Working Principle

The device operates on the principle of negative pressure suction:

• The catheter is gently inserted into the patient’s airway
• Suction is applied via mouthpiece or suction machine
• Mucus is aspirated and collected in the chamber
• The transparent chamber allows monitoring of extracted volume

Performance Features

• High suction efficiency with minimal effort
• Anti-backflow design (optional)
• Smooth internal surface to prevent blockage
• Secure connections to avoid leakage
• Odor-free and non-reactive materials

Quality & Testing Parameters

Each batch undergoes stringent quality checks:

• Visual Inspection – Clarity, defects, finishing
• Leakage Test – Ensures airtight assembly
• Tensile Strength Test – Tube durability
• Biocompatibility Test – As per ISO 10993
• Sterility Assurance Level (SAL): 10⁻⁶
• ETO Residual Testing – Safe limits compliance

Sterilization Details

• Method: Ethylene Oxide (EO) Sterilization
• Validated sterilization cycle
• Residual gas within permissible limits
• Sterility indicator provided on pack

Regulatory & Compliance (India & Export)

• CDSCO Registration
• ISO 13485: Quality Management System
• Complies with international medical device standards

Storage & Handling

• Store in cool, dry environment
• Temperature: 5°C to 40°C
• Protect from direct sunlight
• Avoid moisture exposure

Instructions for Use (IFU)

• Open sterile pack carefully
• Connect to suction source (mouth or machine)
• Insert catheter gently into airway
• Apply controlled suction
• Monitor collection chamber
• Dispose after single use

Safety Information

• Do not reuse or re-sterilize
• Do not use if package is damaged
• Use only by trained personnel
• Avoid excessive suction pressure

Competitive Advantages

• Consistent quality manufacturing
• High clarity & strong tubing
• Reliable sterilization process
• Cost-effective bulk supply
• Suitable for government tenders