Identity
- Trade Name
- Genius Concentration System FDA UDI
- Generic Name
- Haematological concentrate system centrifuge FDA UDI
- Device Name
- Centrifuge FDA UDI
- Model / Reference
- 64002-09 FDA UDI
- Description
- Centrifuge FDA UDI
Identifiers
- Catalog Number
- G00001 FDA UDI
- Primary DI / UDI-DI
- M263G00001K0 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system centrifuge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Genius Concentration System by Dsm Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dsm Biomedical, Inc.
Sources (1)
- FDA UDI a89d1441-8107-4a08-be81-a8b4ee28884e 35 fields · synced May 30, 2026