SynGen® DataTrak
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Basic Information
- Brand Name
- SynGen® DataTrak
- Primary DI
- B039SGI07770
- Version / Model
- SGI-0777
- Company Name
- Thermogenesis Corp.
- Labeler DUNS
- 080690327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-10-13
- Public Version Status
- Update
- Public Device Record Key
- d1ae4a37-0a40-4cb1-9354-fe94cd03be45
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAO | Cord Blood Processing System And Storage Container | Hematology | 864.9900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60338 | Blood 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B039SGI07770 | HIBCC |