Stelo Glucose Biosensor (2pk) UPC

GUDID 00386270004406

Stelo Glucose Biosensor US (2pk)

Dexcom, Inc.

Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Primary Device ID00386270004406
NIH Device Record Keyc67643aa-a34d-46c3-89be-e8f49a287f23
Commercial Distribution StatusIn Commercial Distribution
Brand NameStelo Glucose Biosensor (2pk) UPC
Version Model NumberSTP-XN-002
Company DUNS123160736
Company NameDexcom, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100386270004406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-03
Device Publish Date2024-03-26

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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