Objectives

The primary objective of this tender is to procure the 1st Generation Laryngeal Mask Airway Device with Preformed Curve, suitable for use as a supraglottic airway device in spontaneously breathing or ventilated patients. The device aims to provide a stable, anatomically curved, kink-resistant airway solution that ensures effective sealing and compatibility with positive pressure ventilation.

Scope

The scope encompasses the supply of single-use, sterile laryngeal mask airway devices in various sizes tailored to patient weight categories (from 10kg to 100kg). The devices must meet detailed specifications including material, design, packaging, and quality standards, and be delivered to Harry Gwala Regional Hospital as per the specified requirements. The procurement includes all related documentation, compliance, and quality assurance measures.

Technical Requirements

• The device must be a 1st Generation Laryngeal Mask Airway with a preformed, anatomically curved, kink-resistant PVC airway tube ending in a soft elliptical silicone pharyngeal cuff with a one-way valve and inflation bulb.
• The airway tube should allow easy one-hand insertion, have a 15mm connector proximally, and feature a smooth transition to the posterior aspect of the boot.
• The cuff must create a high-pressure seal suitable for positive pressure ventilation of at least 20cm/H2O, resist folding during insertion, and include a one-way valve with inflation bulb indicating cuff pressure.
• The device must have clear, non-rub-off markings indicating trade name, size, and patient weight guidelines.
• Manufactured from latex-free, medical-grade PVC and silicone, sterile, individually packed in peel pouches for single use.
• Packaging must include trade name, size, specification, manufacturing site, CE number, lot number, and expiry date.
• The device must comply with CE 0086 or equivalent standards.

Skills Requirements

• Bidder must demonstrate technical competence in manufacturing or distributing medical airway devices, with relevant certifications and quality standards compliance.
• Ability to provide detailed technical documentation, including product specifications, CE or equivalent certification, and quality assurance evidence.
• Proficiency in supply chain management to ensure timely delivery, proper packaging, and adherence to sterile handling procedures.
• Capability to provide after-sales support, technical assistance, and compliance with regulatory requirements such as SAHPRA licensing.
• Experience in participating in government procurement processes, including submission of samples, documentation, and adherence to evaluation criteria.