BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Portable Suction Machine

    DI: 00848530088965 · Model: SU100DC · SUNSET HEALTHCARE SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Portable Suction Machine
    Primary DI
    00848530088965
    Version / Model
    SU100DC
    Catalog Number
    SU100DC
    Company Name
    SUNSET HEALTHCARE SOLUTIONS, INC.
    Labeler DUNS
    141668116
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-31
    Public Version
    1
    Public Version Date
    2018-08-31
    Public Version Status
    New
    Public Device Record Key
    f53d1c04-5f6d-4ec5-9606-2eabf068db79

    Device Description

    Portable Suction Machine

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

    GMDN Terms

    Code Name
    36777 General-purpose suction system, line-powered

    Identifiers

    Type ID
    Primary 00848530088965
    Package 10848530088962

    Customer Contacts

    Phone
    877-578-6738
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K102626 000