BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GCE Mediline Nuvo Lite (925GC)

    Reg #: 1039215 · FEI: 1039215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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
    K123738

    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

    GCE Mediline Nuvo Lite (925GC) Mark 5 Nuvo Lite OCSI (525, 925) Mark 5 Nuvo Lite 3 (935) Mark 5 Nuvo Lite STD (520, 920)

    Establishment Types

    Manufacture Medical Device