BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FIRST SIGN®

    DI: 00817763020165 · Model: D0115TC-02 · HEMOSURE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FIRST SIGN®
    Primary DI
    00817763020165
    Version / Model
    D0115TC-02
    Catalog Number
    D0115TC-02
    Company Name
    HEMOSURE INC.
    Labeler DUNS
    806777541
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    3
    Public Version Date
    2018-12-31
    Public Version Status
    Update
    Public Device Record Key
    99e84341-390d-456a-ad7f-fe135d814514
    Distribution End Date
    2018-12-31

    Device Description

    DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for Hemosure AMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OPI/OXY/PCP/TCA/THC

    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
    DIF Drug Mixture Control Materials

    GMDN Terms

    Code Name
    55461 Multiple drugs of abuse IVD, control

    Identifiers

    Type ID
    Primary 00817763020165

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius