21 CFR 876.5895 - Ostomy irrigator.

§ 876.5895 Ostomy irrigator.

(a)Identification. An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the surface of the body.

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

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United States Code