Eversense Power Adapter N/A

GUDID 00817491023858

Power Adapter (i.e., wall plug)

SENSEONICS, INCORPORATED

Implantable glucose monitoring system transmitter
Primary Device ID00817491023858
NIH Device Record Keyc5383124-f3ce-413b-a9e3-d3fc9f8e4524
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense Power Adapter
Version Model NumberFG-6000-01-303
Catalog NumberN/A
Company DUNS966865636
Company NameSENSEONICS, INCORPORATED
Device Count1
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
Phone844-736-7348
Emailsupport@eversensediabetes.com
Phone844-736-7348
Emailsupport@eversensediabetes.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491023858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QHJSensor, Glucose, Implanted, Non-Adjunctive Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-13
Device Publish Date2023-12-05

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.

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