BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Portex

    DI: 10351688517265 · Model: 4307SM · SMITHS MEDICAL ASD, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Portex
    Primary DI
    10351688517265
    Version / Model
    4307SM
    Company Name
    SMITHS MEDICAL ASD, INC.
    Labeler DUNS
    828611934
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-11
    Public Version
    5
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    b56e3100-16d8-4bdc-90ee-6ae577c408a4
    Distribution End Date
    2018-10-29

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAF NEBULIZER (DIRECT PATIENT INTERFACE)

    GMDN Terms

    Code Name
    35457 Benchtop nebulizer, non-heated

    Identifiers

    Type ID
    Package 50351688517263
    Primary 10351688517265

    Premarket Submissions

    Submission Number Supplement Number
    K901315 000