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510(k) Data Aggregation

    K Number
    K251419

    Validate with FDA (Live)

    Device Name
    Laboratorios Biogalenic Sterile Water for Inhalation, USP
    Manufacturer
    Laboratorios Biogalenic S.A. DE C.V.
    Date Cleared
    2026-01-14

    (252 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    0 - 100
    Reference & Predicate Devices
    K090915
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings. The intended patient population is Adults, Pediatrics, Infants and Neonates.

    Device Description

    Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in flexible polyolefin bags, designed for safe and easy handling. The flexible polyolefin bags are prefilled with sterile water and feature a single polypropylene twist-off port used to transfer the sterile water to humidifier chambers using tubular feed sets. The humidifier chamber is then filled with sterile water from the bags via gravity. The device has a hanger to suspend the product during use.

    Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.

    AI/ML Overview

    N/A

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