BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-Fit

    DI: 07540198001005 · Model: Regular Kit with stop disc · Prime Pacific Health Innovations Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pro-Fit
    Primary DI
    07540198001005
    Version / Model
    Regular Kit with stop disc
    Catalog Number
    8116
    Company Name
    Prime Pacific Health Innovations Corporation
    Labeler DUNS
    250896255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-10-22
    Public Version Status
    Update
    Public Device Record Key
    fa2b39ca-3f0d-4608-b303-dbcc6ea4336a

    Device Description

    The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion stop disc, a water inflow tube and a waste hose.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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
    FFQ Speculum, Rectal

    GMDN Terms

    Code Name
    60903 Colonic lavage kit, non-surgical

    Identifiers

    Type ID
    Package 07540198001050
    Primary 07540198001005
    Package 07540198001043