CAFREvent ALS+ CPAP

Basic Information

• Brand Name: CAFREvent ALS+ CPAP
• Primary DI: 07540195025325
• Version / Model: 01CV4000-CPAP
• Catalog Number: 01CV4000-CPAP
• 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: 2015-10-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 48cafaa6-1640-4901-858a-ee80b1fc92bd

Device Description

CAREvent ALS+ CPAP is intended to provide artificial ventilation for patients during respiratory and cardiac arrest. The single control for the simultaneous adjustment of ventilation frequency and tidal volume has 12 settings for a range of patients from 20 kg body weight to large adults. A separate Manual/Automatic control allows the operator to turn off the automatic cycling and ventilate the patient manually. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System. CAREvent ALS+ CPAP also includes an airway Pressure Gauge and pneumatic alarm for Low Pressure Input Pressure. It also allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume. In addition, CAREvent ALS+ CPAP has an adjustable CPAP/PEEP mode, eliminating the need for an external PEEP valve or CPAP device.

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	07540195025325	GS1
Direct Marking	07540195025318	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991195	000

Device Sizes

Type	Value	Unit	Text
Weight	1.5	Kilogram
Height	2.95	Inch
Width	5.5	Inch
Length	8.1	Inch

Storage Conditions

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