DEVICE: Zephyr Delivery Catheter (00811907030720)

Device Identifier (DI) Information

Zephyr Delivery Catheter
EDC-TS-5.5
In Commercial Distribution

PULMONX CORPORATION
00811907030720
GS1

1
958582595 *Terms of Use
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.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47614 Endobronchial valve delivery catheter
A sterile, long, thin, flexible tube designed to deliver and place a non-surgical implantable endobronchial valve, via the working channel of a bronchoscope, into the bronchial lumen of a lung segment. It typically includes a loader; a tool that is used to compress the endobronchial valve and inserts the valve into the catheter. The catheter may be used to deliver multiple size endobronchial valves in a single-patient procedure. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NJK Valve, Pulmonary
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FDA Premarket Submission

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -18 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Bronchial Diameter Range of 5.5-8.5 mm
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Device Record Status

61634073-d75b-4273-b6c1-1bc9aaa16f2b
August 20, 2018
1
July 20, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
866-300-4550
USCustomerService@pulmonx.com
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