BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Halyard

    DI: 10885632389771 · Model: SS003 · OWENS & MINOR DISTRIBUTION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Halyard
    Primary DI
    10885632389771
    Version / Model
    SS003
    Company Name
    OWENS & MINOR DISTRIBUTION, INC.
    Labeler DUNS
    007941230
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-25
    Public Version
    1
    Public Version Date
    2023-02-02
    Public Version Status
    New
    Public Device Record Key
    1b509999-d564-41f2-b0a7-14d2d048d5d6

    Device Description

    Prefilled Syringe Saline Flush Intravenous 3ML PP Clear Not Made with Natural Rubber Latex Halyard

    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
    Yes
    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
    NGT Saline, vascular access flush

    GMDN Terms

    Code Name
    64786 Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

    Identifiers

    Type ID
    Package 30885632389775
    Primary 10885632389771
    Package 20885632389778

    Premarket Submissions

    Submission Number Supplement Number
    K150143 000