Objectives

The primary objective of this tender is to procure the 1st Generation Laryngeal Mask Airway Device with a preformed curved design, suitable for single use, to meet the clinical needs of Harry Gwala Regional Hospital. The procurement aims to ensure the availability of high-quality, sterile airway devices that conform to specified standards and specifications, supporting safe airway management in patients.

Scope

The scope encompasses the supply of various sizes of the 1st Generation Laryngeal Mask Airway Devices with preformed curves, including:

• Sizes 2, 2.5, 3, 4, and 5, each tailored for specific patient weight ranges.
• Manufacture from latex-free, medical-grade PVC and silicone materials.
• Devices must be sterile, individually packed, and compliant with CE 0086 or equivalent standards.
• Delivery to Harry Gwala Regional Hospital within the contract period, with all associated documentation.

The procurement process also includes sample submission, technical compliance verification, and adherence to departmental policies on preference points and procurement regulations.

Technical Requirements

• Device must be a single-use, anatomically curved, kink-resistant PVC airway tube with a soft elliptical silicone pharyngeal cuff.
• The cuff must create a high-pressure seal suitable for positive pressure ventilation (at least 20cm/H2O).
• The airway tube should allow easy one-hand insertion, have a 15mm connector proximally, and a smooth transition to the posterior aspect of the boot.
• The cuff must include a one-way valve and bulb for inflation/deflation, with clear, rub-proof markings indicating trade name, size, and patient weight guidelines.
• Manufactured from latex-free, medical-grade PVC and silicone, sterile, individually packed in peel pouches, and labeled with trade name, size, manufacturing site, CE number, lot number, and expiry date.
• Compliance with CE 0086 or equivalent quality standards is mandatory.

Skills Requirements

• Bidder must demonstrate technical capability in manufacturing or supplying medical airway devices that meet specified standards and specifications.
• Ability to provide samples for evaluation and ensure timely delivery within the contract period.
• Knowledge of regulatory compliance, including CE certification or equivalent, and adherence to international quality standards.
• Capacity to supply multiple sizes in series, with proper labeling and packaging as per specifications.
• Provision of technical documentation, including product specifications, CE or equivalent certification, and manufacturing details.
• Experience in handling government procurement processes, including submission of mandatory documents, preference points claims, and compliance with relevant legislation and policies.