Evolve

GUDID 10816203020083

1000ml Cell Culture Bag, EVO film, "N" tube set, case of 12

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container

• Primary Device ID: 10816203020083
• NIH Device Record Key: b2bdbccd-0cc3-4a5e-8a21-c8a6f4f6b173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolve
• Version Model Number: EV1000N
• Company DUNS: 625272232
• Company Name: ORIGEN BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com
• Phone: 512-474-7278
• Email: regulatory@origen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203020083 [Primary]
GS1	20816203020080 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• KJA: Flask, Tissue Culture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-17
• Device Publish Date: 2016-09-23

On-Brand Devices [Evolve]

• 20816203021865: Evolve Tissue Culture Bag, 500-2000ml, "N" Tubing Set, case of 12
• 10816203021592: Evolve Tissue Culture Bag, 120ml, case of 20
• 10816203020090: 120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm
• 10816203020083: 1000ml Cell Culture Bag, EVO film, "N" tube set, case of 12