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8880.2910 Clinical electronic thermom

eter. (a) Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

(b) Classification. Class II (performance standards). 8880.2920 Clinical mercury thermom

eter. (a) Identification. A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $880.9.

ministered to a patient through an intravascular administration set.

(b) Classification. Class II (performance standards). 8880.5045 Medical recirculating air

cleaner. (a) Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

(b) Classification. Class II (performance standards).

(45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998)

8 880.5075 Elastic bandage.

(a) Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in part 820, with the exception of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. $880.5090 Liquid bandage. (a) Identification. A liquid bandage is

sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

(b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8 880.9. (45 FR 69682-69737, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]

8880.2930 Apgar timer.

(a) Identification. The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8880.9. The device is also exempt from the current good manufacturing practice requirements in part 820 of this chapter, with the exception of $820.180 of this chapter, with respect to general requirements concerning records, and $ 820.198 of this chapter, with respect to complaint files. [63 FR 59718, Nov. 5, 1998]

a

Subparts D-E [Reserved] Subpart F-General Hospital and Personal Use Therapeutic Devices

8880.5025 I.V. container.

(a) Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be ad

$880.5100 AC-powered adjustable hos.

pital bed. (a) Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the

height and surface contour of the bed. an alarm system (infant temperature, The device includes movable and manual mode if present, and failure latchable side rails.

alarms) to alert operators of a tem(b) Classification. Class II (special perature condition over or under the controls). The device is exempt from set temperature, manual mode time the premarket notification procedures limits, and device component failure, in subpart E of part 807 of this chapter respectively. The device may be placed subject to $880.9.

over a pediatric hospital bed or it may [45 FR 69682-69737, Oct. 21, 1980, as amended

be built into the bed as a complete

unit. at 63 FR 59229, Nov. 3, 1998]

(b) Classification. Class II (Special 8880.5110 Hydraulic adjustable hos

Controls): pital bed.

(1) The Association for the Advance

ment of Medical (a) Identification. A hydraulic adjust

Instrumentation able hospital bed is a device intended

(AAMI) Voluntary Standard for the Infor medical purposes that consists of a

fant Radiant Warmer; bed with a hydraulic mechanism oper

(2) A prescription statement in acated by an attendant to adjust the

cordance with $ 801.109 of this chapter height and surface contour of the bed.

(restricted to use by or upon the order The device includes movable and

of qualified practitioners as deterlatchable side rails.

mined by the States); and (b) Classification. Class I. The device

(3) Labeling for use only in health is exempt from the premarket notifica

care facilities and only by persons with tion procedures in subpart E of part 807

specific training and experience in the of this chapter.

use of the device.

(62 FR 33350, June 19, 1997) 8 880.5120 Manual adjustable hospital bed.

8880.5140 Pediatric hospital bed. (a) Identification. A manual adjust- (a) Identification. A pediatric hospital able hospital bed is a device intended bed is a device intended for medical for medical purposes that consists of a purposes that consists of a bed or crib bed with a manual mechanism operated designed for the use of a pediatric paby an attendant to adjust the height tient, with fixed end rails and movable and surface contour of the bed. The de- and latchable side rails. The contour of vice includes movable and latchable the bed surface may be adjustable. side rails.

(b) Classification. Class II (special (b) Classification. Class I. The device controls). The device is exempt from is exempt from the premarket notifica- the premarket notification procedures tion procedures in subpart E of part 807 in subpart E of part 807 of this chapter of this chapter. The device is also ex- subject to 8 880.9. empt from the current good manufacturing practice regulations in part 820

[45 FR 69682-69737, Oct. 21, 1980, as amended

at 63 FR 59229, Nov. 3, 1998] of this chapter, with the exception of $820.180, regarding general require- 8880.5150 Nonpowered flotation therments concerning records, and 8820.198,

apy mattress. regarding complaint files.

(a) Identification. A nonpowered flota(45 FR 69682-69737, Oct. 21, 1980, as amended tion therapy mattress is a mattress inat 54 FR 25050, June 12, 1989)

tended for medical purposes which con

tains air, fluid, or other materials that $ 880.5130 Infant radiant warmer.

have the functionally equivalent effect (a) Identification. The infant radiant of supporting a patient and avoiding warmer is a device consisting of an in- excess pressure on local body areas. frared heating element intended to be The device is intended to treat or preplaced over an infant to maintain the vent decubitus ulcers (bed sores). infant's body temperature by means of (b) Classification. Class I (general conradiant heat. The device may also con- trols). The device is exempt from the tain a temperature monitoring sensor, premarket notification procedures in a heat output control mechanism, and subpart E of part 807. The device also is

exempt from the good manufacturing practice regulation in part 820, with the exception of 8820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

8880.5210 Intravascular catheter se

curement device. (a) Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994)

8 880.5160 Therapeutic medical binder.

(a) Identification. A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

(b) Classification. Class I (general controls). The device is exempt from the premarket notifiction procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

$880.5240 Medical adhesive tape and

adhesive bandage. (a) Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

8 880.5180 Burn sheet.

(a) Identification. A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.

(b) Classification. Class I. The device is exempt from the premarket notification rocedures in subpart E of part 807 of this chapter. [45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994]

(45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994)

as

$ 880.5200 Intravascular catheter.

(a) Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

(b) Classification. Class II (performance standards).

8880.5270 Neonatal eye pad.

(a) Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such phototherapy.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $820.180 of this chapter, with respect to general requirements concerning records, and $820.198 of this (b) Classification. Class II (performance standards).

chapter, with respect to complaint files. (45 FR 69682-69737, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000)

$ 880.5300 Medical absorbent fiber.

(a) Identification. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in part 820, with the exception of $820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

8880.5420 Pressure infusor for an I.V.

bag. (a) Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000)

$ 880.5430 Nonelectrically powered

fluid injector. (a) Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

(b) Classification. Class II (performance standards).

8 880.5400 Neonatal incubator.

(a) Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

(b) Classification. Class II (performance standards).

8880.5410 Neonatal transport incu

bator. (a) Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

$ 880.5440 Intravascular administra

tion set. (a) Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

(b) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled "Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers." Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in $880.9.

in subpart E of part 807 of this chapter subject to 8 880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

(45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001)

$ 880.5450 Patient care reverse isola

tion chamber. (a) Identification. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.

(b) Classification. Class II (performance standards).

8880.5510 Non-AC-powered patient

lift. (a) Identification. A non-AC-powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and transport a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and a sling to support the patient.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989)

8880.5475 Jet lavage.

(a) Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

$880.5550 Alternating pressure air flo

tation mattress. (a) Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8 880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

8 880.5500 AC-powered patient lift.

(a) Identification. An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures

$ 880.5560 Temperature regulated

water mattress. (a) Identification. A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.

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