., saline). Dedicated disposable blood cell washer sets are available as a dispo
cell washers for use by blood banks and transfusion centers to improve the safety of blood transfusion
intended for autotransfusion units used during surgery and/or for treatment of trauma.

Blood pheresis sets in which all the components are preattached as a closed system. These devices ty
tubing, needles, collection bags, and saline solutions and anticoagulants; some closed sets have steril
permit users to provide their own intravenous and anticoagulant solutions. Closed blood pheresis sets
storage life of the products (e.g., five days for platelets). They are used in apheresis units.

Blood pheresis sets in which the components can be attached in-situ, allowing flexibility in the connec
intravenous and anticoagulant solutions. These sets typically include tubing, needles, and collection b
pheresis sets are simpler and allow more flexibility than closed sets, but the pheresis products can be
hours. They are used in apheresis units.
Units designed for the safe disposal of liquid waste, including contaminated or potentially infectious li
blood and/or other body fluids. All types of units include a component that is permanently connected t
drainage systems in one location (e.g., operating room, sterilizing room) and that is used to dispose o
sewage system; the units differ in the way that liquid is collected and/or transported to the unit that is
the sewage. Direct collection units evacuate the waste liquid directly from the suction field and into th
single operation; canister-based units drain the waste liquid directly from standard or dedicated collec
transported to the location; and cart-based systems include a dedicated cart in a separate room for liq
and transport it to the disposal area without moving the collecting canisters. Some units include canis
and/or disinfecting cycles and/or other functions (e.g., smoke evacuation). Liquid waste-disposal units
facilities for liquid waste management, including collection and disposal, with minimal exposure to the
Hypodermic injection needles designed to provide needlestick protection during subcutaneous injectio
cartridge syringes. These needles usually include some manually and/or automatically activated mech
that automatically locks in place after injection) intended to shield the needle after use or, by some ot
the possibility of contact between the healthcare provider and the sharp needle. Hypodermic subcuta
are intended mainly to be used with penlike syringes to inject insulin and/or other drugs (e.g., exenati
from prefilled disposable cartridge syringes (usually from 1 to 3 mL capacity) and/or several types of i

Electromagnetic stimulators designed to apply low flux density (in the order of microtesla) signals to b
stimulators usually apply short-duration, pulsed, radio-frequency energy, resulting in a very small tem
the target tissue (typically less than one degree Celsius). The devices typically consist of a stationary
powered (e.g., battery) generator, probes including appropriate transducers (usually coils) to be place
area, and a cable to deliver the signals from the generator to the probe. Dedicated low-intensity elect
are available with appropriate signal levels and transducers and probes that are intended to promote
wounds; dedicated stimulators are also available for the brain and/or spinal cord that are intended for
to treat behavior disorders.

Electromagnetic stimulators designed to apply electromagnetic energy to soft tissue and wounds at a
order of microtesla) below the patient's heat sensory perception threshold. These stimulators usually
pulsed, radio-frequency energy, resulting in a very small temperature increase on the target tissue (le
Celsius). The stimulators typically consist of a stationary or portable electrically powered (e.g., batter
including appropriate transducers (usually coils) to be placed near the treatment area, and a cable to
from the generator to the probe. Soft tissue/wound electromagnetic stimulators are intended to promo
treatment of wounds and/or other soft-tissue injuries.

Devices designed to allow two independent computer networks and/or systems to communicate with
transmitting data and/or other information between the devices. Data interface units typically include
processing unit and wireless or cable connections to both interfaced devices; they may also include ap
that contains the languages and codes that the applications use to communicate with each other and
Healthcare applications of data interface units include interfacing of bedside devices (e.g., physiologic
of-care and laboratory analyzers and equipment to computers, workstations, and/or hospital informati

Devices designed for alphabetic, numeric, alphanumeric, symbol, and/or function data input. Keypads
separate mechanical and/or electromechanical grid of keys arranged for efficient data entry that are s
enter data. A variety of keypads are available according to the intended use; applications of specific k
input for computers, workstations, and computerized systems (directly or using remote control) often
of equipment.

Computer peripheral devices that are designed for the entry of data in a computer, workstation, or oth
equipment or systems through manipulation of the keys on a keypad. Keypads typically consist of a m
electromechanical grid of keys arranged for efficient data entry that may include alphabetic, numeric,
and/or function keys. A variety of keypads are available according to the intended use; applications of
include data input for computers, workstations, and computerized systems, often as an integral comp
(e.g., laptop computers) and other computerized systems. Dedicated computer keypads are available
applications. Computer keypads that are washable, fully sealed, waterproof, and/or flexible and that c
and disinfected are also available.
Devices designed to display text and/or graphical information on an electronic screen located remotel
information. The devices typically consist of an electronic (e.g., liquid crystal, cathode ray tube) scree
circuitry appropriate to display the information. Auxiliary displays may be intended for display of infor
public and/or the staff in healthcare facilities; dedicated displays intended for physiologic monitoring a

Auxiliary displays designed to provide access to displays of monitored data (e.g., numeric, waveforms
identical to information provided in the central station. These displays typically consist of an electroni
with physiologic monitors or physiologic monitoring systems and shows the parameters and/or wavefo
devices may also display the alarm status of the physiologic monitors. Physiologic monitoring auxiliary
placed in hallways or multipatient rooms, providing healthcare staff ready access to patient alarm info
displays may be available as components of physiologic monitoring system, facilitating their installati
Interactive auxiliary displays that permit input from clinicians (e.g., adjusting or inactivating settings)
(i.e., read only) devices are available.

Physiologic monitoring auxiliary displays designed to provide access to patient information that is sim
on the central monitoring station and to permit the modification of monitor settings. These displays ty
display screen, appropriate electronic circuits appropriate to permit the visualization of patient physio
parameters and/or waveforms, and controls and keypads appropriate for changing alarm settings and
inactivating alarms, as well as making other modifications in the monitoring system. Interactive auxili
known as central station clients) are usually placed in hallways or multipatient rooms, providing ready
information and allowing clinicians to modify monitoring system parameters without going to the cent
each bedside monitor.

Physiologic monitoring auxiliary displays designed to provide access to patient information that is sim
on the central monitoring station, but without allowing any input from the clinician. These displays con
screens with appropriate electronic circuits to permit the visualization of physiologic parameters and/o
Noninteractive auxiliary displays (also known as slave displays) are usually placed in hallways or mult
providing staff ready access to patient information and allowing clinicians to determine patient status
central station or checking each bedside monitor.

Implantable prostheses designed to replace one of the interphalangeal joints of a finger or thumb. The
consist of articulated silicone or, less frequently, ceramic or metal components with a flat end and a s
has stems at both ends for introduction into the hollow marrow cavity previously made in bones that f
Prostheses that permit constrained, semiconstrained, or unconstrained hinged movement of the joint
Finger/thumb joint prostheses are used in patients who suffer from osteoarthritis or rheumatoid arthrit
also be implanted to prevent dislocation of the finger or thumb joints. Prostheses for finger and thumb
available in a variety of sizes; marble-like spherical prostheses that are intended to fit between notche
bones are also available.
Implantable prostheses designed for total replacement of the shoulder joint. These prostheses typicall
combination of a humeral component (consisting of a long stem that is anchored in the hollow center
end and a cup that is attached to the other end forming the ball of the articulation) and a glenoid com
metal tray with a short stem that is anchored directly to the scapula and a plastic cup that replaces th
shoulder blade at the articulation point). Made of a combination of metal, ceramics, and/or polymeric
shapes and technologies, the prostheses may be intended for use with or without bone cement. Total
prostheses are used in patients who suffer from osteoarthritis or rheumatoid arthritis or, less frequent
fracture).

Implantable prostheses designed for total or partial replacement of the temporomandibular joint. Part
prostheses are mandibular fossa components intended to provide an articulation surface for the mand
usually consist of a plastic (e.g., polyethylene) fossa bearing that may include a titanium mesh backin
fossa eminence prosthesis [FEP]). Mandibular condyle partial temporomandibular prostheses are inte
mandibular condylar head and to articulate with the mandibular fossa component; they are used almo
combination with a mandibular fossa component in total temporomandibular prostheses. Intra-articula
temporomandibular prostheses are intended to replace the disc of fibrocartilage attached to the mand
ligaments. Total temporomandibular joint prostheses typically include mandibular fossa and mandibul
components. Temporomandibular joint prostheses are intended for patients who suffer from osteoarth
arthritis, congenital malformations, or neoplasms, as well as after trauma (e.g., fracture).

Implantable prostheses designed for replacement of the carpal lunate bone, one of the eight bones of
the bones of the forearm and the bones of the hand at the wrist joint. These devices are typically one-
of metal (e.g., titanium) or polymeric (e.g., silicone elastomer), materials resembling the shape and ch
natural bone; they may include special features (e.g., beaks, holes) to stabilize the carpal bones. The
prostheses requires the surgical removal of the lunate carpal bone. Carpal lunate wrist joint prosthese
wrist motion in patients who suffer trauma (e.g., fracture) or, more frequently, from a disease causing
the lunate bone (known as Kienbock disease), usually associated with bone death (i.e., osteonecrosis)

Implantable prostheses designed for replacement of the carpal scaphoid bone, one of the eight bones
the bones of the forearm and the bones of the hand at the wrist joint. These devices are typically one-
of metal (e.g., titanium) or polymeric (e.g., silicone elastomer) materials, resembling the shape and ch
natural bone; they may include special features (e.g., beaks, holes) to stabilize the carpal bones. The
prostheses requires the surgical removal of the scaphoid carpal bone. Carpal scaphoid wrist prosthese
restore wrist motion in patients who suffer trauma (e.g., fracture) causing avascular necrosis of the sc

Implantable prostheses designed for replacement of the carpal trapezium bone, one of the eight bone
connecting the bones of the forearm and the bones of the hand at the wrist joint. These devices are ty
prostheses with an intramedullary stem made from polymeric (e.g., silicone elastomer) materials, rese
characteristics of the natural bone. Carpal trapezium wrist prostheses are mainly used to restore wrist
function in patients who suffer from degenerative arthritis or posttraumatic arthritis (e.g., following an
fracture).
Implantable prostheses designed for total replacement of the wrist joint. These prostheses usually hav
radial component (consisting of two pieces, a flat metal device with a long stem at one end that ancho
the hollow center of the bottom of the radius and a very hard, slick plastic cup attached at the other e
the wrist joint) and a distal component (consisting of two metal stems that are placed in the hollow bo
the carpal and metacarpal bones, respectively, with the opposite end shaped as a metallic ball that fit
end of the radius). Both parts are metal; a high-density, tough, slick plastic (e.g., polyethylene) space
components enables the two components of the new joint to glide easily against each other, permittin
wrist in all directions. Less frequently, a total prosthesis with a single across-the-joint component (usu
elastomer) is used. Total wrist joint prostheses are used to stop bones from rubbing against each othe
restore wrist motion and/or strength in patients who suffer from osteoarthritis or rheumatoid arthritis,
(e.g., fracture).

Prostheses designed for total or partial replacement of a missing upper limb. These prostheses typical
more external components; they may also include totally or partially implantable components (e.g., el
prostheses are usually fixed with a socket to the residual limb to replace the lost parts and frequently
customization. Upper limb prostheses are typically made of metal (e.g., cobalt-chromium alloys), hard
polyethylene), carbon fibers, or a combination of materials. The prostheses may include other compon
electrical motors, pneumatic devices, and/or electronic systems with electrodes and sensors that may
placed on the skin. The main components of upper limb prostheses are terminal components (e.g., ha
elbows, shoulders, and bars or rods to replace the arm or forearm. Some of the components may be u
or combined as partial prostheses according to the level of amputation; total replacement prostheses
components to permit complete replacement of the limb. Passive, mechanical (e.g., patient-actuated)
myoelectric upper limb prostheses are available; they are used mainly in patients who have congenita
suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Upper limb prostheses designed for partial or total replacement of a missing finger or thumb for cosm
reasons. These prostheses are typically external or partially implanted devices that resemble a natura
are usually made of metal (e.g., titanium), hard plastics (e.g., polyethylene), silicone, or a combination
usually require some degree of customization. Finger/thumb prostheses may be partial prostheses att
finger or total prostheses attached to the hand using suction, cement, or osseointegration techniques
prostheses are available in a variety of colors, sizes, and designs (e.g., for children, women, men); the
patients who suffered amputations due to traumatic injuries or who have congenital absences or abno

Hand prostheses designed for cosmetic (i.e., passive) replacement of a missing hand. These prosthese
that resemble a natural hand and are made of metal (e.g., cobalt-chromium alloys), hard plastics (e.g.
combination of materials; they are usually fixed with a socket to the wrist and require some degree of
hand prostheses are usually covered with a cosmetic glove; they are available in a great variety of con
The prostheses may be used alone as a replacement for a lost hand or as the terminal component of a
above-the-elbow, or total upper limb prosthesis; some hand prostheses can be locked in several fixed
used mainly in patients who have congenital abnormalities or who suffered amputations due to illness
traumatic accidents.
Hand prostheses operated by mechanical power, usually supplied by other parts of the patient body (
and designed for partial functional and cosmetic replacement of a missing hand. These prostheses are
resemble a natural hand and are made of metal (e.g., cobalt-chromium alloys), hard plastics (e.g., pol
combination of materials; they are usually fixed with a socket to the wrist and require some degree of
Mechanical hand prostheses may be externally or patient-actuated; in the most common configuration
by cables attached to a harness strapped around the shoulders. Movement of the shoulder operates (e
hand. The prostheses may be used alone as a replacement for a lost hand or as the terminal compone
elbow, above-the-elbow, or total upper limb prosthesis in patients who have congenital abnormalities
amputations due to illness (e.g., diabetes) or traumatic accidents.

Hand prostheses operated by electrical power and designed for partial functional and cosmetic replac
hand. These prostheses are typically external devices that resemble a natural hand and that may inclu
implantable components. They are made of metal (e.g., cobalt-chromium alloys), hard plastics (e.g., p
fibers, or a combination of materials; the prostheses are usually fixed with a socket to the wrist and re
customization. Electrically powered hand prostheses incorporate small electrical motors and manual e
control the hand movements. They may be used alone as a replacement for a lost hand or as the term
below-the-elbow, above-the-elbow, or total upper limb prosthesis in patients who have congenital abn
suffered amputations due to illness (e.g., diabetes) or traumatic accidents. Electric powered hand pros
bioelectrical signals from muscle contraction (i.e., myoelectric) are also available.

Hand prostheses operated by myoelectric power and designed for partial functional and cosmetic repl
hand. These prostheses are typically external or partially implanted devices that resemble a natural h
metal (e.g., cobalt-chromium alloys), hard plastics (e.g., polyethylene), carbon fibers, or a combination
usually fixed with a socket to the wrist and require some degree of customization. Myoelectric controll
typically incorporate small electrical motors and electrodes within the socket to pick up bioelectrical s
operation as the muscles in the residual limb contract. They may be used alone as a replacement for a
terminal component of a below-the-elbow, above-the-elbow, or total upper limb prosthesis in patients
abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Upper limb prostheses, usually resembling a hook, that are designed for partial functional replacemen
These prostheses typically consist of an external metal (e.g., stainless steel) device including finger- li
covered with polymers or with serrated holding surfaces and including an appropriate mechanism to p
objects; the prostheses may also include total or partially implantable components (e.g., sensors, elec
prostheses may be mechanically operated (e.g., using cables and springs) or electrically powered; the
great variety of configurations and sizes. Upper limb hook prostheses may be used alone as a replace
hand or as the terminal component of a below-the-elbow, above-the-elbow, or total upper limb prosth
mainly in patients who have congenital abnormalities or who suffered amputations due to illness (e.g.
traumatic accidents.
Hook prostheses operated by mechanical power, usually supplied by other parts of the patient body (i
and designed for partial functional replacement for a missing hand. These prostheses are typically ext
metal (e.g., cobalt-chromium alloys), hard plastics (e.g., polyethylene), carbon fibers, or a combination
usually fixed with a socket to the wrist and require some degree of customization. Mechanical hook pr
externally or patient-actuated; in the most common configuration, the hand is operated by cables atta
strapped around the shoulders. Movement of the shoulder operates (e.g., opens, closes) the hand. Me
prostheses may be used alone as a replacement for a missing hand or as the terminal component of a
above-the-elbow, or total upper limb prosthesis. They are used mainly in patients who have congenita
suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Hook prostheses operated by electric power and designed for partial functional replacement of a miss
prostheses are typically external devices made of metal (e.g., cobalt-chromium alloys), hard plastics (
carbon fibers, or a combination of materials; they are usually fixed with a socket to the wrist and requ
customization. Electrically powered hook prostheses incorporate small electrical motors and manual e
control the hook movements. They may be used alone as a replacement for a missing hand or as the
a below-the-elbow, above-the-elbow, or total upper limb prosthesis in patients who have congenital ab
suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Hook prostheses operated by myoelectric power and designed for partial functional replacement of a
prostheses are typically external devices made of metal (e.g., cobalt-chromium alloys), hard plastics (
carbon fibers, or a combination of materials; they may include totally or partially implanted componen
electrodes). The prostheses are usually fixed with a socket to the wrist and require some degree of cu
Myoelectric controlled hand prostheses typically incorporate small electrical motors and electrodes wi
up electrical signals that trigger hook operation as the muscles in the residual limb contract. They ma
replacement for a missing hand or as the terminal component of a below-the-elbow, above-the-elbow,
prosthesis in patients who have congenital abnormalities or who suffered amputations due to illness (
traumatic accidents.

Upper limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of the wrist
articulation. These prostheses typically consist of external devices with a metal ring-shaped mechanis
rotational and flexion movements and locking positions at the distal end to a terminal device (e.g., ha
include totally or partially implantable components (e.g., sensors, electrodes). The prostheses can be
proximal end with a socket to the residual limb or to another prosthetic device (i.e., forearm replacem
may be mechanically operated (e.g., using cables and springs), electrically powered (e.g., using switc
the electrical signals produced by muscle contractions (i.e., myoelectric). Wrist prostheses are availab
configurations and sizes; they must be used as a component of a below-the-elbow, above-the-elbow, o
prosthesis. Upper limb wrist prostheses are used mainly in patients who have congenital abnormalitie
amputations due to illness (e.g., diabetes) or traumatic accidents.
Wrist prostheses operated by mechanical power, usually supplied by other parts of the patient body (i
and designed for partial functional (e.g., rotation, flexion) replacement of the wrist above the wrist art
prostheses typically consist of external devices with a metal ring-shaped mechanism that can provide
movements and locking positions at the distal end to a terminal device (e.g., hand, hook); they can be
proximal end with a socket to the residual limb or to another prosthetic device (i.e., forearm replacem
powered wrist prostheses may be externally or patient-actuated; in the most common configuration, t
cables attached to a harness strapped around the shoulders. Movement of the shoulder operates the
movement to the terminal device. Wrist component prostheses are available in a great variety of confi
they must be used as a component of a below-the-elbow, above-the-elbow, or total upper limb prosth
have congenital abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic

Wrist prostheses operated by electric power and designed for partial functional (e.g., rotation, flexion)
wrist above the wrist articulation. These prostheses typically consist of external devices with a metal r
mechanism that can provide rotational and flexion movements and locking positions at the distal end
(e.g., hand, hook); they can be attached at the proximal end with a socket to the residual limb or to an
device (i.e., forearm replacement). Electrically powered wrist prostheses incorporate small electrical m
electrical switches to control the wrist and/or terminal prosthesis movements. They are typically used
below-the-elbow, above-the-elbow, or total upper limb prosthesis in patients who have congenital abn
suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Wrist prostheses operated by myoelectric power and designed for partial functional (e.g., rotation, flex
the wrist above the wrist articulation. These prostheses typically consist of external devices with a me
mechanism that can provide rotational and flexion movements and locking positions at the distal end
(e.g., hand, hook); they may include totally or partially implantable components (e.g., sensors, electro
can be attached at the proximal end with a socket to the residual limb or to another prosthetic device
replacement). Myoelectric controlled wrist prostheses typically incorporate small electrical motors and
socket to pick up bioelectrical signals that trigger wrist operation as the muscles in the residual limb c
typically used as a component of a below-the-elbow, above-the-elbow, or total upper limb prosthesis i
congenital abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic accid

Upper limb prostheses designed for partial functional (e.g., rotation, flexion) and/or cosmetic replacem
portion of a limb at the wrist articulation, in which the radial component of the articulation is preserve
are typically external or partially implantable devices that include a mechanism to provide rotational a
and locking positions at the distal end to the terminal device; they are usually attached at the proxima
that preserves pronation and supination. The prosthesis includes a terminal device (e.g., hand, hook)
use of a "screwdriver" type socket provides stability at the distal portion and transmits rotation. The p
mechanically operated (e.g., using cables and springs), electrically powered (e.g., using external moto
triggered by electrical signals produced by normal muscle contractions (i.e., myoelectric). Disarticulat
are available in a great variety of configurations and sizes; they are used mainly in patients who have
abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic accidents.
Upper limb prostheses designed for cosmetic and partial functional (e.g., rotation, flexion) replacemen
amputated below the elbow articulation. These prostheses typically consist of external devices with an
and a terminal (e.g., hand, hook) component that is attached at the proximal end with a socket to the
another prosthetic device (i.e., forearm replacement). They may also include totally or partially implan
(e.g., sensors, electrodes). The wrist component usually includes a metal ring-shaped mechanism that
and flexion movements and locking positions to the terminal (e.g., hand, hook) component. The prosth
mechanically operated (e.g., using cables and springs), electrically powered (e.g., using motors and sw
by the electrical signals produced by muscle contractions (i.e., myoelectric). Below-the-elbow prosthe
great variety of configurations and sizes; they are used mainly in patients who have congenital abnorm
suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Upper limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of the elbow
elbow. These prostheses typically consist of external devices with a metal, hinged, yoke-like mechanis
rotational and flexion movements and several locking positions; they may also include totally or partia
components (e.g., sensors, electrodes). Elbow component prostheses can be attached at the proximal
the residual limb (i.e., the humerus) or to another prosthetic device (e.g., a tube) and at the distal end
(i.e., forearm replacement) that is, in turn, attached to a wrist prosthesis and a terminal device (e.g., h
prostheses may be mechanically operated (e.g., using cables and springs) electrically powered (e.g., u
switches), or triggered by the electrical signals produced by muscle contractions (i.e., myoelectric). El
available in a great variety of configurations and sizes; they must be used as a component of an abov
upper limb prosthesis. Upper limb elbow prostheses are used mainly in patients who have congenital
suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Elbow prostheses that are operated by mechanical power, usually supplied by other parts of the patie
powered), and designed for partial functional (e.g., rotation, flexion) replacement of the elbow above t
These prostheses typically consist of external devices with a metal, hinged, yoke-like mechanism that
and flexion movements and several locking positions; they can be attached at the proximal end with a
limb (i.e., the humerus) or to another prosthetic device (e.g., a tube) and at the distal end to a tubular
replacement) that is, in turn, attached to a wrist prosthesis and a terminal device (e.g., hand, hook). M
prostheses may be externally or patient-actuated; in the most common configuration the elbow is ope
attached to a harness strapped around the shoulders. Elbow prostheses are available in a great variet
sizes; they are typically used as a component of an above-the-elbow or total upper limb prosthesis in
congenital abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic accid
Elbow prostheses that are operated by electric power and designed for partial functional (e.g., rotation
of the elbow component above the elbow. These prostheses typically consist of external devices with
like mechanism that can provide rotational and flexion movements and several locking positions; they
the proximal end with a socket to the residual limb (i.e., the humerus) or to another prosthetic device
the distal end to a tubular device (i.e., forearm replacement) that is, in turn, attached to a wrist prosth
device (e.g., hand, hook). Electrically powered elbow prostheses incorporate small electrical motors an
switches to control the elbow and/or terminal prosthesis movements. They are typically used as a com
the-elbow or total upper limb prosthesis in patients who have congenital abnormalities or who suffere
illness (e.g., diabetes) or traumatic accidents. Electrically powered wrist prostheses controlled by bioe
muscle contractions (i.e., myoelectric) are also available.

Elbow prostheses that are operated by myoelectric power and designed for partial functional (e.g., rot
replacement of the elbow above the elbow articulation. These prostheses typically consist of external
hinged, yoke-like mechanism that can provide rotational and flexion movements and several locking p
include totally or partially implanted components (e.g., sensors, electrodes). Elbow component prosth
at the proximal end with a socket to the residual limb (i.e., the humerus) or to another prosthetic devi
the distal end to a tubular device (i.e., forearm replacement) that is, in turn, attached to a wrist prosth
device (e.g., hand, hook). Myoelectric controlled elbow prostheses typically incorporate small electrica
electrodes within the socket to pick up bioelectrical signals that trigger elbow operation as the muscle
contract. The prostheses are used as a component of an upper limb prosthesis in patients who have c
abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic accidents.

Upper limb prostheses designed for partial functional (e.g., rotation, flexion) and/or cosmetic replacem
portion of a limb at the elbow articulation, in which the distal end of the humerus is preserved. These
consist of external or partially implantable devices that include a socket at the proximal end, intended
humerus epicondyles, that helps to preserve arm rotation; the bulbous ends of the humeral condyles,
suspension. The prosthesis includes a tubular device (i.e., forearm replacement) at the distal end that
a wrist prosthesis and to a terminal device (e.g., hand, hook). Disarticulation elbow prostheses may b
operated (e.g., using cables and springs), electrically powered (e.g., using motors and switches), or tr
electrical signals produced by muscle contractions (i.e., myoelectric). The prostheses are available in
configurations and sizes; they are used in patients who have congenital abnormalities or who suffered
illness (e.g., diabetes) or traumatic accidents.
Upper limb prostheses designed for cosmetic and partial functional (e.g., rotation, flexion) replacemen
elbow articulation. These prostheses typically consist of external devices that include elbow, wrist, an
hook) components; they may include totally or partially implantable components (e.g., sensors, electr
component can provide rotational and flexion movements and locking positions at the distal end. Abo
prostheses include, at the proximal end, a socket to the residual limb (i.e., the humerus) or to another
(e.g., a tube). The elbow and wrist components of an upper limb above-the-elbow prostheses may be
(e.g., using cables and springs); electrically powered (e.g., using motors and switches), or triggered by
produced by muscle contractions (i.e., myoelectric). Some prostheses use a hybrid approach, using m
elbow component and electric power for the wrist component or vice versa. Above-the-elbow prosthes
great variety of configurations and sizes; they are used in patients who suffered amputations due to il
or traumatic accidents or, less frequently, in patients who have congenital abnormalities.

Upper limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of the shoul
completely missing limb (i.e., amputated above the shoulder articulation). These prostheses typically
partially implantable devices that include a mechanism that provides rotational and flexion movemen
at the distal end; they can be anchored directly to the scapula at the articulation point. Shoulder prost
mechanically operated (e.g., using cables and springs) or electrically powered (e.g., using motors and
Shoulder prostheses are available in a great variety of configurations and sizes; they are typically use
other upper limb distal components (e.g., elbow, wrist, hand) in total upper limb prostheses. Upper lim
prostheses are used mainly in patients who suffered amputations due to traumatic accidents or illness
patients who have congenital abnormalities.

Shoulder prostheses operated by mechanical power, usually supplied by other parts of the patient bod
and designed for partial functional (e.g., rotation, flexion) replacement of the shoulder of a completely
amputated above the shoulder articulation). These prostheses typically consist of external or partially
with a mechanism that provides rotational and flexion movements and locking positions at the distal e
anchored directly to the scapula at the proximal (i.e., articulation) point. Mechanical shoulder compon
typically used in combination with other upper limb distal components (e.g., elbow, wrist, hand) as tot
prostheses in patients who suffered amputations due to traumatic accidents or illness or, less frequen
have congenital abnormalities.

Shoulder prostheses operated by electric power and designed for partial functional (e.g., rotation, flex
the shoulder of a completely missing limb (i.e., amputated above the shoulder articulation). These pro
consist of external or partially implantable devices with a mechanism that provides rotational and flex
locking positions at the distal end; they can be anchored directly to the scapula at the articulation poi
shoulder component prostheses incorporate small electrical motors and manual electrical switches to
and/or terminal prosthesis movements. They are typically used in combination with other upper limb d
(e.g., elbow, wrist, hand) as total upper limb prostheses in patients who suffered amputations due to t
illness, or, less frequently, in patients who have congenital abnormalities.
Upper limb prostheses designed for partial functional (e.g., rotation, flexion) and/or cosmetic replacem
portion of a limb amputated at the shoulder articulation, in which the shoulder blade (i.e., the glenoid
articulation is preserved. These prostheses typically consist of external or partially implantable device
wrist, and a terminal device (e.g., hand, hook) and with a mechanism that provides rotational and flex
locking positions at the distal end. They are usually attached at the proximal end with a thoracic socke
style) that encloses and rests on the shoulder girdle and thoracic area to optimize stability and provid
surface for control switches of externally powered prostheses. The prostheses may be mechanically op
cables and springs) or electrically powered (e.g., using external switches, electronic controls, and elec
Shoulder disarticulation prostheses are available in a great variety of configurations and sizes; they ar
suffered amputations due to illness (e.g., diabetes), or traumatic accidents or, less frequently, in patie
congenital abnormalities.

Upper limb prostheses designed for replacement of a completely missing upper limb including the cla
interscapulothoracic amputation). These prostheses consist of external or partially implantable device
shoulder, elbow, wrist, connecting tube, and terminal (e.g., hands, hooks) components; they may also
such as cables, electrical motors, and switches. A symmetrical shoulder is usually achieved, but strap
the contralateral side of the body may be used to distribute weight and to maintain the upper limb pro
when there is very little surface area in the shoulder region to support the weight of the prosthesis. A
made from aluminum strips and fitted around the rib cage on the amputated side is frequently used a
for the prosthetic arm as well as for the switches. Total upper limb prostheses are typically made of m
chromium alloys), hard plastics (e.g., polyethylene), carbon fibers, or a combination of materials. Pass
operated, and electrically powered total upper limb prostheses are available; they are used mainly in
amputations (i.e., forequarter amputees) due to traumatic accident or, less frequently, in patients who
due to illness (e.g., diabetes) or who have congenital abnormalities.

Prostheses designed for total or partial replacement of a missing lower limb. These prostheses typical
devices with one or more components that are fixed with a socket to the residual limb to replace the l
prostheses may include totally or partially implantable components (e.g., sensors, electrodes). Lower
require some degree of customization; they are typically made of metal (e.g., cobalt-chromium alloys)
polyethylene), carbon fibers, or a combination of materials. The main components of lower limb prosth
knees, and hips; they may include devices such as cables, straps, sockets, and pylons. Partial lower lim
consist of a single component (e.g., foot) or several components (e.g., foot, ankle, knee) combined as
according to the level of amputation, while total replacement prostheses include all components for th
replacement of the limb. Passive, mechanical, and patient-actuated lower limb prostheses are availab
mainly in patients who have congenital abnormalities or who suffered amputations due to illness (e.g.
traumatic accidents.
Lower limb foot prostheses designed to store and release energy (i.e., dynamically respond) to and fro
during gait. These foot prostheses typically consist of external devices that incorporate elastic heel str
energy during midstance and terminal stance and release it during preswing and initial swing. Severa
available including prostheses with an S-shaped spring, foam, and spacer that are integral parts of the
made of polymeric material with very specific elasticity and resistance requirements to optimize energ
and prostheses that maximize performance (in both energy and compliance) by using a complex meta
a compressible foam piece and hinges to allow rotation on three planes. Each type uses a variation of
Energy-storing foot prostheses are intended for otherwise healthy people who have lost a foot and wh
activity levels generate enough energy to be worth using.

Lower limb prostheses designed for partial functional and/or cosmetic replacement of the front part of
prostheses typically consist of external devices (some may include totally or partially implantable com
resemble the lost part of a natural foot and are made of metal (e.g., cobalt-chromium alloys), hard pla
polyethylene), carbon fibers, or a combination of materials. Partial foot prostheses that use several te
different purposes are available, including prostheses with shoe inserts and longitudinal arches, patell
prostheses (clamshell prostheses that load the patella tendon), and molded sockets of either ankle or
The prostheses are used mainly in patients who suffered amputations due to illness (e.g., diabetes) an
and, less frequently, in patients who have congenital abnormalities.

Lower limb prostheses designed for partial functional (primarily flexion) replacement of the distal port
amputated at the ankle articulation, in which the tibial component of the articulation is preserved. The
consist of external or partially implantable devices with a mechanism that provides flexion (i.e., acting
degree of internal and external rotation and locking positions at the distal end of the foot component
are usually attached at the proximal end with a socket that allows direct load transfer (i.e., end-bearin
socket fit less crucial than in through-bone amputations. Disarticulation ankle prostheses are available
configurations and sizes; they may be passive, mechanical, or patient-actuated. The prostheses are us
who have congenital abnormalities or who suffered amputations due to illness (e.g., diabetes) or traum

Lower limb prostheses designed for partial functional (primarily flexion) replacement of the ankle port
limb. These prostheses typically consist of external devices with a mechanism that provides flexion (i.
and some degree of internal and external rotation movements and locking positions at the distal end
they are usually attached at the proximal end with a socket to the residual limb or another prosthetic
Ankle component prostheses are available in a great variety of configurations and sizes; they may be
or patient-actuated. The prostheses are used mainly in patients who have congenital abnormalities or
amputations due to illness (e.g., diabetes) or traumatic accidents.
Lower limb prostheses designed for cosmetic and partial functional (primarily flexion) replacement of
amputated below the knee articulation. These prostheses typically consist of external or partially impl
including an assembly of ankle and foot components that are attached at the proximal end with a sock
or another prosthetic device (e.g., a tube resembling the leg); the ankle component usually includes a
provides flexion (i.e., acting as a hinge) and some degree of internal and external rotation movements
to the foot component. Below-the-knee lower limb prostheses are available in a great variety of config
they are used mainly in patients who have congenital abnormalities or who suffered amputations due
diabetes) or traumatic accidents.

Lower limb prostheses designed for partial functional (primarily flexion) replacement of the knee as a
above-the-knee or total lower limb prosthesis. These prostheses typically consist of external devices w
provides flexion (i.e., acting as a hinge) and some degree of internal and external rotational movemen
positions at the distal end; some prostheses include hydraulic devices and/or microprocessors to regu
movements. Knee prostheses can be attached at the proximal end with a socket to the residual limb (
another prosthetic device (e.g., a tube resembling the femur) and at the distal end to a tubular device
attached to ankle and foot prostheses. Knee component prostheses are available in a great variety of
sizes; they are typically used as a component of an above-the-knee or total lower limb prosthesis in p
congenital abnormalities or who suffered amputations due to illness (e.g., diabetes) or traumatic accid

Lower limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of a missing
knee articulation, in which the femoral component of the articulation is preserved. These prostheses t
external or partially implantable devices, including foot and ankle components at the distal end and a
component at the proximal end. A two-section mechanism with an anchor in the upper section connec
frequently, linkage bars connect the upper and lower sections. Some prostheses include hydraulic or p
and/or microprocessors to regulate the knee movements. Disarticulation knee prostheses are attached
to the residual limb (i.e., the intact femur) with a socket; they are available in a great variety of config
Lower limb disarticulation knee prostheses are used mainly in patients who have congenital abnormal
amputations due to illness (e.g., diabetes) or traumatic accidents.

Lower limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of a missing
articulation. These prostheses typically consist of external or partially implantable devices including k
components; the knee and ankle components provide flexion (i.e., acting as a hinge) and some degree
external rotation movements and locking positions at the distal end; some prostheses include hydraul
microprocessors to regulate knee movements. They are usually attached at the proximal end with a so
limb (i.e., the femur) or another prosthetic device (e.g., a tube resembling the femur). Above-the-knee
are available in a great variety of configurations and sizes; they are used mainly in patients who suffe
illness (e.g., diabetes) or traumatic accidents or, less frequently, in patients who have congenital abno
Lower limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of the hip as
prosthesis intended to replace a completely missing limb (i.e., amputated above the hip articulation).
typically consist of external or partially implantable devices with a mechanism that provides rotationa
movements and locking positions at the distal end; they can be anchored directly to the socket lamina
double-hinged plate at the articulation point. Hip prostheses are available in a great variety of configu
must be used combined with other lower limb distal components (e.g., knee, ankle, foot, pylon) as tot
prostheses in patients who suffered amputations due to traumatic accidents or, less frequently, in pat
congenital abnormalities or illness.

Lower limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of a hip amp
articulation (i.e., removing the femur completely but keeping the pelvis intact). These prostheses typi
or partially implantable devices with socket, foot, ankle, knee, and tubular components resembling th
hip component including a mechanism that provides rotational and flexion movements and locking po
end and that can be anchored directly to the socket lamination plate, typically using a double-hinged
articulation point. Disarticulation hip prostheses are available in a great variety of configurations and
used as lower limb prostheses in patients who suffered amputations due to traumatic accidents or, les
patients who have congenital abnormalities or illness.

Lower limb prostheses designed for partial functional (e.g., rotation, flexion) replacement of a complet
the femur and part of the pelvis removed above the hip articulation). These prostheses typically consi
partially implantable devices with socket, foot, ankle, knee, and tubular components resembling the le
knee, and ankle components include mechanisms that can provide rotational and flexion movements
to the components distal to them. Total lower limb prostheses can be anchored directly to the socket l
are available in a great variety of configurations and sizes and are used in patients who suffered ampu
(e.g., cancer) or traumatic accidents or, less frequently, in patients who have congenital abnormalities

Flowmeters designed for non-invasive (i.e., transcranial) measurement of blood flow in the main brain
instruments typically process the spectrum of the shift of pulsed ultrasound waves (i.e., Doppler effec
movement to assess the blood velocity. These flowmeters typically consist of a unit including a radiofr
electronic circuits to process the signal including computerized capabilities and a dedicated software,
ultrasound transducers, controls, and a display; the flowmeters are also available in portable versions
blood flowmeters may be used for external assessment of blood flow in any major artery of the body;
used for evaluation of blood flow in intracranial (e.g., anterior, middle, and posterior cerebral) arteries
emboli and diagnose vasospasm and stenosis.

Germicidal air cleaners designed to kill most bacteria (e.g., Mycobacterium tuberculosis) and many vir
ultraviolet (UV) radiation. These devices are typically enclosed metal (usually stainless steel) air clean
at 254 nm is typical) lamps, particulate filters, fans, and switches. UV germicidal air cleaners are inten
in healthcare facilities, including waiting rooms and doctors' offices, especially where ceiling height or
not allow the installation of UV lamps higher than 7 feet; the devices are less effective against fungus
Testers designed to simultaneously measure, analyze, and display high-speed variable digital signals i
(multichannel) systems by detecting logic threshold levels. These testers are typically stand-alone ele
multiple inputs that detect logic threshold levels and analyze the digital captured data following proce
correlate them to a source code; the testers may convert the data in time graphics, computer program
assembly languages), or other preprogrammed ways. Logic circuit testers are used typically to verify d
operations; to simultaneously trace and correlate many digital signals; to detect and analyze transien
embedded software execution.

Electrothermal cautery units designed to coagulate and/or destroy tissue by applying a probe that con
radiation into heat; they are intended mainly to control bleeding and for therapeutic procedures. Thes
of an electronic power source with a timer and controls, a handpiece with the IR lamp, a detachable p
glass light guide that converts IR radiation into heat, a disposable sterile sheath to reduce the risk of c
and an electric cord to connect the handpiece to the power source. Most units are available with a set
applications. IR electrothermal cautery units are intended for a variety of applications, including anore
hemorrhoidectomy), dermatologic (e.g., tattoo suppression), and hair transplantation procedures.

Laboratory systems designed to store water that is relatively free from chemical and/or organic contam
microorganisms (i.e., purified water) and to subsequently deliver it through pipes for use in a clinical l
systems typically include a stand-alone unit with a sealed water reservoir, filters, and a pump for wate
may also include additional means (e.g., ultraviolet light) to prevent the growth of and/or eliminate m
with capacities ranging from a few hundred to several thousand liters (approximately 20 to 1,000 gallo
Intended for clinical laboratory use when pure water is needed, these systems are not intended to sto
and/or sterile water due to some degree of contamination that is always present in stored water.

Hemodialysis units designed for the continuous replacement of the main activity of the kidneys by rem
wastes at a slow and steady rate (i.e., continuous renal replacement therapy [CRRT] machines). Blood
extracorporeal circuit, using either arteriovenous access (typically femoral artery to femoral vein) or a
(e.g., jugular, femoral, subclavian vein), passed through an extracorporeal dialyzer that allows the tra
usually by diffusion to decrease biochemical abnormalities as well as fluid, electrolyte, and acid-base i
returned to the patient (i.e., a hemodialysis procedure). These units frequently have capabilities to pe
procedures, such as filtration and fluid replacement (usually calcium and lactate) by convection (hemo
combination of hemodialysis and fluid replacement by diffusion and convection (hemodiafiltration). CR
components are usually a dialysate-delivery system that delivers the previously prepared dialysate so
the dialyzer, the extracorporeal blood-delivery circuit that slowly circulates a portion of the patient's b
dialyzer and returns to the patient, a disposable dialyzer with specialized membrane filters in which so
place, and devices to perform fluid replacement. Each component has its own monitoring and control
renal replacement units are intended for temporary continuous partial replacement of renal functions
unstable patients with acute renal failure and excess urea in blood (i.e., uremia, also known as azotem
overload; they are also used for the treatment of other critical diseases, such as refractory pulmonary
hypothermia, or poisonings with a dialyzable toxin.
Hepatic hemodialysis units designed for the partial external support of liver function by removing larg
soluble and albumin-bound substances. Typically, blood is removed via an extracorporeal circuit, pass
and membrane (e.g., polysulphone) that filters out water-soluble toxic substances (e.g., ammonia, bili
fatty acids) and albumin-bound toxins, and returned to the patient. Hepatic hemodialysis machines ar
continuous hemodialysis or as intermittent machines used used for short periods of time. These units
treatment of chronic and/or acute liver disease and dysfunction after liver transplantation; the devices
temporary liver function support while the patient waits for recovery or as a bridge to transplantation.

Hepatic hemodialysis units designed for the partial external support of liver function by removing larg
soluble and albumin-bound substances at a slow and steady rate (i.e., continuous replacement therap
removed via an extracorporeal circuit, using either arteriovenous access (typically femoral artery to fe
venous access (e.g., jugular, femoral, subclavian vein), passed through a dialyzer and membrane (e.g
filters out water-soluble toxic substances (e.g., ammonia, bilirubin, creatinine, urea, fatty acids) and a
and returned to the patient. Continuous replacement therapy hepatic hemodialysis units also perform
as filtration and replacement of fluids (usually calcium and lactate) by convection (hemofiltration) and
hemodialysis and fluid replacement procedure by diffusion and convection (hemodiafiltration). The ma
unit usually include a dialysate delivery system that delivers the previously prepared dialysate solutio
dialyzer, an extracorporeal blood-delivery circuit that slowly circulates a portion of the patient's blood
and returns to the patient, a disposable dialyzer with specialized membrane filters in which the solute
and devices that perform fluid replacement. Each component has its own monitoring and control circu
intended for the treatment of chronic and/or acute liver disease and dysfunction after liver transplanta
usually provide temporary liver function support while the patient waits for recovery or as a bridge to

Tabletop laboratory devices designed to combine shaking and/or orbital movement capabilities. These
consist of an automated, electrically powered countertop unit that provides shaking or orbital (e.g., el
containers (e.g., flasks, funnels, test tubes) in several internal or external holders. Shakers/orbiters ma
for the frequency and/or the degree (intensity) of the movement. Laboratory shakers/orbiters are inte
analytic procedures, including drug testing, water pollution analysis, and hemolysis. Dedicated tableto
for operation in the humid and polluted environment inside fume hoods, incubators, and/or other labo
available.

Dedicated laboratory incubators designed to provide mechanical mixing (either by shaking, rotation, o
containers placed in the incubator chamber. These incubators typically include a corrosion-resistant ch
appropriate racks for a variety of containers; a mechanism that provides the mechanical movement; d
cooling and/or heating the chamber; speed, temperature, and door-opening controls; local and remote
devices to keep a detailed record of all the events during platelet storage. Platelet laboratory shaker/r
available in stand-alone and tabletop models.
Laboratory devices designed to heat a container. These devices typically consist of an insulated, coun
resistant housing with internal heating elements appropriate for partial or total introduction of a conta
usually, a temperature control. Heating mantle housings are frequently semiflexible to permit the tigh
the container; some devices can reach very high temperatures up to 650 degrees C (1,042 degrees F)
used in clinical laboratories for rapid distillation of water and/or cracking of vapor and liquid materials

Laboratory devices designed to remove excess paraffin from a tissue cassette after embedding. These
consist of a electrically powered unit with heaters, a container for the excess paraffin, and a heated ri
appropriate for sliding the cassette surface to facilitate a proper seating in a microtome clamp or vise
acquisition of an appropriate section quality.
Keypads designed to control access to cabinets and/or rooms. These devices typically consist of a stur
electromechanical wall- or door-mounted grid of keys arranged for efficient entry of data (alphabetic,
symbol), that are pressed by the user; the keypads are usually coupled to locking mechanisms. Keypa
access to rooms (e.g., through electric-controlled doors) and/or other enclosures (e.g., cabinets) have
for each user; they are frequently part of identification and security and/or automation (e.g., pharmac
radiology) systems.

Video image processors designed to convert video formats (e.g., PAL and NTSC; high-resolution RGB s
low-resolution RGB monitors/projectors; low resolution RGB signals played back on high-resolution RG
These devices typically consist of electronic units with capabilities that include automatic input signal
and downward conversions, scan line doubling, and other characteristics that improve image quality. F
video image processors are intended to facilitate the operation of multiformat video environments exi
facilities.

Ultrasonic probes designed for lens cutting and emulsification using ultrasonic waves during cataract
typically consist of a hollow probe with a tip, an ultrasonic transducer that converts electric power into
a cable that transmits the electrical signal between a phacoemulsification unit and the probe; the prob
irrigation capabilities. Phacoemulsification unit probes are used mainly in ophthalmic surgical procedu
anterior chamber of the eye to extract natural lenses affected by cataracts.

Modules designed to be used as components of a physiologic monitor, along with related devices, to a
process information for continuously monitoring the level of neuromuscular block (i.e., paralysis of the
muscles). These modules contain electronic circuits, electrodes, and sensors designed to deliver and m
standard stimulation pulsed signals such as train of four (TOF), single twitch (ST), double burst (DB), a
post-tetanic counts, showing the values on an electronic display at manually selected or automatically
The signal is transmitted to the physiologic monitor, which contains the software necessary to support
function(s). Neuromuscular block modules must be inserted into a dedicated location (e.g., "slot") with
monitor (e.g., modular or modular/configured monitor) or related device (e.g., module rack) in order to
function(s). The level of neuromuscular block is routinely measured by stimulating a peripheral nerve,
and evaluating the muscle response; neuromuscular block modules are used mainly to check the drug
status of skeletal muscles during surgical procedures involving general anesthesia, especially when pa
employed.
Cameras designed to obtain still images either one by one or in a limited sequence of images each tim
switch. These cameras typically include one or more lenses positioned in the front of the camera, a sh
operates the camera and frequently also triggers a light flash, and controls to modify the focus, optica
camera also includes a film or an image sensor for film and digital cameras respectively. Dedicated ph
cameras using digital technology or less frequently film techniques are available for a variety of applic
ophthalmology, surgery); autoclavable cameras intended mainly for use in surgical procedures are als

Computerized network devices designed for the dynamic forwarding of information (data) packets to t
devices are typically an electronic unit with a routing table (i.e., a database) that can optimize protoco
separate information for different subnetworks; routers can identify higher layer information within th
bridges that only interpret node addresses. Routers use specific protocols to communicate with each o
best route between any two hosts. The routers periodically exchange information to update the routin
forwarding the packets that they receive. Routers are used mainly in healthcare facilities to forward in
subnetworks of a local area network (LAN), between LANs, or between a LAN and a wide area network
provide firewall protection (i.e., filter out packets that do not contain the expected session and sequen
routers are usually specific for use in a particular network model and/or with equipment from a specifi
dedicated routers are available both for hardwired and wireless networks.

Computerized network devices designed to establish dedicated paths between end users (i.e., person
providing communication channels between them. These devices are typically electronic units with cir
switches; network switches are usually capable of inspecting data packets and may also store and sub
information, offering better performance than a hub. By delivering each message only to the device f
a network switch facilitates the use of multiple computers and/or other devices together in the same l
network switches may be specific for use in a particular network model and/or with equipment from a

Document scanners designed to obtain digital information appropriate for direct printing and/or to be
processing in a computer or computerized system from film or a photographic slide (e.g., a 35 mm ne
These scanners are typically an electronic unit with a dedicated filmstrip and slide holders for film ma
scanning device with focusing capabilities, light sources, and software that may allow image correctio
color reconstruction, grain equalization, and other image quality improvements. Filmstrip/slide scanne
obtain digital information that includes text, images, or both for printing, storing, processing, and/or tr
hospital information system.

Image processors designed to acquire, quantitate, and store fluorescent labels from gel substrates. Th
typically a computerized electronic system with an ultraviolet (usually in the range of 254 to 365 nm)
and image capture and processing devices. Fluorescent label image processors can automate and acc
amount of label that has been incorporated by comparing the control blot with the labeled probe perm
use of riboprobes that have been sufficiently labeled for in situ hybridization studies.
Image processors designed to quantitate and store images from laboratory gel substrates. These devi
a portable unit with a CCD (charge-coupled device) camera, filters, controls, image storage devices, d
software; they are used mainly to take images from visible or ultraviolet transilluminators. Gel image
intended for temporary storage of images and/or transmission of information to digital computerized s
processing and/or to computer system peripherals (e.g., printers). Dedicated gel quantifying processo
quantitate several types of gel substrate images, such as fluorescent labels, bromide-stained agarose
chemiluminescent and electrophoresis gels. Some processors are also capable of imaging chemilumin
nylon/nitrocellulose filters as well as gel-based images.

Optical devices designed to match a slit lamp with a variety of microscope still and/or digital video cam
accurate images. These adapters usually include high-precision optics, an illumination system for hom
and appropriate mechanisms for camera mounting. Slit-lamp/camera adapters are used for image doc
ophthalmic diagnoses, including survey, slit-camera, or high-power endothelium pictures.

Workstations designed to obtain and process the digital data and images acquired by ophthalmic instr
and video cameras (including pictures from slit lamps), and/or from patient records. These workstation
information directly from measuring and imaging instruments (e.g., refraction, corneal topography), in
(e.g., picture archiving and communication), and administrative data (e.g., patient identification, sche
appointments). Ophthalmic workstations typically consist of a high-speed digital computer, high-defin
magneto-optical disks, input and output devices, and processors; they usually follow the instructions o
for data and image processing. The workstations may work as an autonomous unit or be installed as a
interact with hospital information systems, including picture archiving and communication systems. D
workstations, intended to be used to facilitate refractive diagnoses, laser treatments, and the perform
surgery, are also available.

Electric signal amplifiers designed for simultaneous amplification of video (typically in the VHF and/or
signals (typically in a range from a few hundred hertz to 20 kHz). These devices typically consist of a w
fidelity, electronic amplifier with audio and video signal inputs, electronic circuits to amplify the signal
video channels, controls (e.g., gain, contrast), appropriate output ports for the amplified signals, and a
Video/audio amplifiers are used mainly in hospital information and communication systems to compen
losses in remote cable connections throughout the facility.

Masks designed to aid in oxygenation and ventilation of patients weighing 35 kg (77 lbs) and above, a
with pulmonary or cardiopulmonary resuscitation devices. These masks are constructed of rubber or p
include a flexible rim to maintain an adequate seal around the nose and mouth during positive pressu
Resuscitator masks are connected through a hose to the resuscitator; they are intended to deliver air,
of the two gases to the patient. Adult resuscitator masks are designed as either disposable or reuseab

Masks designed to aid in oxygenation and ventilation of pediatric patients weighing between 7 and 35
pounds), and used in conjunction with pulmonary or cardiopulmonary resuscitation devices. These ma
rubber or plastic material and include a flexible rim to maintain an adequate seal around the nose and
pressure ventilation. Resuscitator masks are connected through a hose to the resuscitator; they are in
oxygen, or a mixture of the two to the patient. Pediatric resuscitator masks are designed as either disp
units.
Masks designed to aid in oxygenation and ventilation of infant patients weighing up to 7 kg (15.4 lbs),
conjunction with pulmonary or cardiopulmonary resuscitation devices. These masks are constructed o
material and include a flexible rim to maintain an adequate seal around the nose and mouth during po
ventilation. Resuscitator masks are connected through a hose to the resuscitator; they are intended to
a mixture of the two gases to the patient. Infant resuscitator masks are designed as either disposable

Generators designed to produce and store gamma-emitting radioactive technetium gas mixed with ca
generators typically consist of a calcinations vessel (graphite or carbon crucible) where a gamma emi
technetium 99m is placed. The vessel is located in the generator where a stream of air dries the solut
converted in radioactive technetium gas by heating it at a very high temperature usually in an atmosp
patient inhales the radioactive gas into the respiratory tract from a collection container where the gas
immediately or from an administration set after a storage period. The gamma ray emission images tak
lungs are used for diagnosis of existing and/or potential lung diseases (e.g., pulmonary emphysema).

Testers designed to check the integrity of endoscopes by identifying the presence or absence of air lea
typically consist of a graduated gauge, an insufflating bag, a connecting tube, and appropriate exchan
according to the endoscope to be tested. Air leak endoscope testers are intended for routine testing a
maintenance of endoscopes before use.
Point-of-care hematology analyzers designed to determine the quantity of hemoglobin (the oxygen-ca
erythrocytes) in whole blood; capillary, venous, or arterial blood can be used. These devices are typica
a dual-wavelength photometer, a disposable cuvette for collecting and mixing blood with reagents, an
care hemoglobin hematology analyzers provide results quickly without the need for laboratory technic
samples to a clinical laboratory.

Measuring instruments designed to count solid particles in the environment. These counters are typic
instruments with appropriate sensors that can measure several sizes (e.g., 0.3, 0.5, 1.0, and 5.0 micro
simultaneously and display the results typically in number of particles per unit of volume (e.g., particl
particles/liter). Environmental particle counters may be used for particulate monitoring in clean rooms
and clinical pharmacies, but they have their primary use in pharmaceutical, medical device, and semi

Automated laboratory samplers designed to extract organic samples from solid materials using solven
temperature. These samplers typically include an extraction cell, pump, high-pressure gas container,
containers, oven, and a collection vial for the samples. The solvent is moved through the heated extra
extraction is complete, compressed gas (e.g., nitrogen) moves the solvent to the collection vial for an
temperature automated samplers are used to obtain samples of pharmaceuticals, including herbal pro
(e.g., pesticides, explosives) from environmental samples.
Slide stainers designed for the automated application of specific labeled antibodies, conjugated enzym
individual slides, which are applied in a specific predetermined order. These reagents are applied in sm
volumes to the tissue on the slides; slides are not immersed in the reagents. The slides are usually mo
resembling a matrix (array) or rotary disposition (i.e., using robotic and carousel transfer, respectively
and/or pipette tips are typically used in matrix arrays, and spring-loaded syringe- or cartridge-like disp
carousel dispositions. Other special features of the stainers depend on the physical characteristics of t
Immunohistochemistry (IHC) slide stainers deliver the proprietary reagents to several staining stations
software programs; IHC slide stainers are used to identify specific proteins of interest in biological tiss
in cancerous tissue, using an antigen/antibody reaction very similar in process to that of ELISA (enzym
immunosorbent assay) staining except that the antigen is located on tissue that is fixed on a microsco
stainers are also capable of staining slides intended for in situ hybridization (ISH), a technique that lab
DNA or RNA to target a specific DNA or RNA sequence in a tissue section, and less frequently, of stain
histochemistry (i.e., using special stains) tests.

Laboratory stirrers designed to stir liquids by spinning a magnetic bar immersed in the liquid solution.
consist of a tabletop electronic unit that creates a rotating magnetic field (using either fixed or rotatin
(e.g., aluminum, ceramic) on which the container of the liquid to be stirred is placed, a spinning bar th
liquid, and time and velocity controls. Magnetic stirrers are used in clinical laboratories to stir low- or m
solutions; they are frequently used in devices that combine a hot plate with a magnetic stirrer in an in

Specimen concentrators designed to increase the relative content of substances in a sample (i.e., spe
combination of centrifugal force, vacuum, and heat to speed evaporation. Vacuum concentrators usua
device that includes a centrifugation mechanism capable of using several interchangeable rotors, a va
and time controls, a display, and vacuum relief valves. Vacuum specimen concentrators are used main
laboratories to concentrate biochemistry and/or microbiology samples when maximum throughput is r

Tabletop laboratory devices designed as an integral unit that combines a hot plate and a magnetic sti
typically consist of a unit with a flat plate (e.g., made of aluminum or ceramic) on which the container
and stirred is placed; the device also includes electrically powered heating coils to heat the plate and
create a rotating magnetic field that spins a magnetic bar placed inside the liquid. Hot plate/stirrers ar
clinical laboratories when simultaneous heating and stirring of solutions is needed.

Devices designed to operate as the rotary component of a centrifuge. Rotors typically consist of solid,
titanium), devices containing two, four, or more wells within which containers (typically centrifuge tub
variety of centrifuge rotors are available according to the size and type of centrifuge in which they are
common types of centrifuge rotors are (1) swinging bucket rotors, in which the sample tubes are locat
buckets that hang vertically while the rotor is at rest; the buckets swing out to a horizontal position du
used mainly to separate samples according to their density gradient; (2) fixed-angle rotors, in which t
fixed at the angle of the rotor cavity, used mainly to separate samples according to their size (e.g., ba
and/or density (e.g., DNA, RNA); and (3) vertical rotors, in which on the sample tubes are fixed in a ve
rotation, used mainly for DNA, RNA, and lipoprotein isolation. Most centrifuge rotors are intended for u
model and type of centrifuge.
Laboratory analyzers designed to perform tests using techniques such as immunoassay, molecular as
determinations), and clinical chemistry (e.g., enzymatic assays). These analyzers include a multiwell (
plate; measuring systems, frequently using flow-cytometry techniques; a laser radiation source used t
individual microsphere thus allowing multiple simultaneous assessments; an electronic processing uni
Multitechnology analyzers using microsphere techniques typically apply one of several combinations o
(e.g., Texas Red) to each sphere for a unique spectral identification of the microsphere sets, facilitatin
assays using a single sample volume. The analyzers can perform simultaneous tests in the same well
samples; they are used in clinical laboratories and for pharmaceutical research.

Sterilization process indicator kits designed for testing the effectiveness of a sterilization (e.g., steam)
consist of a standardized viable population of microorganisms (usually nonpathogenic bacteria or bact
resistance to the mode of sterilization being monitored [i.e., a biological sterilization process indicator
(usually a water vapor unit) for testing the biological indicator after the sterilization process. Biologica
indicators are used in clinical laboratories and/or other sterilization areas in a healthcare facility.

Video image processors designed to acquire, store, and process electronic images from laboratory mic
the images to peripheral devices such as video monitors, video cassette recorders (VCRs), still-disk re
printers. These devices take images directly from the microscope with definition and quality appropria
diagnosis; they can also send images to computerized information systems for storage, retrieval, and
manipulation.

Workstations designed to process and store digital data and images acquired by monitors, recorders, a
information systems (e.g., computed tomography, magnetic resonance imaging) in real time. These w
the same screen, data, waveforms, and alarms from bedside and/or telemetric physiologic monitors a
patient data from hospital information systems, such as picture archiving and communication systems
permit the introduction of orders for patient care by physicians. The workstations typically consist of a
computer with a powerful microprocessor, optical/magnetic disks, and input and output devices; they
following instructions from specialized software. Intensive care workstations are intended to integrate
monitors, imaging systems (e.g., PACS), and additional data at the patient's point of care, permitting t
(i.e., physicians, nurses) to interact with the information in real time.

Automated defibrillators designed to be worn externally by the patient to continuously detect, classify
potentially life-threatening arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia). Typical d
like garment containing the defibrillation electrodes; the electrodes are connected to a battery-powere
either worn on a shoulder strap or on a belt around the user's waist. These devices are primarily desig
high risk for life-threatening arrhythmias who are either not yet candidates for an implantable defibrill
have recently undergone coronary revascularization procedures such as coronary bypass surgery or p
intervention), who are unable to tolerate the requirements of an implantable device, and/or who refus
can be used in the home or institutional setting.
Laparoscopic surgery self-retained retractors designed for temporary lifting and holding back the abdo
and facilitating laparoscopic procedures on tissues or organs in the peritoneal cavity. They are intende
disposable). These retractors typically consist of manual, self-retained instruments including two "J-" o
(vanes) radiating from a shaft at the working end, resembling an open fan (also known as fan retracto
usually introduced into the peritoneal space through a small incision at the umbilicus. They are then s
position and then attached using a connector to a specially designed external coupling arm, retracting
the arm is lifted. Disposable laparoscopic retractors may be used both in standard pneumoperitoneum
gasless procedures.

Alarms designed to activate audible (i.e., sound) signals when a pre-established limit (i.e., threshold) o
load) on a foot is reached. These alarms typically consist of a sensor placed in the shoe that continuou
placed on the foot using a dedicated sensor, a wearable electronic module including a sound alarm wh
adjusted to different levels of foot load (e.g., up to 45Kg/100 pounds), batteries, and interconnection c
weight alarms are intended for continuous assessment of patients suffering from lower limb and/or hip
prosthetic replacements; they may be also used during treatment of foot ulcers.

Point-of-care analyzers designed to measure ammonia in whole blood. Many of these analyzers use m
colorimetric methods; the ammonia ion in the specimen is converted to ammonia gas, which is liberat
sample and reaches an indicator (e.g., bromocresol green) to cause a color development proportional
ammonia. These analyzers are used mainly in the diagnosis and follow-up of several hepatic and rena
levels are also high in patients infected with some bacteria (e.g., Helicobacter pylori).

Multianalyte point-of-care analyzers designed to detect and determine the concentration of analytes (
whole blood appropriate for rapid assessment of acute cardiovascular diseases such as acute coronary
myocardial infarction. Key cardiac markers include troponin I or T, myoglobin, creatine kinase MB, D-d
pro-natriuretic peptide (NT-proBNP). These analyzers are typically portable electronic units with a disp
software; tests are performed using disposable reagent strips and/or cartridges. Cardiovascular multia
analyzers are intended for use in emergency rooms and doctors' offices; they may also be used to aid
management of other cardiovascular diseases such as congestive heart failure, deep vein thrombosis,
embolism.

Operating room automation systems designed to control, manage, and/or operate various devices use
surgery procedure via a common interface. These systems typically consist of a combination of hardw
includes a user interface (e.g., touchscreens, voice control) and a networked computerized control sys
information and images can be directed in order to perform frequently used functions (e.g., issuing co
and video), to operate endoscopic surgical and ancillary devices (e.g., endoscopic electrosurgical units
coagulation, lights, instruments), and to provide equipment information, including insufflation pressur
and error messages with appropriate corrective actions. Endoscopic operating room automation syste
improve the ergonomics, safety, and efficiency of endoscopic surgical procedures; they may operate e
in the operating room (i.e., stand-alone systems) or may communicate with information and image sy
operating room (e.g., hospital and/or radiology information systems).
Video cameras designed for use in the oral cavity (i.e., intraoral). These cameras usually include appro
sensors [e.g., charge-coupled devices (CCD)]; the camera may be attached to a long handle for manu
oral surgery and/or dental handpieces or multi holders. Intraoral video cameras are intended for pictu
and/or to facilitate the performance of diagnostic, surgical, and/or dental procedures.

Thermostatically controlled chambers designed to maintain the temperature of one or more chromato
constant. These chambers consist of high-precision (variations of temperature are typically less than
degrees F]) thermostats (e.g., bimetallic) that regulate temperatures up to 100 degrees C (212 degree
exchanging switches to activate heating and/or cooling elements; and special switching valves. Therm
chromatography column chambers can accommodate one or more columns; they are intended for liqu
chromatography procedures (e.g., proteomics) that require minimal temperature variations.

Controllers designed to regulate the performance of a chromatography system from a single point. Th
control each of the modules (e.g., columns, detectors) of a chromatography system from a centralized
controllers typically can identify each component, control the transfer of samples between modules, a
of the system using dedicated software. Chromatography system controllers are intended to facilitate
automated chromatography tests with fewer errors in the procedure; they can interact with a laborato
by receiving and/or sending information.

Flexible cystoscopes equipped with a television camera on the distal tip, typically in the form of a mic
coupled device [CCD]). These endoscopes may be manipulated and aimed in different directions throu
tract; the image is electronically transmitted from the camera through wires inside the endoscope for
display, and recording.
Equipment designed for use in dental laboratories/workshops for modeling of dental wax to shape and
model created from dental wax impressions of the patient's teeth and gums. The electronic dental wa
handpiece, heating pin, and a set of (e.g., modeling, needle) tips and/or spatulas with hand controls a
controls. Tooth veneers, crowns, bridges, and other dental restorations are duplicated from the wax m
dental waxer.

Powered dispensers designed to deliver a spray of disinfecting solution. These devices are typically a
powered unit that includes a tank for the liquid disinfecting solution (e.g., alcohol-based disinfectants,
enzymes), nozzles to deliver the solution spray, and a switch to activate the dispenser. Disinfecting sp
used in healthcare facilities for disinfection of hands or devices such as surgical instruments.

Disinfectors designed to kill or inactivate most of the microorganisms (e.g., fungi, viruses, bacteria) in
volume (typically less than several cubic meters) container using an automated disinfection cycle bas
of formalin (i.e., a formaldehyde solution) and subsequent neutralization with ammonia, followed by e
residual formaldehyde at a temperature about 200?C (close to 400?F). These disinfectors consist of a
alone disinfecting unit that is placed inside the container to be disinfected and includes controls and a
progress of the disinfection procedure. Enclosure disinfectors are intended mainly for decontaminating
microbiological safety cabinets and other microorganism devices intended for isolation (e.g., glove bo
Neuromuscular stimulator electrodes designed for use with external stimulators intended for treatmen
difficulties (i.e., dysphagia). These devices are typically dedicated electrodes fixed externally over the
responsible for swallowing; the electrodes are attached through cables to a neuromuscular stimulator,
stimuli appropriate for this treatment. Dysphagia neuromuscular stimulator electrodes are used in the
deficiencies in swallowing due to illness (e.g., stroke, neurologic disorders, cancer) and/or aging.

Measuring instruments designed primarily to measure very small (in the order of femto coulombs) ele
instruments are frequently based on the accurate measurement of voltages. These devices typically c
instruments including a high-input impedance solid state amplifier (e.g., such as field-effect transistor
supplies, and a display to show charge, voltage, and current values; they may also include external co
ionization chambers to perform radiation measurements. Electrometers are frequently intended for ra
dosimetry; they can measure charge from electrons, x-rays and gamma rays emitted by linear acceler
and other radiation sources.

Recorders designed to measure and record the timing and location of tongue contact with the hard pa
speech (i.e., electropalatography, also known as palatometry). These recorders typically include an ar
molded to fit the roof of the mouth, electrical contacts located on the lingual surface of the artificial pa
link the artificial palate to a computerized unit, dedicated software to process the information, and a r
palate contact patterns synchronized with acoustic recording of the speech. Electropalatographs are in
clinical studies, and assessment of speech therapy.

Lower-gastrointestinal-tract endoscopes designed to access, examine, diagnose, and/or treat the lowe
(rectum and colon) using video cameras and ultrasonic probes. These endoscopes usually consist of a
metal) sheath, a lighting system (e.g., fiber optics), a video camera at the distal tip, an ultrasonic prob
transducers, and a working channel through which catheters and operative devices are introduced. Lo
video/ultrasonic endoscopes are usually flexible devices intended for visual evaluation of the colon an
lesions (e.g., polyps) using ultrasound scanning that may include Doppler techniques.

Upper-gastrointestinal-tract endoscopes designed to access, examine, diagnose, and/or treat the uppe
(usually the stomach and/or esophagus) using video cameras and ultrasonic probes. These endoscope
outer (plastic or metal) sheath, a lighting system (e.g., fiber optics), a video camera at the distal tip, a
appropriate transducers, and a working channel through which catheters and operative devices are in
Gastrointestinal-upper-tract video/ultrasonic endoscopes are usually flexible devices intended for visu
stomach (e.g., esophageal varices, gastric and/or esophageal lesions) and further assessment using u
(including Doppler techniques).
The viewing component (i.e., telescope, also known as scope) of an endoscope or laparoscope designe
observation of internal tissues and/or organs of the human body otherwise inaccessible through natur
cavities, or surgical orifices. These devices may consist of a hollow metal or plastic tube fitted with a l
rodlike, closely spaced lenses) that permits viewing in a fixed, predetermined direction; typically a vid
or replacing the eyepiece allows observation through a fiberoptic bundle on a video monitor. Other en
laparoscopes use a chip (charge-coupled device [CCD]) at the distal tip of the telescope to transmit th
to the video processor without the use of additional lenses. Endoscopic telescopes may be specialized
they are operated (e.g., urinary or gastrointestinal tract endoscopes, arthroscopes, laparoscopes) and
performed.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed f
using a surgically inserted (tunneled) subcutaneous endoscope as a main component. Items in these k
dedicated endoscope with a video camera at its distal end, and several tools, such as dissecting and h
are introduced through a trocar and/or cannula. These kits may be supplied in supporting trays (i.e., p
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Endoscopic vessel harvesting kit
dissection of veins (e.g., the saphenous vein) and arteries (e.g., the radial artery) from the limbs and/o
from the thorax. Other harvesting kits based on a disposable cannula with a control and steering hand
intended for endoscope insertion are also available. The harvesting kits are frequently linked to extern
systems, including a monitor, a radiofrequency generator, an image processor, and light sources mou
Harvested vessels are used mainly as bypass grafts in coronary artery surgical procedures but are som
replace peripheral (e.g., lower limb) vessels; the kits may be used for other dissection procedures (e.g
through a surgically created subcutaneous cavity. Harvesting kits based on a disposable cannula with
handle and a lumen intended for endoscope insertion are also available; the kits may be linked to exte
surgical systems mounted on a cart or rack.

Ergometers designed to measure the work (i.e., the amount of force multiplied by the distance over w
applied) or rate of work (i.e., power) performed by the upper extremity muscles while performing rota
arm exerciser (that is usually an integral part of the ergometer) under controlled conditions. Arm exer
determine the work and power by measuring the force exerted during the rotary movement of the arm
electromagnetic brakes) and the speed of movement of the handgrips of the exerciser. Cyclic arm exe
used in tests intended to assess whether patients have cardiovascular or pulmonary diseases; they m
include use of a stress exercise physiologic monitoring system. The exercisers are available in several
wall mounted, free standing).

Muscle strength exercisers designed to provide resistance to muscular contraction in the arms using a
a system of pulleys and cables or levers. These exercisers usually consist of a stand-alone machine wi
top of each other or a hydraulic mechanism, a system to transmit the force (i.e., to convey the resista
pulley cables on which the user exerts force to counteract the exerciser resistance. Users can raise the
pull the cables to flex the elbow (i.e., arm curl) or push the lever up or down or pull the cables to exte
extension). Arm strength exercisers are intended to improve muscle strength in the upper limbs (main
and wrist musclel), increase muscle size, enhance muscle endurance and power, and improve bone de
Exercisers designed to facilitate the physical exertion of body muscles by voluntary contraction and re
muscles (i.e., active exercisers), intended primarily to improve the range of motion (i.e., flexibility) ar
supporting and/or positioning the user, making it possible to stretch the muscles. These exercisers are
devices that may include handlebars, exercise balls, or stand-alone exercise workstations. Flexibility e
to improve the flexibility of the muscles in the upper limbs, trunk, and the lower limbs; like all exercise
muscular strength, endurance, flexibility, and balance in particular parts of the body (e.g., upper and/
Dedicated flexibility exercisers are available for stretching the upper limb and/or trunk (e.g., inversion
lower body (e.g. slant board), and full body (stretching units).

Muscle strength exercisers designed to provide resistance to muscular contraction in the chest using a
a system of pulleys and cables or levers. These exercisers usually consist of a stand-alone machine wi
top of each other or a hydraulic mechanism, a system to transmit the force (i.e., to convey the resista
pulley cables on which the user exerts force to counteract the exerciser resistance. Users press the lev
handles forward to extend the arms until they are horizontal. Chest press exercisers are intended to im
chest (pectoralis major), shoulder, and arm muscles; increase muscle size; enhance muscle endurance
improve bone density.

Lower limb continuous passive motion exercisers designed to provide controlled movements (flexion,
and/or rotation) to the hip joint without muscular exertion. These exercisers typically consist of an elec
electromechanism that is attached to the leg to provide periodic, rhythmic movements through a rang
intended to prevent joint stiffness in the hip. Hip continuous passive motion exercisers are used for ph
rehabilitation after illness, trauma, and/or surgical treatment.

Lower-limb muscle strength exercisers designed to provide resistance to muscular contraction when th
rotations using a mechanism based on a system of levers. These exercisers are usually a stand-alone
stacked on top of each other, a system to transmit the force (i.e., to convey the resistance), and lever
exerts force to counteract the exerciser resistance. Typically, the user puts one thigh in the bar pad a
movements of the hips. Hip rotation exercisers are intended to improve muscle strength in the hips, in
enhance muscle endurance and power, and improve bone density.

Muscle strength exercisers designed to provide resistance to muscular contraction when the feet pres
using a mechanism based on a system of levers. These exercisers usually consist of a stand-alone ma
stacked on top of each other or a hydraulic mechanism, a system to transmit the force (i.e., to convey
lever bars on which the user exerts force to counteract the exerciser resistance. Users place their feet
push it away to extend the knees. Leg press exercisers are intended to improve the strength in the leg
quadriceps, gluteus, hamstring, calves), increase muscle size, enhance muscle endurance and power,
density.
Aerobic cyclic exercisers designed to provide exercise by facilitating rotary movements of the arms or
can be stand-alone portable machines with pedals that can be moved either by the hands or by the fe
machines consisting of a removable seat, pivot crank arms, handgrips, and a drive system. They are u
devices that enable bidirectional cycling. Cycler exercisers usually are capable of changing resistance
monitor to display the workout time, distance, speed, calories burned, and heart rate. Upper/lower lim
intended to increase cardiovascular endurance by keeping the heart and pulmonary rate elevated for
time; they may provide additional muscular strength and endurance to the muscle groups in the uppe
neck, back, wrists, and elbows) or lower (quadriceps, hamstrings, gluteus muscles, hip flexors, and ca
used mainly by patients with limited limb functions for training and/or rehabilitation.

Eyeglasses designed to facilitate tests for evaluation of nystagmus based in the assessment of involun
eyes due to external stimuli, such as rotation and/or shaking of the head or by warming and/or cooling
liquids or air. These devices are typically eyeglasses with lenses that are capable of magnifying and ill
minimizing fixation during the examination (known as Frenzel lenses); the lenses may be hinged to so
of the line of vision. The eyeglasses also include a head strap for secure fixation, batteries, and a lamp
spectacle illumination, isolating the patient from the environment in a dark room to facilitate observat
Nystagmus test eyeglasses are typically used to evaluate pathological nystagmus, usually as a result
vestibulocochlear nerve (which provides hearing and helps with balance), permitting the determinatio
damage is the cause of dizziness or vertigo. Nystagmus test eyeglasses that incorporates infrared vid
videonystagmography tests are also available.

Corrective lens eyeglasses designed with an attached set of telescopic lenses to assist the vision of a
defects cannot be corrected with standard graduated lenses. These eyeglasses include telescopic wid
be manually focused at different distances; the lenses can be changed according to the user's needs.
eyeglasses are usually prescribed according to the characteristics of the eye with better vision. Dedica
eyeglasses with automated distance focusing are also available.

Telescopic lens eyeglasses designed for automated focus adjustment according to the distance of the
eyeglasses include telescopic wide-field lenses and a computerized autofocusing unit that measures t
many times every second to provide a focused image immediately at any distance of about 12 inches
Automated focus telescopic lens eyeglasses are intended to assist the vision of a person whose vision
corrected with standard graduated lenses; they are usually prescribed according to the characteristics
vision.

Plates designed to become fluorescent temporarily when activated by ionizing radiation (i.e., photons
devices consist of a plate with a substrate typically made of acrylic or polycarbonate and a fluorescen
displays permanent graduated (e.g., in centimeters or inches) marks showing the active radiation field
after the radiation is turned off. The use of appropriate filters avoids activation of the phosphor by oth
Ionizing radiation alignment plates are intended to align the radiation field in relation to the treatment
quality assurance measurements according to established standards and/or recommendations.
Devices designed primarily to sense ionizing radiation from alpha and beta particles at a low counting
also detect high-level gamma radiation. These devices typically consist of a metallic tube (or insulated
covered with a conductive layer) that works as the cathode and a wire placed inside the tube that wor
tube is filled with an inert gas (e.g., helium, argon). Geiger tubes have a thin (e.g., mica) window that
alpha and beta particles; some tubes using glass windows can measure only beta particles. The passa
through the tube creates an avalanche of charged particles that produce an audible click for each par
Geiger tubes are used as the main component of radiation counters and low-level environmental ioniz

Laryngoscope handles designed to be the holding component of and to provide light for a fiberoptic la
These devices usually consist of a hollow handle, fiberoptic bundles, a battery, a light source (e.g., ha
battery charger. The handle and the attached fiberoptic blade compose a working fiberoptic laryngosc

Portable height/length measuring instruments designed only to measure the length of neonates and t
infants. These instruments typically consist of a board that permits a comfortable positioning of the ba
mechanism (e.g., a sliding lever that adjusts to the infant's body) to measure the length of the neonat
of up to about one meter (40 inches) with accuracy and reproducibility; other instruments are also cap
infants' height as soon as they can stand up. Some instruments include electronic displays and/or reco
neonate/infant height/length measuring instruments are intended for periodic assessment of postneon
perform studies of baby growth.

Laboratory hoods designed to be used to prepare for and/or to perform polymerase chain reaction (PC
procedures with a reduced risk of contamination. These hoods usually consist of a nonventilated plast
enclosure with transparent windows, providing a dead air space in which the PCR procedures are perfo
lamps to irradiate the hood, as well as fluorescent working lights, timers, and doors (e.g., hinged sash
of samples, testing devices, and reagents. PCR hoods are intended to prevent product contamination
they do not provide protection to the user. PCR hoods are not biological safety enclosures and should
infectious and/or potentially infectious materials are handled; some PCR hoods may provide appropria
radioactive substances used in the radioactive labeling of DNA.

Image digitization systems designed to acquire and digitize ophthalmic (e.g., fundus camera, fluoresc
images for viewing, storage, and/or printing. The imaging system typically consists of a digital camera
a microchip (a charge-coupled device [CCD]); digital processors for image enhancement; electronic re
CD-ROM); and printers. Ophthalmic digitization systems are intended mainly to obtain images taken fr
fluorescing angiography cameras.

Insufflators designed to maintain a regulated high pressure in a body tract or cavity by blowing a vapo
endoscope. These devices are typically an electronic unit with a high-flow gas (e.g., carbon dioxide) d
manometers for an accurate pressure measurement of flow rate and volume, pressure sensors and tra
electronic display, controls, and alarms. Endoscopic insufflators are intended to produce and maintain
during a wide variety of endoscopic diagnostic and/or therapeutic procedures.
Devices designed for accurate sensing of ionizing radiation in an enclosed chamber. These chambers
electrically closed spherical or cylindrical vessel that usually works as the cathode and an internal ele
is the anode. The presence of radiation from any source causes charged particles to traverse the gas i
chamber, producing ionization of the gas (i.e., creating ionized pairs). The impinging particles might b
particles from a radioactive source and/or gamma or x-rays. When an electric potential is applied betw
chamber and the anode the ionization produced by radiation is collected in the form of a current. The
measured using an external electrometer; some ionization chambers include pre-amplifiers to amplify
before delivering it for external measurement. Ionizing chambers are used in detectors, counters, mon
other instruments intended for measuring radiation.

Irrigators designed to deliver solutions into the oral cavity. These devices typically consist of a main el
manual unit that includes a pump for irrigation/infusion by means of a jet of nonmedicated (e.g., mou
controls for the rate and pressure of irrigation of the liquid, a reservoir for the solution, and a set of de
for particular (e.g., toothbrush, water jet, orthodontic braces) applications. Dental/oral irrigators are in
debris from the mouth and/or to provide gentle massage to the gums. They are used mainly in a dent
home; some units are an integral part of dental delivery units.

Irrigators designed to deliver sterile solutions into the ear canal. These irrigators consist of a main uni
pump, pressure sensors and regulating controls, alarms, a power supply source, and a dedicated auxil
set; some systems include dedicated software used to perform the procedure. Ear irrigators are intend
ear canal and the middle structures of the ear during diagnostic and/or therapeutic (e.g., extraction of
procedures. Dedicated irrigators that provide additional caloric stimulation for testing the vestibular sy
water are also available.

Irrigators designed to deliver sterile solutions into the operating site during surgical procedures. These
main unit with an automated (usually peristaltic) pump, pressure sensors and regulating controls, a po
and a dedicated auxiliary disposable tubing set; some systems include dedicated software used to per
and/or warming devices intended to keep the irrigation solution close to body temperature. Surgical si
intended for irrigation of the operating site; dedicated irrigators intended for particular surgical proced
electrosurgery are also available.

Surgical site irrigators designed to deliver sterile solutions into the operating site during electrosurgica
irrigators consist of a main unit with an automated (usually peristaltic) pump, pressure sensors and re
power supply source, and a dedicated auxiliary disposable tubing set; some systems include dedicate
perform the procedure and/or warming devices intended to keep the irrigation solution close to body t
Electrosurgery irrigators are intended for irrigation of the surgical site concurrent with the performanc
procedure; some electrosurgical irrigators are attached to or an integral part of bipolar electrosurgical
handpiece units.

Irrigators designed to deliver sterile solutions into the upper urinary tract. These irrigators consist of a
automated pump, flow and pressure sensors, regulating controls, and alarms attached to the pump he
overpressure; a power supply source; and a dedicated auxiliary disposable catheter or tubing set. Som
dedicated software to perform the procedure. Upper urinary tract irrigators are intended for irrigation
tract, including the ureter, during diagnostic and/or therapeutic procedures.
Laboratory degassers designed to extract gases from flowing liquids. These devices typically work by
through a membrane that is permeable to gases but not to liquids; the process is usually performed a
pressures. Flowing liquid degassers intended for high- and low-flow (e.g., a few mL/min) are available;
frequently used in combination with or as a component of laboratory pumps in procedures such as hig
chromatography.

Flexible laryngoscopes designed with a video camera attached to its distal tip, typically in the form of
charge-coupled device [CCD]). These endoscopes usually include a flexible fiberoptic system and a bla
and minimize soft-tissue obstruction. Flexible video laryngoscopes are used in routine procedures and
anesthetized patients with difficult airway access. They are frequently used to improve visualization d
intubation and to decrease the possibility of neurological damage in patients with cervical spinal injur

Rigid laryngoscopes designed with a video camera attached to its distal tip, typically in the form of a m
charge-coupled device [CCD]). These endoscopes typically include a fiberoptic system and a rigid blad
and minimize soft-tissue obstruction. Rigid intubation laryngoscopes are used in routine procedures an
anesthetized patients with difficult airway access. They are used to improve visualization during endo
to decrease the possibility of neurological damage in patients with cervical spinal injuries.

Surgical laryngoscopes designed for insertion into the mouth and down the throat, allowing the expos
true vocal cords. These devices consist of a superior blade that engages the tongue and supraglottis w
engages the roof of the mouth and the posterior pharyngeal wall; the triangular shape, length of the b
opening that fits into the shape of the human glottis allows for exposure of the glottis and true vocal c
larynx/glottis laryngoscopes are intended mainly for surgery in the lower larynx.

Detachable distal components of a rigid laryngoscope designed to provide illumination and displace th
larynx, and upper trachea. These devices typically consist of a spatula to hold the tongue; an angular
provide rigidity with an L-shaped or semicircular groove for viewing along its length; and, usually, an i
(using either a conventional lamp or a fiberoptic system). The blade is typically hooked onto the laryn
fold for storage, simultaneously switching off the light. Laryngoscope blades are available in several s
pediatric use; they are also available as a nonfoldable, integral part of plastic laryngoscopes. Some la
designed specifically for use in magnetic resonance imaging (MRI) environments, (i.e., MRI-compatible
and are made from nonmagnetic materials so that they can be safely used in an MRI suite.

Manometers designed for noninvasive measurement of the maximum inspiratory and expiratory press
manometers typically consist of a portable electric powered measuring instrument, sensors for nasal a
measurements, controls, and a display that shows the values and waveforms of the pressure and thei
manometers may also include dedicated software for the assessment of other characteristics. Typicall
loaded by the user onto a computer (e.g., personal computer) that is connected to the manometer for
Maximum inspiratory/expiratory pressure manometers are intended mainly to diagnose and assess th
respiratory muscle strength and endurance, especially during therapeutic and/or rehabilitation treatm
have chronic obstructive pulmonary disease (COPD).
Manometers designed to measure the pressure exerted between a body part and a solid surface while
established sequence of physical exercises. These devices typically consist of an instrument (e.g., a d
to measure the pressure on a pressure cell (sensor), an air-filled pressure cell, and an inflation bulb. M
assessment includes detection and determination of muscle activity during a great variety of exercise
manometers intended to assess the muscles involved in spinal movements are also available. The ma
diagnosis and to check modifications in muscle movement and coordination during therapy and rehab

Flexible nasopharyngoscopes designed to be directly inserted into the nasal cavity, including a televis
distal tip for visual examination, biopsy, and treatment of lesions of the nasal cavity, pharynx, and pha
auditory tube. These devices usually consist of an outer sheath, a fiberoptic lighting system, a working
which catheters and operative devices are inserted, and a digital camera, typically in the form of a mi
coupled device [CCD]). The image is electronically transmitted through wires in the endoscope for ext
display, and recording.

Handheld surgical instruments designed to hold a suture needle while suturing through an endoscope
sleeve, or other appropriate device during minimally invasive surgical procedures. These devices typic
straight or curved, handheld, manual holder with an actuating mechanism to control slim jaws resemb
distal end with a shape (e.g., convex, concave) appropriate for manipulating needles used in endosco
needle holding jaws are connected to a long shaft, usually at least 30 cm (12 inches) in length, which
position or may rotate around the shaft's longitudinal axis and which reaches outside of the endoscop
cannula, or sleeve to a handle (or some type of grasping mechanism) intended for manipulation by th
suture needle holding instruments are available in a range of sizes and shapes, depending on the type
shape of the suture needle used.

Oral feeding aids that employ electromechanical mechanisms to assist or enable disabled patients to
oral self-feeding). These aids are typically a tabletop, electric-powered device that includes a semiaut
operated mechanism that fills an attached spoon, moves it toward the oral cavity, and discards any le
devices also include food containers (e.g., bowls) appropriate for containing liquids or solids. Oral feed
aids are intended to provide independent eating capability to otherwise disabled patients.

Laboratory ovens designed for heating and cooling of thermoluminescent (TL) detectors at a pre-estab
annealing). These ovens typically consist of a thermal isolated chamber made of corrosion-proof mate
large glass window; the oven also includes time-and-temperature sensors and controls (either manual
temperature protection, and alarms. The controls may be an integral part of the oven or provided as a
TL detector annealing ovens can be used for controlled annealing before irradiating and/or reading; so
software that allows custom modifications in the temperature cycles.

Phototherapy units designed to irradiate patients with infrared (IR) light for therapeutic purposes usin
pulsed IR lamps and laser devices. These devices typically apply pulses of radiation in the near-IR spe
1,400 nm) using conventional light sources (e.g., lamps) and/or laser devices (e.g., diode, Nd:YAG, Er:
unit that may use different probes and one or more sets of light filters. Pulsed IR phototherapy units a
dermal treatments, including removal of vascular and/or pigmented lesions; they are also used for hai
reduction.
Power systems designed for use as a source of electric and/or mechanical power to handpieces and/o
devices used during surgical procedures; the systems may include ultrasonic and/or irrigation capabili
usually consist of a main unit that provides electrical and/or mechanical power using a motor to detac
(e.g., rotatory, oscillatory, reciprocating) that can drive dedicated surgical instruments such as saws,
systems also include a power switch (e.g., a hand or foot pedal). Most systems include a line cord and
the handpieces. Surgical electromechanical power systems may also include pumps used for irrigation
purposes and capabilities to deliver pneumatic and/or ultrasonic power; the systems are used in a var
procedures (e.g., orthopedic, otolaryngology, neurosurgery).

Laboratory pumps designed to transfer or deliver fluids (gas and/or liquid) by compression of flexible t
These devices usually consist of a single- or multichannel rotary pump, which uses rollers (also known
outermost diameter to compress a flexible tube inside the pump. Compression advances the tube con
tubing, simultaneously drawing additional fluid into the pump. Peristaltic laboratory pumps are used t
fluids in laboratory procedures; dedicated peristaltic pumps intended for use in chromatographic tests

Laboratory pumps designed to transfer or deliver fluids via a vacuum. These devices frequently consis
vane-membrane pump with one or more channels and vacuum ports; they are usually made of chemi
noncorrosive) plastic materials. Vacuum laboratory pumps are used to transfer aggressive vapors and
vacuum pumps providing specific ultimate vacuum levels (e.g., 2, 8, or 60 torricelli) and others intend
electrophoresis procedures are also available.

Optical coherence tomography (OCT) laser scanning systems that use noncontact partial coherence la
measure the characteristics of eye structures (i.e., optical biometry). These systems typically include
delivers a dual beam of infrared light at two different frequencies; a photodetector to measure the int
measures the distance between the corneal surface and retina; and software with an algorithm to der
distance (geometric separation) based on the refractive indexes of the natural ocular media. Optical b
systems are intended to accurately predict postoperative refraction indexes used for intraocular lense
pseudophakic eyes.

Shoes designed to facilitate walking on mats for balance training. These shoes are typically fixed over
(e.g., sneakers) using straps and bands; the number of bands usually regulates the height of the balan
training shoes are intended for walking on flat mats with appropriate user protection (e.g., helmet, kn
mainly used in training children to improve balance and coordination.

Automated electronic sphygmomanometers designed to measure blood pressure on the wrist. These i
display mean arterial pressure values in addition to systolic and diastolic blood pressure; some device
rate and temperature. These instruments usually consist of a wristband, an automated self-inflation m
display; they typically work with a self-contained program that provides automatic cuff inflation and p
measurement cycles. The instruments typically use oscillometric technology to determine blood press
other measuring techniques are also available. Wrist electronic sphygmomanometers are intended ma
and may keep a record of one or more measurements.
Testers designed to assess the main (i.e., most important) disturbances of the fundamental and/or har
electric power lines during total or partial failures. These testers can usually measure the variations in
amplitude, phase angle, frequency, and power in real time; some testers can also perform other asses
transient and/or harmonic analysis. Power line disturbance testers are intended for testing after electr
installed or modified, during some preventive maintenance procedures, and for routine checking of ele
status in a facility.

Endoscopic video systems with a microchip camera (i.e., a charge-coupled device [CCD]) designed for
of the larynx during intubation procedures. These systems typically consist of a laryngoscope that incl
attached to its blade distal tip, an image processor, a control unit, a fiberoptic light source (e.g., xenon
a display, and output ports for recording; they are frequently mounted on a cart or a self-supported st
systems for laryngoscopic intubation are intended to provide a clear view of the vocal cords; they are
tracheal intubation procedures but may also be used to assess the oropharynx and/or to remove foreig

Vacuum cleaners designed to collect fluids from laboratory equipment. These cleaners typically includ
a refrigerated vapor trap chamber to recover the fluids. Laboratory fluid vacuum cleaners are intende
solvent) recovery from equipment that uses vacuum technologies (e.g., gel dryers).

Prepackaged collection of reusable devices designed for in-vivo accurate measurement of the volume
variations. These kits typically consist of a graduated disposable container with appropriate volume an
immersion of the hand. The container is filled with water or other solution that is displaced by the imm
The container includes an output beak, an overflow liquid container to receive the displaced water cau
and a burette to measure the displaced water. Hand volume measuring kits are intended mainly to as
volume of a hand to evaluate abnormal physiologic conditions such as edema.

Labware washers designed for precise, temperature-controlled washing of slides. These devices typica
compartments appropriate for holding slides mounted on racks that may be inserted in sleeves; these
controls for accurate regulation of the washing temperature (e.g., from ambient to 70 degrees C) durin
procedure. Slide washers are intended to wash laboratory slides used in procedures that require strict
such as hybridization and polymerase chain reaction (PCR).

Simulators designed for use in airway management and intubation training. These simulators usually
model of the human head, neck and torso with life-size anatomic reproductions of the nose, tongue, o
larynx, epiglottis, vocal cords, trachea, esophagus, and stomach. The anatomic models can be intubat
equipment used on actual patients; some manikins can simulate patient vomiting. Instructors can use
anatomic models to demonstrate the proper way to perform face mask ventilation, endotracheal or na
and suction. Emergency medical technicians and other healthcare workers can practice intubation tec
obstructions from the airway. Manikins used in these simulators are available in different body types a
child, adult, and bariatric.
Endosteal dental implants designed for total or partial implantation into the bone and intended to rep
(known as root-form implants) in either the maxillary or mandibular bone. These implants typically co
resembling a screw and made of alloplastics (e.g., metal) materials that closely follow the shape and s
Titanium (and/or titanium alloy) is the most frequently used metal due to its ability to become incorpo
structure (i.e., fused to the bone, known as osseointegration); some implants add a hydroxyapatite ex
implants are used to replace one or more isolated teeth.

Prostheses designed for total or partial replacement of the external part of the nose. These prostheses
removable piece of plastic such as polymethyl methacrylate (PMMA) or silicone elastomers and, less f
(typically titanium) that resemble the shape and other characteristics (e.g., texture, color) of the natu
prostheses may be fixed to the face using different methods, including implant-retained, anatomically
adhesive-retained techniques. Nasal prostheses direct air flow to the nasopharynx, help to maintain p
sinuses and respiratory mucosa, restore normal speech resonance, and provide support for eyeglasses
used after radical surgery, traumatic amputation, and/or serious burns of the nose; they are intended
tissues and/or cavities and to restore physical appearance. Nasal reconstruction may be also performe
and/or allogeneic tissue (e.g., e.g., cartilage) implants.

Prostheses designed to resemble the natural hair growing on the lower part or down the sides of a ma
and sideburns, respectively) or above the upper lip (mustache). These prostheses typically consist of p
in a variety of styles, colors, and hair densities attached to a base that is usually glued on the appropr
Beard, mustache, and/or sideburn prostheses are intended to restore and/or modify the physical appe

Stents designed for deployment into the eustachian tube to maintain patency of the passage. These d
of a hollow, plastic, flanged tube that conforms to the inner contour of the eustachian tube; temporary
made of biodegradable materials and may be capable of eluting a drug. They are usually positioned v
insertion past the tympanic membrane; the flange secures the stent at the tympanic orifice of the eus
Eustachian tube stents are intended for ventilation and/or drainage of the middle ear cavity by enhan
the natural tube.

Stents designed for deployment into the larynx to prevent opposing mucosal surfaces from touching,
360 degrees of support as most stents do. These stents typically consist of a silicone (either clear or r
with a wide T configuration, but some other keels resemble an umbrella; the stents are available in se
are mainly intended to prevent the laryngeal web from reforming; they are frequently used in children
laryngeal web or laryngeal stenosis (i.e., atresia), to repair anterior glottis stenosis, and to prevent ste
hemilaryngectomy.

Esophageal tubes designed to bridge the gap between a pharyngotomy and esophagotomy following
in the first step of a two-stage reconstruction of the cervical esophagus. These devices typically consi
radiopaque plastic (silicone) tube with a funnel-shaped proximal end to conform to the hypopharynx a
to ensure proper positioning and to prevent leakage of saliva after laryngoesophagectomy. Reconstruc
create a passage between a pharyngotomy and esophagotomy, facilitating the second-stage procedu
patency of both the pharyngotomy and esophagotomy.
Prostheses designed for restoration and/or replacement of teeth. These prostheses may consist of fixe
(e.g., cemented) in place so that the user cannot move them or movable devices that permit easy ext
repositioning. Fixed prostheses may be intended for replacement of all or a few teeth (e.g., complete,
crowns); movable dental prostheses (i.e., dentures) may be also intended for replacement of all or a fe
or partial dentures). Dental prostheses are made of metal alloys, ceramic, polymeric resins, or combin
materials.

Dental prostheses designed for total replacement (i.e., restoration) of the teeth of the upper (i.e., max
mandible) jaw. The prostheses are fixed (e.g., cemented) in place by the dentist, and the user cannot
Complete dental prostheses are typically custom-made devices that include two main components: th
castings), joined by connectors, and pontics (artificial teeth that are integral components of the prosth
of cast metal alloys, or combinations of metal alloys and synthetic (e.g., acrylic) resins or ceramic. Com
prostheses are intended to totally replace the missing teeth in edentulous patients.

Dental prostheses designed to replace more than one missing tooth (i.e., dental bridges), that are fixe
the dentist to natural teeth, roots, or dental implants used as abutments and that the patient cannot r
prostheses are typically custom-made devices that include two main components: the retainers (i.e., c
together by connectors, and pontics (artificial teeth that are integral components of the prostheses); t
metal alloys or combinations of metal alloys and synthetic (e.g., acrylic) resins or ceramic. The size of
prostheses is frequently measured in total units; each retainer and pontic counts as one unit.

Dental prostheses designed to fit into a prepared dental cavity (i.e., inlays) to restore one tooth. Inlays
and cemented to the surrounded intact tooth so that the patient cannot remove them. These prosthes
restorations) are typically custom-made devices made of cast metal alloys (e.g., medium-hard gold), s
resins, or ceramics. Inlays are used to restore tooth contours and function; they are not intended to an
dental prostheses.

Dental prostheses designed to restore the posterior teeth by fitting around the remains of a tooth and
of the mesial, occlusal, and distal surfaces; they are precision fitted and cemented to the surrounded
patient cannot remove them. Onlays usually cover the entire occlusal surface of a tooth to include the
them from inlays. These prostheses (i.e., extracoronal restorations) are typically custom-made devices
alloys (e.g., medium-hard gold), synthetic (e.g., acrylic) resins, or ceramic (e.g., porcelain). Onlays are
posterior tooth contours and function.

Dental prostheses designed to restore a tooth by fitting around the remains of the tooth and covering
natural crown surface (i.e., artificial crowns); crowns are precision fitted and cemented to the surround
patient cannot remove them. These prostheses (i.e., extracoronal restorations) are typically custom-m
made of cast metal alloys (e.g., medium-hard gold), synthetic (e.g., acrylic) resins, ceramic (porcelain
these materials (e.g., porcelain fused to metal). Dedicated fixed dental crowns may be intended to co
not the entire natural crown (i.e., partial crowns) or to cover the entire surface of the natural crown (i.
some complete crowns are supported by a metal post inserted into the root canal (i.e., post crowns).
Dental crown prostheses designed to restore a tooth by fitting around the remains of the tooth and co
but not the entire natural crown surface (i.e., partial artificial crowns). Partial crowns are precision fitte
surrounded tooth so that the patient cannot remove them. These prostheses are typically custom-mad
cast metal alloys (e.g., steel, gold). Partial crown prostheses are usually classified according to the fra
they cover (e.g., one-half, three-quarters).

Dental crown prostheses designed to restore a tooth by fitting around the remains of the tooth and co
natural crown surface (i.e., complete or total artificial crowns). Complete crowns are precision fitted an
surrounded tooth so that the patient cannot remove them. These prostheses are typically custom-mad
cast metal alloys (e.g., steel, gold). Total dental crown prostheses are available with a metal structure
or resins for esthetic reasons or as cast metal crowns with porcelain fused on the surface. Preformed c
temporary use are also available; they are used mainly in pediatric patients to cover primary teeth.

Dental crown prostheses designed to restore a tooth by fitting around the remains of the tooth and co
natural crown surface, supported by a metallic post inserted into the root canal (i.e., post artificial cro
patient cannot remove them. These prostheses are typically custom-made devices made of cast meta
gold) that may be covered by resin or porcelain. Post complete dental crown prostheses are mounted
the metallic part or core of the post that protrudes from the root canal) that is cemented into the root

Dental crown prostheses designed for support and retention of a movable partial denture (including ov
crowns are usually fixed (e.g., cemented) to dental implants but may be also fixed to a dental post ins
These crowns typically consist of metallic devices, frequently covered with porcelain, that are the fixed
component dental attachment (i.e., precision or semiprecision attachment), of which the second comp
part of the denture. Abutment crowns are intended to facilitate the attachment of dentures.

Removable dental prostheses designed for replacement of some or all the teeth in either the upper (i.
(i.e., mandible) jaw. These devices typically consist of a custom-made or preformed prosthesis that inc
porcelain or resin teeth (also known as pontics) attached to a metallic (e.g., titanium) or polymeric (e.
fits on the alveolar ridge. Dedicated dentures intended to replace all the natural teeth in one arch (i.e.
or to replace only one or more but not all teeth (i.e., partial dentures) are available.

Dentures designed for replacement of all teeth in the upper (i.e., maxilla) or lower (i.e., mandible) jaw
typically a removable custom-made or preformed prosthesis that includes artificial porcelain or resin t
movable metallic (e.g., titanium) or polymeric (e.g., acrylic) base that fits on the alveolar ridge. Comp
available to replace all natural teeth in the upper (maxillary) or lower (i.e., mandibular) jaw. Dedicated
intended for insertion over one or more remaining teeth, roots, or implants (i.e., overlay dentures) are

Dentures designed for insertion over one or more remaining teeth, roots, or implants for replacement
upper (i.e., maxilla) or lower (i.e., mandible) jaw. These dentures are typically consist of a movable, cu
that includes artificial porcelain or resin teeth attached to movable metallic (e.g., titanium) or polyme
and attachments that fit on the remaining dental parts, dental implants, and/or the alveolar ridge. Com
dentures are available to replace all natural teeth in the upper or lower jaw.
Complete dentures designed for insertion immediately following the removal of natural teeth. These d
made before the natural teeth are extracted using the patient's mouth as a mold for the denture base
artificial teeth will be attached. Immediate complete dentures are inserted directly over the bleeding s
and gingival tissue, which supported the natural teeth, are still intact; they will usually require tempor
dentist office and permanent relining (replacement by a permanent denture) at the dental laboratory
have healed and shrinkage of the underlying bone has occurred.

Dentures designed for insertion over one or more remaining teeth, roots, or implants for replacement
all, teeth in the upper (i.e., maxilla) or lower (i.e., mandible) jaw. These dentures are typically a remov
prosthesis that includes porcelain or resin teeth attached to a movable metal (e.g., titanium) or polym
with attachments that fit on the remaining dental parts and the alveolar ridge.

Partial dentures designed for insertion immediately following the removal of natural teeth. These dent
before the natural teeth are extracted, using the patient's mouth as a mold for the denture base wher
teeth will be attached. Immediate partial dentures are inserted directly over the bleeding sockets whe
gingival tissue, which supported the natural teeth, are still intact; they will usually require temporary r
office and a permanent relining (or replacement by a permanent denture) at the dental laboratory afte
healed and shrinkage of the underlying bone has occurred

Retainers designed for use in dental treatments, either for permanent use as prosthesis support or for
orthodontic and/or restoration procedures. Retainers are typically metallic casts, wires, or bands that m
component of fixed prostheses, partial dentures, or orthodontic devices. Retainers intended to mainta
teeth in an appropriate position are usually attached to abutment teeth; temporary retainers used in o
are used for relatively long periods of time (e.g., weeks, months, years) while temporary retainers inte
bands used to contour and confine dental restorative materials are used only during the dental proced

Orthodontic retainers, that cannot be easily removed by the patient, designed to hold teeth in place d
functional adaptation while surrounding gingival tissue (i.e., gums) and bone adjust to a new position
orthodontic treatment. These retainers typically consist of metallic wires attached to the lower incisor
prevent reversal of the substantial modifications in tooth position (e.g., great modifications in bite) ga
procedures.

Orthodontic retainers that can be easily removed by the user, designed to hold teeth in place during t
adaptation while surrounding gingival tissue (i.e., gums) and bone adjust to a new position following c
treatment. These retainers may consist of metallic wires that surround the teeth and are attached (i.e
resin (e.g., acrylic) plates shaped to fit either on the mouth palate or floor (Hawley retainers). Clear or
resin retainers (e.g., Essix retainers) that fit over the entire arch of teeth and do not allow the upper a
because plastic covers the chewing surfaces of the teeth are also used. Removable orthodontic retain
several hours a day (e.g., during the night) for a period of several months or a few years to prevent re
modifications in tooth position (e.g., great modifications in bite) gained by orthodontic procedures.

Retainers designed to fit onto the abutments (e.g., supporting teeth) and support through a connector
(i.e., pontics) of a fixed dental prosthesis. These retainers are typically metallic castings, bands, or wir
part of complete or partial (e.g., complete or partial crown, onlay) dental prostheses.
Retainers designed to fit on the abutment teeth and support the suspended portion of a partial dentur
typically metallic castings, bands, or wires that are an integral part of a partial denture. The part of th
the abutment tooth is known as a clasp.
Dental retainers designed for retention of matrix bands intended to contour and confine dental restora
retainers typically consist of metallic (typically stainless steel) devices that hold the matrix band durin
procedure; the retainer's shape and mechanical characteristics should match the characteristics of the
the procedure (e.g., Tofflemire, Nystroem). Matrix band dental retainers are used temporarily during th
procedure; procedures using matrix bands without requiring retainers (i.e., retainerless matrix bands)

Artificial teeth designed for attachment (i.e., suspended) to the retainers of a fixed dental prosthesis.
typically made of ceramic (e.g., porcelain) or synthetic resins; they are an integral part of fixed dental
are intended to occupy the space formerly filled by a natural tooth.
Connectors designed to lock artificial teeth to dental retainers used in fixed dental prostheses. These
part of the dental prostheses; they may be rigid (e.g., cast, soldered) or semirigid (i.e., resilient) typica
female locking connection. Dedicated dental prosthesis connectors are also available as a component
denture attachment.
Removable prosthetic plates (i.e., bases) designed to support partial or complete artificial dentures. T
typically made of plastics (e.g., acrylic resin), natural resin (e.g., shellac), or metal and are configured
mouth cavity; the plates are usually an integral part of movable dentures. Dental plates are configure
extraction and repositioning of a removable denture by the user.
Dental devices designed for total or partial implantation in the maxillary or mandibular bone (i.e., end
These implants typically consist of devices resembling a screw and are made of alloplastics (e.g., met
(and/or titanium alloy) is the most frequently used metal due to its ability to become incorporated in t
fused to the bone, known as osseointegration). Standard endosteal dental implants are available in a
shapes, including implants appropriate for individual teeth (i.e., root-form implants), several teeth (i.e
complete denture support. Dedicated long flat implants (i.e., plate-form implants) are available that ca
when the bone is too narrow for a root-form implant and the area is not suitable for a bone graft.

Endosteal dental implants designed for implantation through the posterior alveolar crest and maxillary
the cheekbone (zygomatic implants). These implants typically consist of devices resembling one, two,
screws; usually one or two conventional endosteal dental implants are also needed in the frontal area
stabilize fixed dental prostheses. Zygomatic dental implants are intended for use as an alternative to
patients with severely atrophic maxilla.

Endosteal dental implants designed to attach (i.e., anchor) removable partial dentures to the maxilla o
These implants are typically sharp, pointed metal (e.g., titanium, stainless steel) devices (e.g., a very
that is introduced into the bone. Two main techniques are used to attach partial dentures to anchoring
permanent attachment of the partial denture to the anchoring implant with screws that only the denti
use of dental anchoring implants, including ball heads and sockets inserted into the base of the dentu
denture to snap onto the head of the socket and be held in place; users can remove the denture by ap
lifting motion with their thumbs. Partial denture anchor implants are available in a variety of shapes a
the type of denture that they are intended to fix to the bones.
Dental devices designed for implantation through the mandibular bone (i.e., transosteal or transosseo
typically consist of screws that are inserted through the bone, penetrating the entire jaw and emergin
chin where they are secured with a nut and a pressure plate. Transosteal implants are usually made of
metal) materials; titanium (and/or titanium alloy) is the most frequently used metal due to its ability t
in the bone structure (i.e., fused to the bone, known as osseointegration). Standard transosteal dental
in a variety of sizes and shapes, including implants appropriate for individual teeth, several teeth (i.e.
complete denture support; this type of implant is no longer frequently used in current dental practice.

Dental devices designed for implantation on the surface of either the maxilla or mandible beneath the
metal framework that fits over the bone. These implants are typically custom made based on an impr
made either during a surgical procedure or on a model of the bone made from computed tomography
jawbone. A dental laboratory creates the custom implant to fit the jaw, then the implant is inserted. S
are intended for use when bone width or height is insufficient for a root-form or plate-form implant du
jawbone resorption.

Dental devices designed for attachment to the lateral sides (i.e., inserts) of a denture to improve dent
inserts typically consist of small metal buttons (typically resembling a mushroom) that face toward the
engage the surgically created indentations at diverse angles in the patient's soft tissues bearing the d
inserts are intended to provide stability and holding power to movable dentures.

Electronic devices designed to amplify electrical signals. These amplifiers are typically an electronic u
circuits intended to amplify the signals (either analog or digital) according their technical characteristi
bandwidth, input/output impedance); the amplifiers usually must perform their intended functions acc
standards. Dedicated electric signal amplifiers are available for a variety of signals, including audio, ra
video; some multichannel amplifiers are capable of simultaneous amplification of signals of different c
audio and video).

Environmental monitors designed to display the concentration of oxygen in the atmosphere. These mo
appropriate sensors (e.g., electrochemical), a control unit, and a display; they may also include alarms
activated at several prefixed concentrations, recording capabilities, and/or a transmitter for remote ce
Oxygen monitors are electrically powered devices (either line- or battery-powered) that are typically u
presence of oxygen in rooms. Dedicated monitors intended mainly to initiate a display and/or an alarm
level in the air is below a pre-established limit to protect the safety of patients and/or healthcare pers
available.

Environmental/gas system analyzers designed to measure and display the concentration of carbon dio
of gas. These analyzers are typically portable units based in photometric technologies (e.g., using dua
sensors). CO2 environmental/gas system analyzers are used to determine CO2 concentrations in close
laboratories, laboratory incubators) and/or open air (atmospheric) conditions; they can usually measu
to 100%, but devices intended only for accurate measuring of very small concentrations (e.g., from a
thousand ppm) are also available. Some devices include pressure and/or temperature compensation a
measurement.
Computer-aided training exercisers designed to assess and train a patient for balance. These exercise
force platform with handle rails, a screen that displays biofeedback information, and a computerized u
compares, and analyzes the user's performance using test (static or dynamic) modes and/or or trains
dynamic training modes. Computer-aided training balance exercisers display real-time, visual feedbac
the balance test or training that patients can use to adjust their posture and balance. The devices are
and/or improve balance and the body's ability to sense and regulate the posture and movements usin
(proprioception). Computer-aided training exercisers are used mainly for programmed exercises, train
therapy and rehabilitation.

Devices designed to attach and center rotating tools (typically drill bits and burs) to the equipment th
power (e.g., drill, handpiece). Drill chucks typically consist of a clamp-like device with three jaws that
the rotating tool, most chucks have a capacity up to 0.5 inch (13 mm) diameter, but some may allow
1 inch (25 mm). Drill chucks are usually provided with a special key to tighten and loosen the rotating
permit attachment of rotatory tools using only twisting hand pressure (i.e., keyless chucks). Drill chuck
healthcare facilities for drilling devices during surgical, dental, orthopedic, and postmortem procedure
intended for rotatory drills used to repair medical and other hospital devices.

Diagnostic instruments designed as a combination of a direct ophthalmoscope and a retinoscope. The


include ophthalmoscope and retinoscope heads and a handle with an internal battery that can be use
ophthalmoscope or the retinoscope head; they are usually available in housings. The handle frequentl
charger. Most ophthalmoscope/retinoscope sets are used for primary care or emergency diagnosis, bu
also be used in surgery.

Protective shields (guards) designed for use with burs and/or drill bits when they are operated attache
machine. These guards typically consist of a hollow metallic cylinder (shaft) placed around the drill bit
open at the operating end to allow drilling and includes at the proximal end a coupling to the rotatory
machine. Bur/drill bit guards are intended also to facilitate accurate positioning of the drill bit and/or b
to drill straight forward, avoiding lateral deviations; the main clinical use is for delicate and/or restricte
procedures that require drilling. Dedicated guards are available for specific surgical procedures (e.g., r
laminectomy).

Handrests designed to permit appropriate placement of the surgeon's hands during delicate surgical p
handrests may be made of different materials and have different shapes according to the procedure to
are fixed to and/or are an integral part of a surgical (e.g., neurosurgery, ophthalmic) retractor. Surgica
are intended to make the surgeon more comfortable and facilitate the manipulation of surgical instrum
procedures that require steady control of hand movements, such as neurology and ophthalmic surgery
Automated laboratory chromatography injectors are part of the autosamplers of gas chromatography
chromatography units. Sample delivery systems are designed to interface with gas-liquid chromatogra
pressure liquid chromatography systems to introduce gas, liquid or solid phase micro extraction samp
loop (mobile phase) of the system in the smallest volume possible so that the sample enters the statio
a homogeneous, low-volume plug. Automated injectors are designed to inject consistently sized samp
high reproducibility of results so that many samples (several to hundreds) can be analyzed in a short a
usually have automated injectors consisting of an automated arm with a microsyringe at the bottom t
a tray holding the sample vials. The microsyringe may be interchangeable to handle different sized sa
microsyringe is lowered by the automatically controlled arm through a septum covering the top of the
withdrawing a sample, it is raised and positioned to inject the sample into the chromatography injecto
controlled automatic injectors can sequentially inject several samples for batch processing, automatic
sample loop between each sample to minimize carryover. Some automated chromatography injectors
samples into the chromatography system at a controlled volume, injection speed, temperature, pressu
between samples. Automated injectors are used when consistent sample size and rapid introduction o
for a large number of samples; they offer minimum error in reproducibility of results when compared w

Visual function analyzers designed to measure and evaluate visual acuity and macular integrity under
conditions (i.e., brightness acuity). These analyzers typically consist of an electrically powered device
intensities of light to the patient's eye when using the best possible correcting lens (i.e., eyeglasses o
acuity and macular disturbances are checked under those conditions. Testing visual acuity under brigh
facilitates the assessment of opacities and/or distortions in the ocular media (e.g., corneal opacities, o
cataract surgery); macular test under bright conditions (i.e., photo stress macular test) is intended to
disturbances such as macular edema and senile macular degeneration

Manometers designed to measure the pressure exerted by one or both feet while standing and/or walk
typically consist of an electronic manometer with a dedicated mat that includes multiple sensors to de
between the foot and the mat at many different points. The manometers may be dedicated instrumen
physiologic (e.g., gait) analyzers that permit the detailed assessment of the pressure in different area
computerized algorithms and/or graphic analysis methods. Plantar foot pressure manometers are inte
foot pressure profiles; they are used for different purposes including the identification of discrepancies
exerted by each foot, the identification of potential areas of ulceration, and in the assessment of balan
strength.

Photometers designed for in vivo measuring of the melanin and hemoglobin content (i.e., redness of t
erythema) in the skin. These instruments typically consist of a portable or mobile device that includes
as the source of light for illuminating the skin at several different frequencies, usually in the visible sp
detector (e.g., a photodiode) for measuring the light reflected by the skin at each (e.g., three) frequen
(algorithm) to calculate the melanin and hemoglobin content of the skin as a function of the absorbed
Body pressure distribution physiologic analyzers designed to determine the area of contact and to eva
exerted by the body when sitting and/or leaning on a surface. These analyzers typically include senso
contours of the contact area and the pressure existing at each point of the interface between the body
back surfaces of a chair or wheelchair, an electronic unit to process the information, and a display typ
colored map the areas of contact and the pressure values for each contact point. Back/seating pressur
analyzers are used to determine the high-pressure areas, determine abnormal positioning of the body
surface, facilitate selection of appropriate support surfaces and/or cushions, and help in the treatment
decubitus ulcers.

Balance exercisers designed to improve the user's ability to maintain proper posture when walking or
suspending the user. These exercisers usually consist of a suspension system; patient handrails that s
standing positions; walking slings for partially lifting and supporting the user, which are suspended by
and attached locking casters that can be used to move the device from one place to another. These e
powered, although the weights to be offloaded may be manually adjusted; they are capable of lifting p
wheelchairs and may also be used with a treadmill to allow users to exercise. Patient lifting balance ex
physical therapy and rehabilitation to improve balance, coordination; muscle strength, and muacle ton

Chromatography injectors that are operated manually and are sample-delivery systems designed to in
chromatography or high-pressure liquid chromatography systems to introduce gas, liquid, or solid pha
samples into the sample loop (mobile phase) of the chromatography system in the smallest volume p
sample enters the stationary phase column as a homogeneous, low-volume plug. They come in differe
fit into various chromatography units and typically feature an injection port to receive the sample mic
injection mode, and outflow ports that interface with the stator injection port of the chromatography u
into the chromatography unit while in outflow mode. The injector is manually switched between the tw
operator by rotating the handle of the injector. The manual injectors usually have tight seals between
made of stainless steel or other noncorrosive materials to avoid contamination of samples and wear o
components by the sample material. Manual injectors are usually used when only one or a few sample
introduced into the chromatography unit in a fast and uniform manner at a controlled pressure.

Connectors designed to withdraw liquid nitrogen from vessels containing the cryogenic liquid (e.g., De
connectors can regulate the pressure and the flow of the liquid nitrogen (e.g., up to 8 or 10 liters/minu
attached to Dewar flasks of several different capacities (e.g., 25, 50 liter) following appropriate proced
connection; the content of the Dewar flask usually may be replenished without removing the connecto
container transfer connectors are mainly used for safe transference of the liquid to other devices such
cryogenic container.

Ophthalmic diagnostic instruments designed mainly to assess the characteristic of the tear film. These
consist of electronic handheld instruments that permit noninvasive measurement of the tear film, its l
and mucus), and the tear meniscus between the cornea and lid, and visual determination of corneal s
The device includes grids to facilitate examination and/or disks with patterns (e.g., Placido disks) to as
irregularities. Tear visual functions analyzers are used to evaluate the tear film, evaluate dry-eye prob
selection of appropriate contact lenses.
Cables designed to deliver power to a handpiece by providing connection of the handpiece to a power
devices typically are detachable cables with appropriate caliber that include mechanical strain reliefs
allow the connection of a single handpiece to the console but some consoles permit the connection of
attached handpieces simultaneously. Handpiece/power console cables may be intended to attach han
several models of consoles.

Liquid manifolds designed for use in chromatography procedures. These manifolds typically apply a va
procedure; glass, polycarbonate, and acrylic manifolds are available. Chromatography manifolds are in
pressure liquid chromatography procedures; they may be an integral component of the chromatograp
devices used while processing clinical samples for solid phase and flash extractions.

Multipurpose casework designed for general, nonspecialized storage within healthcare facilities whos
adjusted according to user needs. This casework usually consists of a set of nonspecialized storing un
drawers, boxes, and shelves that are usually fixed to the wall using frames and/or rails with slots that
the casework components at different heights. The casework is typically installed in such a manner th
and the space required for the furniture is minimized while the storage area is maximized; casework m
working surfaces. Adjustable height multipurpose casework is typically designed to cover the needs o
of a healthcare facility, such as a doctor's office or a reception area.

Equipment designed to grind the edges of eyeglass lenses to improve fitting to the eyeglass frame. Th
frequently consists of an automated grinding machine that includes lens holders, grinding and/or polis
supply unit to cool the lens, a scanner to scan and obtain the shape of the eyeglass frame, and a cont
unit. Manually operated stone grinding wheels are also available. Eyeglass lens edgers are capable of
edges into particular forms, such as flat, grooved, or beveled.

Holders designed to hold surgical instruments during operative procedures. These holders typically co
structure that permits easy access and removal, either sequential or simultaneous, of one or more sur
during an operative procedure; the holders may be attached to the surgical table and/or to other struc
retractors). Both flat and curved instruments can be securely held by the holders; most holders can ac
limited range of instrument diameters and curvatures. Surgical instrument holders are intended to fac
manipulation of the instruments during a surgical procedure. Surgical holders can be used for a partic
(e.g., electrosurgical active electrodes, knives, retractors) and/or procedures (e.g., laparoscopes in min

Devices designed for use as a working, detachable component of a surgical retractor. These blades co
structures that typically include a thin, curved (e.g., hook-like) piece of metal (e.g., stainless steel) wit
prongs and dull or sharp edges. They may include bolts or other mechanisms for attachment and lock
frame, some also include a light source to illuminate the surgical field. Several blades (typically two or
retractor frame are used simultaneously. The retractor frame may or may not be fixed to the surgical
retractor blades are usually reusable devices. They are available in a variety of shapes and sizes to ac
surgical procedures.

Ophthalmic diagnostic instruments designed mainly to assess the preoperative retinal acuity in patien
These instruments typically consist of a handheld device that produces a grating pattern projected by
halogen bulb) that produces an interference effect. The pupil is scanned with different values of acuity
ambient light until the patient cannot recognize the angle anymore. Retinometers are intended mostly
prediction of the visual acuity that a patient will have after cataract surgery.
Prepackaged collection of devices and supplies needed for performing diagnosis and basic therapy of
problems, as well as providing training in performing those procedures. These kits usually include mos
and supplies needed to perform the procedure, such as lenses, prisms, filters, occluders, vector graph
red/green targets used with red/green glasses to develop eye teaming skills), slides, and/or goggles. O
diagnostic/therapy kits may be used, in addition to the diagnostic and therapeutic procedures, to impr
eye care providers. The kits may be used in patients who have visual problems, such as strabismus, b
decreased accommodation (i.e., presbyopia), or other eye problems.

Adapters designed to couple a video camera to a power and/or video signal source. These adapters ty
cable (e.g., a dedicated coaxial cable) with appropriate connectors at each end that make possible el
mechanical matching between one or more particular types of video cameras to a given power and/or
cable usually transmits, in addition to the DC power, video and/or synchronism signals between the ca

Environmental/gas system analyzers designed to measure and display the concentration of oxygen in
analyzers are typically portable units based in one of several technologies, including the use of the pa
of oxygen and in the creation of zirconia oxygen electrolytic cells. Oxygen environmental/gas system a
determine oxygen concentrations in closed and/or open air conditions, frequently in contaminated atm
usually measure in a range from 0% to 100%, but devices intended only for accurate measuring of ve
of oxygen are also available.

Point-of-care breath analyzers designed to determine the nitric oxide (NO) content in a breath sample,
parts per billion (ppb, one part in 10^9 ). These analyzers typically use gas-measuring methods based
chemiluminescence and dedicated software; the typical range of measured values is up to 200 ppb. N
intended for the periodic assessment of breath levels of NO to help determine disease (e.g., bronchial
and treatment effectiveness.

Bars designed for surgical retractor fixation to a surgical table or other type of support. These devices
dedicated metallic bar (e.g., with a rectangular cross-section) that is attached to a surgical table and t
secure in position a surgical retractor; some retractors (e.g., abdominal) use two bars for attachment t
surgical table. Retractor bars may be intended for use only in one or a few models of retractors and/or
usually available as accessories of particular retractors.

Physiologic monitors designed primarily for automated continuous measuring and display in real time
parameters, the partial pressure of carbon dioxide (PCO2) in exhaled breath, and the oxygen saturatio
These monitors typically consist of portable (may be handheld) electronic units that facilitate moveme
other; the monitor may be connected to the line and/or powered by internal batteries. The main unit i
display; it also includes appropriate attached probes and sensors that make possible sequential and/o
measurements of the parameters. Carbon dioxide is usually measured using main- or side-stream sen
determined using standard pulse oximetry sensors; other sensors to determine respiration rate are als
Respiration/carbon dioxide/pulse oximetry physiologic monitors are intended mainly for continuous au
the parameters; some devices can show the results of carbon dioxide measurement in the form of a g
The monitors can be used also for continuous measuring as bedside monitors or for monitoring during
Lifts designed for manual and/or automated lifting of a wheelchair or scooter that does not contain a p
unoccupied/empty) inside or to the exterior of a motor vehicle. These lifts may consist of a manual or
mechanism. Automated lift mechanisms may be capable of folding the wheelchair (for manual and fol
sometimes locking it in an enclosure and then lifting. Motor vehicle wheelchair lifts operate by lifting a
wheelchair into the vehicle (e.g., into the trunk) or externally at the rear (e.g., for powered wheelchair
the roof of the vehicle (for foldable wheelchairs); the lifts make possible or facilitate the transportation
wheelchairs.

Pedestals designed as a common component of surgical tables, the pedestals may be attached to one
interchangeable tabletops according to the surgical procedure to be performed. These pedestals typic
base (e.g., a column, lateral supports) that may be mounted on a movable, swivel-caster base. Tableto
pedestals are raised or lowered by mechanical gears or hydraulic piston systems using manual contro
footpedals) or electrical controls (e.g., footpedals, levers, remote-controlled units). Operating table pe
appropriate tabletop may be used for one or more of a variety of surgical specialties(e.g., general surg
gynecology/urology, ophthalmology/ENT, orthopedic, neurosurgery, spinal, vascular surgery).

Tabletop devices designed to cool substances (e.g., solids, liquids) when placed on their surfaces. The
consist of a small unit with an internal refrigeration system, a flat surface intended for cooling objects
the temperature at a fixed temperature (e.g., from -5?to -15?C/5? to 23?F); some include a cover over
from forming. Cold plates are intended mainly to perform several laboratory procedures such as coolin
blocks and/or molds.

Surgical distractors designed to provide a force that produces noninvasive separation of the ankle join
while allowing access to the joint space. These distractors typically consist of an adjustable force mec
include clamps, screws, levers, and a strap attached to the foot; the mechanism may be attached to t
(e.g., on a leg holder) or other type of support. Gross adjustment rotating the bar, constant distraction
are possible using this mechanism; some distractors include a device (dynamometer) to measure the
to the joint. Ankle distractors are intended for use during ankle and/or foot surgical procedures, includ
arthroscopy, ligament repair, and ankle arthrodesis.

Exercisers designed to train users in functional and/or sport movements by means of a virtual game e
computerized unit. These exercisers consist of a computerized unit and a camera that delivers exercis
of virtual sports or games on a screen and monitors, measures, and analyzes users' performance, adju
the exercise programs in real time. The monitor screen displays the users' motions in real time that th
their motions by moving their bodies according to the position of the virtual objects on the screen. Vi
are intended to improve cardiovascular endurance, balance, proprioception, flexibility, and agility. The
programmed exercises, training, and/or physical therapy and rehabilitation.

Pre-assembled pools designed to be filled with water, which are intended for performing exercises in
for therapeutic purposes (hydrotherapy). These pools typically consist of a large container that usually
different and/or variable depths; they may provide a steady water flow that can be adjusted to severa
pools are usually large enough to permit swimming and the performance of other physical exercise su
walking; some pools include an angled platform, exercise benches, water jet massage, and/or a treadm
underwater use. Hydrotherapy pools are used mainly during physical therapy (e.g., arthritis treatment
procedures.
Injectors designed to deliver mold casting fluids into the ear canal to create impressions for fitting hea
injectors usually consist of an electrical, battery operated, handheld gun with a barrel that opens to ac
cartridges containing fluids such as vulcanized silicones. The injector may allow for automatic dosage
impression materials and injection of casting material at variable speeds. Ear canal impression injecto
impressions for customized hearing aid manufacturing.

Injectors designed to deliver vocal cord augmentation material onto damaged laryngeal vocal cords d
These injectors usually consist of a handheld gun with a barrel that opens to accept prefilled cartridge
augmentation material (e.g., hydroxyapatite, lipids, collagen); usually, they are controlled manually an
precise dose delivery of the material. Vocal cord injectors may be used during video-guided surgery to
attachment of the augmentation material to the vocal cords.

Lower and upper limb muscle strength exercisers designed to test a patient's isometric lifting capabili
consist of a platform for the patient to stand on, a chain with a handle that patients lift, and a gauge t
weight the patient can lift and/or the amount of force the patient is exerting. These platforms are ofte
therapists in rehabilitation programs to evaluate a patient's ability to perform job-related duties (e.g.,
amount of weight); a patient's muscle strength; and a patient's physical readiness to return to work af

Bone surgery retractors designed to temporarily separate and hold back one segment (usually one he
of the femur, exposing and providing access to other tissues, organs, or structures during orthopedic (
procedures. These retractors may consist of manual, sturdy, handheld instruments consisting of a curv
two-pronged blunt blade forming a small angle to the shaft at the distal tip and an integral flat handle
Retractors with two adjustable blades and scissors-like proximal end with a self-retention ratchet are a
retractors are used in trauma and/or orthopedic reconstructive procedures involving the femur (e.g., t
head and neck laterally) improving the access to the hip joint.

Operating tabletops designed for use as a detachable component in operating tables using a common
orthopedic surgical procedures. These tabletops typically consist of a rectangular top made of metal, p
metal/plastic/carbon-fiber composite and are supported by a fixed base (pedestal) or a movable, swive
Orthopedic operating tabletops have padding for upper-body support, an apparatus for lower-body sup
bars), and any number of orthopedic accessories. Some orthopedic upper-body supports are interchan
accommodate specific orthopedic procedures; other models are available with tabletops that allow the
orthopedic table to a full-length surgical table or to perform another surgical (e.g., spinal, vascular) pr
operating tabletops and their individual segments are raised and lowered by mechanical gears or hyd
using manual controls (e.g., cranks, foot pedals) or electronic controls (e.g., foot pedals, levers, remot
are available in adult and pediatric sizes.
Operating tabletops designed for use as a detachable component in operating tables using a common
spinal surgical procedures. These tabletops typically consist of a rectangular top made of metal, plasti
metal/plastic/carbon-fiber composite and are supported by a fixed base (pedestal) or a movable, swive
operating tabletops are designed for optimal patient positioning and surgical team access while perfo
procedures. Most of these tabletops have radiolucent supports for intraoperative fluoroscopy and also
capabilities up to 360 degrees. Spinal operating tabletops are used for lumbar and cervical spinal surg
procedures for correction of deformities (e.g., osteotomies, laminectomies). Spinal operating tabletops
segments are raised and lowered by mechanical gears or hydraulic piston systems using manual cont
pedals) or electronic controls (e.g., foot pedals, levers, remote-control units).

Equipment designed to transfer nucleic acid (DNA or RNA) samples typically from an agarose gel onto
nylon, nitrocellulose, polyvinylidene difluoride-PVDF ) or less frequently to a filter or treated paper (i.e
electrophoresis procedure, a procedure that separates the molecules according to the charge and size
performed using a vacuum process, that is a variant of the capillary process transfer. These blotters ty
vacuum pump or are connected by a hose to a central vacuum system; they also include a vacuum pl
chamber to perform the procedure. IVD nucleic acid blotters are intended to provide in an immobilize
copy of the electrophoretic pattern present in the gel allowing the performance of a wide range of an
Vacuum nucleic acid blotters are used in tests usually known as southern or northern blots, for DNA a

Measuring instruments designed to determine the friction of the molecular components of a fluid as th
other when flowing (i.e., viscosity). These devices may be intended to measure viscosity in liquids wh
constant with temperature or shear rate (i.e., Newtonian fluids such as water), in liquids whose viscos
temperature or shear stress (i.e., non-Newtonian fluids), or both. Manual and automated viscosimeter
techniques are available, including falling ball, capillary, and rising bubble techniques.

Powered equipment designed to deliver a turbulent water supply to a whirlpool bath and/or some ther
pools. This equipment (i.e., a turbine) typically consists of an electric motor and a rotatory mechanism
turbulent (jet) flow of water inside the bath or pool. The turbine also includes controls for the water flo
temperature; it is usually mounted on a fixed post close to the whirlpool bath. Whirlpool turbines are a
whirlpool bath installation used to provide hydrotherapy.

Equipment designed primarily for gentle bathing of patients who have compromised skin. These units
bathing tube and a control console to regulate the bathing tube height, water temperature, automate
withdrawal of the water, and scalding protection; some units may include hydro massage capabilities.
configured to permit placing and removing the patient using patient lifts; the combination of the tube
sometimes called a bathing system. Patient bathing units are used mainly in patients who have burns
conditions; they are also used for patients at high risk of skin damage.

Patient transfer lifts designed to carry patients in/out of a swimming pool in a sitting and/or recumben
typically consist of a pole rigidly mounted on a support close to the edge of a swimming pool, a power
motors, hydraulic) mechanism including a swivel arm with a chair (may be interchangeable with a slin
end, and controls for movement regulation. Swimming pool patient transfer lifts are mainly used for p
rehabilitation procedures; they may be installed in existing pools at home and/or in public-use facilitie
schools.
Environmental recorders designed primarily for storing information regarding the environmental air te
recorders typically consist of a portable electronic unit which includes a mechanism for periodically sa
temperature in the air using appropriate sensors, thermometers to measure a wide range of temperat
memory capable of storing samples in the order of several thousands. Dedicated software for downloa
standard computer is necessary for some recorders. Environmental air temperature electronic recorde
term recording of air temperature; they may be intended for use indoors, outdoors, or in both conditio
temperature recorders use a mechanical or electromechanical mechanism to move a rotatory cylinder
to store the temperature information for relatively long-term (e.g., a week) recordings.

Dynamometers designed to measure the force exerted by the thumb and an opposing finger or group
pressed tightly together. These dynamometers typically consist of a manual, handheld measuring inst
mechanism that resists the force applied by the hand (e.g., a bulb, hydraulic system) or a strain gauge
measuring device, and a display (e.g., a gauge) to show the measured value of the force (usually in po
both). Dedicated instruments using bulbs, hydraulic systems, and strain gauge transducers are availa
strain gauges may be sent to computers or other electronic devices for data processing and/or storage
dynamometers are intended mainly for use in doctor's offices, for evaluation of hand trauma, and/or f
physical therapy treatments.

Continuous passive/active motion exercisers designed to provide controlled, rhythmic motion (e.g., cy
and/or lower limbs, which are propelled by a motor without the patient's muscular exertion in the pass
voluntary movements by cycling pedals in the active mode. These exercisers usually consist of an ele
the pedals whenever assistance is needed, a sensor for monitoring the force generated by the patient
resistance, exercise programs to adjust the amount of resistance, and a display that shows the resista
exercise information. Typically, when the patient does not have any muscle power to do the active exe
provides the force for the cycling motion; the motor may provide some assistance as needed when th
exerting some muscle power. Lower-upper-limb combined exercisers are intended to improve muscula
flexibility; they are used in physical therapy and rehabilitation by people with serious disability. Dedica
passive/active motion exercisers are available for the upper limbs (arms) and/or the lower limbs (legs)

Exercisers designed for the physical exertion of body muscles by voluntary contraction and relaxation
are intended primarily to improve the user's ability to maintain proper posture and stability. These exe
an unstable surface made of rubber, wood, or plastic intended to help improve stability, balance, and
additionally, as do all exercisers, they may improve the muscle strength, endurance, flexibility, and ba
of the body (e.g., upper and/or lower body). Dedicated balance exercisers are available in the forms o
domes, and rollers.

Aerobic exercisers designed to provide exercise by bouncing on a resilient (elastic) surface. Trampoline
woven mat attached by coiled steel springs to a metal frame providing a rebounding force. Trampoline
round, but some are oval, rectangular, or other shapes. Bouncing trampolines are used in sports (e.g.,
skiing) and in physical fitness exercises; they are intended to increase cardiovascular endurance by ke
pulmonary rate elevated for a continuous time. Additionally, they provide muscular strength and endu
lower body muscles (e.g., quadriceps, hamstrings, gluteus, hip flexors, calves) and also to the arm and
Aerobic exercisers designed to simulate elliptical (in an oval plane) motions, a combination of stair-ste
country skiing, and walking. These exercisers typically consist of a pair of moving handlebars, a chain
footpedals or platforms on which a user can stride in a forward or reverse direction. Some exercisers c
length; resistance is provided by a mechanical or magnetic belt. Most exercisers are nonpowered, but
motor to regulate speed. The exercisers usually include workout program modes that can adjust resist
display the workout time, distance, speed, calories burned, and heart rate; they often have handlebar
sensors, and some may also have heart-rate controls to adjust resistance level to suit the targeted he
motion aerobic exercisers are intended to increase cardiovascular endurance by keeping the heart and
elevated for a continuous period of time. Additionally, they provide strength and endurance to the mu
(i.e., quadriceps, hamstrings, gluteus, hip flexors, calves) and the upper body (i.e., arms, shoulder, ch

Muscle strength exercisers designed to provide resistance to muscular contraction in the abdomen usi
on a system of pulleys and cables or levers. These exercisers usually consist of a stand-alone machine
on top of each other or a hydraulic mechanism, a system to transmit the force (i.e., to convey the resi
or pulley cables on which the user exerts force to counteract the exerciser resistance. Users grasp the
handles and flex their waist. Abdominal crunch strength exercisers are intended to improve muscle str
increase muscle size, enhance muscle endurance and power, and improve bone density.

Free weight exercisers designed to provide resistance to muscular contraction using two weight plates
bar (i.e., dumbbells and weight); the resistance is provided by the force of gravity acting on the dumb
not attached to any other devices and do not restrict a user's movements. These exercisers are short,
balls or disks attached at each end; they are usually made of metals and/or plastic-covered concrete.
in exercises to train the upper limb/trunk (e.g., bicep curl, hammer curls, bench press, abdominal curl
lunge, squat) muscles. Dumbbell exercisers are intended to improve muscle strength in the upper limb
limb; increase muscle size, muscle endurance, and power; and improve bone density.

Muscle strength exercisers designed to provide resistance to muscular contraction in the upper limbs
a mechanism based on a system of pulleys and cables or levers. These exercisers usually consist of a
with weights stacked on top of each other or a hydraulic mechanism, a system to transmit the force (i
resistance), and lever bars or pulley cables on which the user exerts force to counteract the exerciser
limb/trunk muscle strength exercisers can be used to exercise the upper limb (e.g., bicep curl, triceps
trunk (front pull down, chest press, bent over row, abdominal crunch) muscles. They are intended to im
strength in the upper limbs (arm, shoulder, elbow, forearm, and wrist) and/or trunk.

Surgical distractors designed to apply traction force to the arm allowing access to the shoulder joint sp
allow the surgeon to adjust the angle of abduction and the forward flexion angle. These distractors typ
adjustable force mechanism that may include clamps, screws, levers, and a strap attached to the arm
be attached to the operating table (e.g., on a side rail) or other type of support. Shoulder distractors a
during shoulder (and/or elbow) surgical procedures, such as arthroscopic surgery.
Devices designed to support and keep the patient's head in a fixed position and distance from an oph
device. These devices typically consist of frames with a head rest against which the forehead rests an
shaped or cup shaped) on which the chin rests. The height of the chin rest can be adjusted. These dev
standing independent devices or table-mounted; they may also be a part of an assembly of an ophtha
(e.g., slit lamp). Ophthalmic test head and chin rests are used for patients during ophthalmic examina

Calipers designed to measure the distance between two points during surgical procedures. These inst
handheld, metallic, compasslike instruments with two adjustable, centrally hinged legs and sharp, rigi
angled or curved tips; the proximal end (i.e., the handle) usually includes a calibrated scale and a scre
separation of the legs (i.e., Castroviejo calipers). Other surgical calipers include instruments with an L
linear scale along its longer arm and a second L-shaped sliding arm (i.e., Jameson calipers). Dedicated
for measuring eye and bone structures during ophthalmic and orthopedic surgery procedures.

Surgical calipers designed to measure the dimension of bones and/or eminences on bones (i.e., epicon
procedures. These instruments are typically handheld metallic calipers that consist of a central gradua
shaped bar or two sliding flat bars, and an auxiliary graduated scale to facilitate fine adjustment and t
accuracy of the measurement (i.e., vernier calipers). Bone calipers are used to measure the length, th
the bones. Dedicated bone calipers are available to measure patellar thickness during patellar resurfa
map bone ridges (usually with a central pivot and scissorslike handles), and to measure the bony ridg
containing the alveoli (i.e., alveolar ridge calipers) during maxillofacial procedures.

Calipers designed for external measurement of the distance from side to side of a bony anatomic stru
thorax, pelvis, or cranium or the diameter of a circular or nearly circular structure. These instruments
metallic, compasslike, handheld instruments that may include two adjustable, frequently curved, hing
Campbell-type calipers include a central graduated frame, two sliding flat bars, and an auxiliary gradu
inverted T structure to facilitate fine adjustment and increase the accuracy of measurement (i.e., vern
calipers are intended for anthropometric measurements of the body, such as the shoulder (i.e., acrom
chest, and the external margins of the iliac crest (bicristal). Dedicated external anthropometric caliper
measurement of the pelvis (i.e., external pelvimeters) and of infant craniums to assess abnormal or tw
head (i.e., plagiocephaly).

