Medical-Grade Leak-Proof Blood Transfusion Set is a professional sterile medical device specially designed for clinical safe blood transfusion, blood component infusion and emergency blood replacement treatment. Manufactured from high-quality medical-grade non-DEHP transparent PVC material and latex-free non-toxic plastic accessories, the product is equipped with a standard high-precision blood filter and fully sealed leak-proof connection structure. Adopting single-use sterile processing, it effectively avoids blood contamination, air embolism, liquid leakage and clinical cross-infection risks. Ergonomically optimized for safe and stable blood transfusion operation, it features efficient impurity filtration, stable flow regulation, excellent air isolation and reliable leak-proof performance, fully meeting the standardized blood transfusion needs of general wards, intensive care units, emergency departments and operating rooms, providing safe and reliable technical guarantee for clinical blood treatment.
This medical-grade blood transfusion set adopts high-transparency non-DEHP medical PVC material for the whole pipeline and drip chamber, enabling clear real-time observation of blood flow status, transfusion speed and bubble condition without visual obstruction. Equipped with a standard 170μm-200μm professional blood filter, it can effectively intercept blood clots, fibrin precipitates and micro-aggregates in blood components to prevent transfusion complications. The high-sensitivity roller flow regulator supports stable stepless flow adjustment to adapt to different clinical blood transfusion rate requirements. All connecting interfaces adopt integrated seamless assembly technology with high airtightness and pressure resistance, realizing all-round leak-proof and anti-backflow effects. The flexible anti-kink pipeline ensures unobstructed blood delivery during long-term transfusion and patient activity. The product supports EO gas or gamma ray sterilization, strictly complies with ISO 1135-4 international transfusion set standards and domestic medical device specifications, and is widely applicable for various standardized clinical blood transfusion scenarios.
Product Specification
|
Item |
Description |
|
Application |
Clinical whole blood transfusion, plasma and blood component infusion, emergency blood replacement and postoperative blood recovery treatment |
|
Type |
Disposable sterile medical-grade leak-proof blood transfusion set |
|
Material |
Medical-grade non-DEHP transparent PVC tube, latex-free medical plastic accessories, non-toxic, pyrogen-free, biocompatible |
|
Core Configuration |
Standard vented spike, transparent drip chamber, 170-200μm microaggregate filter, precision roller clamp, standard Luer connector |
|
Transfusion Performance |
Efficient impurity filtration, stable blood flow, zero liquid leakage, anti-air embolism, anti-backflow and anti-blocking |
|
Design Features |
Full-sealed leak-proof structure, professional blood filtration system, high-precision flow control, air isolation design, anti-kink flexible pipeline, latex-free & non-DEHP |
|
Interface Standard |
Universal standard Luer lock interface, compatible with standard blood bags and venous indwelling devices |
|
Sterility |
EO-sterilized or gamma-irradiated, single-use sterile, pyrogen-free |
|
Certifications |
Complies with ISO 1135-4, ISO 13485, CE and NMPA medical device standards |
|
Shelf Life |
3 years |
Product Properties
1. Medical-grade Safety & Zero Contamination: Adopts professional medical sterilization technology with sterility assurance level up to 10⁻⁶ and qualified EO residual content. Single-use design completely eliminates cross-infection and blood contamination risks. Made of latex-free and non-DEHP medical raw materials, the product is non-toxic, odorless and non-irritating, with excellent blood compatibility, no hemolytic reaction or cytotoxicity, ensuring safe and stable blood transfusion treatment.
2. Full-sealed Leak-proof Performance: All assembly interfaces adopt precise seamless fitting and high-pressure resistant sealing structure, which can effectively prevent blood leakage, liquid volatilization and external bacterial intrusion under standard transfusion pressure. The integrated anti-backflow design avoids blood reflux and pipeline contamination, maintaining the full-process tightness and sterility of the transfusion system.
3. Professional Efficient Blood Filtration: Built-in standard medical microaggregate filter can accurately intercept blood clots, fibrin strands and tiny cellular aggregates in blood and blood components. It effectively prevents pulmonary embolism, vascular blockage and transfusion adverse reactions, ensuring high-purity and safe blood transfusion.
4. Stable Flow Regulation & Air Isolation: The high-sensitivity roller flow regulator realizes smooth stepless adjustment of transfusion speed, with stable flow rate and no automatic deviation during operation, adapting to the safe transfusion speed requirements of different patients. The scientific drip chamber air isolation structure effectively traps tiny air bubbles and completely avoids air embolism risks.
5. Anti-kink & Durable Structure: Optimized high-toughness medical PVC pipeline has excellent bending resistance and compression resistance. It can be bent arbitrarily with patient limb movement without pipeline deformation, blockage or blood flow interruption, ensuring continuous and stable transfusion process.
6. High Cost-performance & Standardized Application: Integrated multi-functional design integrates filtration, flow control and leak-proof protection, simplifying clinical operation procedures. Disposable use saves repeated disinfection and cleaning costs, reducing the overall operating burden of medical institutions, suitable for large-scale standardized clinical blood transfusion use.
Application
1. Operating Rooms & Emergency Departments: Suitable for emergency blood transfusion and intraoperative blood replacement treatment for critical trauma patients. Efficient filtration and stable leak-proof performance ensure rapid and safe blood supplementation, improving the success rate of emergency rescue.
2. Intensive Care Units: Applied for continuous blood component transfusion and postoperative blood volume maintenance for critically ill patients. High-precision flow control and safe filtration performance meet the high-standard treatment requirements of critical care scenarios.
