Nelaton Catheter 10Fr PVC Sterile

Description

1. Product Overview

The Nelaton Catheter 10Fr PVC Sterile is a single-use, straight urinary drainage catheter engineered for short-term bladder decompression, specimen collection, and residual urine measurement. Its primary industrial use spans hospital wards, emergency departments, and outpatient surgical centers requiring reliable, low-cost intermittent catheterization. The key value proposition is a balance of standardized French sizing (10Fr), sterile presentation, and cost-efficient PVC construction—enabling high-volume procurement without compromising basic clinical safety. Strategically, this product is critical for emerging-market healthcare systems and large-scale distributors seeking to optimize per-procedure costs while maintaining regulatory compliance.

2. Key Specifications & Technical Characteristics

• Material Composition: Medical-grade polyvinyl chloride (PVC), DEHP-free optional upon request (standard contains trace plasticizers for flexibility)

• Purity / Grade: ISO 10993 biocompatibility certified, non-pyrogenic, sterile (EO gas or gamma irradiation)

• Physical Characteristics:

  • Single-lumen straight tip (Nelaton tip) with two opposed eyes

  • Color: transparent PVC with blue X-ray line

  • Outer diameter: approx. 3.3 mm (10Fr = 3.33 mm)

  • Total length: 400 mm ± 10 mm

  • Density: 1.20–1.25 g/cm³

  • Surface finish: smooth, low-friction

• Packaging Options:

  • Individually peel-open sterile pouch (Tyvek/PE)

  • 100 units / inner box, 20 boxes / master carton

  • Sterile barrier: validated 2-year shelf life from sterilization date

• Shelf Life: 2 years when stored in dry, dark conditions at 10°C–30°C

3. Core Industrial Applications

• Primary Industries: Hospital group purchasing organizations (GPOs), medical device distributors, emergency medical services (EMS), long-term care facilities, veterinary clinics (off-label for small animals)

• Specific Operational Use Cases:

  • Intermittent bladder emptying for post-operative patients (≤ 14 days indwelling not recommended)

  • Obtaining sterile urine samples without bag contamination

  • Bladder irrigation in non-obstructive retention

  • Emergency decompression in trauma settings

• Performance Advantage over Alternatives:
  vs. silicone: lower cost per unit, higher column strength for insertion control, but less biocompatible for long-term use
  vs. latex: zero risk of type I latex allergy, smoother external surface

• Efficiency / Durability / Cost:

  • PVC allows thinner wall without collapse → larger effective drainage lumen for 10Fr

  • Sterile, ready-to-use eliminates on-site preparation labor

  • 50–70% lower unit cost than silicone equivalents, ideal for single-use protocols

4. Competitive Advantages

• Quality Consistency: Production under ISO 13485; lot traceability with certified sterility validation (SAL 10⁻⁶); each batch tested for burst pressure, flow rate, and eye smoothness.

• Supply Reliability: Dual manufacturing lines (Asia + MENA) buffer against regional disruptions; 98% on-time-in-full (OTIF) track record for containers >20 MT.

• Logistics Capability: Warehouse hubs in Rotterdam, Singapore, and Houston enable 7-day dispatch to major ports worldwide.

• Price Competitiveness: Tiered pricing reduces per-unit cost by 18% at 10MT and 27% at 20MT vs. industry average for sterile PVC catheters.

• Sustainability & Compliance: Recyclable PVC (Class 7), compliant with EU MDR 2017/745, UKCA, Saudi FDA, and ANVISA. Upcoming EPR programs supported with waste documentation.

• Technical Support: Full sterility validation report, IFU in 12 languages, and regulatory dossier for import license applications included with first container order.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20MT (approximately 4.2 million units, depending on master carton dimensions)

• Loading Capacity (per container):

  • 20’ dry container: 14 MT (≈ 2.9M units)

  • 40’ high cube container: 26 MT (≈ 5.5M units) – optimal for 20MT order split across two 20’ containers or one 40’

• Lead Time: 25 days ex-works (production + sterility cycle) for first 20MT; 15 days for repeat orders.

• Incoterms: FOB, CIF, or EXW available. Letter of credit (L/C at sight) or net 30 days for approved institutional buyers after credit check.