Zephyr Endobronchial Valve

GUDID 00811907030324

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 ID: 00811907030324
• NIH Device Record Key: f7f28ab0-9293-4929-9408-42e0c2390730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zephyr Endobronchial Valve
• Version Model Number: EBV-TS-5.5
• Company DUNS: 958582595
• Company Name: PULMONX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com
• Phone: 866-300-4550
• Email: USCustomerService@pulmonx.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811907030324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180002

FDA Product Code

• NJK: Valve, Pulmonary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-20
• Device Publish Date: 2018-07-20

On-Brand Devices [Zephyr Endobronchial Valve]

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