Eversense® NOW Mobile App iOS FG-5901-01-300

GUDID 00817491021267

Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system
Primary Device ID00817491021267
NIH Device Record Key1b184d74-18f4-4c06-8b5e-03f6aaee768a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense® NOW Mobile App iOS
Version Model NumberFG-5901-01-300
Catalog NumberFG-5901-01-300
Company DUNS966865636
Company NameSENSEONICS, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491021267 [Primary]

FDA Product Code

PJTContinuous Glucose Monitor Secondary Display

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-20
Device Publish Date2018-07-18

Devices Manufactured by SENSEONICS, INCORPORATED

00817491024046 - Eversense 365 Adhesive Patches Kit2024-10-01 Eversense adhesive patches have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side
00817491024220 - Pouch Containing Grafted Sensor and Holder, Eversense 3652024-10-01 Pouch contains one Eversense 365 Sensor in a Sensor holder.
00817491024237 - Eversense 365 Smart Transmitter Kit (DME)2024-10-01 Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a
00817491024244 - Eversense 365 Smart Transmitter Kit (Retail)2024-10-01 Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a
00817491024251 - Eversense 365 Smart Transmitter Kit (Provider Purchase)2024-10-01 Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a
00817491024268 - Eversense 365 Mobile Application (iOS)2024-10-01 Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) an
00817491024275 - Eversense 365 Mobile Application (Android)2024-10-01 Eversense 365 Mobile Application for Android is a software application that runs on a mobile device (e.g., smart phone or tablet
00817491024282 - Eversense 365 Sensor Kit (DME)2024-10-01 Eversense 365 Sensor Kit contains one Eversense 365 Pouch containing a Sensor in Sensor holder.

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.