Identity
- Trade Name
- CONVATEC FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- 14FR Female Kit FDA UDI
- Model / Reference
- IPN050249 FDA UDI
- Description
- 14FR Female Kit FDA UDI
Identifiers
- Catalog Number
- 1712758 FDA UDI
- Primary DI / UDI-DI
- 14026704582430 FDA UDI
- 510(k) Number
- K010420 FDA UDI
- FDA Product Code
- KOD FDA UDI
- GMDN Term
- Indwelling urethral drainage balloon catheter, non-antimicrobial 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 11 Inch FDA UDIHeight — 0.5 Inch FDA UDIWidth — 6.5 Inch FDA UDI
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Convatec by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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Cleared under the same submission
K010420 also covers:
- CONVATEC — TELEFLEX INCORPORATED
- CONVATEC — TELEFLEX INCORPORATED
- CONVATEC — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 9ba84988-65b6-47e4-97b5-6f099bd03a0b 37 fields · synced May 31, 2026