Cryobag

GUDID 10816203020700

Cryobag, 14 x 28, Kapton/FEP

ORIGEN BIOMEDICAL, INC.

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

• Primary Device ID: 10816203020700
• NIH Device Record Key: e27ae550-9786-4e2d-afa2-d6b9363d0c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryobag
• Version Model Number: CB1428
• 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: 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	10816203020700 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-17
• Device Publish Date: 2016-09-23

On-Brand Devices [Cryobag]

• 10816203020700: Cryobag, 14 x 28, Kapton/FEP
• 10816203020694: Cryobag, 19 x 36, Kapton/FEP
• 10816203020687: Cryobag, 14 x 20, Kapton/FEP
• 10816203020656: Cryobag, 09x15, Kapton/FEP