Catalog Number

STK-CR-001

Brand Name

Dexcom G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US

Version/Model Number

STK-CR-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

9b77196a-7bf1-4436-80a7-1ce722254147

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-