SUPPLEMENTARY INFORMATION:

Electronic Availability

The text of the List is available on the Ukraine-/Russia-Related Sanctions page on OFAC's website, and additional information concerning OFAC is available on OFAC's website ( www.treasury.gov/​ofac).

Background

On December 19, 2014, OFAC issued and posted on its website General License 4 under the Ukraine Related Sanctions program to authorize the exportation or reexportation from the United States or by a U.S. person of agricultural commodities, medicine, medical supplies, and replacement parts to the Crimea region of Ukraine. General License 4 defined the term “medical supplies” to mean those medical devices, as defined in paragraph (d)(3) of General License 4, that are included on the List on OFAC's website ( www.treasury.gov/​ofac) on the Ukraine-/Russia-Related Sanctions page. On the same day, OFAC also posted the List on its website. Most recently, on August 12, 2016, OFAC updated the List to include additional items, and published the List in the Federal Register (82 FR 23716, May 23, 2017).

OFAC incorporated General License 4 into § 589.513 of the Ukraine-/Russia-Related Sanctions Regulations, 31 CFR part 589 (the “Regulations”), on May 2, 2022 (87 FR 26094, May 2, 2022). Accordingly, OFAC is amending the List to replace the reference to General License 4 with a reference to § 589.513 of the Regulations. OFAC is not making substantive changes to any items on the List but is making technical changes to spelling, capitalization, and punctuation, including: Replacing the “%” symbol with the word “percent”; replacing “cu. ft.” with “cubic feet”; replacing “surgical instruments—all types and sizes” with “surgical instruments”; replacing “or” with “and”; replacing “anaesthesia” and terms with this root word such as “anaesthesiology” and “anaethesiometers” with the preferred North American spelling of “anesthesia,” “anesthesiology,” and “anethesiometers”; replacing “haemoglobin” with the preferred North American spelling “hemoglobin”; replacing some semi-colons with commas; and changing several terms from capital letters to lowercase, for example editing “Contact Lens cleaning ( printed page 32501) solutions” to “Contact lens cleaning solutions.” As indicated in Note 1 to § 589.513(j)(4) of the Regulations, the List is maintained on OFAC's website and will be published in the Federal Register , as will any changes to the List.

List of Medical Supplies (Updated May 31, 2022)

The list below comprises the medical supplies defined in § 589.513(j)(4) of the Ukraine-/Russia-Related Sanctions Regulations, 31 CFR part 589.

General Medical Equipment and Supplies

• Adhesive designed for human use
• Adhesive remover designed for human use
• Antiseptic wipes for human use (including alcohol, antimicrobial, benzalkonium, betadine, iodine, and witch hazel)
• Beds: Hospital beds, cribs, and bassinets, including mattresses, overlays, pillows, and bumpers
• Blood lancets
• Blood pressure monitors, gauges, cuffs, aneroids, and infusors
• Bottles (prescription)
• Cabinets: Medical supply or pharmaceutical
• Canes, crutches, walkers, and rollators
• Capnographs
• Carts: Medical, medical utility, medical supply, food service, and hospital laundry carts
• Catheters, including kits
• Chairs: Exam, treatment, surgical, dental, and phlebotomy
• Clinical basins, bowls, baths, pans, urinals, bags, and buckets, and holding devices for such items
• Clinical swabs, applicators, specimen collectors, sponges, pads, tongue depressors, wooden spoons, cotton balls, and cotton rolls
• Coils, guidewire
• Contraceptives (inter-uterine devices (IUDs), hormonal therapy methods, barrier methods) and condoms
• Continuous positive airway pressure (CPAP) systems and all components
• Ear plugs and muffs
• Ear syringes
• Ear wax removers
• Endoscopic devices including laryngoscopes, laparoscopes, anascopes, proctoscopes, arthroscopes, sinuscopes, dematoscopes, ophthalmoscopes, sigmoidscopes, otoscopes, retinoscopes, and colposcopes
• Floor mats: Safety, anti-fatigue, and special-purpose medical floor mats
• Forceps
• Guidewires
• Human body and cadaver bags and shrouds
• Human body positioners, including pads, wedges, cradles, pillows, rests, straps, supports, and holders

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

• Humidifiers
• Hydrocollator heating units
• IV sets, bags, and armboards
• Jars and containers designed for medical supplies and instruments less than 5 liter internal volume
• Lights and lamps: Surgical, medical exam, and magnifying
• Limb prosthesis devices
• Manikins: Medical training and CPR
• Medical bags for medical supplies and equipment, including pre-packed bags
• Medical bandages, gauze, dressings, tape, swabs, sponges, and burn dressings
• Medical carafes, cups, containers, and tumblers
• Medical casts, padding, and casting and removal equipment
• Medical defibrillators
• Medical diagnostic kits, point-of-care, including EAR99 reagents
• Medical flowmeters: Oxygen and air
• Medical labels, labellers, stickers, forms, charts, signage, tags, cards, tape, wrist bands, documents, brochures, and graphics
• Medical lavage systems

