Identity
- Trade Name
- SynGenX®-1000 FDA UDI
- Generic Name
- Umbilical cord blood collection set FDA UDI
- Device Name
- SynGenX®-1000 Disposable Cartridge FDA UDI
- Model / Reference
- SGI-0305 FDA UDI
- Description
- SynGenX®-1000 Disposable Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- B039SGI03050 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Umbilical cord blood collection set 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
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
Yes
FDA UDI
Category: Umbilical cord blood collection set
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 2e68f3a9-9295-4066-8dd1-b50966182bcd 35 fields · synced May 30, 2026