BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BD PhaSeal Optima

    DI: 00382905150784 · Model: 515078 · BECTON DICKINSON PEN LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BD PhaSeal Optima
    Primary DI
    00382905150784
    Version / Model
    515078
    Catalog Number
    515078
    Company Name
    BECTON DICKINSON PEN LIMITED
    Labeler DUNS
    988402590
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-26
    Public Version
    1
    Public Version Date
    2023-05-04
    Public Version Status
    New
    Public Device Record Key
    ced48250-bda0-4065-8b67-a80e01db0cf9

    Device Description

    Infusion Adaptor (C100-O)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ONB Closed antineoplastic and hazardous drug reconstitution and transfer system

    GMDN Terms

    Code Name
    35833 Electric infusion pump administration set, single-use

    Identifiers

    Type ID
    Package 30382905150785
    Primary 00382905150784
    Package 50382905150789