FDA.reportPublic FDA data

Vios Monitoring System Mobile Application

Primary DI
B595VMM2050
Brand
Vios Monitoring System Mobile Application
Company
MURATA VIOS, INC.
Model
VMM2050 Mobile Application
Catalog number
VMM2050
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.
Published
2020-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXJDisplay, Cathode-Ray Tube, Medical
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
OUGMedical Device Data System
QYWHospital Cardiac Telemetry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
OUGMedical Device Data SystemGeneral Hospital1
QYWHospital Cardiac TelemetryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173107000
K232354000
K241728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173107000Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.2018-07-26DXJ
K232354000Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.2024-03-22DRT
K241728000Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050Murata Vios, Inc.2025-01-23DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B595VMM2050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical information system web-based application softwareAn application software program designed as an Internet-based information system to support the administrative, clinical, and quality control activities associated with the provision/utilization of healthcare within a specific clinical specialty (e.g., orthopaedics, general surgery, neurology, ophthalmology, oncology, rheumatology, dermatology). It can be available on any web-enabled interface (including mobile devices at point-of-care) and is intended for use by healthcare professionals in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-990-1434ViosSupport@murata.com
+918044324109ViosSupport@murata.com

Regulatory Flags#

DUNS number
026867345
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B595BSM20500Vios Monitoring System Bedside MonitorBSM2050 SoftwareBSM20502020-05-01
B595CSM20500Vios Monitoring System Central Station MonitorCSM2050 SoftwareCSM20502020-05-01
B595VCS2050Vios Monitoring System Central Server VCS2050 SoftwareVCS20502020-05-01
B595L2050R0Vios Monitoring System Pulse Oximetry SensorL2050R Pulse Oximetry SensorL2050R2020-04-27
B595CS20500Vios Monitoring System Chest SensorCS2050 Chest SensorCS20502020-04-02
B595L2050G0Vios Montioring System AdapterL2050G AdapterL2050G2020-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27