Identity
- Trade Name
- SynGenX®-1000 FDA UDI
- Generic Name
- Blood component separator, automated FDA UDI
- Device Name
- SynGenX®-1000 Control Module FDA UDI
- Model / Reference
- SGI-0046-01 FDA UDI
- Description
- SynGenX®-1000 Control Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- B039SGI0046010 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Blood component separator, automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Commercial Distribution
- 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood component separator, automated
SynGenX®-1000 by Thermogenesis Corp. — 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
- Thermogenesis Corp.
Sources (1)
- FDA UDI 4362df2a-39d6-4cad-b972-e9f1d3008b04 35 fields · synced May 29, 2026