Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181424
    Device Name
    PeDIA
    Manufacturer
    Date Cleared
    2018-09-25

    (117 days)

    Product Code
    Regulation Number
    868.5320
    Why did this record match?
    Product Code :

    BTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction.
    Device Description
    The Pediatric Device for Induction of Anesthesia (PeDIA) is a single-use, disposable, mask-free anesthetic delivery system and method used for children 3 years and older. The balloon is a standard, legally marketed reservoir bag that is modified by the addition of a whistle at the opposite end of the connector (which is a closed end on standard balloons). This balloon is used in place of the initial application of anesthesia gasses. Once the child is sedated the product is removed and replaced with a standard pediatric mask for the duration of anesthesia.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1