Primary Device ID | 04086000101097 |
NIH Device Record Key | b2355055-0e62-47b4-9b44-d801b25d7ee2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PLASMACELL Xi Disposable Set with SPIKESMART |
Version Model Number | 6R2600 |
Catalog Number | 6R2600 |
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 | 04086000101097 [Primary] |
GS1 | 14086000101094 [Package] Package: Carton [24 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 | 2017-01-31 |
04086000101097 | For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile |
10810020441113 | For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile |