Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K153234
    Device Name
    AirLife Adult Heated Wire Circuit
    Manufacturer
    CAREFUSION INC
    Date Cleared
    2016-07-07

    (241 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AirLife Adult Heated Wire Circuit is intended to warm breathing gases before they enter a patient's airway. The AirLife Adult Heated Wire Circuit is used with the adult patient population that requires mechanical ventilation, positive pressure breathing or general medical gases. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire Circuit is compatible to the Fisher & Paykel MR850 humidifier.
    Device Description
    The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier.
    Ask a Question
    K Number
    K151959
    Device Name
    AirLife Infant Single Limb Heated Wire Circuit
    Manufacturer
    CAREFUSION INC
    Date Cleared
    2016-01-20

    (188 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
    Device Description
    The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850.
    Ask a Question

    Page 1 of 1