FDA product code OAG: Garment, Storage, Peritoneal Dialysis Catheter
OAG is the FDA product code for garment, storage, peritoneal dialysis catheter. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Gastroenterology and Urology panel. Devices under OAG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Garment, Storage, Peritoneal Dialysis Catheter |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for OAG devices
openFDA lists no recalls for product code OAG.
Frequently asked questions
What is FDA product code OAG?
OAG is the FDA product code for garment, storage, peritoneal dialysis catheter. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Gastroenterology and Urology panel.
What device class is OAG?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OAG
- Run a recall and safety report across every OAG manufacturer
- Watch product code OAG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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