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AtriCure Switch Box
ATRICURE, INC.
ASB3
A000435
- Electrosurgical cable adaptor
No Description
ATRICURE, INC.
CSK-2060
In Commercial Distribution
- 30840143901663 ()
- 10840143901485 ()
- 50840143902442 ()
A001184
- Cardiac radio-frequency ablation system generator
No Description
DEFIBTECH, L.L.C.
DDU-E2200
In Commercial Distribution
- 10815098020192 ()
- Non-rechargeable public automated external defibrillator
The Model 3150 IPG is the next generation Implantable Pulse Generator (IPG). It contains electronics and a battery that are sealed inside a titanium case. The Model 3150 is smaller in size than the previous model (3028) and eliminates the need of an Inspire respiratory sensing lead by having a built-in sensing accelerometer in the Model 3150 generator itself. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connects to the Inspire stimulation lead. The Model 3150 introduces improved communication speed between the IPG and the external products along with enhanced security. The Inspire system stimulates the hypoglossal nerve, synchronous with the patient’s respiration cycle using closed loop sensing technology. The timed stimulation elicits a neuromuscular response from the base of the tongue thereby preventing upper airway collapse that causes airflow obstruction in many OSA patients. The Model 3150 IPG will also allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-015-001
In Commercial Distribution
- 10855728005960 ()
3150
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-014
In Commercial Distribution
- 10855728005915 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-009-003
In Commercial Distribution
- 10855728005892 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-011
In Commercial Distribution
- 10855728005809 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-010
In Commercial Distribution
- 10855728005762 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
MERIDIAN BIOSCIENCE, INC.
2.0
In Commercial Distribution
- 00840733101458 ()
BRTKCALC
- Helicobacter pylori urease IVD, kit, chromogenic
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution
- 00840733101434 ()
- 00840733101441 ()
8209
- Helicobacter pylori urease IVD, kit, chromogenic