Blood Control Technology
An internal silicone septum mechanism acts as a blood-barrier, containing venous backflow within the hub. Clinicians can establish access without blood spill, protecting health personnel and maintaining a sterile field.
CE Certified ISO 13485:2016 DEHP-Free PUR Tubing EO Sterilised
Medical-Grade Vascular Access
Gen-X™ Integrated Closed IV Catheter Architecture
The Gen-X™ Closed IV Catheter System combines the catheter, integrated extension tubing, stabilization platform, and needle-free connector into a single pre-assembled unit. Developed specifically for emergency departments, intensive care units (ICUs), and high-turnover clinical environments, it streamlines vascular access while minimizing catheter manipulation and line disconnection risks.
Equipped with advanced Blood Control Technology (BCT), Gen-X™ prevents blood leakage from the catheter hub during needle withdrawal, safeguarding healthcare professionals against blood-borne pathogen exposure and eliminating clean-up times during cannulation.
- All-in-One Closed Design: Minimizes infection entry points and reduces catheter-related bloodstream infection (CRBSI) risks.
- Integrated Blood Control Valve: Halts blood reflux automatically upon venipuncture needle retraction.
- Passive Safety Needle Shield: Encapsulates needle point automatically to eliminate accidental needlestick injuries (NSIs).
- Biocompatible Polyurethane (PUR): Softens inside the vein for prolonged indwelling performance and higher mechanical comfort.
Engineering Specifications
Technical Specifications & Size Matrix
Precision-moulded across standard ISO color-coded gauges to accommodate diverse clinical requirements from fragile pediatric veins to rapid adult fluid resuscitation.
| Gauge | Color Code | Inner/Outer Extension Dia. | Catheter Length | Water Flow Rate | Primary Clinical Application |
|---|---|---|---|---|---|
| 18G | Green | 0.9 mm – 1.3 mm | 45 mm | 90 ml/min | Rapid fluid loading, trauma, surgical procedures & blood transfusions |
| 20G | Pink | 0.8 mm – 1.3 mm | 32 mm | 60 ml/min | Routine adult IV infusions, chemotherapy & emergency medications |
| 22G | Blue | 0.6 mm – 0.9 mm | 25 mm | 36 ml/min | Pediatric infusions, elderly patients with fragile peripheral veins |
| 24G | Yellow | 0.5 mm – 0.7 mm | 19 mm | 20 ml/min | Neonatal care, oncology, and micro-dose fluid maintenance |
Standard Logistics & Export Packaging Specs
Lars Medicare manufactures and exports under strict cleanroom conditions, offering robust export packing designed to maintain sterility through long-distance sea and air shipments.
| Product Model | Units per Master Carton | Carton Dimensions (L x W x H) | Sterilization Standard |
|---|---|---|---|
| Gen-X™ Closed System | 200 Pieces / Carton | 72.5 cm x 34.0 cm x 15.2 cm | Ethylene Oxide (EO) validated per ISO 11135 |
Clinical Advantages
Why International Hospital Procurement Officers Trust Gen-X™
Engineered in compliance with OSHA safety mandates, EU Directive 2010/32/EU, and INS (Infusion Nurses Society) recommendations for vascular access management.
Passive Needle Protection
The self-activating safety shield slides over the needle tip automatically upon withdrawal. It requires no additional manual steps by nurses, delivering unconditional compliance against accidental needlestick exposure.
Polyurethane Biocompatibility
Formulated from kink-resistant, radiopaque Polyurethane (PUR) that softens at body temperature. Reduces mechanical phlebitis, vessel trauma, and catheter loss, supporting extended dwell times up to 96 hours.
Instant Flashback Confirmation
A transparent flashback chamber combined with a notched needle design provides immediate, visual blood return along the catheter shaft, confirming early vein entry even in low blood pressure patients.
Multi-Access Flexibility
Integrated flexible extension line with pre-attached stabilization wings distributes leverage away from the insertion site during line manipulation, reducing movement-induced vein trauma.
OEM & Custom Artwork
Factory-direct custom branding, private label artwork, barcode serialization, and multi-language technical IFUs tailored for tender submission in 100+ worldwide markets.
Export Compliance & Regulatory Support
Factory-Direct Supply & Global Tender Assistance
Lars Medicare operates an integrated medical device manufacturing facility in Sonepat, India, housing in-house tool design, automated injection moulding, cleanroom assembly (ISO Class 8), and batch ethylene oxide (EO) sterilization.
We partner with medical importers, regional healthcare distributors, national tender managers, and hospital chains. Each consignment is delivered complete with fully aligned technical regulatory dossiers.
- CE Mark & ISO 13485:2016 Certified: Complete ISO 10993 biocompatibility and safety testing validation reports.
- Comprehensive Regulatory Files: Free Sale Certificates (FSC), Certificate of Analysis (CoA), and EC Declarations provided.
- OEM Branding Options: Full customization of pouch foil printing, shelf boxes, and shipper markings per country requirements.
Cleanroom manufacturing and automated testing of closed IV catheters in Sonepat, India.
Procurement FAQ
Frequently Asked Questions by Importers & Tender Agents
Technical and procurement details for international medical buyers, procurement directors, and hospital administrators.
How does Blood Control Technology (BCT) prevent clinician blood exposure?
The Gen-X™ system incorporates an internal blood-control valve within the catheter hub that restricts blood flow automatically upon needle removal. Blood remains contained within the closed circuit until a Luer lock connector or infusion set is securely attached.
What catheter material is used in the Gen-X™ Closed IV System?
Gen-X™ closed IV catheters are crafted from medical-grade, radiopaque Polyurethane (PUR). Polyurethane softens at body temperature, minimizing mechanical phlebitis, vessel irritation, and kinking for extended indwelling performance.
Are private label and OEM customization options available for international tenders?
Yes, Lars Medicare provides full OEM and private-label manufacturing services. We customize pouch artwork, outer cartons, instructions for use (IFUs) in multiple languages, and packaging configurations according to target market regulatory requirements.
Which gauge sizes and technical specifications are available?
The Gen-X™ range includes 18G (Green, 45mm, 90 ml/min), 20G (Pink, 32mm, 60 ml/min), 22G (Blue, 25mm, 36 ml/min), and 24G (Yellow, 19mm, 20 ml/min) variants to accommodate diverse clinical infusion demands.
What documentation is provided with factory-direct shipments?
Every export order is accompanied by CE Certification, ISO 13485 Quality System certificates, Certificate of Free Sale (FSC), Certificate of Analysis (CoA) per batch, Ethylene Oxide sterilization validation records, and full packing lists.
Request Factory Direct Pricing & Evaluation Samples
Are you evaluating closed IV catheter systems for bulk hospital tenders or regional distribution networks? Connect directly with our export engineering desk to obtain detailed datasheets, volume quotes, and evaluation samples.
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