Primary Device ID | 00817491023506 |
NIH Device Record Key | 585fc9ac-4931-478e-b0e2-eb72fcb2774a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Eversense DMS |
Version Model Number | FG-5705-01-300 |
Catalog Number | FG-5705-01-300 |
Company DUNS | 966865636 |
Company Name | SENSEONICS, INCORPORATED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com | |
Phone | 844-736-7348 |
support@eversensediabetes.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817491023506 [Primary] |
PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-18 |
Device Publish Date | 2022-03-10 |
00817491023841 - Eversense Charging Cable | 2023-12-13 The Micro USB Cable is used to charge Eversense Transmitter |
00817491023858 - Eversense Power Adapter | 2023-12-13 Power Adapter (i.e., wall plug) |
00817491023605 - Eversense® Mobile App iOS | 2022-06-10 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 Android | 2022-06-10 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-pack | 2022-03-18 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 Kit | 2022-03-18 Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor ins |
00817491022912 - Eversense E3 Smart Transmitter Kit | 2022-03-18 Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Gui |
00817491022929 - Eversense E3 Smart Transmitter Kit - Retail | 2022-03-18 Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Gui |