Crystore

GUDID 10816203022889

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 24

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container

• Primary Device ID: 10816203022889
• NIH Device Record Key: 2303392c-9b8f-4bbf-a495-a7dbba6cc0c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crystore
• Version Model Number: CS250N
• Company DUNS: 625272232
• Company Name: ORIGEN BIOMEDICAL, INC.
• Device Count: 4
• 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: 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
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com
• Phone: +1-512-474-7278
• Email: regulatory@origenbio.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not re-use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not resterilize

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816203022882 [Unit of Use]
GS1	10816203022889 [Primary]
GS1	20816203022886 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK030036

FDA Product Code

• KSR: Container, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-17
• Device Publish Date: 2016-09-23

Devices Manufactured by ORIGEN BIOMEDICAL, INC.

• 20816203021100 - CryoStore Freezing Bag: 2024-12-16 CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set
• 20816203022824 - Accessories: 2024-12-16 One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched
• 20816203023449 - Accessories: 2024-12-16 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
• 10816203023657 - PermaLife™ Cell Culture Bag: 2024-12-16 PermaLife Cell Culture Bag, 30ml, "K" Set
• 10816203023664 - PermaLife™ Cell Culture Bag: 2024-12-16 PermaLife Cell Culture Bag, 70ml, "K" Set
• 10816203023671 - PermaLife™ Cell Culture Bag: 2024-12-16 PermaLife Cell Culture Bag, 120ml, "K" Set
• 10816203023688 - PermaLife™ Cell Culture Bag: 2024-12-16 PermaLife Cell Culture Bag, 500ml, "K" Set
• 10816203023695 - PermaLife™ Cell Culture Bag: 2024-12-16 PermaLife Cell Culture Bag, 750ml, "K" Set