BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prodigy Adjustable Depth Lancing Device

    Reg #: 3008789114 · FEI: 3008789114 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRODIGY DIABETES CARE, LLC
    Registration Number
    3008789114
    FEI Number
    3008789114
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7224 Statesville Road, Suite A
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220475

    Owner / Operator

    Firm Name
    Prodigy Diabetes Care, LLC
    Operator Number
    10033726
    Address
    7224 Stateville Road, Suite A
    City
    Charlotte
    State
    NC
    Postal Code
    28269
    Country
    US

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    Prodigy Adjustable Depth Lancing Device Prodigy Twist Top Lancets

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198