Dexcom Studio

GUDID 00386270000149

Dexcom Studio CD

Dexcom, Inc.

Percutaneous glucose monitoring system
Primary Device ID00386270000149
NIH Device Record Key36d9b318-15af-4628-b500-435c830960a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom Studio
Version Model NumberMT21360
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
GS100386270000149 [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 Date2014-09-12

On-Brand Devices [Dexcom Studio]

00386270000149Dexcom Studio CD
10386270000146Dexcom Studio Bundle

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