Home GUDID 08600002495020 Onduo
Primary DI 08600002495020
Brand Onduo
Company VERILY LIFE SCIENCES LLC
Model SW0003
Device description Onduo App iOS
Published 2020-08-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PHV Continuous Glucose Monitor Retrospective Data Analysis Software Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08600002495020 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08600002495020 08600002495020 8600002495020
GMDN Terms# Term, Definition table Term Definition Self-care monitoring/reporting software An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.
Regulatory Flags# DUNS number 080061720 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B553202311OTC0 Welldoc WELLDOC, INC. PHV 2026-03-09 B553202312OTC0 Welldoc WELLDOC, INC. PHV 2026-03-09 B553202313OTC0 Welldoc WELLDOC, INC. PHV 2026-03-09 B553202406OTC0 Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users WELLDOC, INC. PHV 2025-12-09 10385083000152 Omnipod Discover Insulet Corporation PHV 2025-12-04 B553202301OTC0 Welldoc WELLDOC, INC. PHV 2025-07-21 B553202302OTC0 Welldoc WELLDOC, INC. PHV 2025-07-21 B553202303OTC0 Welldoc WELLDOC, INC. PHV 2025-07-21 B553202257OTC0 Welldoc App for Diabetes in Pregnancy and Insulin Pump Users WELLDOC, INC. PHV 2025-05-29 00763000984755 CareLink™ Personal MEDTRONIC MINIMED, INC. PHV 2025-01-02 00763000984762 CareLink™ Clinic MEDTRONIC MINIMED, INC. PHV 2025-01-02 B553202057OTC0 Welldoc App for Diabetes in Pregnancy and Insulin Pump Users WELLDOC, INC. PHV 2024-12-27 00850018992435 Sugarmate, iOS Mobile Application Sugarmate, LLC PHV 2023-09-06 00850018992602 Sugarmate, Mac Glance Application Sugarmate, LLC PHV 2023-09-06 00850018992619 Sugarmate, Web Application Sugarmate, LLC PHV 2023-09-06 00850018992626 Sugarmate, Alexa Skill Application Sugarmate, LLC PHV 2023-09-06 00850003506517 Bigfoot Unity Report Bigfoot Biomedical, Inc. PHV 2023-07-12 00389152106113 Tandem Source Tandem Diabetes Care, Inc. PHV 2023-06-20 07290017735023 endo.digital DREAMED DIABETES LTD PHV 2022-09-20 00817491023506 Eversense DMS SENSEONICS, INCORPORATED PHV 2022-03-10 00817491023513 Eversense DMS Pro SENSEONICS, INCORPORATED PHV 2022-03-10 00357599826000 LibreView Government ABBOTT DIABETES CARE INC PHV 2021-07-15 00357599823009 LibreView ABBOTT DIABETES CARE INC PHV 2021-05-21 00763000424121 CareLink™ Personal MEDTRONIC MINIMED, INC. PHV 2021-03-07 00763000424138 CareLink™ MEDTRONIC MINIMED, INC. PHV 2021-03-07 00855093008033 Glooko Mobile Application GLOOKO, INC. PHV 2021-02-16 00855093008040 Cornerstones4Care® Powered by Glooko Mobile Application GLOOKO, INC. PHV 2021-02-16 00855093008026 Glooko Web Application GLOOKO, INC. PHV 2021-02-16 00860000249515 Onduo VERILY LIFE SCIENCES LLC PHV 2020-08-25 00860000249522 Onduo VERILY LIFE SCIENCES LLC PHV 2020-08-25
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