Product code OAG

Device name

Garment, Storage, Peritoneal Dialysis Catheter

Medical specialty

Physical Medicine

Device class

1

Regulation number

890.5050

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

Y

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset