BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIOCOACH Glucose Control Solution L1/L2

    DI: 00850017460058 · Model: S5800382 · AMVENTUREX, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIOCOACH Glucose Control Solution L1/L2
    Primary DI
    00850017460058
    Version / Model
    S5800382
    Catalog Number
    S5800382
    Company Name
    AMVENTUREX, INC.
    Labeler DUNS
    117225590
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-28
    Public Version
    1
    Public Version Date
    2022-01-05
    Public Version Status
    New
    Public Device Record Key
    776adc13-de91-4c07-b893-a2859a20e534

    Device Description

    Level 1 & 2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00850017460058