Eversense® Mobile App iOS FG-5501-01-300
GUDID 00817491023605
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
Implantable glucose monitoring system| Primary Device ID | 00817491023605 |
| NIH Device Record Key | 341399aa-2736-493a-a35f-5216f57691a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eversense® Mobile App iOS |
| Version Model Number | FG-5501-01-300 |
| Catalog Number | FG-5501-01-300 |
| Company DUNS | 966865636 |
| Company Name | SENSEONICS, INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817491023605 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160048
FDA Product Code
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use |
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 | 2022-06-10 |
| Device Publish Date | 2022-06-02 |
On-Brand Devices [Eversense® Mobile App iOS]
| 00817491020819 | Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e |
| 00817491022370 | Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e |
| 00817491023605 | Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.