Vios Monitoring System Mobile Application

Basic Information

• Brand Name: Vios Monitoring System Mobile Application
• Primary DI: B595VMM2050
• Version / Model: VMM2050 Mobile Application
• Catalog Number: VMM2050
• Company Name: MURATA VIOS, INC.
• Labeler DUNS: 026867345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-01
• Public Version: 5
• Public Version Date: 2025-03-24
• Public Version Status: Update
• Public Device Record Key: 08467e2e-95ec-44d9-a98a-55811f6f60e0

Device Description

The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios Mobile Application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	870.2450	2
OUG	Medical Device Data System	General Hospital	880.6310	1
QYW	Hospital Cardiac Telemetry	Cardiovascular	870.1025	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43239	Cardiac arrhythmia monitoring system	An assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.	No	Active
61087	Clinical management support software	An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B595VMM2050	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173107	000
K232354	000
K241728	000