| Primary Device ID | 00855093008033 |
| NIH Device Record Key | b9ef72b3-1537-4e7a-a0da-56b3085e009e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glooko Mobile Application |
| Version Model Number | 5.xx |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855093008033 [Primary] |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-12-08 |
| Device Publish Date | 2021-02-16 |
| 00855093008033 - Glooko Mobile Application | 2021-12-08The 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 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 | 2018-11-22 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 |