Home GUDID 00860013616885 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm
Primary DI 00860013616885
Brand ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm
Company Anumana, Inc.
Model 1020
Device description v4.0.0, v4.0.1
Published 2026-04-14
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 SAT Pulmonary Hypertension Machine Learning-Based Notification Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SAT Pulmonary Hypertension Machine Learning-Based Notification Software Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860013616885 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 00860013616885 00860013616885 860013616885 0860013616885
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 118190277 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 00860007426469 ECG-AI Cardiac Amyloidosis 12-Lead algorithm 1040 2026-04-14 00860013616823 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm 1010 2026-03-20 00860007426445 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm 1010 2024-12-05 00860007426407 ECG-AI LEF 12-Lead Algorithm 1010 2024-01-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860011843627 Tempus ECG-PH Tempus AI, Inc. SAT 2026-09-28 00869059000443 CorVista® System with PH Add-On Analytics for Life Inc. SAT 2024-04-19