AXP Sorval 11754 Bucket Pads 8-5155

GUDID 00886368000438

Thermogenesis Corp.

Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container Cryobiological storage container
Primary Device ID00886368000438
NIH Device Record Key44102ccb-d255-48fe-a69b-81c0ddb0749d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXP Sorval 11754 Bucket Pads
Version Model Number8-5155
Catalog Number8-5155
Company DUNS080690327
Company NameThermogenesis Corp.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100886368000438 [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 Number6
Public Version Date2021-01-21
Device Publish Date2017-04-05

Devices Manufactured by Thermogenesis Corp.

00886368000612 - ThermoGenesis AXP2023-09-22 AXP II Device
00886368000667 - ThermoGenesis AutoXpress2023-09-22 AXP II Docking Station
00886368000285 - AXP Freezing Bag Set2023-09-21 Freezing Bag Set
00886368000605 - PXP2021-10-15 PXP Disposable Cartridge
00886368000148 - 3D Bag Set2021-10-12 3D Bag Set
00886368000551 - Thermogenesis Start Up Accessory Kit, MarrowXpress2021-10-12 Thermogenesis Start Up Accessory Kit, MarrowXpress
00886368000742 - X-LAB2021-10-12 X-LAB Docking Station
00886368000858 - X-Balance Ring Kit2021-10-12 X-Balance Ring Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.