Home GUDID 00850010298146 ELEFT (Eko Low Ejection Fraction Tool)
Primary DI 00850010298146
Brand ELEFT (Eko Low Ejection Fraction Tool)
Company Eko Health, Inc.
Model v7.x
Catalog number ELEFT
Device description Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Published 2025-03-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QYE Reduced Ejection Fraction Machine Learning-Based Notification Software Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850010298146 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850010298146 00850010298146 850010298146 0850010298146
GMDN Terms# Term, Definition table Term Definition Cardiopulmonary physiological parameter analysis software, professional-only A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.
Regulatory Flags# DUNS number 079670921 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810209880118 CORE 500 Digital Stethoscope - Lilac Chestpiece E8 2026-10-01 00810209880163 CORE 500 Digital Stethoscope FIGS Earpiece - Espresso E8 2026-10-01 00810209880170 CORE 500 Digital Stethoscope FIGS Earpiece - Ruby Red E8 2026-10-01 00810209880187 CORE 500 Digital Stethoscope - Ember Chestpiece E8 2026-10-01 00810209880217 CORE 300™ Digital Stethoscope - Black E10 2026-10-01 00810209880224 CORE 300™ Digital Stethoscope - Berry E10 2026-10-01 00810209880231 CORE 300™ Digital Stethoscope - Sunset E10 2026-10-01 00810209880248 CORE 300™ Digital Stethoscope - Pacific E10 2026-10-01 00810209880255 CORE 300™ Digital Stethoscope - Cloud E10 2026-10-01 00810209880057 CORE 500 Digital Stethoscope - Navy Blue Earpiece E8 CAC500_ENB 2026-06-12 00810209880064 CORE 500 Digital Stethoscope - Military Green Earpiece E8 CAC500_EMG 2026-06-12 00810209880071 CORE 500 Digital Stethoscope - Navy Blue Bundle E8 COR501-SLV/ENB 2026-06-12 00810209880088 CORE 500 Digital Stethoscope - Military Green Bundle E8 COR501-BLK/EMG 2026-06-12 00810209880019 CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink E8 CAC500_FRP 2026-04-03 00810209880026 CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy E8 CAC500_FOT 2026-04-03 00850010298740 CORE 500 Digital Stethoscope - Ruby Chestpiece E8 COR500_RED 2025-10-15 00850010298894 CORE 500 Digital Stethoscope - Cool Blue Chestpiece E8 COR500_CBL 2025-11-07 00850010298900 CORE 500 Digital Stethoscope - Cool Blue Earpiece E8 CAC500_CBL 2025-11-07 00850010298917 CORE 500 Digital Stethoscope FIGS Earpiece - Elderberry E8 CAC500_FEL 2025-10-15 00850010298924 CORE 500 Digital Stethoscope FIGS Earpiece - Off White E8 CAC500_FOW 2025-10-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860013616823 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm Anumana, Inc. QYE 2026-03-20 00860011843610 Tempus ECG-Low EF Tempus AI, Inc. QYE 2025-07-24 00860007426445 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm Anumana, Inc. QYE 2024-12-05 00860007426407 ECG-AI LEF 12-Lead Algorithm Anumana, Inc. QYE 2024-01-15