thermogenesis.comAXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
THERMOGENESIS CORP.
ThermoGenesis Corp.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2950374 | 1000123765 | ThermoGenesis Corp. | 1 | N | 2026-01-01 | 2890 Kilgore Rd RANCHO CORDOVA CA US 95670 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00886368000001 | ThermoGenesis AXP - AXP II Refurbished Device | 9168585100 | customersupport@thermogenesis.com |
| 00886368000285 | AXP Freezing Bag Set - Freezing Bag Set | 9168585100 | customersupport@thermogenesis.com |
| 00886368000292 | AXP Freezing Bag Set - Freezing Bag Set | 9168585100 | customersupport@thermogenesis.com |
| 00886368000612 | ThermoGenesis AXP - AXP II Device | 9168585100 | customersupport@thermogenesis.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 51646 | 1814667406 | K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | JQC | 2008-07-10 |
| 51646 | 1048984614 | BK980038 | |||
| 51646 | 1203489020 | BK980030 | |||
| 51646 | 1781182321 | BK980027 | |||
| 51646 | 1572274889 | BK180198 | |||
| 51646 | 1287621192 | BK120061 | |||
| 51646 | 1907423787 | BK110040 | |||
| 51646 | 1787063549 | BK100066 | |||
| 51646 | 1179799523 | BK070006 | |||
| 51646 | 1158263069 | ||||
| 51646 | 1386222076 | ||||
| 51646 | 1518804821 | ||||
| 51646 | 1177858669 | ||||
| 51646 | 1594597914 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JQC | 1 | 2008-07-10 |
PMN#
CRYOSEAL FS APPLICATOR SYSTEM
THERMOGENESIS CORP.
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
THERMOGENESIS CORP.
GUDID#
ThermoGenesis AXP - AXP II Device
2023-09-14
ThermoGenesis AutoXpress - AXP II Docking Station
2023-09-14
ThermoGenesis AXP - AXP II Refurbished Device
2023-09-14
ThermoGenesis AXP - AXP II Device
2023-09-14
ThermoGenesis AutoXpress - AXP II Docking Station
2023-09-14
AXP Freezing Bag Set - Freezing Bag Set
2023-09-13
AXP Freezing Bag Set - Freezing Bag Set
2023-09-13
PXP - PXP Disposable Cartridge
2021-10-07
PXP - PXP Disposable Cartridge
2021-10-07
CryoPRO™-2 - CryoPRO™-2 Cryopreservation/Storage Bag Set
2016-09-24
CryoPRO™-5 - CryoPRO™-5 Cryopreservation/Storage Bag Set
2016-09-24
PXP-1000 - PXP-1000 Disposable Cartridge
2021-09-29
SynGenX®-1000 - SynGenX®-1000 Control Module
2016-09-24
SynGenX®-1000 - SynGenX®-1000 Docking Station
2016-09-24
SynGenX®-1000 - SynGenX®-1000 Disposable Cartridge
2016-09-24
SynGen® DataTrak - The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.
2016-09-24
X-LAB - X-LAB Docking Station
2021-10-04
X-Counterweight - X-Counterweight Low Packaged
2021-10-04
X-Counterweight - X-Counterweight Medium Packaged
2021-10-04
X-Counterweight - X-Counterweight High Packaged
2021-10-04
X-LAB - X-LAB Disposable Cartridge
2021-10-04
X-WASH - X-WASH Disposable Cartridge
2021-10-04
PXP - PXP Disposable Cartridge
2021-10-04
PXP - PXP Disposable Cartridge
2021-10-04
X-LAB - X-LAB Disposable Cartridge
2021-10-04
X-WASH - X-WASH Disposable Cartridge Copy
2021-10-04
3D Bag Set - 80105
2021-10-04
Thermogenesis Start Up Accessory Kit, MarrowXpress - 8-5142
2021-10-04
X-LAB - X-LAB Docking Station
2021-10-04
X-Balance Ring Kit - 80074
2021-10-04
X-Counterweight - X-Counterweight Low Packaged
2021-10-04
X-Counterweight - X-Counterweight Medium Packaged
2021-10-04
X-Counterweight - X-Counterweight High Packaged
2021-10-04
X-LAB - X-LAB Kit
2021-10-04
X-WASH - X-WASH Kit
2021-10-04
X-Counterweight - X-Counterweight Kit
2021-10-04
PXP - PXP Disposable Cartridge
2021-10-04
X-WASH - X-WASH Disposable Cartridge Copy
2021-10-04
X-WASH - X-WASH Disposable Cartridge
2021-10-01
X-LAB - X-LAB Control Module
2021-10-01