Eversense DMS Pro FG-5905-01-300

GUDID 00817491023513

The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system
Primary Device ID00817491023513
NIH Device Record Key4440403f-23ed-4bab-a2c3-d35c344735c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense DMS Pro
Version Model NumberFG-5905-01-300
Catalog NumberFG-5905-01-300
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
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491023513 [Primary]

FDA Product Code

PHVContinuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-18
Device Publish Date2022-03-10

Devices Manufactured by SENSEONICS, INCORPORATED

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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.

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