BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SuperPole FRS with SuperBar

    DI: 00689281035866 · Model: FRS-SPB · Healthcraft Products Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SuperPole FRS with SuperBar
    Primary DI
    00689281035866
    Version / Model
    FRS-SPB
    Catalog Number
    03596
    Company Name
    Healthcraft Products Inc.
    Labeler DUNS
    252468293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-02
    Public Version
    1
    Public Version Date
    2022-12-12
    Public Version Status
    New
    Public Device Record Key
    7afeae05-a438-41c8-825d-d24078f3a9d1

    Device Description

    The SuperPole F.R.S. (floor receptacle system) with SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole F.R.S. (a support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor). The horizontal bar can be lifted, pivoted, and lowered to the next locking position around the F.R.S. pole. 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 F.R.S. 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 strong enough for the SuperBar to support the user. When the SuperPole F.R.S. is removed from the concrete receptacle, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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 00689281035866