BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vios Monitoring System Pulse Oximetry Sensor

    DI: B595L2050R0 · Model: L2050R Pulse Oximetry Sensor · MURATA VIOS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Vios Monitoring System Pulse Oximetry Sensor
    Primary DI
    B595L2050R0
    Version / Model
    L2050R Pulse Oximetry Sensor
    Catalog Number
    L2050R
    Company Name
    MURATA VIOS, INC.
    Labeler DUNS
    026867345
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-27
    Public Version
    6
    Public Version Date
    2025-03-24
    Public Version Status
    Update
    Public Device Record Key
    bc012b67-d88e-449f-8b4c-2037bdb9f5e0

    Device Description

    The Vios Monitoring System (VMS) Adapter and Chest Sensor are 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 Adapter and Chest Sensor are 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.

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQA Oximeter
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    37808 Pulse oximeter probe, reusable
    47582 Pulse Co-oximeter probe, reusable

    Identifiers

    Type ID
    Primary B595L2050R0
    Package B595L2050R1
    Package B595L2050R2

    Customer Contacts

    Phone
    +1-866-990-1434
    Email
    [email protected]
    Phone
    +918044324109
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K172586 000
    K232354 000
    K241728 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 70 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 95 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    80 – 106 KiloPascal