BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    APOTECA

    DI: 05060304050243 · Model: APOTECAped · AEA SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APOTECA
    Primary DI
    05060304050243
    Version / Model
    APOTECAped
    Company Name
    AEA SRL
    Labeler DUNS
    429415227
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-22
    Public Version
    1
    Public Version Date
    2018-06-22
    Public Version Status
    New
    Public Device Record Key
    5dfe3f12-56e7-46d5-a5e5-da79a9dfd27d

    Device Description

    Automatic system for compouding of non-hazardous drugs for pedriatic patients

    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
    Yes
    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
    NEP System/Device, Pharmacy Compounding

    GMDN Terms

    Code Name
    16807 Pharmaceutical fluid-dispensing system

    Identifiers

    Type ID
    Primary 05060304050243