BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fertility Control

    DI: 00850212007072 · Model: 2130162 · FUJIREBIO DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fertility Control
    Primary DI
    00850212007072
    Version / Model
    2130162
    Company Name
    FUJIREBIO DIAGNOSTICS, INC.
    Labeler DUNS
    079291908
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-07
    Public Version
    3
    Public Version Date
    2020-12-15
    Public Version Status
    Update
    Public Device Record Key
    1c6d8c0e-a1b3-47ad-9add-bccffac1d2c3

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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

    GMDN Terms

    Code Name
    54018 Multiple human hormone IVD, control

    Identifiers

    Type ID
    Primary 00850212007072

    Customer Contacts

    Phone
    800-531-7963
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Size Type = Units per Kit; Units = 6; Unit of Measure = 3mLs

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius