FDA.reportPublic FDA data

Dexcom G6 iOS

Primary DI
00386270000804
Brand
Dexcom G6 iOS
Company
Dexcom, Inc.
Model
SW11677
Device description
G6 iOS
Published
2018-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBJIntegrated Continuous Glucose Monitoring System, Factory CalibratedClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170088000Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc.2018-03-27QBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270000804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270000804003862700008043862700008040386270000804

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous glucose monitoring systemAn assembly of portable, battery-powered devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It consists of a sterile, electrochemical, percutaneously-inserted electrode that connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-738-3646techsupport@dexcom.com

Regulatory Flags#

DUNS number
123160736
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386270005342Dexcom Therapeutic ServicesSW145532026-04-10
00386270005359Dexcom Therapeutic PortalSW144892026-04-10
00386270004857Stelo Glucose Biosensor (2pk)STP-XN-0032025-03-11
00386270004635Dexcom Stelo iOS Mobile AppSW141162024-08-15
00386270004642Dexcom Stelo Android Mobile AppSW141172024-08-15
00386270004659Dexcom Stelo iOS Watch AppSW141312024-08-15
00386270004338Stelo Biosensor9500-1742024-03-26
00386270004345Stelo Glucose Biosensor (1pk)STP-XN-0012024-03-26
00386270004383Stelo Glucose Biosensor (2pk)STP-XN-0022024-03-26
00386270004390Stelo Glucose Biosensor (1pk) UPCSTP-XN-0012024-03-26
00386270004406Stelo Glucose Biosensor (2pk) UPCSTP-XN-0022024-03-26
00386270004475Dexcom Follow 5 Android MobileSW142562025-10-10
00386270004482Dexcom Follow 5 iOS MobileSW142552025-10-10
00386270004802Dexcom Follow 5 iOS Watch Mobile AppSW145132025-10-10
00386270000323Dexcom ReceiverMT229492017-04-10
00386270004574Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System95102025-09-09
00386270004727Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTE-FT-0162025-09-09
00386270004734Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0102025-09-09
00386270004741Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0132025-09-09
00386270004758Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0112025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00357599880002InstinctABBOTT DIABETES CARE INCQBJ2025-09-22
30357599880003InstinctABBOTT DIABETES CARE INCQBJ2025-09-22
00386270004574Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004727Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004734Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004741Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004758Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00386270004765Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.QBJ2025-09-09
00357599820015FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-25
00357599835019FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599836016FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599842017FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-25
30357599835010FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
30357599836017FreeStyle Libre 2 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
30357599842018FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-25
00357599843014FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599844011FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2025-07-25
00357599821005FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-07-18
00357599821012FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-06-25
30357599821013FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2025-06-25
00386270005168Dexcom G7 iOS Watch AppDexcom, Inc.QBJ2025-03-17
00386270005175Dexcom G7 Wear OS Watch AppDexcom, Inc.QBJ2025-03-17
00357599840006Libre AppABBOTT DIABETES CARE INCQBJ2024-12-17
00357599841003Libre AppABBOTT DIABETES CARE INCQBJ2024-12-17
00357599844004FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2024-07-16
00357599843007FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2024-07-16
30357599844005FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2024-07-16
30357599843008FreeStyle Libre 3 PlusABBOTT DIABETES CARE INCQBJ2024-07-16
00386270004550Dexcom G7 GSS (1)Dexcom, Inc.QBJ2024-06-18
00357599842000FreeStyle Libre 3ABBOTT DIABETES CARE INCQBJ2023-12-01