BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Jet Port Plus II

    DI: 07640110987940 · Model: 616.367.2080-A · PFM MEDICAL INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Jet Port Plus II
    Primary DI
    07640110987940
    Version / Model
    616.367.2080-A
    Company Name
    PFM MEDICAL INCORPORATED
    Labeler DUNS
    097736867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-27
    Public Version
    1
    Public Version Date
    2020-03-06
    Public Version Status
    New
    Public Device Record Key
    edf17d07-9c9d-41eb-94f4-0b61a4942d2d

    Device Description

    Jet Port Plus II PUR Kit HF with 8F x 750 mm Attachable Polyurethane Catheter

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

    GMDN Terms

    Code Name
    61494 Vascular port/catheter

    Identifiers

    Type ID
    Package 07640110981702
    Primary 07640110987940

    Customer Contacts

    Phone
    7607588749
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K072481 000