Dexcom G4 Platinum Sensor

GUDID 00386270000019

Sensor Applicator Assembly

Dexcom, Inc.

Percutaneous glucose monitoring system Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Primary Device ID	00386270000019
NIH Device Record Key	4278e5a5-eae6-4220-8e81-ae8b19a202af
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dexcom G4 Platinum Sensor
Version Model Number	9500-27
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	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
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 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
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386270000019 [Primary]
GS1	00386270000637 [Package] Package: 4 Pack (Medicare) [4 Units] In Commercial Distribution
GS1	20386270000013 [Package] Package: 4 Pack Retail [4 Units] In Commercial Distribution
GS1	30386270000010 [Package] Package: 4 Pack [4 Units] In Commercial Distribution

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

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

[00386270000019]

Radiation Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-09-04

Devices Manufactured by Dexcom, Inc.

00386270004338 - Stelo Biosensor	2024-04-03 Stelo Biosensor
00386270004345 - Stelo Glucose Biosensor (1pk)	2024-04-03 Stelo Glucose Biosensor US (1pk)
00386270004383 - Stelo Glucose Biosensor (2pk)	2024-04-03 Stelo Glucose Biosensor US (2pk)
00386270004390 - Stelo Glucose Biosensor (1pk) UPC	2024-04-03 Stelo Glucose Biosensor US (1pk)
00386270004406 - Stelo Glucose Biosensor (2pk) UPC	2024-04-03 Stelo Glucose Biosensor US (2pk)
00386270000378 - Dexcom G7 AR Overlay 10-Pack	2024-02-26 G7 AR Overlay 10-Pack
00386270004017 - Dexcom G7 Overpatch 10 Pack	2024-02-26 Dexcom G7 Overpatch 10 Pack
00386270003478 - Dexcom G7 Sample Pack (155)	2023-09-07 G7 Sample Pack US (1pk) - 155