FDA.reportPublic FDA data

SynGenX®-1000

Primary DI
B039SGI03050
Brand
SynGenX®-1000
Company
Thermogenesis Corp.
Model
SGI-0305
Device description
SynGenX®-1000 Disposable Cartridge
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
B039SGI03051PackageHIBCC36In Commercial Distribution
B039SGI03059PackageHIBCC11In Commercial Distribution
B039SGI03050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord blood collection setA group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature7 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8443630709support@syngeninc.com

Regulatory Flags#

DUNS number
080690327
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
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
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
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