Catalog Number

-

Brand Name

Dexcom G6 iOS

Version/Model Number

SW11677

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

DEN170088

Product Code

QBJ

Product Code Name

Integrated Continuous Glucose Monitoring System, Factory Calibrated

Public Device Record Key

b3709599-8667-4e9a-b502-457dd84b52ce

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

April 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-