Garment, Storage, Peritoneal Dialysis Catheter

What Is This Device?

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.

What Is FDA Product Code OAG?

Garment, Storage, Peritoneal Dialysis Catheter is FDA product code OAG, Class 1, 21 CFR 890.5050.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.