CAREvent DRA 01CV3400

GUDID 07540195025097

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.

O-Two Medical Technologies Inc

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 07540195025097
• NIH Device Record Key: 0ae23ba9-1d3f-4b64-936d-a8febdddb2d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAREvent DRA
• Version Model Number: 01CV3400
• Catalog Number: 01CV3400
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195025097 [Primary]
GS1	07540195025233 [Direct Marking]

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-10
• Device Publish Date: 2019-05-02

On-Brand Devices [CAREvent DRA]

• 07540195025233: CAREvent DRA hand held automatic resuscitator is pneumatically powered, time/volume cycled venti
• 07540195025097: CAREvent DRA hand held automatic resuscitator is pneumatically powered, time/volume cycled venti