BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    First Sign

    DI: 00857338006217 · Model: F2-CT25C · HEMOSURE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    First Sign
    Primary DI
    00857338006217
    Version / Model
    F2-CT25C
    Catalog Number
    F2-CT25C
    Company Name
    HEMOSURE INC.
    Labeler DUNS
    806777541
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2016-05-09
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    75845bdc-57f0-45fc-8d6b-f758b66358d2
    Distribution End Date
    2016-05-09

    Device Description

    First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure

    Device Characteristics

    Single Use
    Yes
    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

    Product Codes

    Code Name
    JHI Visual, Pregnancy Hcg, Prescription Use

    GMDN Terms

    Code Name
    33819 Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 00857338006217
    Unit of Use 00857338006231