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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Metritest

    DI: 00615375003763 · Model: 10-303 · METREX RESEARCH, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Metritest
    Primary DI
    00615375003763
    Version / Model
    10-303
    Company Name
    METREX RESEARCH, LLC
    Labeler DUNS
    145963778
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-24
    Public Version
    1
    Public Version Date
    2023-11-01
    Public Version Status
    New
    Public Device Record Key
    dd939df0-041d-4fc5-8fd2-7253c43f03d8

    Device Description

    METRITEST 1.5% Test Strip 60 PCS Bottle x 2 CS

    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
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

    GMDN Terms

    Code Name
    47056 Glutaraldehyde device disinfectant/sterilant test strip

    Identifiers

    Type ID
    Package 10615375003760
    Primary 00615375003763

    Customer Contacts

    Phone
    18008411428
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K922481 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    59 – 86 Degrees Fahrenheit