BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mark 5 Nuvo 8 OCSI (585, 985)

    Reg #: 1039215 · FEI: 1039215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIDEK MEDICAL PRODUCTS, INC.
    Registration Number
    1039215
    FEI Number
    1039215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3949 VALLEY EAST INDUSTRIAL DR
    City
    Birmingham
    State
    AL
    ZIP
    35217
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093308

    Owner / Operator

    Firm Name
    NIDEK MEDICAL PRODUCTS, INC.
    Operator Number
    1039215
    Address
    3949 VALLEY EAST INDUSTRIAL DR, --
    City
    Birmingham
    State
    AL
    Postal Code
    35217
    Country
    US
    Correspondent
    Olivia H Mullen

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW

    Proprietary Names

    Mark 5 Nuvo 8 OCSI (585, 985) GCE Mediline Nuvo 8 (985GC, 985GCUK) New Aera Source 5 (565NA) Mark 5 Nuvo 8 STD (580, 980) Mark 5 Nuvo 10 OCSI (595, 1005) Mark 5 Nuvo (505, 565, 905, 965)

    Establishment Types

    Manufacture Medical Device