Catalog Number

BMB-001S

Brand Name

Advocate Redi-Code+ Speaking Blood Glucose Meter

Version/Model Number

BMB-001S

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

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

5637e6df-81d9-468b-bc75-8965b34a556e

Public Version Date

November 09, 2020

Public Version Number

4

DI Record Publish Date

August 18, 2016

Package DI Number

20894046001886

Quantity per Package

50

Contains DI Package

00894046001882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BMB-001S-C