Double Spike Accessory 10043

GUDID 07640125650358

Sepax Kit Accessory

Biosafe S.A.

Blood centrifugation system containment kit
Primary Device ID07640125650358
NIH Device Record Key2b3ed28b-f2c6-40cc-9aeb-0b11712b1d2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDouble Spike Accessory
Version Model NumberFA-200.1
Catalog Number10043
Company DUNS488052341
Company NameBiosafe S.A.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640125650341 [Primary]
GS107640125650358 [Package]
Contains: 07640125650341
Package: [24 Units]

FDA Product Code

JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
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
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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