AccessGUDID - DEVICE: SynGen® DataTrak (B039SGI07770)

GUDID

Device Identifier (DI) Information

Brand Name: SynGen® DataTrak
Version or Model: SGI-0777
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermogenesis Corp.

Primary DI Number: B039SGI07770
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080690327 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAO	Cord Blood Processing System And Storage Container

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1ae4a37-0a40-4cb1-9354-fe94cd03be45
Public Version Date: October 13, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016