BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Proov

    DI: 00850035206126 · Model: Pregnancy Pack · Mfb Fertility, Inc.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Proov
    Primary DI
    00850035206126
    Version / Model
    Pregnancy Pack
    Company Name
    Mfb Fertility, Inc.
    Labeler DUNS
    080270263
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-28
    Public Version
    1
    Public Version Date
    2023-04-05
    Public Version Status
    New
    Public Device Record Key
    ebf45ccf-0cba-4a57-8462-b9ac598f386f

    Device Description

    At home fertility test that measures all 4 cycle hormones for a comprehensive fertility map.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JHI Visual, Pregnancy Hcg, Prescription Use
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter
    QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter
    NGE Test, Luteinizing Hormone (Lh), Over The Counter

    GMDN Terms

    Code Name
    60862 Natural conception assistance kit

    Identifiers

    Type ID
    Primary 00850035206126