| Primary Device ID | 04086000903226 |
| NIH Device Record Key | 9a1fbf1d-21bf-4549-94ec-09642f33a6cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fenwal Plasma Extractor |
| Version Model Number | 4R4414 |
| Catalog Number | 4R4414 |
| Company DUNS | 315654579 |
| Company Name | Fresenius Kabi AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| 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 *Per product labeling: When not in use, store in closed position. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000903226 [Primary] |
| GS1 | 14086000903223 [Package] Package: Carton [1 Units] In Commercial Distribution |
| KSS | Supplies, Blood-Bank |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-02 |
| Device Publish Date | 2020-06-24 |
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| 04250273750294 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
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