Identity
- Trade Name
- Vacuette FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, sodium citrate FDA UDI
- Device Name
- VACUETTE® TUBE 9 ml 9NC Coagulation sodium citrate 3,8% 16x100 blue cap-black ring, non-ridged FDA UDI
- Model / Reference
- 455382 FDA UDI
- Description
- VACUETTE® TUBE 9 ml 9NC Coagulation sodium citrate 3,8% 16x100 blue cap-black ring, non-ridged FDA UDI
Identifiers
- Catalog Number
- 455382 FDA UDI
- Primary DI / UDI-DI
- 29120017574860 FDA UDI
- 510(k) Number
- K971221 FDA UDI
- FDA Product Code
- GIM FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, sodium citrate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Vacuette by Greiner Bio-One GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Greiner Bio-One GmbH
Sources (1)
- FDA UDI 1647041b-795a-482d-9f95-516e36359767 37 fields · synced May 30, 2026