Identity
- Trade Name
- Sterile Specimen Cup with Temp Strip FDA UDI
- Generic Name
- Drug-testing urine specimen container IVD FDA UDI
- Device Name
- The urine collection cup is a sterile plastic cup with a temperature strip and leak-resistant lid with a capacity of 90mL. This product can be used for urine, blood, and semen sample testing. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The urine collection cup is a sterile plastic cup with a temperature strip and leak-resistant lid with a capacity of 90mL. This product can be used for urine, blood, and semen sample testing. FDA UDI
Identifiers
- Catalog Number
- DU3100 FDA UDI
- Primary DI / UDI-DI
- 00850014433239 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Drug-testing urine specimen container IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 90 Milliliter FDA UDI
Category: Drug-testing urine specimen container IVD
Sterile Specimen Cup with Temp Strip by Distribution Unlimited, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Distribution Unlimited, Llc
Sources (1)
- FDA UDI ada65324-a0a2-4d6f-a0f3-a5508ca50f51 35 fields · synced May 30, 2026