Duns Number:958582595
Device Description: The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occ
Catalog Number
-
Brand Name
Zephyr Delivery Catheter
Version/Model Number
EDC-TS-5.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P180002
Product Code
NJK
Product Code Name
Valve, Pulmonary
Public Device Record Key
61634073-d75b-4273-b6c1-1bc9aaa16f2b
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| 3 | A medical device with high risk that requires premarket approval | 8 |