BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RED

    DI: B960RED201 · Model: 02 2050 RED · Neuraxis, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    11
    Pkg Device Count
    5

    Basic Information

    Brand Name
    RED
    Primary DI
    B960RED201
    Version / Model
    02 2050 RED
    Catalog Number
    02-2050
    Company Name
    Neuraxis, Inc.
    Labeler DUNS
    063076701
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2025-01-09
    Public Version
    5
    Public Version Date
    2025-03-11
    Public Version Status
    Update
    Public Device Record Key
    85f91867-e0b3-4f98-9588-05ce265ab970

    Device Description

    The Rectal Expulsion Device (RED) is a catheter with a proprietary open-cell foam balloon that naturally expands when inserted into the rectum. RED is used to evaluate the neuromuscular function of the patient's ability to expel its content from the rectum and a qualitative test for rectal hypersensitivity. It is intended to be used in a clinical setting by providers in adult populations. RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume the foam displaces when inflated with room air is 52 - 60 ml. This passive expansion provides the same function as filling an empty balloon with water or air, but the proprietary foam behaves and feels like normal stool. When expanded, the volume of material inside the patient’s rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate at lower volumes. This is measured by asking patients a few questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually. Cartons may have 1-5 devices as needed.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
    FFX System, Gastrointestinal Motility (Electrical)

    GMDN Terms

    Code Name
    17745 Gastrointestinal motility manometric catheter, non-electronic
    17781 Rectosphincteric balloon

    Identifiers

    Type ID
    Primary B960RED201
    Package B960RED2011
    Package B960RED2012
    Unit of Use REDDEVICES5
    Package B960RED2010
    Package B960RED2016
    Package B960RED2015
    Package B960RED2013
    Package B960RED2014
    Package B960RED2017
    Package B960RED2018

    Customer Contacts

    Phone
    812-689-0791
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K242304 000