Electrogoniometers designed to measure angles along or around a particular plane. These goniometer
small-diameter flexible spring with plastic blocks on each end, a strain gauge mechanism housed insid
changes electrical resistance proportionally to the change in angle between the longitudinal axes of th
amplifier, and extension cables to connect to the electronic measuring unit. The end blocks are usuall
segments with double-sided adhesive tape. A number of different potentiometric single-axis goniomet
they are designed to cause a potentiometer shaft to rotate proportionally to the joint angle being mea
electrogoniometers are intended mainly to measure joint (e.g., knee, elbow) bending; dedicated instru
assess finger and/or toe joint movement. They are used mainly by rheumatologists and physiotherapi
Electrogoniometers designed to measure angles along or around two orthogonal planes simultaneous
may consist of a small-diameter flexible spring with two sets of plastic blocks on each end, with strain
housed inside the spring that change electrical resistance proportionally to the change in angle betwe
axes of the end blocks, two independent amplifiers, and possibly an electric meter. The end blocks are
the limb segments with double-sided adhesive tape. Potentiometric double-axis goniometers are also
designed to cause a potentiometer shaft to rotate proportionally to the joint angle being measured. D
electrogoniometers are intended to measure wrist and radial/ulnar movements in two planes; they are
rheumatologists and physiotherapists to measure wrist flexion and/or extension and radial/ulnar devia

Electromechanical measuring instruments designed for automated measurement of angular twisting (


plane), rather than bending. These torsiometers typically consist of small-diameter flexible spring with
a strain gauge mechanism housed inside the spring that changes electrical resistance proportionally t
between the longitudinal axes of the end blocks, an amplifier, and extension cables to connect to the
unit. The end blocks are attached to limb segments with double-sided adhesive tape. Torsiometers are
measure angular torso, forearm, neck, and spine twisting; they are used by rheumatologists and phys

Sizers designed to facilitate the selection of an appropriate size of and position for breast implants. Th
consist of temporary implants attached to a tube; the surgeon can work inside the implant pocket and
placement, size, and fill levels. Once the appropriate size and position have been determined, the size
replaced with the permanent implant; when inflatable implants are used, they are rolled up and pushe
Breast implant sizers are used in reconstructive and/or plastic surgery, frequently after mastectomy.

Sizers designed to facilitate the selection of the appropriate nasal bone and/or cartilage implant size a
sizers typically consist of a set of silicone devices of several sizes that resemble the form of a normal
used in reconstructive and/or plastic surgery procedures intended for the insertion of implants that res
nasal pyramid to augment the nasal bones and/or the upper lateral cartilage.

Sizers designed to measure and calibrate the vascular lumen of a vessel that will be replaced by a vas
sizers typically consist of a set of disposable flat single- and/or dual-gauge instruments made of bioco
materials and usually calibrated in millimeters (e.g., 5 to 24 mm, 24 to 38 mm). Vascular graft sizers a
facilitate the selection of the size of the vascular graft (e.g., a synthetic knitted graft) to be implanted

Sizers designed to facilitate the selection of an appropriate size (i.e., length) of penile prosthesis. Thes
consist of a calibrated (e.g., marked in 0.5 cm [0.02-inch] increments from 2 to 20 cm [0.8 to 8 inches
finished in rigid and softer ends, respectively, that is placed (after sterilization and during a surgical p
corpus cavernosa to determine the size (length) of the prosthesis to be implanted. The prosthesis is se
according to the length determined by the sizer and then inserted. Penile sizers are used in surgical p
the insertion of prostheses to treat erectile dysfunction (i.e., impotence).
Surgical sizers designed to facilitate the selection of an appropriate size (i.e., length) of tracheoesoph
prosthesis. The sizer measures the distance of the puncture between the trachea and the esophagus.
consist of a calibrated (e.g., 16 or 20 Fr diameter, marked in millimeter increments that correspond wi
and a hollow, silicone tube that is similar to the prosthesis but without a slit-valve; the sizer is usually
disposable inserter. The prosthesis is selected according to the length determined by the sizer and the
prosthesis tracheoesophageal sizers are used in surgical procedures intended to insert prostheses to m
for patients after tracheostomy procedures.

Surgical sizers designed to measure and calibrate corneal diameters. These instruments typically cons
handheld, flexible flat templates with size-marking holes (e.g., in 0.5 mm steps from 10 to 13.5 mm).
in the selection of an appropriate diameter during corneal transplants; the sizers may be also used to
corneal size in diagnostic procedures.
Collections of different external eyelid weights intended to facilitate the selection of the appropriate w
devices typically consist of a standard or custom-made set of metal (e.g., tantalum) weights in a rang
grams, disposable adhesive strips to attach the weights to the exterior of the upper eyelid, and an app
Eyelid weight sizer sets permit an ophthalmologist to determine the appropriate weight of an external
eyelid weight before attachment or implantation.

Osmometers designed for indirect determination of a solution's osmotic pressure (i.e., osmolality), a v
particle concentration in the solution, by measuring the freezing point depression of the solution relat
point of a standard solution (e.g., sodium chloride) of known osmolality, based on one of the colligativ
solutions. These instruments typically consist of a sample chamber with an operating head that includ
temperature sensor, a refrigeration device, and a display. Freezing point depression osmometers are i
determination of total solute levels that affect water balance in tissues and the gathering of informatio
electrolyte imbalances. An abnormal ratio between the osmolality in urine and serum may indicate ren
insipidus, or secretion of abnormal levels of antidiuretic hormone; water and electrolyte imbalances ar
patients with acute poisoning and shock trauma.

Osmometers designed for indirect determination of a solution's osmotic pressure (i.e., osmolality), a v
particle concentration in the solution, by measuring the vapor pressure (or dew point) depression with
physical state or the temperature of the sample, based on one of the colligative properties of solution
consist of a sealed chamber with an electronic temperature sensor (e.g., a thermocouple) that is elect
Peltier element that cools the thermocouple to a temperature below the dew point, causing the water
thermocouple's surface. An abnormal ratio between the osmolality in urine and serum may indicate re
insipidus, or secretion of abnormal levels of antidiuretic hormone; water and electrolyte imbalances ar
patients with acute poisoning and shock trauma. Vapor pressure/dew point osmometers cannot be use
volatile components (e.g., ethanol); some instruments include a sweat-collecting device to make ionto
determinations.

Timers designed for the measurement and easy reading of time intervals during procedures performe
processing of x-ray sheets). These timers consist of time-measuring instruments that may use mechan
electromechanical, or electronic technologies (e.g., quartz oscillator); they usually include a luminous
darkness or a luminous electronic display and time-adjustable audible buzzers. Some timers may also
to operate safelights. Darkroom timers are available in tabletop and wall-mounted configurations.
Timers designed to measure the duration of laboratory tests and procedures. These timers typically co
electrical, or, more frequently, electronic (e.g., quartz oscillator) measuring instrument that may inclu
generators (e.g., buzzers) to indicate that the time for a particular test or procedure has finished; som
output signals to control the operation of other laboratory devices. Laboratory timers are frequently tr
(e.g., National Institute of Standards and Technology [NIST]) and/or are periodically and automatically
standardized radio signals. Instruments that include from one to many channels are available in a vari
configurations (e.g., tabletop, wall-mounted, handheld); they can measure many different time interva
some instruments permit the full scheduling of laboratory activities up to several days.

Dynamometers designed to measure the muscle strength of the hand grip, usually a result of the com
hand and forearm muscles. These dynamometers are typically a manual, handheld measuring instrum
mechanism (e.g., a bulb, spring, hydraulic system) that resists the force applied by the hand or a strai
device, and a display (e.g., a gauge) to show the measured value of the force (usually in pounds, kilog
pressure (e.g., pounds per square inch [psi]). Dedicated hand-grip dynamometers that can measure th
between the thumb and one finger (i.e., pinch test) are also available.

Hand-grip dynamometers designed to measure the strength of the hand grip, usually a result of the co
hand and forearm muscles, using a rubber or plastic bulb that is squeezed by the hand. These dynam
handheld instruments that include a handle with the bulb and a calibrated gauge (e.g., a dial) to show
the force (usually in pounds, kilograms, or both) and/or pressure (e.g., pounds per square inch [psi]); s
retain the values of the maximum force reading until reset. Dynamometers with several different size
squeeze bulbs (i.e., Martin squeeze dynamometers) that can be easily fitted to a common gauge are a
dynamometers are the simplest instruments available to measure hand grip, they are intended mainly
offices and for assessment during physical therapy treatments.

Hand grip dynamometers designed to measure the strength of the hand grip, usually a result of the co
hand and forearm muscles, using a spring that is compressed during the grip test. These dynamomete
an adjustable handle that is pulled by the hand and a calibrated gauge (e.g., a dial) to show the meas
(usually in pounds, kilograms, or both) and/or pressure (e.g., pounds per square inch [psi]); these inst
include a second pointer to retain the values of the maximum force reading until reset. The typical tes
scale is 0 to 100 kilograms (0 to 220 pounds). Spring-type hand grip dynamometers are accurate, dur
instruments intended mainly for use in doctor's offices and for assessment during physical therapy tre

Hand-grip dynamometers designed to measure the strength of the hand grip, usually a result of the co
hand and forearm muscles, using a sealed hydraulic system. These dynamometers typically consist of
that can be placed in several grip positions (e.g., in 0.5-inch increments from 1.5 to 3.5 inches) and a
a dial) to show the measured value of the force (usually in pounds, kilograms, or both) and/or pressure
square inch [psi]); these instruments usually include a second pointer to retain the values of the maxi
until reset. The typical testing range on a dual scale is 0 to 100 kg (0 to 220 pounds). Hydraulic-type h
dynamometers are accurate instruments intended mainly for use in physician's offices, for evaluation
for assessment during physical therapy treatments.
Pinch test dynamometers designed to measure the force exerted between the thumb and an opposing
fingers when pressed together tightly, using a seated hydraulic system. These dynamometers typicall
handheld instrument with a gauge that is usually supported by the therapist during the test and an at
measure pressure or force between the thumb and the fingers against the hydraulic resistance. The ca
one dial and one or more scales to show the measured value of the force (usually in pounds, kilogram
instruments usually include a second pointer to retain the values of the maximum force reading until
testing range on a dual scale is 0 to 20 kilograms (0 to 45 pounds). Hydraulic-type pinch force dynamo
instruments intended mainly for use in physician's offices for evaluation of hand trauma and/or for ass
physical therapy treatments.

Dynamometers designed to measure the strength of a weak hand grip and/or the force exerted betwe
opposing finger or groupings of fingers when they are pressed tightly (i.e., pinch force), using small ru
that are squeezed. These dynamometers are manual, handheld instruments that include a handle with
detachable bulbs that can be easily fitted to a calibrated gauge (e.g., a dial) to show the measured va
(usually in pounds, kilograms, or both); some instruments retain the values of the maximum force rea
grip/pinch force bulb squeeze dynamometers are intended mainly to measure the grasping power and
with severely impaired hands due to abnormalities or trauma and/or in children; they are used in phys
assessment during physical therapy treatments.

Multipurpose dynamometers designed to measure forces in a very wide range (e.g., from less than on
kilograms), exerted by either pushing or pulling. These dynamometers are typically a stand-alone or h
instrument that includes a heavy-duty mechanism (e.g., mechanical, hydraulic, strain gauge) that res
the force applied and a gauge with a calibrated scale to show the measured value of the force (usually
or both); some instruments also include dedicated attachments (which may be padded) chains, a sing
tests, and/or a hook and double handle set for pulling and lifting tests to facilitate the measurement o
Multipurpose push-pull dynamometers are intended to measure muscle strength (e.g., arm, shoulder,
patient status assessment and/or physical therapy treatment; they are also used to measure forces du
and calibration of medical devices.

Bicycle ergometers designed to measure the work (i.e., the amount of force multiplied by the distance
is applied) or rate of work (i.e., power) performed by the leg muscles while pedaling, in supine positio
conditions, a static bicycle that is attached to a table (the bicycle is usually an integral part of the erg
mounted bicycle ergometers determine the work and power by measuring the force exerted to oppose
mechanical or electromagnetic brakes) and the speed of the pedals of the static bicycle; the bicycle im
is independent of the body weight. Table-mounted bicycle ergometers are used in tests intended to de
disabled or debilitated patients have cardiovascular or pulmonary diseases; they are frequently used i
use of a stress exercise physiologic monitoring system. These ergometers permit the simultaneous ev
using gamma cameras.
Ergometers designed to measure the work (i.e., the amount of force multiplied by the distance over w
applied) or rate of work (i.e., power) performed by the muscles while the patient walks or runs on the
treadmill (that is usually an integral part of the ergometer) under controlled conditions. Treadmill ergo
work exerted by patients on a controlled treadmill by determining the speed and the ratio of the tread
length (usually expressed as a percent grade); the workload imposed by the treadmill depends on the
Treadmill ergometers are used in tests intended to determine whether patients have cardiovascular or
they are frequently used in tests that include use of a stress exercise physiologic monitoring system.

Small instruments designed to be held and revolved by a rotary device to excavate objects, tissues, o
usually by creating cylindrical holes. These instruments typically consist of a cylindrical shank of steel
with a uniform cross-section. They include a working end with cutting edges (e.g., twisted, helicoidally
elongated proximal end to fit into the rotary device (e.g., a handpiece, hand drill, drilling machine). So
cannulated to allow their use over a guide wire. Dedicated drill bits are used in a variety of surgical (e
otolaryngology), dental, and postmortem procedures.

Breast implants that are either prefilled or filled during surgery with saline solution. These implants ty
single-lumen outer shell (e.g., silicone elastomer), saline solution as filler, and a patch to seal the shel
implants may be either prefilled or filled during surgery through a valve with a fixed volume of saline;
filled during surgery may allow adjustment of the saline content after implantation. Saline breast impl
breast reconstruction and/or augmentation.

Implants designed for replacement of the dura mater, the outermost of the three membranes (i.e., me
brain and the spinal cord. These implants typically consist of patches of biologic or synthetic (usually b
they are available in a variety of shapes and sizes according to the intended site of implantation. Synt
typically bilayered biodegradable composites of a dyed foil (inner face) and an undyed polyglactin; bio
consist of a cross-linked collagen matrix (including physiologically compatible collagen that is free of a
prions) that is available as a sponge, a film, or a nonwoven matrix or, less frequently, of allografts tak
mater implants are used to repair damage to the surface of the brain and/or spinal cord caused by tra
collagen matrix implant pores (typically with a diameter of 10 to 500 micrometers) permit infiltration a
meningeal tissue.

Devices designed for the expansion of penis tissue. These expanders use one of several techniques, in
hanging, traction, or increasing the local blood pressure. These expanders are intended for external pl
helping to correct penis curvature (i.e., straightening the penis after surgery) and/or possibly resulting
Penis tissue expanders are applied externally; they do not include permanent implantable prostheses
dysfunction, which are also available.

Penis tissue expanders designed for the expansion of the penis using constant traction. These expand
plastic device with a mechanism (e.g., consisting of a base located on the pubis bone and a penis hea
with expandable metal rods) that provides constant traction to the penis. Traction penis expanders are
placement on the penis, helping to correct penis curvature (i.e., straightening the penis after surgery)
resulting in penis enlargement.
Implants intended for reconstruction and/or replacement of fibrous bands of tissue connecting bones a
internal organs (i.e., ligaments) or connecting bones to muscles (i.e., tendons). These implants may co
autografts or allografts usually taken from cadaver donors (e.g., quadriceps, Achilles or patellar tendo
synthetic polymers such as polytetrafluoroethylene, polyethylene terephthalate, carbon fibers, or silic

Testicle implants that are prefilled or filled during surgery with saline solution. These implants typically
lumen outer shell (e.g., silicone elastomer), saline solution filler, a self-sealing injection port, and a tab
in a fixed position. The implants may be either prefilled or filled during surgery through a valve with a
some implants may allow saline content adjustment after implantation. Saline-filled testicular implant
variety of sizes; they are used to provide or restore normal physical appearance (i.e., for cosmetic rea
loss (e.g., trauma, illness) or absence of one or both testicles; they are not intended for functional rep
testicles.

Testicle implants designed using solid material. These implants may consist of a soft solid elastomer (
copolymer or an elastomer shell filled with solid polymers and a tab to secure the implant in a fixed po
available in a variety of shapes and sizes. Solid testicular implants are intended to restore normal phy
for cosmetic reasons) in patients with loss (e.g., trauma, illness) or absence of one or both testicles; th
for functional replacement of the testicles.

Ophthalmic stents designed for deployment into the eye to create an artificial drainage pathway for p
These stents may consist of a silastic or metallic (frequently heparin coated titanium) tube: one end is
small incision into the anterior chamber of the eye and the other under the conjunctiva or placed thro
canal in such a way that the fluid is eventually absorbed by blood and/or lymph vessels; the shunt ma
patient's sclera by sutures. Some stents also include a very small reservoir and/or valves to regulate t
Glaucoma drainage stents are typically used in patients with advanced glaucoma disease when, desp
medication regimens, laser treatments, or a previous glaucoma filtration procedure (trabeculectomy),
drainage tube is recommended.

Implants designed for augmentation and/or reconstruction of an anatomic structure. These implants a
during plastic and/or reconstructive surgery; they are typically precontoured sections of synthetic (typ
frequently, biologic (i.e., autograft, allograft, xenograft) materials that reproduce the desired external
anatomic part. Facial implants (e.g., nose, chin, cheek) are intended mainly to improve physical appea
abnormalities that are congenital or the result of illness or trauma; muscle implants are intended main
physical appearance by augmentating the volume of muscles such as the calf, pectoralis, and biceps
reconstructive surgery after illness or trauma. Carving blocks made of solid silicone elastomers are als
of sizes, colors, and textures (i.e., from extra soft to extra firm) to carve customized cosmetic implants
patient requirements.

Implants designed for augmentation and/or reconstruction of the face. These implants are usually inse
and/or reconstructive surgery; facial implants are typically precontoured sections of synthetic (typicall
frequently, biologic (i.e., autograft, allograft, xenograft) materials that reproduce the desired external
anatomic part. Dedicated facial augmentation/reconstruction implants are available for the nose, chin
intended to improve the physical appearance or to correct abnormalities that are congenital or the res
trauma.
Facial implants designed for augmentation and/or reconstruction of the cheeks (i.e., malar bones). The
usually inserted on top of the cheekbone during plastic and/or reconstructive surgery (either through
eyelid). Cheek implants are typically precontoured sections of synthetic (typically silicone) or, less freq
autograft, allograft, xenograft) materials intended to reproduce the desired external shape of the chee
necessary to implant a bone graft. Facial cheek implants are intended to improve the physical appeara
abnormalities that are congenital or the result of illness or trauma.

Facial implants designed for augmentation and/or reconstruction of the mandible and/or chin. These im
inserted in the soft tissue of the chin (e.g. anterior and/or pre-jowl sulcus segmentation) or mandible (
augmentation of mandibular angle) during plastic and/or reconstructive surgery; chin/mandible cosme
consist of pre-contoured sections of synthetic (e.g., silicone) or less frequently biologic (i.e., autograft,
materials intended to reproduce the desired external shape of the chin. They are intended to improve
appearance, to correct congenital abnormalities, or after illness or trauma.

Facial implants designed for augmentation and/or reconstruction of the nose. These implants are usua
the skin of the nose during plastic (i.e., rhinoplasty) and/or reconstructive (e.g., dorsal) surgery. Nasal
augmentation/reconstruction implants are typically precontoured sections of synthetic (typically silico
biologic (i.e., autograft, allograft, xenograft) materials intended to reproduce the desired external shap
also be necessary to implant a bone graft. Nose implants are intended to improve the physical appear
abnormalities that are congenital or the result of illness or trauma. Hollow tubular nasal implants inten
breathing (typically used after surgical procedures) and/or to support the nasal structure are also avai

Implants designed for augmentation and/or reconstruction of the muscles. These implants are usually
and/or reconstructive surgery; they are typically precontoured sections of synthetic (typically silicone)
biologic (i.e., autograft, allograft, xenograft) materials that reproduce the desired external shape of th
part. Muscle augmentation implants are intended to improve the physical appearance or to correct ab
congenital or the result of illness or trauma. Dedicated muscle augmentation/reconstruction implants
calf, pectoralis, biceps/triceps, and gluteus (buttocks).

Muscle augmentation/reconstruction implants designed for augmentation and/or reconstruction of the


implants are usually inserted in surgical pockets between the fascia and the existing muscles during p
reconstructive surgery; they are typically precontoured sections of synthetic (typically silicone) or, les
(i.e., autograft, allograft, xenograft) materials that reproduce the desired external shape and/or size o
are intended to improve the physical appearance or to correct abnormalities that are congenital or the
trauma.

Muscle augmentation/ reconstruction implants designed for augmentation and/or reconstruction of the
muscles. The implants are usually inserted under the pectoral muscles during plastic and/or reconstru
procedure is frequently performed through an opening in the armpit using either open or endoscopic s
are typically precontoured sections of synthetic (typically silicone) or, less frequently, biologic (i.e., au
xenograft) materials that reproduce the desired external shape and/or size of the pectoral muscle. Pec
intended to improve the physical appearance or to correct abnormalities that are congenital or the res
trauma.
Muscle augmentation/reconstruction implants designed for augmentation and/or reconstruction of upp
implants are usually inserted in surgical pockets between the fascia and the existing muscles during p
reconstructive surgery; they are typically precontoured sections of synthetic (typically silicone) or, les
(i.e., autograft, allograft, xenograft) materials that reproduce the desired external shape and/or size o
triceps. Biceps/triceps implants are intended to improve the physical appearance and/or to correct abn
congenital or the result of illness or trauma.

Muscle augmentation/reconstruction implants designed for augmentation and/or reconstruction of the


buttocks). The implants are usually inserted in surgical pockets created in the midline between the ex
gluteus) during plastic and/or reconstructive surgery. These implants typically consist of precontoured
(typically silicone) or, less frequently, biologic (i.e., autograft, allograft, xenograft) materials that repro
external shape and/or size of the buttocks. Buttocks implants are intended to improve the physical ap
abnormalities that are congenital or the result of illness or trauma.

Devices designed to attach the plate (i.e., base) of a removable partial denture (including overlay den
support (abutment) such as a natural tooth, tooth-root, dental implant, abutment crown, or tooth root
attachments may consist of either a single, integral component: a preformed or custom-made metal c
around neighboring natural teeth to support a denture (i.e., clasps); or two components: one compone
prosthesis and a second receptacle is attached to or anchored within a remaining tooth or other type o
precision or semiprecision attachments, respectively). Both precision and semiprecision attachments
rigid (i.e., nonresilient); dedicated attachments intended for partial dentures and overlay partial dentu
are available. Dental attachments intended for fixed partial dental prostheses (i.e., bridges) are usuall
natural teeth.

Dental attachments designed to be adapted around and/or rest on and surround natural tooth abutme
an integral component of a partial denture (including overlay dentures). These clasps typically have th
occlusal rest, a bracing, and a supporting arm; dental clasps are typically metal, flexible castings or w
preformed dental clasps made of synthetic (e.g., polymer) materials are also available but less freque

Clasp dental attachments designed to be adapted around and/or rest on and surround natural tooth ab
usually an integral component of a partial denture. These clasps typically have three components: an
bracing, and a supporting arm; dental clasps are typically metal, flexible castings or wires. Custom-ma
partial denture clasps made of synthetic thermoplastic (e.g., polymer) materials are also available but

Clasp dental attachments designed to be adapted around and/or rest on and surround natural tooth ab
usually an integral component of an overlay partial denture (i.e., overdenture). These clasps typically
components: an occlusal rest, a bracing, and a supporting arm; dental clasps are typically metal flexib
Custom-made and preformed overdenture clasps made of synthetic thermoplastic (e.g., polymer) mat
available but less frequently used.
Precision dental attachments designed to attach partial denture prostheses to receptacles that are con
within an abutment such as a natural tooth, abutment crown, tooth-root stud, or dental implant. These
typically two-component devices that attach to each other with a high degree of precision: one compo
abutment or may be supported by tissue and a second component is an integral part of the partial de
denture precision attachments are available as intra- and extracoronal devices according to the fixatio
dental implants and magnetic-coupled attachments are also available. Both rigid and resilient partial
are available; resilient (i.e., nonrigid) attachments are usually extracoronal devices, but some intracor
provide some degree of resilience. Partial denture precision attachments usually distribute the chewin
provide better cosmetic results than conventional clasp attachments.

Precision partial denture attachments designed to attach the partial denture to receptacles at a point
crown contour. These attachments are typically two-component devices that attach to each other with
precision: one component is fixed within the abutment crown and a second component is an integral p
denture base; they are usually of a dovetailed or a slotted design. Rigid and, less frequently, resilient
available that permit a slight vertical movement, hinging action, or rotational movement as the patien

Precision partial denture attachments designed to attach the partial denture to receptacles that are ex
the crown contour. These attachments are typically two-component devices that attach to each other
precision: one component is externally fixed to the abutment teeth and a second component is an inte
denture base (frequently made of a high-density plastic). Rigid and resilient attachments are available
vertical, hinging, and/or rotational movement as the patient bites.

Precision partial denture attachments designed to attach the partial denture to receptacles that are co
implants and/or tooth-root (radicular or intraradicular) studs. These attachments are typically two-com
attach to each other with a high degree of precision: one component is fixed to the abutment (usually
a second component is an integral part of a partial denture. Rigid and resilient attachments are availa
slight vertical, hinging, and/or rotational movement as the patient bites. Magnetic-coupled fixed impla
also available.

Precision dental attachments designed to attach an overlay partial denture (i.e., overdenture) to recep
connected to or within an abutment such as a natural tooth, abutment crown, dental implant, or tooth
intraradicular) stud. These attachments are typically two-component devices that attach to each othe
precision: one component is fixed to an abutment or may be supported by tissue and a second compo
of the partial denture base. Overdenture precision rigid attachments are available as intra- and extrac
according to the fixation site, while resilient (i.e., nonrigid) precision attachments are usually extracor
coupled attachments are also available.
Dental attachments fabricated using direct casting (e.g., injection molding) of materials such as plasti
small tolerances (i.e., semiprecision attachments), which are designed to attach partial dentures (inclu
dentures also known as overdentures) to receptacles that are connected to an abutment such as a too
dental implant, or tooth-root stud. These attachments are typically two-component devices that attach
lesser degree of precision than precision attachments: one component is fixed to an abutment or is su
the second component is attached to the partial denture base. Semiprecision dental attachments may
several degrees of resilience according to the torque transmitted to the abutment; they are available
extracoronal devices according to the fixation site. Semiprecision dental attachments usually distribut
better and provide better cosmetic results than conventional clasp attachments. Magnetic-coupled att
available; they are usually simpler and less expensive than precision attachments.

Semiprecision attachments designed to attach partial denture prostheses to receptacles that are conn
within an abutment such as a natural tooth, abutment crowns, dental implant, or tooth-root (radicular
These attachments are typically two-component devices that attach to each other with a lesser degre
precision attachments: one component is fixed to the abutment or supported by tissue and a second c
integral part of the partial denture base. The attachments are usually available as intra- and extracoro
to the fixation site. Rigid and resilient partial denture attachments are available; resilient (i.e., nonrigi
usually extracoronal devices. Magnetic-coupled attachments are also available. Semiprecision partial
are usually simpler and less expensive than precision attachments.

Rigid semiprecision partial denture attachments designed to attach a partial denture to receptacles at
abutment crown contour. These attachments are typically two-component devices that attach to each
degree of precision than precision attachments: one component is fixed within the abutment crown an
is an integral part of the partial denture base. Rigid and resilient attachments are available that permi
hinging, or rotational movement as the patient bites.

Semiprecision partial denture attachments designed to attach the partial denture to receptacles that a
connected to the crown contour. These attachments are typically two-component devices that attach
lesser degree of precision than precision attachments: one component is fixed externally to the abutm
second component is an integral part of the partial denture base. Rigid and resilient attachments are
slight vertical, hinging, and/or rotational movement as the patient bites.

Semiprecision partial denture attachments designed to attach the partial denture to receptacles that a
implants and/or tooth-root (radicular or intraradicular) studs. These attachments are typically two-com
attach to each other with a lesser degree of precision than precision attachments: one component is fi
(usually a dental implant) and a second component is an integral part of the partial denture base. Rig
attachments are available that permit a slight vertical, hinging, and/or rotational movement as the pa
Semiprecision dental attachments designed to attach an overlay partial denture (i.e., overdenture) to
connected to or anchored within an abutment such as a natural tooth, abutment crown, dental implan
(radicular or intraradicular) stud. These attachments are typically two-component devices that attach
lesser degree of precision than a precision attachment: one component is fixed to the abutment or sup
(usually resilient attachments) and a second component is integral part of the partial denture base. O
semiprecision attachments are usually available as intra- and extracoronal devices according to the fix
coupled attachments are also available.

Dental devices designed for use as the fixed component of a two-component dental attachment; the o
integral part of a partial denture or overlay partial dentures (i.e., overdentures). Root studs are metal
either soldered or cast to a root coping or directly cemented to the tooth root (i.e., radicular studs) or
(intraradicular studs). Some titanium studs can screw directly into tissues or implants. Dental root stu
provide partial denture prostheses with a better distribution of the chewing forces along the axis of th
and to facilitate oral hygiene.

Dental root studs designed to be fixed to a tooth root by either soldering or casting to a root-cap copin
directly to the tooth root (i.e., radicular). These studs are used as a component of a two-component de
other component is fixed to a partial denture or overlay partial denture (i.e., overdenture) prosthesis b
root studs are intended to provide partial denture prostheses with a better distribution of the chewing
of the abutment tooth root and to facilitate oral hygiene.

Dental root studs designed to be fixed within a tooth root or directly screwed into the root (i.e., intrara
studs are used as a component of a two-component dental attachment; the other component is fixed
overlay partial denture (i.e., overdenture) prosthesis base. Intraradicular dental root studs are intende
denture prostheses with a better distribution of the chewing forces along the axis of the abutment too
oral hygiene.

Denture anchors designed with a spherical locking element for connection to a removable denture. Th
typically a metal or plastic ball (some anchors may have rectangular rather than round cross-sections)
natural tooth (extracoronal fixing) or an implant; both vertical and horizontal ball anchoring devices ar
rigid or resilient attachment to removable dentures and/or overdentures. Ball anchors used as extraco
retaining elements have a wide range of applications; dedicated ball anchors may be used as the fixed
component dental attachment for dentures.

Denture anchors designed with a locking bar element for connection to a removable denture. These a
metal or hard plastic bar that is secured to extracoronal, gingival tissue and/or dental implants for eith
attachment to partial dentures and/or overdentures. Bar anchors used as extracoronal or implant-reta
wide range of applications; dedicated bar anchors may be used as the fixed component of a two-comp
attachment for dentures.

Implants designed for replacement, restoration, and or enhancement of a breast nipple that has been
Breast nipple implants are an elastomeric (e.g., all-silicone) device with a partially visible outer face (i
the nipple) that is usually covered with an outer coating that resembles the nipple in appearance and
implants are used in reconstructive surgery after total or partial mastectomy and/or for cosmetic purp
Neuromuscular stimulators designed to stimulate the nerves that are responsible for swallowing, caus
muscles to contract. These devices are typically portable electrotherapy stimulators that deliver appro
electrical stimuli to the throat muscles involved in swallowing using a dedicated set of electrodes. Dys
stimulators are intended for treatment of deficiency in swallowing (i.e., dysphagia), especially orophar
affecting patients with neuromuscular disorders and/or patients who had suffered troke and/or head a

Phototherapy units designed to irradiate patients with light in the near-infrared (NIR) spectrum (from 7
These units typically consist of one or more lamps (e.g., conventional infrared lamps, light-emitting di
in a stand-alone, mobile, or handheld structure. NIR phototherapy units apply radiation in an intensity
appropriate to the treatment to be performed. Some units include lamps specifically designed with a n
for a particular application (e.g., 890 nm to treat neuropathy). NIR phototherapy units are used mainly
disorders, enhance wound healing, and provide pain relief. Dedicated units with pulsed lamps are also

Solutions with a composition appropriate to rinse and refresh the mouth. These solutions usually inclu
components, using ethanol as a solvent, that provide a refreshing feeling and help prevent bad breath
is usually used to rinse the mouth after brushing and/or flossing; most mouthwash solutions include a
inhibit or kill microorganisms (antiseptics), helping to control tooth decay and gingivitis. Other dedicat
solutions use zinc to prevent halitosis and/or fluorides to prevent tooth decay.

Solutions, gel, or sprays designed to resemble the moisturizing properties of natural saliva. These pro
of water solutions (or gels), including Sorbitol, sodium chloride, and carboxymethylcellulose. Artificial
substitute for natural saliva for alleviating symptoms of dry mouth and/or difficulties of swallowing an
patients with reduced or absent salivary flow as a result of salivary gland dysfunction (xerostomia). Th
products to protect tooth enamel (e.g., fluorides) but is not intended to replace the digestive propertie

Air cleaners designed to remove airborne aerosol microorganisms and other biological agent particula
possibly by applying radiation (e.g., ultraviolet [UV] light). These cleaners typically include a set of fin
particulates (e.g., 99.97% of particles bigger than 0.3 micron), including airborne particulates (aeroso
other biological agents. Germicidal air cleaners are intended for continuous use in healthcare facilities
rooms and doctors' offices. Dedicated germicidal air cleaners, which use UV light radiation that can kil
many virus types, are also available.

Electric signal amplifiers designed for amplification of audio signals, typically in a range from a few he
amplifiers typically consist of a wide-band, high-fidelity, electronic amplifier with audio signal inputs, e
amplify the signal (either for monophonic or stereo signals), controls (e.g., gain, frequency response),
ports for the amplified signals, and a power supply. Audio amplifiers are used mainly in hospital inform
communication systems; dedicated audio amplifiers for specific signals (e.g., stethoscope sounds) and
amplification are also available.

Electric signal amplifiers designed for amplification of video (typically in the VHF and/or UHF bands) si
specific standards (e.g., NTSC, PAL). These devices consist of a wide-band, high-fidelity, electronic am
inputs, electronic circuits to amplify the signal, controls (e.g., gain, brightness), appropriate output po
signals, and a power supply. Video amplifiers are used mainly in hospital information and communicat
compensate for transmission losses in remote cable connections throughout the facility and/or to boos
wireless systems.
Computerized network devices designed exclusively to establish paths between computers and/or com
providing communication channels between them. These devices typically consist of simple electronic
permit the use of multiple computers in a common local area network (LAN); most network hubs supp
standard but other types exist (e.g., USB [Universal Serial Bus] hubs used mainly with computer-assoc
devices such as printers and scanners). Network hubs include multiple ports (typically from 4 to 16); h
each other and also to routers and/or switches to accommodate more devices. By delivering each me
device for which it is intended, a network hub facilitates the use of multiple computers and peripheral
LAN.

Systems designed for vessel harvesting usingminimally invasive surgical techniques. These systems i
instruments, such as dissecting and harvesting rods and scalpels usually introduced through a trocar o
used to dissect and cauterize the harvested vessel and its branches; the instruments are typically sup
kit that may also include a dedicated rigid endoscope with a camera at its distal tip. Harvesting system
include all the external reusable components needed for operation, such as lamps, specialized arms to
blades and other instruments (usually attached to the operating table), and retractors and other comp
that include external multipurpose units such as a monitor, insufflator, radiofrequency generator, ima
sources usually mounted on a cart or rack are also available. Harvested veins (e.g., saphenous vein, r
mammary artery) from the limbs and/or thorax for are used mainly as bypass grafts in coronary artery
but are sometimes used to replace peripheral (e.g., lower limb) vessels.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed f
using surgical procedures. Items in these kits usually include appropriate instruments (e.g., scalpels, d
cautery probes), cannulae, blades, and other supplies. These kits may be supplied in supporting trays
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Vessel harvesting procedure kits
for use during bypass grafts in coronary artery surgical procedures but are sometimes used during pro
peripheral (e.g., lower limb) vessels; they may be also used for other dissection procedures (e.g., nerv
surgically created subcutaneous cavity. Dedicated vessel harvesting kits and trays are available for op
techniques using special strippers) and also for minimally invasive surgical procedures (that may inclu
endoscopes).

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed f
using minimally invasive surgical procedures. Items in these kits usually include instruments appropria
invasive surgery (e.g., scalpels, dissectors, strippers, cautery probes), cannulae, blades, and other sup
be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a b
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Minimally invasive vessel harvesting kits are intended for dissecting veins (e.g., the saphenous vein) a
radial artery) from the limbs and/or the mammary artery from the thorax. Harvested vessels are main
grafts in coronary artery surgical procedures but are sometimes used to replace peripheral (e.g., lowe
may be also used for other dissection procedures (e.g., nerve dissection) through a surgically created
Dedicated harvesting kits with a dedicated endoscope and a camera are also available.
Endoscopes designed to be introduced through a surgically created subcutaneous tunnel, facilitating v
minimally invasive surgical techniques. These devices are typically a dedicated small-diameter (e.g., 5
endoscope with a video camera at its distal end. Vessel-harvesting endoscopes are mainly component
kits used to obtain grafts for subsequent cardiac surgery; the endoscopes are used for dissection and
saphenous vein and arteries (e.g., radial, internal mammary) and their corresponding branches by fac
introduction of appropriate instruments for vessel dissection, ligation, and retraction.

Laboratory incubators designed to mechanically mix (by shaking and/or rotation) the contents of cont
incubator chamber during the incubation process. These incubators typically include a corrosion-resist
appropriate racks for a variety of containers, a mechanism that shakes the containers, devices for cha
heating, and shaking speed and temperature controls. Laboratory shaker incubators are used mainly f
compounds and biological samples; stand-alone units and smaller tabletop devices are available. Ded
intended for platelet mixing are also available.

Devices designed to acquire and process an electronic image obtained from a separate source (e.g., c
system). These processors usually include an electronic unit that processes, stores, or transmits the in
it to peripheral devices (e.g., monitors, printers, workstations) and/or to other computerized systems f
and/or processing. Dedicated image processors are available for still and video images; devices intend
fluorescent and ultraviolet images are also available.

Data management information systems designed to provide up-to-date patient information during crit
systems typically consist of a combination of hardware and software. The hardware typically includes
servers and computers; the software consists of a dedicated software package that can integrate data
critical care process including vital signs, fluid intake and output, medications, laboratory data, and do
care information management systems support intensive care units, facilitating clinical decisions by m
information quickly available to the clinician. The system may function as stand-alone systems or may
hospital-wide data management information system network.

Data management information systems designed to give patients access to their personal information
healthcare, and communicate with the healthcare staff over the Internet. These systems typically con
hardware and software. The hardware typically includes dedicated network servers and computers; th
dedicated software package that provides laboratory reports, diagnostics, account statements, and fu
Patient portal data management systems allow safe and secure communication between patients and
web interface. This allows patient access to laboratory reports, diagnostics, account statements, and f
any time. Appointments, prescription refills, and referrals can be requested by the patient without call
physicians can set up automatic reminders for patient appointments and health maintenance requirem
the need for patient calls. Patient portal systems may function as stand-alone systems or may be inte
wide data management information system network.

Highly purified, sterile liquid silicone oil with specific gravity, refractive index, and surface tension cha
for use as a temporary vitreous media replacement in intraocular operative procedures or for a longer
months). Silicone oil is usually supplied in sterilized pre-filled syringes or vials, the oil is injected into t
vitreous gel is withdrawn and it is usually removed after a few months. Intraocular silicone oil as vitreo
media is mainly used in the treatment of retinal detachments.
Testers designed to detect leaks or fluid during the reprocessing of flexible or rigid endoscopes. These
manual devices that use an air bag, tubing, and connectors or automated electronic units that automa
unwanted liquids in the endoscope channels, recording and exporting data to computerized systems.
testers permit the detection of minor leaks and fluid invasion frequently before or while reprocessing e
testers are components of the reprocessing unit), facilitating endoscope repair and decreasing the pos
contamination when reusing the endoscopes; the testers are usually compatible with a great variety o

Laboratory thermocycling incubators designed to detect and quantify the number of target sequences
incubators include, in addition to a thermocycler, an optic system to monitor fluorescent emission (e.g
mirrors, filters) and a computerized unit with appropriate software to analyze the results in real time. T
a fluorescent dye that binds to the polymerase chain reaction products and emits light upon stimulatio
performed using one of several techniques (e.g., adjusting the temperature in a single block, moving
to block, using microcapillary tubes and halogen lamps). Real-time quantification thermocycler incuba
facilitate faster, more accurate, and reproducible results.

Telemedicine information systems designed to electronically transmit and receive ophthalmic images
the retina) and consultative text between remote sites. These systems typically include, in addition to
devices, fundus cameras, ophthalmoscopes, and/or ophthalmic workstations. Ophthalmology telemed
mainly by small remote hospitals and in emergency situations to transmit images to technicians and/o
specialists for review, interpretation, and/or consultation. Dedicated systems intended for retinopathy
available, making it possible to determine, in remote places, whether retinopathy is present and whet
care is needed.

Implantable cardiac devices designed to restrain the heart ventricles, preventing further enlargement
use different technologies, including implantable mesh (made of fabric or metal), adjustable bands to
the ventricles, and two pads that rest opposite each other against the outside of the left ventricular w
place by a flexible cord. Ventricular restraints are implanted during open or minimally invasive surgica
intended to slow or stop the cascade effect in which further enlargement occurs to compensate for red
efficiency, worsening the heart function.

Abdominal ultrasonic scanning systems designed to noninvasively measure liver stiffness (i.e., elastog
assessment of the degree of scar tissue accumulation in the liver (i.e., liver fibrosis). These systems a
ultrasound probe (e.g., 5 MHz) on which an ultrasonic transducer is mounted with a mechanical vibrat
electronic unit with a radiofrequency generator, data processing circuits, appropriate software, and a d
delivers a low-frequency wave to the liver; the pulsed Doppler ultrasound echo simultaneously determ
wave as a measure of the tissue stiffness, and the results are shown in pressure units (e.g., kilopascal
ultrasonic systems (also known as elastography systems) are intended to assess liver damage (i.e., ci
patients with chronic liver disease, as an alternative to liver biopsy.
Radiofrequency therapy systems designed to disrupt the division of cancer cells by delivering alternat
These systems typically consist of a wearable unit including a battery- operated radiofrequency gener
appropriate (usually placed on the scalp) to deliver radiofrequency waves in two different directions, a
Tumor treating radiofrequency therapy systems are intended to destroy cancer cells by physical disrup
with microtubule dynamics and/or by destruction of dividing cells) rather than chemical means withou
cells; the systems are intended mainly to attenuate tumor cell division and/or destroy tumor cells in b
gliobastomas).

Upper-gastrointestinal-tract endoscopes with double balloons designed to access, examine, diagnose,


gastrointestinal tract. These devices are used mainly for visual examination, biopsy, retrieval of foreig
treatment of lesions in the entire upper tract (i.e., esophagus, stomach, small intestine), including are
intestine that are difficult to reach using conventional endoscopes. Double-balloon endoscopes used t
intestine typically include dedicated balloons (for guiding and stabilization of the endoscope) that are
special tube that runs along the endoscope to facilitate full positioning of the endoscope and insertion
in the area of small intestine targeted for diagnosis or treatment.

Nasal catheters designed to widen the nasal sinus passages (i.e., sinus ostia) to restore normal draina
catheters typically consist of a soft plastic tube that is introduced in the sinus passages through a nas
nasoscope); the catheter includes a balloon at its distal tip intended to enlarge the patient's sinus ope
passageways and restoring normal sinus ventilation and drainage. Nasal sinus dilation catheters are t
minimally invasive functional endoscopic sinus surgery (FESS) procedures.

Prepackaged collections of the devices and supplies (either custom or standard) needed for insertion o
nasal sinuses. Items in these kits usually include a sinus dilation catheter, an illumination system, guid
irrigation and balloon catheters, and extension tubes; the kit may also include devices that permit its
stereotactic navigation systems. The kits may be supplied in supporting trays (i.e., procedure trays) co
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Nasal sinus surgical kits are intended mainly to e
sinus openings, clearing the passageways and restoring normal sinus ventilation and drainage; they a
minimally invasive functional endoscopic sinus surgery (FESS) procedures.

Tags containing personal and medical information designed for patient identification using radiofreque
These tags frequently consist of electronic chips with antennae that can transmit data using RF electro
tags may include batteries to power an attached radio transmitter (active tag); other tags work with th
a location device (passive tags). Patient identification tags are usually attached to an ankle band, wris
dedicated tags (i.e., chips) intended for implantation in the patient's body are also available. The tags
locate patients (e.g., to identify unconscious patients, to prevent mentally disoriented patients from w
infant and children); other intended uses include preventing identification mistakes during surgical an
procedures.
Radiofrequency (RF) patient identification tags designed for implantation in the human body. These ta
electronic microchips that contain numerical data that permit patient identification by a location devic
are usually implanted under the skin, frequently using a syringe loaded with the implant. The chips us
that can transmit data using RF electromagnetic radiation. RF tags may include batteries to power an
transmitter (active tag); other tags work with the RF energy supplied by a location device (passive tag
batteries only to supply energy to the internal circuitry or to attached sensors (semi-active tags) but n
signals. Implantable RF patient identification tags are used mainly to locate patients (e.g., to identify u
to prevent mentally disoriented patients from wandering); other intended uses include preventing ide
during surgical and radiotherapy procedures.

Prepackaged collections (either custom or standard) of devices and supplies used for insertion of a ca
deliver fluids to the spinal intervertebral disc (i.e., intradiscal) space. Items in these kits usually includ
microcatheter that may have a balloon attached at its distal tip to deliver the fluid, dedicated guide w
needles; syringes, stopcocks, connectors, and solutions appropriate for the intended procedure. The k
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
catheterization kits are intended mainly for delivery of contrast media, anesthetics, and saline to the i
procedures such as functional anesthetic discography for radiographic evaluation of disc damage and
pain response provoked by disc injection.

Scanning systems designed to combine computed tomography (CT), frequently a multislice helical CT
emission computed tomography (SPECT) system capabilities. The combined system uses SPECT imag
abnormalities and CT scanning to localize lesions within the body; this combination permits acquisition
integration) of anatomic and functional (molecular) information with a multiple scan in a single proced
than those obtained when the two images are taken separately. These systems usually consist of CT a
mounted in a common mechanical support within a single gantry, common tables, workstation, monit
software to allign both scanning systems' data and images. The systems may be also used when need
SPECT studies without loss of technical performance. CT/SPECT combined systems are intended to fac
accurate evaluations; they are used mainly for diagnosis, treatment planning, and evaluation of thera
orthopedic, and oncology patients.

Electrothermal cautery units designed to coagulate and/or destroy tissue by applying an electrical cur
resistance element to control bleeding (i.e., hemostatis) and for therapeutic procedures. Electrotherm
deliver electric current to the tissue; the high-resistance tip becomes heated when electric current is p
These devices typically include a power source (either line or battery) that delivers the electric curren
a pencil- or pistol-like handle (handpiece) with a probe that includes a high-resistance wire attached a
electric cord to connect the probe to the power source. Most units are available with a set of probes fo
applications; the most common are (1) probes in which the high-resistance wire is uncovered or attach
(for cutting and/or coagulation) and (2) probes in which the heating wire has a nonstick coating (for co
control bleeding). Some probes include an internal irrigation system. Electrocautery units using high-r
intended for one or more clinical procedures (e.g., dermatologic, gynecologic) are available; dedicated
or transcatheter use are also available. The units are frequently controlled by a computer that facilitat
appropriate temperature and/or energy level.
Handles designed to hold and supply power (i.e., battery) to a laryngoscope blade. These devices usu
handle with a battery and, usually, a battery charger. The handle and an attached standard, conventio
working laryngoscope. Dedicated fiberoptic laryngoscope handles are also available. Some laryngosco
designed specifically for use in magnetic resonance imaging [MRI] environments, i.e., MRI-compatible
and are made from nonmagnetic materials so that they can be safely used in an MRI suite.

Laryngoscope blades designed for use as a detachable component of a fiberoptic laryngoscope; the b
provide illumination and to displace the lower pharynx, larynx, and upper trachea. These blades typic
to hold the tongue, an angular or curved flange to provide rigidity with an L-shaped or semicircular gro
its length, and a fiberoptic illumination system. The blade is usually hooked onto the laryngoscope han
storage, simultaneously switching off the light. Fiberoptic laryngoscope blades are available in severa
pediatric use; they are also available as nonfoldable, integral parts of plastic fiberoptic laryngoscopes.
the illumination system component, plastic fiberoptic laryngoscopes are usually single-use devices.

Rigid nasopharyngoscopes designed to be directly inserted into the nasal cavity, including a television
tip for visual examination, biopsy, and treatment of lesions of the nasal cavity, pharynx, and pharynge
tube. These devices usually consist of an outer sheath, a fiberoptic lighting system, a working channe
catheters and operative devices may be inserted, and a digital camera, typically in the form of a micro
coupled device [CCD]). The image is electronically transmitted through wires in the endoscope for ext
display, and recording.

Hypodermic needles designed for subcutaneous injection from a penlike cartridge syringe. These devi
a small, very fine caliber needle (10 to 12 mm [5 inches] long), appropriate for injecting solutions and
Subcutaneous hypodermic injection needles are intended mainly to be used with penlike syringes to in
other drugs (e.g., gonadotropin) from a prefilled disposable cartridge syringe (usually from 1 to 3 mL c
several types of injectors.

Hypodermic needles designed to provide needlestick protection. These needles include some manuall
activated mechanism intended to shield, blunt, or recess the needle during or after use or, by some o
the possibility of contact between the healthcare provider and the sharp needle. Protective hypoderm
with hypodermic syringes designed for specific injection sites (e.g., dental).

Molecular assay reagents intended to for use in identifying stable and usually irreversible modification
chromosomes that may cause disorders in humans, including uniparental disomy, in which both memb
pair are inherited from one parent, and trisomy, in which three copies of a chromosome are present ra
two; changes (inversions, deletions) in the sequence of the genetic order; and translocations of differe
parts of the same chromosome. Chromosome anomalies may be de novo or inherited (familial).

Controllers designed to allow diabled patients to remotely control a variety of equipment usually in th
immediate environment, which are activated using voice commands. These controllers are typically el
be customized to the particular user's pronunciation; the control unit interacts (e.g., using radiofreque
with receiving devices interfaced with appliances such as light switches, appliances (e.g., television se
and bed and door controls; the controller typically includes a built-in telephone set. Voice-activated di
assistance controllers are intended to help people with different degrees of disability perform daily ac
degree of independence.
Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair are inherited from one parent (i.e., uniparental disomy [UPD]) and the other parent's chromosome
missing. UPD for some chromosomes is without consequence but, for a few chromosomes, can result i
including syndromes affecting growth and development. To date, only maternally derived chromosome
paternally derived chromosomes 6, 11, 14, and 15 have been shown to have a definite phenotypic eff

Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair 11 are inherited from the father (i.e., uniparental disomy [UPD]) and the mother's chromosome fo
(i.e., UPD of chromosome 11). Paternally inherited disomy 11 is associated with Beckwith-Wiedemann

Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair 14 are inherited from the mother (i.e., uniparental disomy [UPD]) and the father's chromosome fo
Maternally inherited disomy 14 is associated with short stature, hypotonia, hyperextensible joints, sco
dysmorphic features, mild developmental delay, and precocious puberty.

Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair 14 are inherited from the father (i.e., uniparental disomy [UPD]) and the mother's chromosome fo
Paternally inherited disomy 14 is characterized by developmental disability, skeletal abnormalities tha
dwarfism with narrow thorax, decreased survival due to respiratory difficulties, dysmorphic facies, and

Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair 15 are inherited from the father (i.e., uniparental disomy [UPD]) and the mother's chromosome fo
Paternally inherited disomy 15 results in Angelman's syndrome, which is characterized by developmen
absent speech, ataxic movements and gait, seizures, and paroxysmal laughter. 2-3% of Angelman's sy
paternal UPD15, and 70% have a deletion in 15q11-15q13.

Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair 15 are inherited from the mother (i.e., uniparental disomy [UPD]) and the father's chromosome fo
Maternally inherited disomy 15 results in Prader-Willi syndrome, which is characterized by neonatal hy
failure to thrive, developmental delay and/or disability, childhood onset obesity, short stature, hypogo
behavior problems. 25% of Prader-Willi syndrome patients have maternal UPD15, and 70% have a par

Molecular assay reagents intended for use in identifying the presence of the abnormal situation in whi
the chromosome pair 6 are inherited from the father (i.e., uniparental disomy [UPD]) and the mother's
pair is missing. Paternally inherited disomy 6 is associated with transient neonatal diabetes mellitus, a
that usually resolves by 6 months of life. Macroglossia and other anomalies, in addition to the transien
are also frequent in individuals with paternal UPD6.

Molecular assay reagents intended for use in identifying the abnormal situation in which both membe
pair 7 are inherited from the mother (i.e., uniparental disomy [UPD]) and the father's chromosome for
Maternally inherited disomy 7 results in Russell-Silver syndrome. Approximately 10% of Russell-Silver
maternal UPD7.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 13 band q14, usually involving the fusion of PAX7 and FKHR genes. This translocatio
patients with soft-tissue malignant tumors (e.g., alveolar rhabdomyosarcoma). Its detection may be u

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 19 band p13, usually involving genes PBX1 and E2A, respectively. This translocation
patients with acute lymphoblastic leukemia. Its detection may be used as a tumor marker. This chrom
associated with adverse prognoses.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 5 band q35, usually involving genes ALK and NPM1, respectively. This translocation
half the cases of anaplasic large-cell lymphoma (ALCL), a high-grade non-Hodgkin's lymphoma (NHL).
used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 8 band q24, usually involving gene C-MYC on chromosome 8 juxtaposed with gene I
immunoglobulin locus on chromosome 2. Other translocations involving the MYC locus include t(8:22)(
(q24:q32); C-MYC gene translocations are associated with Burkitt's lymphoma.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 13 band q14, usually involving the fusion of the PAX3 and FKHR genes. This transloc
alveolar rhabdomyosarcoma. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 11 band p15, usually involving the NUP 98 gene on chromosome 11, which rearrang
gene in chromosome 4. This translocation is most frequently found in children with T-cell acute lymph
detection may be used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 11 band q23, usually involving genes AF4 and MLL, respectively. This translocation i
with acute lymphoblastic leukemia (ALL) and some patients with acute nonlymphocytic leukemia (ANL
be used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 14 band q32, usually involving genes FGFR3 and IGH, respectively. This translocatio
with plasma cell leukemia and multiple myeloma. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 12 band p13, usually involving genes PDGFRB and ETV6, respectively. This transloca
myeloproliferative/myelodysplastic syndromes with eosinophilia. Its detection may be used as a tumo

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 9 band q34, usually involving genes DEK and CAN, respectively. This translocation is
patients with acute nonlymphocytic leukemia (ANLL) and myleodysplastic syndrome (MDS). Its detect
tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 14 band q11, usually involving genes C-MYC on chromosome 8 juxtaposed with gene
immunoglobulin locus on chromosome 14. Other translocations involving the MYC locus include t(8:22
(p12;q24); C-MYC gene translocations are associated with Burkitt's lymphoma.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 21 band q22, usually involving genes RUNX1T1 (aka as ETO) and RUN XW (aka as A
translocation is the most frequent anomaly in children with acute nonlymphocytic leukemia (ANLL); it
patients with ANLL. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 22 band q11, usually involving gene C-MYC on chromosome 8 juxtaposed with gene
immunoglobulin locus on chromosome 22. This translocation is characteristic of most patients with Bu
Burkitt's lymphoma; other translocations involving the MYC locus and associated with Burkitt's lympho
(q24:q32) and t(2;8)(p12;q24). Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 11 band q23, usually involving genes AF9 and MLL, respectively. This translocation i
with de novo and therapy-related acute nonlymphocytic leukemia (ANLL). Its detection may be used a

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 22 band q12. This translocation is characteristic of extraskeletal myxoid chondrosarc
may be used as a tumor marker. Other less-common translocations involving the genes RBP 56 and TC
this disorder.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 22 band q11. This translocation is characteristic of extraskeletal myxoid chondrosarc
may be used as a tumor marker. Other less-common translocations involving the genes RBP 56 and TC
this disorder.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations)between chrom
and chromosome 14 band q32, usually involving genes BCL-1 and IGH, respectively. This translocation
patients with B-cell chronic lymphocytic leukemia (B-CLL), but it is also associated with other types of
myeloma. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 19 band p13.1, usually involving genes MLL and ELL, respectively. This translocation
acute nonlymphocytic leukemia (ANLL) in adults and, less often, in children; congenital cases are rare
used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 19 band p13.3, usually involving genes MLL and ENL, respectively. This translocation
with both acute lymphoblastic leukemia and acute nonlymphocytic leukemia (ALL and ANLL, respectiv
found in infants (congenital leukemia). Its detection may be used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 22 band q12, usually involving genes WT1 and EWS, respectively. This translocation
with desmoplastic small-cell tumors and Wilms' tumors. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 22 band q12, usually involving genes FLI1 and EWSR1, respectively. This translocati
sarcomas (e.g., Ewing's sarcomas, primitive neuroectodermal tumors); it is also associated with periph
and esthesioneuroblastomas. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges between chromosome 12 band p1
band q25, usually involving genes ETV6 and NTRK3, respectively. This translocation is characteristic o
fibrosarcoma; the mutation is also associated with mesoblastic nephroma and found in a subset of pat
myeloma. Its detection may be used as a tumor marker.
Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 16 band p11, usually involving genes FUS and DDIT3, respectively. This translocatio
myxoid and round-cell liposarcomas. Its detection may be used as a tumor marker.

Computer aided detection systems designed to detect and classify areas in MRI breast images with ab
be indicative of breast cancer, such as micro calcifications, spiculated lesions, and other abnormal ma
may include an image digitizer or a means to import digital information, a computer capable of using
to process the information, and a display/and or printer that provides an image that shows the detecte
MRI images.

Molecular assay reagents intended to identify exchanges (i.e., translocations) between chromosome 1
chromosome 21 band q22; usually involving genes ETV6 and AML1 (acute myeloid leukemia 1 gene) r
translocation is one of the most frequent translocations found in B cell acute lymphoblastic leukemia o
associated with a long disease-free survival. Its detection may be used as a tumor marker.

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 22 band q12, usually involving genes ATF1 and EWSR1, respectively. This translocat
cases of malignant melanoma and soft-tissue clear-cell sarcoma. Its detection may be used as a tumo

Molecular assay reagents intended for use in identifying stable and irreversible exchanges (i.e., transl
chromosomes 14 band q32 and 18 band q21, usually involving the exchange of the BCL2 gene with th
immunoglobin heavy chain of chromosome 14. The detection of these translocations may be used a tu
translocation is present in most patients with follicular lymphomas and in some patients with acute ly

Molecular assay reagents intended for use in identifying exchanges (i.e., translocations) between chro
and chromosome 17 band q21, usually involving genes PML and RAPa, respectively. This translocation
acute promyelocytic leukemia. Its detection may be used as a tumor marker.
Molecular assay reagents intended for use in identifying the presence of three homologous chromosom
normal two (i.e., trisomy) in a patient sample. Congenital trisomies are typically characterized by phys
developmental disorders (e.g., trisomy in chromosome 21 is known as Down syndrome); acquired triso
result of malignancy, tumors, and/or other disorders (e.g., trisomy in chromosome 12 is associated wit
leukemia). Some individuals show mosaicism, a condition in which normal and three-chromosome cell
same person.

Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
chromosome 7 in a patient sample, rather than the normal two (i.e., trisomy 7). Individuals with trisom
mosaic, a condition in which normal and three-chromosome cells are present in the same person. To d
congenital trisomy 7 has never been reported in live-born infant.
Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
8 in a patient sample, rather than the normal two (i.e., trisomy 8). Some individuals with trisomy 8 are
which normal and three-chromosome cells are present in the same person. Congenital trisomy 8 is ass
myelogenous leukemia and other chronic myeloproliferative diseases (e.g., polycythemia vera, idiopa
myelodysplastic syndromes, and acute nonlymphocytic leukemias.

Molecular assay reagents intended for use in identifying the inborn (i.e., congenital) presence of three
9 in a patient sample, rather than the normal two (i.e., trisomy 9). Trisomy 9 is associated with eye an
anophthalmia, microphthalmia), congenital heart disease, kidney anomalies, and growth and developm
individuals with trisomy 9 are mosaic, a condition in which normal and three-chromosome cells are pre
person.

Molecular assay reagents intended for use in identifying the acquired presence of three chromosomes
(e.g., cells obtained from peripheral blood lymphocytes), rather than the normal two (i.e., trisomy). Ac
occur in chromosome 12 (associated with chronic lymphocytic leukemia), chromosome 9 (associated w
hematopoietic disease and myelodysplastic syndromes), and less frequently, in other chromosomes.

Molecular assay reagents intended to identify the acquired presence of three copies of chromosomes
a patient's sample (e.g., cells obtained from peripheral blood lymphocytes), rather than the normal tw
is the most common chromosomal abnormality associated with chronic lymphocytic leukemia (CLL), a
by the presence in the blood of an increased number of mature lymphocytes.

Molecular assay reagents intended for use in identifying the acquired presence of three copies of chro
patient sample, rather than the normal two (i.e., trisomy 7). Trisomy 7 is associated with various carci
of the bladder, brain, and prostate.
Molecular assay reagents intended for use in identifying the acquired presence of three copies of chro
sample, rather than the normal two (i.e., trisomy 8). Acquired trisomy 8 is associated with chronic mye
and other chronic myeloproliferative diseases (e.g., polycythemia vera, idiopathic myelofibrosis), mye
syndromes, and acute nonlymphocytic leukemias.

Molecular assay reagents intended for use in identifying the acquired presence of three copies of chro
sample, rather than the normal two (i.e, trisomy 9). Acquired trisomy 9 is most frequently observed in
hematopoietic diseases, including acute nonlymphocytic leukemia (ANLL), and myelodysplastic syndro
myelofibrosis, polycythemia vera).
Molecular assay reagents intended for use in identifying stable and usually irreversible chromosome d
congenital) cell samples (e.g., fetal cells from amniotic fluid, infant cells). Pathologic chromosome del
characterized by physical and developmental disorders.
Molecular assay reagents intended for use in identifying deletions in chromosome 22 band q11.2. The
are present in patients with an inherited autosomal dominant disorder characterized by congenital he
individuals), velopharyngeal incompetence, cleft palate, learning difficulties, and immunodeficiency.

Molecular assay reagents intended for use in identifying deletions in chromosome 22 band q13.3. The
are present in patients with a disorder that may be the result of a de novo chromosome deletion or of
chromosome abnormality, characterized by neonatal hypotonia, normal-to-accelerated growth, absen
and anatomic abnormalities (e.g., face, hands, toenails).
Molecular assay reagents intended for use in identifying deletions in the Angelman syndrome/Prader-W
(AS/PWS) region, located in 15q11.2-q13. This genetic deletion is the most frequent and severe genet
patients with Prader-Willi syndrome.
Point-of-care analyzers designed to determine the presence of nonvisible (i.e., occult) blood (i.e., hum
feces samples. These analyzers usually perform automated tests using clinical chemistry and/or immu
short time (several minutes); most of them require the technician to take the sample in a dedicated co
directly in the instrument, usually one specimen at a time. Occult blood feces analyzers are intended
diagnose blood loss from the gastrointestinal tract; they are mostly used for screening patients for col
are also used to detect bleeding ulcers and/or other malignant diseases in the gastrointestinal tract.

Equipment designed for the automatic or semiautomatic washing (i.e., elimination of dirt and/or stains
physical decontamination) of organic debris from the endoscope channels. These units typically consis
electromechanical central unit that includes pumps, operation time controls, and output and input por
solutions. The flushing solutions (e.g., dedicated detergents) circulate in the endoscope channels thro
attached to the central unit, providing cleaning and some decontamination by removing the organic d
and biofilms from the endoscope channels.

Physiologic monitors designed primarily for automated continuous measuring and display in real time
that is attached to hemoglobin found in the peripheral circulation (i.e., tissue oxygen saturation [StO2
tissue). Light at several frequencies, typically in the near infrared spectrum, is transmitted through th
subcutaneous tissue and the value of the absorbed light is determined based on the measurement of
These monitors typically consist of portable electronic units that facilitate movement from one locatio
may be connected to the line and/or powered by internal batteries. The main unit typically includes co
also includes an attached probe that is fixed to the skin and includes the light sources and a light dete
scattered light reflected to the skin surface. The monitor software includes algorithms to calculate the
several different frequencies and give as a result the oxygen status of the hemoglobin in the tissues. T
monitors are used mainly for noninvasive identification and tracking of the hemodynamic conditions in
Respiratory function mechanics analyzers designed to measure the patency of the upper respiratory a
using acoustic reflection. These analyzers consist of a mouthpiece, a sound source, microphones for b
reflected sounds, filters, a wave tube that matches the diameter of the oral airways, and a computeriz
dedicated software to process the measured data and display and/or record the airway patency graph
reflectometry respiratory analyzers are used to assess the patency of the upper respiratory tract durin
diagnostic procedures including changes in the tract due to patient breathing.

Respiratory function analyzers designed to assess the mechanics of the respiratory function in the nas
and/or older children (typically older than 12 years of age). These analyzers use one of several techniq
measuring the volume, pressure, and airflow in the nose while breathing or indirectly by determining t
canals using other techniques. Dedicated nasal respiratory function analyzers for respiratory breathin
measurement and those using acoustic reflectometry are available.

Respiratory function mechanics analyzers designed to measure the patency of the nasal conducts usin
These analyzers include a tube with an appropriate nose tip, a sound source, microphones to pick up t
reflected sounds, filters, a wave tube that matches the diameter of the nose, and a computerized unit
software to process the measured data and display and/or record a nasal patency graph. Acoustic refle
respiratory analyzers are used to assess the patency of the nasal tract during screening and/or diagno

Powered functional total lower/upper-limb orthoses designed for external modification of the structura
characteristics of the lower and upper limbs using power sources (usually electric) and powered mech
muscular bioelectric (i.e., myoelectric) signals. These devices provide support, supplement, and/or au
functions and/or its structure. These orthoses typically consist of dynamic wearable devices that inclu
control unit, appropriate software, an actuator, myoelectric sensors, power sources, motors, and a var
appropriate to facilitate the normal function of otherwise disabled lower and upper limbs. Autonomous
powered lower/upper-limb orthoses are mainly used to make functions such as grasping and gait poss

Powered functional total lower-limb orthoses designed for external modification of the structural and/o
characteristics of the lower limbs using power (usually electric) sources and powered mechanisms tha
bioelectric (i.e., myoelectric) signals. These devices provide support, supplement, and/or augment the
its structure. These orthoses typically consist of dynamic wearable devices that include a computerize
appropriate software, an actuator, myoelectric sensors, power sources, motors, and a variety of mech
facilitate the normal function of otherwise disabled one or both lower limbs. Myoelectric powered lowe
mainly used to make gait possible.

Powered orthoses designed for external modification of the structural and/or functional characteristics
limb using power sources (usually electric) and powered mechanisms that respond to muscular bioele
signals. These devices provide support, supplement, and/or augment the limb functions and/or its stru
typically consist of dynamic wearable devices that include a computerized control unit, appropriate so
myoelectric sensors, power sources, motors, and a variety of mechanisms appropriate to facilitate the
otherwise disabled upper limbs.
Devices designed to be used in combination with a catheter/stylet to enable visualization/detection of
location, thereby guiding correct positioning/placement of the catheter. These locators typically work i
the locator unit emits a type of energy, such as a low-level, high-frequency magnetic field or near infr
detected by a sensor embedded in a catheter/stylet tip, and is subsequently interpreted and relayed b
(2) the catheter/stylet tip emits a type of energy that is detected by a sensor incorporated in the locat
to emit/sense the energy as the stylet/central venous catheter (e.g., peripherally inserted central cath
advanced through the vasculature. These devices are typically hand-held, portable, reusable, and bat
locators may consist of several components (e.g., a detector/sensor unit, a visualization module, a sta
allows visualization of the catheter tip/stylet, etc.).

Stylets designed to be used in combination with a locator unit to enable visualization/detection of the
catheter tip location, thereby guiding correct positioning/placement of the catheter. These stylets typi
two ways: (1) the stylet tip emits a low-level, high-frequency magnetic field that is detected by a sens
locator unit, or (2) the stylet contains a sensor embedded in its tip that detects a the electromagnetic
locator unit. These stylets are designed to be used in conjunction with specific catheter/stylet tip locat

Embolectomy/thrombectomy catheters designed to deliver thrombolytic agents to intravenous clots a


(i.e., fragment) a clot into particles. These devices usually consist of a multilumen catheter including t
(to be located distally and proximally to the clot), drug infusion and aspiration ports, infusion holes, an
to the distal balloon, an internal dispersion wire, anand a motor drive that is attached to the proximal
control the movement of the dispersion wire. After the catheter is introduced and the balloons are loca
agent is delivered; then the dispersion wire is activated, the clot is fragmented and the remaining deb
the catheter.

Lower-limb muscle strength exercisers based on a system of levers that are designed to provide resist
contraction when the user performs hip abduction or adduction. The user exerts force on levers to co
resistance. These exercisers are usually stand-alone machines consisting of weights stacked on top of
to transmit the force (i.e., to convey the resistance), and a seat with two padded levers attached, one
rests at the bottom. Typically, the user sits in the seat with the sides of their knees and legs resting o
and their feet on the foot rests. For hip abduction exercise the user puts one thigh inside each padded
outwards against the resistance. For adduction exercises, the user puts one thigh outside each padde
inwards. These exercisers are intended to improve muscle strength in the hips, increase muscle size, e
endurance and power, and improve bone density.

Detectors designed to facilitate the visualization and identification of abnormalities in the periodontal
using fluorescent light. These devices are typically a light source (usually blue) that causes tissue fluo
tissue observed through the handpiece has a bright green color, while abnormal and/or suspicious tiss
to a loss of fluorescence. Induced fluorescence periodontal/oral cavity tissue abnormality examination
dental and other healthcare providers to identify abnormal tissue (e.g., oral cancer, dysplasia) that is
light; the devices are also used by surgeons to help distinguish diseased tissue that should be resecte
Ultrasound surgical units designed for the performance of dental/oral surgery procedures. These devic
a dedicated handpiece that incorporates an ultrasound transducer and an irrigation port to which one
tips may be attached. The handpiece is permanently attached through an electrical cord and a hose fo
portable unit that includes a radiofrequency generator, a power level control, and a peristaltic pump.
units may be used for a variety of dental (e.g., endodontic, periodontal cleaning) procedures and/or fo
hard tissue/bone (e.g., for osteotomy, bone harvesting) according to the type of tip attached and pow

Non-metabolic solutions or creams applied to the skin around the nostrils and base of the nose or that
These solutions create a physical barrier against allergens such as pollen and temporarily prevent alle
solutions and creams are often made from plant materials; they do not contain drugs and do not act m

Endoscopic magnetic resonance imaging (MRI) coils designed for introduction through the rectum to o
imaging of the prostate, colorectal area, and/or cervix. These coils typically consist of isolated indepen
of conducting rings that resonate at a given radiofrequency; the coils are placed inside a dedicated pr
insertion. The probe is attached to an external unit for procedure control and contrast media infusion;
usually need special interface devices and are compatible only one or a few specific models of MRI sy
coils are mostly used in the detection and staging of cancer tumors and other diseases of the imaged

Data management information systems designed to manage patient insurance verification, gathering
demographic information, financial requirement review, and co-pay collection. These systems typically
combination of hardware and software. The hardware typically includes dedicated network servers an
software consists of a dedicated software package that ensures that the patient carries proper insuran
and accurate reimbursement process as requirements are verified before treatment is administered. R
information data management systems may function as stand-alone systems or may be integrated in
financial data management information system network.

Data management information systems designed to streamline work-flow, increase productivity, and i
throughput. These systems typically consist of a combination of hardware and software. The hardware
dedicated network servers and computers; the software consists of a dedicated software package tha
update, and review care plans, which improves the capture of clinical data and makes information mu
Case management systems also assist in appropriate reporting of clinical/patient information; they ma
alone systems or may be integrated in a hospital-wide data management information system network

Data management information systems designed to facilitate the submission of claims and/or possible
and efficiently. These systems typically consist of a combination of hardware and software. The hardw
dedicated network servers and computers; the software consists of a dedicated software package tha
submission of claims and possible claim denials. Some systems also include software intended to proc
provider claims (i.e., secondary claims) and/or to prevent, analyze, and track denied claims as well as
resubmission of corrected claims (i.e., denial claims). Claim/denial financial management systems sup
submission process including claims processing, remittance posting, eligibility verification, and statem
systems may function as stand-alone systems or may be integrated in a hospital-wide financial data m
information system network.
Clinical pharmacy data management information systems designed to manage and record the proper
medications to patients throughout a healthcare facility (i.e., the electronic medication and administra
eMAR). These systems typically consist of a combination of hardware and software. The hardware typi
dedicated network servers, computers, printers, and barcode readers; the software consists of a dedic
package. Prior to dosage administration, the software helps to verify patient and drug data to make s
can be safely administered. After the drug has been given, the administration report is documented in
ultimately stored in the patient's medical record. Electronic medication administration record systems
alone systems or may be integrated in a hospital-wide data management information system network

Simulators designed for training users in the operation of an automated external defibrillator (AED) an
These simulators typically include one or more anatomic models of the head, neck, and torso with app
landmarks, a set of electrodes and cables, and a defibrillator that simulates the controls found in a rea
different simulators are available; some provide different rescue/emergency situation scenarios that p
to train and practice all aspects of AED use. Other AED simulators can provide the opportunity to train
of a specific component of an AED (e.g., applying defibrillator pads in the correct position). Anatomic m
these simulators are available in different body types and sizes such as infant, child, adult, and bariat

Warming/cooling units designed to warm or cool substances, materials, and/or devices in a clinical lab
temperature may be adjusted below and/or above the room temperature. These units typically consis
regulated open or closed bath (i.e., a reservoir) or, less frequently, a dry enclosure; a pump to circulat
controller to regulate the temperature and/or liquid flow; a recorder to keep track of the variations in t
heating and refrigerating components. Laboratory warming/cooling units accurately maintain regulate
integral bath or dry enclosure; some units may be also capable of circulating liquid to external system
laboratories for procedures such as crystallization and other low-temperature chemical reactions, tem
procedures, and viscosity testing.

Contrast media injectors designed to inject contrast media into the vascular system to selectively alte
anatomic region of interest. These devices are typically automated electromechanical injectors with a
be either reusable or disposable. Ultrasonic contrast media injectors are capable of delivering contras
encapsulated microbubbles filled with perfluorochemicals or, less frequently, particle suspensions) wit
range (typically from 0.5 to 3.0 mL/s), and volume required for ultrasonic studies. They are intended t
amplitude in some specific ultrasonic and Doppler ultrasonic procedures, such as those used for imagi
vascular abnormalities.

Near-infrared spectroscopy (NIR spectroscopy) laser scanning systems designed to provide data and im
lipid composition of the inner layers of the vascular walls (i.e., intravascular). The light wavelength ch
and automatically analyzed to determine the absorption and changes in speed after the light passes a
reflected back;, resulting in optical slice color images showing the chemical composition of the vascul
be viewed on a video display terminal. The system usually consists of a central computerized unit tha
source, optical processors, analysis software, and a detachable intravascular dedicated fiberoptic cath
spectroscopy systems are intended to assess the lipid content of artery (e.g., coronary) plaque to faci
and/or treatment.
Readers designed to determine the radiation dose that is absorbed by thermoluminescent dosimeters
typically heat the dosimeters one at a time using a heating system (e.g., a hot plate, hot gas) and the
from the TLD crystal is then measured in a dark chamber. Automated readers can process several TLD
by mounting the dosimeters on an aluminum and Teflon card. The automated units typically use phot
electronic circuits, and dedicated software. TLD readers are intended for a variety of applications, inc
body irradiation dose verification and/or radiotherapy planning.

Devices designed to measure and display the intradiscal pressure and volume during a discography p
devices usually consist of a syringe used to inject the contrast medium into the disc to stimulate the n
pressure transducer on the syringe plunger that transfers the data of the pressure to a central unit tha
the fluid delivery pressure and volume; software that calculates the disc pressure and volume; and a d
procedure and/or patient data. Intradiscal pressure/volume spinal disc diagnostic systems are used to
procedures on patients, especially for those with chronic back pain.

Adult respiratory function mechanics analyzers designed to determine the resistance of the nasal pass
measuring the volume and airflow through the nasal passages including the partition of airflow betwe
passages. These analyzers typically consist of a measuring unit and appropriate tubes and nasal adap
independent measure of the volume of air breathed from each side of the nose; usually the ratio of th
measure of the difference between the air passage is calculated (i.e., a nasal partitioning ratio, NPR).
mechanics analyzers are intended to assess nasal septum deviation and/or to evaluate the upper airw

Laboratory analyzers designed to analyze the main characteristics of microparticles. The analysis typi
evaluation of one or more characteristics, such as microparticle size (from fractions of a nanometer to
molecular weight (usually expressed in daltons), and electrokinetic (zeta) potential (usually expressed
measure of the magnitude of the repulsion or attraction between particles. These analyzers consist of
performs measurements using one or more technologies that may include Doppler laser and light scat
cell or a chamber for the sample container; and appropriate software. The unit is typically connected t
or laboratory workstation that processes and displays particle characteristics. Microparticle laboratory
for microparticle characterization; they may be used for particle size analysis and other related proced
determination of polymer and protein melting points) in clinical pharmacies, and laboratories and for m

Equipment designed for the endoscopic ligation of rectal hemorrhoids using ultrasound as a guide for
These devices consist of an electronic unit connected to a dedicated anoscope that includes a Dopple
and an integral needle for artery ligation (typically using an absorbable suture), a fiberoptic illuminatio
display. Ultrasound-guided rectal hemorrhoid ligation units are intended to facilitate the location of art
to hemorrhoids and to provide a more accurate and repeatable means of hemorrhoid ligation.
Enclosures designed to provide a confined environment for the delivery and/or exhaustion of gases, va
Hoods are typically made of rigid plastics or metal (e.g., stainless steel); they are frequently connecte
gas sources to provide a controlled atmosphere inside the hood and/or to exhaust gases and vapors to
hoods include blowers, filters, and other devices according to the procedure to be performed or the pr
particular application; ductless hoods recirculate the air inside the hood to the room environment afte
Hoods are used in the performance of procedures such as distillation and chemical reactions isolated f
environment and/or to exhaust toxic fumes from areas where hazardous or potentially hazardous mate
(e.g., clinical laboratories). Laboratory hoods are not biological safety enclosures; they should not be u
potentially infectious materials are handled.

Chemical fume hoods constructed with a tall interior (e.g., 2 meters/6.5 feet) that permits roll-in and a
heavy, bulky equipment. These hoods are constructed with chemical-resistant plastics or metals; they
on the floor as stand-alone units. Walk-in hoods permit personnel to enter the hood, but the operators
the hood when chemical fumes are generated. Walk-in chemical fume hoods are not biological safety
should not be used when infectious or potentially infectious materials are handled.

Chemical fume hoods designed to provide a tall working interior (e.g., 2 meters/6.5 feet) to accommo
and/or distillation apparatus sets (e.g., distillation columns). These hoods are usually mounted on an a
base to provide convenient access to the floor of the hood. Tall equipment/distillation hoods are const
and heat-resistant plastics or metals and usually include heat- and vapor-proof light fixtures.

Chemical fume hoods designed for applications involving the use of perchloric acid. These hoods inclu
and liners made of nonporous, inorganic materials that can withstand reaction with perchloric acid (e.
316) especially when the acid is heated above ambient temperature; they usually include water wash
systems to permit rinsing after each use to prevent the accumulation of perchloric salts.

Chemical fume hoods designed to filter the air exhaust and recirculate it into a room. These hoods typ
filters that trap solid, liquid, and gas chemicals from the air, eliminating the need for outside venting a
ducts. The filters typically include a gross solids prefilter, a high-efficiency particulate-air (HEPA) filter,
(e.g., charcoal) for general applications (e.g., acid, organic products, particles, solvents) or chemical-s
ammonia, formaldehyde) for particular uses (e.g., histology, forensics). Ductless chemical fume hood
stationary or mobile versions; they are used in laboratories, clinical pharmacies, and for some specific
rooms where limited quantities of chemicals are processed or where ducting is not feasible. Since duc
hoods recirculate the filtered air in the room, they generally include alarms for hazardous concentratio
exhaust port.

Ductless small chemical fume hoods that are usually mounted on a cart. These hoods typically consist
the hood itself and a filtering unit, coupled by a hose. Mobile ductless chemical fume hoods are used m
laboratories but may also be used to exhaust some of the most common gases and/or particulate con
sources found in clinical laboratories, pharmacies, and clean rooms.
Laboratory hoods designed to provide a working enclosure appropriate for fingerprint development us
fingerprint powder (e.g., ethyl cyanoacrylate). These hoods are typically a small, hard plastic enclosur
stainless steel) working surface; the hood may provide an internal vertical (usually downward) airflow
of exposure for the operator. They may also include fluorescent lights, a fan for uniform distribution of
external air filters or internal carbon filters, and a humidifier. Fingerprint development hoods are used
also by police officers to detect and process hard-to-find (i.e., latent) fingerprints on forensic evidence

Laboratory hoods designed to be used for applications involving radioactive isotopes. These hoods typ
integral working surfaces and liners that are easy to decontaminate, a dedicated remote blower, and
made of or lined with radiation-shielding materials. Radioisotope hoods are intended for use in nuclea
departments and clinical laboratories and for the preparation and dispensing of radioisotopes.

Hoods designed to displace all the air mass within the enclosure with uniform velocity and parallel dire
airflow), distorted only by objects in the flow pathway. They include blowers and filters as integral equ
laminar airflow inside the hood. Laminar flow hoods may produce either horizontal or, less frequently,
prevent contamination of sterile materials (e.g., culture media, drug preparations) but do not offer pro
or to the environment. These hoods are frequently used in clinical laboratories and pharmacies; they a
enclosures and should not be used when infectious or potentially infectious materials are handled.

Laminar flow hoods designed to create a horizontal laminar airflow in the working area, providing an a
environment in which sterile materials such as culture media and drug preparations do not become co
laminar flow hoods typically include blowers and may also include a high-efficiency particulate-air (HE
of air. Horizontal laminar flow hoods are used in clinical laboratories and in clinical pharmacies to prep
(e.g., antibiotics, enteral and parenteral nutrition products) under sterile conditions; they do not prote
the materials under preparation. They are not biological safety enclosures and should not be used wh
potentially infectious materials are handled.

Laminar flow hoods designed to create a vertical laminar airflow in the working area, providing an app
in which sterile materials such as culture media and drug preparations do not become contaminated.
hoods typically include blowers and may include a high-efficiency particulate-air (HEPA) filter for the in
laminar flow hoods are used in clinical laboratories and to prepare drugs (including cytostatics) under
do not protect the operator from the materials under preparation. They are not biological safety enclo
be used when infectious or potentially infectious materials are handled.

Vertical laminar flow hoods designed to be used to perform polymerase chain reaction (PCR) amplifica
reduced risk of contamination. These hoods provide a vertical (typically downward) laminar airflow in
are peformed and usually consist of a plastic and/or stainless steel enclosure that includes a high-effic
(HEPA) prefilter and ultraviolet lamps to irradiate the hood, as well as fluorescent working lights, timer
hinged sash) for the manipulation of samples, testing devices, and reagents. PCR laminar flow hoods a
contamination during the procedures, but they do not provide protection to the user. The hoods are no
enclosures and should not be used when infectious and/or potentially infectious materials and handled
may provide appropriate shielding for radioactive substances used in the radioactive labeling of DNA.
Vertical laminar airflow hoods designed to prevent airborne contamination during manipulation and/or
evidence. These hoods typically consist of a hard plastic (e.g., PVC) enclosure with a high-efficiency pa
filter and provide a steady laminar airflow to the enclosed forensic (e.g., crime scene) evidence. Vertic
forensic evidence laboratory hoods are intended to provide a working environment for nonbiohazardo
minimizing the possibility of its contamination and the release of fumes, odors, and/or particulates du
They are not biological safety enclosures and should not be used when infectious or potentially infecti
handled.

Oxygen delivery hoods consisting of a rigid transparent plastic shell that encloses the patient's head;
mounted on a neck ring that provides a gas-tight seal. These hoods may include temperature, humidi
concentration sensors; they may also include supply and exhaust ports for gas tube connections; som
ports for gas concentration analysis and to permit the patient to hear. The hoods are connected to the
tubes or hoses. Adult oxygen supply hoods are frequently used for administration of high-pressure oxy
are inside hyperbaric chambers.

Oxygen delivery hoods designed for infant use. These hoods typically consist of a rigid transparent pla
the entire body of the infant or, less frequently, only his or her head. The hoods include a diffuser to p
blowing directly on the infant and may also include temperature, humidity, and oxygen concentration
connected to the oxygen source using tubes or hoses. Infant oxygen delivery hoods are used to admin
(usually 10-15 liters per minute) of oxygen at high concentration (80% to 90%) under controlled humi
conditions; they are typically used for newborns and children younger than two years who can breathe
extra oxygen. Both reusable and disposable infant hoods are available.

Infant oxygen delivery hoods designed for a single use (i.e., disposable devices). These hoods typicall
transparent plastic shell that encloses the infant's head; the hoods include a diffuser to prevent oxyge
on the infant and may also include temperature, humidity, and oxygen concentration sensors. The hoo
the oxygen source using tubes or hoses. Disposable infant oxygen delivery hoods are used to adminis
(usually 10-15 liters per minute) of oxygen at high concentration (80% to 90%) under controlled humi
conditions; they are typically used for newborns and children younger than two years who can breathe
extra oxygen.

Molecular assay reagents intended to identify stable and usually irreversible anomalies (e.g., mutation
trinucleotide repeats) in the genes that may cause disorders in humans; genetic anomalies many be d
(familial), frequently in x-linked, autosomal dominant, or recessive form. Genetic anomalies are comm
disorders and/or associated with tumor development.
Molecular assay reagents intended to identify stable and usually irreversible deletions in the genes th
in humans; genetic deletions many be de novo or inherited (familial), frequently in X-linked, autosoma
recessive form. Genetic deletions are common in many hereditary disorders (e.g., Menkes' syndrome,
dysfunctions) and tumor development.
Molecular assay reagents intended to identify deletions in the copper-transporting alpha polypeptide (
in Xq13.2-q13.3, which encodes for a protein that regulates copper levels. Inherited deletions are pres
disorders of copper transport such as Menkes' syndrome and, less frequently, with occipital horn synd
Danlos syndrome type IX).
Molecular assay reagents intended to identify deletions in the azoospermia factor (AZF1) region of the
chromosome, located in Yq11.2, that encodes for an RNA binding protein important in spermatogenes
are present in most male patients with Y chromosome infertility, a spectrum of diseases characterized
sperm (azoospermia) or decreased number of spermatozoa in the semen (oligospermia, also known as

Molecular assay reagents intended to identify deletions in the Berardinelli-Seip congenital lipodystrop
located in 11q13, which encodes for seipin, an amino acid protein that is an integral membrane protei
reticulum. Inherited deletions are associated with Berardinelli-Seip congenital lipodystrophy type 2.

Molecular assay reagents intended to identify deletions in the AGPAT2 gene (formerly Berardinelli-Seip
lipodystrophy 1, BSCL1 gene), located in 9q34.3, that encodes for the enzyme lysophosphatidic acid a
which catalyzes the conversion of lysophosphatidic acid to phosphatidic acid, thus metabolizing lipids
deletions are the cause of congenital generalized lipodystrophy (CGL1), also known as Berardinelli-Sei
lipodystrophy type 1.

Molecular assay reagents intended to identify deletions in the dystrophin muscular dystrophy (DMD) g
which encodes for the protein dystrophin that may anchor the cytoskeleton to the plasma membrane
muscle during contractions. X-linked recessive inherited deletions are present in Duchenne muscular d
also in a somewhat milder disease known as Becker muscular dystrophy (BMD).

Molecular assay reagents intended to identify deletions in the elastin (ELN) gene, located in 7q11.23,
elastin, a major structural protein of tissue that must expand quickly and contract completely (e.g., th
genetic deletions are present in most patients with Williams-Beuren syndrome; some deletions may ca
tissue abnormalities and supravalvular aortic stenosis (SVAS).
Implantable electrocardiographs designed for recording the variations of the electric potential caused
activity of the heart muscle only for a pre-established, relatively short period of time (typically less tha
record again on the same memory erasing the previous information (i.e., loop recording). These record
leadless devices implanted in the chest that include two or more electrodes on the surface of the reco
and record arrhythmia episodes lasting several minutes either automatically and/or after patient activ
can be transferred to a patient-operated device that allows the telemetric communication of the store
physician's office, usually through standard telephone lines. A programmer-tester device used to set u
time of implantation and to save or retrieve the recorder information later is also available. The record
patients who have syncope or presyncope events and/or cardiac arrhythmia. Implantable loop-recordi
intended for a real-time assessment of the electrocardiogram or other cardiac conditions.

Molecular assay reagents intended to identify deletions in the facioscapulohumeral muscular dystroph
located in 4q35, which may have a role in the processing of pre-rRNA (ribosomal RNA) or in the assem
subunits. It is expressed in adult muscle and lymphocytes and also in fetal muscle, brain tissue, and p
genetic deletions are present in most patients with facioscapulohumeral muscular dystrophy type 1A.

Molecular assay reagents intended to identify deletions in the galactosylceramidase (GALC) gene, loca
encodes for the enzyme galactosylceramidase that hydrolyzes several galactolipids, important in the
kidney, and epithelial cells of the colon and small intestine. Inherited genetic deletions are present in
(infant) onset of Krabbe's disease.
Molecular assay reagents intended to identify deletions in the jagged 1 (JAG1) gene, located in 20p12
jagged 1 protein, the ligand for the receptor NOTCH 1. Inherited genetic deletions are associated with
syndrome; mutations in JAG1 are involved in hematopoiesis.
Molecular assay reagents intended to identify mitochondrial deletions. These maternally inherited or d
deletions are present in all tissues of patients with several pathologic diseases, including Kearns-Sayre
progressive external ophthalmoplegia (PEO), and Pearson marrow pancreas syndrome (PMPS).

Molecular assay reagents intended to identify mitochondrial deletions in the Kearns-Sayre syndrome (
inherited genetic mitochondrial deletions are present in all tissues of patients with KSS.
Molecular assay reagents intended to identify mitochondrial deletions in the progressive external opht
gene, located in 10q23.3-24.3, that is involved in mitochondrial DNA (mtDNA) metabolism. The gene c
adenine nucleotide-dependent DNA helicase; its function is considered critical for lifetime maintenanc
Maternally inherited genetic mitochondrial deletions are usually confined to the skeletal muscles of pa

Molecular assay reagents intended to identify mitochondrial DNA deletions in the Pearson marrow pan
(PMPS) gene. Maternally inherited or de novo genetic deletions are usually more abundant in hematop
other tissue of patients with PMPS.
Molecular assay reagents intended to identify deletions in the nuclear receptor subfamily 0, group B, m
gene, located in Xp21.3-p21.2. Inherited genetic deletions are present in male patients with adrenal h
Most males are infertile; carrier females may have symptoms of adrenal insufficiency and/or hypogona
hypogonadism.
Molecular assay reagents intended to identify deletions in the nuclear receptor binding SET domain pr
located in 5q35.2-q35.3, which encodes for a protein whose exact function is unknown. Inherited gen
present in most patients with Sotos and Weaver syndromes.
Molecular assay reagents intended to identify deletions in the oculocutaneous albinism II (OCA2) gene
q12, these genes are involved in producing a pigment called melanin, which is the substance that give
their color. When associated with Angelman's and Prader-Willi syndromes, clinical effects are a result o
copy of OCA2 and a mutation in the other copy of OCA2.

Molecular assay reagents intended to identify deletions in the paired box gene 6 (PAX6) gene, located
encodes for a transcriptional regulator involved in oculogenesis and other development processes; the
the eye and brain. Inherited genetic deletions are present in patients with isolated aniridia; deletions i
gene and the adjacent WT1 locus are present in patients with WAGR syndrome, which includes Wilms'
abnormalities, and developmental disabilities.

Mesh made of biocompatible collagen obtained from the extracellular part of animal (e.g., porcine) sk
soft tissue repair/reinforcement procedures. This mesh usually consists of an acellular collagen matrix
combination of collagen matrix and synthetic polymeric mesh (e.g., PLGA mesh). Collagen meshes are
scaffolds and implants for reinforcing and repairing weak or damaged soft tissue (e.g., repairing hernia
other soft tissues) that may have been repaired by sutures or suture anchors in surgical or dental proc
care.
Wound irrigators designed for automated or semiautomated irrigation, washing, and debridement of e
irrigation and ultrasonic energy. These irrigators consist of a main electromechanical unit that typically
frequency generator; a pump for irrigation with nonmedicated liquids (e.g., saline); controls for the tem
and rate of irrigation; and frequently a splash shield to avoid accidental contamination. The units are c
handpieces with ultrasonic transducers and irrigation nozzles to facilitate easy removal of debris and n
Ultrasound debridement irrigators are used to remove damaged (e.g., necrotic) tissue and/or debris (e
objects) in emergency departments and surgical rooms.

Third-wheel devices that are controlled and pedaled by the hands designed for attachment to a wheel
usually consist of a front wheel with a crank mechanism including hand pedals and handbrakes, kick s
third wheel upright in a parking position, and an adapter for connecting to a wheelchair. These device
They make a three-wheel cycle by being attached to a wheelchair. Mechanical wheelchair handcycles
facilitating locomotion by people who are usually restricted to a wheelchair. They can also be used for

Third-wheel devices that are equipped with a battery-powered motor and controlled by the patient's h
designed for attachment to a wheelchair. These devices usually consist of a front wheel with handles,
stands for keeping the third wheel upright in a parking position, an adapter for connecting to a wheelc
with a battery, a LED lamp, a speed control, and they usually have hand pedals to propel or maneuver
whenever needed. They make a three-wheel cycle by being attached to a wheelchair. These devices a
on slopes or when higher speeds are needed. Powered wheelchair handcycles are mainly used for faci
people who are usually restricted to a wheelchair. They can also be used for recreational purposes.

Warming units intended to heat breast milk, infant formula, and semi-solid infant food, to room or bod
feeding them to an infant. Heating is typically accomplished with dry heat or steam heat mechanisms
incorporate a cup or well into which a bottle or bag containing the nutritional (e.g., breast milk, infant
can be placed to be heated, digital displays, automatic shut-off options, etc. These devices may be ba
and are typically reusable.

Molecular assay reagents designed for nucleic acid (e.g., DNA, RNA) purification, usually from samples
fluid specimens. The reagents are intended to isolate the desired nucleic acids (e.g., viral nucleic acid
contamination; the reagents are usually supplied as kits intended for a specific type of test. The separ
nucleic acids from other constituents of the primary sample may be achieved using a variety of techn
magnetic beads. Nucleic acid purification reagents are used in clinical laboratories to isolate nucleic a
procedures, such as replication (e.g., polymerase chain reaction, [PCR]), either for analysis as a diagn
research.

Molecular assay reagents designed for the determination of the precise sequence of the nucleotides (
cytosine, and guanine for DNA) in a sample of nucleic acid. These reagents are intended mainly to pro
samples to prepare them for sequence detection and to perform the actual detection steps of nucleot
determination. Typically, the sequence of nucleotides for the analyzed portion of the sample (i.e., read
several hundred base pairs) is determined and then displayed and/or printed after computer-based int
acid sequencing reagents are used in clinical laboratories to obtain the actual sequence of nucleotides
samples either for diagnosis or research.
Molecular assay reagents designed for nucleic acid (e.g., DNA, RNA) amplification (i.e., replication). Sa
from body fluid specimens and follow a repetitive process that increases the target nucleic acid copy n
These reagents may be applied directly to DNA samples; however, RNA samples usually require prepr
reverse transcription procedure. Reagents that can perform the replication either at constant tempera
thermal cycle are available. Nucleic acid replication reagents are used in clinical laboratories to gener
nucleic acid from a previously purified nucleic acid sample; the amplified sample is usually used for su
research.

Functional total upper-limb orthoses that use power sources (usually electric) and powered mechanism
make possible and/or improve the functional activities of the limb. They provide support, supplement,
limb functions. These orthoses typically consist of dynamic wearable devices that include sensors, pow
and a variety of mechanisms appropriate to facilitate the normal function of otherwise disabled upper
powered upper-limb orthoses controlled by bioelectric muscular (i.e., myoelectric) or central nerve (ne
and/or user operated switches (i.e., autonomous) are available.

Powered orthoses designed for external modification of the structural and/or functional characteristics
limb using power sources (usually electric) and powered mechanisms that respond to muscular and ne
(i.e., myoelectric and neuroelectric respectively) signals. These devices provide support, supplement,
limb functions and/or its structure. These orthoses typically consist of dynamic wearable devices that
control unit with appropriate software to coordinate the neuro and myoelectric signals, an actuator, m
neuroelectric sensors, power sources, motors, and a variety of mechanisms appropriate to facilitate th
otherwise disabled upper limbs.

Powered orthoses designed for external modification of the structural and/or functional characteristics
limb using power (usually electric) sources and powered mechanisms that respond to the user's switch
autonomous). They provide support, supplement, and/or augment the limb functions and/or its structu
typically consist of dynamic wearable devices that include a control unit, an actuator, power sources,
a variety of mechanisms appropriate to facilitate the normal function of otherwise disabled upper limb

Powered orthoses designed for external modification of the structural and/or functional characteristics
limb using power sources (usually electric) and powered mechanisms that may respond to the user's s
autonomous) or to the muscular and neurologic bioelectric (i.e., myoelectric and neuroelectric respect
provide support, supplement, and/or augment the limb functions and/or its structure. These orthoses
dynamic wearable devices that include a computerized control unit with appropriate software to coord
switching signals with the neuro and myoelectric signals. They also include an actuator, myoelectric a
sensors, power sources, motors, switches, and a variety of mechanisms appropriate to facilitate the n
otherwise disabled upper limbs.

Functional total lower-limb orthoses using power sources (usually electric) and powered mechanisms t
make possible and/or improve the functional activities (i.e., gait) of the lower limbs. These devices pro
supplement, and/or augment the limb functions. These orthoses typically consist of dynamic wearable
sensors, power sources, motors, and a variety of mechanisms appropriate to facilitate the normal func
partially or totally disabled lower limbs. Also available are dedicated powered lower-limb orthoses con
muscular (i.e., myoelectric) and/or central nerve (neuroelectric) signals, and/or user operated switche
Powered lower-limb orthoses are mainly used to make gait possible.
Powered functional total lower-limb orthoses designed for external modification of the structural and/o
characteristics of the lower limbs using power sources (usually electric) and powered mechanisms tha
bioelectric (i.e., myoelectric) and neurologic bioelectric (i.e., neuroelectric) signals. These devices prov
supplement, and/or augment the limb functions and/or its structure. These orthoses typically consist o
devices that include a computerized control unit with appropriate software to coordinate the neuro an
an actuator, myoelectric and neuroelectric sensors, power sources, motors, and a variety of mechanis
facilitate the normal function of otherwise disabled lower limbs. Neuro-myoelectric powered lower-lim
used to make gait possible.

Powered functional total lower-limb orthoses designed for external modification of the structural and/o
characteristics of the complete lower limb using power sources (usually electric) and powered mechan
the user's switching actions (i.e., autonomous). These devices provide support, supplement, and/or au
functions and/or its structure. These orthoses typically consist of dynamic wearable devices that inclu
actuator, power sources, motors, and a variety of mechanisms appropriate to facilitate the normal fun
disabled one or both lower limbs. Autonomous powered lower-limb orthoses are used to make gait pos

Powered functional total lower-limb orthoses designed for external modification of the structural and/o
characteristics of the complete lower limb using power sources (usually electric) and powered mechan
to the user's switching actions (i.e., autonomous) or to the muscular bioelectric (i.e., myoelectric) and
(i.e., neuroelectric) signals. These devices provide support, supplement, and/or augment the limb func
structure. These orthoses typically consist of dynamic wearable devices that include a computerized c
appropriate software to coordinate the user switching signals with the neuro and myoelectric signals,
myoelectric and neuroelectric sensors, power sources, motors, and a variety of mechanisms appropria
normal function of otherwise disabled one or both lower limbs. Autonomous powered lower-limb ortho
make gait possible.

Functional total lower/upper-limb orthoses using power (usually electric) sources and powered mechan
designed to make possible and/or improve the functional activities (e.g., gaiting) of the lower and upp
support, supplementing, and/or augmenting the limb's functions and/or modifying its structure. These
consist of dynamic wearable devices that include sensors, power sources, motors, and a variety of me
to facilitate the normal function of otherwise partially or totally disabled lower and upper limbs. Dedic
controlled by bioelectric muscular (i.e., myoelectric) and/or central nerve (neuroelectric) signals, and/o
switches (i.e., autonomous) are available. Powered lower/upper-limb orthoses are mainly used to make
grasping and gait possible.

Powered orthoses designed for external modification of the structural and/or functional characteristics
and lower limbs using power sources (usually electric) and powered mechanisms that respond to mus
bioelectric (i.e., myoelectric and neuroelectric respectively) signals. These devices provide support, su
augment the limb functions and/or its structure. These orthoses typically consist of dynamic wearable
computerized control unit with appropriate software to coordinate the neuro and myoelectric signals,
myoelectric and neuroelectric sensors, power sources, motors, and a variety of mechanisms appropria
normal function of otherwise disabled lower and upper limbs. Neuro-myoelectric powered lower/upper
mainly used to make functions such as grasping and gait possible.
Powered orthoses designed for external modification of the structural and/or functional characteristics
and upper limbs using power sources (usually electric) and powered mechanisms that respond to the
actions (i.e., autonomous). These devices provide support, supplement, and/or augment the limb fun
structure. These orthoses typically consist of dynamic wearable devices that include a control unit, an
sources, motors, and a variety of mechanisms appropriate to facilitate the normal function of otherwis
upper limbs. Autonomous powered lower-/upper-limb orthoses are mainly used to make functions such
possible.

Powered functional total lower-limb orthoses designed for external modification of the structural and/o
characteristics of the complete lower and upper limbs using power sources (usually electric) and powe
may respond to the user's switching actions (i.e., autonomous) or to the muscular bioelectric (i.e., my
neurologic bioelectric (i.e., neuroelectric) signals. These devices provide support, supplement, and/or
functions and/or its structure. These orthoses typically consist of dynamic wearable devices that inclu
control unit with appropriate software to coordinate the user switching signals with the neuro and myo
actuator; myoelectric and neuroelectric sensors; power sources; motors; and a variety of mechanisms
facilitate the normal function of otherwise disabled upper limbs. Autonomous/neuro-myoelectric powe
orthoses are mainly used to make functions such as grasping and gait possible.

Dispensers designed to store and deliver one or more small protective garments (e.g., gloves, masks,
These devices typically consist of several enclosed compartments that permit the delivery of one or m
same and/or different type (e.g., gloves, masks). Protection garment dispensers are used mainly in ho
examination, treatment, and operating rooms; clinical laboratories) and in other healthcare facilities s
and nursing homes. They are intended mainly to provide garments for hygienic purposes and/or perso
dispensers are usually available for mounting on a table or on the wall. Dedicated dispensers intended
of garment (e.g., gloves) are also available; some dispensers permit delivery of garments while isolati
garments.

Dispensers designed to hold open containers of garments of several types (e.g., gloves, masks, bootie
quick and easy access. These devices typically consist of several compartments (e.g., plastic holders)
delivery of one or more garments of the same and/or different type. Protection garment dispensers ar
hospital areas (e.g., examination, treatment, and operating rooms; clinical laboratories) and in other h
such as doctors' offices and nursing homes. Multiple protection garment dispensers are intended main
for hygienic purposes and/or personal protection. The dispensers are usually available for mounting on
Dedicated dispensers intended for a particular type of garment (e.g., gloves) are also available; some
delivery of garments while isolating the remaining garments.
Multiple garment dispensers designed to store and deliver a controlled number of small protective gar
masks, booties, hairnets), isolating the remaining garments. These devices typically consist of several
compartments that permit the delivery of one or more garments of the same and/or different type (e.g
an external mechanism that does not permit the user to touch the remaining garments. Isolated multi
dispensers are used mainly in hospital areas (e.g., examination, treatment, and operating rooms; clini
other healthcare facilities such as doctors' offices and nursing homes; they are intended mainly to pro
hygienic purposes and/or personal protection, keeping the remaining garments in clean and/or sterile
delivery multiple garment dispensers are usually available for mounting on a table or on the wall; ded
delivery dispensers intended for a particular type of garment (e.g., gloves) are also available.

Protection garment dispensers designed to hold open containers of gloves, facilitating quick and easy
typically consist of one or more compartments (e.g., wire and/or plastic holders) that permit the delive
gloves of the same and/or different type (e.g., examination, surgical, hypoallergenic). Glove dispenser
hospital areas (e.g., examination, treatment, and operating rooms; clinical laboratories) and/or are loc
facility; they are also used in other healthcare facilities such as doctors' offices and nursing homes. Th
intended mainly to provide gloves for hygienic purposes and/or personal protection. They are usually
on a table or on the wall; portable units are also available. Some dispensers permit the controlled deli
isolating the remaining gloves.

Garment dispensers designed to store and deliver a controlled number of gloves, isolating the remain
devices typically consist of one or more enclosed compartments (e.g., plastic holders) that permit the
more gloves of the same and/or different type (e.g., standard, hypoallergenic, nitrile), using an extern
does not permit the user to touch the remaining gloves. Controlled delivery glove dispensers are used
areas (e.g., examination, treatment, and operating rooms; clinical laboratories) and/or are located thro
they are also used in other healthcare facilities such as doctors' offices and nursing homes. They are i
provide gloves for hygienic purposes and/or personal protection, keeping the remaining gloves in clea
condition. The dispensers are usually available for mounting on a table or on the wall; portable units a

Racks designed for the temporary storage of devices and/or other products during a sterilization proce
usually consist of a heavy-duty metal structure (typically stainless steel) with several shelves that is c
high temperature and humidity and/or the chemical parameters that characterize many sterilization p
unit racks are used to hold the devices undergoing sterilization (e.g., surgical instruments) in appropri
are usually attached inside the unit during sterilizing processes performed in a healthcare facility.

Baskets designed for the temporary storage of devices and/or other products during a sterilization pro
usually consist of a heavy-duty, interwoven, metal (typically stainless steel) structure, open at the top
withstanding high temperature and humidity and/or chemical parameters that characterize many ster
Sterilizing unit baskets are used to hold the items undergoing sterilization (e.g., surgical instruments)
conditions; they are usually attached to pull-out trays of units used in sterilizing processes performed
While most of these baskets are designed to contain generic devices, some are custom made for spec
hold them in optimal positions to protect the instruments and facilitate sterilization.
Plethysmographs designed for non-invasive measuring and recording data and graphics (i.e., a plethy
volume and variations in volume of the limbs due to the presence and flow of blood in the peripheral v
limbs (arms, legs, or both) based on the measurement of the volume waveform and amplitude using p
technique is also known as segmental plethysmography, pulse volume recording (PVR) plethysmograp
plethysmography. These devices typically consist of a unit that measures, records, and displays the re
graphic format). They also include compression cuffs, sensors (e.g., pressure, volume), transducers, a
The sensors are applied to several points (e.g., thigh, calf, arm, wrist) to measure pressure changes in
wrapped around the limb, these changes reflect changes in the cuff volume, which is a direct reflectio
limb volume. Lower/upper limb segmental plethysmographs are used to assess peripheral circulation
diagnosing diseases/disorders related to venous blood flow (e.g., peripheral vascular disease, thrombo
Lower/upper limb segmental plethysmographs that include detectors and/or flowmeters using ultrason
techniques are also available; they include ultrasound transducers attached to the main unit. The Dop
an adjunct to plethysmography to monitor changes within the extremities.

Devices designed to assess the performance of oxygen concentrators. Oxygen concentrators produce
mixture by drawing in available room air and extracting the nitrogen from it. These testers measure,
may also record, a set of the concentrator output characteristics (e.g., the oxygen percentage of deliv
pressure [typically in kPa or psi], and the output flow rate in liter/min). Most testers are microprocesso
display. Oxygen concentrator testers are intended to check the status of single-patient devices that a
long-term oxygen therapy to patients at home and in healthcare facilities (e.g., nursing homes).

Electronic storage data recorders designed to measure and record long-term (typically 24 hours) urod
ambulatory patients. These recorders typically include a portable (i.e., wearable) recorder to store dat
determine sphincter electromyography (EMG), and an appropriate urinary catheter to obtain data, inc
urethra pressure, urinary flow, and volume of micturition. Dedicated software for downloading the resu
computer (e.g., personal computer) is necessary for some recorders. Urodynamic electronic storage re
evaluate lower urinary tract functioning, including analysis of obstructions, bladder contractility, and i
recorders may be used as a component of a urodynamic measuring system.

Video systems designed to transmit images and sound from the operating field. These systems are m
headband or helmet that is used to hold the surgeon's headlight. They typically consist of standard o
cameras and are coupled to video signal processors and high-definition video recorders, monitors, and
camera video systems permit the simultaneous observation of the operatory field by several surgeons
the transmission of images to remote locations (e.g., for educational purposes); and a video record of
available are dedicated video systems that include a camera that is mounted coaxial to the light align
designed to eliminate the loose alignment (i.e., parallax) that can occur when the line of sight is not fu
Devices designed to provide visual stimuli to patients. These stimulators are used for patient relaxati
therapeutic treatments. They typically consist of light-emitting or glowing devices that deliver variabl
stimuli using a variety of different sources and configurations. Types of light-emitting stimulators may
glow when illuminated with black light and show images (e.g., stars, planets); cylindrical tubes filled w
patients to track motion; and devices that show images that are constantly changing (e.g., an aquariu
Relaxation/therapeutic visual stimulators are intended to help users (i.e., disabled children, patients w
learn how to improve their interactions with the environment. These stimulators are also used to prov
to depressed patients.

Laboratory stirrers designed to stir liquids by immersing a rotating gear inside the container of liquid t
stirrers typically consist of a tabletop electromechanical device with a small unit that is mounted at th
on a base; the unit also includes a motor with an attached stirring shaft that is immersed in the liquid
and/or time controls. Some stirrers include a plate on which the container of liquid is placed. Motorized
used in clinical laboratories to stir solutions of any volume; dedicated motorized stirrers are particular
medium- and/or high-viscosity liquids. Some stirrers are intended for handheld use, and others may b
the post or as handheld devices.

Magnetic bars designed to stir solutions by spinning in synchrony with an external magnetic field usua
electronic unit located below the solution container. These devices typically consist of small (from a fe
several centimeters) bars made of ferromagnetic materials with a variety of cross-sections (e.g., octag
covered with a chemically inert material (e.g., Teflon, glass). Magnetic stirring bars are part of magnet
clinical laboratories to stir low- or medium-volume solutions.

Computer-aided detection systems that analyze digital information (typically digital images) from pros
slides to detect abnormalities. They may either digitize the original information or use information pro
systems. These systems typically consist of a digitizer or a means to import digital information, a com
appropriate algorithms, and a display and/or printer to show the detected abnormalities in prostate tis
may include capabilities of archiving and/or communication of view and annotated digital images of p
slides. Prostate tissue computer-aided detection systems are used for prostate cancer screening and i
molecular markers and clinical patient data to aid in the prediction of prostate cancer recurrence.

Reagents available as home test kits that permit the rapid collection of sample (i.e., specimen) of who
usually include the necessary devices and materials to obtain a whole blood sample (e.g., lancets, blo
alcohol towelettes, gauze pads, bandage); the kit usually includes a unique personal identification cod
sampling instructions and information appropriate to the intended test to be performed. Whole blood
use permit patients to collect specimens in the privacy of their home; the samples are intended for an
qualified laboratory for primary detection of microorganisms (e.g., HIV, hepatitis C virus), which are no
or convenient for home assessment.
Equipment designed to make temporary pores in cell plasma membranes by applying an appropriate
hundred volts) external voltage (i.e., electric potential) that is higher than the dielectric strength of th
extracellular compounds foreign genes (e.g., plasmids - extra-chromosomal self-replicating structures
protein material to penetrate into the cell while the membrane is porous. Laboratory electroporators t
generator that delivers electric current to electrodes placed inside cuvettes and a solution containing
cells). Plasmids are introduced into the cuvette, and the electric voltage is applied to the electrodes. A
electroporation procedure, the cells are incubated to produce new cells, which include the reproduced
electroporators for laboratory transfection of DNA into mammalian cells and/or the transformation of c
and other devices intended for in vivo introduction of genes into cells (e.g., through the skin) during g
tumor treatment are also available.

Microbiology reagents intended to identify antimicrobial-resistant strains of Staphylococcus aureus, a


bacterium of the family Micrococcaceae. These bacteria are an etiologic agent of suppurative infection
immunodepressed patients, neonates, and the elderly, through damaged skin or in viral infections of t

Computer-aided detection systems designed for automated in-vitro detection, identification, and pre-c
cells in peripheral blood and/or other body fluid samples placed on slides (i.e., smears). The system m
original information from the slide or use information provided by other digital systems. These system
location and identification of red blood cells (RBC) and white blood cells (WBC) and they pre-classify R
morphology and WBCs according to their different types. They also provide an overview image of the
areas of interest in the slides for pathology review. These systems usually include an optical scanning
feeder, microscope, and camera), a computerized unit with appropriate software, a display, and record
digital images; they may include communication capabilities. Blood cell classification systems are inte
uniform processing of hematology smears and/or blood cells in other body fluids (e.g., cerebrospinal fl
technicians.

Ambulatory electrocardiographs designed for recording the variations of the electric potential caused
activity of the heart muscle only for a pre-established, relatively short period of time (typically less tha
record again on the same memory erasing the previous information (i.e., loop recording). The recorde
information continuously, thus detecting and recording arrhythmia episodes lasting several minutes; t
may be increased a few minutes after patient activation. ECG loop-recorders may be used externally o
the skin; external units can usually provide signal outputs appropriate to send to the physician's office
telephone lines. The recorders are mainly used in patients who have syncope or presyncope events an
arrhythmia. Loop-recording ECGs are not intended for a real-time assessment of the electrocardiogram
conditions.
Ambulatory electrocardiographs designed for external recording of the variations of the electric poten
electrical activity of the heart muscle only for a pre-established, relatively short period of time (typica
and then record again on the same memory erasing the previous information. (i.e., loop recording). Th
consist of an electronic storage device attached to the patient (e.g., on a belt) and two or more electro
chest and connected to the recorder. The recorder measures and stores information continuously, thus
recording arrhythmia episodes lasting several minutes; the recording period may be increased a few m
activation. The information can be transferred to a patient-operated device that allows the telemetric
stored data to the physician's office, usually through standard telephone lines. A programmer-tester d
the recorders at the time of setup and to save or retrieve the recorder information later is also availab
mainly used in patients who have syncope or presyncope events and/or cardiac arrhythmia. Loop reco
intended for a real-time assessment of the electrocardiogram or other cardiac conditions.

Metal structures (frames) with a mechanically adjustable height platform at the top designed to hold a
the appropriate position during blood drawing (i.e., phlebotomy) procedures. These stands typically co
frame that include a straight column or tubular structure with a metal or plastic platform at the top to
appropriate position. These units also have a heavy base, typically mounted on casters with wheel lo
The stand also includes a mechanism that permits manual adjustment of the height of the upper platf
blood drawing stands are used by phlebotomists to facilitate blood drawing, either as isolated devices
a blood drawing station.

Adsorbers designed for use during extracorporeal procedures, including extracorporeal blood circulatio
lipopolysaccharides (LPS). These adsorbers typically consist of adsorbents made from polyethylene di
polypeptide that binds LPS, reducing its level (i.e., when blood flow is passed through the adsorbing d
LPS adsorbers are intended mainly to reduce gram-negative bacteria endotoxins (typically lipopolysac
(i.e., to treat or avoid endotoxemia) and/or from an external body area in septic patients; the adsorber
association with the performance of surgery (e.g., cardiac) and/or other procedures (e.g., continuous r
therapy, liver support therapy).

Molecular assay reagents intended to identify stable and usually irreversible modifications (anomalies
message (i.e., gene mutations) that may cause disorders in humans; genetic mutations many be de n
(familial), frequently in X-linked, autosomal dominant, or autosomal recessive form. Most mutations ar
rearrangements or small changes in the number or type of bases (e.g., trinucleotide repeats). Genetic
common in many hereditary disorders (e.g., cerebellar ataxia, retinitis pigmentosa); they are also asso
types of nonhereditary diseases (e.g., lymphomas, leukemia, carcinomas).

Molecular assay reagents intended to identify mutations in the ATP-binding cassette, subfamily A (ABC
(ABCA4) gene, located at chromosome 1p22.1-p21, which encodes for a membrane-associated protein
binding cassette (ABC) transporter. ABC proteins transport various molecules across extra- and intrace
Mutations at this locus have been identified in patients with retinitis pigmentosa type 19 (RP19), Starg
age-related macular degeneration.

Molecular assay reagents intended to identify mutations in the ATP-binding cassette, subfamily C, mem
located at chromosome 11p15.1. Autosomal recessive mutations have been identified in patients with
severe familial hyperinsulinism (FHI). Mutation of ABCC8 is associated with deficiencies in insulin secre
Molecular assay reagents intended to identify mutations in the ATP-binding cassette, subfamily D, me
located at chromosome Xq28. X-linked recessive inherited genetic mutations have been identified in m
adrenoleukodystrophy, an early-onset (childhood to young adult) continuum spectrum of diseases affe
system white matter and the adrenal cortex. Three main diseases have been characterized in males: a
four to eight years of age is typical) "cerebral" form; a second form (adrenomyeloneuropathy [AMN]) w
third decade of age; and a third form (Addison's disease) with variable (frequently in childhood) onset
AMN. Carrier females may develop milder late-onset neurological manifestations resembling AMN.

Molecular assay reagents intended to identify mutations in the acyl-Coenzyme A dehydrogenase, C-4
(ACADM) gene, located at chromosome 1p31. Mutations at this locus have been identified in most pat
chain acyl-Coenzyme A dehydrogenase (MCAD) deficiency.
Molecular assay reagents intended to identify mutations in the acetyl-Coenzyme A acetyltransferase 1
Coenzyme A thiolase) (ACAT1) gene, located at chromosome 11q22.3-q23.1, which encodes for a mito
is specific for processing isoleucine and ketones. Mutations at this locus have been identified in patien
deficiency (3ktd) also known as alpha-methylacetoacetic aciduria and with beta-ketothiolase deficienc

Molecular assay reagents intended to identify mutations in the actin, alpha 1, skeletal muscle (ACTA1)
chromosome 1q42.13-q42.2, which encodes for skeletal muscle actin, a component of muscle tissue a
of the contractile apparatus. Mutations at this locus have been identified in patients with nemaline my
congenital myopathy, and various cardiomyopathies; a genetic interaction between ACTA1 mutations
mutations is also associated with deafness.

Molecular assay reagents intended to identify mutations in the activin A receptor type II-like 1 (ACVRL
chromosome 12q11-q14, which encodes for activin receptor-like kinase-1, a protein found on cell surfa
receptor serine/threonine kinase. These receptors bind transforming growth factor beta (TGF-beta) an
Mutations at this locus have been identified in patients with hereditary hemorrhagic telangiectasia typ
known as Osler-Rendu-Weber syndrome (ORW2).

Molecular assay reagents intended to identify mutations in the alanine-glyoxylate aminotransferase (A


chromosome 2q36-q37, which encodes for a liver enzyme called alanine-glyoxylate aminotransferase
peroxisomes. Mutations at this locus have been identified in most patients with primary hyperoxaluria
onset disease with recurrent nephrolithiasis, nephrocalcinosis, and renal calculi.

Molecular assay reagents intended to identify mutations in the aryl hydrocarbon receptor interacting p
gene, located at chromosome 17p13.1, which appears to be involved in protein trafficking and or prot
stabilization. Mutations at this locus have been identified in patients with Leber's congenital amaurosi
disease, and also in a pigmentary retinopathy similar to retinitis pigmentosa.

Molecular assay reagents intended to identify mutations in the aldehyde dehydrogenase 5 family, me
semialdehyde dehydrogenase) (ALDH5A1) gene, located at chromosome 6p22.2-p22.3, which is involv
of the neurotransmitter 4-aminobutyric acid (GABA). Mutations at this locus have been identified in m
succinic semialdehyde dehydrogenase (SSADH) deficiency and 4-hydroxybutyric aciduria.
Molecular assay reagents intended to identify mutations in the Alstrom syndrome 1 (ALMS1) gene, loc
2p13, which encodes for a protein of unknown function that has been shown to localize to the centros
bodies of cilia and may play a role in hearing, sight, obesity, and function of the heart, kidney and live
the pancreatic regulation of insulin. Mutations at this locus have been identified in patients with Alstro

Molecular assay reagents intended to identify mutations in the aristaless-like homeobox 4 (ALX4) gen
chromosome 11p11.2, which is believed to be a transcription factor involved in skull and limb develop
locus have been identified in patients with enlarged parietal foramina type 2.

Molecular assay reagents intended to identify mutations in the adenomatous polyposis coli (APC) tum
located at chromosome 5q21, which encodes for a tumor suppressor protein. Mutations at this locus h
patients with familial adenomatous polyposis (FAP); Gardner's syndrome (GS); hereditary desmoid dise
also known as familial infiltrative fibromatosis (FIF); and Turcot's syndrome.

Molecular assay reagents intended to identify mutations in the apolipoprotein E (APOE) gene, located
19q13.2, which encodes for apolipoprotein E, a major component of very-low-density lipoproteins (VLD
excess cholesterol from the blood and transfering it to the liver for processing. Mutations at this locus
patients with cardiovascular disorders and especially with hyperlipoproteinemia type 3 (also known as
dysbetalipoproteinemia) and to late-onset Alzheimer's disease type 3.

Molecular assay reagents intended to identify mutations in the amyloid beta (A4) precursor protein (p
gene, located at chromosome 21q21, which functions as a cell surface receptor and performs physiolo
surface of neurons. Mutations at this locus have been identified in patients with familial (early onset) A
(AD) type 1, Flemish-type AD, and cerebral hemorrhage with amyloidosis (HCHWAD).

Molecular assay reagents intended to identify mutations in the aprataxin (APTX) gene, located at chro
encodes for a member of the histidine triad (HIT) superfamily, whose members have nucleotide-bindin
polyphosphate hydrolase activities. This gene is probably involved in the repair of or response to DNA
Mutations at this locus have been identified in patients with early-onset ataxia with oculomotor apraxi
syndrome and hypoalbuminemia.

Molecular assay reagents intended to identify mutations in the aquaporin 2 (collecting duct) (AQP2) ge
chromosome 12q12-q13, which encodes for a collecting duct water channel protein located in the coll
kidney. Mutations at this locus have been identified in patients with early-onset nephrogenic diabetes

Molecular assay reagents intended to identify mutations in the androgen receptor (dihydrotestosteron
located at chromosome Xq11.21-q12.1, which encodes for a protein that functions as a steroid-hormo
transcription factor. Mutations at this locus have been identified in patients with androgen insensitivity
testicular feminization syndrome), including Reifenstein's syndrome, and X-linked spinal and bulbar m

Molecular assay reagents intended to identify mutations in the arginase, liver (ARG1) gene, located at
which encodes for arginase isoform A1 or liver arginase, the catalytic agent in the last step of the urea
this locus have been identified in patients with arginase deficiency and early-onset hyperargininemia
hyperammoniemia.
Molecular assay reagents intended to identify mutations in the arginase, type II (ARG2) gene, located
14q24.1-q24.3, which may be essential in the regulation of nitric acid synthesis isoform A2 or mitocho
found primarily in the kidney. Mutations at this locus have not been definitively linked to any specific d

Molecular assay reagents intended to identify mutations in the arylsulfatase A (ARSA) gene, located a
22q13.33, which encodes for the enzyme lysosomal arylsulfatase A that hydrolyzes ester bonds in cer
Mutations at this locus have been identified in patients with metachromatic leukodystrophy (MLD) and
deficiency (MSD).
Molecular assay reagents intended to identify mutations in the argininosuccinate lyase (ASL) gene, loc
7cen-q11.2, which encodes for a protein which catalyzes the cleavage of argininosuccinate, which is v
ammonia via the urea cycle. Mutations at this locus have been identified in patients with early-onset a
aciduria, also known as argininosuccinate lyase (ASL) deficiency.
Molecular assay reagents intended to identify mutations in the aspartoacylase (aminoacylase 2) (ASPA
chromosome 17p13.3, which encodes for an enzyme that breaks down N-acetyl-L-aspartic acid (NAA)
acetic acid. NAA is critical for maintaining the white matter of the brain and may also play a role in tra
molecules out of nerve cells. Mutations at this locus have been identified in most patients with a type
known as Canavan's disease (CD). The disease is also known as Canavan-van-Bogaert Bertrand diseas

Molecular assay reagents intended to identify mutations in the argininosuccinate synthetase 1 (ASS1)
chromosome 9q34, which encodes for the enzyme argininosuccinate that is responsible for the third s
The urea cycle transforms excess nitrogen into urea, which is excreted. Mutations at this locus have b
patients with early- and late-onset citrullinemia type I (CTLN1).

Molecular assay reagents intended to identify mutations in the ataxia telangiectasia mutated (ATM) ge
chromosome 11q22-q23, which encodes for a member of the protein PI3/PI4-kinase family that functio
wide variety of downstream proteins. This protein functions as a signal transducer and cell cycle contr
DNA repair. Mutations at this locus have been identified in patients with ataxia telangiectasia (Louis-B
called Boder-Sedgwick syndrome) and cancers of the blood-forming tissue (leukemia) and of immune
(lymphoma).

Molecular assay reagents intended to identify mutations in the copper-transporting, alpha polypeptide
at chromosome Xq13.2-q13.3, which encodes for a protein that regulates copper levels in the body. M
have been identified in male patients with Menke's syndrome.
Molecular assay reagents intended to identify mutations in the copper-transporting, beta polypeptide
at chromosome 13q14.3, which encodes for a protein that transports copper out of cells. Mutations at
identified in patients with Wilson's disease.
Molecular assay reagents intended to identify mutations in the alpha thalassemia/mental retardation s
(ATRX) gene, located at chromosome Xq13, which takes part in the global transcriptional regulation fu
expression by affecting chromatin, and may be involved in brain development and face morphogenes
locus have been identified in most patients with X-linked alpha-thalassemia, repining syndrome 1 (ren
syndrome (CWS), and alpha-thalassemia myelodysplasia syndrome (ATMDS).

Molecular assay reagents intended to identify mutations in the arginine vasopressin receptor 2 (nephr
insipidus) (AVPR2) gene, located at chromosome Xq28, which encodes for vasopressor receptor type 2
locus have been identified in male patients with early-onset nephrogenic diabetes insipidus (AVRP2).
Molecular assay reagents intended to identify mutations in the Bardet-Biedl syndrome (BBS1) gene, lo
11q13, which encodes for a protein that may be involved in eye, limb, cardiac, and reproductive syste
Mutations at this locus have been identified in patients with Bardet-Biedl syndrome type 1 (BBSI), a he
linked to various other loci.
Molecular assay reagents intended to identify mutations in the branched-chain keto-acid dehydrogena
polypeptide (BCKDHA) gene, located at chromosome 19q13.1-q13.2, which encodes for the E1-alpha s
branched-chain alpha-keto acid (BCAA) dehydrogenase complex. This enzyme is responsible for one s
of three amino acids: leucine, isoleucine, and valine; the breakdown products of these amino acids are
Mutations at this locus have been identified in patients with early-onset maple syrup urine disease (M

Computed tomography scanning systems capable of delivering and detecting a cone-shaped x-ray be
typically consist of: 1) an x-ray subsystem that utilizes a beam which radiates from the x-ray source in
cone beam) which encompasses a large volume with a single rotation about the patient thus applying
of radiation; 2) a flat 2-D planar detector rather than a curve-shaped detector; 3) image display monit
unit; and 4) a computerized subsystem for image processing that is capable of producing high-resolut
D) images reconstructed using dedicated software (algorithms). Cone-beam scanning systems are typ
conventional fan-beam systems; they are frequently intended for use with the patient in a sitting posi
systems intended for imaging of the head, neck, and teeth are available. Dedicated systems may be a
clinical applications such as angiographic studies and to obtain breast images in gynecologic departm

Cone-beam computed tomography (CT) scanning systems designed for neck and/or head imaging, inc
applications. These systems typically consist of: 1) an x-ray subsystem that utilizes a cone beam (i.e.,
from the x-ray source in a cone shape) which encompasses a large volume with a single rotation abou
and/or neck thus applying a relatively low dose of radiation; 2) a flat 2-D planar detector rather than a
detector; 3) image display monitors; 4) a data storage unit; and 5) a computerized subsystem for ima
capable of producing high-resolution tri-dimensional (3-D) images reconstructed using dedicated softw
Head/neck CT scanning systems are typically used with the patient sitting on a dedicated chair which
(e.g., chin supports) to restraint head movements. Some systems combine conventional panoramic de
same unit. The systems are used to obtain images for maxillo-facial, oral, and head surgery; they are
office procedures (e.g., prior to dental implants and/or oral surgery) to permit simultaneous scanning
mandible.

Molecular assay reagents intended to identify mutations in the branched-chain keto-acid dehydrogena
polypeptide (BCKDHB) gene, located at chromosome 6q13-q15, which encodes for the E1-beta subuni
alpha-keto acid (BCAA) dehydrogenase complex. This enzyme is responsible for one step in the breakd
acids: leucine, isoleucine, and valine; the breakdown products of these amino acids are used for energ
locus have been identified in patients with early-onset maple syrup urine disease (MSUD).

Molecular assay reagents intended to identify mutations in the B-cell CLL/lymphoma 2 (BCL2) gene, lo
18q2, which encodes for an outer mitochondrial membrane protein that suppresses apoptotic cell dea
(rearrangements) involving the BCL2 gene are indicators of follicular lymphoma type II, chronic lymph
B-cell lymphoma.
Molecular assay reagents intended to identify mutations in the B-cell/lymphoma 6 (BCL6) gene, locate
3q27, which functions as a transcription regulator involved in lymphogenesis. Genetic mutations (rear
the BCL6 gene are indicators of B-cell chronic lymphocytic leukemia (B-CLL), B-cell leukemia, CLL/lymp
Hodgkin's lymphoma.
Molecular assay reagents intended to identify mutations in the BCL6 corepressor (BCOR) gene, located
Xp11.4, which functions as a corepressor of B-cell chronic lymphocytic leukemia (B-CLL)/lymphoma 6
mutations in BCOR are associated with B-CLL, microphthalmia, and oculofaciocardiodental (OFCD) syn
Lenz syndrome.
Molecular assay reagents intended to identify mutations in the Bloom syndrome RecQ helicase-like (B
chromosome 15q26.1, which encodes for a protein involved in DNA strand separation and replication.
have been identified in patients with Bloom syndrome, a cancer-prone anomaly.

Molecular assay reagents intended to identify mutations in the bone morphogenetic protein receptor,
gene, located at chromosome 10q22.3, which functions as a receptor protein in cellular processes me
Mutations at this locus have been identified in patients with early-onset juvenile polyposis syndrome,
this gene in juvenile polyposis is not clear.
Molecular assay reagents intended to identify mutations in the breast cancer 1 (BRCA1) gene, located
17q21; these mutations facilitate cellular response to DNA repair. BRCA1 functions with BRCA2 in the r
DNA. Mutations at this locus have been identified in patients with familial breast cancer and genetic s
breast and/or breast-ovarian cancer.
Molecular assay reagents intended to identify mutations in the breast cancer 2 (BRCA2) gene, located
13q12.3; these mutations facilitate cellular response to DNA repair. BRCA1 functions with BRCA2 in the
DNA. Mutations at this locus have been identified in patients with increased risk of breast cancer, Fanc
ovarian, prostate, and pancreatic cancer.
Molecular assay reagents intended to identify mutations in the Berardinelli-Seip congenital lipodystrop
gene, located at chromosome 11q13, which encodes for the protein sepin, found in the endoplasmic r
function is not well known. Mutations at this locus have been identified in most patients with early-ons
congenital lipodystrophy type 2, Charcot-Marie-tooth syndrome type 2, distal hereditary motor neurop
Silver's syndrome (also known as spastic paraplegia 17).

Molecular assay reagents intended to identify mutations in the biotinidase (BTD) gene, located at chro
encodes for the enzyme biotinase that facilitates the use and regulation of B vitamin (biotin). Mutation
been identified in patients with biotinidase deficiency (also called late-onset multiple carboxylase defi

Molecular assay reagents intended to identify mutations in the Bruton agammaglobulinemia tyrosine
located at chromosome Xq22.1-q22.2, which is crucial in B-cell differentiation and activation. Mutation
been identified in patients with agammaglobulinemia type 1 (XLA).
Molecular assay reagents intended to identify mutations in the calcium channel, voltage-dependent, P
subunit (CACNA1A) gene, located at chromosome 19p13.2-13.1, which encodes for the alpha-1A subu
channels, with predominant expression in neuronal tissue. Mutations at this locus have been identified
several diseases with clinical overlaps, including spinocerebellar ataxia type 6, familial hemiplegic 1 (M
ataxia type 2 (EA-2), also known as acetazolamide-responsive hereditary paroxysmal cerebellar ataxia
Molecular assay reagents intended to identify mutations in the calcium channel, voltage-dependent, L
(CACNA1S), located at chromosome 1q32, which encodes for the alpha-1S subunit of L-type calcium c
involved in excitation-contraction coupling in skeletal muscle. Mutations at this locus have been ident
with hyperkalemic periodic paralysis (HKPP) and malignant hyperthermia susceptibility 5 (MHS5).

Molecular assay reagents intended to identify mutations in the calpain 3 (CAPN3) gene, located at chr
q21.1, which encodes for a muscle-specific calpain, a calcium-activated, neutral proteinase. Mutations
been identified in patients with limb-girdle muscular dystrophy type 2A (calpainopathy).

Molecular assay reagents intended to identify mutations in the cystathionine-beta-synthase (CBS) gen
chromosome 21q22.3, which encodes for a protein involved in the transsulfuration pathway. Mutations
been identified in patients with homocystinuria.
Molecular assay reagents intended to identify mutations in the cyclin D1 (CCND1) gene, located at ch
which is essential for control of the cell cycle at the G1/S (start) transition. Genetic rearrangements or
increase the expression of this gene have been identified in patients with B-cell lymphocytic malignan
mantle cell lymphoma (MCL) and parathyroid adenomatosis type 1 (PRAD1).

Molecular assay reagents intended to identify mutations in the chemokine (C-C motif) receptor 5 (CCR
chromosome 3p21, which encodes for a member of the beta-chemokine receptor family, which is expr
macrophages. Mutations in this gene are associated with HIV infection resistance.

Molecular assay reagents intended to identify mutations in the cadherin 1, type 1, E-cadherin (epithel
located at chromosome 16q22.1, which encodes for a calcium-dependent cell-cell adhesion glycoprote
locus have been identified in patients with early-onset gastric, breast, colorectal, thyroid, and ovarian

Molecular assay reagents intended to identify mutations in the cyclin-dependent kinase inhibitor 1C (C
at chromosome 11p15.5, which encodes for a protein that is a negative regulator of cell proliferation a
maintenance of the nonproliferative state throughout life. Mutations at this locus have been identified
Beckwith-Wiedemann syndrome (BWS), Wilms' tumor, adrenocortical carcinoma, and rhabdomyosarco

Molecular assay reagents intended to identify mutations in the cystic fibrosis transmembrane conduct
gene, located at chromosome 7q31.2, which encodes for the cystic fibrosis transmembrane conductan
This protein functions as a channel across the membrane of cells that produce mucus, sweat, saliva, t
enzymes. Transport of chloride ions helps control the movement of water in tissues and maintains the
other secretions. Mutations at this locus have been identified in patients with cystic fibrosis and conge
of the vas deferens.

Molecular assay reagents intended to identify mutations in the choroideremia (CHM) gene, located at
which encodes for the Rab escort protein-1 (REP1) that is involved in membrane trafficking. Mutations
been identified in most patients with choroideremia (X-linked blindness) and other hereditary eye dise
Molecular assay reagents intended to identify mutations in the cholinergic receptor, nicotinic, alpha po
gene, located at chromosome 20q13.2-q13.3, which encodes for a subunit of a receptor that mediates
transmission at synapses. Mutations at this locus have been identified in many patients with autosom
frontal lobe epilepsy (ADNFLE) and other forms of epilepsy.

Molecular assay reagents intended to identify mutations in the cholinergic receptor, nicotinic, beta po
(CHRNB2) gene, located at chromosome 1q21.3, which encodes for a subunit of a receptor that media
transmission at synapses. Mutations at this locus have been identified in many patients with autosom
frontal lobe epilepsy type 3 (ADNFLE type 3) and other forms of epilepsy.

Molecular assay reagents intended to identify mutations in the Cockayne syndrome 1 (CKN1) gene, lo
5q12.1, which is involved in transcription-coupled DNA repair. Mutations at this locus have been ident
early onset of classical Cockayne's syndrome symptoms, including retinitis pigmentosa.

Molecular assay reagents intended to identify mutations in the cerebellar ataxia 2 (X-linked) (CLA2) ge
chromosome Xp11.21-q21.3, which encodes for a little-understood protein. Mutations at this locus hav
patients with cerebellar ataxia type 2 (also called spinocerebellar ataxia).
Molecular assay reagents intended to identify mutations in the ceroid-lipofuscinosis, neuronal 1(CLN1)
chromosome 1p32, which encodes for nonspecific lysosomal peptidase that generates tripeptides. Mu
have been identified in patients with neuronal ceroid-lipofuscinoses (NCL) diseases.

Molecular assay reagents intended to identify mutations in the ceroid-lipofuscinosis, neuronal 2 (CLN2
chromosome 11p15, which encodes for nonspecific lysosomal peptidase that generates tripeptides. M
have been identified in patients with infantile late-onset neuronal ceroid-lipofuscinoses (NCL) type 2.

Molecular assay reagents intended to identify mutations in the ceroid-lipofuscinosis, neuronal 3 (CLN3
chromosome 16p12.1, which encodes for a polypeptide that may function as a chaperone involved in
assembly/disassembly of other proteins, specifically subunit C of the ATP synthase complex. Mutations
been identified in patients with Batten disease and infantile early-onset neuronal ceroid-lipofuscinoses

Molecular assay reagents intended to identify mutations in the ceroid-lipofuscinosis neuronal 5 (CLN5)
chromosome 13q21.1-q32, whose function is uncertain but has been associated with a putative lysoso
protein. Mutations at this locus have been identified in patients with neuronal ceroid-lipofuscinoses (N

Molecular assay reagents intended to identify mutations in the ceroid-lipofuscinosis neuronal 6, late in
gene, located at chromosome 15q23, whose function is not well known. Mutations at this locus have b
patients with a variant of infantile late-onset neuronal ceroid-lipofuscinoses (NCL) type 6.

Molecular assay reagents intended to identify mutations in the ceroid-lipofuscinosis neuronal 8 (epilip
mental retardation) (CLN8) gene, located at chromosome 8p23, which encodes for a transmission prot
in the endoplasmic reticulum. Mutations at this locus have been identified in patients with neuronal ce
(NCL) type 8, associated with progressive epilepsy with mental retardation.
Molecular assay reagents intended to identify mutations in Charcot-Marie-Tooth neuropathy 1B (CMT1
the myelin protein zero gene [MPZ]), located at chromosome 1q22, which encodes for myelin protein
protein of peripheral myelin. Mutations at this locus have been identified in patients with various form
sensory neuropathy (HMSN1-3), such as Charcot-Marie-Tooth disease.

Molecular assay reagents intended to identify mutations in the cyclic nucleotide gated channel alpha
located at chromosome 2q11, which encodes for a protein essential to visual and olfactory signal tran
essential to the generation of light-evoked electrical potential responses in the red-, green-, and blue-
Mutations at this locus have been identified in patients with achromatopsia (total color blindness).

Molecular assay reagents intended to identify mutations in the cyclic nucleotide gated channel beta 1
at chromosome 16q13, which encodes for cyclic guanine nucleotide-gated channel (cGMP) rod photor
role in photoreceptor cell generation. Mutations at this locus have been identified in patients with retin

Molecular assay reagents intended to identify mutations in the cyclic nucleotide gated channel beta 3
at chromosome 8q21-q22, which encodes for a protein that produces a beta subunit essential to the g
evoked electrical potential response in red-, green-, and blue-sensitive cones. Mutations at this locus h
patients with achromatopsia 3 (Pingelapese achromatopsia), which is distinct from total color blindnes
concurrent myopia.

Molecular assay reagents intended to identify mutations in the coagulation factor C homologue (COCH
chromosome 14q12-q13, which encodes for a protein called cochlin that is involved in the structure of
Mutations at this locus have been identified in patients with autosomal dominant nonsyndromic senso
(DFNA9); the exact effects of COCH mutations are unclear.
Molecular assay reagents intended to identify mutations in the collagen type XI, alpha1 (COL11A1) ge
chromosome 1p21, which encodes for the pro alpha 1 polypeptide chain of collagen XI that adds struc
the connective tissues that support the body's muscles, organs, and skin. Mutations at this locus have
patients with early-onset Stickler syndrome type II and Marshall syndrome.

Molecular assay reagents intended to identify mutations in the collagen, type XI, alpha 2 (COL11A2) g
chromosome 6p21.3, which encodes for the pro-alpha 2 polypeptide chain of collagen XI that adds str
the connective tissues that support the body's muscles, organs, and skin. Mutations at this locus have
patients with Stickler syndrome type III, autosomal dominant nonsyndromic deafness, otospondylome
(OSMED), and Weissenbacher-Zweymulller syndrome.

