CAREvent ATV+

Basic Information

• Brand Name: CAREvent ATV+
• Primary DI: 07540195030121
• Version / Model: 01CV6000
• Catalog Number: 01CV6000
• 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: 2015-10-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7e41b435-16f7-439c-b18d-88b8cc3640fa

Device Description

CAREvent ATV+ is pneumatically powered, time/volume cycled, intermittent positive pressure patient ventilators specifically designed for use by trained personnel in the pre-hospital, hospital, interhospital and air ambulance environments. It has independent controls for minute volume and frequency that provide a comprehensive range of 12 ventilation frequencies and 12 minute-volume settings. This provides a possible 144 combinations of delivered tidal volume and respiratory rate. The various modes of operation of the ventilators support the resuscitation and transportation of a wide range of patients (from infants to adults).

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
41148	Portable pneumatic ventilator	A pneumatically-powered, lightweight device that is easily moved/mounted and used to provide long-term alveolar ventilation support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube, tracheostomy cannula, or mask. It includes a control system and alarms, sometimes with additional features (e.g., humidification). Several methods of cycling and ventilation modes may be used. It is typically used in the home, but may also be used in an extended care facility, and/or by emergency medical services (EMS).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540195030121	GS1
Direct Marking	07540195030114	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	6.25	Pound
Height	4.3	Inch
Width	6.5	Inch
Length	9.25	Inch

Storage Conditions

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