Dexcom G7 Overpatch 10 Pack

GUDID 00386270004017

Dexcom G7 Overpatch 10 Pack

Dexcom, Inc.

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 ID00386270004017
NIH Device Record Keyf5418cea-938a-454f-977a-90d96a721b7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G7 Overpatch 10 Pack
Version Model NumberMT-1000392
Company DUNS123160736
Company NameDexcom, Inc.
Device Count10
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270004017 [Unit of Use]
GS100386270004024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

Devices Manufactured by Dexcom, Inc.

00386270004338 - Stelo Biosensor2024-04-03 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) 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 Pack2024-02-26Dexcom G7 Overpatch 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

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