CryoSC-D Freezing Bag 10032

GUDID 7640125650396

Biosafe S.A.

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

• Primary Device ID: 7640125650396
• NIH Device Record Key: 113c7bfe-320a-4135-8c81-fd2b77f20faa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoSC-D Freezing Bag
• Version Model Number: FB-100.2
• Catalog Number: 10032
• Company DUNS: 488052341
• Company Name: Biosafe S.A.
• 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: true
• 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: +41223652727
• Email: support.biosafe@ge.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com
• Phone: +41848802810
• Email: ordersch@cytiva.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640125650389 [Primary]
GS1	7640125650396 [Package]; Contains: 07640125650389; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK090037

FDA Product Code

• OOF: Cryogenic Cord Blood Storage Container

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: 2018-07-06
• Device Publish Date: 2017-01-13

Devices Manufactured by Biosafe S.A.

• 07640125650372 - CryoSC-S Freezing Bag: 2018-07-06
• 7640125650396 - CryoSC-D Freezing Bag: 2018-07-06
• 7640125650396 - CryoSC-D Freezing Bag: 2018-07-06
• 07640125650419 - CryoSC-Db Freezing Bag: 2018-07-06
• 07640125650495 - Traceability Labels for cryopreservation: 2018-07-06
• 07640125650501 - Traceability Labels for Bioarchive: 2018-07-06
• 07640125650518 - Overwrap Bag: 2018-07-06
• 07640125650549 - Metal Storage Canister: 2018-07-06
• 07640125650556 - Insertion Tool: 2018-07-06