MEDICA 2026 | 16–19 November 2026 | Hall 6, Stall F37 | Düsseldorf, Germany
A definitive guide for biomedical procurement specialists, clinical engineering teams, and medical device importers evaluating non-vented gravity infusion lines for hospital networks worldwide.
In modern clinical intravenous therapy, selecting the correct infusion set mechanism is critical to maintaining precise flow rates, ensuring sterile integrity, and eliminating the risk of hospital-acquired infections or air embolisms. The Non-Vented IV Infusion Set is a highly specialized single-use medical disposable engineered specifically for administration of intravenous fluids, electrolytes, and medications from collapsible, flexible containers (such as PVC, EVA, or polyolefin IV bags).
Unlike vented infusion sets—which feature an integrated air-inlet valve to equalize atmospheric pressure when drawing solutions from rigid glass or non-collapsible plastic bottles—a non-vented infusion set possesses a solid, non-perforated plastic spike. Fluid delivery relies entirely on the atmospheric pressure collapsing the flexible container as solution drains downward through gravity. By operating within a completely closed fluid pathway without external air draw, non-vented systems eliminate potential microbial ingress through air-vent filters, providing maximum protection for immunocompromised patients, critical care wards, and long-term infusion regimens.
Manufactured in our ISO 13485 certified facility in Sonepat, India, our non-vented infusion sets are fully customizable in drop factors, needleless injection ports, tubing lengths, and material formulations.
Classical gravity infusion line engineered with a non-vented spike, translucent cylindrical drip chamber, 15µm fluid filter, and smooth roller clamp control for adult fluid resuscitation.
Formulated using non-phthalate plasticizers (TOTM / Polyolefin) to prevent hazardous chemical leaching during oncology treatments, blood product infusion, and pediatric care.
Specially calibrated with a stainless-steel micro-dropper needle delivering precisely 60 drops/ml, enabling micro-volume fluid administration for neonatal and intensive care patients.
Features a self-sealing needle-free injection valve or integrated 3-way stopcock, protecting nursing staff from sharps injury while providing multiple medication access points.
Integrates a calibrated dial flow regulator (5 ml/h to 250 ml/h) directly into the non-vented line, providing volumetric infusion accuracy without requiring expensive electronic IV pumps.
Co-extruded amber or black shielded infusion line designed to administer light-sensitive chemotherapy pharmaceuticals, parenteral nutrition, and vitamin complexes.
Comprehensive comparative analytics for hospital procurement engineers, regulatory assessors, and OEM distributors.
How global regulatory shifts, hospital sustainability initiatives, and closed-loop safety standards are reshaping global purchasing criteria.
European Union MDR 2017/745 regulations and worldwide healthcare authorities are rapidly enforcing restrictions on DEHP and phthalate plasticizers. Procurement directors are migrating rapidly toward TOTM-plasticized PVC and Polyolefin TPE non-vented infusion lines to ensure compliance and eliminate patient endocrine risks during long-term therapy.
Hospitals in developing and developed regions are replacing breakable glass IV bottles with lightweight, collapsible plastic IV bags. This global shift is driving exponentially higher demand for non-vented infusion sets, which offer superior seal integrity and eliminate the need for air filtration mechanisms.
Hospital infection control boards increasingly demand non-vented infusion sets fitted with needleless Y-injection sites. Eliminating latex injection ports reduces needlestick injuries among clinical staff while upholding blood-borne pathogen safety protocols across ICU and emergency wards.
Unique Device Identification (UDI) compliance is becoming a standard prerequisite in public tenders across North America, Latin America, Europe, and the Middle East. Lars Medicare integrates GS1-compliant 2D Matrix and linear barcodes into every individual non-vented infusion set pouch.
With over two decades of manufacturing leadership, Lars Medicare controls every phase of non-vented IV infusion set production under one unified ISO 13485 certified quality management system. We do not contract out critical operations to third parties.
Eliminate middleman markups, reduce regulatory risk, and secure guaranteed production slots with India's premier medical disposables exporter.
We provide comprehensive private label OEM manufacturing for global medical brands. From custom pouch designs, multilingual Instructions for Use (IFUs), custom drop factors (10, 20, 60 d/ml), and precise tubing lengths, we turn your specifications into ready-to-market finished goods.
