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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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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 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
Scatter Radiation Pad
Manus Medical, LLC
SJAA 601-X-1
In Commercial Distribution

  • 20811870037805 ()
  • 00811870037801 ()


  • Patient radiation shielding pad/drape, single-use
Peripheral Triple Ctrscp
Manus Medical, LLC
SEPA 403-CTRSCP-1
In Commercial Distribution

  • 20811870037799 ()
  • 00811870037795 ()


  • Patient radiation shielding pad/drape, single-use
CYSTO PACK
Cardinal Health 200, LLC
SOT1PCPFMA
In Commercial Distribution

  • 50197106401130 ()
  • 10197106401132 ()
SOT1PCPFMA

  • Urological surgical procedure kit, non-medicated, single-use
PALMAZ MULLINS 8F UNEXP L59MM D10MM
Cordis US Corp.
PM5910PXD
In Commercial Distribution

  • 20705032101223 ()
PM5910PXD

  • Bare-metal tracheal/bronchial/vascular stent
PALMAZ MULLINS 8F UNEXP L29MM D10-12MM
Cordis US Corp.
PM3910PXD
In Commercial Distribution

  • 20705032101216 ()
PM3910PXD

  • Bare-metal tracheal/bronchial/vascular stent
PALMAZ MULLINS 8F UNEXP L25MM D10-12MM
Cordis US Corp.
PM2910PXD
In Commercial Distribution

  • 20705032101209 ()
PM2910PXD

  • Bare-metal tracheal/bronchial/vascular stent
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