BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOMEDIX WAI

    Reg #: 1833470 · FEI: 1000115518 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    BIOMEDIX WAI
    Registration Number
    1833470
    FEI Number
    1000115518
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8600 Shelby Court
    City
    Chanhassen
    State
    MN
    ZIP
    55317
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142097

    Owner / Operator

    Firm Name
    WAI Medical Technologies LLC
    Operator Number
    10052511
    Address
    8600 Shelby Court, Suite 100
    City
    Chanhassen
    State
    MN
    Postal Code
    55317
    Country
    US
    Correspondent
    Emilie Andrews

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    Select 3 IV admin set MedSource I.V. Administration Set

    Establishment Types

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