Identity
- Trade Name
- Vacuette FDA UDI
- Generic Name
- Luer-ended blood collection tube spike FDA UDI
- Device Name
- VACUETTE® SAFELINK Holder with male luer lock single-packed, not made with natural rubber latex FDA UDI
- Model / Reference
- 450210 FDA UDI
- Description
- VACUETTE® SAFELINK Holder with male luer lock single-packed, not made with natural rubber latex FDA UDI
Identifiers
- Catalog Number
- 450210 FDA UDI
- Primary DI / UDI-DI
- 19120049207487 FDA UDI
- 510(k) Number
- K180545 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Luer-ended blood collection tube spike FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
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
Category: Luer-ended blood collection tube spike
Vacuette by Greiner Bio-One GmbH — 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
- Greiner Bio-One GmbH
Sources (1)
- FDA UDI 3a2e2c60-bb1b-44a0-b7cc-d7d91aa05327 36 fields · synced Jun 8, 2026