Zephyr Endobronchial Valve
Basic Information
- Brand Name
- Zephyr Endobronchial Valve
- Primary DI
- 00811907030423
- Version / Model
- EBV-TS-5.5-LP
- Company Name
- PULMONX CORPORATION
- Labeler DUNS
- 958582595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-23
- Public Version
- 1
- Public Version Date
- 2019-09-02
- Public Version Status
- New
- Public Device Record Key
- 525f2468-3a50-4385-b73c-77a1e03be8dc
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJK | Valve, Pulmonary | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811907030423 | GS1 |
Customer Contacts
- Phone
- 866-300-4550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180002 | 005 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Bronchial Diameter Range of 5.5-8.5 mm |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius