Catalog Number

-

Brand Name

GE

Version/Model Number

333

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

da0634ae-38c0-40b8-9e42-c98b714916cc

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

November 01, 2018

Package DI Number

00883489001641

Quantity per Package

1

Contains DI Package

00883489001634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-