Catalog Number

-

Brand Name

Dexcom G5 Transmitter Kit

Version/Model Number

STT-GF-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P120005

Product Code

MDS

Product Code Name

Sensor, Glucose, Invasive

Public Device Record Key

065a01cc-a4bd-4403-a391-5e2ea5f27abd

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-