BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Scentific Test Kit

    DI: 07290019255109 · Model: 1 · APPSCENT MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Scentific Test Kit
    Primary DI
    07290019255109
    Version / Model
    1
    Catalog Number
    02U111000
    Company Name
    APPSCENT MEDICAL LTD
    Labeler DUNS
    532387650
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-16
    Public Version
    1
    Public Version Date
    2026-02-24
    Public Version Status
    New
    Public Device Record Key
    c06cedbc-387d-4724-b868-56216b2f4b70

    Device Description

    The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are presented to the patient's nose to subjectively assess the patient's ability to perceive scents.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NRK Kit, Test, Olfactory

    GMDN Terms

    Code Name
    65154 Olfactory test stick

    Identifiers

    Type ID
    Primary 07290019255109

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    77 – 101 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    5 – 35 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    77 – 101 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius