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The Qora AIM™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days. The Qora Aeon™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days. The Qora Arida™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi- formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days.

The Qora AIM™, Qora Aeon™, and Qora Arida™ Stool Management Kits are non-sterile, single-use devices packaged in a product box. Each kit contains one hygienic device applicator that houses a soft indwelling fecal diverter. The Qora AIM™ and Qora Aeon™ kits contain an additional two odor-proof collection bags. The primary component of the device is the fecal diverter. It consists of soft, pliable, and self-expanding indwelling diverter that remains apposed to the rectal wall and the transit sheath. The indwelling diverter is sufficiently compliant to collapse and expand with the adjacent anatomy during peristaltic contractions of the rectum. This pliancy within the rectum is designed to help reduce abrasion and subsequent clinical complicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum. The Qora Arida™ collection pouch is a thin, biocompatible conduit that facilitates the transfer and collection of fecal material from the indwelling diverter. The use of thin material is engineered to reduce the foreign body sensation and risk of anal sphinction. Furthermore, the Qora Arida™ kit offers a single port attached to the side of the collection pouch. The port is used to withdraw the device in a trauma-free way from the patient. The Qora AIM™ and Qora Aeon™ kits utilize a transit sheath that is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath is designed to reduce the foreign body sensation and risk of anal sphinction. The bag connection interface at the end of the transit sheath prevents accidental soiling of bed sheets, garments, etc. during the exchange of a collection bag or other regular maneuvers during patient handling. Furthermore, the Qora AlM™ and Qora Aeon™ kits offer three ports attached to the side of the transit sheath. One port is used to irrigate the indwelling diverter if needed. The second port is used to collect samples from within the transit sheath if desired. The third and final port is used to withdraw the device in a trauma-free way from the patient.

Consure 120 SMS is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients.

The Consure 120 Stool Management System is a non-sterile device packaged in individual SteriClin (medical grade paper with peel-away PE lamination) pouches. Ten such individual pouches are packed in corrugated boxes for shipping. Each Consure 120 SMS pouch contains: -- I soft and hygienic applicator that houses a soft in-dwelling diverter and -- 3 collection bags. The primary component of the device is the fecal diverter. It consists of an indwelling, pliable, self-expanding lattice structure that remains apposed to the rectal wall and the transit sheath. The indwelling diverter is sufficiently compliant to collapse and expand with the adjacent anatomy during peristaltic contractions of the rectum. This pliancy within the rectum can reduce abrasion and subsequent clinical complications originating from the mucosal damage. The transit sheath is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath reduces the foreign body sensation and risk of anal sphincter dysfunction. The applicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum. Whereas the bag connection interface allows the prevention of accidental soiling of bed sheets, garments, etc. during exchange of collection bag or other regular maneuvers during patient handling.