Molecular assay reagents intended to identify mutations in the collagen, type I, alpha 1 (COL1A1) gen
chromosome 17q21.3-q22.1, which provides instructions to make type I collagen, pro-alpha 1 (I) chain
locus have been identified in patients with diseases that include osteogenesis imperfecta (types I to IV
syndrome.
Molecular assay reagents intended to identify mutations in the collagen, type XI, alpha 2 (COL11A2) g
chromosome 6p21.3, which encodes for the pro-alpha 2 polypeptide chain of collagen XI that adds str
the connective tissues that support the body's muscles, organs, and skin. Mutations at this locus have
patients with Stickler syndrome type III, autosomal dominant nonsyndromic deafness, otospondylome
(OSMED), and Weissenbacher-Zweymulller syndrome.
Molecular assay reagents intended to identify mutations in the collagen, type 2, alpha 1 (COL2A1) gen
chromosome 12q13.11-q13.2, which provides instructions to make collagen type II alpha 1 chain foun
vitreous humor. Mutations at this locus have been identified in patients with of diseases that include o
imperfecta (types I to IV) and Ehlers-Danos syndrome.
Molecular assay reagents intended to identify mutations in the collagen, type III, alpha 1 (COL3A1) ge
chromosome 2q31, which encodes for type III fibrillar collagen, found in the connective tissue of the lu
system. Mutations at this locus have been identified in most patients with Ehlers-Danlos syndrome typ
type).
Molecular assay reagents intended to identify mutations in the collagen, type IV, alpha 3 (COL4A3) ge
chromosome 2q36-q37, which encodes for a component of type IV collagen and makes the alpha III (4
collagen that composes a large portion of the basement membranes of the kidney, eye, cochlea, brain
at this locus have been identified in patients with diseases that include Alport's syndrome, basement
nephropathy, and Goodpasture's syndrome.

Molecular assay reagents intended to identify mutations in the collagen, type IV, alpha 4 (COL4A4) ge
chromosome 2q35-37, which encodes for alpha 4 (IV) chain of type IV collagen. Mutations at this locus
in patients with diseases that include Alport's syndrome and basement membrane nephropathy.

Molecular assay reagents intended to identify mutations in the collagen, type IV, alpha 5 (COL4A5) ge
chromosome Xq22, which encodes for the alpha 5 (IV) chain of type IV collagen that makes up a large
membranes. Mutations at this locus have been identified in patients with diseases that include Alport'
hereditary nephritis.
Molecular assay reagents intended to identify mutations in the collagen, type V, alpha 1 (COL5A1) gen
chromosome 9q34.2-q34.3, which encodes for the alpha 1 (V) chain of collagen type V (pro alpha 1 [V
this locus have been identified in patients with diseases that include Ehlers-Danlos syndrome types I a

Molecular assay reagents intended to identify mutations in the collagen, type IX, alpha 2 (COL9A1) ge
chromosome 6q12-q14, which encodes for one of three chains of type IX collagen, the structural comp
cartilage and vitreous of the eye. Mutations at this locus have been identified in patients with multiple

Molecular assay reagents intended to identify mutations in the collagen, type IX, alpha 2 (COL9A2) ge
chromosome 1p33-p32, which encodes for collagen type IX alpha 2, the major collagen component of
Mutations at this locus have been identified in patients with multiple epiphyseal dysplasia type II.

Molecular assay reagents intended to identify mutations in the collagen, type IX, alpha 3 (COL9A3) ge
chromosome 20q13.3, which encodes for the alpha 3 subunit of collagen type IX, a major subunit of h
Mutations at this locus have been identified in patients with multiple epiphyseal dysplasia type III.

Molecular assay reagents intended to identify mutations in the cartilage oligomeric matrix protein (CO
chromosome 19p13.1, which encodes for an noncollagenous extracellular matrix (ECM) protein. Mutat
been identified in patients with childhood early-onset multiple epiphyseal dysplasia (MED) and have a
with pseudoachondroplasia (PSACH).
Molecular assay reagents intended to identify mutations in the ceruloplasmin (ferroxidase) (CP) gene,
chromosome 3q23-q25, which encodes for the protein ceruloplasmin (a plasma metalloprotein) respon
copper in plasma. Mutations at this locus have been identified in patients with aceruloplasminemia an
Molecular assay reagents intended to identify mutations in the carbamoyl-phosphate synthetase 1, m
gene, located at chromosome 2q35, which encodes for carbamoyl-phosphate synthetase 1, a rate-lim
hepatic urea cycle that plays a role in removing ammonia from the cell. Mutations at this locus have b
patients with infantile early-onset carbamoyl-phosphate synthetase I (CPS1) deficiency.

Molecular assay reagents intended to identify mutations in the carnitine palmitoyltransferase II (CPT2)
chromosome 1p32, which encodes for carnitine palmitoyltransferase II that participates in transportin
into the mitochondria. Mutations at this locus have been identified in patients with carnitine palmitoyl
deficiency.
Molecular assay reagents intended to identify mutations in the crumbs homologue 1 (CRB1) gene, loc
1q31-q32.1, which encodes for a protein that is involved in photoreceptor morphogenesis in the retina
locus have been identified in patients with infantile early-onset Leber's congenital amaurosis, retinitis
pigmented paravenous chorioretinal atrophy.
Molecular assay reagents intended to identify mutations in the CREB binding protein (CREBBP) gene, l
16p13.3, which encodes for CBP, a transcriptional coactivator involved in embryogenesis, cell differen
proliferation. Mutations at this locus have been identified in patients with Rubinstein-Taybi syndrome.

Molecular assay reagents intended to identify mutations in the cone-rod homeobox (CRX) gene, locate
19q13.3, which encodes for a protein that is a photoreceptor-specific transcription factor involved in th
photoreceptor cells. Mutations at this locus have been identified in patients with Leber's congenital am
dystrophy 2 (CORD2).
Molecular assay reagents intended to identify mutations in the catenin (cadherin-associated protein),
(CTNNB1) gene, located at chromosome 3p21, which encodes for an adherens junction protein critical
and maintenance of epithelial layers and for signal transduction. Mutations at this locus have been ide
several types of adenomatous and carcinomatous lesions, including colorectal cancer, hepatoblastom

Molecular assay reagents intended to identify mutations in the cystinosis, nephropathic (CTNS) gene,
17p13, which encodes for the protein cystinosin that transports cystine out of the lysosomes. Mutation
been identified in patients with several types of cystinosis, including nephropathic cystinosis (CTNS).

Molecular assay reagents intended to identify mutations in the cytochrome P450, family 1, subfamily
(CYP1B1) gene, located at chromosome 2p21, which provides instructions for producing a form of cyto
Mutations at this locus have been identified in patients with early-onset primary congenital glaucoma

Molecular assay reagents intended to identify mutations in the cytochrome P450, family 21, subfamily
(CYP21A2) gene, located at chromosome 6p21.3, which encodes for the manufacture of an enzyme st
that belongs to the cytochrome P450 family of enzymes. P450 cytochrome is involved in the processin
and synthesizing of cholesterol, steroid hormones, and lipids. Mutations at this locus have been identi
several types of congenital adrenal hyperplasia (CAH), including salt wasting (SW) and simple virilizing
Molecular assay reagents intended to identify mutations in cytochrome P450, family 2, subfamily D, p
gene, located at chromosome 22q13.1, which is responsible for the metabolism of many drugs and en
that it oxidizes. The gene is involved in the metabolism of drugs such as antiarrhythmics, adrenorecep
tricyclic antidepressants. Mutations at this locus have been identified in patients with poor metabolism
Parkinson's disease, ankylosing spondylitis, and leukemia.

Molecular assay reagents intended to identify mutations in the dihydrolipoamide branched chain trans
gene, located at chromosome 1p31, which encodes for a protein that catalyzes the conversion of alph
coenzyme A (acyl-CoA) and carbon dioxide. Mutations at this locus have been identified in infants with
syrup urine disease (MSUD) type II.
Molecular assay reagents intended to identify mutations in the DiGeorge syndrome critical region gen
located at chromosome 22q11, which putatively encodes for an adhesion receptor protein that may pl
crest cell migration. This adhesion cell receptor could be involved in cell-cell or cell-matrix interactions
cell differentiation and migration. Mutations at this locus have been identified in patients with a diseas
cardiac abnormality, T-cell defect, clefting, and hypocalcaemia (CATCH 22); DiGeorge syndrome; cono
syndrome; and Shprintzen's syndrome (also known as velocardiofacial syndrome).

Molecular assay reagents intended to identify mutations in the 7-dehydrocholesterol reductase (DHCR
chromosome 11q13.2-q13.5, which encodes for the enzyme 7-dehyrocholesterol reductase, responsib
cholesterol production in many types of cells. Mutations at this locus have been identified in infants w
congenital Smith-Lemli-Opitz syndrome.
Molecular assay reagents intended to identify mutations in the dystrophin (muscular dystrophy, Duche
(DMD) gene, located at chromosome Xp21.2, which encodes for the protein dystrophin, part of a prote
strengthens muscle fibers and protects them from injury as the muscle contracts and relaxes. Mutatio
been identified in patients with several types of skeletal muscle dysfunctions; the two main types are
dystrophy (DMD) and a somewhat milder disease known as Becker muscular dystrophy (BMD).

Molecular assay reagents intended to identify mutations in the dystrophia myotonica-protein kinase (D
chromosome 19q13.3, which encodes for the protein myotonic dystrophy protein kinase whose exact
Mutations at this locus have been identified in patients with myotonic dystrophy type 1 (DM1) and mu

Molecular assay reagents intended to identify mutations in the dysferlin (DYSF) gene, located at chrom
which encodes for a skeletal muscle protein belonging to the ferlin family that is associated with sarco
with muscle contraction. Mutations at this locus have been identified in patients with early-onset dysf
deficiency dystrophy) and limb-girdle muscular dystrophy type 2B (LGMD2B).

Molecular assay reagents intended to identify mutations in the endothelial cell growth factor 1 (platele
gene, located at chromosome 22q13, which plays a role in maintaining blood vessel integrity and prom
endothelial cells. Mutations at this locus have been identified in most patients with mitochondrial neu
encephalopathy (MNGIE).
Molecular assay reagents intended to identify mutations in the ectodysplasin A (EDA) gene, located at
q13.1, which is involved in epidermal-mesenchymal signaling during morphogenesis of ectodermic org
locus have been identified in most children with early-onset X-linked hypohidrotic ectodermic dysplasi
Molecular assay reagents intended to identify mutations in the ectodysplasin A receptor (EDAR) gene,
chromosome 2q11-q13, which encodes for a protein that acts as a receptor for EDA isoform A1. This in
responsible for critical chemical signaling pathways controlling interactions between the ectoderm and
embryos. Other reports suggest a role in caspase-independent cell death. Mutations at this locus have
children with early-onset hypohidrotic ectodermic dysplasia (HED).

Molecular assay reagents intended to identify mutations in the epidermal growth factor receptor (EGF
chromosome 7p12.3-p12.1. Mutations at this locus have been identified in most patients with non-sm
adenocarcinoma of the lung and may be associated with other carcinomas (e.g., glioblastoma).

Molecular assay reagents intended to identify mutations in the early growth response 2 (EGR2) gene,
chromosome 10q21.1-q22.1, which encodes for a member of the early growth response family of prot
activates genes involved in the formation and maintenance of myelin. Mutations at this locus have be
patients with recessive congenital hypomyelination neuropathy (CHN), also known as Charcot-Marie-To
(CMT4E) and type ID (Dejerine-Sottas syndrome).

Molecular assay reagents intended to identify mutations in the eukaryotic translation initiation factor 2
26kDa (EIF2B1) gene, located at chromosome 12q24.2-q24.31, that catalyzes the exchange of eukary
bound guanosine diphosphate (GDP) for guanosine triphosphate (GTP). Mutations at this locus have be
patients with leukoencephalopathy with vanishing white matter (VWM).

Molecular assay reagents intended to identify mutations in the eukaryotic translation initiation factor 2
39kDa (EIF2B2) gene, located at chromosome 14q24.3, which catalyzes the exchange of eukaryotic in
guanosine diphosphate (GDP) for guanosine triphosphate (GTP). Mutations at this locus have been ide
leukoencephalopathy and ovarioleukodystrophy (vanishing white matter leukodystrophy with ovarian

Molecular assay reagents intended to identify mutations in the eukaryotic translation initiation factor 2
58kDa (EIF2B3) gene, located at chromosome 1p34.1, that catalyzes the exchange of eukaryotic initia
guanosine diphosphate (GDP) for guanosine triphosphate (GTP). Mutations at this locus have been ide
leukoencephalopathy with vanishing white matter (VWM).

Molecular assay reagents intended to identify mutations in the eukaryotic translation initiation factor 2
67kDa (EIF2B4) gene, located at chromosome 2p23.3, that catalyzes the exchange of eukaryotic initia
guanosine diphosphate (GDP) for guanosine triphosphate (GTP). Mutations at this locus have been ide
leukoencephalopathy and ovario-leukodystrophy (vanishing white matter leukodystrophy with ovarian

Molecular assay reagents intended to identify mutations in the eukaryotic translation initiation factor 2
82kDa (EIF2B5) gene, located at chromosome 3q27, which encodes for a subunit of EIF2B. EIF2B cata
eukaryotic initiation factor 2-bound guanosine diphosphate (GDP) for guanosine triphosphate (GTP). M
have been identified in patients with leukoencephalopathy and ovarioleukodystrophy (vanishing white
leukodystrophy with ovarian failure) and Cree leukoencephalopathy.

Molecular assay reagents intended to identify mutations in the elastase 2, neutrophil (ELA2) gene, loc
19p13.3, which is involved in the destruction of tissue at the sites of inflammation and is a target for p
alpha-1-antitrypsin. Mutations at this locus have been identified in most patients with cyclic hematopo
neutropenia (ELA2-related neutropenia).
Molecular assay reagents intended to identify mutations in the elastin (ELN) gene, located at chromos
encodes for the protein elastin, a major component of elastic fibers that provide strength and flexibilit
Mutations at this locus have been identified in patients with supravalvular aortic stenosis and Williams

Molecular assay reagents intended to identify mutations in the emerin (EMD) gene, located at chromo
mediates membrane anchorage to the cytoskeleton. Mutations at this locus have been identified in al
X-linked Emery-Dreifuss muscular dystrophy (EDMD).
Molecular assay reagents intended to identify mutations in the endoglin (ENG) gene, located at chrom
encodes for the protein endolase found on the surface of cells, especially in the lining of newly formed
is involved in the specialization of new blood vessels into arteries or veins. Mutations at this locus hav
patients with hereditary hemorrhagic telangiectasia type 1 (HHT1).

Molecular assay reagents intended to identify mutations in the excision repair cross-complementing ro
complementation group 6 (ERCC6) gene, located at chromosome 10q11, which is involved in two cell
damaged DNA and assisting with transcription. Mutations at this locus have been identified in patients
syndrome type 2 (also known as cerebro-oculo-facio-skeletal syndrome (COFS) and xeroderma pigmen

Molecular assay reagents intended to identify mutations in the essential tremor 1 (ETM1) gene, locate
3q13. Mutations at this locus have been identified in patients with essential tremor type 1.
Molecular assay reagents intended to identify mutations in the essential tremor 2 (ETM2) gene, locate
2p25-p22. Mutations at this locus have been identified in patients with essential tremor type 2.
Molecular assay reagents intended to identify mutations in the exostoses (multiple) 1 (EXT1) gene, loc
8q24.11-q24.13, which may act as a tumor suppressor. Mutations at this locus have been identified in
exostoses type 1, alpha Langer-Giedion syndrome, and chondrosarcoma.
Molecular assay reagents intended to identify mutations in the exostoses (multiple) 2 (EXT2) gene, loc
11p12-p11, which may act as a tumor suppressor. Mutations at this locus have been identified in patie
exostoses type 2 and Potocki-Shaffer syndrome.
Molecular assay reagents intended to identify mutations in the eyes absent homolog 1 (EYA1) gene, lo
8q13.3, which is thought to play a role in organogenesis through its intrinsic protein phosphatase activ
locus have been identified in patients with branchio-oto-renal (BOR) syndrome, also known as Melnick

Molecular assay reagents intended to identify mutations in the coagulation factor II (thrombin) (F2) ge
chromosome 11p11-q12, which encodes for the protein thrombin that converts fibrinogen to fibrin. Mu
have been identified in patients with dysprothrombinemia and as a risk factor for cerebrovascular isch
vein thrombosis, and idiopathic portal vein thrombosis.
Molecular assay reagents intended to identify genetic mutations in the proaccelerin, labile factor (F5)
chromosome 1q23, which encodes for coagulation factor V. Mutations at this locus have been identifie
factor V Leiden thrombophilia.
Molecular assay reagents intended to identify mutations in serum prothrombin conversion accelerator
chromosome 13q34, which encodes for coagulation factor VII. Mutations at this locus have been ident
hereditary factor VII deficiency (hypoproconvertinemia).
Molecular assay reagents intended to identify mutations in the procoagulant component VIII (F8) gene
chromosome Xq28, which encodes for deficiency in coagulation factor VIII gene. Mutations at this locu
in patients with hemophilia A, also known as classic hemophilia.
Molecular assay reagents intended to identify mutations in the plasma thromboplastic component (F9
chromosome Xq27.1-q27.2, which encodes for a deficiency in coagulation factor IX gene. Mutations at
identified in patients with hemophilia B, also known as Christmas disease.
Molecular assay reagents intended to identify mutations in the Fanconi anemia complementation grou
located at chromosome 16q24.3, which encodes for a protein that functions in the Fanconi anemia cor
interstrand DNA cross-link repair, and in the maintenance of normal chromosome stability. Mutations a
identified in patients with Fanconi anemia (FA).
Molecular assay reagents intended to identify mutations in the Fanconi anemia, complementation gro
located at chromosome 9q22.3, which encodes for a protein involved in delaying the onset of apoptos
homologous recombination repair of damaged DNA. Mutations at this locus have been identified in pa
anemia (FA).
Molecular assay reagents intended to identify mutations in the Fanconi anemia, complementation gro
located at chromosome 11p15, which encodes for a DNA repair protein that may operate in a postrepl
cycle checkpoint function and may also be implicated in interstrand DNA cross-link repair and in the m
chromosome stability. Mutations at this locus have been identified in patients with Fanconi anemia (FA

Molecular assay reagents intended to identify mutations in the Fanconi anemia, complementation gro
located at chromosome 9p13, which encodes for a DNA repair protein that may operate in a postreplic
cycle checkpoint function and may also be implicated in interstrand DNA cross-link repair and in the m
chromosome stability. The gene may be also a candidate for a tumor suppressor gene. Mutations at th
identified in patients with Fanconi anemia (FA).

Molecular assay reagents intended to identify mutations in the fibrillin 1 (FBN1) gene, located at chrom
which encodes for fibrillin, a structural component of 10-12 mm extracellular calcium-binding microfib
micro bundles that are involved in the maintenance of elastic fibers and in anchoring epithelial cells to
Mutations at this locus have been identified in patients with Marfan syndrome and Shprintzen-Goldber

Molecular assay reagents intended to identify mutations in the Fukuyama-type congenital muscular dy
(FCMD) gene, located at chromosome 9q31-9q33, which encodes for fukutin, a secretory protein expre
extracellular matrix that interacts with muscle membranes and could be involved with brain developm
locus have been identified in patients with Fukuyama-type congenital muscular dystrophy (FCMD); the
with Walker-Warburg syndrome.

Molecular assay reagents intended to identify mutations in the fibroblast growth factor receptor 1 (FG
chromosome 8p11.2-p11.1, which encodes for a basic fibroblast growth factor receptor. Mutations at t
identified in patients with hereditary defects in the normal ossification of fetal cranial cartilages (crani
are associated with the three types of Pfeiffer's syndromes (i.e., variants 1, 2, and 3); they are also the
syndrome 2 (KAL2) and may be associated with Jackson-Weiss syndrome.

Molecular assay reagents intended to identify mutations in the fibroblast growth factor receptor 2 (FG
chromosome 10q26, which encodes for acidic and basic fibroblast growth factor receptors. Mutations a
identified in patients with hereditary defects in the normal ossification of fetal cranial cartilages (crani
including several different but related diseases such as Apert's syndrome, Beare-Stevenson cutis gyra
syndrome, Pfeiffer's syndrome (variants 1, 2, and 3), and Jackson-Weiss syndrome.
Molecular assay reagents intended to identify mutations in the fibroblast growth factor receptor 3 (FG
chromosome 4p16.3, that encodes for acidic and basic fibroblast growth factor receptors. Mutations a
identified in patients with hereditary defects in the normal ossification of fetal cranial cartilages (crani
including patients with Crouzon syndrome with acanthosis nigrican and Muenke syndrome. Mutations
also disorders such as achondroplasia, hypochondroplasia, and neonatal thanatophoric dwarfism.

Molecular assay reagents intended to identify mutations in the fukutin-related protein (FKRP) gene, lo
19q13.3, which possibly encodes for a transferase involved in the modification of glycan moieties of a
(DAG-1). Mutations at this locus have been identified in patients with early-onset (neonatal) congenita
type 1C (MDC1C) and type 21 (LDMG21).
Molecular assay reagents intended to identify mutations in the filamin A, alpha (actin binding protein
located at chromosome Xq28, which functions by promoting branching of actin filaments and links act
membrane glycoproteins. Mutations at this locus have been identified in male patients with periventri
are also associated with otopalatodigital syndrome type I and Type II and periventricular nodular heter

Molecular assay reagents intended to identify mutations in the forkhead box L2 (FOXL2) gene, located
a probable transcription regulator. Mutations at this locus have been identified in patients with classic
syndrome (BPES); they are also associated with infertility caused by premature ovarian failure (POF).

Molecular assay reagents intended to identify mutations in the Freidreich's ataxia (FRDA) gene, locate
9q13-q21.1, which encodes for a mitochondrial protein that belongs to the fraxin family. The protein re
iron transport and respiration. Mutations at this locus have been identified in some patients with Fried
Babinski's reflex; these mutations are also associated with cardiomyopathy and diabetes mellitus.

Molecular assay reagents intended to identify mutations in the glucose-6-phosphate dehydrogenase (


chromosome Xq28, which encodes for the glucose-6-phosphate dehydrogenase enzyme. Mutations at
identified in patients with congenital hemolytic anemia caused by G6PD deficiency.

Molecular assay reagents intended to identify mutations in the galactosylceramidase (GALC) gene, loc
14q31, which encodes for the enzyme galactosylceramidase. Mutations at this locus have been identi
Krabbe disease, characterized by low activity of the galactocerebrosidase (GALC) enzyme.

Molecular assay reagents intended to identify mutations in the galactose-1-phosphate uridylyltransfer


located at chromosome 9p13, which encodes for the manufacture of the galactose-1-phosphate uridyl
that converts modified sugar galactose-1-phosphate to an active form that can be further used by the
locus have been identified in patients with galactosemia.
Molecular assay reagents intended to identify mutations in the glucocerebrosidase (GBA) gene, (also k
beta, acid gene), located at chromosome 1q21, which encodes for beta-glucocerebrosidase, an enzym
lysosomes. Mutations at this locus have been identified in patients with galactosemia and Gaucher-lik
mutations may be also linked to Parkinson's or Parkinson's-like disorders.

Molecular assay reagents intended to identify mutations in the glutaryl-coenzyme A dehydrogenase (G


chromosome 19p13.2, which provides instructions for the protein glutaryl-CoA dehydrogenase, formed
Mutations at this locus have been identified in patients with early-onset neonatal glutaricaciduria type
Molecular assay reagents intended to identify mutations in the guanosine triphosphate cyclohydrolase
located at chromosome 14q22.1-q22.2, which encodes for the enzyme guanosine triphosphate (GTP) c
important in the manufacture of tetrahydrobiopterin (BH4). BH4 is essential for the normal function of
Mutations at this locus have been identified in more than half of patients with early childhood onset o
dystonia type 5 (DYT5).

Molecular assay reagents intended to identify mutations in the glucokinase (hexokinase 4) (GCK) gene
chromosome 7p15.3-p15.1, which catalyzes the first step in glucose utilization by the beta cells and li
glucose concentrations; the specific role of GCK is to provide glucose-6-phosphate for the synthesis of
this locus have been identified in patients with early-onset (neonatal) mild familial hyperinsulinism (FH
associated with adult-onset diabetes type II.

Molecular assay reagents intended to identify mutations in the ganglioside-induced differentiation-ass


(GDAP1) gene, located at chromosome 8q13.3-q21.1, which encodes for the production of a gangliosid
differentiation-associated protein 1. This protein is made in several different types of cells throughout
in cells of the nervous system. Mutations at this locus have been identified in patients with Charcot-M
types 4A (CMT4A) and 2K.

Molecular assay reagents intended to identify mutations in the glial fibrillary acidic protein (GFAP) gen
chromosome 17q21, which encodes for one of the major intermediate filament proteins of mature astr
this locus have been identified in patients with both early-onset neonatal and infant forms of Alexande

Molecular assay reagents intended to identify mutations in the gap junction protein, beta 1, 32kDa (co
gene, located at chromosome Xq13.1, which encodes for the gap junction protein, beta 1 (also known
plays a role in cell communication. Mutations at this locus have been identified in 90% of patients with
dominant Charcot-Marie-Tooth neuropathy type 1.
Molecular assay reagents intended to identify mutations in the gap junction protein, beta 2 (26kDa co
gene, located at chromosome 13q11-q12, which encodes for a gap juniction pprotein, beta 2 (connexi
called gap junctions between neighboring cells. Mutations at this locus have been identified in patient
nonsyndromic hearing loss and deafness type 3 (NSHLD3); they are also associated with Vohwinkel's s
palmoplantar keratoderma with deafness; Bart-Pumphrey syndrome, and keratitis-ichthyosis-deafness

Molecular assay reagents intended to identify mutations in the gap junction protein, beta 6 (connexin
chromosome 13q12, which encodes for the protein connexin 30 that forms channels called gap junctio
neighboring cells. Mutations at this locus have been identified in patients with both neurosensory non
and deafness type 3 (NSHLD3); they are also present in patients with hydrotic ectodermal dysplasia (C
HED2).

Molecular assay reagents intended to identify mutations in the GLI-Kruppel family member 3 (GLI3) ge
chromosome 7p13, which is involved in the normal shaping of many tissues and organs during embry
protein made by this gene helps control gene expression. Mutations at this locus have been identified
cephalopolysyndactyly syndrome; they are also present in patients with Pallister-Hall syndrome (PHS).

Molecular assay reagents intended to identify mutations in the galactosidase, alpha (GLA) gene, locat
Xq22, which encodes for the enzyme alpha-galactosidase active in lysosomes. Mutations at this locus
male patients with diffuse angiokeratoderma (Fabry's disease), caused by alpha-galactosidase A defic
Molecular assay reagents intended to identify mutations in the glutamate dehydrogenase 1 (GLUD1) g
chromosome 10q23.3, which regulates the elevation of glutamate dehydrogenase activity and may in
stimulated insulin secretion. Mutations at this locus have been identified in patients with early-onset i
hyperinsulinism-hyperammonemia syndrome.
Molecular assay reagents intended to identify mutations in the glucosamine (UDP-N-acetyl)-2-epimera
acetylmannosamine kinase (GNE) gene, located at chromosome 9p13.3, which encodes for the bifunc
acetyl glucosamine 2 epimerase. The enzyme regulates and initiates biosynthesis of N-acetylneurami
precursor of sialic acids. Mutations at this locus have been identified in most adult patients with inclus
type 2 (IBM2), Nonaka myopathy (NM), and early-infant-onset sialuria.

Molecular assay reagents intended to identify mutations in the glypican 3 (GPC3) gene, located at chr
which may be involved in the suppression or modulation of growth in tissue and organs of mesoderma
regulate growth and tumor predisposition. Mutations at this locus have been identified in patients with
schisis syndrome, also known as Simpson-Golabi-Behmel syndrome type 1.

Molecular assay reagents intended to identify mutations in the G protein-coupled receptor 56 (GPR56)
chromosome 16q12.2-q21, which encodes for a protein involved in cell-to-cell interactions. Mutations
identified in patients with bilateral frontoparietal polymicrogyria (BFPP) but not in patients with other f
bilateral generalized, bilateral perisylvian) of polymicrogyria.

Molecular assay reagents intended to identify mutations in the guanylate cyclase 2D, membrane (reti
gene, located at chromosome 17p13.1, which encodes for a protein that may function in the rods and
photoreceptors. Mutations at this locus have been identified in patients with early-infant-onset Leber's
and cone-rod dystrophy.
Molecular assay reagents intended to identify mutations in the H19 gene (imprinted maternally expre
mRNA), located at chromosome 11p15.5, which putatively functions as a tumor suppressor. Mutations
been identified in patients with Beckwith-Wiedemann syndrome (BWS); they are also associated with S
syndrome.
Molecular assay reagents intended to identify mutations in the hydroxyacyl-Coenzyme A dehydrogena
Coenzyme A thiolase/enoyl-Coenzyme A hydratase (trifunctional protein), alpha subunit (HADHA) gen
chromosome 2p23, which encodes for part of an enzyme complex called the mitochondrial trifunction
the alpha subunit. Mutations at this locus have been identified in patients with long-chain 3-hydroxyac
deficiency (trifunctional protein deficiency, type 1); they are also present in patients with acute fatty l
with a disease characterized by simultaneous hemolysis, elevated liver enzyme levels, and a low num
syndrome).

Molecular assay reagents intended to identify mutations in the hydroxyacyl-Coenzyme A dehydrogena


Coenzyme A thiolase/enoyl-Coenzyme A hydratase (trifunctional protein), beta subunit (HADHB) gene
chromosome 2p23, which produces beta subunit of mitochondrial trifunctional protein. Mutations at th
identified in patients with long-chain hydroxyacyl-CoA dehydrogenase deficiency (trifunctional protein
they are also present in patients with acute fatty liver of pregnancy and with a disease characterized b
hemolysis, elevated liver enzyme levels, and a low number of platelets (HELLP syndrome).
Molecular assay reagents intended to identify mutations in the hepcidin antimicrobial peptide (HAMP)
chromosome 19q13.1, which is involved in the production of hepcidin protein. Hepcidin protein plays a
iron balance in the body. Mutations at this locus have been identified in patients with early-onset adul
hemochromatosis.
Molecular assay reagents intended to identify mutations in the hemoglobin, alpha 1 (HBA1) gene, loca
16p13.3, which is involved in the transport of oxygen from the lung to the peripheral tissues. Mutation
been identified in patients with methemoglobinemia, hemoglobinopathy H (alpha) types, erythrema a
alpha, and Heinz body anemia alpha.
Molecular assay reagents intended to identify mutations in the hemoglobin, beta (HBB) gene, located
11p15.5, which encodes for beta chain of hemoglobin. Mutations at this locus have been identified in
of symptomatic disorders characterized by the presence of hemoglobin S (Hb S), especially sickle cell
are also associated with sickle-hemoglobin C disease (Hb SC) and with two types of sickle beta-thalass

Molecular assay reagents intended to identify mutations in the hexosaminidase A (alpha polypeptide)
at chromosome 15q23-q24, which encodes for a subunit of the enzyme beta hexose aminidase A in ly
lysosome, beta aminidase A forms part of a complex that breaks down fatty acids. Mutations at this lo
identified in patients with hexosaminidase A (HEXA) deficiency in three variants: acute infantile (Tay-S
(subacute), and adult onset/chronic; mutations are also present in several forms of GM2 gangliosidosis

Molecular assay reagents intended to identify mutations in the hemochromatosis (HFE) gene, located
6p21.3, which encodes instructions for producing a protein located on the cell surface that helps to re
metabolism. Mutations at this locus have been identified in patients with late adult onset of hereditary
X-linked sideroblastic anemia; they are also associated with severe variants of porphyria variegate and
tarda.

Molecular assay reagents intended to identify mutations in the hemojuvelin (HJV) gene, located at chr
encodes instructions for producing a hemojuvelin protein that helps to regulate iron metabolism. Muta
been identified in most adult patients with early-onset juvenile hemochromatosis.

Molecular assay reagents intended to identify mutations in the 3-hydroxymethyl-3-methylglutaryl-Coe


(hydroxymethylglutaricaciduria) (HMGCL) gene, located at chromosome 1p36.1-p35, which produces a
mitochondria that is involved in breaking down dietary fat and proteins. Mutations at this locus have b
patients with early-onset infantile hydroxymethylglutaric aciduria coenzyme A (HMG-CoA) lyase defici
syndrome.

Molecular assay reagents intended to identify mutations in the hypoxanthine-guanine phosphoribosylt


gene, located at chromosome Xq26.1, which encodes for the HPRT1 enzyme that allows recycling of p
RNA and DNA. Mutations at this locus have been identified in patients with early infant onset of Lesch
gout, and acute renal failure.
Molecular assay reagents intended to identify mutations in the Hermansky-Pudlak syndrome 1 (HPS1)
chromosome 10q23.1-q23.3, which encodes for a transmembrane protein that is a component of mult
organelles and may be involved in intracellular protein sorting. Mutations at this locus have been iden
Hermansky-Pudlak syndrome type 1.
Molecular assay reagents intended to identify mutations in the Hermansky-Pudlak syndrome 3 (HPS3)
chromosome 3q24, which is involved in early stages of melanosome biogenesis and maturation. Muta
been identified in patients with Hermansky-Pudlak syndrome type 3.
Molecular assay reagents intended to identify mutations in the Harvey rat sarcoma viral oncogene hom
located at chromosome 11p15.5, an oncogene that encodes for a protein involved in cell division. Mut
have been identified in patients with solid tumor cancers, including bladder cancer, invasive breast ca
differentiated liposarcoma; they are also associated with Costello syndrome.

Molecular assay reagents intended to identify mutations in the heat shock 27kDa protein 1 (HSPB1) ge
chromosome 7q11.23, which encodes for a heat-shock protein beta 1 or protein 27. Mutations at this l
identified in patients with early-onset Charcot-Marie-Tooth neuropathy type 2F (CMT2F) and distal here
neuropathy.
Molecular assay reagents intended to identify mutations in the hyaluronoglucosaminidase 1 (HYAL1) g
chromosome 3p21.3-p21.2, which may have a role in tumor progression. Mutations at this locus have
patients with mucopolysaccharidosis type IX (also called hyaluronidase deficiency).
Molecular assay reagents intended to identify mutations in the iduronidase, alpha-L- (IDUA) gene, loca
4p16.3, which is involved in the hydrolysis of unsulfated alpha-L-iduronosidic linkages in dermatan sul
gene is involved in breakdown of muccopolysaccarides. Mutations at this locus have been identified in
mucopolysaccharidosis type I (MPS1); patients may be classified according to the severity of the disea
or severe (known as Scheie's, Hurler-Scheie, and Hurler's syndromes, respectively).

Molecular assay reagents intended to identify mutations in the inhibitor of kappa light polypeptide gen
kinase complex-associated protein (IKBKAP) gene, located at chromosome 9q31, which provides instru
protein found in variety of cells. The gene function is not fully known; it is probably involved in transcr
this locus have been identified in patients with early-onset familial dysautonomia (hereditary sensory
neuropathy type III, HSAN-III).

Molecular assay reagents intended to identify mutations in the inhibitor of kappa light polypeptide gen
kinase gamma (IKbKG) gene, located at chromosome Xq28, which encodes for a protein involved in re
factor kappa B, which controls the activity of other genes. Mutations at this locus have been identified
incontinentia pigmenti (IP); mutations are also present in males with a type of hypohidrotic ectoderma

Molecular assay reagents intended to identify mutations in the ankyrin repeat containing (KRIT1) gene
chromosome 7q21-q22, which encodes for a protein that is involved in the formation of blood vessels
development. Mutations at this locus have been identified in many patients with cerebral cavernous m
also known as familial cavernous angioma.
Controllers designed to regulate the operation of a specialty bed/mattress system in order to provide a
function/therapy. Bed/mattress system controllers can be an integral part of the specialty bed/mattres
stand-alone devices that are used in conjunction with the specialty bed/mattress systems, or as modu
inserted into a dedicated location within the specialty bed frame, and then used to expand the existin
specialty bed/mattress system and regulate that functions' operation. Specialty bed/mattress system
in conjunction with a specialty bed and/or correlating mattress system allow users to configure and de
therapy via the bed and/or mattress surface, such as continual lateral rotation therapy or percussion/v
provide a low air-loss surface.
Controllers designed to facilitate the delivery of percussion/vibration therapy in specialty beds and ass
systems to mobilize respiratory secretions in the patient's lungs so that they can be cleared more eas
controllers for specialty beds/mattress systems allow users to configure and deliver specific modes of
vibration therapy for predetermined/preset periods of time and at predetermined levels of intensity.

Controllers designed to be programmed to inflate and deflate interconnected synthetic fabric pillows a
provide specialty beds and associated mattress systems with a low-air-loss surface. Typically, inflation
alternate with deflation intervals at a controlled rate. These controllers, when used in conjunction with
mattress surface, allow a specialty bed to convert into a low-air-loss therapy bed. Low-air-loss therapy
used in the care and management of patients who require a mattress surface specifically for facilitatin
pressure ulcers, burns)

Controllers designed to facilitate turning a patient laterally, either intermittently or continuously in spe
associated mattress systems to prevent and/or treat respiratory difficulties, skin complications, and re
critically ill, immobile (e.g., ventilated, sedated) patients. These controllers, when used in conjunction
and mattress surface, allow the specialty bed to be converted into a lateral rotation therapy bed.

Systems designed to infuse medications in the vasculature through dedicated infusion catheters (e.g.
pulmonary). The system includes a pump and a control unit that are frequently mounted on a cart; so
include a radiofrequency generator that delivers ultrasonic energy through appropriate transducers an
catheters. The infusion is performed though infusion catheters according to the vasculature to be infu
pulmonary). Vascular infusion systems are used to administer medications (including thrombolitics).

Tubing made of metal or metal alloys. Metallic tubing is typically a small-diameter, hollow, cylinder de
of materials, either liquids or gases. These devices may be rigid, semirigid, or flexible; they are typica
structures (e.g., reinforced) according to the intended use. Metallic tubing is usually available in stand
a variety of diameters and wall thicknesses (i.e., gauges) that permit the use of segments of different
given application in the healthcare facility.

Tubing made of natural rubber, manufactured either by a dry curing and manufacturing process (i.e., d
by processing (e.g., dipping, extruding) the natural milky fluid (latex) from the tree in its original liquid
latex). Rubber tubing is typically a small-diameter, hollow, flexible cylinder designed for the transfer o
or gases; latex rubber is a product usually supplied as amber or black tubing with greater flexibility an
dry natural rubbers. Rubber/latex tubing is usually available in standardized lengths and in a variety o
thicknesses (i.e., gauges) that permit the use of segments of different sizes appropriate for a given ap
healthcare facility; rubber/ latex rubber tubing is commonly used when highly elastic tubing with long
to glass is needed.

Tubing made of synthetic polymers such as nylon, polyurethane, and silicone. Polymer tubing is typica
designed for the transfer of fluids, either liquids or gases. These devices may be rigid, semirigid, or fle
typically made with different structures (e.g., braided, reinforced) according to the intended use. Synt
usually available in standardized lengths and in a variety of diameters and wall thicknesses (i.e., gaug
of segments of different sizes appropriate for a given application in the healthcare facility.
Synthetic polymer tubing made of polytetrafluoroethylene (Teflon). Polytetrafluoroethylene tubing is ty
diameter, hollow, flexible or semirigid cylinder designed for the transfer of fluids, either liquids or gase
usually available in standardized lengths and in a variety of diameters and wall thicknesses (i.e., gaug
of segments of different sizes appropriate for a given application in the healthcare facility (e.g., clinica
especially for the transfer of organic solvents or liquids when resistance to high pressure, chemicals, a
needed.

Synthetic polymer tubing made of a clear polyvinyl plastic substance modified with plasticizers for flex
tubing is typically a small- or medium-diameter, flexible hollow cylinder designed for the transfer of fl
gases. Tygon tubing is usually available in standardized lengths and in a variety of diameters and wall
gauges) that permit the use of segments of different sizes appropriate for a given application in the he
clinical laboratory), especially when high resistance to chemicals is needed.

Synthetic polymer tubing made of polyurethane, an elastomer also known as polyurethane rubber. Po
typically a small-diameter, hollow, flexible or semirigid cylinder designed for the transfer of fluids, eith
Polyurethane tubing is usually available in standardized lengths and in a variety of diameters and wal
gauges) that permit the use of segments of different sizes appropriate for a given application in the he
including the transfer of liquids between laboratory devices and/or when high resistance to oils and ch

Tubing made of glass. Glass tubing typically consists of small-diameter, hollow, rigid cylinders designe
fluids, either liquids or gases. This tubing is usually available in standardized lengths and in a variety
thicknesses (i.e., gauges) that permit the use of segments of different sizes using appropriate tools; g
mainly in clinical laboratories. A glass tube with a closed bottom is frequently used as a container. Ded
special characteristics (e.g., high-temperature, standard walls, low-expansion) is available; borosilicat
resistance to chemicals is also available.

Glass tubing made of low-alkali-content borosilicate. Borosilicate tubing is typically a small-diameter,


designed for the transfer of fluids, either liquids or gases. This tubing is usually available in standardiz
variety of diameters and wall thicknesses (i.e., gauges) that that permit the use of segments of differe
appropriate tools; borosilicate glass tubing is used mainly in clinical laboratories when a low coefficien
high resistance to chemicals is needed. Dedicated capillary borosilicate tubing is also available.

Standard walkers designed with nonwheeled frameworks that are adjustable in width. These walkers t
metal (some also include hard plastics) structure that frames the front and sides of users at waist leve
supports (i.e., grips) for the hands. The rails that connects the handles and those that connect the two
pipes that telescope, either manually or automatically by pressing a button allowing a width adjustme
15 cm (5 or 6 inches). Standard adjustable-width walkers permit users to customize the walkers for th
and facilitate ambulation through doors and along narrow halls. They are used for permanent assistan
and/or during rehabilitation.
Standard walkers designed with nonwheeled frameworks that can be easily folded. These walkers typ
(some also include hard plastics) structure that may frame the front and sides of users at waist level;
supports (i.e., grips) for the hands. The sides may fold over onto each other or fold in toward the front
automatically by pressing a button) to facilitate manipulation, storage, and transport. Standard folding
permanent assistance of disabled patients and/or during rehabilitation; they also can provide adjustab
bags intended to store and facilitate transportation of folding walkers are also available.

Walkers designed with wheeled frameworks that are adjustable in width. These walkers typically cons
also include hard plastics) structure that frames the front and sides of users at waist level; they usuall
casters (i.e., wheels) and supports (i.e., grips) for the hands. The rails that connect the handles and th
front two wheels are made of pipes that telescope either manually or automatically by pressing a butt
adjustment typically from 12 to 15 cm (5 or 6 inches). Adjustable-width wheeled walkers permit users
walkers for their particular needs and to facilitate ambulation through doors and along narrow halls. T
permanent assistance of disabled (e.g., infirm) patients and/or during rehabilitation.

Wheeled walkers designed with frameworks that can be easily folded. These walkers typically consist
include hard plastics) structure that may frame the front and sides of users at waist level; they usually
grips) for the hands. The sides may bend over onto each other or fold in toward the front part manual
pressing a button. Wheeled folding walkers facilitate their manipulation, storage, and transport; they a
assistance of disabled (e.g., infirm) patients and/or during rehabilitation. Carrying bags intended to sto
transportation of folding walkers are also available.

Walkers designed with wheeled frameworks that provide support for one knee during ambulation. The
consist of a metal (some also include hard plastics) structure that includes a flat support (usually adju
one knee. Wheeled knee-support walkers are used for permanent assistance of disabled patients and/
preventing weight-bearing on the affected ankle or foot by users who have one leg affected distal to t
ankle surgery) during rehabilitation.

Electronic scanners designed for the optical capture and data processing of images and/or text in such
saving the information as digital data in a computer or computerized system. These scanners may con
head (typically including devices such as mirrors, lenses, filters, and CCD arrays) that moves above a
flat-bed scanners) or is fixed while the document moves (i.e., sheet-bed scanners). Handheld, photom
that move on an automated belt (also known as drum scanners) and dedicated scanners intended for
photographic slides (typically 35 mm) are also available. Document scanners are used in healthcare fa
information from printed documents and/or films, both for clinical and administrative purposes.

Document scanners designed to obtain digital information appropriate for direct printing and/or storag
processing in a computer or computerized system from a film or photographic slide (e.g., a 35 mm ne
These scanners typically consist of an electronic unit with dedicated filmstrip and slide holders for film
optical scanning device with focusing capabilities, light sources, and software that may allow image co
enhancement, color reconstruction, grain equalization, and other image quality improvements. Filmstr
intended to obtain digital information that includes text, images, or both for printing, storing, processi
transmission through a hospital information system.
Electronic equipment designed to acquire and process digital data obtained from a separate source (e
system). This equipment consists of a computerized reader, electronic circuits, a display, controls for c
modifying analysis parameters, and dedicated software according to the nature and/or the source of d
may analyze digital data from images but are not intended to process images from an external source
amount of data recorded, scanning techniques are frequently used to decrease review time. Dedicate
available for analysis of previously recorded data taken from devices such as recorders (e.g., tape, dig
(e.g., ultrasonic) systems; the processors are frequently a component of and/or are interconnected to
and/or information systems.

Data processors designed to acquire and process digital data obtained from signals (e.g., electrocardio
electroencephalographic) previously recorded on tape. Data is transferred from the recorder (usually a
recorder) to the processor (also known as a scanner) for quantification, processing, display, and storag
software; the processor may also generate reports. Tape recording processors are used to analyze tap
event data; they are intended mainly for the detection of temporary abnormalities and to check the p
a relatively long period of time (e.g., 48 or 72 hours). Tape recording processors dedicated for electroc
electroencephalographic tapes are also available.

Data processors designed to acquire and process digital data obtained from electrocardiographic signa
on tape. Data is transferred from the ambulatory (i.e., Holter) electrocardiography recorder to the proc
electrocardiogram scanner) for quantification, processing, display, and storage using dedicated softwa
also generate reports. Due to the large amount of data recorded, scanning techniques are used to dec
Electrocardiography processors are used to analyze taped continuous and event data; they are intend
detection of cardiac problems, such as temporary abnormalities, and/or to check progress of therapy (
drugs) over a relatively long period of time (e.g., 48 hours).

Data processors designed to acquire and process digital data obtained from electroencephalographic
recorded on tape. Data is transferred from the electroencephalographic recorder to the processor (also
electroencephalogram scanner) for quantification, processing, display, and storage using dedicated so
may also generate reports. Due to the large amount of data recorded, scanning techniques are used t
time. Electroencephalography processors data are used with taped continuous and event data; they a
the detection of cerebral problems, such as temporary abnormalities (e.g., seizures), and sleep disord
progress of therapy (e.g., antiepileptic drugs) over a relatively long period of time (e.g., 24 to 72 hour

Data processors designed to acquire and process digital data obtained from signals (e.g., electrocardio
electroencephalographic) previously recorded electronically. Data is transferred from the recorder (usu
recorder) to the processor (also known as a scanner) for quantification, processing, display, and storag
software; the processor may also generate reports. Electronic data recording processors are used to a
event tape recorder data; they are intended mainly for detection of temporary abnormalities and to ch
therapy over a relatively long period of time (e.g., 48 or 72 hours). Dedicated electronic recording dat
electrocardiographic, electroencephalographic, activity) are also available.
Data processors designed to acquire and process digital data obtained from electrocardiographic signa
electronically recorded (e.g., using a flash card). Data is transferred from the ambulatory (i.e., Holter)
recorder to the processor (also known as a electrocardiogram scanner) for quantification, processing,
using dedicated software; the processor may also generate reports. Electrocardiography processors ar
continuous and event data; they are intended mainly for the detection of cardiac problems, such as te
abnormalities, and/or to check the progress of therapy (e.g., antiarrhythmic drugs) over a relatively lo
48 hours).

Data processors designed to acquire and process digital data obtained from electroencephalographic
previously electronically recorded (e.g., using a flash card). Data is transferred from the electroenceph
the processor (also known as a electroencephalogram scanner) for quantification, processing, display,
dedicated software; the processor may also generate reports. Due to the large amount of data recorde
techniques are used to decrease review time. Electroencephalography processors are used with electr
event recorders; they are intended mainly for the detection of cerebral problems, such as temporary a
seizures), and sleep disorders) and to check the progress of therapy (e.g., antiepileptic drugs) over a r
time (e.g., 24 to 72 hours).

Collections of 2 or more cross cylinder lenses designed to assess refractive error (cylinder power and a
examinee's responses by using the cylinder lenses with equal powers and opposite signs in the prope
principal meridians). The sets usually contain several cylinder lenses (with optical powers that can be
+0.75D, or +1.0D), the lens rotation mechanism, and the lens mount. Ophthalmic cross-cylinder sets
astigmatism and refine cylinder power and axis for eyeglass fitting.

Ophthalmic devices designed to assess the refractive error (cylinder power and axis) that require an e
by using two cylinder lenses with equal powers and opposite signs in the proper axis positions (two pr
These lenses are available with different optical powers (e.g., +0.25D, +0.50D, +0.75D, +1.0D); they
astigmatism and refine cylinder power and axis for eyeglass fitting.

Ophthalmic refractors designed for automated detection and measuring of the refractive error by mea
the light reflex from the eye to find the best focus on the retina over a variety of meridians. There are
automatic refractors, frequently consisting of light sources (LEDs), beam splitters mounted in a rotatin
mechanism (Scheiner's refractors); Badal lens systems which consist of a light sensor or photodetecto
controlled mechanism to detect the change of light reflection from the eye, and a digital display for th
Usually, the lens system or the light sources are moved to make the optimal focus on the eyes. Other
retinoscopic scanning method are available; they consist of light sources, a slit mechanism, lenses, an
measuring the movement of the light reflex (e.g., speed, motion) from the eye. Automated refractors
lens fitting; they are frequently combined with keratometers in a single measuring device.

Ophthalmic refractors designed to measure the refractive error by changing a set of different lenses m
and other settings (also known as manual phoropters or phorometers); these instruments require the
These instruments usually consist of a refraction unit including a set of calibrated (i.e., containing a nu
minus sphere and clylinder graduations) lenses, a cross-cylinder, a pulillary distance setting, prisms, l
external eye chart. Manual ophthalmic refractors measure sphere power and cylinder power and axis,
convergence, and binocular balancing of the eyes; they are used mainly to establish eyeglass prescrip
Ophthalmic measuring instruments designed for determining aberration by measuring the direction o
from the eye and reconstructing the wavefront. Instruments that use several different technologies ar
instrument based on the Hartmann-Shack principle consists of a light source (most often a laser); a wa
of an array of micro-lenses (known as lenslets) that spilt the wavefront into a number of light spots to
charge-coupled device (CCD) camera; computer data processing capabilities and a display for the resu
use the ray tracing principle and consist of a light source (most often a laser), a lens system, an x-y sc
and a photodetector to project a series of beam of light into the eye sequentially and to capture the r
light. Aberrometers are mainly used to plan laser refractive surgery and for lens fitting.

Lensometers designed for the manual measurement of the optical characteristics of spectacle and/or
spherical power, cylinder power, cylinder axis, prismatic power, lens diameter). Manual lensometers a
devices that mainly consist of an eyepiece, lens platform, power dial, axis wheel, and marking device
instruments measure how the light is refracted as it passes through the lens. Manual lensometers are
determine whether the lens characteristics and the prescription match.

Lensometers designed for the automated measurement of the optical characteristics of spectacle and
spherical power, cylinder power, cylinder axis, prismatic power, lens diameter). The instruments consi
sources, a lens mount, microprocessor, camera imaging devices, and a display. They use an imaging c
patterns of light projected from the lens and analyze the result automatically. Automated lensometers
determine whether the lens characteristics and the prescription match.

Gonioscopes designed for indirectly examining the angle of the anterior chamber of the eye using a co
lens incorporated with mirrors (so that light refracts from the mirror). Indirect gonioscopes usually con
or four-mirror contact lens through which the light projecting from the anterior chamber angle structur
from the mirrors, a slit-lamp microscope, and an illumination source to obtain a magnified image of th
The instruments are usually one of two types: one with a lens that comes into contact with the centra
indentation (indentation gonioscopes) or one with a lens that comes into contact with the cornea with
(Goldmann gonioscopes). Gonioscopes are used mainly in the diagnosis, monitoring and treatment of

Gonioscopes designed for directly examining the angle of the anterior chamber of the eye using a mir
shaped contact lens (without light refracting from mirrors). Direct gonioscopes usually consist of a mir
through which the light projecting from the anterior chamber angle structures passes, a handheld mic
illumination source to obtain a magnified image of the anterior chamber. Gonioscopes are used mainly
monitoring, and treatment of glaucoma.

Ophthalmic rods designed to detect the misalignment of the eyes (heterophoria). The devices may co
several parallel cylindrical glass rods attached together; when a rod is placed in front of the eye under
light appears as a line. The person with heterophoria will see a point of light at one side of the line of
with normal vision will see the line passing through the point. The amount of deviation can be measur
diopter prisms put in front of the test eye. Heterophoria assessment rods (known as Maddox rods) are
heterophoria.
Devices that consist of a small pin (i.e., a piece of metal with a sharp point on one end) that is bent ba
spring mechanism, and that incorporates a guard to cover the point (i.e., a clasp). The clasp serves tw
a closed loop thereby providing a mechanism to properly fasten the pin to whatever it is applied to; an
of the pin to protect the user from the sharp point. In healthcare, safety pins are commonly used to fa
clothing, or other material together. They are available separately, or may be packaged together with
typically utilize safety pins (e.g., triangular bandages), or in kits of common supplies used for a specifi
aid kits).

Molecular assay reagents intended to identify mutations in the interleukin 2 receptor, gamma (IL2RG)
chromosome Xq13.1, which encodes for the protein common gamma chain that partners with other pr
forming cells to form lymphocytes. The receptor also directs the growth and maturation of lymphocyte
cells, and natural killer cells. Mutations at this locus have been identified in patients with X-linked seve
immunodeficiency (XSCID), also called agammaglobulinemia, Swiss type.

Molecular assay reagents intended to identify mutations in the interferon regulatory factor 6 (IRF6) ge
chromosome 1q32.3-q41, which encodes for a transcription factor of the interferon regulatory factor (
at this locus have been identified in patients with Van der Woude's syndrome (VWS) and popliteal pter
(PPS), also known as lip-pit syndrome.
Molecular assay reagents intended to identify mutations in the jagged 1 (JAG1) gene, located at chrom
p11.23, which encodes for a protein that acts as a ligand to Notch proteins, a family of transmembran
at this locus have been identified in patients with Alagille syndrome, a disorder characterized by highl
complex multisystem disorders.
Molecular assay reagents intended to identify mutations in the potassium voltage-gated channel, Isk-r
1 (KCNE1) gene, located at chromosome 21q22.1-q22.2, which is involved in the formation and activa
channels in cells. Mutations at this locus have been identified in patients with Jervell and Lange-Nielse
long QT Syndrome.
Molecular assay reagents intended to identify mutations in the potassium voltage-gated channel, Isk-r
2 (KCNE2) gene, located at chromosome 21q22.12, which encodes for a protein that regulates the act
channels. Mutations at this locus have been identified in patients with Romano-Ward syndrome and fa

Molecular assay reagents intended to identify mutations in the potassium voltage-gated channel, subf
(KCNH2) gene, located at chromosome 7q35-q36, which belongs to a family of genes that provide inst
potassium channels. Mutations at this locus have been identified in patients with Romano-Ward, short
long QT syndrome.
Molecular assay reagents intended to identify mutations in the potassium inwardly rectifying channel,
11 (KCNJ11) gene, located at chromosome 11p15.1, which encodes for a protein that an is integral me
inward-rectifier type potassium channel. Mutations at this locus have been identified in patients with f
hyperinsulinemic hypoglycemia of infancy (PHHI).
Molecular assay reagents intended to identify mutations in the potassium inwardly rectifying channel,
(KCNJ2) gene, located at chromosome 17q23.1-q24.2, that encodes for a protein that may participate
potential waveform and excitability of neuronal and muscle tissues. Mutations at this locus have been
with Andersen-Tawil syndrome, short QT syndrome, and familial atrial fibrillation.
Molecular assay reagents intended to identify mutations in the potassium voltage-gated channel, KQT
member 1 (KCNQ1) gene, located at chromosome 11p15.5, which encodes for a protein involved in po
formation and function and helps move potassium out of the cell. Mutations at this locus have been id
with familial atrial fibrillation, JLNS, Romano-Ward syndrome, and short QT syndromes.

Molecular assay reagents intended to identify mutations in the potassium voltage-gated channel, KQT
member 4 (KCNQ4) gene, located at chromosome 1p34, which encodes for a protein that forms potass
to be critical in the regulation of neuronal excitability, particularly in the sensor cells of the cochlea. M
have been identified in patients with nonsyndromic sensorineural deafness, type 2 (DFNA2)

Molecular assay reagents intended to identify mutations in the kinesin family member 21A (KIF21A) g
chromosome 12q12, which encodes for a protein involved in the transport of essential cellular compon
microtubules. Mutations at this locus have been identified in patients with congenital fibrosis of extra-
(CFEOM1).
Molecular assay reagents intended to identify mutations in the Kallmann syndrome 1 sequence (KAL1
chromosome Xp22.3, which encodes for the protein anosmin. The protein anosmin is important in the
and olfactory nerves to the hypothalamus. Mutations at this locus have been identified in patients wit
syndrome, a form of hypothalamic hypogonadism.
Molecular assay reagents intended to identify mutations in the v-Ki-ras2 Kirsten rat sarcoma 2 viral on
(KRAS2), located at chromosome 12p12.1, which encodes proteins that play a role in normal tissue sig
proliferation, differentiation and senescence. This is an oncogene. Mutations at this locus have been id
with lung, pancreatic, endometrial, and colorectal cancers.
Molecular assay reagents intended to identify mutations in the keratin 14 (KRT14) gene, located at ch
which provides instructions for making keratin 14. The protein product of the gene works with keratin
to the outer layers of skin. Mutations at this locus have been identified in patients with epidermolysis

Molecular assay reagents intended to identify mutations in the keratin 5 (KRT5) gene, located at chrom
which encodes for the protein keratin 5 that works with keratin 14 to provide resiliency to the outer la
at this locus have been identified in patients with epidermolysis bullosa simplex.

Molecular assay reagents intended to identify mutations in the L1 cell adhesion molecule (L1CAM) gen
chromosome Xq28, which encodes for an integral membrane glycoprotein that mediates cell-to-cell ad
primarily in the nervous system. Mutations at this locus have been identified in patients with L1 syndr
associated with a wide range of neurologic abnormalities.
Molecular assay reagents intended to identify mutations in the laminin, alpha 2 (LAMA2) gene, located
q23, which encodes for merosin or laminin M, a striated muscle-specific basal-lamina-associated prote
locus have been identified in patients with congenital muscular dystrophy.

Molecular assay reagents intended to identify mutations in the like-glycosyltransferase (LARGE) gene,
chromosome 22q12.3-q13.1, which encodes for a protein that is a key determinant in the biosynthetic
mature and functional dystroglycan. mutations at this locus have been identified in patients with cong
dystrophy type 1D.
Molecular assay reagents intended to identify mutations in the lipopolysaccharide-induced TNF factor
at chromosome 16p13.3-p12, which encodes for a protein that causes secretion of TNF-alpha. Mutatio
been identified in patients with Charcot-Marie-Tooth-neuropathy type 1C (CMT1C).

Molecular assay reagents intended to identify mutations in the lamin A/C (LMNA) gene, located at chro
q21.3, which provides instructions for making several different lamin proteins. Lamin A and lamin C ar
the body. Mutations at this locus have been identified in patients with Charcot-Marie-Tooth-neuropathy
Dreifuss muscular dystrophy.
Molecular assay reagents intended to identify mutations in the LIM homeobox transcription factor 1, b
located at chromosome 9q34, which encodes for a protein necessary for proper limb development. Mu
have been identified in patients with nail-patella syndrome.
Molecular assay reagents intended to identify mutations in the lipoprotein lipase (LPL) gene, located a
which encodes for lipoprotein lipase. Lipoprotein lipase carries out a step in the breakdown of lipoprot
locus have been identified in patients with lipoprotein lipase deficiency.

Molecular assay reagents intended to identify mutations in the mothers against decapentaplegic hom
gene, located at 18q21.1, which encodes for a protein that acts as a tumor suppressor. Mutations at th
identified in patients with juvenile polyposis syndrome.
Molecular assay reagents intended to identify mutations in the mannosidase, alpha, class 2B, membe
located at chromosome 19cen-q12, which encodes for an alpha-mannosidase enzyme that works in ly
lysosome, the enzyme breaks down oligosaccharides attached to glycoproteins. Mutations at this locu
in patients with alpha mannosidosis (lysosomal alpha-D-mannosidase deficiency).

Molecular assay reagents intended to identify mutations in the microtubule-associated protein tau (MA
chromosome 17q21.1, which encodes for the microtubule-associated protein tau (MAPT). The MAPT tra
complex, regulated alternative splicing, giving rise to several mRNA species. MAPT transcripts are diff
the nervous system, depending on stage of neuronal maturation and neuron type. Mutations at this lo
identifed in patients with a variety of frontotemporal dementias.

Molecular assay reagents intended to identify mutations in the matrilin 3 (MATN3) gene, located at ch
which encodes for matrilin-3 protein found in cartilage extracellular matrix. Mutations at this locus hav
patients with multiple epiphyseal dysplasias.
Molecular assay reagents intended to identify mutations in the mucolipin 1 (MCOLN1) gene, located a
19p13.3-13.2, which encodes a cation channel involved in lysosome exocytosis. Mutations at this locu
in patients with mucolipidosis type IV, a lysosomal storage disorder with an early onset on infants.

Molecular assay reagents intended to identify mutations in the methyl CpG binding protein 2 (MECP2)
chromosome Xq28, which encodes for a protein essential for normal brain development. Mutations at
identified in patients with Rett syndrome, an early-onset, almost exclusively female, disease.

Molecular assay reagents intended to identify mutations in the Mediterranean fever (MEFV) gene, loca
16p13.3, which encodes for the protein pyrin (also known as Marenostrin), produced in certain white b
inflammation. Mutations at this locus have been identified in patients with familial Mediterranean feve
Molecular assay reagents intended to identify mutations in the multiple endocrine neoplasia I (MEN1)
chromosome 11q13, which encodes for menin that acts as a tumor suppressor. Mutations at this locus
in patients with multiple endocrine neoplasia type I, hyperparathyroidism, Wermer syndrome (MEN1 d
tumors of the lungs.
Molecular assay reagents intended to identify mutations in the megalencephalic leukoencephalopathy
1 (MLC1) gene, located at chromosome 22q13.33, which encodes for a protein whose functions are no
it is suspected to be a transport protein. This genetic mutation has been identified in patients with me
leukoencephalopathy with subcortical cysts type 1.
Molecular assay reagents intended to identify mutations in the mitofusin 2 (MFN2) gene, located at ch
which encodes for mitofusin 2 protein, that helps determine the morphology of mitochondria. Mutation
been identified in patients with Charcot-Marie-Tooth neuropathy type 2A2 (CMT2A2).

Molecular assay reagents intended to identify mutations in the mutL homologue 1 (MLH1) gene, locat
3p22.3, which encodes for a protein essential for DNA repair. Mutations at this locus have been identifi
hereditary nonpolyposis colorectal cancer (NPCC) type 2, including Turcot's syndrome.

Molecular assay reagents intended to identify mutations in the MT-CO2 gene, located in the mitochond
encodes for the protein cytochrome C oxidase II. Mutations at this locus have been identified in patien
myopathy (MM).
Molecular assay reagents intended to identify mutations in the methylmalonic aciduria (cobalamin defi
(MMAA) gene, located at chromosome 4q31.21, which encodes for a protein involved in the formation
Adenosylocoalamin is required for the normal function of methylmalonyl-CoA mutase, which breaks do
fats, and cholesterol. Mutations at this locus have been identified in patients with early-onset methylm
(MMA).

Molecular assay reagents intended to identify mutations in the methylmalonic aciduria (cobalamin defi
gene, located at chromosome 12q24, which encodes for a protein involved in the formation of adenos
for methylmalonyl CoA mutase to break down certain proteins, fats, and cholesterol. Mutations at this
identified in patients with early-onset methylmalonic acidemia (MMA).

Molecular assay reagents intended to identify mutations in the myelin protein zero (MPZ) gene, locate
1q22, which encodes for the myelin protein zero made in the Schwann cells. Myelin protein zero is req
formation and maintenance of myelin. Mutations at this locus have been identified in patients with Ch
neuropathy 1B (HMSN Ib).
Molecular assay reagents intended to identify mutations in the mutS homologue 6 (E. coli) (MSH6) gen
chromosome 2p16, which encodes for a protein essential to repairing simple DNA replication errors. M
have been identified in patients with hereditary non-polyposis colorectal (NPCC) cancer type 5.

Molecular assay reagents intended to identify mutations in the mutS homologue 6 (E. coli) (MSH6) gen
chromosome 2p16, which encodes for a protein essential to repairing simple DNA replication errors. M
have been identified in patients with hereditary non-polyposis colorectal (NPCC) cancer type 5.

Molecular assay reagents intended to identify mutations in the muscle segment homeo box homologu
located at chromosome 5q34-q35, which encodes for a transcription factor protein presumed to be cri
development. Mutations at this locus have been identified in patients with parietal foramina type 1 an
2.
Molecular assay reagents intended to identify mutations in the mitochondrially encoded ATP synthase
located in the mitochondrial genome, which encodes for a protein that is essential for normal mitocho
Mutations at this locus have been identified in patients with mitochondrial disorders, including mitoch
Leigh syndrome; neurogenic muscle weakness; ataxia; and neuropathy, ataxia, and retinitis pigmento

Molecular assay reagents intended to identify mutations in the mitochondrially encoded cytochrome b
located in the mitochondrial genome, which encodes for a protein involved in the production of energy
mitochondria. Mutations at this locus have been identified in patients with Leber's hereditary optic ne

Molecular assay reagents intended to identify mutations in the 5,10-methylenetetrahydrofolate reduc


located at chromosome 1p36.3, which encodes for methylenetetrahydrofolate reductase enzyme invo
amino acids. Mutations at ths locus have been identified in patients with homocystinuria due to MTHF
premature atherosclerosis.
Molecular assay reagents intended to identify mutations in the myotubular myopathy 1 (MTM1) gene,
chromosome Xq28, which encodes for a lipid phosphatase required for muscle cell differentiation. Mut
have been identified in patients with X-linked myotubular myopathy type 1 (also called X-linked centro

Molecular assay reagents intended to identify mutations in the mitochondrially encoded NADH dehydr
gene, located in the mitochondrial genome, which encodes for NADH dehydrogenase subunit 1 protein
complex 1, a large enzyme complex active in mitochondria. Mutations at ths locus have been identifie
onset of Leber's hereditary optic neuropathy (LHON).

Molecular assay reagents intended to identify mutations in the NADH dehydrogenase 4 (MTND4) gene
mitochondria, which encodes for NADH dehydrogenase subunit 4 protein that is complex 1, part of a l
active in mitochondria. Mutations at this locus have been identified in patients with Leber's hereditary
(LHON).
Molecular assay reagents intended to identify mutations in the mitochondrially encoded NADH dehydr
gene, located in the mitochondria, which encodes for NADH dehydrogenase subunit 5 protein that com
large enzyme complex active in mitochondria. Mutations at this locus have been identified in patients
encephalopathy with lactic acidosis and stroke-like episodes (MELAS) syndrome.

Molecular assay reagents intended to identify mutations in the limb-girdle muscular dystrophy 2B (LG
chromosome 2p13.3-p13.1, which encodes for the dysferlin protein that is located in muscle fibers. M
have been identified in patients with limb-girdle muscular dystrophy 2B and Miyoshi myopathy.

Molecular assay reagents intended to identify mutations in the mitochondrially encoded NADH dehydr
gene, located in the mitochondrial genome which encodes for NADH dehydrogenase 6 protein that is p
large enzyme complex active in mitochondria. Mutations at this locus have been identified in patients
Leber's hereditary optic neuropathy (LHON).

Molecular assay reagents intended to identify mutations in the mitochondrially encoded 12S, RNA (MT
in the mitochondrial genome, which provides instructions for making ribosomal 12S RNA present only
Mutations at this locus have been identified in patients with mitochondrial nonsyndromic hearing loss
Molecular assay reagents intended to identify mutations in the mitochondrially encoded tRNA lysine (M
the mitochondrial genome, which encodes for tRNA lysine found in the mitochondria and is important
Mutations at this locus have been identified in patients with mitochondrial disorders and myoclonic ep
ragged red fibers (MERRF).
Molecular assay reagents intended to identify mutations in the mitochondrially encoded tRNA leucine
gene, located in the mitochondrial genome, which encodes for a specific form of transfer RNA, tRNA L
amino acid leucine (Leu) and inserts it into the appropriate locations in many different proteins during
at this locus have been identified in patients with mitochondrial disorders, including a disease charact
mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS). The entry terms
hearing loss.

Molecular assay reagents intended to identify mutations in the mitochondrially encoded tRNA serine 1
located in the mitochondrial genome, which encodes for a specific form of transfer RNA , tRNASer, tha
amino acid serine (ser) and inserts it into the appropriate locations in many different proteins during t
at this locus have been identified in patients with mitochondrial nonsyndromic hearing loss and deafn

Molecular assay reagents intended to identify mutations in the methylmalonyl coenzyme A mutase (M
chromosome 6p21, which encodes for the methylmalonyl Coenzyme A (CoA) mutase enzyme that is a
Methylmalonyl CoA mutase is responsible for the breakdown of isoleucine, methionine, threonine, and
and cholesterol. Mutations at this locus have been identified in patients with methylmalonic acidemia

Molecular assay reagents intended to identify mutations in the MAX interacting protein 1 (MXI1) gene,
chromosome 10q24-25, which encodes for a protein that is a transcriptional repressor, thought to neg
function. This gene is a potential tumor suppressor. Mutations at this locus have been identified in pat
neurofibrosarcoma and susceptibility to prostate cancer.
Molecular assay reagents intended to identify mutations in the myocilin, trabecular meshwork inducib
response (MYOC) gene, located at chromosome 1q23-24, which encodes for the protein myocilin found
meshwork and the ciliary body of the eye. Myocilin may help to control the intraocular pressure of the
in the muscle tissue of the ciliary body. Mutations at this locus have been identified in patients with pr
1A glaucoma.

Molecular assay reagents intended to identify mutations in the N-acetylglutamate synthase (NAGS) ge
chromosome 17q21.31, which encodes for the enzyme N-acetylglutamate synthase, needed for the ur
this locus have been identified in patients with N-acetylglutamate synthase (NAGS) deficiency, an ear
urea cycle disorder characterized by severe hyperammonemia, spasticity, seizures, and loss of menta

Molecular assay reagents intended to identify mutations in the Nijmegen breakage syndrome 1 (nibrin
at chromosome 8q21, which encodes for the protein nibrin that is involved in several critical cellular fu
repair of damaged DNA. Mutations at this locus have been identified in patients with Nijmegen breaka
aplastic anemia, and acute lymphoblastic leukemia (ALL).

Molecular assay reagents intended to identify mutations in the Norrie's disease (pseudoglioma) (NDP)
chromosome Xp11.4, which encodes for the protein norrin that participates in the Wnt cascade, a sign
affects the way cells and tissues develop. Norrin seems to play critical roles in the specialization of the
Mutations at this locus have been identified in patients with Norrie's disease and familial exudative vit
Molecular assay reagents intended to identify mutations in the neurofilament, light polypeptide 68kDa
at chromosome 8p21, which encodes for a protein component (the light subunit) of neurofilaments. M
have been identified in patients with Charcot-Marie-Tooth disease type 1F and type 2E.

Molecular assay reagents intended to identify mutations in the neurofibromin 1 (NF1) gene, located at
which encodes for the protein neurofibromin, produced in many cells, including nerve cells (oligodend
cells). Neurofibromin acts as a tumor suppressor protein. Mutations at this locus have identified in pat
neurofibromatosis 1 (von Recklinghausen's disease); it is also associated with related diseases includin

Molecular assay reagents intended to identify mutations in the neurofibromin 2 (NF2) gene, located at
which encodes for the protein merlin (also known as schwannomin), made in Schwann cells. Merlin pla
cell shape, cell movement, and communication between cells. Mutations at this locus have been ident
neurofibromatosis type 2 (NF2), a young adult onset disease characterized by bilateral vestibular neop
cells of neurons (i.e., schwannomas) causing tinnitus, hearing loss, and loss of balance.

Molecular assay reagents intended to identify mutations in the Notch homologue 3 (NOTCH3) gene, lo
19p13.2-p13.1, which encodes for the Notch3 receptor protein is located on the surface of the muscle
blood vessels. Notch3 receptors play a key role in the function and survival of vascular smooth muscle
this locus have been identified in patients with inherited cerebral autosomal dominant arteriopathy wi
and leukoencephalopathy (CADASIL), a disease characterized by migraine headaches linked to hemod

Molecular assay reagents intended to identify mutations in the Niemann-Pick disease, type C2 (NPC2)
chromosome 14q24.3, which encodes for the protein NPC2 that is located inside lysosomes. The NPC2
cholesterol and plays a role in moving cholesterol and certain other lipids (fats) out of the lysosomes t
cell. Mutations at this locus have been identified in patients with Niemann-Pick disease type C2.

Molecular assay reagents intended to identify mutations in the Niemann-Pick disease, type C1 (NPC1)
chromosome 18q11-q12, which encodes for the protein NPC1 that is located on the surface of enodos
The NPC1 protein binds to cholesterol and plays a role in moving cholesterol and certain other lipids (f
lysosomes to other parts of the cell. Mutations at this locus have been identified in patients with Niem
C1, a fatal lipid storage disorder.

Molecular assay reagents intended to identify mutations in the nephrosis 1, congenital, Finnish type (n
located at chromosome 19q13.1, which encodes for the protein nephrin that is a kidney glomerular fil
Mutations at this locus have been identified in patients with congenital nephrotic syndrome of the Finn

Molecular assay reagents intended to identify mutations in the nuclear receptor subfamily 0, group B,
gene, located at chromosome Xp21.3-p21.2, which encodes for the protein DAX1 that is involved in th
function of several hormone-producing (endocrine) tissues in the body. This genetic mutation causes c
hypoplasia, X-linked adrenal hypoplasia congenital, and Swyer syndrome.

Molecular assay reagents intended to identify mutations in the nuclear receptor binding SET domain p
located at chromosome 5q35.2-q35.3, which encodes for a protein whose exact function is unknown b
regulate the transcription of genes involved in growth and development. Mutations at this locus have
patients with Soto's syndrome and childhood acute myeloid leukemia.
Molecular assay reagents intended to identify mutations in the ocular albinism GPR143 (formerly OA1
chromosome Xp22.3, which encodes for a protein that is involved in the coloring (pigmentation) of the
Mutations at this locus have been identified in patients with congenital (newborn) ocular albinism type
Nettleship-Falls type ocular albinism).
Molecular assay reagents intended to identify mutations in the oculocutaneous albinism II (OCA2) gen
chromosome 15q11.2-q12, which is involved in producing the pigment melanin, the substance that gi
their color. Mutations at this locus have been identified in individuals with light-colored hair and fair sk

Molecular assay reagents intended to identify mutations in the oculocerebrorenal syndrome of Lowe (O
chromosome Xq26.1, which encodes for an enzyme that helps modify membrane phospholipids known
Mutations at this locus have been identified in male patients with early-onset (newborn) Lowe syndrom
develop opacities in the eye lens that may progress to cataracts.

Molecular assay reagents intended to identify mutations in the ornithine carbamoyltransferase (OTC) g
chromosome Xp21.1, which encodes for the enzyme ornithine transcarbamylase that participates in th
Mutations at this locus have been identified in male patients with ornithine transcarbamylase deficien
females may suffer vomiting, lethargy, and seizures.
Molecular assay reagents intended to identify mutations in the poly(A)-binding protein, nuclear 1 (PAB
chromosome 14q11.2-q13, which encodes for a nuclear protein that binds to nascent poly(A) tails. Mu
have been identified in patients with oculopharyngeal muscular dystrophy.
Molecular assay reagents intended to identify mutations in the phenylalanine hydroxylase (PAH) gene
chromosome 12q22-q24.2, which encodes for the enzyme phenylalanine hydroxylase. The enzyme is
step in processing phenylalanine, an amino acid obtained through the diet. Mutations at this locus hav
patients with phenylketonuria (PKU).
Molecular assay reagents intended to identify mutations in the neurodegeneration, pantothenate kina
gene, located at chromosome 20p13, which encodes for the enzyme pantothenate kinase 2 that is act
Pantothenate kinase 2 regulates the formation of Coenzyme A. Mutations at this locus have been iden
pantothenate kinase-associated neurodegeneration (Hallervorden-Spatz syndrome) and with HARP
(hypoprebetalipoproteinemia, acanthocytosis, retinitis pigmentosa, and pallidal degeneration) syndrom

Molecular assay reagents intended to identify mutations in the parkin 2 (PARK2) gene, located at chro
which encodes for the protein parkin that is involved in degrading unwanted proteins by attaching ubi
excess proteins. Parkin may also act as a tumor suppressor protein and regulate the supply and releas
from nerve cells. This genetic mutation is associated with early onset (juvenile) Parkinson's disease.

Molecular assay reagents intended to identify mutations in the paired box gene 3 (PAX3) gene, located
q37, which encodes for a transcription factor. Mutations at this locus have been identified in patients w
syndrome type 1 (WS1), a disease characterized by partial albinism and severe hearing loss or deafne
syndrome type 3 (Klein-Waardenburg syndrome) and craniofacial-deafness-hand syndrome (CDHS).
Molecular assay reagents intended to identify mutations in the paired box gene 6 (PAX6) gene, located
11p13, which encodes for a transcriptional regulator involved in oculogenesis and other development
expressed in the eye and brain. Inherited mutations are present in patients with isolated aniridia. Mut
have been identified in patients with early onset of isolated aniridia, a disease characterized by comp
foveal hypoplasia with reduced visual acuity and nystagmus progressing to cataract, glaucoma, and c
with vascularization.

Molecular assay reagents intended to identify mutations in the propionyl Coenzyme A carboxylase, alp
gene, located at chromosome 13q32, which encodes for the alpha subunit of the enzyme propionyl-Co
involved in the normal processing of proteins. Mutations at this locus have been identified in patients
acidemia and early-onset organic aciduria.
Molecular assay reagents intended to identify mutations in the propionyl Coenzyme A carboxylase, be
gene, located at chromosome 3q21-q22, which encodes for the beta subunit of the enzyme propionyl-
is involved in the normal processing of proteins. Mutations at this locus have been identified in patien
acidemia and early-onset organic aciduria.
Molecular assay reagents intended to identify mutations in the chromosome 10 open reading frame C
PEO1, PEOA3) gene, located at chromosome 10q23.3-q24.3, which encodes for a mitochondrial protei
mtDNA in mitochondrial nucleoids and is thought to be necessary for lifetime maintenance of mtDNA
this locus have been identified in patients with progressive external ophthalmoplegia (paralysis of the

Molecular assay reagents intended to identify mutations in the peroxisome biogenesis factor 1 (PEX1)
chromosome 7q21-q22, which encodes for a member of the AAA ATPase family. This protein is cytopla
associated with the peroxisomal membrane and plays a role in the import of proteins into peroxisome
biogenesis. Mutations at this locus have been identified in patients with early-onset Zellweger syndrom
continuum of peroxisome biogenesis disorders including three well differentiated forms, from severe t

Molecular assay reagents intended to identify mutations in the peroxisome biogenesis factor 10 (PEX1
1p36.32 which encodes for a protein involved in import of peroxisomal matrix proteins. Mutations at th
identified in patients with early-onset Zellweger syndrome spectrum, a continuum of peroxisome biog
include three well-differentiated forms, from severe to mild.

Molecular assay reagents intended to identify mutations in the peroxisomal biogenesis factor 12 (PEX1
chromosome 17q12, which encodes for a protein involved in import of peroxisomal matrix proteins. M
have been identified in patients with early-onset Zellweger syndrome spectrum, a continuum of perox
disorders that include three well-differentiated forms, from severe to mild.

Molecular assay reagents intended to identify mutations in the peroxisomal biogenesis factor 6 (PEX6)
chromosome 6p21.1, which encodes for a protein involved in import of peroxisomal matrix proteins. M
have been identified in patients with Zellweger syndrome (ZS), infantile Refsum disease (IRD), neonat
adrenoleukodystrophy (NALD), and classic rhizomelic chondrodysplasia punctata.

Molecular assay reagents intended to identify mutations in the peroxisomal biogenesis factor 7 (PEX7)
chromosome 6q21-q22.2, which encodes for a protein involved in import of peroxisomal matrix protein
locus have been identified in patients with Zellweger syndrome (ZS), neonatal adrenoleukodystrophy
Refsum disease (IRD).
Molecular assay reagents intended to identify mutations in the paired-like homeobox 2b (PHOX2B) gen
chromosome 4p12, which encodes for a DNA-associated protein and is a member of the paired family
localized to the nucleus that function as transcription factors. Mutations at this locus have been identi
congenital hypoventilation syndrome and predisposition to hereditary neuroblastoma.

Molecular assay reagents intended to identify mutations in the polycystic kidney disease 1 (autosoma
gene, located at chromosome 16p13.3-p13.12, which encodes for the protein polycystin-1 that with po
cell growth and division, cell movement and cellular interactions. Mutations at this locus have been id
with late-onset polycystic kidney disease type 1 (PKD1).
Molecular assay reagents intended to identify mutations in the polycystic kidney disease type 2 (auto
(PKD2) gene, located at chromosome 4q21-q23, which encodes for the protein polycystin-2 that with p
cell growth and division, cell movement and cellular interactions. Mutations at this locus have been id
with late-onset polycystic kidney disease type 2 (PKD2).
Molecular assay reagents intended to identify mutations in the polycystic kidney and hepatic disease
located at chromosome 6p21.1-p12, which encodes for the protein fibrocystin (also known as polyduc
receptor, interacting with molecules outside the cell and receiving signals that help the cell respond to
Fibrocystin may be involved in connecting cells together (adhesion), keeping cells apart (repulsion), an
growth and division of cells (proliferation). Mutations at this locus have been identified in patients with
kidney and hepatic disease type 1.

Molecular assay reagents intended to identify mutations in the proteolipid protein 1 (PLP1) gene, locat
Xq22, which encodes for 2 protein isoforms: the proteolipid protein 1 and DM20. Proteolipid protein 1
main proteins found in myelin of the central nervous system. Mutations at this locus have been identi
with a PLP1 gene-related disorder of the central nervous system (CNS) myelination, resulting in a spec
the severe connatal Pelizaeus-Merzbacher disease (PMD) to the milder uncomplicated spastic paraple
intermediate severity disorders are classic PMD, PLP1 null syndrome, and complicated SPG2.

Molecular assay reagents intended to identify mutations in the phosphomannomutase 2 (PMM2) gene
chromosome 16p13.2, which encodes for phosphomannomutase 2, an enzyme necessary for the synt
Mutations at this locus have been identified in patients with a congenital disorder of glycosylation typ
phosphomannomutase deficiency.
Molecular assay reagents intended to identify mutations in the peripheral myelin protein 22 (PMP22) g
chromosome 17p12-p11.2, which encodes for the protein peripheral myelin protein 22, crucial to deve
maintenance of myelin. The PMP22 gene may also be involved in regulating cell division and maturati
death. Mutations at this locus have been identified in patients with Charcot-Marie-Tooth neuropathy ty
Dejerine-Sottas syndrome, hereditary neuropathy with liability to pressure palsies (HNPP), hereditary m
neuropathy III (HMSNIII), and Roussy-Levy syndrome.

Molecular assay reagents intended to identify mutations in the protein O-mannose N-acetylglucosamin
(POMGnT1) gene, located at chromosome 1p34.1, which encodes for a protein involved in o-mannosyl
Mutations at this locus have been identified in patients with muscle-eye-brain muscular dystrophy (ME
abnormalities, and brain malformation.
Stainless steel tubing designed to provide flexibility and corrosion-resistance capabilities. This tubing
cylinder of corrugated annealed stainless steel sections designed for the transfer of materials, usually
and/or high pressure. Flexible stainless steel tubing is usually available in standardized lengths and in
and wall thicknesses (i.e., gauges) that permit the use of segments of different sizes appropriate for a
the healthcare facility; they are frequently supplied with connectors at one or both ends.

Exercisers designed to facilitate the physical exertion of body muscles by the voluntary contraction an
muscle groups (i.e., active exercisers), which are intended primarily for making users breathe more de
work harder; activities in aerobic exercises can be usually maintained continuously and are rhythmic i
exercisers are usually intended to improve cardiovascular endurance by keeping the heart and pulmo
continuous period of time. Aerobic exercisers, as all exercisers, may also improve muscular strength, e
and balance in specific parts of the body (e.g., upper and/or lower). Dedicated aerobic exercisers are a
and jogging (e.g., treadmills), cycling (e.g., stationary bicycles), and other activities such as rowing, el
bouncing.

Stationary bicycle exercisers designed to simulate the motions of riding a bicycle with the user sitting
position. These exercisers are usually self-powered devices; they may use friction belts or wheels, mag
hydraulics to increase resistance. Some stationary bicycles may include a motor that can regulate spe
adjustable while the rider remains in a reclined position with the legs extending forward to the pedals
reduce strain on the neck and lower back. The bicycles usually include workout program modes that c
and a monitor to display the workout time, distance, speed, calories burned, and heart rate; they ofte
handlebars with grip pulse sensors, and some bicycles have heart-rate control tools that can adjust th
suit the targeted heart rate. Recumbent bicycles are intended to increase cardiovascular endurance b
and pulmonary rate elevated for a continuous period of time. Additionally, they provide strength and e
limb muscles (e.g., quadriceps, hamstrings, calves, gluteus).

Stationary bicycle exercisers designed to simulate the motions of riding a bicycle with the user sitting
These exercisers are usually self-powered devices; they may use friction belts or wheels, magnets, fan
increase resistance. Some stationary bicycles may include a motor that can regulate speed. Seats are
while the rider is in an upright position. The bicycles usually include workout program modes that can
monitor to display the workout time, distance, speed, calories burned, and heart rate; and adjustable
pulse sensors; some bicycles also have heart-rate control tools that can adjust the resistance level to
rate. Upright bicycles are intended to increase cardiovascular endurance by keeping the heart and pu
for a continuous period of time. Additionally, they provide strength and endurance to the lower-limb m
quadriceps, hamstrings, calves, gluteus).
Climbing aerobic exercisers designed to simulate the motion of climbing stairs using movable stairs or
exercisers may be movable, motorized staircases that constantly revolve, or footpedals or platforms w
side handrails, and/or front handlebars, which are usually called climbers or steppers. The two terms a
interchangeably, but climbers can train both the upper body and lower body while steppers train only
because they do not have movable or fixed front handlebars. These exercisers can use pneumatic, hy
electromagnetic resistance. Motorized stair/stepper exercisers usually include workout program mode
levels; a monitor to display the workout time, distance, speed, calories burned, and heart rate; and ha
pulse sensors or wireless heart-rate tools; some may also have heart-rate controls to adjust the resista
targeted heart rate. These exercisers are intended to increase cardiovascular endurance by keeping th
pulmonary rate elevated for a continuous period of time. Additionally, they provide strength and endu
of the lower body (i.e., quadriceps, hamstrings, gluteus, hip flexors, calves) and the upper body (i.e., a
back).

Nonpowered stair/stepper climbing exercisers designed to simulate the motion of climbing stairs using
manual) movable stairs or steppers. These exercisers usually consist of footpedals and side handrails
fixed front handlebars. The pedals are propelled by the movements of the user; resistance is provided
hydraulic, or electromagnetic mechanisms. The exercisers usually include workout program modes to
levels; a monitor to display the workout time, distance, speed, calories burned, and heart-rate; and ad
with grip pulse sensors or wireless heart-rate tools; some may also have heart rate controls to adjust t
suit the targeted heart rate. Nonpowered stair/stepper climbing exercisers are intended to increase ca
endurance by keeping the heart and pulmonary rate elevated for a continuous period of time. Addition
strength and endurance to the muscles of the lower body (i.e., quadriceps, hamstrings, gluteus, hip fle
the upper body (i.e., arms, shoulders, chest, back).

Stair/stepper climbing exercisers designed to simulate the motion of climbing stairs which are powere
that adjusts the movements of the pedals. Stair/stepper exercisers usually consist of footpedals and s
moveable or fixed front handlebars; the resistance is provided by penumatic, hydraulic, or electromag
exercisers usually include workout program modes to adjust resistance levels; a monitor to display the
distance, speed, calories burned, and heart rate; and adjustable handlebars with grip pulse sensors or
tools; some may also have heart-rate controls to adjust the resistance level to suit the targeted heart
stair/stepper climbing exercisers are intended to increase cardiovascular endurance by keeping the he
rate elevated for a continuous period of time. Additionally, they provide strength and endurance to th
body (e.g., quadriceps, hamstrings, gluteus, hip flexors, calves) and the upper body (i.e., arms, should

Aerobic exercisers that may consist simply of a rope or cord that users swing over themselves and jum
time it reaches the feet and the two handles that users hold. The cords may be made of nylon, polyvin
leather, or rubber, and some cords may be braided or segmented and/or permit length adjustment; th
wooden or plastic and may be mounted with removable weights to add resistance to the muscles invo
Jumping rope aerobic exercisers are intended to increase cardiovascular endurance by keeping the he
elevated for a continuous period of time. Additionally, they provide strength and endurance to the mu
body (i.e., arm, chest, back), lower body, and abdomen; they can also contribute to the development
balance for the users.
Exercisers designed primarily to facilitate the physical exertion of body muscles by voluntary contract
large muscle groups (i.e., active exercisers) that are intended primarily to provide resistance to muscu
development of muscular strength and endurance. The resistance to muscular contractions may be pr
using free weights or constrained weights, pneumatic, or hydraulic resistance mechanisms, elastic res
sources. These exercisers are intended to improve the strength in the upper limb (arm, shoulder, elbo
hand), trunk (chest, back, abdomen), and the lower limb (buttock, thigh, calf, ankle, foot) muscles; as
increase muscle size, endurance, and power and improve bone density. Muscle strength exercisers, lik
also improve flexibility and balance in particular parts of the body (e.g., upper, lower). A variety of ded
strength exercisers are available, such as free weights (e.g., dumbbell, barbell), weight machines, and
hydraulic devices.

Muscle strength exercisers designed to provide resistance to muscular contraction using unconstraine
resistance is provided by the force of gravity acting on the free weights. Free weights are not attached
and do not restrict the user's movements; they usually include barbells and dumbbells. Barbells are u
removable weighted disks attached to each end; dumbbells are short, handheld bars with balls or disk
end. Free weight exercisers are intended to improve muscle strength in the upper limbs, trunk, and low
muscle size, muscle endurance, and power; and imporve bone density. Free weights can be added to l
exercise machines to increase resistance.

Free weight exercisers designed to provide resistance to muscular contraction. These devices are long
weighted disks attached to each end. Using the weight on the barbells, resistance is provided by the f
on the barbell. Barbells are not attached to any other devices and do not restrict a user's movements.
in exercises to train the upper limb/trunk (e.g., bench press, bicep curl, abdominal curls) or lower limb
muscles. Barbell exercisers are intended to improve muscle strength in the upper limbs, trunk, and low
muscle size, muscle endurance, and power; and improve bone density.

Muscle strength exercisers designed to provide resistance to muscular contraction using a mechanism
pulleys and cables or levers; resistance is provided by the force of gravity exerted on constrained weig
exercisers usually consist of a stand-alone machine with weights stacked on top of each other and/or a
system to transmit the force (i.e., to convey the resistance), and lever bars or pulley cables on which t
counteract the exerciser resistance. Dedicated lever-pulley-cable exercisers intended to improve the s
specific body muscle groups such as the upper and lower limbs, trunk, and neck are available; the exe
increase muscle size, muscle endurance, and power and improve bone density.

Muscle strength exercisers designed to provide resistance to muscular contraction in the neck using a
a system of pulleys and cables or levers; resistance is usually provided by the force of gravity exerted
stacks. These exercisers usually consist of a stand-alone machine with weights stacked on top of each
transmit the force (i.e., to convey the resistance), and lever bars or pulley cables on which the user ex
counteract the exerciser resistance. Users put padded lever bars on their heads or wear the cables to
the resistance. Neck strength exercisers are intended to improve muscle strength in the neck, increas
muscle endurance and power, and improve bone density.
Muscle strength exercisers designed to provide resistance to muscular contraction in the back using a
a system of pulleys and cables or levers. These exercisers usually consist of a stand-alone machine wi
top of each other or a hydraulic mechanism, a system to transmit the force (i.e., to convey the resista
pulley cables on which the user exerts force to counteract the exerciser resistance. Users grasp the le
handles and pull them down toward their chest. Pulldown strength exercisers are intended to improve
(latissimus dorsi), chest and arm muscles, increase muscle size; enhance muscle endurance and powe
density. Dedicated pulldown exercisers using pulley cables or lever bars are available.

Muscle strength exercisers that simulate the motion of rowing using a mechanism based on a system
or levers. These exercisers usually consist of a stand-alone machine with weights stacked on top of ea
mechanism, a system to transmit the force (i.e., to convey the resistance), and lever bars or pulley ca
exerts force to counteract the exerciser resistance. Users grasp the lever bar or cable handles and pul
waist. Rowing strength exercisers are intended to improve the muscle strength in the back (trapezius
muscles), increase muscle size, enhance muscle endurance and improve power, and bone density. De
exercisers using pulley cables or lever bars are available.

Muscle strength exercisers designed to provide resistance to muscular contraction in the lower limbs u
based on a system of pulleys and cables or levers. These exercisers usually consist of a stand-alone m
stacked on top of each other or a hydraulic mechanism, a system to transmit the force (i.e., to convey
lever bars or pulley cables on which the user exerts force to counteract the exerciser resistance. These
exercise the lower-limb (e.g., squat, lunge, leg press, leg extension, heel raise) muscles. Lower-limb st
intended to improve muscle strength in the lower limbs (e.g., buttock, thigh, calf, ankle); increase mu
and power; and improve bone density. Dedicated lower-limb strength exercisers are available for leg e
and leg curl.

Muscle strength exercisers designed to provide resistance to muscular contraction when the knees are
resistance using equipment based on a system of pulleys and cables or levers. These exercisers usual
alone machine with weights stacked on top of each other or a hydraulic mechanism, a system to tran
convey the resistance), and lever bars or pulley cables on which the user exerts force to counteract th
Lever bar machines require the users to push a padded lever bar down with their ankles to flex their k
of their thighs or lie prone and, with the pads above the ankles, flex the knees toward the back of thei
cable machines, the users attach the cable to their ankles and flex the knees. Leg curl exercisers are i
strength in the hamstring muscles, increase muscle size, enhance muscle endurance and power, and

Muscle strength exercisers designed to provide resistance to muscular contraction when the legs are e
resistance using a mechanism based on a system of pulleys and cables or levers. These exercisers usu
alone machine with weights stacked on top of each other or a hydraulic mechanism, a system to trans
convey the resistance), and lever bars or cables on which the user exerts force to counteract the exer
Typically, users lift a padded lever bar with their ankles to extend the knees; less frequently, using the
the cables to extend their knees. Leg extension exercisers are intended to improve the strength of qua
increase muscle size, enhance muscle endurance and power, and improve bone density.
Muscle strength exercisers designed to provide resistance to contraction of any major body muscle gr
based on a system of pulleys and cables, or levers. These exercisers usually consist of a stand-alone m
stacked on top of each other, a system to transmit the force (i.e., to convey resistance), and lever bar
which the user exerts force to counteract the exerciser resistance. Pulley-cable full-body exercisers us
cables with adjustable positions to train the upper body, trunk, and lower body. Full-body strength exe
improve muscle strength in the entire body (arm, chest, back, abdomen, leg); they may also increase
endurance, and power and improve bone density.

Muscle strength exercisers designed to provide resistance to muscular contraction when the user lifts
movement is restricted to a fixed path; the barbells provide resistance. The movement of a barbell is u
runners and a series of slots, so the barbell can only be moved up and down; sometimes the barbells
collars of a pair of weight crutches. An adjustable bench may be included in these exercisers. These e
for bench presses, squats, and lunges. Constrained barbell exercisers are intended to improve the stre
(arm, shoulder, chest, and upper back) and lower body (buttocks, thigh, and calf) muscles; they can a
size, endurance, and power and improve bone density.

Strength exercisers designed to provide elastic resistance to muscular contraction for developing mus
endurance. These exercisers typically consist of an elastic material such as a flexible (e.g., rubber) ba
metal spring; the elastic resistance increases as the elastic element is stretched. Elastic resistance ex
portable, but they can also be built as exercise machines. They can be used in strength exercises such
leg press, shoulder raise, torso twist, and squat. Elastic resistance strength exercisers are intended to
of the muscles in the upper body/torso and lower body and the flexibility of the muscles and the joints
muscles.

Elastic resistance strength exercisers designed to provide elastic resistance to muscular contraction in
fingers. Elastic resistance increases as the elastic is stretched. These exercisers are usually made of e
springs. Dedicated exercisers are available in the form of rubber balls, elastic rings, elastic tubes, or e
squeeze these exercisers and/or bend their fingers against the elastic resistance. Hand/finger/wrist ex
to improve the strength of the muscles in the hands, fingers, wrists, and forearms; improve the flexibi
the joints; and increase muscle mass.

Flexibility exercisers designed to improve the range of motion (i.e., flexibility) around a joint by suppo
the user, making it possible to stretch the muscles in the upper limbs and/or trunk. These exercisers a
devices with handlebars or stand-alone exercise workstations. Upper-limb/trunk flexibility exercisers a
the flexibility of the muscles in the upper limbs and/or the trunk; they can increase muscle strength an
and stability. Dedicated flexibility exercisers are available for stretching the upper limbs (e.g., stretch
(e.g., inversion table).
Upper-limb/trunk flexibility exercisers designed to improve the range of motion around a joint by stret
the back while the body is in an inverse (i.e., head down) position; they reduce the stress on the back
gravity compression of the vertebrae. These exercisers usually consist of portable, manually operated
chairs and pivot arms, hand grips, and a footrest; some exercisers are powered by a motor to adjust th
inverse rotations. The user usually lies in the supine or, less frequently, the prone inversion position, k
inversion position (meaning bending 90 degrees at the knees and 90 degrees at the waist). Inverse po
exercisers are intended to improve the flexibility of the muscles in the back and abdomen, increase m
reduce pain and stress on the back.

Flexibility exercisers designed to improve the range of motion (i.e., flexibility) around a joint by suppo
the user, making it possible to stretch the muscles in the lower limbs. These exercisers are usually por
handlebars or stand-alone exercise workstations. Lower-limb flexibility exercisers are intended to impr
the muscles in the lower limbs; they can also increase muscle (e.g., quadriceps, gluteus, hamstring, c
improve balance and stability. Dedicated flexibility exercisers, such as a quadriceps board, and a slant
for stretching the lower limbs.

Flexibility exercisers designed to improve the range of motion (i.e., flexibility) around a joint by suppo
the user, making it possible to stretch any of the major muscle groups in the body. These exercisers ar
devices with handlebars or stand-alone exercise workstations. Full-body flexibility exercisers are inten
flexibility of the muscles in the upper limbs (e.g., shoulder stretch, chest stretch), trunk (e.g., back str
(e.g., quadriceps and/or calf stretch); they may also increase muscle strength and improve balance an

Balance exercisers designed to improve the user's ability to maintain proper posture. These exercisers
wooden or plastic boards with a fulcrum attached below that provides a rocking surface; users try to m
while standing on the unstable surface. Board balance exercisers are used to train for stability and ba
as standing, walking, squatting, or jumping on the boards. They are intended to improve stability, bala
additionally, they can improve muscle strength, endurance, and flexibility in the upper body/torso and

Board balance exercisers designed to improve the user's ability to maintain proper posture. Wobble bo
round, flat, wooden or plastic board with a plastic, semispherical fulcrum attached underneath; they c
multiple angular degrees, and tile angles are also adjustable. Users try to maintain their balance durin
standing on the unstable surface. Wobble-board balance exercisers are used to train for stability and b
that entail standing, walking, or squatting on the boards. They are intended to improve stability, balan
additionally, they can improve muscle strength, endurance, and flexibility in the upper body/torso and

Board balance exercisers designed to improve the user's ability to maintain proper posture. Rocker bo
square or rectangular, wooden board and a wooden or plastic fulcrum attached underneath. Users try
balance while on the unstable surface. Rocker board exercisers are used to train for stability and balan
standing, walking, squatting, or jumping on the boards. Rocker board balance exercisers are intended
balance, and coordination; additionally, they can improve muscle strength, endurance, and flexibility i
and lower body.
Balance exercisers designed to improve the user's ability to maintain proper posture. These exercisers
surfaces in the form of a hollow rubber ball (i.e., a dome) that is inflated with air. Users try to maintain
the unstable surface. Balance dome exercisers are used to train for stability and balance, in exercises
sitting on the domes; they are intended to improve stability, balance, and coordination; additionally, t
muscle strength, endurance, and flexibility in the upper body/torso and lower body.

Balance exercisers designed to improve the user's ability to maintain proper posture. These exercisers
surfaces in the form of round hollow rubber disks that are inflated with air. Users try to maintain their
unstable surface. Balance disk exercisers are used to train for stability and balance in exercises such a
squatting on the disks. Disk balance exercisers are intended to improve stability, balance, and coordin
they can improve muscle strength, endurance, and flexibility in the upper body/torso and lower body.

Balance exercisers designed to improve the user's ability to maintain proper posture. These exercisers
surfaces in the form of a plastic foam cylindrical roller; users try to maintain balance while on the unst
are used to train for stability and balance in exercises such as standing, walking, or jumping on the ro
exercisers are intended to improve stability, balance, coordination, muscle strength, endurance, and fl
body/torso and lower body.

Balance exercisers designed to improve the ability to maintain proper posture by using the unstable s
exercisers usually consist of a synthetic or rubber ball approximately 65 cm in diamter; users try to m
during exercises on the unstable surfaces. Ball balance exercisers are used to train for stability and ba
exercises such as twisting, walking, or sitting on the ball; for flexibility by means of exercises such as
holding, sitting, or lying on the ball; they are also used in strength exercises using the user's own weig
as lying on the ball doing push-ups or holding the ball between the user's back and the wall doing squ
exercisers are intended to improve stability, balance, and coordination; additionally, they can improve
endurance, and flexibility in the upper body/torso and lower body.

Exercisers designed to assess and train patients. These exercisers usually consist of a computerized u
measures, analyzes, and gives real-time feedback on user's performance (e.g., speed, strength, range
or exercise modes, adjusts the pattern of the exercise programs (e.g., temporal sequence, force load,
motion) in real time and a monitor that displays visual biofeedback that users can see and use to adju
according to the exercise. The exercisers may include dedicated devices (e.g., force platform, weight l
aided training exercisers are intended for programmed exercises, training, physical therapy, and reha

Upper-limb continuous passive motion exercisers designed to provide controlled movements (flexion,
and/or rotation) to the shoulder joint without the patient's muscular exertion. These exercisers are typ
controlled electromechanism that is attached to the patient's arm to provide periodic, rhythmic movem
of motion; they are intended to prevent joint stiffness in the shoulder. Shoulder continuous passive mo
used for physical therapy and rehabilitation after illness, trauma, and/or surgical treatment.

Lower-limb continuous passive motion exercisers designed to provide controlled flexion and/or extens
without the patient's muscular exertion. These exercisers are typically an electronically controlled elec
attached to the leg to provide periodic, rhythmic movements through a range of motion; they are inte
stiffness in the knee. Knee continuous passive motion exercisers are used for physical therapy and reh
trauma, and/or surgical treatment.
Gas flowmeters designed to measure the rate of inhaled and/or exhaled gases (i.e., respiratory flow or
lungs. Breathing flowmeters are typically powered instruments, frequently with computerized capabili
flow using electromechanical, laser, electromagnetic, ultrasonic, and/or other techniques. Dedicated b
intended to measure the flow of specific gases (e.g., oxygen, anesthetics), frequently used with or att
part of a particular device (e.g., oxygen cylinder) and/or equipment (e.g., anesthesia machine), are av
instruments intended to measure only the peak expiratory flow are also available, and other devices i
both volume and flow of respiratory gases are usually known as spirometers. Some respiratory gas flo
specifically for use in magnetic resonance imaging [MRI] environments, i.e., MRI-compatible oxygen fl
compatible air flowmeters, and are made from nonmagnetic materials so that they can be safely used

Respiratory flowmeters designed to measure the rate and amount of anesthetic (e.g., nitrous oxide, ha
medical gases delivered to a patient breathing circuit during general anesthesia or diagnostic procedu
are electronic devices with a digital display, which measure flow using electromechanical, electromag
techniques, or variable area flowmeters (also known as rotameters) that consist of a vertical tapered g
cone or ball that is pushed by the moving gas stream and lowered by gravity allowing the measureme
position of the ball in the graduated tube. One or more anesthetics gas flowmeters are typically integr
gas dispensing unit of an anesthesia machine or pulmonary diagnosis equipment; dedicated stand-alo
flowmeters (usually for special evaluations, calibration, and/or research) are also available. Some flow
control valve as an attachment that regulates the flow of the gas delivery.

Respiratory flowmeters designed to measure the flow rate and amount of oxygen delivered to a patien
system or oxygen cylinder via appropriate devices. Oxygen breathing flowmeters are typically mechan
electromechanical instruments that are placed in the low-pressure section of the oxygen supply, usua
regulator in high-pressure oxygen supplies (e.g., high-pressure oxygen cylinders). Oxygen respiration
intended for use with a variety of oxygen-delivery systems, including those that use nasal cannulae or
patient. Some flowmeters may include a control valve as an attachment that regulates the flow of oxy
provide a preestablished constant flow).

Gas flowmeters designed to measure the gas flow rate through pipes or equipment tubing for the insp
maintenance of medical devices. These instruments are typically mechanical or electronic instrument
that may use one of several measuring techniques (e.g., ultrasound, electromagnetic) and different ra
capacity (e.g., 0.1 to 1 L/min for anesthesia units, 1 to 15 L/min for gaseous lasers, 10 to 50 L/min for
250 L/min for medical gas/vacuum systems). Simpler instruments (variable area flowmeters, also know
consisting of a vertical tapered glass tube containing a cone or ball that is pushed by the moving gas
gravity measuring flow by the position of the ball in the graduated tube, are also available. Inspection
flowmeters are used to assess gas circulation during inspection, preventive maintenance, and/or field
devices.
Flowmeters designed to measure the rate and, frequently, the volume of liquid flowing through a pipe
for the inspection and/or maintenance of medical devices. These instruments are typically powered de
measurement of liquid flow, typically in a range up to 10 mL/min, using several techniques (e.g., ultra
electromagnetic). Simpler instruments (variable area flowmeters, also known as rotameters), consistin
glass tube containing a cone or ball that is pushed by the moving fluid stream and lowered by gravity
position of the ball in the graduated tube are also available. Inspection/maintenance liquid flowmeters
liquid circulation during inspection, preventive maintenance, and/or field calibration of medical device
bypass units and infusion pumps.

Flowmeters designed to measure the infusion rate of fluids during gravity intravenous administration.
frequently consist of photometric instruments employing technologies that include light sources and o
the drip chamber and drop-counting algorithms, and displays to show the infusion rate in drops or mL
volume infused in a given time. Infusion rate flowmeters are typically used with gravity administration

Spirometers designed to measure only the maximum volume of gas which can be expired from the lun
vital capacity [EVC]) and/or a few breathing parameters (e.g., forced expiratory volume at 1 and/or 6 s
but not the complete set of parameters needed for complete diagnosis. These spirometers may consis
handheld instruments with a disposable mouthpiece where the person blows and a gauge with an ind
registers the EVC usually up to a limit (e.g., 7 liters) or more elaborate instruments with additional me
Screening spirometers are used to discriminate the pulmonary status in routine tests performed in hos
and the field; some instruments (also known as incentive spirometers) may be used as pulmonary exe

Adult respiratory function mechanics analyzers designed to measure airway volume and airflow throug
including the partition of airflow between the two nasal passages. These analyzers typically consist of
appropriate tubes and nasal adapters that permit the independent measure of the volume of air breat
the nose; usually the ratio of the two volumes is calculated as a measure of the difference between th
nasal partitioning ratio [NPR]). Adult nasal respiratory mechanics analyzers are intended to assess nas
and/or to evaluate the upper airway respiratory cycle.

Manometers designed to measure the pressure in one or more segments of the gastrointestinal (GI) tr
typically consist of a computerized electronic measuring unit, recorders, controls, a display, and a set
(transducer tip, water-perfused, or both) appropriate for pressure measurement in different segments
lower GI tract. The instrument and catheters may permit its configuration according to the particular n
including protocols that can be customized for different tests and/or patients. Dedicated GI tract mano
for assessment of the GI function in specific segments of the tract (e.g., esophagus-stomach, anorecta
sphincter of Oddi) and for the assessment of esophageal and/or colonic motility.

Manometers designed to measure the pressure of liquids, gases, and vapors in medical device and me
system calibration and inspection procedures. These instruments consist of an electronic unit with a d
but possibly analog) that shows pressure values in pounds per square inch (psi), millimeters of mercur
(KPa), or other appropriate units and a transducer that may provide either millivolt, volt (including am
output. The devices usually include attached sensors and pressure transducers. These manometers ar
technical inspections and calibrations and after equipment or system repair; the instruments are not a
measurement of pressure in patients.
Ophthalmic tonometers designed to determine intraocular pressure by measuring the corneal indenta
known weight. These instruments are typically handheld and reusable (known also as Schiotz tonome
body consisting of a cylinder hollow barrel with a movable plunger fixed to a measuring scale that incl
pointer (i.e., needle), a weight screwed in the proximal end of the plunger opposite to the working end
the force produced by the attached weight pressed to the cornea produces a small indentation, the co
is proportional to the intraocular pressure) displaces the plunger upward within the barrel, deflecting t
measuring scale. Indentation ophthalmic tonometers are intended mainly for assessing ocular hyperte
pressure between 10 and 24 mm Hg is considered normal), usually to screen patients for glaucoma.

Ophthalmic tonometers designed to determine intraocular pressure without making contact with the e
applying a small puff of air against the cornea. These instruments (known as air-puff tonometers) have
a small puff of air and a measuring instrument with a pressure-sensing membrane that measures the
the corneal surface, an electronic processing unit, and a display. Noncontact ophthalmic tonometers a
assessing ocular hypertension (intraocular pressure between 10 and 24 mm Hg is considered normal)
patients for glaucoma.

Dressings impregnated or coated with substances (e.g., antimicrobial agents, charcoal, petrolatum, sa
for additional specific functions as well as to cover and protect a wound. These dressings are usually m
materials such as gauze, nonwoven fabric, and alginate that are easily impregnated and/or covered w
substance. Impregnated dressings are used to prevent infection, reduce adhesion, or absorb odors.

Dressings impregnated with saline solution or dry sodium chloride. The substrate of these dressings is
Saline dressings facilitate the cleaning of wound drain exudates, helping to keep debris and bacteria a
moist environment; they are used mainly to treat necrotic or heavily exuding wounds.

Dressings impregnated with activated charcoal. The substrate of these dressings is usually foam, algin
dressings absorb odors, helping to control odor in malodorous wounds.
Dressings impregnated with petrolatum. The substrate of these dressings is usually gauze and nonwo
dressings reduce the adhesion of the dressing to the wound and provide a moist environment; petrola
intended mainly to protect wounds, preventing and/or reducing the formation of scar tissue.

Antimicrobial dressings impregnated with silver. The most common substrates used in these dressings
foam, hydrocolloid, and hydrogel. Silver-impregnated antimicrobial dressings reduce the number of an
microorganisms (e.g., bacteria, fungi, viruses); they are intended mainly to reduce the risk of infection
and skin grafts.
Antimicrobial dressings impregnated with iodine solutions (e.g., povidone-iodine). The most common s
dressings is gauze, but other fabrics are also used. Iodine-impregnated antimicrobial dressings reduce
kill microorganisms (bacteria); they are intended mainly to reduce the risk of infections in wounds and

Antimicrobial dressings impregnated with zinc oxide. The most common substrate used in these dress
other fabrics are also used. Zinc-oxide-impregnated antimicrobial dressings reduce itching and and/or
(e.g., bacteria); they are used mainly to treat eczema or dermatitis.
Antimicrobial dressings impregnated with bismuth tribromophenate (BTP). The most common substrat
dressings is gauze, but other fabrics are also used. BTP-impregnated antimicrobial dressings reduce th
microorganisms (e.g., bacteria); they are intended mainly to reduce the risk of infections in wounds.

Antimicrobial dressings impregnated with two or more agents, either two antimicrobial agents (e.g. m
benzalkonium chloride solution BP) or two agents, one antimicrobial and one that is not (e.g., an antim
charcoal). Any type of substrate may be used. Combined impregnated antimicrobial dressings reduce
kill microorganisms (i.e., bacteria, fungi, viruses); they are intended mainly to reduce the risk of infect
and skin grafts.

Plain (nonimpregnated) dressings designed to cover and protect a wound without any additional funct
are usually made of raw materials such as natural fibers (e.g., cotton, alginate), biological products (e
materials (e.g., polymers), or of materials. Nonimpregnated dressings are used mainly to maintain a m
absorb exudates, and/or to prevent contact with bacteria.
Plain (nonimpregnated) dressings made of materials derived from natural fibers. These dressings are u
made of one or more fibers, including cotton and alginate. Natural fiber dressings are intended to abs
and maintain a moist environment; they are used mainly in wound management.

Natural fiber dressings derived from seaweed containing calcium or sodium salts of alginic acid. These
nonadhesive; they become a hydrophilic gel when in contact with wet wounds. Alginate dressings are
wound exudates and maintain a moist environment; they are used mainly in the wound management.

Natural fiber dressings derived from cotton or natural woven fibers (i.e., gauze). These dressings may
unwoven cotton or other natural fibers (e.g., linen); they are typically available in a variety of shapes
sheets). Cotton/gauze dressings are intended to absorb wound exudates; they are used mainly in wou

Plain (nonimpregnated) dressings made of inert materials of animal and/or human origin. These dress
nonadhesive, typically made of pig and/or human cadaver tissue. Biological dressings are intended to
exudates and promote wound healing; they are frequently used in the management of large skin wou

Biological dressings derived from collagen, a protein obtained from animals such as cows, pigs, and bi
are intended to maintain a moist wound environment, absorb wound exudates, facilitate clotting, and
healing by stimulating fibroblast activities; they are used mainly in wound management.

Biological dressings made of an acellular matrix derived from animal tissues. These dressings are typi
extracellular components (e.g., collagen, proteoglycans, elastins) derived from animal (e.g., pig) or hu
Acellular matrix dressings are intended to maintain a moist wound environment, absorb wound exuda
wound healing; they are used as skin substitutes in the management of wounds such as ulcers.

Plain (nonimpregnated) dressings made of synthetic (e.g., polymers) or semisynthetic materials. Thes
adhesive or nonadhesive, and made of one or more synthetic polymers, including polyethylene and po
dressings are intended to maintain a moist environment, absorb wound exudates and/or prevent the d
with bacteria; they are used in the management of dry or exudative wounds.
Synthetic dressings made of polymers. These dressings may be made of woven or unwoven polymeric
a variety of shapes (e.g., pads, sponges, sheets). Fabric/gauze dressings are intended to absorb woun
used mainly in wound management.
Synthetic dressings made of polymers that combine hydrophilic absorptive ingredients such as carbox
pectin, and an adhesive elastomer (e.g., gelatin). These dressings are self-adhesive; they become a h
when they come into contact with wet wounds. Hydrocolloid dressings are available in wafer, powder
are used in the management of moderately exudative and/or necrotic wounds.

Semisynthetic dressings made of carboxymethylcellulose polymers with substrates that are natural or
dressings are usually available as sheets or ribbons; they may become a hydrophilic occlusive gel whe
contact with wet wounds. Hydrofiber dressings are used mainly in wound management.

Semisynthetic dressings made of a matrix of hydrophilic polymers with high water content (at least 50
dressings typically donate moisture to the wound beds and are permeable to vapors and oxygen but i
Hydrogel dressings are available in the form of amorphous, impregnated sheets; they are used mainly
environment in the management of necrotic wounds.
Synthetic dressings made of a semisynthetic hyaluronic acid, a carbohydrate component of the extrac
carbohydrate component of the extracellular matrix that usually becomes a hydrophilic gel when it co
wet wounds. Hyaluronic acid dressings are intended to absorb wound exudates, to maintain a moist e
promote wound healing; they are used mainly in wound management.
Synthetic dressings made of silicone. These dressings may consist of a plain silicone gel film or a knitt
polymeric, frequently made of polyamide) that is bonded to a layer of soft silicone gel. Silicone dressin
dry skin but not adhesive to wet wounds. Silicone-impregnated dressings are intended mainly to redu
keloid scars.
Plain (nonimpregnated) dressings that combine two or more components of raw materials such as nat
alginate), biological products (e.g., collagen), or synthetic materials (e.g., two or more polymers). Com
intended to maintain a moist environment, absorb wound exudates, prevent contact with bacteria, an
healing; they are used mainly to cover and protect wounds. Frequently available combined dressings
alginate/collagen dressings.

Dressings that combine two or more components that each have a different function. These devices u
several layers of distinct components including bacterail barrier or without an adhesive border; a laye
wound exudates made of materials other than alginate, foam, hydrocolloid, or hydrogel; a layer for wo
or may not be adhesive. Composite dressings are used in the management of complex wounds, such
require wound exudate absorption, maintainance of a moist wound environment, and prevention of co
They usually consist of a bacterial barrier with or without an adhesive border, an absorptive layer othe
foam, hydrocolloid, or hydrogel, and a semi-adherent or non-adherent layer for wound contact. Compo
used in the management of wounds.

Dressings that combine a high percentage of collagen with a small percentage of alginate. Collagen p
healing, and alginate maintains a moist wound environment and absorbs wound exudates. Combined
dressings are used in wound management.
Physiologic analyzers designed to determine gastric accommodation and/or peristaltic motility in som
gastrointestinal (GI) tract, including the esophagus, stomach, and the small and/or large intestines. Th
consist of catheters with one or more balloons that are inflated and/or deflated to maintain constant p
tract and an external electronic unit that regulates the balloon pressure by providing insufflation throu
monitors the balloon pressure, displays and/or records the results, and processes the data to assess th
response and/or motility of the GI tract segment. Barostatic GI analyzers are intended for the determin
motility, accommodation, sensations, and pain thresholds in a section of the GI tract (e.g., colon) and
conditions and/or diseases in the stomach and small intestine, such as proximal gastric motility and ac
response after meals.

Chemical-resistant gloves designed to protect the hands against chemotherapy drugs by offering a hig
permeation by antineoplastic agents. These gloves are typically made of thick plastics (e.g., nitrile, ne
rubber; some are made of combined layers of latex and neoprene; they are available in pairs as sterile
products. Chemotherapy-agent-resistant gloves are used by healthcare personnel (e.g., oncologists, o
pharmacy and laboratory technicians) for protection during the handling and transport of chemothera
cleaning, decontamination, and transport of patients and objects contaminated with this type of drugs

Ultrasonic scanning systems designed to provide high-resolution images of anatomy that is a short dis
(e.g., 1.5 to 6 cm), facilitating access to the vasculature and/or other superficial organs. These scannin
consist of a portable, handheld unit that operates at frequencies from 5 to 12 MHz using dedicated pro
ultrasonic scanners are used mainly to guide placement of needles and/or catheters in the vasculature
or intraoperatively; the scanners may be also used to locate organs and other anatomic structures tha
the body surface.

Electrically (usually battery) powered equipment designed to be attached to healthcare equipment to


inside a healthcare facility. These movers typically consist of a supporting metal structure with an elec
battery; the mover is attached to the frame of the device to be moved, permitting it to be lifted to a p
the floor during transportation. The movers include mechanisms and controls that allow them to tow e
hospital corridors, in rooms, and in lifts; they also include controllers for speed and rotation. Healthcar
are intended to move heavy hospital equipment (e.g., surgical tables, hemodialysis machines, radiolo
with or without the patient; they can facilitate more controlled transport for heavy patients and equipm
operator effort. Dedicated healthcare equipment movers for beds/stretchers, carts, wheelchairs, and o
surgical tables, hemodialysis machines, carts) are available.

Electrically (usually battery) powered equipment designed to be attached to (i.e., hitched) healthcare
to facilitate moving them inside a healthcare facility. These movers typically consist of a supporting m
electric motor, and a battery; the mover is attached to the frame of the bed or stretcher, permitting it
position slightly above the floor during transportation. The movers include mechanisms and controls t
equipment along hospital corridors, in rooms, and in lifts; they also include controllers for speed and r
have capabilities to provide electric power to the bed, stretcher, and associated devices and/or for con
administered to patients. Healthcare bed/stretcher movers are intended to move standard or bariatric
with or without the patient; they can facilitate a more controlled transport for patients and equipment
effort.
Electrically (usually battery) powered equipment designed to be attached to (i.e., hitching) wheelchair
them inside a healthcare facility. These movers typically consist of a supporting metal structure, an el
battery; the mover is attached to the frame of the wheelchair, permitting it to be lifted to a position sl
during transportation. The movers include mechanisms and controls that allow wheelchairs to be towe
corridors, in rooms, and lifts, with rotations of at least 180 degrees; they also include controllers for sp
Healthcare wheelchair movers are intended to move standard or bariatric wheelchairs typically with th
them; they facilitate safer in-hospital transport for patients, reducing operator effort.

Gas delivery systems designed for the intravenous administration of stable (i.e., nonradioactive), met
gas as a tracer. These systems usually consist of an operator console with a digital computer, monitor
that is intended for remote control of a mobile gas delivery unit and a mobile unit used to deliver the
moved around the computed tomography (CT) scanners. Stable xenon gas delivery systems are inten
cerebral blood flow (CBF) in cortical and deep brain tissues using standard CT scanners, especially for
treatment of stroke.

Light (optical) microscopes designed to magnify minute structures (e.g., tooth cavities, gum tissue), w
from 2x to 20x) magnification and focus that are especially suited for dental procedures. These micros
optical stereo microscopes that may be mounted as stand-alone units on the floor, attached to dental
and/or suspended from the ceiling. Still image and/or video cameras are frequently attached to the m
time observation and/or recording of the dental procedure. Examination/operating dental microscope
facilitate a variety of examination, operative, and/or microsurgical dental procedures, including endod
practice, periodontal microsurgery, and restorative dentistry.

Controllers designed to assist disabled individuals remotely control a variety of equipment, usually in
immediate environment. These controllers typically consist of electronic units that interact (e.g., using
infrared energy) with receiving devices interfaced with appliances such as light switches, appliances (
VCRs, CD players, thermostats), and bed and door controls; the controller typically includes a built-in t
Disabled-patient-assistance controllers are intended to help people with different degrees of disability
activities with a high degree of independence. A variety of activation modes for the controllers are ava
switch, voice, head motion, blowing straw-like sensors (i.e., mouth activated), and eye movement trac
of several.

Controllers designed to allow disabled patients to remotely control a variety of equipment, usually loc
immediate environment, which are activated using switch commands. These controllers are typically e
easily accessible and securely mounted switches; they include a menu of commands. The control unit
radiofrequency or infrared energy) with receiving devices interfaced with appliances such as light swit
television sets, VCRs, CD players), and bed and door controls. The controllers typically include a built-
Switch-activated disabled-patient-assistance controllers are intended to help people with different deg
perform daily activities with a high degree of independence. Single-switch devices intended for patien
more elaborated controllers are available.

Devices designed for automated sealing of thermoplastic tubing ends in sterile conditions. These seal
electromechanical devices that include high temperature components (e.g., hot blades, ceramic elem
sealing of thermoplastic tubing in sterile conditions in a non-sterile environment. Dedicated thermopla
available for sterile connection of two lengths of tubing in a single device and to separate single lengt
both with sealed ends.
Thermoplastic tubing sealers designed for automated connection of tubing (i.e., welding) using a steri
sealers typically consist of an electromechanical unit where two lengths of tubing are inserted on two
holders; both thermoplastic tubing ends are cut by a sterile hot disposable blade, automatically aligne
and fused (welded) together as the hot blade moves out. Sterile connection tubing sealers are intende
sterile connection of thermoplastic tubes, forming a single length of tubing in a nonsterile environmen

Thermoplastic tubing sealers designed for the automated sealing of tubing ends that have been cut a
procedure, permanently sealing each segment. These sealers typically consist of an electromechanica
tubing is inserted; the inserted tube is then compressed and heated using two ceramic elements (if liq
be evacuated), producing a segment between the two seals that can be cut (e.g., using scissors) thus
separation (e.g., disconnections between tubing and a plastic bag).

Gas delivery units designed to deliver heliox, a mixture of helium and oxygen (usually 20 to 30% in vo
units should accurately determine the flow and volume of heliox, a low-density and high-thermal-cond
also provide low leakage for very low-density gases, including the gas source (typically a gas cylinder)
for connection to the patient airways (e.g., tubing). Heliox delivery units may also include dedicated s
appropriate algorithms for the automated calculation of heliox flow and volume. The units may be use
intensive care mechanical ventilators that can usually deliver other breathing gases such as oxygen a
noninvasive use through sealed masks to patients that can breathe spontaneously. They are frequentl
nebulizer for additional administration of medications.

Readers designed for automated, passive determination of a radiation dose absorbed by two or more
thermoluminescence dosimeters (TLD) simultaneously. These readers typically include a heating syste
tube, electronic circuits, and dedicated software that may be used in the reader or on an associated c
data acquisition, storage, retrieval, and the sequence of the measurement and assessment procedure
dosimeter identification, date and timing, and reading parameters and possibly other information such
glow curve and the value of the test light. TLD readers are intended for a variety of applications, inclu
planning and total body irradiation dose verifications.

Powered elbow orthoses designed for external modification of the structural and/or functional characte
using power sources (usually electric) and powered mechanisms that respond to muscular bioelectric
signals. They provide support, supplement, and/or augment the elbow functions and/or its structure. T
consist of wearable devices (e.g., braces) that are actuated by the electrical activity (i.e., electromyog
muscles triggered by attempted movement; sensors (e.g., skin electrodes) that detect the biological e
skin; and automated (robotic) devices with very small electric motors that provide actual motion to th
Myoelectric elbow brace orthoses are intended to facilitate patient training guided by a physical thera
and control of weak muscles in the upper limbs caused by physical accidents and/or illness (e.g., after
Implantable prostheses designed to functionally replace the anal sphincter. These prostheses are typic
implantable hydraulic devices with a fluid reservoir (e.g., balloon), a mechanism with a small pump th
situated under the skin, and an inflatable and deflatable cuff that surrounds the anal canal; the compo
connected to each other using silastic tubes. Other devices intended to occlude the bowel by reprodu
puborectal muscle are also available. Anal sphincter prostheses are used to help the patient control m
continence; the cuff remains inflated to maintain continence and is deflated by the user to produce a

External orthopedic fixation systems designed to lengthen and reshape limb bones by means of surgic
systems consist of a set of rings fixed to both extremes of the fractured bone with adjustment devices
regulate the distance between the rings. The rings are periodically separated (e.g., at a rate of 1 mm/
process and bone growth starts, increasing the separation between the extremes of bone, thus promo
and/or reshaping of the fractured bone. A new surgery is needed after complete healing to remove the
lengthening/reshaping orthopedic external fixation systems are intended for the treatment of open an
(e.g., tibia, femur) fractures, especially when lengthening and or reshaping of abnormal limbs is neede

Hemodialysis units designed to replace the main activity of the kidneys by removing large amounts of
wastes. Typically, blood is removed via an extracorporeal circuit, passed through an extracorporeal dia
toxic substances, and returned to the patient. Renal hemodialysis machines are available to perform c
hemodialysis (a procedure known as continuous renal replacement therapy) or as intermittent machin
periods of time (usually over 2 to 4 hours, 3 to 5 times a week).

Hemodialysis units designed for the intermittent replacement of the main activity of the kidneys by re
of water and wastes in short periods of time (usually over 2 to 4 hours, 3 to 5 times a week). Blood is
extracorporeal circuit (typically from an arteriovenous shunt or indwelling central venous catheter); pa
extracorporeal dialyzer that allows the transfer of substances by diffusion and convection to decrease
abnormalities as well as fluid, electrolyte, and acid-base imbalances; and returned to the patient. Thes
three main components: a dialysate delivery system that prepares the dialysate solution and delivers
extracorporeal blood-delivery circuit that circulates a portion of the patient's blood through the dialyze
patient; and a disposable, typically hollow-fiber dialyzer, in which solute exchange takes place. Each c
monitoring and control circuits. Intermittent renal hemodialysis units are intended for intermittent chr
replacement of renal functions in patients with impaired renal function, such as those with end-stage

Implantable devices specifically designed for surgical reconstruction and/or fixation of the foot anatom
typically consist of sterile solid elastomer (e.g., silicone), plastic (e.g., high-molecular-weight polyethy
titanium) or a combination of these materials; the implants may include plates, screws, and other mec
Some implants may consist of or include absorbable biomaterials. Dedicated foot implants are used fo
including fracture repair and hammertoe fixation and correction of subtalar instabilities and/or deform
Foot implants are intended to restore the functional capacity of the feet; they are usually delivered us
designed for each specific type of implant and/or procedure.
Foot implants specifically designed for the repair and/or fixation of foot fractures. These implants typic
plates or variable thicknesses and angle stabilization and a set of screws and other mechanical compo
implants are available for fixation of the posterior portion of the foot, including the talus and calcaneu
Foot implants are also available for fixation of forefoot fractures.

Foot implants designed for the stabilization of the subtalar joint; blocking forward, downward, and me
the talus and allowing normal motion of the joint. These implants are available in several shapes and
plastic (e.g., high-weight polyethylene) angled discs (that may be cemented) that are placed on the su
calcaneus, domes that are placed in a hole in the dorsal surface of the calcaneus, and metal (e.g., tita
that are placed and threaded in the space between the calcaneus and talus (i.e., sinus tarsi). Tempora
known as endorthoses) that are usually threaded in the sinus tarsi, made of a combination of titanium
intended for removal after joint stabilization are also available. Subtarsal foot implants are used in a v
treatments, including for subtalar instability, flat foot, deformities associated with tibial tendon dysfun
pronation.

Kits designed for the delivery of foot implants. These kits typically consist of prepackaged collections
standard) of devices and supplies, including delivery devices (e.g., insertion tool probes); one or more
trial sizers; and solid plastic or metal implants with several mechanical components necessary for the
implants. Dedicated foot implant delivery kits are available for the implantation of devices intended fo
procedures (either open or minimally invasive surgery), such as fracture repair, hammertoe treatment
stabilization.

Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
in appropriate positions. Items in these kits usually consist of delivery devices (e.g., insertion tools); o
guides, and trial sizers; and also solid plastic or metal implants that may include several mechanical c
may be supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle wit
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Foot implant delivery kits and trays are used to facilitate delivery and implantation of foot implants in
procedures using either open or minimally access surgery. Dedicated kits are available to deliver impl
procedures such as fracture fixing, hammertoe treatments, and subtarsal stabilization.

Bladder support implants made of biological tissue, designed for stabilizing the urethrovesical junction
compression of the urethral lumen and support to the urinary bladder. These implants are typically slin
made of biological tissue and may be autografts (e.g., fascia lata, vaginal wall), allografts (usually from
fascia lata, or dermis), or xenografts (e.g., porcine dermis), which are intended for placement during s
transobturator, suprapubic) procedures; some devices are fixed to the posterior pubic bone by sharp-t

Bladder support implants made of bioengineered materials, designed for stabilizing the urethrovesica
compression of the urethral lumen and support to the urinary bladder. These implants consist of a tiss
derived from porcine small intestine submucosa (SIS) that has been mechanically separated from the
layers. SIS consists primarily of acellular collagen, with the original three-dimensional structure of the
collagen remaining intact, which is used as a scaffold for urologic tissue growth. Bioengineered bladde
intended for urethral, pubovaginal placement during surgical (e.g., prepubic, transobturator, suprapub
devices are fixed to the posterior pubic bone by sharp-tipped bone anchors.
Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
appropriate positions according to the intended use. Items in these kits usually consist of the implanta
bladder support slings, cardiac valves, foot implants), instruments for delivery (e.g., inserters, applica
needles, sizers, trial implants), and ancillary devices and/or supplies (e.g., catheters, cannulae, solutio
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Implant delivery kits are available according to the type of surgical procedure to be performed (e.g., o
laparoscopy, catheterization), the natural cavity and/or surgical orifices through which they will be dep
to be implanted.

Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
support implants (typically solid or mesh slings) in appropriate positions. Items in these kits usually co
devices (e.g., needles), one or more dilating tubes, and a solid or mesh sling (i.e., the implant). The ki
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
support implant delivery kits are intended to facilitate delivery and implantation of a urethral sling for
urinary incontinence; dedicated kits intended to deliver implants according to a specific surgical techn
transvaginal, transobturator, suprapubic, prepubic) and a particular type of device are also available.

Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
delivery of solid or mesh sling implants, typically to place them in a midurethral position. Items in thes
of a curved needle that fits behind the pubic bone which is used for implant delivery; one or more dila
minimize tissue damage; and a solid or mesh (frequently synthetic) sling (i.e., the implant). The sling
tab to facilitate its placement. The kits may be supplied in supporting trays (i.e., procedure trays) con
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Transvaginal delivery kits are intended for delive
a urethral sling for the treatment of stress urinary incontinence in female patients.

Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
delivery of solid or mesh sling implants, typically to place them in a midurethral position. Items in thes
of a needle-like hook with a handle (e.g., curved, helical configurations) that facilitates the implant de
incision, the obturator membrane, and around the descending ischiopubic ramus; a dedicated assemb
tightening the sling; and a solid or mesh (e.g., biologic, synthetic) sling (i.e., the implant). The kits ma
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
Transobturator delivery kits are intended for delivery and implantation of a urethral sling for the treatm
incontinence in female patients.
Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
support implants (typically solid or mesh slings) in an appropriate suburethral position. Items in these
one or more curved, needle-like hooks with a handle that facilitates implant delivery thorough the ana
associated loops to facilitate needle engagement, a dedicated assembly (e.g., a sleeve) for carrying a
and a solid or mesh (e.g., synthetic) sling (i.e., the implant). The kits may be supplied in supporting tr
trays) consisting of a flat-bottomed receptacle with a border around the periphery supporting all the in
supplies needed for the procedure; the trays are usually covered or wrapped. Suprapubic delivery kits
delivery and implantation of a urethral sling for the treatment of stress urinary incontinence in female

Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
support implants (typically solid or mesh slings) in an appropriate position outside the pelvic bowl (i.e
these kits usually consist of a curved, needle-like hook with a handle that facilitates the implant delive
dilating tapered tubes that minimize tissue damage, and a solid or mesh (frequently synthetic) sling (
sling may include a center tab to facilitate its placement. The kits may be supplied in supporting trays
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Prepubic delivery kits are intend
implantation of a urethral sling for the treatment of stress urinary incontinence in female patients.

Molecular assay reagents intended to identify mutations in the protein O-mannosyltransferase 1 (POM
chromosome 9q34.1, which encodes for a protein involved in o-mannosylation, an important protein m
be required for normal structure and function of alpha-dystroglycan in muscle and the brain. This gene
identified in patients with Walker-Warburg syndrome (WWS) muscular dystrophy, and muscular dystro
2K.

Molecular assay reagents intended to identify mutations in the POU class 3 homeobox 4 (POU3F4) gen
chromosome Xq21.1, which encodes for a protein that helps regulate the activity of other genes (tran
genetic mutation has been identified in patients with X-linked nonsyndromic deafness type 3 (i.e., DFN

Molecular assay reagents intended to identify mutations in the palmitoyl-protein thioesterase 1 (PPT1)
chromosome 1p32, which encodes for a glycoprotein that removes palmitate groups from cysteine res
proteins. This genetic mutation has been identified in patients with neuronal ceroid-lipofuscinosis (CLN

Molecular assay reagents intended to identify mutations in the perforin 1 (pore forming protein) (PRF1
chromosome 10q22, which encodes for a protein that can create transmembrane tubules and is a com
granules that can cause apoptosis in a variety of target cells. This protein is known to be a key effecto
and natural killer-cell-mediated cytotoxicity. This genetic mutation has been identified in patients with
hemophagocytic lymphohistiocytosis type 2.

Molecular assay reagents intended to identify mutations in the protein kinase, cAMP-dependent, regul
(tissue specific extinguisher 1) (PRKAR1A) gene, located at chromosome 17q23-q24, which encodes fo
of protein kinase A (PKA). PKA is activated by the second messenger cAMP and has a variety of import
genetic mutation has been identified in patients with familial myxoma (Carney complex type 1, CNC1)
Molecular assay reagents intended to identify mutations in the protein kinase C, gamma (PRKCG) gen
chromosome 19q13.4, which encodes for a calcium-activated and phospholipid-dependent enzyme an
involved in diverse cellular signaling pathways. The enzyme of this gene is expressed solely in the bra
its localization is restricted to neurons. This genetic mutation has been identified in patients with spin
14; mutations are also associated with axial myoclonus, cerebellar atrophy, cognitive deficit, tremor, a

Molecular assay reagents intended to identify mutations in the prion protein (PRNP) gene, located at c
p12, which encodes for the prion protein that has been implicated in various types of transmissible ne
spongiform encephalopathies. This genetic mutation has been identified in patients with genetically tr
diseases such as familial Creutzfeldt-Jakob disease (fCJD), Gerstmann-Straussler-Scheinker (GSS) synd
familial insomnia (FFI).

Molecular assay reagents intended to identify mutations in the prophet of Pit1, paired-like homeodom
(PROP1) gene, located at chromosome 5q35.3, which encodes for a protein with both DNA-binding and
activation activity. This genetic mutation has been identified in patients with combined pituitary horm

Molecular assay reagents intended to identify mutations in the PRP3 pre-mRNA processing factor 3 ho
gene, located at chromosome 1q21.1, which encodes for a protein that participates in premessenger
genetic mutation has been identified in patients with retinitis pigmentosa type 18 (RP18).

Molecular assay reagents intended to identify mutations in the PRP8 pre-mRNA processing factor 8 ho
gene, located at chromosome 17p13.3, which encodes for a protein that is essential for the catalytic s
splicing process. This genetic mutation has been identified in patients with retinitis pigmentosa type 1

Molecular assay reagents intended to identify mutations in the protease, serine, 1 (trypsin 1) (PRSS1)
chromosome 7q35, which encodes for an enzyme that hydrolyzes peptide bonds. This genetic mutatio
in patients with trypsinogen deficiency and hereditary (chronic) pancreatitis.
Molecular assay reagents intended to identify mutations in the periaxin (PRX) gene, located at chromo
which encodes for the protein periaxin, required for the maintenance of myelin; research suggests tha
the myelin. This genetic mutation has been identified in patients with demyelinating peripheral neuro
Charcot-Marie-Tooth disease type 4) and with Dejerine-Sottas neuropathy.

Molecular assay reagents intended to identify mutations in the prosaposin (PSAP) gene, located at chr
which encodes for a protein involved in multiple biologic functions of the nervous and reproductive sy
mutation has been identified in patients with variants of (i.e., atypical) Gaucher's disease and metach
leukodystrophy; mutations are also present in complex sphingolipidosis with fatal infantile glycogen st

Molecular assay reagents intended to identify mutations in the presenilin 1 (PSEN1) gene, located at c
which encodes for the protein presenilin 1 that helps process certain proteins important for transmittin
from the cell membrane into the nucleus of the cell. Genetic mutations are associated with early-onse
disease type 3.
Molecular assay reagents intended to identify mutations in the presenilin 2 (PSEN2) gene, located at c
which encodes for the protein presenilin 2, involved in processing certain proteins important for transm
signals from the cell membrane into the nucleus of the cell. Genetic mutations are associated with fam
disease type 4.
Molecular assay reagents intended to identify mutations in the patched homologue (PTCH) gene, locat
9q22.3, which encodes for a protein implicated in the formation of embryonic structures and in tumori
functions as a tumor suppressor. This genetic mutation has been identified in patients with holoprose
basal cell carcinoma syndrome (NBCSS), also known as Gorlin's syndrome.

Molecular assay reagents intended to identify mutations in the phosphatase and tensin homologue (P
chromosome 10q23.3, which encodes for a protein that acts as a tumor suppressor. This genetic muta
identified in patients with PTEN hamartoma tumor syndrome (PHTS), a family of diseases that include
(CS), Bannayan-Riley-Ruvalcaba syndrome (BRRS), Proteus syndrome (PS), and Proteus-like syndrome
by similar but not all Proteus syndrome features.

Molecular assay reagents intended to identify mutations in the protein tyrosine phosphatase, nonrece
gene, located at chromosome 12q24.1, which encodes for a protein that generates signals within a ce
cells function and how often they divide. This is an oncogene. This genetic mutation has been identifie
Noonan's syndrome type 1, Noonan-like/multiple giant-cell lesion syndrome, and with a disease chara
lentigines, electrocardiographic conduction abnormalities, ocular hypertelorism, and pulmonary steno
(also known as LEOPARD syndrome).

Molecular assay reagents intended to identify mutations in the peroxisomal membrane protein 3, 35kD
located at chromosome 8q21.1, which encodes for a protein required for peroxisome biogenesis. The p
involved in peroxisomal matrix protein import. This genetic mutation has been identified in patients w
syndrome spectrum, including three well-differentiated forms: Zellweger syndrome (ZS), neonatal adr
(NALD), and infantile Refsum's disease (IRD).

Molecular assay reagents intended to identify mutations in the peroxisomal biogenesis factor 5 target
(PEX5) (formerly PXR1) gene, located at chromosome 12p13.3, which encodes for a protein involved in
import. This genetic mutation has been identified in patients with Zellweger syndrome.

