| Primary Device ID | 04086000101097 |
| NIH Device Record Key | b2355055-0e62-47b4-9b44-d801b25d7ee2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLASMACELL Xi Disposable Set with SPIKESMART |
| Version Model Number | 6R2600 |
| Catalog Number | 6R2600 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 *Store at Room Temperature. Protect from freezing. Avoid excessive heat. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000101097 [Primary] |
| GS1 | 14086000101094 [Package] Package: Carton [24 Units] In Commercial Distribution |
| GKT | Separator, Automated, Blood Cell, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-31 |
| 04086000101097 | For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile |
| 10810020441113 | For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile |