Vios Monitoring System Bedside Monitor

Primary DI
B595BSM20500
Brand
Vios Monitoring System Bedside Monitor
Company
MURATA VIOS, INC.
Model
BSM2050 Software
Catalog number
BSM2050
Device description
The Vios Monitoring System (VMS) Bedside Monitor (BSM) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.The VMS BSM is intended to be used by Vios-trained clinical professionals who also 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
DPZOximeter, Ear
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
QYWHospital Cardiac Telemetry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
QYWHospital Cardiac TelemetryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172586000
K232354000
K241728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172586000Vios Monitoring System™ Model 2050Vios Medical, Inc.2018-06-22DRT
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
B595BSM20500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

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
B595CSM20500Vios Monitoring System Central Station MonitorCSM2050 SoftwareCSM20502020-05-01
B595VMM2050Vios Monitoring System Mobile ApplicationVMM2050 Mobile ApplicationVMM20502020-05-01
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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