Dexcom G4 SBT Transmitter

GUDID 00386270000125

G4 SBT Transmitter

Dexcom, Inc.

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Primary Device ID	00386270000125
NIH Device Record Key	ed472c03-6a0f-43db-8e7a-cefb32f400d4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dexcom G4 SBT Transmitter
Version Model Number	9438-05
Company DUNS	123160736
Company Name	Dexcom, Inc.
Device Count	1
DM Exempt	true
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	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
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
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 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386270000125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120005

FDA Product Code

MDS	Sensor, Glucose, Invasive

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-12-02

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