| Primary Device ID | 00810020440300 |
| NIH Device Record Key | ddb48358-d4b5-44b0-9e3f-672bb175f07c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aurora Software Version 2.1C Upgrade |
| Version Model Number | Version 2.1C |
| Catalog Number | X6S4021USB |
| 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 | false |
| 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 | 00810020440300 [Primary] |
| GS1 | 10810020440307 [Package] Package: Carton [3 Units] In Commercial Distribution |
| GKT | Separator, Automated, Blood Cell, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-17 |
| Device Publish Date | 2021-06-09 |
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| 10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter | 2025-01-23 For the collection of blood components. Sterile Fluid Path |
| 10810020440512 - Adaptive Nomogram Transfer Pack | 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path |
| 00811505030450 - Ivenix Infusion System | 2024-12-16 Infusion Management System (IMS) |
| 00811505030467 - Ivenix Infusion System | 2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump) |
| 14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector | 2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol |