| Primary Device ID | 04086000101950 |
| NIH Device Record Key | d414ac03-5718-4198-87f8-5d080b5c99f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMICUS Exchange Kit - Therapeutics |
| Version Model Number | X6R2349 |
| Catalog Number | X6R2349 |
| 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 *Store at room temperature. Protect from freezing. Avoid excessive heat. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000101950 [Primary] |
| GS1 | 14086000101957 [Package] Package: Shipping Carton [6 Units] In Commercial Distribution |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-20 |
| 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 |
| 04250273750164 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 04250273750218 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 04250273750287 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 04250273750294 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual | 2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol |
| 10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual | 2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F |