BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABMRC LLC

    Reg #: 3016774528 · FEI: 3016774528 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ABMRC LLC
    Registration Number
    3016774528
    FEI Number
    3016774528
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    860 Blue Gentian Road, Suite 200
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231728

    Owner / Operator

    Firm Name
    ABMRC LLC
    Operator Number
    10071982
    Address
    860 Blue Gentian Road, Suite 200
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    Priyanka Paul

    Products

    Device Name Product Code
    Device, Positive Pressure Breathing, Intermittent NHJ

    Proprietary Names

    BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Medium BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Large BiWaze Clear Dual Lumen Breathing Circuit - Acute BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Child BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Small BiWaze Clear System BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Infant BiWaze Clear Dual Lumen Breathing Circuit With Mouthpiece BiWaze Clear Dual Lumen Breathing Circuit With Trach Adapter BiWaze Cough

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198