RED 02-2050

GUDID B960RED201

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.

Neuraxis, Inc.

Rectosphincteric balloon
Primary Device IDB960RED201
NIH Device Record Key85f91867-e0b3-4f98-9588-05ce265ab970
Commercial Distribution StatusIn Commercial Distribution
Brand NameRED
Version Model Number02 2050 RED
Catalog Number02-2050
Company DUNS063076701
Company NameNeuraxis, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com
Phone812-689-0791
EmailTcarrico@neuraxis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB960RED201 [Primary]
HIBCCB960RED2010 [Package]
Package: CARTON [1 Units]
In Commercial Distribution
HIBCCB960RED2011 [Package]
Package: CARTON [2 Units]
In Commercial Distribution
HIBCCB960RED2012 [Package]
Package: box [4 Units]
In Commercial Distribution
HIBCCB960RED2013 [Package]
Contains: B960RED2010
Package: BOX [3 Units]
In Commercial Distribution
HIBCCB960RED2014 [Package]
Contains: B960RED2010
Package: BOX [4 Units]
In Commercial Distribution
HIBCCB960RED2015 [Package]
Contains: B960RED2010
Package: BOX [5 Units]
In Commercial Distribution
HIBCCB960RED2016 [Package]
Contains: B960RED2010
Package: BOX [6 Units]
In Commercial Distribution
HIBCCB960RED2017 [Package]
Contains: B960RED2010
Package: BOX [2 Units]
In Commercial Distribution
HIBCCB960RED2018 [Package]
Contains: B960RED2010
Package: BOX [1 Units]
In Commercial Distribution
HIBCCREDDEVICES5 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

Devices Manufactured by Neuraxis, Inc.

B960RED201 - RED2025-01-17The 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.
B960RED201 - RED2025-01-17 The Rectal Expulsion Device (RED) is a catheter with a proprietary open-cell foam balloon that naturally expands when inserted i
B960RED202 - RED Prep-Kit2025-01-17 The Rectal Expulsion Device Prep-kit (RED Prep-kit, PN 02-2051) consists of the following items and is to be used with the NeurA
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