Home GUDID 00869059000443 CorVista® System with PH Add-On
Primary DI 00869059000443
Brand CorVista® System with PH Add-On
Company Analytics for Life Inc.
Model CorVista System with PH Add-On
Device description CorVista System with PH Add-On
Published 2024-04-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true 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 00869059000443 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 00869059000443 00869059000443 869059000443 0869059000443
GMDN Terms# Term, Definition table Term Definition Multiparameter physiologic analysis workstation A computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 45 Degrees Celsius
Regulatory Flags# DUNS number 119363911 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00869059000436 CorVista® System with CAD Add-On CorVista System with CAD Add-On 2024-04-19 00869059000429 CorVista® System 10-0020 2024-02-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860013616885 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm Anumana, Inc. SAT 2026-04-14
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