Eversense E3 Insertion Tools Kit FG-8300-01-201

GUDID 00817491022905

Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.

SENSEONICS, INCORPORATED

Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated Subcutaneous implantation kit, non-medicated
Primary Device ID00817491022905
NIH Device Record Key5f91607c-7c06-4f6e-88cf-1f3738c32b9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense E3 Insertion Tools Kit
Version Model NumberFG-8300-01-201
Catalog NumberFG-8300-01-201
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 Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491022905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QHJSensor, Glucose, Implanted, Non-Adjunctive Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

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 Kit2022-03-18Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.
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

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