BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Jelco

    DI: 20351688060508 · Model: 982106 · SMITHS MEDICAL ASD, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Jelco
    Primary DI
    20351688060508
    Version / Model
    982106
    Company Name
    SMITHS MEDICAL ASD, INC.
    Labeler DUNS
    137835299
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-12
    Public Version
    5
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    eefd3879-3098-46ed-b91b-4bac3a8ef8d9

    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
    FMI Needle, hypodermic, single lumen

    GMDN Terms

    Code Name
    35209 Non-fixed blood collection needle

    Identifiers

    Type ID
    Package 30351688060505
    Package 10351688060501
    Primary 20351688060508

    Premarket Submissions

    Submission Number Supplement Number
    K895705 000