Duns Number:090508636
Device Description: The PercussiveNEB 2.0 is an intrapulmonary percussive treatment device that incorporates a The PercussiveNEB 2.0 is an intrapulmonary percussive treatment device that incorporates a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions.
Catalog Number
8030
Brand Name
VORTRAN PercussiveNEB 2.0
Version/Model Number
8030
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
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
K003684,K003684
Product Code
NHJ
Product Code Name
Device, Positive Pressure Breathing, Intermittent
Public Device Record Key
a3a93cda-f594-4dc5-b0a5-22b690c721d2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 02, 2017
Package DI Number
20637320080302
Quantity per Package
10
Contains DI Package
10637320080305
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |