BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NuvoMed

    DI: 04719871820315 · Model: P5228 BGM-6/0352 · BIOTEST MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NuvoMed
    Primary DI
    04719871820315
    Version / Model
    P5228 BGM-6/0352
    Company Name
    BIOTEST MEDICAL CORPORATION
    Labeler DUNS
    658447255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-07
    Public Version
    1
    Public Version Date
    2018-04-09
    Public Version Status
    New
    Public Device Record Key
    b57e17e7-45e2-475a-bc60-e729fffdb20f

    Device Description

    NuvoMed Wireless Blood Glucose Monitoring System

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    Combination Product
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 04719871820315