Garment, Storage, Peritoneal Dialysis Catheter

OAG · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5050

Classification

FDA Product Code: OAG
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 890.5050
Review panel: GU
Medical specialty: Physical Medicine
Submission type: 4
GMP exempt: Y
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 13

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown