Duns Number:206449154
Device Description: CAREvent ALS kit 01CV3212 contains a CAREvent ALS resuscitator, a pressure regulator, and CAREvent ALS kit 01CV3212 contains a CAREvent ALS resuscitator, a pressure regulator, and an aspirator in moulded case with a Yankauer Scution Tip with Tubing.CAREvent ALS hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent ALS delivers automatic ventilation with controlled flow rates, airway pressure, tidal volume and frequencies. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
Catalog Number
01CV3212
Brand Name
CARevent ALS
Version/Model Number
01CV3212
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
bd3c2e38-6159-4d53-beb2-44c719d01378
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |