Eversense Adhesive Patches, 10-pack White

GUDID 00817491021342

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
Primary Device ID00817491021342
NIH Device Record Key5d5f6772-180b-4aff-8e93-5176ecf1f35b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEversense Adhesive Patches, 10-pack White
Version Model NumberFG-6404-01-300
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
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 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817491021342 [Unit of Use]
GS100817491023056 [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 Date2022-03-18
Device Publish Date2022-03-10

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.

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