MXP Device 8-5139

GUDID 00886368000353

Cell separation processing device

CESCA THERAPEUTICS INC.

Haematological concentrate system preparation kit, bone marrow concentration
Primary Device ID00886368000353
NIH Device Record Key600a6c0a-dd51-4a08-aa5c-d6800272da85
Commercial Distribution StatusIn Commercial Distribution
Brand NameMXP Device
Version Model Number8-5139
Catalog Number8-5139
Company DUNS175719335
Company NameCESCA THERAPEUTICS INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *15 deg C to 30 deg C, Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100886368000353 [Primary]
GS110886368000350 [Package]
Package: Box [1 Units]
In Commercial Distribution

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 Number3
Public Version Date2019-04-09
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 Device2019-04-09Cell separation processing device
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.