Duns Number:315654579
Device Description: For Collection of Plasma by Membrane Filtration. For Use with the AUTOPHERESIS-C Instrumen For Collection of Plasma by Membrane Filtration. For Use with the AUTOPHERESIS-C Instrument. Sterile Fluid Path.
Catalog Number
4R2252
Brand Name
Fenwal PLASMACELL-C Disposable Set
Version/Model Number
4R2252
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
BP850001,BP850001
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
b94314a3-82e8-4ac0-8959-234655056129
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
14086000101452
Quantity per Package
60
Contains DI Package
04086000101455
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 |