Catalog Number

-

Brand Name

MCS+

Version/Model Number

09081-00

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

-

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

055e69e2-5828-49ad-bc90-6f3044e951ef

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 17, 2017

Package DI Number

20812747012482

Quantity per Package

1

Contains DI Package

10812747012485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-