| Primary Device ID | 00817491023520 |
| NIH Device Record Key | 22d36c42-f306-408c-b03f-819256e60e71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eversense Mobile App iOS |
| Version Model Number | FG-5501-02-300 |
| Catalog Number | FG-5501-02-300 |
| Company DUNS | 966865636 |
| Company Name | SENSEONICS, INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 00817491023520 [Primary] |
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use |
| 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 |
| 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. |