BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gmate® Blood Glucose Test Strips

    DI: 08809301161029 · Model: PS-004 · PHILOSYS Co., Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    25

    Basic Information

    Brand Name
    Gmate® Blood Glucose Test Strips
    Primary DI
    08809301161029
    Version / Model
    PS-004
    Company Name
    PHILOSYS Co., Ltd
    Labeler DUNS
    690184887
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2017-06-06
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    a2c057f8-4f6e-4702-a9c5-9e15de5636ab

    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
    CGA Glucose Oxidase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Package 08809301161012
    Primary 08809301161029
    Unit of Use 08809301161081

    Premarket Submissions

    Submission Number Supplement Number
    K113636 000
    K141656 000
    K150299 000
    K151658 000