General Medical Equipment and Supplies

 Syringes, cannulas, and needles – all sizes and types; including kits

 Catheters – all sizes and types; including kits

 Coils, guidewire

 Guidewires, all

 Medical tubing or hoses less than 2” diameter; including associated adaptors, connectors, caps, clamps, retainers, brackets, valves, washers, vents, stopcocks, or flow sensors; and peristaltic pumps with flowrates of less than 600 liters/hr for such tubing (note: does not include tubing made of butyl rubber or greater than 35% fluoropolymers)

 Endoscopic devices including laryngoscopes, laparoscopes, anascopes, proctoscopes, arthroscopes, sinuscopes, dematoscopes, ophthalmoscopes, sigmoidscopes, otoscopes, retinoscopes, or colposcopes

 Blood pressure monitors, gauges, cuffs, aneroids, or infusors

 Monitor for glucose management

 Medical defibrillators

 Medical lavage systems

 IV sets, bags, and armboards

 Medical penlights

 Stethoscopes

 Speculums

 Medical scissors

 Forceps

 Single-use medical procedure trays and kits

 Medical diagnostic kits, point-of-care; including EAR99 reagents

 Reflex hammers

 Blood lancets

 Ear plugs and muffs

 Otology sponges

 Ear syringes

 Ear wax removers

 Clinical swabs, applicators, specimen collectors, sponges, pads, tongue depressors, wooden spoons, cotton balls, or cotton rolls

 Antiseptic wipes for human use (including alcohol, antimicrobial, benzalkonium, betadine, iodine, and witch hazel)

 Splints

 Canes, crutches, walkers, rollators

 Patient wheelchairs, chairs, gurneys, stretchers, mats, and cots

 Patient transfer chairs, lifts, benches, boards, slides, discs, slings, and sheets

 Safety poles, rails, handles, benches, grab bars, commode aids, and shower aids

Patient vital-sign monitoring devices

 Limb prosthesis devices

 Orthopedic supports, braces, wraps, shoes, boots, or pads

 Medical casts, padding; and casting and removal equipment

 Orthopedic traction devices and tables

 Human body positioners including pads, wedges, cradles, pillows, rests, straps, supports, and holders

 Human specimen collectors and containers (e.g., urine, blood, tissue)

 Medical bandages, gauze, dressings, tape, swabs, sponges, and burn dressings

 Surgical sutures and staples; and removal kits

 Tourniquets

 Thermometers for measuring human body temperature

 Clinical basins, bowls, baths, pans, urinals, bags, and buckets; and holding devices for such items

 Medical carafes, cups, containers and tumblers

 Medicine cups

 Syringe aspirators

 Medical bags for medical supplies and equipment; including pre-packed bags

 Condoms

 Medical labels, labellers, stickers, forms, charts, signage, tags, cards, tape, wrist bands, documents, brochures, and graphics

 Non-electronic patient medical record file systems and organizers

 Beds: hospital beds, cribs, or bassinets; including mattresses, overlays, pillows, and bumpers

 Medical linens (e.g., blankets, sheets, pillow cases, towels, washcloths, drapes, covers)

 Chairs: exam, treatment, surgical, dental, or phlebotomy

 Stools: designed for clinical use

 Stands: IV, instrument, solution, or hamper

 Carts: medical, medical utility, medical supply, food service, or hospital laundry carts

 Tables: operating, exam, therapy, overbed, treatment, medical utility, or medical instrument

 Jars and containers designed for medical supplies and instruments less than 5 L internal volume

 Privacy screens and curtains

 Cabinets: medical supply or pharmaceutical

 Floor mats: safety, anti-fatigue or special-purpose medical floor mats

 Hydrocollator heating units

 Warmers: bottle, gel, lotion, or blanket

 Patient heating and cooling devices: pads, packs, bottles, bags, warmers, blankets, patches, lamps, bags

 Paraffin baths

 Lights and lamps: surgical, or medical exam, magnifying

 Scales, stadiometers, rulers, sticks, tapes, protractors, volumeters, gauges, or calipers designed for human measurement

