Identity
- Trade Name
- GENTLECATH AIR FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- GENTLECATH AIR MEN CH14 (1X30PK) US FDA UDI
- Model / Reference
- 510690 FDA UDI
- Description
- GENTLECATH AIR MEN CH14 (1X30PK) US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455196272 FDA UDI
- 510(k) Number
- K213283 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Length — 365 Millimeter FDA UDICatheter Gauge — 14 French FDA UDI
Category: Single-administration urethral drainage catheter
Gentlecath Air by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral drainage catheter.
- Bardex® Urethral Catheter Robinson Model — C. R. Bard, Inc. · Class II
- Self-Cath — Coloplast A/S · Class II
- Apogee Plus — Hollister Incorporated · Class II
- Magic3™ Intermittent Catheter — C. R. Bard, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Bard® Rubber Utility Catheter — C. R. Bard, Inc. · Class II
- Self-Cath — Coloplast A/S · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K213283 also covers:
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
- GENTLECATH AIR — CONVATEC, PURCHASING DEPARTMENT
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 7fe19480-37f1-49ea-a801-c30da55c6ab3 37 fields · synced Jun 8, 2026