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 IdentifiersDevice 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