Nelaton Catheter 12Fr PVC Sterile

Description

1. Product Overview

The Nelaton Catheter 12Fr PVC Sterile is a single-use, flexible medical drainage device engineered for short-term bladder catheterization in clinical and surgical settings. Its primary industrial application lies in hospital procurement, home healthcare supply chains, and emergency medical kits where reliable, cost-effective urine drainage is required. The key value proposition is the optimal balance of patient-safe rigidity (12Fr diameter), sterile presentation, and PVC’s proven track record for high-volume, low-cost manufacturing. Strategically, this product is critical for healthcare systems seeking to standardize consumables without compromising aseptic reliability—reducing cross-contamination risks while maintaining procurement efficiency.

2. Key Specifications & Technical Characteristics

• Material Composition: Medical-grade polyvinyl chloride (PVC), DEHP or non-DEHP options available depending on regulatory requirement; radiopaque line embedded for X-ray visibility

• Sterility & Grade: EO (ethylene oxide) or gamma sterilized; sterile, single-use, non-pyrogenic; latex-free

• Physical Characteristics:

  • Color: Transparent with visible radiopaque stripe

  • French size: 12Fr (4.0 mm outer diameter)

  • Length: Standard 40 cm (pediatric) or 45–50 cm (adult) – confirm per batch

  • Tip: Rounded, atraumatic closed tip with 2 lateral eyes

  • Connector: Standard Luer or funnel-type urine drainage connector

• Packaging Options:

  • Individually peel-open sterile pouch (medical paper/PE film)

  • Bulk inner carton: 100 units

  • Master carton: 10–20 inner cartons (1,000–2,000 units per master)

• Shelf Life: 3–5 years from date of sterilization, stored in dry, cool, dark conditions (15–25°C)

3. Core Industrial Applications

• Primary Industries: Hospital group purchasing organizations (GPOs), surgical centers, long-term care facilities, medical device distributors, emergency response (EMS) suppliers, and home healthcare logistics providers

• Specific Use Cases:

  • Intermittent or indwelling bladder drainage for post-operative patients

  • Urine output monitoring in ICU or general ward settings

  • Overflow incontinence management in geriatric care

  • Backup catheter for emergency medical kits and disaster relief supplies

• Performance vs. Alternatives:

  • Versus silicone: Lower unit cost, sufficient for short-term use (<14 days); no silicone shedding concerns

  • Versus latex: Zero allergic reaction risk (latex-free)

  • Durability advantage: PVC offers consistent flow rate (lumen integrity) at 12Fr—ideal for non-viscous urine

  • Cost advantage: Up to 60–70% lower than silicone equivalents, enabling high-volume replenishment contracts

4. Competitive Advantages

• Quality Consistency: ISO 13485:2016 certified production; each lot tested for tensile strength, kink resistance, flow rate, and sterilization integrity

• Supply Reliability: Dual-source raw material (PVC compound) strategy; buffer stock maintained regionally (Asia, EU, NA); lead time 15–25 days for repeat orders

• Logistics Capability: Export-ready master cartons optimized for palletization; temperature-stable shipment (no cold chain required)

• Price Competitiveness: Direct factory pricing with tiered volume discounts (2,000+ units), eliminating distributor markup for qualified buyers

• Sustainability: Non-DEHP PVC options available for EU MDR compliance; reduced packaging waste via high-density master carton design

• Technical Support: Full sterilization validation documentation (EO residue report, bioburden test); IFU and regulatory filing support for local market registration

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ):

  • Standard: 10,000 units (10 master cartons)

  • Sample order (non-sterile evaluation): 100 units

• Bulk Loading Capacity (per 20FT container):

  • Approx. 400,000–500,000 individually pouched catheters, depending on master carton dimensions and inner tray design

  • Palletized configuration: 20–22 pallets (EU/Asia standard pallet)

• Note: Sterile units must not be repackaged. Buyer to verify biocompatibility (ISO 10993) for specific patient risk profiles. Volume >1M units/year qualifies for dedicated production line and consignment stock.