Dexcom G7 AR Overlay 10-Pack

GUDID 00386270000378

G7 AR Overlay 10-Pack

Dexcom, Inc.

Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID00386270000378
NIH Device Record Key9248259a-1a5c-42ab-9906-5a62b5aadbbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexcom G7 AR Overlay 10-Pack
Version Model NumberMT-1000564
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
GS100386270000378 [Unit of Use]
GS100386270000415 [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.

00386270004635 - Dexcom Stelo iOS Mobile App2024-08-23
00386270004642 - Dexcom Stelo Android Mobile App2024-08-23
00386270004659 - Dexcom Stelo iOS Watch App2024-08-23
00386270004550 - Dexcom G7 GSS (1)2024-06-26 G7 GSS US (1pk) -161 (Government Payor)
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)

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