BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TruePoint

    DI: 00193169642362 · Model: 64236 · OK BIOTECH CO., LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    300

    Basic Information

    Brand Name
    TruePoint
    Primary DI
    00193169642362
    Version / Model
    64236
    Catalog Number
    64236
    Company Name
    OK BIOTECH CO., LTD.
    Labeler DUNS
    658796458
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    300
    Record Status
    Published
    Publish Date
    2018-12-03
    Public Version
    1
    Public Version Date
    2019-01-03
    Public Version Status
    New
    Public Device Record Key
    74397424-1758-42b8-9774-312a17c8933e

    Device Description

    Blood Glucose Test Strips

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    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
    CGA Glucose Oxidase, Glucose

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00193169642362
    Unit of Use 50193169642305