BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FIRST SIGN®

    DI: 00817763021759 · Model: FSCDIP234 · HEMOSURE INC.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    FIRST SIGN®
    Primary DI
    00817763021759
    Version / Model
    FSCDIP234
    Catalog Number
    FSCDIP234
    Company Name
    HEMOSURE INC.
    Labeler DUNS
    806777541
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2017-02-08
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    6cb957b2-b693-48c2-92e4-ce2b5bbf71d2
    Distribution End Date
    2017-07-26

    Device Description

    DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BUP/BZO/COC/MOR/OXY

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    JXM Enzyme Immunoassay, Benzodiazepine
    DJG Enzyme Immunoassay, Opiates
    DKZ Enzyme Immunoassay, Amphetamine
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

    GMDN Terms

    Code Name
    46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 00817763021759
    Unit of Use 00817763021766