CryoSC-D Seal positioner 7026

GUDID 07640125650563

Biosafe S.A.

Blood centrifugation system containment kit 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 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: 07640125650563
• NIH Device Record Key: e627b402-aec9-4831-8a3e-445a37e2679a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoSC-D Seal positioner
• Version Model Number: CryoSC-D Seal positioner
• Catalog Number: 7026
• 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: false
• 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
• 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	07640125650563 [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
• 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