Duns Number:078605143
Device Description: The Glooko Mobile application for iOS and Android displays retrospective data that is capt The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
Catalog Number
-
Brand Name
Glooko Mobile Application
Version/Model Number
5.xx
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PHV
Product Code Name
Continuous Glucose Monitor Retrospective Data Analysis Software
Public Device Record Key
b9ef72b3-1537-4e7a-a0da-56b3085e009e
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
February 16, 2021
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |