BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Easy@Home Ovulation Test Kit (20 LH strips + 5 HCG strips )

    DI: 00810038634586 · Model: EZW2-S, EZW1-S · EASY HEALTHCARE CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    25

    Basic Information

    Brand Name
    Easy@Home Ovulation Test Kit (20 LH strips + 5 HCG strips )
    Primary DI
    00810038634586
    Version / Model
    EZW2-S, EZW1-S
    Catalog Number
    EZ-WS205(E)
    Company Name
    EASY HEALTHCARE CORPORATION
    Labeler DUNS
    080278407
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2023-01-11
    Public Version
    1
    Public Version Date
    2023-01-19
    Public Version Status
    New
    Public Device Record Key
    7353639e-137d-41ce-afcf-e8ac8354ec88

    Device Description

    20 LH strips +5HCG strips ;Ovulation Test Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter
    CEP Radioimmunoassay, Luteinizing Hormone

    GMDN Terms

    Code Name
    60862 Natural conception assistance kit

    Identifiers

    Type ID
    Package 10810038634583
    Primary 00810038634586
    Unit of Use 30810038634587