Duns Number:966865636
Device Description: Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile dev 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.
Catalog Number
FG-5500-01-300
Brand Name
Eversense® Mobile App iOS
Version/Model Number
FG-5500-01-300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P160048
Product Code
QCD
Product Code Name
Continuous Glucose Monitor, Implanted, Adjunctive Use
Public Device Record Key
66a36483-328d-43cd-8dc5-70e4551e5378
Public Version Date
March 11, 2022
Public Version Number
2
DI Record Publish Date
July 16, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 33 |