Catalog Number

99GS291I51

Brand Name

ODM

Version/Model Number

iGlucose test strips

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161790,K161790,K161790,K161790,K161790

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

85cb07ac-4b70-4d4b-be50-ec5fea6656d4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 19, 2017

Package DI Number

00883489001559

Quantity per Package

2

Contains DI Package

00883489001542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box