| Primary Device ID | 00886368000674 |
| NIH Device Record Key | 51849f70-edc5-4a7b-91a5-e28dd10f6f2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-LAB |
| Version Model Number | 80060 |
| Company DUNS | 080690327 |
| Company Name | Thermogenesis Corp. |
| Device Count | 36 |
| 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 | 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 |
| 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 | 00886368000674 [Unit of Use] |
| GS1 | 00886368000681 [Primary] |
| GS1 | 00886368000926 [Primary] |
| GS1 | 00886368001022 [Primary] |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
[00886368000674]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-07 |
| Device Publish Date | 2021-09-29 |
| 00886368000674 | X-LAB Disposable Cartridge |
| 00886368000933 | X-LAB Disposable Cartridge |
| 00886368000728 | X-LAB Control Module |
| 00886368000988 | X-LAB Kit |
| 00886368000742 | X-LAB Docking Station |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() X-LAB 87637311 5591637 Live/Registered |
Thermogenesis Corp. 2017-10-06 |
![]() X-LAB 87382662 not registered Live/Pending |
Sagar Distribution LLC 2017-03-23 |