Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- Urine Drainage Bag Add-A-Foley Tray, Needle Sampling Port, 2000 mL FDA UDI
- Model / Reference
- 3515 FDA UDI
- Description
- Urine Drainage Bag Add-A-Foley Tray, Needle Sampling Port, 2000 mL FDA UDI
Identifiers
- Catalog Number
- 3515 FDA UDI
- Primary DI / UDI-DI
- 10192253027945 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 2000 Milliliter FDA UDI
Category: Indwelling urethral catheterization kit, adult
Dover by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral catheterization kit, adult.
- Bard® Drain Bag Foley Tray with Bardex® All-Silicone Catheter — C. R. Bard, Inc. · Class II
- Dover — Cardinalhealth · Class II
- Dover — Cardinalhealth · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinalhealth · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
- Bardex® I.C. Foley Catheter Tray — C. R. Bard, Inc. · Class II
- Medline — MEDLINE INDUSTRIES, 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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 964eccf7-1df4-443c-9bf2-c974a6bef348 36 fields · synced Jun 8, 2026