Duns Number:315654579
Device Description: Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.
Catalog Number
6R4601
Brand Name
Aurora Plasmapheresis System
Version/Model Number
6R4601
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK110072,BK160012
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
2b41ab1c-ca0c-4d6d-8c55-54eb29e3c6cd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |