Catalog Number

005

Brand Name

Advocate BMB Control Solutions High

Version/Model Number

005

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

5a9066d3-b20d-42e1-a86d-7c494f12c7ae

Public Version Date

August 31, 2020

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

20894046001602

Quantity per Package

1000

Contains DI Package

00894046001608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

005-C