3. General Clinical Wards: Used for routine blood transfusion treatment of anemia patients, postoperative rehabilitation patients and patients with blood loss diseases, realizing standardized and safe blood transfusion nursing.
4. Obstetrics & Gynecology Departments: Adaptable for blood transfusion treatment for postpartum hemorrhage and high-risk parturient patients. The reliable leak-proof and anti-backflow design ensures stable and safe blood supplementation during special physiological periods.
5. Grassroots Medical Institutions & First Aid: Meet the basic blood transfusion and emergency first-aid blood replacement needs of community clinics and grassroots hospitals. With high safety and strong versatility, it supports standardized grassroots blood transfusion treatment.
Physical Properties
|
Item |
Specification |
|
Operating & Storage Temperature |
2℃~30℃ (long-term storage); 10℃~40℃ (transfusion operation) |
|
Pipeline Material |
High-transparency medical non-DEHP PVC, latex-free |
|
Tensile Strength |
≥15 MPa |
|
Leak-Proof Performance |
No blood leakage, air infiltration or liquid backflow under 0.3MPa working pressure |
|
Filter Pore Size |
170μm-200μm standard medical microaggregate filter |
|
Anti-kink Performance |
No pipeline blockage or deformation after arbitrary bending and extrusion |
|
Transparency |
High transparency for real-time observation of blood flow and transfusion status |
QA&QC
The Medical-Grade Leak-Proof Blood Transfusion Set strictly complies with ISO 1135-4, ISO 13485, CE and NMPA medical device quality management standards. Each production batch undergoes comprehensive and rigorous quality inspection, including material safety detection (non-DEHP & latex-free verification, blood biocompatibility evaluation, non-toxic and pyrogen-free test), filter impurity interception efficiency calibration, pipeline tensile and anti-kink performance test, interface high-pressure leak-proof detection and flow rate stability verification. For sterile products, strict sterility validation is implemented, with EO residual content ≤10 μg/g and sterility assurance level reaching 10⁻⁶. All products are verified to be compatible with standard blood bags and clinical venous transfusion equipment to ensure stable and safe blood transfusion procedures. Each batch is assigned an independent traceable batch number to realize full-process quality supervision from production to sales. Each package is equipped with a complete Instruction for Use (IFU), specifying standard assembly methods, blood transfusion operation specifications and safety precautions.
Packing, Storage, Handling and Transportation
1. Packing: Sterile single blood transfusion sets are individually sealed and packaged in medical paper-plastic composite bags or blister packs to ensure independent sterility. Batch products are packed in sturdy corrugated cartons with anti-collision and pressure-resistant protection. All packaging is clearly labeled with product name, specification, batch number, production date, expiration date and certification information.
2. Storage: Store in a clean, dry, dust-free and well-ventilated environment with temperature controlled at 2℃~30℃ and relative humidity ≤70%. Keep away from direct sunlight, high-temperature heat sources, sharp hard objects and corrosive chemical substances. Keep the original packaging sealed before use to avoid secondary pollution and material aging.
3. Handling: For single-patient single use only, reuse and cross-use are strictly prohibited to prevent cross-infection. Before use, check whether the packaging is intact, free from damage, moisture and expiration. Inspect pipeline patency, filter integrity and sealing performance before operation. Discard the product immediately if the sterility is compromised or any component is damaged. Complete assembly and blood transfusion operation in accordance with standard medical procedures, and dispose of waste products in accordance with medical waste management regulations after use.
4. Transportation: Transport in accordance with national and international medical device transportation specifications. Avoid violent collision, extrusion, moisture and long-term direct sunlight. The transportation environment temperature is controlled within 2℃~30℃ to ensure product packaging integrity, sterility and structural stability.
Reasons for choosing us
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.
Certificate
FAQ
Q:What is your standard production lead time?
A:Our standard production lead time for bulk orders is 3-4 weeks after order confirmation and receipt of the deposit. For large-volume orders (exceeding 100,000 units) or customized products, the lead time may be extended to 4-7 weeks. We will provide a detailed production schedule upon order placement and keep you updated on the production progress in real-time.
Q:Do you have experience shipping to our country/region?
A:Yes, we have extensive experience shipping to countries and regions worldwide, including North America, Europe, Asia, South America, and Africa. We are familiar with the local import regulations, customs clearance requirements, and logistics channels of different regions, and can cooperate with reputable logistics partners (e.g., DHL, FedEx, UPS, or sea freight forwarders) to ensure smooth delivery. We also provide all necessary shipping documents (e.g., commercial invoice, packing list, certificate of origin, and customs clearance documents) to facilitate customs clearance.
Q:How do you ensure proper packaging, labeling, and transport safety?
A:We take multiple measures to ensure packaging, labeling, and transport safety:
Packaging: Use shockproof, moisture-proof, and sterile packaging (if applicable) that meets international shipping standards. For fragile products, we add extra protective materials (e.g., bubble wrap, foam) to prevent damage during transportation;
Labeling: All labels comply with UDI/GS1 and local regulatory requirements, including product name, batch number, expiration date, usage instructions, and warning information. Multilingual labels are available upon request;
Transport Safety: Cooperate with logistics partners with experience in medical product transportation, ensuring compliance with temperature control requirements (if applicable) and providing transport insurance to cover any potential losses during shipment.
Hot Tags: medical-grade leak-proof blood transfusion set, China medical-grade leak-proof blood transfusion set manufacturers, suppliers, factory
