respect to general requirements concerning records, and § 820.198, with respect to complaint files. § 880.6100 Ethylene oxide gas aerator cabinet. (a) Identification. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air. (b) Classification. Class II (performance standards). § 880.6140 Medical chair and table. (a) Identification. A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device 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. § 880.6150 Ultrasonic cleaner for medical instruments. (a) Identification. An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter, except that any solutions intended for use with the device for cleaning or sanitizing the instruments are not exempt. [45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989] § 880.6175 [Reserved] § 880.6185 Cast cover. (a) Identification. A cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or a bath. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart 807. If the device is not labeled or otherwise represented as sterile it is also 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. § 880.6190 Mattress cover for medical purposes. (a) Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide. (b) Classification. Class I (general controls). If the device is not labeled or otherwise represented as sterile, it 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. § 880.6200 Ring cutter. (a) Identification. A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820 with the exception of § 820.180, with respect to general requirements con cerning records, and § 820.198, with respect to complaint files. § 880.6230 Tongue depressor. (a) Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues. (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. § 880.6250 Patient examination glove. (a) Identification. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (b) Classification. Class I (general controls). [45 FR 69682-69737, Oct. 21, 1980, as amended at 53 FR 1604, Jan. 13, 1989] 8880.6265 Examination gown. (a) Identification. An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination. (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. § 880.6280 Medical insole. (a) Identification. A medical insole is a device intended for medical purposes that is placed inside a shoe to re lieve the symptoms of athlete's foot infection by absorbing moisture. (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] § 880.6320 AC-powered medical examination light. (a) Identification. An AC-powered medical examination light is an ACpowered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination. (b) Classification. Class II (performance standards). § 880.6350 Battery-powered medical examination light. (a) Identification. A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart E of Part 807. The device 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. § 880.6375 Patient lubricant. (a) Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. (b) Classification. Class I (general controls). § 880.6430 Liquid medication dispenser. (a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device 341-073 0-93--12 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. § 880.6450 Skin pressure protectors. (a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device 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. § 880.6500 Medical ultraviolet air purifier. (a) Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. (b) Classification. Class II (performance standards). § 880.6710 Medical ultraviolet water purifier. (a) Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation. (b) Classification. Class II (performance standards). § 880.6730 Body waste receptacle. (a) Identification. A body waste receptacle is a device intended for medical purposes tht is not attached to the body and that is used to collect the body wastes of a bed patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements con cerning records, and § 820.198, with respect to complaint files. § 880.6740 Vacuum-powered body fluid suction apparatus. (a) Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). (b) Classification. Class II (performance standards). § 880.6760 Protective restraint. (a) Identification. A protective restraint is a device, usually a wristlet, anklet, or other type of strap, that is intended for medical purposes and that limits a patient's movements to the extent necessary for treatment, examination, or protection of the patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device is also 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. on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart E of Part 807. The divice 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. § 880.6800 Washers for body waste receptacles. (a) Identification. A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan. The device consists of a wall-mounted plumbing th fixture with a door through which a Es body waste receptacle is inserted. When the door is closed the body waste receptacle is cleaned by hot water, steam, or germicide. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device 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. § 880.6820 Medical disposable scissors. (a) Identification. Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart E of Part 807. 8 880.6850 Sterilization wrap. (a) Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed med (b) Classification. Class II (performance standards). § 880.6920 Syringe needle introducer. (a) Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface. (b) Classification. Class II (performance standards). § 880.6960 Irrigating syringe. (a) Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound. (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. § 880.6970 Liquid crystal vein locator. (a) Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters). (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] § 880.6980 Vein stabilizer. (a) Identification. A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein. |