Zephyr Endobronchial Valve

Primary DI
00811907030423
Brand
Zephyr Endobronchial Valve
Company
PULMONX CORPORATION
Model
EBV-TS-5.5-LP
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 throughthe 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.
Published
2019-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJKValve, Pulmonary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJKValve, PulmonaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180002005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180002005Zephyr Endobronchial Valve SystemPulmonx Corporation2018-06-29NJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811907030423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811907030423008119070304238119070304230811907030423

GMDN Terms#

Term, Definition table
TermDefinition
Endobronchial valveA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-300-4550USCustomerService@pulmonx.com

Regulatory Flags#

DUNS number
958582595
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811907031925Chartis Precision CatheterG4CHR-CA-15.02024-03-15
00811907031819Lung Image AnalysisLIA-01-0012022-09-05
00811907031161Pulmonx Chartis Tablet ConsoleCHR-CO-3002021-04-20
M776CHRCO100Chartis ConsoleG3CHR-CO-1002016-03-25
00811907031123Pulmonx Chartis Tablet ConsoleCHR-CO-3002018-07-20
00811907031222Zephyr Delivery CatheterEDC-TS-5.5-DM2019-08-23
00811907030928Chartis CatheterG3CHR-CA-12.02018-10-03
00811907030126Zephyr Endobronchial ValveEBV-TS-4.02018-07-20
00811907030225Zephyr Endobronchial ValveEBV-TS-4.0-LP2018-07-20
00811907030324Zephyr Endobronchial ValveEBV-TS-5.52018-07-20
00811907030522Zephyr Delivery CatheterEDC-TS-4.02018-07-20
00811907030621Zephyr Delivery CatheterEDC-TS-4.0-J2018-07-20
00811907030720Zephyr Delivery CatheterEDC-TS-5.52018-07-20
M776CHRCA120Chartis CatheterG3CHR-CA-12.02016-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811907031222Zephyr Delivery CatheterPULMONX CORPORATIONNJK2019-08-23
00896506002279Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002286Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002293Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002309Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002316Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00896506002323Spiration Valve SystemGyrus Acmi, LlcNJK2019-03-29
00811907030126Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2018-07-20
00811907030225Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2018-07-20
00811907030324Zephyr Endobronchial ValvePULMONX CORPORATIONNJK2018-07-20
00811907030522Zephyr Delivery CatheterPULMONX CORPORATIONNJK2018-07-20
00811907030621Zephyr Delivery CatheterPULMONX CORPORATIONNJK2018-07-20
00811907030720Zephyr Delivery CatheterPULMONX CORPORATIONNJK2018-07-20