Carefusion 22543-001 - ApneaRx Oral Appliance Adjustable Anti-Snoring and Sleep Apnea Device
The Carefusion 22543-001 ApneaRx Oral Appliance is a clinically validated, adjustable mandibular advancement device (MAD) developed to manage mild to moderate obstructive sleep apnea (OSA) and reduce snoring. Designed for comfort, effectiveness, and ease of use, this non-invasive oral appliance gently repositions the lower jaw forward during sleep, helping to keep the airway open and reduce apneic episodes.
ApneaRx is FDA-cleared, latex-free, and designed with a patented adjustable mechanism that allows users to customize the fit in 1 mm incrementsno tools required. This makes it an ideal solution for both clinical sleep disorder programs and individual use under the supervision of a healthcare provider.
Key Benefits
Clinically Proven Effectiveness: Reduces snoring and alleviates symptoms of mild to moderate OSA by advancing the lower jaw to maintain open airways.
Precision-Fit Technology: Features an easy boil-and-bite fitting process, along with 10 customizable advancement settings (1 mm increments) for optimal comfort and effectiveness.
Non-Invasive Alternative: Offers a comfortable, portable, and convenient alternative to CPAP machines for patients unable to tolerate traditional therapy.
Latex-Free and BPA-Free: Made with medical-grade materials to ensure safety and comfort.
Tool-Free Adjustment: Users can easily fine-tune the advancement without specialized tools or dental visits.
Compatibility and Applications
The ApneaRx oral appliance is intended for:
Adults with mild to moderate obstructive sleep apnea (OSA)
Individuals suffering from chronic or positional snoring
Patients seeking a CPAP alternative due to discomfort or non-compliance
It is suitable for use in:
Sleep clinics and outpatient respiratory centers
At-home therapy under physician or sleep specialist guidance
Pre-screening scenarios before prescribing long-term CPAP therapy
Usage Guidelines
Follow the included instructions to fit the appliance using the boil-and-bite method.
Place the appliance in the mouth before bedtime, ensuring a snug fit over the upper and lower teeth.
Adjust the advancement as needed using the integrated 1 mm step system.
Clean daily with a toothbrush and mild soap or a non-alcoholic denture cleaning solution.
Store in the provided case when not in use.
Certifications, Safety Standards, and Regulatory Approvals
FDA Cleared for treatment of snoring and OSA
CE Marked for use in Europe
Complies with ISO 13485 standards for medical device manufacturing
These certifications confirm its safety, performance, and quality for clinical and home use.
Comparison with Competitor Products
Compared to generic over-the-counter snoring devices, the ApneaRx stands out for its clinical validation, adjustability, and medical-grade construction. Unlike static MADs, it allows progressive titration, enhancing comfort and treatment efficacy. It also provides a more cost-effective and portable alternative to CPAP therapy for appropriate patient profiles.
Typical User Profile and Application Scenarios
This appliance is typically used by:
Adults diagnosed with mild to moderate sleep apnea
Chronic snorers without apnea but seeking relief
Patients who are CPAP-intolerant or prefer a travel-friendly solution
Common scenarios include home-based sleep therapy, temporary CPAP replacement, and pre-diagnostic trial use in sleep medicine practices.
Best Practices for Use and Maintenance
Ensure proper fit and advancement adjustment before use.
Maintain daily cleaning hygiene to prevent bacterial buildup.
Monitor for any discomfort or dental pressure and adjust as needed.
Replace if signs of wear, cracking, or deformation appear.
Consult a sleep specialist for long-term use recommendations or if symptoms persist.
Regulatory and Safety Information
The ApneaRx Oral Appliance is manufactured under strict quality control, ensuring biocompatibility, patient safety, and effectiveness. It adheres to medical device directives and is safe for long-term, repeat use in accordance with manufacturer instructions.
How to Order
To order the Carefusion 22543-001 ApneaRx Oral Appliance, simply add the product to your cart and complete checkout on CIA Medicals secure ordering platform.
For clinical bulk orders or questions about integration into your sleep therapy program, contact CIA Medical at (312) 275-5850 or use the contact form on this page to speak with a product expert.
