PermaLife™ Cell Culture Bag PL1000K

GUDID 10816203023701

PermaLife Cell Culture Bag, 1000ml, "K" Set

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container

• Primary Device ID: 10816203023701
• NIH Device Record Key: ada11caf-d4bb-4292-b350-4d138815c761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermaLife™ Cell Culture Bag
• Version Model Number: PL1000K
• Catalog Number: PL1000K
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	10816203023701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021702

FDA Product Code

• LPZ: Container, Frozen Donor Tissue Storage

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 [PermaLife™ Cell Culture Bag]

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• 10816203023701: PermaLife Cell Culture Bag, 1000ml, "K" Set
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• 10816203023688: PermaLife Cell Culture Bag, 500ml, "K" Set
• 10816203023671: PermaLife Cell Culture Bag, 120ml, "K" Set
• 10816203023664: PermaLife Cell Culture Bag, 70ml, "K" Set
• 10816203023657: PermaLife Cell Culture Bag, 30ml, "K" Set