Eversense® DMS FG-5700-01-300
GUDID 00817491021878
Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
Implantable glucose monitoring system| Primary Device ID | 00817491021878 |
| NIH Device Record Key | 8ee77b35-44f4-408b-af7d-126e68f794b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eversense® DMS |
| Version Model Number | FG-5700-01-300 |
| Catalog Number | FG-5700-01-300 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817491021878 [Primary] |
FDA Product Code
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-16 |
| Device Publish Date | 2018-07-16 |
Devices Manufactured by SENSEONICS, INCORPORATED
| 00817491024046 - Eversense 365 Adhesive Patches Kit | 2024-10-01 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 365 | 2024-10-01 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. |
Trademark Results [Eversense]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVERSENSE 87077093 5590760 Live/Registered |
Senseonics, Incorporated 2016-06-20 |
 EVERSENSE 87025094 5590731 Live/Registered |
Senseonics, Incorporated 2016-05-04 |
 EVERSENSE 86755445 5423830 Live/Registered |
Senseonics, Incorporated 2015-09-14 |
 EVERSENSE 86755442 5051167 Live/Registered |
Senseonics, Incorporated 2015-09-14 |
 EVERSENSE 86695085 5050956 Live/Registered |
Senseonics, Incorporated 2015-07-16 |
 EVERSENSE 86695079 5423802 Live/Registered |
Senseonics, Incorporated 2015-07-16 |
 EVERSENSE 85504885 4515110 Live/Registered |
ALLURE ENERGY, INC. 2011-12-28 |
 EVERSENSE 79084125 3995823 Live/Registered |
SOLETANCHE FREYSSINET 2010-03-12 |
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