Sterile Disposable Epidural Kit

Sterile Disposable Epidural Kit is a professional sterile medical puncture and anesthesia auxiliary kit specially designed for clinical epidural anesthesia, postoperative analgesia and spinal minimally invasive puncture treatment. Equipped with complete standardized epidural puncture and auxiliary nursing accessories, the whole set is manufactured from high-quality medical-grade raw materials and non-toxic biocompatible accessories. Adopting integrated single-use sterile packaging and processing, it effectively avoids cross-infection, accessory contamination and clinical operational risks. Ergonomically optimized for accurate puncture, safe catheterization and standardized anesthesia operation, it features complete accessory configuration, stable puncture performance, high safety and easy assembly, fully meeting the clinical anesthesia and pain treatment needs of operating rooms, obstetric departments and pain management centers, providing reliable standardized guarantee for clinical epidural puncture and analgesia treatment.

The Sterile Disposable Epidural Kit adopts full set of medical-grade safe materials, all accessories are strictly screened for biocompatibility and safety. The matched high-precision epidural puncture needle features smooth needle body and ultra-sharp bevel tip, realizing low-resistance and low-trauma puncture to reduce patient pain and tissue damage. The flexible epidural catheter is soft and kink-resistant, which can be smoothly implanted into the epidural space without vascular or nerve irritation. Supporting tools such as guide wire, filter and injection accessories are reasonably configured to realize one-stop puncture, catheterization and drug delivery operation. All components are independently sterile and tightly packaged, with no dead space for contamination. The whole kit supports EO gas or gamma ray sterilization, complies with international and domestic medical device industry standards, and is widely applicable for standardized clinical epidural anesthesia and postoperative analgesia treatment.

Product Properties

 

1. Full Sterile Safety & Anti-contamination: Adopts professional medical sterilization technology with sterility assurance level up to 10⁻⁶ and qualified EO residual content. Single-use integrated packaging completely eliminates cross-infection and accessory contamination risks. All medical-grade raw materials are non-toxic, odorless, latex-free and BPA-free, with excellent human tissue compatibility, no irritation or allergic reaction, ensuring safe clinical anesthesia operation.

2. Low-trauma & Precise Puncture Performance: The epidural puncture needle adopts precision multi-bevel polishing technology, with ultra-sharp needle tip and low puncture resistance. It effectively reduces subcutaneous tissue and ligament damage, minimizes patient puncture pain and improves the accuracy of epidural space positioning.

3. Flexible Anti-kink Catheter & Stable Indwelling: The matched epidural catheter is made of high-elastic flexible polymer material, featuring excellent bending resistance and kink resistance. It can adapt to patient postoperative body position changes, avoiding catheter blockage, prolapse and analgesia interruption, ensuring continuous and stable drug delivery effect.

4. Complete Configuration & Efficient Operation: The integrated kit contains all accessories required for epidural puncture and analgesia, realizing one-stop operation without additional matching tools. The humanized structural design simplifies clinical anesthesia procedures, shortens operation time and improves medical work efficiency.

5. Safe Drug Delivery & Low Residue: Equipped with professional medical drug filter, it can effectively filter tiny impurities and particles in anesthetic drugs, preventing vascular irritation and postoperative adverse reactions. The smooth inner wall of the catheter reduces drug residue and ensures accurate and uniform drug delivery.

6. High Cost-performance & Standardized Application: Integrated accessory design avoids repeated procurement and matching costs. Disposable use saves disinfection and maintenance procedures, reduces clinical operational burden, and is suitable for large-scale standardized application in major clinical anesthesia scenarios.

Application

 

1. Operating Room Anesthesia: Specially used for epidural anesthesia for general surgery, orthopedics, gynecological and obstetric operations. Precise puncture and stable drug delivery ensure safe and effective intraoperative anesthesia, meeting various surgical anesthesia needs.

2. Obstetric Labor Analgesia: Suitable for painless childbirth epidural analgesia treatment. Safe and low-trauma design effectively relieves maternal labor pain, ensures stable maternal and fetal vital signs, and improves childbirth comfort and safety.

3. Postoperative Continuous Analgesia: Applied for continuous epidural analgesia after major surgery. The indwelling catheter can realize long-term and stable pain relief, reduce postoperative pain response and accelerate patient rehabilitation.

4. Pain Management Department: Used for clinical chronic pain treatment and spinal nerve block analgesia. Accurate drug delivery positioning effectively relieves neuropathic pain and soft tissue pain, improving clinical pain treatment effect.

5. Grassroots Medical & Emergency Treatment: Meet the standardized epidural anesthesia and analgesia needs of grassroots hospitals and primary medical institutions. With complete configuration and simple operation, it improves the standardization of grassroots anesthesia diagnosis and treatment.

The Sterile Disposable Epidural Kit strictly complies with ISO 13485, CE and NMPA medical device quality management standards. Each production batch undergoes comprehensive and rigorous quality inspection, including material safety detection (latex-free & BPA-free verification, medical biocompatibility evaluation, non-toxic and pyrogen-free test), puncture needle sharpness and smoothness calibration, catheter tensile and anti-kink performance test, interface leak-proof detection and accessory matching compatibility test. 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 mainstream clinical anesthesia equipment and analgesia pumps to ensure accurate and safe anesthesia and analgesia 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 puncture steps, catheterization methods and clinical safety precautions.

1. Packing: Sterile single epidural kits are individually sealed and packaged in medical paper-plastic composite bags or blister packs to ensure independent sterility and complete accessory configuration. 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 of internal accessories.

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, and confirm all accessories are complete. Discard the product immediately if the sterility is compromised or any accessory is damaged. Complete epidural puncture and catheterization operation in accordance with standard medical anesthesia 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, accessory completeness and sterility stability.

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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