Philips Hemodynamic Application

Basic Information

• Brand Name: Philips Hemodynamic Application
• Primary DI: 00884838084544
• Version / Model: Philips Hemodynamic Application - 1
• Catalog Number: 002010
• Company Name: Philips Medical Systems Nederland B.V.
• Labeler DUNS: 413819707
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-01
• Public Version: 8
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: bf0e6c6e-94de-4f87-93c5-b3ad99964c9e

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42407	Haemodynamic monitoring system application software	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838084544	GS1