IV Infusion Set Adult Vented Latex Free

Description

1. Product Overview

The IV Infusion Set Adult Vented Latex Free is a precision-engineered medical device designed for controlled intravenous administration of fluids, medications, or blood products in adult patients requiring vented systems to allow air entry into non-collapsible fluid containers. Its primary industrial use spans acute care hospitals, ambulatory surgical centers, and emergency medical services where reliable gravity-fed infusion is critical. The key value proposition lies in its vented spike mechanism—enabling smooth flow from rigid bottles—combined with a 100% latex-free construction that eliminates Type I hypersensitivity risks, a strategic differentiator in global markets prioritizing patient safety and regulatory compliance. As healthcare systems increasingly mandate allergen-free consumables, this product offers a future-proof solution that reduces adverse event liability while maintaining clinical efficacy.

2. Key Specifications & Technical Characteristics

• Material Components:

  • Spike: Medical-grade ABS (acrylonitrile butadiene styrene), vented with 0.2 µm hydrophobic air filter

  • Drip chamber: Non-DEHP PVC, transparent with 15–20 drops/mL calibration

  • Tubing: Flexible, kink-resistant PVC (length: 150–180 cm ±5%)

  • Roller clamp: Polypropylene, micro-adjustable

  • Luer lock connector: Polycarbonate, female with integral latex-free injection port

• Latex Status: 100% latex-free (no natural rubber latex; verified by ELISA testing)

• Physical Characteristics:

  • Color: Transparent tubing with blue-tinged drip chamber for air bubble visibility

  • Sterility: Gamma irradiated to SAL 10⁻⁶

  • Particle size retention: Standard IV filter optional (15 µm integral filter in select variants)

• Packaging Options:

  • Individual peel-open sterile pouch (Tyvek/polyethylene)

  • Bulk inner carton: 50 units

  • Master export carton: 500 units (10 inner cartons)

• Shelf Life: 3 years from date of manufacture, when stored in original packaging at 5°C–30°C, <80% RH

3. Core Industrial Applications

• Primary Industries:

  • Acute care hospitals (emergency, ICU, general wards)

  • Pre-hospital emergency services (ambulance, field hospitals)

  • Long-term care facilities and infusion clinics

• Specific Operational Use Cases:

  • Administration of IV fluids from glass or rigid plastic bottles (e.g., saline, dextrose, Ringer’s lactate)

  • Gravity-driven medication infusions (antibiotics, analgesics, antiemetics)

  • Blood or blood component transfusion (when used with blood filter—separate SKU available)

• Performance Advantages Over Alternatives:

  • Vented spike eliminates need for separate air-inlet tubes, reducing connection errors by ~40% compared to non-vented sets with added vent adapters.

  • Latex-free composition matches or exceeds flow rates (≥110 mL/min with water at 1m head height) of latex-containing sets, without anaphylaxis risk.

  • Durability: Kink resistance tested to 10,000 cycles on roller clamp; tubing withstands 20 psi burst pressure.

  • Cost efficiency: Fewer nursing interventions for air handling and allergy screening lowers total procedure cost by an estimated 12–15% in high-volume settings.

4. Competitive Advantages

• Quality Consistency: ISO 8536-4 certified; batch release testing for particulate matter, sterility, and flow accuracy with <2% inter-lot variation in drip chamber calibration.

• Supply Reliability: Dual manufacturing sites (Asia and Europe) with 12-month rolling forecast buffer stock; 99.5% on-time delivery rate over 24 months.

• Logistics Capability: Ambient temperature chain with GPS-tracked containers for priority lanes to 50+ countries.

• Price Competitiveness: Volume-tiered pricing 8–10% below leading EU and US brands for equivalent latex-free vented spec.

• Sustainability: 100% recyclable outer cardboard; PVC tubing manufactured via mercury-free process; committed to reducing primary plastic by 15% by 2027.

• Technical Support: Full EIFU (electronic instructions for use), validation dossiers for regulatory submissions (FDA 510(k) summary, CE MDR technical file, WHO prequalification data available under NDA).

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20MT (metric tons) — equivalent to approximately 1.2 million units, depending on packaging variant.

• Loading Capacity per 20FT Container: 20MT (maximum payload) — standard configuration: 1,000 master cartons (500 units each) = 500,000 units per 20FT container. For 40FT HC container: 40MT / approx. 1,000,000 units.

• Lead Time for MOQ: 30–45 days after confirmed purchase order and deposit.

• Incoterms Supported: FOB (Ningbo/Shanghai), CIF (major global ports), EXW.

• Payment Terms: Letter of credit at sight (L/C) for first order; net 30 days for qualified institutional buyers after credit approval.