Duns Number:658755160
Device Description: The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult pati The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when placed inside a monoplace hyperbaric chamber for prescribed therapy.
Catalog Number
-
Brand Name
PAHI VersalVent
Version/Model Number
Model V1
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
K122560
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
8607f4b5-4fa4-49dc-88a5-360fe9796e9b
Public Version Date
July 10, 2018
Public Version Number
4
DI Record Publish Date
October 10, 2015
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. | 2 |