| Primary Device ID | 04086000101523 |
| NIH Device Record Key | 7a4ce3bf-522a-4599-8d96-0129558b469b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aurora Xi Plasmapheresis System |
| Version Model Number | 6R4612 |
| Catalog Number | 6R4612 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude 0 – 15000 feet |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000101523 [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 | 2017-03-02 |
| 04086000101967 | Aurora Xi Plasmapheresis System Software Version 1.2 |
| 04086000101523 | For collection of plasma by membrane filtration.For Use With the Plasmacell Xi Disposable Sets. |
| 00810020440898 | Software Version 1.3 for Aurora Xi |