510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OAGClass I

Garment, Storage, Peritoneal Dialysis Catheter

21 CFR 890.5050 / Physical Medicine
FDA source (opens on fda.gov)

OAG is the FDA product code for Garment, Storage, Peritoneal Dialysis Catheter, a class I device type, regulated under 21 CFR 890.5050. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OAG
Device name
Garment, Storage, Peritoneal Dialysis Catheter
FDA 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.
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code