Primary Device ID | 04086000100236 |
NIH Device Record Key | 2b41ab1c-ca0c-4d6d-8c55-54eb29e3c6cd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aurora Plasmapheresis System |
Version Model Number | 6R4601 |
Catalog Number | 6R4601 |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04086000100236 [Primary] |
GKT | Separator, Automated, Blood Cell, Diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-05 |
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