Garment, Storage, Peritoneal Dialysis Catheter
The Garment, Storage, Peritoneal Dialysis Catheter (product code OAG) is a wearable garment designed to store the external portion of a peritoneal dialysis catheter between treatment sessions, while supporting, stabilizing, and improving care and cleanliness of the catheter and reducing the need for adhesive tape on the skin. It is classified as FDA Class 1, GMP-exempt, and regulated under 21 CFR 890.5050 within the Physical Medicine specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAG
- Device Class
- FDA class 1
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.