Identity
- Trade Name
- SynGen® DataTrak FDA UDI
- Generic Name
- Blood centrifugation system application software FDA UDI
- Device Name
- The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance. FDA UDI
- Model / Reference
- SGI-0777 FDA UDI
- Description
- The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B039SGI07770 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Blood centrifugation system application software 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood centrifugation system application software
SynGen® DataTrak by Thermogenesis Corp. — 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
- Thermogenesis Corp.
Sources (1)
- FDA UDI d1ae4a37-0a40-4cb1-9354-fe94cd03be45 33 fields · synced May 29, 2026