Duns Number:090508636
Device Description: The PercussiveNEB® device is a single-patient use percussor, which makes it possible for i The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home
Catalog Number
PNB-4030
Brand Name
VORTRAN PercussiveNEB
Version/Model Number
PNB-4030
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"
-
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
e1843de4-b1d1-4056-96a9-77a080e725dd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 14, 2016
Package DI Number
20637320040306
Quantity per Package
10
Contains DI Package
10637320040309
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 |