Duns Number:090508636
Device Description: The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure The VORTRAN Medical Air Compressor is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital uses. It is capable of servicing nebulizer and humidifiers to product particle aerosol mist.
Catalog Number
8100
Brand Name
VORTRAN Medical Air Compressor
Version/Model Number
8100
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
-
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
K072634
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
2ab63847-dfe6-40f4-8645-bab4b0145342
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2017
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. | 22 |