Catalog Number

X6R2302

Brand Name

AMICUS Apheresis Kit – Double Needle with Platelet Additive Solution Connector

Version/Model Number

X6R2302

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

BK160112,BK160112

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Public Device Record Key

99c700a6-3ece-4ad9-aa6d-be630581dda9

Public Version Date

July 01, 2020

Public Version Number

1

DI Record Publish Date

June 23, 2020

Package DI Number

14086000100967

Quantity per Package

6

Contains DI Package

04086000100960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton