BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Freestyle Blood Glucose Monitoring System

    Reg #: 3006371704 · FEI: 3006371704 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RR DONNELLEY-SUPPLY CHAIN SOLUTIONS
    Registration Number
    3006371704
    FEI Number
    3006371704
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1600 DISK DR.
    City
    Plover
    State
    WI
    ZIP
    54467
    Country
    US

    Regulatory Submissions

    510(k) Number
    K000582

    Owner / Operator

    Firm Name
    RRDonnelley
    Operator Number
    9077726
    Address
    1600 Disk Drive
    City
    Plover
    State
    WI
    Postal Code
    54467
    Country
    US
    Correspondent
    Lee Rush

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    Freestyle Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)