FDA.reportPublic FDA data

Eversense 365 Mobile Application (Android)

Primary DI
00817491024275
Brand
Eversense 365 Mobile Application (Android)
Company
SENSEONICS, INCORPORATED
Model
FG-5504-06-300
Catalog number
FG-5504-06-300
Device description
Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
Published
2024-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone AcetateClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241335000Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated2024-09-16SBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817491024275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817491024275008174910242758174910242750817491024275

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
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
00817491023605Eversense® Mobile App iOSFG-5501-01-300FG-5501-01-3002022-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817491024589Grafted Eversense 365 Sensor and Holder in Sealed Pouch, GlobalSENSEONICS, INCORPORATEDSBA2026-04-14
00817491024794Eversense 365 Smart Transmitter Kit (DME)SENSEONICS, INCORPORATEDSBA2026-02-25
00817491024800Eversense 365 Smart Transmitter Kit (Retail)SENSEONICS, INCORPORATEDSBA2026-02-25
00817491024817Eversense 365 Smart Transmitter Kit (Provider Purchase)SENSEONICS, INCORPORATEDSBA2026-02-25
00817491024046Eversense 365 Adhesive Patches KitSENSEONICS, INCORPORATEDSBA2024-09-23
00817491024220Pouch Containing Grafted Sensor and Holder, Eversense 365SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024237Eversense 365 Smart Transmitter Kit (DME)SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024244Eversense 365 Smart Transmitter Kit (Retail)SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024251Eversense 365 Smart Transmitter Kit (Provider Purchase)SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024268Eversense 365 Mobile Application (iOS)SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024282Eversense 365 Sensor Kit (DME)SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024299Eversense 365 Sensor Kit (Retail)SENSEONICS, INCORPORATEDSBA2024-09-23
00817491024305Eversense 365 Sensor Kit (Provider Purchase)SENSEONICS, INCORPORATEDSBA2024-09-23