BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EMPACT 6+ Patient Hard Case Refurbish Kit

    DI: B283E6HCXPAC0 · Model: B283E6HCXPAC · Pro1tek
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EMPACT 6+ Patient Hard Case Refurbish Kit
    Primary DI
    B283E6HCXPAC0
    Version / Model
    B283E6HCXPAC
    Company Name
    Pro1tek
    Labeler DUNS
    827067880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-02
    Public Version
    1
    Public Version Date
    2020-11-10
    Public Version Status
    New
    Public Device Record Key
    3aa12a35-768e-4014-aa91-d62c88746dd9

    Device Description

    EMPACT is an Emergency Medical Passive Active Shooter Countermeasure Tool Kit. Medical Trauma, First Aid, Bleeding Control 6+ Patient Refurbished Kit with Tactical. Specialized refurbish kit to convert our 10+ Patient Kit into a 6+ Patient Hard Case.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OVR Kit, First Aid, Talking

    GMDN Terms

    Code Name
    44039 First aid kit, medicated

    Identifiers

    Type ID
    Primary B283E6HCXPAC0