Product code
OAG: Garment, storage, peritoneal dialysis catheter
FDA product code · Class I · Gastroenterology/Urology
Key facts
| Product code | OAG |
|---|---|
| Device | Garment, storage, peritoneal dialysis catheter |
| Device class | Class I |
| Regulation number | 890.5050 |
| Review panel | Gastroenterology/Urology |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database