BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MINIHEART HI FLO

    Reg #: 2028807 · FEI: 1000374126 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    WESTMED, INC.
    Registration Number
    2028807
    FEI Number
    1000374126
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5580 S NOGALES HWY
    City
    TUCSON
    State
    AZ
    ZIP
    85706
    Country
    US

    Regulatory Submissions

    510(k) Number
    K920443

    Owner / Operator

    Firm Name
    WESTMED, INC.
    Operator Number
    9006543
    Address
    5580 S. NOGALES HIGHWAY, --
    City
    Tucson
    State
    AZ
    Postal Code
    85706
    Country
    US
    Correspondent
    Peter Tountas

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    MINIHEART HI FLO MINIHEART LO FLOW

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility