FDA.reportPublic FDA data

Dexcom Follow 5 iOS Mobile

Primary DI
00386270004482
Brand
Dexcom Follow 5 iOS Mobile
Company
Dexcom, Inc.
Model
SW14255
Device description
Dexcom Follow app for iOS mobile devices
Published
2025-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJTContinuous Glucose Monitor Secondary Display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJTContinuous Glucose Monitor Secondary DisplayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140038000Dexcom Share Direct Secondary DisplaysDexcom, Inc.2015-01-23PJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386270004482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386270004482003862700044823862700044820386270004482

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically 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 and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

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
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
00386270004765Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemSTP-FT-0122025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B553202407OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2025-12-09
00386270004475Dexcom Follow 5 Android MobileDexcom, Inc.PJT2025-10-10
00386270004802Dexcom Follow 5 iOS Watch Mobile AppDexcom, Inc.PJT2025-10-10
00199150034130MiniMed Mobile AppMEDTRONIC MINIMED, INC.PJT2025-09-26
B553202258OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2025-05-29
B553202058OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PJT2024-12-27
00763000968175MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2024-09-30
00763000943264MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2024-07-28
00763000910150MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2024-03-08
00763000867638MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2023-11-27
00763000827793MiniMed™ MobileMEDTRONIC MINIMED, INC.PJT2023-05-20
00386270001917Dexcom Follow App for AndroidDexcom, Inc.PJT2023-05-16
00386270001931Dexcom Follow App for iOSDexcom, Inc.PJT2023-05-16
90850018992445t:connect Mobile Application, Mobile Bolus Enabled (Android)Tandem Diabetes Care, Inc.PJT2022-04-15
90850018992452t:connect Mobile Application, Mobile Bolus Enabled (iOS)Tandem Diabetes Care, Inc.PJT2022-04-15
00817491023490Eversense NOW Mobile App AndroidSENSEONICS, INCORPORATEDPJT2022-01-21
00357599824006LibreLinkUpABBOTT DIABETES CARE INCPJT2021-05-25
00850006613267t:connect Mobile Application (Android)Tandem Diabetes Care, Inc.PJT2019-12-18
00850006613274t:connect Mobile Application (iOS)Tandem Diabetes Care, Inc.PJT2019-12-18
00817491021267Eversense® NOW Mobile App iOSSENSEONICS, INCORPORATEDPJT2018-07-18