| Primary Device ID | 00886368000797 |
| NIH Device Record Key | 31e1c408-f5c7-45e3-98ba-fedd0be941a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X- WASH |
| Version Model Number | 80070 |
| Company DUNS | 080690327 |
| Company Name | Thermogenesis Corp. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com | |
| Phone | 916-858-5100 |
| customerservice@thermogenesis.com |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 7 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886368000780 [Direct Marking] |
| GS1 | 00886368000797 [Primary] |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-11 |
| Device Publish Date | 2021-10-01 |
| 00886368000612 - ThermoGenesis AXP | 2023-09-22 AXP II Device |
| 00886368000667 - ThermoGenesis AutoXpress | 2023-09-22 AXP II Docking Station |
| 00886368000285 - AXP Freezing Bag Set | 2023-09-21 Freezing Bag Set |
| 00886368000605 - PXP | 2021-10-15 PXP Disposable Cartridge |
| 00886368000148 - 3D Bag Set | 2021-10-12 3D Bag Set |
| 00886368000551 - Thermogenesis Start Up Accessory Kit, MarrowXpress | 2021-10-12 Thermogenesis Start Up Accessory Kit, MarrowXpress |
| 00886368000742 - X-LAB | 2021-10-12 X-LAB Docking Station |
| 00886368000858 - X-Balance Ring Kit | 2021-10-12 X-Balance Ring Kit |