Duns Number:090508636
Device Description: The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands-free ventilator support via a mask or endotracheal tube using a continuous gas flow source. The VAR® device can be operated on a compressor, oxygen or compressed air. Since it does not require the use of electricity or batteries, it is an ideal backup ventilator for the management of mass casualty incidents, natural disasters, disease outbreaks, major power outages and other extraordinary emergencies. An additional advantage of the VAR® device is that it does not interfere with MRI and CT scans.
Catalog Number
PCE-5012
Brand Name
VAR (VORTRAN Automatic Resuscitator) with Extension
Version/Model Number
PCE-5012
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
K041473,K041473
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
9b713cf5-a247-4479-8f87-b5962277bd47
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 04, 2015
Package DI Number
20637320050121
Quantity per Package
10
Contains DI Package
10637320050124
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 |