FDA.reportPublic FDA data

Eversense 365 Smart Transmitter Kit (DME)

Primary DI
00817491024237
Brand
Eversense 365 Smart Transmitter Kit (DME)
Company
SENSEONICS, INCORPORATED
Model
FG-4000-01-001
Catalog number
FG-4000-01-001
Device description
Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
Published
2024-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00817491024237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817491024237008174910242378174910242370817491024237

GMDN Terms#

Term, Definition table
TermDefinition
Implantable glucose monitoring system transmitterA body-worn, battery-powered component of an implantable glucose monitoring system designed to wirelessly transmit glucose measurements continuously from the implanted sensor to a receiver (e.g., a mobile device). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit95 Degrees Fahrenheit

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
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
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
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
00817491024275Eversense 365 Mobile Application (Android)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