FDA.reportPublic FDA data

Eversense NOW Mobile App Android

Primary DI
00817491023490
Brand
Eversense NOW Mobile App Android
Company
SENSEONICS, INCORPORATED
Model
FG-5902-01-300
Catalog number
FG-5902-01-300
Device description
The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
Published
2022-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817491023490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817491023490008174910234908174910234900817491023490

GMDN Terms#

Term, Definition table
TermDefinition
Implantable 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 typically consists of a sterile, subcutaneously-implanted sensor with dedicated implantation devices (e.g., blunt dissector, introducer needle), and an externally worn 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 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
844-736-7348support@eversensediabetes.com

Regulatory Flags#

DUNS number
966865636
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817491024589Grafted Eversense 365 Sensor and Holder in Sealed Pouch, Global102606-3302026-04-14
00817491022882Eversense E3 Adhesive Patches Kit, 180-packFG-6500-01-300FG-6500-01-3002022-03-10
00817491022905Eversense E3 Insertion Tools KitFG-8300-01-201FG-8300-01-2012022-03-10
00817491022912Eversense E3 Smart Transmitter KitFG-5900-01-001FG-5900-01-0012022-03-10
00817491022929Eversense E3 Smart Transmitter Kit - RetailFG-5901-01-001FG-5901-01-0012022-03-10
00817491022936Eversense E3 Smart Transmitter Kit - Provider PurchaseFG-5902-01-001FG-5902-01-0012022-03-10
00817491022950Eversense E3 Sensor Kit - DMEFG-7200-00-301FG-7200-00-3012022-03-10
00817491022967Eversense E3 Sensor Kit - RetailFG-7201-00-301FG-7201-00-3012022-03-10
00817491022974Eversense E3 Sensor Kit – Provider PurchaseFG-7202-00-301FG-7202-00-3012022-03-10
00817491023063Eversense E3 Pouch Containing Sensor and Holder102095-81A2022-03-10
00817491023520Eversense Mobile App iOSFG-5501-02-300FG-5501-02-3002022-03-10
00817491023537Eversense Mobile App AndroidFG-5502-02-300FG-5502-02-3002022-03-10
00817491024794Eversense 365 Smart Transmitter Kit (DME)FG-4000-01-001FG-4000-01-0012026-02-25
00817491024800Eversense 365 Smart Transmitter Kit (Retail)FG-4001-01-001FG-4001-01-0012026-02-25
00817491024817Eversense 365 Smart Transmitter Kit (Provider Purchase)FG-4002-01-001FG-4002-01-0012026-02-25
00817491021298Eversense® Adhesive Patches, 30-Pack ClearFG-6401-01-300FG-6401-01-3002018-07-16
00817491023056Eversense Adhesive Patches, 10-pack WhiteFG-6404-01-3002022-03-10
00817491024046Eversense 365 Adhesive Patches KitFG-6700-01-300FG-6700-01-3002024-09-23
00817491024268Eversense 365 Mobile Application (iOS)FG-5503-06-300FG-5503-06-3002024-09-23
00817491024275Eversense 365 Mobile Application (Android)FG-5504-06-300FG-5504-06-3002024-09-23

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
00386270004482Dexcom Follow 5 iOS 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
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