Catalog Number

-

Brand Name

Coulter 6C Plus Cell Control

Version/Model Number

C07297

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JPK

Product Code Name

Mixture, Hematology Quality Control

Public Device Record Key

4c9b59b2-08c5-434a-80cd-8de2d9cfbbf5

Public Version Date

April 19, 2019

Public Version Number

1

DI Record Publish Date

April 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-