Counterweight, AXP 8-5104

GUDID 00886368000520

AXP Accessory

CESCA THERAPEUTICS INC.

Cryobiological storage container
Primary Device ID00886368000520
NIH Device Record Key308c97a1-7360-4f0c-a09a-b49d3cad8090
Commercial Distribution StatusIn Commercial Distribution
Brand NameCounterweight, AXP
Version Model Number8-5104
Catalog Number8-5104
Company DUNS175719335
Company NameCESCA THERAPEUTICS INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com
Phone916-858-5100
Emailcustomerservice@cescatherapeutics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100886368000520 [Primary]

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 Date2017-04-05

Devices Manufactured by CESCA THERAPEUTICS INC.

10886368000312 - MXP Processing Bagset2019-04-09 Cell separation processing and collection bag set.
00886368000353 - MXP Device2019-04-09 Cell separation processing device
00886368000384 - MXP Docking Station2019-04-09 Cell separation processing, docking station
00886368000391 - MXP Start Up Kit2019-04-09 Startup kit for the MXP System
10886368000305 - AXP Disposable Processing Bagset2018-07-06 Cord blood processing system and storage container
20886368000326 - QC Bagset2018-07-06 Utilized for quality control testing of the AXP Device.
00886368000346 - AXP Device2018-07-06 Cord blood processing system
00886368000360 - AXP Docking Station2018-07-06 Cord blood processing system docking station

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