Overwrap Bag 4085

GUDID 07640125650518

Biosafe S.A.

Blood centrifugation system containment kit
Primary Device ID07640125650518
NIH Device Record Key950812b0-6339-41a0-845c-359224c7f392
Commercial Distribution StatusIn Commercial Distribution
Brand NameOverwrap Bag
Version Model NumberOverwrap Bag
Catalog Number4085
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640125650518 [Primary]
GS107640125650525 [Package]
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAOCord Blood Processing System And Storage Container

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-18

Devices Manufactured by Biosafe S.A.

07640125650372 - CryoSC-S 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
07640125650518 - Overwrap Bag2018-07-06
07640125650549 - Metal Storage Canister2018-07-06
07640125650556 - Insertion Tool2018-07-06

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