FDA.reportPublic FDA data

Eversense® Insertion Tools Kit

Primary DI
00817491021397
Brand
Eversense® Insertion Tools Kit
Company
SENSEONICS, INCORPORATED
Model
FG-8211-01-201
Catalog number
FG-8211-01-201
Device description
Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
Published
2018-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P160048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160048000EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMSenseonics, Incorporated2018-06-21QCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817491021397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817491021397008174910213978174910213970817491021397

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous implantation kit, non-medicatedA collection of devices intended to be used for the implantation of a subcutaneous device (e.g., implantable glucose sensor) [not included]. It typically consists of a blunt dissector, cannula and may include non-dedicated devices (e.g., dressings); it does not contain pharmaceutical components. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit86 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
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, INCORPORATEDQHJ2022-01-21
00817491022493Eversense Insertion Tools TraySENSEONICS, INCORPORATEDQCD2022-01-21
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
00817491022356Eversense® Sensor Kit - RetailSENSEONICS, INCORPORATEDQHJ2019-02-06
00817491022356Eversense® Sensor Kit - RetailSENSEONICS, INCORPORATEDQCD2019-02-06
00817491022363Eversense® Pouch Containing Sensor and HolderSENSEONICS, INCORPORATEDQHJ2019-02-06