Molecular assay reagents intended to identify mutations in the muscle glycogen phosphorylase (PYGM
chromosome 11q12-q13.2, which encodes for a protein that catalyzes the hydrolysis of intracellular gl
mutation has been identified in patients with hereditary glycogen storage disease type V (McArdle's d

Molecular assay reagents intended to identify mutations in the retinoblastoma 1 (RB1) gene, located a
13q14.2, a key regulator of cell division initiation that acts as a tumor suppressor. This genetic mutatio
in patients with retinoblastoma.
Molecular assay reagents intended to identify mutations in the peripherin 2 (retinal degeneration, slow
RDS) gene, located at chromosome 6p21.2-p12.3, which encodes for a protein that mediates signal tr
involved in photoreceptor disk morphogenesis. This genetic mutation has been identified in patients w
dominant retinitis pigmentosa, progressive macular degeneration, macular dystrophy, and digenic ret

Molecular assay reagents intended to identify mutations in the RecQ protein-like 4 (RECQL4) gene, loc
8q24.3, whose exact function is not known but appears to maintain the stability of cellular DNA in rep
genetic mutation has been identified in patients with Rothmund-Thompson syndrome and Baller-Gerol
Molecular assay reagents intended to identify mutations in the rhodopsin (opsin 2, rod pigment) (RHO
chromosome 3q21-q24, which encodes for a rod photoreceptor-specific protein that, when photo-excit
transduction cascade. This genetic mutation has been identified in patients with retinitis pigmentosa t

Molecular assay reagents intended to identify mutations in the retinaldehyde binding protein 1 (RLBP1
chromosome 15q26, which encodes for a protein that may be a functional component of the visual cy
mutation has been identified in patients with inherited retinitis pigmentosa of Bothnia type.

Molecular assay reagents intended to identify mutations in the ribonuclease L (2',5'-oligoisoadenylate


dependent) (RNASEL) gene, located at chromosome 1q25, which encodes for a component of the inte
functions in the antiviral and antiproliferative roles of the interferon response. This genetic mutation h
patients with familial prostate cancer type 1.
Molecular assay reagents intended to identify mutations in the retinitis pigmentosa 1 (RP1) gene, loca
8q11-q13, which encodes for a protein that has an important but unknown role in photoreceptor biolo
mutation has been identified in patients with retinitis pigmentosa type 1 (RP1).

Molecular assay reagents intended to identify mutations in the retinal pigment epithelium-specific pro
gene, located at chromosome 1p31. These genetic mutations have been indentified in patients with L
amaurosis.
Molecular assay reagents intended to identify mutations in the retinitis pigmentosa GTPase regulator i
(RPGRIP1) gene, located at chromosome 14q11, which encodes for a protein involved in normal disk m
genetic mutations have been identified in patients with Leber's congenital amaurosis.

Molecular assay reagents intended to identify mutations in the ribosomal protein S6 kinase, 90kDa, po
gene, located at chromosome Xp22.13, which encodes for ribosomal protein S6 kinase 2 that helps re
other genes and signaling within the cell. These proteins are involved in cell proliferation, differentiati
These genetic mutations have been identified in patients with X-linked inherited Coffin-Lowry syndrom

Molecular assay reagents intended to identify mutations in the retinoschisin 1 (RS1) gene, located at c
p22.1, which encodes for a secreted protein crucial to the cellular organization of the retina. This gene
identified in patients with X-linked inherited juvenile retinoschisis.
Molecular assay reagents intended to identify mutations in the ryanodine receptor 1 (skeletal) (RYR1)
chromosome 19q13.1, which encodes for a receptor found in skeletal muscle. The encoded protein fun
release channel. Inherited genetic mutations are associated with congenital myopathies, including cen
(CCD) and multiminicore diseases (MmD); mutations are also associated with malignant hyperthermia

Molecular assay reagents intended to identify mutations in the ryanodine receptor 2 (cardiac) (RYR2) g
chromosome 1q42.1-q43, which encodes for a receptor found in cardiac muscle. The encoded protein
components of a calcium channel. This genetic mutation has been identified in patients with arrhythm
ventricular dysplasia 2.
Molecular assay reagents intended to identify mutations in the sacsin (SACS) gene, located at chromo
encodes for a protein found in the brain, skin cells, skeletal muscle, and pancreas that may function in
protein folding, but its exact function is unknown. These inherited genetic mutations have been identi
spastic ataxia of Charlevoix-Saguenay (ARSACS).
Molecular assay reagents intended to identify mutations in the sal-like 4 (SALL4) gene, located at chro
q13.2, which is part of a gene family that encodes for proteins involved in formation of tissue and orga
This genetic mutation has been identified in patients with SALL4-related disorders, a spectrum of dise
Duane and anomaly radial-ray malformation (DARRM/Okihiro syndrome), acro-renal-ocular syndrome,
Holt-Oram syndrome.

Molecular assay reagents intended to identify mutations in the sodium channel, voltage-gated, type IV
(SCN4A) gene, located at chromosome 17q23-q25.3, which encodes for the alpha subunit of a voltage
channel. This genetic mutation has been identified in patients with hyperkalemic periodic paralysis, hy
paralysis, and paramyotonia congenita.
Molecular assay reagents intended to identify mutations in the sodium channel, voltage-gated, type V
(SCN5A) gene, located at chromosome 3p21, which encodes for a protein that encodes the alpha subu
sodium channel found primarily in cardiac muscle. This inherited genetic mutation has been identified
Brugada (long QT syndrome 3) syndrome and Romano-Ward syndrome (RWS).

Molecular assay reagents intended to identify mutations in the succinate dehydrogenase complex, sub
(SDHB) gene, located at chromosome 1p36.1-p35, which encodes for succinate dehydrogenase compl
involved in the oxidation of succinate. This genetic mutation has been identified in patients with succi
complex B deficiency, associated with carotid body tumors, pheochromocytoma, and early-onset rena

Molecular assay reagents intended to identify mutations in the succinate dehydrogenase complex, sub
membrane protein (SDHD), located at chromosome 11q23, which encodes for succinate dehydrogena
an integral membrane protein. This genetic mutation has been identified in patients with carcinoid tum
cell carcinoma, paraganglioma and gastric stromal sarcoma, and pheochromocytoma.

Molecular assay reagents intended to identify mutations in the trafficking protein particle complex 2 (
SEDL) gene, located at chromosome Xp22, which encodes for a protein thought to be part of a large m
involved in the targeting and fusion of endoplasmic reticulum-to-Golgi transport vesicles with their ac

Molecular assay reagents intended to identify mutations in the serine (or cysteine) proteinase inhibito
(SERPINA1) gene, located at chromosome 14q32.1, which encodes for a protein that controls trypsin a
activity. This genetic mutation has been identified in patients with alpha-1-antitypsin deficiency, assoc
emphysema, neonatal hepatitis, chronic cirrhosis, and chronic obstructive pulmonary disease.

Molecular assay reagents intended to identify mutations in the sarcoglycan, alpha (50kDa dystrophin-
glycoprotein) (SGCA) gene, located at chromosome 17q21, which encodes for a member of a multisub
necessary for the stability of muscle fiber membranes and to link the actin cytoskeleton to the extrace
genetic mutation has been identified in patients with Duchenne-like muscular dystrophy type 2.

Molecular assay reagents intended to identify mutations in the sarcoglycan, beta (43kDa dystrophin-a
(SGCB) gene, located at chromosome 4q12, which encodes for a member of a multisubunit protein co
structural linkage between the subsarcolemmal cytoskeleton and the extracellular matrix of muscle ce
genetic mutation has been identified in patients with limb-girdle muscular dystrophy type 2E.
Molecular assay reagents intended to identify mutations in the sarcoglycan, delta (35kDa dystrophin-a
glycoprotein) (SGCD) gene, located at chromosome 5q33-q34, which encodes for part of a multisubun
forms a link between the F-actin cytoskeleton and the extracellular matrix. The protein encoded by th
most often in skeletal and cardiac muscle. This genetic mutation has been identified in patients with d
type 1L and muscular dystrophy, limb-girdle type 2F.

Molecular assay reagents intended to identify mutations in the sarcoglycan, epsilon (SGCE) gene, loca
7q21, which encodes for a member of a multisubunit protein complex necessary for the stability of mu
and to link the actin cytoskeleton to the extracellular matrix. This genetic mutation has been identifie
myoclonus dystonia (dystonia type 11, DYT11).
Molecular assay reagents intended to identify mutations in the sarcoglycan, gamma (35kDa dystrophi
glycoprotein) (SGCG) gene, located at chromosome 13q12, which encodes for a member of a multisub
necessary for the stability of muscle fiber membranes and to link the actin cytoskeleton to the extrace
inherited genetic mutation has been identified in patients with muscular dystrophy, limb-girdle type 2

Molecular assay reagents intended to identify mutations in the SH2 domain protein 1A (SH2D1A) gene
chromosome Xq25-q26, which encodes for a protein with a major role in bidirectional stimulation of T
inherited genetic mutation has been identified in patients with X-linked type 1 lymphoproliferative syn

Molecular assay reagents intended to identify mutations in the sonic hedgehog homologue (SHH) gen
chromosome 7q36, which encodes for a protein that is important in embryonic development and diffe
inherited genetic mutation has been identified in patients with ocular coloboma, holoprosencephaly ty

Molecular assay reagents intended to identify mutations in the sine oculis homeobox homologue 3 (SI
chromosome 2p16-p21, which encodes for a protein involved in the regulation of eye development. Th
mutation has been identified in patients with holoprosencephaly-2.
Molecular assay reagents intended to identify mutations in the solute carrier family 12 (sodium/chlorid
member 3 (SLC12A3) gene, located at chromosome 16q13, which encodes for a protein that acts as a
mediating sodium-chloride reabsorbtion in the distal convoluted tubule of the kidney. This inherited ge
been identified in patients with familial hypokalemia-hypomagnesemia (Gitelman's syndrome).

Molecular assay reagents intended to identify mutations in the solute carrier family 17 (anion/sugar tr
(SLC17A5) gene, located at chromosome 6q14-q15, which encodes for a protein that moves free sialic
lysosomes to other parts of the cell. This inherited genetic mutation has been identified in patients wi
storage disorders, including early-onset (neonatal) severe infantile free sialic acid storage disease (ISS
Salla disease.

Molecular assay reagents intended to identify mutations in the solute carrier family 22 (organic cation
18 (SLC22A1L) gene, located at chromosome 11p15.5, which may be involved in malignancies and dis
11p15.5 tumor suppressor gene region as well as the transport of chloroquine- and quinidine-related c
kidney. Anomalies in this gene are associated with several malignances and diseases, including Beckw
syndrome.

Molecular assay reagents intended to identify mutations in the solute carrier family 25 (mitochondrial
deoxynucleotide carrier), member 19 (SLC25A19) gene, located at chromosome 17q25.3, which encod
transports thiamine pyrophosphate into the mitochondria. This inherited genetic mutation has been id
with Amish lethal microcephaly.
Molecular assay reagents intended to identify mutations in the solute carrier family 26 (sulfate transp
(SLC26A2) gene, located at chromosome 5q31-q34, which encodes for a protein that transports ions, p
ions, across cell membranes. This inherited genetic mutation has been identified in patients with diast
and atelosteogenesis type 2 (AO2, also known as neonatal osseous dysplasia type I).

Molecular assay reagents intended to identify mutations in the solute carrier family 26, member 4 (SL
at chromosome 7q31, which encodes for a transport protein that is a sodium-independent transporter
and is active in the thyroid, kidney, and inner ear. This inherited genetic mutation has been identified
nonsyndromic deafness.
Molecular assay reagents intended to identify mutations in the solute carrier family 2 (facilitated gluco
member 1 (SLC2A1) gene, located at chromosome 1p35-p31.3, which encodes for a major glucose tra
mammalian blood-brain barrier. This inherited genetic mutation has been identified in patients with gl
1 deficiency syndrome.
Molecular assay reagents intended to identify mutations in the survival of motor neuron 1, telomeric (
chromosome 5q12.2-q13.3, which is part of a 500 kb inverted duplication on chromosome 5q13 that c
genes and is prone to rearrangements. The gene encodes for a protein that localizes to both the cytop
This inherited genetic mutation is associated with spinal muscular atrophy (SMA), a continuum range
(neonatal to young adult) disorders.

Molecular assay reagents intended to identify mutations in the synuclein, alpha (non A4 component o
(SNCA) gene, located at chromosome 4q22, which encodes for a protein that may integrate presynapt
membrane transport of dopamine. This inherited genetic mutation has been identified in patients with
disease.
Molecular assay reagents intended to identify mutations in the superoxide dismutase 1, soluble (SOD1
chromosome 21q22.1, which encodes for a protein that is one of two isozymes responsible for destroy
radicals in the body. This inherited genetic mutation has been identified in patients with amyotrophic
also known as Lou Gehrig's disease.
Molecular assay reagents intended to identify mutations in the spastin (SPAST) gene, located at chrom
which encodes for a protein that is involved many cell activities, including membrane transport, intrac
organelle biogenesis, protein folding, and proteolysis. This inherited genetic mutation has been identifi
hereditary spastic paraplegia type 4 (SPG4).
Molecular assay reagents intended to identify mutations in the spastic paraplegia 20, spartin (SPG20)
chromosome 13q13.3, which encodes for a protein that may be involved in endosomal transport, micr
both. This inherited genetic mutation has been identified in patients with Troyer syndrome (hereditary
type 20).
Molecular assay reagents intended to identify mutations in the spastic paraplegia 3A, atlastin (SPG3A)
chromosome 14q22.1, which encodes for a protein that may be involved in axonal maintenance. This
mutation has been identified in patients with spastic paraplegia type 3A.
Molecular assay reagents intended to identify mutations in the spastic paraplegia 7, paraplegin (SPG7
chromosome 16q24.3, which encodes for a subunit of the m-AAA protease that is localized to the inne
membrane and functions as a chaperone to facilitate protein folding as well as proteolytic degradation
This inherited genetic mutation has been identified in patients with spastic paraplegia type 7 (HSP7).
Molecular assay reagents intended to identify mutations in the serine protease inhibitor, Kazal type 1
at chromosome 5q32, which encodes for a trypsin inhibitor that may prevent trypsin-catalyzed prema
zymogens. This inherited genetic mutation has been identified in patients with chronic pancreatitis.

Molecular assay reagents intended to identify mutations in the serine palmitoyltransferase, long chain
(SPTLC1) gene, located at chromosome 9q22.1-q22.3, which encodes for a subunit of the primary enz
sphingolipid synthesis. This inherited genetic mutation has been identified in patients with hereditary
type 1 (HSN1).
Molecular assay reagents intended to identify mutations in the sex determining region Y (SRY) gene, l
Yp11.3, which encodes for a transcription regulator protein that is the controlling genetic "switch" in m
inherited genetic mutation has been identified in patients with gonadal dysgenesis XY female type (Sw

Molecular assay reagents intended to identify mutations in the serine/threonine kinase 11 (STK11) ge
chromosome 19p13.3, which encodes for a member of the serine/threonine kinase family, regulates c
functions as a tumor suppressor. This inherited genetic mutation has been identified in patients with P
(PJS).
Molecular assay reagents intended to identify mutations in the T-box 5 (TBX5) gene, located at chrom
encodes for a protein that is involvd in the formation of tissues and organs during embryonic developm
proteins function as transcription factors. This inherited genetic mutation has been identified in patien
syndrome.
Molecular assay reagents intended to identify mutations in the Treacher Collins-Franceschetti syndrom
located at chromosome 5q32-q33.1, which encodes for a nucleolar protein that is involved in ribosoma
transcription and may be fundamental in early embryonic development, particularly in development o
complex. This inherited genetic mutation has been identified in patients who have Treacher Collins syn

Molecular assay reagents intended to identify mutations in the T-cell receptor beta locus (TCB2) (form
gene, located at chromosome 7q34, which encodes for a protein T-cell receptor beta chain. These gen
been identified in patients with and are used as markers of lymphomas and leukemias.

Molecular assay reagents intended to identify mutations in the T cell receptor delta locus (TRB2) (form
located at chromosome 14q11.2, which encodes for the protein T-cell receptor delta chains. These gen
been identified in patients with and are used as markers of lymphomas and leukemias.

Molecular assay reagents intended to identify mutations in the T cell receptor gamma locus (TCG2) (fo
located at chromosome 7p15-p14, which encodes for the protein T-cell receptor gamma chains. These
have been identified in patients with and are used as markers of lymphomas and leukemias.

Molecular assay reagents intended to identify mutations in the transforming growth factor, beta 1 (TG
chromosome 19q13.1-q13.2, which encodes for a multifunctional protein that controls proliferative diff
functions in many types of cell. This inherited genetic mutation is associated with progressive diaphys
(Camurati-Engelmann disease).
Molecular assay reagents intended to identify mutations in the TGFB-induced factor homeobox 1) (TG
gene, located at chromosome 18p11.3, which encodes for a protein that is a transcription regulator. T
mutation has been identified in patients with early-onset holoprosencephaly-4.
Molecular assay reagents intended to identify mutations in the transglutaminase 1 (K polypeptide epid
glutamine-gamma-glutamyltransferase) (TGM1) gene, located at chromosome 14q11.2, which encode
protein that catalyzes the cross-linking of proteins and the conjugation of polyamines to proteins. This
mutation has been identified in patients with autosomal recessive congenital ichthyosis (ARCI).

Molecular assay reagents intended to identify mutations in the tyrosine hydroxylase (TH) gene, locate
encodes for a protein which is involved in the conversion of tyrosine to dihydroxyphenylalanine (DOPA
genetic mutation has been identified in patients with autosomal recessive Segawa syndrome, a DOPA

Molecular assay reagents intended to identify mutations in the translocase of inner mitochondrial mem
(yeast) (TIMM8A) gene, located at chromosome Xq22.1, which is a mitochondrial intermembrane chap
in the import and insertion of multipass transmembrane proteins into the mitochondrial inner membra
inherited genetic mutation has been identified in patients with Mohr-Tranebjaerg syndrome, also know
syndrome or X-linked recessive deafness type 1.

Molecular assay reagents intended to identify mutations in the tumor protein p53 (TP53) gene, located
17p13.1, which encodes for a protein that acts as a tumor suppressor and induces cellular apoptosis.
mutation and/or genetic anomalies have been identified in patients with many types of cancers.

Molecular assay reagents intended to identify mutations in the thiopurine S-methyltransferase (TPMT)
chromosome 6p22.3, which encodes for an enzyme that metabolizes thiopurine drugs. Genetic polym
this enzymatic activity are correlated with variations in sensitivity and toxicity to such drugs within ind
mutation has been identified in patients with thiopurine S-methyltransferase deficiency.

Molecular assay reagents intended to identify mutations in the tripeptidyl peptidase I (TPP1) gene, loc
11p15, which encodes for an enzyme that acts as a nonspecific lysosomal peptidase. This inherited ge
been identified in patients with neuronal ceroid-lipofuscinosis (NCL).
Molecular assay reagents intended to identify mutations in the tuberous sclerosis 1 (TSC1) gene, locat
9q34, which is implicated as a tumor suppressor. This inherited genetic mutation has been identified i
tuberous sclerosis type 1; it is also associated with focal cortical dysplasia of Taylor balloon cell subtyp
and lymphangiomyomatosis in females.
Molecular assay reagents intended to identify mutations in the tuberous sclerosis 2 (TSC2) gene, locat
16p13.3, which is implicated as a tumor suppressor and may be involved in cell growth, arrest, and tra
by steroid receptors. This inherited genetic mutation has been identified in patients with tuberous scle

Molecular assay reagents intended to identify mutations in the titin (TTN) gene, located at chromosom
encodes for a key component in the assembly and function of striated muscle. This inherited genetic m
identified in patients with udd distal myopathy; it is also associated with familial hypertrophic cardiom
(CMH9).
Molecular assay reagents intended to identify mutations in the transthyretin (prealbumin) (TTR) gene,
chromosome 18q12.1, which encodes for the protein transthyretin that transports thyroxine and retino
These inherited genetic mutations have been identified in patients with transthyretin
Molecular assay reagents intended to identify mutations in the twist homologue 1 (TWIST1) gene, loca
7p21.2, which encodes for a probable transcription factor that may be involved in the negative regula
determination and in the differentiation of several lineages including myogenesis, osteogenesis, and n
inherited genetic mutation has been identified in patients with acrocephalosyndactyly type III syndrom
Chotzen's or Saethre-Chotzen syndrome); it is also associated with craniosynostosis combined with ra
Gerold syndrome).

Molecular assay reagents intended to identify mutations in the tyrosinase (oculocutaneous albinism IA
at chromosome 11q14-q21, which encodes for a copper-containing oxidase that functions in the forma
as melanins and other polyphenolic compounds. This inherited genetic mutation has been identified in
oculocutaneous albinism (tyrosinase negative) types 1A (OCA1A) or 1B (OCA1B).

Molecular assay reagents intended to identify mutations in the ubiquitin protein ligase E3A (human pa
associated protein) (UBE3A) gene, located at chromosome 15q11-q13, which encodes for an E3 ubiqu
UBE3A is one of many E3 ubiquitin ligases that provide target specificity for the polyubiquitination-init
degradation pathway. This inherited genetic mutation has been identified in patients with Angelman's

Molecular assay reagents intended to identify mutations in the UDP glycosyltransferase 1 family, poly
gene, located at chromosome 2q37, which encodes for an enzyme that is important in the conjugation
toxic xenobiotics and endogenous compounds. This inherited genetic mutation has been identified in
Najjar syndrome types I and II.
Molecular assay reagents intended to identify mutations in the uroporphyrinogen decarboxylase (URO
chromosome 1p34.1, which encodes for an enzyme that is responsible for one step in the heme biosy
inherited genetic mutation has been identified in patients with familial porphyria cutanea tarda (PCT),
porphyria cutanea tarda type II.
Molecular assay reagents intended to identify mutations in the Usher syndrome 2A (USH2A) gene, loc
1q41, which encodes for a protein that is an important component of basement membranes and whos
established. This inherited genetic mutation has been identified in patients with Usher's syndrome typ
associated with nonsyndromic retinitis pigmentosa (type 15).
Molecular assay reagents intended to identify mutations in the von Hippel-Lindau tumor suppressor (V
chromosome 3p26-p25, a tumor which makes a protein that is part of a complex (VCB) that targets ot
broken down in the cell. This inherited genetic mutation has been identified in patients with clear cell
Hippel-Lindau syndrome; it is also associated with hereditary renal cell carcinoma and polycythemia.

Molecular assay reagents intended to identify mutations in the vitelliform macular dystrophy protein 2
bestrophin) (BEST1) (formerly VMD2) gene, located at chromosome 11q13, which encodes for a protei
is not known but that appears to be critical to normal vision. This inherited genetic mutation has been
with vitelliform macular dystrophy type 2.
Molecular assay reagents intended to identify mutations in the Wiskott-Aldrich syndrome (WAS) gene,
chromosome Xp11.4-p11.21, which encodes for one of a family of proteins involved in the transductio
receptors on cell surfaces to the actin cytoskeleton. This X-linked inherited genetic mutation has been
with WAS-related disorders, a spectrum of early (infant) onset disorders of the hematopoietic cells in m
Molecular assay reagents intended to identify mutations in the Wolfram syndrome 1 (wolframin) (WFS
chromosome 4p16, which encodes for a transmembrane protein that participates in the regulation of c
homeostasis by modulating the filling state of the endoplasmic reticulum Ca(2+) store. This inherited
been identified in patients with nonsyndromic deafness; it is also associated with Wolfram syndrome.

Molecular assay reagents intended to identify mutations in the Wilms tumor 1 (WT1) gene, located at
which encodes for a transcription factor essential to the normal development of the urogenital system
mutation has been identified in patients with predisposition to Wilms' tumor (nephroblastoma) type 1
associated with Denys-Drash and Frasier syndromes.
Molecular assay reagents intended to identify mutations in the Zic family member 2 (ZIC2) gene, loca
13q32, which encodes for a protein that functions as a transcriptional repressor and may regulate tiss
of the dopamine receptor D1. This inherited genetic mutation has been identified in patients with earl
holoprosencephaly-5.
Molecular assay reagents intended to identify the number of copies of a sequence of three-letter word
trinucleotide repeats in a gene's DNA. A variation from the normal number of trinucleotide repeat copi
altered DNA and improper gene functioning, resulting in full mutation. Mutations in specific genes are
particular diseases, including spinocerebellar ataxia, fragile X syndrome, and Friedreich's ataxia.

Molecular assay reagents intended to identify the number of copies of a CAG trinucleotide repeat in a
variation from the expected number of normal CAG trinucleotide repeats produces altered DNA and im
functioning, resulting in full mutation. CAG trinucleotide repeats in specific genes are related to partic
spinocerebellar ataxia type 3 and Huntington's disease.
Molecular assay reagents intended to identify CAG repeats in the atropin 1 (ATN1) gene, located at ch
which provides instructions for making a protein called atropin 1. Normal alleles have from 6 to 35 CA
A variation from the expected number of normal CAG trinucleotide repeat copies may produce altered
gene functioning, resulting in full mutation. Alleles with 43 to 93 CAG trinucleotide repeats have been
dentatorubral-pallidoluysian atrophy (dyssynergia cerebellaris progressiva).

Molecular assay reagents intended to identify CAG repeats in the calcium channel, voltage-dependent
subunit (CACNA1A) gene, located at chromosome 19p13. Normal alleles have from 4 to 18 CAG repea
expected number of normal CAG trinucleotide repeat copies may produce altered DNA and improper g
resulting in full mutation. Alleles with 20 to 30 CAG trinucleotide repeats have been associated with sp
type 6 (SCA6).

Molecular assay reagents intended to identify CAG repeats in the androgen receptor (AR) gene, locate
Xq11-q12. A variation from the expected number of normal CAG trinucleotide repeat copies may prod
improper gene functioniing, resulting in full mutation. Normal alleles have from10 to 36 CAG repeats.
more than 60 CAG trinucleotide repeats have been associated with spinobulbar muscular atrophy (Ken

Molecular assay reagents intended to identify CAG repeats in the ataxin 1 (ATXN1) gene, located at ch
variation from the expected number of normal CAG trinucleotide repeat copies may produce altered D
functioning, resulting in full mutation. Normal alleles have from 6 to 44 CAG repeats which are interru
trinucleotide repeats. Alleles with more than 39 uninterrupted CAG trinucleotide repeats have been as
spinocerebellar ataxia type 1 (SCA1).
Molecular assay reagents intended to identify CAG repeats in the ataxin 2 (ATXN2) gene, located at ch
variation from the expected number of normal CAG trinucleotide repeat copies may produce altered D
functioning, resulting in full mutation. Normal alleles have 31 or fewer CAG trinucleotide repeats. Allel
CAG trinucleotide repeats have been associated with spinocerebellar ataxia type 2 (SCA2).

Molecular assay reagents intended to identify CAG repeats in the ataxin 3 (ATXN3) gene, located at ch
q32.1. Normal alleles have from 13 to 36 CAG trinucleotide repeats. A variation from the expected num
trinucleotide repeat copies may produce altered DNA and improper gene functioning, resulting in full m
from 68 to 79 CAG trinucleotide repeats have been associated with spinocerebellar ataxia type 3 (SCA
Machado-Joseph disease).

Molecular assay reagents intended to identify CAG repeats in the ataxin 7 (ATXN7) gene, located at ch
p12. Normal alleles have from 7 to 17 CAG trinucleotide repeats. A variation from the expected numbe
trinucleotide repeat copies may produce altered DNA and improper gene functioning, resulting in full m
from 38 to 100 CAG trinucleotide repeats have been associated with spinocerebellar type 7 (SCA7).

Molecular assay reagents intended to identify CAG repeats in the Huntingtin (HTT) gene, located at ch
Normal alleles have from 10 to 35 CAG trinucleotide repeats. A variation from the expected number of
trinucleotide repeat copies may produce altered DNA and improper gene functioning, resulting in full m
36 to more than 120 CAG trinucleotide repeats have been associated with Huntingdon's disease.

Molecular assay reagents intended to identify CAG repeats in the protein phosphatase 2 (formerly 2A)
(PR 52), beta isoform (PPP2R2B) gene, located at chromosome 5q31-q33. Normal alleles have from 7 t
repeats.A variation from the expected number of normal CAG trinucleotide repeat copies may produce
improper gene functioning, resulting in full mutation. Alleles with from 66 to 78 CAG trinucleotide rep
associated with spinocerebellar ataxia type 12 (SCA12).

Molecular assay reagents intended to identify CAG repeats in the TATA box binding protein (TBP) gene
chromosome 6q27. Normal alleles have from 25 to 42 CAG/CAA trinucleotide repeats. A variation from
of normal CAG trinucleotide repeat copies may produce altered DNA and improper gene functioning, r
mutation. Alleles with from 43 to 66 CAG/CAA trinucleotide repeats have been associated with spinoce
(SCA17).

Molecular assay reagents intended to identify the number of copies of a CGG trinucleotide repeat in a
variation from the normal number of CGG trinucleotide repeats produces altered DNA with improper g
resulting in a full mutation CGG trinucleotide repeats in specific genes are related to particular disease
syndrome.
Molecular assay reagents intended to identify CGG repeats in the fragile X mental retardation 1 (FMR1
chromosome Xq27.3. Normal alleles have from10 to 40 CGG trinucleotide repeats and are typically int
trinucleotide repeats. A variation from the expected number of normal CGG trinucleotide repeat copie
DNA and improper gene functioning, resulting in full mutation. Alleles with from 200 to 1,000 CGG trin
been associated with fragile X-associated mental retardation (FRAXE). Alleles with from 55 to 200 CGG
associated with fragile X-associated tremor/ataxia syndrome (FXTAS). Women that have alleles with fr
trinucleotide repeats have an increased risk of developing premature ovarian failure.
Molecular assay reagents intended to identify CGG repeats in the fragile X mental retardation 2 (AFF2
gene, located at chromosome Xq28. The absence of CGG repeats causes an expansion of GCC repeats
with mental retardation, including X-linked mental retardation fragile site (FRAXE).

Molecular assay reagents intended to identify the number of copies of a CTG trinucleotide repeat in a
variation from the expected number of normal CTG trinucleotide repeats produces altered DNA and im
functioning, resulting in full mutation. CTG trinucleotide repeats in specific genes are related to partic
dystrophia myotonica (Steinert's disease).
Molecular assay reagents intended to identify CTG repeats in the dystrophia myotonica-protein kinase
at chromosome 19q13.3 Normal alleles have from 5 to 35 CTG trinucleotide repeats. A variation from
of normal CTG trinucleotide repeat copies may produce altered DNA and improper gene functioning, r
mutation. Alleles with from 50 to 5000 CTG trinucleotide repeats have been associated with dystroph
(DM1 Steinert's disease)

Molecular assay reagents intended to identify CTG repeats in the junctophilin 3 (JPH3) gene, located a
16q24.3. Normal alleles have from 6 to 28 CAG/CTG trinucleotide repeats. A variation from the expect
CAG/CTG trinucleotide repeat copies may produce altered DNA and improper gene functioning, resulti
Alleles with from 44 to 59 CAG/CTG trinucleotide repeats have been associated with Huntingdon's dise
however, individuals with from 29 to 43 CAG/CTG repeats may not develop symptoms.

Molecular assay reagents intended to identify CAG/CTA repeats in the kelch-like 1 antisense (KLHL1AS
chromosome 13q21. The expansion of the allele with a TAC/TGC trinucleotide repeats interferes with a
and is associated with spinocerebellar ataxia type 8 (SCA8).
Molecular assay reagents intended to identify the number of copies of a GAA trinucleotide repeat in a
variation from the expected number of normal GAA trinucleotide repeats produces altered DNA with im
functioning, resulting in full mutation. GAA trinucleotide repeats in specific genes are related to partic
Friedreich's ataxia.
Molecular assay reagents intended to identify GAA repeats in the frataxin (FRDA) gene, located at chr
p11. Normal alleles have from 5 to 33 GAA trinucleotide repeats. A variation from the expected numbe
trinucleotide repeat copies may produce altered DNA and improper gene functioning, resulting in full m
from 66 to 1,000 GAA trinucleotide repeats disrupt the production of frataxin, which severely reduces
protein in cells; they are associated with Friedreich's ataxia.

Molecular assay reagents intended to identify the number of copies of a GCG trinucleotide repeat in a
variation from the expected number of normal GCG trinucleotide repeats produces altered DNA with im
functioning, resulting in full mutation. GCG trinucleotide repeats in specific genes are related to partic
oculopharyngeal muscular dystrophy.
Molecular assay reagents intended to identify GCG repeats in the poly(A) binding protein, nuclear 1 (P
at chromosome 14q11.2-q13. Normal alleles have 6 or 7 CGC trinucleotide repeats. A variation from th
normal CGC trinucleotide repeat copies may produce altered DNA and improper gene functioning, resu
Alleles with 8 to 13 GCG trinucleotide repeats are associated with oculopharyngeal muscular dystroph

Molecular assay reagents intended to identify the number of copies of a sequence (code) of five-letter
pentanucleotide repeats in a gene's DNA. A variation from the expected number of normal pentanucle
may produce altered DNA and improper gene functioning, resulting in a full mutation. Mutations in spe
to particular diseases.
Molecular assay reagents intended to identify the number of copies of a ATTCT pentanucleotide repea
variation from the expected number of normal ATTCT pentanucleotide repeats produces altered DNA w
functioning, resulting in a full mutation. ATTCT pentanucleotide repeats in specific genes are related to
including spinocerebellar ataxia type 10 (SCA10).
Molecular assay reagents intended to identify ATTCT repeats in the ataxin 10 (ATXN10) gene, located
Normal alleles have from 10 to 29 ATTCT pentanucleotide repeats. A variation from the expected num
trinucleotide repeat copies may produce altered DNA and improper gene functioning, resulting in full m
from 800 to 4,500 ATTCT pentanucleotide repeats are present in patients with spinocerebellar ataxia t
slowly progressive cerebellar ataxia. The repeats are also associated with seizures, peripheral neuropa
disturbances.

Devices designed to detect blood leaking from the extracorporeal connection of a hemodialysis circuit
needle site, and to notify the user/attending staff of the situation by means of visible and audible alar
devices detect blood leakages by sensing colormetric, moisture, chemical, or light modulation change
sensor component of the device is exposed to the leaking blood.
Container-like devices with low sides designed to provide an appropriate sleeping/resting/support surf
infants (i.e., neonates). These devices are intended to be used with infants during the first few days/w
baskets can be made from a variety of materials. A common type of bassinet basket is made from clea
is designed to fit into the top of a bassinet frame/stand. Specialized bassinet baskets may be made fro
foam and may be designed for both support and transport of very small neonates.

Eyeglasses designed to observe eye movement on a video monitor. These devices typically consist of
magnify and illuminate the eyes while minimizing fixation during the examination (known as Frenzel le
be hinged to so they can be folded out of the line of vision. One or two infrared video cameras are atta
eyeglasses; the eyeglasses also include a head strap for secure fixation, batteries, and a lamp to prov
illumination. Video nystagmus test eyeglasses are used to evaluate for pathologic nystagmus vestibul
to determine whether ear nerve damage may be the cause of dizziness or vertigo. These glasses are u
videonystagmographs.

Eyeglasses designed with two corrective (i.e., graduated) lenses mounted in a frame that holds them
position before the eyes to assist vision (i.e., vision aids). The lenses are usually graduated to improve
the user (e.g., to correct myopia, presbyopia); they may be configured as monofocal, bifocal, trifocal,
Dedicated corrective lens eyeglasses that incorporate a set of telescopic lenses intended to correct th
of standard lenses is not appropriate are also available.

Eyeglasses designed with two lenses that filter out ultraviolet (UV) radiation mounted in a frame that
appropriate position before the eyes. These eyeglasses typically consist of two protective lenses (e.g.,
polarizing), a metal or plastic frame that is placed on the nose and attached to two hinged legs that a
earlobes. The lenses may protect from different intensities of UV radiation in a given range of frequen
B, or both).

Respiratory flowmeters designed to measure the flow rate and volume of medical air delivered to a pa
gas system or other appropriate supply source via appropriate devices. Medical air flowmeters are typ
electromechanical instruments that are placed in the low pressure section of the medical air supply.
Image digitization systems designed to provide in-vivo bioluminescent and fluorescent images by ima
fluorescent and bioluminescent reporters) between the blue and near infrared spectrum. These system
fluorescent light sources that can provide reflected illumination and transillumination through a fiber-o
bundle switch, a charge coupled device (CCD) camera, emission and excitation filters, a scanning lase
for alignment and surface topography, and imaging software for data acquisition and processing; and
with a liquid-crystal display (LCD) monitor. Bioluminescence/fluorescence image digitization systems a
provide in-vivo images intended to detect cell activity, gene expression, and to assess disease progres
research.

Switches or buttons that can be activated in an emergency, such as a fire or other hazardous situation
medical equipment or devices in use, in order to prevent injury or damage to persons, machinery, or w
activation of the emergency stop switch immediately terminates the electrical power supply to the ma
the functions of a machine. Emergency stop switches can be used by the patient or by health personn
must be released or reset before the device can begin functioning again. They are often colored red a
make them easily seen on the machine to which they are integrated; they differ visually from the dev

Electromagnetic external shock wave therapy (ESWT) systems designed for orthopedic procedures. Th
consist of an electromagnetic generator that produces a magnetic field when an electric current circul
attached to a thin metallic membrane. A shock wave is then generated when the membrane is repelle
field. Orthopedic ESWT systems include an imaging system (e.g., ultrasonic) to follow the therapeutic
applicator (e.g., an articulated arm), usually filled with water, to deliver the shock wave to the intende
ESWT systems are used for orthopedic procedures to alleviate pain; they are also intended for treatme
orthopedic diseases such as plantar fasciitis, lateral epicondylitis, and calcifying tendonitis of the rotat

Printers used to label slides with alphanumeric characters, barcodes, or logos onto the ends of the slid
printing technology and chemical-resistant ink to help with identifying and tracking the slides. The slid
cytology and/or histology tissue specimens are applied.
Monitoring systems that track patient position in real time during radiotherapy procedures so that the
adjusted to allow the radiation to more precisely reach its target (i.e., tumors) thus avoiding unnecess
to surrounding healthy tissues and allowing for a higher dosage of radiation to be delivered, a process
guided radiotherapy (IGRT). These monitoring systems usually consist of scanning devices (infrared ca
scanners) mounted on the ceiling near the patient, and integrated computer workstations and dedicat
calculate needed adjustments in patient position. Infrared monitoring systems may also have a positio
mounted over the treatment couch. Through the use of computer algorithms, the monitoring systems
position from pre-established parameters (usually in the 1 mm range or less). The monitoring systems
displays to show patient movement and alarms to alert the technician if adjustments in patient positio
monitoring systems can be interfaced with the patient couch to make automatic adjustments to the p
treatment. Some monitoring systems work in conjunction with other IGRT systems to track respiratory
radiotherapy delivery. Radiotherapy patient position monitoring systems that use infrared light or lase
system are available. They are used in radiotherapy suites to detect patient position changes in real t
radiotherapy.
Environmental emergency alarms designed to activate audible (i.e., sound) and/or visual warnings wh
threshold level and/or fire in a closed environment are detected. These alarms usually consist of a hea
detector, appropriate transducers to generate an electrical signal, amplifiers, separate electric power
batteries, and sound and/or light sources that deliver signals (e.g., high-pitched sounds, intense flashi
people that a fire is present. Fire/smoke alarms intended to be fixed in a particular room providing only
locally and alarm systems intended for a complete facility that may also include remote alarms (e.g.,
stations) are available. They may be used also to activate safety (e.g., unlock doors) and/or protection
mechanisms.

Photon radiation detectors designed for sensing the position of photon beams used in radiotherapy tre
detectors typically consist of a stand-alone or handheld instrument, controls, and a display that shows
position of the photon radiation beam. Some detectors are based on a technology that includes a gase
metal converters and gas electron multipliers (GEMs); detectors based on amorphous silicon technolo
portal imaging devices/EPIDs) are also available. Radiotherapy photon radiation detectors are intende
radiotherapy treatments (e.g., cone beam computed tomography radiotherapy) to improve the positio
delivery of photon radiation; they may be also used in conventional x-ray treatments.

Kits containing the necessary templates and delivery cylinders (sometimes called sleeves) to guide de
to prepare tissue, drill into the maxilla or mandible (osteomy) and deliver a dental implant during guid
These kits typically contain small hollow metal cylinder-shaped sleeves of different diameters (e.g. 2.8
diameter) with lips at the instrument interface ends that are fixed in specially molded template matric
to the bone, gum, or teeth of patients, hold the cylinders adjacent to the spot in the bone where the im
The sleeves are designed to accept dedicated dental instruments (e.g., mills, taps, C-handles, drill han
place the implant with precision to a predetermined depth into the bone. The building of the template
is often determined by computer modeling based on patient measurements. Dental implant delivery k
surgery are used in dental care settings for precision delivery and placement of dental implants.
Systems designed for manufacturing and/or repair of dental prostheses using computer-assisted desig
(CAD/CAM) techniques. These systems typically consist of a scanning unit that combines light sources
that may be mounted on a wand for in-vivo scanning of teeth, a central computer with appropriate so
data from the digital topographical image taken by the scanner and provide output for a computerized
automated computer milling/drilling machine that manufacture the prosthesis. Some systems may als
dental impressions or stone models. CAD/CAM dental prosthesis systems are intended for automated
prostheses and restorations from ceramic, composite plastics, and/or metal blocks. All units of the sys
dentists' offices or the manufacturing unit may be located in a separate dental laboratory. Systems de
manufacturing and/or repair of dental prostheses using computer-assisted design and manufacturing
These systems typically consist of a scanning unit that combines light sources and a video camera tha
a wand for in-vivo scanning of teeth, a central computer with appropriate software to process the data
topographical image taken by the scanner and provide output for a computerized milling unit, and an
milling/drilling machine that manufacture the prosthesis. Some systems may also take images from de
stone models. CAD/CAM dental prosthesis systems are intended for automated manufacturing of pros
from ceramic, composite plastics, and/or metal blocks. All units of the systems may be located in dent
manufacturing unit may be located in a separate dental laboratory.

Image-guided computer-aided stereotactic surgical systems designed to aid in the performance of min
surgical procedures by combining medical imaging, dedicated computer software, and surgical instrum
for guidance. The systems provide surgeons with real-time, three-dimensional (3-D) positioning and or
instruments relative to the patient's anatomy on a video display during surgery without requiring the
Image-guided surgical systems work in a similar way to global positions systems (GPS) applied to the
medical images that show the location of the instruments in real time during the surgical procedure; o
modalities such as computed tomography (CT) and/or magnetic resonance imaging (MRI) may be used
Dedicated image-guided stereotactic surgical systems intended for particular specialties such as neur
spinal, orthopedic, and laryngological procedures are available.

Immunoassay reagents intended to perform qualitative and/or quantitative analyses of body fluids (e.
determine the level of the protein procalcitonin (PCT), a prohormone of the hormone calcitonin, that c
several cell types and many organs and circulates in plasma. Procalcitonin levels increase rapidly (val
are usually below 0.1 ng/mL) in response to pro-inflammatory stimuli, in particular those produced by
evaluation of PCT concentration facilitates the assessment of the patient's risk of progression to sever
shock; localized infections, allergic disorders, transplant rejection, and other diseases do not usually in
increases in the PCT value above 0.5 ng/mL.

Equipment designed to apply heat to endodontic fillings by means of probes electrically heated at the
typically consist of a line-powered electronic unit with temperature control and a handpiece with a set
(e.g., heat carriers, pluggers) with tips that are internally heated from the main unit through an electr
endodontic units are used to deliver gutta percha points and/or polymeric resin fillings, avoiding the n
warming of the point. Endodontic fillings are used mainly for temporary filling of root canals.
Equipment designed to combine the application of heat to endodontic fillings (i.e., gutta percha points
powered extrusion in one unit. This equipment typically consists of a line-powered heating electronic u
control and two handpieces. One handpiece manages one set of electrically heated detachable probes
pluggers) with tips that are internally heated by the main unit, and the other handpiece (i.e., the extru
electrically powered micro motor, speed control, a cartridge with the filling material, and detachable e
Combined obturation/extrusion units are used to deliver gutta percha points and/or polymeric resin fil
device, thus avoiding the need to pre-warm the fillings. They are mainly used for temporary filling of r

Physiologic analyzers designed to measure and evaluate the main visual characteristics of the facial s
simultaneously obtain high-resolution images of the face from different angles, including 3-D and ultra
assess some conditions under the skin surface (e.g., vascular abnormalities). These analyzers typicall
computerized system that consists of high-resolution cameras and displays showing images of the wh
unit using software with algorithms to evaluate skin characteristics such as pigmentation, wrinkles, an
and a printer to provide reports of the skin conditions. Face image physiologic analyzers are intended
assessment and track the treatment of skin disorders such as acne, spider veins, and rosacea; they ar
evaluation and planning of cosmetic treatments of the facial skin.

Adjustable-height tables designed to test for syncope by moving the patient through various positions
strapped to the table (i.e., tilt test). These tables move by electric motors (usually with battery back-u
electronically-controlled hand units. The patient is placed on the examination/tilt table in a head up po
elevated higher than the feet and legs in a reverse Trendelenburg position. The table is then moved so
the head-down position where the head is lower than the feet and legs in the standard Trendelenburg
tables can travel from 70 degrees head up reverse Trendelenburg to 15 degrees head down Trendelen
Adjustable tilt test tables have straps to secure the patient to the table, a foot-board support for when
head-up position and removable drop sections to allow for the introduction of imaging and cardiovascu
syncope testing. Sections of the table may also fold-up to offer back support to the patient when the p
his/her side. Tilt test adjustable examination/treatment tables are used in cardiovascular and neurolog
to test patients that experience syncope.

Computer-aided detection systems designed to detect and classify areas in virtual colonoscopy (i.e., C
images with abnormalities (e.g., polyps, lesions) that may be indicative of colon cancer. These system
image digitizer, a computer capable of using appropriate algorithms to map the colon centerline and fi
tissue regions (i.e., polyps), and a display that provides images showing regions of interest (ROI) in th
that may require further review. Virtual colonoscopy systems may also display maximum, minimum, a
measurements of the polyps for segmented tissue regions.
Hematology reagents used to determine the intrinsic clotting activity of the whole blood (i.e., activate
using kaolin (a type of purified aluminum silicate clay) as an activator. The test is usually performed b
blood to a test tube or cartridge containing kaolin (i.e., the surface activator). The formation of a clot i
normal body temperature (about 37 degrees Celsius/98.5 degrees Fahrenheit) determines the ACT val
should be usually in the range of 90 to 150 seconds. This test is intended to monitor the effect and reg
administration of high-dose unfractionated heparin before, during, and shortly after procedures (usual
cardiopulmonary bypass) that require intense anticoagulant administration.

Hematology reagents used to determine the intrinsic clotting activity of the whole blood (i.e., activate
using the diatomaceous earth Celite (a naturally formed soft rock) as an activator. The test is usually p
the whole blood to a test tube or cartridge containing Celite (i.e., the surface activator). The formation
is kept at normal body temperature (about 37 degrees Celsius/98.5 degrees Fahrenheit) determines th
which should be in the range of 100 to 170 seconds. This test is intended to monitor the effect and reg
administration of high-dose unfractionated heparin before, during, and shortly after procedures (usual
cardiopulmonary bypass) that require intense anticoagulant administration.

Leads designed to conduct electrical signals from the pulse generating unit of an electric stimulator to
of the body according to the intended purpose of the stimulation. These leads typically consist of flexi
completely isolated except at the electrode tip that makes external contact with the intended area of
electrodes may be percutaneously inserted needle-type electrodes or, less frequently, used paddle ele
of the lead is attached to the stimulator (i.e., pulse generator). Implantable leads that are directly atta
and that are usually also implanted in the body after a test period are also available. A variety of singl
arrays is available; lead size, connector type, and other characteristics of the leads must be compatib
generator and the therapy prescribed. Dedicated leads for particular types of stimulators are also ava
for cardiac, brain, peripheral nerve, neuromuscular, spinal cord, and nerve stimulation.

Injectors designed to be used to insert or inject substances, such as DNA, RNA, proteins, toxins, or dye
level through a fine-tipped needle roughly 0.5 to 5 micrometers in diameter into sub-cellular, cellular,
They are used with specialized microscopes and micromanipulators, allowing for small movement und
The substances are injected through the microinjectors by pressure provided through pneumatic, mot
controls. Pneumatic microinjectors connect to and are controlled by pressurized gas and are used to in
microinjectors are controlled by foot- or hand-switches and they can be used to inject small volumes a
reproducibly and precisely and with minimal vibration. Manual control is applied through a syringe att
microinjectors. Applications in which microinjectors are used include: basic genetics research; cloning
cytotoxicity tests; embryonic stem cell transfer into blastocyst; in vitro fertilization; intracytoplasmic s
ophthalmology procedures such as retinal pigment epithelial and intra-ocular injection; and somatic ce
Microinjectors are used in clinical laboratories. Prefilled microinjection systems filled with solution to b
intradermally, such as medicines or vaccines, are available.
Snares designed to position and tighten fine-gauge flexible, adjustable, wire loops around a region of
Eustachian tube tissue for mechanical resection. These devices typically consist of a hollow tubular st
cannula), with one or more adjustable wire loops that protrude at the working end; frequently they inc
and a sliding loop. A mechanism at the proximal end controls how much wire extends out of the chann
of the sliding (cutting) loop; the handle is usually straight (e.g., Krause type) to the cannula. Ear (enda
single-use or reusable; they are used mainly to remove polyps, tumors, and other abnormal tissue from

Snares designed to position and tighten fine gauge flexible adjustable wire loops around the optical ne
resection. These devices typically consist of a hollow tubular structure (e.g., a cannula), with one or m
gauge wire loops that protrude at the working end. The snare loops are made of twisted wires that are
mechanism at the proximal end that includes a butterfly nut and a ratchet (e.g., Foster enucleation sn
much wire extends out of the channel and may stop the movement at any time; the handle is usually
the cannula. Ophthalmic enucleation snares are usually reusable devices intended for resection of the
into the orbit when total eye enucleation procedures are performed (e.g., to insert implants).

Respiratory tract snares designed to position and tighten fine-gauge, flexible or semirigid, adjustable w
region of tissue through an endoscope for mechanical or electrosurgical resection and hemostasis. The
consist of a hollow tubular structure (e.g., a cannula), with one or more adjustable wire loops that prot
end. The snare is introduced into the respiratory tract through the working channel of a bronchoscope
the nose); a mechanism at the proximal end (handle) controls how much wire extends out of the chan
of the sliding cutting loop as the loop is withdrawn into the cannula. The snare loops (e.g., 0.5 and 1 in
size) are made of monofilament or braided wires that are attached at the proximal end to an electrosu
monopolar) unit that provides circulation of radio-frequency electric current between the isolated met
an active electrode) and an external neutral electrode to heat the tissues and facilitate resection and
Endoscopic respiratory tract snares are used mainly for electrosurgical removal of polyps, tumors, and
from the respiratory tract, but mechanical (cold) resection may be used for small polyps.

Gastrointestinal snares designed to position and tighten fine-gauge, flexible or semirigid, adjustable w
region of tissue through an endoscope for mechanical or electrosurgical resection and hemostasis. The
consist of a hollow tubular structure (e.g., a cannula), with one or more adjustable wire loops (rings) th
working end. The snare is introduced in the upper or lower gastrointestinal tract through the working c
endoscope (e.g., colonoscope, gastroscope); a mechanism at the proximal end (handle) controls how m
of the channel and the movement of the sliding (cutting) loop as the loop is withdrawn into the cannu
made of monofilament or braided wires that are attached at the proximal end to an electrosurgical (us
that provides circulation of radio-frequency electric current between the isolated metal loop (i.e., actin
electrode) and an external neutral electrode to heat the tissues and facilitate resection and cauterizat
gastrointestinal snares are used mainly for electrosurgical removal of polyps, tumors, and other abnor
upper or lower gastrointestinal tract, but mechanical (cold) resection may be used for small polyps.
Endoscopic uterine snares designed to position and tighten fine-gauge, flexible or semirigid, adjustabl
region of tissue for mechanical or electrosurgical resection and hemostasis. These devices typically co
tubular structure (e.g., a cannula), with one or more adjustable wire loops that protrude at the working
introduced into the uterus through the working channel of a hysteroscope; a mechanism at the proxim
controls how much wire extends out of the channel and the movement of the sliding cutting loop as th
into the cannula. The snare loops are made of monofilament or braided wires with a beak-like side (ty
duckbill snares) that may be attached at the proximal end to an electrosurgical (usually monopolar) un
circulation of radio-frequency electric current between the isolated metal loop (i.e., acting as an active
external neutral electrode to heat the tissues, facilitating coagulation. Endoscopic uterine snares may
disposable) or reusable; they are used mainly for electrosurgical removal of polyps, tumors, and fibroi
uterus, but mechanical (cold) resection may be used for small polyps and fibroids.

Endoscopic urinary tract snares designed to position and tighten fine-gauge, flexible or semirigid, adju
around a region of tissue for mechanical or electrosurgical resection and hemostasis. These devices ty
hollow tubular structure (e.g., a cannula), with one or more adjustable wire loops that protrude at the
is introduced into the urinary tract through the working channel of a cystoscope or ureteroscope; a me
proximal end (handle) controls how much wire extends out of the channel and the movement of the sl
the loop is withdrawn into the cannula. The snare loops are made of monofilament or braided wires an
the proximal end to an electrosurgical (usually monopolar) unit that provides circulation of radio-frequ
between the isolated metal loop (i.e., acting as an active electrode) and an external neutral electrode
facilitating coagulation. Endoscopic urinary tract snares may be single-use (i.e., disposable) or reusab
mainly for electrosurgical removal of polyps, tumors, and other abnormal tissue from the urinary tract
resection may be used for small polyps.

Wires designed to be conformed as loops used in surgical snares. These wires may consist of a single
monofilament), metal (usually stainless steel) wire or a combination of several wire filaments that are
twisted; the wires may be soft or stiff according to the intended use of the snare. Snare wires are usua
components of surgical snares, dedicated wires intended for a particular type of snare (e.g., eye enuc
resection) and model and/or manufacturer are also available.

Wire loops designed for use in surgical snares. These wire loops may consist of a single filament (i.e.,
(usually stainless steel) wire loop or a combination of several wire filaments that are typically braided
may be soft or stiff according to the intended use of the snare. Wire loops are available in a variety of
shapes (e.g., oval, circular, hexagonal, and crescent); dedicated wire loops intended for a particular ty
enucleation, tonsil resection, and gastrointestinal polypectomy) and model and/or manufacturer are a
Dedicated snare wire loops may be used through insulated snare guides to act as active electrodes wh
to an external electrical supply.

Guides designed to position and manipulate wires through snare instruments. These devices typically
mechanical tube that matches the snare configuration and permits the introduction and manipulation
the distal (working) end of the snares. Snare wire guides are frequently electrically insulated to permit
loops as active electrodes when externally attached to an electrical supply.
Manual handheld instruments that consist of a metallic wire or plastic fixed loop at the distal end and
manipulate small objects, substances, or tissues. Fixed loop instruments may be used for surgical proc
ophthalmic), clinical laboratory procedures (bacterial inoculation of culture media), or other procedure
extraction) requiring fine manipulation using a solid loop.
Fixed loop instruments designed for extraction of secretions or small objects from the external ear can
typically consist of a manual, handheld instrument with a small, fixed, rigid, wire loop at its distal tip a
easy manipulation (e.g., Billeau ear loop); both reusable (i.e., metallic) and single-use (i.e., plastic) de
canal fixed loop instruments mainly are used for extraction of hard but thin ear cerumen (i.e., earwax)
from the ear canal; some devices are intended for attachment to light sources.

Equipment designed for implanting and welding polymer implants to bone structures using ultrasound
typically consists of a central unit with an electric generator, including time and temperature controls
handpieces. These handpieces provide ultrasonic vibration while driving a dedicated thermoplastic (us
pin into a pre-drilled hole in the bone. The pin melts during the implantation procedure, adapting to th
welds the bone and/or other implanted structures (e.g., plates) when returned to a solid state a few se
implantation. Ultrasonic polymer pin delivery instruments are intended for use in orthopedic procedur
that do not bear heavy loads; they are mainly used in the reconstruction (e.g., after fracture) of the cr
and facial skeletal structures.

Bandages mainly designed to hold dressings or small devices (i.e., intravenous catheters, splints) in p
can be nonelastic or elastic and conform to body contours. Retention bandages may be covered with a
but they are not intended to support or compress a body part.
Bandages designed with elastic properties. These bandages are usually made of mechanically crimpe
some elastomer; they usually readily conform to body contour. The bandages usually extend in multip
stretch), imparting elasticity but little compression capability to the bandage. Elastic retention bandag
with an adherent substance, and they are intended to retain dressings or other small devices (e.g., sp
catheters) in an appropriate position. They are not intended to support or compress a body part.

Bandages designed with no elastic properties. These bandages usually are made of cotton and may in
that permit minor stretching (usually less than 40%) of their resting length. Nonelastic retention band
with an adherent substance, and they are intended to retain dressings and/or other small devices (e.g
catheters, splints) in an appropriate position. They are not intended to support or compress a body pa

Bandages made of woven cotton or a cotton and viscose combination. These bandages have little or n
typically stretching less than 40% of their resting length. Cotton/gauze retention bandages mainly are
dressings or other small devices (e.g., splints, intravenous catheters) in an appropriate position.

Elastic bandages made of a light crinkled fabric woven of any of various fibers (i.e., cotton, crepe). The
include some elastomeric material that provides light (usually less than 20 mm Hg) pressure to a body
are used mainly to provide support and light pressure to a limb to treat mild sprains and strains or to p

Elastic bandages with two or more layers with different characteristics. These bandages typically cons
layers that provide padding, support, and compression respectively. Multilayer bandages are intended
of venous leg ulcers. Bandages that are intended only for use in the field and that may be self-applied
Bandages designed to cast a body part and to provide protection and immobilization. These bandages
coated with wet calcium sulfate hemihydrates (plaster) that becomes a rigid orthopedic cast when dry
materials (such as a fiberglass substrate with polyurethane resin). Casting bandages mainly are used
management of fractures and sprains.
Casting bandages made of plaster. These bandages consist of a combination of a fabric (e.g., cotton g
calcium sulfate hemihydrates (plaster) that becomes a rigid orthopedic cast when dry. Plaster bandag
immobilize the limbs in the management of fractures and sprains.
Casting bandages made of synthetic materials. These bandages typically consist of a combination of a
and water-activated polymeric (e.g., polyurethane) resins. Synthetic casting bandages are used to imm
the management of fractures and sprains.
Bandages designed to protect wounds that are supplied as liquids. These bandages consist of a liquid
(some may contain antiseptics also) that quickly dries and provides a protective cover that protects w
and moisture. Liquid bandages are used to protect wounds caused by minor cuts and scrapes, and to
bleeding.
Bandages impregnated with medication (e.g., zinc paste, icthammol). These bandages usually are ma
material (i.e., cotton). Medicated bandages are used in the management of skin lesions, leg ulcers, ec

Bandages impregnated with zinc oxide paste. These bandages usually are made of an absorbent mate
impregnated with a zinc oxide paste or a zinc oxide mixture (e.g., 10%, 20%) and may contain other d
medicated bandages are usually supplied in long, rolled pieces; they are used in the management of w
ulcers, eczema and dermatitis.
Laboratory samplers designed for sequentially aspirating cell samples to provide specimens for cytolo
delivering them to automated chemical analyzers or other laboratory equipment by using robotic arm
automated mechanisms. The specimen cells are obtained by health personnel by scraping and collec
particular area of the body. Automated cytology samplers are intended for use as independent units a
laboratory automation system.

Devices designed to convert information from laboratory slides (i.e., data, images) to digital format ty
scanner that captures the specified information. These devices usually include light sources, a mecha
system, an optical scanner, an analog-to-digital converter, an electronic processor, and a computer in
slide digitizers are mainly intended to provide digital data and images that may be stored and/or displ
pathology laboratories to document diagnostic findings and/or to facilitate analysis by a pathologist us
aided detection systems.

Water-jet surgical units designed to perform surgical procedures in wounds by means of a pressurized
units typically consist of an electrically powered central console that includes a power display, a foot s
a fault indicator, and a pressurized liquid system connected to a liquid pump. The procedure is typical
of a variety of detachable single-use handpieces that provide the water-jet to the wound. Wound wate
intended to dissect and remove tissue and debris from wounds and surgical sites.
In vitro diagnosis (IVD) quality controls designed for automated electronic control of the operation of b
coagulation analyzers. These devices (also known as electronic clotting tubes) provide an electronic si
sample characteristics resembling the patient clot response at a test endpoint, either a normal respon
an abnormal one for longer clotting times (e.g., 300 and 500 seconds). The tests with the sample simu
for calibration of the parameters assessed by whole blood coagulation analyzer. Blood clotting time el
used for periodic routine assessment of proper operation and quality control of point-of-care coagulati
frequently intended only for a particular model or manufacturer.

Telephone transmitter/receiver systems designed to transmit and receive voice and/or text messages
relatives or caregivers through telephone channels (either wired or wireless). The system may also pro
communication to the patient with an assistance center to get rapid help in case of emergencies. The
include a wireless communication channel and a global positioning system (GPS) for continuous locati
wearable cell telephone intended for continuous use by the patient, and appropriate receivers in remo
telephones include automated or button-operated alarms for emergency calls. Patient location/commu
used mainly by disabled patients and the elderly to improve their safety and autonomy. Many systems
that are capable of sending automated messages when the patient wanders outside a pre-determined

Telephones designed for rapid automated patient location and communication. These devices typically
telephone (usually wearable) and include a global positioning system (GPS) module that continuously
location and permit sending and receiving voice and text messages from and to the patient by relative
Some telephones include automated or button-operated alarms for emergency calls. The telephones a
of sending automated messages when the patient wanders outside a pre-determined area. Patient lo
telephones are used mainly by disabled patients and the elderly to improve their safety and/or autono

Supporting structures (i.e., docks) designed to facilitate connectivity to otherwise handheld or portabl
and/or for automated charging of their internal rechargeable batteries. These docks (also known as do
typically consist of a structure made of metal, hard plastic, or a combination of these that is mounted
on a tabletop. The docks hold and provide appropriate connectors to plug-in or cradle the handheld m
connectivity and/or providing means to recharge their internal batteries. The docks may also include w
connection to other devices and /or communication (e.g., nurse call systems) or information systems f
download of data, a power converter (e.g., 120 VAC to 12 VDC), and a line cord for connection to the m

Cooling units designed to lower a patient's body temperature by circulating liquid through hoses in clo
outside of the patient's body. These units consist of a central refrigerator system which pumps cooled
other hoses contained inside a device in contact with the patient's body (e.g., a pad, mattress, or blan
vest worn by a patient); most also feature temperature controls and alarms. Patient temperature is typ
a thermometer. Circulating-liquid patient cooling units are used for cooling patients with fever or to in
the operating room. They may also be used to induce temporary hypothermia, in order to limit tissue
who have suffered a stroke or other cardiovascular or neurological event.
Physiologic monitors designed primarily for automated periodic and/or quasi-continuous real-time mea
two or more of the vital signs (e.g., noninvasive blood pressure, temperature, heart rate) and oxygen
(SpO2); many devices may also perform continuous monitoring during transportation or at the bedsid
typically consist of portable or mobile electronic units that facilitate movement from one location to ot
be connected to the line and/or powered by internal batteries. The main unit includes controls and a d
appropriate attached probes and sensors that make possible sequential and/or simultaneous measure
parameters. Noninvasive blood pressure (NIBP) is usually measured using cuffs and either auscultator
techniques; the measurement of temperature is typically accomplished using an intraoral sensor, and
using pulse oximetry sensors. Vital signs physiologic monitors are intended mainly for periodic automa
parameters of one or more patients. Some monitors have additional capabilities (e.g., recording, alarm
signs monitors are designed specifically for use in magnetic resonance imaging (MRI) environments (i
anesthesia units) and are made from nonmagnetic materials so that they can be safely used in an MR
physiologic monitors that can provide electrocardiographic waveforms and/or invasive measurements
pressure measurements are not usually considered vital signs monitors.

Wall-mounted height/length measuring instruments that use a completely mechanical design to meas
These instruments typically consist of a graduated (either metric, inches, or both) wall-mounted rod, a
and hardware appropriate to fix the instrument to a wall; the instrument permits simple mechanical m
person's height. Wall-mounted height measuring instruments are used in doctors' offices, hospitals, an
facilities for routine evaluation of people's height.

Cooling systems designed to keep water at a cold temperature and pump it though hoses to cooling g
ponchos) worn by surgeons and other operating room personnel while they are working in the operati
are usually made of an insulated plastic box or cylinder with a tight-fitting lid that holds ice and water.
pumped via an electrical pump in the cooling system through long hoses. These hoses are connected
cooling system on one end and to the cooling clothing on the other end. The operating room personne
the cooling system by the long hoses while they are wearing the cooling clothing. Some cooling system
use pumps that are operated by batteries. Some operating room personnel cooling systems have mor
connection port to connect to different pieces of cooling garments so that the unit can cool more than
same time.

Special garments (e.g., neck bands, neck wraps, vests, ponchos) worn by persons working in the oper
body temperature of the wearer. Some cooling garments connect to cooling units via hoses through w
circulated, while other cooling garments use cold packs (ice packs) that are placed into pockets inside
to keep the wearer cool while allowing them to move about freely without being tethered to a cooling
serve to cool the operating room personnel and allow them to remain comfortable while working in op
other environments with higher room temperatures.
Wall-mounted height measuring instruments that use electronic sensors and circuits to measure peop
instruments typically consist of a graduated wall-mounted rod, a head positioner, optical sensors, elec
battery, and a remote display that shows the results either in metric values, inches, or both. Electronic
measuring instruments are used in doctors' offices, hospitals, and other healthcare facilities for routin
people's height. High-precision electronic instruments intended to evaluate the growth of children and
as digital stadiometers) are also available.

Detachable tabletops designed for use as a component of surgical tables when used with common pe
typically consist of a rectangular top made of metal, plastic, or a metal/plastic/carbon-fiber composite
pedestal (e.g., central column, lateral supports) that may be fixed or mounted on a movable, swivel-c
tabletop can also be transferred to trolleys to transport patients to and from the operating room. Table
individual segments are raised and lowered by mechanical gears or hydraulic piston systems using m
cranks, foot pedals) or electronic controls (e.g., foot pedals, levers, remote-control units). Some multi-
tabletops can be configured for a variety of surgical specialties (e.g., general surgery, gynecology/uro
ear, nose, and/or throat [ENT]) frequently adding detachable accessories, while other tabletops canno
designated for one type of surgical procedure. These tabletops are available both in adult and pediatr

Detachable tabletops designed for use as a component of surgical tables that may be configured for s
procedures. These tabletops typically consist of a rectangular top made of metal, plastic, or a metal/p
composite that is supported by a fixed pedestal (e.g., central column, lateral supports) that may be m
swivel-caster base. The tabletop can also be transferred to trolleys to transport patients to and from th
Multi-specialty tabletops and their individual segments are raised and lowered by mechanical gears or
systems using manual controls (e.g., cranks, foot pedals) or electronic controls (e.g., foot pedals, leve
units). Some multi-specialty operating tabletops can be configured for a variety of surgical specialties
gynecology/urology, ophthalmology/ ear, nose, and/or throat [ENT], orthopedic, neurosurgery, vascula
by adding detachable accessories. The tabletops are available both in adult and pediatric sizes.

Evaporators that are used to rapidly separate liquids in a mixture, usually solvents from reaction mixt
rotation of the vessels holding the samples. Rotary evaporators (also called rotovaps) consist of a con
vessel, and a rotating vessel (usually a large flask) maintained under vacuum and that is heated by pa
hot water bath. Rotary evaporation provides heat transfer to the contained mixture and increases the
speeding up the evaporation process and preventing local overheating. Rotary evaporators reduce the
so that it is lower than atmospheric pressure, allowing solvents to boil at lower temperatures. The con
drained through a tube into a condenser where they are collected for reuse or disposal. Rotary evapor
chemical laboratories for processes such as chromatography and for the recovery of solvents for recyc
Electrically powered consoles that usually interface with cassettes designed for noninvasive vacuum c
nipple aspirates which can be examined for the presence of precancerous and cancerous cells (somet
breast Pap test). These samplers typically consist of microprocessor-controlled breast cell samplers th
ensure every cycle remains within specifications for vacuum, temperature and compression. The tubin
the console connects to adjustable, non-latex breast cups that fit any size breast and which apply suc
massage to the breasts to elicit the aspirate from the nipples. The breast cups and sample wells that c
disposable so there is no patient contact with the console. Swabs and prep pads are used to sample th
cytological examination. Designated wheeled carts that attach to the sampling consoles are also avail
from room to room. Non-invasive breast cell samplers are used in women's health care settings for ea
changes in breast cells that may lead to cancer.

Multipurpose adhesive strips designed with a wound contact layer that includes an absorbent pad con
agents. These strips typically are short (usually less than 4 inches/10 cm) in length and narrow (typica
5 cm) flexible strips evenly covered on one side with pressure-sensitive adhesive and a central wound
antimicrobial agent (e.g., silver). Antimicrobial multipurpose adhesive strips are intended for single us
they are usually supplied in precut sizes and/or shapes that may be packaged sterile; they are used to
and/or treat infected wounds.

Adhesive strips designed to approximate (i.e., close) the edges of small, superficial wounds. These str
porous cloth or plastic materials covered on one side with pressure-sensitive adhesives; they are pack
intended for single use. Wound closure adhesive strips are usually placed at short intervals across the
wounds; they are mainly used to close and support small wounds; they are usually supplied in precut
that may be packaged sterile. Dedicated wound closure adhesive strips with hypoallergenic and/or wa
also available.

Prepackaged collection of reusable devices designed for in-vivo accurate measurement of the volume
and/or its variations. These kits typically consist of a graduated disposable container with appropriate
total immersion of the anatomic part to be measured, usually a limb or part of it such as the hand, arm
container is filled with water or other solution that is displaced by the immersion of the anatomic segm
includes an output beak, an overflow liquid container to receive the displaced water caused by the im
to measure the displaced water. Volume measuring kits are intended mainly to assess changes in the
to evaluate abnormal physiologic conditions such as edema.

Gas concentrators designed to increase the percentage of nitrogen in a mixture of gases, usually air. N
filter out moisture, oxygen, and other gases from compressed air, leaving ultra-high-purity nitrogen. A
is usually comprised of a compressed air tank; a permeable membrane or a sieve material that captur
gases, and water vapor; and a nitrogen receiving tank. Nitrogen concentrators are used mainly to obta
appropriate for use as a carrier gas for use in laboratories (e.g., gas chromatography analytical labora
Computer peripheral devices that are hand-operated electronic devices used to control the coordinate
screens of computers, workstations, or other computerized equipment or systems. These computer in
consist of hand-held or hand-guided pointing devices used on a mouse pad or on a desktop to move a
screen to point to and click on various data elements within a computer program. They typically includ
button and a scroll wheel, and are used to navigate around a computer program or web page. A variet
mice are available according to the intended use, such as mechanical (using an internal ball on two ro
(which tracks mouse movement through sensing the small, red light-emitting diode light reflecting off
complimentary sensor). Applications of specific computer mouse devices include data input for compu
computerized systems, often as an integral component of computers (e.g., laptop computers) and oth
systems. Computer input mice can be either plugged into the computer system or can be operated wi
computer input mice that are washable, fully sealed, waterproof, and/or flexible and that can be easily
disinfected.

Vein finders that pass infrared or near-infrared light through targeted body tissues to non-invasively lo
peripheral veins through transillumination or imaging. The vein finder projects infrared light onto the p
infrared light is absorbed by red blood cells and reflected by other cells, which helps differentiate the
surrounding tissue. The reflected light is digitized by the device, revealing an image of underlying vein
finders are used to locate veins before the introduction of diagnostic or therapeutic devices into the p
They are also used to locate blood vessels before inserting needles for fluid collection (e.g., blood draw
vein finders are often used with patients with hard-to-find veins, such as those with low body tempera
neonate, dehydrated, obese, or dark-skinned.

Vaginal rings are flexible copolymer rings that release or emit drugs during use and are intended to be
drug-delivery devices. Drug delivery vaginal rings that emit hormones to prevent pregnancy in women
or to treat urogenital symptoms, are available. The muscles of the vagina keep the drug delivery vagin
place until removed by the user. Drug delivery vaginal rings are used for continuous drug delivery for
treatment is prescribed, after which they must be removed. If treatment should continue (as in birth c
patient removes the expired ring and replaces it on a schedule.

Facility booms designed to be securely and permanently attached to the floor and intended to organiz
utility services (e.g., electricity, gas) and medical devices. These booms typically consist of a floor-mo
system equipped with movable arms, a pendant head, and an equipment carrier. Single support arms
pendant head and some also allow vertical involvement; double movable arms extend the pendant's r
include medical gas outlets, vacuum inlets, electric power outlets, communication systems, medical d
and attachments such as suction canisters and intravenous solution hangers. Floor-mounted facility b
installed in operating rooms, intensive care units, catheterization and other special procedure areas, e
other healthcare areas.
Detectors designed to determine accidental leakages of intravenously (IV) infused medications into th
and/or tissue around infusion sites from mis-positioned venous access devices. These detectors are us
radiofrequency techniques using sensors that can detect when fluid is under the patient's skin, usually
than 20 ml. Other techniques may be used for detection of the extravasated fluid (e.g., tissue impeda
detectors may be coupled to manual or automated injectors (typically contrast media injectors) to sto
extravasation is detected. Extravasation IV fluid detectors are used to limit the quantity of accidental
(especially of vesicant or irritant medications); consequences of extravasation may include from mild
erythema, tenderness) to serious effects such as tissue necrosis.

Loupes designed to be worn close to the practitioner's eyes to provide stereo-optic (i.e., binocular) vis
the patient during medical examinations or procedures. Binocular loupes are fitted with two sets of len
1/2 inches (12.7 mm) or less, that can be attached to headbands or eyeglasses worn by the health pra
parameters include magnification, optics, working distance, mounting options, and illumination. Optio
to the binocular loupes. Binocular loupes are used by specialists such as ophthalmologists, surgeons,
dentists.

Hospital communication systems designed to provide entertainment for patients and to provide two-w
between healthcare personnel and patients during medical procedures, such as magnetic resonance i
intended to help patients become more comfortable by providing a distraction in order to reduce anxi
during medical procedures. These systems are usually comprised of video and audio capabilities, such
and radio input, and adjustable, integrated audio-video headset with volume adjustments that can be
patient and by healthcare personnel. Hospital communication/entertainment systems that can provide
entertainment, educational programming, web content, and e-mail, are also available.

Simulators designed for training on various surgical procedures (e.g., incision, biopsy, suturing, laparo
Surgical training simulators usually consist of human anatomic models that may simulate the whole b
parts of the physical anatomy in normal and/or disease states. The simulators include surgical instrum
other devices needed to simulate the intended procedure. Typically, the manikins and anatomic mode
parts of the anatomy (made from foams, hard and soft plastics, and other materials) and that are typi
table. They house a system of guide wires or other sensors that can detect motion of the surgical instr
them. Most surgical simulators are computerized and include a central unit with appropriate software.
transmit signals to a computer which uses a dedicated software to display feedback to the surgeon on
and/or show a virtual image (usually taken from procedures on actual patients) on the monitor accord
instruments are being manipulated. Some computerized surgical training simulators include ultrasonic
guidance interfaces to simulate surgical procedures that are normally performed using these technolo
software used is specific to the surgical procedures that are being learned, and can simulate different
encountered during actual surgery and provide feedback on patient discomfort, 3-D maps, and proble
technique. Surgical training simulators are used to provide surgical trainees with a visual and haptic (t
practice platform to acquire the skills they need to work on actual patients.

Mixers designed to form otologic cement in a homogenous, reproducible mixture that can be quickly t
delivery device. Otologic cement mixers include a timed mechanism that mixes the cement powder a
(such as autologous blood and antibiotic) together, a reusable applicator used to express the cement
cement packages. They are intended to mix cement used for otologic procedures.
Physiologic analyzers designed to determine the area of contact and evaluate the pressure exerted by
part of it when lying or sitting on a surface. These analyzers typically include sensors to determine the
contact and the pressure existing at each point of the interface between the body and the resting surf
bed), an electronic unit to process the information, and a display typically showing in a colored map th
the pressure values for each contact point. Body pressure distribution analyzers are used to determine
determine abnormal positioning of the body while resting on a surface, facilitate selection of appropria
and/or cushions, and help in the treatment and prevention of decubitus ulcers. Dedicated analyzers in
pressure on the body surface while sitting are also available.

Multitherapy elastomeric ambulatory infusion pumps designed for use in only one patient (i.e., single-
enough to be worn or carried by patients and are designed for use in delivering liquids through intrave
subcutaneous routes from internal reservoirs at pre-established accurate flow rates. Single-patient ela
infusion pumps usually consist of a mechanism (without any electrical or electronic components) that
reservoir or membrane with an elastomeric layer; the pumps usually include a mechanical controller t
medicine. When the pump is filled, the elastomeric layer is stretched. During the infusion, as the elast
the liquid medicine is delivered through dedicated infusion tubing and then to an infusion catheter or
(e.g., epidural catheter, subcutaneous injection/infusion port) and into the patient. Multitherapy single
ambulatory pumps are usually programmed to deliver in continuous mode, although some units offer
pumps are used to administer analgesics, cytostatics, antibiotics, and some other medicines.

Adhesive tapes made of natural (e.g., cotton), semi-synthetic or synthetic (e.g. nylon, polyester) fibers
are usually long and narrow strips supplied in rolls; most tapes are permeable to air and water vapors
intended to attach objects (e.g. dressings, bandages, tubes, catheters) to the body. Adhesive tapes m
particular (e.g., hypoallergenic, waterproof, or both) properties and/or including medications are also a

Adhesive cloth tapes designed to prevent allergic reactions. These tapes are usually long and narrow s
they are made of and/or covered with materials that are not prone to provoke allergic reactions (i.e., h
Hypoallergenic adhesive cloth tapes are designed to attach objects (e.g., dressings, bandages, tubes,

Adhesive cloth tapes designed to prevent the permeation by water (i.e. waterproof). These tapes are u
strips supplied in rolls; they are made of and/or covered with waterproof materials. Waterproof adhesi
intended to attach objects (dressings, bandages, tubes, catheters) to the body.

Adhesive cloth tapes designed to prevent allergic reactions and permeation by water. These tapes are
narrow strips supplied in rolls; they are made of and/or covered with hypoallergenic and waterproof m
Hypoallergenic/ waterproof cloth tapes are designed to attach objects (e.g. dressings, bandages, tube
body.
Adhesive cloth tapes coated with a layer of adhesives that contain medicated agents (e.g., zinc oxide)
usually long and narrow strips supplied in rolls. Medicated tapes are intended to attach objects (dressi
simultaneously providing skin protection from infections.
Medicated adhesive cloth tapes coated with a layer of adhesives that contain zinc oxide. These tapes
narrow strips supplied in rolls. Zinc oxide medicated tapes are intended to attach objects (dressings, t
body, simultaneously providing relief from skin irritation and protection from infections.
Adhesive tapes made of paper. These tapes are usually long and narrow strips supplied in rolls; they a
to air and water vapors and are frequently coated with adhesives that prevent allergic reactions (i.e. h
tapes are intended to attach objects (dressings, bandages, tubes, catheters) to the body.

Adhesive tapes made of plastic material (e.g., polyethylene, PVC). These tapes are usually long and n
rolls. They may be available as foams or nonwoven films; they are usually waterproof. Plastic tapes ar
objects (dressings, bandages, tubes, catheters) to the body.
Plastic adhesive tapes made of plastic (e.g., polyethylene, PVC) foam. These tapes are usually long an
supplied in rolls; they are available as semipermeable or waterproof foam. Foam plastic tapes are inte
(dressings, bandages, tubes, catheters) to the body. Hypoallergenic foam plastic tapes are also availab

Adhesive foam tapes designed to prevent allergic reactions. These tapes are usually long and narrow
they are made of and/or covered with materials that are not prone to provoke allergic reactions (i.e. h
Hypoallergenic adhesive foam plastic tapes are designed to attach objects (dressings, bandages, tube
body.
Plastic adhesive tapes made of nonwoven plastic (e.g., polyethylene, PVC) films. These tapes are usua
strips supplied in rolls; they are available perforated and nonperforated (waterproof). Film plastic tape
attach objects (dressings, bandages, tubes, catheters) to the body.
Adhesive plastic film tapes designed to prevent allergic reactions. These tapes are usually long and na
rolls; they are made of and/or covered with materials that are not prone to provoke allergic reactions (
Hypoallergenic adhesive plastic film tapes are designed to attach objects (dressings, bandages, tubes
body.
Equipment designed to provide a video camera with DC power and/or video and synchronism signals.
consist of electronic units that are connected to the line power that include a DC source and a video s
are used to provide the video camera with power and video signals through a cable (e.g., a dedicated
appropriate connectors at each end; making possible electrical and mechanical matching between on
types of video cameras to the power supply/signal generator unit. The equipment is frequently supplie
video cameras.

Measuring instruments designed to measure the air and/or other gas speed in the environment. These
consist of a mechanical or more frequently an electronic instrument with a display to show the air spe
probe including a sensor and transducer. Environmental anemometers usually measure air velocity at
(200 miles/hour) or more; they are mainly intended for outdoor measurement of the air speed. Dedica
anemometers intended for evaluation of low-speed air flow are also available. Some instruments incor
for simultaneous measurement of air speed and temperature.
Workstations designed to acquire, process, and store data and/or electrocardiographic (ECG) images t
observation of variations of the electric potential caused by the electrical activity of the heart muscle,
the body surface. Electrocardiographs are used to study the action of the heart muscle, for diagnosis o
abnormalities, and to reveal trends or changes in heart function. ECG workstations typically obtain the
electrocardiographic electrodes affixed to certain anatomic points of the patient, which transmit the e
workstation's recorder through a wired or wireless interface. Wireless ECG systems consist of a monito
receives data wirelessly from the patient transceiver that is attached to the patient with an armband.
typically consist of a high-speed digital computer with a powerful microprocessor, optical/magnetic dis
output devices. A workstation usually follows the instructions of specialized software for data and/or im
Workstations are frequently installed as a component of or interact with department and/or hospital in
including picture archiving and communication systems.

Demand valves used in medical gas systems to control the flow of oxygen according to the patient's d
the oxygen. The oxygen flow is controlled by the patient's respiratory effort; the deeper the inhalation
demand for the oxygen and the greater the flow. During inspiration, a negative pressure is applied tha
valve, thereby increasing flow of the oxygen. During exhalation, a positive pressure is applied that clo
and shuts off the oxygen supply. Oxygen demand valves are used in hospitals and most other healthc
patients who need assisted breathing. They can be hand-held, used with portable medical gas cylinde
gas supply line.

Demand valves used in medical gas systems to control the flow of analgesic/anesthetic gas according
demand, or need, for sedation. The analgesic/anesthetic gas flow is controlled by the patient's respira
the inhalation, the greater the demand for the analgesic/anesthetic gas and the greater the flow. Duri
negative pressure is applied that opens the demand valve, thereby increasing flow of the analgesic/an
exhalation, a positive is applied that closes the demand valve and shuts off the analgesic/anesthetic g
Analgesic/anesthetic gas demand valves are used in hospitals and most other healthcare facilities wit
sedation. They can be hand-held, used with portable medical gas cylinders, or with a central gas supp

Devices used in otolaryngology that consist of an audiometer and an otoscope combined into a single
of the audiometer/otoscope allows viewing of the tympanic membrane and ear canal while simultaneo
hearing loss in a patient. Audiometers/otoscopes usually include multiple audio screening levels, audi
source, and a charging transformer and charging stand.
Injection needles designed to penetrate into the urethra and/or the urinary bladder neck or wall during
procedures. These devices typically consist of 23-gauge needles, 35 to 45 cm (14 to 18 inches) in leng
to 8 mm tips to minimize cutting and/or lesion of adjacent tissues and nerves. Cystoscopic injection ne
intended to administer filling materials such as collagen to treat stress urinary incontinence; they are
Teflon and/or other polymers in the treatment of vesicoureteral reflux.
Visual function physiologic analyzers that measure the interior structures of the eye (e.g., anterior seg
corneal shape and thickness, anterior chamber angle information, iris morphology) in a non-contact m
combination of optical coherence tomography and corneal topography. The analyzers consist of a pati
chin rest on a corneal topographer into which the patient gazes with the dilated pupil. A Placido disk (
rings) is projected onto the eye. The rings are reflected back from the cornea and are captured by a ca
a computer to create a topographic map of the cornea using special computer software. When combin
thickness map (pachymetry) from an anterior segment optical coherence tomographer, the analyzers
about the back surface of the cornea and therefore the entire cornea. Other features include automati
software to compensate for eye movements while tracking the corneal vertex. Dedicated software allo
produce visual images and reports of results that may be displayed on a screen and/or printed out. Vis
physiologic analyzers of eye structure are used by ophthalmologists to detect eye structure abnormal
selection for various ophthalmological procedures (e.g., refractive surgery, aspheric intraocular lens se
fitting, pre- and post-excimer laser surgery, glaucoma surgery, corneal transplant, and phakic intraocu

Endoscopic morcellators consisting of a system that combines an electrically powered unit, a hand pie
blades, brushes, and extractors designed to be used in varicose vein removal surgery (i.e., phlebectom
endoscope. Endoscopic phlebectomy morcellators include a powered suction resector introduced throu
varicosity is sucked into the resector, morcellated and removed by suction.

Bronchoscopes designed to access, examine, diagnose, obtain samples for biopsy, and/or treat the low
(i.e., the bronchi) and surrounding anatomic structures using ultrasonic probes. These bronchoscopes
outer (plastic or metal) sheath, an ultrasonic probe with appropriate transducers at the distal tip, and
through which catheters, fine biopsy needles, and other operative devices are introduced. Flexible bro
ultrasonic capabilities are intended for evaluation of the bronchi to detect lesions, take tissue samples
and provide further assessment of surrounding structures using the ultrasound scanning images. The
color and Doppler) permit the visualization of the mediastinum and lymph nodes in the chest surround
(bronchi) that are used to facilitate the staging of lung cancer.

Flexible bronchoscopes with video capabilities designed to reach deep into the lungs near the pleura a
and mediastinal) lymph nodes. These devices consist of a flexible video bronchoscope that includes a
guide with a location sensor at its distal tip and a disposable catheter that extends the reach of the wo
bronchoscope typically works using electromagnetic guidance (i.e., navigation) provided by previous i
The bronchoscope also includes a computerized central unit with a display showing real time images a
that permits electromagnetic tracking and guiding of the guide tip and /or planning of the procedures
of dedicated disposable tools (e.g., forceps, brushes) intended for use with the instrument through the
channel are also available. Extended-reach peripheral lung flexible video bronchoscopes are intended
biopsy of peripheral lung lesions, accurate localization of lymph nodes, and marking of tumors to guid
and/or brachytherapy procedures.
Therapeutic systems designed to combine radiofrequency (RF) and ultrasound (US) therapy by combin
modules in one unit. These units typically include a US module that delivers ultrasonic waves that pen
produce both thermal and nonthermal (e.g., mechanical, cavitation) effects and an RF module that de
warm localized body tissues using their resistance to the passage of high-frequency electromagnetic r
module consists of an RF generator, a cable that transmits the RF energy to the applicator, and an app
handpiece), including a piezoelectric transducer that applies the ultrasonic energy to the patient's tiss
the RF module consists of an RF generator, a power amplifier, and an applicator (i.e., handpiece) to de
patient. Combined RF/US therapy systems are intended to reduce fat under the skin (lipolysis), to trea
conditions (e.g., cellulitis), and to improve body contour; they are mainly used for dermal and cosmeti
physical therapy.

Thin pieces of material shaped and designed for implantation as vascular and/or cardiac patches to re
heart structures. These patches usually consist of thin, sterile materials that are biocompatible and ca
stress suffered by the vascular and cardiac structures; typical patches are made of polymers (e.g., pol
sealants. Cardiovascular patch implants are intended for surgical repair of the vasculature and structu
the heart, including patching of the carotid arteries after endarterectomy and repair of congenital defe
and/or hearts of children.

Circulatory assist units designed to apply and release pressure on a patient's arms or legs, facilitating
through the veins to the heart while also producing hot or cold air to warm and/or cool the patient. Th
minimize venous stasis during and immediately following surgery, as well as during long periods of im
risk of deep venous thrombosis, which can produce pulmonary embolism. These units typically consist
compression pump, a pressure-control mechanism, a timing mechanism, tubing connectors, and tubin
from the pump to cuffs or pneumatic stockings, and an electrically controlled solid state heating and c
and/or cool the patient. Peripheral circulatory assist units are used in clinical facilities or at home; som
treat chronic edema, including lymphedema.

Third-wheel devices that are controlled and/or pedaled by the hands designed for attachment to a wh
usually consist of a front wheel with a crank mechanism including hand pedals and handbrakes, kick s
third wheel upright in a parking position, and an adapter for connecting to a wheelchair. They make a
their attachment to the front of a wheelchair. These devices can either be manually operated, or batte
Wheelchair handcycles are mainly used for facilitating locomotion by people who are usually restricted
can also be used for recreational purposes.

Computer-aided training exercisers designed to train and assess a patient's gait. These exercisers incl
support system employing a harness attached to a metal frame. Some of these exercisers include two
the bottom of the structure and others have a treadmill that patients walk on with the aid of a robotic
styles of exercisers assist patients in moving their legs while bearing some of their body weight. All of
include a computerized unit that monitors, measures, analyzes, and gives feedback on a user's ambul
exercisers can be adjusted to meet specific physical therapy needs of an individual patient; weight-be
speed can be customized for each patient, sometimes pre-programmed, and adjusted as patients prog
Computer-aided training exercisers designed to train and assess patients during upper arm rehabilitat
usually consist of a computerized unit that adjusts exercise resistance, and then monitors, measures,
feedback on the user's performance. These exercisers can be adjusted to meet specific physical thera
individual patient. The exercisers also include a patient support such as a small platform for the arm t
appropriate mechanisms to provide easy adjustments for height, tilt, and arm movements.

Distractors designed to separate the surfaces of a joint without displacement and/or rupture of the lig
distraction) during surgical procedures. These devices are typically a mechanism that may include cla
and a platform; the mechanism is frequently attached to the operating table. Surgical distractors are i
permit manipulation and locking of an articulation in several positions while maintaining distraction, im
of articulated spaces, and providing greater distance between distracted surfaces, facilitating operativ
joints; they may also provide stable traction for reduction and fixation of joint and other small fracture
distractors intended for use in the hand, wrist, shoulder, knee, spine, and hip articulations are availab

Surgical distractors designed to apply traction force to a lower limb (leg) allowing access to the hip joi
distractor applies traction, allowing the surgeon to adjust the angle of abduction/adduction of the upp
pelvis acetabulum. These distractors typically consist of an adjustable mechanism that may include cl
and a strap and/or other accessory attached to the leg; the mechanism is attached at the other end to
(e.g., on a side rail) or other type of support. The mechanism is usually adjustable to different sizes of
distractors are intended for use during hip joint surgical procedures, such as arthroscopic surgery.

Surgical distractors designed to apply traction force to a lower limb (leg) allowing access to the knee j
distractors allow the surgeon to adjust the angle of abduction/adduction, allowing control of flexion, ex
rotation. These distractors typically consist of an adjustable force mechanism that may include clamps
strap attached and/or other accessory attached to the leg; the mechanism is attached at the other en
table (e.g., on a side rail) or other type of support. Knee distractors are intended for use during surgic
performed in the knee, such as arthroplasty.

Auxiliary displays designed to allow manipulation of the screen's display when the user touches differe
with the finger or with a stylus. These devices typically consist of an electronic (e.g., liquid crystal, cat
with electronic circuitry appropriate to display the information that is supplied to the screen via interfa
and dedicated software programs that are located remotely from the screen. Auxiliary touchscreen dis
sizes and can be mounted to the wall or ceiling or can stand on a cart or table. Auxiliary touchscreen d
intended for display of information for the general public and/or the staff in healthcare facilities where
interfaced with other computerized hospital information systems (e.g. operating room automation sys
information systems, computerized medical records systems). Some displays permit limited or comple
system by the user.
Controllers of externally worn or in-canal hearing aids that use wireless technology designed to turn h
and mute or adjust the volume. Hearing aid remote controllers are usually palm-sized or pocket-sized
attach to clothing or belts; some are designed to look like inconspicuous objects (e.g., wristwatches, p
hearing aid remote controllers collect and store data from the hearing aids and remember settings an
user. Some are capable of connecting directly to other devices (e.g., telephones, mobile phones, porta
players, televisions) for hearing aid signal inputs using FM bandwidths or Bluetooth? technology. Hear
controllers are usually specific to the hearing aid models that they operate. Larger hearing aid remote
buttons or symbols are also available for hearing aid users with dexterity and/or vision problems.

Patient warming units comprised of a heat conducting layer (e.g., carbon polymer) placed above a flex
foam) pad that conducts heat supplied by a low voltage power source (either mains or rechargeable b
come in various sizes and is placed under or over the patient as a mattress or blanket and can mold to
patient's body to evenly heat the patient. A control unit is used to maintain the pads at the user-selec
Temperature is monitored by a thermistor built into the pads and this signal is used to allow control of
The control unit uses a transformer to convert the mains input to a very low voltage (usually 24 volts
and regulates this to achieve and maintain the required heating. A thermal cut-out is also integrated i
blanket to prevent over-heating of the patient. Conductive layer patient warming units are used in em
transport, rescue and military applications, perioperative areas, intensive care units, and home care s
infant-sized conductive layer warming units are also available for use in neonatal care settings.

Infant warming units comprised of a heat conducting layer (e.g., carbon polymer) placed above a flexi
viscoelastic foam) that conducts heat supplied by a low voltage power source (either mains or recharg
pad is sized to fit an infant bassinet and is usually placed under the infant as a mattress but may be p
as a blanket. The conductive layer pad can mold to the shape of the infant's body to evenly heat the i
conductive layer patient warming units have slightly lower temperature ranges (usually 28 degrees C
degrees F to 102 degrees F) than those used for adults. A thermal cut-out is also integrated into the m
prevent over-heating of the patient. Infant conductive layer warming units are used to prevent hypoth
delivery room, neonatal intensive care units or other neonatal care settings.

Prepackaged collection of reusable devices designed for in-vivo accurate measurement of the volume
the forearm and arm (i.e., the complete upper limb) volume and/or its variations. These kits typically c
disposable container with appropriate volume and shape for total immersion of the forearm/arm. The
water or other solution that is displaced by the immersion of the limb. The container includes an outpu
liquid container to receive the displaced water caused by the immersion, and a burette to measure th
Arm/forearm volume measuring kits are intended mainly to assess changes in the volume of an arm to
physiologic conditions such as edema.

Prepackaged collection of reusable devices designed for in-vivo accurate measurement of the volume
variations. These kits typically consist of a graduated disposable container with appropriate volume an
immersion of the foot. The container is filled with water or other solution that is displaced by the imm
container includes an output beak, an overflow liquid container to receive the displaced water caused
a burette to measure the displaced water. Foot volume measuring kits are intended mainly to assess c
of a foot to evaluate abnormal physiologic conditions such as edema.
Physiologic analyzers designed for non-invasive assessment of the main characteristics of the cardiov
the blood circulatory system. These analyzers usually measure and/or asses the main parameters tha
and vasculature status, such as the ratio of the systolic pressures at the ankle to the systolic pressure
brachial pressure) known as ankle-brachial index (ABI) that is considered a measure of the stenosis an
They also measure the cardio-ankle vascular index (CAVI) which is a measure of the vascular stiffness
characteristics such as the toe-brachial index (TBI) that are also useful in the evaluation of the vascula
function analyzers usually consist of a computerized unit with a display, a printer, and controllers; the
dedicated software with algorithms for automated assessment of the patient's status. They also includ
electrocardiograph, a sphygmomanometer to determine the non-invasive blood pressure (NIBP); appro
measurement of the brachial, ankle, and toe blood pressure; and interconnection cables. Vascular fun
used to screen the vascular function status and/or to follow the progress of vascular diseases (e.g., ar
patient; some analyzers are based in the variation of length of the interval between heart beats.

Compresses that contain medication and/or herbs. The devices may consist of soft bags containing th
or be ready to soak in medicated solutions. They may be applied with some pressure on the specific a
Medicated compresses are intended to provide therapies to a specific body surface; they are used to r
reduce pain, strains and fatigue, and/or promote wound healing.

Cold compresses or packs that become cold due to an internal chemical reaction. These devices typic
pouch that contains some chemicals (e.g., ammonium nitrate) and an inner pouch that contains water
squeezed and a chemical reaction is generated so as to cool the fluid. Chemical cold compresses/pack
to apply cold therapy to a specific body surface; they are used to reduce pain, swelling, bruising, and

Cold compresses or packs containing gels that retain cold temperature for a long period of time. Thes
consist of compact plastic or fabric bags or pads containing pliable silica gels that can retain cold for a
capable of conforming to the contour of the body; they are typically cooled by placing in cold water, a
freezer. Gel cold compresses/packs are intended to apply cold therapy to a specific body surface; they
reduce pain, swelling, bruising, and bleeding.

Hot compresses or packs that become hot due to an internal chemical reaction. These devices typical
pouch that contains some chemicals (e.g., calcium chloride or magnesium sulfate) and an inner pouch
the inner pouch is squeezed and a chemical reaction is generated so as to warm the fluid. Chemical h
are mainly intended to apply heat therapy to a specific body surface; they are used mainly to improve
reduce pain, muscle spasms and joint stiffness.

Hot compresses or packs containing gels that retain hot temperature for a long period of time. These
consist of compact plastic or fabric bags containing pliable silica gels that can retain heat for a long tim
conforming to the contour of the body; they are typically warmed by placing in hot water or microwav
compresses/packs are intended to apply heat therapy to a specific body surface; they are mainly used
circulation and reduce pain, muscle spasms and joint stiffness.
Compresses or packs designed to apply either cold or heat. These devices typically consist of compac
made of several layers of cotton, gauze, or linen (i.e., compresses), or compact plastic or fabric bags (
contain temperature-retaining substances such as pliable silica gels; the devices are usually capable o
contour of the body. Cold/hot compresses and packs may be cooled by immersion in cold water, a refr
and warmed using a microwave oven. Cold/hot compresses are intended to apply a thermal therapy to
surface; they are mainly used in the treatment of pain, muscle spasms, strains and sprains and joint s

Radioaerosol administration sets designed to administer radioactive gamma technetium gas mixed wi
inhalation into the respiratory tract. These sets typically consist of a combination of an encapsulated c
crucible) containing the gamma radiation gas, a T-section with one-way valves, a mouthpiece, and con
Radioactive technetium administration sets deliver the radioactive gas when the patient inhales from
was previously stored; they are intended for single-use because of the radiation content. The gamma
taken from the patient's lungs are used for diagnosis of existing and/or potential lung diseases (e.g., p
emphysema).

Photographic cameras designed to provide still images from the proximal end of an endoscope. These
include one or more lenses positioned in the front of the camera, a shutter button that operates the ca
modify the focus, optical zoom, and time. The endoscopic camera also includes a film or an image sen
cameras, respectively; the sensors are attached to the endoscope externally. Endoscope photographic
mainly to provide diagnostic data and picture documentation of endoscopic findings.

Hemostatic agents designed for intraoperative control of organ and/or tissue bleeding (i.e., hemorrhag
procedures. These agents may consist of products intended to control bleeding and/or to seal tissues
synthetic absorbable sealants); non-absorbable biological adhesives; or non-absorbable synthetic glue
of cyanoacrylate compounds. Surgical hemostatic agents are intended mainly to facilitate permanent
organs, tissues, and the vasculature. They are also designed to facilitate recovery after surgery and to
surgical procedures. They may be also used in some emergency situations (e.g., to stop hemorrhage i

Computer-aided training exercisers designed to assess and train a patient during neurologic rehabilita
usually consist of a computerized unit that monitors, measures, analyzes, and gives feedback on the u
can be adjusted to meet specific physical therapy needs of an individual patient. The exercisers also in
support (e.g., resembling a physical therapy table) with appropriate mechanisms to provide easy adju
and leg movements; the table also provides motorized cyclic loading of the limbs. Neurologic rehabilit
intended to provide mobilization to neurological patients that are bed-ridden or in the early phase of r

Measuring instruments designed to determine consistency (i.e., degree of firmness), viscosity, and/or
molecules of high-viscosity (viscous) fluids. These instruments typically consist of a mechanism by wh
under its own weight on a graduated scale, a spring-loaded gate to prevent premature flow of the sam
to determine the distance that the substance flows in a given time (i.e., flow rate). The values obtaine
appropriate standards that permit the determination of the fluid characteristics. Dedicated consistome
different mechanisms (e.g., Bostwick consistometers) are also available, including consistometers whe
substances is performed on a scale at a specific angle (i.e., with a predetermined slope).
Video cameras designed for attachment as an integral component at the distal end of a flexible or rigi
These cameras usually include appropriate semiconductor sensors (e.g., CCD, C-MOS) located at the d
endoscope; the captured signal is delivered through fiber optics to the proximal end of the endoscope
video processor. Endoscope tip video cameras are intended for picture documentation of the endoscop
instantaneous display of the images; facilitating diagnoses and/or making possible the performance o
and/or surgical procedures through the endoscope.

Video cameras designed for external use during surgical procedures. These cameras usually include l
visual image, semiconductor sensors (e.g., CCD, C-MOS), a mosaic or rotating color filter and electron
the video signal; appropriate means to hold the camera and a light source for illumination. Typically th
the camera are displayed and/or send to a video processor or to a remote station; some video camera
recording the images (commonly known as camcorders). Surgical video cameras are intended to docu
procedures, to show the results in real time to observers outside the operating room, and to be used f
Dedicated surgical video cameras integrated with the surgical or head lights are available; camcorder
any structure are available; autoclavable cameras intended mainly for use in surgical procedures are a

Video cameras designed to transmit images from the organs inside the abdominal cavity through a lap
cameras usually include appropriate semiconductor sensors (e.g., CCD, C-MOS) at the distal tip of a la
captured signal is delivered through fiber optics to a video monitor and/or to a video recorder or proce
video cameras permit diagnoses, treatment, and/or performance of laparoscopic surgery in real time b
the surgeon; they are also intended for picture documentation of the laparoscopic findings and/or inst
the images for observers outside the operating room and/or for teaching purposes.

Central gas system alarms designed to activate audible (i.e., sound) and/or visual alarms when the pr
partial vacuum level) of a central gas system line is outside (e.g., 20%) predetermined normal system
These devices typically consist of an independent electronic unit, pressure sensors, amplifiers, pressu
visual displays and/or audible warnings that may be located at the site and/or in a central station. Pre
to warn users of abnormal conditions in the delivered gas pressures; alarms are also available for use
station to determine its status.

Central gas system alarms designed to activate audible (i.e., sound) and/or visual alarms when the ox
line is below its normal (about 21%) atmospheric concentration (i.e., oxygen depletion). These device
independent electronic unit, sensors for continuous assessment of the pressure and/or concentration o
circuits to amplify the signal, and visual displays and/or audible warnings that usually activate an alar
concentration of oxygen is in a range from 18% to 19%. Oxygen depletion alarms are usually activate
(e.g., in central gas system oxygen lines and oxygen cylinder delivery lines). The alarms may be locat
a central station. Dedicated oxygen depletion alarms are frequently included as an integral part of dev
anesthesia machines and ventilators.

Alarms designed to activate audible (i.e., sound) and/or visual warnings when the temperature inside
becomes outside pre-established limits. These alarms typically include an electronic unit for data proc
sensors, and visual (e.g., displays) and/or audible warnings that may be located at the site of the equi
central station. Equipment temperature alarm systems are used in clinical laboratory devices (e.g., re
water baths), pharmacy equipment (e.g., freezers), and other healthcare facility equipment.
Temperature alarms designed to activate audible (i.e., sound) and/or visual warnings when the tempe
refrigerator or freezer intended for clinical use becomes outside pre-established limits. These alarms t
electronic unit (frequently battery operated) with temperature measurement controls that can be fixed
temperatures (e.g., from -80 to 125 degrees C, or -112 to 257 degrees F), temperature sensors, and v
and/or audible warnings that may be located at the site of the equipment and/or less frequently at a c
alarms are suitable for working inside freezers and refrigerators. Refrigerator/freezer temperature alar
such as clinical laboratories, pharmacies, and blood banks to facilitate the control of refrigerated and/
sensitive samples and/or supplies (e.g., blood samples, biological products).

Alarms designed to activate audible (i.e., sound) and/or visual warnings when a hazardous condition b
level in a closed environment is detected. These alarms usually consist of a detector, appropriate tran
electrical signal, amplifiers, separate electric power systems and/or batteries, and sound and/or light s
signals (e.g., high-pitched sounds, intense flashing lights) to warn people that the hazardous condition
intended to be fixed in a particular room providing only emergency signals locally and alarm systems
complete facility that may also include remote alarms (e.g., police and/or fire stations) are available. E
emergency alarms are used in healthcare facilities for detecting a variety of hazardous conditions, inc
carbon monoxide, explosive and toxic gases. Alarms intended to be fixed in a particular room providin
signals locally and alarm systems intended for a complete facility that may also include remote alarm
fire stations) are available. Dedicated alarms intended for fire and/or smoke, carbon monoxide, and ot
conditions are also available. Emergency alarms may be used also to activate safety (e.g., unlock doo
(e.g., sprinklers) mechanisms.

Environmental emergency alarms designed to activate audible (i.e., sound) and/or visual warnings wh
(CO) beyond a threshold level in a closed environment is detected. These alarms usually consist of a C
oxide), appropriate transducers to generate an electrical signal, amplifiers, separate electric power sy
and sound and/or light sources that deliver signals (e.g., high-pitched sounds, intense flashing lights)
high CO levels are present. CO alarms intended to be fixed in a particular room providing only emerge
alarm systems intended for a complete facility that may also include remote alarms (e.g., police and/o
available. CO alarms are usually required in facilities that use fuel-burning appliances such as furnace
room heaters, motor-powered equipment such as portable generators, and/or fireplaces, and other ch
used in homes and other enclosed areas.

Environmental emergency alarms designed to activate audible (i.e., sound) and/or visual warnings wh
concentration in a closed environment is below its normal (about 21%) atmospheric value (i.e., oxyge
devices typically consist of a sensor for continuous assessment of oxygen concentration, electronic cir
signal, and visual displays and/or audible warnings that usually initiate an alarm when the concentrati
between 18% and 19%. Oxygen depletion environmental emergency alarms are intended mainly for u
where other gases are manipulated, such as clinical laboratories that perform procedures involving ca
liquid nitrogen for cryopreservation. Alarms intended to be fixed in a particular room providing only em
locally and alarm systems intended for a complete facility that may also include remote alarms (e.g.,
stations) are available. These alarms are usually fixed permanently on the walls.
Drilling machines designed for drilling small holes (i.e., pinholes) in dental prostheses during manufac
These machines typically consist of a high-speed rotatory motor, a fine beam laser, and a rotating ass
spindle) that includes a dedicated jig and associated detachable very small diameter (e.g., 1/16 inch/1
machine also includes a support (e.g., a vise clamped to a table) for the piece that is being drilled and
depth control for the perforation and appropriate means for extraction of dust. Laser-Guided dental dr
intended for use in dental laboratories to obtain accurate pinholes in plastic prostheses using a laser g

Sample delivery systems designed to interface with gas-liquid chromatography systems or high-press
chromatography systems to introduce gas, liquid or solid phase micro extraction samples into the sam
phase) of the system in the smallest volume possible so that the sample enters the stationary phase c
homogeneous, low-volume plug. Chromatography injectors can be manual or automated. Some chrom
have a microsyringe that is lowered into a sample vial through a septum to draw gas, liquid or solid ph
samples into the syringe in measured amounts. After the syringe injector is filled, the chromatography
interfaced with the injection port of the chromatography unit to introduce the sample. Both automated
injectors are available for use with gas chromatography and high-pressure liquid chromatography syst

Devices designed to permit the mixing (i.e., blending) of compressed medical gases achieving blend c
proportions) appropriate for a particular application. Typically the proportioners receive pure gases fro
pipeline or from other compressed gas sources (e.g., cylinders). These proportioners are usually equip
regulating mechanism and connectors for the primary gas sources and also for delivering of the blend
gas proportioners are used in healthcare facilities, doctors' offices, and at home. Dedicated devices ar
obtaining specific combinations of gases, such as oxygen-air, nitrous oxide-oxygen, and heliox-oxygen

Pre-packaged kits with several components designed to kill and remove lice and their eggs from the u
include a shampoo treatment and a very fine-toothed comb, some also include a foam or gel solution
and an upholstery spray. The shampoo is used first to wash the infested person's hair and scalp. The s
kill the lice and their eggs with pesticides or by smothering them. Then the comb (sometimes with the
applied to the scalp) is used to comb the hair and scalp physically removing the lice and their eggs. A
applied to linens and upholstery to kill any lice and eggs on pillows, hats, car seats, etc.

Surgical hemostatic agents designed for intraoperative control of organ and/or tissue bleeding (i.e., h
surgical procedures and are not absorbed by the body. These agents may consist of adhesive products
that create a mechanical barrier to decrease blood flow. Products that polymerize after application, as
consisting of sterile foams (e.g., sponges) or collagen that are frequently impregnated with thrombin,
Non-absorbable surgical hemostatic agents are intended mainly for permanent bleeding control in the
They are designed to facilitate recovery after surgery and to help avoid additional surgical procedures
used in some emergency situations (e.g., to stop hemorrhage in open wounds).

Prostheses that combine a biological cardiac valve and a synthetic vascular graft (i.e., a conduct that
as an internal component) designed for surgical implantation. These prostheses may consist either of
human cadavers (i.e., allografts) or animals such as pigs or cows (i.e., xenografts) that are harvested a
valves are preattached (e.g., presewn) to a synthetic graft (i.e., conduct) before the surgical implantat
facilitate the surgical implantation procedures and reduce patient risks. Combined prostheses intende
the aortic valve and the ascending aorta are also available.
Electromagnetic external shock wave therapy (ESWT) systems designed for cardiac procedures. These
consist of an electromagnetic shock wave generator that applies the shock waves only during the refr
cardiac cycle. The generator's energy may be accurately adjusted and controlled across a wide range
with an energy level several times less than that of systems used for lithotripsy or orthopedic applicat
systems include a dedicated applicator to deliver the shock waves to the ischemic areas of the myoca
intended to perform repetitive cardiac treatments to generate new capillary vessels, increasing blood
who have severe coronary artery disease and/or refractory angina.

Radiosurgical image-guided computer-aided stereotactic surgical systems designed to aid in the perfo
procedures from the exterior of the body using a single high dose of ionizing radiation provided by line
linacs). These systems typically combine medical imaging, dedicated computer software, and a dedica
with a movable gantry and a single or multileaf collimator. Standard linacs may be adapted also for lim
applications. Image-guided linac radiosurgical systems typically incorporate a miniature linac mounted
arm and an image-guidance system that can track target location during treatment using fiducials as
need for an invasive head frame. Radiosurgical linac stereotactic systems are mainly intended to prov
of ionizing radiation; they are used in neurosurgery (i.e., for brain, neck, and spinal tumors) and, less f
radiosurgery of extracranial tumors (e.g., to ablate abdominal tumors). Dedicated linac systems that c
location in the body and employ computer-controlled beam-shaping (known as intensity modulated ra
to conform the radiation dose to the shape of the tumor or other lesion are also available.

Products consisting of solutions, creams, and/or gels often made from plant materials, which do not co
act metabolically but can have other properties (e.g., some anesthetic or mild germicidal protection) t
topical application. These products are applied locally and externally to specific areas of the body and
create a physical barrier on the surface of the skin. These topical solutions (that may be applied as an
gels can be also used to prevent absorption of certain environmental hazards (such as ultraviolet rays

Non-metabolic solutions or creams applied to the skin to create a barrier from the sun's ultraviolet ray
prolonged absorption of ultraviolet rays may lead to burnt skin and increased odds of developing certa
these products is intended to help prevent skin damage and help reduce the risk of developing certain
solutions or creams remain effective at blocking the sun's rays for a limited amount of time (usually a
These solutions and creams are often made from plant materials and minerals; they do not contain dr
metabolically.

Non-metabolic solutions or creams applied to the feet. These solutions create a physical barrier agains
as water, sun, or dry air) which can cause dry skin on the heels and other parts of the foot. These solu
and temporarily control foot odor as well. These solutions and creams are often made from plant mate
contain drugs and do not act metabolically.
Piezoelectric external shock wave therapy (ESWT) systems designed for orthopedic procedures that ar
alleviate pain. These systems typically consist of a low-power shock wave generator which contains se
piezoelectric (ceramic) elements in a two-layer arrangement similar to a mosaic that is aligned to the
points; the ceramic elements are excited by a high-voltage pulse generator. The systems also include
shape, triggering, and variable delay setting controls. The therapy is provided using detachable probe
shock wave depth of penetration can be varied by using gel pads of different thickness. These permit
full ESWT or more superficial treatment at pain trigger points and/or areas that may trigger pain in ad
of the body (known as trigger point shock wave therapy or TPST).

Jejunostomy tubes designed for insertion of the distal tip into the pancreatic duct for passive external
surgery. These devices typically consist of a single-lumen plastic or silastic tube with a stopper (e.g., a
attachment, stopper rings) at the distal end for easy fixation in the pancreatic duct and an external en
collection container (e.g., bag, vessel). Pancreatic drainage tubes are used for passive (i.e., through ca
gravity) draining of pancreatic fluids (also known as pancreatic juices) after surgical procedures involv
as pancreatoduodenectomy and/or pancreatojejunostomy.

Ureteral dilators designed to provide access through a passage (i.e., sheath) into the upper urinary tra
typically consist of a flexible plastic sheath that may have one or more channels that permit the introd
and working instruments (e.g., stone baskets, laser fibers) into the ureters; the dilators may be used a
introduction of contrast media. Access sheath ureteral dilators are intended for use during urologic en
the ureters and/or other parts of the upper urinary tract.

Liquid germicide disinfectors designed to kill or inactivate many microorganisms (e.g., fungi, viruses,
transesophageal echocardiography (TEE) probes following a diagnostic TEE procedure. These disinfect
microorganisms including mycobacteria, all fungi, and small nonlipid viruses (medium-level disinfectio
disinfectors can also kill spore-forming bacteria (except when there is a large number) which provides
disinfection (near-sterile disinfection). TEE ultrasonic probe disinfectors typically apply a chemical ger
glutaraldehyde-based) to the probe, using mechanisms that facilitate the circulation of the germicide
usually taking a period of time shorter than that required for sterilization or when using manual proce
provide fast automated disinfection and rinsing cycles; some equipment provides neutralization and/o
germicide. The results of each cycle may be printed to confirm the validity of the procedure. TEE prob
in healthcare facilities areas where a high turn-around of TEE probes is needed.

Controllers designed to regulate the performance of infusion pump systems that may follow a program
consist of a centralized electronic unit that controls each of several interconnected infusion pumps an
(including some monitors) of the infusion system; the controllers permit the introduction of pre-establ
programs related to the infusion process and/or monitoring and alarms. Programmable infusion system
include dedicated software that can be configured to the special needs of the healthcare facility, spec
patient characteristics; the software may be also capable of detecting medication administration error
reduction systems). Programmable infusion system controllers are used in areas of healthcare facilitie
simultaneous use of several infusion pumps is frequent.
Equipment designed to deliver fluid (i.e., irrigate) to a cavity or other specific area of the body. These
consist of a main unit, including one or more pumps to deliver the liquid, an easy-to-handle (e.g., pisto
a control (e.g., valve, clamp) for the rate of the irrigation flush, and appropriate tubing to connect the
unit; some automated irrigators may use dedicated software. The equipment may also include an aux
connectors, splash shields, and adapters. Irrigators are intended to improve visualization and provide
clinical or surgical procedure sites (e.g., body cavities); dedicated irrigators are available for particular
surgical, wound) procedures.

Equipment designed for automated cleaning, lubricating, and purging of dental handpieces, including
channels. These units consist of electromechanical equipment with openings to place one or more den
appropriate adapters for a variety of different dental handpieces; a keyboard to control time and chara
cleaning/purging/lubricating cycle following pre-established programs; and an internal mechanism tha
appropriate products (e.g., cleaning solutions, lubricants) during each phase of the cycle. Dental hand
cleaning/lubricating units are used to facilitate the periodic (e.g., daily) maintenance of dental handpi
shorten the period needed for reprocessing of the handpieces. Some units may be used also to proces
and/or air driven dental scalers.

Treadmill exercisers designed to reduce the effect of gravity by using a pressurized-air controlled cham
These exercisers typically consist of a continuous tread and an electric motor, a pressurized-air contro
reduce the patient's weight (e.g., in a range from 20% to 100%), controls for the tread (i.e., belt) spee
display that shows equipment characteristics and training information (e.g., speed, time, slope ([i.e., e
consumption, percentage of weight reduction). Patient air lifting treadmills are used in healthcare faci
training and/or rehabilitation; especially after lower extremity injuries, neurological diseases, and/or fo
people.

Hospital data management information systems designed for automated managing of ambulatory pat
from registration to discharge in a healthcare facility. These systems typically consist of a combination
dedicated software. The hardware typically includes dedicated network servers, computers, and other
printers, displays, and audio systems to supply information to the patient. The software consists of a d
package that ensures that the patient is properly guided through the hospital facility and that the proc
every step (e.g., appointment validation, proper procedure). The software can also provide statistics r
periods and time spent in each procedure, permitting informed decisions about the staff and clinic per
information data management systems may function as stand-alone systems or may be integrated in
management information system network; some systems may also perform a complete patient registr

Irrigators designed for automated or semiautomated irrigation and washing of tissue and/or debris fro
nasal sinuses. These devices typically consist of a main electromechanical unit that includes a pump f
a jet of nonmedicated (e.g., saline) liquids, controls for the rate and pressure of irrigation of the liquid
solution, and a handpiece that may include a set of detachable tips intended for introduction in the na
lavage units are intended to remove debris from the nose and/or nasal sinuses; they are used mainly
for allergy treatment, nasal congestion, and before and after surgery; some devices are used for home
Simulators designed for training in endoscopic diagnostic and therapeutic procedures performed in th
simulators typically include an anatomic model resembling the characteristics of the bronchial tree tha
simulating coughing, breathing, and bleeding; the anatomic models are made of plastics, metal, or a c
The equipment simulates the conditions for endoscopic procedures by providing access to entrances i
resembling the body natural airways, permitting the use of flexible endoscopes, surgical instruments,
external use of video monitors. The simulator also includes a main control unit with dedicated softwar
training and recording of the simulated endoscopic procedure in real time. Bronchial endoscopic traini
include as integral parts or attached modules and/or accessories intended for training in particular pro
diagnostic, emergency, ultrasonic, and other interventional bronchial procedures.

Irrigators designed for automated or semiautomated irrigation, washing, and debridement of external
consist of a main electromechanical unit that typically includes a pump for irrigation with nonmedicate
controls for the temperature, pressure, and rate of irrigation; and frequently a splash shield to avoid a
contamination. The units are coupled to dedicated handpieces for irrigation and to facilitate easy rem
necrotic tissue. Wound irrigators are used to remove damaged (e.g., necrotic) tissue and/or debris (e.g
in emergency departments and other healthcare areas. Dedicated wound irrigators using ultrasound e
procedure and provide better debridement are also available.

Aspirators/irrigators designed for automated or semiautomated irrigation, washing, and evacuation of


and other segments of the large intestines from the rectum to the cecum. These devices typically con
electromechanical unit that includes a pump for infusion of nonmedicated liquids (e.g., saline), an ext
vacuum), and controls for the temperature and the rate of infusion (e.g., using a nozzle) and withdraw
units are coupled to dedicated handpieces and/or to disposable catheters that are introduced through
lavage units are used to remove damaged tissue and/or debris (e.g., feces, foreign objects) in emerge
are also used for cleaning and evacuation of the large intestine before or during particular (e.g., endo
procedures.

Aspirators/irrigators designed for automated or semiautomated irrigation and washing of the eye surfa
cornea). These devices typically consist of a main electromechanical unit that may include a pump for
nonmedicated liquids (e.g., saline), an extractor, and controls for the temperature and the rate of irrig
coupled to special (e.g., Morgan therapeutic) lenses and/or to dedicated (e.g., Lewis) handpieces, can
and/or probes. Eye lavage units are used to remove damaged tissue and/or debris (e.g., foreign object
ophthalmic procedures or surgery and in emergency departments; the units are frequently available a
be attached to ophthalmic examination and/or surgical (e.g., phacoemulsification) units.

Aspirators/irrigators designed for automated or semiautomated irrigation, washing, and evacuation of


surgical site. These devices typically consist of an electromechanical main unit that usually includes a
irrigation/infusion of liquids (e.g., saline), an extractor (frequently using vacuum), and controls for the
irrigation/infusion and withdrawal of the liquid; surgical aspiration/irrigation units are usually coupled
include the irrigation/suction controls. A set of dedicated detachable tips and other accessories for par
applications are also available. Surgical lavage units are intended for use in surgical rooms and in doc
minor surgical procedures. Dedicated surgical irrigators/aspirators intended for endoscopic and laparo
also available.
Aspirators/irrigators designed for automated or semiautomated irrigation, washing, and evacuation of
substances) from the stomach. These devices typically consist of a main electromechanical unit that i
infusion of nonmedicated liquids (e.g., saline); an extractor (frequently using vacuum); controls for the
infusion and withdrawal of the liquid, and pressure; and bags for the irrigation solution and waste. Mo
charcoal to the stomach for absorption of toxic substances. Stomach aspiration/irrigation units are usu
disposable vented tubes that are introduced into the stomach through the mouth. The units are intend
emergency departments; they are also used for cleaning and evacuation of the stomach before some
surgical procedures.

Aspirators/irrigators designed for automated or semiautomated irrigation, washing, and evacuation of


peritoneum during laparoscopic procedures. These devices typically consist of an electromechanical m
includes a pump for irrigation/infusion of liquids (e.g., saline), an extractor (frequently using vacuum),
rate of irrigation/infusion and withdrawal of the liquid; surgical aspirators/irrigators are usually coupled
laparoscopic handpieces and/or other laparoscopic instruments such as high-capacity tubing and elec
bipolar forceps) instruments.

One-lung ventilation tracheal tubes designed as a double-lumen tube. These tubes typically include tw
terminating in the trachea and the other in the main stem bronchus. Some tubes (e.g., Robertshaw tu
or right-lung isolation (clamping the bronchial lumen and ventilating the tracheal lumen and vice vers
tubes that include a carinal hook are designed either for left-side (e.g., Carlens tube) or right-side (e.g
ventilation. Wire-guided tubes introduced through a bronchoscope are also available. Double-lumen on
tracheal tubes are used mainly during thoracic surgery and/or intensive care procedures; they usually
suction and/or continuous positive airway pressure ventilation. Double lumen tubes that include a vide
the distal tip to facilitate visualization of the procedures are also available.

One-lung ventilation tracheal tubes consisting of a single-lumen tube. Some single-lumen devices (e.g
include a movable bronchial blocker shaft inside the tube, a main cuff, and a bronchial balloon permitt
of one or more lobes of the lung; other single-lumen tubes include an inflatable balloon at the tip to b
cannot be used for suction or ventilation of the blocked lung. Single-lumen one-lung ventilation trache
mainly during thoracic surgery and/or intensive care procedures; some devices can be used for postop
avoiding the need of tube change.
Tubes designed for insertion into an opening (i.e., stoma) performed in the neck and trachea (windpip
facilitating breathing. Most of these devices (i.e., double-cannula tubes) consist of the following: (1) an
more frequently, plastic or silicone curved tube (outer cannula) that fits directly into the tracheal stom
flange (neck plate) designed to accommodate mechanisms for securing the tube (e.g., an external tra
an obturator inserted into the outer cannula to guide the external tube during insertion into the trache
removed after the outer cannula is in proper position; and (3) an internal cannula (including a lock to p
coughed out) that is inserted through the external tube after the obturator is removed. This cannula m
for use with ventilatory equipment. Some simpler and smaller devices (single-cannula tubes) used ma
include an internal cannula. Tracheostomy tubes are available in a variety of sizes and configurations;
balloon to allow for mechanical ventilation (i.e., cuffed tracheostomy tubes) and/or an opening (i.e., a
permits speech through the upper airway. Tracheostomy/laryngectomy tubes may be used in patients
surgical opening (stoma) in the otherwise intact larynx and trachea; they are also used in a permanen
trachea performed after total or partial surgical removal of the larynx (i.e., laryngectomy) that may re
early stages.

Software designed to operate physiologic monitors, control/monitor a limited number of their function
obtained while monitoring. This software is intended to work only with one or a few models of physiolo
monitoring systems, usually from the same manufacturer. The software may perform a variety of algo
operation and analysis of the measurements performed while monitoring and/or while processing and
transmitting/receiving patient information from and to workstations and hospital information systems.
dedicated physiologic monitoring software intended to assess physiologic parameters at the bedside,
using telemetry or physiologic monitoring systems.

Information, either instruction or data that is typically stored electronically. Software is frequently clas
system software that includes the operating systems or the utilities that enable the computer to funct
software consisting of programs that perform specific tasks for users. Software specifically intended fo
usually application software; not included in this term is software that is not intended to be modified,
supplied as an integral component of a particular piece of equipment or system (i.e., firmware) or use
devices. Software used in healthcare facilities is usually associated with a device or system (e.g., mon
monitors, chemical chemistry analysis software to laboratory analyzers, data management software to
and is not frequently obtained separately from the equipment. But updates, upgrades and new applic
frequently available from the manufacturers of the equipment. Dedicated healthcare software intende
other purposes and that is typically intended for use with standard computers (e.g., personal compute

Physiologic monitoring software designed to operate blood gas monitors, control/monitor a limited num
and/or process data obtained while monitoring. This software is intended to work only with one or a fe
monitors, usually from the same manufacturer. The software may perform a variety of algorithms to fa
and analysis of the measurements performed while monitoring blood gases and/or while processing a
transmitting/receiving patient information from workstations, and/or hospital information systems. Blo
software is not usually available separate from the monitor but may be updated (i.e., through the rele
versions) during the lifeduring the life of the equipment; the software is mainly used by bedside and t
and/or physiologic monitoring systems.
Physiologic monitoring software designed to operate blood pressure monitors, control/monitor a limite
functions, and/or process data obtained while monitoring. This software is intended to work only with
blood pressure monitors, usually from the same manufacturer. The software may perform a variety of
the operation and analysis of the measurements performed while monitoring blood pressure and/or w
transmitting/receiving patient information from workstations, and/or hospital information systems. Blo
software is not usually available separate from the monitor but may be updated (i.e., through the rele
versions) during the lifeduring the life of the equipment; the software is mainly used by bedside and t
and/or physiologic monitoring systems. Dedicated software is available for non-invasive and invasive
monitoring (NIBP and IBP) respectively.

Physiologic monitoring software designed to operate cardiac output monitors, control/monitor a limite
functions, and/or process data obtained while monitoring. This software is intended to work only with
cardiac output monitors, usually from the same manufacturer. The software may perform a variety of
the operation and analysis of the measurements performed while monitoring cardiac output and/or wh
transmitting/receiving patient information from workstations, and/or hospital information systems. Car
software is not usually available separate from the monitor but may be updated (i.e., through the rele
versions) during the lifeduring the life of the equipment; the software is mainly used by bedside, telem
physiologic monitoring systems. Dedicated software specific to a particular technique used to measur
available.

Physiologic monitoring software designed to operate electrocardiography (ECG) monitors, control/mon


of their functions, and/or process data obtained while monitoring. This software is intended to work on
models of electrocardiography monitors, usually from the same manufacturer. The software may perfo
algorithms to facilitate the operation and analysis of the measurements performed while monitoring E
while processing and/or transmitting/receiving patient information from workstations, and/or hospital
ECG monitoring software is not usually available separate from the monitor but may be updated (i.e.,
modified versions) during the lifeduring the life of the equipment; the software is mainly used by beds
monitors, and/or physiologic monitoring systems. Dedicated ECG software is available according to th
equipment can measure (e.g., pulse rate, electrocardiogram, hemodynamic).

Physiologic monitoring software designed to operate electroencephalography (EEG) monitors, control/


number of their functions, and/or process data obtained while monitoring. This software is intended to
a few models of EEG monitors, usually from the same manufacturer. The software may perform a varie
facilitate the operation and analysis of the measurements performed while monitoring the EEG param
processing and/or transmitting/receiving patient information from workstations, and/or hospital inform
monitoring software is not usually available separate from the monitor but may be updated (i.e., throu
modified versions) during the life of the equipment; the software is mainly used by bedside and telem
Dedicated software is available according to the parameters that the equipment can measure (e.g., sp
analysis, level-of-consciousness).
Physiologic monitoring software designed to operate fetal monitors, control/monitor a limited number
and/or process data obtained while monitoring. This software is intended to work only with one or a fe
monitors, usually from the same manufacturer. The software may perform a variety of algorithms to fa
and analysis of the measurements performed while monitoring the fetus and/or while processing and/
transmitting/receiving patient information from workstations, and/or hospital information systems. Fet
is not usually available separate from the monitor but may be updated (i.e., through the release of mo
the life of the equipment; the software is mainly used by bedside and telemetric monitors. Dedicated
for antepartum and intrapartum fetal monitors.

Physiologic monitoring software designed to control/monitor a limited number of glucose monitor func
data obtained while monitoring. This software is intended to work only with one or a few models of glu
from the same manufacturer. The software may perform a variety of algorithms to facilitate the opera
measurements performed while monitoring glucose levels and/or while processing and/or transmitting
information from workstations and/or hospital information systems. Glucose monitoring software may
from the monitor (e.g., as a central station or telephone system software) and may be updated (i.e., th
modified versions) during the life of the monitor; the software is mainly used to process data from per
monitors.

Physiologic monitoring software designed to operate intracranial pressure monitors, control/monitor a


functions, and/or process data obtained while monitoring. This software is intended to work only with
intracranial pressure monitors, usually from the same manufacturer. The software may perform a varie
facilitate the operation and analysis of the measurements performed while monitoring intracranial pre
processing and/or transmitting/receiving patient information from workstations, and/or hospital inform
Intracranial pressure monitoring software is not usually available separate from the monitor but may b
through the release of modified versions) during the life of the equipment; the software is mainly used
telemetric monitors, and/or physiologic monitoring systems.

Physiologic monitoring software designed to operate neurology monitors, control/monitor a limited nu


and/or process data obtained while monitoring. This software is intended to work only with one or a fe
monitors, usually from the same manufacturer. The software may perform a variety of algorithms to fa
and analysis of the measurements performed while monitoring neurologic parameters such as evoked
electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response and/or
and/or transmitting/receiving patient information from workstations, and/or hospital information syste
monitoring software is not usually available separate from the monitor but may be updated (i.e., throu
modified versions) during the life of the equipment; the software is mainly used by bedside and telem
physiologic monitoring systems. Dedicated software is available to measure all or several EP, EMG, an
Physiologic monitoring software designed to operate multipurpose, multiparameter monitors, control/m
number of their functions, and/or process data obtained while monitoring. This software is intended to
a few models of multipurpose monitors, usually from the same manufacturer. The software may perfo
algorithms to facilitate the operation and analysis of the measurements performed while monitoring t
while processing and/or transmitting/receiving patient information from workstations, and/or hospital
Multipurpose monitoring software is not usually available separate from the monitor but may be upda
release of modified versions) during the life of the equipment; the software is mainly used for simultan
telemetric, and central station monitoring used in physiologic monitoring systems. Dedicated software
to the parameters that the physiologic monitor or monitoring system can measure; additional software
capabilities to modular monitors or monitoring systems is also available.

Physiologic monitoring software designed to operate vital sign monitors, control/monitor a limited num
and/or process data obtained while monitoring. This software is intended to work only with one or a fe
monitors, usually from the same manufacturer. The software may perform a variety of algorithms to fa
and analysis of the measurements performed while monitoring vital signs (e.g., temperature, non-inva
and/or while processing and/or transmitting/receiving patient information from workstations, and/or ho
systems. Vital signs monitoring software is not usually available separate from the monitor but may b
through the release of modified versions) during the life of the equipment; the software is mainly used
to perform periodic measurements but that may be used also during transportation or at the bedside.

Physiologic monitoring software designed to operate respiration monitors, control/monitor a limited nu


functions, and/or process data obtained while monitoring. This software is intended to work only with
respiration monitors, usually from the same manufacturer. The software may perform a variety of algo
operation and analysis of the measurements performed while monitoring respiration (e.g., respiration
apnea) and/or while processing and/or transmitting/receiving patient information from workstations, a
information systems. Respiration monitoring software is not usually available separate from the monit
(i.e., through the release of modified versions) during the life of the equipment; the software is mainly
telemetric monitors, and/or physiologic monitoring systems. Dedicated software is available according
to measure respiration (e.g., electrical impedance).

Physiologic monitoring software designed to operate uterine activity monitors, control/monitor a limite
functions, and/or process data obtained while monitoring. This software is intended to work only with
uterine activity monitors, usually from the same manufacturer. The software may perform a variety of
the operation and analysis of the measurements performed while monitoring uterine activity and/or w
transmitting/receiving patient information from workstations and/or hospital information systems. Ute
software is not usually available separate from the monitor but may be updated (i.e., through the rele
versions) during the life of the equipment; the software is mainly used by bedside and telemetric mon
Physiologic monitoring software designed to operate electro-oculography monitors, control/monitor a
functions, and/or process data obtained while monitoring. This software is intended to work only with
electro-oculography monitors, usually from the same manufacturer. The software may perform a varie
facilitate the operation and analysis of the measurements performed while monitoring electro-oculogr
processing and/or transmitting/receiving patient information from workstations, and/or hospital inform
oculography monitoring software is not usually available separate from the monitor but may be updat
release of modified versions) during the life of the equipment; the software is mainly used by telemet
physiologic monitoring systems.

Physiologic monitoring software designed to operate electromyography (EMG) monitors, control/monit


their functions, and/or process data obtained while monitoring. This software is intended to work only
models of EMG monitors, usually from the same manufacturer. The software may perform a variety of
the operation and analysis of the measurements performed while monitoring EMG bioelectrical signals
processing and/or transmitting/receiving patient information from workstations, and/or hospital inform
monitoring software is not usually available separate from the monitor but may be updated (i.e., throu
modified versions) during the life of the equipment; the software is mainly used by bedside, telemetri
physiologic monitoring systems. Dedicated software is available according to the type of monitor used
electromyography.

Physiologic monitoring software designed to operate acute care monitoring systems, control/monitor a
their functions, and/or process data obtained while monitoring. This software is usually installed in a c
dedicated workstation, acting as an interface between the central station and bedside or telemetric m
perform a variety of algorithms to facilitate the operation and analysis of the measurements performe
Acute care monitoring software is intended to work only with one or a few models of acute care monit
from the same manufacturer, also facilitating the processing and/or sending data from the acute care
a hospital information system. The software is not usually available separate from the monitoring syst
updated (i.e., through the release of modified versions) during the life of the equipment.

Physiologic monitoring software designed to operate cardiac catheterization monitoring systems, cont
number of their functions, and/or process data obtained while monitoring. This software is usually inst
station or dedicated workstation, acting as an interface between the central station and other devices
bedside or telemetric monitors. It may also perform a variety of algorithms to facilitate the operation
measurements performed while monitoring. Cardiac catheterization monitoring software is intended t
a few models of acute care monitoring systems, usually from the same manufacturer, also facilitating
transmitting/sending data from the acute care monitoring system to and from other catheterization la
hospital information system. The software is not usually available separate from the monitoring system
(i.e., through the release of modified versions) during the life of the equipment. Dedicated software in
ventriculography and coronary arteriography procedures is also available.
Physiologic monitoring software designed to operate cardiac electrophysiology monitoring systems, co
number of their functions, and/or process data obtained while monitoring. This software usually install
or dedicated workstation, acting as an interface between the central station and other devices such a
stimulators, and bedside or telemetric monitors. It may also perform a variety of algorithms to facilita
analysis of the measurements performed while monitoring. Cardiac electrophysiology monitoring softw
work only with one or a few models of acute care monitoring systems, usually from the same manufac
the processing and/or transmitting/sending data from the cardiac electrophysiology monitoring system
catheterization laboratories and/or a hospital information system. The software is not usually available
monitoring system but may be updated (i.e., through the release of modified versions) during the life

Physiologic monitoring software designed to operate monitoring systems while performing stress exer
limited number of their functions, and/or process data obtained while monitoring. This software is usu
central station or dedicated workstation, acting as an interface between the central station and other
monitors, exercisers, and ergometers. It may also perform a variety of algorithms to facilitate the ope
the measurements performed while monitoring. Stress exercise monitoring software is intended to wo
few models of stress exercise monitoring systems, usually from the same manufacturer, also facilitatin
and/or transmitting/sending data from the acute care monitoring system to and from a hospital inform
software is not usually available separate from the monitoring system but may be updated (i.e., throu
modified versions) during the life of the equipment. Dedicated software packages intended only for ca
stress exercise are also available.

Physiologic monitoring software designed to operate remote alarms, control/monitor a limited number
and/or process data obtained while gathering information about a patient's physiologic parameters. Th
to work only with one or a few models of physiologic monitors or monitoring systems, usually from the
The software may perform a variety of algorithms to facilitate the analysis of the monitored paramete
for the alarm and/or the room number of the patient whose status triggered the alarm. Physiologic m
software is intended for use with alarm systems placed in hallways and/or multipatient rooms, helping
obtain ready access to real time patient alarm information.

Software designed to operate anesthetic gas monitors, control/monitor a limited number of their funct
data obtained while monitoring. This software is intended to work only with one or a few models of an
usually from the same manufacturer. The software may perform a variety of algorithms to facilitate th
analysis of the measurements performed while monitoring anesthetic gases and/or while processing a
transmitting/receiving patient information from anesthesia units, workstations, and/or hospital informa
Anesthetic gas monitoring software is not usually available separate from the monitor but may be upd
release of modified versions) during the life of the equipment. Dedicated software intended for comb
gas/physiologic monitoring is also available.
Physiologic recording software designed for later processing of physiologic data obtained while record
intended to work only with one or a few models of physiologic recorders, usually from the same manu
may perform a variety of algorithms to facilitate the analysis of measurements performed during phys
recording; it may also be used to transmit and/or receive patient information from and to hospital info
Physiologic recording software is mainly intended for use with recorders and recorded data processors
include the software needed for processing the information using a standard computer (e.g., a person
Dedicated software for analysis of the recording of one or more physiologic parameter (e.g., blood pre
also available.

Physiologic recording software designed for later processing of blood pressure data obtained while rec
intended to work only with one or a few models of blood pressure recorders, usually from the same m
software may perform a variety of algorithms to facilitate the analysis of measurements performed du
recording; it may also be; it may also be used to send and/or receive patient information from and to h
systems. Blood pressure recording software is mainly intended for use with recorded data processors;
include the software needed for processing the information using a standard computer (e.g., a person

Physiologic recording software designed for later processing of electrocardiography (ECG) data obtain
software is intended to work only with one or a few models of ECG recorders, usually from the same m
software may perform a variety of algorithms to facilitate the analysis of measurements performed du
may also be; it may also be used to send and/or receive patient information from and to hospital infor
Electrocardiography recording software is mainly intended for use with recorders and recorded data p
recorders include the software needed for processing the information using a standard computer (e.g.
Dedicated software for analysis of data from impedance and magnetic recorders, as well as from echo
available.

Physiologic recording software designed for later processing of electroencephalography (EEG) data ob
This software is intended to work only with one or a few models of EEG recorders, usually from the sam
software may perform a variety of algorithms to facilitate the analysis of measurements performed du
may also be; it may also be used to send and/or receive patient information from and to hospital infor
Electroencephalography recording software is mainly intended for use with recorders and recorded da
recorders include the software needed for processing the information using a standard computer (e.g.
Dedicated software for analysis of data from magnetic and/or echoencephalographs is also available.

Physiologic recording software designed for later processing of respiratory data obtained while recordi
intended to work only with one or a few models of respiratory recorders, usually from the same manuf
may perform a variety of algorithms to facilitate the analysis of measurements performed during reco
used to send and/or receive patient information from and to hospital information systems. Respiratory
mainly intended for use with the recorders and/or recorded data processors.
Physiologic recording software designed for later processing of temperature data obtained while recor
intended to work only with one or a few models of temperature recorders, usually from the same man
may perform a variety of algorithms to facilitate the analysis of measurements performed during reco
used to send and/or receive patient information from and to hospital information systems. Temperatur
mainly intended for use with recorders and recorded data processors; some recorders include the soft
processing the information using a standard computer (e.g., a personal computer).

Physiologic recording software designed for later processing of evoked potential (EP) data obtained wh
software is intended to work only with one or a few models of evoked potential recorders, usually from
manufacturer. The software may perform a variety of algorithms to facilitate the analysis of measurem
EP recording; the software may also be used to send and/or receive patient information from and to ho
systems. Evoked potential recording software may be intended for processing the data using a dedica
standard computer (e.g., a personal computer). Dedicated software to assess recordings of visual, som
auditory evoked potential (VEP, SEP, and AEP respectively) is also available.

Physiologic recording software designed for later processing of electromyography (EMG) data obtained
software is intended to work only with one or a few models of EMG recorders, usually from the same m
software may perform a variety of algorithms to facilitate the analysis of measurements performed du
may also be used to send and/or receive patient information from and to hospital information systems
potential recording software is mainly intended for processing the data using a standard computer (e.
computer).

Physiologic recording software designed for later processing of physical activity (i.e., movement) data
recording. This software is intended to work only with one or a few models of physical activity recorde
same manufacturer. The software may perform a variety of algorithms to facilitate the analysis of mea
during recording; the software may also be used to send and/or receive patient information from and t
systems. Physical activity recording software is mainly intended for processing the data using a record
standard computer (e.g., a personal computer).

