Duns Number:315654579
Device Description: For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Pa
Catalog Number
X6R2326
Brand Name
Amicus MNC Apheresis Kit - Double Needle
Version/Model Number
X6R2326
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
BK000047,BK000047
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
c2acaef4-7581-4891-8e04-a586154d485d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
14086000100141
Quantity per Package
6
Contains DI Package
04086000100144
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 |