Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- Hydrogel Coated Latex Urine Meter Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Slip Sampling FDA UDI
- Model / Reference
- 7016C FDA UDI
- Description
- Hydrogel Coated Latex Urine Meter Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Slip Sampling FDA UDI
Identifiers
- Catalog Number
- 7016C FDA UDI
- Primary DI / UDI-DI
- 10884521001299 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
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
No
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 — 400 Milliliter FDA UDI
Category: Indwelling urethral catheterization kit, adult
Dover by Cardinalhealth — 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
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinal Health 200, LLC · 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
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter — 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
- Cardinalhealth
Sources (1)
- FDA UDI 3fa9dfd5-57dd-413f-af23-ed83ae6706f4 37 fields · synced Jun 1, 2026