SynGen® DataTrak

GUDID B039SGI07770

The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC

SYNGEN INC.

Blood centrifugation system application software

• Primary Device ID: B039SGI07770
• NIH Device Record Key: d1ae4a37-0a40-4cb1-9354-fe94cd03be45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynGen® DataTrak
• Version Model Number: SGI-0777
• Company DUNS: 078487711
• Company Name: SYNGEN INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B039SGI07770 [Primary]

FDA Product Code

• OAO: Cord Blood Processing System And Storage Container

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by SYNGEN INC.

• B039SGI0120010 - SynGenX®-1000: 2020-02-06 SynGenX®-1000 Docking Station
• B039SGI03050 - SynGenX®-1000: 2019-09-23 SynGenX®-1000 Disposable Cartridge
• B039SGI0046010 - SynGenX®-1000: 2018-03-29 SynGenX®-1000 Control Module
• B039SGI00911 - CryoPRO™-2: 2018-03-29 CryoPRO™-2 Cryopreservation/Storage Bag Set
• B039SGI04421 - CryoPRO™-5: 2018-03-29 CryoPRO™-5 Cryopreservation/Storage Bag Set
• B039SGI07770 - SynGen® DataTrak: 2018-03-29The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC
• B039SGI07770 - SynGen® DataTrak: 2018-03-29 The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000