Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Midstream urine specimen container IVD FDA UDI
- Device Name
- Urine Collection Kit FDA UDI
- Model / Reference
- 5204 FDA UDI
- Description
- Urine Collection Kit FDA UDI
Identifiers
- Catalog Number
- 5204 FDA UDI
- Primary DI / UDI-DI
- 10192253051612 FDA UDI
- FDA Product Code
- FCN FDA UDI
- GMDN Term
- Midstream urine specimen container IVD 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 4.5 Fluid Ounce FDA UDI
Category: Midstream urine specimen container IVD
Dover by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Midstream urine specimen container IVD.
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- Bioseal Inc. — BIOSEAL · Class I
- Dover — Cardinalhealth · Class I
- Medical Action Industries — MEDICAL ACTION INDUSTRIES INC. · Class I
- Bioseal Inc. — BIOSEAL · Class I
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 cb3228a4-b287-4f70-8fff-94fe4da3afc7 36 fields · synced Jun 8, 2026