Objectives

The primary objective of this tender is to procure the 1st Generation Laryngeal Mask Airway Device with a preformed curved single-use design, suitable for use as a supraglottic airway device in spontaneously breathing or ventilated patients. The device aims to ensure a high-pressure seal, ease of insertion, and compatibility with positive pressure ventilation, thereby enhancing airway management in clinical settings.

Scope

The scope encompasses the supply of various sizes of the 1st Generation Laryngeal Mask Airway Device, including sizes 2, 2.5, 3, 4, and 5, tailored to patient weight ranges from 10kg to 100kg. The procurement is for use at Harry Gwala Regional Hospital under the Department of Health, KwaZulu-Natal. The devices must meet specified standards, be sterile, individually packed, and comply with CE or equivalent standards.

Technical Requirements

• The device must consist of an 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 transition smoothly to the posterior 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 lack aperture bars.
• The cuff must include a one-way valve and inflation bulb indicating cuff inflation/deflation status.
• The device must have clear, non-rub-off markings indicating trade name, size, and recommended patient weight, with orientation guidelines on the posterior aspect.
• Manufactured from latex-free, medical-grade PVC and silicone, sterile, individually packed in peel pouches for single use.
• Packaging must display trade name, size, specifications, manufacturing site, CE number, lot number, and expiry date.
• Standards compliance with CE 0086 or equivalent is mandatory.

Skills Requirements

Applicants should possess:

• Technical expertise in manufacturing or distributing medical airway devices compliant with international standards.
• Knowledge of sterile packaging and medical device safety standards.
• Ability to provide samples for testing and verification as part of the evaluation process.
• Experience in supplying medical devices to healthcare facilities, ensuring adherence to specifications and quality standards.
• Capability to provide technical documentation, including CE certification, manufacturing details, and expiry information.