Catalog Number

-

Brand Name

Element™ Meter

Version/Model Number

IGM-0021B

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

K113670

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

f922f389-fe8e-4cdc-8e32-36d24d2edf47

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-