BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prodigy AutoCode Blood Glucose Monitoring System

    DI: 00384840701205 · Model: 070120 · Prodigy Diabetes Care, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prodigy AutoCode Blood Glucose Monitoring System
    Primary DI
    00384840701205
    Version / Model
    070120
    Catalog Number
    070120
    Company Name
    Prodigy Diabetes Care, LLC
    Labeler DUNS
    832875905
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    3
    Public Version Date
    2023-09-27
    Public Version Status
    Update
    Public Device Record Key
    1bf5f0d9-789b-4e6c-99c3-1aed96c1be82

    Device Description

    Prodigy AutoCode Blood Glucose Monitoring System

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    Yes
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    30854 Home-use/point-of-care blood glucose monitoring system IVD

    Identifiers

    Type ID
    Direct Marking 00384841518505
    Package 00384843701202
    Primary 00384840701205