BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-Fit

    DI: 07540198000343 · Model: Small Speculum Pack with guide rings · Prime Pacific Health Innovations Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Pro-Fit
    Primary DI
    07540198000343
    Version / Model
    Small Speculum Pack with guide rings
    Catalog Number
    8141
    Company Name
    Prime Pacific Health Innovations Corporation
    Labeler DUNS
    250896255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-30
    Public Version
    6
    Public Version Date
    2023-12-22
    Public Version Status
    Update
    Public Device Record Key
    542010b5-a0ee-49b0-b226-3023246704fe

    Device Description

    The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.

    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
    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
    14187 Colonic lavage nozzle, single-use

    Identifiers

    Type ID
    Primary 07540198000343
    Unit of Use 07540198000428