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
Rx
false
OTC
false
Sterile
false
Single use
false

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
Cardiac arrhythmia monitoring systemAn 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.

Contacts#

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

Regulatory Flags#

DUNS number
026867345
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B595CSM20500Vios Monitoring System Central Station MonitorCSM2050 SoftwareCSM20502020-05-01
B595BSM20500Vios Monitoring System Bedside MonitorBSM2050 SoftwareBSM20502020-05-01
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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