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Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
SENSEONICS, INCORPORATED
FG-5900-01-001
In Commercial Distribution
- 00817491022912 ()
FG-5900-01-001
- Implantable glucose monitoring system transmitter
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope.
Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced.
The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-4.0-LP
In Commercial Distribution
- 00811907030225 ()
- Bronchial Diameter Range 4.0-7.0 mm
- Endobronchial valve
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope.
Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced.
The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-4.0
In Commercial Distribution
- 00811907030126 ()
- Bronchial Diameter Range of 4.0-7.0 mm
- Endobronchial valve
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) selfexpanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through
the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EDC-TS-5.5-DM
In Commercial Distribution
- 00811907031222 ()
- Bronchial Diameter Range of 5.5 - 8.5 mm
- Endobronchial valve delivery catheter
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope.
Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced.
The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EDC-TS-5.5
In Commercial Distribution
- 00811907030720 ()
- Bronchial Diameter Range of 5.5-8.5 mm
- Endobronchial valve delivery catheter
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope.
Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced.
The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EDC-TS-4.0-J
In Commercial Distribution
- 00811907030621 ()
- Bronchial Diameter Range of 4.0-7.0 mm
- Endobronchial valve delivery catheter
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope.
Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced.
The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EDC-TS-4.0
In Commercial Distribution
- 00811907030522 ()
- Bronchial Diameter Range of 4.0-7.0 mm
- Endobronchial valve delivery catheter
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through
the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-5.5-LP
In Commercial Distribution
- 00811907030423 ()
- Bronchial Diameter Range of 5.5-8.5 mm
- Endobronchial valve
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope.
Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced.
The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-5.5
In Commercial Distribution
- 00811907030324 ()
- Bronchial Diameter Range of 5.5-8.5 mm
- Endobronchial valve
The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a rescue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)
It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.
The i-PAD NFI200 is capable of saving data and transmitting them to an external device.
Indications for Use
The i-PAD NFI200 is used to treat a person suffering from sudden cardiac arrest
(SCA) and who exhibits symptoms of
· No movement and no response when shaken
· No normal breathing
Contraindication for Use
The device must not be used on a person who:
* Is moving or is responsive when shaken
* Is breathing normally
Target Patients
* Adults
* Children over 55 lbs or 8 years old
* The device is not to be used on children below 8 years old or under 55 lbs
Intended User
The device is intended for use by persons:
* who have been specifically trained in its operation
* who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized emergency medical response program in accordance with local and state requirements
CU Medical Systems, Inc.
NF1200
In Commercial Distribution
- 08809435480003 ()
- Non-rechargeable public semi-automated external defibrillator