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

Duns Number:206449154

Device Description: CAREvent DRA hand held automatic resuscitator is pneumatically powered, time/volume cycled CAREvent DRA 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 DRA 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 DRA allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. The 01CV3400 is a kit which consists of a CAREvent DRA resuscitator, a pressure regulator, a universal resuscitation facemask, an oxygen mask with oxygen tubing, a oxygen supply hose and a carrying case.

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More Product Details

Catalog Number

01CV3400

Brand Name

CAREvent DRA

Version/Model Number

01CV3400

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

-

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

0ae23ba9-1d3f-4b64-936d-a8febdddb2d2

Public Version Date

May 10, 2019

Public Version Number

1

DI Record Publish Date

May 02, 2019

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