ISO 13485 Certified Laryngeal Mask Airway for General Anesthesia with Medical

Product Specification

Laryngeal Mask Airway General Anesthesia ISO 13485 Certified

Product Overview

The Laryngeal Mask Airway (LMA) series is a premier supraglottic airway device specifically designed for general anesthesia and emergency airway management. As an ideal alternative to endotracheal intubation, it minimizes trauma to the airway mucosa while offering ease of use and a high first-pass success rate. Manufactured under ISO 13485 certification, our LMAs meet the highest international clinical safety standards.

Key Benefits

• Clinical Efficiency: Allows for rapid, blind insertion without the need for a laryngoscope, significantly reducing the time required to establish a patent airway.

• Superior Sealing Performance: The ergonomically designed cuff conforms perfectly to the pharyngeal anatomy, achieving high seal pressures at low mucosal contact pressures.

• Enhanced Patient Comfort: Reduces the incidence of post-operative sore throat (POST) and coughing, leading to faster patient recovery.

• Certified Quality: Produced in strict accordance with ISO 13485, ensuring excellent biocompatibility and safety.

Material Comparison: Silicone vs. PVC

1. Medical Grade Silicone: Exceptionally soft and flexible, providing superior anatomical compliance and minimizing tissue pressure. Ideal for prolonged procedures.

2. Medical Grade PVC: Offers excellent structural integrity and cost-effectiveness, making it the preferred choice for high-volume, single-use clinical applications.

Specifications & Parameters

(Please refer to the table in the Chinese section for detailed weight ranges and cuff volumes by size).

Intended Use & Target Population

• Target Population: Suitable for all patients ranging from neonates and infants to large adults.

• Typical Applications: Routine elective surgery, ambulatory/day surgery, rescue airway management, and emergency ventilation during CPR.

FAQ

• Q: Is the device Latex-free? A: Yes, the device is 100% Latex-free to prevent any allergic reactions in sensitive patients.

• Q: Is this device autoclavable? A: This specific model is designed for single-use to eliminate cross-contamination risks and save sterilization costs.

• Q: What type of lubricant should be used? A: A water-soluble lubricant is recommended for the posterior surface of the cuff to facilitate smooth insertion.