| Primary Device ID | 00886368000957 |
| NIH Device Record Key | f23d25d0-0fb0-44e1-b5e7-845dd34179bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-WASH |
| Version Model Number | 80086 |
| Company DUNS | 080690327 |
| Company Name | Thermogenesis Corp. |
| Device Count | 2 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 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 |
| 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 | 00886368000940 [Primary] |
| GS1 | 00886368000957 [Unit of Use] |
| GS1 | 00886368001039 [Primary] |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
[00886368000957]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-12 |
| Device Publish Date | 2021-10-04 |
| 00886368000766 | X-WASH Control Module |
| 00886368000698 | X-WASH Disposable Cartridge |
| 00886368000957 | X-WASH Disposable Cartridge Copy |
| 00886368000995 | X-WASH Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() X-WASH 87637318 5526318 Live/Registered |
Thermogenesis Corp. 2017-10-06 |