FDA.reportPublic FDA data

Thermogenesis BioArchive

Primary DI
00886368000582
Brand
Thermogenesis BioArchive
Company
Thermogenesis Corp.
Model
8-4000-1
Device description
BioArchive Device 220V
Published
2021-10-01
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886368000582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886368000582008863680005828863680005820886368000582

GMDN Terms#

Term, Definition table
TermDefinition
Ultralow-temperature laboratory freezerA mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
916-858-5100customerservice@thermogenesis.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886368000619ThermoGenesis AXP80056800562023-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886368000619ThermoGenesis AXPThermogenesis Corp.OAO2023-09-14
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
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