BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Proneb Max

    Reg #: 2954963 · FEI: 1000142942 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PARI RESPIRATORY EQUIPMENT, INC.
    Registration Number
    2954963
    FEI Number
    1000142942
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2412 PARI Way
    City
    MIDLOTHIAN
    State
    VA
    ZIP
    23112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191270

    Owner / Operator

    Firm Name
    PRE HOLDING, INC.
    Operator Number
    9008012
    Address
    2412 PARI Way, --
    City
    Midlothian
    State
    VA
    Postal Code
    23112
    Country
    US
    Correspondent
    MICHAEL N JUDGE

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Compressor, Air, Portable BTI

    Proprietary Names

    Proneb Max

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility