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
CodeName
SATPulmonary Hypertension Machine Learning-Based Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SATPulmonary Hypertension Machine Learning-Based Notification SoftwareCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013616885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013616885008600136168858600136168850860013616885

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis software, professional-onlyA 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 DIBrandModelCatalogPublished
00860007426469ECG-AI Cardiac Amyloidosis 12-Lead algorithm10402026-04-14
00860013616823ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm10102026-03-20
00860007426445ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm10102024-12-05
00860007426407ECG-AI LEF 12-Lead Algorithm10102024-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869059000443CorVista® System with PH Add-OnAnalytics for Life Inc.SAT2024-04-19