Adult-Pediatric Mechanical Filter HME,Large


Product Overview

Adult
DAR - 354U5876


Device Description

A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Tidal Volume, 300-1500, ML;
    • Tidal Volume, 300-1500, ML;


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: BYD

    Device Name: Condenser, Heat And Moisture (Artificial Nose)

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5375

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 20884521130965

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521130968

    Package Quantity: 50

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884521130968

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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