 Patient safety devices including vests, aprons, finger mitts, limb or body holders, jackets, belts, restraints, cuffs, straps, or protectors

 Human body or cadaver bags and shrouds

 Adhesive designed for human use

 Adhesive remover designed for human use

 Telemetry pouches designed for human use

 Bottles (prescription)

 Capnograph

 CPAP (continuous positive airway pressure) systems and all components

 Medical Flowmeters, oxygen & air

 Humidifiers

 Manikin, medical training, CPR

 Medical Pumps

 Ventilator, adult and tubing and accessories

 Oxygen apparatus, all

 Pulse oximeter

 Refrigerator, compartmental for morgues

 Spirometer

 Tents, pediatric, aerosol, & mist



 Air bags and tidal volume bags

 Air bellows

 Anaesthesia circuits

 Anaesthesia machines, vaporizers, nebulizers, and inhalers designed for individual human use

 Anaesthesia masks (including laryngeal)

 Anti-siphon equipment

 Block and epidural trays packaged for individual use

 Endotrach tubes

 Head straps and harnesses

 Hyperinflation systems

 In-line filters and cartridges, thermometers, CO2 detectors, sodalime canisters, and temperature and moisture exchangers (note: gas mask canisters, other than sodalime canisters designed for anaesthesia systems, require a specific license)

 Intubation sets, probes and related equipment

 Anaesthesiometers

 Oral airways

 Peripheral nerve stimulators

 Anaesthesia pressure tubes and controllers

 Cardiopulmonary resuscitation (CPR) training manikins and lung bags

 Vibration dampening mounts 4


 Medical gowns, scrubs, aprons, uniforms, lab coats, and coveralls; only those without integrated hoods

 Patient clothing including gowns, slippers, underpads, or undergarments

 Head or beard covers and nets

 Medical shoe and boot covers

 Surgical sleeve protectors

 Ventilated Safety eyeshields and goggles (does not include full face shield or indirectly-vented goggles)

 Disposable latex, nitrile, polyethylene, vinyl gloves/finger cots or other medical gloves

 Surgicalface or dust masks (does not include masks with respirators)




 Electrocardiography machines

 Ablation devices and accessories, radio frequency

 Balloon (extractor, retrieval)

 Cardiac pacemaker

 Cardiac programmer

 Cardiac monitors, implantable or external

 Cardiopulmonary oxygenation systems, devices, and monitors

 Coagulation machines

 Heart positioners, surgical revascularization

 Heart valves , surgical, transcatheter (non-surgical)

 Inflation devices, interventional

 Filters, arterial

 Grafts, peripheral bypass





Dental equipment and supplies

 Bone graft matrix

 Dentures, crowns, molds, orthodontics, all

 Dental instruments – all types and sizes

 Dental instrument cases, trays, mats or tray liners, racks, covers, wraps, stands, holders, stringers, or protectors

 Dental and oral implants or devices

 Tooth and denture brushes

 Denture and temporary oral device containers

 Yankauers

Gynecology & Urology

 Bladder scanners

 Pouches, urostomy

 Bladder control pads, briefs, liners, underwear, pants and diapers

 Feminine hygiene products

 Fecal/stool management devices, kits, and catheters

 Enema sets

 Extracorporeal Lithotripter


 Autoclaves for medical instrument sterilization and accessories

 Flow cytometry accessories, reagents and components

 Laboratory balances and scales not to exceed 10 Kg

 Patient blood gas analyzers

 Medical specimen centrifuges

 Automated clinical chemistry analyzers for patient care

 Coagulation analyzers

 Co-oximeters for haemoglobin analysis

 Medical bone densitometers

 Medical differential counters

 Bench-top dry bath incubators

 Electrolyte analyzers

 Hematology analyzers

 Histology and cytology strainers and tissue baths

 Laboratory hot plates with less than 1.0 sq. ft. heating surface

 Clinical immunoassay analyzers

 Luminometers

 Laboratory pH meter (with or without temperature probe)

