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510(k) Data Aggregation

    K Number
    K251631

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-24

    (180 days)

    Product Code
    Regulation Number
    868.5915
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.

    The sizes versions also include indications for the patient population:

    Adult: The Adult model is intended for patients over 20 kg (44 lbs).
    Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs).
    Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).

    The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.

    The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

    Device Description

    The BAG is a non-sterile self-inflating manual resuscitator. It is indicated for patients requiring ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG manual resuscitator is intended for short-term use (< 24 hours per patient) and may be used multiple times on a single patient when kept free from contamination. It is available in three sizes: adult (for patients > 20 kg (44 lbs.)), pediatric (for patients 2.5-20 kg (5.5-44 lbs.)), and newborn (for patients 2.5-5 kg (5.5-11 lbs.)).

    AI/ML Overview

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