Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE FDA UDI
- Model / Reference
- P4P16SD FDA UDI
- Description
- 100% SILICONE 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE FDA UDI
Identifiers
- Catalog Number
- P4P16SD FDA UDI
- Primary DI / UDI-DI
- 10192253031805 FDA UDI
- FDA Product Code
- PPG FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult 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
Dimensions & Sizes
- Size
- Total Volume — 400 Milliliter FDA UDICatheter Gauge — 16 French 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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- 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 71af8c4c-b2c9-4e46-b72b-bbab048b185e 36 fields · synced Jun 8, 2026