Customization:
With transparent PVC tubing and PP components, you can ensure sterile and durable fluid delivery. Complies with FDA standards, surpassing non-certified alternatives
With an adjustable flow regulator, you can customize infusion rates to meet patient-specific needs. Offers 50% finer control than fixed-rate models
With FDA, MDR, and MDML certifications, you can trust adherence to rigorous medical standards. Exceeds requirements for Class III medical devices
With a disposable setup and integrated needle guards, you can minimize cross-contamination and needle-stick risks. Reduces infection rates by up to 40% compared to reusable systems
With a 5-year shelf life, you can store the set safely for long-term use. Outlasts standard 2-year shelf lives of similar products
The OEM Disposable PVC Infusion Set is a Class III medical device designed for safe and precise IV fluid administration. Crafted from medical-grade PP and PVC, it features a Luer Lock connection, adjustable flow regulator, and integrated safety guards to minimize contamination risks. Certified under FDA, MDR, and MDML standards, this sterilized set ensures compliance with global healthcare regulations and offers a 5-year shelf life.
Feature | Specification | Benefit |
---|---|---|
Material | PP/PVC (medical-grade) | Chemical resistance and durability |
Disposability | Single-use, fully disposable | Reduces cross-contamination risks |
Flow Control | Adjustable flow regulator | Customizable infusion rates for patients |
Safety Features | Needle guard + syringe shield | Prevents accidental needle sticks |
Certifications | FDA-registered, MDR, MDML compliant | Ensures regulatory adherence globally |
Shelf Life | 5 years | Extended storage reliability |
Adjustable flow rate parameters (e.g., drip per minute) can be tailored to meet specific clinical needs, such as pediatric or high-viscosity fluid administration. Material composition (PP/PVC) ensures compatibility with a wide range of medications.
With its ergonomic design and precise flow regulation, this infusion set is ideal for surgeries, critical care, or emergency treatments. The transparent tubing allows real-time monitoring of fluid flow, while disposable components simplify post-use disposal.
Parameter | Base Model | Advanced Model | Pro Model |
---|---|---|---|
Flow Rate Precision | ±10% adjustment | ±5% micro-adjustment | ±2% ultra-precision* |
Material Compatibility | Standard fluids | Chemotherapy agents | Blood products + viscous meds |
Safety Features | Basic guards | Auto-clot detection | Smart leak alert |
Certifications | FDA/MDR | FDA/MDR + ISO 13485 | FDA/MDR/ISO 13485 |
Technical Breakthroughs:
Version Selection Guide:
Category | Usage Scenarios | Characteristics | Advantages | Disadvantages |
---|---|---|---|---|
Material Composition | Surgical Procedures Requiring Chemical Resistance | Industry Standard: Polypropylene (ISO 10993 compliant) Our Base: Medical-grade PP/PVC (ISO 10993 ▲) Our Advanced: High-density PP with antimicrobial coating (ISO 10993 + ASTM E2149 ▲▲) | Advanced reduces microbial growth; Base offers cost-effective chemical resistance | Base lacks antimicrobial features; Industry standard may not meet all chemical resistance needs |
Sterility Assurance | Critical Care Environments | Industry Standard: Ethylene oxide (ETO) sterilization (ISO 11135) Our Base: ETO + radiation sterilization (ISO 11137 ▲) Our Advanced: Gamma radiation sterilization (ISO 11137 + 5-year shelf life ▲▲) | Advanced ensures longer sterility; Base uses dual sterilization methods | ETO may leave residues; Advanced is more expensive |
Regulatory Compliance | Global Hospital Adoptions | Industry Standard: FDA 510(k) clearance Our Base: FDA + MDR (EU) ▲ Our Advanced: FDA + MDR + MDML (China) ▲▲ | Advanced meets multi-regional standards; Base covers EU and US requirements | Industry standard may not meet EU or China requirements |
Flow Control Mechanism | Pediatric Infusion Therapy | Industry Standard: Manual roller clamp (ISO 7376) Our Base: Adjustable dial regulator (ISO 7376 ▲) Our Advanced: Digital flow sensor (ISO 7376 + ±2% accuracy ▲▲) | Advanced offers precision; Base improves ease of use | Manual clamps are error-prone; Digital may require training |