Physiologic recording software designed for later process of recorded data such as ECG, EEG, and resp
sleeping (i.e., somnography). This software is intended to work only with one or a few models of recor
same manufacturer. The software may perform a variety of algorithms to facilitate the analysis of mea
during somnography recording; it may also be used to send and/or receive patient information from a
information systems. Somnography recording software is mainly intended for processing the data usin
processor or a standard computer (e.g., a personal computer). Dedicated software used to assess data
recording (i.e., using a reduced number of parameters to compare to somnography studies) is also av

Physiologic recording software designed for later processing of plethysmograph data obtained while re
is intended to work only with one or a few models of plethysmography recorders, usually from the sam
software may perform a variety of algorithms to facilitate the analysis of measurements performed du
recording; it may also be used to send and/or receive patient information from and to hospital informa
Plethysmography recording software is mainly intended for processing the data using recorded data p
standard computer (e.g., a personal computer). Dedicated software intended for whole body and/or fo
plethysmography (e.g., eye, lower limb, brain) is also available.
Software designed for later processing of anesthetic gas data obtained while recording. This software
only with one or a few models of anesthetic gas recorders, usually from the same manufacturer; the s
variety of algorithms to facilitate the analysis of measurements performed during anesthetic gas conc
may also be used to send and/or receive patient information from and to anesthesia units and/or hosp
systems. Anesthetic gas recording software is mainly intended for use with recorded data processors;
the software needed for processing the information using a standard computer (e.g., a personal comp

Software designed to operate physiologic measuring instruments, control/monitor a limited number of


process data obtained while measuring. This software is intended to work only with one or a few mode
measuring instruments, usually from the same manufacturer. The software may perform a variety of a
the operation and analysis of the measurements. Physiologic measuring software is not usually availa
tester but may be updated (i.e., through the release of modified versions) during the life of the measu
Dedicated physiologic measuring software intended for a great variety of measurements (e.g., cardiac
blood pressure) is available.

Physiologic measuring software designed to operate spirometers, control/monitor a limited number of


process data obtained while measuring. This software is intended to work only with one or a few mode
spirometers, usually from the same manufacturer. Spirometer software may perform a variety of algor
operation and analysis of the measurements (e.g., volume, flow). Spirometer software is not usually a
the instrument but may be updated (i.e., through the release of modified versions) during the life of th
instrument.

Physiologic measuring software designed to operate ultrasonic transcranial flowmeters, control/monito


their functions, and/or process data obtained while measuring. This software is intended to work only
models of transcranial flowmeters, usually from the same manufacturer. Ultrasonic transcranial flowm
perform a variety of algorithms to facilitate the operation and analysis of the measurements (e.g., vol
software is not usually available separate from the instrument but may be updated (i.e., through the r
versions) during the life of the measuring instrument. Dedicated software intended for detection of em
vasospasm and/or stenosis is also available.

Infusion pump software designed to reduce programming errors during the administration of medicati
pumps (the pumps are typically known as 'smart' pumps) by using drug dose libraries and standard lim
medications, electrolytes, and other infusates. Dose error reduction system (also known as DERS) soft
improve the safety of infusion procedures by warning users of incorrect medication orders, calculation
programming; the software only works with one or a few models of infusion pumps, usually from the s
Some software packages include automated programming and data logging and perform a variety of a
the analysis of the information related to the drug to be administered; the software typically includes
pharmacy, electronic documentation, and/or other hospital information systems.
Software designed to operate device testers, control/monitor a limited number of the tester functions,
obtained while testing. This software may be intended to work with one or a few models of device test
same manufacturer. The software may perform a variety of algorithms to facilitate the operation and a
measurements performed while assessing the device parameters, and/or while processing and or rece
hospital information systems. Device testing software is not usually available separate from the tester
(i.e., through the release of modified versions) during the life of the tester; the software is mainly used
engineering departments located in healthcare facilities. Dedicated device testing software is availab
functions and/or devices, including electrical safety, cardiac pacemakers, infusion pumps, and ventilat

Device testing software designed to operate electrical safety device testers, control/monitor a limited
functions, and/or process data obtained while testing. This software may be intended to work with one
electrical safety testers, usually from the same manufacturer. The software may perform a variety of a
the operation and analysis of the measurements performed while assessing the device electrical safet
processing and or receiving information from hospital information systems. Electrical safety testing so
available separate from the tester but may be updated (i.e., through the release of modified versions)
tester; the software is mainly used in biomedical engineering departments located in healthcare facili
electrical safety software intended to assess the safety of electrical devices and accessories, such as l
receptacles and the integrity and operation of ground-fault circuit interrupters is also available.

Device testing software designed to operate external defibrillator testers, control/monitor a limited nu
functions, and/or process data obtained while testing. This software may be intended to work with one
defibrillator testers, usually from the same manufacturer. The software may perform a variety of algor
operation and analysis of the measurements performed while assessing the defibrillator tester parame
testers software is not usually available separate from the tester but may be updated (i.e., through th
versions) during the life of the tester; the software is mainly used in biomedical engineering departme
healthcare facilities. Dedicated defibrillator testing software that can simulate human electrocardiogr
arrhythmia waveforms to verify the monitoring capabilities of the defibrillator is also available; the sof
includes test sequence protocols to test both semi- and fully automatic defibrillators.

Device testing software designed to operate electrosurgical unit (ESU) testers, control/monitor a limite
functions, and/or process data obtained while testing. This software may be intended to work with one
electrosurgical unit testers, usually from the same manufacturer. The software may perform a variety
facilitate the operation and analysis of the measurements performed while assessing the electrosurgic
Electrosurgical unit testing software is not usually available separate from the tester but may be upda
release of modified versions) during the life of the tester; the software is mainly used in biomedical en
located in healthcare facilities. Dedicated device testing software that can run user-programmable au
for a specific ESU is also available.
Device testing software designed to operate external cardiac pacemaker testers, control/monitor a lim
tester functions, and/or process data obtained while testing. This software may be intended to work w
models of external pacemaker testers, usually from the same manufacturer. The software may perform
algorithms to facilitate the operation and analysis of the measurements performed while assessing th
parameters. External cardiac pacemaker testing software is not usually available separate from the te
updated (i.e., through the release of modified versions) during the life of the tester; the software is ma
biomedical engineering departments located in healthcare facilities. Dedicated device testing softwar
the electrocardiographic signal and arrhythmia waveform to verify the monitoring capabilities of the p
available.

Device testing software designed to operate infusion pump testers, control/monitor a limited number
and/or process data obtained while testing. This software may be intended to work with one or a few m
pump testers, usually from the same manufacturer. The software may perform a variety of algorithms
operation and analysis of the measurements performed while assessing the infusion pump parameter
testing software is not usually available separate from the tester but may be updated (i.e., through th
versions) during the life of the tester; the software is mainly used in biomedical engineering departme
healthcare facilities.

Device testing software designed to operate mechanical ventilator testers, control/monitor a limited n
functions, and/or process data obtained while testing. This software may be intended to work with one
ventilator testers, usually from the same manufacturer. The software may perform a variety of algorith
operation and analysis of the measurements performed while assessing the ventilator parameters. Ve
software is not usually available separate from the tester but may be updated (i.e., through the releas
during the life of the tester; the software is mainly used in biomedical engineering departments locate
facilities. Dedicated ventilator testing software that can simulate the human respiration is also availa

Software designed to operate non-invasive device programmer/testers, control/monitor a limited num


and/or process data obtained while testing. This software is intended to work with one or a few model
programmer/testers, usually from the same manufacturer. The software may perform a variety of algo
operation and analysis of the measurements performed while assessing and/or changing the characte
programming) of a medical device parameters, and/or while processing and or receiving information f
information systems. Device programming/testing software is not usually available separate from the
updated (i.e., through the release of modified versions) during the life of the tester; the software is ma
areas of a healthcare facility such as cardiac and neurology departments. Dedicated device programm
available for several, frequently implantable, medical devices such as implantable pacemakers, defibr
stimulators, and infusion pumps.
Device programming and testing software designed for non-invasively re-programming (e.g., modifyin
and testing implantable cardiac pacemakers, control/monitor a limited number of the implanted pacem
process data obtained from the pacemaker. This software is intended to work with one or a few model
programmer/testers, usually from the same manufacturer. The software performs a variety of algorith
operation and analysis of the measurements performed while assessing and/or changing the characte
programming) of the implanted cardiac pacemaker; the software may also transmit and/or receive info
information systems. Implantable cardiac pacemaker programming/testing software is not usually ava
the tester but may be updated (i.e., through the release of modified versions) during the life of the pro
software is mainly used in particular areas of a healthcare facility such as cardiac and neurology depa
implantable pacemaker programming/testing software is also available for implantable defibrillator/pa

Device programming and testing software designed for non-invasively re-programming (e.g., modifyin
rate) and testing implantable infusion pumps, control/monitor a limited number of the implanted pum
process data obtained from the pump. This software is intended to work with one or a few models of in
programmer/testers, usually from the same manufacturer. The software performs a variety of algorith
operation and analysis of the measurements performed while assessing and/or changing the characte
programming) of the implanted infusion pump; the software may also transmit and/or receive informa
information systems. Implantable infusion pump programming/testing software is not usually available
tester but may be updated (i.e., through the release of modified versions) during the life of the progra

Software designed to operate computerized physiologic analyzers, control/monitor a limited number o


and/or process data obtained while testing. This software is intended to work with one or a few model
analyzers, usually from the same manufacturer. The software performs a variety of algorithms to facili
analysis of the measurements performed while assessing physiologic data, and/or while processing an
information from hospital information systems. Physiologic analyzer software is not usually available s
analyzer but may be updated (i.e., through the release of modified versions) during the life of the ana
physiologic analyzer software is available to assess a variety (e.g., neuromuscular, visual, peristaltic m
well as other physiologic characteristics (e.g., body composition, somnography assessment).

Physiologic analysis software designed to operate computerized body composition analyzers, control/m
number of their functions, and/or process data obtained while testing. This software is intended to wo
models of body composition analyzers, usually from the same manufacturer. The software performs a
facilitate the operation and analysis of the measurements performed while assessing body compositio
processing and or receiving information from hospital information systems. Physiologic analyzer softw
available separate from the analyzer but may be updated (i.e., through the release of modified versio
the analyzer. Dedicated body composition analysis software is available for several different techniqu
assessment of the body composition, including direct (e.g., neutron activation analysis) or indirect (e.g
absorptiometry, electrical conductivity) techniques.
Physiologic analysis software designed to operate computerized erection and tumescence analyzers, c
limited number of their functions, and/or process data obtained while testing. This software is intende
few models of erection and tumescence analyzers, usually from the same manufacturer. The software
algorithms to facilitate the operation and analysis of the measurements performed while assessing m
and/or while processing and or receiving information from hospital information systems. Erection/tume
usually available separate from the analyzer but may be updated (i.e., through the release of modified
life of the analyzer. Dedicated body composition analysis software is used in the diagnosis of erectile
(impotence).

Physiologic analysis software designed to operate computerized joint laxity analyzers, control/monitor
their functions, and/or process data obtained while testing. This software is intended to work with one
joint laxity analyzers, usually from the same manufacturer. The software may perform a variety of algo
operation and analysis of the measurements performed while assessing joint laxity data (e.g., range o
and/or while processing and or receiving information from hospital information systems. Joint laxity an
usually available separate from the analyzer but may be updated (i.e., through the release of modified
life of the analyzer. Dedicated joint laxity analysis software that can assess other characteristics of th
laxity and stability of the knee and the length of reconstructed ligaments is available.

Physiologic analysis software designed to operate computerized metabolic rate analyzers, control/mon
of their functions, and/or process data obtained while testing. This software is intended to work with o
metabolic analyzers, usually from the same manufacturer. The software performs a variety of algorith
operation and analysis of the measurements performed while assessing metabolism data, and/or whil
receiving information from hospital information systems. Metabolic analyzer software is not usually av
the analyzer but may be updated (i.e., through the release of modified versions) during the life of the
body metabolic rate analysis software based in oxygen or oxygen/carbon dioxide measurements is av
intended to evaluate metabolism during stress exercises is also available.

Physiologic analysis software designed to operate computerized middle ear analyzers, control/monitor
their functions, and/or process data obtained while testing. This software is intended to work with one
middle ear analyzers, usually from the same manufacturer. The software performs a variety of algorith
operation and analysis of the measurements performed while assessing middle ear data, and/or while
receiving information from hospital information systems. Middle ear analyzer software is not usually a
the analyzer but may be updated (i.e., through the release of modified versions) during the life of the
middle ear analysis software is available for several different techniques (e.g., impedance tympanome
reflectometry) used for assessment of the middle ear characteristics (e.g., obstructions, stiffness or fla
membrane).
Physiologic analysis software designed to operate computerized neuromuscular analyzers, control/mo
of their functions, and/or process data obtained while testing. This software is intended to work with o
neuromuscular function analyzers, usually from the same manufacturer. The software performs a varie
facilitate the operation and analysis of the measurements performed while assessing neuromuscular (
somatosensory evoked potentials, electromyography, diagnostic imaging, biomechanical) data, and/o
or receiving information from hospital information systems. Neuromuscular analyzer software is not us
separate from the analyzer but may be updated (i.e., through the release of modified versions) during
analyzer. Dedicated neuromuscular function analyzer software intended for assessment of body motio
for dynamometric and posturographic evaluation is also available.

Neuromuscular function analysis software designed to operate computerized body motion analyzers, c
limited number of their functions, and/or process data obtained while testing. This software is intende
few models of body motion neuromuscular analyzers, usually from the same manufacturer. The softwa
of algorithms to facilitate the operation and analysis of the measurements performed by equipment (e
image processors, electromagnetic devices) while assessing body motion data, and/or while processin
information from hospital information systems. Body motion neuromuscular analyzer software is not u
separate from the analyzer but may be updated (i.e., through the release of modified versions) during
analyzer. Dedicated neuromuscular function analyzer software intended for assessment of body motio
devices and pattern recognition, video systems, or electromagnetic sensing equipment is also availab

Neuromuscular function analysis software designed to operate computerized dynamometric (i.e., mus
control/monitor a limited number of their functions, and/or process data obtained while testing. This s
work with one or a few models of dynamometric neuromuscular analyzers, usually from the same man
software performs a variety of algorithms to facilitate the operation and analysis of the measurements
equipment (e.g., constant length, resistance, or speed; known as isometric, isotonic, and isokinetic me
respectively) while assessing dynamometric data, and/or while processing and or receiving informatio
information systems. Dynamometric neuromuscular analyzer software is not usually available separat
may be updated (i.e., through the release of modified versions) during the life of the analyzer. Dedica
neuromuscular function analyzer software intended for assessment of muscle strength in the extremit
also available.

Neuromuscular function analysis software designed to operate computerized gait (i.e., human walking
control/monitor a limited number of their functions, and/or process data obtained while testing. This s
work with one or a few models of gait neuromuscular analyzers, usually from the same manufacturer.
a variety of algorithms to facilitate the operation and analysis of the measurements performed by equ
movement in the space, forces on the ground) while assessing gait data, and/or while processing and
information from hospital information systems. Gait neuromuscular analyzer software is not usually av
the analyzer but may be updated (i.e., through the release of modified versions) during the life of the
neuromuscular function analyzer software intended for assessment of dynamic and static body balanc
joint movement is also available.
Neuromuscular function analysis software designed to operate posturographic (i.e., upright posture, b
equilibrium) analyzers, control/monitor a limited number of their functions, and/or process data obtain
software is intended to work with one or a few models of posturographic neuromuscular analyzers, us
manufacturer. The software performs a variety of algorithms to facilitate the operation and analysis of
performed by equipment (e.g., stability under destabilizing perturbations) while assessing posturograp
processing and or receiving information from hospital information systems. Posturographic neuromusc
is not usually available separate from the analyzer but may be updated (i.e., through the release of m
during the life of the analyzer. Posturographic neuromuscular function analyzer software is intended f
equilibrium disorders and other diseases of the nervous system.

Physiologic analysis software designed to operate computerized peristaltic motility (i.e., the smooth m
of the digestive tract) analyzers, control/monitor a limited number of their functions, and/or process d
testing. This software is intended to work with one or a few models of peristaltic motility analyzers, us
manufacturer. The software performs a variety of algorithms to facilitate the operation and analysis of
performed while assessing peristaltic motility (e.g., pressure, pH) data, and/or while processing and or
from hospital information systems. Peristaltic motility analyzer software is not usually available separa
but may be updated (i.e., through the release of modified versions) during the life of the analyzer. De
motility analyzer software intended for the complete gastrointestinal tract as well as software used on
motility in the esophagus and/or colon/rectum is also available.

Physiologic analysis software designed to operate computerized respiratory function mechanics (i.e., a
air flow, the devices are also known as pulmonary function analyzers), control/monitor a limited numb
functions, and/or process data obtained while testing. This software is intended to work with one or a
pulmonary function analyzers, usually from the same manufacturer. The software performs a variety o
facilitate the operation and analysis of the measurements performed while assessing pulmonary funct
and distribution of tracking gases, airway compliance and resistance), and/or while processing and or
from hospital information systems. Respiratory function mechanics software is not usually available se
analyzer but may be updated (i.e., through the release of modified versions) during the life of the ana
respiratory function mechanics analyzer software intended for assessment of adults, children, and neo

Physiologic analysis software designed to operate computerized somnography analyzers, control/mon


of their functions, and/or process data obtained while testing. This software is intended to work with o
somnography function analyzers, usually from the same manufacturer. The software performs a variet
facilitate the operation and analysis of the measurements performed while assessing somnography (e
electroencephalography, electrocardiography, temperature, behavior while sleeping) data, and/or whi
receiving information from hospital information systems. Somnography analyzer software is not usua
from the analyzer but may be updated (i.e., through the release of modified versions) during the life o
Dedicated somnography analyzer software with additional capabilities of analysis (e.g., gastroesophag
penile tumescence) is also available.
Physiologic analysis software designed to operate computerized visual function analyzers, control/mon
of their functions, and/or process data obtained while testing. This software is intended to work with o
visual function analyzers, usually from the same manufacturer. The software performs a variety of alg
operation and analysis of the measurements performed while assessing visual function (e.g., visual ac
visual field) data, and/or while processing and or receiving information from hospital information syste
analyzer software is not usually available separate from the analyzer but may be updated (i.e., throug
modified versions) during the life of the analyzer. Dedicated neuromuscular function analyzer softwar
assessment of eye movement and macular integrity is also available.

Prepackaged collections of the necessary devices and supplies (either custom or standard) designed f
intended to treat aorta (including the aortic arch) dissections. Items in these kits usually include the im
endoprostheses (e.g., stainless steel stents in a variety of lumen diameters and lengths) mounted on
include a compliant section near the distal end appropriate for stent delivery and deployment; ancillar
syringe, biocompatible glue, and saline solution may be also included for use during the stenting proc
supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a bord
periphery supporting all the instruments and supplies needed for the procedure; the trays are usually
Aorta dissection vascular stent delivery procedure kits and trays are intended for treating patients wit
for whom surgery is indicated. Appropriate delivery kits and trays for treatment of upper aorta (type A
be combined with placement of aorta prostheses during open surgery) and for lower aorta dissections
percutaneously through the vasculature) are available.

Aorta vascular stents designed to be expanded by the application of a constant radial pressure to the
low-pressure balloon after delivery through an appropriate stent delivery system. These endoprosthes
(e.g., stainless steel) stents; they are available in a variety of lengths (e.g., from 4 to 25 cm/1.5 to 10
diameter after expansion about 50 mm (2 inches). Balloon-expandable aorta stents are intended to fo
holds and reinforces the aorta open to prevent restenosis; they are usually mounted on balloon delive
intended to treat aorta (type A) dissections (that may be combined with placement of aorta prosthese
and for lower aorta dissections (usually performed percutaneously through the vasculature) are availa

Vascular catheters designed for use during the insertion (i.e., delivery and deployment) of stents into
aortic arch. These devices typically consist of low-pressure balloon catheters available with several lum
20 French) and lengths (usually from 40 to 240 mm/1.6 to 9.5 inches) that include a compliant section
appropriate for stent delivery and deployment. Dedicated catheters used to deliver stents intended to
dissections (typically during open surgery) and for treatment of lower aorta dissections (usually perfor
through the vasculature) are available.

Filtration systems designed to trap emboli and/or other debris that is liberated during intravascular pr
filter. These systems typically include a hollow guidewire, a membrane filter, delivery and/or retrieval
mechanism to actuate the filter. The system filter is routed through the artery and deployed distal to t
after the procedure is finished the filter is retrieved (usually through a retrieval sheath) and removed f
Some systems are based on the use of delivery and retrieval catheters or other similar technologies. I
filtration systems are used temporarily during deployment of stents or catheter balloons; some dedica
are only intended for a particular application (e.g., carotid artery, saphenous vein graft).
Electroporation therapy systems designed to induce the death of tissue cells by applying an electric fi
permanent permeability of the cell membrane (i.e., irreversible electroporation) with negligible therm
systems typically include an electric generator capable of delivering appropriate short-term (e.g., mic
pulses with a voltage high enough to cause permanent perforation of the cell walls,; a computerized u
control and monitor the delivery of electric energy;, and a set of detachable probes with very thin nee
distal end that are inserted around the tissue to be ablated. Irreversible electroporation tissue ablation
defined areas without extending its effects to surrounding tissue, sparing large blood vessel scaffolds
ducts. Tissue ablation irreversible electroporation therapy systems are intended for ablation of abnorm
also used for treatment of tumors in difficult to access areas of the body and/or near large blood vesse

Software designed to operate environmental parameter monitors, control/monitor a limited number of


process data obtained while monitoring. This software is intended to work only with one or a few mod
monitors, usually from the same manufacturer. The software may perform a variety of algorithms to fa
and analysis of the measurements performed while monitoring environmental parameters either in th
enclosed environments (e.g., patient or clean rooms), and/or while processing and or transmitting/rec
from hospital information systems. Environmental monitoring software is not usually available separa
but may be updated (i.e., through the release of modified versions) during the life of the equipment; t
used in closed environments located in healthcare facilities. Dedicated software for environmental me
temperature, gases (e.g., oxygen, ethylene oxide), and radiation is available.

Environmental monitoring software designed to operate temperature monitors, control/monitor a limit


functions, and/or process data obtained while monitoring. This software is intended to work only with
temperature monitors, usually from the same manufacturer. The software may perform a variety of alg
the operation and analysis of the measurements performed while monitoring temperature (e.g., graph
temperature trends in a period of time) in enclosed environments such as chambers, refrigerators, an

Environmental monitoring software designed to operate carbon dioxide monitors, control/monitor a lim
functions, and/or process data obtained while monitoring. This software is intended to work only with
carbon dioxide monitors, usually from the same manufacturer. The software may perform a variety of
the operation and analysis of the measurements performed while monitoring carbon dioxide (e.g., gra
concentration in a period of time) in enclosed environments such as anaerobic chambers, glove boxes

Environmental monitoring software designed to operate ethylene oxide monitors, control/monitor a lim
functions, and/or process data obtained while monitoring. This software is intended to work only with
ethylene oxide monitors, usually from the same manufacturer. The software may perform a variety of
the operation and analysis of the measurements performed while monitoring ethylene oxide (e.g., gra
concentration in a period of time, staff exposure) in enclosed environments and/or while processing an
transmitting/receiving information from hospital information systems. Ethylene oxide monitoring softw
available separate from the monitor but may be updated (i.e., through the release of modified version
equipment; the software is mainly used in closed environments located in healthcare facilities such as
and gas cylinder storage areas.
Environmental monitoring software designed to operate multigas (including toxic and/or flammable ga
control/monitor a limited number of their functions, and/or process data obtained while monitoring. Th
to work only with one or a few models of multigas monitors, usually from the same manufacturer. The
variety of algorithms to facilitate the operation, analysis (may trigger alarms) of the measurements pe
monitoring the gas concentration (e.g., graphical display of concentration in a period of time, staff exp
environments and/or while processing and or receiving information from hospital information systems
software is not usually available separate from the monitor but may be updated (i.e., through the rele
versions) during the life of the equipment; the software is mainly used in closed environments located
such as operating rooms, intensive care units, clinical laboratories.

Software designed to operate laboratory measuring instruments, control/monitor a limited number of


process data obtained while measuring. This software is intended to work only with one or a few mode
instruments usually from the same manufacturer; the software may perform a variety of algorithms su
detect out of range specimens, provide customized reports, and send/receive patient information from
system. Laboratory measuring instrument software is usually not available separate from the instrum
updated (i.e., through the release of modified versions) during the lifetime of the equipment.

Laboratory measurement software designed to operate in-vitro oximeters, control/monitor a limited nu


functions, and/or process data obtained while measuring (e.g., hemoglobin forms). This software is int
with one or a few models of in-vitro oximeters, usually from the same manufacturer. The software may
algorithms such as quality control, detecting out-of-range specimens, provide customized reports, and
information from the local information system. Laboratory oximeter software is usually not available s
oximeter but may be updated (i.e., through the release of modified versions) during the life of the equ

Software designed to operate computerized laboratory analyzers and monitor a limited number of the
software is intended to work only with one or a few models of laboratory analyzers, usually from the s
software performs a variety of algorithms such as quality control, detecting out-of-range specimens, a
patient information from the local information system, in addition to facilitating the operation of the co
Laboratory analyzer software is usually not available separate from the analyzer but may be updated
release of modified versions) during the life of the equipment. Dedicated laboratory analysis software
using clinical chemistry, hematology, immunoassay, and molecular assay (both infectious diseases an
techniques is available.

Laboratory analysis software designed to operate computerized chemical chemistry analyzers and mo
of their functions. This software is intended to work only with one or a few models of clinical chemistry
from the same manufacturer. The software performs a variety of algorithms such as quality control, de
specimens, and send/receive patient information from the local information system. Clinical chemistry
usually not available separate from the analyzer but may be updated (i.e., through the release of mod
the life of the equipment.
Laboratory analysis software designed to operate computerized hematology analyzers and monitor a
functions. This software is intended to work only with one or a few models of hematology analyzers, u
manufacturer. The software performs a variety of algorithms such as quality control, detecting out-of-r
send/receive patient information from the local information system. Hematology analyzer software is
separate from the analyzer but may be updated (i.e., through the release of modified versions) during
equipment.

Laboratory analysis software designed to operate computerized coagulation hematology analyzers an


number of their functions. This software is intended to work only with one or a few models of coagulat
from the same manufacturer. The software performs a variety of algorithms such as quality control, de
specimens, and send/receive patient information from the local information system. Coagulation hem
software is usually not available separate from the analyzer but may be updated (i.e., through the rele
versions) during the life of the equipment.

Laboratory analysis software designed to operate computerized immunoassay analyzers and monitor
their functions. This software is intended to work only with one or a few models of immunoassay analy
same manufacturer. The software performs a variety of algorithms such as quality control, detecting o
and send/receive patient information from the local information system. Immunoassay analyzer softw
available separate from the analyzer but may be updated (i.e., through the release of modified versio
the equipment.

Laboratory analysis software designed to operate computerized microbiology analyzers and monitor a
their functions. This software is intended to work only with one or a few models of microbiology analyz
same manufacture. The software performs a variety of algorithms such as quality control, detecting ou
and send/receive patient information from the local information system. Microbiology analyzer softwa
available separate from the analyzer but may be updated (i.e., through the release of modified versio
the equipment.

Laboratory analysis software designed to operate computerized molecular assay analyzers and monito
their functions. This software is intended to work only with one or a few models of molecular assay an
the same manufacturer. The software performs a variety of algorithms such as quality control, detecti
specimens, and send/receive patient information from the local information system. Molecular assay a
usually not available separate from the analyzer but may be updated (i.e., through the release of mod
the life of the equipment. Dedicated software intended for analysis of infectious microorganisms and g
available.

Molecular laboratory analysis software designed to operate computerized molecular assay analyzers i
microorganisms and to monitor a limited number of their functions. This software is intended to work
models of molecular assay analyzers, usually from the same manufacturer. The software performs a v
such as quality control, detecting out-of-range specimens, and send/receive patient information from t
system. Infectious microorganism molecular assay analyzer software is usually not available separate
may be updated (i.e., through the release of modified versions) during the life of the equipment.
Laboratory analysis software designed to operate computerized molecular assay analyzers intended f
monitor a limited number of their functions. This software is intended to work only with one or a few m
assay analyzers, usually from the same manufacturer. The software performs a variety of algorithms s
detecting out-of-range specimens, and send/receive patient information from the local information sys
molecular assay analyzer software is usually not available separately from the analyzer but may be up
the release of modified versions) during the life of the equipment.

Software designed to operate computerized urine analyzers and perform automated microscopy. This
work only with one or a few models of urine analyzers, usually from the same manufacturer. The softw
variety of algorithms to provide initial identification of formed element in the urine (automated micros
facilitating the operation of the computerized device. Urine analyzer software is usually not available
analyzer but may be updated (i.e., through the release of modified versions) during the life of the equ

Software designed to capture all downloaded test results from any interfaced point-of-care analyzer an
number of the analyzer's functions. This software is intended to work only with one or a few models of
analyzers, usually from the same manufacturer. The software performs a variety of algorithms such as
detecting out-of-range specimens, and send/receive patient information from the laboratory or hospita
system. Point-of-care analyzer software is usually not available separate from a set of point-of-care an
updated (i.e., through the release of modified versions) during the life of the equipment.

Software designed to provide operating parameters for a chromatography system. The analysis of res
by a library. The library, which would have its own separate, periodic updates, would suggest possible
previously run, known specimens. The software is intended to only work with one or a few models of
systems, usually from the same manufacturer. The software may send/receive patient information fro
hospital local information system. Chromatography software is usually not available separate from th
system but may be updated (i.e., through the release of modified versions) during the life of the equip
software intended for particular chromatography systems (e.g., gas, liquid, high-pressure liquid) is als

Chromatography system software designed to provide operating parameters for a gas chromatograph
of results can be facilitated by a library. The library, which would have its own separate, periodic upda
possible results based on previously run, known specimens. This software is intended to work only wi
of gas chromatography systems, usually from the same manufacturer. The software may send/receive
from the laboratory or hospital local information system. Gas chromatography software is usually not
the chromatography system but may be updated (i.e., through the release of modified versions) durin
equipment.

Chromatography system software designed to provide operating parameters for a liquid chromatograp
analysis of results can be facilitated by a library. The library, which would have its own separate, perio
suggest possible results based on previously run, known specimens. This software is intended to work
models of liquid chromatography systems usually, from the same manufacturer. The software may sen
information from the laboratory or hospital local information system. Liquid chromatography software
separate from the chromatography system but may be updated (i.e., through the release of modified
life of the equipment.
Chromatography system software designed to provide operating parameters for a high-pressure liquid
(HPLC) system. The analysis of results can be facilitated by a library. The library, which would have its
updates, would suggest possible results based on previously run, known specimens. This software is
with one or a few models of HPLC systems, usually from the same manufacturer. The software may se
information from the laboratory or hospital local information system. HPLC chromatography software i
separate from the chromatography system but may be updated (i.e., through the release of modified
life of the equipment.

Software designed to provide operating parameters for an electrophoresis system. The analysis of res
by a library. The library, which would have its own separate, periodic updates, would suggest possible
previously run, known specimens. This software is intended to work only with one or a few models of
systems, usually from the same manufacturer. The software may send/receive patient information from
hospital local information system. Electrophoresis software is usually not available separate from the e
but may be updated (i.e., through the release of modified versions) during the life of the equipment; d
intended for capillary electrophoresis systems are also available.

Software designed to provide operating parameters for a capillary electrophoresis system. The analys
facilitated by a library. The library, which would have its own separate, periodic updates, would sugge
based on previously run, known specimens. This software is intended to work only with one or a few m
electrophoresis systems, usually from the same manufacturer. The software may send/receive patient
laboratory or hospital local information system. Capillary electrophoresis software is usually not availa
electrophoresis system but may be updated (i.e., through the release of modified versions) during the

Software designed to operate a workstation, control/monitor a limited number of their functions, and/o
images obtained during a particular procedure. This software usually interacts with devices used in th
recorders, measuring instruments, and monitors. It may also perform a variety of algorithms to facilita
analysis of the measurements performed during the procedure. Workstation management software is
with one or a few models of workstations and related devices, usually supplied by the same manufact
processing and/or sending of data from the workstation to and from picture archiving and communica
and/or other hospital information systems. The software is not usually available separate from the wor
updated (i.e., through the release of modified versions) during the life of the equipment. Dedicated wo
management software intended for specific procedures such as cardiac catheterization, radiotherapy,
radiotherapy planning and treatment is available.
Software designed to operate a laboratory clinical chemistry and immunoassay test workstation, contr
number of their functions, and/or process data and images obtained during a particular procedure. Th
interacts with devices used in the procedure, such as recorders, measuring instruments, and analyzer
a variety of algorithms to facilitate the operation and analysis of the measurements performed during
Workstation management software used in clinical chemistry and immunoassay analysis is intended t
a few models of workstations and related devices, usually supplied by the same manufacturer. They a
processing and/or sending data from the workstation to and from picture archiving and communicatio
and/or other laboratory and/or hospital information systems. The software is not usually available sep
workstation but may be updated (i.e., through the release of modified versions) during the life of the e
workstation management software intended for specific procedures such as the determination of the c
metabolites, electrolytes, proteins, and drugs in body fluids (e.g., plasma, serum, urine, cerebrospinal
Software for endocrine hormone testing and for protein, viral, or bacterial toxin determination is also a

Computer-aided detection system software designed to operate detection systems that are intended t
slides and control/monitor a limited number of their functions. This software is typically intended to wo
few models of computer-aided systems, usually from the same manufacturer. The software performs a
to facilitate the analysis of the slides and sending/receiving patient information from and to the local i
The software is usually not available separately from the computer-aided system but may be updated
release of modified versions) during the life of the system. Dedicated pathology slide computer-aided
software that is intended for particular applications, such as the analysis of Papanicolaou smears and
available.

Pathology slide computer-aided detection system software designed to operate detection systems tha
analyze Papanicolaou smear slides and control/monitor a limited number of their functions. This softw
to work only with one or a few models of computer-aided systems, usually from the same manufacture
performs a variety of algorithms to facilitate the analysis of the slides and sending/receiving patient in
the local information system. The software is usually not available separate from the computer-aided
updated (i.e., through the release of modified versions) during the life of the system. This software fac
slides intended for screening for malignant conditions of the female genital tract.

Software designed to control a system that performs a specialized procedure that can follow a pre-est
minimal human intervention, through a user interface, or a combination of both (i.e., an automation s
usually interacts with the hardware needed to perform the mechanical operations and that shares the
protocol. Automation system software is intended to work only with one or a few models of automatio
devices, usually supplied from the same manufacturer and/or configured according to particular health
requirements. The system also facilitates the processing and/or sending of information from the autom
from picture archiving and communication systems (PACS) and/or other hospital information systems.
usually available separate from the automation system but may be updated (i.e., through the release
during the life of the equipment. Dedicated automation system software intended for the operation of
surgery, medication and/or supplies dispensing, and other particular procedures is also available.
Automation system software designed to control a system that prepares, analyzes, and evaluates clin
(i.e., a laboratory automation system).This software usually interacts with the hardware needed to per
procedure (e.g., modules for specimen handling and processing connected by a transportation system
operator intervention. Laboratory automation system software is intended to work only with one or a f
automation systems and related devices, usually supplied from the same manufacturer and/or configu
particular clinical laboratory requirements. The system may also facilitate the processing and/or sendi
the automation system to and from picture archiving and communication systems (PACS) and/or other
systems. The software is not usually available separate from the automation system but may be upda
release of modified versions) during the life of the equipment. Laboratory automation system software
improve the safety and/or efficiency of laboratory procedures.

Supporting structures (i.e., docks) designed to facilitate connectivity to physiologic monitoring and rec
for automated charging of their internal rechargeable batteries. These docks (also known as docking s
consist of a structure made of metal, hard plastic, or a combination of these that is mounted on the w
tabletop. The docks hold and provide appropriate connectors to plug-in or cradle the handheld or port
facilitating their connectivity and/or providing means to recharge their internal batteries. The docks m
or wireless connection to other devices such as configured monitors and/or infusion pump, communica
systems facilitating the download of data; a power converter (e.g., 120 VAC to 12 VDC); and a line cor
mains.

Software designed to operate cardiac catheterization workstations, control/monitor a limited number o


and/or process data and images obtained during the catheterization procedure. This software usually
used in the procedure, such as recorders, cardiac output units, and monitors; it may also perform a va
facilitate the operation and analysis of the measurements performed during the catheterization proce
catheterization workstation software is intended to work only with one or a few models of workstation
usually supplied by the same manufacturer. This facilitates the processing and/or sending of data from
and from picture archiving and communication systems (PACS) and/or other hospital information syste
not usually available separate from the workstation but may be updated (i.e., through the release of m
during the life of the equipment. Dedicated software intended for ventriculography and coronary arte
is also available.

Software designed to operate dental digital radiography workstations, control/monitor a limited numb
and/or process data and images obtained during the dental radiographic procedure. This software usu
devices used in the procedure, such as digital dental radiographic systems, recorders, displays, and so
scans of radiography films or image plates; it also performs a variety of algorithms to facilitate the op
the data obtained during the dental procedure. Digital radiography dental workstation management s
work only with one or a few models of workstations and related devices, usually supplied by the same
software is not usually available separate from the workstation but may be updated (i.e., through the
versions) during the life time of the equipment.
Software designed to operate mammographic digital radiography workstations, control/monitor a limit
functions, and/or process data and images obtained during the mammographic procedure. This softwa
with devices used in the procedure, such as digital mammography systems, recorders, displays, breas
sometimes with digitized scans of radiography films or image plates; it may also perform a variety of
the operation and analysis of the data obtained during the procedure. Digital radiography mammogra
management software is intended to work only with one or a few models of workstations and related d
supplied by the same manufacturer. The software is not usually available separate from the workstatio
(i.e., through the release of modified versions) during the life of the equipment.

Software designed to operate gamma camera and single photon emission tomography (SPECT) works
a limited number of their functions, and/or process data and images obtained during the scanning pro
usually interacts with devices used in the procedure, such as a gamma camera, recorders, and array p
perform a variety of algorithms to facilitate the operation of the workstation and the analysis of the sp
intensity of radiation emitted from radiopharmaceuticals. Gamma camera workstation management s
work only with one or a few models of workstations and related devices, usually supplied by the same
facilitates the processing and/or sending data from the workstation to and from picture archiving and
systems (PACS) and/or other hospital information systems. The software is not usually available separ
workstation but may be updated (i.e., through the release of modified versions) during the life of the e
available is dedicated software intended for SPECT scanning systems. This permits computer reconstr
image slices taken through the patient's body.

Software designed to operate hemodialysis treatment workstations, control/monitor a limited number


and/or process data obtained during the hemodialysis procedure. This software usually interacts with
procedure, such as hemodialysis machines, measuring instruments, and recorders. It may also perform
algorithms to facilitate the operation of the hemodialysis machine and process patient and treatment
parameters to the hemodialysis machines, and provide complete patient prescription and treatment. H
workstation management software is intended to work only with one or a few models of workstations
usually supplied by the same manufacturer. This facilitates the processing and/or sending of data from
and from other hospital information systems. The software is not usually available separate from the h
workstation but may be updated (i.e., through the release of modified versions) during the life of the e

Software designed to operate nuclear medicine workstations, control/monitor a limited number of thei
acquire, process, and archive data and images obtained during nuclear medicine studies. This softwar
devices used in the procedures, such as gamma cameras, single photon emission computed tomograp
systems. Nuclear medicine workstation management software is intended to work only with one or a f
workstations and related devices, usually supplied by the same manufacturer. This facilitates the proc
of data from the workstation to and from other hospital information systems. The software is not usua
from the nuclear medicine workstation but may be updated (i.e., through the release of modified vers
the equipment. Dedicated software is available for a variety of nuclear medicine procedures (studies),
tomographic, cardiac, pulmonary, and renal studies.
Software designed to operate picture archiving and communication systems (PACS) workstations, cont
number of their functions, and/or process data and images obtained during scanning imaging procedu
usually interacts with devices used in the procedure, such as diagnostic imaging systems (e.g., compu
magnetic resonance imaging, and ultrasound scanning systems) as well as with recorders with high im
capabilities. The software also performs a variety of algorithms to facilitate the operation and analysis
obtained during the procedures. PACS workstation management software is intended to work only with
of workstations and related devices, usually supplied by the same manufacturer. This facilitates the pr
sending of data from the workstation to and from other hospital information systems. PACS software is
separate from the workstation but may be updated (i.e., through the release of modified versions) dur
equipment. Dedicated software intended for three-dimensional processing and analysis of the images

Picture archiving and communication systems (PACS) workstation management software designed to o
control/monitor a limited number of their functions, and/or process data and high-resolution volumetri
obtained during imaging procedures, typically providing three-dimensional (3-D) images and segment
obtained during imaging procedure. This software usually interacts with devices used in the procedure
imaging systems (e.g., computed tomography, magnetic resonance imaging, and ultrasound scanning
with recorders with very high image quality and archiving capabilities. The software may also perform
to facilitate the operation and analysis of the images obtained during the procedures. Three dimensio
software is intended to work only with one or a few models of PACS workstations and related devices,
same manufacturer. This facilitates the processing and/or sending data from the workstation to and fr
information systems. The software is not usually available separate from the workstation but may be u
the release of modified versions) during the life of the equipment.

Software designed to operate radiotherapy record and verify workstations, control/monitor a limited n
functions, and/or process data obtained during the radiotherapy procedure. The software may interrup
procedure if the parameters (e.g., radiation intensity, target area) are outside pre-established values.
interacts with devices used in the procedure, such as the radiotherapy unit (e.g., linear accelerator, co
and monitors; it may also run a variety of algorithms to facilitate the analysis of the measurements pe
radiotherapy procedure. Radiotherapy record and verify workstation management software is intende
or a few models of workstations and related devices, usually supplied by the same manufacturer, facil
processing and/or sending data from the workstation to and from hospital information systems. The so
available separate from the workstation but may be updated (i.e., through the release of modified ver
the equipment.
Software designed to operate radiotherapy treatment workstations, control/monitor a limited number
and/or process data and images obtained during radiotherapy treatment performance or simulation pr
software usually interacts with the radiotherapy units or systems using during the procedure, (e.g., re
accelerators, and automated brachytherapy systems). It may also perform a variety of algorithms to f
and analysis of the measurements performed and images obtained during the radiotherapy procedure
workstation management software is intended to work only with one or a few models of workstations
usually supplied by the same manufacturer. This facilitates the processing and/or sending of data from
and from picture archiving and communication systems (PACS) and/or other hospital information syste
not usually available separate from the workstation but may be updated (i.e., through the release of m
during the life of the equipment.

Software designed to operate radiotherapy planning workstations, control/monitor a limited number o


process data and images obtained during the radiotherapy planning or simulation procedures. This so
with the radiotherapy units or systems using during the procedure (e.g., recorders, linear accelerators
brachytherapy systems). It may also perform a variety of algorithms to facilitate an accurate planning
and choosing of radiation beams and modalities needed for the best possible radiotherapy treatment.
workstation management software is intended to work only with one or a few models of workstations
usually supplied by the same manufacturer. This facilitates the processing and/or sending data from t
from picture archiving and communication systems (PACS) and/or other hospital information systems.
usually available separate from the workstation but may be updated (i.e., through the release of modi
the life of the equipment.

Software designed to operate stereotactic surgery workstations, control/monitor a limited number of t


process data and images obtained during the surgical planning or performance. This software usually
surgical system and devices used during the procedure, such as image recorders, instrument tracking
systems, printers, and displays; it may also perform a variety of algorithms to facilitate an accurate pl
performance of the surgical procedure. Stereotactic surgery workstation management software is inte
one or a few models of stereotactic workstations and related, devices usually supplied by the same m
facilitates the processing and/or sending of data from the workstation to and from picture archiving an
systems (PACS) and/or other hospital information systems. The software is not usually available separ
workstation but may be updated (i.e., through the release of modified versions) during the life of the e
stereotactic surgery workstation software intended for a variety of procedures (e.g., neurologic, orthop
image-guided, imageless, or frame-guided surgical systems is also available.
Software designed to operate stress (cardiac and/or pulmonary) exercise workstations, control/monito
their functions, and/or process data and images obtained during the stress exercise procedure. This so
interacts with devices used in the procedure, such as recorders, electrocardiography monitors, static b
and ergometers; it may also perform a variety of algorithms to facilitate the operation and analysis of
performed during the exercise procedure. Stress exercise workstation management software is intend
one or a few models of workstations and related devices, usually supplied by the same manufacturer.
the processing and/or sending of data from the workstation to and from hospital information systems.
usually available separate from the workstation but may be updated (i.e., through the release of modi
the life of the equipment. Dedicated software intended for cardiac, pulmonary, and cardiopulmonary p
available.

Software designed to manage/operate computerized systems intended for asset and/or person identifi
due to safety and/or security concerns. This software is intended to work with one or a few models of
location systems, usually supplied by the same manufacturer. The software may perform a variety of
and/or person location and movement throughout a healthcare facility and to manage the operation o
system. Identification, tracking, and security system software is available as part of the complete sys
component; the software may be modified (i.e., through the release of modified versions) during the l
releasing updated versions. Dedicated software intended only for asset, adults, and infants is also ava

Identification/tracking/security system software designed to manage/operate computerized systems in


identification and tracking due to safety and/or security concerns. This software is intended to work w
of asset identification and location systems, usually supplied by the same manufacturer. The software
of algorithms for asset location and movement throughout a healthcare facility. Asset identification, t
system software is available as part of the complete system or as a separate component; the software
through the release of modified versions) during the life of the equipment by releasing updated versio

Identification/tracking/security system software designed to manage/operate computerized systems in


identification and tracking due to safety and/or security concerns. This software is intended to work w
of person identification and location systems, usually supplied by the same manufacturer. The softwa
variety of algorithms for person location and movement throughout a healthcare facility and to manag
computerized system. Person identification, tracking and security system software is available as par
system or as a separate component; the software may be modified (i.e., through the release of modifi
life of the equipment by releasing updated versions.

Identification/tracking/security system software designed to manage/operate computerized systems in


identification and tracking due to safety and/or security concerns. This software is intended to work w
of infant identification and location systems, usually supplied by the same manufacturer. The softwar
variety of algorithms for infant location and movement throughout a healthcare facility. Infant identific
security system software is available as part of the complete system or as a separate component; the
modified (i.e., through the release of modified versions) during the life of the equipment by releasing
Identification/tracking/security system software designed to manage/operate computerized systems in
pharmaceutical identification and tracking due to safety and/or security concerns. This software is inte
track pharmaceutical container entry, exit, and location within factories, distribution centers, healthca
pharmacies, permitting the tracking of pharmaceuticals along the supply chain. The software usually w
models of pharmaceutical identification and location systems, usually supplied by the same manufact
variety of algorithms for pharmaceutical location and movement throughout all the distribution chain.
identification, tracking and security system software is available as part of the complete system or as
the software may be modified (i.e., through the release of modified versions) during the life of the equ
updated versions.

Software designed to manage/operate computerized information systems intended for healthcare faci
intended to work with one or a few models of information systems, usually supplied by the same man
software performs a variety of algorithms to process the data obtained in specific areas or throughout
system software is available as part of the complete information system or as a separate component;
modified (i.e., through the release of modified versions) during the life of the system by releasing upd
versions. Dedicated information software intended for one or more particular applications such as dat
telemedicine, and education is also available.

Information system software designed to manage/operate computerized information systems intende


data management. This software is intended to work with one or a few models of data management in
usually supplied by the same manufacturer. The software performs a variety of algorithms to process
specific areas or throughout the facility. Information system data management software is available as
information system or as a separate component; the software may be modified (i.e., through the relea
versions) during the life of the system by releasing updated versions. Dedicated software intended for
hospital record, and clinical data is available.

Data management information system software designed to manage/operate computerized informatio


for healthcare facility administrative data management. This software is intended to work with one or
administrative data management information systems, usually supplied by the same manufacturer. T
variety of algorithms to process the data obtained in specific areas or throughout the facility. Administ
management information system software is available as part of the complete information system or a
component; the software may be modified (i.e., through the release of modified versions) during the l
releasing updated versions. Dedicated administrative data management software intended only for pa
such as bed management, coding/reimbursement, financial, human resources, and materials manage

Data management information system software designed to manage/operate computerized informatio


for hospital centralized data management. This software is intended to work with one or a few models
management information systems, usually supplied by the same manufacturer. The software perform
algorithms to process the data obtained throughout the facility. Hospital data management informatio
available as part of the complete information system or as a separate component; the software may b
through the release of modified versions) during the life of the system by releasing updated versions.
data management software intended only for particular applications, such as centralized scheduling,
admission/discharge/transfer, integrated (high-level patient management), and master patient index i
Data management information system software designed to manage/operate computerized informatio
for clinical and patient data management. This software is intended to work with one or a few models
management information systems, usually supplied by the same manufacturer. The software perform
algorithms to process the data usually in specific areas or particular procedures or, less frequently, thr
and also manage the operation of the system. Clinical data management information system software
the complete information system or as a separate component; the software may be modified (i.e., thro
modified versions) during the life of the system by releasing updated versions. Dedicated clinical data
intended only for particular healthcare applications, such as electrocardiography, clinical pharmacy, e
laboratory, anatomic pathology, obstetrics, oncology, radiotherapy, radiology, bedside, blood bank, pr
home care, health record, perioperative, physician practice, and risk management is also available.

Mills designed for grinding at a very low (i.e., cryogenic) temperature, usually below -180 degrees C (-
mills typically consist of an electrically powered device in which the grinding container is continuously
gas (e.g., nitrogen); the liquid nitrogen circulates from a cooling system that keeps the material being
appropriate, stable cryogenic temperature. Cryogenic mills are used in healthcare facilities to grind a
and/or pharmaceutical products (e.g., chemicals, tablets, tissue) keeping the volatile components inta
used to grind small quantities of bone for dental and/or orthopedic use.

Neutralizing stations designed to neutralize glutaraldehyde and some other aldehyde-based high-leve
ortho-phthalaldehyde (OPA) before disposal into the drain. These stations typically consist of a neutra
to detect when the tank is full, a pump, and input/output tubing for connection to the disinfectant solu
disinfector) and to the drain, respectively. The station tank receives the disinfecting solution after use
solution); then the solution is mixed with an appropriate neutralizing agent such as glycine that conve
product. When the tank is completely full, an integral pump automatically delivers the neutralized solu
the sewerage system. Glutaraldehyde/aldehyde-based disinfectant neutralizing stations are intended
neutralization process following existing standards, protecting both the operator and the environment
vapors.

Dental inserters designed for holding and placement of small dental prostheses (i.e., dental restoratio
sensitive adhesive at the tip. These devices typically consist of a disposable inserter resembling a swa
proximal end (i.e., making contact with the teeth) carries a pressure-dependent adhesive which permi
appropriate pressure between the inserter and the prosthesis according to the size and weight of the
inserted. After the correct position of the restoration is verified, the inserter is taken away leaving the
Small restoration dental inserters are used mainly to insert dental (mainly cosmetic) fixed prostheses
brackets, crowns, inlays, and onlays.

Syringe tips designed to deliver materials during dental procedures. These tips are usually made of ho
plastic cylinders and are available in both reusable and disposable varieties. The cylinders can be ben
attached (or more frequently threaded) to a dental syringe. Dental material syringe tips are intended
offices. Dedicated tips with appropriate gauge to deliver dental composites, etchants, cements, sealan
materials are available.
Software designed to manage/operate telemedicine systems intended for clinical and patient data ma
software is intended to work with one or a few models of telemedicine systems, usually supplied by th
The software performs a variety of algorithms to process the data, frequently for specific areas or part
also manage the operation of the system. Telemedicine software is available as part of the complete s
component; the software may be modified (i.e., through the release of modified versions) during the l
releasing updated versions. Dedicated telemedicine data management software intended for particula
radiology, pathology, ophthalmology, and videoconferencing is also available.

Software designed to manage/operate patient and/or clinical staff educational information systems. Th
to work with one or a few models of educational information systems, usually supplied by the same m
software performs a variety of algorithms to process the data, either for education of staff and/or cred
software is available as part of the complete system or as a separate component; the software may be
through the release of modified versions) during the life of the system by releasing updated versions.
software intended for patients and for healthcare staff and/or human resources databases is also avai

Software designed to manage/operate picture archiving and communication systems (PACS) intended
data management. This software is intended to work with one or a few models of hospital PACS, usual
same manufacturer. The software performs a variety of algorithms to process the data, usually in spe
procedures or throughout the facility. This software permits a film-less environment in reading rooms a
PACS software is available as part of the complete system or as a separate component; the software m
through the release of modified versions) during the life of the system by releasing updated versions.
software intended for particular applications, such as radiology, cardiology, and endoscopy is also ava

Software designed to operate video systems and control/monitor a limited number of their functions. T
intended to work only with one or a few models of video systems, usually supplied by the same manu
performs a variety of algorithms to facilitate the analysis of data obtained during the video system op
the sending/receiving of patient data from and to information systems. Video system software is usua
separate from the video system but may be updated (i.e., through the release of modified versions) d
system. Dedicated video system software is available for a variety of different techniques and/or appl
endoscopic, operating room, patient monitoring, and microscope video images.

Video system software designed to operate endoscopic video systems and control/monitor a limited n
functions. This software is usually intended to work only with one or a few models of endoscopic video
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
and images obtained during the endoscopic procedure and also facilitates the sending/receiving of pa
information systems. Endoscopic video system software is usually not available separate from the vid
updated (i.e., through the release of modified versions) during the life of the system. Dedicated endos
software is available for a variety of different video techniques, including systems that use a chip cam
dedicated catheter, systems using external cameras, and also for systems using ingestible cameras.
Video system software designed to operate surgical video systems and control/monitor a limited numb
This software is usually intended to work only with one or a few models of surgical video systems, typ
same manufacturer. The software performs a variety of algorithms to facilitate the analysis of measure
obtained during the surgical procedure and also facilitates the sending/receiving of patient data from
systems. Surgical video system software is usually not available separate from the video system but m
through the release of modified versions) during the lifetime of the system. The software is intended t
observation of the operatory field simultaneously by several surgeons in the operating room, the trans
remote locations (e.g., for educational purposes), and keeping a record of the procedures.

Video system software designed to operate video systems used for remote observation of patients in
and control/monitor a limited number of video systems' functions. This software is usually intended to
a few models of patient video systems, typically supplied by the same manufacturer. The software ma
algorithms to facilitate the analysis of images obtained in patient rooms and also facilitates the sendin
data from and to information systems. Patient monitoring video system software is usually not availab
video system but may be updated (i.e., through the release of modified versions) during the lifetime o
Dedicated patient video system software is intended mainly to facilitate the observation of patients fr
(e.g., a nurse station).

Software designed to operate computed tomography (CT) scanning systems and control/monitor a lim
functions. This software is usually intended to work only with one or a few models of CT scanning syst
same manufacturer. The software performs a variety of algorithms to facilitate the analysis of measure
during the scanning procedure and facilitate sending/receiving patient information from and to inform
scanning system software is usually not available separate from the CT system but may be updated (i
of modified versions) during the life of the system. Dedicated CT scanning system software is availabl
different applications (e.g., renal, cardiac, pulmonary) performed using axial (either whole body or hea
beam CT scanning systems.

Software designed to acquire, process, and archive data and images obtained during computed tomog
This software usually works with CT scanning systems and may also interact with devices used in the
monitors, printers, contrast media injectors, and recorders. CT study software is intended to work only
models of CT scanning systems and related devices, usually supplied by the same manufacturer. This
processing and/or sending of data to and from hospital information systems. The software may or may
separate from the CT equipment and may be updated and/or upgraded (i.e., through the release of m
the life of the equipment. Dedicated software is available for a variety of CT studies, such as bone min
blood flow analysis and also for cardiac, dental, and pulmonary image studies.
Computed tomography (CT) study software designed to acquire, process, and archive data and image
studies intended for bone mineral density (BMD) assessment. This software usually works with CT sca
workstations; it may also interact with devices used in the procedures, such as monitors, printers, con
and recorders. The software is intended to work only with one or a few models of CT scanning systems
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
information systems and other (e.g., picture archiving and communication) workstations. Bone minera
typically use CT images to provide measurements and assessments of BMD in particular areas of the b
The software may be used also to detect areas of bone growth, fractures, tumors, bone infections, and
software may or may not be available separate from the CT equipment and may be updated and/or up
the release of modified versions) during the life of the equipment.

Computed tomography (CT) study software designed to acquire, process, and archive data and image
studies intended for cardiac assessment. This software usually works with CT scanning systems and p
workstations; it may also interact with devices used in the procedures, such as monitors, printers, con
and recorders. The software is intended to work only with one or a few models of CT scanning systems
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
information systems and other (e.g., picture archiving and communication) workstations. Cardiac stud
images to analyze the cardiac functions, such as ejection fractions and cardiac chamber and stroke vo
be used to assess cardiac wall motion and thickness. The software may or may not be available separ
equipment and may be updated and/or upgraded (i.e., through the release of modified versions) durin
equipment.

Computed tomography (CT) study software designed to acquire, process, and archive data and image
dental studies. This software usually works with CT scanning systems and post-imaging workstations;
with devices used in the procedures, such as monitors, printers, and recorders. The software is intend
one or a few models of dental CT scanning systems and related devices, usually supplied by the same
also facilitates the processing and/or sending of data to and from hospital information systems and ot
archiving and communication) workstations. Dental studies typically use CT panoramic images to perf
reformation and/or other dental assessments. The software may or may not be available separate from
and may be updated and/or upgraded (i.e., through the release of modified versions) during the life of

Computed tomography (CT) study software designed to acquire, process, and archive data and image
blood flow studies. This software usually works with CT scanning systems and post-imaging workstatio
with devices used in the procedures, such as monitors, printers, contrast media injectors, and recorde
intended to work only with one or a few models of CT scanning systems and related devices, usually s
manufacturer. This also facilitates the processing and/or sending of data to and from hospital informat
(e.g., picture archiving and communication) workstations. Blood flow studies typically use CT images t
lumen and stenosis and/or thrombus characteristics; dedicated software for assessment of the aorta a
is also available. The software may or may not be available separate from the CT equipment and may
upgraded (i.e., through the release of modified versions) during the life of the equipment
Blood flow computed tomography (CT) study software designed to acquire, process, and archive data
during cerebral (intracranial) blood flow studies. This software usually works with CT scanning system
workstations; it may also interact with devices used in the procedures, such as monitors, printers, con
and recorders. The software is intended to work only with one or a few models of CT scanning system
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
information systems and other (e.g., picture archiving and communication) workstations. Cerebral blo
typically use CT images to analyze blood vessel lumen and stenosis, brain strokes, and tumors. The so
be available separate from the CT equipment and may be updated and/or upgraded (i.e., through the
versions) during the life of the equipment.

Computed tomography (CT) study software designed to acquire, process, and archive data and image
(i.e., pulmonary) studies. This software usually works with CT scanning systems and post-imaging wor
interact with devices used in the procedures, such as monitors, printers, contrast media injectors, and
software is intended to work only with one or a few models of CT scanning systems and related device
the same manufacturer. This also facilitates the processing and/or sending of data to and from hospita
and other (e.g., picture archiving and communication) workstations. Pulmonary studies typically use C
structures of interest in the lung, assess nodule types (e.g., solid and non-solid), as well as evaluate p
and its progress. The software may or may not be available separate from the CT equipment and may
upgraded (i.e., through the release of modified versions) during the life of the equipment.

Software designed to operate equipment that combines computed tomography (CT) scanning and pos
tomography (PET) systems in a single combined system, providing control/monitor of a limited numbe
This software is usually intended to work only with one or a few models of the combined scanning sys
by the same manufacturer. The software performs a variety of algorithms to facilitate the analysis of m
performed during the scanning procedures. The software usually provides fusion (i.e., integration) of a
provided by CT slices and the functional (metabolic) images from PET scans taken in the same session
treatment position. CT/PET scanning system software is usually not available separate from the comb
be updated (i.e., through the release of modified versions) during the life of the system. Dedicated CT
software is intended to facilitate faster and more accurate evaluation than separate CT and PET system
are mostly used for the diagnosis, treatment planning, and evaluation of therapy in cancer patients, c
disease by both its anatomic and biological features.
Software designed to operate equipment that combines a computed tomography (CT) scanning (frequ
helical CT) and a single emission photon computed tomography (SPECT) scanning in a single system.
control/monitoring of a limited number of their functions. This software is usually intended to work onl
models of the combined scanning systems usually supplied by the same manufacturer. The software p
algorithms to facilitate the analysis of measurements performed during the scanning procedures. The
SPECT imaging to detect metabolic abnormalities and CT scanning to localize lesions within the body;
permits acquisition of images from multislice CT and SPECT systems taken in the same session with th
position. CT/SPECT scanning system software is usually not available separate from the combined sys
updated (i.e., through the release of modified versions) during the life of the system. Dedicated CT/PE
software is intended to facilitate faster and more accurate evaluations than separate CT and SPECT sy
Dedicated software intended for diagnosis, treatment planning, and evaluation of therapy in patients
such as cardiac, orthopedic, and oncology is available.

Software designed to operate electrical impedance scanning systems and control/monitor a limited nu
functions. This software is usually intended to work only with one or a few models of electrical impeda
usually supplied by the same manufacturer. The software performs a variety of algorithms to facilitate
measurements performed during the scanning procedure and facilitate sending/receiving patient infor
information systems. Electrical impedance scanning system software is usually not available separat
impedance system but may be updated (i.e., through the release of modified versions) during the life
Dedicated electrical impedance scanning system software intended for use as an adjunct test for amb
is also available.

Electrical impedance software designed to operate mammographic systems and control/monitor a lim
functions. This software is usually intended to work only with one or a few models of electrical impeda
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
of impedance measurements performed during the scanning procedure and facilitate the sending/rece
from and to information systems. The software is usually not available separate from the electrical im
may be updated (i.e., through the release of modified versions) during the life of the system. Mammo
impedance scanning system software is mainly intended as an adjunct test for ambiguous mammogra
diagnostics and reduce the number of biopsies.

Software designed to operate gamma camera scanning systems and control/monitor a limited numbe
software is usually intended to work only with one or a few models of gamma camera scanning syste
the same manufacturer. The software performs a variety of algorithms to facilitate the analysis of mea
during the scanning procedure and facilitate the sending/receiving of patient data from and to informa
camera scanning system software is usually not available separate from the gamma camera system b
(i.e., through the release of modified versions) during the life of the system. Dedicated software inten
(planar) imaging and for the assessment of cross-sectional slices that are reconstructed as tomograph
photon emission tomography [SPET]) is also available. The software is used for a variety of clinical eva
nuclear cardiology studies, and imaging of cerebral blood flow.
Software designed to operate a two-dimension (planar) imaging gamma camera scanning systems an
limited number of their functions. This software is usually intended to work only with one or a few mod
scanning systems usually, supplied by the same manufacturer. The software performs a variety of alg
analysis of measurements performed during the scanning procedure and facilitate the sending/receivi
and to information systems. Gamma camera scanning system software is usually not available separa
camera system but may be updated (i.e., through the release of modified versions) during the life of t
dimension (planar) imaging system software is used for a variety of clinical evaluations, including nuc
and imaging of cerebral blood flow.

Gamma camera scanning software designed to operate single photon emission computed tomography
systems and control/monitor a limited number of their functions. This software is intended to work onl
models of SPECT systems, usually supplied by the same manufacturer. The software performs a variet
facilitate the analysis of measurements performed during the scanning procedure and facilitate the se
patient data from and to information systems. SPECT scanning system software is usually not availa
gamma camera scanning system but may be updated (i.e., through the release of modified versions)
system. SPECT system software is intended for the reconstruction of tomographic images of the cross
obtained during the scanning procedure. Dedicated SPECT software is available for particular applicat
body bone imaging, brain perfusion studies, and cardiac imaging.

Software designed to operate computed ultrasonic scanning systems and control/monitor a limited nu
functions. This software is usually intended to work only with one or a few models of ultrasonic scanni
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
Ultrasonic scanning system software is usually not available separate from the ultrasonic system but m
through the release of modified versions) during the life of the system. Dedicated ultrasonic scanning
available for a variety of different procedures (e.g., small parts, endoscopy) and/or applications (e.g.,
ophthalmology, cardiology).

Ultrasonic scanning software designed to operate computed general (i.e., multi) purpose ultrasonic sc
control/monitor a limited number of their functions. This software is intended to work only with one or
ultrasonic scanning systems, usually supplied by the same manufacturer. The software performs a var
facilitate the analysis of measurements performed during the scanning procedure and the sending/rec
from and to information systems. General purpose ultrasonic scanning system software is usually not
from the ultrasonic system but may be updated (i.e., through the release of modified versions) during

Ultrasonic scanning software designed to operate computed abdominal ultrasonic scanning systems a
limited number of their functions. This software is intended to work only with one or a few models of a
scanning systems, usually supplied by the same manufacturer. The software performs a variety of alg
analysis of measurements performed during the scanning procedure and the sending/receiving of pati
information systems. Abdominal ultrasonic scanning system software is usually not available separate
system but may be updated (i.e., through the release of modified versions) during the life of the syste
Ultrasonic scanning software designed to operate cardiac scanning systems and control/monitor a lim
functions. This software is intended to work only with one or a few models of ultrasonic scanning syste
by the same manufacturer. The software performs a variety of algorithms to facilitate the analysis of m
performed during the scanning procedure and the sending/receiving of patient data from and to inform
Cardiac ultrasonic scanning system software is usually not available separate from the ultrasonic syst
updated (i.e., through the release of modified versions) during the lifetime of the system.

Ultrasonic scanning software designed to operate endoscopic scanning systems and control/monitor a
their functions. This software is intended to work only with one or a few models of ultrasonic scanning
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
Endoscopic ultrasonic scanning system software is usually not available separate from the ultrasonic s
updated (i.e., through the release of modified versions) during the life of the system.

Ultrasonic scanning software designed to operate intravascular scanning systems and control/monitor
their functions. This software is intended to work only with one or a few models of ultrasonic scanning
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
Intravascular ultrasonic scanning system software is usually not available separate from the ultrasonic
updated (i.e., through the release of modified versions) during the life of the system.

Ultrasonic scanning software designed to operate mammographic scanning systems and control/moni
their functions. This software is intended to work only with one or a few models of ultrasonic scanning
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
Mammographic ultrasonic scanning system software is usually not available separate from the ultraso
updated (i.e., through the release of modified versions) during the life of the system.

Ultrasonic scanning software designed to operate obstetric and/or gynecologic scanning systems and
limited number of their functions. This software is intended to work only with one or a few models of u
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
of measurements performed during the scanning procedure and the sending/receiving of patient data
information systems. Obstetric/gynecologic ultrasonic scanning system software is usually not availab
ultrasonic system but may be updated (i.e., through the release of modified versions) during the life o

Ultrasonic scanning software designed to operate ophthalmic scanning systems and control/monitor a
their functions. This software is intended to work only with one or a few models of ultrasonic scanning
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
addition to facilitating the operation of the computed device. Ophthalmic ultrasonic scanning system
available separate from the ultrasonic system but may be updated (i.e., through the release of modifie
life of the system.
Ultrasonic scanning software designed to operate small-part (usually for examinations close to the bod
bladder, thyroid, renal, dermatologic, and prostate examinations) scanning systems and control/monit
their functions. This software is intended to work only with one or a few models of ultrasonic scanning
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
parts ultrasonic scanning system software is usually not available separate from the ultrasonic system
(i.e., through the release of modified versions) during the life of the system.

Ultrasonic scanning software designed to operate vascular scanning systems and control/monitor a lim
functions. This software is intended to work only with one or a few models of ultrasonic scanning syste
by the same manufacturer. The software performs a variety of algorithms to facilitate the analysis of m
performed during the scanning procedure and the sending/receiving of patient data from and to inform
addition to facilitating the operation of the computed device. Vascular ultrasonic scanning system soft
available separate from the ultrasonic system but may be updated (i.e., through the release of modifie
life of the system.

Ultrasonic scanning software designed to operate intracardiac scanning systems and control/monitor a
their functions. This software is intended to work only with one or a few models of ultrasonic scanning
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
performed during the scanning procedure and the sending/receiving of patient data from and to inform
Intracardiac ultrasonic scanning system software is usually not available separate from the ultrasonic
updated (i.e., through the release of modified versions) during the life of the system.

Software designed to operate magnetic resonance imaging (MRI) systems and control/monitor a limite
functions. This software is usually intended to work only with one or a few models of MRI systems, usu
same manufacturer. The software performs a variety of algorithms to facilitate the analysis of measure
obtained during the scanning procedure and the sending/receiving of patient data from and to informa
scanning system software is usually not available separate from the MRI system but may be updated
release of modified versions) during the life of the system. Dedicated MRI scanning system software is
of different applications, such as whole body, extremity, mammography, neurosurgery, and endoscop

Magnetic resonance imaging (MRI) software designed to operate systems intended for scanning the b
control/monitor a limited number of their functions. This software is usually intended to work only with
of MRI systems, usually supplied by the same manufacturer. The software performs a variety of algorit
analysis of measurements and images obtained during the scanning procedure and the sending/receiv
from and to information systems. Extremity MRI scanning system software is usually not available sep
system but may be updated (i.e., through the release of modified versions) during the life of the syste
facilitates the assessment of MRI procedures using specialized surface coils (e.g., knee, upper extremi
Magnetic resonance imaging (MRI) software designed to operate whole (i.e., full) body scanning syst
control/monitor a limited number of their functions. This software is usually intended tow work only wi
of MRI systems usually supplied by the same manufacturer. The software performs a variety of algorit
analysis of measurements and images obtained during the scanning procedure and the sending/receiv
from and to information systems. Whole body MRI scanning system software is usually not available s
system but may be updated (i.e., through the release of modified versions) during the life of the syste
body MRI scanning system software is also available for open MRI systems.

Magnetic resonance imaging (MRI) software designed to operate mammographic systems and control
number of their functions. This software is usually intended to work only with one or a few models of M
supplied by the same manufacturer. The software performs a variety of algorithms to facilitate the ana
and images obtained during the scanning procedure and the sending/receiving of patient data from an
systems. Mammographic MRI scanning system software is usually not available separate from the MR
updated (i.e., through the release of modified versions) during the life of the system. The software fac
assessment of MRI procedures using specialized breast surface coils; it is used as an adjunct to mamm
mammograms that are difficult to interpret.

Magnetic resonance imaging (MRI) software designed to operate neurosurgical (i.e., intraoperative) sy
control/monitor a limited number of their functions. This software is usually intended to work only with
of MRI systems, usually supplied by the same manufacturer. The software performs a variety of algorit
analysis of measurements and images obtained during the scanning procedure and the sending/receiv
from and to information systems. Neurosurgical MRI scanning system software is usually not available
system but may be updated (i.e., through the release of modified versions) during the life of the syste
scanning system software is available for neurosurgery; software with 3-D analysis capabilities is used
performing stereotactic procedures.

Magnetic resonance imaging (MRI) software designed to operate MRI systems that use endoscopic sca
and control/monitor a limited number of their functions. This software is usually intended to work with
of MRI systems, usually supplied by the same manufacturer. The software performs a variety of algorit
analysis of measurements and images obtained during the scanning procedure and the sending/receiv
from and to information systems. Endoscopic MRI scanning system software may be available separa
and updated (i.e., through the release of modified versions) during the lifetime of the system. Dedicat
scanning system software is available for MRI procedures in the gastrointestinal tract; either for the lo
both.

Software designed to acquire, process, and archive data and images obtained during magnetic resona
studies. This software usually works with MRI scanning systems and may also interact with devices us
such as monitors, printers, contrast media injectors, and recorders. MRI study software is intended to
few models of MRI scanning systems and related devices, usually supplied by the same manufacturer.
the processing and/or sending of data to and from hospital information systems. The software may or
separate from the MRI equipment and may be updated and/or upgraded (i.e., through the release of m
during the life of the equipment. Dedicated software is available for a variety of MRI studies; some sof
of processing spectrographic data. Dedicated MRI study software is available for particular studies, su
analysis and also for cardiac, prostatic, and breast image studies.
Magnetic resonance imaging (MRI) study software designed to acquire, process, and archive data and
during studies intended for cardiac assessment. This software usually works with MRI scanning system
workstations; it may also interact with devices used in the procedures, such as monitors, printers, con
and recorders. The software is intended to work only with one or a few models of MRI scanning system
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
information systems and other (e.g., picture archiving and communication) workstations. Cardiac stud
images to analyze the cardiac functions in real time, such as ejection fractions and cardiac chamber a
they may also assess cardiac wall motion and thickness. The software may or may not be available se
equipment and may be updated and/or upgraded (i.e., through the release of modified versions) durin
equipment.

Magnetic resonance imaging (MRI) study software designed to acquire, process, and archive data and
during prostate assessment studies. This software usually works with MRI scanning systems and post-
it may also interact with devices used in the procedures, such as monitors, printers, contrast media in
The software is intended to work only with one or a few models of MRI scanning systems and related d
supplied by the same manufacturer. This also facilitates the processing and/or sending of data to and
information systems and other (e.g., picture archiving and communication) workstations. Prostatic stu
images to analyze the prostate providing positional and functional information about abnormalities. So
capable of processing spectrographic data. The software may or may not be available separate from t
may be updated and/or upgraded (i.e., through the release of modified versions) during the life of the

Magnetic resonance imaging (MRI) study software designed to acquire, process, and archive data and
during blood flow studies. This software usually works with MRI scanning systems and post-imaging w
interact with devices used in the procedures, such as monitors, printers, contrast media injectors, and
software is intended to work only with one or a few models of MRI scanning systems and related devic
the same manufacturer. This also facilitates the processing and/or sending of data to and from hospita
and other (e.g., picture archiving and communication) workstations. Blood flow studies typically use M
blood vessel lumen, stenosis, and/or arterio-venous malformations. The software may or may not be a
the MRI equipment and may be updated and/or upgraded (i.e., through the release of modified versio
the equipment.

Magnetic resonance imaging (MRI) study software designed to acquire, process, and archive data and
during breast (i.e., mammographic) studies. This software usually works with MRI mammographic scan
post-imaging workstations; it may also interact with devices used in the procedures, such as monitors
recorders. The software is intended to work only with one or a few models of MRI scanning systems a
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
information systems and other (e.g., picture archiving and communication) workstations. Breast studie
images for a better characterization of lesions and monitoring of treatment progress. The software m
available separate from the MRI equipment and may be updated and/or upgraded (i.e., through the re
versions) during the life of the equipment.
Software designed to acquire, process, and archive data and images obtained during nuclear medicine
usually works with nuclear medicine and/or gamma camera workstations and interacts with devices u
such as gamma cameras, single photon emission computed tomography, and thyroid uptake systems
study software is intended to work only with one or a few models of nuclear medicine equipment and
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
information systems. The software may or may not be available separate from the nuclear medicine e
updated and/or upgraded (i.e., through the release of modified versions) during the life of the equipm
software is available for a variety of nuclear medicine studies, including programs for thyroid function
liver, pulmonary, and renal scanned imaging.

Nuclear medicine study software designed to acquire, process, and archive data and images obtained
thyroid gland. This software usually works with nuclear medicine workstations; the software may also
used in the procedures, such as gamma cameras and thyroid uptake systems. The software is intende
or a few models of nuclear medicine equipment and related devices, usually supplied by the same ma
facilitates the processing and/or data interchange with other nuclear medicine workstations and/or ho
systems. Thyroid function software may or may not be available separate from the nuclear medicine e
updated and/or upgraded (i.e., through the release of modified versions) during the life of the equipm
function nuclear medicine software facilitates the determination of how active the thyroid gland is; it i
size and shape of the gland and to localize nodules or tumors.

Nuclear medicine study software designed to acquire, process, and archive data and images obtained
medicine studies. These studies are performed on patients during and after practicing stress exercises
administration of drugs such as dipyridamole for patients not capable of exercising) with radioactive t
bloodstream. This software usually interacts with devices used in the procedures, such as scanning ga
nuclear medicine workstations. Thallium stress exercise nuclear medicine study software is intended t
a few models of nuclear medicine equipment and related devices, usually supplied by the same manu
facilitates the processing and/or sending of data to nuclear medicine workstations to and from other h
systems. Thallium-based nuclear medicine studies are used to diagnose the presence of coronary arte
assessing the Thallium absorbed by the heart walls. The software may or may not be available separa
medicine equipment and may be updated and/or upgraded (i.e., through the release of modified versi
the equipment. Dedicated software for Thallium studies performed using planar and/or single photon
tomography (SPECT) images are also available.

Nuclear medicine study software designed to acquire, process, and archive data and images obtained
liver performed on patients after injection of a radioactive substance in the bloodstream. This software
nuclear medicine and/or gamma camera workstation and may also interact with other devices used in
as scanning gamma cameras; the software is intended to work only with one or a few models of nucle
and related devices, usually supplied by the same manufacturer. This also facilitates facilitating the pr
sending of data to other nuclear medicine workstations and hospital information systems. The softwar
available separate from the nuclear medicine equipment and may be updated and/or upgraded (i.e., t
modified versions) during the life of the equipment. Liver nuclear medicine studies are used to diagno
tumors and/or liver cirrhosis.
Nuclear medicine study software designed to acquire, process, and archive data and images obtained
study is usually performed in two parts: first, a series of images are taken after inhalation of a radioac
tissue of the lungs; then, a radioactive substance is injected in the bloodstream and more images are
blood supply to the lungs. This software usually works with a nuclear medicine and/or gamma camera
also interact with other devices used in the procedures such as scanning gamma cameras. Lung nucle
software is intended to work only with one or a few models of nuclear medicine equipment and related
supplied by the same manufacturer. This also facilitates the processing and/or sending of data to othe
workstations and hospital information systems. Lung nuclear medicine studies are used mainly to dete
circulation in the lungs, especially to find blood clots in the lungs (i.e., to diagnose pulmonary embolis
or may not be available separate from the nuclear medicine equipment and may be updated and/or u
the release of modified versions) during the life of the equipment.

Nuclear medicine study software designed to acquire, process, and archive data and images obtained
kidneys performed on patients after injection of a radioactive substance in the bloodstream. This softw
a nuclear medicine and/or gamma camera workstation and may also interact with other devices used
as scanning gamma cameras; the software is intended to work only with one or a few models of nucle
and related devices, usually supplied by the same manufacturer. This also facilitates the processing a
to other nuclear medicine workstations and hospital information systems. The software may or may n
separate from the nuclear medicine equipment and may be updated and/or upgraded (i.e., through th
versions) during the life of the equipment. Renal (i.e., kidney) nuclear medicine studies are used to as
function, and blood supply to the kidneys, especially to diagnose the presence of tumors and/or liver c

Nuclear medicine study software designed to acquire, process, and archive data and images obtained
performed on the patient's whole body. These studies are mainly intended to scan for bone absorption
radioactive substance (e.g., Technetium) in the bloodstream. This software usually works with a nuclea
gamma camera workstation and may also interact with other devices used in the procedures such as
cameras. The software is intended to work only with one or a few models of nuclear medicine equipm
devices, usually supplied by the same manufacturer. This also facilitates the processing and/or sendin
nuclear medicine workstations and hospital information systems. Whole-body/bone nuclear medicine
used to detect areas of bone growth, fractures, tumors, bone infections, and/or arthritis; some bone st
particular area of the body. The software may or may not be available separate from the nuclear medi
may be updated and/or upgraded (i.e., through the release of modified versions) during the life of the

Software designed to operate light (i.e., photo) scanning systems and control/monitor a limited numbe
This software is usually intended to work only with one or a few models of light scanning systems, usu
same manufacturer. The software performs a variety of algorithms to facilitate the analysis of measure
obtained during the scanning procedure and the sending/receiving of patient data from and to informa
scanning system software is usually not available separate from the scanning system but may be upd
release of modified versions) during the lifetime of the system. Dedicated light scanning system softw
tissue (i.e., mammographic) assessment systems that typically use infrared light for scanning is also a
Light scanning software designed to operate mammographic scanning systems and control/monitor a
functions. This software is usually intended to work only with one or a few models of mammographic s
usually supplied by the same manufacturer. The software performs a variety of algorithms to facilitate
measurements and images obtained during the scanning procedure (typically using infrared light) and
of patient data from and to information system. Mammographic light scanning system software is usu
separate from the scanning system but may be updated (i.e., through the release of modified versions
system.

Software designed to operate laser scanning systems and control/monitor a limited number of their fu
is usually intended to work only with one or a few models of laser scanning systems, usually supplied
manufacturer. The software performs a variety of algorithms to facilitate the analysis of measurement
during the scanning procedure and the sending/receiving of patient data from and to information syst
system software is usually not available separate from the laser scanning system but may be updated
release of modified versions) during the life of the system. Dedicated laser scanning system software
variety of different applications, such as mammography and optical tomography, including the charac
structure (i.e., optical biometry).

Laser scanning software designed to operate scanning systems that use interferometer techniques to
images of the retina and cornea (i.e., optical tomography) and control/monitor a limited number of the
software is usually intended to work only with one or a few models of optical tomography scanning sy
by the same manufacturer. The software performs a variety of algorithms to facilitate the analysis of m
images that reveal the underlying structure of the eye that are obtained during the scanning procedur
sending/receiving of patient data from and to information systems. Optical tomography laser scanning
usually not available separate from the laser scanning system but may be updated (i.e., through the r
versions) during the life of the system. Dedicated optical tomography laser scanning system software
derive the intraocular distances (geometric separation) based on the refractive of the structures of the

Software designed to operate computer-aided detection systems and control/monitor a limited numbe
This software is usually intended to work only with one or a few models of computer-aided systems, u
same manufacturer. The software performs a variety of algorithms to facilitate the analysis of images
sending/receiving of patient information from and to information systems. Computer-aided detection
usually not available separate from the computer-aided system but may be updated (i.e., through the
versions) during the life of the system. Dedicated computer-aided system software is available for a v
applications, either using in-vivo images (e.g., breast, pulmonary) or from tissue (pathology) slides (e.
prostatic).

Computer-aided detection system software designed to operate detection systems intended to analyz
control/monitor a limited number of their functions. This software is usually intended to work only with
of computer-aided systems, usually supplied by the same manufacturer. The software performs a varie
facilitate the analysis of images and the sending/receiving of patient data from and to information sys
computer-aided detection system software is usually not available separate from the computer-aided
updated (i.e., through the release of modified versions) during the life of the system. Dedicated image
system software is available for a variety of different applications, such as the analysis of in-vivo imag
breast and lung, using scanning imaging systems (e.g., MRI, CT, ultrasonic).
Image computer-aided detection system software designed to operate detection systems intended to
images and control/monitor a limited number of their functions. This software is usually intended to w
few models of computer-aided systems, usually supplied by the same manufacturer. The software per
algorithms to facilitate the analysis of pulmonary images and facilitate the sending/receiving of patien
information systems. The software is usually not available separate from the computer-aided system b
(i.e., through the release of modified versions) during the life of the system. Lung image computer-aid
software facilitates the analysis of in-vivo images intended to detect lung nodules by showing regions
chest radiography, including lung and mediastinum.

Image computer-aided detection system software designed to operate detection systems intended to
and control/monitor a limited number of their functions. This software is usually intended to work only
models of computer-aided systems, usually supplied by the same manufacturer. The software may pe
algorithms to facilitate the analysis of mammographic images and facilitate the sending/receiving of p
from and to information system. The software is usually not available separate from the computer-aid
updated (i.e., through the release of modified versions) during the life of the system. Mammographic
detection system software facilitates the analysis of images intended to detect abnormalities in mamm

Software designed to operate systems that process and store digital data and images (i.e., a digitizati
from an external source (e.g., video camera) and control/monitor a limited number of the system func
usually interacts with devices used in the procedure, such as computers, digital storage recorders, and
perform a variety of algorithms to facilitate the operation and analysis of the data obtained from a vid
other data or image source. Digitization system software is intended to work only with one or a few m
systems and related devices, usually supplied by the same manufacturer. This also facilitates the proc
of data from the digitization system to and from picture archiving and communication systems (PACS)
information systems. Image digitization system software is not usually available separate from the dig
may be updated (i.e., through the release of modified versions) during the life of the equipment. Dedi
system software intended for specific data and images obtained in angiographic/cardiovascular, comp
mammographic, microscopic, ophthalmic, and other particular procedures is available.

Image digitization system software designed to operate systems that process and store digital angiog
cardiovascular data and images obtained from an external source (e.g., video camera) and control/mo
of the system functions. This software usually interacts with devices used in the procedure, such as co
storage recorders, and monitors. It may also perform a variety of algorithms to facilitate the operation
data obtained from a video camera and/or other data or image source. Angiography/cardiovascular di
software is intended to work only with one or a few models of digitization systems and related devices
the same manufacturer. This also facilitates the processing and/or sending of data from the digitizatio
picture archiving and communication systems (PACS) and/or other hospital information systems. The s
available separate from the digitization system but may be updated (i.e., through the release of modifi
the life of the equipment. Angiography/cardiovascular digitization system software permit the perform
subtraction angiography and other computer assisted procedures when using radiographic/fluoroscop
Image digitization system software designed to operate systems that process and store digital data an
data obtained from an external source (e.g., phosphor plate) and control/monitor a limited number of
This software usually interacts with devices used in the procedure, such as computers, digital storage
monitors. It may also perform a variety of algorithms to facilitate the operation and analysis of the dat
and/or image source. The software is intended to work only with one or a few models of digitization sy
devices, usually supplied by the same manufacturer. This also facilitates the processing and/or sendin
digitization system to and from picture archiving and communication systems (PACS) and/or other hos
systems. Computed radiography digitization system software is not usually available separate from th
but may be updated (i.e., through the release of modified versions) during the life of the equipment. D
radiography digitization system software intended for specific data and images obtained in dental, ma
other particular procedures is available.

Image digitization system software designed to operate systems that process and store digital dental
radiographic data and images obtained from an external source (e.g., phosphor plates) and control/mo
of the system functions. This software usually interacts with devices used in the procedure, such as an
control console. It may also perform a variety of algorithms to facilitate the operation and analysis of t
the external radiographic data or image source. Computed dental radiography digitization system soft
work only with one or a few models of radiographic digitization systems and related devices usually su
manufacturer; the system may allow also the processing and/or sending data from the digitization sys
picture archiving and communication systems (PACS) and/or other hospital information systems. The s
available separate from the digitization system but may be updated (i.e., through the release of modifi
the life of the equipment. Dental image digitization system software is used mainly in a dentist's office

Image digitization system software designed to operate systems that process and store digital mamm
images obtained from an external source (e.g., phosphor plate) and control/monitor a limited number
functions. This software usually interacts with devices used in the procedure, such as computers, digit
and monitors. It may also perform a variety of algorithms to facilitate the operation and analysis of th
the data and image source. Mammographic digitization system software is intended to work only with
mammographic systems and related devices usually supplied by the same manufacturer. This also fac
and/or sending of data from the digitization system to and from picture archiving and communication
other hospital information systems. The software is not usually available separate from the mammogr
system but may be updated (i.e., through the release of modified versions) during the life of the equip
Image digitization system software designed to operate systems that process and store digital microsc
obtained from a microscope and control/monitor a limited number of the system functions. This softwa
with devices used in the procedure, such as a control console, digital storage recorders, and monitors.
variety of algorithms to facilitate the operation and analysis of the data obtained from the optical path
Microscopy digitization system software is intended to work only with one or a few models of digitizati
devices, usually supplied by the same manufacturer. This also facilitates the processing and/or sendin
digitization system to and from picture archiving and communication systems (PACS) and/or other hos
systems. The software is not usually available separate from the microscopy digitization system but m
through the release of modified versions) during the life of the equipment. Microscopy digitization sys
the performance of a variety of computer assisted image acquisitions; dedicated software is also avail
scanning laser confocal microscopes.

Microscopy Image digitization system software designed to operate systems that process and store di
and images obtained from a scanning laser confocal microscope and control/monitor a limited number
functions. This software usually interacts with devices used in the procedure, such as a light source, d
recorders, and monitors. It may also perform a variety of algorithms to facilitate the operation and ana
obtained from the optical path of a scanning laser confocal microscope. Scanning laser confocal micro
system software is intended to work only with one or a few models of microscopy digitization systems
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
system to and from picture archiving and communication systems (PACS) and/or other hospital inform
software is not usually available separate from the microscopy digitization system but may be update
release of modified versions) during the life of the equipment. Scanning laser confocal microscopy dig
software permit the performance of a variety of computer assisted image acquisitions; including obse
both normal and living cancer cells assisting in-vivo histological diagnosis (e.g., in the gastrointestinal
need for biopsy.

Image digitization system software designed to operate system that process and store digital ophthalm
obtained from a fundus camera, fluorescent angiography, and/or other source; the digitization system
control/monitor a limited number of the system functions. This software usually interacts with devices
such as a digital video camera, digital storage recorders, and monitors. It may also perform a variety o
facilitate the operation and analysis of ophthalmic data and images obtained from the source. Ophtha
system software is intended to work only with one or a few models of ophthalmic digitization systems
usually supplied by the same manufacturer. This also facilitates the processing and/or sending of data
system to and from picture archiving and communication systems (PACS) and/or other hospital inform
software is not usually available separate from the ophthalmic digitization system but may be updated
release of modified versions) during the life of the equipment. Ophthalmic digitization system softwar
performance of a variety of computer assisted image procedures from images taken from fundus and
angiography cameras.
Software designed to operate digital radiography systems and control/monitor a limited number of the
functions. This software usually interacts with the x-ray subsystem, detectors, and monitors. It may al
algorithms to facilitate the operation and analysis of the data and images obtained during the radiogr
Digital radiographic system software is intended to work only with one or a few models of radiographi
devices, usually supplied by the same manufacturer. This also facilitates the processing and/or sendin
digital radiographic system to and from picture archiving and communication systems (PACS) and/or o
information systems. The software is not usually available separate from the radiographic system but
through the release of modified versions) during the life of the equipment. Dedicated digital radiograp
intended for chest, dental, mammographic, and other radiographic procedures is also available.

Digital radiography software designed to operate chest (thoracic) radiography systems and control/mo
of the chest radiographic system functions. This software usually interacts with the radiographic unit,
monitors. It may also perform a variety of algorithms to facilitate the operation and analysis of the dat
during the radiographic procedure. Chest digital radiographic system software is intended to work onl
models of radiographic systems and related devices, usually supplied by the same manufacturer. This
processing and/or sending of data from the digital radiographic system to and from picture archiving a
systems (PACS) and/or other hospital information systems. The software is not usually available separ
radiographic system but may be updated (i.e., through the release of modified versions) during the lif
Dedicated digital chest radiography system software is intended mainly for assessing pulmonary and/

Digital radiography software designed to operate dental radiography systems and control/monitor a lim
dental radiographic system functions. This software usually interacts with a conventional dental radiog
and monitors. It may also perform a variety of algorithms to facilitate the operation and analysis of th
(e.g., zooming, multi-image viewing) obtained during the dental radiographic procedure. Dental digita
software is intended to work only with one or a few models of dental radiographic systems and related
supplied by the same manufacturer. The software may also facilitate the processing and/or sending of
digital radiographic system to and from to a local patient information system located in the dentist's o
hospitals, to and from picture archiving and communication systems (PACS) and/or other hospital infor
software is not usually available separate from the dental radiographic system but may be updated (i.
of modified versions) during the life of the equipment.

Digital radiography software designed to operate breast radiography (i.e., mammographic) systems a
limited number of the mammographic system functions. This software usually interacts with mammog
units, detectors, and monitors; it may also perform a variety of algorithms to facilitate the operation a
and images (e.g., zooming, multi-image viewing) obtained during the mammographic procedure. Digi
system software is intended to work only with one or a few models of mammographic systems and rel
supplied by the same manufacturer. This also facilitates the processing and/or sending of data from th
mammographic system to and from picture archiving and communication systems (PACS) and/or othe
systems. The software is not usually available separate from the chest radiographic system but may b
through the release of modified versions) during the life of the equipment. Digital mammographic soft
assessing or screening breast lesions and/or tumors.
Software designed to operate digital radiographic and fluoroscopic (R/F) systems and control/monitor
R/F system functions. This software usually interacts with the x-ray subsystem, detectors, and monito
a variety of algorithms to facilitate the operation and analysis of the data and images obtained during
radiographic/fluoroscopic system software is intended to work only with one or a few models of R/F sy
devices, usually supplied by the same manufacturer. This also facilitates the processing and/or sendin
digital system to and from picture archiving and communication systems (PACS) and/or other hospital
The software is not usually available separate from the radiographic system but may be updated (i.e.,
modified versions) during the life of the equipment. Dedicated digital radiographic/fluoroscopic system
angiographic, interventional, renal, and other special procedures is also available.

Radiographic/fluoroscopic system software designed to operate angiographic and/or interventional dig


fluoroscopic (R/F) systems and control/monitor a limited number of the system functions. This softwar
the x-ray subsystem, detectors, tables, contrast media injectors, and monitors; it may also perform a
facilitate the operation and analysis of the data and images obtained during the procedure. Angiograp
digital radiographic/fluoroscopic system software is intended to work only with one or a few models of
related devices, usually supplied by the same manufacturer. This also facilitates the processing and/or
R/F digital system to and from picture archiving and communication systems (PACS) and/or other hosp
systems. The software is not usually available separate from the radiographic system but may be upd
release of modified versions) during the life of the equipment. Angiography/interventional digital radio
system software is mainly used in a special imaging suite (angiographic or special procedures room).

Radiographic/fluoroscopic software designed to operate cardiovascular digital radiographic and fluoros


and control/monitor a limited number of the system functions. This software usually interacts with the
detectors, tables, contrast media injectors, and monitors; it may also perform a variety of algorithms t
operation and analysis of the data and images obtained during the cardiovascular procedure. Cardiova
radiographic/fluoroscopic system software is intended to work only with one or a few models of R/F sy
devices usually supplied by the same manufacturer. This also facilitates the processing and/or sending
digital system to and from picture archiving and communication systems (PACS) and/or other hospital
The software is not usually available separate from the radiographic system but may be updated (i.e.,
modified versions) during the life of the equipment. Cardiovascular digital radiographic/fluoroscopic sy
mainly used in special cardiac catheterization rooms.
Radiographic/fluoroscopic software designed to operate urologic digital radiographic and fluoroscopic
control/monitor a limited number of the system functions. This software usually interacts with the x-ra
detectors, tables, contrast media injectors, and monitors; it may also perform a variety of algorithms t
operation and analysis of the data and images obtained during the urologic procedure. Urology digital
radiographic/fluoroscopic system software is intended to work only with one or a few models of R/F ur
related devices usually supplied by the same manufacturer. This also facilitates the processing and/or
R/F digital system to and from picture archiving and communication systems (PACS) and/or other hos
systems. The software is not usually available separate from the urologic system but may be updated
release of modified versions) during the life of the equipment. Urologic digital radiographic/fluoroscop
mainly used in the urinary tract and/or gynecologic procedures that require radiography and fluorosco

Software designed to operate digital radiographic and tomographic (R/T) systems and control/monitor
the system functions. This software usually interacts with the x-ray subsystem, detectors, and monito
a variety of algorithms to facilitate the operation and analysis of the data and images obtained during
procedure. Digital radiographic/tomographic system software is intended to work only with one or a fe
systems and related devices, usually supplied by the same manufacturer. This also facilitates the proc
data from the R/T digital system to and from picture archiving and communication systems (PACS) and
information systems. The software is not usually available separate from the R/T system but may be u
the release of modified versions) during the life of the equipment. Dedicated digital radiographic/tomo
software intended for linear and multidirectional R/T systems is also available.

Software designed to operate radiotherapy systems and control/monitor a limited number of the radio
functions. This software usually interacts with the radiation delivery equipment, control units, monitor
may also perform a variety of algorithms to facilitate the operation and analysis of the data and image
procedure. Radiotherapy system software is intended to work only with one or a few models of radioth
related devices, usually supplied by the same manufacturer. This also facilitates the processing and/or
radiotherapy system to and from picture archiving and communication systems (PACS) and/or other h
systems. The software is not usually available separate from the radiotherapy system but may be upd
release of modified versions) during the life of the equipment. Dedicated radiotherapy system softwar
linear accelerator, neutron and proton beam, and orthovoltage radiotherapy systems is available.

Radiotherapy system software designed to operate cobalt radiotherapy systems and control/monitor a
radiotherapy system functions. This software usually interacts with the cobalt unit, control units, moni
may also perform a variety of algorithms to facilitate the operation and analysis of the data and image
procedure. Cobalt radiotherapy system software is intended to work only with one or a few models of
systems and related devices, usually supplied by the same manufacturer. This also facilitates the proc
data from the cobalt radiotherapy system to and from picture archiving and communication systems (
hospital information systems. The software is not usually available separate from the radiotherapy sys
updated (i.e., through the release of modified versions) during the life of the equipment. Dedicated co
system software intended for specific areas of the body (e.g., head, neck, breast) is also available.
Radiotherapy system software designed to operate linear accelerator radiotherapy systems and contr
number of the radiotherapy system functions. This software usually interacts with the linear accelerat
monitors, and recorders; it may also perform a variety of algorithms to facilitate the operation and ana
images obtained during the procedure. Linear accelerator radiotherapy system software is intended to
a few models of linear accelerator radiotherapy systems and related devices, usually supplied by the
This also facilitates the processing and/or sending data from the linear accelerator radiotherapy syste
archiving and communication systems (PACS) and/or other hospital information systems. The software
available separate from the radiotherapy system but may be updated (i.e., through the release of mod
the life of the equipment. Dedicated linear accelerator radiotherapy system software intended for low
treat superficial areas (e.g., head, neck, breast) and for deeper tumors (e.g., pelvis and thorax tumors

Radiotherapy system software designed to operate neutron beam radiotherapy systems and control/m
number of the radiotherapy system functions. This software usually interacts with the radiation unit (e
control units, monitors, and recorders; it may also perform a variety of algorithms to facilitate the ope
the data and images obtained during the procedure. Neutron beam radiotherapy system software is in
with one or a few models of neutron beam radiotherapy systems and related devices, usually supplied
manufacturer. This also facilitates the processing and/or sending data from the neutron beam radiothe
from picture archiving and communication systems (PACS) and/or other hospital information systems.
usually available separate from the radiotherapy system but may be updated (i.e., through the releas
during the life of the equipment. Dedicated neutron beam radiotherapy system software intended for
(epithermal) systems to treat tumors in particular areas (e.g., gliomas) and for high-energy neutron sy
tumors (e.g., inoperable sarcomas) is also available.

Radiotherapy system software designed to operate orthovoltage radiotherapy systems and control/mo
of the radiotherapy system functions. This software usually interacts with the radiation unit. Orthovol
system software is intended to work only with one or a few models of orthovoltage radiotherapy syste
devices, usually supplied by the same manufacturer. The software is not usually available separate fro
system but may be updated (i.e., through the release of modified versions) during the life of the equip

Radiotherapy system software designed to operate proton beam radiotherapy systems and control/mo
of the radiotherapy system functions. This software usually interacts with the radiation unit (e.g., a cy
control units, monitors, and patient alignment devices; it may also perform a variety of algorithms to f
and analysis of the data and images obtained during the procedure. Proton beam radiotherapy system
to work only with one or a few models of proton beam radiotherapy systems and related devices, usua
same manufacturer. This also facilitates the processing and/or sending data from the proton beam rad
and from picture archiving and communication systems (PACS) and/or other hospital information syste
not usually available separate from the radiotherapy system but may be updated (i.e., through the rel
versions) during the life of the equipment. Dedicated proton beam radiotherapy system software inte
deliver low energy protons intended to treat superficial disorders and software for high-energy neutro
treat deep tumors in the chest and abdomen is available; software intended for specific tumor treatme
skull based tumors) is also available.
Software designed to operate stereotactic computer-aided systems and control/monitor their functions
usually intended to work only with one or a few models of stereotactic systems usually supplied by th
The software performs a variety of algorithms to make possible the appropriate performance of the sy
surgical, or radiosurgical procedure and to facilitate the sending/receiving of patient data from and to
imaging and information systems. Stereotactic system software is frequently available separate from
and may be also updated (i.e., through the release of modified versions) during the life of the surgical
stereotactic system software using computerized data that are either guided by images, do not use im
or are guided by a rigid frame is also available for a variety of applications (e.g., mammographic biops
orthopedics).

Stereotactic system software designed to operate image guided, computer-aided biopsy systems and
functions. This software is usually intended to work only with one or a few models of stereotactic syste
by the same manufacturer. The software performs a variety of algorithms to make possible the approp
the system during a biopsy or surgical procedure and to facilitate the sending/receiving of patient dat
workstation and/or imaging and information systems. Image-guided stereotactic system software is fr
separate from the surgical system and may be also updated (i.e., through the release of modified vers
the surgical system. Dedicated image-guided surgical system software is available for a variety of diff
applications.

Image-guided stereotactic system software designed to operate computer-aided mammography biops


control/monitor their functions. This software is usually intended to work only with one or a few model
mammography biopsy systems, usually supplied by the same manufacturer. The software performs a
make possible the appropriate performance of the system during a biopsy procedure and to facilitate
of patient data from and to a workstation and/or imaging and information systems. Mammographic bi
stereotactic system software is frequently available separate from the biopsy system and may be also
the release of modified versions) during the life of the system.

Image-guided stereotactic system software designed to operate computer-aided cardiac mapping and
systems and control/monitor their functions. This software is usually intended to work only with one or
stereotactic cardiac mapping/ablation systems, usually supplied by the same manufacturer. The softw
of algorithms to make possible the appropriate performance of the system during a mapping and/or a
to facilitate the sending/receiving of patient data from and to a workstation and/or imaging and inform
mapping/ablation image-guided stereotactic system software is frequently available separate from the
may be also updated (i.e., through the release of modified versions) during the life of the surgical syst
guided system software intended only for cardiac mapping or cardiac ablation procedures is also avail
Image-guided surgery stereotactic system software designed to operate computer-aided surgical syste
control/monitor their functions. This software is usually intended to work only with one or a few model
usually supplied by the same manufacturer. The software performs a variety of algorithms to make po
performance of the system during the surgical procedure and to facilitate the sending/receiving of pat
workstation and/or imaging and information systems. Image-guided surgical stereotactic system softw
available separate from the surgical system and may be also updated (i.e., through the release of mod
the life of the surgical system. Dedicated image-guided surgical system software is available for a var
applications, including intracranial, spinal, orthopedic, otolaryngology, and trauma procedures or com

Image-guided surgery stereotactic system software designed to operate computer-aided intracranial n


and control/monitor their functions. This software is usually intended to work only with one or a few m
neurosurgical systems, usually supplied by the same manufacturer. The software performs a variety o
possible the appropriate performance of the system during the surgical procedure and to facilitate the
patient data from and to a workstation and/or imaging and information systems. Intracranial image-g
stereotactic system software is frequently available separate from the surgical system and may be als
through the release of modified versions) during the life of the surgical system.

Image-guided surgery stereotactic system software designed to operate computer-aided spinal surger
control/monitor their functions. This software is usually intended to work only with one or a few model
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
appropriate performance of the system during the surgical procedure and to facilitate the sending/rec
from and to a workstation and/or imaging and information systems. Spinal image-guided surgical stere
software is frequently available separate from the surgical system and may be also updated (i.e., thro
modified versions) during the life of the surgical system.

Image-guided surgery stereotactic system software designed to operate computer-aided orthopedic su


control/monitor their functions. This software is usually intended to work only with one or a few model
systems usually, supplied by the same manufacturer. The software performs a variety of algorithms to
appropriate performance of the system during the surgical procedure and to facilitate the sending/rec
from and to a workstation and/or imaging and information systems. Orthopedic image-guided surgical
software is frequently available separate from the surgical system and may be also updated (i.e., thro
modified versions) during the life of the surgical system.

Image-guided surgery stereotactic system software designed to operate computer-aided otolaryngolo


and control/monitor their functions. This software is usually intended to work only with one or a few m
otolaryngology surgery systems, usually supplied by the same manufacturer. The software performs a
to make possible the appropriate performance of the system during the surgical procedure and to faci
sending/receiving of patient data from and to a workstation and/or imaging and information systems.
guided surgical stereotactic system software is frequently available separate from the surgical system
updated (i.e., through the release of modified versions) during the life of the surgical system.
Image-guided surgery stereotactic system software designed to assess traumatic lesions using image
and/orthopedic systems, frequently controlling and/or monitoring the functions of the system. This sof
intended to work only with one or a few models of surgical (e.g., orthopedic, spinal) systems, usually s
manufacturer. The software performs a variety of algorithms to make possible the appropriate perform
during the procedure and to facilitate the sending/receiving of patient data from and to a workstation
information systems. Trauma image-guided stereotactic system software is frequently available separ
system and may be also updated (i.e., through the release of modified versions) during the life of the
Dedicated image-guided trauma software is available for a variety of different applications, including o
applications.

Image-guided radiosurgery stereotactic system software designed to operate computer-aided radiosur


control/monitor their functions. This software is usually intended to work only with one or a few model
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
appropriate performance of the system during the procedure and to facilitate the sending/receiving of
to a workstation and/or imaging and information systems. Image-guided radiosurgery stereotactic sys
available separate from the radiosurgery system and may be also updated (i.e., through the release o
during the life of the system. Dedicated image-guided radiosurgery system software is available for a
applications, either for cobalt systems using gamma radiation (e.g., gamma knife) or linear accelerato

Image-guided radiosurgery stereotactic system software designed to operate computer-aided gamma


control/monitor their functions. This software is usually intended to work only with one or a few model
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
appropriate performance of the system during the procedure and to facilitate the sending/receiving of
to a workstation and/or imaging and information systems. Gamma radiation image-guided radiosurge
software may be available separate from the radiosurgery system and may be also updated (i.e., thro
modified versions) during the life of the system; dedicated software for a variety of different applicatio

Image-guided radiosurgery stereotactic system software designed to operate computer-aided linear a


control/monitor their functions. This software is usually intended to work only with one or a few model
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
appropriate performance of the system during the procedure and to facilitate the sending/receiving of
to a workstation and/or imaging and information systems. Linear accelerator Image-guided radiosurge
software may be available separate from the radiosurgery system and may be also updated (i.e., thro
modified versions) during the life of the system; dedicated software for a variety of different applicatio
Software designed to operate imageless computer-aided surgical systems and control/monitor their fu
is usually intended to work only with one or a few models of imageless surgical systems, usually supp
manufacturer. The software performs a variety of algorithms to make possible the appropriate perform
during the surgical procedure and to facilitate the sending/receiving of patient data from and to a wor
imaging and information systems. Imageless surgical stereotactic system software is frequently availa
surgical system and may be also updated (i.e., through the release of modified versions) during the lif
system. Dedicated image-guided surgical system software is also available for a few of different applic
orthopedics

Imageless surgery stereotactic system software designed to operate computer-aided orthopedic surge
control/monitor their functions. This software is usually intended to work only with one or a few model
imageless surgery systems, usually supplied by the same manufacturer. The software performs a varie
make possible the appropriate performance of the system during the surgical procedure and to facilita
sending/receiving of patient data from and to a workstation and/or imaging and information systems.
surgical stereotactic system software is frequently available separate from the surgical system and m
(i.e., through the release of modified versions) during the life of the surgical system.

Stereotactic system software designed to operate frame-guided, computer-aided stereotactic systems


their functions. This software is usually intended to work only with one or a few models of frame-guide
supplied by the same manufacturer. Tthe software performs a variety of algorithms to make possible t
performance of the system during the procedure and to facilitate the sending/receiving of patient info
workstation and/or imaging and information systems. Frame-guided surgical stereotactic system softw
available separate from the stereotactic system and may be also updated (i.e., through the release of
during the life of the surgical system. Dedicated frame-guided stereotactic system software intended
radiosurgery is available.

Frame-guided stereotactic system software designed to operate frame-guided, computer-aided neuros


control/monitor their functions. This software is usually intended to work only with one or a few model
neurosurgical systems, usually supplied by the same manufacturer. The software performs a variety o
possible the appropriate performance of the system during the surgical procedure and to facilitate the
patient data from and to a workstation and/or imaging and information systems. Neurosurgical frame
stereotactic system software is frequently available separate from the surgical system and may be als
through the release of modified versions) during the life of the surgical system.

Frame-guided stereotactic system software designed to operate computer-aided radiosurgery systems


their functions. This software is usually intended to work only with one or a few models of frame-guide
systems, usually supplied by the same manufacturer. The software performs a variety of algorithms to
appropriate performance of the system during the surgical procedure and to facilitate the sending/rec
from and to a workstation and/or imaging and information systems. Radiosurgical frame-guided surgi
software is frequently available separate from the surgical system and may be also updated (i.e., thro
modified versions) during the life of the surgical system. Dedicated software for cobalt systems using
gamma knife) and linear accelerators is also available.
Frame-guided radiosurgical stereotactic system software designed to operate computer-aided gamma
control/monitor their functions. This software is usually intended to work only with one or a few model
gamma radiosurgical (e.g., gamma knife) systems, usually supplied by the same manufacturer. The so
variety of algorithms to make possible the appropriate performance of the system during the surgical
facilitate the sending/receiving of patient data from and to a workstation and/or imaging and informat
Radiosurgical frame-guided surgical stereotactic system software is frequently available separate from
and may be also updated (i.e., through the release of modified versions) during the life of the surgical

Frame-guided radiosurgical stereotactic system software designed to operate computer-aided linear a


control/monitor their functions. This software is usually intended to work only with one or a few model
linear accelerator radiosurgical systems, usually supplied by the same manufacturer. The software ma
algorithms to make possible the appropriate performance of the system during the surgical procedure
sending/receiving of patient data from and to a workstation and/or imaging and information systems.
frame-guided radiosurgical stereotactic system software is frequently available separate from the surg
be also updated (i.e., through the release of modified versions) during the lifetime of the surgical syst

Automation system software designed to control a system that performs a specialized surgical proced
pre-established program with minimal human intervention, through a user interface, or a combination
operating room automation system).This software usually interacts with hardware needed to perform
such as a user interface, surgical and ancillary devices, and video systems that share the same inform
Operating room automation system software is intended to work only with one or a few models of aut
related devices, usually supplied by the same manufacturer and/or configured according particular he
requirements. The system may also facilitate the processing and/or sending of data from the automat
picture archiving and communication systems (PACS) and/or other hospital information systems. The s
available separate from the digitization system but may be updated (i.e., through the release of modifi
the life of the equipment. Operating room automation system software is intended to improve the erg
efficiency of surgical procedures, particularly during minimally invasive surgery; software intended for
surgical procedures is available.

Molecular assay reagents intended to identify mutations in the cytochrome P450, family 2, subfamily
(CYP2C9) gene, located at chromosome 10q24, which encodes a member of the cytochrome P450 sup
P450 cytochrome is involved in the processing of ingested drugs and synthesizing of cholesterol, stero
lipids. Mutations at this locus have been identified in patients who have a slower rate of warfarin meta
of the patient's CYP2C9 genotype may guide the choice of the initial warfarin dose, potentially reducin
before the standard method of measuring the extrinsic pathway of coagulation (i.e., prothrombin time
international normalized ratio [INR]) stabilizes.

Molecular assay reagents intended to identify mutations in the vitamin K epoxide reductase complex,
located at chromosome 16p11.2, which encodes the enzyme that is responsible for reducing vitamin K
enzymatically activated form. Fatal bleeding can be caused by vitamin K deficiency and by the vitamin
and it is the product of this gene that is sensitive to warfarin. Mutations at this locus, such as the pres
AA genotype, can be associated with a high sensitivity to the effects of warfarin; on the contrary, the
genotype usually is associated with a high resistance to the effects of warfarin.
Molecular assay reagents intended to determine the level at which certain genes are expressed (i.e., t
tissue sample. The tissue sample is analyzed to determine the presence or levels of nucleic acids, pro
molecular products by one or more of a variety of methods, such as reverse transcription-polymerase
PCR), fluorescent in-situ hybridization (FISH), or microarray analysis. The overexpression or underexpr
may be associated with the likelihood of certain patient outcomes. Gene expression tests are frequent
appropriate (e.g., drug-specific) treatment, identify the tissue of origin for tumors with unclear patholo
more precise estimate of the risk of disease recurrence.

Gene expression molecular assay reagents intended to determine the level at which certain genes are
gene activity) in a cancer tumor tissue. The tissue sample is analyzed to determine the presence or le
proteins, and/or other molecular products by one or more of a variety of methods, such as reverse tra
chain reaction (RT-PCR), fluorescent in-situ hybridization (FISH), or microarray analysis. The overexpre
underexpression of these genes may be associated with the likelihood of certain cancer patient outcom
gene expression tests are frequently used to obtain a more precise estimate of the risk of disease recu
may be used to determine appropriate (e.g., drug-specific) treatment and/or to identify the tissue of o
unclear pathology. Some tests give a recurrence score that predicts the chance of the cancer returning
(e.g., 10 years) of the original diagnosis.

Cancer recurrence gene expression molecular assay reagents intended to determine the level at whic
expressed (i.e., the gene activity) in a breast cancer tumor tissue sample. The tissue sample is analyz
presence or levels of nucleic acids, proteins, and/or other molecular products by one or more of a vari
as reverse transcription-polymerase chain reaction (RT-PCR), fluorescent in-situ hybridization (FISH), o
The overexpression or underexpression of these genes may be associated with the likelihood of breas
Breast cancer recurrence expression analysis tests also may be used to determine appropriate (e.g., d
and/or identify the tissue of origin for tumors with unclear pathology. Some tests give a recurrence sco
chance of the cancer returning within a given period (e.g., 10 years) of the original diagnosis.

Cancer recurrence gene expression molecular assays reagents intended to determine the level at whi
expressed (i.e., the gene activity) in a colon cancer tumor tissue sample. The tissue sample is analyze
presence or levels of nucleic acids, proteins, and/or other molecular products by one or more of a vari
as reverse transcription-polymerase chain reaction (RT-PCR), fluorescent in-situ hybridization (FISH), o
The overexpression or underexpression of these genes may be associated with the likelihood of colon
Colon cancer recurrence expression analysis also may be used to determine appropriate (e.g., drug-sp
and/or identify the tissue of origin for tumors with unclear pathology. Some tests give a recurrence sco
chance of the cancer returning within a given period (e.g., 10 years) of the original diagnosis.
Surgical hemostatic agents that are designed for intraoperative control of organ and/or tissue bleedin
during surgical procedures and are absorbed by the body. These agents may consist of adhesive produ
sealants) that create a mechanical porous barrier to decrease blood flow; some blood is allowed to pe
cellular aggregation and hemostasis. Some absorbable hemostatic agents are supplied as a two-comp
combines to form foam when applied; two-component absorbable synthetic products (absorbable synt
also available. Absorbable surgical hemostatic agents are intended mainly to facilitate permanent ble
(frequently the liver and/or spleen) and/or tissues. They are designed to facilitate recovery after surge
additional surgical procedures. They may be also used in some emergency situations (e.g., to stop hem
wounds.

Systems designed to restore blood flow to arteries and veins occluded with a stationary blood clot (i.e
lodged in the vasculature (i.e., embolus) using hydrodynamic technology. These systems typically con
(console) usually mounted on a cart that includes a pump to deliver the liquid (e.g., saline solution) at
detachable intravascular catheter; controls for the volume and flow of the infused solution; and a mon
performance of the system (e.g., run time, liquid volume and speed) and the type of catheter used. A
dedicated (e.g., coronary, peripheral) catheters may be used with the console; the catheters usually a
devices that inject a high-velocity liquid (e.g., saline solution) jet near their distal tip, creating a hydro
consequence of the pressure reduction (Venturi effect), thrombus and/or embolus is sucked, fragment
typically into a collection bag. Intravascular embolectomy/thrombectomy hydrodynamic systems are i
normal flow of blood and to permit better visualization of the disease area, reducing the risk of further
systems are mainly used in procedures performed in catheterization laboratories.

Temporary ophthalmic implants designed to stretch and dilate the pupil. These flexible implants are o
approximately 5-7 mm in diameter. Surgeons can insert the rings manually or with a plunger inserter
rings are intended to keep the pupil widened during phacoemulsification (a form of cataract surgery).

Ophthalmic implants designed to stretch and support the eye's capsular bag. These flexible implants a
rings approximately 10-13 mm in diameter. The rings expand slightly once they are implanted. Surgeo
manually or with a plunger inserter system. Capsular rings are intended to stabilize intraocular lens im
posterior chamber opacification during and/or after cataract surgery.

Hand-held syringe-type inserters with a plunger and a hook used for loading and inserting ophthalmic
Depressing the plunger releases a hook on the other end of the syringe. The hook attaches to a small
implant and then the plunger is released which pulls the implant into the barrel of the inserter. When
to the eye and the plunger is depressed, the ring implant is slowly released into the eye and can be ad
position. Both reusable and single-use inserters are available and some single-use inserters are availa
pre-loaded.
Artificial airways designed for insertion through the mouth into the pharynx, producing a peri-pharyng
permitting the passage of oxygen to the lungs. These airways typically consist of a hollow, large-diam
tube with a protruding rim (flange) at the proximal end and a mask with an inflatable cuff at the distal
mask is introduced through the mouth into the pharynx with the cuff deflated until it sits in the pharyn
inflated, producing a tight seal. Some devices can provide both pharyngeal and tongue sealing, but th
protect the lungs from aspiration of regurgitated materials. Laryngeal mask artificial airways, both reu
are available in several sizes to accommodate the patient's anatomic characteristics. They are intend
of anesthesia during minor surgical procedures; the masks are also used for spontaneous and/or mech
especially in emergency situations when endotracheal intubation is unsuccessful.

Cuffs designed to apply localized external pressure (i.e., compression) on a limb artery (e.g., femoral,
hemostasis. These devices typically consist of a soft fabric and/or plastic disposable cuff with an inner
button) that is applied on the skin over the artery; the cuffs may include a manual mechanism for pre
compression vascular closure cuffs are intended to promote hemostasis faster and/or easier than is po
application only of manual pressure; they are used mainly after catheterization procedures performed
radial vasculature.

Measuring instruments designed to measure electric resistance, a measure of a substance opposition


charges when a voltage is applied. This parameter is frequently represented by an uppercase omega a
in ohms. Resistance meters (ohmmeters) may consist of electromechanical or electronic instruments w
Practical instruments may measure in ohm, fractions of ohm (e.g., milliohm) or multiples of ohm (kilo-
frequently called megohmmeters). Dedicated resistance meters are used to measure solid material an
incorporated in testers used in the inspection and/or maintenance of medical devices and other health
equipment.

Measuring instruments designed to measure the electric impedance, a measure of a substance oppos
alternating current at a given frequency when a voltage is applied. This parameter is a complex quant
vector in a plane, abbreviated as an upper case Z and measured in ohms. Impedance meters typically
instruments with appropriate leads and a display; practical instruments may display the impedance as
components of a rectangular-coordinate system with a real part (i.e., the resistance R) and an "imagin
reactance), or in polar form as a magnitude |Z| and phase angle. Dedicated impedance meters are use
material and/or liquids; some are incorporated in testers used in the inspection and/or maintenance o
other healthcare facility equipment. Some instruments are also capable of direct measurement of the
inverse of impedance and its components conductance (G) and susceptance (B).

Measuring instruments designed to measure the flow of electric current (either direct or alternating, D
or both) along a conductor of an electric or electronic circuit, usually expressed in amperes. These ins
consist of electromechanical (analog) or more frequently electronic (usually digital) instruments with a
Practical instruments can perform the most common current measurements needed for electric and e
circuits, and components. Ammeters are mainly used in healthcare facilities in inspection, preventive
and calibration of medical devices and other hospital equipment.
Voltmeters designed to measure voltage (i.e., alternating, AC, and/or direct current, DC, electric poten
order of thousands of volts. These instruments typically consist of portable or handheld instruments th
voltage levels (from a few to hundreds of thousands volts) without physical contact with the measured
instruments should be physically connected to the measured equipment using a resistive voltage divid
usually includes an integral or attached display to show the results of voltage measurements. Kilovolt
for testing radiographic and fluoroscopic units and systems for quality assurance purposes; dedicated
to measure voltage in mammographic or dental units are also available. The instruments may be used
voltage power supplies and other high voltage equipment. Kilovoltmeters included in integrated units
during quality control of radiologic equipment that can also measure other values (e.g., time, exposur
available.

Measuring instruments designed to measure several electric variables and parameters, including, at le
(both direct and alternating current, DC and AC respectively), and resistance in several scales. Multim
of electromechanical (analog) or more frequently electronic (usually digital) instruments with appropri
instruments can perform the most common electric measurements performed on electric and electron
and components; some digital instruments include capabilities to test specific devices such as diodes,
and/or batteries. Multimeters are mainly used in healthcare facilities in inspection, preventive mainten
calibration of medical devices and other hospital equipment.

Pumps designed to inflate balloons attached to the distal tips of catheters with fluids (e.g., saline); the
measure the pressure of the fluid. These pumps are usually single-use devices that include a relatively
20 ml); a manual knob used to turn a screw-driven mechanism that advances the plunger of the syrin
rate; controls to select the volume and flow rate of the fluid to be infused; an extension tube to be pla
and the catheter; and a manometer with an appropriate scale (e.g., up to 30 atmosphere of pressure [
Manometric catheter balloon inflation pumps are used during catheterization procedures, frequently t
and they require an accurate measurement of the pressure during fluid delivery. Also available are ded
pumps intended for percutaneous transluminal coronary angioplasty balloon catheters and for cathete
dilatation of the Eustachian tube through a special micro nasoscope.

Measuring instruments designed to measure the height of people or their length when they cannot sta
These devices may consist of mechanical instruments (e.g., height rods including mounting hardware)
instruments that may include optical sensors and a separate display. Height/length measuring instrum
results in inches or metric values; mobile instruments (using wheels) and portable (typically foldable d
The instruments are used in doctors' offices, hospitals, and other healthcare facilities for routine evalu
height or length (typically infants and/or disabled people). Dedicated instruments used to measure th
(known as infantometers) and for accurate assessment of the progress of children's growth (known as
available; wall-mounted instruments are intended only to measure a person's height.

Height/length measuring instruments designed to be mounted on a wall. These instruments may cons
(either metric, inches, or both) wall-mounted rod that permits a direct mechanical measurement; som
instruments link the rod to a remote display that shows the person's height. Wall-mounted height mea
used in doctors' offices, hospitals, and other healthcare facilities for routine evaluation of a standing p
precision instruments intended to evaluate the growth of children and young adults (known as stadiom
available.
Height/length measuring instruments designed to be mounted on wheels permitting easy movement.
typically consist of a lockable telescopic graduated (either metric, inches, or both) rod that facilitates
measurement of the person's height or length when they cannot stand up by themselves (e.g., infants
measuring instruments are used in doctors' offices, hospitals, other healthcare facilities, and in the fie
evaluation of adults, children, and/or infants.

Height/length measuring instruments designed for easy manual carrying; the instrument typically ma
pieces to facilitate transportation. These instruments typically consist of a calibrated rod and a sliding
to a floor base; the base includes a handle that makes it easy to transport the whole set. Portable heig
instruments are mainly used in the field (e.g., rural areas, schools) for measuring and assessing of chi
growth (known as stadiometers).

Computer-aided detection systems designed to analyze digital information (typically images) from pat
cell and tissue abnormalities; they may either digitize the original information or use information prov
systems. These systems typically consist of a digitizer or a means to import digital information, a com
appropriate algorithms, and a display and/or printer to show the detected abnormalities. Pathology sli
detection systems are intended to facilitate the detection and classification of tissues during in vitro d
systems may include capabilities of archiving and/or communication of view and annotated digital ima
scanned slides. Dedicated systems for detection and analysis of tissue (pathology) slides (e.g., Pap sm
available.

Scanning systems designed to capture three-dimensional (3-D) in-vivo images of the topographical fe
combination of a focused point (i.e., confocal) laser and light scanning systems. These systems typica
handheld wand that is displaced along the dental arches to scan and capture images from the teeth, a
process the data and 3-D images, and a monitor that displays the video images in real time. The syste
record the digital data corresponding to the images as a digital dental impression using dedicated soft
impression is assessed, it is sent electronically to a dental laboratory for conventional prosthesis manu
computer-aided manufacturing milling machine for automated manufacturing of the model of an appr
digital information may be used also to manufacture orthodontic devices.

Organ preservation systems that provide oxygenated warm perfusion to the organ. These systems typ
mobile unit (e.g., a cart); a pulsatile pump that supplies blood to the organ; a perfusion chamber that
functioning; an oxygen and other gases supply module; a solution tubing set to supply organ-specific
organ functioning; a monitor for system functioning and organ assessment, and batteries. Warm perf
preservation systems are intended to keep organs viable for a longer time and in better conditions tha
perfusion; the batteries included in the system permit its use during transportation. The systems are u
(e.g., kidney, liver) viability for a period of time (a few hours) in a healthcare facility while waiting for
procedure and/or for transportation of organs between facilities (e.g., from the donor place to the reci
Electrosurgical units (ESUs) designed with monopolar and bipolar capabilities that can also provide co
energy and physical pressure to perform autologous tissue fusion. These units consist of a central unit
houses a radiofrequency (RF) generator that delivers the RF power to the tissues through appropriate
permitting its operation as a conventional monopolar/bipolar electrosurgical unit. In addition, these ES
system that senses and accurately controls the delivery of energy to the tissues simultaneously with t
pressure when performing tissue fusion (i.e., sealing). A variety of dedicated detachable tools is availa
electrodes that also apply the required physical pressure. The fusion mechanism is mainly used to fus
based on the formation of an autologous seal (i.e., sutureless) in the vessel walls by melting the collag
fusion is usually possible for vessels up to 7.5 mm (0.3 inch) diameter. The seal obtained in the proced
similar bursting strength (i.e., the pressure required to rupture the vessel) as a sutured seal. The unit
lymphatic vessels and some tissue bundles. Electrosurgical units with tissue fusion capabilities are int
surgery and laparoscopic procedures. They may also be used for hemostasis in difficult procedures su
on the infant and child vasculature and in sutureless surgery for hemorrhoids (i.e., hemorrhoidectomy
a variety of specialties (e.g., ophthalmology, dermatology, otolaryngology, gastroenterology, urology)

Casework designed for use in dental offices. This furniture typically includes cabinets and shelves app
and easy availability of small devices (e.g., forceps, handpieces), small instruments, utensils, and med
procedures; some casework includes sinks and other special cabinets for particular procedures (e.g., d
casework is used in dental operation rooms and dentists' and/or orthodontists' offices.

Casework designed for use in examination rooms. This furniture usually includes sturdy wall cabinets;
furniture may also include other stand-alone cabinets with dedicated sinks and faucets. Examination r
of hard plastic and/or metallic materials with an appropriate finish for ease of cleaning and sanitation.

Casework designed for use in healthcare facility kitchens. This casework usually includes cabinets, cou
the components are configured to provide adequate storage capacity and appropriate space for locati
appliances such as microwave ovens, refrigerators (either upright or under the counter), and dishwash
is used in hospitals, assisted living facilities, nursing homes, and other healthcare facilities.

Casework designed for use in surgical and/or special procedures rooms. This casework usually include
several cabinets, desks, and tables arranged to meet the needs of an operating and/or procedure room
warming units, sinks, and other special furniture. Most casework units are made of stainless steel, freq
doors to facilitate ease of cleaning and/or sterilization. Operating/procedure room casework is used in
homes, and other healthcare facilities in dedicated areas or rooms intended for surgical and/or some s
(e.g., catheterization).

Tubes designed to provide access to the small intestines (duodenum or jejunum) through the nose. Th
consist of a rubber or plastic tube that is inserted through the nose, down the throat, through the esop
lesser curvature of the stomach, through the pyloric sphincter, and into the duodenum. Nasoenteral tu
nasogastric tubes. Dedicated tubes used for decompression and/or enteral feeding are also available.
Esophageal tubes designed for treatment of sudden hemorrhage (i.e., tamponade) using balloons. The
consist of a multilumen rubber or polymeric flexible tube with two balloons, one asymmetric gastric ba
elongated esophageal balloon. Typically, the tube is passed through the nose or mouth into the stoma
gastric balloon is inflated, and then the tube is pulled back until the balloon meets the narrow valve a
stomach, where it can go no farther. The upper esophageal balloon is then inflated, putting pressure o
esophagus where the bleeding veins are located. Some tubes (Sengstaken-Blakemore tubes) include a
aspirate stomach contents to determine whether the bleeding has stopped; the tube may also include
aspiration (Minnesota tube). Balloon tamponade esophageal tubes are used for emergency control of
varices and to facilitate evaluation of the extent of the hemorrhage into the stomach.

Esophageal tubes designed to remove air and liquids from the esophagus (i.e., decompression) using
apparatus. These devices typically consist of a double-lumen radiopaque tube that may include an an
permitting continuous air flow while preventing contact with the gastric reflux; the tube usually includ
connector that can be cut to form a funnel. Esophageal suction tubes are used to eliminate fluids and/
the esophagus secretions (e.g., from the proximal portion of an atretic esophagus); they are frequentl
upper pouch of the esophagus during treatment of congenital esophagus atresia in newborns.

Esophageal decompression tubes designed for continuous suction and irrigation through a blind endin
devices typically consist of a radiopaque double-lumen tube (e.g., Replogle tube); one lumen (typicall
diameter) is used for suction and instillation of liquids; the other lumen is used for venting and should
periodically. The proximal end of the tube is usually connected to an intermittent suction device. Infan
decompression tubes are used mainly for babies with esophageal or gastric problems (e.g., esophagea
before surgical procedures.

Nasogastric tubes designed to access the stomach for temporary enteral feeding. These devices typic
diameter (e.g., 8 to 12 French diameter) very soft (e.g., polyurethane, silicone) single-lumen plastic tu
as Dobhoff tubes) of appropriate length to reach the stomach; the tubes may be attached or not to su
nasogastric tubes are used mainly in patients who need only enteral feeding and not gastric aspiration
consequences (e.g., rhinitis, pharyngitis, esophageal strictures) related to the use of larger-diameter t

Nasoenteral tubes designed for use with an external suction apparatus (e.g., a three-bottle system) to
(i.e., decompression) from the stomach and duodenum. These devices typically consist of a clear plas
through the nose, down the throat, through the esophagus and stomach, and into the duodenum. Dec
nasoenteral tubes are used to remove air and liquids from the stomach, frequently after surgical proce
emergency procedures.

Nasoenteral tubes with weighted distal ends that are designed to provide decompression to the small
devices typically consist of a multiple-lumen, radiopaque rubber or plastic tube appropriate for inserti
with an inflatable balloon at the distal tip filled with water, saline, and/or tungsten gel (e.g., Andersen
peristalsis in propelling the catheter farther into the gastrointestinal tract; the tubes usually have seve
and/or suction drainage. Weighted nasoenteral decompression tubes are used to aspirate liquid and g
the stomach and small bowels (e.g., duodenum, jejunum), as an aid in the diagnosis and location of in
as in the treatment of intestinal obstructions. The use of tungsten gel rather than mercury avoids haza
the use of mercury-weighted (e.g., Cantor, Kaslow, Miller-Abbott) tubes.
Gastrostomy tubes designed for surgical insertion of the distal tip into the stomach for direct enteral f
may be placed surgically (e.g., open surgery, laparotomy) or by using a percutaneous endoscopic proc
usually secured by a soft balloon or bumper on the inside and a firm plastic device on the outside. Gas
tubes are mostly used for feeding patients who require medium- or long-term enteral feeding but who
sufficient oral intake (e.g., patients who have severe neurologic impairment; those with tumors of the
esophagus; and infants who require enteral nutrition). Gastrostomy tubes may be used to administer
tubes for insertion using open surgery or endoscopic procedures are available. Gastrostomy tubes wit
advanced into the jejunum for jejunal feeding are also available.

Gastrostomy tubes designed for surgical insertion of the distal tip into the stomach for direct enteral f
surgery procedures (known as Stamm gastrostomy). These devices typically consist of a single-lumen
plastic tube with a Malecot or mushroom-like tip that is placed in the stomach; some thread or suture
around the tube and then stitched to the skin around the gastrostomy to keep it in place. Open surger
tubes are used for short- or medium-term (up to two to four weeks) use; they may be replaced by ano
(e.g., a balloon, Foley-type catheter, or a low-profile device known as a gastrostomy button) for long-t

Gastrostomy tubes designed for simultaneous decompression of the stomach and the proximal duode
distal duodenum; the tubes may be placed using open surgery or a percutaneous endoscopic procedu
typically consist of a triple-lumen tube, x-ray tip, and a gastric balloon. The tip is manipulated through
the distal duodenum; then the gastric balloon is inflated with sterile water and secured in position by
against the skin. The suction lumen provides aspiration through holes at the proximal duodenum, whil
delivers enteral food several centimeters (a few inches) into the distal duodenum. Duodenal decompr
gastrostomy tubes are used in patients who need continuous decompression of the stomach (e.g., afte
malignancies) and/or enteral feeding.

Jejunostomy tubes designed for insertion of the distal tip into the jejunum using open surgery procedu
typically consist of a single-lumen clear, brown rubber or plastic tube with a Malecot or mushroom-like
the jejunum; some thread or suture material is wrapped around the tube and then stitched to the skin
jejunostomy opening to keep it in place. Open surgery jejunostomy tubes are used mainly for long-ter
who are at increased risk of complications related to surgery while preventing aspiration.

Tubes designed to access the colon through the rectum for irrigation purposes. These devices typically
lumen rubber or plastic (e.g., silicon) tube of 14 to 20 French diameter or larger, about 40 cm (15 inch
inserted through the anus and rectum into the colon; the proximal end is attached to an enema bag c
to be infused. Enema colonic tubes are used mainly for lavage, diagnostic, or therapeutic purposes; d
intended for antegrade colon irrigation (e.g., cecostomy tubes) are also available.
Colon tubes designed for percutaneous insertion through the abdominal wall into the colon (frequently
performing a surgical colostomy or cecostomy. These devices typically consist of a single-lumen plasti
that is inserted through the abdominal wall into the cecum, flushed with saline solution, and capped. T
a phosphate enema solution that is passed through the tube into the colon followed by a saline solutio
enema) is performed three to four times a week. The initial tube is usually substituted about two mon
by a lower-profile cecostomy tube that sits on the surface of the skin; the new tube is hooked up to ba
solution during the periodic irrigations. Cecostomy/colostomy tubes are used mainly for treatment of c
impaired by spina bifida, imperforate anus, or a spinal cord injury.

Rectum tubes designed to deliver water and sterile or therapeutic solutions (i.e., enemas) into the rec
typically consist of a single-lumen rubber or plastic (e.g., silicon) tube of 14 to 30 French diameter, ab
long that is inserted through the anus into the rectum. Enema rectum tubes are connected to an enem
external tubing that runs from an external reservoir (i.e., enema bag) using gravity; dedicated enema
delivery are also available.

Rectum tubes designed to deliver an injection of barium (i.e., enema) into the rectum, covering the lin
colon. These devices typically consist of a single-lumen rubber or plastic (e.g., silicon) tube of 14 to 30
about 10 cm (4 inches) long, with a small balloon at the end that is inflated to keep the barium inside;
the anus into the rectum. Barium enema rectum tubes are used to enhance the x-ray images before a
procedure of the lower intestines is performed, typically to facilitate the location of abnormal growths
and/or diverticula.

Adhesive tapes made of nonwoven plastic films with both sides covered with an adhesive (e.g., polym
usually consist of long and narrow hypoallergenic (latex-free) plastic (e.g., polyethylene, PVC) strips w
temperature sensitive adhesives on both sides. The adhesive applied to the drape side is soluble duri
drape reuse; the adhesive applied to the patient skin is usually not soluble in water. Doubled-sided ad
tapes are usually supplied in rolls; the tapes are mainly intended to attach reusable drapes to the pati

Blades designed for use as the cutting component of a manual hair clipper, either for grooming or as a
preparation before a surgical procedure. These blades typically consist of a very thin flat piece of meta
with one or both sharp edges; they may be intended either for reuse or single-use.
Blades designed for use as the cutting component of a manually operated rotatory electric hair clippe
or as a part of skin preparation before a surgical procedure. These blades typically consist of a flat pie
stainless steel) with circular section and a sharp edge; they are usually intended for multiple use.

Blades designed as the cutting component of powered (electric or pneumatic) surgical instruments int
skin graft harvesting (i.e., dermatomes). These blades typically consist of a flat piece of metal (e.g., st
sharp edge that can cut large skin grafts with uniform-thickness by performing a rapidly oscillating sid
the dermatome is manually advanced over the skin. Dedicated blades are available according to the p
characteristics of the dermatomes (e.g., Castroviejo, Brown). Dermatomes are mainly used to obtain s
sites, but they are sometimes used in other procedures (e.g., to remove tattoos).

Blades designed for use as the cutting component of a manually operated rotatory electric or pneuma
materials, objects, or anatomic structures. These blades typically consist of a flat piece of metal (e.g.,
circular section and a sharp edge; they may be intended either for single or multiple use. Dedicated b
electric/pneumatic saws used to cut tissues and/or bones during surgical procedures and also to cut p
patient's body.
Saw blades designed for use as the cutting component of a manually operated reciprocating electric o
to cut materials, objects, or anatomic structures. These devices typically consist of a detachable, tooth
flat blade that is attached to a saw that includes a mechanism that generates a back and forth (i.e., re
Reciprocating electric/pneumatic blades are mainly used in orthopedic surgery (e.g., to cut bones); de
available for saws intended for cutting cast.

Saw blades designed for use as the cutting component of a manually operated reciprocating electric o
to cut plaster casts. These devices typically consist of a detachable, toothed, straight or curved flat bl
a saw that includes a mechanism that generates a back and forth (i.e., reciprocating) motion. Reciproc
electric/pneumatic cast blades are used in dedicated manual, handheld electric or pneumatic saws in
(also known as cast cutters) while placed on the body of patients.

Stations designed for treatment of immunohistochemistry specimen slides obtained from tissue proce
These stations provide automated rinsing, deparaffinization, rehydration, and target (e.g., antigenic) r
computerized unit and associated processing tanks. The stations consist of a computerized unit that i
the solution's (e.g., buffer) temperature and running time of the process. The unit may also include de
intended to manage (i.e., run) the process and also to provide electronic reports on the process and a
options. The process is performed in associated (e.g., rinsing) tanks where slide racks are totally or pa
Immunohistochemistry pre-staining stations are intended to provide slide specimens that facilitate fur
consistency.

Gantry driving units designed for direct coupling of a gantry and/or table of a radiographic, imaging, o
which is capable of movements in more than a single axis (i.e., multi-axes) to the driving motors used
These devices usually consist of a mechanism that couples the driving motors to the gantry; the mech
includes integral electronic controls to regulate the speed and direction of the movement of the gantr
axes. Multi-axes direct coupling driving units are intended to improve the characteristics of the gantry
permitting faster acceleration/deceleration and increasing the speed of operation). Dedicated driving
movements (i.e., two or three axes, XY and XYZ respectively) at various speeds and/or resolutions are

Systems designed for use in crossing through chronic total occlusions (CTO) in the vasculature (usuall
high-frequency mechanical vibrations. These systems typically consist of a high-frequency generator (
ultrasound transducers to produce mechanical vibration from the electrical power, a sterile powered in
(e.g., saline) of the catheter, and a single-use switch-activated catheter with a core wire that transmit
tip of the catheter. Also available are vascular occlusion crossing systems typically including dedicated
to the intended use (e.g., coronary or peripheral arteries). The systems are used to facilitate guidewire
CTO, permitting subsequent angioplasty procedures and/or stent placement; they are typically mount
pole.

Vascular catheters designed for use in crossing through chronic total occlusions (CTO) in the periphera
frequency mechanical vibrations. These devices are catheters with appropriate dimensions (i.e., diam
use in the peripheral arteries; they typically include a core wire that transmits the mechanical vibratio
catheter and also have irrigation capabilities. Peripheral artery occlusion crossing vascular catheters a
facilitate guidewire passage across the CTO, permitting subsequent angioplasty procedures and/or ste
Saw blades designed for use as the cutting component of a manually operated oscillating electric or p
cut materials, objects, or anatomic structures. These devices typically consist of a detachable, toothed
semicircular flat blade that is attached to a saw that includes a mechanism that oscillates at a very hi
to the axis of the machine without full rotation. Oscillating electric/pneumatic blades are mainly used
(e.g., to cut bones) and postmortem procedures; dedicated blades are also available for saws used for

Saw blades designed for use as the cutting component of a manually operated oscillating electric or p
cut plaster casts. These devices typically consist of a detachable, toothed, circular or semicircular flat
edge. It is attached to a saw that includes a mechanism that oscillates at a very high speed perpendic
machine without full rotation. Oscillating electric/pneumatic cast blades are used in dedicated manual
pneumatic saws intended to cut cast (also known as cast cutters) while placed on the body of patient

Blades designed for use as the cutting component of a surgical scalpel that combines a detachable bla
handle. These blades typically consist of a flat piece of metal (e.g., stainless steel), diamond, or ceram
sharp edges; the shape and size of the blade is determined by the procedure to be performed and the
handle. Surgical scalpel blades are usually intended for disposal (i.e., single-use) or, less frequently, fo
used for cutting tissues and other anatomic structures during surgical (e.g., middle ear, oral, ophthalm
Dedicated blades intended for use with microsurgical handles are also available.

Saw blades designed for use as the cutting component of a manually operated usually handheld saw u
objects, or anatomic structures. These devices typically consist of a detachable, toothed, flat blade th
that includes a mechanism that is typically a manually operated frame. Dedicated manual saw blades
orthopedic surgery to cut bone and other hard tissue, for amputation, to cut cast, and for use in postm

Blades designed for use as the cutting component of a microsurgical scalpel that combines a detacha
reusable handle. These blades typically consist of a flat piece of metal (e.g., stainless steel) with one o
the shape and size of the blade is determined by the procedure to be performed and the particular ins
Microsurgical scalpel blades are usually intended for disposal (i.e., single-use) or, less frequently, for r
used for cutting tissues and other anatomic structures during microsurgical (e.g., middle ear, neurosu
procedures.

Saw blades designed for use as the cutting component of a manually operated sagittal electric or pne
materials, objects, or anatomic structures. These devices typically consist of a detachable, toothed, fla
attached to a saw that includes a mechanism that oscillates at a very high speed in the same or a par
of the machine without full rotation. Dedicated sagittal electric/pneumatic blades are available to cut
tissue during orthopedic surgery.

