BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Clearblue

    DI: 00633472601897 · Model: Connected Ovulation Test System · SPD SWISS PRECISION DIAGNOSTICS GMBH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    40

    Basic Information

    Brand Name
    Clearblue
    Primary DI
    00633472601897
    Version / Model
    Connected Ovulation Test System
    Company Name
    SPD SWISS PRECISION DIAGNOSTICS GMBH
    Labeler DUNS
    483609579
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    40
    Record Status
    Published
    Publish Date
    2019-04-17
    Public Version
    2
    Public Version Date
    2023-11-23
    Public Version Status
    Update
    Public Device Record Key
    760c9bee-4fa9-4842-ac51-f8fbc26e4b78
    Distribution End Date
    2023-11-22

    Device Description

    CBCOT Ovulation Advanced 40ct

    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
    CEP Radioimmunoassay, Luteinizing Hormone

    GMDN Terms

    Code Name
    60862 Natural conception assistance kit

    Identifiers

    Type ID
    Package 10633472601894
    Primary 00633472601897
    Unit of Use 00633472000300

    Customer Contacts

    Phone
    1-800-321-3279
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius