OAG

Garment, Storage, Peritoneal Dialysis Catheter

Product code: OAG
Device name: Garment, Storage, Peritoneal Dialysis Catheter
Device class: Class 1
21 CFR: 21 CFR 890.5050
Medical specialty: Physical Medicine
Marketing pathway: 510(K) Exempt
Flag: GMP exempt

FDA classification definition

To store the external peritoneal catheter portion between treatment sessions and to support, stabilize, and improve the care and cleanliness of the peritoneal catheter and reduce the need to use tape on the skin.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OAG

Classification and pathway per current FDA publications. Data from openFDA (CC0).