| Primary Device ID | 14086000101377 |
| NIH Device Record Key | c57053ee-1e01-482d-9797-d387a6d01f45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fenwal AMICUS Single Needle Advanced Kit |
| Version Model Number | 4R2353 |
| Catalog Number | 4R2353 |
| 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 Controlled Room Temperature. Protect from freezing. Avoid excessive heat. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000101370 [Primary] |
| GS1 | 14086000101377 [Package] Contains: 04086000101370 Package: Carton [3 Units] In Commercial Distribution |
| GKT | Separator, Automated, Blood Cell, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-02 |
| 10810020440512 - Adaptive Nomogram Transfer Pack | 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path |
| 00811505030450 - Ivenix Infusion System | 2024-12-16 Infusion Management System (IMS) |
| 00811505030467 - Ivenix Infusion System | 2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump) |
| 14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector | 2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol |
| 04086000860888 - COMPOGUARD Advance Basic | 2024-11-07 Device, Blood Mixing and Weighing |
| 04086000860895 - COMPOGUARD Advance Data | 2024-11-06 Device, Blood Mixing and Weighing |
| 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 |