Dexcom G4 Platinum Sensor Kit 1PK US

GUDID 10386270000016

Sensor Kit 1 Pack US

Dexcom, Inc.

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Primary Device ID	10386270000016
NIH Device Record Key	276645c2-4c46-481c-8370-6d29e6b42451
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dexcom G4 Platinum Sensor Kit 1PK US
Version Model Number	STS-GL-011
Company DUNS	123160736
Company Name	Dexcom, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com
Phone	1-888-738-3646
Email	Techsupport@dexcom.com

Operating and Storage Conditions

Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386270000016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P120005

FDA Product Code

MDS	Sensor, Glucose, Invasive

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

[10386270000016]

Radiation Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-09-09
Device Publish Date	2014-09-10

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