CAREvent CA - CAREvent CA hand held automatic resuscitator is - O-Two Medical Technologies Inc

Duns Number:206449154

Device Description: CAREvent CA hand held automatic resuscitator is pneumatically powered, time/volume cycled CAREvent CA 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 CA delivers automatic ventilation with controlled flow rate, airway pressure, tidal volume and frequency. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. In addition, CAREvent ALS, CA, DRA and Genesis II allow the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. The CAREvent CA is designed for resuscitation in toxic environments. A constant bleed flow reduces the risk of a patient drawing toxic air into the mask should a leak occur.

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More Product Details

Catalog Number

01CV3000-CA

Brand Name

CAREvent CA

Version/Model Number

01CV3000-CA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K051889,K051889

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

8880b856-0f2c-466c-a315-e696d5ec3cbd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"O-TWO MEDICAL TECHNOLOGIES INC" Characteristics
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