CryoSC-D Freezing Bag 10032

GUDID 7640125650396

Biosafe S.A.

Blood/tissue storage/culture container
Primary Device ID7640125650396
NIH Device Record Key113c7bfe-320a-4135-8c81-fd2b77f20faa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryoSC-D Freezing Bag
Version Model NumberFB-100.2
Catalog Number10032
Company DUNS488052341
Company NameBiosafe S.A.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41223652727
Emailsupport.biosafe@ge.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com
Phone+41848802810
Emailordersch@cytiva.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640125650389 [Primary]
GS17640125650396 [Package]
Contains: 07640125650389
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOFCryogenic Cord Blood Storage Container

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-13

Devices Manufactured by Biosafe S.A.

07640125650372 - CryoSC-S Freezing Bag2018-07-06
7640125650396 - CryoSC-D Freezing Bag2018-07-06
7640125650396 - CryoSC-D Freezing Bag2018-07-06
07640125650419 - CryoSC-Db Freezing Bag2018-07-06
07640125650495 - Traceability Labels for cryopreservation2018-07-06
07640125650501 - Traceability Labels for Bioarchive2018-07-06
07640125650518 - Overwrap Bag2018-07-06
07640125650549 - Metal Storage Canister2018-07-06
07640125650556 - Insertion Tool2018-07-06

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