Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application

GUDID 00855093008002

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.

GLOOKO, INC.

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• Primary Device ID: 00855093008002
• NIH Device Record Key: 3eb66960-d617-4339-8dcd-81eaf5b3c445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application
• Version Model Number: 5.x
• Company DUNS: 078605143
• Company Name: GLOOKO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855093008002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171450

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-06-22

Devices Manufactured by GLOOKO, INC.

• 00855093008033 - Glooko Mobile Application: 2021-12-08 The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and
• 00855093008040 - Cornerstones4Care® Powered by Glooko Mobile Application: 2021-12-08 Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, ins
• 00855093008026 - Glooko Web Application: 2021-02-24 Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters,
• 00855093008002 - Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application: 2018-11-22Glooko 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.
• 00855093008002 - Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application: 2018-11-22 Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available t
• 00855093008019 - Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard: 2018-11-22 Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the pres