Title 21

SECTION 880.6800

880.6800 Washers for body waste receptacles.

§ 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 fixture with a door through which a 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 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]

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