Duns Number:315654579
Device Description: Automated blood cell separator indicated for the collection of blood components and in the Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Catalog Number
6R4580R
Brand Name
AMICUS Separator
Version/Model Number
6R4580R
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
-
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
BK030085,BK080018,BK080048,BK090058,BK100044,BK110030,BK120018,BK120041,BK960005,K141019,K162462
Product Code
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
a9c53cd0-f0ca-441c-ba5b-0e41a87d4b59
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |