Home/CFR/Title 21/Part 880
FEDERAL · 21 CFR

Part 880 — General Hospital and Personal Use Devices

122 sections · Title 21: Food and Drugs

§ 880.1Scope.
§ 880.3Effective dates of requirement for premarket approval.
§ 880.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 880.2200Liquid crystal forehead temperature strip.
§ 880.2400Bed-patient monitor.
§ 880.2420Electronic monitor for gravity flow infusion systems.
§ 880.2460Electrically powered spinal fluid pressure monitor.
§ 880.2500Spinal fluid manometer.
§ 880.2700Stand-on patient scale.
§ 880.2720Patient scale.
§ 880.2740Surgical sponge scale.
§ 880.2750Image processing device for estimation of external blood loss.
§ 880.2800Sterilization process indicator.
§ 880.2900Clinical color change thermometer.
§ 880.2910Clinical electronic thermometer.
§ 880.2920Clinical mercury thermometer.
§ 880.2930Apgar timer.
§ 880.5025I.V. container.
§ 880.5045Medical recirculating air cleaner.
§ 880.5075Elastic bandage.
§ 880.5090Liquid bandage.
§ 880.5100AC-powered adjustable hospital bed.
§ 880.5110Hydraulic adjustable hospital bed.
§ 880.5120Manual adjustable hospital bed.
§ 880.5130Infant radiant warmer.
§ 880.5140Pediatric medical crib.
§ 880.5145Medical bassinet.
§ 880.5150Nonpowered flotation therapy mattress.
§ 880.5160Therapeutic medical binder.
§ 880.5180Burn sheet.
§ 880.5200Intravascular catheter.
§ 880.5210Intravascular catheter securement device.
§ 880.5220Intravenous catheter force-activated separation device.
§ 880.5240Medical adhesive tape and adhesive bandage.
§ 880.5270Neonatal eye pad.
§ 880.5300Medical absorbent fiber.
§ 880.5400Neonatal incubator.
§ 880.5410Neonatal transport incubator.
§ 880.5420Pressure infusor for an I.V. bag.
§ 880.5430Nonelectrically powered fluid injector.
§ 880.5440Intravascular administration set.
§ 880.5445Intravascular administration set, automated air removal system.
§ 880.5450Patient care reverse isolation chamber.
§ 880.5475Jet lavage.
§ 880.5500AC-powered patient lift.
§ 880.5510Non-AC-powered patient lift.
§ 880.5550Alternating pressure air flotation mattress.
§ 880.5560Temperature regulated water mattress.
§ 880.5570Hypodermic single lumen needle.
§ 880.5580Acupuncture needle.
§ 880.5630Nipple shield.
§ 880.5640Lamb feeding nipple.
§ 880.5680Pediatric position holder.
§ 880.5690Infant supine sleep system.
§ 880.5700Neonatal phototherapy unit.
§ 880.5725Infusion pump.
§ 880.5730Alternate controller enabled infusion pump.
§ 880.5740Suction snakebite kit.
§ 880.5760Chemical cold pack snakebite kit.
§ 880.5780Medical support stocking.
§ 880.5820Therapeutic scrotal support.
§ 880.5860Piston syringe.
§ 880.5950Umbilical occlusion device.
§ 880.5960Lice removal kit.
§ 880.5965Subcutaneous, implanted, intravascular infusion port and catheter.
§ 880.5970Percutaneous, implanted, long-term intravascular catheter.
§ 880.6025Absorbent tipped applicator.
§ 880.6050Ice bag.
§ 880.6060Medical disposable bedding.
§ 880.6070Bed board.
§ 880.6080Cardiopulmonary resuscitation board.
§ 880.6085Hot/cold water bottle.
§ 880.6100Ethylene oxide gas aerator cabinet.
§ 880.6140Medical chair and table.
§ 880.6150Ultrasonic cleaner for medical instruments.
§ 880.6175§ 880.6175 [Reserved]
§ 880.6185Cast cover.
§ 880.6190Mattress cover for medical purposes.
§ 880.6200Ring cutter.
§ 880.6210Sharps needle destruction device.
§ 880.6230Tongue depressor.
§ 880.6250Non-powdered patient examination glove.
§ 880.6260Filtering facepiece respirator for use by the general public in public health medical emergencies.
§ 880.6265Examination gown.
§ 880.6280Medical insole.
§ 880.6300Implantable radiofrequency transponder system for patient identification and health information.
§ 880.6305Ingestible event marker.
§ 880.6310Medical device data system.
§ 880.6315Remote Medication Management System.
§ 880.6320AC-powered medical examination light.
§ 880.6350Battery-powered medical examination light.
§ 880.6375Patient lubricant.
§ 880.6430Liquid medication dispenser.
§ 880.6450Skin pressure protectors.
§ 880.6500Medical ultraviolet air purifier.
§ 880.6600Ultraviolet (UV) radiation chamber disinfection device.
§ 880.6710Medical ultraviolet water purifier.
§ 880.6730Body waste receptacle.
§ 880.6740Vacuum-powered body fluid suction apparatus.
§ 880.6760Protective restraint.
§ 880.6775Powered patient transfer device.
§ 880.6785Manual patient transfer device.
§ 880.6800Washers for body waste receptacles.
§ 880.6820Medical disposable scissors.
§ 880.6850Sterilization wrap.
§ 880.6855Rigid sterilization container with electronic monitoring.
§ 880.6860Ethylene oxide gas sterilizer.
§ 880.6870Dry-heat sterilizer.
§ 880.6880Steam sterilizer.
§ 880.6885Liquid chemical sterilants/high level disinfectants.
§ 880.6886Foam or gel chemical sterilant/high level disinfectant.
§ 880.6887Spore test strip.
§ 880.6890General purpose disinfectants.
§ 880.6900Hand-carried stretcher.
§ 880.6910Wheeled stretcher.
§ 880.6920Syringe needle introducer.
§ 880.6960Irrigating syringe.
§ 880.6970Liquid crystal vein locator.
§ 880.6980Vein stabilizer.
§ 880.6990Infusion stand.
§ 880.6991Medical washer.
§ 880.6992Medical washer-disinfector.