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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
In Commercial Distribution

  • 00811907030126 ()

  • Bronchial Diameter Range of 4.0-7.0 mm


  • Endobronchial valve
Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)
Wallac Oy
B079-201
Not in Commercial Distribution

  • 06438147321315 ()
B079-201

  • Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
This is the Metabolic Solutions Kit version of the kit.
Otsuka America Pharmaceutical Inc
01M
In Commercial Distribution

  • 00857335005039 ()
  • 10857335005043 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP)
Wallac Oy
B079-212
In Commercial Distribution

  • 06438147321322 ()
B079-212

  • Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
KIT, ADAPTER, AIRWAY, PEDIATRIC/INFANT, BOX OF 10, (REF: 3572INF-00)
Zoll Medical Corporation
9355-0310
In Commercial Distribution

  • 00847946024079 ()


  • Gas dehumidification tubing set, single-use
KIT, ADAPTER, AIRWAY, ADULT/PEDIATRIC, BOX OF 10, (REF: 3572ADU-00)
Zoll Medical Corporation
9355-0276
In Commercial Distribution

  • 00847946024000 ()


  • Gas dehumidification tubing set, single-use
CANNULA, NASAL, PEDIATRIC, CO2/WO2, BOX OF 10, (REF: 3569PED-00)
Zoll Medical Corporation
9355-0271
In Commercial Distribution

  • 00847946023973 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
CANNULA, NASAL, INFANT, CO2 SAMPLING, BOX OF 10, (REF: 3568INF-00)
Zoll Medical Corporation
9355-0267
In Commercial Distribution

  • 00847946023935 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
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