| Primary Device ID | 00810020440232 |
| NIH Device Record Key | bfd7adbe-ead9-44c9-8a76-257c8b4c13c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMICUS Separator |
| Version Model Number | 6R4590TH-T |
| Catalog Number | 6R4590TH-T |
| 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 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Handling as defined on Label |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810020440232 [Primary] |
| 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 | 2020-10-28 |
| Device Publish Date | 2020-10-20 |
| 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 |