BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SuperPole™ SuperPole™ with SuperBar™

    DI: 00689281015264 · Model: SPB-S · Healthcraft Products Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SuperPole™ SuperPole™ with SuperBar™
    Primary DI
    00689281015264
    Version / Model
    SPB-S
    Catalog Number
    01526
    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
    d58f337f-dc86-45f2-bbd3-57c0bf8d7903

    Device Description

    The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. The floor to ceiling range and maximum user weight dependent on model. Note: Product is not intended to support full body weight. The SuperBar is only to be used with HealthCraft’s SuperPole System. The SuperBar is not to be used with the SuperPole Ultra. The SuperBar is not to be used in any other way than described above. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight300lbs / 136kgs The SuperBar 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 plastic bushings of the SuperBar allow the horizontal bar to be rotated without marking or damaging the pole. The top plate and base plate can be easily separated from the pole by use of multiple use fasteners (clevis and cotter pin).The non-latex grip provides both comfort and traction for the hand. 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

    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 00689281015264