Dexcom G6 Sensor Applicator Assembly

GUDID 00386270000255

G6 Sensor Applicator Assembly

Dexcom, Inc.

Percutaneous glucose monitoring system
Primary Device ID00386270000255
NIH Device Record Keya89e24e1-d6da-4180-8147-e6d286ac6a72
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G6 Sensor Applicator Assembly
Version Model Number9500-45
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
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 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270000255 [Primary]
GS100386270000866 [Package]
Package: BOX [3 Units]
In Commercial Distribution
GS100386270001047 [Package]
Package: Box [3 Units]
In Commercial Distribution
GS140386270000253 [Package]
Package: BOX [1 Units]
In Commercial Distribution
GS150386270000250 [Package]
Package: BOX [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


[00386270000255]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-25

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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