Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Midstream urine specimen container IVD FDA UDI
- Device Name
- PEDIATRIC URINE SPECIMEN COLLECTOR, 100 ML FDA UDI
- Model / Reference
- 145501 FDA UDI
- Description
- PEDIATRIC URINE SPECIMEN COLLECTOR, 100 ML FDA UDI
Identifiers
- Catalog Number
- 145501 FDA UDI
- Primary DI / UDI-DI
- 10192253028980 FDA UDI
- FDA Product Code
- FFG FDA UDI
- GMDN Term
- Midstream urine specimen container IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1800 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter 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.
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC. · Class II
- 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 b807270a-1b31-47ca-b4a7-95de14ea150e 35 fields · synced Jun 8, 2026