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

• Medical penlights
• Medical pumps
• Medical scissors

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

• Medicine cups
• Monitor for glucose management
• Non-electronic patient medical record file systems and organizers
• Orthopedic supports, braces, wraps, shoes, boots, and pads
• Orthopedic traction devices and tables
• Otology sponges
• Oxygen apparatus
• Paraffin baths
• Patient heating and cooling devices: Pads, packs, bottles, bags, warmers, blankets, patches, lamps, and bags
• Patient safety devices, including vests, aprons, finger mitts, limb or body holders, jackets, belts, restraints, cuffs, straps, and protectors
• Patient transfer chairs, lifts, benches, boards, slides, discs, slings, and sheets
• Patient vital-sign monitoring devices
• Patient wheelchairs, chairs, gurneys, stretchers, mats, and cots
• Privacy screens and curtains
• Pulse oximeters
• Reflex hammers
• Refrigerator: Compartmental for morgues
• Safety poles, rails, handles, benches, grab bars, commode aids, and shower aids
• Scales, stadiometers, rulers, sticks, tapes, protractors, volumeters, gauges, and calipers designed for human measurement
• Single-use medical procedure trays and kits
• Speculums
• Spirometers
• Splints
• Stands: IV, instrument, solution, and hamper
• Stethoscopes
• Stools designed for clinical use
• Surgical sutures, staples, and removal kits
• Syringes, aspirators, cannulas, and needles, including kits
• Tables: Operating, exam, therapy, overbed, treatment, medical utility, and medical instrument
• Telemetry pouches designed for human use
• Tents: Pediatric, aerosol, and mist
• Thermometers for measuring human body temperature
• Tourniquets
• Ventilator: Adult, tubing, and accessories
• Warmers: Bottle, gel, lotion, and blanket

Anesthesiology

• Air bags and tidal volume bags
• Air bellows
• Anesthesia circuits
• Anesthesia machines, vaporizers, nebulizers, and inhalers designed for individual human use
• Anesthesia 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 anesthesia systems, require a specific license)

• Intubation sets, probes, and related equipment
• Anesthesiometers
• Oral airways
• Peripheral nerve stimulators

Anesthesia pressure tubes and controllers ( printed page 32502)

• Cardiopulmonary resuscitation (CPR) training manikins and lung bags
• Vibration dampening mounts

Apparel

• Medical gowns, scrubs, aprons, uniforms, lab coats, and coveralls (only those without integrated hoods)
• Patient clothing including gowns, slippers, underpads, and 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, and other medical gloves
• Surgical face or dust masks (does not include masks with respirators)

Cardiology

• Ablation devices
• Balloons extractor, retrieval
• Cardiac monitors: Implantable and external
• Cardiac pacemakers
• Cardiac programmers
• Cardiopulmonary oxygenation systems, devices, and monitors
• Coagulation machines
• Electrocardiography machines
• Filters: Arterial
• Grafts: Peripheral bypass
• Heart positioners: Surgical revascularization
• Heart valves: Surgical, transcatheter (non-surgical)
• Inflation devices: Interventional

Dental Equipment and Supplies

• Bone graft matrices
• Dental and oral implants and devices
• Dental instrument cases, trays, mats and tray liners, racks, covers, wraps, stands, holders, stringers, and protectors
• Dental instruments
• Denture and temporary oral device containers
• Dentures, crowns, molds, orthodontics
• Tooth and denture brushes
• Yankauers

Gynecology & Urology

• Bladder control pads, briefs, liners, underwear, pants, and diapers
• Bladder scanners
• Enema sets
• Extracorporeal lithotripters
• Fecal/stool management devices, kits, and catheters
• Feminine hygiene products
• Pouches, urostomy

Inherited Preventative Care

• Genetic testing products

Laboratory

• Autoclaves (20 liter or smaller only) for medical instrument sterilization and accessories
• Automated blood culture systems
• Automated clinical chemistry analyzers for patient care
• Bench-top dry bath incubators
• Clinical immunoassay analyzers
• Clinical laboratory water baths less than 10 liter
• Coagulation analyzers
• Co-oximeters for hemoglobin analysis
• Electrolyte analyzers
• Flow cytometry accessories, reagents, and components
• Hematology analyzers
• Histology and cytology strainers and tissue baths
• Laboratory balances and scales not to exceed 10 kilograms
• Laboratory hot plates with less than 1.0 square feet heating surface
• Laboratory pH meter (with or without temperature probe)
• Light microscopes
• Luminometers
• Medical bone densitometers
• Medical differential counters
• Medical refrigerators and freezers with less than 5.0 cubic feet internal volume
• Medical specimen centrifuges
• Microplate readers/washers
• Osmometers
• Patient blood gas analyzers
• Pipettes
• Spectrophotometers, photometers, and colorimeters designed for clinical use
• Urinalysis analyzers

