Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Test tube/reservoir cap IVD FDA UDI
- Device Name
- Sample Cup for 13 mm Tubes FDA UDI
- Model / Reference
- 1270013000 FDA UDI
- Description
- Sample Cup for 13 mm Tubes FDA UDI
Identifiers
- Catalog Number
- 1270013000 FDA UDI
- Primary DI / UDI-DI
- 20192253050896 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Test tube/reservoir cap IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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 — 1 Milliliter FDA UDI
Category: Test tube/reservoir cap IVD
Monoject by Cardinal Health 200, LLC — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI ea27a747-d97f-428c-9471-9ab3a79ce5f9 35 fields · synced Jun 8, 2026