Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT FDA UDI
- Model / Reference
- 8946 FDA UDI
- Description
- HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT FDA UDI
Identifiers
- Catalog Number
- 8946 FDA UDI
- Primary DI / UDI-DI
- 10192253028539 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
Yes
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
- Catheter Gauge — 16 French FDA UDITotal 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.
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- 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 8c2b30bf-c059-4ffc-849e-62e11a5810e0 36 fields · synced Jun 8, 2026