OAG — Garment, Storage, Peritoneal Dialysis Catheter Class I
FDA product code OAG covers "Garment, Storage, Peritoneal Dialysis Catheter", a Class I medical device regulated under 21 CFR 890.5050. Submissions are reviewed by the Physical Medicine panel.
Classification Details
- Product Code
- OAG
- Device Class
- Class I
- Regulation Number
- 890.5050
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Physical Medicine
- Implant
- No
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.