 Automated blood culture systems

 Microplate readers/washers

 Light microscopes

 Osmometers

 Pipettes

 Medical refrigerators and freezers with less than 5.0 cu. ft. internal volume

 Spectrophotometers, photometers, and colorimeters designed for clinical use

 Urinalysis analyzers

 Clinical laboratory water baths less than 10 liter


 Hemodialysis machines; and dialysis filters designed for such machines (Note: Other dialysis equipment, filters, and parts not used for hemodialysis require a specific license and may be controlled under 15 CFR, part. 774, supp. 1, ECCN 2B352.d)

 Hemodialysis connection or tubing kits


 Electroencephalography machines

 Neurostimulator, implantable

Obstetrics and Maternity Care

 Umbilical cord clamps

 Neonatal equipment (phototherapy, nasal CPAP, etc and all components)

 Incubator /Isolette

 Ventilator, infant/pediatric and tubing and accessories

 Infant Radiant Warmer and parts and accessories

Ophthalmology and Optometry

 Contact Lenses, corrective

 Contact Lens cleaning solutions

 Glasses, corrective

 Eyecharts

 Phoropter

 Tonometer



Otology and Neurotology

 Hearing Aids, accessories and components

Physical and Occupational Therapy

 Bath cubes, therapy

 Boots, mitts, and liners for therapeutic pain relief

 Orthopedic shoes, boots, etc

 Parallel bars

 Exercise bars

 Hand bars

 Mat Platforms

Exercise table

 Medical Whirlpools

 Mobility platforms, parallel bars, ladders, stairs

 Balance pads, platforms, and beams

 Cognitive measuring devices and equipment

 Manipulation boards

 Dining aids

 Hydraulic dynamometer

 Scoliometer

 Goniometers

 Pedometers

 Ergometers

 Rulonmeters

 Fine motor assessment equipment designed for human use

 Tactile sensation, sensitization, and desensitization equipment

 Rehabilitation exercise, weights, band, balls, boards, and mobility equipment

 Therapeutic putty

 Aquatic floats and training devices

 Protective headgear

 Electrotherapy, muscle stimulators, and tens units

 Ultrasound stimulators

 Massaging equipment


 Computed Tomography Scanners (CT, MDCT)

 Positron Emission Tomography (PET)

 Scintillation Camera/Anger camera for medical imaging

 Magnetic Resonance Imaging (MRI) machines

 X-ray machines

 Parts and accessories for medical imaging devices above that do not contain nuclear or chemical components.

 Medical ultrasound machines

 Medical/dental film


 Aseptic, germicidal, or disinfectant wipes or clothes for medical equipment, devices or furniture

 Ready-to-use disinfectant in 32 oz. containers or less

 Aseptic, germicidal, or medical-grade soap, detergent, pre-soak

 Hand sanitizer, lotion, soap, scrub, wash, gel, or foam; including dispensing devices

 Medical cleaning brushes for equipment, patients, and furniture

 Sterilization or disinfection indicator strips, tape, or test packs

 Medical instrument sterilization pouches, mats, protector guards, or tubing

 Sterilization containers or cases less than 0.3 cu. ft.

 Autoclaves with chamber sizes less than 0.3 cu. ft.; including trays, containers, cassettes, cases, and filters for such systems.


 Cervical fusion kit

 Image- guiding surgery products, ear, nose and throat

 Orthopedic plates/screws, fixators, implants, cement

 Surgical shunts

 Tissue Stabilizer, surgical revascularization

 Surgical clips

 Surgical instruments – all types and sizes

 Surgical instrument cases, trays, mats or tray liners, racks, covers, wraps, stands, holders, stringers, or protectors

 Stents – all types and sizes

 Surgical linens, drapes, or covers

 Chest drains

 Surgical case carts

 Blood transfusion equipment

 Surgical clean-up kits

 Wound drainage equipment

 Stockinettes

 Surgical mesh

 Surgical smoke evacuators and specialized supporting equipment

 Electrosurgery devices and supporting equipment

 Lubricant specially-formulated for surgical equipment in 1 gallon containers or less