| 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 |
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| 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 |
| 00810020440607 - AMICUS Separator Life Extension Software | 2024-04-04 Software version for AMICUS Separator Life Extension Device |
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| 04250273750218 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |