Catalog Number

-

Brand Name

GE

Version/Model Number

Max Strip

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

K173638,K173638,K173638,K173638,K173638

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

5cbc2990-2ecc-4c73-b35f-ebeb6840a8d6

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

October 31, 2018

Package DI Number

20883489001744

Quantity per Package

12

Contains DI Package

10883489001747

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-