Zephyr Endobronchial Valve

GUDID 00811907030423

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

Endobronchial valve
Primary Device ID00811907030423
NIH Device Record Key525f2468-3a50-4385-b73c-77a1e03be8dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameZephyr Endobronchial Valve
Version Model NumberEBV-TS-5.5-LP
Company DUNS958582595
Company NamePULMONX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-300-4550
EmailUSCustomerService@pulmonx.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100811907030423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJKValve, Pulmonary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-02
Device Publish Date2019-08-23

On-Brand Devices [Zephyr Endobronchial Valve]

00811907030324The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude
00811907030225The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude
00811907030126The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude
00811907030423The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude

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