Glooko Web Application

GUDID 00855093008026

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)

GLOOKO, INC.

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• Primary Device ID: 00855093008026
• NIH Device Record Key: 67928ef8-980b-4035-866a-eac9fa4cc3f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glooko Web Application
• Version Model Number: xx.yy (xx is model year and yy is a serial number)
• Company DUNS: 078605143
• Company Name: GLOOKO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855093008026 [Primary]

FDA Product Code

• PHV: Continuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-24
• Device Publish Date: 2021-02-16

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: 2021-02-24Glooko 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)
• 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: 2018-11-22 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