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    BREAS MEDICAL, INC.

    FDA registration
    BREAS MEDICAL, INC.·13 products·🇺🇸 United States

    BREAS MEDICAL INC.

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code CBK·October 13, 2021

    VIVI 65

    FDA Adverse Event
    Death ·BREAS MEDICAL AB·Product code CBK·August 9, 2022

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004123·Ventilator, Non Continuous Respirator

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004000·Ventilator, Non Continuous Respirator with Batt...

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004017·Ventilator, Non Continuous Respirator

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004116·Battery Source for Ventilator, Non Continuous R...

    HUMAN DESIGN MEDICAL

    FDA UDI
    BREAS MEDICAL, INC.·00859477004161·Ventilator, Non Continuous Respirator with Batt...

    VIVO 45 LS

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 5, 2023

    VIVO 45LS

    FDA Adverse Event
    Death ·BREAS MEDICAL AB·Product code NOU·May 7, 2026

    VIVO 45LS

    FDA Adverse Event
    Death ·BREAS MEDICAL AB·Product code CBK·March 10, 2025

    VIVO 45 LS

    FDA Adverse Event
    Death ·BREAS MEDICAL AB·Product code NOU·August 13, 2024

    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·July 25, 2024

    VIVO 45 LS

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·March 8, 2023

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45 LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·August 11, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL, INC.·Product code NOU·July 7, 2025

    BREAS VIVO 45LS

    FDA Adverse Event
    Injury ·BREAS MEDICAL INC.·Product code NOU·July 7, 2025

    VIVO VENTILATOR

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL, INC.·Product code NOU·July 9, 2025