Traceability Labels for cryopreservation 7011

GUDID 07640125650495

Biosafe S.A.

Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit Blood centrifugation system containment kit

• Primary Device ID: 07640125650495
• NIH Device Record Key: 70af8243-c130-44b0-8cf2-13cbc13867e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traceability Labels for cryopreservation
• Version Model Number: Traceability Labels for cryopreservation
• Catalog Number: 7011
• 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: false
• Serial Number: false
• 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: +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
• 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	07640125650495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK090037

FDA Product Code

• OAO: Cord Blood Processing System And Storage Container

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-18

Devices Manufactured by Biosafe S.A.

• 07640125650372 - CryoSC-S 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
• 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