Dexcom G4 SBT Transmitter

GUDID 00386270000125

G4 SBT Transmitter

Dexcom, Inc.

Percutaneous glucose monitoring system
Primary Device ID00386270000125
NIH Device Record Keyed472c03-6a0f-43db-8e7a-cefb32f400d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G4 SBT Transmitter
Version Model Number9438-05
Company DUNS123160736
Company NameDexcom, Inc.
Device Count1
DM Exempttrue
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 Datetrue
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
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 TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270000125 [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 Date2014-12-02

Devices Manufactured by Dexcom, Inc.

00386270004574 - Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-09-17 G7 GSS 15-day Sensor
00386270004727 - Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-09-17 G7 15 Day US Sample Pack
00386270004734 - Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-09-17 G7 15 Day US Retail Gov Sensor 1pk
00386270004741 - Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-09-17 G7 15 Day US Medicare Sensor 1pk
00386270004758 - Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-09-17 G7 15 Day US DME 1 Pack
00386270004765 - Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-09-17 G7 15 Day US Retail Sensor 1pk
00386270005168 - Dexcom G7 iOS Watch App2025-03-25 G7 iOS Watch App
00386270005175 - Dexcom G7 Wear OS Watch App2025-03-25 G7 Wear OS Watch App

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