Glooko Mobile Application

GUDID 00855093008033

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

GLOOKO, INC.

Clinical management support software
Primary Device ID00855093008033
NIH Device Record Keyb9ef72b3-1537-4e7a-a0da-56b3085e009e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlooko Mobile Application
Version Model Number5.xx
Company DUNS078605143
Company NameGLOOKO, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100855093008033 [Primary]

FDA Product Code

PHVContinuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-12-08
Device Publish Date2021-02-16

Devices Manufactured by GLOOKO, INC.

00855093008033 - Glooko Mobile Application2021-12-08The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
00855093008033 - Glooko Mobile Application2021-12-08 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 Application2021-12-08 Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, ins
00855093008026 - Glooko Web Application2021-02-24 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 WebDashboard2018-11-22 Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the pres

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