CryoStore Freezing Bag CS250KS

GUDID 20816203023753

CryoStore 250 EVA Freezing Bag, 30-70ml, K Tube Set, double aseptically packed

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container

• Primary Device ID: 20816203023753
• NIH Device Record Key: 22c0d945-fbed-4dfd-9ff0-f30f74609e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoStore Freezing Bag
• Version Model Number: CS250KS
• Catalog Number: CS250KS
• Company DUNS: 625272232
• Company Name: ORIGEN BIOMEDICAL, 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: 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: +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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816203023756 [Primary]
GS1	20816203023753 [Package]; Contains: 10816203023756; Package: Carton [12 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-16
• Device Publish Date: 2024-12-06

On-Brand Devices [CryoStore Freezing Bag]

• 20816203023753: CryoStore 250 EVA Freezing Bag, 30-70ml, K Tube Set, double aseptically packed
• 20816203021100: CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set