Dexcom G5 Mobile IOS App

GUDID 00386270000002

G5 Mobile IOS App Stand Alone Software

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
Primary Device ID00386270000002
NIH Device Record Keya18e283a-14af-4759-ae5c-56d6e34e3b31
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G5 Mobile IOS App
Version Model NumberSW10611
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270000002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDSSensor, Glucose, Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-09

Devices Manufactured by Dexcom, Inc.

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00386270004383 - Stelo Glucose Biosensor (2pk)2024-04-03 Stelo Glucose Biosensor US (2pk)
00386270004390 - Stelo Glucose Biosensor (1pk) UPC2024-04-03 Stelo Glucose Biosensor US (1pk)
00386270004406 - Stelo Glucose Biosensor (2pk) UPC2024-04-03 Stelo Glucose Biosensor US (2pk)
00386270000378 - Dexcom G7 AR Overlay 10-Pack2024-02-26 G7 AR Overlay 10-Pack
00386270004017 - Dexcom G7 Overpatch 10 Pack2024-02-26 Dexcom G7 Overpatch 10 Pack
00386270003478 - Dexcom G7 Sample Pack (155)2023-09-07 G7 Sample Pack US (1pk) - 155

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