AccessGUDID - DEVICE: Zephyr Endobronchial Valve (00811907030225)

GUDID

Device Identifier (DI) Information

Brand Name: Zephyr Endobronchial Valve
Version or Model: EBV-TS-4.0-LP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULMONX CORPORATION

Primary DI Number: 00811907030225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 958582595 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47613	Endobronchial valve	A sterile, non-surgical implantable device designed to be placed in a bronchial lumen to control bronchial airflow and improve health status, typically in a patient with emphysema and/or to reduce bronchial air leaks. It consists of a one-way valve that includes an expanding frame (e.g., Nitinol) with features to prevent migration after implantation, and a plastic membrane. It is intended to limit airflow distal to the valve while allowing mucus and air movement proximally. This results in the valve redirecting air to healthy portions of the lungs and/or venting lung segments to achieve pneumoreduction. The valve may remain permanently implanted or removed when medical indicated.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NJK	Valve, Pulmonary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Bronchial Diameter Range 4.0-7.0 mm

Device Record Status

Public Device Record Key: 0b1066c0-4a66-47c2-afea-8ad81c27e584
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 20, 2018