Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- Closed Urethral Tray with Vinyl Catheter,14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag FDA UDI
- Model / Reference
- 3420 FDA UDI
- Description
- Closed Urethral Tray with Vinyl Catheter,14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag FDA UDI
Identifiers
- Catalog Number
- 3420 FDA UDI
- Primary DI / UDI-DI
- 10884521009455 FDA UDI
- FDA Product Code
- FCM 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
- Not 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
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 — 14 French FDA UDITotal Volume — 1000 Milliliter FDA UDI
Dover by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 0af7f90e-606d-4067-9cbe-57792221aff5 37 fields · synced Jun 8, 2026