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The Qora® Stool Management Kit is indicated for fecal management by diverting liquid or semi-formed stool to minimize skin contact with bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use of this device, including replacement with other same devices, should not exceed 29 days.

Similar to the predicate device, the modified device is a non-sterile, single-use device intended to use for the management of fecal incontinence in bedridden patients. The device consists of an indwelling diverter, an external transit sheath, and an external collection bag. The kit also includes a collection bag hanger and a transit sheath clamp. The self-conforming indwelling fecal diverter, which is provided pre-loaded into a hygienic applicator used to deploy inside the rectum, remains in place by apposition to the rectal wall when deployed. The transit sheath acts as a conduit to facilitate the transfer of fecal matter from the indwelling diverter to the collection bag. The device includes three ports attached to the transit sheath, to facilitate irrigating of the indwelling divery, sample collection, and to allow withdrawal in a trauma-free manner.