Saw blades designed for use as the cutting component of a manually operated rotatory electric or pne
materials, objects, or anatomic structures. These devices typically consist of a circular section that is a
flat blade and is attached to a saw that includes a mechanism that rotates at a controllable, variable s
rotatory electric/pneumatic blades are available for use in laboratory and postmortem procedures.

Blades designed for use as the cutting component of a handheld, manually operated razor. These blad
a very thin flat piece of metal (e.g., stainless steel) with one or both sharp edges; they may be intend
single-use. Manual razor blades are intended for shaving, either for grooming or as a part of skin prep
surgical procedure.
Blades designed for use as the cutting component of a handheld, electrically operated rotatory razor.
consist of a flat piece of metal (e.g., stainless steel) with circular section and a sharp edge; they are u
multiple use. Electric razor blades are intended for shaving, either for grooming or as a part of the skin
surgical procedure.
Devices designed to remove hair from the surface of the skin. These devices are handheld and operat
electrically. Manually operated handheld reusable and disposable razors with a flat blade are available
operated handheld razors. Electrically operated razors may include several (e.g., three) rotatory blade
grooming and may be used for skin preparation before some surgical procedures; dedicated razors int
preparation before surgery are also available.

Molecular assay reagents designed for use in processing high-molecular-weight nucleotide polymers (
most common of which are DNA and RNA. These reagents are intended to perform one of many proce
These processes may include purification, replication, or amplification (i.e., increasing copy number th
using polymerase chain reaction), or sequencing (i.e., determining the order of the nucleic acid compo

Blades attached to a manually operated rotary mechanical, electric, or pneumatically powered handpi
cut and remove circular sections of anatomic tissues. These devices typically consist of hollow cylindr
circular saw-like working edge a shaft, and a proximal end appropriate for connection to the rotary han
intended either for single or multiple use. Dedicated blades are available for electric/pneumatic trephi
tissues (e.g., ophthalmic) and/or bones during dental, biopsy, or surgical procedures.

Trephine blades designed to cut and remove circular sections of anatomic tissues for histological exam
These devices typically consist of a hollow cylindrical blade having circular saw-like edges, a shaft, an
appropriate for connection to the rotary handpiece. The biopsy sample occupies the hollow center of t
it can be removed after trephine extraction. Dedicated trephine biopsy blades, both reusable and sing
for skin biopsy (either standard or excision biopsy), bone biopsy, and intraosseous biopsy (e.g., bone m

Trephine blades designed to cut and remove circular sections of tissues during surgical procedures. Th
consist of hollow cylindrical blades in a variety of diameters having circular saw-like edges, a shaft, an
appropriate for connection to a common rotary handpiece. Dedicated trephine blades are available for
such as skull and eye surgery and also for bone harvesting.
Trephine blades designed to cut and remove circular sections of eye tissues during surgical procedure
typically consist of hollow cylindrical blades in a variety of diameters having circular saw-like edges, a
end appropriate for connection to a common rotary handpiece. Dedicated eye surgery trephine blades
several ophthalmic procedures, including corneal and scleral implantation and chalazion treatment.

Trephine blades designed to cut and remove circular sections of skull tissue during surgical procedure
usually includes two hollow cylindrical blades; the external cutting blade has a circular-saw-like workin
internal blade at the center is used for guiding purposes. Some trephines have detachable blades and
(i.e., a hand brace) or power (e.g., electrical) rotary handpiece. Skull surgery trephine blades are used
the cranium for insertion of catheters and/or encephaloscopes for diagnosis or treatment purposes.
Electric and/or pneumatic trephine blades designed to cut and remove circular sections of tissue durin
These devices typically consist of a hollow cylindrical blade having a circular saw-like edge, a shaft, an
appropriate for connection to a low-speed rotary dental handpiece. Dedicated dental trephine blades a
facilitate the retrieval of broken files and silver points from root canals, for artificial tooth root implant
failed implant removal. Manual dental trephines that include a blade as an integral part are also availa
used.

Molecular assay reagents designed for nucleic acid (e.g., DNA, RNA) replication, usually from samples
fluid specimens, following a temperature controlled repetitive process (thermal cycle) that multiplies t
in each cycle. The reagents are commonly used in a process known as polymerase chain reaction, whi
vial containing template or target nucleic acid (i.e., the DNA or RNA to be copied), short (i.e., 15 to 5
acid primers that specify the boundaries of the amplified nucleic acid(s), a salt buffer, and a thermost
Reagents for thermal cycle nucleic acid replication are used in clinical laboratories to generate large a
from a previously purified nucleic acid sample, which is usually used for subsequent diagnostic or rese

Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
germicidal gas. These units usually include a treatment chamber with shelves on which the devices to
placed, usually after being cleaned of gross debris and packed in gas permeable wraps; means to intr
chamber; and controls to choose one of the sterilization cycles. After the sterilization cycle is complete
to eliminate the gas residues is usually activated. Gas sterilizing units are available in a variety of sha
as both stand-alone and tabletop units. The units are used to sterilize devices and supplies that are se
temperature and humidity, such as those including plastic and rubber components. Dedicated gas ste
particular germicidal gas, such as chlorine dioxide or ethylene oxide, are also available.

Sterilizing units designed for total inactivation of microorganisms that are or may be present on medic
chlorine dioxide gas with low humidity content. These units usually include a treatment chamber with
devices to be sterilized are placed, usually after being cleaned of gross debris and packed in gas perm
introduce the gas into the chamber; and controls to choose one of the sterilization cycles. After the ste
complete an evacuation system to eliminate the gas residues is usually activated. Chlorine dioxide ga
available in a variety of shapes and sizes; usually as both stand-alone and tabletop units. The units ar
devices and supplies that are sensitive to high temperature and humidity, such as those including pla
components.
Sterilizing equipment that combines the simultaneous use of low-pressure, low-temperature steam an
one unit; the equipment is designed for total inactivation of microorganisms that are or may be presen
that are sensitive to high temperature. These equipment usually consist of a free-standing or tabletop
treatment chamber with shelves on which the devices to be sterilized are placed, usually after being c
and then packed; means to introduce the steam (either from an external boiler using a dedicated line
steam generator) and the formaldehyde gas into the chamber; and controls to regulate the time and/o
procedure. Frequently the time and temperature of the sterilizing cycles are pre-established according
be sterilized; the typical low-temperature sterilization cycles may operate at or below 60 or 80 degree
degrees Fahrenheit). After the sterilization cycle is complete, the steam and gas residues are exhauste
partial vacuum to facilitate the extraction. These sterilizing units are used mainly in hospital central su
and/or in other healthcare facility areas that perform a great deal of sterilization of heat-sensitive dev
with plastic and/or rubber components such as endoscopes and disposable syringes. Some equipment
capabilities for standard steam sterilization procedures at higher temperatures.

Sterilizing units designed for partial or total removal of microorganisms from liquids by filtration. Thes
consist of a unit that includes a cartridge with a porous membrane; filters whose pore size is about 0.4
in some applications, but porous sizes of 0.2 micron or even 0.1 micron may be needed for bacteria st
pores in the order of smaller than 10 nanometers are needed for virus filtration. The filtering characte
the adsorptive qualities of the filter material and the filtration conditions (e.g., pressure). Filtration ste
appropriate filters for particular solutions, microorganisms, and/or flow rates are available; the units a
clinical laboratories and pharmacies.

Blades designed as the cutting component of manual surgical instruments intended for mechanical sk
(i.e., manual, mechanical dermatomes). These blades typically consist of a flat piece of metal (e.g., st
sharp edge that can cut large skin grafts with uniform-thickness by moving a handheld frame with the
or, more frequently, by operating a drum with an oscillating blade that cuts the skin grafts as the drum
Manual dermatome blades are typically available as disposable (single-use) devices, but some are inte
sterilization Dedicated blades are available according to the particular characteristics of the dermatom
used to obtain skin grafts from donor sites but they may be also used in other procedures (e.g., to rem

Blades designed for use as the cutting component of manual surgical instruments intended for the ex
(i.e., adenotomes). These blades typically consist of a flat piece of metal (e.g., stainless steel) with on
that are attached at the working end of an adenotome; they may be intended either for single or mult

Blades designed for use as the cutting component of laboratory microtomes that are used to cut very
samples, usually intended for histology examination. Microtome blades typically consist of a flat piece
diamond; they are typically reusable devices. These blades are usually intended for use in a particular
microtome.
Equipment designed to clean hearing aids using vacuum. This equipment typically consists of a portab
partial vacuum pressure and includes a vacuum drying (i.e., desiccator) chamber where the hearing a
hose with a probe that may be connected to several detachable tips at its distal end for external clean
components, controls to regulate the pressure inside the chamber, and filters. The units may also incl
measure the pressure inside the vacuum chamber and/or a set of tools (e.g., brushes, picks) to facilita
cleaning procedure. Vacuum hearing aid cleaning units are used for periodic cleaning, preventive main
repair of hearing aids and/or ear molds as an alternative to manual cleaning procedures.

Endoscopes designed to access, examine, diagnose, and/or treat the upper gastrointestinal (GI) tract
extension tube with a balloon attached at its distal tip (known as single-balloon GI endoscopes). These
consist of an endoscope with a video system including a CCD camera and a working channel appropri
insertion; the endoscope also includes a smaller diameter disposable sliding plastic (e.g., silicon) tube
attached at its distal tip that permits deep insertion of the endoscope to reach remote regions (deep i
small intestine (i.e., to work as an enteroscope). The balloon at the tip of the tube guides and stabilize
inflated through a special tube that runs along the endoscope to facilitate full positioning of the endos
the endoscope tip in the area of small intestine targeted for diagnosis or treatment. Single-balloon up
tract endoscopes may be used for visual examination, biopsy, retrieval of foreign objects, and treatme
entire upper tract (i.e., esophagus, stomach, and small intestine), but they are mainly intended for dia
of areas of the small intestine that are difficult to reach using conventional GI tract endoscopes. Perfor
procedures reaching the ileum through the anus and colon are also possible with the endoscope.

Gamma counters designed to detect and measure localized gamma radiation from human body tissue
procedures (i.e., intraoperative) after the ingestion or injection of a radiopharmaceutical tracer (i.e., ra
counters usually consist of a central, usually portable, unit that includes controls to adjust unit setting
the number of gamma photons detected (i.e., the events) in a short period of time simultaneously wit
indicator that shows the selected isotope, and a battery. The instrument also includes dedicated detac
radiation detection probes intended for particular areas of the body (e.g., neck, head, thorax). Probes
straight tips) that are intended to perform lymphatic mapping are also available. Intraoperative gamm
used to measure the quantity of radionuclides absorbed for particular tissues and organs during open
frequently, during laparoscopic procedures; the instruments may be used also in intra-surgical sentine
procedures.
Absorbable periodontal regeneration membrane implants are thin flexible sheets intended to facilitate
regeneration. They are implanted during periodontal surgeries such as guide bone regeneration (GBR
regeneration (GTR). These implants, available in various shapes and sizes, are usually small flexible sh
different layers and can be made from several different bioabsorbable materials including calcium sul
polylactate/polygalactide copolymers, and collagen. On one side of the implant is a barrier with either
spaced small openings. On the other side of the implant is a matrix with a woven or mesh-like appear
multiple large openings. The barrier side of the implant is placed toward the teeth and the matrix sid
gums. Gingival tissue grows faster than bone; by creating a space between the teeth and the gums, t
for bones to regrow and prevent the gums from filling up all the space. At the same time, the opening
gingival tissue to continue growing so permanent gaps between teeth and gums are not created. The
place after GBR, GTR, or other periodontal surgery, usually maintaining their structure for several mon
completely absorbed by the body within two years.

Systems designed to kill, remove, or render inert pathogenic microorganisms present in a closed envir
inanimate surfaces and objects located in that environment. These systems are intended to remove m
the environment (i.e., most viruses and bacteria, including mycobacteria) but not necessarily all micro
spores. There are several different technologies appropriate for use by the systems, including ultravio
dedicated lamps (e.g., mercury, xenon) and systems using hydrogen peroxide vapors as a chemical di
frequently used technologies (e.g., ozone gas) are also available. Environmental disinfection systems
term use (e.g., from several minutes to a few hours) in patient rooms, operating rooms, and other hea
areas.

Systems that use hydrogen peroxide vapor (H2O2) as a chemical disinfectant that are designed to kill
inert pathogenic microorganisms present in a closed environment and on hard inanimate surfaces and
environment (frequently limited to one room). These systems are intended to remove microorganisms
(i.e., most viruses and bacteria, including mycobacteria) and may reduce other microbial forms such a
utilize the formation of free radicals from H2O2 to kill the microorganisms; frequently the H2O2 vapor
condensation over all surfaces at ambient room temperature. The systems are usually automated and
capabilities that permit the operation and monitoring of the system from outside the processed room
nature of the vapor. Hydrogen peroxide vapor environmental disinfection systems are intended for sho
several minutes to a few hours) in patient rooms, operating rooms, and other healthcare facility closed
usually used after a terminal cleaning that is performed when a patient is transferred or discharged fro
Systems that use ultraviolet (UV) light designed to kill, remove, or render inert pathogenic microorgan
closed environment and on hard inanimate surfaces and objects located in that environment (frequen
room). These systems are intended to remove microorganisms from the environment (i.e., most viruse
including mycobacteria) and other microbial forms, including spores when using appropriate waveleng
spectrum. The UV radiation is obtained from dedicated (e.g., low-pressure mercury, pulsed-xenon) lam
in the UV-B and C ranges (e.g., from 200 to 320 nm wavelength); a fixed wavelength of 254 nm is freq
systems are usually automated and include computerized and remote monitoring capabilities. Some s
choosing one of several working cycles according to the room disinfection needs. UV environmental d
intended for short-term use (e.g., from several minutes to a few hours) in patient rooms, operating roo
healthcare facility closed areas; they are usually used after a terminal cleaning that is performed whe
transferred or discharged from a room.

Stereotactic computer-aided surgical systems designed to aid in the performance of minimally invasiv
combining medical imaging, dedicated computer software, and instrument tracking systems for guida
provide real-time, three-dimensional (3-D) positioning and orientation of instruments relative to the pa
video display during surgery without requiring the use of an endoscope. Image-guided stereotactic sy
way to global positions systems (GPS) applied to the human body. They provide medical images that s
instruments in real time during the procedure, and one or more imaging modalities, such as computed
and/or magnetic resonance imaging (MRI), may be used in the procedure. Dedicated image-guided ste
intended for particular procedures such as neurosurgery, cardiac mapping and ablation, mammograph
spinal, orthopedic, and laryngological surgery procedures are available. Image-guided systems intend
radiosurgical procedures from the exterior of the body are also available.

Image-guided stereotactic computer-aided surgical systems designed to aid in the performance of min
procedures by combining medical imaging, dedicated computer software, and surgical instrument trac
guidance. The systems provide surgeons with real-time, three-dimensional (3-D) positioning and orien
instruments relative to the patient's anatomy on a video display during the spinal surgery without the
One or more imaging modalities, such as computed tomography (CT) and/or magnetic resonance imag
used in the procedure. Spinal image-guided surgical systems are used in many procedures, including
fusion, pedicle screw placement, laminectomies and discectomies. Some systems include software ca
possible spinal trauma procedures.

Image-guided stereotactic computer-aided surgical systems designed to aid in the performance of min
orthopedic procedures by combining medical imaging, dedicated computer software, and surgical inst
systems for guidance. The systems provide surgeons with real-time, three-dimensional (3-D) positioni
surgical instruments relative to the patient's anatomy on a video display during the orthopedic surger
an endoscope. One or more imaging modalities, such as computed tomography (CT) and/or magnetic
(MRI), may be used in the procedure. Orthopedic image-guided stereotactic surgery systems are used
procedures, including total knee and hip arthroplasty, partial hip resurfacing, anterior cruciate ligamen
orthopedic oncology; some systems include software capabilities to make possible spinal trauma proc
Image-guided computer-aided surgical systems designed to aid in the performance a variety of minim
procedures by combining medical imaging, several dedicated computer software packages, and a surg
tracking systems for guidance. These systems provide surgeons with real-time, three-dimensional (3-D
orientation of surgical instruments relative to the patient's anatomy on a video display during surgery
endoscope. One or more imaging modalities, such as computed tomography (CT) and/or magnetic res
may be used in the procedure. Dedicated multipurpose image-guided systems intended for two or mo
cranial neurosurgery, orthopedics, spinal, otorhinolaryngology) are available. Dedicated software pack
needed for each of the specialties, including software intended for trauma surgery procedures.

Image-guided computer-aided stereotactic surgical systems designed to aid in the performance of sur
the exterior of the body using a single high dose of ionizing radiation. These systems typically combin
dedicated computer software, and a strong source of radiation. Image-guided radiosurgical systems w
global positioning systems (GPS) applied to the human body. The systems provide surgeons with real-
dimensional (3-D) positioning and orientation of the target and the radiation source relative to the pat
video display during the procedure. One or more imaging modalities, such as computed tomography (
resonance imaging (MRI), may be used in the procedure. Dedicated systems that use linear accelerato
for particular applications such as intracranial and spinal neurosurgery (e.g., brain, neck, and spinal tu
laryngological procedures, are available.

Stereotactic computer-aided surgical systems designed to aid in the performance of minimally invasiv
combining medical imaging, dedicated computer software, and a rigid frame (e.g., headframe, body fr
patient body for guidance. The systems provide three-dimensional (3-D) positioning and orientation of
patient's anatomy relative to the frame position during surgery without the use of an endoscope. Fram
systems typically provide medical images that show the location of the instruments relative to pre-ope
obtained from one or more imaging modalities such as computed tomography (CT) and/or magnetic re
(MRI). Dedicated frame-guided stereotactic systems intended for particular procedures such as intracr
other intracranial and spinal procedures are available as are frame-guided systems intended to facilita
procedures.

Frame-guided computer-aided stereotactic surgical systems designed to aid in the performance of rad
from the exterior of the body using a single high dose of ionizing radiation. These systems typically co
imaging, a rigid frame (e.g., a headframe) attached to the patient body for guidance, dedicated comp
strong source of radiation. Frame-guided stereotactic systems typically provide medical images that s
instruments relative to pre-operative images obtained from one or more imaging modalities such as c
(CT) and/or magnetic resonance imaging (MRI). Dedicated systems using either gamma radiation (e.g
linear accelerators intended for particular applications such as intracranial and spinal neurosurgery ar
Computer-aided stereotactic systems designed to aid in the performance of minimally invasive proced
navigation system that is not guided by images (i.e., imageless) but by registering and tracking appro
reference points (i.e., landmarks). Imageless systems provide real-time, three-dimensional (3-D) posit
of instruments relative to the patient's anatomy similar to the systems that use image-guiding. These
surgical guidance without the need for pre- or intra-operative image acquisition, though registration is
Navigation is achieved by selecting specific anatomical parts or bone-implanted tracker pins intra-ope
and using a reference pointer to create a reference frame for the computer model. Dedicated imagele
intended mainly to facilitate surgical procedures, but systems designed for other purposes (e.g., biops

Imageless computer-aided stereotactic systems designed to aid in the performance of minimally invas
procedures. These systems use a navigation system that is not guided by images (i.e., imageless) but
tracking appropriate anatomic reference points (i.e., landmarks). Imageless surgical systems provide s
time, three-dimensional (3-D) positioning and orientation of surgical instruments relative to the patien
similar to the systems that use image-guiding and these system provide surgical guidance without the
operative image acquisition, though registration is still necessary. Navigation is achieved by selecting
parts or bone-implanted tracker pins intra-operatively as landmarks and using a reference pointer to c
frame for the computer model. Dedicated imageless surgical systems intended for particular specialti
and procedures (e.g., total knee or hip replacement and hip resurfacing) are available; dedicated softw
imageless trauma procedures is also available.

Imageless stereotactic computer-aided surgical systems designed to aid in the performance of minima
procedures. These systems use a navigation system that is not guided by images (i.e., imageless) but
tracking appropriate anatomic reference points (i.e., landmarks). Orthopedic imageless systems provi
time, three-dimensional (3-D) positioning and orientation of surgical instruments relative to the patien
the systems that use image-guiding. These systems also provide surgical guidance without the need f
operative image acquisition, though registration is still necessary. Navigation is achieved by selecting
parts or bone-implanted tracker pins intra-operatively as landmarks and using a reference pointer to c
frame for the computer model. Orthopedic imageless stereotactic surgery systems are used in severa
including knee and hip arthroplasty; some systems include software capabilities to make possible ima
procedures.

Imageless stereotactic computer-aided surgical systems designed to aid in the performance of a varie
invasive surgical procedures using a navigation system that is not guided by images (i.e., imageless)
tracking appropriate anatomic reference points (i.e., landmarks). Multipurpose imageless systems pro
real-time, three-dimensional (3-D) positioning and orientation of surgical instruments relative to the p
are similar to the systems that use image-guiding. These systems also provide surgical guidance with
intra-operative image acquisition, though registration is still necessary. Navigation is achieved by sele
anatomical parts or bone-implanted tracker pins intra-operatively as landmarks and using a reference
reference frame for the computer model. Multipurpose imageless stereotactic systems may be used in
abdominal, and other applications.
Radiosurgical frame-guided stereotactic computer-aided surgical systems designed to aid in the perfo
procedures from the exterior of the body using a single high dose of ionizing radiation provided by line
linac). These systems typically combine medical imaging, a rigid frame (e.g., a headframe) attached t
guidance, dedicated computer software, and a dedicated linear accelerator with a movable gantry and
collimator. Standard linacs may also be adapted for limited radiosurgery applications. Frame-guided ra
stereotactic systems are mainly intended for use in neurosurgery (e.g., for brain, neck, and spinal tum
frequently for other intracranial malformations.

Simulators designed for dental procedure training. These simulators usually include a life-size model o
a full set of teeth and a tongue. Some of these models are made with plastic to look and feel like hum
made of metal structures. Most of these anatomic models include radio-opaque metal teeth and flexib
articulation. The anatomic models can be used to practice dental procedures using the same tools and
real patient. Most of these head models can be clamped to dental chairs and many can be also used t
facilitate the learning and/or improving practical skills needed for proper x-ray procedures before takin
actual patient. Anatomic models used in the simulators are often available in different sizes (e.g., child

Nucleic acid processors designed for the automated determination of the precise sequence of the bas
thymine, cytosine, and guanine for DNA) in a sample of nucleic acid using pyrosequencing technology
technology based on the principle of sequencing by synthesis which involves taking a single strand of
sequenced and then synthesizing its complementary strand enzymatically. These processors typically
computerized unit (i.e., the sequencing instrument) with a software that permits the analysis of result
appropriate reagents; and test kits appropriate for the determination performed (e.g., mutation, meth
samples are usually prepared in a dedicated vacuum station. Pyrogenic sequencing nucleic acid proce
for rapid assessment of sequences during genetic analysis (e.g., KRAS mutations, genotyping sequenc
epigenetics (e.g., methylation patterns), and microbiology applications.

Luminometers designed to measure organic contamination by quantifying adenosine triphosphate (AT


surface. These luminometers typically consist of a portable and handheld instrument, which includes a
photomultiplier detector to quantify ATP, a display to show the results, an internal battery, an electron
dedicated detachable disposable probes. After the probe is swabbed on a surface, the ATP present on
with a reagent (e.g., luciferase/luciferin) included in the probe; then light emitted according to the qua
measured by the luminometer. Some luminometers also include dedicated probes to assess ATP unde
such as wet environments or in water samples. Reports of results of the measured data (e.g., records,
assessed in a standard personal computer using dedicated software usually available with the instrum
luminometers are mainly used to determine the hygienic status by detecting organic residues on a su
frequently as part of Hazard Analysis and Critical Control Point (HACCP) programs.
Pools or tubs designed to be filled with water and used by pregnant women during labor and delivery.
designed to have enough room for a laboring woman to move around in and give birth. These pools a
mobile pools are either inflatable (made of vinyl or other soft plastics) or are molded hard plastic tubs
birthing pools made of molded hard plastics are also available. These birthing pools can sometimes b
facility's plumbing but most are filled from a separate water source (e.g., hose, faucet). Birthing pools
edges or side doors where health care personnel or others can easily access the laboring woman. Som
lowered and raised to make entering and exiting the pool easier. These pools are used in hospitals, bi
home.

Scanning systems designed to capture three dimensional (3D) in-vivo images of the topographical fea
combination of blue light emitting diodes (LEDs) and multiple lens optical systems. These systems ty
wand including an intraoral video camera that is displaced along the dental arches, delivering light an
from the teeth, a central unit that process the data and 3D images, and a monitor that displays the vi
time. The systems simultaneously record the digital data corresponding to the images as a digital den
dedicated software. Once the digital impression is assessed it is sent to a dental laboratory for conven
manufacturing or to a computer-aided manufacturing milling machine, either locally at the dentist's offi
laboratory, for automated manufacturing of the appropriate prosthesis.

Dental equipment designed for use in working dental materials into desired prostheses by performing
such as drilling and cutting. These machines usually consist of table-top or stand-alone equipment tha
assembly (also known as spindle) that includes a shaft, bearings and associated detachable drilling de
burs), and a support (e.g., a vise clamped to a table) for the piece that is being conformed. Unlike a co
machine which holds the piece under work stationary as the drill moves axially to penetrate the mate
also move the piece under work radially and/or laterally against the rotating spindle. Both the piece a
are precisely controlled (e.g., to less than 25 microns). Dental milling machines may be manually oper
automated, or digitally controlled (e.g., using computer-aided design/manufacturing [CAD/CAM]) meth
milling/drilling machines may be used to manufacture prostheses from a variety of materials (e.g., cer
many applications (e.g., partial prostheses, dentures); dedicated machines intended to manufacture d
computer-aided systems are also available.

Dental equipment designed for use in machining dental materials (e.g., ceramic blocks) into desired p
performing mechanical operations such as drilling and cutting using computer-aided design and manu
CAD/CAM) procedures. These machines usually consist of table-top or stand-alone equipment that inc
chamber with a rotating assembly (also known as spindle), associated detachable drilling devices (e.g
burs), and a holder for the piece (e.g., ceramic block) that is being machined. The spindle movements
controlled (e.g., to less than 25 microns). CAD/CAM dental milling/drilling machines are digitally contro
a local area network (LAN) from a computer that includes appropriate software. Dental milling/drilling
to manufacture prostheses for many different applications (e.g., partial prostheses, dentures) using di
digital scanning impression units; some machines are intended for use in both dentists' offices and/or
Computer-aided design and manufacturing (CAD/CAM) dental prosthesis system software designed to
obtain, process, and store digital dental topographic data and images (i.e., digital dental impressions)
directly or through a network to milling units for automated manufacturing and/or repair of the require
software may also control/monitor a limited number of the system functions. This software usually inte
used in the procedure, such as the optical scanning system and milling/drilling machines; it may also
algorithms to facilitate the operation and analysis of the data obtained from the unit used to obtain th
impression data. Computed dental CAD/CAM system software may be intended for the unit (e.g., digit
designs the dental impression, the dental milling machine, or both; the software is intended to work o
models of dental CAD/CAM systems and related devices usually supplied by the same manufacturer. S
may allow also the processing and/or sending data from the digitization system to and from hospital in
Dental image digitization system software is not usually available separately from the digitization syst
updated (i.e., through the release of modified versions) during the life of the equipment; it is used in d
dental laboratories.

Narrow paper strips or threads coated with a fluorescent dye or stain (e.g., fluorescein) used as a tool
syndrome. The strips (some of which are printed with a calibrated scale) are held up to the inside of t
specific amount of time to measure tear production.
Optical coherence tomography (OCT) laser scanning systems designed to obtain real-time images insi
(i.e., intravascular). These systems typically consist of a central computerized unit that provides a lase
includes a high-definition display showing the intravascular images, patient data management capabi
both data and image characteristics; and an intravascular fiberoptic catheter that uses OCT technolog
central unit. Intravascular OCT scanning systems are intended to assess complex lesions inside the va
coronary arteries), to facilitate internal measurement. These devices assess lesion length and size of
patients that are, or will be, candidates for intravascular procedures. Evaluation of coronary and perip
atherosclerotic plaque components is also possible using this technique.

Infusion pump system software designed for controlling and programming infusion systems and their
pumps and/or to reduce programming errors (i.e., dose error reduction systems, also known as DERS)
administration of medications. The software is intended to facilitate control and programming and to i
infusion procedures by warning users of incorrect medication orders, calculation errors, and misses in
software only works with only one or a few models of infusion pumps, usually from the same manufac
packages include automated programming and data logging. Some can perform a variety of algorithm
analysis of the information related to the drug to be administered by using drug dose libraries and sta
facility's medications, electrolytes, and other infusates. Control/programming software for infusion pum
includes interfaces to pharmacy, electronic documentation, and/or other hospital information systems
areas of healthcare facilities where the simultaneous use of several infusion pumps is frequent.
Equipment designed to provide mechanical vibrations to the whole body. This equipment typically con
powered floor platform (i.e., a vibration platform) with internal motors and a mechanism that provides
20-50 Hz) vibration (e.g., oscillating, pivotal) to the whole body while the person stands on the platfor
include a vertical handle for user support and controls for the frequency and intensity (i.e., amplitude)
some devices include pre-established and/or custom designed vibration programs. Whole body vibrati
intended to increase bone density, as well as prevent and/or stop the progression of osteoporosis and
fractures. These units may be also used for other physical therapy treatments after trauma.

External shock wave therapy (ESWT) systems designed for orthopedic procedures that are mainly inte
These systems typically consist of an electrically powered main unit that provides compressed-air (i.e.
to drive a projectile-like device located in a dedicated handpiece attached to the unit. The projectile in
applicator at the distal end of the handpiece which applies shockwaves directly to the body area affec
ESWT orthopedic systems are intended to trigger body actions such as inhibiting inflammatory mediat
defenses, and release of pain mediators. They may be used in a variety of orthopedic diseases (e.g., p
and/or irritation of ligaments and/or tendons).

Dental impression materials with elastomeric properties whose main component is rubber based. The
an accurate negative reproduction of a given area of the oral cavity. These dental impression material
catalyst (also known as accelerator) and inner substances or plasticizers to make a paste of a consiste
an impression tray until polymerization has taken place. Rubber-based dental impression materials wi
available. They are not adhesive; therefore, a tray adhesive is needed to prevent the impression from
tray. These dental impression materials are supplied in bulk, packages, and tubes. They are used in de
impressions of areas containing undercuts, especially for crowns, inlays, and removable and fixed part

Dental impression materials with elastomeric properties whose main component is vinyl polysiloxane.
make an accurate negative reproduction of a given area of the oral cavity. These dental impression m
base (silicone polymer), a catalyst (e.g., chloroplatinic acid) and a filler (silica). Vinyl polysiloxane (VPS
materials usually have excellent elastic recovery, minimal permanent deformation, and adequate tear
impression integrity and precision upon removal. These dental impression materials are available with
and/or several degrees of viscosity. They are usually supplied in cartridges with or without mixing tips
materials are used in dental offices for immediate denture and reline impression procedures and for m
bridge, and denture impressions.

Dental impression materials with elastomeric properties whose main components are vinyl polysiloxan
are designed to make an accurate negative reproduction of a given area of the oral cavity. These dent
bring together the benefits of polyether and vinyl polysiloxane (VPS) in one material. VPS-polyether de
materials are available with a fast setting time and/or several degrees of viscosity. They are usually su
with or without mixing tips. These dental impression materials are used in dental offices.
Dental impression materials with rigid and inelastic properties, whose main components are zinc oxide
They are designed to make an accurate negative reproduction of a given area of the oral cavity. These
materials consist of zinc oxide, eugenol, rosin, and a vegetable or mineral oil that acts as a plasticizer
action of the eugenol as an irritant. ZOE dental impression materials are supplied in paste form and ar
They are used in dental offices for preliminary compound impressions, mucostatic impressions, correc
dentures, and denture relines.

Dental impression materials with thermoplastic properties (known as compounds) designed to make a
reproduction of a given area of the oral cavity. These dental impression materials may consist of dedic
a wax-like mixture of stearic acid, resins, and oils mixed with an inner filler (e.g., talc) and a pigment.
impression materials are supplied as cakes, wafers, or sticks and in various colors to aid in distinguish
of different softening temperature ranges. These dental impression materials allow easy corrections a
viscosity is controlled with temperature. They are used in dental offices for preliminary full denture an
impressions, for support of edentulous areas or saddle areas, and to facilitate either preliminary or fin
partial dentures or better study models. Dedicated compound materials based on wax or synthetic res

Compound dental impression materials with thermoplastic properties, whose main component is wax.
make an accurate negative reproduction of a given area of the oral cavity. These compound dental im
consist of a base wax (e.g., hydrocarbon or ester types), additional waxes acting as modifiers, coloran
Compound wax dental impression materials are supplied in sheets, wafers, and/or sticks. These comp
materials should not shrink or distort as they cool. They are used in dental offices for checking and ma
occlusal records, for construction of nonmetallic denture bases and for laboratory work.

Compound dental impression materials, whose main component is synthetic resin. They are designed
negative reproduction of a given area of the oral cavity. These compound dental impression materials
physical properties of natural resins but are different chemically; they consist of a synthetic polymer a
synthetic resin dental impression materials are supplied in fine powder (polymer) and in liquid (monom
form a gel or dough and processed into a rigid solid. They are used in dental offices for rebasing and f
missing portions of dentures.

Information systems designed to assist healthcare facilities in making decisions by effectively organiz
planning and forecasting the probable outcomes of a process or procedure through software that anal
facility's information data using an electronic format. The main focus of the decision support systems
information to all involved in the decision making process. These systems typically consist of a combin
software. The hardware typically includes dedicated network servers and computers; the software con
software packages that are capable of processing information regarding clinical, financial, and/or othe
to make major healthcare facility decisions. They may function as stand-alone systems or may be inte
wide data management information system network. Dedicated decision support information systems
financial and clinical decision support.
Cell therapy information system software designed to manage/operate cord blood patient and product
information needed for transplantation. This software is intended to work with standard clinical health
data management information systems which meet appropriate technical characteristics. The softwar
algorithms to process and store all data related to cord blood standard working procedures, including
cord blood, apheresis procedures, and/or other particular dedicated procedures performed in the facili
interact with other information systems and/or equipment, keep track of consumable availability and i
provide outcome reports according to the facility needs. Cord blood data management information sys
available as part of a cell therapy department and/or blood bank complete information system softwa
separate component. The software may be modified during the life of the system by releasing update

Bags designed for retrieval of tissues and/or small organs during laparoscopic procedures. These devic
a disposable folded bag made of plastic (e.g., polyethylene), fabrics, or other soft material usually wit
(commonly known as the mouth), and an integral drawstring. Laparoscopic bags may also include rigi
metal wires around the neck to facilitate opening of the bag when deployed; some bags also include a
There are a variety of configurations and sizes according to the tissue or organ to be retrieved (e.g., g
bowel, kidney, appendix) and/or the procedure performed. Laparoscopy retrieval bags are deployed a
several different techniques that may include catheters, sleeves, rods, and/or cannulae.

Portable telephones designed to provide full duplex mobile communication through a network of wirel
telephones usually consist of a small computerized device that includes voice communication, a displa
touch screen and/or a keypad used for entering data; smartphones may provide access to the interne
typically include several capabilities such as text messaging (also known as short message service or
and/or video camera, audio recording, gaming, and voice messaging. They may provide access to app
software) that permit the performance of a great quantity of additional functions. The use of smartpho
environment includes receiving and displaying data and images from physiologic monitors (e.g., gluco
electrocardiography) using dedicated applications and the transmission of text and voice messages (i.
from hospital communication and/or information systems.

Multitherapy electronic ambulatory infusion pumps designed for use on only one patient (i.e., single-p
enough to be worn or carried by patients and designed for use in delivering liquids through intravenou
subcutaneous routes from internal reservoirs at pre-established accurate flow rates. Single-patient pu
a battery-powered pumping mechanism which uses fingerlike disks to occlude the IV tubing successiv
wavelike motion. This moves fluid from the internal solution container to the patient. Less frequently,
drivers with spring-powered mechanisms are used. Single-patient electronic ambulatory pumps may i
controls to select the infused dose or volume and alert messages to indicate abnormal conditions; the
a refillable reservoir for long-term therapy. Multitherapy electronic single-patient ambulatory pumps a
deliver medicines in continuous or intermittent mode but some may permit bolus delivery.
Prepackaged collections of devices and supplies (either custom or standard) designed to deliver stent
locations inside the vasculature according to the intended use (e.g., angioplasty, aorta dissection trea
typically include the implantable endoprostheses (i.e., the stent) that may be inserted or mounted on
a compliant section near the distal end appropriate for stent delivery and deployment. Ancillary devic
needles) and products (e.g., glue, saline, alcohol) may be also included for use during the stenting pr
kits for the lower and upper gastrointestinal tract, the biliary ducts, and the vasculature are available.

Dispensers designed to store and deliver medications. These dispensers usually consist of a container
several trays for storing the medications; they can be manually or power (e.g., electrically) operated.
can be self-standing and wall or tabletop mounted; liquid and/or pill dispensers are available. They are
home and in healthcare facilities; dedicated unit-dose drug dispensers, both for liquid and pills are als

Medication dispensers designed to store and deliver pills and/or other medications (e.g., tablets, caps
state. These dispensers help to ensure that medications are taken properly and on time. Pill dispenser
container made of plastic, metal or a combination of these. Some dispensers feature a locking mecha
to help prevent medication errors. Medication dispensers are autonomous units that are not part or in
medication dispensing system. Portable, wall mounted and over-the-counter dispensers are also availa
used at home and in healthcare facilities.

Medication dispensers designed to store and deliver medications in liquid state. These dispensers deli
drug from a medication container (e.g., nasal spray, eye-drop bottle, cough syrup bottle). Medication l
be manually or power operated. They are usually made of plastic, metal or a combination of these. Th
at home and healthcare facilities.
Dispensers designed to store and deliver specula intended to be attached to otoscopes. These dispen
a container made of plastic, metal or a combination of these. Otoscope specula dispensers come in al
(e.g., pediatric and adult size) and can be wall mounted. They are commonly used at home and in hea

Dispensers designed to store and deliver scrub brushes. These dispensers usually consist of a contain
(e.g., acrylic) or metal (e.g., stainless steel). Some may include bracket holes for wall mounting or the
front of a scrub station. Scrub dispensers that can be autoclave-sterilized are also available. They are
nurses and surgeons on preoperative procedures.
Dispensers designed to store and deliver one or different kinds of cytology brushes. These dispensers
container made of plastic (e.g., acrylic) or metal (e.g., stainless steel) that supply individually wrapped
commonly used by nurses and doctors during biopsy procedures.
Protection garment dispensers designed to store and deliver gowns. These dispensers typically consis
compartments with a hinged lid and an opening at the bottom to provide easy access to gowns. Gown
available for mounting on a table or on the wall. Some of these dispensers permit delivery of gowns w
remaining ones. They are mainly intended to provide gowns for hygienic purposes and/or personal pro
dispensers are used in hospitals, clinics, doctor's and dentist's offices (e.g., examination, treatment, a
and in other healthcare facilities.
Protection garment dispensers designed to store and deliver face masks. These dispensers usually con
with an opening at the bottom to provide easy access to masks. The dispensers keep face masks orga
accessibility to personal protection apparel. Face mask dispensers are usually available as tabletop or
Some of these dispensers are available with adjustable dividers and hinge lids and can store a bulk of
used mainly in hospital areas (e.g., examination, treatment, operating rooms, clinical laboratories) and
facilities.

Dispensers designed to store and deliver supplies used in dental procedures. These dispensers may co
made of plastic and/or metal. They are usually mounted on walls or counters; self-standing units are a
Dedicated dental dispensers intended for impression materials, adhesives and silicones, dental alloy/a
sterilized cotton rolls, and dental floss are available. They are used extensively in dental clinics.

Dispensers designed to store and deliver disposable paper or plastic cups. These dispensers usually c
made of metal, plastic, or a combination of these, with an opening to deliver the cups. Paper/plastic cu
mounted on walls, installed as adjustable in-counter units or can stand upright on any flat surface. So
may include a mechanism with a calibrated compression spring which ensures one-at-a-time cup disp
mounting positions. They are used extensively in healthcare facilities.

Dispensers designed to store and deliver toilet paper. These dispensers consist of a container with an
at time pieces of toilet paper. Toilet paper dispensers are made of plastic and/or metal; they can be su
horizontally or vertically. Some of these dispensers may include a mechanism which makes an extra ro
in place when bottom roll is depleted. They are used extensively in healthcare facilities.

Dispensers designed to store and deliver paper towels. These dispensers consist of a container with a
bottom to dispense paper towels without tearing. Paper towel dispensers can either be manually or po
operated. These dispensers are made of plastic and/or metal. The most common types are counter-top
and lever-roll towel dispensers. Some of them may incorporate a key lock for safety. They are used ex
facilities.

Dispensers designed to store and discharge a fine jet of disinfecting solution. These dispensers are ba
pressurized plastic container with a nozzle to deliver the solution spray manually. Disinfecting spray d
used in hospitals and other installations; dedicated powered dispensers are also available.

Dispensers designed to store and deliver measured amounts of material. These dispensers consist of
out the material into trays, vessels, microplates, or centrifuges, without human contact with the samp
dispensers may be operated manually, automatically timed or computer controlled for more complica
dispensers are used instead of simply pouring out materials because they are more accurate, help to
lessen the risk of sample contamination. Dedicated dispensers for laboratory liquids, laboratory slides
sensitivity disks are available. They are commonly used in clinical and pharmaceutical laboratories.

Installations designed to obtain digital photographs in a pathology (e.g., grossing) laboratory. These st
of a metal stand that includes an integral digital photographic camera, appropriate spot (e.g., LED) lig
keyboard to introduce annotations and/or labels on the photographic images. These stations may also
to facilitate the operation. Pathology photograph stations are mainly used in clinical pathology laborat
diagnostic, forensic, and other procedures and for digital transmission of images by providing direct co
network information systems.
Data management information systems designed to provide patient entertainment and promote overa
These systems typically consist of a combination of hardware and software. The hardware typically inc
network servers and workstations, computers, printers, and touch screens; the software consists of a
package that is capable of providing entertainment (e.g., video, audio, news) and/or promoting wellne
information on health conditions, nutrition, health risks). Patient entertainment/wellness data manage
leisure and good health habits during the recovery period; they are also intended to entertain, and pro
interaction to strengthen the emotional temperament of the patient. Theymay function as stand-alone
integrated in a hospital-wide data management information system network.

Anti-fogging products designed to provide anti-fog protection when applied on the lenses of endoscop
devices, including endoscopic photographic and video cameras. These products typically consist of ste
with a variety of different components including substances that prevent and/or eliminate fogging of l
endoscopic and/or laparoscopic instruments and other devices (e.g., endoscopes, laparoscopes, came
the endoscopic lenses and avoiding distortion of images obtained through the lenses. Some products
alcohol are also available. Anti-fogging products are usually applied using dedicated wipes, but cleani
units are also available to facilitate the procedure. Anti-fogging solutions and gels used on endoscopic
intended for intraoperative minimal access surgical procedures using endoscopes and/or laparoscopes

Products consisting of solutions or gels designed to provide anti-fogging protection; they are mainly us
glass and plastic lenses, and also on mirrors. These products typically consist of a solution with a varie
components including substances that prevent and/or eliminate fogging of lenses used in optical devi
similar substances but usually at a higher concentration are also available. Some products that do not
also available. Dedicated solutions with formulations intended specifically for endoscopic and/or lapar
available. Anti-fogging solutions and gels are used in many healthcare device lenses or face/eye shiel
surgical helmets, microscopes, and photographic and video cameras; they are also used in other healt
including refrigerators and freezers.

Electromyography (EMG) neurological monitors designed to continuously identify, measure, and displa
potentials generated by muscle fibers (i.e., electromyographic) from several nerve-muscle combinatio
procedures. These monitors typically consist of a computerized central unit (including controls and a d
EMG potential waveforms) and detachable surface or needle electrodes placed on or in a group of mu
common nerve. The monitor continuously assesses the EMG muscular activity through the electrodes
and/or sound alarms to warn the surgeon when the nerve is stimulated. Both monopolar and bipolar p
stimulate the muscles prior to the surgical procedure for nerve identification and nerve function asses
EMG monitors are used to help in the reduction of nerve damage during otolaryngology and other surg

Knives designed to cut in-vivo a sample of tissue from an anatomic structure of the body that is intend
examination and/or test (i.e., biopsy). These knives are typically manual, handheld instruments with a
blade with a sharp convex edge. Biopsy knives include instruments of a variety of shapes and sizes ac
be cut and/or the biopsy procedure to be performed. Dedicated biopsy knives (known as cone knives)
tissue specimens from the uterine cervix
Biopsy knives (also known as cone knives) designed to cut a conical sample of tissue from the uterine
are typically manual, handheld instruments with a straight handle and a conical distal blade with shar
biopsy is performed as a surgical procedure; it is performed only when there is evidence or suspicion o
cervix.
Knives designed to cut and dissect oral tissues during dental procedures and/or cut dental prosthetic m
dental laboratory. These knives typically consist of handheld, manual instruments with a handle and a
blade at the distal end. They are available in a variety of shapes and sizes according to the procedure
Dental knives are used mainly during oral surgical procedures of teeth and/or gums; dedicated dental
available for particular periodontal and/or prosthodontic procedures.

Dental knives designed to cut tissues around the teeth (i.e., periodontic). These knives typically consi
instruments with a handle and an integral cutting blade at one or both of the distal ends (i.e., single o
are available in a variety of blade shapes (e.g., flat, triangular) and sizes according to the periodontal
performed. Dedicated periodontal knives are available for particular procedures such as interdental gu
removal; they can also be used for gingival contouring.

Periodontal knives designed for surgical excision of the gingiva (i.e., gum) at the level of its attachmen
These knives typically consist of handheld, manual instruments with a handle and an angled shaft wit
integral cutting blade at the distal end; some gingivectomy knives have a long narrow triangular blade
are used mainly in dental procedures intended to eliminate periodontal or gingival problems; they can
surgeries of the gums.

Periodontal knives designed to cut tissues between contiguous teeth (i.e., interdental). These knives t
handheld, manual instruments with a handle and a long, flat, and very thin integral cutting blade at th
interdental knives have a pear-like cutting blade at the distal end. Interdental periodontal knives are u
localized gum (i.e., gingival) procedures.
Dental knives designed to cut dental prosthetic materials. These knives typically consist of handheld,
with a handle and an integral strong cutting blade at the distal end. These knives are available in a va
and sizes according to the material to be cut or trimmed. Dedicated prosthodontic knives are mainly u
laboratories and they are also available for cutting and/or trimming plaster products (i.e., gypsum) or
including plastics compounds and wax.

Prosthodontic knives designed to cut dental and model plasters obtained from gypsum. These knives
handheld, manual instruments with a sturdy handle at the proximal end and an integral strong flat cut
end. They are available in a variety of blade shapes. Plaster prosthodontic knives are intended to cut a
trim) plaster models.
Prosthodontic knives designed to cut and trim dental compounds. These knives typically consist of ha
instruments with a large handle and a detachable very sharp and strong cutting blade at the distal en
available in a variety of sizes and should be replaced as soon as they become dull. Compound prostho
mainly to trim dental plastic, impression compounds, and dental wax.

Knives designed to cut and dissect tissues during procedures performed on the body following death (
procedures). These knives typically consist of sturdy handheld, manual instruments with a proximal ha
cutting blade at the distal end. Postmortem knives are used mainly during autopsy and cadaver dissec
postmortem knives are available for a variety of procedures, including grossing, organ dissection, and
Postmortem knives designed for gross cutting and preliminary dissection of tissues during autopsy. Th
consist of sturdy handheld, manual instruments with a handle at the proximal end and an integral sha
distal end; the blades are available in a variety of sizes and shapes. Some blades include a heavy edg
of the cutting edge to permit hitting with a mallet when necessary. Grossing postmortem knives are u
steps of autopsy and cadaver dissection.

Postmortem knives designed for dissection of organ and tissues during autopsy. These knives typically
manual instruments with a handle at the proximal end and an integral sharp cutting blade at the dista
available in a variety of sizes and shapes according to the organs and tissues to be dissected. Dedicat
postmortem knives intended for general autopsy and/or for particular dissection of the lung, cartilage
dissections are also available.

Knives designed for cutting tissues and/or other anatomic structures during surgical procedures. Thes
manual, handheld instruments of a variety of shapes and sizes according to the site and/or the tissue
Surgical knives may consist of a cutting blade integral to a handle (usually single-use, disposable instr
knives (e.g., scalpels) are two-part instruments with disposable blades that can be attached to a comm
Dedicated surgical knives are available for ophthalmic, orthopedic, middle ear, plastic, and other oper

Surgical knives designed for cutting bones and/or other hard tissue structures during surgical procedu
consist of manual, sturdy, handheld instruments of a variety of geometric shapes and sizes usually wi
handle and a wide cutting blade. Bone surgery knives are mainly used in orthopedic procedures. Dedi
intended for interosseous or periostium procedures are available; knives intended to cut particular bon
sternum) and acetabular joint procedures are also available.

Bone surgery knives designed for cutting bones and/or other hard tissue structures at the articulation
the femoral head during surgical procedures. These devices consist of manual, sturdy, handheld instru
geometric shapes and sizes. They usually have a straight handle and a wide curved cutting blade at it
conforms to the surface of the pelvis which articulates to the femoral head. Acetabular bone surgical
and/or femur orthopedic surgery.

Bone surgery knives designed for cutting tissue between two adjacent bones. These devices consist o
handheld instruments usually with a straight handle and a wide double cutting blade at the distal tip t
bone surfaces. Interosseous bone surgical knives are mainly used in orthopedic procedures.

Middle-ear surgical knives designed to cut the bony structures of the external auditory canal (i.e., the
middle ear structures and the exterior of the ear). These devices consist of manual, slender, handheld
flat handle and a long, curved shaft ending in a sharp cutting rotatory component. Knives that cut par
to the main shaft are available.
Middle-ear surgical knives designed to incise the tympanic membrane by creating a small hole (i.e., m
tympanometry). These knives consist of manual, slender, handheld instruments with a flat or rounded
extremely fine curved shaft which ends in a sharp, frequently triangular cutting edge. Myringotomy kn
surgical procedures performed for treatment of otitis media; they are intended to relieve pressure cau
buildup of fluid or to drain pus.

Middle-ear surgery knives designed to dissect tissue during endaural microsurgical procedures. These
very small handheld, manual instruments with a flat or rounded handle and a long, extremely fine sha
sharp cutting edge. Middle-ear microsurgery knives are used to cut soft tissue in procedures involving
such as the stapes and/or to repair the tympanic membrane (i.e., tympanoplasty).
Surgical knives designed to cut the anatomical structures of the nose and/or the nasal sinuses. These
manual, slender, handheld instruments that may have one of a variety of different geometric shapes a
frequently include a straight, swivel, or bayonet handle and a small blade with a sharp cutting distal e
knives are used mainly in nasal reconstruction and cosmetic (i.e., rhinoplasty) procedures. Dedicated
to cut the nasal septum, as well as those that include a revolving cutting component (e.g., to cut the n
available.

Nasal surgical knives designed to cut the nasal septum. These devices consist of manual, slender, han
usually include a straight handle and a D-shaped (half-moon) sharp cutting blade at the shaft's distal e
surgical knives are used mainly for nasal reconstruction and cosmetic (i.e., rhinoplasty) procedures.

Surgical knives designed for cutting the anatomical structures of the eye. These devices consist of ma
handheld instruments that may have a variety of different geometric shapes and sizes. They usually in
flat handle attached to a very fine tapered straight or curved metallic, diamond, or silicon blade that e
sharp or semi-sharp cutting edge. Dedicated eye surgery knives both reusable and disposable are ava
microsurgical procedures such as cornea and lens capsule cutting, cataract surgery, and eye tendon c

Power systems designed for use as a source of electric and/or mechanical power to otolaryngology ins
powered devices used in otolaryngology surgical procedures. The systems may include irrigation capa
usually consist of a main unit that provides electric and/or mechanical power using a motor to detach
appropriate to drive dedicated otolaryngology instruments (e.g., saws, burs, blades, drills, debriders);
foot-control unit), and pumps used for irrigation, cooling, and/or other purposes (e.g., endoscope lens
Otolaryngology power systems also include a line cord and a panel for handpiece/instrument connecti
irrigation and/or coolant bags and a clamp for fixation to a standard intravenous pole. The systems are
surgical procedures performed in the ear, nose, and/or throat involving soft and hard tissue.

Cataract eye (ophthalmic) surgery knives designed to make micro incisions in the eye capsule during
knives typically consist of a straight handle at the proximal end and a straight or angled trapezoid dou
the distal end. Microsurgery cataract knives are used to make a micro (usually a little more than 1.0 m
larger at the external than at the internal corneal margin during the lens extraction (e.g., phacoemuls
These knives are also used to enlarge the incision before intraocular lens implantation.

Eye (ophthalmic) surgery knives designed to make incisions in the cornea (i.e., corneal splitting). Thes
consist of manual, slender, handheld instruments that have a straight handle and a small blade that c
wide and straight or angled. Corneal splitting knives are used mainly for anterior flap sclerotomy in th
glaucoma.
Eye (ophthalmic) surgery knives designed to make incisions that open the capsule of the eye lens (als
capsulotomy, cystitomy, and cystotomy). These devices typically consist of manual, slender, handheld
include a hollow cannula with a sharp point and sharp cutting edges (either straight, curved, or angled
These knives usually include an adapter at the proximal end that permits irrigation and/or aspiration t
using a syringe. Lens capsule eye knives are used mainly for posterior capsulotomy performed after c
Anterior capsulotomy knives are also available.
Surgical knives designed to cut the anatomical structures of the throat. These devices consist of manu
instruments that usually have a sturdy, straight handle and a long, wide blade with a sharp cutting ed
Throat surgery knives are used in a variety of surgical procedures; dedicated throat knives intended to
tonsillectomy), incision of the larynx (i.e., laryngotomy), and to resect small tumors are also available.

Surgical knives designed to cut through a surgical sheath located in the abdominal wall during laparos
These knives typically consist of a long shaft instrument with a blade at its distal tip and a handle at t
remains outside the patient. Some laparoscopic knives include detachable (e.g., using a screwing mec
distal tip. Laparoscopic surgical knives are intended for a few particular uses (e.g., incision of the hepa
bile duct during exploration for stones); they are not frequently used due the inherit risks.

Surgical knives designed for cutting and/or dissecting nerves. These knives consist of manual, needle-
instruments, usually with a straight tubular handle and a shaft with a flat cutting blade at its distal tip
mainly used in neurosurgical procedures; dedicated knives intended for dissection of particular nerves
available.
Surgical knives designed to cut the anatomical structures of the vertebral column. These devices cons
instruments that usually have a sturdy flat or rounded straight handle and a long blade with a sharp c
distal end. Spinal surgery knives are used in a variety of surgical procedures. Dedicated knives intend
procedures and to interrupt the lateral spinothalamic tract (i.e., cordotomy) are also available.

Surgical knives designed for cutting and/or dissecting tumors during microsurgical procedures. These
of manual, needle-like handheld instruments, usually with a straight tubular handle and a shaft with a
cutting blade (e.g., ovoid, round) at its distal tip. Microsurgery tumor knives are mainly used in neuros
dedicated knives intended for dissection of particular tumors (e.g., acoustic neurinomas, also known a
also available.

Surgical knives designed for cutting and/or dissecting blood vessels during microsurgical procedures.
consist of manual, needle-like handheld instruments, usually with a straight tubular handle and a stra
ended in a pointed cutting blade that is curved upward or downward at its distal tip. Microsurgery bloo
mainly used in neurosurgical procedures, especially to treat aneurisms.

Surgical multipurpose scalpels smaller than standard scalpels that are designed to cut or dissect tissu
procedures. These scalpels typically consist of manual, handheld knives with a straight handle and a s
the distal tip. The blades are of one of a variety of shapes (e.g., pointed, crescent, trapezoid) and may
or angled positions related to the handle. Microsurgery scalpels are available as reusable or single-use
Microsurgery scalpels may also consist of a combination of a reusable handle and a detachable single
the distal end. They are used in a great variety of microsurgical procedures (e.g., neurosurgery, middl

Surgical knives designed for cutting and/or dissecting the thyroid gland. These knives typically consist
handheld instruments, usually with a flat handle. This facilitates grasping at the proximal end. They a
straight or concave blade that has a hole with sharp cutting edges along its center at the distal end. T
mainly in surgical procedures intended to resect thyroid gland tissue and/or associated tumors.
Surgical knives designed to cut the anatomical structures of the urinary tract including the bladder. Th
consist of manual handheld instruments that usually have a straight handle and a long narrow blade w
edge at the distal end. Urinary tract knives are frequently appropriate for use through the working cha
Urinary tract surgery knives are used in a variety of endoscopic minimal access surgical procedures fo
upper urinary tract. Dedicated urinary tract knives used for percutaneous incision of the ureters are al

Urinary tract surgical knives designed to cut the anatomical structures of the lower urinary tract (i.e.,
during endoscopic procedures. These knives typically consist of manual handheld instruments with a h
finished in a cutting end (e.g., straight, half-moon-shaped) at the distal end. These knives are usually
through the working channels of urinary tract resectoscopes, urinary tract endoscopes, and/or cystosc
urinary bladder/urethra surgery knives are used in a variety of endoscopic minimal access surgical pro
the lower urinary tract (e.g., treatment of strictures, resection of tumors).

Urinary tract surgical knives designed to cut the anatomical structures of the upper urinary tract (i.e.,
endoscopic procedures. These knives typically consist of manual handheld instruments with a handle
finished in a cutting end at the distal tip. These knives are usually intended for use through the workin
tract ureteroscopes and urinary tract endoscopes. Endoscopic ureter surgery knives are used in a vari
minimal-access surgical procedures performed in the upper urinary tract (e.g., the treatment of strict
tumors).

Knife/scalpel handles designed to hold and manipulate a very small cutting or dissecting blade approp
procedures. These devices typically consist of a straight, reusable handheld instrument made of eithe
an appropriate shape for easy manipulation and a distal tip that can hold a microsurgical disposable b
for rapid blade exchange. The combination of the handle and the attached blade results in a microsur

Environmental monitors designed to continuously detect, measure, and display the difference in air pr
closed room and the surrounding environment (i.e., the differential pressure, either positive or negativ
typically include high accuracy airflow sensors capable of measuring very low differential pressures in
+25 Pa (-0.10 to +0.10 inch of water), a display, and alarms for abnormal pressure conditions. The mo
include recording capabilities and provide local and/or remote signals that can be used for manual or
the pressure inside the room. Differential pressure environmental monitors are used in areas of health
patient isolation rooms, autopsy departments, operating rooms, clean rooms, and also in particular ar
laboratories and hospital pharmacies where strict control of pressure and airflow are necessary.

Detectors designed to locate the presence or absence of sponges by means of a handheld radiofreque
the last steps of a surgical procedure to help prevent the retention of surgical sponges inside the patie
the operative field. These detectors typically consist of a central unit that provides and detects RF sig
and that also shows successful scanning evidence; a handheld wand that is displaced (i.e., scans) alon
vertical and horizontal scans) to detect sponges with integrated radiofrequency tags; and a mat that i
RF antenna that is placed on the operating table. Sponge retention prevention surgical RF detectors c
the presence of sponges and/or other related devices (e.g., RF labeled swabs and towels) as long as th
radiofrequency tag. However, they cannot count and/or identify particular sponges or other devices.
Tissue ablation cryotherapy systems designed to ablate (i.e., produce a therapeutic lesion) regions of
give rise to or support cardiac arrhythmia. These systems typically consist of a central computerized u
that provides the coolant (usually liquid nitrous oxide) from an integral tank; the console also includes
mechanical components to perform and control the ablation during the catheterization procedure usin
Several detachable guiding and cryoablation catheters that may include balloon and single-point cryo
also components of the system. Cardiac tissue ablation cryotherapy systems can be used under fluor
are mainly intended for patients suffering from drug refractory paroxysmal atrial fibrillation.

Cardiac ablation catheters designed to destroy target endocardial tissue using very low temperature c
cryotherapy). These devices typically consist of a 10.5 Fr (3.5 mm) diameter polymeric catheter with
polyurethane) balloon near its distal tip that may be inflated to more than 20 mm in diameter. The liq
through the catheter and expands (i.e., vaporizes) inside the balloon at the distal end to provide the c
The catheter is placed and inflated inside the left atrium of the heart and advanced to the entrance (i.
pulmonary vein; a circular-pattern cryoablation is performed at the points where the balloon contacts
cryotherapy ablation catheters are intended for electrical isolation of pulmonary veins in the treatmen
fibrillation; they are used as a component of a cryotherapy ablation system under fluoroscopic guidan
part of the cryogenic ablation system are small-diameter cryotherapy ablation catheters with a short d
catheters include appropriate electrodes intended for monitoring procedure results and for cryogenic
focal trigger sites.

Measuring instruments designed to determine the quantity of water that passes through the skin (i.e.,
evaporates from the surface, known as transepidermal water loss (TEWL) instruments. These devices
instrument (probe) that measures and display the value of TEWL usually in gram per square meter pe
instrument may use one of a variety of technologies including: (1) instruments that measure the relat
closed chamber; (2) instruments based on the measurement following the diffusion principle in an ope
instruments based on the ability to measure the vapor pressure gradient of water at two distances ad
the skin and then to compute the partial pressure gradient and the evaporation rate. TEWL instrume
most important parameters for assessing the skin barrier function during dermal, neonatal status, cos
occupational medicine studies.

Semiautomated laboratory analyzers designed to perform rapid qualitative immunology (e.g., using
immunochromatography) tests to determine the presence of certain analytes that are considered drug
barbiturates, amphetamines, oxycodone, propoxyphene) when the concentrations are above a pre-de
in a urine sample. These analyzers may consist of a combination of a cassette with several wells for th
filter photometer reader (i.e., a colorimeter); other technologies involving enzyme immunoassays and
may also be used. Typically the urine samples are placed in the cassette wells where the reagents are
colors the intensity of which depends on the presence and concentration of each drug. The reader sca
processes the information using dedicated software, and displays and/or prints the results as positive
the substances in a few minutes. Toxicology screening urine analyzers provide only preliminary results
confirmed using more specific analytical tests (e.g., high-performance liquid chromatography); they ar
as point-of-care analyzers.
Linear-accelerator-based radiotherapy systems designed to deliver radiation combining computer-con
(known as intensity modulated radiation therapy [IMRT]) and spiral scanning to deliver the radiation s
all the volume at once. These systems provide image guidance before and during (i.e., in real-time) th
These systems deliver radiation following the three-dimensional image of the tumor, adjusting the int
across the treatment area by using the properties of a spiral scanning accelerator and dedicated softw
linear accelerator radiotherapy systems are intended to deliver more accurate and higher doses of rad
order to spare adjacent tissues. The systems may also be used for single-dose (radiosurgical) treatme
treatment of cancers of the brain, as well as head and neck tumors.

Equipment designed for melting and dispensing low-melting alloys (the melting point is usually below
[212 degrees Fahrenheit]). This equipment typically consists of (1) a melter made of a metal (e.g., sta
double walls and a ceramic heater to melt the alloy, an accurate temperature control, and a display; a
a dedicated faucet with a no-drip ball valve. Low-melting alloy dispensers/melters are used mainly in h
manufacture custom-made radiotherapy block shields in dedicated workshops. This equipment may a
medium-melt alloys (i.e., alloys with melting temperatures up to 150 degrees Celsius [302 degrees Fa

Equipment designed for automated adipose tissue (i.e., fat) transfer from a donor site to other area of
person (i.e., autologous) in one procedure. This equipment typically consists of a central unit that inclu
a centrifuge, and a filtering system to separate adipose tissue from other fluids such as blood; the uni
detachable probe with a cannula or a small diameter needle at the distal end intended for fat harvesti
respectively. Autologous fat transfer units are used mainly in body reconstruction and/or cosmetic pro
augmentation or reconstruction, cosmetic procedures in the face).

Forced-air convection laboratory ovens intended for thawing and/or warming frozen plasma and/or oth
(e.g., whole blood, erythrocytes, cryopreparations) in a dry environment. Typically heat is transferred f
conduction and also by forced-air convection to the plasma bag. These devices usually consist of a ta
includes an enclosure where the plasma bags are inserted, electronic processing circuits, heating elem
temperature sensors and controls, and data output ports to keep record of the process. The ovens ma
means to provide gentle agitation (e.g., rocking) to the bags during the thawing/warming process. Pla
ovens are mainly used in laboratories, blood banks, and trauma centers to thaw and/or warm blood pr
temperature (i.e., 37 degrees Celsius/98.5 degrees Fahrenheit) prior to transfusion.

Simulators designed for periodic biological audiometer calibration checks without the involvement of h
simulators typically consist of tabletop or portable, electrically (e.g., battery) powered devices capable
or intermittent sound levels in a frequency range from 125 Hz to 8 kHz, usually from standard earphon
includes sound to electrical transducers (i.e., microphones), electronic circuits, and controls; some dev
display. Bioacoustic simulators are intended to check (typically daily) the appropriate calibration of ma
audiometers following a given standard (e.g., OSHA, FDA). Some devices may also measure backgrou
environment (e.g., inside an audiometric booth). Bioacoustic simulators are not intended for the electr
of audiometers that is usually performed during preventive maintenance procedures or after a main re
Data management information system software designed to manage/operate cell therapy patient and
including information needed for transplantation. This software is intended to work with standard clini
information systems which meet appropriate technical characteristics. The software performs a variet
process and store all data related to cell therapy standard working procedures and/or other particular
performed in the facility. The software may interact with other information systems and/or equipment,
consumable availability and inventories, and provide outcome reports according to the healthcare fac
data management information system software may be available as part of a complete clinical inform
or as a separate component intended for use in specialized departments of healthcare facilities (e.g.,
laboratories, blood banks, cell distribution centers). The software may be modified during the life of th
by releasing updated versions. Dedicated software intended for particular applications, such as cord b
oncology, and bone marrow cell/transplantation is available.

Dental restorative materials in which the main component is zirconia oxide. The composition is usuall
zirconia polycrystal (Y-TZP) material where Yttria (Y20 a) is an oxide of the metallic element yttrium. B
(using hot or cold isostatic pressing) and partially sintered zirconia products (typically blocks and discs
dental materials. Zirconia is used to manufacture crowns, bridges, onlays, inlays, and other dental res
restorations are usually shaped using computer aided design/computer aided manufacturing procedur

Humidifiers designed to add moisture and heat to the gases that are insufflated into the abdominal ca
laparoscopic procedures. The humidifying devices (e.g., cassettes) are usually inserted in the tubes ru
insufflator to the port that provides access to the patient's abdomen (e.g., a trocar or insufflation need
typically include a control module that houses the control and safety circuits for the humidifier and ap
addition to the cassette containing the heating elements, humidifying media, and filters. Heated hum
accessories of laparoscopic insufflators; they are typically intended to increase the humidity of the gas
warm the gas to a temperature close to the normal body temperature (i.e., close to 36.5 degrees C/98

Small intestine catheters designed to be left in the intestine during a long-term (e.g., several days or
These devices typically consist of a multilumen (e.g., three -lumen), usually plastic (e.g., PVC) cathete
includes an inflatable balloon; the catheter may also include radiopaque markers, a stopcock, stiffenin
retention cuff. The channels of the catheter are used for irrigation, administration of medications, and
gas to the distal balloon. Small intestine indwelling catheters are mainly used to keep the intestine in
position during therapeutic procedures.
Aspirators designed to evacuate obstructive secretions, gas, liquids (e.g., blood), and/or foreign bodie
airway (including nose, mouth, pharynx, and trachea), to keep the air passages to the lungs open. Suc
remove secretions from the upper airway above the glottis (e.g., mouth, nose, and pharynx) or to rem
the trachea. These devices usually consist of a powered (or less frequently) manual vacuum pump, a
gauge, one or more collection canisters, plastic tubes connecting the components to each other, over
bacteria filter, the suction tubing (e.g., tubes, catheters, cannulae), and a carrying case. Free flow rate
are usually higher than 25 liter/min. For tracheal suctioning, the aspirator should provide a low vacuum
120 mm Hg; for oropharyngeal suctioning, the aspirator should provide a high vacuum level less than
Hg. Many units are portable and battery-operated, and some can have a manual pump and are handh
aspiration is frequently used to prepare the patient for emergency intubation, while tracheal aspiratio
maintain airway patency of an intubated patient. Dedicated aspirators intended only for tracheal aspir
available.

Alarm systems designed to activate audible and/or visual signals when patients attempt to move from
such as a chair, wheelchair, bed, or room. These alarm systems are typically comprised of sensors dep
the patient's location and connected to an electronic control unit. Occupancy alarm systems have sev
configurations and usually include one transmitter which can be used interchangeably with several se
floor mats, clothing clips, pressure pads and infrared motion detectors. Some occupancy alarm system
different sensors at the same time such as a bed pressure pad and an infrared motion detector. Some
systems can interface with nurse call systems providing remote alarms. Occupancy alarm systems are
caregivers that a patient has or is attempting to move. Occupancy alarm systems can help reduce the
can promote speedy assistance to patients who have already fallen by alerting caregivers that a patie
up unassisted is doing so.

Microbiology reagents in the form of liquids, solids, or semisolids used as a selective medium capable
growth of certain types of fungi/yeast, while inhibiting the growth of other microorganisms. These sele
usually contain a source of carbon (e.g., glucose, fructose, mannose), nitrogen (e.g., peptone, yeast e
amino acids, ammonium), and vitamins. Fungi/yeast selective culture media successfully isolate speci
slowing down or inhibiting the growth of antagonistic associated fungi, bacteria and/or actinomycetes
culture media are used for the isolation and identification of particular fungi/yeast.

Utensils that are used to channel the flow of substances between containers. Funnels are usually mad
plastic and are open at both ends, usually with a wide mouth at one end and a narrow pipe or cylinder
There are funnels that are designed for specialized applications in the medical laboratory.

Funnels used for vacuum filtration intended to separate solids from liquids. Vacuum funnels are usuall
but can also be made of glass or plastic. A vacuum funnel has either vertical walls (Buchner funnels)
outward (Hirsch funnels) attached with a tight seal to a vacuum flask. A perforated plate separates th
filter paper between the funnel and flask can also be used. A fitting for a vacuum source can be incorp
funnel or the flask. The vacuum source is attached through the fitting with a rubber adaptor or stoppe
filtered is poured into the funnel and drawn through the perforated plate into the flask by vacuum suc
are used in medical and/or chemical laboratories.
Funnels that are made of glass and fitted with a stopcock to control the flow of fluids being transferred
and a flask, such as when adding reagents slowly, drop-by-drop, to a solution. Some dropping funnels
narrow-bore glass tube intended to equalize the pressure between a receiving flask and the funnel. Dr
used in medical and/or clinical laboratories.
Funnels used to separate solids from liquids through filter paper placed within the mouth of the funne
vary in size depending on use, and can be made of plastic, glass, or metal. Filter funnels are used in m
laboratories.
Funnels used for quickly pouring powders between containers. Powder funnels can vary in size depend
be made of plastic, glass, or metal; and they have short and wide necks to facilitate funneling. Powde
medical and/or chemical laboratories.
Funnels that are made of glass and used for liquid-liquid extraction. Separation funnels are fitted with
closed when the mixture to be separated is added. The funnel is then closed and is shaken and invert
is opened to release excess vapor pressure and the mixture is allowed to separate. Separation funnels
and/or chemical laboratories.Funnels that are made of glass and used for liquid-liquid extraction. Sepa
fitted with a stopcock, which is closed when the mixture to be separated is added. The funnel is then c
and inverted; then the stopcock is opened to release excess vapor pressure and the mixture is allowed
Separation funnels are used in medical and/or chemical laboratories.

Funnels that consist of a long, narrow shaft with a reservoir and funnel-like section at the top. Thistle f
made of glass and can vary in size depending on use. They are used to add liquids to narrow-necked o
containers. Thistle funnels are used in medical and/or chemical laboratories.

Funnels that are flat on one side so they can be set on a scale or balance and the contents can be wei
made of plastic or glass and can vary in size depending on use. Weighing funnels are used in medical
laboratories.
Pipettors designed for automated or semi-automated transfer of programmed volumes of liquids from
another container by displacing a plunger in a cylinder or capillary tube that makes direct contact with
pipettors include a plunger that is displaced to a given position to set the volume of liquid to be transf
button is depressed to expel the same volume of air from the tube. After immersion of the pipettor tip
control button is released to create a partial vacuum that aspirates an identical volume of the transfer
tip and into the pipetter until the liquid makes direct contact to the plunger. Single-channel and multic
displacement pipettors are used in clinical laboratories; they improve the precision of measurements a
possibility of cross-contamination among samples when compared with manual pipetting procedures.

Measuring pipettes designed to measure and deliver multiple different amounts of liquid whose gradu
into the pipette's tip. These pipettes typically consist of a straight glass or plastic tube calibrated, in s
graduation marks), usually in the range from 0.1 to 25.0 milliliters, and one tapered end. Serological m
used in healthcare facilities, mainly in clinical laboratories. Serological pipettes that permit the user to
after all the liquid has been allowed to drain out by gravity (i.e., blow-out pipettes) are also used.
Calorimeters designed to determine the heat exchange and other thermodynamic parameter (i.e., rela
reaction) values during a titration assay. These instruments typically consist of a unit (i.e., the calorim
small-volume (frequently in the order of micro- or nano-liter) identical sample and reference cells, an e
cooling system, and a detachable syringe assembly to deliver the titrant into the sample cell. The pow
both cells at the same temperature (the titration may be endothermic or exothermic) is measured dur
process. The data is obtained as a series of pulses of power that are processed using a dedicated softw
heat exchanged per each injection of titrant; further evaluation provides the thermodynamic paramet
entropy, enthalpy) of the reaction under test. Isothermal titration calorimeters are mainly used in bioc
determine the substrates binding to enzymes); they are also used in pharmacology to assess new pot

Pharmacy workstations designed to obtain and process data related to prescription verification, tracki
and/or manual dispensing of medications. These workstations typically consist of a computerized unit
data input devices (e.g., keyboards, touchscreens), and barcode scanners and labelers; the workstatio
dedicated software that permits communication with clinical pharmacy data management systems. M
workstations are intended to manage, check and verify the status of the complete dispensing process
placed at the point of dispensing the workstation facilitates proper identification and tracking of both
medications.

Computer-aided training exercisers designed to train and assess patients during rehabilitation of the h
the wrist and finger joints. These exercisers usually consist of a computerized unit with detachable sen
glove) that detect the wrist and finger joint movements and appropriate software. The computerized u
assess, and provide feedback of the user's performance while moving the wrist and finger joints, inclu
the accuracy of movement and exerted pinch forces. Hand/wrist computer-aided exercisers are intend
motor rehabilitation of the hand; they are used for physical therapy and rehabilitation after neurologic
trauma or disease.

Ophthalmic solutions and creams designed for lubrication of the eyes. These products frequently rese
of natural tears; they may also include components (e.g., mineral oils, polymers such as sodium hyalu
alleviate severe ocular dryness, thereby increasing eye comfort. Some of these solutions may be used
wearers without damage to the lens. A few drops of eye lubricating solution, liquefied gels, or ointmen
on each eye. Eye lubrication solutions and creams are intended only for temporary local relief of ocula

Solutions that have viscous and some elastic properties intended to be instilled into the urinary bladd
which the main component is sodium hyaluronate, a purified sodium salt of hyaluronic acid (a glycosa
These solutions typically consist of aqueous mixtures containing 40 mg sodium hyaluronate (e.g., a 50
buffered saline solution containing 40 mg sodium hyaluronate). The solutions are instilled into the bla
catheter; they are designed to help temporarily replenish the deficient GAG layer on the bladder epith
interstitial cystitis. The products used for cystitis relief are usually supplied in sterilized vials.

Protection garments designed for patient use during the performance of whole body cryogenic treatm
These garments typically consist of a bathing suit and include dedicated masks covering the mouth an
shoes, and ear protectors that provide appropriate protection during a short time (i.e., a few minutes)
Whole body cryotherapy protection garments are used mainly to prevent frostbite during treatment.
Treatment chambers designed to perform whole-body cryogenic treatments (i.e., cryotherapy). These
consist of an enclosed compartment maintained at very low cryogenic temperature; a refrigerating sy
based on liquid nitrogen; monitors; and controls. The cryogenic compartment is kept at very low temp
below -150 degrees Celsius/-238 degrees Fahrenheit. Patients, wearing only a bathing suit and some
(e.g., a mask, gloves, socks), are placed into the chamber for a few minutes (typically less than ten m
cryotherapy treatment chambers are intended, in the short term, to alleviate pain. In the long term, th
treatment of stress, muscle pain, itching, and insomnia; they may also be used in athlete recovery tre

Ear solutions and creams designed to facilitate cleaning the ear canal and/or wax removal. These solu
be based on natural oil (e.g., olive, eucalyptus, chamomile, lemon) or water (e.g., saline) solutions; th
additional components such aloe vera and/or other chemical products. Some products also include com
peroxide) that may reduce ear wax production and/or help in its disintegration. The product is availab
application of drops, in spray, and as a cream or gel.

Computer-aided detection systems designed to obtain fluorescent angiographic images of blood flow
infrared spectrum. These systems typically consist of a CCD camera, light sources, a monitor, and a p
images. The central processing unit is usually mounted on a cart with an attached monitor and an arti
the camera. The angiographic (i.e., blood-flow) images from the area of interest are taken by the cam
injection of a fluorescent agent (e.g., indocyanine green). The data is processed using a software and
display as images of the blood flow in vessels and/or tissue and organ perfusion. The systems are use
(e.g., cardiovascular and gastrointestinal), organ transplant, plastic surgery and wound care procedure
ulcers); the angiographic systems may be integrated with robotic surgical systems. Systems combinin
visible light images intended for laparoscopic procedures are also available.

Orthopedic cements, whose main components are polymethyl methacrylate (PMMA) and an antimicro
antibiotic), are designed to produce a mechanical interlocking effect upon hardening. These orthopedi
powder (PMMA, prepolymerized PMMA, or methyl methacrylate co-polymer) including a pre-mixed ant
liquid (methyl methacrylate monomer). Antimicrobial orthopedic cements are typically applied as runn
solid material in a time period that can be tailored to the surgeon's needs. These orthopedic cements
inconvenience of mixing an antimicrobial agent into the cement; the premixed powder helps to preven
cement-handling characteristics. They are used in orthopedic procedures to anchor metal or plastic pr
bone or to treat spinal osteoporotic compression fractures while preventing microbial infection.
Composite resin restorative dental materials designed to be used as plastic fillings, for in situ restorat
structure and/or function of a patient's teeth and require an activator and a catalyst to activate polym
composite restorative dental materials consist of a synthetic organic photo-polymerizable resin matrix
particles (e.g., glass, quartz, silica) acting as fillers are dispersed. Light-cured composite resin restorat
are supplied in a single-paste system that is polymerized in situ by the application of ultraviolet or vis
usually strong, durable, easy to manipulate and shape. These composite resin restorative dental mate
restorations because no mixing is required that might introduce air bubbles (i.e., porosity). Light-cured
dental materials are placed in highly visible areas (e.g., the central incisors or any other teeth that can
smiling) or in areas where conservation of tooth structure is a top priority. They are used in dentists' o

Cavity lining dental materials designed for use as a coating inside of the wall surfaces of a dental cavi
preparation to facilitate the placement of other materials (i.e., cavity primers), and to enhance bondin
restorative) materials to the tooth surfaces. There are a variety of dental primers which composition is
restorative materials to be used (e.g., composites, amalgam). Primer cavity lining materials are used i
during operative dental procedures.

Dental materials designed for oral cavity disinfection during endodontic (i.e., root canal) procedures. T
typically consist of appropriate formulations of one or more of the following products: formocresol, sod
3%), and camphor mono-clorophenol. Endodontic disinfection materials are applied topically and are u
diluted solutions. They are used in dentists' offices for disinfection of the root-canal, frequently after e
pulp (i.e., pulpectomy) and/or pulp dressing.

Dental materials designed for sealing during endodontic (i.e., root canal) procedures consisting of calc
as the main component. These dental materials are supplied usually in different forms; as a liquid con
suspended in a solvent, as a paste in which CaOH is suspended in methylcellulose, and as a two-paste
marked "catalyst" and "base," respectively. Calcium hydroxide dental materials usually provide protec
promote the formation of secondary dentin. They have easy handling properties and are used in denti

Scrub tops are usually short-sleeved shirts made of light-weight woven (reusable) or nonwoven (dispo
are designed to be worn by personnel and visitors in hospitals or other healthcare facilities. Scrub top
to provide a clean barrier in sterile and other clinical treatment environments such as emergency room
areas, and intensive care units. To prevent people from carrying infectious materials on their clothing
environments, medical and facilities personnel, as well as visitors, are often required to change into cl
before entering the area. Some healthcare facilities also require the wearer to change out of the used
leaving certain areas of the facility to help prevent the spread of infectious materials out of those are
tops can be laundered and re-worn multiple times while disposable scrub tops are typically worn for o
discarded.
Scrub pants are usually full-length pants made of light-weight woven (reusable) or nonwoven (disposa
designed to be worn by personnel and visitors in hospitals or other healthcare facilities. Scrub pants a
provide a clean barrier in sterile and other clinical treatment environments such as emergency rooms,
areas, and intensive care units. To prevent people from carrying infectious materials on their clothing
environments, medical and facilities personnel, as well as visitors, are often required to change into cl
entering the area. Some healthcare facilities also require the wearer to change out of the used scrub p
certain areas of the facility to help prevent the spread of infectious materials out of those areas. Reus
be laundered and re-worn multiple times while disposable scrub pants are typically worn for one proce
discarded.

Devices designed for manual application of rotatory forces (i.e., torque) to the external (proximal) end
wire, providing appropriate steering and rotatory motion to the working tip of the guide wire. These de
an interlocking flexible mechanism with a handle that permits the application of torque to guide wires
diameters (e.g., from 0.26 to 1.0 mm/ 0.010 to 0.040 inch), facilitating the guide wire manipulation an
External torque guide wire devices are used mainly in vascular procedures in the peripheral and centr
frequently in other body tracts (e.g., bile ducts) to apply high-torque to dedicated guide wires intende

Valves designed to prevent and/or control bleeding during endovascular procedures. These devices ty
plastic valve that may be an integral part or attached to a catheter using a Luer (frequently rotatory) fi
typically includes a lateral port for flushing and a seal at the proximal end that closes the catheter to p
may also include a side tubing extension intended for administration of fluids. Hemostasis valves are
prevent blood loss and/or the entry of air in the circulation.

Devices designed to provide an image to one eye that must be drawn in a space only visible by the ot
typically include a septum that separates the two fields of views and a small mirror used to reflect the
Cheiroscopes are intended for assessing patient's binocular stability, eye alignment, and the presence
suppression, a neurological condition in which the patient's brain shuts off an eye by blocking its visua
vision. Training using cheiroscopes may contribute to improvement of binocular control and the elimin
Stereoscopes and other ophthalmic equipment may be modified to work as cheiroscopes (e.g., by usin
viewer attachment).

Ophthalmic instruments designed for assessing and/or training patients with eye fixation in points oth
macula region of the retina (i.e., fovea), a condition known as eccentric fixation. The device measures
of two conical, brushlike images with apexes touching (similar to a bow tie, known as Haidinger's brus
white surface through rotating polarized filters. Eccentric fixation assessment/training instruments ma
and reversal of rotation, and a light source that projects light dots to facilitate patient training. In patie
fixation the Haidinger's brushes are not centered on the central fixation dot, making possible the dete
fixation point. These devices are used in patients with abnormal macular integrity and/or strabismus.
Bed Mattresses filled with buckwheat hulls to provide comfort and pressure relief to the user. These m
consist of an outer cover of fabric (e.g., cotton) sewn into many sections filled with thousands of outer
of buckwheat (an annual Asian plant having small triangular fruits) seeds. Buckwheat hulls are not he
frequently flattened before filling the mattress. Buckwheat hull mattresses are intended to provide a
comfortable organic surface for sleeping that may reduce perspiration and/or allergic reactions; they m
pressure delivered from the mattress surface to the patient's skin (e.g., to prevent pressure sores).

Reusable antimicrobial cubicle curtains inhibit the growth of a large variety of bacteria, fungi, and viru
to partition off an area (i.e., form a cubicle). These reusable cubicle curtains usually consist of a piece
antimicrobial agent integrated into it, hung from a wall-mounted rod or a ceiling track. They are desig
and/or provide privacy by keeping people outside the curtain from being able to see inside. They are u
healthcare facilities such as holding areas, preparation areas, procedure areas, overflow areas, examin
rooms, and inventory areas. These curtains are manually or power operated and come in a variety of s
materials (e.g., cotton, polyester, nylon, vinyl). Fire-retardant, tear-resistant and liquid-repellant cubicl
available. Reusable antimicrobial cubicle curtains are able to withstand institutional laundering and m
antimicrobial effect.

Surgical instruments designed to enlarge a hole into the bone cavity. These instruments typically are s
manual instruments that include a distal end that has appropriate means to enlarge and smooth the b
tamps are mainly used in surgical procedures intended to insert grafts and/or bone cement, such as th
ligaments with anterior cruciate ligament tears. Dedicated bone tamps using mechanical expanders a
distal tip are also available.

Large safety pins designed to fasten a baby's cloth diaper in place. These devices usually consist of sa
metal snap locks for the locking mechanism and/or plastic safety caps covering the pin heads to preve
accidently opening.
Digital data copiers designed to make copies of a compact disk (CD) and/or a digital versatile disk (DV
digital video disk). These copiers usually consist of a high-speed automated handheld or portable elec
that can make one or more copies from a master disk to several single disks; the copiers usually inclu
mechanisms, controls, and appropriate holders for the CDs and/or DVDs to be copied. The copiers ma
with drives that have different interfaces, such as universal serial bus (USB), or parallel and serial atta
and SATA respectively); most copiers can support a variety of DVD and CD formats, including DVD-RO
DVD-RW, DVD+R, DVD+RW, CD-DA, and CD-ROM. CD/DVD disk copiers are mainly used to duplicate m
video, and/or music.

Devices designed to hold lenses in an appropriate position in front of the eyes. Lens types include cor
prescribed by an eye care specialist (ophthalmologist or optometrist) to assist vision (i.e., vision aids),
sunglasses), or nonfunctional for aesthetic purposes. Eyeglass frames are usually available in many co
metal or plastic or a composite material, such as graphite or titanium, with two arms that are supporte
arms are hinged at the wearer's temples. Usually, the nose pads that line the frames against the wear
adjustable for fit; in some eyeglass frames, the bridge that spans the top of the nose between the two
adjustable for fit.
Irrigation pumps designed to deliver liquids to a body cavity or other specific area of the body using a
typically consist of a central unit with a pumping (e.g., peristaltic) mechanism; a control (e.g., a valve,
foot-switch) to regulate the rate of the irrigation; and detachable (frequently disposable) tubing appro
catheter irrigation pumps are frequently used to irrigate body tracts (e.g., urinary, biliary) with no eas
some dedicated pumps are used as a component of therapeutic (e.g., radiofrequency) systems for coo
catheter during minimally invasive catheterization procedures (e.g., cardiac ablation).

Carts designed for filing and local transport of documents (e.g., folders, charts, cards, radiographic film
typically consist of an open or enclosed structure made of metal, glass, plastic, wood, or a combinatio
and may include drawers, shelves, and doors. The structure is mounted on medium-sized (e.g., 7.5 to
diameter) wheels that are usually an integral part of the cart. Filing carts are available in many differe
sizes; many carts are manufactured to store some particular type of document such as standard letter
(e.g., medical records, library). Filing carts dedicated to storage of a particular medium such as radiog
documents (e.g., blueprints) or hanging folders, audio or video cassettes, and compact discs are also
used in clinical and non-clinical areas of the healthcare facility, including intensive care units, patient
offices, pharmacies, and clinical laboratories.

Filing carts designed to store and transport x-ray films and/or x-ray cassettes. These carts typically co
steel, aluminum) structure that may include several shelves with built-in large (e.g., 35 x 43 cm/ 14 x
x 51 in) compartments to keep the cassettes separated. The structure is mounted on medium-sized (e
4 in in diameter) wheels that are usually an integral part of the cart. Some carts permit horizontal film
identification. Radiographic film/cassette carts are used mainly in radiology departments of healthcare

Carts designed for storing and local transport of small equipment, instruments, and materials used in
and/or other medical procedures. These devices are usually confined to a particular area of a healthca
clear display and ready access to all items. These carts typically consist of stand-alone multiple-drawe
-shelf/drawer structure with a working surface (e.g., the top of the cart) appropriate for use while perf
treatment or procedure; the structure is mounted on large wheels (e.g., diameter of at least 10 cm/4 i
integral part of the cart. Some carts also include built-in grounded outlets and/or security locks. Treatm
general procedures performed in emergency situations or in the field; dedicated carts specially design
particular procedures such as resuscitation, anesthesia, dental, ophthalmologic, and endoscopic proce
casting, are available.

Treatment carts designed for organized storage and transport of cleaned endoscopes, drugs, endosco
other supplies used during endoscopic procedures (e.g., bronchoscopy, gastroscopy, colonoscopy), fac
performing the procedure. These carts typically consist of a multiple-drawer, -shelf, or -shelf/drawer ca
they usually have sliding doors, swivel casters of at least 10 cm (4 in) diameter, and a working surface
cart). Most carts include holders for the endoscopes; some also include special soft plastic brackets to
heads and or a means to warm endoscopic (e.g., specula) devices used in the procedure. Endoscopy c
manufactured using materials (e.g., stainless steel, polypropylene, acrylic) that permit ease of cleanin
hospitals and in other healthcare facilities and doctors' offices. Dedicated endoscopy carts may also in
and/or attachments appropriate to perform laparoscopic or arthroscopic endoscopy procedures.
Endoscopy treatment carts designed to transport stand-alone endoscopic video systems. These carts
shelf, or shelf/drawer cabinet-like structure that is mounted on swivel casters of at least 10 cm (4 in) d
drawers and shelves are appropriate for cleaned or sterile endoscopes, drugs, and other supplies used
procedures; the carts may also include sliding doors and/or electrical outlets. Video procedure endosc
diagnostic and therapeutic endoscopic procedures such as gastrointestinal, urologic, hysteroscopic, an
endoscopy. Some carts include equipment and/or attachments appropriate to perform laparoscopic or
endoscopic procedures; the carts are usually moved manually but electrically (battery) operated carts

Treatment carts designed for organized storage and transport of instruments, devices, and materials u
casting and/or splinting procedures. These carts typically consist of a multiple-drawer, -shelf, or -shelf
structure with sliding doors that is mounted on swivel casters of at least 10 cm (4 in) diameter wheels
shelves are appropriate to facilitate the preparation of splints and casts. Casting/splinting treatment c
cast cutters (i.e., knives, saws) and attachments for suction, built-in grounded electrical outlets, and a
(e.g., the top of the cart) appropriate to prepare splints and casts; they are used in casting and/or eme
doctors' offices for outpatient treatment.

Central supply carts designed for distribution of sterile supplies from a central pharmacy or sterilizatio
stations, operating rooms, and patient rooms. These carts usually consist of a metallic tubing open or
includes appropriate wire shelves, drawers, and/or baskets to store the sterile supplies. The structure
large wheels (e.g., 12.5 cm/5 in or more in diameter) that are usually an integral part of the cart to fac
throughout the facility. Sterile product carts are usually manufactured using materials (e.g., stainless s
wire) that permit ease of cleaning and sterilization. Dedicated carts with hanger bars intended to tran
also available.

Central supply carts designed for distribution of intravenous (IV) solution bags and containers (e.g., bo
pharmacy to nurse stations, operating rooms, and patient rooms. These carts usually consist of a met
structure that includes wire shelves and/or baskets to store the bags and/or containers, The structure
large wheels (e.g., 12.5 cm/5 in or more) that are usually an integral part of the cart to facilitate their
the facility. Intravenous solution bag/container carts may be used also to transport syringes filled with
and/or to return the reusable containers to the central location for reprocessing. Some carts may also
preparation of the IV infusion at the point of care.

Multipurpose central supply carts designed for delivery of a variety of supplies from a central location
healthcare facility that can be folded for storage. These carts typically consist of an easy to clean, larg
plastic structure, with vertical and horizontal (resembling a platform) hinged components. They are m
(e.g., 12.5 cm/ 5in or more in diameter) wheels that are usually an integral part of the cart to facilitate
throughout the facility. The cart typically includes detachable drawers, shelves, and/or cassettes to pe
configuration that makes it versatile enough for use according to the facility needs.
Service/utility carts designed with an open structure that includes wire shelves and/or baskets but doe
enclosures or drawers. These carts are intended for temporary storing and local transportation, usuall
particular area of a healthcare facility. These carts consist of a tubular structure made of metal, plastic
these materials; the structure is mounted on medium or large (e.g., 7.5 cm/3 in or more in diameter) w
an integral part of the cart. Wire open service/utility carts are mainly intended for products large enou
through the wire structure and that do not require any special transportation conditions.

Service/utility carts designed with an open structure that may include solid shelves and/or baskets bu
enclosures or drawers. These carts consist of a tubular structure made of metal, plastic, or a combinat
including metal and/or hard plastic shelves and/or baskets. The structure is mounted on medium or la
more in diameter) wheels that are usually an integral part of the cart. Solid metal/hard plastic open s
mainly intended for products that do not require any special transportation conditions.

Service/utility carts designed with a flat platform that are intended for temporary storage and local tra
confined to a particular area of a healthcare facility. These carts typically consist of a flat metallic or p
mounted on large (e.g., 7.5 cm/3 in in diameter) wheels or on a dolly. Platform carts are usually moved
electrically (battery) operated carts are frequently available. they are available in a variety of configur
capabilities. Some carts include attachments to secure the loads while transporting. They are mostly u
areas, warehouses, maintenance departments, and other areas in the healthcare facilities where heav
handled. Heavy duty platform carts that can manipulate heavy (e.g., 450 kg/1,000 pound) or large-siz
dedicated platform carts that use detachable pallets as the load transporting platform are also availab

Service/utility carts designed with an enclosed structure that are intended for temporary storing and l
inside a particular area of a healthcare facility. These carts consist of structure made of metal, plastic,
these materials that includes solid metal, or hard plastic enclosures and drawers. The structure is mou
large (7.5 cm/3 in or more in diameter) wheels that are usually an integral part of the cart. Enclosed s
mainly used for products that require local transportation protected from the environmental or other c

Carts designed for the storage and local transportation of books, magazines, and/or other printed pub
are usually confined to a particular area of a healthcare facility. These carts typically consist of an ope
made of metal, plastic, glass, or a combination of these materials that may include shelves, and doors
mounted on wheels that are usually an integral part of the cart. Book/magazine carts are used mainly
areas of healthcare facilities intended for staff training.

Carts designed for storage and local transportation of one or more compressed medical gas (e.g., oxy
These carts usually consist of an open metal structure that can securely hold the gas cylinders. They
different sizes and configurations that can hold the cylinders in horizontal or vertical position. Dedicat
intended to transport one or two cylinders in vertical position (known as trucks) and carts that may be
or more cylinders are available. These carts are used to deliver gas cylinders to operating and patient
areas in the healthcare facility.
Gas cylinder carts designed for transportation of one or two gas cylinders simultaneously. These carts
"trucks," usually consist of a metallic structure with two wheels and two handles intended for easy ma
person. Some models include two rear wheels that fold in place when the cart tips back. Single-double
may be used to hold the cylinder during use at the point of care; the carts may also include attachme
hooking to beds and/or wheelchairs.

Carts designed for storage and local transportation of physiologic monitors, accessories, and products
monitoring inside a particular area of a healthcare facility. These carts typically consist of an open or e
made of metal, plastic, or a combination of these materials and may include drawers and shelves. The
on wheels that are usually an integral part of the cart. Physiologic monitor carts are used in intensive
rooms, patient rooms, and doctors' offices for temporary assessment or to evaluate particular physiolo

Heavy duty carts designed for organized storage and local transportation of tools inside a particular a
facility. These carts typically consist of a wide, multi-drawer cart with wheels of ball-bearing sliders, an
They typically include 1 m (40 in) or wider drawers that have a weight capacity of 100 kg (220 lb) or m
storage carts are made of metals (e.g., steel, aluminum) with a painting or coating (e.g., epoxy) that c
solvents, most cabinets have holders to keep tools in place. Some carts are available with a working s
(e.g., drills) can be mounted, others may include a detachable tool chest on their top to facilitate tool
used in healthcare facilities for preventive maintenance and/or fixing of medical devices and other eq
usually moved manually but electrically (battery) operated carts are also available.

Racks designed to provide temporary or long-term storage to many different articles. These racks typi
metal, wooden, and/or plastic framework with several shelves on which items can be stored. They ma
freestanding. Food, cane/crutch, book/magazine, and multipurpose storage racks are available.

Storage racks designed for holding exercise weights. These racks typically consist of an open, heavy m
rails, bars, or tubes on which weights intended for exercise (e.g., dumbbells, barbells) are hung. Most
units that may be mounted on small wheels, but wall-mounted racks are also available. Exercise weig
used in physical therapy and rehabilitation areas of healthcare facilities.

Storage racks designed for temporarily holding and storing canes and/or crutches. These racks typica
heavy metal, wooden, and/or plastic framework with rails, bars, or hangers on which canes and/or cru
may be wall-mounted or freestanding. Cane and/or crutch storage racks are used in hospitals, other h
at home.
Racks designed for holding and storing books and/or magazines. These racks typically consist of a me
framework with several small shelves with brackets or pockets in which books and magazines are held
racks have adjustable shelves and supports to make them sturdier.

Racks designed for holding and storing laboratory containers (e.g., standard laboratory boxes, plates a
a laboratory refrigerator and/or freezer. These racks typically consist of a heavy duty metal frame (typ
which holds boxes and plates secure without a locking rod. Laboratory freezer racks are mainly intend
laboratory products and samples before or during the performance of a laboratory procedure that requ
they are used in clinical laboratories, during research, and/or in other areas of healthcare facilities.
Racks designed for temporarily storing and holding garments. These racks typically consist of an open
and/or plastic framework with rails, bars, hooks, or pegs on which garments are hung; wall-mounted g
hooks/hangers are also available. Some garment racks have small wheels to facilitate placement. Som
intended for clean rooms. Dedicated garment racks intended for aprons, gowns, hats, and coats are a

Garment racks designed for temporarily holding hats and/or coats. These racks typically consist of an
wooden, and/or plastic framework with rails, bars, or hooks on which hats and/or coats are hung. Hat a
be floor-standing (with or without wheels) or wall-mounted.
Racks designed to file medical and/or administrative documents or other media used in a healthcare f
typically consist of an open metal, wooden, and/or plastic framework in which files are usually hung; fi
in many different configurations and sizes such as freestanding or under- or over-the-counter structure
manufactured to store some particular type of documents such as standard letters or legal papers, ca
records, library), or larger documents (e.g., blueprints); others are appropriate for storage of a particu
hanging folders, audio or video cassettes, compact discs). Filing racks are used throughout hospitals, o
facilities, and at home.

Filing racks designed to store files and/or file folders larger than the standard letter or legal size. Thes
consist of an open metal, wooden, and/or plastic framework that can store maps, blueprints, large x-ra
without requiring folding; the rack may include vertical clamps or compartments. Large document filin
used in radiology departments, medical offices, and in administrative areas of healthcare facilities tha
large documents.

Storage cabinets designed to accommodate and protect automated external defibrillators (AEDs). The
consist of either a surface or recessed wall-mounted unit and are typically made of metal (e.g., steel,
fiberglass, or wood. Many cabinets include a glass or transparent-plastic front door to make the AED v
these cabinets may incorporate an alarm that will sound when the cabinet door is opened. AED storag
in many public locations including both healthcare facilities (e.g., hospitals, physician's offices) and no
(e.g., airports, office buildings, recreational facilities).

Installations (stations) designed for blood drawing (i.e., phlebotomy) procedures. These stations typica
combination of an easy-access rack or shelf for consumables (e.g., sample test tubes, gloves, strap to
containers. The station also includes either a chair, typically with an adjustable arm board, or a standa
adjustable height stand to accommodate the patient's arm. Blood drawing stations are intended for us
facilities to facilitate the procedure and improve safety for the phlebotomist. They are mainly used in
great volume of procedures, such as blood banks, hospitals, and clinical laboratories. Dedicated blood
intended for infants and/or disabled people are also available.

Incubators designed to provide the appropriate environmental conditions (e.g., temperature, humidity
necessary for long-term laboratory tests or procedures. These incubators typically consist of an enclos
that provides heat and humidity sources, gas supplies, and the controls to supply them. These chamb
devices and may also include recorders and displays for continuous monitoring of the incubator cham
Dedicated aerobic (oxygen containing) and anaerobic (oxygen free) laboratory incubators and incubat
rotational capabilities are available. Open laboratory incubators intended for total or partial insertion o
(e.g., test tubes) are also available.
Multitherapy infusion pumps designed to deliver from very small to large volumes of liquid medication
therapeutic solutions stored in bags, vials, bottles (or, with an adaptor, syringes) through a single cha
flow rates. Single-channel large-volume pumps typically deliver fluid through intravenous (IV) or epidu
subcutaneous and peritoneal infusion may be performed as well. These infusion pumps usually consis
mechanism to move fluid from the solution container through the IV set to the patient. Three common
linear peristaltic mechanism which uses fingerlike disks to occlude the IV tubing successively in a ripp
(2) the rotatory peristaltic mechanism that uses a short length of silicone rubber tubing held taut arou
a rotor; and (3) the cassette-type mechanism that periodically fills a compartment from the upstream
the downstream side. The pumps also include controls used to select the dose or volume to be infused
to register the actual infusion volume and rate, and audible and/or visual alarms to indicate abnormal
pumps can deliver secondary (piggyback) infusions, controlling two different solutions sequentially. So
"smart pumps") include software capable of detecting medication administration errors (i.e., dose erro
are also available. Single-channel large-volume multitherapy infusion pumps are usually intended for
are used mainly in hospitals, other healthcare facilities, and at home.

Pneumatic tourniquets designed to circumferentially constrict/compress circumferentially an extremity


time by applying a precise amount of pressure using an automated gas-inflated cuff. The pressure is a
surface and underlying tissues using the cuff; pressure is then transferred to the blood vessels causing
occlusion. The pressure should be at least equal or higher than the minimum required to occlude the b
occlusion pressure or [LOP]). These tourniquets typically include an inflatable cuff and a compressed g
tourniquets include a control unit that supplies the compressed gas from a gas cartridge, central supp
container (e.g., a cylinder), or from an integral electric pump. Automated tourniquets also include con
monitors for the applied pressure, and alarms for abnormal conditions; computerized automated tourn
self-calibration checks and display elapsed inflation time. Automated pneumatic tourniquets are used
procedures on the extremities enabling surgeons to perform delicate procedures in bloodless operativ

Dedicated platform service/utility carts designed with a fork-like structure appropriate to manipulate d
pallets. These carts are intended for temporary storing and local transportation, usually confined to a
healthcare facility. These carts (also known as pallet jacks) typically consist of a sturdy metal, wooden
that is placed as a horizontal platform mounted in a two-prong frontal fork that is an integral part of a
mounted on large (e.g., 7.5 cm/3 in in diameter) wheels. Pallet carts are usually moved manually but
operated carts are also available; they are available in a variety of configurations, sizes, and load capa
include attachments to secure the loads while transporting. They are mostly used in central supply are
maintenance departments, and other areas in healthcare facilities where heavy loads are frequently h

Rehabilitation simulators used for the rehabilitation of patients who are partially disabled. These units
recuperation by improving and evaluating their capabilities to enter and exit a parked car. These simu
of a structure that resembles the front compartment of an actual car, including doors, seat, steering w
accelerator pedals, and other standard and/or custom components.
Analgesic infusion pumps intended for implantation that are designed for use in the administration of
spinal fluid space (i.e., intrathecal). These pumps are frequently battery-powered devices. They are co
driven mechanism that is inserted between the skin and the muscle of the lower abdomen; an infusio
an internal reservoir containing the analgesic solution. The analgesic solution is delivered from the pu
tube and then to a catheter with a needle at the distal end that is typically inserted in the intrathecal
implantable pumps that deliver the analgesic without the use of batteries are also available; they are
chamber pump with an inner chamber containing the analgesic drug and an outer chamber containing
temperature of the patient warms the propellant which in turn exerts a constant pressure on accordion
divide both chambers. The pump must be also able to deliver a continuous or intermittent flow and/or
analgesics when necessary. Intrathecal analgesic infusion pumps are used mainly by patients with oth
chronic pain. These pumps may be used also to administer drugs (e.g., baclofen) for refractory spastic

Solutions, creams, or gels designed for application on injured skin to help healing. These solutions and
locally to specific areas of the body to create a physical barrier on the surface of the skin; they are fre
variety of plant materials (e.g., aloe vera, tea-tree oil, witch hazel) and may also include some additio
ozonized olive oil, silicon, zinc oxide, petroleum jelly). Some products may have scar and/or keloid inh
provide local germicidal effects. Injured skin topical solutions and/or creams are intended to promote t
mechanism; they do not contain drugs and do not act metabolically.

Collectors designed to remove dust and other debris from the environment during dental laboratory p
cutting, sawing, and/or drilling of dental prostheses and implants. These collectors typically consist of
tabletop unit that includes filters that entrap fine particle debris having a diameter of one micron or le
that provides suction of the polluted air or a connection to a vacuum source; a collection canister; and
Dental laboratory dust/debris collectors are used in manufacturing and trimming procedures performe
laboratories; some collectors are conformed as small semi-enclosed chambers that allow grinding and
procedures inside the chamber. Dust collectors may be an integral part of dental devices such as polis

Equipment designed to trim the edges of a full-scale reproduction (i.e., a model) of dental prostheses
crowns), orthodontic devices, and/or nearby tissues. These trimmers typically consists of a bench-top
equipment with a frontal working swinging door, coarse and fine abrasive wheels, and a built-in water
trimmers may also include a trimming tray, angulation tools, and a drain hose. Dental model trimmers
laboratories and in dental offices.

Thermoplastic forming units designed to manufacture plastic dental products in a pre-established sha
process. These units consist of a relatively small, typically bench-mounted machine that heats plastic
polycarbonate, nylon) sheets until soft and then applies vacuum to suck the sheet into a mold; after th
shape of the final product, it is ejected. The machines usually include electric motors to drive a suctio
as well as heat, pneumatic, and/or hydraulic controls. They may also include a variety of tools (e.g., va
tray handles, cutting knives and burs) to facilitate the procedure. Dental laboratory vacuum thermopla
also, but less frequently, used in dentists' offices.
Accommodative foot orthoses designed to fill the space between the shoe insole and the user's foot, p
some degree of foot control but without applying corrective forces. These orthoses typically consist of
made of several layers of materials with different characteristics (e.g., plastics, plastic foams) with a s
appropriate for the user. Shoe inserts are intended for pain relief by providing cushioning and pressure
to prevent foot ulcers). They are frequently used by patients with vascular diseases or neuropathies o

Cement that is a glass-ionomeric, hydrophilic, osteoconductive, and biocompatible material used in ot


cement powder and liquid ingredients (such as autologous blood and antibiotics). It is intended for oto
as middle-ear reconstruction; to cement bone grafts, stapes prostheses, or cochlear implant electrode
implantable hearing aid devices.
Nonabsorbable periodontal regeneration membrane implants are thin flexible sheets usually made of
(PTFE) and are intended to facilitate both bone and tissue regeneration. PTFE membranes are implan
surgeries such as bone and socket grafting procedures. Gingival tissue grows faster than bone; by cre
the teeth and the gums, the membranes create barriers between the gum tissue and bone, allowing t
regrow and preventing the gums from filling up all the space. When implanted, a small portion of the
above the patient's gum line so that it can later be removed by dental professionals without requiring
implants are available in various sizes and thicknesses.

Central supply carts designed for delivery of a variety of supplies from a central location to other area
facility. These carts typically consist of an easy to clean, large, heavy duty metal or plastic structure, w
horizontal (resembling a platform) components. They are mounted on extra-large wheels (e.g., 12.5 cm
are usually an integral part of the cart to facilitate movement throughout the facility. The carts are usu
but electrically (battery) operated carts are also available. They typically include detachable drawers,
cassettes to permit a modular configuration that makes it versatile enough for use according to the fa
Multipurpose central supply carts are intended for distribution of centralized material management, st
kitchen, and clinical laboratory supplies; some may be foldable to facilitate their storage when not in u

Medication supply carts designed for direct medication dispensing from the clinical pharmacy in single
Typically the pharmacist dispenses the proper medication for a day (or a longer period of time) into se
marked with each patient's name and/or room number, using information taken from the patient's car
include a removable section of drawers (known as cassettes) that may be intended either one for each
in compartments to hold individual dosages. Other carts include punch cards that hold doses for longe
week, a month). Some carts include a flat storage area for cups and bottles containing pills or liquids i
a working area for preparing oral medicines and/or syringes. Unit-dose medication carts reduce waste
pharmacist time; they also provide better tracking and security for distribution of controlled substance
appropriate for daily distribution of medicines in hospitals, and/or for long term distribution of medicin
facilities.
Carts designed to store, display, and provide ready access to instruments (e.g., scissors, knives), mate
bandages), and drugs (e.g., alcohol, saline) needed for wound care; the top of the cart is typically use
during the procedure. These carts usually include medium or large wheels (e.g., diameter of 7.5 to 12
closed stainless steel multiple drawer, shelf, or shelf/drawer cabinet-like structure; they may have hin
glass or metallic) doors. Some carts also include bottle racks, trays, a sponge bowl, and a pail for trash
used in doctors' offices and emergency rooms in healthcare facilities to treat minor wounds; they are a
surgical treatment of wounds.

Carts designed for storing and local transport of devices, instruments, and materials used in dental tre
clear display and ready access to all items. These carts typically consist of stand-alone multiple-drawe
-shelf/drawer structure with an adjustable height working surface (e.g., the top of the cart) appropriat
performing dental treatments and sometimes other dental procedures; the structure is mounted on m
7.5 cm/3 in) wheels that are usually an integral part of the cart. The working top is typically appropria
drugs, instruments, vials, or other small devices, attachments for handpieces, a high volume evacuato
saliva ejector; some also include built-in grounded outlets, and security locks.

Carts designed for temporary storage and local transportation of devices, instruments, medicine, and/
carts are usually confined to a particular area of a healthcare facility and carry items that are of freque
Storage/transport carts typically consist of an open or enclosed structure made of metal, glass, plastic
combination of these materials. They may include drawers, shelves, and doors and the structure is m
sized wheels (typical diameter of 7.5 cm/3 in). The carts are usually moved manually but electrically (
are also available. Dedicated storage/transport carts are used in clinical and non-clinical areas of the h
including intensive care units, patient rooms, doctors' offices, laboratories, pharmacies, libraries, cafe

Storage/transport carts designed for temporary storage and transport before, during, and after washin
procedures are performed in automated machines. These carts usually consist of a sturdy structure m
plastic, or a combination of these that can resist high temperature and/or gas sterilization, The structu
wheels (typical diameter of 7.5 to 12.5 cm/3 to 5 in). The carts typically include fixed and/or detachab
include other attachments to facilitate loading of products to be sterilized. Washer/sterilizers carts are
process of removal of organic debris and/or killing of microorganisms that may be present in the cart;
performed in dedicated cart washers/decontaminators located in a central station of healthcare faciliti
such as those used for surgical case transportation may also fulfill the requirements needed for washi
automated machines.

Storage/transport carts designed for temporary storage and local transportation of radioactive materia
area of a healthcare facility. These carts usually consist of a sturdy metal structure mounted on mediu
(typical diameter of 7.5 to 12.5 cm/3 to 5 in) that are capable of supporting heavy weights. The carts
detachable container with a single- or double-lined as shielding for the radioactive material. Some car
shielding, making it necessary to use double-shielded radioactive safe containers for transportation. R
carts are used to transport radioactive materials such as radiopharmaceuticals, PET isotopes, and radi
medicine areas and/or from those areas to the patient room.
Devices including one or more metal prongs designed for electrical and mechanical connection. These
consist of an insulated covering with conductive metallic male prongs (typically made of brass and oth
which are connected internally to one or more cords that extend from the other side of the plug. Most
have two or three (e.g., live, neutral, earth) prongs; they are mainly used to connect electrical equipm
diagnostic and therapeutic devices) to the main electrical supply. Explosion-proof, ground connection,
locking electric plugs are also available.

Devices intended for obstructing or tightly closing an external body passage. These devices may cons
material provided with a guiding channel and elements for urging the plug into the passage. The plug
plastic (e.g., polyurethane, silicone) because of its biocompatibility, resiliency, elasticity, and durabilit
tear. Occlusion plugs may have different shapes and sizes. Ear and lacrimal punctum occlusion plugs a

Devices designed to permit electrical and mechanical connection of electric equipment from the main
electric plug. These electric devices commonly have female features (e.g., slots or holes), or a combin
which devices are plugged; the slots or holes have metal contacts that are connected on the opposite
to electrical wiring. Electric receptacles are used to connect electrical equipment (e.g., instruments, d
therapeutic devices) to the main electrical supply. Explosion-proof, ground connection, hospital grade,
receptacles are also available.

Spatulas designed to remove small samples of tissue from the body for cytology. These instruments ty
handheld metallic (e.g., stainless steel) or plastic instrument with a straight or curved blunt distal wor
Dedicated cytology spatulas are used in the vagina and uterine cervix, and on other body surfaces (e.

Spatulas designed for use in dental preparatory and/or operative procedures. These instruments typic
metallic (e.g., stainless steel) or plastic handheld instrument with a straight or curved thin. Flat, blunt
spatulas have working tips on both ends; others are double-ended instruments combined with picks a
Dental spatulas are used in the preparation of restorative materials (e.g., cement, composites, plaster
also used occasionally to spread dental restorative materials during prosthodontic procedures or to sh
making of dental impressions.

Dental spatulas designed to mix dental materials used for impressions, restoration, and/or other denta
procedures. These instruments typically consist of a sturdy metallic (e.g., stainless steel) handheld ins
working distal tip that may be flat or curved. The tips of some of these spatulas are made from materi
to the materials being mixed. Some material mixing disposable spatulas may be wood or plastic. Dent
spatulas are used in the preparation of dental materials used for prosthodontics procedures, such as im
and restoration (e.g., composite resins); they are also used to mix cements and/or other dental mater
procedures. Dedicated smaller spatulas used to mix small quantities of cements are also available.

Dental mixing spatulas designed to mix dental cements. These instruments typically consist of a sturd
stainless steel) handheld instrument with a working distal tip that may be flat or curved. Some may h
both ends. The tip may have a wider surface area to aid in the mixing of cement powders with liquids
stick to the cement being mixed. Some dental mixing spatulas are made from plastic (used mainly for
cement) because stainless steel would react with the material being mixed. Dental cement mixing sp
preparation of dental cements for prosthodontics procedures.
Spatulas designed to spread a substance (e.g., an ointment) on the surface of the eye during ophthalm
These instruments typically consist of a plastic or wooden straight handheld instrument with a thin, fla
Although some may be metal and reusuable, they are usually made from cheaper materials and are d
for a single use application.
Spatulas designed to spread/remove materials, cells, and/or tissues from the body (e.g., skin, body ca
death (i.e., autopsy procedures). Postmortem spatulas are typically sturdier than regular spatulas and
(e.g., stainless steel) handheld instrument with a straight or curved, thin, flat, blunt distal tip. Some p
have working tips on both ends and can be used in gross dissection. Postmortem spatulas are used du
and other procedures on cadavers.

Spatulas designed to manipulate and/or dissect tissues during surgical procedures. These devices typ
metallic (e.g., stainless steel) handheld instrument with a very thin straight or curved, flat, blunt dista
spatulas have working tips on both ends. Dedicated surgical spatulas are used in ophthalmic, brain (n
ear, and other delicate or microsurgical procedures.
Spatulas designed to manipulate and/or dissect abdominal or intestinal tissue during surgical procedu
typically consist of a metallic (e.g., stainless steel) handheld instrument with a straight or curved very
tip. They come in various sizes and some may have a working tip at each end. The working end is usu
manipulate tissues in the abdomen or intestines without damaging the tissues. Intestinal surgical spat
manipulate and/or dissect intestinal tissue during surgical procedures.

Spatulas designed to manipulate and/or dissect bone tissue during surgical procedures. These devices
sturdy metallic (e.g., stainless steel) handheld instrument with a straight or curved very thin, flat, blun
spatulas are sharp enough to be used in the dissection of the bone medulla soft section. Bone surgica
orthopedic and other bone surgical procedures.
Small brain surgical spatulas designed to manipulate and/or dissect brain tissue during microsurgical
devices typically consist of a metallic (e.g., stainless steel) very slender, delicate handheld instrument
curved very thin, flat blunt distal tip. Some brain microsurgical spatulas are flexible and include silicon
them less traumatic to the delicate brain tissue.
Spatulas designed to manipulate and/or dissect eye tissue during surgical ophthalmological procedure
typically consist of a metallic (e.g., stainless steel) handheld instrument with a straight or curved very
in some cases, a semi-sharp distal tip. Dedicated eye surgical spatulas are available for adhesions (sy
surgical procedures for glaucoma, implantation of intraocular lenses, and other ophthalmic microsurgi

Spatulas designed to manipulate and/or dissect eye tissue adhesions, especially iris adhesions to the
(synechiae). These devices typically consist of a metallic (e.g., stainless steel) handheld instrument w
very thin, flat, semi-sharp distal tip. Surgical eye spatulas for adhesions are used during synechiolysis
procedures.
Spatulas designed to manipulate and/or dissect eye tissue during the surgical formation of a commun
anterior chamber of the eye and the suprachoroidal space (i.e., cyclodialysis) performed during surgic
treatment of glaucoma. These devices typically consist of a metallic (e.g., stainless steel) handheld in
straight or curved very thin, flat, blunt distal tip. Some glaucoma surgical eye spatulas are double-end
each end of the handle. Surgical eye spatulas for glaucoma are used in cyclodialysis ophthalmic surgic
Spatulas designed to manipulate and/or dissect eye tissue during implantation of intraocular lenses or
intraocular lens during placement. These devices typically consist of a metallic (e.g., stainless steel) h
with a straight or curved very thin, flat, blunt distal tip. Intraocular lens implant spatulas sometimes h
the spatula for manipulating the intraocular lens. Surgical eye spatulas for intraocular lens implantatio
during ophthalmic surgery for the implantation of an intraocular lens after cataract removal or other r

Small eye surgical spatulas designed to manipulate and/or dissect eye tissue during ophthalmic micro
These devices typically consist of a slender, delicate, metallic (e.g., stainless steel) handheld instrume
curved very thin, flat, blunt distal tip that is sometimes coated with a fine diamond dust. The tips may
ranges of angulation and can attach to a standard handle. Eye microsurgical spatulas are used mainly
dissect eye tissue during ophthalmic microsurgical procedures such as vitreoretinal surgery.

Small ear surgical spatulas designed to manipulate and/or dissect middle ear tissue during microsurgi
devices typically consist of a very slender, delicate, metallic (e.g., stainless steel) handheld instrumen
curved, very thin, flat, blunt distal tip. Some middle ear microsurgery spatulas have angled tips to rea
middle ear canal structures during cochlear surgery. Middle ear microsurgical spatulas are used for mi
procedures on the middle ear.

Spatulas designed to manipulate and/or dissect tissues during vaginal surgical procedures. These dev
a metallic (e.g., stainless steel) handheld instrument with a straight or curved, very thin, flat, blunt dis
spatulas have sturdy handles and curved distal tips to conform to the walls of the vagina to assist in s
vagina for various procedures. Surgical vaginal spatulas are used to manipulate and/or dissect vagina
gynecologic surgical procedures.

Special garments (e.g., neck bands, neck wraps, hats, vests, ponchos) worn to lower the body temper
The cooling garments may achieve cooling by various methods including air cooling, water cooling, ev
or phase-change of water or hydrocarbon gel present within the garments. Some cooling garments ma
or connected to a main power supply to offer refrigeration-type cooling. Other cooling garments may c
packs or the garments may be tethered by hoses to cooling units that circulate forced cool air or cold
hoses to the cooling garments. Cooling garments have many applications in outdoor activities, sports,
preparedness, the military, and home care. Dedicated cooling garments are used by operating room p
in operating rooms and other environments with higher room temperatures.

Spatulas designed to mix and spread bone cement. These instruments typically consist of a metallic (
handheld instrument with a straight or curved thin flat blunt distal tip. Most bone cement spatulas are
finishes so that the cement will not stick to them. Bone cement spatulas are used in the preparation o
also to spread the cement during orthopedic procedures.
Lasers designed to produce alexandrite and Nd:YAG beams that are combined in one system intended
treatments. The beams produced by the laser with alexandrite as an active medium usually operates
755 nm (red) while the radiation from the Nd:YAG laser (yttrium-aluminum-garnet crystal doped with n
nm (near-infrared). The combined systems may be used in the same dermatologic applications that ea
alexandrite and Nd:YAG lasers are intended; the combined systems are particularly used for hair rem
treatments.
Systems designed with capabilities to perform cataract extraction using phacoemulsification and vitre
include a hollow probe that cuts and emulsifies the lenses using ultrasonic waves (phacoemulsification
irrigation and illumination systems; cautery capabilities; and a channel for aspiration of lens and tissu
systems also include a vacuum pump and controls for the power level, irrigation rate, and mode of op
treatment can also be performed using a laser probe to seal blood vessels in the retina (photocoagula
phacoemulsification/vitrectomy systems are used for phacoemulsification and cataract removal in the
also for vitreal/retinal surgery in the posterior chamber of the eye.

Diode lasers designed for thermal liquefaction of a small region (i.e., drilling a small hole) on the non-
the oocyte (i.e., zona pellucida [ZP]), providing access to the embryo. These systems consist of a puls
(typically with a power of 300 mW at a wavelength in the range of 1450 to 1480 nm) and a visible ligh
alignment of the drilling beam. The system is usually attached to the turret of an inverted light micros
camera and appropriate software intended for use in the procedure are also available. Assisted-reprod
intended to enhance the ability of the embryo to escape the surrounding ZP and implant into the uter
laser-assisted hatching). A biopsy process (known as laser-assisted biopsy) where the laser beam pene
completely the entire thickness of the ZP is also possible to facilitate removal of cells from an embryo
diagnosis.

Mobile modular medical facilities designed to provide autonomous integral intensive care to patients.
facilities include capabilities for patient resuscitation, ventilation, cardiac defibrillation and pacing, pu
physiologic monitoring and recording, suction, and some limited clinical in-vitro analysis. The facility a
more stretchers, external or integral (e.g., batteries) power capabilities, and communication systems;
the performance of minor surgery procedures. Mobile intensive care modular facilities are appropriate
operations in the field (e.g., car accidents, natural disasters, combat), in healthcare facilities during em
during patient inter-hospital transfer.

Tubing sets designed for external transport of contrast media from an injector to a peripherally inserte
catheter at high pressure (i.e., using powered-injectors). These sets typically include a plastic (e.g., po
silicon tube that connects the injector syringe with the catheter and an anti-reflux valve. Contrast med
extension sets are intended for use with automated contrast media injectors that provide powered (ab
or more) injection during computerized tomography and magnetic resonance procedures.

Electronic recorders designed for continuous storage of data that show changes in intraocular pressur
recorders typically consist of a wearable electronic recorder that receives signals from an electro-mec
embedded in a disposable contact lens or implanted in the eye. These signals provide information on
sensor incorporates a wireless transmitter that delivers the signals, usually during a 24-hour time peri
includes sleep time. These recorders typically consist of a wearable electronic recorder that receives s
information on IOP changes from an electro-mechanical sensor that is embedded in a disposable cont
the eye; the sensor incorporates a wireless transmitter that delivers the signals usually during a time
less including sleep time. The data stored in the recorder is then downloaded to a computer (e.g., per
a dedicated software that permits the analysis of the recorded data by an ophthalmologist. IOP record
facilitate the diagnosis and evaluation of glaucoma.
Contact lenses designed to diagnose changes in intraocular pressure. These lenses typically consist of
lens with an embedded sensor (e.g., a strain gauge) that detects changes in the curvature of the corn
transmitter with an antenna. The transmitter sends signals with the detected variations to a wearable
usually during a 24-hour time period, including sleep time. The data stored in the recorder is then dow
(e.g., personal computer) using a dedicated software that permits the analysis of the recorded data by
IOP contact lenses and recorders are mainly used to facilitate the diagnosis and evaluation of glaucom

Physiologic recording software designed for later processing of intraocular pressure (IOP) data obtaine
software is intended to work only with one or a few models of IOP recorders, usually from the same m
software may perform a variety of algorithms to facilitate the analysis of measurements performed du
recording is usually performed in a time period of 24 hours or less. IOP recording software is mainly in
the information by an ophthalmologist using a standard computer (e.g., a personal computer), to facil
diagnosis and evaluation of glaucoma.

Flexible video tracheoscopes designed to pass through the vocal cords to view the carina and trachea
assisting endotracheal intubation procedures. These tracheoscopes consist of a flexible endoscope ab
long with a working channel, a suction channel to extract mucous and/or bronchial secretions, a fiber
appropriate lenses, and a small battery-powered light (e.g., halogen) source. The tracheoscopes are u
single lumen tracheal tubes, but some permit passing through double lumen tubes. Add-on cameras a
through video systems. Intubation tracheoscopes are mainly used to facilitate placement of tracheal
situations even when a laryngeal fracture is present; they may be also used as standard laryngoscope

Healthcare workstations designed to facilitate the diagnosis of common diseases by performing a set
physiologic tests. These units are placed in installations known as medical kiosks and operated by the
and/or images obtained are then compared with the information available in the kiosk workstation. Se
(automated) medical diagnostic kiosk workstations typically consist of mobile computerized units (e.g
laptops) that include input devices (e.g., keypads, touch-screens), output devices (e.g., monitors, prin
memories and processors. The kiosk workstations also include as integral components physiologic me
monitors, recorders, and appropriate software; they may also include interfaces with healthcare inform
operated diagnostic kiosk workstations usually provide a limited set of tests (e.g., blood pressure, puls
electrocardiography, height and weight measurement, spirometry, blood glucose). In addition to heal
workstations may be available in pharmacies and other non-clinical locations.

Carts designed for organized storage and transport, and also to provide ready access and facilitate the
supplies needed to treat sensory processing disorders (also known as sensory integration dysfunction
dysfunction of the vestibular system. These carts usually include several compartments intended to h
intended for sophisticated stimulation of the senses. These devices may include light sources, project
vibration pillows, mirrors, tactile balls, and aroma diffusers. Sensorial therapy carts are mainly used to
by providing stimuli to their senses.
Computer input devices that are designed for the entry of data in a computer, workstation, or other co
or systems through manipulation of a handheld lever. This lever can be moved in several directions to
of an image on a computer display screen. A variety of joysticks are available according to the intende
specific joysticks include data input for computers, workstations, and computerized systems, often as
of computers (e.g., laptop computers) and other computerized systems.

Computer peripheral devices that consist of a touch-sensitive display screen that responds when the c
a finger or stylus to the screen to move a cursor on a computer screen, or manipulate images, icons, o
Computer input touchscreens are used to navigate around a computer program or web page. Applicat
computer touchscreens include data input for computers, workstations, and computerized systems, of
component of computers (e.g., laptop computers) and other computerized systems.

Computer peripheral devices that consist of a small, rotatable ball (i.e., trackball) set inside a stationa
trackball is rotated to enter motion data into computers in order to direct the cursor on a computer sc
mountings also include left-click and right-click buttons that are used to select desktop objects or posi
entry on a computer screen, and to manipulate images, icons, or items on the screen. Computer input
navigate around a computer program or web page. Applications of specific computer input trackballs
computers, workstations, and computerized systems, often as an integral component of computers (e
and other computerized systems.

Endoscopic morcellators consisting of a system that combines an electrically powered unit, a hand pie
blades, brushes, and extractors designed to perform the division and removal (i.e., morcellation) of tis
endoscope using minimally invasive surgery (e.g., laparoscopic) procedures. They work by suction, wh
into its tip where it is minced by a rapidly rotating blade, thereby excising and evacuating the tissue t
Endoscopic gynecology morcellators are mostly used for dissection of the large tissue masses typicall
gynecological procedures, such as in the extraction of the uterus or benign tumors (myomas).

Ophthalmic instruments designed to assess the ability of a patient's vision systems to coordinate with
performing a given task. These instruments also help train the patient to control and guide their hand
variety of instruments used to assess or train vision systems are maze tests, during which the users tr
through a maze without deviating from the borders (usually an audio signal indicates a mistake); mirro
simple shape that should be traced on a piece of paper using only a mirror reflection of it as a referen
tests. Pursuit rotor tests consist of a circular metal plate marked with a spot near the edge of the plate
motor that can speed up or slow down, and a sensor in the turntable. The sensor records the amount
maintain contact and compares that with the amount of time they lose track of the spot in a given per
coordination instruments are intended to evaluate and improve the capabilities of children with strabi
people who require well-coordinated capabilities for working or to perform other special tasks.

Visual photic stimulators designed to apply stimuli to the eyes in the form of rotating discs with black
different width and spacing. These stimulators usually include a set of discs that are chosen according
visual problem (usually amblyopia). Alternating applications of the stimuli to the normal eye and to th
result in an improvement of the accommodation function. Grating visual photic stimulators (also know
stimulators) are mainly used in the treatment of monocular strabismus, especially in children. Devices
sources are also available.
Exercisers designed for training of the ocular muscles to improve the alignment and coordination of st
These exercisers consist of a tabletop stand that includes a chin rest, an adjustable arch that may be p
different planes which allows a luminous signal to move along it, and a light source. The device also in
light speed and total arch of displacement. Ocular muscle training exercisers are intended for patients

Caps designed to disinfect and provide mechanical protection to intravenous (IV) ports and needleless
reduce the risk of infection. These devices typically consist of a sterilized sealed plastic threading cap
like pad soaked with a disinfectant such as isopropyl alcohol. The pads are used as a friction scrub, the
port or connector to protect until the next use, typically up to seven days.

Solutions that have viscous and some elastic properties intended to be instilled into the urinary bladd
which main component is chondroitin sulfate, a sulfated glycosaminoglycan (GAG) composed of a cha
(N-acetylgalactosamine and glucuronic acid).The solutions are instilled into the bladder via a urinary c
designed to help temporarily replenish the deficient GAG layer on the bladder epithelium in order to tr
The products used for cystitis relief are usually supplied in sterilized vials. The products used for cystit
available as a two percent concentration solution of chondroitin sulfate.

Equipment designed to exchange heat from water to a substance that is capable of a reversible phase
to gas (i.e., a refrigerant). This equipment typically consists of a powered (e.g., electrical, steam) mec
provides the heat exchange from the water to the refrigerant in a closed loop; then the refrigerant ma
the local environment or pump it to the external atmosphere. Water chillers frequently use the vapor-c
technology (i.e., the reverse Rankine cycle) which main components are: (1) the refrigeration compres
exchanger (i.e., condenser), and (3) an evaporator (that is also a heat exchanger); other technologies
on absorption technology are also available. Water chillers are used in many applications that require
temperature low, including air conditioning, bringing down the water temperature in processes (e.g., s
produce heating (e.g., to speed the drying cycles), and during laboratory analysis that require low tem

Clinical chemistry reagents intended to be used in the performance of qualitative and/or quantitative
body fluids (typically in a sample of plasma or urine) to determine the level of one or more amino acid
organic compounds including both an amino group and a carboxyl group; alpha amino acids are the m
proteins. The clinical significance of amino acid levels depends on the amino acid and body fluid chose

Clinical chemistry reagents intended to be used in the performance of quantitative chemical analysis
(typically plasma or urine) to determine the total (i.e., the sum of protein bound, oxidized and reduced
homocysteine. Homocysteine (Hcy) is a sulfur-containing amino acid that is a metabolic intermediary
essential sulfur containing amino acid methionine. The clinical significance of total Hcy levels are is re
conditions (vitamin B deficiency, renal diseases, genetic defects, drug consumption, age, general hea
of total Hcy may be indicators of atherosclerosis and of other cardiovascular diseases. The tests are al
diagnosis and treatment of patients with hyperhomocysteinemia and homocystinuria.
Clinical chemistry reagents intended to be used in the performance of qualitative and/or quantitative
body fluids (e.g., serum, plasma) to determine the level of the enzyme adenosine deaminase (ADA) pr
instruction given by the ADA genes. Low ADA levels in blood are related to systemic metabolic disorde
may cause opportunistic infections associated with marked lymphocytopenia and the absence of both
immune function. Early onset of ADA deficiency, usually diagnosed before age six months, characteriz
severe combined immunodeficiency disease (SCID).

Immunoassay reagents intended to be used in the performance of quantitative analysis of body fluid
determine the level of the protein Ccystatin C. Determination of cystatin C level in serum provides its
detection of small to moderate decrease in kidney function (e.g., by giving an estimate of the glomeru
[GFR]).; hHigh levels of this protein in serum are also related to general health status and to a variety
diseases.

Synthetic tissue adhesive compounds that include a cyanocrylate (e.g., N-butyl-2-cyanoacrylate) as th


Cyanoacrylates solidify (i.e., polymerize) in contact with weak bases, such as water and blood. These
known as cyanocrylate glue) are frequently mixed before application with lipiodol to slow the rate of p
allow visualization using fluoroscopy. Cyanocrylate tissue adhesives are mainly used for hemostasis, w
fistula repair. They are also used during endoscopic procedures for gastric or esophageal varices.

Multitherapy systems designed to provide musculoskeletal treatments by means of several modules o


energy sources. These systems usually consist of a central control unit and modular or integral source
shock wave generators, electrical stimulators, lasers) and appropriate leads and probes designed to a
muscles and bones; the system may also include a common display (e.g., touch screen) and software
according to the type of energy to be applied. Musculoskeletal treatment systems are used for the app
(typically ultrasonic and electric) during a variety of procedures performed in different areas of the bo
used mainly in physical therapy and rehabilitation procedures.

Systems designed to provide therapeutic treatments by means of several modules of different externa
making possible a variety of external treatments. These systems usually consist of a central control un
integral sources of energy (e.g., shock wave generators, electrical and electromagnetic stimulators, la
leads and probes to apply each of the stimuli; the system may also include a common display (e.g., to
software using several protocols according to the therapy to be performed. These systems are used fo
energy from one or more sources to the patient during a variety of procedures performed during treat
used mainly in physical therapy but they are also used in other specialties such as dermatology, gyne
otolaryngology.

Topical tablets designed for introduction into the vagina which do not contain drugs and do not act me
tablets are often made from plant materials; they are dissolved inside the vagina to provide the intend
topical tablets are used for several purposes, such as acidity regulation and vagina tightening, itch red
lubrication of the vagina.
Reagents used in cytology and/or histology assays to determine sperm (i.e., spermatozoa) chromosom
fragmentation (i.e., lack of integrity) and/or other DNA damage present in the seminal fluid. Reagents
chromatin dispersion (SCD) tests typically consist of a kit including devices such as Eppendorf tubes, s
consisting of denaturing and lysing solutions, stains, and ethanol. The DNA disruption is assessed on
light microscope. Other methods of testing sperm DNA fragmentation are also available, such as those
chromatin structure assay (SCSA); (2) terminal deoxynucleotidyl transferase TdT-mediated deoxyuridi
nick end labeling (known as TUNEL assay); and (3) a single-cell gel electrophoresis assay (known as th
these methods use flow-cytometry and/or microscopes for assessing the results.

Laboratory instruments designed for dispensing and placement of minimum inhibitory concentration (
inoculated agar plates. These instruments consist of benchtop units that apply the strips by means of
automated or manual procedures, frequently using a handheld vacuum probe attached to the unit. MI
dispensing/placement instruments are used to facilitate laboratory manual tests intended to determin
antibiotic treatments of microorganisms such as bacteria and fungi; the instruments may be intended
placement of strips or discs manufactured only by a particular manufacturer or model.

Generators designed to produce rubidium 82 chloride (RbCl) solutions for intravenous administration.
typically consist of a lead-shielded column containing strontium (Sr) 82 (usually obtained from a partic
adsorbed on stannic oxide; the generator provides a sterile solution (eluate) of radioactive rubidium 8
82. Radioactive rubidium 82 injection is used for imaging of the myocardium and/or to evaluate myoc
positron emission tomography (PET) in patients with suspected or existing coronary artery disease or

Supporting structures (i.e., docks) designed to facilitate connectivity to otherwise handheld (or portab
automated charging of their internal rechargeable batteries. These docks (also known as docking stat
of a structure made of metal, hard plastic, or a combination of these that is usually mounted on the w
tabletop. The docks hold and provide appropriate connectors to plug-in or cradle the handheld device
connectivity and/or providing means to recharge their internal batteries. The docks may also include w
connection to other devices and /or information systems, a power converter (e.g., 120 VAC to 12 VDC)
connection to the mains.

Endoscope attachments designed for placement on the distal tip of endoscopes that are intended to f
of the submucosal tissue using endoscopic tools. These attachments usually consist of disposable tran
tubes available in a variety of shapes and sizes with appropriate fenestrations to provide a clear endo
the mucosa (i.e., submucosal) and also facilitating the sharp dissection of tissue using an endoscopic
(e.g., electrosurgical). Submucosal dissection attachments are mainly used in procedures performed in
tract; some dedicated devices are especially intended for use in the esophagus and stomach.

External shock wave therapy (ESWT) systems designed to produce shockwaves from spark-gap (also k
generators. These systems consist of a generator that includes a spark-gap electrode; when a high vo
across the electrodes placed on a water-filler tank, the discharge of energy generates a vaporization b
and then collapses with the result of a high-energy pressure wave (i.e., the shock wave). Electrohydra
intended to produce mechanical and biological effects on tissues. Both dedicated systems intended fo
other applications and systems that provide strong mechanical effects (i.e., lithotripters) for the destru
gallbladder stones are available.
Thermally isolated containers designed to provide mechanical protection and a high degree of therma
blood products (e.g., red blood cells) during transportation without using refrigeration or frozen substa
passive thermal isolation). These containers typically consist of vacuum isolated panels tightly covere
(usually a cardboard box); the panels are filled with modules appropriate to transport blood and/or blo
product thermally isolated containers permit the transportation of the products within a narrow range
temperatures during a limited period of time (e.g., 48 to 72 hours) even in an extremely hot or cold (e
-20 to 40 degrees Celsius/-4 to 104 degrees Fahrenheit) environment. Passive isolation thermally prote
containers may be portable or mobile; the modules usually should be conditioned in a freezer prior to

Tissue ablation radio-frequency (RF) therapy systems designed to ablate regions of the airway smooth
bronchi. These systems consist of a central unit with low-power temperature controlled RF generator,
bronchoscope that may be introduced through the nose or mouth, and a catheter with an electrode ar
introduced through the bronchoscope lumen into the airways. Once the electrode array reaches the ta
expanded against the airway wall and activated to perform the muscle ablation. The process may be r
segments of the bronchi in the same procedure and usually in other areas of the lung during other ses

Posturographic analyzers designed to evaluate an abnormal posture due to variations in the spinal str
and/or the position that it takes during body movements. These analyzers usually consist of a video im
multiple photographic image system, a control console, markers for a set of reference (e.g., reflective
computerized image processing systems, an image display, printers, and appropriate software includi
evaluate abnormal spinal curvatures based on the measured parameters (e.g., the spinal rotation). Th
include ionizing radiation equipment. Spinal posturographic analyzers are used for screening, diagnos
progress of patients who suffer from a curvature of the spine usually combined with a rotation of the v
scoliosis), extreme curvature of the upper back (i.e., kyphosis), or inward abnormal curvature in the lu
lordosis).

Video reading -aid magnifiers that integrate a camera, lighting, viewing screen, and battery charger in
they are intended to be used as reading and vision aids. Handheld video magnifiers are designed to b
unit over the images or objects, such as labels on packages of food or medicine, reading materials, m
or pictures, to be magnified and viewed on the unit's screen. These magnifiers include adjustable opti
magnification, brightness, text and background colors, and contrast levels. Some models include the a
save an image.

Solutions and creams designed to apply on the throat to produce topical, non-metabolic effects. These
may be based on natural oils (e.g., olive, glycerin, chamomile) or water (e.g., saline) solutions; they m
additional components such herbal extracts and/or other chemical products (e.g., analgesics). Throat
solutions/creams are available in liquid state for application of drops or as spray; they are also availab
They are formulated to moisturize and protect the throat, to alleviate sore throat, to prevent snoring, a
analgesic effects intended to reduce pain and/or to facilitate the introduction of instruments for exami
the respiratory tract.
Multitherapy infusion pumps design to deliver from very small to large volumes of liquid medications a
solutions stored in bags, vials, bottles (or, with an adaptor, syringes), at programmed flow rates. Large
typically deliver fluid through intravenous (IV) or epidural routes, although subcutaneous and peritone
performed as well. These infusion pumps usually consist of a pumping mechanism to move fluid from
through the IV set to the patient. Three common types are: (1) the linear peristaltic mechanism which
occlude the IV tubing successively in a rippling, wavelike motion; (2) the rotatory peristaltic mechanis
length of silicone rubber tubing held taut around rollers mounted on a rotor; and (3) the cassette-type
periodically fills a compartment from the upstream side and empties to the downstream side. The pum
infusion liquids through only one channel (i.e., single-channel pumps) or simultaneously using several
channel pumps). They also include controls used to select the dose or volume to be infused; recording
the actual infusion volume and rate; and audible and/or visual alarms to indicate abnormal conditions
deliver secondary (piggyback) infusions, controlling two different solutions sequentially per pumping c
(known as "smart pumps") include software capable of detecting medication administration errors (i.e
systems) are also available. Large-volume multitherapy infusion pumps are usually intended for IV po
used mainly in hospitals, other healthcare facilities, and at home.

