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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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COREVENT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels and 3-leads of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface. The Peerbridge System Cor Event is configured for the following: - 24 hours of Holter monitoring - Patient Activated Event with Surveillance
PEERBRIDGE HEALTH, INC.
COREVENT
In Commercial Distribution

  • B608COREVENT0 ()
  • B608COREVENT1 ()
COREVENT

  • Wearable multiple physiological parameter recorder, reusable
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.
Neuraxis, Inc.
02 2050 RED
In Commercial Distribution

  • B960RED201 ()
  • B960RED2011 ()
  • B960RED2012 ()
  • REDDEVICES5 ()
  • B960RED2010 ()
  • B960RED2016 ()
  • B960RED2015 ()
  • B960RED2013 ()
  • B960RED2014 ()
  • B960RED2017 ()
  • B960RED2018 ()
02-2050

  • Rectosphincteric balloon
  • Gastrointestinal motility manometric catheter, non-electronic
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