Identity
- Trade Name
- Biotronix Healthcare Urethral Catheter Trays FDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Device Name
- Intermittent Urethral Catheter Tray 14FR, PVC FDA UDI
- Model / Reference
- UR22014 FDA UDI
- Description
- Intermittent Urethral Catheter Tray 14FR, PVC FDA UDI
Identifiers
- Catalog Number
- UR22014 FDA UDI
- Primary DI / UDI-DI
- 00850005165019 FDA UDI
- FDA Product Code
- OHR FDA UDI
- GMDN Term
- Intermittent urethral catheterization kit 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent urethral catheterization kit
Biotronix Healthcare Urethral Catheter Trays by Biotronix Healthcare Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral catheterization kit.
- TruCath — H R Pharmaceuticals, Inc. · Class II
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- AMSure® Add-A-Foley Catheter Tray — AMSINO INTERNATIONAL, INC. · Class II
- GLOBAL HEALTHCARE — GHC HEALTHCARE, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- AMSure® Pre-Connected Urethral Tray — AMSINO INTERNATIONAL, INC. · Class II
- TruCath — H R Pharmaceuticals, Inc. · Class II
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
- Biotronix Healthcare Industries Inc.
Sources (1)
- FDA UDI 2f55dc3a-10aa-4fa1-8e88-945405a1b6af 36 fields · synced May 30, 2026