Catalog Number

BMB003

Brand Name

Advocate Control Solutions Low

Version/Model Number

003

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

4213e192-00b3-4793-9359-dd7f83ea964a

Public Version Date

September 02, 2020

Public Version Number

5

DI Record Publish Date

August 19, 2016

Package DI Number

20894046001589

Quantity per Package

1000

Contains DI Package

00894046001585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

003-C