Identity
- Trade Name
- Closed Circuit Foley Catheter FDA UDI
- Generic Name
- Urethral catheterization support kit, urinary drainage FDA UDI
- Device Name
- Closed Circuit Foley Catheter, Sterile 14 Fr. FDA UDI
- Model / Reference
- 5005 FDA UDI
- Description
- Closed Circuit Foley Catheter, Sterile 14 Fr. FDA UDI
Identifiers
- Catalog Number
- 5005 FDA UDI
- Primary DI / UDI-DI
- 00860008059574 FDA UDI
- FDA Product Code
- OHR FDA UDI
- GMDN Term
- Urethral catheterization support kit, urinary drainage 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
No
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: Urethral catheterization support kit, urinary drainage
Closed Circuit Foley Catheter by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral catheterization support kit, urinary drainage.
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber — C. R. Bard, Inc. · Class II
- Bardia® Foley Catheter Insertion Tray — C. R. Bard, Inc. · Class II
- Bard® Add-A-Foley Tray with Bard EZ-LOK® Sampling Port — C. R. Bard, Inc. · Class II
- NEOMED* — Avanos Medical, Inc. · Class II
- Bard® Foley Catheterization Tray — C. R. Bard, Inc. · Class II
- Bard® Foley Catheterization Tray Uro-Prep™ Tray — C. R. Bard, Inc. · Class II
- ADDTO — ADDTO, INC. · Class I
- Bardia® Foley Catheter Insertion Tray — C. R. Bard, 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
- Dynarex Corp.
Sources (1)
- FDA UDI c158a6f2-5a8e-43c1-a35d-f59059759be4 34 fields · synced May 30, 2026