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SynGen® DataTrak
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.
Details
Device typeBlood centrifugation system application software: An application software program intended to enable the user to select parameters for specific system applications (protocols) within a blood centrifugation system. The system is a dedicated hardware platform designed for the automated processing of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), in a closed sterile environment using centrifugation to isolate constituent components (e.g., cells, plasma. The device typically includes upgrades to the software.
FDA categoryCord Blood Processing System And Storage Container
Device IDB039SGI07770
MRI safetyLabeling does not contain MRI Safety Information