FDA.reportPublic FDA data

Eversense® Sensor Kit - Retail

Primary DI
00817491022356
Brand
Eversense® Sensor Kit - Retail
Company
SENSEONICS, INCORPORATED
Model
FG-4201-00-301
Catalog number
FG-4201-00-301
Device description
Eversense Sensor Kit contains one Eversense Sensor.
Published
2019-02-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QCDContinuous Glucose Monitor, Implanted, Adjunctive Use
QHJSensor, Glucose, Implanted, Non-Adjunctive Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCDContinuous Glucose Monitor, Implanted, Adjunctive UseUnknown3
QHJSensor, Glucose, Implanted, Non-Adjunctive UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160048008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160048008EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMSenseonics, Incorporated2018-06-21QCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817491022356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817491022356008174910223568174910223560817491022356

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
966865636
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
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
00817491024336Eversense Insertion Tools KitSENSEONICS, INCORPORATEDQHJ2024-05-17
00817491023841Eversense Charging Cable SENSEONICS, INCORPORATEDQHJ2023-12-05
00817491023858Eversense Power AdapterSENSEONICS, INCORPORATEDQHJ2023-12-05
00817491023605Eversense® Mobile App iOSSENSEONICS, INCORPORATEDQHJ2022-06-02
00817491023612Eversense® Mobile App AndroidSENSEONICS, INCORPORATEDQHJ2022-06-02
00817491023056Eversense Adhesive Patches, 10-pack WhiteSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491023056Eversense Adhesive Patches, 10-pack WhiteSENSEONICS, INCORPORATEDQCD2022-03-10
00817491022882Eversense E3 Adhesive Patches Kit, 180-packSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022905Eversense E3 Insertion Tools KitSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022912Eversense E3 Smart Transmitter KitSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022929Eversense E3 Smart Transmitter Kit - RetailSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022936Eversense E3 Smart Transmitter Kit - Provider PurchaseSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022950Eversense E3 Sensor Kit - DMESENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022967Eversense E3 Sensor Kit - RetailSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022974Eversense E3 Sensor Kit – Provider PurchaseSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491021342Eversense Adhesive Patches, 10-pack WhiteSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491023063Eversense E3 Pouch Containing Sensor and HolderSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491023520Eversense Mobile App iOSSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491023537Eversense Mobile App AndroidSENSEONICS, INCORPORATEDQHJ2022-03-10
00817491022493Eversense Insertion Tools TraySENSEONICS, INCORPORATEDQCD2022-01-21
00817491022493Eversense Insertion Tools TraySENSEONICS, INCORPORATEDQHJ2022-01-21
00817491022516Eversense® Smart Transmitter Kit – Provider PurchaseSENSEONICS, INCORPORATEDQHJ2019-11-19
00817491022523Eversense® Sensor Kit – Provider PurchaseSENSEONICS, INCORPORATEDQHJ2019-11-19
00817491022370Eversense® Mobile App iOSSENSEONICS, INCORPORATEDQHJ2019-07-16
00817491022387Eversense® Mobile App AndroidSENSEONICS, INCORPORATEDQHJ2019-07-16
00817491022349Eversense® Sensor KitSENSEONICS, INCORPORATEDQHJ2019-02-06
00817491022349Eversense® Sensor KitSENSEONICS, INCORPORATEDQCD2019-02-06
00817491022363Eversense® Pouch Containing Sensor and HolderSENSEONICS, INCORPORATEDQHJ2019-02-06
00817491022363Eversense® Pouch Containing Sensor and HolderSENSEONICS, INCORPORATEDQCD2019-02-06
00817491021908Eversense® Charging Accessories PackSENSEONICS, INCORPORATEDQCD2018-10-09