Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.


Product Overview

Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.
Philips Hemodynamic Application - Philips Hemodynamic Application - 1


Device Description

An application software program intended to be used as part of a haemodynamic monitoring system to continuously collect, display, and record real-time cardiovascular physiology data [e.g., haemodynamic parameters, electrocardiogram (ECG), SpO2] to monitor a patient during cardiovascular catheterization procedures. It is not intended for bedside monitoring.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: MWI

Device Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2300

Third Party Flag: Y

Medical Specialty: CV


Device Identifiers

Device Id: 00884838084544

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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