BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Parts Box, SuperPole Heavy Duty

    DI: 00689281015400 · Model: SP-BXHD · Healthcraft Products Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Parts Box, SuperPole Heavy Duty
    Primary DI
    00689281015400
    Version / Model
    SP-BXHD
    Catalog Number
    01540
    Company Name
    Healthcraft Products Inc.
    Labeler DUNS
    252468293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-25
    Public Version
    1
    Public Version Date
    2021-09-02
    Public Version Status
    New
    Public Device Record Key
    17c04062-92ae-40a9-98e8-484880b6f9a8

    Device Description

    The SuperPole is a high quality, commercial grade floor to ceiling safety pole. The SuperPole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperPole is installed between a structural floor and ceiling by turning a jackscrew at the bottom of the pole. The pressure created by the jackscrew is strong enough for the SuperPole to support the user, yet it does not require drilling holes into the floor or ceiling. This is ideal for relocating or removing the pole. The floor to ceiling range and maximum user weight dependent on model. Note: Product is not intended to support full body weight. The SuperPole is not to be used in any other way than described above. The SuperPole is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the pole are made from metal. The components of the pole that make direct contact with the floor and ceiling are made of non-slip rubber to protect the surfaces from damage, as well as provide traction. The top plate and base plate can be easily separated from the pole by use of multiple use fasteners (clevis and cotter pin). The top plate can be secured to the structural ceiling joist with wood screws: - if regular inspection (and if necessary, tightening) cannot be done - if pole is subjected to aggressive usage - if using SuperPole Heavy Duty (SP-HD)

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    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
    FMR Device, Transfer, Patient, Manual

    GMDN Terms

    Code Name
    35586 Hand rail

    Identifiers

    Type ID
    Primary 00689281015400