FDA.reportPublic FDA data

Grafted Eversense 365 Sensor and Holder in Sealed Pouch, Global

Primary DI
00817491024589
Brand
Grafted Eversense 365 Sensor and Holder in Sealed Pouch, Global
Company
SENSEONICS, INCORPORATED
Model
102606-330
Device description
Pouch contains one Eversense 365 Sensor in a Sensor holder.
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
00817491024589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817491024589008174910245898174910245890817491024589

GMDN Terms#

Term, Definition table
TermDefinition
Implantable glucose monitoring system sensorA sterile device intended to be implanted subcutaneously for continuous monitoring of glucose levels in interstitial fluid, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is a small, rod-shaped sensor consisting of an electrochemical or optical glucose detector that emits signals which are sent to an externally-worn transmitter (not included) via a wireless connection. It is passively-powered by the transmitter. Dedicated implantation devices (e.g., blunt dissector, cannula) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
844-736-7348support@eversensediabetes.com

Regulatory Flags#

DUNS number
966865636
Device count
1
Combination product
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
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
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
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
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