GLOOKO, INC.

Address:411 High Street,Palo Alto,CA,94301,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Continuous Glucose Monitor Retrospective Data Analysis Software (PHV) (3) Calculator, Drug Dose (NDC) (2)

Premarket Exempt

No Yes

Clear

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application - 00855093008002 Catalog Number :

Device Description : Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Gl Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.

Device Class : 2

Duns Number: 078605143

Premarket Exempt : No

Product Code : NDC

Prescription Use : Yes

Device Count : 1

Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard - 00855093008019 Catalog Number :

Device Description : Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MI 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.

Device Class : 2

Duns Number: 078605143

Premarket Exempt : No

Product Code : NDC

Prescription Use : Yes

Device Count : 1

Glooko Web Application - 00855093008026 Catalog Number :

Device Description : Glooko Web Application is a web based application that displays and analyzes ret Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)

Device Class : 1

Duns Number: 078605143

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : No

Device Count : 1

Glooko Mobile Application - 00855093008033 Catalog Number :

Device Description : The Glooko Mobile application for iOS and Android displays retrospective data th The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)

Device Class : 1

Duns Number: 078605143

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : No

Device Count : 1

Cornerstones4Care® Powered by Glooko Mobile Application - 00855093008040 Catalog Number :

Device Description : Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes re Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, insulin pumps and continuous glucose monitors

Device Class : 1

Duns Number: 078605143

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : No

Device Count : 1

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