BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET

    DI: 00646311553189 · Model: PA01N01 · SB-KAWASUMI LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET
    Primary DI
    00646311553189
    Version / Model
    PA01N01
    Catalog Number
    PA01N01
    Company Name
    SB-KAWASUMI LABORATORIES, INC.
    Labeler DUNS
    690625850
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-20
    Public Version
    5
    Public Version Date
    2024-01-25
    Public Version Status
    Update
    Public Device Record Key
    006c477a-2fe1-4c18-882e-2379e8a7f6bb

    Device Description

    The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.

    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
    Yes
    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
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    17701 Vascular port administration set

    Identifiers

    Type ID
    Primary 00646311553189

    Customer Contacts

    Phone
    (813) 630-5554
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Needle Gauge 20 Gauge