| Primary Device ID | 14086000100950 |
| NIH Device Record Key | 4c7108ab-6000-4d09-a19e-fdd2107b5bb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector |
| Version Model Number | X6R2301 |
| Catalog Number | X6R2301 |
| 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 *Storage and Handling as defined on label |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000100953 [Primary] |
| GS1 | 14086000100950 [Package] Contains: 04086000100953 Package: Carton [6 Units] In Commercial Distribution |
| GKT | Separator, Automated, Blood Cell, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-01 |
| Device Publish Date | 2020-06-23 |
| 14086000100950 | AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector |
| 14086000100059 | For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in |