BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Easy Talk

    DI: 04719871820193 · Model: GOD11(BYGOD11BT) · BIOTEST MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Easy Talk
    Primary DI
    04719871820193
    Version / Model
    GOD11(BYGOD11BT)
    Company Name
    BIOTEST MEDICAL CORPORATION
    Labeler DUNS
    658447255
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-02
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7029c70d-51a5-4762-9baa-51b36fcb709d
    Distribution End Date
    2016-05-02

    Device Description

    Easy Talk Control Solution-Low(Vial)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
    CGA Glucose Oxidase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 04719871820193