Eversense® Adhesive Patches, 10-pack Clear N/A

GUDID 00817491021335

Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system Implantable glucose monitoring system Implantable glucose monitoring system
Primary Device ID00817491021335
NIH Device Record Key826e5f07-19d8-4e1b-93f9-637f6ace6b3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense® Adhesive Patches, 10-pack Clear
Version Model NumberFG-6400-01-300
Catalog NumberN/A
Company DUNS966865636
Company NameSENSEONICS, INCORPORATED
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491021335 [Primary]
GS100817491021359 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCDContinuous Glucose Monitor, Implanted, Adjunctive Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2018-07-16

Devices Manufactured by SENSEONICS, INCORPORATED

00817491023841 - Eversense Charging Cable 2023-12-13 The Micro USB Cable is used to charge Eversense Transmitter
00817491023858 - Eversense Power Adapter2023-12-13 Power Adapter (i.e., wall plug)
00817491023605 - Eversense® Mobile App iOS2022-06-10 Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and d
00817491023612 - Eversense® Mobile App Android2022-06-10 Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet)
00817491022882 - Eversense E3 Adhesive Patches Kit, 180-pack2022-03-18 Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone
00817491022905 - Eversense E3 Insertion Tools Kit2022-03-18 Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor ins
00817491022912 - Eversense E3 Smart Transmitter Kit2022-03-18 Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Gui
00817491022929 - Eversense E3 Smart Transmitter Kit - Retail2022-03-18 Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Gui

Trademark Results [Eversense]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVERSENSE
EVERSENSE
87077093 5590760 Live/Registered
Senseonics, Incorporated
2016-06-20
EVERSENSE
EVERSENSE
87025094 5590731 Live/Registered
Senseonics, Incorporated
2016-05-04
EVERSENSE
EVERSENSE
86755445 5423830 Live/Registered
Senseonics, Incorporated
2015-09-14
EVERSENSE
EVERSENSE
86755442 5051167 Live/Registered
Senseonics, Incorporated
2015-09-14
EVERSENSE
EVERSENSE
86695085 5050956 Live/Registered
Senseonics, Incorporated
2015-07-16
EVERSENSE
EVERSENSE
86695079 5423802 Live/Registered
Senseonics, Incorporated
2015-07-16
EVERSENSE
EVERSENSE
85504885 4515110 Live/Registered
ALLURE ENERGY, INC.
2011-12-28
EVERSENSE
EVERSENSE
79084125 3995823 Live/Registered
SOLETANCHE FREYSSINET
2010-03-12

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