Catalog Number

0089

Brand Name

Whole Blood Control

Version/Model Number

0089

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

LAS

Product Code Name

Drug Specific Control Materials

Public Device Record Key

247a4123-7c15-4317-b2e7-6620bdb98187

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Package DI Number

04250317515506

Quantity per Package

5

Contains DI Package

04250317544087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-