Duns Number:315654579
Device Description: For Collection of Virtually Cell Free Plasma by Membrane Filtration. For Use with the AURO For Collection of Virtually Cell Free Plasma by Membrane Filtration. For Use with the AURORA Instrument or the AUTOPHERESIS-C Instrument. Sterile Fluid Path.
Catalog Number
4R2256
Brand Name
Fenwal PLASMACELL-C Disposable Set For Use With SPIKESMART System
Version/Model Number
4R2256
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
Yes
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,BK110072
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
22c87499-4f88-45db-a3be-9edb8c3d3cb8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
14086000101353
Quantity per Package
60
Contains DI Package
04086000101356
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |