Identity
- Trade Name
- Insertion Tool FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Model / Reference
- Insertion Tool FDA UDI
Identifiers
- Catalog Number
- 7030 FDA UDI
- Primary DI / UDI-DI
- 07640125650556 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Blood centrifugation system containment kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Insertion Tool by Biosafe S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
BK090037 also covers:
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
- Biosafe S.A.
Sources (1)
- FDA UDI 1c40d890-f2d4-4a35-b8c9-640162df8153 36 fields · synced Jun 1, 2026