CAREvent PAR

Basic Information

• Brand Name: CAREvent PAR
• Primary DI: 07540195025349
• Version / Model: 01CV0100
• Catalog Number: 01CV0100
• 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: 2016-02-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8f04463c-8d88-42d5-b1fb-6f262b90161c

Device Description

CAREvent PAR assists the rescuer in providing efficient and effective CPR by providing with audible and visual prompts for chest compression, ventilation timing and automatic ventilation. The visual prompts aid the rescuer in their CPR efforts by providing illuminated pictograms of the CPR process, timed with the audible voice prompts. These voice and visual prompts help to significantly reduce interruptions in chest compression. The audible and visual warnings of mask leakage or airway obstruction assist the rescuer in ensuring that adequate tidal volumes are delivered.

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
Direct Marking	07540195025332	GS1
Primary	07540195025349	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081330	000

Device Sizes

Type	Value	Unit	Text
Weight	1.2	Kilogram
Height	3.1	Inch
Width	9.6	Inch
Length	9.8	Inch

Storage Conditions

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