Duns Number:315654579
Device Description: For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platel For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Catalog Number
4R2354G
Brand Name
AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly
Version/Model Number
4R2354G
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
BK150357,BK150357
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
9d647c71-bddd-4427-8d3b-7249962cbbe7
Public Version Date
October 28, 2020
Public Version Number
1
DI Record Publish Date
October 20, 2020
Package DI Number
10810020440147
Quantity per Package
3
Contains DI Package
00810020440140
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 |