BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Drew Scientific

    DI: 00817274020159 · Model: 014-175SA · DREW SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Drew Scientific
    Primary DI
    00817274020159
    Version / Model
    014-175SA
    Company Name
    DREW SCIENTIFIC, INC.
    Labeler DUNS
    144968104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    3
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    0461bfc4-2fcc-4cfb-8f5b-0f53f96256c7

    Device Description

    DS5 HbA1c Control (2-level) (2 x 3 x 0.5mL)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    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
    JPK Mixture, Hematology Quality Control

    GMDN Terms

    Code Name
    30591 Prothrombin time (PT) IVD, kit, rapid clotting, clinical

    Identifiers

    Type ID
    Primary 00817274020159

    Customer Contacts

    Phone
    1-305-324-2300
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius