| Primary Device ID | 04086000100120 |
| NIH Device Record Key | 9946c0a9-4901-41b8-b378-e95b2d34beb2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMICUS Separator |
| Version Model Number | 6R4580 |
| Catalog Number | 6R4580 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000100120 [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 | 2016-09-02 |
| 04086000100137 | Automated blood cell separator indicated for the collection of blood components and in therapeut |
| 04086000100120 | Automated blood cell separator indicated for the collection of blood components and in therapeut |
| 00810020440232 | The AMICUS Separator is an automated blood cell separator indicated for the collection of blood |
| 00810020440249 | The AMICUS Separator is an automated blood cell separator indicated for the collection of blood |
| 00810020440218 | The AMICUS Separator is an automated blood cell separator indicated for the collection of blood |