BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Mui Scientific

    DI: 00678467004161 · Model: PIP-5-2SS · H & A Mui Enterprises Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mui Scientific
    Primary DI
    00678467004161
    Version / Model
    PIP-5-2SS
    Company Name
    H & A Mui Enterprises Inc
    Labeler DUNS
    243872611
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2020-06-08
    Public Version Status
    Update
    Public Device Record Key
    55c9d9ed-9faf-49d7-982b-3404d2fad50a
    Distribution End Date
    2020-06-05

    Device Description

    2 Channel Compressed Air SOM Pump

    Device Characteristics

    Single Use
    No
    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
    FFX System, Gastrointestinal Motility (Electrical)

    GMDN Terms

    Code Name
    35053 Manometric gastrointestinal motility analysis system

    Identifiers

    Type ID
    Primary 00678467004161

    Customer Contacts

    Phone
    (905) 890-5525
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K120524 000