BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Feminine Screening Kit

    DI: 17290006558937 · Model: F-1-VO-CVS02 · SAVYON DIAGNOSTICS LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Feminine Screening Kit
    Primary DI
    17290006558937
    Version / Model
    F-1-VO-CVS02
    Company Name
    SAVYON DIAGNOSTICS LTD
    Labeler DUNS
    533708202
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2026-02-22
    Public Version
    2
    Public Version Date
    2026-04-30
    Public Version Status
    Update
    Public Device Record Key
    8071f8b1-3499-4271-acd3-b48ca68ab97e

    Device Description

    For vaginal health

    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
    Yes
    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
    CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)

    GMDN Terms

    Code Name
    54552 Vaginal pH screening IVD, kit, rapid colorimetric, clinical

    Identifiers

    Type ID
    Unit of Use 07290006558930
    Primary 17290006558937
    Previous 17290006558135

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius