Carefusion 001013 - Disposable Thermoplastic Mouthpiece Single-Use Spirometry Interface, Latex-Free, Smooth Fit

The Carefusion 001013 Disposable Thermoplastic Mouthpiece is a single-use, medical-grade component designed to ensure clean, accurate, and hygienic patient interface during pulmonary function testing (PFT). Made from smooth, latex-free thermoplastic, this mouthpiece offers a comfortable fit that promotes proper seal and airflow during spirometry tests.

Its disposable nature supports infection control by eliminating the need for cleaning or sterilization between uses, making it ideal for busy respiratory labs, clinics, and hospital environments. Whether testing adults or children (with appropriate adapters), this mouthpiece ensures consistent performance in both routine and high-volume diagnostic settings.

Key Benefits:

• Infection Control: Single-use design reduces cross-contamination risk between patients.

• Smooth, Comfortable Design: Thermoplastic material offers a patient-friendly surface for enhanced comfort and cooperation.

• Consistent Airflow Performance: Maintains optimal air passage for accurate spirometry and lung function readings.

• Universal Fit: Designed to fit standard spirometry systems, filters, and flow sensors without leakage.

• Cost-Effective Hygiene: Supports high throughput in clinical environments while maintaining quality control.

These benefits make it a go-to choice for facilities that prioritize both efficiency and patient safety in respiratory testing.

Compatibility and Applications:
The Carefusion 001013 mouthpiece is compatible with:

• Carefusion spirometers

• Vmax Encore systems

• Standard flow sensors and filters

• Most pulmonary testing devices with standard mouthpiece fittings

Applications include:

• Baseline spirometry

• Forced vital capacity (FVC) testing

• Bronchodilator reversibility testing

• Occupational lung health evaluations

• Asthma and COPD diagnostics

Usage Guidelines:

• Open the individually packaged mouthpiece immediately before use.

• Attach securely to the spirometer or inline filter to ensure a tight seal.

• Instruct the patient to place their lips tightly around the mouthpiece during the test.

• After testing, remove and dispose of the mouthpiece according to biohazard waste protocols.

• Do not reuse or attempt to clean.

Certifications, Safety Standards, and Regulatory Approvals:

• FDA-listed Class I medical device

• CE Marked for EU compliance

• Manufactured under ISO 13485 quality management

• Latex-free and DEHP-free to prevent allergic reactions

• Biocompatible materials compliant with ISO 10993

These certifications affirm the mouthpieces safety, reliability, and suitability for professional clinical use.

Comparison with Competitor Products:
While similar in function to disposable mouthpieces from brands like NDD or MIR, the Carefusion 001013 stands out for its smooth thermoplastic construction, superior comfort, and tight universal fit. Many competitors lack the same combination of cost-efficiency, compatibility, and consistent manufacturing quality backed by a trusted name in respiratory care.

Typical User Profile and Application Scenarios:
Used by:

• Respiratory therapists

• Pulmonologists

• General practitioners

• Occupational health examiners

• Researchers conducting population-level lung health studies

Ideal for:

• Daily outpatient spirometry

• Hospital-based lung function labs

• Workplace respiratory screenings

• Clinical trial protocols involving PFT

• Pediatric and adult testing (with appropriate adaptors if needed)

Best Practices for Use and Maintenance:

• Always verify packaging integrity before use.

• Discard after each use to ensure hygienic testing.

• Keep mouthpieces stored in a clean, dry environment.

• Use with inline bacterial/viral filters if required by facility protocols for added protection.

Regulatory and Safety Information:
This mouthpiece complies with U.S. and EU medical device regulations, ensuring safe use in clinical settings. Its single-use nature aligns with infection prevention protocols, and its latex- and DEHP-free construction makes it suitable for use across diverse patient populations, including those with known sensitivities or allergies.

How to Order:
To order the Carefusion 001013 Disposable Thermoplastic Mouthpiece, add the product to your cart and proceed with the secure checkout process.

For bulk purchases, institutional pricing, or additional assistance, contact CIA Medical customer service at (312) 275-5850 or use the contact form on this page. Our dedicated team is available to help with ordering, inventory planning, or product compatibility inquiries.