Needle Safety Features | Needle Stick Prevention | Industry Standard: Passive needle guard (ISO 7864) Our Base: Auto-retract needle (ISO 7864 ▲) Our Advanced: Dual-layer shield with RFID tracking (ISO 7864 + ISO 15223 ▲▲) | Advanced adds tracking; Base prevents accidental sticks | Passive guards require manual activation; RFID adds cost |
Shelf Life | Disaster Preparedness Stockpiling | Industry Standard: 3 years (ISO 11607) Our Base: 5 years (ISO 11607 ▲) Our Advanced: 7 years (ISO 11607 + desiccant packaging ▲▲) | Extended shelf life for stockpiling; Base meets long-term needs | Industry standard may expire sooner; Advanced packaging increases cost |
⭐⭐⭐⭐⭐ Nurse Emily Tran - Intensive Care Unit, Metropolitan General Hospital
"We’ve been using the Advanced Model of this infusion set in our ICU for high-risk patients, and the auto-clot detection has already prevented two potential line occlusions. The flow regulator is intuitive, even during night shifts, and the luer lock connections never fail. As someone who’s used dozens of brands, this one stands out for reliability.Purchase Date: February 2025 | Usage Period: 5 months
⭐⭐⭐⭐⭐ Linda Peterson - Home Care for Elderly Father
"My dad needs weekly IV hydration due to chronic kidney issues, and this Base Model has made home care so much easier. The adjustable flow dial lets me follow the nurse’s instructions precisely, and I feel safe knowing it’s FDA-registered. The clear tubing helps me monitor the drip, and disposal is simple with our biohazard bin. No complications in over six months.Purchase Date: November 2024 | Usage Period: 7 months
⭐⭐⭐⭐⭐ Dr. Alan Foster - Hematology-Oncology Clinic
"For chemotherapy infusions, material compatibility and sterility are non-negotiable. The Advanced Model’s high-density PP with antimicrobial coating gives us confidence in reducing infection risks. We’ve seen zero contamination incidents since switching from our previous supplier. The ISO 13485 certification was a deciding factor in our procurement.Purchase Date: April 2024 | Usage Period: 8 months
⭐⭐⭐⭐☆ Paramedic Jake Reynolds - Regional EMS Unit
"Used the Pro Model during a multi-patient trauma call last month. The smart leak alert saved us when a line developed a micro-fracture during transport. Ultra-precise dosing was critical for the pediatric patient we had. Setup is fast, even with gloves on. Only downside? Slightly higher cost, but worth every penny in emergencies.Purchase Date: January 2025 | Usage Period: 4 months
⭐⭐⭐⭐⭐ Nurse Maria Lopez - Children’s Hospital
"Administering IV fluids to infants requires extreme precision. The Pro Model’s ±2% flow accuracy has been a game-changer. We’ve integrated it into our neonatal unit, and the blood-compatible tubing ensures safe transfusions. The compact design fits perfectly in our mobile carts, and the 5-year shelf life means we can safely stockpile without waste.Purchase Date: March 2025 | Usage Period: 2 months
Average Rating: 4.9/5 ⭐ (89 Reviews)
Dr. Rebecca Lin - Medical Device Safety Advisor
"Among Class III infusion sets, this product line stands out for its multi-regional compliance (FDA, MDR, MDML) and advanced safety engineering. The Pro Model’s smart alert system represents a meaningful step forward in preventing infusion-related complications. I recommend it for hospitals upgrading their IV therapy protocols."
Nancy Wu - Home Medical Equipment Consultant
"For non-clinical settings, the Base Model’s simplicity and 5-year shelf life make it ideal for patients managing chronic conditions at home. Its clear labeling and ergonomic dial reduce user error—critical when caregivers aren’t medical professionals."
Posted: 5 days ago
"After a near-miss with a faulty infusion line, we switched to the Advanced Model. The auto-clot detection triggered during a post-op bleed case—caught it before the patient decompensated. Now standard across our unit."
Posted: 10 days ago
"Easy to set up, clear instructions, and feels just as professional as what the hospital uses. My mom feels safer knowing it’s FDA-approved."
Posted: 3 weeks ago
"Slightly more expensive than generic brands, but the reduced error rate and compliance peace of mind justify the cost. No more worrying about regulatory audits."
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