BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Regulated Software Application (RSA), Version 2

    Reg #: 3016690356 · FEI: 3016690356 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARC-ONE SOLUTIONS, LLC
    Registration Number
    3016690356
    FEI Number
    3016690356
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8669 Commodity Cir
    City
    Orlando
    State
    FL
    ZIP
    32819
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK200512

    Owner / Operator

    Firm Name
    ARC-ONE Solutions
    Operator Number
    10068067
    Address
    8669 Commodity Circle
    City
    Orlando
    State
    FL
    Postal Code
    32819
    Country
    US
    Correspondent
    Adrienne Hammond

    Products

    Device Name Product Code
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    Regulated Software Application (RSA), Version 2

    Establishment Types

    Manufacture Medical Device