AccessGUDID - DEVICE: SynGenX®-1000 (B039SGI0046010)

GUDID

Device Identifier (DI) Information

Brand Name: SynGenX®-1000
Version or Model: SGI-0046-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermogenesis Corp.

Primary DI Number: B039SGI0046010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080690327 *Terms of Use

Device Description: SynGenX®-1000 Control Module

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?
61618	Blood component separator, automated	A mains electricity (AC-powered) device designed for the automated separation of whole blood or previously centrifuged blood into components [e.g., red blood cells (RBCs), platelets, leukocytes] for further processing or storage. It is a programmable device with a user interface that uses a mechanical separation method (e.g., pressure plates, microfluidics) to transfer the blood component(s) from the donor bag into a removable disposable receptacle. It may have additional features such as sensors, scales, and an automatic mechanism for opening the valve(s) on the donor bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected.	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
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4362df2a-39d6-4cad-b972-e9f1d3008b04
Public Version Date: October 13, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B039SGI0046011	1	B039SGI0046010		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8443630709
Email: support@syngeninc.com

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