Catalog Number

-

Brand Name

Meijer Essential Wireless Blood Glucose Meter

Version/Model Number

8000-10578

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

f25c859e-0996-4eaa-abf8-cb32e4ef1f96

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

August 31, 2017

Package DI Number

20713733405243

Quantity per Package

12

Contains DI Package

00713733405249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper