← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

OAG — Garment, Storage, Peritoneal Dialysis Catheter

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.

DEVICE CLASS
Class I
REGULATION
21 CFR 890.5050
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
GU
— Implant— Life-sustaining✓ GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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