FDA.reportPublic FDA data

ThermoGenesis AXP

Primary DI
10886368000619
Brand
ThermoGenesis AXP
Company
Thermogenesis Corp.
Model
80056
Catalog number
80056
Device description
AXP II Device
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAOCord Blood Processing System And Storage Container

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAOCord Blood Processing System And Storage ContainerHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1801980

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1801980

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886368000612Direct MarkingGS10
10886368000619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886368000612008863680006128863680006120886368000612
1088636800061910886368000619

GMDN Terms#

Term, Definition table
TermDefinition
Blood centrifugation system containment kitA collection of sterile devices that is a component of a blood centrifugation system intended to be used during the centrifugation of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), to automatically isolate constituent components (e.g., cells, plasma). The kit is not donor or patient connected and is placed in the centrifuge of the processing unit. It includes a centrifugation chamber into which blood is introduced and sedimented into its components during centrifugation, a stopcock manifold and tubing intended to direct and control the sequential movement of each component, and collection containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9168585100customersupport@thermogenesis.com

Regulatory Flags#

DUNS number
080690327
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886368000664ThermoGenesis AutoXpress80055800552023-09-14
00886368000001ThermoGenesis AXP80056-RFB80056-RFB2023-09-14
00886368000612ThermoGenesis AXP80056800562023-09-14
00886368000667ThermoGenesis AutoXpress80055800552023-09-14
00886368000292AXP Freezing Bag Set80135801352023-09-13
00886368000285AXP Freezing Bag Set80135801352023-09-13
00886368000711PXP800632021-10-07
00886368000605PXP800632021-10-07
B039SGI00910CryoPRO™-2SGI-00912016-09-24
B039SGI04420CryoPRO™-5SGI-04422016-09-24
00886368000094PXP-1000801002021-09-29
B039SGI0046010SynGenX®-1000SGI-0046-012016-09-24
B039SGI0120010SynGenX®-1000SGI-0120-012016-09-24
B039SGI03050SynGenX®-1000SGI-03052016-09-24
B039SGI07770SynGen® DataTrakSGI-07772016-09-24
00886368000759X-LAB800692021-10-04
00886368000872X-Counterweight800732021-10-04
00886368000896X-Counterweight800792021-10-04
00886368000919X-Counterweight800802021-10-04
00886368000926X-LAB800832021-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886368000664ThermoGenesis AutoXpressThermogenesis Corp.OAO2023-09-14
00886368000001ThermoGenesis AXPThermogenesis Corp.OAO2023-09-14
00886368000612ThermoGenesis AXPThermogenesis Corp.OAO2023-09-14
00886368000667ThermoGenesis AutoXpressThermogenesis Corp.OAO2023-09-14
00886368000292AXP Freezing Bag SetThermogenesis Corp.OAO2023-09-13
00886368000285AXP Freezing Bag SetThermogenesis Corp.OAO2023-09-13
00861880000333PrepaCyte-CB 500CRYO-CELL INTERNATIONAL, INC.OAO2022-01-21
00886368000711PXPThermogenesis Corp.OAO2021-10-07
00886368000605PXPThermogenesis Corp.OAO2021-10-07
00886368000964PXPThermogenesis Corp.OAO2021-10-04
00886368001015PXPThermogenesis Corp.OAO2021-10-04
00886368000155PXPThermogenesis Corp.OAO2021-10-04
00886368000056PXP-1000Thermogenesis Corp.OAO2021-10-01
00886368000193PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000209PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000216PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000223PXP-LAVAREThermogenesis Corp.OAO2021-10-01
00886368000582Thermogenesis BioArchiveThermogenesis Corp.OAO2021-10-01
00886368000971PXPThermogenesis Corp.OAO2021-10-01
00886368000117PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000636PXPThermogenesis Corp.OAO2021-09-29
00886368000650PXPThermogenesis Corp.OAO2021-09-29
00886368000070PXP-1000 Docking StationThermogenesis Corp.OAO2021-09-29
00886368000094PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000100PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000087PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000124PXP-1000Thermogenesis Corp.OAO2021-09-29
00886368000186PXP-LAVAREThermogenesis Corp.OAO2021-09-29
00886368000544Thermogenesis Start Up Accessory Kit, AXPThermogenesis Corp.OAO2021-09-29
00886368000629PXPThermogenesis Corp.OAO2021-09-29