Nephrology

• 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. No. 1, Export Control Classification Number (ECCN) 2B352.d)
• Hemodialysis connection and tubing kits

Neurology

• Electroencephalography machines
• Neurostimulators, implantable

Obstetrics and Maternity Care

• Assisted reproductive technology and related equipment
• Incubators/Isolettes
• Infant radiant warmer and parts and accessories
• Neonatal equipment (phototherapy, nasal CPAP, and all components)
• Umbilical cord clamps
• Ventilator: infant/pediatric and tubing and accessories

Ophthalmology and Optometry

• Contact lens cleaning solutions
• Contact lenses, corrective
• Eyecharts
• Glasses, corrective
• Phoropters
• Tonomets
• Vision/Optometry related machines and supplies

Otology and Neurotology

• Hearing aids, accessories, and components

Physical and Occupational Therapy

• Aquatic floats and training devices
• Balance pads, platforms, and beams
• Bath cubes, therapy
• Boots, mitts, and liners for therapeutic pain relief
• Cognitive measuring devices and equipment
• Dining aids
• Electrotherapy, muscle stimulators, and tens units
• Ergometers
• Exercise bars
• Exercise table
• Fine motor assessment equipment designed for human use
• Goniometers
• Hand bars
• Hydraulic dynamometer
• Manipulation boards
• Massaging equipment
• Mat platforms
• Medical whirlpools
• Mobility platforms, parallel bars, ladders, and stairs
• Orthopedic shoes and boots
• Parallel bars
• Pedometers
• Protective headgear
• Rehabilitation exercise, weights, band, balls, boards, and mobility equipment
• Rulonmeters
• Scoliometer
• Tactile sensation, sensitization, and desensitization equipment
• Therapeutic putty
• Ultrasound stimulators

Radiology

• Computer tomography scanners (CT, MDCT)
• Contrasting agents, both injectable and non-injectable
• Magnetic resonance imaging (MRI) machines
• Medical ultrasound machines
• Medical/Dental film
• Nuclear medicine imaging machines
• Positron Emission Tomography (PET)
• PET cyclotron machines
• PET radiopharmaceutical tracer machines, including cassettes

Scintillation camera/Anger cameras for medical imaging ( printed page 32503)

• Single Photon Emission Computed Tomography (SPECT) machines
• X-ray machines, including mammography machines
• Parts and accessories for medical imaging devices above that do not contain nuclear or chemical components

Sterilization

• Aseptic, germicidal, and disinfectant wipes or clothes for medical equipment, devices and furniture
• Ready-to-use disinfectant in 32 ounce containers or less
• Aseptic, germicidal, and medical-grade soap, detergent, pre-soak, and rinse in one gallon containers or less
• Hand sanitizer, lotion, soap, scrub, wash, gel, and foam, including dispensing devices
• Medical cleaning brushes for equipment, patients, and furniture
• Sterilization or disinfection indicator strips, tape, and test packs
• Medical instrument sterilization pouches, mats, protector guards, and tubing
• Sterilization containers and cases less than 0.3 cubic feet
• Autoclaves with chamber size less than 0.3 cubic feet, including trays, containers, cassettes, cases, and filters for such systems

Surgery

• Blood transfusion equipment
• Cervical fusion kits
• Chest drains
• Cosmetic or reconstructive implants (jaw implants, breast implants, skin grafts)
• Electrosurgery devices and supporting equipment
• Lubricant specially formulated for surgical equipment in one gallon containers or less
• Orthopedic plates/screws, fixators, implants, and cement
• Stents
• Stockinettes
• Surgical case carts
• Surgical clean-up kits
• Surgical clips
• Surgical imaging machines, including image-guiding surgery products, ear, nose and throat
• Surgical instrument cases, trays, mats or tray liners, racks, covers, wraps, stands, holders, stringers, and protectors
• Surgical instruments
• Surgical linens, drapes, and covers
• Surgical mesh
• Surgical shunts
• Surgical smoke evacuators and specialized supporting equipment
• Tissue stabilizers and surgical revascularizations
• Wound drainage equipment

EAR99-classified components, accessories, and optional equipment that are designed for and are for use with an EAR99-classified medical device included elsewhere on the list.

87 FR 32500