CAREvent DRA

Basic Information

• Brand Name: CAREvent DRA
• Primary DI: 07540195025097
• Version / Model: 01CV3400
• Catalog Number: 01CV3400
• Company Name: O-Two Medical Technologies Inc
• Labeler DUNS: 206449154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-02
• Public Version: 1
• Public Version Date: 2019-05-10
• Public Version Status: New
• Public Device Record Key: 0ae23ba9-1d3f-4b64-936d-a8febdddb2d2

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	868.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13366	Pulmonary resuscitator, pneumatic, reusable	A device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a breathing circuit with, e.g., a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540195025097	GS1
Direct Marking	07540195025233	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius