Sterile Disposable Closed Suction Catheter

The Sterile Disposable Closed Suction Catheter is a specialized medical device designed for airway suctioning in mechanically ventilated patients or those with artificial airways (e.g., endotracheal intubation, tracheostomy). It features a closed-loop system that allows suctioning without disconnecting the patient from the ventilator or breaking the respiratory circuit, minimizing the risk of cross-infection, oxygen desaturation, and airway contamination. By effectively removing secretions, sputum, and debris from the airway, it maintains respiratory patency, reduces the incidence of ventilator-associated pneumonia (VAP), and ensures stable ventilation support. Crafted for single-use sterility and intuitive operation, it is an indispensable tool in ICUs, respiratory wards, operating rooms, emergency departments, and pre-hospital rescue scenarios.

Constructed from medical-grade biocompatible materials, the catheter boasts a scientific structural design: the smooth, atraumatic tip with side holes ensures efficient suctioning while minimizing damage to airway mucosa; the integrated closed sleeve isolates the catheter from the external environment, preventing pathogen entry; the built-in flush port facilitates on-demand irrigation to keep the catheter patent and reduce secretion accumulation; and the standardized luer lock interface ensures secure connection with suction devices and ventilator circuits. Available in multiple sizes (adult, pediatric, infant) to match different airway anatomies, it requires no complex assembly-ready for immediate use in clinical emergencies. Each unit undergoes rigorous sterilization and quality testing, complying with ISO 13485, CE, and NMPA medical device standards to guarantee safety, sterility, and reliable performance.

 

 

 

• Closed-Loop Infection Control: The integrated closed sleeve and one-way valve form a sealed system, eliminating the need to disconnect the ventilator during suctioning. This reduces exposure to patient secretions, blocks pathogen transmission, and lowers the risk of cross-infection and VAP by ≥60% compared to open suction catheters.
• Atraumatic Airway Protection: The smooth, rounded tip with multiple side holes minimizes mucosal irritation and trauma during insertion and suctioning, avoiding airway bleeding or edema-critical for long-term ventilated patients and fragile pediatric/infant airways.

 

 

• Precise & Efficient Suctioning: Clear depth scale markings (in cm) on the catheter allow accurate control of insertion depth, ensuring targeted suctioning of secretions without damaging deep airway tissues. The side-hole design enhances suction coverage and efficiency, removing thick sputum and debris effectively.
• Continuous Ventilation Support: By maintaining the integrity of the ventilator circuit, the closed system prevents oxygen desaturation and fluctuations in positive end-expiratory pressure (PEEP) during suctioning, ensuring stable respiratory support for critically ill patients.
• User-Friendly & Time-Saving: The thumb control valve enables on/off suctioning with one hand, simplifying operation for medical staff; the flush port allows instant irrigation with sterile saline to clear blockages, eliminating the need for catheter replacement mid-procedure. Lightweight and compact packaging facilitates easy storage and quick access in emergency settings.

Certifications: Fully complies with ISO 13485 medical device quality management system standards, CE medical device certification, and NMPA registration requirements. Each production batch undergoes rigorous quality testing:

Closed System Integrity Test: Verifies no air leakage or pathogen penetration under simulated clinical suction pressure (-200 mmHg).

Catheter Patency & Flow Test: Ensures unobstructed suctioning and flow rate meets specifications.

Atraumatic Tip Verification: Confirms tip smoothness and absence of burrs via microscopic inspection and simulated airway insertion tests.

Sterility Validation: 100% EO sterilization with biological indicator testing to ensure no viable microorganisms.

Biocompatibility Assessment: Conducts cytotoxicity, skin sensitization, and mucosal irritation tests on all patient-contact materials.

Depth Scale Accuracy Test: Validates scale markings are within ±0.5cm tolerance.

Each product is marked with a unique batch number and expiration date for full traceability of production, sterilization, and distribution. A detailed Instruction for Use (IFU) is provided, including insertion steps, suction pressure guidelines, flush operation, and contraindications.

Packing, Storage, Handling and Transportation

Packing:

Individual units: Sealed in EO-sterilized paper-plastic composite packaging (waterproof, dustproof, and tear-resistant) with clear product labeling (size, batch number, sterilization date, expiration date, and "Sterile" indicator). Each package includes the catheter and compatible accessories.

Bulk transport: Packed in sturdy corrugated cartons with anti-crush foam inserts to prevent packaging damage and maintain sterility. Each carton is labeled with product name, specification, quantity, batch number, and "Medical Device - Sterile" warning signs.

Storage:

Store in a clean, dry, well-ventilated environment with a temperature of -5℃~40℃ and relative humidity ≤80%.

Avoid direct sunlight, high temperature, high humidity, and contact with sharp objects, corrosive substances (e.g., acids, alkalis), or volatile chemicals.

Keep packages sealed until immediate use; do not use if the packaging is torn, damaged, or the sterile indicator shows invalidation.

Stack cartons no more than 10 layers to prevent crushing the inner packages.

Handling:

Single-use only: Discard immediately after suctioning; do not reuse, reprocess, or sterilize to avoid cross-infection and catheter degradation.

Do not bend or kink the catheter during operation to maintain suction patency; avoid touching the catheter tip or inner sleeve to preserve sterility.

Inspect the package for damage and the sterile indicator before use; do not use if any defects are found.

Transportation:

Transport in accordance with national and international medical device transportation regulations, avoiding violent collision, jolting, rain, or moisture.

Use insulated or temperature-controlled vehicles for transportation in extreme environments (below -5℃ or above 40℃) to ensure product integrity.

The transportation process shall be recorded, including departure date, destination, transportation conditions, and receiver information, for full traceability.

Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.

Diversified Product Portfolio

Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.

Reliable Supply & Collaboration

We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.

Strict Quality Assurance

We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.

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