| Primary Device ID | 04086000901550 |
| NIH Device Record Key | 574d3266-5468-4759-95a6-a99527552009 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TPE Plasma Exchange Set |
| Version Model Number | 9400451 |
| Catalog Number | 9400451 |
| 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 | true |
| 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 |
| Phone | +31591355864 |
| wilma.hilhorst@fresenius-kabi. |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000901543 [Primary] |
| GS1 | 04086000901550 [Package] Contains: 04086000901543 Package: [5 Units] In Commercial Distribution |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-03 |
| Device Publish Date | 2016-09-16 |
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| 04086000860901 - COMPOGUARD Advance COMPLETE | 2024-11-06 Device, Blood Mixing and Weighing |
| 00810020440591 - AMICUS Separator Legacy Software | 2024-04-04 Software version for AMICUS Separator Legacy Device |
| 00810020440607 - AMICUS Separator Life Extension Software | 2024-04-04 Software version for AMICUS Separator Life Extension Device |
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