External shock-wave therapy (ESWT) systems that combine electromagnetic and pneumatic ESWT un
orthopedic procedures. These systems typically consist of: (1) a unit consisting of an electromagnetic
produces a magnetic field when an electric current circulates through a coil attached to a thin metallic
low frequency (e.g., frequencies up to 15 Hz) shock wave is then generated when the membrane is re
field; the shock waves are then applied through a radial applicator to provide radial-pressure-wave the
that consists of a compressor used to generate pneumatic ESWT of low frequencies (usually up to 35H
using an applicator to the affected areas to provide vibration therapy. Electromagnetic (radial) ESWT t
orthopedic procedures to alleviate pain and treatment of chronic orthopedic diseases (e.g., plantar fas
tendinitis); pneumatic ESWT (vibration) therapy is intended to trigger body actions such as inhibiting i
mediators, activate cellular defenses, and release of pain mediators.

Infusion pumps designed to deliver large volumes of liquid medications and other therapeutic solution
intravenous (IV) or epidural routes at pre-established accurate flow rates capable of working in high in
such as those present during magnetic resonance imaging (MRI) procedures without introducing hazar
producing artifacts in the MRI images. MRI safe infusion pumps do not have ferromagnetic parts or pro
interference; conditional safe pumps may be safe up to a magnetic intensity value (e.g., up to 3 Tesla)
of the suite depending on gauss line locations, but cannot be identified as having no ferromagnetic pa
pumps usually consist of a pumping mechanism that is not affected by magnetic fields to move fluid f
container through the IV set to the patient. The most common type is the linear peristaltic mechanism
disks to occlude the IV tubing successively in a rippling, wavelike motion); the mechanisms may be al
or cassette type. They also include controls used to select the dose or volume to be infused; recordin
register the actual infusion volume and rate; and audible and/or visual alarms to indicate abnormal co
(known as "smart pumps") include software capable of detecting medication administration errors (i.e
systems) are also available. MRI large-volume multitherapy infusion pumps are usually intended for IV
are used mainly in MRI areas in hospitals and other healthcare facilities.
Infusion pumps designed to deliver large volumes of liquid medications and other therapeutic solution
intravenous (IV) or epidural routes at pre-established accurate flow rates capable of working in high-p
(usually up to three absolute atmospheres) such as those present in hyperbaric chambers. These infus
consist of a battery-powered pumping mechanism that is not significantly affected by high pressure to
solution container through the IV set to the patient. The most common type is the cassette mechanism
fills a compartment from the upstream side and empties to the downstream side. The pumps also inc
the dose or volume to be infused, recording capabilities to register the actual infusion volume and rat
visual alarms to indicate abnormal conditions. Some pumps (known as "smart pumps") include softwa
medication administration errors (i.e., dose error reduction systems) are also available. Hyperbaric in
in hospitals and other healthcare facilities during procedures performed inside single- or multiple-patie
chambers.

Syringe infusion pumps designed for use in delivering relatively small volumes of liquid medications a
through intravenous (IV), epidural, and subcutaneous routes at pre-established accurate flow rates (e.
ml/hour). These devices are capable of working in high intensity magnetic fields such as those presen
resonance imaging (MRI) procedures without introducing hazardous conditions or producing artifacts i
safe infusion pumps do not have ferromagnetic parts or produce radiofrequency interference; conditio
be safe up to a certain magnetic intensity value (e.g., up to 3 Tesla) or in certain locations of the suite
line locations, but cannot be identified as having no ferromagnetic parts. These pumps usually consist
that drives a screw or gear mechanism that is not affected by magnetic fields (e.g., constructed with n
metals) which advances either the plunger or barrel of the syringe at a predetermined rate. They also
controls used to select the dose or volume to be infused, and audible and/or visual alarms to indicate
most pumps the syringe containing the infusate must be manually replaced once it has emptied to co
MRI-compatible syringe infusion pumps are especially appropriate for delivery of small volumes of con
syringe pumps (known as "smart pumps") include software capable of detecting medication administr
error reduction systems) are also available. MRI-compatible syringe multitherapy infusion pumps are u
pole mounting and/or to be placed on tabletops; they are used mainly in MRI procedure areas in hospi
healthcare facilities.
Infusion pumps that are small enough to be worn or carried by patients (i.e., ambulatory) including ele
mechanisms that are designed to deliver liquids to a patient through intravenous, epidural, or subcuta
internal reservoirs at pre-established accurate flow rates. Electronic ambulatory infusion pumps typica
disposable syringe or a disposable, collapsible bag reservoir; a mechanism for propelling the infusate;
control mechanism; and means of displaying alarm conditions and/or user prompts. Pumps using peris
successively squeeze and release the IV delivery tubing, moving the fluid into the patient catheter. Sy
syringe as a drug reservoir, propelling the fluid by forcing the plunger, or piston, into the syringe barre
electronic ambulatory infusion pumps are usually microprocessor controlled; some models can be prog
complex infusion regimens. Some pumps (known as "smart pumps") include software capable of dete
administration errors (i.e., dose error reduction systems) are also available. Many electronic, battery-p
alarms to indicate high pressure (usually signifying occlusion), near end of infusion, empty reservoir, a
malfunction, unlocked reservoir, and low battery. Most pumps can detect flow errors and electronic ma
conditions are typically identified on a display integral to the pump and/or by an audible signal. Electr
are used mainly by ambulatory patients in hospitals, other healthcare facilities, and at home.

Infusion pumps designed for use only in thesubcutaneous administration of insulin. These pumps typic
pumping mechanism, an infusion rate controller, and an internal reservoir (e.g., 3 ml) containing the i
insulin is delivered from the pump to a subcutaneous catheter that is typically inserted in the abdome
pumps infuse in micro volume pulses that mimic the function of a normal pancreas; the pump must be
mealtime or supplementary bolus doses of insulin when necessary and many pumps also offer profile-
account for daily patterns of insulin needs. Most pumps have memory capabilities, and most pumps h
that terminates insulin infusion if a button on the pump is not pushed within a preprogrammed period
are used mainly by patients with diabetes. Both ambulatory and implantable insulin pumps are availa

Infusion pumps designed to deliver insulin that are intended for implantation. These pumps are freque
devices that use a syringe-driven mechanism, an infusion rate controller, and an internal small-volum
containing the insulin solution; the insulin is delivered from the implanted pump to a subcutaneous ca
the distal end that is typically inserted in the subcutaneous tissue or the peritoneal cavity. Implantable
usually programmable using an external telemetric programing device according to the individual nee
insulin rates. Many units offer profile-based programming to account for daily patterns of insulin need
in micro volume pulses that mimic the function of a normal pancreas; the pump must be also able to d
supplementary bolus doses of insulin when necessary. They are intended for patients having type I dia
possible to obtain appropriate results using other conventional insulin administration methods.
Infusion pumps designed to deliver liquid analgesics through intravenous (IV), subcutaneous, or epidu
established accurate flow rates. These pumps typically include electronic (e.g., syringe-driven, perista
nonelectronic elastomeric mechanisms. Analgesic pumps are designed with specific safeguards that re
drug that can be requested and/or delivered over a specific period of time (e.g., 1 mg of analgesic eve
pumps are usually capable of recording cumulative data regarding number of doses delivered, date/tim
delivered, number of requests received, and total volume of drug delivered. They are mainly used to g
postoperative, obstetric, terminally ill, and trauma suffering patients. Pumps that allow for self-admini
(i.e., patient-controlled), within pre-established limits, are also available. These self-administration pu
ambulatory or implantable.

Infusion pumps designed to deliver a predetermined amount of analgesic drug on demand (i.e., when
patient) as well as delivering continuous pain control. These devices are small enough to be worn or c
prevent tampering or diversion, PCA pumps typically offer a method of securing the controls and med
which is connected to a proprietary administration set. The administration set is connected to an infus
infusion device (e.g., epidural catheter, subcutaneous injection/infusion port). Ambulatory PCA pumps
programmed to deliver in any one of the following modes: demand dose, demand dose plus continuou
continuous infusion; these pumps can also be programmed to deliver one-time doses (i.e., bolus dose
designed with specific safeguards that restrict the amount of drug that can be requested and delivere
of time (e.g., 1 mg of drug every 6 minutes for a total of 10 mg per hour). The pumps allow narcotic a
morphine, meperidine, hydromorphone) and fentanyl to be administered as needed by the patient wh
within the prescribed limits and preventing unauthorized access to the medication. The software inhe
is typically capable of storing cumulative data regarding number of doses delivered, date/time of each
number of requests received, and total volume of drug delivered. Ambulatory PCA pumps are intended
pain by permitting self-administration of analgesics (i.e., patient-controlled analgesic pumps) within p
most pumps can be attached to intravenous poles if necessary.

Infusion pumps designed for use in the administration of analgesics that are intended for implantation
frequently battery-powered devices that use a syringe-driven mechanism, an infusion rate controller,
reservoir containing the analgesic solution. The solution is delivered from the implanted pump to a su
with a needle at the distal end that is typically inserted in the desired position. The pump must be abl
continuous or intermittent flow and/or deliver bolus doses of analgesics when necessary. Implantable
pumps are used mainly to treat otherwise intractable chronic pain; dedicated implantable pumps desi
medication to the space that contains the spinal fluid (i.e., the intrathecal space) are also available.
Infusion pumps including syringe mechanisms that are designed for use only in administering anesthe
intravenous (IV) routes at pre-established accurate flow rates (e.g., 0.1 ml/hour). These pumps usually
motor that drives a screw or gear mechanism to advance either the plunger or barrel of the syringe at
electronic controls used to select the dose or volume to be infused, and audible and/or visual alarms t
conditions. In most pumps, the syringe containing the infusate must be manually replaced once it has
continue the infusion. Some pumps (known as "smart pumps") include software capable of detecting m
administration errors (i.e., dose error reduction systems) are also available. Some units have over-dos
pharmacokinetic profiling (e.g., rate is tailored to a target bloodstream level). Anesthesia syringe pum
surgical and special procedures (e.g., catheterization) areas in hospitals and other healthcare facilities
pumps are used mainly in surgical and special procedures (e.g., catheterization) areas in hospitals and
facilities.

Pumps designed for delivering and withdrawing liquids to and from laboratory equipment at pre-estab
rates simultaneously and/or sequentially. These pumps typically consist of a syringe pump with a pisto
propelling and withdrawing liquids (e.g., sample solutions). The pumps are capable of delivering and w
and/or small volumes of liquids through one or several channels; they are used for liquid managemen
injection) in clinical laboratories and other health facility areas.

Metal spikes applied to the distal end of crutches (i.e., crutch tips) designed to provide skid-resistant t
spikes are intended for use outdoors on snow, ice or other slippery or uneven surfaces. These spikes h
gain traction, ease shock to the shoulder, and help prevent accidental falls. The spikes can easily be r
for indoor use of canes and crutches.
Neuromuscular function physiologic analyzers designed to evaluate the strength, dexterity, and range
functional capacity evaluation [FCE]) of a person. To make a complete FCE, the analyzers should inclu
permit the (frequently computerized) assessment of dexterity and range of movement of the main bo
fingers, hands), muscular strength (e.g., weight lifting), as well as the coordination between the senso
vision) and the performance of different tasks. FCE analyzers typically consist of a rack that includes t
gauges, dynamometers, pinch measurement) and attachments (e.g., weight lifting boxes) needed to p
evaluation; the analyzer may also include dedicated software to make a computerized fast evaluation
mainly used during rehabilitation treatments and/or to evaluate the working capabilities.

Treatment cabinets designed for use during infant resuscitation. These cabinets typically consist of a w
metallic structure typically including a slide-out bassinet or infant bed and a warming system. The cab
the devices needed for infant and/or neonate resuscitation such as an internal oxygen tank and/or a h
an aspirator, a resuscitation bag, timers (e.g., for Apgar score), manometers, and monitors. Adjustable
drawers for storage of supplies and rails to attach additional devices are also integral parts of the cab
stand-alone units but some may be mounted on the wall. Infant resuscitation cabinets are located in m
areas and in emergency departments of healthcare facilities.
Aerobic laboratory incubators that provide accurate control on the carbon dioxide (CO2) level in the in
These incubators typically consist of a chamber with controlled temperature (e.g., from 30 to 42 degr
degrees Fahrenheit); high relative humidity (typically higher than 90%); and controlled levels of carbo
5 to 10 percent that are appropriate for cells to thrive. These incubators typically consist of an interna
a water or air jacket; microprocessor controllers for temperature, humidity, and CO2 levels(frequently
sensors); they may also include air filters and/or copper components (e.g., copper stainless steel alloy
contamination. Carbon dioxide laboratory incubators are used mainly for growing cells that require ox
bacteriology, virology cultures) and CO2 to promote cell growth; they are also used in other applicatio
cancer tests, and in vitro fertilization procedures. They are available as tabletop and self-supported (i.

Rehabilitation simulators used for the rehabilitation of patients to help them recover their driving capa
their progress. These simulators frequently consist of a structure that resembles the main component
compartment of an actual vehicle; the structure includes a driver seat mounted on casters, a steering
doors, turn signals, brakes and accelerator pedals, and a horn. Driving training simulators are comput
dedicated software that permits the user perform interactive operations such as steering, throttle and
activate turn signals. The training includes most of the actual operations performed with a vehicle, su
control of speed, and reading of road signals. The software program also assesses the performance of
virtual driving training (i.e., keeping in the appropriate lane, reaction times, attention deficit), and pro
after each training session. Driving training simulators are mainly used for rehabilitation of patients w
diseases or accidents, permitting a faster recuperation of the driving capabilities. Dedicated training a
trucks are available.

Equipment designed for use in working materials into a desired form by performing mechanical opera
and cutting. These machines usually consist of a rotating assembly (also known as spindle) that includ
and associated detachable drilling or cutting devices (e.g., drill bits, saws) and a support (e.g., a vise c
the piece that is being conformed. Unlike a conventional drilling machine which holds the piece under
drill moves axially to penetrate the material, milling machines also move the piece under work radiall
against the rotating spindle. Both the piece and spindle movements are precisely controlled (e.g., to le
inch/0.025 mm); milling machines may be manually operated, mechanically automated, or digitally co
computer-aided design/manufacturing, CAD/CAM) methods. Milling/drilling machines may be used for
applications; dedicated machines intended to manufacture dental prostheses are available.

Bristled mats designed to apply pressure on points that are very close to each other on a particular ar
therapeutic purposes. These devices typically consist of a symmetrical arrangement of many plastic b
uniform distances (e.g., 3 or 6 mm/0.125 or 0.25 inches). The bristles are usually shaped as needles o
they are fixed in a fabric or plastic mat. Bristled mats are available in a variety of shapes and sizes, ac
intended area of the body to be treated. The mats may stimulate the skin and the peripheral blood ci
intended to have a therapeutic effect on the musculoskeletal system, spine, joints, and muscles and a
improve sleeping.
Devices designed to be partially introduced in the outer ear canal of a patient that is lying on one side
device (i.e., the ear candle) is vertically located on the upper ear and then the distal end of the candle
flame. The flame produces a low pressure intended to draw out cerumen (ear wax) and/or debris from
candles usually consist of piece of fabric (e.g., cotton) with the shape of a cone or cylinder that is imp
and/or other products (e.g., honey, herbs); some ear candles may include a one-way valve to prevent
being introduced in the ear canal during the use of the candle. Ear candles are intended to clean the e
treatment of blocked ears due to ear wax or other causes, and/or to regulate the internal ear pressure

Measuring instruments designed to determine the elasticity of the skin by suctioning a small skin area
instrument consists of a main unit that provides a relatively low pressure to a probe; a light source; el
controls; and a display that shows data and curves for the elasticity of the skin and other skin parame
performed using one of a set of detachable probes that apply constant pressure to the skin and draw i
2 to 8 mm diameter) skin sections according to the diameter of the probe aperture. A light system is u
depth of the skin drawn into the probe. The ability of the skin to return to its original position when su
the elasticity) and its resistance to be sucked by the probe (i.e., firmness) are the main parameters de
elasticity measuring instruments usually work together with a personal computer that process data in
physiologic analyzers may include modules for measuring elasticity.

Products that combine solid paraffin with dry mud that have medical (e.g., analgesic) properties obtai
sources. The product is usually heated until it melts and is applied in thick layers on areas of skin just
again, at a temperature in the range between 38 to 45 degrees Celsius (100 to 113 degrees Fahrenhe
typically applied for a time period of less than one hour. Combined products of natural mud with para
help in relieving chronic pain and stiffness and also to alleviate muscle spasms.

Topical solutions and creams designed to produce temporary local anesthetic effects in a small extern
without causing any metabolic effect. These products usually consist of a solution with some chemica
ethyl chloride, solutions combining pentafluoropropane and tetrafluoroethane) which evaporate quick
the area where it is applied. The rapid evaporation causes a cooling effect that acts as a local anesthe
solutions/creams may be used before needle procedures (e.g., injection) and/or minor surgeries. Topic
and creams that are absorbed by the tissues and may produce considerable metabolic effects (e.g., lid
included under this category of solutions.

Gas cylinder carts designed for simultaneous transportation of several gas cylinders (typically up to 20
carts usually consist of a metallic structure with 4 or (less frequently) 6 wheels. They are available in c
securely hold the cylinders either in horizontal or vertical position during transportation. Multiple gas c
include handles and bumpers to facilitate easy maneuvering by only one person; the carts are usually
electrically (battery) operated carts are also available.
Sterile product central supply carts designed for distribution of sterile wraps from a central supply are
These carts usually consist of a metallic tubing open structure without side panels that includes stainl
posts, long horizontal hanger bars, and wire shelves to store and/or hang the sterile wraps. The struct
large wheels (usually 12.5 cm/5 in or more) that are usually an integral part of the cart to facilitate its
the facility. Sterile wrap carts are usually manufactured using materials (e.g., stainless steel, chromium
permit ease of cleaning and sterilization; they are used to transport sterile wraps from the pharmacy o
nurse stations, operating rooms, and patient rooms.

Lasers designed to emit optical ultrashort pulses with duration in the range of the femtoseconds (one
well below one picosecond (one ps = 10-12 second). Femtosecond pulse lasers usually generate the u
passive mode locking, typically achieved by incorporating a saturable absorber with appropriate chara
resonator. There is a variety of lasers capable of generating femtosecond pulses, including solid-state
piece of doped crystal or glass (i.e., bulk lasers, especially ttitanium:sapphire lasers), dye lasers, and
semiconductor (e.g., diode-pumped) lasers. Ultrashort pulse lasers are used in clinical applications for
such as those performed in ophthalmic surgery procedures.

Service/utility carts designed with an open structure that does not include enclosures or drawers that
temporary storage and local transportation inside a particular area of a healthcare facility. These carts
structure made of metal, plastic, or a combination of these materials. They may include solid metal, w
and/or baskets; the structure is mounted on medium or large (e.g., 7.5 cm/3 in or more) wheels that a
part of the cart. Open service/utility carts are mainly used for products that do not require any special
conditions.

Mechanical routers designed for making smooth (e.g., rounded) edges and/or to mill out the surface o
frequently following a template. Dental laboratory routers typically consist of a benchtop machine wit
base, and a revolving vertical spindle and cutting tools (e.g., bits); the routers may include lights to pr
heated knives for wax cutting, and/or a support for the piece (e.g., a vise clamped to a bench) that is
Dental laboratory routers may be used to trim and/or repair prostheses from a variety of materials (e.
and of many different types, including partial prostheses and dentures. Dedicated routers using comp
also available.

Monitors designed to display electronic images with a definition higher than the standard-definition te
time as they are obtained using a video camera or from a video or digital versatile disk player, a telev
digital computer or computerized network. These monitors typically include electronic circuitry to proc
and a screen (e.g., liquid crystal or plasma display, projection sets) to display the image. Monitors use
definition commercial television (HDTV) are usually standardized to 720 (720 pixels of vertical resoluti
pixels) or full high-definition (1080 pixels of vertical resolution, i.e., 1920 ? 1080 pixels). High-definitio
be used for many purposes, including monitoring patient activity and displaying non-diagnostic image
endoscopic, and fluoroscopic procedures.
Digital data copiers designed to make exact duplicate copies of encrypted digital data collected from
or other devices capable of storing digital data (e.g., smartphones, digital camera memories) involved
These copiers usually consist of a high-speed automated portable electromechanical unit that can obt
by sector) or total copies of data from a computer hard drive or from other digital data storing devices
and secure copies onto another digital computer through a universal serial bus (USB) or serial attachm
following a dedicated software. The copier verifies that no data is lost in the process; the copier has al
such as test reading of the disk sectors and a security erasing procedure that guarantees that no unw
These devices make certain that the copied data cannot be changed or manipulated once it is copied.
copiers are used mainly to preserve and document computer data forensic evidence in legal, governm
procedures. Some units are dedicated computer forensic copiers intended only to copy computer hard

Instruments designed to deliver surgical glue during operative procedures. These instruments are man
instruments typically including a mechanism (e.g., syringe or pistol-like structure) to store and deliver
liquid or spray; the instruments may include appropriate containers for the glue and a pressurized gas
the glue as a spray. Surgical glue delivery instruments may include a detachable tube or catheter that
end for internal applications. Surgical glue delivery instruments are used in surgical and endoscopic p
other procedures including wound closure. Dedicated instruments intended to deliver only a particular
are also available.

Systems designed for minimally invasive treatment of diseases by applying cold at temperatures belo
water (i.e., less than zero degrees Celsius/32 degrees Fahrenheit). These systems typically consist of a
cryogenic substance (e.g., carbon dioxide, liquid nitrogen, argon, helium) and a delivery system that m
applicators, needles, cannulae, or catheters; the type of cryogen used and the configuration of the de
on the intended use.

Cryotherapy systems designed to produce tissue necrosis at temperatures well below the freezing poi
less than -20 degrees Celsius/-4 degrees Fahrenheit) using minimally invasive procedures. These syst
a central unit that provides the cryogen and includes electronic and mechanical components to perfor
ablation; tubing to deliver the cryogen; and a probe (e.g., an applicator, needle, cannula, or catheter)
directly or indirectly to the tissue. Ablation occurs when the cryogenic substance or cryogenic probe c
the cells freeze, ice crystals form inside the cell and the subsequent cycle of freezing and thawing tha
destroys the tissue cells. Cryotherapy systems intended to ablate particular tissues using catheteriza
cardiac, prostatic) are available.

Dressing aids designed to assist patients in putting on their clothes by reducing the need for bending/
dressing aids usually consist of long sticks with a handle on one end and a hook on the other end. The
to grab, pull or push off clothes (e.g., pull the pant on or off the leg, push the shirt over the head, or p
shoulder). Clothing dressing aids are mainly used to assist people who have limited mobility in the up
extremities or who have difficulty in bending/reaching and/or whose manual dexterity/strength is limit
Dressing aids designed to assist patients in putting on their shoes by reducing the need for bending/re
usually consist of a long handle made of plastic, wood or metal with a handle at one end and a curved
shoehorn) at the other end; some may have springs connecting the stick to the shoehorn. These devic
shoe to allow the foot to slip in more easily. They can be made in different shapes (e.g., round -shaped
shaped shoehorns in order to fit the shape of the heel) and lengths (e.g., as short as 12 inches, and as
Shoe dressing aids are mainly used to assist people who have limited mobility in the upper or lower ex
difficulty in bending/reaching and/or whose manual dexterity/strength is limited.

Dressing aids designed to assist patients in putting on their stockings or socks by reducing the need f
These devices usually consist of plastic or fabric shells with two straps. The devices are put inside the
keep them open and help the foot slip into the stocking or sock, and then they are pulled to help ease
over the foot, ankle, and leg. Stocking and sock dressing aids are mainly used to assist people who ha
the upper or lower extremities, difficulty in bending/reaching, and/or whose manual dexterity/strength

Dressing aids designed to assist patients in grasping and pulling their buttons or zippers. These device
handle with a hook on one end which is put through the button hole and grips the button; or a hook w
that can be attached to a zipper to help pull the zipper. Button/zipper dressing aids are mainly used fo
limited manual dexterity/strength.
Dressing aids designed to keep the patients' shoelaces tied. These devices usually consist of elastic s
locking mechanism (e.g., knots). Once tied, the feet can slip in and out of the shoes, avoiding the nec
retying the shoelaces. The devices can adjust the tension of the shoes over the feet to provide comfor
dressing aids are mainly used for people who have difficulty in tying their shoes; they can also be use
sports.

Test tubes designed for polymerase chain reaction (PCR) laboratory procedures. These test tubes are u
plastic tubes with a pointed, conical bottom and an open top; they usually include an attached cap (i.e
intended to minimize the risk of carry-over contamination. PCR test tubes are usually appropriate for
cyclers. The shape and characteristics of PCR test tubes, especially the thin wall for fast heat transfer,
increase the efficiency of PCR procedures performed in clinical laboratories and/or other areas of med

Devices designed for grinding hard materials to convert them into finer particles. These mills typically
with a rotatory mechanism that is manually or electrically powered; the size of the particles usually de
exerted on the material and/or the duration of operation of the mill. Mills are used in healthcare to gr
laboratory and/or pharmaceutical products; dedicated mills intended to grind bone are also available.

Catheters designed for percutaneous insertion through the secondary costal space into the pleural cav
of sudden air accumulation. These devices typically consist of a strong needle catheter of a relatively
gauge) and short length (about 3.25 inch/8 cm) and a mechanism for immediate confirmation of appro
catheter may be attached to a vacuum source to facilitate the procedure. The catheter may also inclu
open case intended to facilitate its removal and handling. Pleural tension pneumothorax catheters are
emergency situations to facilitate a quick and accurate management of patients with symptoms of ten
frequently due to trauma.
Drivers designed to insert ultrasonic probes into the channel of standard endoscopes, permitting ultra
body tracts. These drivers are usually handheld manual powered instruments that permit the location
detachable ultrasonic probes at the distal end; then the probes are inserted in the working channel of
(e.g., a choledochoscope) which is attached to a video endoscopy system at the proximal end. The dri
reconstruction (DPR) scanning with simultaneous display of radial and linear images when used with D
ultrasonic probe drivers are intended to perform ultrasonic procedures using standard endoscopes rat
ultrasonic endoscopes. They are usually dedicated devices that can be used only with endoscopes and
few models and/or manufacturers.

Software designed to operate equipment that combines magnetic resonance imaging (MRI) and positr
tomography (PET) scanning in a single combined system, providing control/monitor of a limited numb
This software is usually intended to work with only one or a few models of the combined scanning sys
by the same manufacturer. The software performs a variety of algorithms to facilitate the analysis of m
performed during the scanning procedures. The software usually provides fusion (i.e., integration) of a
provided by MRI slices and the functional (metabolic) images from PET scans taken in the same sessio
simultaneously or sequentially, with the patient in treatment position. MRI/PET scanning system softw
available separately from the combined system but may be updated (i.e., through the release of modi
the life of the system. Dedicated MRI/PET scanning system software is intended to facilitate faster and
evaluation than separate MRI and PET systems can provide; they are mostly used for the diagnosis, tr
evaluation of therapy in specialties such as oncology, cardiology, and neurology, characterizing the di
anatomic and biological features.

Vascular stents designed for deployment into the intracranial arteries to enlarge the lumen of an intra
diameter. These stents have a self-expanding design with flexible cells to improve conformability in cu
vessels; the stents support the vessel by providing an outward radial force intended to minimize vesse
artery stents are typically delivered following percutaneous transluminal angioplasty (PTA) performed
that dilates the stenotic portion of intracranial arteries prior to stenting. Intracranial artery vascular st
for the purpose of improving long term intracranial perfusion in patients with intracranial atherosclero
to medical therapy.

Garments designed to maintain body temperature without applying an external source of heat. These
consist of clothing (e.g., vests, jackets, pajamas) made of fabrics with special properties (e.g., wool, sy
provides the user isolation from the environment and permits appropriate warming by keeping his/her
Warming garments are intended for use when the environment is cold or to provide warmth to patient
anatomical or brain damage or disease (e.g., muscle inflammation, poor blood circulation, cerebral pa
garment may also be used during rehabilitation treatments.

Stents designed for deployment into one of the paranasal sinus ducts to provide support and/or maint
stents may consist of a metallic or, more frequently, plastic tubes. They are available in several differe
according to the sinus on which they are deployed (i.e., frontal, ethmoid, or sphenoid) and/or include a
mechanism that may incorporate sutures to prevent migration. Paranasal sinus stents are intended fo
weeks) ventilation and drainage of fluids from the sinus. They may be manually implanted or delivere
instruments and/or stent delivery kits (e.g., catheters, deployment guides) and then manually remove
time. The stents are mainly used after functional endoscopic sinus surgery (FESS). Absorbable and/or
also available.
Prepackaged collections of devices and supplies designed to deliver stents intended to enlarge the lum
a paranasal sinus (i.e., frontal, ethmoid, or sphenoid). These kits typically include an instrument consi
to deploy the stent at the proximal end and a hydrophilic sheath that permit sinus access at the distal
endoprosthesis (i.e., the stent) is mounted on the distal tip and fixed to the sinus mucosa. Other produ
alcohol, anesthetics) may be also included in the kits for use during the stenting procedure. Paranasal
intended to deploy stents used for ventilation and drainage of fluids from the sinus; they are mainly u
endoscopic sinus surgery (FESS).

Solutions, creams, or suppositories applied around and/or into the rectum to produce topical, non-met
products are typically based on natural products, such as oil (e.g., olive, glycerin) or water compounds
polyethylene glycol); they may also include additional components such herbal extracts and/or other c
(e.g., analgesics). Rectal topical solutions/creams/suppositories available in liquid state may be applie
They are formulated to moisturize, lubricate, and/or protect the anal canal and rectum; some products
relief of constipation or produce analgesic effects to reduce pain and/or to facilitate the introduction o
examination of the lower gastrointestinal tract. The products are frequently used as laxatives or for lo
hemorrhoids; they are not intended for drug administration and do not act metabolically.

Dental equipment designed for use in manual machining dental materials (e.g., ceramic blocks) into d
performing mechanical operations such as drilling and cutting. These machines typically consist of a t
usually includes a handpiece with a shank that can manipulate a variety of detachable tools (e.g., dril
motor; the unit may also include a pantograph and/or other attachments. The mills typically can be u
prostheses such as crowns, bridges, inlays/onlays, partial dentures, and dental implants from material
composites, zirconia, and cobalt-chrome/titanium alloys. Manually operated dental milling/drilling mac
in dental laboratories but compact portable units may be used also at dentists' offices.

Equipment designed for drilling pieces of materials (e.g., metals, plastics) typically using detachable d
rotating mechanism. These machines usually consist of a rotating assembly (also known as spindle) th
bearings, and associated detachable burs and/or drill bits; the machine also includes a support (e.g., a
table) for the piece that is being drilled. The piece under work is held stationary as the drill moves axi
material; the spindle movements is precisely controlled (e.g., to less than 0.001 inch/0.025 mm). Drill
usually mounted on a working bench; they may be manually operated, mechanically automated, or di
Drilling machines may be used for a variety of applications; dedicated machines intended to manufac
are also available.

Drilling machines designed for drilling holes in dental prostheses during manufacturing and/or repair.
typically consist of an electric-powered unit including a high-speed rotatory motor, a manually or auto
rotating assembly (also known as spindle) that includes a dedicated jig and associated detachable (e.
to 6 mm) drill bits or burs. The machine also includes a support (e.g., a vise clamped to a table) for th
drilled and also may include a guide and a depth control for the perforation. Dental drilling machines a
dental laboratories to obtain accurate perforations in dental prostheses; dedicated machines using las
are also available to perform small and accurate perforations.
Tables and platforms designed to provide isolation and/or cancellation on their surface from floor vibra
intended for use while performing tests using equipment that is sensitive to motion and vibration. The
platforms include one of a variety of passive or, less frequently, active isolation systems. Passive syste
pneumatic, honeycomb or other type of isolators while active systems use semiconductors and are ba
techniques that may provide better vibration isolation or cancellation that is not possible with passive
vibration tables and platforms are used for delicate measurements and/or in other delicate procedures
performed using microtomes, cell injection, and optical and electronic microscopy, including scanning
laser scanning microscopy.

Workstations designed to manipulate laboratory automation equipment in real time by retrieving, proc
digital data using minimal operator intervention. These workstations may operate all or only some of t
a complete laboratory process. They may perform sample preparation in pre-analytical modules (e.g.,
sorting, decapping); sample transport to analytical modules (e.g., hematology, molecular assay, clinic
immunology analyzers); perform a particular type of procedure (e.g., nucleic acid processes); and han
storage of samples. The individual units may be standard IVD equipment (e.g., centrifuges, sorters, pi
refrigerators, analyzers) or, more frequently, standard manufacturer or custom designed modules acc
healthcare facility needs. Workstations controlling laboratory automation may interact with clinical la
hospital information systems. The workstations are intended to improve the efficiency of the process,
time of samples, and reduce errors in the process.

Orthopedic equipment designed for use in machining orthopedic materials into desired prostheses by
operations such as drilling and cutting using computer-aided design and manufacturing (i.e., CAD/CAM
machines usually consist of table-top or stand-alone equipment that includes a milling chamber with a
(also known as spindle), associated detachable drilling devices (e.g., drill bits, end mills, burs), and a h
(e.g., ceramic block) that is being machined; the spindle movements are precisely controlled (e.g., to
Some machines include robotic arms to perform the procedures. CAD/CAM orthopedic milling/drilling m
controlled directly or through a local area network (LAN) from a computer that includes appropriate so
milling/drilling machines may be used to manufacture prostheses, implants, and/or orthoses for many
(e.g., ankle-foot, maxilo-facial, and limb prostheses) using digital data from orthopedic digital scannin

Computer-aided design and manufacturing (CAD/CAM) orthopedic prosthesis system software designe
that obtain, process, and store digital orthopedic topographic data and images (i.e., orthopedic impres
data directly or through a network to milling units for automated manufacturing of the required prosth
molds; the software may also control/monitor a limited number of the system functions. This software
other devices used in the procedure, such as the optical scanning system and milling/drilling machine
a variety of algorithms to facilitate the operation and analysis of the data obtained from the unit (e.g.,
obtain the digital orthopedic impression data. Computed orthopedic CAD/CAM system software may b
(e.g., digital scanner) that designs the impression, the orthopedic milling machine, or both; the softwa
only with one or a few models of orthopedic CAD/CAM systems and related devices usually supplied b
manufacturer. Some system software may allow also the processing and/or sending data from the digi
from hospital information systems.
Physiologic recorders designed to store information of the breathing sounds produced during respirati
bronchi) sounds, cough, and wheezing in ambulatory patients and/or during sleep. These recorders ty
dedicated sound sensors, a processing unit, and an electronic digital recorder that can store the data
The data can be retrieved and assessed both in numerical and graphic format using computer algorith
dedicated software that is supplied with the recorder or available from the manufacturer. Breathing so
recorders are intended for continuous assessment of patients suffering from wheezing, cough, shortne
nocturnal asthma; they may be used for continuous acoustic measurements of respiratory function for

Respiratory physiologic recording software designed for later processing of breathing sound data (e.g.
bronchi sounds) obtained while recording, typically during a time period of 24 hours or less. This softw
only with one or a few models of breathing sound respiratory recorders, usually from the same manufa
may perform a variety of algorithms to facilitate the analysis of measurements performed during reco
used to send and/or receive patient information to and from hospital information systems. Breathing s
recording software is mainly intended for use in computers that retrieve and assess the information st

Physiologic measuring instruments designed to detect, quantify, and give a real-time analysis of breat
during a short span of time (e.g., 30 seconds). These instruments also measure the proportion of the
occupied by continuous high-pitched whistling noises (i.e., wheezing). These instruments typically con
with on/off controls; an electronic processor with dedicated software; a display; and a detachable prob
sound sensor which is placed on the patient's neck. Breathing sounds measuring instruments are use
facilities, in the field, and at home for a quick evaluation of the patient's status and to detect the pres
drug (e.g., bronchodilator) administration.

Luminometer software designed to process data obtained while measuring adenosine triphosphate (AT
contamination using a standard computer. This software is intended to evaluate the results of measur
the luminometer; they work only with one or a few models of ATP luminometers, usually from the sam
software may perform a variety of algorithms to provide customized reports, differentiate re-testing da
archive capabilities that enable analysis of historical records; the software may also establish limits fo
interpretation. ATP organic contamination software is usually not available separate from the luminom
updated (i.e., through the release of modified versions) during the life of the equipment.

Pathology slide computer-aided detection system software designed to operate detection systems tha
analyze prostate tissue histologic slides and control/monitor a limited number of their functions. This s
intended to work only with one or a few models of computer-aided systems, usually from the same ma
software performs a variety of algorithms to facilitate the analysis of the slides and sending/receiving
from and to the local information system. The software is usually not available separate from the com
may be updated (i.e., through the release of modified versions) during the life of the system. Prostate
detection system software facilitates the analysis of slides intended for screening of malignant conditi
to aid in the prediction of prostate cancer recurrence.
Computer-aided detection systems that analyze digital information and in-vivo images to detect tissue
may either digitize the original information or use information provided by digital imaging systems (e.
These systems typically consist of an image digitizer or a means to import digital information, a comp
appropriate algorithms to process the information, and a display and/or printer to show the detected a
systems may include archiving and/or communication capabilities. Dedicated systems for detection an
images of particular tissues such as breast and lung tissues are available.

Pathology slide computer-aided detection system software designed to operate detection systems des
in-vitro detection, identification, and pre-classification of blood cells in peripheral blood and/or other b
placed on slides and control/monitor a limited number of their functions. The software performs a vari
facilitate the analysis of the slides, providing automated location and identification of red blood cells (
cells (WBC) and pre-classification of RBCs according to their morphology and WBCs according to their
software also provides an overview image of the platelets and identifies areas of interest in the slides
also facilitates sending/receiving patient information from and to the local information system. Blood c
computer-aided detection system software facilitates a uniform processing of hematology smears and
other body fluids (e.g., cerebrospinal fluid) by laboratory technicians.

Detectors designed to locate sponges during the last steps of a surgical procedure to help prevent the
sponges inside the patient before closure of the operative field. These detectors may consist of conve
portable radiographic units that can detect sponges which include a radio opaque label or handheld d
radiofrequency labeled sponges. Sponge retention prevention surgical detectors can detect sponges a
devices (e.g., swabs, towels) that are difficult to locate during the surgical procedure but cannot count
particular sponges or other items.

Counters that include a holding rack to help organize and facilitate manual counting of surgical spong
surgical procedure. These devices typically consist of a holding frame (i.e., rack) that permits the loca
bags; each bag has several pockets to place individual sponges. Holding rack counters used for spong
typically hung from intravenous poles close to the operating table.
Counters designed to verify the quantity of sponges used during a surgical procedure to help prevent
surgical sponges inside the patient before closure of the operative field by reading passive radiofreque
sponges. These counters typically consist of a central unit that delivers and detects the RF signals fro
The unit counts the initial number of sponges introduced into a surgical case, and using a software pro
sponges discarded at the end of the procedure. A comparison of the count of items entered into surge
removed from the surgical field, provides information regarding the sponges that may still remain in th
closing the patient.

Counters designed to verify the quantity of sponges used during a surgical procedure to help prevent
surgical sponges inside the patient before closure of the operative field by reading bar-coded identifie
counters typically consist of a bar-code handheld reader that is used to scan a unique code identifier p
the sponges before and at the end of the surgical procedure. The reader is linked to a central compute
in real time the results of the sponge identification and counting and also other patient and/or procedu
computerized unit may be connected to hospital information systems. Sponge retention prevention su
counters are used to identify and count the sponges and other related devices (e.g., bar-code labeled
during a surgical procedure.
Inclinometers designed to measure the angle of displacement (known as the range of motion or ROM)
mechanism that includes a calibrated dial. These inclinometers consist of a calibrated dial that directl
typically the inclinometer is placed against the bone and never leaves contact with the patient during
joint. Inclinometers may be used in pairs when the motion to be evaluated has two joint components (
movements). Dial calibrated inclinometers are available in a variety of types, including (1) bubble incl
a circular tube partially-filled with a colored fluid that moves with motion and a circular dial with degre
gravity inclinometers consisting of twin rotating dials with a locking mechanism and frequently with a
body. Dedicated dial calibrated inclinometers intended for a particular joint (e.g., wrist) are also availa
used by rheumatologists and physical therapists to assess joint function and to diagnose and treat loc
diseases; they can be included as a component of gait and joint laxity analyzers. Inclinometers have r
many applications to obtain more accurate measurements.

Inclinometers designed for automated measuring of the angle of displacement (known as the range o
joint by means of sensors and a central electronic unit (known as digital inclinometers). These inclino
consist of a central unit that processes, displays, and records the information and wired or wireless se
linear electronic output relative to the measured angle. Typically the inclinometer sensors are placed a
never leave contact with the patient during the movement of the joint. Inclinometers may be used in
to be evaluated has two joint components (e.g., spinal movements). Digital inclinometers are usually
measurement from very small to large ROM. Digital inclinometers are used by rheumatologists and ph
assess joint function and to diagnose and treat locomotor system diseases; they can be included as a
joint laxity analyzers., Inclinometers, and especially digital inclinometers, have replaced goniometer in
obtain more accurate measurements.

Radiofrequency (RF) therapy systems designed to deliver RF energy into the cornea to modify its curv
index (i.e., conductive keratoplasty). These systems typically consist of a central unit that includes an
display, controls, and detachable cords with dedicated circular probes at the distal end; the system m
template that is placed on the eye to facilitate the application of the RF energy on the proper location
energy is applied in a series of points on the outer cornea following a circular pattern, shrinking small
producing a compression on the cornea that increases its curvature. Conductive keratoplasty RF thera
intended to improve near vision temporarily but for a relatively long time (i.e., months or a few years)
in patients with presbyopia or hyperopia.

Measuring instruments designed to measure the angle of displacement (known as the range of motion
Typically the inclinometer or the inclinometer sensor is placed against the bone and never leaves cont
during the movement of the joint. Inclinometers may be used in pairs when the motion to be evaluate
components (e.g., spinal movements). Inclinometers are available as mechanical instruments typically
to show the results or as digital inclinometers consisting of a central unit that processes, displays, and
information obtained from wired or wireless sensors. Inclinometers are used by rheumatologists and p
assess joint function and to diagnose and treat locomotor system diseases; they are frequently includ
gait and joint laxity analyzers. Inclinometers have replaced goniometers in many applications to obtai
measurements.
Solutions formulated to fill catheter lumens when not in active use (i.e., catheter lock). These solution
patency, remove bacteria, and avoid clot formation. They usually contain a broad-spectrum antimicrob
gentamicin) or an anticoagulant such as citrate or heparin or a combination of both. Catheter-locking
used for central venous (frequently tunneled) catheters, especially for hemodialysis procedures and in
treatments; they are mainly intended to avoid catheter related bacteremia, a serious blood infection.
ethyl or isopropyl alcohol) may be also used in some particular applications.

Injectors designed for subcutaneous administration of carbon dioxide gas. These injectors typically co
control unit to regulate the volume and time of gas injection, a handpiece (applicator) including a fine
subcutaneous administration of the gas, a gas cylinder filled with carbon dioxide, and a hose to conne
gas cylinder. Carbon dioxide injectors are intended for physiotherapy and pain treatments.

Equipment designed for cleaning medical and other healthcare devices, as well as samples used in cli
use gases in a plasma state. These plasma-state gases are a form of matter that includes electrons an
resulting from the application of a strong electromagnetic (e.g., radio frequency) field. These cleaners
(frequently vacuum) chamber with shelves on which the devices to be cleaned are placed, usually afte
debris; a means to introduce the gases (e.g., oxygen, argon) or mixtures of these into the chamber; el
activated to convert the gas to plasma; a radio-frequency generator; holders for different types of pro
controls to start/stop automated cycles of the procedure. Some equipment includes an integral evacua
system to eliminate residue after the cleaning cycle is complete. Plasma cleaners are available in a va
sizes in both stand-alone (bulk) and tabletop models; they are mainly used to remove organic and ino
increase bond strength, and remove residues. Dedicated plasma cleaners intended specifically to clea
samples and/or sample holders are also used.

Consoles designed to control the operation of radiographic, fluoroscopic, and/or tomographic systems
control a variety of parameters, such as radiographic x-ray exposure and cassette positioning, exposu
selection and x-ray exposure indicators, cassette transfer and reload; skip exposure options; cone tran
transfer; shutter-mode switches; image intensifier mode selection; and photo selection to prepare for
consoles are computerized; they may also include automatic brightness control, fluoroscopic mA selec
tabletop drive. Routinely performed sequences can be preset and/or included in pre-established progr
typically consist of a stand-alone table or stand that includes a panel with multiple switches (e.g., pus
usually operated sequentially; each switch includes an indicator (e.g., a light, meter) that shows the c
controlled parameter. Radiographic/fluoroscopic/tomographic system consoles may be computerized,
intended for digital systems. Stand-alone consoles work as components of the systems; they are frequ
remote to the procedure room. Systems that place the controls on the spot-film device or on a side of
not include separate consoles.

Catheters designed to be introduced through the rectum that are long enough to be advanced until th
the middle or distal portion of the colon. These catheters typically consist of single or multilumen tube
rubber or plastic (e.g., Teflon). Colon catheters are used for irrigation (i.e., clearing out) of the large bo
and/or for manometric measurements. Dedicated colon catheters intended for delivery of stents and/o
incontinence (typically indwelling catheters) and to perform other treatments are also available.
Colon catheters designed to be left in the colon during a long-term (e.g., several days or weeks) proce
typically consist of a multilumen catheter, usually plastic, whose distal tip includes an inflatable balloo
also include radiopaque markers, a stopcock, and a retention cuff. The channels of the catheter are us
administration of medications, and for delivery/withdrawal of fluids to or from the distal balloon; some
channel to allow stool to drain. The catheters are usually attached at the proximal end to irrigation pu
attached to a fecal collection bag. Colon indwelling catheters are mainly used in the management of
may be used also for other treatments of the colon and large intestine.

Catheters designed to be introduced through the rectum that are long enough to be advanced until th
the small intestine (typically in the ileum or jejunum and less frequently in the duodenum). These cath
of single or multilumen tubes made of silicone rubber or plastic (e.g., Teflon). Small intestine catheter
(i.e., clearing out), enemas, to inject contrast media, or for manometric measurements in the small in
small intestine (typically indwelling) catheters intended to keep the intestine in a controlled, stable po
therapeutic procedures are also available.

Humidifiers designed to add moisture to the gases that are insufflated into the abdominal cavity durin
procedures. The humidifying devices (e.g., cassettes) are usually inserted in the tubes running from th
port that provides access to the patient's abdomen (e.g., a trocar or insufflation needle). These humid
a control module that houses the control and safety circuits for the humidifier, appropriate tubing, hum
filters. Humidifiers are used as accessories of laparoscopic insufflators; they are typically intended to i
of the gas over 90 percent. Laparoscopic insufflation humidifiers that also provide heat to the gas to re
close to the normal body temperature are also available.

Room environment humidifiers designed to add moisture and heat to the air flowing in the environme
typically include a water container, electric heaters, air filters, a fan, and temperature and air speed c
introduce the moisture and heat either by forcing the incoming air through a heated reservoir of wate
incoming gas over a wet and heated surface. Most humidifiers include sensors and controls to regulat
the humidity in the environment. Heated room humidifiers are usually available in three configuration
consoles, and in-duct installation.; they are used in healthcare facilities such as hospitals and nursing
home to help in the prevention of dryness in the airways and to increase comfort especially for babies
patients with serious illness.

Stretchers (also called shower trolleys) upon which patients can be bathed or showered. These stretch
either be rolled into a shower/bathing area, or a patient could be bathed with the help of a handheld s
bath/shower stretchers are attached to the wall in the patient bathing area; these can be hinged to fo
adjusted for height. To facilitate bathing, some bath/shower stretchers come equipped with side walls
container that can be filled with water to provide a shallow bath for the patient. Bath/shower stretcher
lowered, as needed, and can be tilted for patient comfort and to drain water. Standard models are des
150 kg/330 lbs of weight, including the patient and water; bariatric bath/shower stretchers designed t
kg/1,000 lbs of weight are available. Bath/shower stretchers are used in hospitals, assisted living and
and in nursing homes.
Scanning systems designed to generate an image of tissue in a given plane of the body using near-inf
sources, usually at more than one frequency (i.e., a process known as NIR spectroscopy). The light det
across the tissue is analyzed to determine the absorption and changes in speed. This results in optica
reconstructed to form a continuous image showing the chemical composition of tissue that can be vie
on a video display terminal. These systems can be used in diagnostic procedures to differentiate tissu
chemical and/or molecular composition; dedicated systems used to obtain intravascular images are av

Solid-state lasers with a rod of sapphire (Al2O3,) crystal doped with titanium (Ti) ions as the active me
emission wavelength is in the range from 650 to 1,100 nanometers (i.e., in the red and near-infrared s
are usually operated in pulsed and Q-switched modes; ultrashort pulses (in the range of the femtosec
mode locking can be also generated. Ti:sapphire laser clinical applications are mainly intended for res
used to perform ophthalmic procedures.

Software designed to operate ophthalmology workstations, control/monitor a limited number of their f


process data and images obtained during the procedure planning or performance. This software usual
ophthalmic devices used during the procedure, such as image recorders, surgical microscopes, lasers,
and displays. The software may also perform a variety of algorithms to facilitate an accurate planning
the ophthalmic procedure. Ophthalmology workstation management software is intended to work only
models of ophthalmic workstations and related devices which are usually supplied by the same manuf
may also facilitate the processing and/or sending of data from the workstation to and from picture arc
communication systems (PACS) and/or other hospital information systems. Ophthalmology workstation
software is not usually available separate from the workstation but may be updated (i.e., through the
versions) during the life of the equipment. Dedicated ophthalmic workstation software intended for a
procedures including procedures performed using laser technology (e.g., treatment of presbyopia, end
LASIK flap procedures) and cataract surgery are also available.

Solid-state lasers that incorporate a rod of glass (e.g., silicate, phosphate) doped with erbium (Er), a ra
the active medium. Their emission wavelength range usually is between 1,530 and 1,600 nm (near in
are usually operated in pulsed and Q-switched modes. The laser energy is typically delivered through
fiber. Dedicated Er:Glass lasers intended for dermatologic use are available.

Erbium:glass (Er:Glass) lasers designed for use in skin resurfacing procedures (i.e., dermatologic). The
consist of lasers that emit light at 1,540 nm wavelength (near infrared) targeting intracellular water a
mm with minimal absorption by melanin in individuals with dark pigmentation skin. The laser energy i
through a flexible optical glass fiber to the application handpiece. Dermatologic Er:glass lasers are int
treatment of acne and/or photo-induced wrinkles in the face.

Stylets designed to be used in combination with a nasoenteral tube and a locator to enable visualizati
nasoenteral tube tip location, thereby guiding the positioning/placement of the tube in the alimentary
emit a type of energy, e.g., a low-level, high-frequency magnetic field, that is detected by a sensor em
unit. These stylets are designed to be used in conjunction with specific nasoenteral tube/stylet tip loca
included as a component of the nasoenteral tube.
Installations designed to obtain pictures using a photographic camera. These stations typically consist
working board at the top, printers, a keyboard, a computer, shelves to keep the supplies (e.g., photog
cartridges, labels), lights, and chairs in addition to the camera. Most photographic stations can be con
information systems or the Internet. Dedicated photographic stations intended for specific application
including particular health care facility areas (e.g., clinical and pathology laboratories) and home use.

Surgical retractors designed to temporarily separate and hold back any of the various abdominal orga
providing access to other tissues, organs, or abdominal structures. These retractors are manual, hand
usually with wide, deep blades capable of holding back the intra-abdominal organs, frequently by plac
between the organ and the retractor. Abdominal organ retractors are available in a variety of shapes a
selected according to the thoracic structure or organ to be exposed or retracted. Dedicated abdomina
available for particular structures and/or organs (e.g., liver, gall bladder).

Abdominal wall surgical retractors designed with a mechanism that retains its position once set (i.e., s
These retractors usually include a very sturdy mechanism with blunt distal blades that are deep enoug
tissues from the skin to the peritoneum. The opening mechanisms ensure that the blades remain para
they move apart. Self-retained abdominal retractors are provided in a great variety of shapes and mec
the tissue and/or abdominal structure or organ to be exposed; dedicated self-retained retractors are a
abdominal structures and/or organs (e.g., liver, appendix).

Pumps designed to deliver liquids (i.e., irrigate) to a cavity or other specific area of the body. These pu
of a central unit with a pumping (e.g., peristaltic) mechanism; a control (e.g., a valve, clamp, or manu
regulate the rate of the irrigation; and detachable (frequently disposable) tubing appropriate for irriga
body cavity or area. Irrigation pumps intended for particular equipment such as surgical, dental, and n
available; dedicated irrigation pumps intended for use with appropriate tubing coupled to irrigation ca
are also available.

Physiologic analyzers designed to measure and evaluate all or most of the main characteristics of the
elasticity, surface moisture and sebum, pigmentation and transepidermal water loss (TEWL). Some an
microscope or video microscope to assess the skin conditions and/or ultrasound devices to assess the
The analyzer is usually microprocessor- or computer-controlled and contains appropriate software for d
digital recording. Skin physiologic analyzers are used to assess the skin characteristics during dermal,
occupational medicine studies. Dedicated measuring instruments intended only to measure one or a f
the skin (e.g., TEWL, elasticity, surface moisture or sebum) are also available.

Scanning systems that combine ultrasonic and near-infrared (NIR) laser scanning spectroscopy that ar
data and images showing both the characteristics of the structure (e.g., degree of stenosis) of the blo
composition of the inner layers of the vascular walls (i.e., intravascular). These systems consist of a ce
mounted on a cart that includes a high frequency generator, a laser source, data processors, appropri
display; the system also includes a detachable catheter with a hub at the proximal end with connecto
and optical output of the central unit. Intravascular ultrasonic/NIR laser scanning systems are intende
and most appropriate treatment of vascular diseases.
Vascular catheters designed to combine ultrasound and near infrared (NIR) laser light capabilities. The
consist of a low-profile shaft with a distal tip that delivers and detects both ultrasound waves and NIR
connected at the proximal end to a rotating hub that includes appropriate connections to the ultrason
systems located in the central unit of a dedicated scanning system. Ultrasound/near-infrared light vas
intended for intravascular imaging of the structure of the blood vessels; the images also show the che
the tissues and fatty deposits.

Laboratory equipment designed to automate the washing and staining of microarray chips. The equip
software package with a variety of specific protocols according to the array format, reagents used, and
the equipment. Microarray washer/stainers are capable of performing other operations such as washin
hybridization involving liquid reagents (e.g., buffers, antibody reagents) using custom protocols.

Simulators designed for training in the performance of intraocular surgical procedures. These simulato
anatomic model of a movable artificial eye mounted on a simulated head that lies on an adjustable-he
computerized control unit. The equipment simulates a complete scenario of an ophthalmology operati
surgeon stool; surgical instruments, an ophthalmic surgery microscope with a display coupled with a c
control unit, and dedicated software that permits a simulation of the surgical procedure in real time. O
training simulators may include (as integral parts or attached modules) components intended for train
procedures such as cataract and/or vitrectomy surgical procedures.

Stimulators designed with capabilities to provide photic (visual), acoustic, and tactile stimuli to patien
procedures. These devices consist of powered light-emitting devices that deliver various types of mon
visual stimuli using a variety of different sources and configurations. The stimulators may include stan
mounting and remote light (i.e., photic) controls for brightness, color, or other physical characteristics
stimulators have additional capabilities to provide acoustic and tactile stimuli, either pre-programmed
that may be delivered simultaneously with the light stimuli during the treatment. Relaxation/therapeu
photic/acoustic/tactile stimulators are used in therapeutic procedures mainly to provide relaxation, de
treatment of trauma-related psychological disorders.

Root form dental implants designed with the shape of a common screw. These implants are typically m
titanium) materials conformed to follow the shape and size of a natural tooth root; they are intended f
implantation into the bone to replace a single tooth root in either the maxillary or mandibular bone. S
intended for attachment to pillars which in turn support at the other end dental prostheses such as de
and bridges.

Root form dental implants designed with the shape of a screw with an extended head configured as a
These implants are typically made of metal (e.g., titanium) materials conformed to follow the shape a
tooth root; they are intended for total or almost total implantation into the bone to replace a single too
maxillary or mandibular bone. Roller implants are intended for attachment to dedicated pillars which
other end dental prostheses such as dental pontics, crowns, and bridges.
Devices designed to provide a mechanical link between a dental implant and an external prosthesis. P
of a metal piece (a connector) which links externally (frequently threaded) to the dental implant at on
prosthesis (e.g., pontic, bridge or crown) at the other end. The pillar end intended for attaching to the
straight, angled, or round; standard and custom shaped types of attachments are available. Pillars tha
the dental implant to facilitate mounting and/or removal are also frequently available. Dental implant
of fixed partial or total dental prostheses.

Simulators designed for training in laparoscopic surgical procedures. These simulators typically includ
model of the torso that is made of plastics, metal, or a combination of these and a central computeriz
adjustable-height table or cart. The equipment simulates the conditions for abdominal minimally invas
conditions by providing the anatomic model of the torso with a great number of openings with gromm
trocars located in the appropriate positions, laparoscopic equipment such as insufflators and laparosco
instruments, cameras, and video monitors. The simulator also includes a main control unit with dedica
permits both training and recording of the simulated surgical procedure in real time. Laparoscopy surg
may include (as integral parts or attached modules) anatomic models and accessories intended for tra
laparoscopy procedures such as suturing, anastomosis, urinary, and gynecologic.

Thermoplastic forming units designed to manufacture dental plastic products using positive pressure t
Typically these machines consist of a unit that includes a solid base plate for thin models and/or a cup
that act as a base for taller (i.e., thicker) models; a small chamber for the thermoplastic material shee
(e.g., infrared light); and time and pressure controllers for the heating and processing times and press
material (alternatively, a scanner that automatically reads the code of the material). High positive pre
bar) is applied to the thermoplastic material placed on top of the original model using compressed air
conformed to the original model. Positive-pressure thermoplastic forming units are mostly used to ma
appliances, such as dental retainers, splints, temporary dentures, and mouth guards.

Video systems designed to display in video monitors oocyte images in real time taken from microscop
systems typically consist of an adapter used to attach a video camera (usually a charge-coupled devic
system of a microscope, an image processor with dedicated software to process information from the
monitor, and recording devices; the system also uses a microscope with appropriate optical character
imaging video systems provide images of the meiotic and mitotic spindle (i.e., the subcellular structur
chromosomes between daughter cells during cell division processes known as meiosis and mitosis res
layered zona pellucida, and/or other birefringent structures. The systems are used to evaluate the qua
(e.g., by monitoring changes in spindle parameters) without the use of stains.

Chambers designed to provide appropriate conditions to perform in-vitro fertilization procedures. Thes
consist of a vibration resistant enclosure with a controlled atmosphere that provides uniform temperat
usually a controlled carbon dioxide environment; the air supply includes both high-efficiency particula
filters. Access to the chamber is possible though hinged doors and/or bare-hand-entrances (i.e., iris po
large enough to hold microscopes, lasers, video cameras, and micromanipulation devices used in the
fertilization chambers are used to facilitate successful in-vitro procedures by providing an environmen
microbial and volatile organic compounds.
Examination/treatment chairs designed to facilitate obstetric and/or gynecologic examination, treatme
fertilization, and/or minor surgical procedures. These chairs are typically adjustable to a height that al
staff to perform procedures while standing. The chair usually includes head- and armrests, a reclining
from a vertical to a horizontal or near-horizontal position, and rotating capabilities (frequently up to 36
facilitate examination and/or treatment. The chairs may be mechanically operated or hydraulic or elec
chairs can be programmed to several standard positions and/or have slow-motion capabilities to facili
fertilization procedures. Obstetric/gynecologic examination and/or treatment devices (e.g., colposcope
may be partially or completely attached as integral components of the chair. These chairs are designe
woman's body in appropriate positions during labor, delivery, artificial fertilization, and in other obstet
procedures.

Dilators designed for mechanically augmenting the diameter (caliber) of the internal layer of fibrous ti
of anatomic tubular structures facilitating the introduction of dedicated catheters. These dilators typic
radiopaque plastic shaft with a long distal tapered end that is located over the guidewire, facilitating a
prior to catheter introduction. Dedicated fascial tissue dilators intended for catheterization procedures
such as the vasculature (e.g., iliac arteries) and the ureters (e.g., ureteroscopy, stone removal) are av
usually supplied for single use in sterile packages.

Dilators designed for mechanically augmenting the diameter (caliber) of the internal layer of fibrous ti
of the vasculature facilitating the introduction of dedicated catheters. These dilators typically consist o
shaft with a long distal tapered end that is located over the guidewire, facilitating an effective dilation
introduction. Dedicated endovascular fascial tissue dilators are intended for catheterization procedure
vasculature (e.g., iliac arteries); they are usually supplied for single use in sterile packages.

Electromechanical surgical units designed for electrically powered mechanical ablation (resection) of a
(i.e., tumors) in the central nervous system. This equipment typically consist of (1) a central unit (a co
power and may also provide suction to a cutting handpiece that includes controls (e.g., to choose from
aspiration mode), (2) a detachable cutting handpiece, and (3) a switch, that may consist of a foot swit
The central unit also provides appropriate connections to the electric power supply, handpiece, aspira
disposable material canister. Neurologic electromechanical surgical units are mostly intended for cutti
intracranial (i.e., brain) and/or spinal soft tissue tumors during minimally invasive surgical procedures
stereotactic surgery) or open surgery procedures.

Disposable surgical ports used as an adjunct to minimally invasive abdominal surgery (i.e., laparoscop
permit the simultaneous pass and independent manipulation of multiple instruments and cameras, wh
peritoneum isolation and pneumoperitoneum. These ports usually include an introducer, a retractor, a
pneumoperitoneum. Single-port procedures permit the introduction of multiple instruments, video cam
laparoscopes into the abdominal cavity through a single incision smaller than normally required for tra
laparotomy but are larger than standard laparoscopy ports. This allows for surgical procedures through
ports may also include an adhesive attachment to the skin to keep isolation, and may include other co
blood/fluid absorbing materials). These ports are used for some particular laparoscopic procedures tha
Vascular stents designed for deployment into the intracranial arteries at or near a vessel bifurcation to
across the neck of a wide-neck aneurysm, allowing the aneurysm to be filled with coils or other approp
formed around the implanted coils are intended to provide aneurysm sealing. Intracranial aneurysm b
usually flexible nitinol self-expanding stents with a hybrid cell structure that allows the pass of the coi
they are used when open intracranial surgery is not possible or desirable.

Equipment designed to recover water from the exhaust steam of sterilizers by condensing the steam a
water back to the sterilizing unit for reuse. The recovery systems typically consist of a unit that includ
the water back to the sterilizing unit; a motor; a temperature switch; a level gauge; a water tank; and
and connectors that is placed between the sterilizing and water recovery units. Water recovery system
the amount of water wasted by the process of steam sterilization.

Washers designed for cleaning using steam. This equipment does not provide disinfection or sterilizat
typically consist of a metallic (e.g., stainless steel) unit including heating elements, one or more tanks
and solutions (e.g., buffing solutions), and a wand for manual application of steam. The unit may also
polishing, shining (i.e., buffing), and/or rinsing capabilities. Steam washers (commonly known as steam
are mostly used in healthcare facilities in dental (e.g., to remove wax, oil) and ophthalmic laboratories
intended to clean and polish a variety of other small devices.

Holders designed to store or hold bottles (e.g., rinse bottles, reagent bottles) in an upright position to
bottles and spillage of their contents. Bottle holders usually hold more than one bottle and may be ma
metal, or a combination of these materials. The shape of the holder usually conforms to the shape of t
designed to hold.
Environmental samplers designed to obtain samples of nitrous oxide (N2O) from the air in a closed en
samplers are typically portable units that include a small constant-sampling pump, filters, and a casse
or devices that include a material such as charcoal that adsorbs the nitrous oxide (passive sampler). T
N2O is obtained later by measuring the value in the collected sample or by desorbing the vapor from
Nitrous oxide environmental samplers are used to determine the accumulated long-term value N2O in
when the gas is used for inhalation as an analgesic (e.g. during dental or minor surgical procedures); s
are also used as personal dosimeters. Some samplers are also used to check leaks in N2O administrat
Liquid chromatography detectors designed to assess the individual molecules that come out (i.e., elut
chromatography column of a liquid and/or high-performance liquid chromatography (HPLC) system ba
charge that is in proportion to the amount of analyte. These detectors consist of a unit that includes: (
converts (i.e., nebulizes) the eluant in droplets; large droplets are removed and the solvent is evapora
drops leaving dry charged particles whose size is in proportion to the analyte concentration; (2) an ion
the dry particles collide with a stream of positive charged gas ions that transfer a charge to the partic
to each particle size; (3) a particle trap intended to remove excess gas ions; (4) a particle collector to
charge using an electrometer; and (5) a computerized system with appropriate software that displays
showing the constituents of the sample with an amplitude proportional to the quantity in the sample a
obtained from the electrometer output. Aerosol-charged liquid chromatography detectors are used as
that is independent of the chemical structure of the sample; it is intended for use in biochemical analy
pharmaceutical drug and biologic research.

Data interface units designed to allow a computer with an appropriate programming software to comm
programmable hearing aid. The interface units transmit re-formatted data between the computer and
devices consist of an electronic unit with dedicated software that connects to the computer on one sid
aids (left and right) through other two external ports. The software on the interface unit allows it to wo
(when connected also to the computer) for almost all types of programmable hearing aids. Programm
are used for initial and/or periodic programming and fitting the hearing aids according to the needs of

Device programming and testing software designed for non-invasively programming or re-programmin
aids by processing data from an associated computer. The software performs a variety of algorithms t
the measurements performed on the user while assessing and/or changing the characteristics (i.e., pr
known as fitting) of the hearing aid. Hearing aid programming/testing software is not usually available
tester (e.g., a hearing aid/computer interface) but may be updated (i.e., through the release of modifi
life of the programmer/tester. The software is used for programming, testing, and/or fitting a program
particular patient in audiometry departments or doctors' offices; some programs may be intended for

Solutions, creams, and gels designed for vaginal application to lubricate and moisturize the internal la
tissue. The products are frequently made of a variety of water-, oil-, and silicon-based, products which
obtained from plants. The products may also include some additional agents (e.g., germicides). Vagina
creams, and gels are mainly intended to treat vaginal dryness, to facilitate intercourse, and/or to facili
devices (e.g., thermometers, specula, surgical instruments) during the performance of diagnostic, the
surgical procedures in the interior of the vagina.

Solutions, creams, or gels designed for application inside the oral cavity. These solutions and creams a
oral cavity (i.e., the mouth) to produce a local effect (e.g., germicidal) or to create a physical barrier o
cavity; some liquid products can be applied as sprays. Oral cavity topical products are frequently mad
plant materials and may also include some additives for particular purposes. Some products are inten
use as antioxidants, or to treat small mouth ulcers (also known as canker sores or aphthous ulceration
combine the creation of a physical barrier (e.g., a film) and germicidal properties against microorganis
Physiologic analyzers designed to obtain estimates of a variety of physiologic parameters (e.g., blood
the variations of the external temperature in a group of selected body areas. These analyzers typically
and several attached temperature sensors. The main unit digitizes the temperature values taken by th
established rate and time (usually about 12 minutes) and delivers the data to a computer for processi
software. The temperature sensors are placed in several reference points on the body (e.g., armpits, u
artery). Temperature-based screening analyzers are mostly intended to obtain preliminary estimate of
such as hemoglobin and hematocrit levels; red, white, and lymphocyte cell counts; electrolytes (e.g.,
calcium); and other blood components (e.g., cholesterol). They may be used for health status screenin

Computer aided detection systems designed for automated detection and classification of the size, sh
chromosomes (i.e., karyotyping) on a slide containing a suspension of cell samples. These systems inc
that typically detects the second step of cell division (i.e., metaphase) in a specific area of the slide us
fluorescence stains and then performs automated karyotyping on the associated images. The process
software for automated detection of chromosomes, classification according the karyotype, data proces
delivery of report templates in electronic and printed format. Computer-aided karyotyping detection s
detect extra, missing, or abnormal chromosomes for genetic diagnostic (cytogenetics) and/or research

Physiologic analyzers designed for a pre-diagnosis of the presence of a variety of physiologic diseases
(e.g., cancer tumors) based on the variations of the external electrical resistance on the skin in a grou
areas (e.g., pulse points, dermal-visceral zones). Skin electrical-resistance analyzers (that are not imp
typically consist of a main unit and a set of attached resistance sensors placed around the wrist, ankle
the body. The sensors detect the resistance values before and after the application of electrical stimul
and passive electrodes. The main unit digitizes and records the resistance values taken by the sensors
to a computer for processing using a dedicated software. The results are then shown in a graphical dis
component of the system. Skin electrical-resistance-based screening analyzers are mostly intended fo
diagnosis of cardiovascular, respiratory, gastrointestinal, and/or other physiologic diseases.

Neuromuscular function physiologic analyzers designed to evaluate several biological measures (i.e.,
assess biological states that are essential for activities of daily living, thus characterizing the functiona
analyzers evaluate both neurologic (e.g., memory, reaction times) and physical conditions (e.g., heari
functions) and compare the results with standard values from healthy people adjusted for sex and age
biomarkers' decline in a given person. The set of biomarkers (typically about 12) chosen is related to t
are involved in mental and physical activities that better characterize normal day-to-day living. These
consist of a set of measuring instruments and transducers (e.g., headphones, lenses, vibrometers, spi
with push buttons to evaluate the physiologic parameters and reaction times. The analyzer also includ
appropriate software to calculate and provide the results including a value of the functional age for co
chronological age. Functional-age physiologic analyzers are used to assess the status of a person, fac
development of programs for lifestyle, diet, exercise, and/or other therapeutic (e.g., use of assistive d
to improve daily living of aging people.
Equipment that combines the simultaneous administration of heat with gentle massage to the tissues
therapy treatments. These machines typically consist of a unit that provides heating energy (e.g., rad
infrared [IR] light) and vibratory (e.g., suctioning) massage to the tissues simultaneously using a comm
applicator. A typical machine combines in the same unit: (1) a device to deliver vibration (may be ultr
negative pressure suctioning to the skin through the applicator; (2) dedicated heating sources such as
lamps and/or radiofrequency (RF) generators to provide monopolar and/or bipolar RF energy in the for
tissues; and (3) one or more detachable applicators for simultaneous delivery of the IR and RF energy
suctioning massage. Some machines may incorporate other forms of heating energy, including laser a
Physical therapy massage and tissue heating machines are used for relieving muscle spasms and alle
pains. They are also intended for temporary improvement of the local blood circulation and/or the exte
the body (i.e., cosmetic contouring), especially in areas affected by cellulitis.

Devices designed for maximum temporary restriction of movement and/or total immobilization of the
emergency situations. Dedicated emergency immobilizers are mainly used for the total restriction of m
whole body, the head and cervical spine, or the whole spine; immobilizers for the extremities are also
immobilizers are mainly used after traumatic injuries, allowing easy transportation and/or diagnosis of

Whole body emergency immobilizers designed for maximum restriction of movement and/or immobili
entire body. These immobilizers usually consist of rigid structures (typically a backboard) with a size th
use in adults to permit the rigid attachment of the entire body. The board is frequently made of light m
radiolucent materials and compatible with head immobilizers. Adult whole body immobilizers are main
injuries in emergency situations, allowing easy transportation and/or diagnosis including radiographic

Whole-body emergency immobilizers designed for maximum restriction of movement and/or immobili
entire body. These immobilizers usually consist of rigid structures (typically a backboard) with a size a
children that permit the rigid attachment of the entire body. The board is frequently made of light met
radiolucent materials and either includes or is compatible with head immobilizers. Pediatric whole-bod
mainly used after traumatic injuries as they allow for easy transportation and/or diagnosis, and ease o
radiographic procedures.

Emergency immobilizers designed for maximum restriction of movements and/or total immobilization
cervical vertebrae. These immobilizers usually consist of rigid structures (e.g., short boards) that perm
the head and the proximal (i.e., cervical) section of the spine. The board is frequently made of light m
radiolucent materials. Head/cervical spine immobilizers are frequently attached to whole body immob
backboards) and/or stretchers, to provide additional restriction of the body movement. They are main
injuries, and facilitate safer and easier transportation and/or diagnosis including radiographic procedu
mainly intended for use after vehicle accidents, are also available. Dedicated head/spine immobilizers
pediatric, and infant use are available.
Emergency immobilizers designed for maximum restriction of movements and/or total immobilization
cervical vertebrae of adults. These immobilizers usually consist of rigid structures (e.g., short boards)
size that permits the attachment of the head and the proximal (i.e., cervical) section of the spine of an
frequently made of light metallic or hard plastic radiolucent materials. Head/cervical spine immobilize
attached to whole-body immobilizers (i.e., long backboards) and/or stretchers, providing additional res
movement. They are mainly used after traumatic injuries, to facilitate safer and easier transportation
ease of access to radiographic procedures. Extrication collars mainly intended for use after vehicle ac
available.

Emergency immobilizers consisting of a rigid collar designed for maximum restriction of movements a
immobilization of the head and the cervical vertebrae. These devices usually consist of rigid collars m
hard plastic radiolucent materials. The immobilizer permits quick placement around the neck and a ho
the trachea. Rigid-collar cervical spine emergency immobilizers restrict head, neck, and cervical spine
motion to a great degree. The collar frequently permits its attachment to a whole-body board immobil
providing additional restriction of the body movement. Extrication collars are mainly used after traum
injuries to facilitate safer and easier transportation and/or diagnosis, and ease of access to radiograph

Emergency immobilizers designed for maximum restriction of movements and/or total immobilization
cervical vertebrae of children. These immobilizers usually consist of rigid structures (e.g., short boards
size that permits the attachment of the head and the proximal (i.e., cervical) section of the spine of a
frequently made of light metallic or hard plastic radiolucent materials. Head/cervical spine immobilize
attached to whole-body immobilizers (i.e., long backboards) and/or stretchers, providing additional res
movement. They are mainly used after traumatic injuries to facilitate safer and easier transportation a
ease of access to radiographic procedures. Extrication collars mainly intended for use after vehicle ac
available. Dedicated head/cervical spine immobilizers intended for infants are also available.

Emergency immobilizers consisting of a rigid collar designed for maximum restriction of movements a
immobilization of a child's head and cervical vertebrae. These devices usually consist of rigid collars m
hard plastic radiolucent materials. The immobilizer permits quick placement around the neck and a ho
the trachea. Rigid-collar cervical spine immobilizers restrict head, neck, and cervical spine anterior-po
great degree. The collar frequently permits its attachment to a whole-body board immobilizer or to a s
additional restriction of the body movement. Pediatric extrication collars are mainly used after trauma
injuries to facilitate safer and easier transportation and/or diagnosis, and ease of access to radiograph

Emergency immobilizers designed for maximum restriction of movements and/or total immobilization
cervical vertebrae of infants. These immobilizers usually consist of rigid structures (e.g., clamshell) wi
that permits the attachment of the head and the spine of an infant. The immobilizer is frequently mad
hard plastic radiolucent materials. Infant head/cervical spine immobilizers are frequently placed into in
bassinets. Infant emergency immobilizers are mainly used after traumatic injuries to facilitate safer an
and/or diagnosis, and ease of access to radiographic procedures.
Head orthoses designed for external modification of the structural and/or functional characteristics of
cranium) during therapeutic treatments. These orthoses are prefabricated (or, more frequently, custom
intended for long-term use. They usually include bands, joints, pads and other rigid or semi-rigid meta
components that are placed encompassing the cranium or the whole head. Therapeutic head orthoses
and/or modify the shape of the skull on patients with congenital deformities or after trauma; dedicated
intended to correct cranial malformations in infants and/or toddlers are also available.

Therapeutic head orthoses designed to modify some deformities of the head. These orthoses are often
polypropylene, styrene, or polyethylene) foam formed in the shape of a headband or helmet that appl
the most protuberant areas of the patient's skull. Therapeutic (i.e., corrective) head orthoses are used
infants and young children that are not related to premature bone union (i.e., non-synostotic deformat
asymmetries in the cranial vault, skull base, and face.

Spine orthoses designed for external modification of the structural and/or functional characteristics of
of the spine, that provide immobilization and/or support. Cervical spine orthoses include soft cervical o
collars) that are intended to provide limited support and stabilization or semi-rigid and rigid orthoses t
immobilization of the cervical spine. Cervical orthoses are intended mainly to reduce pain, to provide
control or complete immobilization of the cervical spine; they are frequently intended for therapeutic
functional use) after injuries or trauma.

Cervical spine immobilizer orthoses designed for maximum restriction of movements and/or total imm
cervical segment of the spine; they usually restrict head, neck, and cervical spine lateral and rotationa
orthoses usually consist of rigid (prefabricated or, less frequently, custom-made) structures made of li
plastic radiolucent materials that are placed encircling the neck. Cervical spine immobilizers are used
stabilization of injured patients and for long-term care of patients after injuries or surgery. Dedicated r
collars and braces intended for immobilization of the cervical spine are available. Orthoses that provid
lateral flexion and rotation (e.g., poster-style orthoses) are also available.

Caps designed for covering the extreme end of a fiberoptic light cable to diffuse the intense light ener
cable tip when the cables are not in active use. These caps usually consist of an optical translucent an
(e.g., Teflon, polysulfone) and metals (e.g., stainless steel) that may be temporarily attached and deta
end several times using an adapter, making the cap temperature low enough to allow manual touch w
Energy diffusion fiberoptic cable caps are mostly used during minimum access (e.g., laparoscopic) pro
risk of burns to patients and healthcare staff, also reducing the risk of fire when the cable contacts the
placed in oxygen rich environments. Both reusable caps (which can be re-sterilized) and pre-sterilized
(intended for single-use) are available.
Cervical spine immobilizer orthoses designed to encircle the neck (e.g., rigid collars) for maximum res
and/or total immobilization of the cervical segment of the spine; they usually include some head contr
orthoses usually consist of rigid (prefabricated or, less frequently, custom-made) collars made of light
radiolucent materials. Rigid collar cervical spine immobilizers restrict head, neck, and cervical spine a
motion to a great degree but allow some rotation and lateral bending. They are used for emergency st
patients and for long-term care of patients after injuries or surgery. Dedicated rigid and semi-rigid coll
immobilizations of the cervical spine are also available (e.g., Philadelphia Cervical Collar, Miami J-Style
orthoses, and Malibu cervical brace).

Cervical spine immobilizer orthoses incorporating posters designed for maximum restriction of movem
immobilization of the cervical segment of the spine. These orthoses usually consist of rigid (prefabrica
custom-made) orthoses made of metal or hard plastic materials. The orthoses usually include two or f
pads (e.g., mandibular, sternal, thoracic, occipital) that increase the rigidity of the structure. Poster st
immobilizers provide additional control of the head, neck, and cervical spine motion than other immob
for long-term care of patients after injuries or surgery.

Cervical spine orthoses designed to provide support and some degree of movement restriction of the
spine. These orthoses usually consist of soft (usually prefabricated foam) structures encircling the nec
are frequently made of light plastic and/or other soft materials. Soft collar cervical spine support ortho
limited restriction of head, neck, and cervical spine lateral and rotational motion; they are used mainly
for short-term care of patients after injuries or surgery.

Spine orthoses designed for external modification of the structural and/or functional characteristics of
thoracic (trunk) segments of the spine, providing immobilization, motion control, and/or support to the
Cervicothoracic spine orthoses usually consist of rigid (e.g., metallic, hard plastic) orthoses that can p
of the cervicothoracic segment of the spine. The orthoses are intended mainly to reduce pain and to p
or complete immobilization of the cervicothoracic segment of the spine; they may be used for rehabili
trauma (e.g., lower cervical and upper thoracic fractures).

Cervical spine orthoses designed for maximum restriction of movements and/or total immobilization (
the cervical and thoracic (trunk) segments of the spine; they may restrict head, neck, and cervical and
segments' lateral and rotational motion. These orthoses usually consist of rigid (prefabricated or, less
made) structures in a variety of shapes and sizes that usually include a thoracic extension to provide
the lower segment of the cervical spine. Cervicothoracic spine immobilizers are used for long-term ca
trauma (e.g., spinal fractures) and less frequently to alleviate pain. Dedicated immobilizers for the cer
including halo vests, sternal immobilizers, and braces (e.g., Malibu, Minerva, Yale) are also available.

Cervicothoracic immobilizer orthoses designed for maximum restriction of movements and/or total im
cervical and thoracic (trunk) segments of the spine using a chest jacket (known as a halo vest) and a
These vest orthoses consist of rigid structures that include three basic parts: a vest that is fitted on th
weight of the device, a metal "halo" ring that is fixed around the head by metal pins, and metal rods t
the vest. Vest orthoses provide triplanar motion control of the cervical spine; they are used for long-te
fractures and less frequently to lessen spinal pain.
Cervicothoracic immobilizer orthoses designed for maximum restriction of movements and/or total im
motion control) of the cervical and thoracic (trunk) segments of the spine using a sternal plate. These
rigid structures that include a sternal plate with shoulder extensions and both mandibular and occipita
Sternal immobilizer orthoses provide good flexion control of the cervical spine; they are used for long-
spinal fractures and less frequently to alleviate spinal pain.

Spine orthoses designed for external modification of the structural and/or functional characteristics of
lumbar, and sacral segments of the spine, providing immobilization (i.e., motion control) and support
Cervicothoracic-lumbosacral spine orthoses usually consist of rigid metallic (e.g., stainless steel) and s
leather) orthoses that can provide immobilization of the cervicothoracic and lumbosacral segments of
intended mainly to provide motion control or complete immobilization of the spine. Dedicated cervico
orthoses intended for the treatment of spinal deformities are also available.

Cervicothoracic-lumbosacral spine immobilizer orthoses designed for maximum restriction of moveme


immobilization of the cervical, thoracic, lumbar, and sacral segments of the spine. These orthoses (als
braces) typically consist of a metallic (usually steel) and leather structure that is placed from the pelv
cranium (occiput); it includes a neck ring, two occipital pads and also a lateral pad that is located in th
spinal deformity. Cervicothoracic-lumbosacral braces are intended to keep the thoracic spine constrain
the treatment of scoliosis located in the cervicothoracic segment of the spine.

Spine orthoses designed for external modification of the structural and/or functional characteristics of
segments of the spine, providing immobilization and support. These orthoses consist of a structure tha
lumbosacral part of the trunk to keep that segment of the spine constrained. Lumbosacral spine ortho
mainly to alleviate low-back pain by providing immobilization (i.e., motion control) and/or support to t
may consist of fabric and/or plastic either elastic, semi-rigid, or rigid devices. These orthoses may be u
supports for daily activities (i.e., functional) use.

Lumbosacral spine orthoses designed for maximum restriction of movements and/or total immobilizat
control) of the lumbar and sacral segments of the spine; they may restrict spine segment movements
extension) in the sagittal, coronal, and/or sagittal and coronal planes. These orthoses usually consist o
and prefabricated orthoses are available) structures typically made of malleable radiolucent aluminum
shapes and sizes; the orthoses usually include thoracic and/or inter-scapular bands and paraspinal and
Immobilizer lumbosacral orthosis are intended for long-term control of movement of the spinal segme
rehabilitation after trauma; dedicated orthoses for movement control and/or complete immobilization
chairback type), coronal (e.g., Williams) and sagittal/coronal (e.g., Knight) planes are available.

Lumbosacral spine orthoses designed to provide support and some degree of movement restriction of
segments of the spine. These orthoses usually consist of soft or semi-rigid structures (belts, bands, co
lumbar and sacral segments of the spine; they are frequently made of fabrics combined with light me
components. Lumbosacral spine support orthoses also provide limited restriction of the lumbar spine l
motion; they are used mainly to alleviate pain and/or for short-term care of patients after injuries or su
Support lumbosacral spine orthoses consisting of a garment of soft or semi-rigid materials (i.e., corset
provide support and some degree of movement restriction of the lumbar and/or sacral segments of th
orthoses usually consist of inelastic garments made of soft fabric (e.g., canvas), plastic (e.g., Dacron),
these that are usually reinforced with metal (e.g., stainless steel) stays. Lumbosacral corsets can be fi
of the lumbosacral spine, surrounding the pelvis and abdomen and providing support and limited restr
and sacral spine lateral and rotational motion.They are used mainly to alleviate lower back pain by red
the spinal and abdominal muscles and/or for short-term care of patients after injuries or surgery.

Spine orthoses designed for external modification of the structural and/or functional characteristics of
and sacral segments of the spine, providing immobilization and/or support. These orthoses consist of
encircles the thoracic and lumbosacral spine that constrains those segments of the spine. Thoracic-lum
orthoses are intended for long-term care of spinal deformities and for rehabilitation after trauma, and
pain and/or to provide trunk support. They may consist of fabric and/or plastic orthoses that are either
rigid devices.

Thoracic-lumbosacral spine orthoses designed for maximum restriction of movements and/or total imm
motion control) of the thoracic, lumbar, and sacral segments of the spine. They may restrict spine seg
(flexion and/or extension) in one or more of the sagittal, coronal, and/or transverse planes. These orth
rigid (custom-made and prefabricated orthoses are available) structures typically made of malleable r
alloys in a variety of shapes and sizes. The orthoses usually include thoracic and/or inter-scapular ban
and/or lateral bars. Immobilizer thoracic-lumbosacral orthoses are intended for long-term care of spina
rehabilitation after trauma. Dedicated orthoses for movement control in the sagittal (e.g., Taylor), sag
Knight-Taylor) planes and triplanar control are available.

Thoracic-lumbosacral spine immobilizer orthoses designed for maximum restriction of movements and
immobilization of the thoracic, lumbar, and sacral segments of the spine. They restrict spine segment
and/or extension) in the sagittal, coronal, and/or transverse planes (i.e., provide control of movement
These orthoses usually consist of rigid (custom-made and prefabricated orthoses are available) structu
malleable radiolucent aluminum alloys. The orthosis includes a thoracic band with sub-clavicular exte
cowhorn projections) as well as pelvic, lateral, and paraspinal bars. Triplanar control immobilizer ortho
long-term care of spinal deformities and for rehabilitation after trauma when movement control in the
needed.

Triplanar control thoracic-lumbosacral spine immobilizer orthoses designed for maximum restriction of
total immobilization in the sagittal, coronal, and/or transverse planes (i.e., provide maximum control o
three planes) that consist of a custom-made jacket. These orthoses usually consist of rigid or semi-rig
custom-made structures typically made of thermoplastics that are fabricated using a model of the use
made jackets used as triplanar control immobilizer orthoses are intended for long-term care of spinal d
rehabilitation after trauma when movement control in the three planes is needed.

Thoracic-lumbosacral spine orthoses designed to provide support and some degree of movement rest
and sacral segments of the spine. These orthoses usually consist of soft or semi-rigid structures (belts
encircling the thoracic and lumbosacral spine; they are frequently made of fabrics combined with light
components. Thoracic-lumbosacral spine support orthoses are intended for long-term rehabilitation af
alleviate back pain and/or to provide trunk support.
Support thoracic-lumbosacral spine orthoses consisting of a garment of soft or semi-rigid materials (i.e
designed to provide support and some degree of movement restriction of the thoracic, lumbar, and sa
spine. These orthoses usually consist of garments made of soft fabric (e.g., canvas), plastic (e.g., Dacr
these that are usually reinforced with metal (e.g., stainless steel) stays. Lumbosacral support corsets
encircling of the thoracic and lumbosacral spine, surrounding the pelvis and abdomen with the poster
extending to the scapular spine and including shoulder straps. They are used for long-term care of spi
rehabilitation after trauma, and also to alleviate back pain and/or to provide trunk support.

Spine orthoses designed for external modification of the structural and/or functional characteristics of
segments of the spine, providing immobilization and support and/or increasing comfort. These orthose
that encircles the sacral and iliac segments of the spine to keep that segment of the spine constrained
orthoses are intended mainly to alleviate low-back pain by providing support and very limited motion
spine; they may consist of fabric and/or plastic orthoses that are either elastic or semi-rigid devices. D
orthoses intended for support, therapeutic, and/or daily activities (i.e., functional) use are available; c
to alleviate pressure on the sacroiliac region are also available.

Sacroiliac spine orthoses designed to provide support and some degree of movement restriction of the
segments of the spine. These orthoses usually consist of soft or semi-rigid structures (e.g., corsets) en
iliac segment of the spine; they are frequently made of fabrics combined with light metal or plastic co
spine support orthoses provide limited restriction of the lumbar spine lateral and rotational motion; th
alleviate lower back pain.

Sacroiliac spine support orthoses consisting of a garment of soft or semi-rigid materials (i.e., corsets)
provide limited support and some degree of movement restriction of the sacral and iliac segments of t
assistance to the pelvis. These orthoses usually consist of inelastic garments made of soft fabric (e.g.,
Dacron), or combinations of these that are usually reinforced with metal (e.g., stainless steel) stays. S
corsets can be fitted for tight encircling of the sacroiliac spine, surrounding the pelvis below the waist
providing support and limited restriction of the lumbar and sacral spine lateral and rotational motion;
to alleviate mild lower back pain.

Sacroiliac orthoses designed for external modification of the structural and/or functional characteristic
region of the spine and the pelvis during therapeutic treatment. These orthoses typically hold and sup
dynamic treatment of the area. They may consist of a sling to suspend the complete pelvis, a belt fitte
other appropriate device that holds the pelvis. Therapeutic sacroiliac orthoses are mainly used during
treatment intended to alleviate pain, align the vertebrae, or after traumatic injuries. Dedicated therap
belts and slings are available.

Orthoses designed for external modification of the structural and/or functional characteristics of the a
muscular and bone structures, providing immobilization and support or supplementing and/or augmen
functions and/or structure. These orthoses typically consist of flexible or semi-rigid structures with ela
have appropriate physical characteristics (e.g., shape, consistency) to encircle the chest totally or at a
Thoracic orthoses are typically made of fabrics, plastics, malleable metals or a combination of these. D
prefabricated or, less frequently, custom-made orthoses intended for a particular region of the anterio
ribs) are available.
Thoracic orthoses designed to encircle the thorax to provide support to the muscles and bones and to
of the thorax in appropriate position. These devices may consist of wide pieces of elastic fabric or narr
materials (e.g., belts) available in several sizes; the orthoses are usually reinforced with metallic stays
support of the muscles and thoracic bones. Thoracic support orthoses are used mainly to support and
muscles, sternum, ribs, and/or other chest anatomical structures during rehabilitation from traumatic
fracture) and/or to provide relief from pain and strain.

Thoracic flexible orthoses designed to encircle the complete thorax to provide support to the muscles
the anterior part of the thorax in appropriate position. These devices are usually made of wide pieces
hook-and-loop closures (e.g., Velcro) for adjustment of their size; the orthoses are usually reinforced w
appropriate support of the muscles and thoracic bones. Whole thorax orthoses are used mainly to sup
chest muscles, sternum, ribs, and/or other chest anatomical structures for rehabilitation from traumat
fracture) and/or to provide relief from pain and strain.

Thoracic support narrow flexible orthoses designed to encircle the thorax (i.e., belts) to provide suppo
and associated muscles in appropriate position. These devices are usually made of narrow pieces of e
with attached pads. The belts may include hook-and-loop closures (e.g., Velcro) for adjustment of the
are usually reinforced with metallic stays for appropriate support of the muscles and ribs. Belt rib supp
intended to support the ribs and/or other thoracic anatomical structures for rehabilitation from trauma
fracture) and/or to provide relief from pain and strain.

Orthoses designed for external modification of the structural and/or functional characteristics of part o
limb, providing immobilization and/or support. These orthoses consist of rigid or semi-rigid malleable m
stainless steel) structures (e.g., supports, immobilizers, movement restraints) that may provide static
and/or assistance during normal use of the musculoskeletal structure using body or external (e.g., ele
limb orthoses are intended mainly for treatment of deformities and injuries after trauma. Dedicated pr
made orthoses that are intended for a particular region of the limb (e.g., finger, hand, wrist, arm); pro
alignment, support); treatment (e.g., deformity, trauma, arthritis); or for long-term functional assistan

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
limb, to provide immobilization and/or support. These orthoses are prefabricated or custom-made dev
or semi-rigid malleable metal (e.g., aluminum, stainless steel) structures (e.g., supports, restraints) th
fabric bands that encircle the upper limb at a particular area. Total upper-limb orthoses are frequently
of deformities and injuries after trauma. Dedicated orthoses intended for static or dynamic therapy th
immobilization, alignment, or support, treatment (e.g., deformity, trauma, arthritis), or for long-term f
are also available. Some upper-limb total orthoses may use power provided by other muscles of the b
(e.g., electric) power.

Total upper-limb support orthoses consisting of a rigid board that are designed for attachment to a cha
provide support and some degree of movement restriction to the upper limb. These orthoses typically
hard plastic board whose thickness is appropriate to the user needs and is attached to the arms of a c
frequently, a wheelchair. Chair and wheelchair lapboard upper-limb support orthoses are frequently u
by positioning it in an appropriate position, thus compensating for muscle weakness.
Total upper-limb orthoses designed to make possible and/or improve the functional activities of the lim
daily activities. These devices provide support, supplement, and/or augment the limb functions. These
of static or dynamic mechanisms appropriate to facilitate the normal function of otherwise partially or
limbs. Dedicated functional orthoses that use power provided by other muscles of the body or by exte
power are available. Some powered orthoses may be controlled by the action of switches, bioelectric s
combination of these.

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
to provide immobilization and support. These orthoses are usually classified according to the function
immobilization, functional, therapeutic) and the physical characteristics (e.g., shape, consistency) and
make the orthosis (metal, plastic, or a combination of these). Shoulder upper-limb orthoses may consi
orthoses (e.g., a combination of sleeves and caps) that are intended to provide limited support and st
orthoses that can provide total immobilization of the shoulder joint usually by attaching the orthoses t
Shoulder upper-limb orthoses are intended mainly to provide motion control of the shoulder movemen
complete immobilization of the shoulder joint; they are also used to avoid pain and/or for rehabilitatio
trauma.

Upper-limb orthoses designed to provide support and some degree of movement restriction to the sho
consist of a variety of devices that assist the support and positioning of the shoulder; they typically in
sleeve or cap and straps fixed to the trunk. Shoulder support orthoses are frequently used to assist th
in an appropriate position to provide partial restriction and control of its movement during rehabilitatio
trauma.

Upper-limb support orthoses designed to provide support by displacing the arm away from the midline
abduction). They are also designed to provide some degree of movement restriction to the shoulder jo
consist of a variety of devices with several bands and/or straps that assist the support and positioning
abducted position. Typically this is achieved by the inclusion of foam pads or wedges attached to the u
shoulder support orthoses are frequently used to assist the limb by positioning it in an abducted posit
restriction and control of its movement during rehabilitation from injuries or trauma.

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
provide immobilization and/or support. These orthoses usually consist of rigid or semi-rigid structures
and metal stays that provide assistance during use of the arm. Forearm orthoses are intended mainly
injuries or trauma (e.g., fractures).
Upper-limb arm orthoses designed to support to the forearm by providing soft-tissue compression to m
stabilization of the ulna (one of the two forearm bones). They permit movement of the adjacent joints
These orthoses typically consist of sleeves of fabric or other soft material that are tightened on a laye
previously placed on the forearm and that may include metallic or hard plastic stays. Some orthoses c
(i.e., bi-valved devices) that allow an easier adjustment during the period of use. Upper-limb forearm o
known as functional braces) are used instead of rigid casting to treat specific types of closed fractures
rehabilitation.
Upper-limb orthoses designed for external modification of the structural and/or functional characterist
elbow joints, providing immobilization (i.e., motion control) and/or support to both joints. These orthos
classified according to the function of the orthoses (e.g., immobilization, support, correction) and the p
(e.g., shape, consistency) and/or material used to make the orthoses (metal, plastics or a combination
shoulder-elbow orthoses intended for support of very painful shoulder joints and/or for therapeutic tre
or trauma of the upper limbs are also available.

Shoulder-elbow upper-limb orthoses designed to support the function of the shoulder and elbow joints
also some degree of movement restriction to the shoulder and elbow joints. These orthoses may cons
that may provide abduction to the arm while permitting a variety of flexion and/or rotation movement
orthoses for the shoulder-elbow joints mounted on wheelchairs for muscular disabled patients are also
elbow support orthoses are intended to assist the motion of the upper limb after illness, trauma, and/o
disabled patients.

Upper-limb orthoses designed to provide support by displacing the arm away from the midline of the b
These also provide some degree of movement restriction to the shoulder and elbow joints. These orth
of a forearm with an adjustable coupling that is attached to a plastic band placed around the pelvis; p
restricted flexion and rotation movements to the abducted limb. Abduction shoulder-elbow support ort
gunslinger orthoses) are frequently used to assist the limb function by positioning it in an abducted po
restriction and control of its movement during rehabilitation from injuries or trauma.

Functional shoulder-elbow orthoses designed to support to the weight of the upper limb that are moun
wheelchair arm, providing assistance to the shoulder and elbow joints during normal activities. These
wheelchair bracket and a proximal (standard) or "elevating" arm; the device may include springs or ru
supplement the lack of strength of the muscles. Wheelchair mounted shoulder-elbow support orthoses
arm supports (MAS), are frequently used to assist the upper-limb function of patients with severe mus
consequence of illness or spinal cord trauma.

Therapeutic upper-limb orthoses designed for external modification of the structural and/or functional
shoulder, elbow, and wrist joints. These orthoses are prefabricated or, more frequently, custom-made
needed. They usually include bands, cuffs, joints, pads, and other components (including sub-axillary
placed around the upper limb and also encircling the trunk of the user. Shoulder-elbow-wrist orthoses
shoulder stabilizers and airplane orthoses) provide support and motion control to the joints; they are i
prevent contractures of soft tissues after surgery (e.g., rotator cuff), injuries, trauma, and/or axillary b

Elbow upper-limb semi-rigid orthoses (i.e., splints) designed for protection and maximum restriction o
total immobilization of the elbow joint. These orthoses consist of a one- or two-part (encircling both th
semi-rigid foam or lightweight plastic structure with aluminum stays and closure straps. The splint can
the elbow extended or at any appropriate bending angle up to 90 degrees. Splint elbow immobilizers
rehabilitation after surgery or traumatic injuries (e.g., fractures, sprains, sprains, and dislocated joints

Elbow upper-limb orthoses designed to support the function of the elbow joint also allowing some deg
restriction to the joint. These orthoses may consist of wearable devices that permit a variety of flexion
movements to the elbow joint; they include wrappings and flexible supports. Elbow support orthoses a
the motion of the upper limb after illness, trauma, and/or for muscle-disabled patients.
Elbow orthoses designed for external modification of the structural or functional characteristics of the
therapeutic treatment. These orthoses may provide static (i.e., with the joint immobilized) or dynamic
controlled and limited joint movement) therapy. Static-therapy orthoses are typically custom-made de
sections of plastic bands, cuffs, and straps fixed in the arm and forearm respectively with an adjustabl
can be deliberately altered to accomplish a progressive extension of the elbow tissues. Dynamic thera
typically prefabricated devices typically consisting of soft cuffs fixed at the arm and forearm respectiv
and an adjustable mechanical joint placed at the elbow to regulate the range of the elbow movement.
for static therapy treatment (e.g., long-arm casts) and dynamic therapy are also available.

Therapeutic elbow upper-limb orthoses designed to provide static therapy to the elbow joint. These or
stabilize, and support the elbow joint in a desired position (i.e., without allowing movement of the join
arm and forearm (known as long-arm casts). These orthoses typically consist of a cast that is placed a
from above the wrist to the mid portion of the arm with the elbow in its maximum extended position.
placed with the elbow flexed; in that case, the cast is changed periodically to get more extended posit
arm casts are used mainly to treat flexion contractures of the elbow; bi-valved long-arm casts are also

Elbow therapeutic orthoses designed to provide a force and torque across the elbow joint increasing it
permitting a limited and adjustable range of motion of the joint by means of a dynamic splint. These o
prefabricated devices consisting of soft cuffs fixed at the arm and forearm, multiple straps, and an ad
joint placed at the elbow to regulate the range of the elbow movement. Dynamic splint elbow orthose
surgery, trauma, or brain injuries; they are used also after cast removal for stable fractures. Dedicated
articulated splints and/or using ratchet mechanisms are also available.

Elbow upper-limb orthoses designed to make possible and/or improve the functional activities of the e
daily activities by providing support, supplementing, and/or augmenting the limb functions. These ort
custom-made devices consisting of soft cuffs fixed at the arm and forearm, multiple straps, and an ad
elastic spring mechanism with several locking positions at different elbow angles. Functional elbow or
long-term use in normal activities by patients with congenital or traumatic loss of elbow flexibility.

Functional powered elbow orthoses designed for external modification of the structural and/or function
the elbow using power sources (usually electric) and powered mechanisms that provide support, supp
augment the elbow functions and/or its structure. These orthoses typically consist of wearable devices
automated (robotic) devices, usually wearable, with very small electric motors that provide actual mo
Powered elbow functional orthoses are intended to facilitate patient training guided by a physical ther
and control of weak muscles in the upper limbs caused by physical accidents and/or illness (e.g., after
(i.e., switch actuated) orthoses and orthoses controlled by muscular bio-signals (i.e., myoelectric) are

Wrist-hand upper-limb orthoses designed for external modification of the structural and/or functional c
wrist joint and the hand during therapeutic treatment. These orthoses may provide static (i.e., with th
immobilized) or dynamic (i.e., permitting a controlled and limited wrist joint movement) therapy. Stati
typically prefabricated devices consisting of a plastic splint that runs from the tip of the fingers to the
forearm (e.g., a platform splint). Dynamic therapy orthoses that include a semi-rigid structure with an
joint (e.g., hinged) are also available. Dynamic therapy orthoses are placed at the wrist to regulate the
Therapeutic wrist orthoses designed for external modification of the structural and/or functional chara
joint. These devices keep the joint in an extended position (i.e., without allowing movement of the join
frame along the forearm and wrist to the thumb (known as a volar splint). These orthoses typically con
aluminum frame placed along the forearm using soft pads and straps. The frame is attached to the th
permits the hand and fingers normal function with the wrist in slight extended position. Static therapy
mainly to treat injuries after trauma, including tendonitis, and post-wrist sprains and fractures.

Therapeutic wrist orthoses designed for external modification of the functional characteristics of the w
a limited and adjustable limited range of flexion motion of the joint. These orthoses are prefabricated
consisting of semi-rigid articulated devices that include forearm and hand straps, and an adjustable m
at the wrist to regulate the range of the joint flexion. Flexion dynamic therapy wrist orthoses are used
suffering from hyperextension deformity of the wrist.

Therapeutic wrist orthoses designed for external modification of the functional characteristics of the w
limited and adjustable range of extension of the joint. These orthoses are prefabricated devices typica
rigid articulated devices that include forearm and hand straps, and an adjustable mechanical joint pla
regulate the range of the joint extension. Extension dynamic wrist orthoses are used to treat patients
deformity of the wrist.

Wrist orthoses designed to make possible and/or improve the functional activities of the wrist during c
These devices provide support, supplement, and/or augment the wrist functions while allowing finger
movements and thumb opposition. These orthoses typically consist of a splint (known as cock-up splin
the palmar crease of the hand to the distal part of the forearm which positions the wrist at about 30 d
Splint functional static wrist orthoses are used mainly to alleviate pain and permit better functioning o
with rheumatoid arthritis and/or other diseases (e.g., carpal tunnel syndrome) affecting the wrist.

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
and the hand, providing motion control or total immobilization to the wrist and support to the wrist an
are usually classified according to the function of the orthoses (e.g., therapeutic, functional) and the p
(e.g., shape, consistency) and/or material used to make the orthoses (metal, plastics or a combination
upper-limb orthoses may consist of soft orthoses (e.g., a combination of cuffs, straps, and flexible mec
intended to provide limited support and stabilization or semi-rigid orthoses that can provide a high de
immobilization of the wrist joint and hand. Wrist-hand orthoses are intended mainly to provide motion
movements and/or to avoid pain after injuries or trauma. Dedicated wrist orthoses for static and/or dy
use during normal daily activities (i.e., functional) are also available.

Wrist-hand upper-limb orthoses designed for external modification of the structural and/or functional c
wrist joint and the hand during therapeutic treatment. These orthoses may provide static (i.e., with th
immobilized) or dynamic (i.e., permitting a controlled and limited wrist joint movement) therapy. Stati
typically prefabricated devices consisting of a plastic splint that runs from the tip of the fingers to the
forearm (e.g., a platform splint). Dynamic therapy orthoses that include a semi-rigid structure with an
joint (e.g., hinged) are also available. Dynamic therapy orthoses are placed at the wrist to regulate the
Therapeutic wrist upper-limb orthoses designed for external modification of the characteristics of the
while allowing very limited finger articulation movements. These orthoses typically consist of a long, l
splint (known as platform splint) that runs from the tip of the fingers to the distal part of the forearm.
neutral position and restricts the movement of the fingers and thumb. Therapeutic platform splint wris
mainly for night treatment, frequently after surgery for traumatic injuries.

Therapeutic wrist-hand upper-limb orthoses designed for external modification of the characteristic of
devices provide a force across the joint and permit a limited and adjustable range of motion. These or
prefabricated devices typically consisting of a semi-rigid cuff or sleeve fixed at the forearm using one
soft pad or band fixed on the hand. The orthosis also includes an adjustable mechanical joint (hinge) p
regulate the range of its movement, usually by extension and flexion movement controls (i.e., stops).
incorporate an elastic band to assist weak extension muscles. Therapeutic dynamic wrist-hand orthos
with weak wrist muscle extensors and paralyzed hand muscles after surgery, trauma, or brain injuries

Wrist-hand upper-limb orthoses designed to make possible and/or improve the functional activities of
hand during common daily activities using a mechanism that is triggered or propelled by the user. The
consist of prefabricated devices, including a mechanism that permits closing the hand in several discr
possible to pinch objects. Wrist-hand functional orthoses are operated by power external to the wrist a
(e.g., using the other arm). They provide support, supplement, and/or augment the limb functions. Th
activities such as feeding, grooming, and writing by patients with paralysis or severe weakness of the
muscles. Dedicated functional wrist-hand orthoses that use ratchet mechanisms or are driven by trans
the wrist extensor muscles to the fingers (i.e., wrist driven) are available, and electrically powered ort
available.

Functional wrist-hand upper-limb orthoses designed to grasp and release objects using a ratchet mech
external to the wrist or hand. These orthoses typically consist of prefabricated devices, including a se
fixed at the forearm with one or more straps, soft pads or bands fixed on the hand, and an adjustable
joint that permits closing the hand in several discrete positions and making it possible to pinch objects
functional orthoses are operated by power external to the wrist and/or hand muscles (e.g., using the o
with the chin), providing support, supplementing, and/or augmenting the hand functions. They are use
such as feeding, grooming, and writing by patients with paralysis or severe weakness of the hand and

Functional wrist-hand upper-limb orthoses designed to grasp and release object using a mechanism po
extensor muscles. These orthoses typically consist of prefabricated devices including a semi-rigid cuff
forearm with one or more straps, soft pads or bands fixed on the hand, and a mechanism that transmi
extensors to the weak or disabled finger muscles. These devices permit closing the hand in several di
making it possible to pinch objects between the fingers and thumb. Wrist-driven functional orthoses a
activities such as feeding, grooming, and writing by patients with paralysis or severe weakness of the
muscles.
Functional wrist-hand upper-limb orthoses using power sources (usually electric) and powered mechan
to make possible and/or improve the functional activities of the wrist joint and hand. These orthoses t
prefabricated devices including a semi-rigid cuff or sleeve fixed at the forearm using one or more stra
fixed on the hand, and a battery powered motor and mechanism that allows the hand to close in seve
The mechanism is also used to pinch objects. Wrist-hand powered orthoses used for daily activities su
grooming, and writing by patients with paralysis or severe weakness of the hand and wrist muscles (e
plexus injuries, stroke, quadriplegics). They are usually operated using switches (i.e., autonomous) bu
controlled by bioelectric muscular (i.e., myoelectric) signals are also available.

Upper-limb orthoses encompassing the wrist, hand, and fingers that are designed to immobilize, stabi
wrist joint, hand, one or more fingers and/or the thumb. They provide motion control, total immobiliza
These orthoses may consist of a variety of devices intended for immobilization or static or dynamic th
frequently, for functional use. These orthoses typically include both dorsal and palmar (volar) adjustab
along the hand and fingers and permit appropriate positioning of the wrist, fingers, and thumb. Wrist-h
are used mainly for immobilization during rehabilitation after surgery (e.g., arthroplasty surgery) and/
purposes.

Wrist-hand-finger immobilizer orthoses consisting of a semi-rigid structure (i.e., a splint) that are desig
restriction of movements and/or total immobilization of the wrist joint by keeping the hand, fingers, an
functional position. These orthoses typically consist of a splint with a component made of fabric, leath
placed encircling the distal segment of the forearm and wrist to keep the wrist in a fixed position. A se
used to keep in appropriate position the fingers and thumb while malleable aluminum strays connect
providing a rigid or semi-rigid structure. Immobilizer wrist-hand-finger splints are used mainly to preve
and after wrist surgery (e.g., surgical arthroplasty).

Wrist-hand-finger upper-limb orthoses designed for external modification of the structural and/or func
the wrist joint and the hand during therapeutic procedures. These orthoses may consist of a device th
forearm, including both dorsal and palmar (volar) adjustable solid stays attached along the hand and
appropriate positioning of the wrist, fingers, and thumb. Static therapy wrist-hand-finger orthoses are
surgery (e.g., arthroplasty surgery).

Therapeutic wrist-hand-finger orthoses designed for external modification of the structural and/or func
of the wrist joint, hand, and fingers that consist of a splint resembling a platform. These orthoses cons
encircles the forearm and include both a both dorsal and a palmar (volar) wide platform structure (i.e.
adjustable solid stays attached along the hand and fingers to permit appropriate positioning of the wr
platform orthosis splints are used mainly for therapeutic treatments after surgery (e.g., arthroplasty s

Wrist-hand-thumb upper-limb orthoses designed to immobilize, stabilize, and support the wrist joint in
(i.e., without allowing movement of the joint) and also to immobilize the hand and thumb. These ortho
rigid plastic device that encircles the forearm including adjustable (e.g., Velcro) straps that can be trim
The orthoses permit appropriate positioning of the wrist, hand, and thumb according to the users' nee
hand-thumb orthoses are used mainly for rehabilitation after surgery or traumatic injuries.
Orthoses designed to stabilize the hand, provide hand immobilization and/or support while keeping its
and position while permitting the movement of the fingers and thumb. These orthoses typically consis
placed encircling the distal segment of the forearm and is attached to a rigid component used to supp
orthoses are used mainly in patients with severe weakness or complete paralysis of the hand muscles
used for therapeutic purposes (e.g., to avoid hyperextension) and/or including attachments intended f
are also available.

Hand orthoses designed to stabilize and support the hand during therapeutic treatments and/or while
daily activities, permitting the movement of the fingers and thumb. They are also used to help preven
These orthoses typically consist of a device that is placed encircling the distal segment of the forearm
rigid component used to support the hand in an appropriate, functional position. Static therapy wrist-h
mainly in patients with severe weakness or complete paralysis of the hand muscles but having strong
including some quadriplegics, preventing hand deformities. Several attachments (e.g., clips, clamps, e
these orthoses permit the performance of functional activities such as writing and page turning. Also
dedicated custom-made hand orthoses intended to keep the thumb in opposition (using thumb adduc
used in the treatment of arthritic or burned patients. Dorsal orthoses intended to prevent metacarpo-p
hyperextension are also available.

Upper-limb orthoses encompassing the hand and fingers that are designed to stabilize the hand by pr
and support to the hand and one or more fingers and/or the thumb. These orthoses may consist of a v
includes a structure that encircles the forearm while permitting wrist normal movements. The orthosis
palmar (volar), or both types of adjustable solid stays attached along the hand and fingers. Hand-finge
appropriate positioning of the fingers and thumb according to the user needs. The orthoses are used f
during rehabilitation and/or for treatment and/or during normal daily activities (i.e., functional) use.

Hand-finger orthoses designed for external modification of the structural and/or functional characteris
fingers, and the thumb, typically keeping the hand and fingers in a static (fixed) position during therap
These orthoses typically consist of a device that is placed encircling the distal segment of the forearm
attached to a semi-rigid component used to support the fingers in an appropriate static position. Stati
orthoses are used mainly to prevent finger contractures after brain damage; dedicated splints and sof
for static finger therapy are available.

Therapeutic hand-finger upper-limb orthoses consisting of a semi-rigid structure (splint) that are desig
support the hand and fingers, keeping its functional structure and providing a static (fixed) position. T
consist of a splint with a component made of fabrics, leather, or plastic that is placed encircling the di
forearm and wrist. A second component is used to keep in appropriate position the fingers and thumb
strays connect both components providing a semi-rigid structure that allows the splint use without ad
therapy hand-finger splints are used mainly to prevent finger contractures after brain damage.

Static therapy hand-finger orthoses consisting of a soft roll designed to stabilize and support the hand
its functional structure and providing a static (fixed) position. These orthoses typically consist of a cyli
cone roll made of fabrics, leather, plastics or a combination of these that is placed inside the hand so
encircle the roll, keeping them in an appropriate static position. Static therapy soft rolls are used main
contractures after brain damage.
Hand-finger upper-limb orthoses designed to make possible and/or improve the functional activities of
during common daily activities by providing active finger flexion that makes it possible to grasp objec
prefabricated devices available in several different types, including gloves with elastic strips to improv
plastic mitts; and splints using rubber bands used to keep the fingers extended and the thumb abduct
hand-finger orthoses are used by patients that can grasp objects but cannot open the hands or extend
thumb appropriately, typically after brain traumatic injuries or strokes.

Upper-limb orthoses designed for external modification of the structural and/or functional characterist
(including the thumb) by providing immobilization and support. These orthoses are usually classified a
function of the orthoses (e.g., immobilization, therapeutic, functional); the physical characteristics (e.g
and/or material used to make the orthoses (metal, plastics or a combination of these). Finger upper-lim
consist of soft orthoses (e.g., a combination of cuffs, straps, and flexible mechanisms) that are intende
support and stabilization or semi-rigid orthoses that can provide a high degree or total immobilization
finger joint. Dedicated finger and/or thumb orthoses for immobilization after trauma, to provide static
therapy, and for use during normal function of the fingers are available. Finger orthoses intended for s
thumb joints are also available.

Finger orthoses designed to immobilize, support, or supplement, and/or augment the functions and/or
between the finger phalanges (i.e., inter-phalangeal joints). These orthoses may consist of soft, semi-r
that are fixed to the hand and fingers keeping the inter-phalangeal joints (proximal, distal, or both) im
only controlled motion. Also available are dedicated inter-phalangeal orthoses for immobilization durin
trauma, to provide static and/or dynamic therapy, and for use during normal function of the fingers.

Finger upper-limb orthoses designed for maximum restriction of movements and/or total immobilizatio
phalangeal (IP) joints. These orthoses may consist of a variety of devices typically including a semi-rig
structure with aluminum stays (e.g., a splint) and closure straps or sleeves. Finger upper-limb static im
mainly to protect and/or stabilize the fingers after traumatic injuries and to alleviate pain. Dedicated
intended for the thumb joints are also available.

Inter-phalangeal (IP) joint orthoses designed for external modification of the structural and/or function
fingers. These devices control and restrict movement of the IP joints during therapeutic treatments. Th
consist of a variety of devices, typically including a semi-rigid, lightweight, plastic structure with alum
straps or sleeves that permit controlled flexion and/or extension of both (proximal and distal) IP joints.
splints) are used to prevent further development of finger deformities and/or for rehabilitation usually
surgery. Dedicated orthoses intended to keep the proximal and distal IP joints in controlled flexion and
respectively (e.g., swan-neck splints), are also available.

Therapeutic inter-phalangeal (IP) orthoses designed for external modification of the structural and/or f
characteristics of the fingers by providing a controlled flexion of the proximal IP joint and simultaneou
distal IP joint during therapeutic treatment. Known as neck-swan splints, these orthoses typically cons
splint extending along the finger. The splint includes several straps encircling the finger. Neck-swan sp
therapy after surgical correction of neck-swan deformities of the fingers.
Inter-phalangeal (IP) joint orthoses designed to make possible and/or improve the functional activities
common daily activities. These devices provide active finger use and facilitate the functional use of th
are prefabricated devices available in several different types to prevent and/or compensate for malfun
they may be also intended for repositioning one or more of the finger and/or thumb joints. The device
or soft orthoses that may include malleable metal stays. Functional IP joint orthoses are intended main
traumatic brain damage, strokes, or those suffering from arthritis diseases. Dedicated functional IP joi
rings) are available.

Functional inter-phalangeal (IP) joint orthoses designed to make possible and/or improve the functiona
proximal and distal IP joints during common daily activities using a split ring. These devices permit ac
facilitate the functional use of the hand. Split ring orthoses typically consist of plastic or metallic semi
devices with a central slot that are placed encircling the finger in a way that permit joint movements.
use during daily activities to improve functional use of the hand after brain injuries.

Finger orthoses designed to provide immobilization and support to to the proximal inter-phalangeal joi
also support, supplement, and/or augment the functions and/or structure of these joints. These orthos
semi-rigid, or rigid devices that are fixed to the hand and fingers, keeping the proximal inter-phalange
allowing only controlled motion. Dedicated proximal inter-phalangeal orthoses for immobilization after
static and/or dynamic therapy, and for use during normal function of the fingers are also available.

Proximal inter-phalangeal (PIP) orthoses designed for maximum restriction of movements and/or total
PIP joints. These orthoses may consist of a variety of devices, typically including a semi-rigid lightweig
with aluminum stays (e.g., splints) and closure straps or sleeves. PIP joint immobilizers are used main
stabilize the fingers during rehabilitation after traumatic injuries.

Proximal inter-phalangeal (PIP) orthoses designed for external modification of the structural and/or fun
of the fingers by a controlled restriction of movement of the proximal IP joints during therapeutic treat
may consist of a variety of devices, typically including a semi-rigid lightweight plastic structure with a
closure straps or sleeves. PIP joint immobilizers are used to prevent further development of finger def
rehabilitation after surgery or trauma; dedicated orthoses intended to provide maximum extension of
Boutonniere splints) are also available.

Proximal inter-phalangeal (PIP) orthoses designed to provide maximum extension of the PIP joint and s
movement of the distal phalangeal joint during therapeutic treatment that are static splints. These or
of a padded splint (known as Boutonniere splints) extending along the finger but not including the dis
includes several straps encircling the finger. Boutonniere splints are used for therapy after surgical co
deformities.

Proximal inter-phalangeal (PIP) orthoses that are dynamic splints designed to provide external forces t
the PIP joint during therapeutic treatment. These orthoses typically consist of a padded splint with a s
hand while the splint extends along the affected finger. The splint includes elastic bands from the han
attached to a cuff placed around the finger. Dynamic splints are used for therapy after surgical correc
Finger orthoses designed to provide immobilization and support to the distal inter-phalangeal (DIP) joi
also support, supplement, and/or augment the functions and/or structure of these joints. These orthos
semi-rigid, or rigid devices that are fixed to the hand and fingers keeping the distal inter-phalangeal jo
allowing only controlled motion. Dedicated DIP orthoses for immobilization during rehabilitation after t
static and/or dynamic therapy, and for use during normal function of the fingers are available.

Finger upper-limb orthoses designed to encompass the metacarpo-phalangeal (MCP) joint of a finger d
functional procedures. These orthoses consist of a variety of devices frequently including a semi-rigid
structure with aluminum stays (e.g., a splint) and closure straps or sleeves. Finger MCP orthoses are u
development of finger deformities, for rehabilitation and/or therapy after surgery or trauma, and less
functional purposes.

Finger upper-limb, custom-made orthoses designed for external modification of the structural and/or f
characteristics of the fingers that control and restrict movement of the metacarpo-phalangeal (MCP) fi
Using either static or dynamic therapy, these devices keep the joint functional and allow a measure o
while correcting residual deformities. These orthoses typically consist of a mechanism that applies fo
in a small radial deviation while still promoting extension. They usually include slings that are placed
phalanx of each finger and they may include auxiliary slings. Therapeutic MCP joint orthoses are inten
surgical treatment (e.g., to obtain the desired range of motion for each finger) after implant resection
patients suffering from rheumatoid arthritis. Also available are dedicated pain-relieving splints, and o
apply short periods of passive flexion and extension to the MCP joint (through slings attached to a hig
splint).

Therapeutic metacarpo-phalangeal (MP) joint finger orthoses consisting of a semi-rigid structure (splin
for external modification of the functional characteristics of the fingers by a controlled restriction of m
joints during therapeutic treatments. These devices also help keep functional structure while restricti
the fingers radially. These orthoses typically consist of a plastic splint applied to the palm and fingers
separators which support the MP joints in a neutral position. Alignment splints are used mainly to allev
rheumatoid arthritis patients with ulnar deviation; the splint is frequently intended for night use.

Finger orthoses designed to make possible and/or improve the functional activities of the metacarpo-p
joints during common daily activities. These devices allow for active thumb use and they facilitate the
hand. These orthoses typically consist of semi-rigid devices with plastic and/or aluminum finger rings.
hinges at the MP joints to allow for flexion and extension of the joints, and permit unimpeded grasp an
orthoses are intended for patients with chronic diseases such as arthritis; dedicated ulnar deviation sp

Functional finger upper-limb orthoses designed to make possible and/or improve the functional activit
phalangeal finger (MP) joints during common daily activities. These devices also provide active thumb
the functional use of the hand. These orthoses (known ulnar deviation splint orthoses) typically consis
with plastic and/or aluminum finger rings. The orthoses may include hinges at the MP joints to make it
extension of the joints providing unimpeded grasp and pinch. Functional ulnar deviation splint orthose
patients with ulnar deviations at the MP joints, frequently due to arthritis diseases.
Finger upper-limb orthoses designed to encompass the carpo-metacarpal and metacarpo-phalangeal (
thumb during therapeutic or functional procedures. These orthoses consist of a variety of devices, freq
semi-rigid lightweight plastic structure with aluminum stays (e.g., splints), closure straps, and sleeves
in abducted position. Thumb CMC/MCP orthoses are used to help the hand carry out normal functional
frequently the devices are used to prevent further development of finger or thumb deformities during
surgery or trauma.

Carpo-metacarpal/metacarpo-phalangeal (CMC/MCP) joint orthoses designed to make possible and/or


activities of the thumb joints during common daily activities. They also facilitate active thumb use and
of the hand. These orthoses typically consist of semi-rigid devices that may place the thumb in the ab
opposed to the fingers. Functional CMC/MCP orthoses are used mainly during daily activities to improv
hand and/or to reduce pain after injuries; the orthoses may be also used to prevent thumb deformities
and/or boutonniere types) in arthritis patients. Dedicated functional CMC/MCP orthoses, such as thum
available.

Functional carpo-metacarpal/metacarpo-phalangeal (CMC/MCP) joint orthoses designed to make possi


functional activities of the thumb joints during common daily activities. These devices also facilitate a
functional use of the hand. These orthoses (known as thumb spica orthosis) typically consist of semi-r
the thumb in the abducted position, opposed to the fingers. Both thumb spica orthoses that only enco
orthoses that encircle the lower part of the forearm are also available. Thumb spica orthoses are used
activities to improve functional use of the hand and/or to reduce pain after injuries. The orthoses may
prevent thumb deformities (e.g., swan-neck and/or boutonniere types) in arthritis patients.

Lower-limb orthoses designed for external modification of the structural and/or functional characterist
lower limb (also known as hip-knee-ankle-foot orthoses), providing immobilization and/or support to th
joints. These orthoses consist of prefabricated or custom-made rigid or semi-rigid malleable metallic (
stainless steel) structures (e.g., supports, restraints) that may include elastic fabric bands that encircl
particular area. Total lower-limb orthoses are intended mainly for supplementing and/or augmenting th
and/or structure. Dedicated lower-limb orthoses for therapy (i.e., static therapy, dynamic therapy, or b
possible or improve the gait function are available.

Total lower-limb orthoses designed for maximum restriction of movements and/or total immobilization
These orthoses may consist of a variety of devices worn by the person, typically including a modified
means (e.g., trunk or shoulder straps) for fixed attachment to the user's body. Total upper-limb immob
mainly for rehabilitation after injuries and/or trauma.
Total lower-limb functional orthoses designed to make possible and/or improve a patient's gait. These
supplement, and/or augment the limb functions through a linkage between both legs that permits sim
one hip and flexion of the contralateral hip. These orthoses may include a mechanism that provides th
between the legs for step-over-step gait (known as reciprocating gait orthoses, [RGO]). Dedicated orth
mechanism propelled by the patien's own muscular power (i.e., self-propelled) and using external pow
sources are available.
Gait total lower-limb functional orthoses propelled by the user's muscular power that are designed to
improve a patient's gait. These devices provide support, supplement, and/or augment the limb functio
between both legs that permits simultaneous extension of one hip and flexion of the contralateral hip
include a mechanism that provides the appropriate linkage between the legs for step-over-step gait (k
gait orthoses, [RGO]). The mechanism usually includes a cable system to couple the leg extension and
crutches are frequently needed to provide balance to the user.

Self-propelled gait total lower-limb functional orthoses propelled by muscular power that are designed
and/or improve gaiting by augmenting the limb functions through a linkage between both legs that pe
extension of one hip and flexion of the contralateral hip. These orthoses include a mechanism that pro
linkage between the legs for step-over-step gait (known as reciprocating gait orthoses, [RGO]). The m
includes a cable and pulley system to couple the leg extension and flexion; crutches are frequently ne
balance. Also available are dedicated RGOs that use a frame resembling a walker and a pivoted centra
These facilitate the reciprocating gait capability with less effort. Known as isocentric reciprocating gait
these orthoses are frequently used by children.

Hip lower-limb orthoses designed for external modification of the structural and/or functional characte
during therapeutic procedures. These orthoses consist of a variety of devices that assist the support a
the orthosis is usually worn by the patient. Hip lower-limb orthoses are frequently used to keep the hip
position during rehabilitation after surgery, injuries, or disease. Dedicated hip static therapy orthoses
dislocation and to provide therapy for children with malformations are also available.

Hip lower-limb orthoses designed for external modification of the structural and/or functional characte
during therapeutic (e.g., static therapy) procedures to prevent dislocation. Orthoses intended to preve
dislocations (e.g., braces) typically consist of a pelvic band attached to a thigh cuff placed close to the
the range of movement, including extension, flexion, abduction, and adduction. To prevent anterior di
knee-ankle-foot or hip-knee-ankle-foot orthosis should be used. Static therapy dislocation prevention o
mainly to avoid dislocation following hip surgery. They are typically used for periods of 8 to 12 weeks
for patients with hip instability.

Hip lower-limb orthoses designed for external modification of the structural and/or functional characte
therapeutic (e.g., static therapy) procedures to treat developmental dysplasia of the hip (DDH) in child
may consist of a variety of devices, many of which keep the hip joints in the abducted position, and th
control of movement is different for each orthoses. Developmental dysplasia hip orthoses are intende
use during several weeks by infants suffering the disease; the orthoses have been used also to treat h
infants.

Therapeutic hip orthoses designed for external modification of the structural and/or functional charact
keeping the joint in abducted position. These orthoses may consist of a variety of prefabricated or cus
keep the hip joint in abducted position with a degree of flexion and control of movement different for e
Pediatric hip abduction orthoses are used for static therapy intended to treat congenital malformation
Pertes disease) in children. Dedicated orthoses intended for ambulatory use, usually after surgery, an
night use to treat hip subluxation in children are also available.
Therapeutic hip orthoses designed to keep the hip joint in abducted position during treatment of amb
permitting a limited degree of movement. These orthoses may consist of a variety of prefabricated or
that keep the hip joint in abducted position with a degree of flexion and control of movement different
orthoses. A frequently used device is the Atlanta Scottish Rice orthosis that consists of a waist band a
that are frequently joined using an abduction bar. Some other orthoses include extensions below the k
control (e.g., Toronto and Newington orthoses). Abduction pediatric hip orthoses are used mainly to tre
malformations (e.g., Leg-Calve-Pertes disease); they are intended for quasi-continuous use during sev
suffering the disease. The orthoses have been used also to treat hip dislocations in infants.

Therapeutic hip orthoses designed to provide support to the hip joint during nocturnal therapeutic trea
children, promoting acetabular growth and improving range of motion. These orthoses may consist of
prefabricated or custom-made devices that keep the hip joint in an abducted position while the child i
night sleeping time). Also available are foam wedges either isolated or integral to the mattress that ar
child's legs and custom-made orthoses with adjustable abduction angle (e.g., Hope orthosis). Night-us
are used in children with hip subluxation, frequently due to spastic quadriplegia.

Knee orthoses designed to provide support and some degree of movement control to the knee joint in
excessive load on the joint. These orthoses include semi-rigid devices with pads and straps (e.g., brac
pressure on the knee joint and/or reducing partially its motion. Knee support orthoses are intended m
pressure on the knee in patients with ligament injuries, permitting a shorter period of rehabilitation.

Knee support orthoses that consist of a brace designed to provide support and some degree of movem
knee joint, preventing excessive load on the joint. These braces usually are devices that include semi-
pads and straps that unload the pressure on the knee joint, partially reducing its motion. Brace knee o
mainly to reduce the pressure on the knee in patients with ligament injuries, permitting a shorter peri

Knee lower-limb orthoses designed for external modification of the structural and/or functional charac
joint during static or dynamic therapeutic treatments. Orthoses used for static therapy are typically in
pressure on the knee joint and reducing its motion. They may consist of patient-worn custom-made br
suspended from a bed, post, or other structure. Knee orthoses intended for dynamic therapy usually
or custom-made devices typically including semi-rigid stays and straps encircling the thigh and leg, re
adjustable pivoting mechanism at the knee joint. Static therapy orthotic knee braces are intended ma
severe arthritis destruction while slings are used mainly for orthopedic traction treatments during reha
traumatic injuries. Dynamic therapy flexion/extension knee orthoses are also available and are intend
range of motion and to improve the function and stability of the joint, they are mainly used after knee

Therapeutic knee orthoses designed to provide dynamic flexion and/or extension motion for a period o
may consist of prefabricated or custom-made devices, typically including semi-rigid stays and straps e
leg, respectively, and an adjustable pivoting mechanism at the knee joint. Dynamic therapy flexion/ex
are intended to increase the range of motion and to improve the function and stability of the knee join
used after knee replacement surgery.
Knee orthoses designed to support and assist the knee joint during normal motion, making it possible
independent gait. These orthoses may consist of prefabricated or custom-made devices, typically incl
the thigh and leg respectively, multiple straps, and an adjustable ratchet or elastic spring mechanism
may include several locking positions at different knee angles. Functional knee (gait) orthoses are inte
in normal activities by patients with weak knee ligaments and/or other congenital or traumatic loss of
strength.

Gait orthoses designed to support and assist the knee joint during normal motion (known as functiona
with weak anterior cruciate ligaments. These orthoses may consist of prefabricated or custom-made d
including soft cuffs and straps encircling the thigh and leg, respectively, and an adjustable mechanism
may have several locking positions at different knee angles. Ligament functional knee orthoses are in
use in normal activities by patients with traumatic (e.g., cruciate, lateral, medial) ligament injuries.

Gait (i.e., functional) knee lower-limb orthoses consisting of an orthotic joint designed to support and
during normal motion. These orthoses consist of prefabricated or custom-made devices, typically inclu
encircling the thigh and leg, respectively, and an adjustable mechanism at the knee joint that limits a
direction and/or range of motion of the joint. Orthotic joint knee orthoses intended to limit the extensi
automatically lock and free the joint (i.e., stance and swing control) of the joint movement are also av
functional knee orthoses are intended mainly for long-term use in normal activities by users with unila
weakness, such as patients who previously suffered from poliomyelitis (i.e., post-polio paralysis and/o

Gait orthotic joint knee orthoses designed to support and assist the knee joint during normal motion in
unilateral hyperextension of the knee. These orthoses consist of prefabricated or custom-made device
soft cuffs encircling the thigh and leg, respectively, and an adjustable mechanism at the knee joint tha
hyperextension of the joint to a few (e.g., five) degrees. Hyperextension functional knee orthoses are
long-term use in normal activities by users with unilateral muscle weakness, such as patients that pre
poliomyelitis (i.e., post-polio paralysis and/or syndrome).

Gait orthotic joint knee orthoses designed to support and assist the knee joint during normal motion b
joint when the patient is standing, pushing the legs in fully extended position. These orthoses consist
custom-made devices, typically including soft cuffs encircling the thigh and leg, respectively, and a m
dropping ring or lever lock orthosis joint that prevents the knee from bending. Joint locking functional
intended mainly for long-term use in normal activities by users with poor quadriceps muscle strength,
patients who previously suffered from poliomyelitis (i.e., post-polio paralysis and/or syndrome).

Orthotic joint functional knee lower-limb orthoses designed to support and assist the knee joint during
locking the knee joint when the patient is standing and providing a free knee joint during the swing w
orthoses consist of prefabricated or custom-made devices, typically including long thigh and leg rods
encircling the thigh and leg, respectively, and a mechanism that prevent the knee from bending in the
and frees the joint when swinging the leg. The mechanism is activated by the user using a mechanica
Stance control functional knee orthoses are intended mainly for long-term use in normal activities by
muscle weakness, such as patients who previously suffered from poliomyelitis (i.e., post-polio paralysi
Lower-limb orthoses designed for external modification of the structural and/or functional characterist
ankle joints and the foot, providing controlled motion, complete immobilization, and/or support. Knee
(KAFO) usually consist of an ankle foot orthosis with the addition of metal uprights, and thigh straps. F
usually include articulated orthotic knee joints. Also available are KAFO orthoses intended for therapy
debilitated quadriceps. These help knee stability and limit the weight bearing of the thigh, leg, and fo
orthoses intended for pediatric therapy are available. Functional (i.e., gait) KAFOs are also available.

Knee-ankle-foot lower-limb orthoses (KAFO) designed for external modification of the structural and/or
characteristics of the knee and ankle joints and foot during static or dynamic therapy treatments. Orth
therapy are typically intended to unload the pressure on the knee joint, reducing its motion. They may
worn prefabricated or custom-made static braces and/or A-frames. Knee orthoses intended for dynam
consist of prefabricated or custom-made dynamic braces, typically including semi-rigid stays and stra
and leg, respectively, and an adjustable pivoting mechanism at the knee joint. Therapeutic KAFOs are
for infants with progressive bowing disorder due to abnormal grow of the tibia (known as tibia vara or

Therapeutic knee-ankle-foot orthoses (KAFO) designed for external modification of the structural and/
characteristics of the knee and ankle joints and foot of infants (typically before three years of age) wit
providing support and permitting a limited range of movement to the joints. Also available are static t
permit a very limited range of movement or completely immobilize the knee and ankle joints (e.g., A-F
dynamic therapy orthoses mainly intended for infants with progressive bowing disorder due to abnorm
(known as tibia vara or Blount disease).

Therapeutic knee-ankle-foot orthoses (KAFO) designed for external modification of the structural and/
characteristics of the knee and ankle joints and foot of infants (typically before three years of age) wit
orthoses use static braces and provide support and permit a limited range of movement to the joints.
consist of an ankle foot brace, including a foot plate, a medial metal upright bar, an orthotic knee (e.g
joint, and thigh straps. Braces used for treatment of infant bowleg are intended for patients with mode
bowing disorder due to abnormal growth of the tibia (known as tibia vara or Blount disease).

Therapeutic knee-ankle-foot orthoses (KAFO) designed for external modification of the structural and/
characteristics of the knee and ankle joints and foot of infants (typically before three years of age) wit
orthoses use frames and provide support and permit a limited range of movement to the joints. These
include a rigid frame structure with the shape of a letter A (known as A-frames), they usually include a
metal upright bar, an orthotic knee (e.g., locked or drop-lock) joint, and thigh straps. A-frames orthose
infant bowleg are intended for infants with moderate progressive bowing disorder due to abnormal gro
as tibia vara or Blount disease).

Therapeutic knee-ankle-foot orthoses (KAFO) designed for external modification of the structural and/
characteristics of the knee and ankle joints and foot of infants (typically before three years of age) wit
devices use a dynamic brace which provides support and permits a limited range of movement to the
usually consist of an articulated, dynamic ankle foot orthosis with the addition of metal uprights, an or
thigh and calf straps. Dynamic therapy infant bowleg KAFO orthoses are intended for therapeutic trea
progressive bowing disorder due to abnormal grow of the tibia (known as tibia vara or Blount disease)
Knee-ankle-foot lower-limb orthoses (KAFO) designed to provide support during normal function (i.e., g
These orthoses usually consist of an ankle foot orthosis with the addition of metal uprights, an orthoti
straps. KAFOs are usually intended for patients with debilitated quadriceps to keep knee stability and
bearing of the thigh, leg, and foot while standing and/or walking.

Gait (functional) knee-ankle-foot orthoses (KAFO) designed with a stance control orthotic knee joint th
stabilization to the knee joint during the stance phase of gait (i.e., when bearing weight) and permittin
swing. These orthoses usually consist of an ankle foot orthosis with the addition of metal uprights, an
knee joint, and thigh straps. Stance control gait KAFOs are intended to permit indoor and outdoor walk
severe knee paresis or paralysis.

Gait (functional) knee-ankle-foot orthoses (KAFO) designed with a lock orthotic knee joint that holds in
knee joint during the stance and swing phases of gait. These orthoses usually consist of a rigid ankle,
and posterior stops, double uprights, thigh straps, and a locking knee joint bale and/or ring controls. K
permit limited ambulation for patients using crutches who have with bilateral paralysis of the lower lim

Lower-limb orthoses designed for external modification of the structural and/or functional characterist
providing immobilization and/or support. These orthoses may be classified according to the function o
support, functional), the physical characteristics (e.g., shape, consistency), and/or material used to m
plastics, carbon fiber or a combination of these). Ankle lower-limb orthoses frequently consist of soft o
that can provide immobilization and/or control of movement during therapy, normal functional activiti
sports. Some therapeutic ankle orthoses are intended to provide support and some motion control of t
rehabilitation after surgery.

Ankle-foot orthoses (AFO) designed to provide support and/or movement restriction to the ankle joint
therapeutic (static or dynamic therapy) treatments. These orthoses usually consist of prefabricated se
devices encompassing the ankle joint and the foot. Therapeutic AFOs are frequently intended for treat
spinal cord injuries. Dedicated orthoses used to prevent plantar flexion contractures (known as anti-fo
also available.

Therapeutic ankle-foot orthoses designed to prevent plantar flexion contractures by keeping the ankle
(i.e., anti-footdrop orthoses) during therapeutic treatments. These orthoses typically consist of a prefa
device with a padded structure with straps that extends along the distal part of the leg and encircles t
orthoses are intended mainly for treatment of patients with spinal cord injuries; they are typically use

Ankle-foot orthoses designed to make possible and/or improve the functional (i.e., gait) activities of th
by providing support, supplementing, and/or augmenting the ankle and foot functions. These orthoses
dynamic mechanisms; they are usually made of thermoplastics or, less frequently, of metal and leathe
orthoses facilitate the normal function or make gait possible to an otherwise partially or totally disable
Dedicated ankle-foot gait orthoses that provide additional neuromuscular electrical stimulation are als
Gait ankle-foot orthoses designed to make possible and/or improve the normal activities of the ankle j
providing control (e.g., inversion and eversion of the ankle, dorsiflexion) of the combined ankle joint a
rigid ankle articulation. These orthoses typically consist of semi-rigid or rigid orthoses encircling the lo
the shoes. They are made of thermoplastics or, less frequently, of metal and leather. Rigid ankle ortho
normal function of otherwise partially or totally disabled ankle joint or foot to alleviate pain and facilita
with a weak ankle joint (e.g., as a sequel of poliomyelitis). Dedicated solid ankle orthoses intended for
peripheral vascular diseases are also available.

Gait rigid ankle-foot orthoses designed to provide an additional reactive (i.e., the floor reaction) force
knee. These devices carefully choose the orthotic ankle angle which blocks the forward tibial moveme
ankle articulation. These orthoses typically consist of semi-rigid or rigid orthoses encircling the lower l
made of thermoplastics or, less frequently, of metal and leather. Floor reaction rigid ankle orthoses fac
function of otherwise partially or totally disabled ankle joint or foot, alleviating pain and facilitating sta
weak ankle joint (e.g., as a sequel of poliomyelitis).

Gait ankle-foot orthoses including an articulated ankle that are designed to make possible and/or impr
activities of the ankle joint and foot. These devices provide a controlled fore-and-aft range of moveme
ankle joint and foot. These orthoses typically consist of semi-rigid or rigid orthoses encircling the lowe
articulated joint mechanism at the ankle joint. Articulated ankle orthoses facilitate the normal function
partially or totally disabled ankle joint and/or foot. These devices are intended to alleviate pain and fa
swing in patients with weak ankle joints (e.g., as a sequel of poliomyelitis). Dedicated articulated ankl
double adjustable ankle joint orthoses (also known as double upright ankle-foot orthoses) are also ava

Gait articulated ankle-foot orthoses including an articulated ankle joint that are designed to provide an
(i.e., the floor reaction) force and momentum to the knee by carefully choosing the orthotic ankle ang
forward tibial movement. These orthoses typically consist of semi-rigid or rigid orthoses encircling the
an ankle joint mechanism; they are made of thermoplastics or, less frequently, of metal and leather. F
articulated ankle orthoses facilitate the normal function of an otherwise partially or totally disabled an
devices alleviate pain and facilitate stance in patients with weak ankle joints (e.g., as a sequel of polio

Gait ankle-foot orthoses designed to make possible and/or improve the functional activities of the ank
gait) by providing total contact weight redistribution, reducing forces through the ankle, and alleviatin
areas of the foot. These orthoses typically consist of anterior and posterior plastic shells with a foam li
rocker sole. They also include an adjustable, removable insert that is used to redistribute the pressure
areas of the foot. Neuropathic walker orthoses may be intended for permanent use by patients with un
(e.g., Charcot) disease and/or chronic ulcers. They are also intended for therapeutic use during neurop
and other treatments.

