Dexcom G4 Platinum Sensor US

GUDID 00386270000033

Sensor Applicator Assembly Automation

Dexcom, Inc.

Percutaneous glucose monitoring system
Primary Device ID00386270000033
NIH Device Record Key41a0bd3b-4ff4-4291-b613-d4e4216d3843
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G4 Platinum Sensor US
Version Model Number9500-39
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270000033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, Glucose, Invasive

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

[00386270000033]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-04

Devices Manufactured by Dexcom, Inc.

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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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