Dexcom G4 PLATINUM (Pediatric) Receiver with Share STK-CR-BLU

GUDID 20386270000204

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

Dexcom, Inc.

Percutaneous glucose monitoring system Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID20386270000204
NIH Device Record Keyae8a8c69-72fd-4213-b821-8e31821fe6fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G4 PLATINUM (Pediatric) Receiver with Share
Version Model NumberSTK-CR-BLU
Catalog NumberSTK-CR-BLU
Company DUNS123160736
Company NameDexcom, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com
Phone1-888-738-3646
Emailtechsupport@dexcom.com

Operating and Storage Conditions

Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 32 Percent (%) Relative Humidity and 113 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS120386270000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, Glucose, Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-02-27

On-Brand Devices [Dexcom G4 PLATINUM (Pediatric) Receiver with Share]

20386270000204G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US Blue
20386270000198G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US Pink
20386270000181G4 PLATINUM (Pediatric) Receiver with Share Kit (Retail) US Black

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