Lower-limb orthoses designed for external modification of the structural and/or functional (i.e., gait) ch
foot, providing accommodation and/or support. These orthoses may be classified according to the fun
(e.g., therapeutic, functional, accommodative), the physical characteristics (e.g., shape, consistency),
used to make the orthosis (metal, plastics or a combination of these). Foot lower-limb orthoses freque
semi-rigid orthoses that can provide comfort (e.g., cushioning), facilitate control of movement during
procedures, or be used during normal daily functional (i.e., gait) activities or practice of sports.
Arch support foot orthoses designed to support the foot arch by providing foot control and pressure re
orthoses typically consist of a semi-rigid prefabricated or custom-made device that is inserted inside t
is made of several layers of different materials (e.g., fabrics, hard plastics) with a shape and size appr
Foot arch rigid or semi-rigid supports intended for a child's flexible flatfoot (i.e., a foot that become fla
may be used as part of a therapy treatment to correct the deformity; they also provide cushioning and

Foot orthoses designed to facilitate and/or make possible gait for patients with rigid deformities of the
additional control and comfort. These orthoses typically consist of a prefabricated or custom-made de
semi-rigid, and/or rigid materials (e.g., fabrics, plastics, foam, steel) or a combination of these. Most fo
gaiting are permanently attached to the shoe (i.e., shoe modifiers); foot supports used to facilitate ga

Gait foot orthoses designed as a permanent modification of a shoe to improve the user's gaiting capab
provide additional control, comfort, and/or facilitating donning and doffing of the shoes. These orthose
prefabricated or custom-made device made of soft, semi-rigid, and/or rigid materials (e.g., fabrics, pla
combination of these that is frequently attached externally to the shoe. Shoe modifier gait orthoses m
and/or orthopedic shoes; dedicated orthoses including wedges, flares, elevators, shanks, and /or rocke

Shoe modifier gait foot orthoses designed as a permanent modification of a shoe by attaching a sole t
heel strike to toe off without bending. These devices improve the user's gating capabilities by enhanc
These orthoses typically consist of prefabricated, or more frequently, custom-made devices, whose sh
depend on the patient's problems and/or the gaiting characteristic to be improved. Rocker sole shoe m
be intended for a variety of deformities, to reduce pressure on the plantar area of the foot, and/or to f
Rocker soles are usually classified according to the shape and/or the desired effect on the feet (e.g., m
toe rocker soles).

Shoe modifier gait foot orthoses designed as a permanent modification of a shoe by attaching a wedg
externally as a permanent modification of a shoe. These devices improve the user's gaiting capabilitie
deformities of the foot. These orthoses may consist of prefabricated or custom-made wedges, whose s
characteristics (e.g., material) depend on the patient's deformity and/or the gaiting characteristic to b
wedges include flexible (e.g., rubber) orthoses inserted into the heel to absorb impact and median an
intended to promote inversion and eversion respectively. Internal wedges include medial heel wedges
hindfoot into inversion and lateral heel wedges used for eversion of the hindfoot to reduce pressure.

Shoe modifier foot gait orthoses designed as a permanent modification of a shoe by attaching an exte
sole as a permanent modification of the shoe, controlling side-to-side motion. These orthoses typically
prefabricated or custom-made device that widens the sole; flares may be limited to the heels or exten
Usually medial flares are used to resist inversion while lateral flares are used to resist eversion. Both t
stabilization while standing and/or during gait.

Shoe modifier foot gait orthoses designed as a permanent modification of a shoe by attaching an inte
elevation) as a permanent modification of a shoe. These orthoses typically consist of a prefabricated o
that is attached internally to the heel (usually when less than 0.5 inch/2.5 cm lift is needed) or externa
Elevations may be limited to the heels or extend all along the shoe. Elevation orthoses are used to com
discrepancy due to congenital or acquired conditions. They are also used to compensate for fixed equ
to reduce strain on the Achilles tendon.
Shoe modifier foot gait orthoses designed as a permanent modification of a shoe by attaching an exte
as a permanent modification of a shoe, reducing bending stress to the foot. These orthoses typically c
semi-rigid strip (e.g., stainless steel, carbon fiber) longer than the usual size of the shank that is place
reinforcing the area from the anterior border of the heel to the middle part of the toes. Extended shan
stress in the mid- and fore-foot, improving the stability and strength of the feet during gait.

Shoe modifier foot gait orthoses designed as a permanent modification of a shoe by attaching a spring
sole. These orthoses typically consist of a metallic wire spring that may be interchangeable among se
Spring-loaded shoe modifiers are mainly used to compensate for weak (i.e., flaccid or paralyzed) equin
muscular dystrophy, typically after cerebrovascular accidents, and/or caused by other diseases.

Orthoses designed for external modification of the structural and/or functional characteristics of the co
upper limbs These devices provide immobilization and/or support; supplement and/or augment the lim
structure. These orthoses consist of rigid or semi-rigid malleable metallic (e.g., aluminum, stainless st
are mainly used for functional purposes making possible activities such as hand prehension and/or ga
orthoses that use external power (e.g., electric) are also available.

Orthoses designed for external modification of the structural and/or functional characteristics of the co
upper limbs These devices provide immobilization and/or support; supplement and/or augment the lim
structure. These orthoses consist of rigid or semi-rigid malleable metallic (e.g., aluminum, stainless st
are mainly used for functional purposes making possible activities such as hand prehension and/or ga
orthoses that use external power (e.g., electric) are also available.

Lower/upper-limb orthoses designed to make possible and/or improve the functional activities of the li
support, supplementing, and/or augmenting the limb functions and/or modifying its structure. These o
static or dynamic mechanisms appropriate to facilitate the normal function of otherwise partially or to
and lower limbs. Dedicated functional orthoses intended to make possible activities such as hand app
are available; some lower/upper orthoses that use external power (e.g., electric) are also available

Orthoses (i.e., multipurpose splints) designed for rapid and easy support, immobilization and protectio
body parts after fractures, sprains, and/or dislocations. These orthoses typically consist of a semi-rigid
of plastics, metal, wood, or a combination of these; splints are usually moldable or pre-molded approp
are usually kept in position attached to the body part using straps, cuffs, or belts. Multipurpose splint
used on the limbs after fractures, sprains, and/or dislocations; they may be used also around the neck
anatomic parts. The splints may be used during all the treatment procedure, before casting, and/or to
radiographic images of the affected body part.

Multipurpose splints made of aluminum that are designed to be conformed to the appropriate shape (
point of care site. These splints typically consist of a thin aluminum sheet usually covered with paddin
sides that can be manually cut and molded to the necessary shape using appropriate profiles (e.g., as
the body part and the needs of the patient. Moldable aluminum splint orthoses are intended mainly fo
treatment of patients suffering fractures, sprains, dislocations, and/or other injuries of the limbs, neck
parts.
Multipurpose splints made of thermo-setting plastics that are designed to be conformed to the approp
molded) at the point of care site. These splints typically consist of a thin thermoplastic splint sheet tha
and molded using a heat source (e.g., warm water) to the necessary shape according to the body part
patient. Moldable plastic splint orthoses are intended mainly for emergency treatment of patients suff
sprains, dislocations, and/or other injuries of the limbs, neck, and/or other body parts.

Orthopedic shoes designed to compensate for weak muscles by attaching a spring-loaded device to th
typically consist of a double-soled shoe with metallic wire springs between them that provide addition
when walking, facilitating gait. Spring-loaded shoes are intended for weak (i.e., flaccid or paralyzed) e
suffering from muscular dystrophy, usually after cerebrovascular accidents, and/or other diseases.

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
procedure on a patient. Items in these kits usually include most or all the instruments and supplies ne
procedure. These kits are frequently supplied in supporting trays (i.e., procedure trays) consisting of a
receptacle with a border around the periphery supporting all the instruments and supplies needed for
trays are usually covered or wrapped. Procedure kits and trays are mainly intended for use during diag
therapeutic procedures. Dedicated procedure kits and trays are available for a variety of procedures, s
amniocentesis, anesthesia, angiography, biopsy, blood culture, and catheterization.

Prepackaged collections of the devices and supplies (either custom or standard) intended for the injec
fluid (e.g., contrast media) into arteries and/or veins in order to visualize these systems, e.g., under fl
these kits usually include a barrel syringe, contrast media bottles, and appropriate tubing. They may b
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
Angiographic contrast media injector procedure kits and trays are used as a detachable component of
deliver contrast media into the arteries and/or veins for medical imaging techniques in angiographic p
contrast media injector procedure kits and trays including a syringe and manifold sub-assemblies are

Prepackaged collections of the devices and supplies (either custom or standard) needed for insertion o
peripheral vasculature. Items in these kits usually include sterile gloves, gauge needles, appropriate in
catheters, a tourniquet, alcohol swabs, gauze pads, transparent dressing, an IV bag with solution, and
frequently supplied in supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle
the periphery supporting all the instruments and supplies needed for the procedure; the trays are usu
wrapped. Peripheral intravenous catheterization procedure kits and trays are intended mainly for the
solutions; they are also used in a variety of procedures performed in the peripheral vasculature in hos
and other healthcare facilities.
Prepackaged collections of the devices and supplies (either custom or standard) needed for the liquid
stomach. Items in these kits usually include a bulb or plunger syringe, a dedicated (e.g., nasogastric)
tube, a container, waterproof drape, and an alcohol prep pad. The syringe used for irrigation in the kit
aspiration (i.e., removal) of the irrigating fluid and/or debris. Some kits also include the solutions used
activated charcoal to treat toxic substances. These kits may be supplied in supporting trays (i.e., proc
of a flat-bottomed receptacle with a border around the periphery supporting all the instruments and s
procedure; the trays are usually covered or wrapped. Gastric irrigation/lavage kits and trays are used
departments (e.g., to remove toxic substances); they are also used for cleaning and evacuation of the
endoscopic and/or surgical procedures.

Prepackaged collections of the devices and supplies (either custom or standard) designed for the liqui
upper urinary tract, in particular the ureters. Items in these kits usually include a needleless bulb or p
container, a dedicated ureteral catheter, a waterproof drape, and an alcohol prep pad. The syringe us
kit may be also used for aspiration (i.e., removal) of the irrigating fluid and/or debris. These kits may b
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
urinary tract irrigation kits and trays are used for therapeutic treatment of infection and inflammation
remove clots (e.g., after surgical procedures), to instill drugs, and/or for treatment of renal stones.

Powered laboratory turntables designed for microorganism inoculation in Petri dishes. The turntables t
electric rotatory mechanism to provide a circular motion to an upper platform allowing even distributio
in Petri dishes. The upper platform usually includes and anti-skid surface where the Petri dish (up to 1
diameter) is placed. The turntable typically includes on-off, rotation speed, and time controls to impro
the dishes. Powered Petri dish turntables are intended to facilitate the placement of concentric circles
(e.g., bacteria) from the edge of the dish to its center.

Radiofrequency (RF) therapy systems designed to warm the skin and subcutaneous tissues by the ext
high-frequency electromagnetic radiation. These systems typically consist of a main unit which includ
generator; controls (e.g., touch-screen buttons) to regulate the therapeutic parameters; a display show
of the programmed and real settings; and an applicator attached to the main unit to deliver the RF en
tissues get warm due to the tissue electric resistance to the passage of RF radiation. Dermatologic dia
mainly intended for non-invasive treatment of the skin, especially for treatment of wrinkles in the skin
may be also used to reduce pain and to treat muscle spasms.

Lights designed to provide illumination to the working board of a photographic station. These lights sh
illumination according to the application (e.g., pathology laboratory); the lights frequently provide ste
incandescent bulbs, LEDs) or high-frequency fluorescent light to avoid flickering. Xenon lamps are also
illumination for flash photography (e.g., for moving objects). Most photographic lights are mounted on
vertical and horizontal movement and/or also variations in the angle related to the photographic boar
(i.e., lamps). Photographic station lights usually are capable of providing one or more of the illuminatio
including top-light, back-light, and shadow-less; lights with special attachments (e.g., dark field and/o
dark-field and polarized illumination.
Gastrointestinal liners that are deployed through an endoscopic tube. They are designed to cover a se
intestine close to the stomach to promote weight loss and improve diabetes treatment in obese patien
typically consist of thin and flexible polymeric tubes inserted through the mouth using an endoscopic
of the liner is fixed (e.g., anchored) into the segment of the small intestine near to the stomach. Food
liner without contact with the covered segment of the intestine, thereby preventing the absorption in
intestine. The liner may be removed at any time using a retrieval system that is also inserted through
Endoscopically-deployed gastrointestinal liners are mainly intended for bariatric patients who suffer a

Equipment designed for administration of electrical stimuli and/or gentle massage to the tissues durin
treatments. These machines usually combine: (1) a device to deliver gentle negative pressure to the s
cups (i.e., vacuum suctioning);, (2) dedicated electrical stimulators to provide monopolar and/or bipola
the neuromuscular tissue;, and (3) one or more detachable cups for simultaneous or separate delivery
stimuli and the suctioning massage. Physical therapy electrical stimulation and massage machines are
muscle aches, pains, and/or edema; the machines are also intended for temporary improvement of th
circulation.

Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
procedure on a patient or dental prostheses. Items in these kits usually include most or all the instrum
needed to perform a particular dental procedure. These kits are frequently supplied in supporting tray
consisting of a flat-bottomed receptacle with a border around the periphery supporting all the instrum
needed for the procedure; the trays are usually covered or wrapped. Dental procedure kits and trays a
use during prophylactic, diagnostic, and/or operatory procedures. Dedicated procedure kits and trays
variety of dental procedures, such as dental impression, gingival retraction, prophylaxis, and dental re

Prepackaged collections of the devices and supplies (i.e., either custom or standard kits) needed for in
appearance, structure and/or function of a patient's teeth, requiring an activator and a catalyst to acti
the composite resin. Items in these kits usually include a dental syringe, a mixing palette, a mixing pa
cured composite resin; they may also include liquid etching products and a shade guide. The kits are f
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
composite resin restorative procedure kits and trays are used in dental offices for dental restoration in
(e.g. the central incisors or any other teeth that can be seen when smiling), in areas where conservati
a top priority or in areas inaccessible to light.

Prepackaged collections of the devices and supplies (either custom or standard) needed for removing
Items in these kits usually include a drainage bag/vacuum bottle, a sterile dressing, gauze, alcohol sw
clamps; some kits may include a catheter. They are frequently supplied in supporting trays (i.e., proce
of a flat-bottomed receptacle with a border around the periphery supporting all the instruments and s
procedure; the trays are usually covered or wrapped. Typically one end of the drainage catheters (i.e.,
through the skin to the specific body cavity to stay there and the other end is connected to an externa
permanently or temporarily. Drainage procedure kits and trays may be intended for long or short term
to promote healing.
Prepackaged collections of the devices and supplies (either custom or standard) needed for delivery o
appropriate locations inside the vasculature or other body tracts. Items in these kits usually include th
endoprostheses (i.e., the stent) and catheters that include a compliant section near the distal end for
deployment; ancillary devices (e.g., syringes, needles) and products (e.g., glue, saline, alcohol) may b
during the stenting procedure. The kits may be supplied in supporting trays (i.e., procedure trays) con
bottomed receptacle with a border around the periphery supporting all the instruments and supplies n
procedure; the trays are usually covered or wrapped. Stent delivery procedure kits and trays are typic
treating conditions resulting from narrow or blocked arteries, and other tube-shaped structures in the
ureters, bronchi).

Combination of assembled devices designed as components of angiographic kits intended for use with
injectors. These assamblies may include as main components controls, syringes, manifolds, or other d
typically includes other ancillary components. Contrast media injector kit assemblies may be reusable
single-use). The assemblies facilitate the contrast media injection procedures and may also reduce the
media and/or accelerate the procedures.

Computer-aided detection systems that analyze digital information and in-vivo images of the spine us
the spine structure from the skin surface without using ionizing radiation. Some of these systems use
sensor that is displaced along the spine from previously identified marks and send the information to
time assessment, display, and/or printing images of the spine. These systems use a dedicated softwar
algorithms that assess the spine configuration and its abnormalities. Systems using other techniques,
on electromagnetic signals with fixed sensors located on several points of the skin along the spine are
surface spine computer-aided systems are intended for assessment of spinal deformity in the sagittal
(e.g., segmental angles, perpendicular inclination) and the segmental motion of the spine; they are m
determine the status and progress of spinal disorders, including kyphosis or lordosis of particular spina

Image computer-aided detection system software designed to operate detection systems used to ana
the spine. These detection systems assess the spine structure (i.e., spine configuration and its abnorm
surface without using ionizing radiation. This software can work with personal computers that provide
required capabilities; the software performs a variety of algorithms to facilitate the analysis of spinal i
skin. The software is usually supplied with the computer-aided systems and may be updated (i.e., thro
modified versions) during the life of the system. Spine skin surface image computer-aided detection s
facilitates the analysis of deformities in the sagittal and frontal planes (e.g., segmental angles, perpen
the segmental motion of the spine; it is mainly used to determine the status and progress of spinal dis
kyphosis or lordosis of particular spinal areas.
External defibrillators that combine in one unit the capabilities of automated and manual defibrillators
operation of these defibrillators only requires the user to apply the electrodes to the patient's thorax a
prompts and/or on-screen messages. Then the defibrillators analyze the ECG rhythm to determine if a
needed; if it is, the defibrillator warns the operator and automatically charges and discharges. When o
mode the defibrillators require the operator to observe the ECG waveform, confirm ventricular fibrillat
necessary operations to apply the selected level of stored energy through the paddles to the thorax o
device may also provide cardioversion in manual mode. Combined automated/manual defibrillators us
electrocardiographic monitor as an integral part. The devices are typically battery-operated and easy
the use in automated mode by people with very little training in the field, during transportation, and i
situations.

Brushes designed for application of dental materials in or on small and/or difficult to reach places of a
typically consist of a disposable micro brush with a plastic handle (straight or bent) and a tip at the dis
carry the adhesive. The micro brush applies the material (e.g., cement, etchant, sealant, conditioner)
inner walls) and/or interior of a tooth (e.g., root canal) before positioning the restoration in place. Micr
brushes may be used for a variety of applications; including cementation of onlays and inlays, placing
other minor restorations on teeth.

Supporting structures (i.e., docks) designed to provide connectivity to laptop portable computers and/
charging of their internal rechargeable batteries. These docks (also known as docking stations) typica
structure made of metal, hard plastic, or a combination of these that is usually placed on a tabletop. T
provide appropriate connectors to plug in the laptop computer, facilitating their connectivity and/or pr
recharge their internal batteries. The docks may also include wired or wireless connection to other dev
peripheral equipment (e.g., monitors, printers) and information systems facilitating the download of d
(e.g., 120 VAC to 12 VDC), and a line cord for connection to the mains.

Supporting structures (i.e., docks) designed mainly for automated charging of the internal rechargeab
handheld, cellular, and mobile telephones. These docks (also known as docking stations) typically con
made of metal, hard plastic, or a combination of these that is mounted on the wall or placed on a tabl
and provide appropriate connectors to plug-in or cradle the handheld telephone, providing means to r
batteries; some docks may also facilitate the connectivity of the telephone. The docks may also includ
connection to other devices and /or information systems, a power converter (e.g., 120 VAC to 12 VDC)
connection to the mains.

Supporting structures (i.e., docks) designed to facilitate connectivity and automated charging of the in
batteries of powered carts used in healthcare facilities. These docks (also known as docking stations)
structure made of metal, hard plastic, or a combination of these that is usually plugged to an electric
and can be connected cordlessly on the opposite side to carts that include appropriate connectors. Th
connectivity and/or provide means to recharge the internal batteries of carts while docked. Powered c
chargers are used for a variety of healthcare carts, including ultrasonic procedure and crash carts.
Solutions that have viscous and some elastic properties formulated in appropriate concentrations for u
intraocular procedures. These solutions typically consist of aqueous mixtures containing as main comp
such as sodium hyaluronate, a purified sodium salt of hyaluronic acid (a glycosaminoglycan [GAG]); ch
sulfated GAG; polymers with a long molecular chain ( hydroxypropylmethylcellulose [HPMC]); or a com
Intraocular viscoelastic solutions are usually supplied in sterilized pre-filled syringes or vials; syringes
solutions with different physicochemical properties each intended for a specific intraocular purpose ar
solutions may be intended for use, but are not limited to, the temporary replacement for the vitreous

Pressure Scanning systems designed to provide images of the pressure exerted by the foot on a fixed
standing. These systems usually include a floor platform with many pressure sensors, a data processin
monitor with a display that shows images and data related to the pressure exerted by each foot region
to provide color images (i.e., a pressure mapping) according to the pressure values and also data rela
characteristics (e.g., foot size, arch type, high pressure points). Plantar pressure scanning systems are
selection of appropriate foot orthoses and also in the diagnostic of other orthopedic problems.

Injection systems that include a microinjector, a microscope, a micromanipulator, and capillary (or mic
hold the substances to be injected. The microinjection system attaches to a power source and a press
compressed gas cylinder, lab air jet, or foot- or hand-switch controls. Microinjector systems are used in

High-definition video monitors designed to display electronic images with a definition that is high enou
and diagnosis of most medical images (e.g., radiographic, ultrasonic, MRI). These device either in real
obtained using a dedicated video camera or, more frequently, from a digital computer or computerize
or workstation. These monitors typically include electronic circuitry to process the video signal and a s
crystal or plasma) to display the image. Monitors used to display images appropriate for medical exam
resolution that is similar or better than full high-definition (1080 pixels of vertical resolution, i.e., 1920
Medical image high-definition video monitors are used to display images with a definition that is good
medical (e.g., radiologic) images and to perform diagnosis interpretation except for mammographic st

High-definition video monitors designed to display dual (i.e., paired) electronic images with a definitio
for diagnoses made using medical images (e.g., radiologic, ultrasonic, MRI) from a digital computer, c
information system, or workstation. These monitors typically include electronic circuitry to process the
screens (e.g., liquid crystal or plasma) to display the images. Monitors used to display medical images
medical diagnosis interpretation usually have a resolution of not less than three megapixels. Doubled-
definition video monitors are used to display images with a definition that is good enough to perform
radiology studies) using two images simultaneously.

High-definition video monitors designed to display electronic gray-scale images with a definition that i
perform mammographic diagnoses using medical images (e.g., radiologic) from a digital computer, co
information system, or workstation. These monitors typically include electronic circuitry to process the
screen (e.g., liquid crystal or plasma) to display the image. Monitors used to display medical images a
mammographic diagnoses interpretation usually have a definition of not less than five megapixels.
High-definition video monitors designed to simultaneously display multiple electronic images with a d
enough for examination and/or diagnosis of each medical image (e.g., radiographic, ultrasonic, MRI). T
images either in real time as they are obtained using a dedicated video camera or, more frequently, fr
or computerized information system or workstation. These monitors typically include an input multiple
integral part or separate accessory) that can manage multiple video signals (usually at least 16) and a
simultaneously display a subset of them (e.g., 8 or more); additional electronic circuitry to process the
large (e.g., 60 inch/1.5 meter or larger) screen (e.g., liquid crystal or plasma) to display simultaneousl
The monitors have usually a resolution of at least 5 megapixels. Medical image high-definition video m
display images with a definition that is good enough to assess medical (e.g., radiologic) images and to
interpretation.

Laser scanning systems that use coherent light and interferometer techniques (i.e., optical coherence
obtain cross-sectional images. These systems typically consist of a computerized unit including a light
photodetector, and a display. The light beam (usually in the infrared range) is divided into two beams,
the sample and the other towards a mirror; tomographic images are obtained by detecting the interfe
light reflected by both beams. The images obtained can show tissue about two or three mm (0.08 to 0
which provides axial and lateral resolution in the order of micrometers. Clinical use of OCT laser scann
intended mainly to obtain detailed tomographic images of tissues, especially ophthalmology and intra

Vascular catheters designed to obtain intravascular images using optical coherence tomography (OCT
typically consist of a plastic tube with a fiberoptic core; the catheter delivers near-infrared light and pe
100 MB/sec) data sampling rate. OCT imaging catheters are attached to an OTC laser scanning system
lesions inside the vasculature, to facilitate the evaluation of atherosclerotic plaque components and p
measurements. These devices assess lesion length and size of appropriate stents in patients that are,
for intravascular procedures. Dedicated catheters intended for OTC in the coronary arteries are availa

Stents designed for deployment into one of the paranasal sinus (i.e., frontal, ethmoid, or sphenoid) du
and/or maintain patency that include a drug that is released into the surrounding tissue over time. Th
of a polymeric (frequently a bio-absorbable poly-lactide) tubes that resembles a soft balloon and relea
drugs (e.g., triamcinolone acetate, mometasone furoate). The stents are, available in several different
according to the sinus on which they are deployed and may include a self-retention mechanism to pre
eluting paranasal sinus stents are intended for temporary (e.g., two to four weeks) ventilation and dra
the sinus. They are usually delivered using dedicated instruments (e.g., deployment guides). The sten
after functional endoscopic sinus surgery (FESS).

Vascular catheters designed to obtain intravascular images of the coronary arteries using optical cohe
(OCT). These catheters typically consist of a plastic tube with a fiberoptic core and a lumen for saline
injection; the catheter delivers near-infrared light and performs a fast (e.g., 100 MB/sec) data samplin
measurements in a few seconds. OCT coronary artery imaging catheters are attached to OTC laser sca
assess complex lesions inside the arteries, facilitating the evaluation of atherosclerotic plaque compon
internal measurements in the coronary arteries such as lesion length and size of appropriate stents in
will be candidates for coronary artery catheterization procedures.
Laser scanning software designed to operate optical coherence tomography (OCT) scanning systems t
techniques to get real-time images inside the vasculature (i.e., intravascular). The software performs a
for analysis of both data and image characteristics. This permits the assessment of complex lesions in
(e.g., peripheral and coronary arteries). The software allows for accurate internal measurement in the
lesion length and determination of the size of appropriate stents in patients that are or will be candida
procedures. Intravascular OCT laser scanning system software is usually not available separate from t
system but may be updated (i.e., through the release of modified versions) during the life of the syste
intravascular OCT laser scanning system software with algorithms for evaluation of atherosclerotic pla
performing internal measurements in the coronary arteries is also available.

Automated cytometers that use scanning laser microscopy for cell illumination and measurement, ena
viability, proliferation and function; live cell assays; immunophenotyping; and automated tissue analy
DNA content. Laser microscopy cytometers can be used to analyze cells in fluids and solid-phase sam
adherent cultured cells and tissue sections. These cytometers include microscope slides and microtite
photomultiplier tubes, and a scatter detector to measure properties of cells resulting from multicolor fl
Scanning laser microscopy automated cytometers include software that is intended to be used to inte
develop further applications.

Occlusal splints (also known as intraoral orthoses) designed to fit tightly overlaying the occlusal surfac
lower arch of the teeth (i.e., occlusal splints) during dental treatments. These splints usually consist o
designed soft or semi-rigid devices that are made of cured acrylic resins. They are created using a mo
patient's dental arches and may be made from plastics (e.g., vinyl). Dental occlusal splints are often p
management of teeth and may have a role in protecting both teeth and restorations from excessive lo
The splints may be also used to provide relaxation to the masticatory muscles to help in mandibular re
treatments.

Obstructive sleep apnea (OSA)/anti-snoring occlusal splints designed for placing inside the mouth for
sleeps. These devices help avoid inspiratory noise produced by the vibration of the pharyngeal soft ti
advancing and holding the tongue forward. These splints usually consist of prefabricated plastic devic
fitted around the teeth. This stops the tongue from falling back and thus avoids the obstruction that r
obstructive sleep apnea. Dedicated occlusal splints that use suction to hold the tongue in place are a
usually positioned in dental offices.

Obstructive sleep apnea (OSA)/anti-snoring occlusal splints designed for placing inside the mouth for
sleeps. These devices help avoid inspiratory noise produced by the vibration of the pharyngeal soft ti
increasing the pharyngeal space, repositioning and stabilizing the lower jaw and bringing it forward. T
consist of custom-made devices made of plastic that are fitted on the teeth. Prefabricated thermoplas
fitted to the jaw by softening the device in hot water and then biting down on it to get a proper fit (kn
devices) are also available. Mandibular repositioning OSA/anti-snoring occlusal splints are intended fo
breathing problems are related to the jaw position. The splints may also be used to provide relaxation
muscles to help in other mandibular repositioning treatments. These devices are typically positioned
Obstructive sleep apnea (OSA)/anti-snoring occlusal splints designed for placing inside the mouth for
sleeps. These devices help avoid inspiratory noise produced by the vibration of the pharyngeal soft ti
lifting the soft palate. These splints usually consist of prefabricated or custom-made plastic devices th
mouth. They position and stabilize the soft palate and, occasionally, the uvula. These devices are int
breathing problems that cause OSA and/or snoring; they are usually positioned in dental offices.

Organ preservation/transport containers designed to be carried by a person (i.e., portable) while provi
cold perfusion to the organ. These containers typically consist of a portable unit that includes a casse
cold environment and is used for the perfused organ; an ice chamber; a perfusion pump; a bubble det
perfusion tubing circuit; a pressure regulator; batteries; and a monitor that may externally display pre
and perfusion time. All perfusion components are usually disposable. Portable cold perfusion containe
to preserve and transport kidneys while waiting for the transplantation procedure and/or for transport
used for other organs such as liver, pancreas, and heart.

Ventilators designed to maintain the proper tidal volume during ventilation of patients placed in hyper
Because hyperbaric chambers can have changing atmospheric pressures and high-pressure conditions
atmospheres), these ventilators use an inspiratory flow adjustable controller to maintain proper outpu
pressurizing or depressurizing. Hyperbaric chamber compatible ventilators usually include a control m
breathing circuit, tidal volume gas hose, pressure relief valve, and an airway pressure gauge. They are
through adult patients.

Devices designed for introduction into cavities, wounds, or natural tracts and that are intended mainly
purposes. These devices typically consist of a slender metallic or plastic cylinder with appropriate size
the intended passage that may be attached to a handle at the proximal end. Exploratory probes, whic
sounds, can be flexible or rigid. Some probes are also used to locate foreign objects or to measure stri
probes intended for particular areas of the anatomy, such as the eyes, anal fistulas, nasal sinus, ureth
specific procedures are available. Exploratory probes with one working end or working ends at both en

Testers designed for automated assessment of the main physical parameters of steam sterilization un
sterilization process. These testers are computerized electronic devices that include measuring capab
such as temperature, time, and pressure. The testers also perform an assessment of the conditions of
as a steam penetration test and sterilizing chamber seal integrity and may provide calibration and/or
sterilizer status. The testers usually include software programs for data analysis, recording, and comm
laboratory and hospital information systems. Steam sterilization unit and process testers are used to d
conditions of the sterilization unit and process are appropriate to sterilize devices.

Devices designed to deliver hemostatic agents derived from the patient's own blood (i.e., autologous
These applicators typically consist of a single-use, sterile handheld device intended for the application
agent in a given area of the body (e.g., topical, intracavitary, endoscopic). The applicator is coupled w
which the patient's blood is collected and processed; the applicators have specific configurations acco
application.
Equipment designed with combined capabilities to perform both sputtering and carbon evaporation pr
even coating of metal or carbon on the surface of a sample to be observed using an electron microsco
process of bombarding a material with heavy atoms or ions with sufficient energy to dislodge and tran
different location. A high voltage creates a charge at the target surface and at the same time strips an
sputtering gas (usually argon). Since the target has the opposite charge to the argon ion, the ions are
forming a thin and even (usually in the order of nanometers) coating on samples placed close to the a
usually performed in a partial vacuum container with a suitable gas environment. Carbon evaporation
in the controlled evaporation of a high purity carbon rod in a dedicated sample coater that deposits a
carbon on the surface of non-metal samples, providing a uniform layer of carbon with a thickness (usu
nanometers) according to the microscopic analysis to be performed. Metallic coating of the samples a
sample, reduce thermal damage, and improve secondary electron emission during scanning electron m
coating is typically used for scanning and transmission electron microscopy examinations but may be
micro-analysis and other thin film applications.

Supporting structures designed to hold and charge the internal rechargeable batteries of hearing aid d
time (usually about 5 hours for a full charge). These docks (also known as docking stations) typically c
made of metal, hard plastic, or a combination of these that is usually placed on a tabletop. The docks
appropriate connectors to plug-in or cradle the hearing aids for one or both ears, providing means to r
batteries. Some feature LED lights that indicate how far along the recharging cycle is. The docking sta
for connection to the mains or they can use special adaptors that plug into car power outlets. Some he
docks/battery chargers have lids and dehumidifiers to remove moisture from the hearing aid devices w
recharging. Hearing aid docks/battery chargers are usually specific to the brand or model of hearing a
recharge. They are used in the homes or sometimes in the automobiles of the hearing aid wearers.

Magnifiers that are intended to be used as reading and vision aids by magnifying images or objects, s
packages of food or medicine, reading materials, maps, color photographs, or pictures. They can be e
hand or used as a tabletop model; the magnified image is viewed by looking through the transparent
Reading-aid magnifiers are electronically or battery-powered and include a light source and/or electro
magnifiers are also available.

Software designed to make a computerized assessment of a neurophysiological conditions of a patien


dedicated program. The software can detect, evaluate, and record the relationship between the functi
cognitive processes or behavior (i.e., neuropsychological characteristics) such as speed and accuracy
and thinking capability of people by self-testing using a computer. This software is intended to work b
responses provided by the patient to a computer program. Neuropsychological computerized assessm
used to store the parameters of a group of people (e.g., workers, military personnel) in a database. It
of the registered data with new assessments performed after trauma or illness by a medical specialist
facilitates the evaluation of the capability for future performance during work or combat and/or the ne
treatment.
Implants designed for retraction of the prostate lobes from the urethra. These implants typically consi
suture with two appropriate terminal pieces for the urethral and prostate ends respectively. The impla
through the urethra using a dedicated delivery unit that includes a rigid sheath and a needle that com
end of the sheath. When the sheath reaches the obstruction point, the implants are deployed, retracti
(usually two implants are needed for the right and left lobes of the prostate gland); once the implants
and the delivery unit are removed. Urethral prostate retraction implants are intended to open the uret
incisions; they are mainly used to treat patients suffering from lower urinary tract difficulties due to pr

Equipment designed to deliver urethral prostate retraction implants through the urethra. These units t
handheld mechanical instrument used to manipulate and control the delivery of the implant that also
rigid sheath and a needle that comes out from the distal end of the sheath. The rigid sheath is introdu
urethra and when the sheath reaches the obstruction point, the implants are deployed, retracting the
two implants are needed for the right and left lobes of the prostate gland); once the implants are in pl
delivery unit are removed. Urethral prostate retraction implant delivery units are mainly used to insert
treatment of patients suffering from lower urinary tract difficulties due to prostatic hyperplasia.

Vascular catheters designed for use in crossing through chronic total occlusions (CTO) in the vasculatu
arteries) using high-frequency mechanical vibrations. These devices consist of a catheter with approp
diameter and length) according to the artery and/or location of the occlusion. They typically include a
transmits the mechanical vibrations to the tip of the catheter and irrigation capabilities. The catheter
vascular occlusion crossing systems that also include a high frequency generator, transducers, and irr
Occlusion crossing vascular catheters are mainly intended to facilitate guidewire passage across the C
subsequent angioplasty procedures and/or stent placement. Dedicated catheters are available accord
they are used such as the coronary and peripheral arteries.

Equipment designed to transfer protein and blood circulating antibodies samples typically from an aga
membrane (e.g., nylon, nitrocellulose, polyvinylidene difluoride-PVDF ) or less frequently to a filter or
blotting) after a gel electrophoresis procedure, a procedure that separates the molecules according to
The transfer is usually performed using an electric gradient process (either wet or semi-dry); some sys
capillary transfer process or less frequently a diffusion transfer. IVD protein blotters are intended to pr
immobilized matrix an identical copy of the electrophoretic pattern present in the gel allowing the pe
range of analytical procedures. Protein blotters are used in tests usually known as western blots or on
eastern and southwestern blots).
Laboratory incubators designed to maintain a controlled and suitable aerobic or anaerobic environmen
can either keep the molecular oxygen at a level similar to or greater than the atmosphere at (i.e., aero
oxygen-free environment (i.e., anaerobic) while providing an accurate control on the carbon dioxide (C
incubator chamber in a pre-determined range of temperatures. These incubators typically consist of a
with a controlled temperature that is isolated with a water or air jacket; microprocessor sensors and co
providing appropriated levels of temperature, humidity, oxygen, carbon dioxide, and nitrogen levels; a
gas level recorders. The incubator may also include air filters and/or copper components (e.g., copper
to prevent contamination. The incubator keeps high levels of oxygen (usually from 22 to 80%), high re
(typically higher than 90%), and carbon dioxide levels from 5 to 10% appropriate for aerobic cell grow
very low level of oxygen (i.e., anaerobic) the incubator displaces the oxygen with nitrogen gas. Aerobi
are intended for a variety of cell cultures that require different environmental conditions for growth.

Vascular catheters designed to obtain intravascular images of the coronary arteries using optical cohe
(OCT). These catheters typically consist of a plastic tube with a fiberoptic core and a lumen for saline
injection; the catheter delivers near-infrared light and performs a fast (e.g., 100 MB/sec) data samplin
measurements in a few seconds. OCT coronary artery imaging catheters are attached to OTC laser sca
assess complex lesions inside the arteries, facilitating the evaluation of atherosclerotic plaque compon
internal measurements in the coronary arteries such as lesion length and size of appropriate stents in
will be candidates for coronary artery catheterization procedures.

Non-inflatable strap tourniquets designed to circumferentially constrict/compress an extremity for a lim


control venous and arterial bleeding (i.e., hemorrhage) in emergency situations. These tourniquets us
(e.g., rubber, fabric) elastic band that may include some means for easy and quick fixing around the a
injured person. Emergency strap non-inflatable tourniquets are used mainly in the field by paramedics
trained personnel during emergency situations including traumatic accidents, natural disasters, riots,
emergency tourniquets intended for self-application, typically using only one hand, are also available.

Non-inflatable strap tourniquets designed for self-application (i.e., one-hand) to circumferentially cons
extremity for a limited period of time to control venous and arterial bleeding (i.e., hemorrhage) in eme
These tourniquets usually consist of a plain (e.g., plastic) band that includes some means for easy and
strips, clips, self-adhesive bands, built-in ratchets) around the affected limb usually using only one han
tourniquets intended for carrying attached (e.g., belt) to the body of the user are also available. Self-a
strap non-inflatable tourniquets are mainly used in the field by people subject to high risk of injuries, s
firemen, and members of the armed forces during combat; they may be also used by paramedics and
personnel during emergency situations including traumatic accidents, natural disasters, riots, and war
Pneumatic tourniquets designed to circumferentially constrict/compress an extremity for a limited per
a precise amount of pressure using a manually air-inflated cuff. The pressure is applied upon the limb
tissues using the cuff; pressure is then transferred to the blood vessels causing a temporary occlusion
should be at least equal or higher than the minimum required to occlude the blood flow (i.e., limb occ
These tourniquets typically include an inflatable cuff, a hand pump (e.g., a rubber bulb) or, less freque
gas cartridge, and an integral manometer. Manual pneumatic tourniquets are used mainly during eme
control hemorrhage and for amputations, but they may be also used during surgical procedures on the
bloodless operative fields when automated tourniquets are not available or their operation is not poss

Pneumatic tourniquets designed to constrict/compress circumferentially an extremity for a limited per


venous and arterial bleeding (i.e., hemorrhage) in emergency situations, frequently intended for self-a
one hand. The pressure is applied all-around upon the limb surface and underlying tissues using the c
transferred to the blood vessels causing a temporary occlusion. These tourniquets typically consist of
hand pump (e.g., a rubber bulb), and some means for easy and quick self-fixing (e.g., clips, self-adhes
ratchets) around the affected limb usually using only one hand. Emergency/self-application pneumatic
mainly in the field by people subject to high risk of injuries, such as policemen, firemen, and members
during combat. They may be also used by paramedics and/or other trained personnel during emergen
traumatic accidents, natural disasters, riots, and war.

Pneumatic tourniquets that include an electrically powered compressed air pump that are designed to
constrict/compress an extremity for a limited period of time by applying a precise amount of pressure
gas-inflated cuff. The pressure is applied upon the limb surface and underlying tissues using the cuff;
transferred to the blood vessels causing a temporary occlusion. The pressure should be at least equal
minimum required to occlude the blood flow (i.e., limb occlusion pressure [LOP]). These tourniquets ty
more inflatable cuffs and an electric-powered control unit with a compressed air pump; usually integra
also included in the control unit for use in case of power failures. The tourniquets also include controls
for the applied pressure, and alarms for abnormal conditions. Computerized automated tourniquets ca
calibration checks and display elapsed inflation time. Automated electric-powered pneumatic tourniqu
during surgical procedures on the extremities enabling surgeons to perform delicate procedures in blo

Pneumatic tourniquets including tubing for connection to a compressed gas source designed to constr
circumferentially an extremity for a limited period of time by applying a precise amount of pressure us
inflated cuff. The pressure is applied to the limb surface and underlying tissues using the cuff; pressur
the blood vessels causing a temporary occlusion. The pressure should be at least equal or higher than
to occlude the blood flow (i.e., limb occlusion pressure [LOP]). These tourniquets typically include one
and a unit connected to a central air system unit or a compressed gas cylinder. The tourniquet main u
controls, regulators, monitors for the applied pressure, and alarms for abnormal conditions; computeri
tourniquets can perform self-calibration checks and display elapsed inflation time. Compressed gas pn
are used mainly during surgical procedures in the extremities which enable surgeons to perform delica
bloodless operative fields; they may be used also to stop bleeding during emergency care.
Inflatable cuffs with a single inflatable bladder designed to exert a pressure on the circumference of a
of a compressed gas. These devices typically include a bladder within the cuff that is inflated through
the bladder connectors to the source of compressed air located in the control unit of the tourniquet. T
the extremity using contact mechanisms (e.g., clips) and frequently secured with an external ribbon. S
pneumatic tourniquet cuffs are used mainly during surgical procedures in the extremities using genera
enables surgeons to perform delicate procedures in bloodless operative fields. Dedicated single-bladd
shapes including rectangular, cylindrical, conical, and contoured (i.e., with a smaller diameter distally
wrapped) are available in a variety of sizes. Both reusable and disposable cuffs intended for use on sp
(e.g., arm, thigh, wrist, ankle) are also available.

Cuffs including an inflatable bladder and a regular (typically cylindrical or rectangular), non-tapered (i
that are designed to exert a pressure on the circumference of an extremity by means of a compressed
pneumatic tourniquet. These devices usually include one small bladder within the cuff that is inflated
hoses) that run from the bladder connectors to the source of compressed air located in the control uni
cuff is fastened to the extremity using contact mechanisms (e.g., clips) and frequently secured with an
Single-bladder standard cuffs (both reusable and disposable) are used mainly during surgical procedu
using general anesthesia which enable surgeons to perform delicate procedures in bloodless operative
single-bladder cuffs (both reusable and disposable) intended for use in specific extremity areas (e.g., a
ankle) are available. Dedicated non-standard cuffs with a smaller diameter distally than proximal whe
contoured cuffs) are also available.

Single-bladder cuffs intended for a single-use (i.e., disposable) including an inflatable bladder and a st
cylindrical or rectangular) shape that are designed to exert a pressure on the circumference of an extr
compressed gas delivered by a pneumatic tourniquet. These devices usually include one bladder with
inflated through tubes (e.g., hoses) that run from the bladder connectors to the source of compressed
control unit of the tourniquet. The cuff is fastened to the extremity using contact mechanisms (e.g., cl
secured with an external ribbon. Disposable single-bladder standard cuffs are usually supplied sterile
for only one use and are not intended for sterilization processes at the healthcare facility; they are usu
integral unit with components (e.g., bladder) that cannot be replaced. The cuffs are used mainly durin
in the extremities using general anesthesia that need a completely sterile operating field. Disposable
bladder cuffs are intended for use in specific extremity areas (e.g., arm, thigh, wrist, ankle) are availab
disposable non-standard cuffs with a smaller diameter distally than proximal when wrapped (i.e., cont
available.

Single-bladder cuffs intended for reuse including an inflatable bladder and a standard (typically cylind
shape that are designed to exert a pressure on the circumference of an extremity by means of a comp
by a pneumatic tourniquet. These devices usually include one bladder within the cuff that is inflated t
hoses) that run from the bladder connectors to the source of compressed air located in the control uni
cuff is fastened to the extremity using contact mechanisms (e.g., clips) and frequently secured with an
Reusable single-bladder standard cuffs may be washed and/or sterilized after each use; some of the c
(e.g., bladder, sleeve) may be replaced. They are used mainly during surgical procedures in the extrem
anesthesia. Reusable standard single-bladder cuffs are intended for use in specific extremity areas (e.
ankle) are available. Dedicated reusable non-standard cuffs with a smaller diameter distally than prox
(i.e., contoured cuffs) are also available.
Cuffs consisting of an inflatable bladder and a tapered (i.e., non-standard) shape cuff that has a small
than proximally when wrapped (i.e., contoured cuffs). The cuffs are designed to exert a pressure on th
extremity by means of a compressed gas delivered by a pneumatic tourniquet. These devices usually
within a wide cuff that is inflated through tubes (e.g., hoses) that run from the bladder connectors to t
compressed air located in the control unit of the tourniquet. The cuff is fastened to the extremity using
(e.g., clips) and frequently secured with an external ribbon. Contoured cuffs have an arced design to g
distal diameter when wrapped; some cuffs include pivoting fastening straps to allow adjustment of bo
diameters to suit the limb which also provides more comfort to patients. Single-bladder contoured cuff
during surgical procedures in the extremities for patients who are obese or extremely muscular, thus e
perform delicate procedures in bloodless operative fields. Contoured single bladder cuffs (both reusab
intended for use in specific extremity areas (e.g., arm, thigh) are available

Single-bladder cuffs intended for a single-use (i.e., disposable) including an inflatable bladder and a co
a smaller diameter distally than proximally when wrapped. The cuffs are designed to exert a pressure
of an extremity by means of a compressed gas delivered by a pneumatic tourniquet. These devices us
bladder within the cuff that is inflated through tubes (e.g., hoses) that run from the bladder connector
compressed air located in the control unit of the tourniquet. The cuff is fastened to the extremity using
(e.g., clips) and frequently secured with an external ribbon. Contoured cuffs have an arced design to g
distal diameter when wrapped; some cuffs include pivoting fastening straps to allow adjustment of bo
diameters to suit the limb providing also more comfort to patients. Disposable single-bladder contoure
supplied sterile in individual pouches for only one use and are not intended for sterilization processes
facility; they are usually made as an integral unit with components (e.g., bladder) that cannot be repla
contoured cuffs are used mainly during surgical procedures in the extremities for patients who are obe
muscular thus enabling surgeons to perform delicate procedures in bloodless operative fields. Contou
(both reusable and disposable) intended for use on specific extremity areas (e.g., arm, thigh) are also

Single-bladder cuffs intended for reuse including an inflatable bladder and a contoured cuff that has a
distally than proximally when wrapped. The cuffs are designed to exert a pressure on the circumferenc
means of a compressed gas delivered by a pneumatic tourniquet. These devices usually include one b
that is inflated through tubes (e.g., hoses) that run from the bladder connectors to the source of comp
the control unit of the tourniquet. The cuff is fastened to the extremity using contact mechanisms (e.g
secured with an external ribbon. Contoured cuffs have an arced design to give them the smaller distal
wrapped; some cuffs include pivoting fastening straps to allow adjustment of both distal and proximal
limb which also provides more comfort to patients. Reusable single-bladder contoured cuffs may be w
after each use; some of the components of the cuff (e.g., bladder, sleeve) may be replaced. They are
surgical procedures in the extremities using general anesthesia. Reusable contoured single-bladder c
specific extremity areas (e.g., arm, thigh, wrist, ankle) are also available.
Cuffs with two inflatable bladders designed to exert a pressure on the circumference of an extremity b
compressed gas delivered by a pneumatic tourniquet. These devices typically include two small bladd
are inflated through tubes (e.g., hoses) that run from the bladder connectors to the source of compres
control unit of the tourniquet. The cuff is fastened to the extremity using contact mechanisms (e.g., cl
secured with an external ribbon. Each bladder may be inflated and deflated separately, improving safe
comfort. Double-bladder pneumatic tourniquet cuffs are used mainly during surgical procedures in the
intravenous regional anesthesia. This enables surgeons to perform delicate procedures in bloodless op
standard double-bladder cylindrical cuffs and double-bladder cuffs with other shapes (e.g., rectangula
dedicated cuffs with a smaller diameter distally than proximal when wrapped (i.e., contoured cuffs) ar
of sizes. Both reusable and disposable cuffs intended for use in specific extremity areas (e.g., arm, thi
also available.

Cuffs with a regular (typically cylindrical or rectangular), non-tapered (i.e., standard) shape. The cuffs
pressure on the circumference of an extremity by means of a compressed gas delivered by a pneuma
devices usually include two small bladders within the cuff that are inflated through tubes (e.g., hoses)
bladders' connectors to the source of compressed air located in the control unit of the tourniquet. The
extremity using contact mechanisms (e.g., clips) and frequently secured with an external ribbon. Each
inflated and deflated separately, improving safety and patient comfort. Double-bladder standard cuffs
during surgical procedures in the extremities using intravenous regional anesthesia enabling surgeons
procedures in bloodless operative fields. Standard double-bladder cuffs (both reusable and disposable
specific extremity areas (e.g., arm, thigh, wrist, ankle) are usually cylindrical in shape; standard cuffs
as rectangular and conical are also available. Dedicated non-standard cuffs with a smaller diameter di
when wrapped (i.e., contoured cuffs) are also available.

Double-bladder cuffs intended for a single-use (i.e., disposable), including two inflatable bladders and
cylindrical) shape that are designed to exert a pressure on the circumference of an extremity by mean
delivered by a pneumatic tourniquet. These devices usually include two small bladders within the cuff
through tubes (e.g., hoses) that run from the bladder connectors to the source of compressed air loca
of the tourniquet. The cuff is fastened to the extremity using contact mechanisms (e.g., clips) and freq
external ribbon. Disposable double-bladder standard cuffs are usually supplied sterile in individual pou
and are not intended for sterilization processes at the healthcare facility. They are usually made of one
components (e.g., bladders) cannot be replaced. Disposable standard double-bladder cuffs intended f
extremity areas (e.g., arm, thigh, wrist, ankle) are available. Dedicated disposable non-standard cuffs
diameter distally than proximally when wrapped (i.e., contoured cuffs) are also available.
Double-bladder cuffs intended for reuse including two inflatable bladders and a standard (typically cyl
designed to exert a pressure on the circumference of an extremity by means of a compressed gas del
tourniquet. These devices usually include two small bladders within the cuff that are inflated through
run from the bladders' connectors to the source of compressed air located in the control unit of the to
fastened to the extremity using contact mechanisms (e.g., clips) and frequently secured with an exter
double-bladder standard cuffs may be washed and/or sterilized after each use; some of the componen
bladder, sleeve) may be replaced. They are used mainly during surgical procedures in the extremities
anesthesia. Reusable standard double-bladder cuffs are intended for use in specific extremity areas (
ankle) are available. Dedicated reusable non-standard cuffs with a smaller diameter distally than prox
(i.e., contoured cuffs) are also available.

Cuffs including two inflatable bladders and a tapered (i.e., non-standard) shape cuff that has a smaller
proximally when wrapped (i.e., contoured cuffs). The cuffs are designed to exert a pressure on the circ
extremity by means of a compressed gas delivered by a pneumatic tourniquet. These devices usually
within the cuff that are inflated through tubes (e.g., hoses) that run from the bladders' connectors to t
compressed air located in the control unit of the tourniquet. The cuff is fastened to the extremity using
(e.g., clips) and frequently secured with an external ribbon. Contoured cuffs have an arced design to g
distal diameter when wrapped; some cuffs include pivoting fastening straps to allow adjustment of bo
diameters to suit the limb which also provides more comfort to patients. Double-bladder contoured cu
during surgical procedures in the extremities for patients who are obese or extremely muscular which
perform delicate procedures in bloodless operative fields. Contoured double bladder cuffs (both reusa
use in specific extremity areas (e.g., arm, thigh) are also available.

Double-bladder cuffs intended for a single-use (i.e., disposable) including two inflatable bladders and
has a smaller diameter distally than proximally when wrapped; the cuffs are designed to exert a press
circumference of an extremity by means of a compressed gas delivered by a pneumatic tourniquet. Th
include two bladders within the cuff that are inflated through tubes (e.g., hoses) that run from the blad
the source of compressed air located in the control unit of the tourniquet. The cuff is fastened to the e
mechanisms (e.g., clips) and frequently secured with an external ribbon. Contoured cuffs have an arce
the smaller distal diameter when wrapped; some cuffs include pivoting fastening straps to allow adjus
and proximal diameters to suit the limb which also provides more comfort to patients. The cuffs are us
in individual pouches for only one use and are not intended for sterilization processes at the healthcar
usually made as an integral unit in which components (e.g., bladder) cannot be replaced. Disposable
contoured cuffs are used mainly during surgical procedures in the extremities for patients that are obe
muscular enabling surgeons to perform delicate procedures in bloodless operative fields. Disposable c
bladder cuffs intended for use on specific extremity areas (e.g., arm, thigh) are also available.
Double-bladder cuffs intended for reuse including two inflatable bladders and a contoured cuff that ha
distally than proximally when wrapped; the cuffs are designed to exert a pressure on the circumferenc
means of a compressed gas delivered by a pneumatic tourniquet. These devices usually include two b
that are inflated through tubes (e.g., hoses) that run from the bladder connectors to the source of com
the control unit of the tourniquet. The cuff is fastened to the extremity using contact mechanisms (e.g
secured with an external ribbon. Contoured cuffs have an arced design to give them the smaller distal
wrapped; some cuffs include pivoting fastening straps to allow adjustment of both distal and proximal
limb providing also more comfort to patients. They are used mainly during surgical procedures in the e
general anesthesia. Reusable contoured double-bladder cuffs are intended for use in specific extremit
thigh) are available.

Cuffs designed for exsanguination of an extremity by rolling it from the distal to the proximal end of th
devices typically consist of inflatable (e.g., rubber, plastic) cuffs in a variety of diameters; the cuffs are
manual pump (e.g., bulb) while regulating the pressure with a manometer. Exsanguination roll-on cuff
obtain and keep a bloodless operating field during surgical procedures in the extremities (e.g., hands

Garments designed for exsanguination of an extremity by applying pressure sequentially from the dis
of the garment by means of a compressed gas delivered by a pneumatic tourniquet. These devices ty
inflatable hollow garments with several bladders (e.g., three) within the cuff that are inflated and defla
sequence through tubes (e.g., hoses) that run from the bladder connectors to the source of compresse
control unit of the tourniquet. The garment usually includes mechanisms (e.g., zippers) to adapt to diff
extremities according to the patient and limb characteristics. Dedicated pneumatic tourniquet exsang
used mainly to obtain and keep a bloodless operating field during surgical procedures in the extremiti
for the upper and lower limbs are available.

Garments designed for exsanguination of an extremity by pulling (i.e., rolling) it from the distal to the
extremity. These devices typically consist of a tubular elastic sleeve (a stockinette) including a dedica
silicone) ring and a set of pulling straps. The garment is placed on the fingers or toes and when the st
sleeve rolls up the limb pushing the blood away. The ring keeps the arteries blocked during the surgic
end of the procedure the ring is removed. Exsanguination roll-on garments are used mainly to obtain a
operating field during surgical procedures in the extremities (e.g., hands or feet).
Medication carts designed with computerized capabilities to facilitate the storage and transportation o
supplies to the point of care (e.g., patient bed). These carts usually include shelves and compartment
organizing the storage and transportation of medication, instruments (e.g., syringes), and other suppl
administration of medications. They frequently include a removable section of drawers (a "cassette")
dose system to dispense individual daily medications from the pharmacy to each patient. A computer
software is also an integral part of the cart. Computerized medication carts record all access to the sy
lock medication drawers to keep medications inaccessible without authentication (e.g., using a magne
The carts usually require a scan of the medication and the patient wristband, reducing the risk of wron
duplicate dosing. Computerized medication carts may provide data to hospital information systems an
component of medication-dispensing automated systems designed to provide safe and orderly contro
dispensing throughout a healthcare facility (i.e., decentralized medication management systems); the
further increase of patient safety and data accessibility while reducing the chance of medication error

Phototherapy units designed to irradiate the cornea with relatively long-wave (in the range of 315 to 4
type A (UVA) light, producing a strengthening effect on the stromal layers of the cornea. These device
lamp used to apply UVA radiation with a frequency and intensity according to the treatment performe
photoactivating a dedicated solution (e.g., riboflavin). Collagen cross-linking ophthalmic phototherapy
ophthalmic therapeutic procedures, such as keratoconus and ectasia (i.e., thinning) of the cornea follo
keratomileusis (LASIK) procedures.

Sterile pieces of paper designed for drying root canals during endodontic treatments. These devices ty
highly absorbent long and narrow rolled sterile papers with a tapered point appropriate to fill into the
available in a variety of sizes for use according to the size of the root canal into which they are being
paper points are used during root canal therapy before a temporary or permanent restorative materia
percha points) is used to fill the canal.

Exploratory probes intended mainly to keep open a channel between the anterior chamber of the eye
subconjunctival space for drainage of fluid. These devices typically consist of slender flexible metallic
that can be passed through the trabeculum. They may be attached to a handle at the proximal end. T
into the main collector channel (Schlemm's canal) and is pushed through into the front chamber of the
exploratory probes are intended to facilitate drainage of the aqueous humor in patients suffering from

Dose calibration kits designed for testing the linearity of dose calibrators used in nuclear medicine du
procedures. These kits typically consist of a set of lead-wrapped tubes, each capable of attenuating by
radioactivity of a nuclear source (typically a 99m Technetium). The kits simulate the decay of a nuclea
of a few hours up to several days allowing the measurement of the decay-equivalent activity, eliminat
fractionate eluents or to decay them for several days. These kits are used in nuclear medicine departm
quality control procedures of nuclear medicine dose calibrators which are intended to calibrate the do
radiopharmaceutical vials and syringes and other small radiation sources.
Controllers designed to regulate the performance of perfusion pumps that deliver solutions to induce
cardiopulmonary bypass surgical procedures. These controllers typically consist of an electronic unit th
attached to pressure transducers and a bubble sensor. The controller may also include a display show
parameters (e.g., the total volume of solution delivered, ischemia time) and alarms. The controller is c
perfusion pump (typically a double roller pump); it may work in manual mode, allowing the operator t
pump delivery or in automated mode controlling the pump delivery up to a pre-established dose of ca
Cardioplegia perfusion pump controllers are mainly used as components (modules) of heart-lung bypa
heart surgery procedures.

Controllers designed to regulate the performance of one or more infusion pumps from a remote locatio
typically consist of a centralized electronic wireless unit that shows in a display and allows the control
pump parameters, such as infusion rate and bolus administration. The controllers may interact with pu
components such as blood oxygenation (SpO2) monitors and also allow to provide immediate remote
pump alarms. Remote infusion pump controllers are used to control infusion pumps from a centralized
control of infusion pumps located in areas of healthcare facilities with limited or difficult access (e.g., u
MRI procedures).

Physiologic analyzers designed for use during the assessment of a person's attention level by means o
that provides a series of tasks that the person under evaluation should perform. These analyzers cons
and/or sound system that provides the stimuli which should be recognized by the person; input device
switches, keypads) to be operated each time a given stimuli is provided; computerized electronic circu
record the response. and software to perform the analysis of the person's response. The analyzer also
signals that can be linked to computers or computerized systems and printers. Attention level physiol
intended to evaluate a person's ability to obtain and sustain attention for a given period of time; they
evaluation of attention deficit, hyperactive, behavioral, and/or other inherited or acquired neurologic d

Vehicles designed as a tricycle that combine a wheelchair and the rear of a bicycle in tandem. The ve
frame, pedals, seat, handlebars, and back wheel of a bicycle and a detachable wheelchair at the front
pedaled and steered by the person who is seated on the bicycle frame while the disabled person is se
typically the wheelchair can detach from the bike frame for stand-alone use. Some of these vehicles in
capabilities (i.e., batteries and electric motors) to assist the pedaler; they may also include wheelchai
lap belts and adjustable head and foot rests. Wheelchair/bicycles are intended to bring long-range out
temporarily or permanently disabled person who cannot operate a powered wheelchair by him or hers

Templates designed from images previously obtained (i.e., pre-operatively) from computerized tomog
resonance imaging, or other imaging procedures that are intended for use in arthroplasty procedures.
consist of very accurate computerized (digital) maps made of solid materials that are used as guides f
(e.g., drills, knives, probes) during procedures and/or to determine the proper size of arthroplasty imp
arthroplasty templates are available for specific bones and/or joints and/or for particular procedures, s
repair.
Arthroplasty templates of the knees designed from images previously obtained (i.e., pre-operatively) f
tomography, magnetic resonance imaging, or other imaging procedures. The templates consist of ver
computerized (digital) maps of the knee articulation and are made of solid materials that permit guida
instruments such as drills and knives when placed on the articulation surface. Knee templates are use
procedures to determine the size of the implants and the cutting strategy. They are also used to repai
plugs of cartilage (i.e., autografts) from other areas of the knee less critical to its function in a procedu

Software designed to manage/operate telemedicine systems intended for patient image management
intended to work with a variety of image devices (e.g., smart phones, tablet computers) which are use
information through a healthcare Internet telephone network that follows a set of security and privacy
Insurance Portability and Accountability Act [HIPAA]). The software performs a variety of algorithms to
data, frequently for particular conditions (e.g., burnt skin) and/or procedures as well as manage the op
Diagnostic image telemedicine software is available as part of the complete system or as a separate c
software may be modified (i.e., through the release of modified versions) during the life of the system
versions. Dedicated telemedicine image management software intended for particular applications su
radiology, pathology, ophthalmology, and videoconferencing is also available.

Alloys with a composition that usually melts at temperatures below the temperature of boiling water (
[212 degrees Fahrenheit]) and that are commonly known as low-temperature melting alloys. These all
metal compositions; low-temperature melting alloys can expand up to 3.3% when solidifying from liqu
property permits its expansion to cover possible holes in casting procedures. An eutectic alloy that me
Celsius (158 degrees Fahrenheit) and has a composition of 50% bismuth, 26.7% lead, 13.3% tin, and
weight (known under the names of Wood metal, Lipowitz's alloy, and Cerrobend alloy) is very common
manufacturing radiotherapy block shields. Alloys, not including cadmium, that melt at 95 degrees Cel
Fahrenheit) are also frequently used. Low-temperature melting alloys are mainly used for healthcare
molding rooms to manufacture radiotherapy block shields. The molding rooms are frequently located i
facility that provides the radiotherapy treatment. The alloys are less frequently used in other healthca
dentistry).

Shields designed to block or attenuate the radiation beam during radiotherapy procedures (also know
shields or shielding blocks). These shields may consist of pre-shaped lead blocks or custom-made dev
low-melting-point alloy (i.e., one that melts at less than 100 degrees Celsius [212 degrees Fahrenheit]
procedure. These low-melting-point alloys are also known as Cerrobend and Lipowitz's alloys. Radiothe
have a shape that permits the performance of the radiotherapy procedure on the target tissues while
radiation in order to avoid damage to healthy tissues. They are used in radiotherapy areas in healthca
alloys (e.g., tungsten based) are also used to make radiotherapy block shields.

Casting stations designed to manufacture custom-made radiotherapy block shields made with low-me
with a melting point usually below 100 degrees Celsius [212 degrees Fahrenheit]). These stations typi
dispensing/melting unit that provides the appropriate alloy for the block, a refrigerated surface to acc
air cleaning systems (e.g., a ventilated hood), and cabinets to store the blocks. Some stations include
more homogeneous blocks. Low-melting alloy casting stations are used in healthcare facilities to man
radiotherapy block shields in dedicated workshops. A dedicated cutter to appropriately shape the mol
styrofoam) is usually located close to the casting station.
Portable urinals designed for female use. These urinals typically are containers with appropriate openi
female anatomy and are intended for direct urination. These urinals typically consist of handheld port
of plastic (for single-patient use) or made of glass or metal (reusable). Female urinals usually add som
foam ring around the opening of the urinal) to provide a better fit. Some urinals include attached lids
prevent spills and may or may not be attached to a tube for drainage of urine to a collection bag, leav
and ready for the next use. Female personal urinals are mainly used by bedridden patients, patients u
people with other disabilities or incontinence.

Computerized systems designed to detect and perform quantitative analysis of body fluids to detect o
of drugs that either are illegal or are frequently taken for nonmedical purposes (i.e., drugs with a high
Drugs-of-abuse include but are not limited to cocaine, lysergic acid diethylamide (LSD), and morphine
not include drugs that may be taken as prescription drugs (e.g., barbiturates). The system typically co
computer and peripherals (e.g., printers, monitors), urine sampling devices that prevent tampering, a
analyze the samples, and usually an internet-based link to provide automated assessment and respon
results are obtained. Some systems may include a pre-screening assessment based on a scanning of t
central nervous system abnormalities that may be caused by drugs of abuse and require further urine
package that controls the process is typically operated through the internet connection; the system m
introduction of additional results from laboratory and breath tests (e.g., alcohol), and/or manual data o
examinations. Drug-of-abuse screening test systems are mainly intended for use in occupational healt
employee screening as well as for use in emergency situations when use of drugs-of-abuse may be inv

Video systems designed to display images of the blood capillaries taken from a microscope placed on
are shown on a video monitor or personal computer display. The systems typically consist of a handhe
connected to a personal computer; the handheld device includes at the tip interchangeable microscop
(usually from 20X to 200X magnification), a video camera, and controls for image capture, illumination
system usually includes a software with algorithms that allow measurement, recording, and assessme
characteristics, as well as permitmapping the examined positions and fingers (known as nail fold cap
Capillaroscopy video systems are mainly used to analyze microvascular abnormalities, frequently pres
autoimmune rheumatoid diseases, especially for differentiation of primary and secondary Raynaud's p

Heating units designed to warm the gases used for insufflation of the abdomen during laparoscopic pr
usually use electric elements to provide heat along the tube from a central gas or cylinder supply to th
to the port that provides access to the abdomen. The heated gas is delivered to fill the pneumoperiton
normal body temperature. Heating units used to warm gases used in laparoscopic procedure systems
prevent hypothermia during long procedures and facilitate postoperative recovery.
Disinfectors designed to kill or inactivate most of the microorganisms (e.g., fungi, viruses, bacteria) fo
transducer probes following ultrasonic procedures on patients. These disinfectors typically kill microor
mycobacteria, all fungi, and spore-forming bacteria (except when there is a large number) providing a
disinfection (near-sterile disinfection). The equipment provides an automated disinfection cycle based
a liquid germicide (typically hydrogen peroxide [H2O2]) leaving only residues of non-toxic products to
disinfector usually consists of a disinfection chamber to place the probes, a container with the liquid g
nebulizer that converts the liquid germicide into a high-concentration vapor that is evenly introduced
equipment may also include chemical indicators to show successful disinfection results and an interna
the residual germicide into non-toxic products (e.g., water vapor and oxygen).

Physiologic analyzers designed to measure the bioelectrical impedance in the extracellular fluid found
analyzers consist of a main unit with an instrument that includes a low-frequency electric signal gener
electric current in a spectrum of frequencies (e.g., up to one kHz) to determine the impedance of the e
limbs, computerized circuits that analyze the impedance measurements using firmware, and detachab
electrodes at the distal end that are located on pre-determined areas on the patient limbs. The main u
recording capabilities and a display to show the appropriate disposition of the electrodes on the patien
the measurement, and the impedance value changes from previous measurements. The analyzer gen
intended to help physicians to identify the early stages of unilateral lymphedema in a limb (arm or leg
index variation with time. The instrument may include an optional software for further data analysis in
computer.

Systems designed as a combination of ophthalmoscopes, otoscopes, and vital signs measuring instrum
common frame that is usually attached on a wall. The systems are intended for an early assessment o
and the measuring of one or more vital signs of a patient. These systems typically include standard di
ophthalmoscopes intended to view the eye fundus, otoscopes (e.g., pneumatic), and one or more vita
instruments. The vital signs measuring instruments in the system typically are aneroid and/or electron
sphygmomanometers (for noninvasive blood pressure measurements), thermometers, and instrument
(pulse) rate; the system may also include a pulse oximeter to measure oxygen saturation in the blood
instruments in the system may use a common transformer inserted in the frame. The systems are ma
and doctors during primary physical assessment of patients.

Solid-state lasers with a rod of yttrium-aluminum-garnet (YAG) crystal doped with ytterbium (Yb), a ra
the active medium. Their emission wavelength is 1,030 nm (near infrared), although it is sometimes o
These lasers are usually operated in pulsed or mode-locked modes; they typically work as a high-powe
source. Yb:YAG lasers can be used to generate ultrashort pulses (in the range of the femtoseconds) us
locking. Yb:YAG lasers are mainly intended for very accurate cutting such as that performed in ophtha
refractive surgery, keratoplasty, lamellar resection) and/or in other applications when ultra-short high-
required.
Gas germicides, whose main component is chlorine dioxide that are intended for killing and/or total in
sterilization) of microorganisms (i.e., viruses, bacteria, fungi, and their spores). These gas germicides
synthetic, green-yellowish gas with a chlorine-like odor. They are used in sterilizing units that include a
which the time, temperature, and/or concentration of the germicide during the sterilization process ar
germicide is toxic and must be eliminated after the sterilization cycle is complete. Chlorine dioxide ge
used to sterilize surgical instruments, reusable supplies, and pharmaceutical products that cannot sup
temperature sterilization (e.g., devices that contain plastic or rubber components); the germicide is us
site and rarely stored as a gas, because it is explosive under pressure.

Liquid germicides, whose main active ingredient is, Ortho-phthalaldehyde that are intended for killing
many microorganisms (e.g., viruses, bacteria, fungi). These liquid germicides are typically used in disi
disinfecting process (typically by immersion) under controlled time, temperature, and concentration is
phthalaldehyde is used mainly to disinfect endoscopes.

Patient bed sheets intended for multiple uses to be placed on the surface of the patient's bed. These p
consist of soft fabrics able to withstand institutional laundering. Reusable patient bed sheets are made
(e.g., cotton and/or polyester); they provide patient comfort and ease of care. They are widely used in
hospitals, nursing homes, and medical offices.
Equipment designed for use in making smooth (e.g., rounded) edges and/or milling out the surface of
plastics, wood, and metal. These routers frequently follow a template. Mechanical routers typically con
benchtop machine with an electric motor, a base, and a revolving vertical spindle and cutting tools (e
may include lights to provide illumination and/or a support for the piece (e.g., a vise clamped to a ben
conformed. Mechanical routers are used mainly in carpentry work (e.g., to make furniture); dedicated
intended for use in dental laboratories and/or to conform bones in orthopedic procedures are also ava

Auditory stimulators designed to apply mechanical (i.e., vibratory) stimuli containing sound informatio
structures. These devices consist of a fully implantable device which includes a processor that obtains
transduces it into electrical signals and, after processing the signal, turns it back into vibrations that a
middle ear ossicles. Two types of vibratory stimulators are available: (1) Stimulators that pick the natu
incus (i.e., without any microphone) resulting from external sound and reintroduce them after process
surgically disarticulating the natural chain of sound transmission in the ossicles; and (2) stimulators th
microphone that is implanted close to the skin to pick up the external sounds and convert them into e
processing the electrical signals they are turned back into vibrations which are delivered to the ossicle
mechanical stimulators are intended for patients suffering from a moderate to severe deafness (typica
loss).

Canes using a single fixed-length shaft designed to provide additional support to the user while walkin
consist of a one-piece straight shaft with handle at the proximal end, and a rubber tip at the distal end
made of sturdy materials such as wood (e.g., walnut), light metals (e.g., aluminum), plastics (e.g., acr
combination of these. Fixed-length canes are mainly designed for use by patients with mobility disabi
support when walking.
Canes using a single fixed-length shaft and offset handle designed to provide additional support and b
while walking. These canes usually consist of a one-piece straight shaft with an offset handle at the pr
rubber tip at the distal end. They are typically made of sturdy materials such as wood (e.g., walnut), li
aluminum), plastics (e.g., acrylics), fiberglass, or a combination of these. Offset-handle fixed-length c
designed for use by patients with mobility disabilities to provide support and aid balance when walkin
with different offset handles (i.e., a crook-style handle featuring a flattened top for ease of grip and p
distribution, a saddle-shaped handle to allow for correct grip requiring minimal finger and hand streng
handle for proper weight distribution.

Crutches supported by forearm platforms that are designed to provide additional support to users with
These crutches usually consist of a shaft that bifurcates partway up from the distal tip and a platform
load to the shoulder girdle. They also include padded troughs upon which the forearms rest; vertical h
straps to be applied around the forearm to keep it in place; and a rubber tip(s) at the distal end that m
are typically made of sturdy materials such as light metals (e.g., aluminum, titanium), plastic (e.g., ru
of these. Platform forearm crutches are intended to be used by individuals with gripping limitations or
weight in the hand, wrist, or forearm thus providing a larger area of contact and more stability than th
crutch.

Crutches mimicking the action of the triceps muscles designed to provide the user with additional sup
These crutches resemble the axillary crutch, but ends proximally at the midarm level. They usually co
bifurcates partway up from the distal tip; they also include additional bands (i.e., for the arm to ensure
remains extended despite upper extremity involvement); an upper cuff to contact the upper third of th
of the underarm; a lower cuff placed below the elbow to avoid making contact with it; and a rubber tip
that meets the floor. Triceps crutches (also known as Warm Springs crutches) were originally designed
currently they are mainly intended for use by patients with upper-extremity deficits.

Angioplasty vascular catheters designed to dilate a stenotic intracranial artery by controlled inflation o
These catheters usually consist of a double-lumen polymeric, hydrophilic covered tube of more than 1
working length with a balloon (e.g., a polymeric balloon available in several diameters) and radiopaqu
tip. Typically the catheter is peripherally inserted and advanced into the section of the artery requiring
balloon is inflated across the stenosis to a predetermined maximal outer diameter, thereby enlarging
artery balloon catheters may be used for enlargement of the lumen of the arteries previous to the del
stent; they may also be used for the treatment of obstructions (i.e., angioplasty) in the intracranial art

Prepackaged collections of devices and supplies designed to deliver stents intended to enlarge the lum
artery diameter. Items in these kits typically include the implantable endoprosthesis (i.e., the stent) m
hydrophilic coated single-lumen over-the-wire coaxial catheter which is tapered at the distal tip and w
Luer fitting at the proximal end. Other products (e.g., saline, alcohol, anesthetics) may be also include
during the stenting procedure. Intracranial artery stent delivery kits are intended to deploy stents inte
term intracranial perfusion.
Physiologic analyzers designed for non-invasive assessment of the main characteristics of the cardiov
the blood circulatory system based on the variations in length of the interval between heartbeats. Ana
variability (HRV) measure the times elapsed between successive heartbeats (usually R-R intervals) ob
plethysmographic signals. Dedicated software is used to determine the HRV and associated abnormal
analysis, frequency domain analysis, or both methods. Heart rate variability analyzers provide informa
cardiovascular system conditions and also on the autonomous nervous system (the system that regul
venous blood circulation) status. Conditions such as the cardiac function status and vascular elasticity
helping in the evaluation of risks for diseases such as arteriosclerosis, ventricular arrhythmia, and sud

Magnetic stimulators designed to apply static low flux density magnetic energy to the pelvis that are i
relief of perimenopause and menopause symptoms. These devices typically consist of a fixed magnet
cover that is attached inside the underwear close to the front of the pelvis. The magnetic field could h
painful menstruation, abdominal cramps, and headaches. The stimulators are usually single-patient re

Monitors designed for continuous measurement and display of the percent saturation of hemoglobin in
taken from a distant location through a point-to-point radio or other appropriate communication link (i
monitors usually determine the relative amount of oxygenated and deoxygenated hemoglobin (O2Hb
by measuring light absorbance changes resulting from arterial blood flow pulsations. These monitors c
electronic unit that is worn by the patient (e.g., placed around the wrist, carried in a pouch) that includ
red and infrared light sources (typically light emitting diodes [LEDs]), photodetectors, sensors typically
and a radio transmitter. The monitor also includes a receiver that is integral or associated to the centr
information is displayed. The monitor may include audible and/or visual alarms that are triggered whe
drops below preset limits. Telemetric pulse oximetry monitors are used for monitoring of adults and/or
non-critical care areas of healthcare facilities; they may be also used for routine evaluations during sh

Patient bed sheets intended for single use to be placed on the surface of patient beds. These patient b
and then discarded. Disposable patient bed sheets are made of nonwoven materials (e.g., tissue, pap
absorbency and strength; they protect against stains and spills and aid in infection control. They are w
healthcare facilities, hospitals, nursing homes.
Surgical drapes designed to provide a bacteria-proof barrier between the unsterile skin of the patient
field. These surgical drapes are mainly used in operating rooms during surgical procedures and are im
They are used to minimize risk of infection or contamination. Patient surgical drapes are usually made
disposable nonwoven materials. Some surgical drapes have cutouts of different shapes and size to ac
surgical field. These drapes can have alligator clips or adhesive to hold them in place. Some are also
patients warm (for comfort or for medical reasons) during long surgical procedures. Laser-resistant, an
loss prevention surgical drapes are also available.
Devices designed for direct coupling of the gantry of a radiographic, imaging, or radiotherapy unit and
used to move and position the gantry and/or the patient table. These units usually consist of a mecha
driving motors to the gantry or table; the mechanism may include integral electronic controls to regul
direction of movement of the gantry. Direct coupling driving units are intended to improve the charact
system (e.g., by permitting faster acceleration/deceleration and increasing the speed of operation). D
for single (i.e., x-axis) or multi-axes movements (i.e., two or three axes, known as XY and XYZ axes, re
speeds and/or resolutions are available. Dedicated units intended for rotatory motion gantries are also

Gantry driving units designed for direct coupling a gantry and/or patient table of a radiographic, imag
unit which is capable of movements only in one axis (i.e., single axis) to the driving motors used to m
devices usually consist of a mechanism that couples the driving motors to the gantry; the mechanism
integral electronic controls to regulate the speed and direction of the movement of the gantry followin
direct coupling driving units are intended to improve the characteristics of the gantry system (e.g., by
acceleration/deceleration and increasing the speed of operation). Dedicated driving units for single-ax
various speeds and/or resolutions are available.

Gantry driving units designed for direct coupling of a gantry and/or table of a radiographic, imaging, o
which is capable of rotatory movements (e.g., around the patient) to the driving motors used to move
devices usually consist of a mechanism that couples the driving motors to the gantry; the mechanism
integral electronic controls to regulate the angular speed and direction of the movement of the gantry
elliptical path. Rotatory direct coupling driving units are intended to improve the characteristics of the
by permitting faster acceleration/deceleration and increasing the speed of operation). Dedicated drivi
movements at various speeds and/or resolutions are available.

Systems designed to allow most or all of the independent computerized networks, information system
devices of a healthcare facility to communicate with each other (i.e., interfacing) by controlling a cont
transmission of data and/or other information between the computerized medical devices and informa
interface systems typically include electronic workstations to process and control the information flow
connections to devices, equipment, and local or whole hospital information systems. These systems fr
and/or are associated with a dedicated connection server. The system also includes appropriate softw
languages and codes that the applications use to communicate with each other, as well as the hardwa
information systems. Data interface systems that interact with medical devices are considered medica
follow the regulations (e.g., FDA, EC) concerning these types of medical devices. Dedicated data inter
intended to provide a link between medical devices and information systems and/or between two or m
systems. Data interface systems may be intended for a particular set of devices and information syste
to permit the modification and/or integration of new devices and systems from different manufacturer
Data interface systems designed to allow medical devices of a healthcare facility to communicate with
the information systems (i.e., interfacing) by controlling a continuous smooth transmission of data and
between the computerized devices and the information systems. These data interface systems typica
workstations at the point of care to process and control the information flow; and wireless and/or cable
devices (e.g., physiologic monitors, ventilators) and the information systems (e.g., hospital data mana
and/or intensive care). The systems frequently include and/or are associated with a dedicated connec
systems are considered medical devices and must follow the regulations (e.g., FDA, EC) concerning th
devices. Data interface systems that link medical devices with information systems also include appro
contains the languages and codes that the applications use to communicate with each other and with
software may include several different algorithms that work according to the characteristics of particu
healthcare facility (e.g., intensive and/or emergency care, surgical areas, patient rooms). Data interfac
intended for a particular set of devices and information systems or flexible enough to permit the modi
integration of new devices and systems from different manufacturers and technologies.

Data interface systems designed to allow information systems of a healthcare facility to communicate
interfacing) by controlling a continuous smooth transmission of data and/or other information between
systems. These interface systems do not interact with medical devices directly. These systems typical
workstations to process and control the information flow; and wireless and/or cable connections amon
information systems (e.g., hospital data management, emergency and/or intensive care, financial, risk
systems frequently include and/or are associated with a dedicated and flexible connection server. Dat
that link information systems also include appropriate software that contains the languages and codes
use to communicate with each other and with the hardware. The software may include several differe
according to the characteristics of the interfaced information systems and/or to particular areas of the
Interface systems may be intended for a particular set of information systems or flexible enough to pe
and/or integration of new information systems from different manufacturers and technologies.

Software designed to manage/operate computerized data interface information units or systems inten
facilities. This software may be intended for a particular set of devices and information systems or flex
integrate the entire network of the healthcare facility, including most or all of the independent inform
devices of the facility; the software is usually associated with a dedicated network server. Data interfa
variety of algorithms to process the data obtained in specific areas or throughout the facility; software
separate component that is matched to the existing network is also available. Data interface software
through the release of modified versions) during the life of the system by releasing updated and/or up
Dedicated software intended only for interfacing medical devices to information systems and for inter
systems to each other are also available.
Peripheral-nerve electrical stimulators that apply periodic low-level stimuli to the vagus nerve with ap
characteristics (e.g., frequency, pulse shape) to block the nerve signals. These stimulators consist of a
typically implanted subcutaneously and lead wires that run to electrodes placed on the anterior and p
trunks of the vagus nerve (just above the junction between the esophagus and the stomach). The stim
external battery-powered controller. Vagus nerve blocking electrical stimulators are mainly intended to
overweight patients by increasing the sensation of full-feeling (i.e., satiety); the stimulators may be al
treatment of other gastrointestinal disorders.

Testers designed to manually and/or automatically verify the performance of equipment (i.e., quality a
radiographic diagnostic rooms. These testers can measure all or most of the parameters of a radiogra
kilovolt (kV), electric current, time, dose, dose rate, half-value layer (HVL), and total filtration; the resu
using dedicated software usually installed in a standard personal computer. The tester typically includ
current (milliampere), light, and low-dose probes. Dedicated radiographic quality assurance testers in
diagnostic radiography, combined radiography/fluoroscopy, mammography, computed tomography, a
are also available.

Equipment designed for automated, computer-aided, manufacturing of corrective (i.e., graduated) pla
from lens blocks. These machines perform the process by taking the prescription data (e.g., using a ba
then: (1) surfacing: shaving layers of plastic from lens blocks appropriate for the requirements of the u
bifocal, progressives) to obtain lenses with the required curvatures and thickness; (2) fining: polishing
lenses (i.e., by turning the lenses when needed) by mechanical means; (3) edging: reducing the lens t
edge finish (E.G., beveled) that fit the chosen eyeglass frames. Some machines can only perform the
procedure and require an additional eyeglass lens edger to finish the procedure, When lens coating is
scratching, reduce reflection) an additional machine is usually needed to finish the manufacturing pro
may use laser-based technologies for eyeglass lens manufacturing.

Surgical trephines designed to cut and remove circular sections of the trachea resulting in accurate siz
the insertion of a tracheostomy tube or tracheal cannula. These trephines are handheld, manual instru
hollow metal cylinder with a serrated circular-saw-like edge and an inner concentric cannula that is at
wall in the desired location, The serrated edge is rotated to make the appropriate circular hole through
and cartilage while the internal cannula is usually connected to a vacuum (suction) tube to aspirate th
tissue. Tracheal fenestration trephines are available in several diameter sizes (e.g., 6, 8, 11mm) to ma
cannula to be inserted, either as individual devices or as sets of several different sizes.

Implants designed to improve the voice quality by altering the position of a paralyzed vocal cord that
through a natural fold of the neck (i.e., a thyroplasty surgery). These implants typically consist of two
rectangular base made of rigid radiopaque plastic (e.g., silicone) material with several pieces intended
implant (i.e., to prevent displacement and/or rotation) and (2) a usually triangular component made o
that pushes the paralyzed vocal cord to the midline (i.e., medialization) allowing the functional vocal c
preventing aspiration when swallowing, and helping to produce an effective cough. Typically the base
different size for males and females; the triangular component is available in several different heights
females. Thyroplasty implants are used to improve quality of vocalization in patients with unilateral vo
Prepackaged collections of the devices and supplies (either custom or standard) needed for performin
through a natural fold of the neck (i.e., a thyroplasty surgery) that are designed to improve the voice q
position of a paralyzed vocal cord. Items in these kits usually include hooks, elevators, implant inserte
and a set of thyroplasty implants of several sizes usually in male and female versions. The kits are fre
supporting trays (i.e., procedure trays) consisting of a flat-bottomed receptacle with a border around t
supporting all the instruments and supplies needed for the procedure; the trays are usually covered o
kits and trays are used for the location of the thyroplasty window, creation of the window, and insertio
additional set of sizers allow to determine the appropriate implant size.

Sizers designed to facilitate the selection of an appropriate size of implant that are used to improve th
altering the position of a paralyzed vocal cord (i.e., a thyroplasty implant). These sizers typically consi
measuring devices that are inserted in the laryngeal surgical window to determine the appropriate siz
placed. Once the appropriate size of the implant is determined the sizer is removed and replaced with
implant. Thyroplasty implant sizers are used in surgical procedures performed in patients with unilate

Prepackaged collections of devices and supplies (either custom or standard) needed to perform perito
procedures. Peritoneal lavage involves washing out the peritoneal cavity by instilling fluid (e.g., norma
Ringer's solution) into the peritoneal cavity and subsequently draining the administered fluid back out
Peritoneal lavage can be performed as a diagnostic procedure, (e.g., for detecting visceral injury follow
penetrating abdominal trauma), as well as a therapeutic procedure (e.g., for the application of cytosta
peritoneum for the treatment of malignancies). Typical kit components include introducer needles, inje
catheters, guide wires, tubing sets, and supplies for obtaining/maintaining sterility (e.g., drapes, disin

Trocars designed to puncture the abdominal wall in order to provide access to the peritoneum and abd
laparoscopic procedures. These instruments typically include a manual, handheld device (i.e., the troc
insertion, and an outer cannula or sheath which becomes a port to allow passage of instruments and i
large variety of trocar designs available but they may be classified in two types: cutting trocars that in
metal or plastic rod with a cutting pyramidal or conical tip, and dilating trocars with a tip that bluntly s
tissue as force is applied; some instruments incorporate elements of both cutting and dilating trocars.
pierce the skin and the abdominal wall (i.e., percutaneously) and then it is usually removed, leaving th
place. Laparoscopic trocars are intended to provide access to the abdominal cavity by permitting the p
diagnostic, therapeutic, and/or surgical procedures. Trocars are used in laparoscopic surgery to provid
introduction of devices such as surgical instruments and video cameras. Both reusable and single-use

Trocars designed to puncture the thoracic wall in order to provide access to the heart and the central c
during minimal-access surgical procedures. These instruments typically consist of a manual handheld
pyramidal or conical pointed rod at the distal end and a handle at the proximal end. Surgical cardiovas
usually fitted into a cannula or sleeve; the trocar is used to pierce the skin and the thoracic cavity wal
and then it is usually removed, leaving the sleeve or cannula in place as a working channel for the int
instruments and other devices during surgery. Minimal-access surgery cardiovascular trocars are used
during the performance of cardiothoracic surgery procedures, such as percutaneous valve implantatio
interventions.
Insufflators designed to deliver a flow of air into the nose for treatment of Eustachian tube dysfunction
typically work by simultaneous delivery of air flow to one nostril while the person compress the other
liquid. The devices may consist of a rubber or polymeric elastic balloon (also known as a Politzer ballo
shaped tips to deliver the pressurized air, and inflatable balloons that are attached to a dedicated mo
The insufflators may also consist of more elaborate devices that provide mechanisms to control the ai
and flow. Eustachian tube dysfunction insufflators are mainly intended for treatment of dysfunctions f
travel and otitis media.

Systems that combine lasers, lamps, and light emitting diode (LEDs) units and are designed to provide
phototherapy treatments. These systems usually consist of: (1) a central unit (console) that includes t
controls, and switches for the operation of the system; (2) several units intended to deliver the indepe
treatments (e.g., lamps, LEDs, and Nd:YAG, Er:YAG Lasers); and (3) dedicated handpieces used to del
particular units to the patient. The combined system is intended for general and plastic surgery and a
dermatologic treatments such as benign vascular lesions, psoriasis, vitiligo, eczema, warts, and scars;
hair and tattoo removal.

Lasers designed to produce pulsed dye and Nd:YAG laser beams combined in one unit that are intende
treatments. The beams produced by the laser with dye as an active medium usually operate at a wav
(yellow) while the radiation from the Nd:YAG laser (yttrium-aluminum-garnet crystal doped with neody
(near-infrared). The combined systems operate sequentially, the application of the laser dye beam pre
provides a qualitative different result in some dermatologic applications and capillary vascular malform
stains).

Lasers designed to produce pulsed alexandrite and dye beams combined in one unit that are intended
treatments. The beams produced by the laser with alexandrite as an active medium usually operates
755 nm (red) while the radiation from the dye laser is typically at 595 nm (yellow). The combined syst
the same dermatologic applications that each of the individual alexandrite and dye lasers are intende
using the laser sources sequentially in the same session or each one in alternative sessions, are partic
treatment of keratotic follicular papules (i.e., keratosis pilaris) and capillary vascular malformations (e
Some systems are also used for cosmetic (plastic surgery) treatments.

Positioning aids designed to provide an appropriate position for the head during radiography and/or ra
procedures. These devices make possible and/or improve the results of radiographic procedures. The
typically consist of a stand-alone or wall-mounted bar with a structure at the distal end that includes r
be placed in the external auditory canal. The structure can be rotated to provide lateral, frontal, and o
head; the aids are usually intended for use with specific models of radiographic equipment. Cephalom
permit an accurate alignment of the x-ray beam and the patient by using the auditory canal as a refer
improving the accuracy and repeatability of cephalograms and/or other radiographic/radiotherapeutic

Anthropometry calipers that externally measure the dimension of the cranium. They are also used to m
structures or deformations of the head. These handheld instruments are frequently sturdy metal or ha
compass-like in shape. They may include two adjustable, frequently curved, hinged legs or jaws. Some
central graduated frame, two sliding flat bars with ball ends for introduction in the ear canal, and an a
scale to facilitate fine adjustment and increase the accuracy of measurement (i.e., vernier calipers). S
are intended to measure head deformation (i.e., plagiocephaly) in infants.
Craniotomy calipers designed for external measurement of the distance from an ear to the eye that is
the face. The normal distance between the chin and the nose (i.e., vertical occlusal dimension) for a g
determined based on the anatomical correlation that has been found to exist between these two cran
handheld instruments are frequently sturdy, metal or hard plastic with an L-shaped frame. They includ
the longer arm and a second L-shaped sliding arm that may include an auxiliary graduated scale to fa
and to increase the accuracy of measurement. The results of the ear-eye distance are mainly used to
distance and determining occlusal vertical dimension in edentulous patients.

Quality controls that are either an integral component or a detachable accessory of in-vitro diagnosis
They are used to assess the electronic components and/or a portion of their analytic characteristics (e
test completion time). These controls may check the device each time a test is performed and provide
external quality control procedures. Electronic quality controls may be used for IVD test devices of me
complexity that are capable of maintaining stable performance specifications over a long period of tim

Stickers or other types of labels, which are attached to and used for identifying various healthcare pro
warnings and reminders in various areas of hospitals and healthcare facilities. Healthcare tags maybe
and able to be written on by healthcare employees. These tags can be opaque or translucent and are
adhesive paper or plastic so that the backing can be peeled off and the tag can be affixed to the relev

Stickers or other types of labels, which are attached to and used for identifying various clinical sample
and pharmacological products. Clinical sample tags maybe pre-printed or blank and able to be written
employees. These tags can be opaque or translucent and are usually made with an adhesive paper or
backing can be peeled off and the tag can be affixed to the relevant healthcare product or sample.

Equipment designed to collect (i.e., remove) dust and other debris from the environment created whil
procedures that produce a high concentration of air particles. These collectors typically consist of a st
includes filters that entrap particles one micron or less in diameter. A low-noise motor then provides s
air or a connection to a vacuum source, a collection canister, and appropriate controls. Dedicated dus
available for particular procedures, including bone and related products cutting (e.g., orthopedic surge
autopsies) and also for dental laboratories. Some dust collectors are integral part of medical equipme
dental trimmers).

Equipment designed to manufacture thermoplastic products in a pre-established shape. There are sev
techniques used to obtain thermoplastic products, including: (1) pressure extrusion machines consisti
barrel and screw assembly that melts the polymer (e.g., polyvinyl chloride); the molten polymer is led
emerge as a hollow pipe section called a parison. A mold is wrapped around the parison, closing its bo
seal; then the parison is cut at the top and air is blown into the parison to inflate it until reaching the s
After cooling, the mold is opened and the final product is ejected; (2) injection molding machines cons
barrel including a reciprocating screw driven by a motor that feeds molten polymer (e.g., nylon, polyp
temperature-controlled split mold conformed in the shape of the final product; the product is ejected f
process is finished; (3) vacuum molding units consisting of a machine that heats plastic (e.g., polystyr
sheets until soft and then applies vacuum to suck the sheet into a mold; after the sheet takes the sha
it is ejected. Vacuum molding is a process that requires less pressure than other techniques. All machi
pneumatic, and/or hydraulic controls.
Bowls designed to hold guide wires in an appropriate position and facilitate easy removal during the p
devices typically consist of plastic material bowls with integral lips and recessed bottoms that hold th
wire bowls are usually available as sterile disposable devices that are supplied in individually package
frequently as components of angiography procedure kits.

Computer-aided detection system software designed for systems used to analyze images performed d
colonoscopy (i.e., CT or MRI colonography) and to control/monitor a limited number of their functions.
intended to work only with one or a few models of computer-aided detection systems, usually from th
The software performs a variety of algorithms to facilitate the analysis of the images with abnormalitie
may be indicative of colon cancer and the sending/receiving patient information from and to the local
The software is usually not available separate from the computer-aided system but may be updated (i
of modified versions) during the life of the system. Virtual colonoscopy computer-aided detection syst
the analysis of images intended for screening of malignant conditions of the colon, aid in the follow-up
help to determine cancer recurrence.

Enclosures that are completely sealed off from the rest of a facility's environment and in which the con
particles is controlled to specific limits but the room is not considered sterile. Clean rooms typically co
metallic room-like structure that includes pre-filters to eliminate gross contamination. They also conta
efficiency particulate air (HEPA) filters or ultra-low penetration air (ULPA) filters to provide a filtered air
enclosure and controls for the humidity, temperature, and air velocity. Clean rooms typically include in
(frequently with air showers) in the walls that permit the passage of materials, objects, and/or personn
are mobile for field or emergency applications Clean rooms are usually classified according to the clea
provide inside the room (i.e., cleanliness classes); typically the classification is established according t
particles bigger than a given size (e.g., 0.5 micron) per cubic foot in classes 1, 10, and up 100,000/ISO
The air flow inside a clean room may be laminar, partially laminar, or turbulent according to the desig
of the clean room. Clean rooms are used in healthcare facilities (e.g., clinical pharmacies, surgery room
rooms) and in field applications; dedicated clean rooms providing laminar air flow are also available fo
laboratories, biotechnology work, and operating rooms.

Magnetic stimulators designed to apply static low flux density magnetic energy to a local area of the b
to alleviate pain. These devices typically consist of a permanent magnet enclosed in a plastic or fabric
directly to the intended body area or placed inside the underwear close to the painful area. The magn
help in the reduction of local pain in different areas of the body such as the back, shoulder, and neck t
traumas and/or a variety of diseases (e.g., arthritis).

Hooks designed to temporarily secure tissues or organs by catching and/or pulling them during dissec
to perform other surgical procedures with minimal trauma. Surgical hooks are handheld manual instru
bent near the distal end (usually at angles from 135 to 180 degrees) and a blunt or sharp tip; these ho
handle at the proximal end. Some surgical hooks (also known as forks) include two or more prongs at
Dedicated hooks intended for use in specific types of surgical procedures (e.g., ophthalmology, middle
surgeries) are also available.
Surgical hooks designed to temporarily secure bones by catching and/or pulling them during dissectio
perform other surgical procedures with minimal trauma. These surgical hooks are handheld manual st
instruments with either curved or sharply bent working ends (usually at angles from 135 to 180 degre
tips. Surgical bone hooks typically include a gripped T-handle at the proximal end. They are available
according to the type of surgery. Surgical bone hooks are used for conducting orthopedic surgeries an

Surgical hooks designed to temporarily secure the dura mater by catching and/or pulling it during diss
and/or to perform other surgical procedures with minimal trauma. These surgical hooks are handheld
instruments with either curved or sharply bent working ends (usually at angles from 135 to 180 degre
sharp tips; the hooks typically include a handle at the proximal end. Dura mater surgical hooks are us
tools. They are typically maneuvered via a micromanipulator. Dura mater surgical hooks are used duri
procedures to cause minimal damage to the meninges.

Surgical hooks designed to temporarily secure eye tissue by catching and/or pulling it during dissectio
perform other surgical procedures with minimal trauma. These surgical hooks typically consist of hand
steel instruments either curved or sharply bent at the working end (usually at angles from 135 to 180
typically include a slender handle at the proximal end. Standard or custom surgical eye hooks are ava
They are usually provided with a smooth finish, durability and flexibility. Dedicated eye tendon, strabis
hooks are also available. Eye surgical hooks are used during ocular surgical procedures.

Eye surgical hooks designed to temporarily secure eye lenses by catching and/or pulling them during
and/or to perform other surgical procedures with minimal trauma. These eye surgical hooks are handh
instruments with either curved or sharply bent working ends (usually at angles from 135 to 180 degre
include a slender handle at the proximal end. Eye lens surgical hooks with blunt, straight or angled tip
They are usually provided with a smooth finish, durability and flexibility. Eye lens surgical hooks are us
surgical procedures (e.g., iris retraction procedures, intraocular lens manipulators procedures).

Eye surgical hooks designed to temporarily secure eye tissue by catching and/or pulling it during disse
to perform other microsurgical procedures with minimal trauma. These eye surgical hooks are handhe
steel instruments and usually have a 45-degree curved blunt tip at the working end; the hooks typical
handle at the proximal end. Eye microsurgery hooks can be constructed with titanium which provides
material that does not corrode and is not magnetic. Eye microsurgery hooks are used during microsur
selective trabeculectomy in the surgical treatment of glaucoma).

Eye surgical hooks designed to temporarily secure the tendons of the eye during dissection, excision,
other surgical procedures with minimal trauma. These eye surgical hooks typically consist of handheld
instruments either curved or sharply bent at a 90 degrees angle at the working end and finished in a b
typically include a slender handle at the proximal end. They are passed beneath the eye tendons to se
tendon hooks are used during ocular surgical procedures.
Devices designed to reduce pressure on a bariatric patient's abdomen created by his/her own anterior
weight during surgical procedures. These units typically consist of a set (e.g., four) of suction cups tha
frame located above the patient's abdomen and a vacuum pump that is connected through tubes to e
necessary suction. Intraoperative abdominal wall suction cup units are intended to facilitate patient br
oxygenation during surgical procedures (e.g., cardiac catheterization, pacemaker implantation) that m
without mechanical ventilation.

Surgical hooks designed to temporarily secure tissues in the middle ear region by catching and/or pull
dissection, excision, and/or to perform other otological surgical procedures with minimal trauma. Thes
typically consist of handheld manual stainless steel or plastic instruments either curved or sharply ben
(usually at angles of 45 or 90 degrees). Middle-ear surgical hooks are usually finished with a ball tip. F
oval window hooks are available. Middle-ear hooks are commonly used during otological surgical proc
also be used for dislodging difficult to remove cerumen.

Middle-ear surgical hooks designed to temporarily secure the flat portion of the stapes (i.e. foot plate)
pulling it during dissection, excision, and/or to perform other otological surgical procedures with minim
middle-ear surgical hooks typically consist of handheld manual stainless steel instruments offering a n
bacterial feature which provides greater durability. Foot-plate hooks are usually supplied with a shank
end (usually at angles from 135 to 180 degrees) and finished with a ball tip; the hooks typically includ
and an angled shaft at the proximal end for better handling; they are available in different sizes. Foot
commonly used during otological surgical procedures.

Middle-ear hooks designed to temporarily secure tissues in the middle-ear region by catching and/or p
dissection, excision, and/or to perform other otological microsurgical procedures with minimal trauma
surgical hooks typically consist of small and fine handheld stainless steel manual instruments with a s
distal end (usually at angles of 45 degrees) and finished in a blunt tip. Microsurgery middle-ear hooks
handle at the proximal end. They are used in otological microsurgical procedures (e.g., tympanoplasty
if present, for the dissection and release of fibrous adhesions).

Middle-ear surgical hooks designed to temporarily secure the oval window by catching and/or pulling i
excision, and/or to perform other otological surgical procedures with minimal trauma. These middle-ea
typically consist of handheld manual malleable instruments with a shank bent near the distal end (usu
degrees) and finished in a blunt or sharp tip; the hooks typically include a handle at the proximal end.
with different shafts (e.g., fine, medium) are available. They are used during otological surgical proced
the oval window during revision stapes surgery and tympanoplasty surgery).

Middle-ear surgical hooks designed to temporarily secure the stapes by catching and/or pulling it duri
and/or to perform other otological surgical procedures with minimal trauma. These middle-ear surgica
consist of handheld manual stainless steel instruments with a shank bent near the distal end (usually
180 degrees) and finished in a small blunt or sharp tip. Stapes hooks typically include an angled and m
proximal end. They are used during otological surgical procedures (e.g., stapedectomy surgery, remov
by lifting plaque from stapes in anterior direction).
Surgical hooks designed to temporarily secure nasal tissues by catching and/or pulling them during di
and/or to perform other surgical procedures with minimal trauma. These surgical hooks typically consi
stainless steel instruments with a shank bent near the distal end (usually at angles from 135 to 180 d
a blunt or sharp tip; the hooks typically include a handle at the proximal end. Nasal surgical hooks usu
prongs at the distal tip; they are provided with a proper smooth finish, durability and flexibility. Micros
rhinoplasty hooks are also available. Nasal hooks are used during surgical and outpatient procedures t
bodies from the nose.

Nasal surgical hooks designed to temporarily secure nasal tissues by catching and/or pulling them dur
excision, and/or to perform other microsurgical procedures with minimal trauma. These nasal surgical
of small handheld manual stainless steel instruments with a shank bent near the distal end (usually a
and finished in a ball tip; the hooks typically include a handle at the proximal end. They are used durin
(e.g., plastic surgery).

Nasal surgical hooks designed to temporarily secure nasal tissues by catching and/or pulling them dur
nasal polyp with minimal trauma. These nasal surgical hooks typically consist of handheld manual sta
instruments with a shank shallow bent near the distal end (usually at angles from 135 to 180 degrees
blunt or sharp tip; the hooks typically include a handle at the proximal end. Nasal polyp hooks usually
forward to allow inspection of the mass; they are provided with a proper smooth finish, durability and
hooks are used during medical procedures (e.g., to examine the palate in search of evidence of polyps

Surgical hooks designed to temporarily secure nerves/ganglions during surgical procedures by catchin
during dissection, excision, and/or to perform other procedures with minimal trauma. These surgical h
of handheld manual stainless steel instruments with a shank bent near the distal end (usually at angle
finished in a blunt or sharp tip; hooks typically include a handle at the proximal end. Nerve/ganglion s
ball or probe tip at the working end and a shaft angled either to the right, left, or straight are also ava
used in surgical procedures (e.g., minimally invasive surgeries to gently move a nerve while working i

Apheresis units designed to automate the separation and collection of red blood cells (RBC) from a he
Typically, RBCs (i.e., erythrocytes) are collected and the rest of the blood with additional volume repla
solution) is automatically reinfused; with the use of automated methods, large quantities of RBCs (e.g
obtained from a single donor. Blood donor RBC apheresis units usually consist of a disposable pheresis
that connects the patient to the apheresis unit), pumps (e.g., rotary peristaltic pumps), a centrifugatio
filters, clamps, controls (e.g., centrifuge and pump speed, volume of solution added), alarms, and bub
apheresis separates red cells and plasma while blood is being drawn rather than blood donations whe
are separated later in the process. Some units are portable and appropriate for use in the field.
Therapeutic apheresis units primarily designed to automate the removal and replacement (i.e., excha
platelets from the blood of a patient. Typically, plasma is collected, abnormal blood cells (e.g., sickle c
constituents (e.g., antibodies, toxins) are extracted, and the rest of the blood (with the addition of rep
automatically reinfused. The units may also reduce (deplete) platelets in the blood prior to reinfusion.
usually consist of a disposable pheresis set (i.e., a tubing set that connects the patient to the apheres
rotary peristaltic pumps); a centrifugation chamber or membrane filtration unit; centrifugation bowls;
(e.g., centrifuge and pump speed, volume of solution added); alarms; and bubble detectors. Platelet/p
are used to extract abnormal blood cells and plasma constituents' mainly in patients with autoimmune
Guillain-Barre and Goodpasture's syndromes, Waldenstrom's macroglobulinemia, Myasthenia gravis, a
leukemia; they are also used to deplete platelets in patients with essential thrombocytosis. Most of th
also to perform plasmapheresis and plateletpheresis on healthy blood donors.

Apheresis units designed to automate the removal of white blood cells (WBC) from the blood of a patie
collected, and the excess of WBC (i.e., leukocytes) is depleted prior to reinfusion of the rest of the bloo
units usually consist of a disposable pheresis set (i.e., a tubing set that connects the patient to the ap
(e.g., rotary peristaltic pumps); a centrifugation chamber or membrane filtration unit; centrifugation b
cartridges capable of removing specific target cells such as leukocyte and granulocyte in excess; filter
(e.g., centrifuge and pump speed, volume of solution added); alarms; and bubble detectors. Therapeu
units are used mainly to deplete WBCs such as granulocytes, monocytes, and lymphocytes from the b
affected by leukemia. This reduces the amount of white blood cells and may help prevent the excess w
blocking blood flow. Leukapheresis units may be also used in the treatment of inflammatory bowel dis

Apheresis units primarily designed to automate the removal of hematopoietic stem cells (HSC), from t
a patient, close relative, or other appropriate donor. Typically, peripheral blood is collected and mono
cells and peripheral blood stem cells are harvested in a blood cell separator and transferred to a colle
other blood components (plasma, red blood cells, platelets) are returned to the patient. These aphere
of a disposable pheresis set (i.e., a tubing set that connects the patient to the apheresis unit); pumps
pumps); a centrifugation chamber or membrane filtration unit; centrifugation bowls; dedicated cartrid
controls (e.g., centrifuge and pump speed, volume of solution added); alarms; and bubble detectors. O
harvests are usually sufficient to obtain enough cells from normal allogeneic donors, but in autologous
may have to undergo three, four, or more daily apheresis procedures; the collected cells can be used
transplantation usually after chemotherapy procedures.

Collection bags designed for capturing feces. These bags are usually plastic or elastomeric single-use
of feces collection bags are available, including bags intended for feces sample collection from natura
for attachment to patients after a surgical colostomy; or that can be fixed to a rectal or colon indwellin
catheterization kit intended for management of incontinence. Feces collection bags may include drain
other containers or for disposal of feces into the toilet.
Rectal catheters designed to be temporarily placed in the rectum during a relatively long term (e.g., s
weeks). These devices typically consist of a multilumen, usually plastic catheter, whose distal tip may
balloon. The catheter usually includes radiopaque markers, a stopcock, a retention cuff, and a connec
to make possible the attachment of irrigation pumps and a fecal collection bag. Indwelling rectal cathe
to allow feces drain to the external bag; they are mainly used as a component of a kit intended for the
incontinence but may be also used for irrigation, administration of medications, and for delivery/withd
from the distal balloon.

Prepackaged collections (either custom or standard) of the necessary devices and supplies needed for
into the rectum through the anal sphincter for collection of the patient's feces. Items included in these
a rectal catheter and supplies needed for catheter insertion and use (e.g., lubricant jelly), a syringe, a
bag. The kits may also include materials for prepping the patient, such as a sterile drape, germicides,
cotton/rayon balls. The kits may be supplied in supporting trays (i.e., procedure trays) consisting of a
with a border around the periphery supporting all the instruments and supplies needed for the proced
usually covered by a sterile wrap. Fecal catheterization/collection kits and trays are intended for the m
incontinence but may be also used for irrigation, administration of medications, and for delivery/withd
from the distal balloon.

Rectal surgical hooks designed to temporarily secure rectal tissues by catching and/or pulling them du
excision, and/or to perform other examination procedures with minimal trauma. These rectal surgical
of handheld manual stainless steel instruments with a shank bent near the distal end (usually at angle
and finished in a blunt tip; the hooks typically include a handle at the proximal end. Rectal fistula hook
ended and barbed are also available. They are usually used during diagnostic examinations of the ana

Surgical hooks designed to temporarily secure tissues of the spermatic cord by catching and/or pulling
dissection, excision, and/or to perform other surgical procedures with minimal trauma. These surgical
of handheld manual stainless steel instruments slightly curved at the working end (usually at angles f
degrees); the hooks typically include a handle at the proximal end. Spermatic cord hooks are usually fi
They are commonly used during surgical procedures by urologists (e.g., microsurgical varicocelectomy

Surgical hooks designed to temporarily secure the spinal cord by catching and/or pulling it during diss
to perform other surgical procedures with minimal trauma. These surgical hooks typically consist of ha
stainless steel instruments with a shank bent near the distal end (usually at angles of 45 or 90 degree
blunt or sharp tip; the hooks typically include a handle at the proximal end. Spinal cord hooks can be s
and are usually sized to isolate the spinal cord from the dura mater, so the cord can be cut with minim
mater. They are commonly used during surgical procedures involving spinal cord injuries.

Surgical hooks designed to temporarily secure tendons by catching and/or pulling them during dissect
perform other surgical procedures with minimal trauma. These surgical hooks are usually handheld m
instruments and are either slightly curved or have a 90-degree angle at the working end and a blunt o
typically include a handle at the proximal end. Tendon surgical hooks usually have a probe tip and hav
durability and flexibility. Wide tendon hooks with four prongs are also available. They are used during
such as tenotomy.
Surgical hooks designed to temporarily secure the tonsils by catching and/or pulling them during disse
to perform other surgical procedures with minimal trauma. These surgical hooks typically consist of ha
stainless steel instruments with a shank bent near the distal end (usually at angles from 135 to 180 d
a sharp or blunt tip; the hooks typically include a handle at the proximal end. Tonsil surgical hooks are
sized instruments that include two prongs at the distal tip. They are used during surgical procedures (
bring the tonsil forward for excision and to remove caseous plugs).

Devices designed to establish dedicated paths from a computer to other computers and/or peripheral
keyboards, video displays, and mice. Also known as KVM switches, these devices provide communicat
them and may consist of simple mechanical, multi-pole switches that use rotatory knobs to perform sw
have electronic, computerized switches which use dedicated software. The characteristics of the switc
compatible with the operative systems of the computers/peripherals under control, including appropri
and video bandwidth) and mechanical (e.g., type of connectors and pin disposition) characteristics. T
switches, according to the characteristics of the devices to be connected (e.g., cable, wireless) and/or
they work (e.g., home, small facilities, big companies, or governmental use). Some switches are dedic
switching of several heads per computer which are intended for high-definition video broadcasting an

Tonsil surgical hooks designed to temporarily seize, pull, or exert traction on sutures during dissection
perform other surgical procedures with minimal trauma. These tonsil surgical hooks typically consist o
stainless steel instruments with a shank bent near the distal end (usually at angles from 135 to 180 d
a blunt or sharp tip; the hooks typically include a sure-grip handle for improved control at the proxima
hooks either straight or curved to the right or to the left are also available. They are used to grasp the
pull it away during surgical procedures such as tonsillectomy.

Surgical hooks designed to temporarily secure fibroids in the uterus by catching and/or pulling them d
excision, and/or to perform other surgical procedures with minimal trauma. Surgical hooks typically co
manual instruments with a shank bent near the distal end (usually at angles from 135 to 180 degrees
blunt or sharp tip; the hooks typically include a handle at the proximal end. Stainless steel or plastic fi
available. Fibroid uterine hooks are used during medical procedures (e.g., to perform simple obstetric
manipulative functions such as incising the muscular wall of the uterus).

Surgical hooks designed to temporarily secure vasa deferentia tissues by catching and/or pulling them
excision, and/or to perform other surgical procedures with minimal trauma. These surgical hooks typic
handheld manual stainless steel instruments that are straight at the working end and finished in a blu
hooks typically include a handle at the proximal end. Vasectomy surgical hooks are usually small and
penetrate the skin of the scrotum and pull out the vas deferens so that the surgeon can sever them. T
surgical procedures for male sterilization and/or permanent birth control (i.e. vasectomy).

Surgical hooks designed to temporarily secure vessels by catching and/or pulling them during dissecti
perform other surgical procedures with minimal trauma. These surgical hooks typically consist of hand
instruments with a shank bent near the distal end (usually at angles of 90 degrees) and finished in a b
usually include a handle at the proximal end. Vessel surgical hooks in different sizes are available. The
during surgical procedures (e.g., for fixation and exploration during blood-vessel surgery).
Hooks designed to temporarily secure tissues or organs by catching and/or pulling them during dissec
to perform other postmortem procedures. These hooks typically consist of sturdy handheld manual sta
instruments with a shank slightly bent near the distal end (usually at angles from 135 to 180 degrees)
or sharp tip. Postmortem hooks are usually supplied with a hammer at the other end of the hook. They
postmortem procedures (e.g., for bone cutting).

Hooks designed to temporarily secure tissues or organs by catching and/or pulling them during biopsy
minimal trauma. These hooks typically consist of handheld metallic (e.g., titanium) or other hard mate
shank bent near the distal end (usually at angles from 135 to 180 degrees) and finished in a blunt or s
typically include a handle at the proximal end. Biopsy hooks are designed to be easily visible under m
ultrasound, and MRI guidance; they also have dual anchoring technology to reduce the risk of migratio
used during biopsy procedures (e.g., to help obtain multiple core samples from soft tissue such as live
abdominal masses) in healthcare facilities.

Solid compounds of varying weight, shape, and size often made from plant materials, which do not co
act metabolically. These tablets (also known as pills) are inserted in specific cavities of the body (e.g.,
have a local effect; the tablets are not intended for swallowing. Topical tablets can be used to alleviate
(i.e., pH), and/or for lubrication or itch reduction.
Mirrors designed for use as a hand-held instrument. These mirrors typically consist of a small glass or
surface is sufficiently polished to reflect an image of an object placed in front of it; the mirror usually i
hard or flexible shaft, and a handle. Some hand-held mirrors come with an additional finger loop on th
holding and manipulating the mirror. Mirrors may be supplied as square or oval double-sided, break-re
Dedicated hand-held mirrors are available for examination, therapeutic, and/or surgical purposes in a
specialties including but not limited to dental, middle ear, larynx/pharynx, and nasal procedures.

Hand-held mirrors designed for operation inside the mouth as a dental instrument. These mirrors typic
lightweight glass instrument that is compact and easy to manipulate and whose surface is sufficiently
image of a dental structure located in front of them and a metal (e.g., stainless steel) shaft that suppo
also used as a handle. Some dental mirrors can only capture half of each dental arch while others can
the mouth. Hand-held dental mirrors are used in dental offices, permitting the dentist indirect vision o
reflect light onto desired surfaces, and to retract soft tissues.

Hand-held mirrors designed for visualization of the nasal cavity. These mirrors typically consist of a sm
glass device whose surface is sufficiently polished to reflect an image of the proximal sections of the n
mirrors are compact and easy to manipulate, and have a very thin metal (e.g., stainless steel) shaft th
and is also used as a handle. Nasal hand-held mirrors are available in a variety of diameter sizes; the
permanently attached to the mirror or detachable, permitting the use of several different handles (e.g
shaped) with a given mirror. Nasal mirrors are used for examination and some other nasal procedures
foreign objects, excision of tissue).
Cabinets designed to store, display, and provide ready access to small equipment, garment, and prod
rooms, keeping the same or better conditions that the clean room provides. Clean room cabinets usua
efficiency particulate air (HEPA) filters and a blower that may provide laminar air flow in the interior of
cabinets are usually made of a combination of metal (e.g., stainless steel) and transparent doors mad
acrylic, transparent PVC) or, less frequently, glass, to permit ease of cleaning and sterilization. They m
drawers, shelves, or a drawer/shelf combination; they are available in multiple configurations (e.g., sta
mounted) and usually include sliding or self-closing hinged doors; some also include security locks. De
cabinets intended for garment, supplies, and other small devices or instruments are also available.

Clean room cabinets designed to store, display, and provide ready access to garments used in clean r
same or better conditions than the clean room provides. Garment clean room cabinets usually include
particulate air (HEPA) filters and a blower that may provide laminar air flow in the interior of the cabin
usually made of a combination of metal (e.g., stainless steel) and transparent doors made of plastic (e
transparent PVC) or, less frequently, glass, to permit ease of cleaning and sterilization. They may inclu
hang the garment and/or shelves for folded cloth and/or boots, gloves, head caps; they are available i
configurations (e.g., stand-alone, wall-mounted) and usually include sliding or self-closing hinged door
security locks.

Phototherapy units designed for in-vivo blood irradiation of blood with red and/or near infrared light. T
consist of a light source with attached dedicated probes to apply the light. The devices may provide li
spectrum (from 620 to 750nm) or near-IR spectrum (from 700 to 1,400 nm) typically using light emitti
light sources and/or laser devices (e.g., diode, Nd:YAG, Er:YAG) as coherent light sources. The light app
the nose nostrils, transcutaneous (e.g., on the wrist) or intravenous typically using a dedicated cathet
phototherapy is mainly intended to reduce blood viscosity and improve blood flow.

Stationary modular medical facilities that include appropriate installations to perform a variety of exer
procedures (e.g., orthopedic traction) during physical therapy and/or rehabilitation treatments. These
assembled as a large volume chamber or cage that includes appropriate devices (e.g., pulleys, weight
perform a variety of traction procedures (e.g. limbs and spine), heat and cold therapies, and both pass
exercises. The modular facilities usually need external connections to the main hospital systems for el
and other services such as compressed air. Physical therapy and rehabilitation medical facilities are us
capabilities to hospitals, rehabilitation centers, and other healthcare institutions for inpatient and outp

Modules designed to be used as a component of a physiologic monitor or other monitoring system, to


process information related to the state of the central nervous system (i.e., level-of-consciousness) ba
entropy values during general anesthesia procedures. Entropy values are calculated as state entropy
entropy (RE). The values of SE and RE are respectively based on: (1) continuously monitoring electric
the brain and the associated electroencephalogram (EEG) and (2) frontal electromyographic (FEMG) s
frontal facial muscles. These modules contain electronic circuits or other technology designed to acqu
signal from one or more physiologic sensors (e.g., electrodes) and transmit it to the physiologic monit
software with appropriate algorithms to calculate the entropy values of the signals. Level of conscious
mostly intended to help in the evaluation of the brain state changes (e.g., depth of anesthesia) in resp
during surgery; their use may reduce the quantity of anesthetic agents required and accelerate the re
the post anesthesia care units.
Physiologic monitoring software designed to operate level-of-consciousness neurology monitors or mo
control/monitor a limited number of their functions, and/or process data obtained while monitoring ba
entropy values during general anesthesia procedures. The software performs a variety of algorithms t
operation and analysis of the signal entropy while monitoring neurologic parameters. Entropy values a
entropy (SE) and response entropy (RE). The values of SE and RE are respectively based on: (1) contin
electrical signals generated by the brain and the associated electroencephalogram (EEG) and (2) fron
(FEMG) signals taken from the frontal facial muscles. _x000D_
Entropy level-of-consciousness software is not usually available separate from the monitor but may be
the release of modified versions) during the life of the equipment; the software is mainly used for intra
during general surgery procedures.

Testers designed to verify the image quality of endoscopes. These testers typically consist of a measu
assessing the optical and mechanical characteristics of rigid and/or flexible endoscopes. These testers
appropriate attachments for testing endoscopes that include fiberoptic cables and/or video systems.
endoscope testers can usually assess the field of view, direction of view, and image sharpness of the e
also determine other values of the image quality of an endoscope, such as the apparent field of view,
transmission, and fiberoptic illumination brightness and distribution. Image quality endoscope testers
status of new endoscopes, during preventive maintenance procedures, and before and after endoscop

Tissue-ablation microwave therapy systems designed for external ablation of regions in the underarm
glands are located to lessen local sweat. These systems typically consist of a central unit with a micro
handpiece to deliver the microwave energy that includes antennas and a detachable usually disposab
energy, a control to regulate the quantity of energy applied, and additional cooling means for thermal
The system may also include a software to guide the performance of the procedure and the applicatio
stabilization. Sweat gland ablation (i.e., thermolysis) are used to treat patients with axillary hyperhidro

Computer-aided detection systems designed to detect and classify areas of skin images with atypical
color, morphology) that may be indicative of melanoma. These systems consist of: (1) conventional im
including a handheld detector, light sources, a computerized unit with algorithms to assess the image
display; or (2) systems that use several visible and near-infrared light sources which allow the capture
lesion using multiple wavelengths of light (i.e., working as a dermoscope). Then the software computa
generates a binary outcome indicating whether or not the assayed lesion image is probably a melanom
computer-aided detection systems are mainly used as an additional source to corroborate the need of
diagnosis of melanoma.

Exploratory dental probes designed for introduction into the gingiva that are mainly intended to deter
of gingival tissue and to find the presence, depth, and form of periodontal pockets and sulcus. These p
of a slender, flexible, metal, elongated, tapered shank with a working end at about a 45-degree angle
proximal handle. The tapered tip usually include gradations at about one mm separations. There are
of periodontal probes. A more slender variant of the probes with longer tips known as furcation probe
is involvement of the bone attached to multi-rooted teeth (i.e., the furcation area).
Simulators designed for training clinicians in the use of ultrasound images and surgical instruments ne
needle thyroid biopsy procedures. These simulators typically include anatomical models made of mate
human soft tissues. The models simulate the characteristics of the left and right lobes and the isthmu
as well as the surrounding anatomic structures such as the trachea, esophagus, carotid arteries, and j
anatomic model also includes masses that simulate a variety of sonographic appearances (e.g., hypoe

Blankets designed with inserted objects that locally increase the weight to stimulate the sensory syste
improve sleep and to help calm anxiety and stress. These devices usually consist of soft, flat blankets
(typically balls or pellets) made of hard plastics and/or polystyrene, depending on the degree of stimu
blankets are available in a variety of sizes according to the anatomy of the user (e.g., infants, children
blankets are mainly used to facilitate sleeping conditions in patients (especially children) suffering fro
deficit/hyperactivity disorder (ADHD); the blankets may be also used to alleviate chronic pain, and/or
other neurologic or psychiatric conditions.

Capsules designed for clamping onto the esophageal wall tissue to obtain data of pH values in the eso
capsules usually consist of a pH sensor (e.g., antimony electrode) and a telemetry (i.e., wireless) trans
pH data to a receiver worn by the patient. The data are recorded during a period of hours or a few day
includes dedicated software that permits recording and further viewing and analyzing the data at the
capsules are used by ambulatory patients for esophageal pH measurement and recording; they facilita
to patient symptoms of gastro-esophageal reflux disease. These capsules are especially suited for pat
tolerate nasal intubation; the capsules spontaneously detach and pass through the digestive system a
finished. Esophageal recording pH capsules may be supplied with accessories to facilitate calibration o
values).

Immunoassay reagents intended to perform quantitative analyses of body fluids (typically plasma or s
the level of the lipoprotein-associated enzyme phospholipase A2 (Lp-PLA2). These tests are usually ba
ELISA tests that use specific antibodies to identify the level of (Lp-PLA2). They may be used as an aid
inflammation and the risk for coronary heart disease and ischemic stroke associated with atherosclero

Physiologic recording software designed for processing of esophageal pH data recorded at a previous
usually intended to work with a limited number of pH recorder models, typically from the same manuf
may perform a variety of algorithms to facilitate the analysis of measurements performed during pH r
correlation to gastroesophageal reflux events and/or to interpret other study results. It may also be us
receive patient information from and to hospital information systems. Software of esophageal pH store
intended for processing the data using a standard computer (e.g., a personal computer) or, less frequ
processor.
Prepackaged collections (either custom or standard) of devices, instruments, and supplies necessary t
access spinal surgery procedures such as the injection of bone cement into a fractured vertebra (i.e.,
variation known as kyphoplasty). Items in these kits usually include surgical instruments and devices
balloons (also known as bone tamps), cement delivery and intraosseous biopsy needles, percutaneou
balloon inflation syringes appropriate to the particular surgical procedure and/or technique. The kits a
such as orthopedic cement and anesthetics. These kits may be supplied in supporting trays (i.e., proc
of a metal or plastic flat-bottom receptacle with a border around the periphery supporting all the instr
needed for the procedure. The trays are usually covered by a sterile wrap. Kyphoplasty/vertebroplasty
trays are intended for spinal minimally access surgery used in the treatment of vertebral compression

Bone tamps designed as inflatable balloons intended to perform dilatation of vertebral bone cavities d
procedures. These devices typically consist of flexible balloons with radiopaque markers that are inflat
after appropriate positioned positioning inside the vertebra using a small-diameter hollow cannula att
Both the balloon and the cannulae are available in several sizes. Vertebral cavity expansion balloons a
kyphoplasty procedures to expand the vertebral cavities prior to filling with orthopedic cement; the pr
the treatment of vertebral compression fractures.

Instruments designed to permit percutaneous access to the spine, facilitating the introduction of devic
inside the spinal vertebrae during surgical procedures. These instruments consist of devices that com
cannulae, and needles; they may also include drill tips at the distal end to facilitate the creation of tun
Spinal surgery percutaneous introducers are intended for use in minimum invasive surgery of the spin
such as vertebroplasty and kyphoplasty.

Orthopedic cement dispensers designed for controlled delivery of cement into the spinal vertebrae du
surgical procedures. These dispensers typically consist of a hollow tube, cannula, or needle that includ
(e.g., a valve) incorporated in the proximal knob intended to control the flow of orthopedic cement in
vertebra. Spinal surgery orthopedic cement dispensers are used in minimally invasive surgical proced
vertebroplasty and kyphoplasty.

Compressed gas proportioners designed to mix compressed nitrous oxide (N2O) and oxygen (O2) to a
concentrations adjustable up to 70 percent at either high- or low-output flows. Typically, the device re
and oxygen from the hospital gas pipeline or from compressed gas sources. These proportioners are u
pressure-regulating mechanism; connectors for the primary gas sources and the delivery of the blend
that signals if the oxygen content is below 25 percent. The mixed gas output can be delivered to patie
ranging from 3 L/min to more than 30 L/min. N2O/O2 proportioners are frequently used in combination
tubing, and masks for administration of analgesia in oral surgery, dentistry, obstetrics, and other clinic
Compressed gas proportioners designed to mix oxygen (O2) with compressed heliox, a mixture of heli
(O2), in helium/oxygen proportions of 80/20, 70/30, or less frequently, 60/40. These proportioners con
with inputs from a cylinder of compressed heliox gas and oxygen that may be provided by a compress
the hospital gas pipeline. The proportioner's output may achieve concentrations, volume, and flow val
patients' needs. The proportioners also include pressure controls, flowmeters, and an alarm if the oxyg
delivered gas is below 20 percent. The output of the proportioners (i.e., the blend of oxygen and helio
either at high (typically in a range from15 to 120 L/min) or at low (typically in a range from 2 to 30 L/m
mixtures facilitate spontaneous breathing in patients with reduced respiratory capabilities due to the l

Ophthalmic implants designed to substitute the function of the natural retina, totally or partially resto
devices usually consist of electronic microchips that are implanted in the eye, either behind or on the
(i.e., subretinal and epiretinal, respectively). One type of implant consists of an array of electrodes pla
(epiretinal) that receives wireless signals from the antenna of a camera that is housed in the patient's
other implants available (both epiretinal and subretinal) that use a variety of different techniques inclu
uses the direct reception of light from photodiodes included as components of the implant and that on
power. Ophthalmic retinal implants can be used for partial recovery (e.g., detection of light and shape
images) of vision after a period of training; they are intended for people whose optical nerve is intact
retina (e.g., retinitis pigmentosa and macular degeneration patients).

Compressed gas proportioners designed to mix compressed nitrogen and oxygen to achieve oxygen c
composition close to the atmospheric values (i.e., about 21 percent of oxygen and 79 percent nitrogen
volumes of the blend through a central supply system. The proportioners typically receive nitrogen an
liquefied gas containers after evaporation of the gases. The mixed gas (known as synthetic air) may b
humidifier and delivered through the central gas pipeline at high flows (e.g., up to 250 cubic meter/ho
oxygen proportioners are equipped with flowmeters, a pressure-regulating mechanism, gas analyzers,
primary gas sources and also for the delivery of the blended gas.

Compressed gas proportioners designed to mix compressed nitric oxide (NO) and oxygen (O2) to achie
oxide concentrations usually from 100 to 800 ppm; the device receives nitric oxide and oxygen from c
sources. These proportioners are usually equipped with a pressure-regulating mechanism, connectors
sources and also for delivering of the blended gas, and an alarm that signals if the nitrous oxide (N2O
combination of NO with oxygen content is above safe values (e.g., 1 ppm). Nitric oxide is intended for
pulmonary vasodilator; it is used for pulmonary diseases (e.g., asthma) and especially in newborns wi
failure. Some proportioners are dedicated proportioners intended to provide nitric oxide by mixing oxy
mixture of nitric oxide (NO) and nitrogen (N2).
Hematology reagents used to determine the intrinsic clotting activity of the whole blood (i.e., activate
The test is usually performed by adding the whole blood to a test tube or cartridge containing a surfac
formation of a clot in a tube that is kept at normal body temperature (about 37 degrees Celsius/98.5 d
determines the ACT value which depends on the activator. Both automated point-of-care analyzers an
manual procedures are used to perform the test. ACT coagulation tests are intended to monitor the e
the administration of high-dose unfractionated heparin before, during, and shortly after procedures (u
require intense anticoagulant administration. Dedicated ACT tests using particular reagent activators
glass) are available.

Hematology reagents used to determine the intrinsic clotting activity of the whole blood (i.e., activate
using glass as an activator. The test is usually performed by adding the whole blood to a test tube or c
glass balls (i.e., the surface activator). The formation of a clot in a tube that is kept at normal body tem
degrees Celsius/98.5 degrees Fahrenheit) determines the ACT value for glass which should be in the r
seconds. This test is intended to monitor the effect and regulate the administration of high-dose unfra
before, during, and shortly after procedures (usually surgical, such as cardiopulmonary bypass) that re
anticoagulant administration.

Reagents designed for artificial coloration of cells and/or tissues that have been labeled with a primar
immunocytochemistry or immunohistochemistry tests. Typically, these reagents are intended to allow
fluorescent detection of antibody binding. Chromogenic detection methods typically use a secondary
an enzyme (e.g., alkaline phosphatase, horseradish peroxidase). When the enzyme is provided the ap
(e.g., nitro-blue tetrazolium and 5-bromo-4-chloro-3'-indolyphosphate [BCIP/NBT], diaminobenzidine [D
colored precipitates that stain the cells. Slides stained using chromogenic methods are typically visua
microscopy. Fluorescent detection methods typically use a secondary antibody conjugated to a fluorop
isothiocyanate [FITC], rhodamine) that re-emits light at a specific wavelength when exposed to light. S
flourophores are typically visualized using fluorescence or confocal microscopy. Simultaneous staining
antibodies can be accomplished by appropriate selection of secondary antibodies that are able to disc
used primary antibodies. In the case of chromogenic detection methods, secondary antibodies conjug
specific for different substrates and producing different colored pigments are used. In the case of fluor
secondary antibodies conjugated to fluorophores with non-overlapping excitation and emission spectr

Microscope platforms (i.e., stages) designed for automated positioning of microscope slides with spec
usually include automated mechanisms (e.g., using servomotors and/or linear piezoelectric actuators)
movement along one or more orthogonal directions (i.e., x, y, z movement) and/or rotation in one or m
precision of micro or even nanometers. Some devices can be used for high-resolution microscopic sca
Automated positioning microscope stages are usually coupled to computerized controllers that provid
repeatability required for high-resolution optical microscopy; they are frequently interfaced with comp
information systems.
Orthopedic implant designed as a solid rod that is surgically inserted in the lower spine to reshape spi
have lateral angular deformation from the normal vertical line (i.e., scoliosis). These implants are strai
stainless steel, titanium) rods that are surgically inserted and fixed along the spine to hold the vertebr
deviation. One or two rods are usually implanted in patients, mainly children, diagnosed with scoliosis
dedicated implanted rods that can be mechanically elongated every several months using surgical pro
controlled magnetic rods to perform distraction of the vertebrae.

Orthopedic implants designed as a solid mechanically expandable rod that are surgically inserted to re
vertebrae that have lateral angular deformation from the normal vertical line (i.e., scoliosis). These im
metal (e.g., stainless steel, titanium) rods that are surgically inserted and fixed along the spine to hold
avoid further deviation; the rods permit elongation along the axis (i.e., perform mechanical distraction
during further surgical procedures after implantation (e.g., in six-month intervals). One or two mechan
are usually implanted in patients, mainly children, diagnosed with scoliosis.

Orthopedic implants designed as a solid magnetically expandable rod that are surgically inserted to re
that have lateral angular deformation from the normal vertical line (i.e., scoliosis). These implants are
stainless steel, titanium) rods that are surgically inserted and fixed along the spine to hold the vertebr
deviation; the rods permit elongation along the axis using external magnetic control (i.e., perform per
vertebrae) without the need of additional surgical procedures after implantation. One or two magnetic
rods are usually implanted in patients, mainly children, diagnosed with scoliosis.

Osmometers designed for in-vitro determination of a solution's osmotic pressure (i.e., osmolality), a va
ion concentration in the solution, by measuring its electrical impedance. These instruments typically c
chamber where the solution is placed and an electric impedance meter with appropriate electrodes th
solution. The electrical impedance depends on the composition and concentration of the ions within th
changes in the impedance when compared with a standard solution can be correlated with the osmola
of the solution under test. For example, an abnormal ratio between the osmolality in urine and serum
disease, diabetes insipidus, or secretion of abnormal levels of antidiuretic hormone; water and electro
occur in patients with acute poisoning and shock trauma. Dedicated impedance osmometers used to d
osmolarity of a tear film are also available.

Osmometers designed for in-vitro determination of the osmotic pressure of a tear film. These instrume
handheld sampler that absorbs by capillarity a tiny sample (in the order of nanoliters) of tears from th
also includes a microchip and electrodes that permit measurement of the electrical impedance of the
central portable unit that process the data from the sampler and displays the osmolarity (or osmolality
impedance depends on the composition and concentration of the ions in the tear film, so any changes
when compared with a standard solution of normal tear can be correlated with the osmolarity of the te
abnormal value of the tear film osmolarity may help in the determination of some eye conditions; the
diagnosis of dry eyes and/or other eye diseases. Tests for tear osmolarity may be also performed usin
vapor pressure osmometers, but the size of the sample required and/or the volume of the equipment
only for research.
Prepackaged collections of the necessary devices and supplies (i.e., either custom or standard kits) ne
intended to obtain a sample of tissues for in-vitro tests (e.g., biopsy) taken through an endoscope. Item
include a specimen collector (e.g., a container with one or more compartments) with a cap; a collectio
introduced through the working channel of an endoscope and another tube for connection to the aspir
pump (both tubes are attached to the specimen collector); and filters. The kit may also include supplie
and tissue preservation solutions. The kits may be supplied in supporting trays (i.e., procedure trays)
bottom receptacle with a border around the periphery which supports all the devices and supplies nee
the trays are usually covered by a sterile wrap. Endoscopic aspiration procedure kits and trays are ma
tissue samples (e.g., polyps) from the colon; the specimen collector is usually appropriate for transpor
to the clinical laboratory for analysis based upon tissue examination. They are used in hospital clinical
offices, and in other healthcare facilities.

Ovens designed for clinical laboratory procedures (e.g., melting, drying, desiccating) that heat substa
electromagnetic field with frequencies in the range of the microwaves (typically around 2.45 GHz). Th
consist of a metallic box with a microwave generator capable of delivering power in the order of one k
with a front door; and time and power controls. The ovens usually include a ventilation system with du
evacuation) that may be coupled to a fume hood or other laboratory gas extraction system. Laborator
intended for a variety of applications, including drying slides and melting agar. Dedicated microwave o
particular use, such as plasma thawing, histology procedures, slide staining, and tissue fixation, are al

Microwave laboratory ovens designed for cytology and/or histology procedures. These ovens consist o
microwave oven using a magnetron to generate the heating power. They include a relatively large cha
where the samples are heated and have exhaust fans that may be connected to the laboratory exhau
also include additional safety features (e.g., temperature sensors) to protect both the equipment and
should also include dedicated temperature probes and feedback systems to avoid damage to the proc
specimens. Some ovens may also have high rotational speed, vacuum, and controlled temperature cy
Cytology/histology microwave ovens are used in clinical laboratories for a variety of procedures, includ
tissue fixation, decalcification, and other procedures used for sample preparation.

Peripheral nerve stimulators designed to apply electrical stimuli to the peripheral nerves in the wrist t
prevent emesis (i.e., vomiting). These stimulators typically consist of a wrist band with an electronic d
watch positioned on the underside of the wrist. The device includes a pulse generator, electrodes, bat
that are used to deliver low-level electric pulses to the nerves when needed. Antinausea/emesis preve
stimulators are used to provide relief to people suffering from nausea and/or vomiting. Some of these
disposable and intended to treat patients suffering from motion sickness, undergoing chemotherapy,
surgery, and by pregnant women for a limited period of time.

Manual instruments designed to remove crimp seals and caps from tubes, bottles, and small containe
medical procedures and/or laboratory tests. These decrimpers are typically handheld, manual instrum
at the working end that facilitates the removal of crimp seals. The seals are removed by positioning th
the handle. Seal decrimpers are used in clinical laboratories, pharmacies, and/or other areas of health
perform a low volume of daily operations.
Automated powered instruments designed to remove crimp seals and caps from tubes, bottles, and sm
vials) used in medical procedures and/or laboratory tests; the automated instruments usually can perf
decrimping cycles. These decrimpers may be handheld (e.g., pistol-like) or bench-mounted instrumen
automated decrimping controlled cycles using electric or pneumatic powered mechanisms. The electr
battery-powered cordless decrimpers. Automated seal decrimpers are used in clinical laboratories, ph
areas of healthcare facilities when great quantities (e.g., several hundreds) of operations are needed i

Electron microscopy stains designed to bind a specific protein or other cell components using colloida
known as immunogold). These stains consist of a suspension of sub-micrometer-sized particles of gold
the particles are often bound following an immunologic process to a specific protein or other cell comp
microscopy stains have high electron density providing high contrast dark spots; they are commonly u
microscopy to visualize more than one target simultaneously.

Electron microscopy stains designed for staining cell specimens using phosphotungstic acid. These ele
stains are mild acidic irritants which have the appearance of small, colorless-grayish or slightly yellow
Phosphotungstic acid electron microscopy stains are odorless, soluble in water, electron dense, and op
some can produce either a positive or a negative stain. They are used commonly in histology for bindi
fibers of connective tissues, and also for replacing dye anions from these materials, selectively discol

Electron microscopy stains designed for staining lipids to provide contrast to the specimen using osmi
electron microscopy stains dissolve in fats, and are reduced by organic materials to elemental osmium
black substance). Osmium tetroxide stains should have excellent stability when kept cold and in the d
corrosive and irritant properties. Some of these stains can produce either a positive or a negative stain
stains are used widely in transmission electron microscopy (TEM) to provide contrast to the image, in
microscopy (SEM), fixing biological samples, and in optical microscopy to stain lipids.

Electron microscopy stains designed to provide contrast to the specimen using ruthenium tetroxide. T
microscopy stains are quite volatile and aggressive oxidants. Ruthenium tetroxide stains saturated an
materials as well as stabilizing thin sections under the bombardment of the electron beam; some can
positive or a negative stain. They are used as fixation/staining agents for electron microscopy.

Electron microscopy stains designed for staining histological sections using silver nitrate. These electr
are an inorganic compound and a versatile precursor to many other silver compounds. Silver nitrate s
demonstrate proteins (e.g., type III collagen), DNA, and both substances inside and outside cells; som
positive or a negative stain. They are used widely in temperature gradient gel electrophoresis, in scan
microscopy, and in light microscopy; they also aid in the perception of reticular fibers and in the study
calcium phosphate particles during bone growth.

Electron microscopy stains designed to provide contrast to the specimen using uranyl nitrate. These e
stains are water soluble yellow uranium salts. Uranyl nitrate stains have oxidizing and highly toxic pro
produce either a positive or a negative stain. They are used as negative stains for viruses in electron m
tissue samples fo

You might also like