AccessGUDID - DEVICE: Evolve (10816203020090)

GUDID

Device Identifier (DI) Information

Brand Name: Evolve
Version or Model: EV120 + F-M12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORIGEN BIOMEDICAL, INC.

Primary DI Number: 10816203020090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625272232 *Terms of Use

Device Description: 120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Blood/tissue storage/culture container	A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KJA	Flask, Tissue Culture

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 624f93d0-d04f-4aba-9bc8-d1845bc5d1bc
Public Version Date: June 17, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2016