| Primary Device ID | 04086000101516 |
| NIH Device Record Key | 81c0f603-710d-43b7-a894-02df31104688 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aurora Xi Software |
| Version Model Number | 1.1 |
| Company DUNS | 315654579 |
| Company Name | Fresenius Kabi AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000101516 [Primary] |
| GKT | Separator, Automated, Blood Cell, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-12-18 |
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| 04086000860901 - COMPOGUARD Advance COMPLETE | 2024-11-06 Device, Blood Mixing and Weighing |
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