Duns Number:315654579
Device Description: For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Catalog Number
4R2367
Brand Name
Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed
Version/Model Number
4R2367
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
BK150288,BK160112,BK150288,BK160112
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
9c1f7fba-44be-45c5-8627-9e1eba6c0767
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
14086000100998
Quantity per Package
6
Contains DI Package
04086000100991
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 |