Dexcom G7 Receiver

GUDID 00386270002518

G7 Receiver US

Dexcom, Inc.

Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID00386270002518
NIH Device Record Key4f2c12ae-7078-4343-a2af-9a5d132a1101
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G7 Receiver
Version Model NumberSTK-AT-012
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270002518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-07
Device Publish Date2023-03-30

On-Brand Devices [Dexcom G7 Receiver]

00386270002525G7 Receiver US (Medicare/Medicaid)
00386270002518G7 Receiver US
00386270002198G7 US DME Receiver
00386270002174G7 Receiver US HLA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.