Duns Number:078605143
Device Description: Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web sof Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
Catalog Number
-
Brand Name
Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard
Version/Model Number
18.x
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"
-
For Single-Use
-
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
K171450
Product Code
NDC
Product Code Name
Calculator, Drug Dose
Public Device Record Key
c4c7f171-27b9-4d36-82ca-d602653e1f90
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
June 11, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |