Duns Number:090508636
Device Description: The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
Catalog Number
IPM-4022
Brand Name
VORTRAN-IPPB with Manomter
Version/Model Number
IPM-4022
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
K982016,K982016
Product Code
NHJ
Product Code Name
Device, Positive Pressure Breathing, Intermittent
Public Device Record Key
65d5cad9-efbd-4903-af17-0c5e48b8207e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 14, 2016
Package DI Number
20637320040221
Quantity per Package
10
Contains DI Package
10637320040224
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 |