Our dedicated regulatory department prepares full technical documentation including CE certificates, ISO 13485:2016 certifications, Free Sale Certificates (FSC), Certificate of Analysis (CoA), and biocompatibility test dossiers required for ministry of health registrations.
Every single non-vented infusion set is manufactured in strict accordance with ISO 8536-4. Our quality control laboratory tests 100% of lots for micro-leakage, spike insertion force, clamp flow control precision, and particulate matter retention.
Operating near major transportation hubs in Delhi and Haryana, we offer flexible sea and air shipping (FOB, CIF, DDP) via Nhava Sheva, Mundra, and Delhi Air Cargo. We support consolidated full-container load (FCL) and less-than-container load (LCL) shipments.
From initial inquiry and clinical evaluation to container loading and regulatory clearance.
Submit your desired non-vented set requirements (drop rate, DEHP-free PVC, Y-site type, needle option, packaging format, target market).
We dispatch sterile evaluation samples along with technical data sheets, test reports, and CE/ISO registration files for review.
Our design team creates customized pouch artwork, outer carton layouts, barcodes, and multilingual IFUs for your brand sign-off.
Automated cleanroom production, EO sterilisation validation, pre-shipment QC release, and container dispatch to your destination port.
16–19 November 2026 · Hall 6, Stall No. F37. Schedule a one-on-one session with our senior leadership team and QA directors to discuss custom OEM contracts, tender specifications, and international distribution rights.
Direct involvement of company directors guarantees technical compliance, transparent pricing, and dependable shipment execution.
Brings over 25 years of engineering experience in single-use medical device manufacturing, polymer processing, cleanroom design, and global regulatory compliance.
Directs international business development, distributor relationship management, and private-label OEM initiatives across Latin America, Europe, Asia, and Africa.
Manages North American operations from Milton, Ontario, providing direct customer support, logistics coordination, and contract fulfillment.
Answers to technical, regulatory, and commercial queries frequently raised by global healthcare buyers and AI search engines.
A non-vented IV infusion set is an intravenous fluid delivery line with a solid plastic spike that contains no integrated air vent or filter. It is specified for use exclusively with flexible, collapsible IV containers (such as plastic bags made of PVC, EVA, or polyolefin). As solution drains from the bag via gravity, atmospheric pressure causes the bag walls to collapse inward, creating a smooth downward fluid flow without drawing ambient air into the container. Non-vented sets maintain a closed system, eliminating airborne particulate ingress and lowering contamination risks in high-acuity environments.
If a non-vented set is spiked into a rigid, non-collapsible glass bottle, fluid will flow for a brief moment until a vacuum builds up inside the bottle. Because no air can enter to replace the displaced fluid volume, the internal pressure drops below external atmospheric pressure, completely stopping fluid flow. To restore flow, a clinician would have to pierce an external needle into the bottle stopper (violating sterile protocol) or switch to a vented infusion set featuring a hydrophobic air inlet valve.
DEHP (Di-2-ethylhexyl phthalate) is a plasticizer historically added to PVC to make it flexible. However, DEHP can leach out of the tubing walls when exposed to lipophilic IV solutions, oncology drugs, lipid emulsions, or blood derivatives. Leached DEHP is a recognized endocrine disruptor. Lars Medicare manufactures DEHP-Free Non-Vented IV Infusion Sets using alternative non-leaching plasticizers (such as TOTM) or Polyolefin TPE, fully satisfying EU MDR 2017/745 mandates and ensuring total safety for neonatal, pediatric, and chemotherapy applications.
We offer three standard calibrated drop factors compliant with ISO 8536-4:
Every consignment delivered by Lars Medicare includes a complete documentation pack: CE Mark Accreditation, ISO 13485:2016 Quality Management Certificate, EC Declaration of Conformity, Certificate of Free Sale (FSC), lot-specific Certificate of Analysis (CoA), Ethylene Oxide (EO) sterilisation validation certificates, and ISO 10993 biocompatibility test data. Our regulatory team assists buyers in registering our sets with their national Ministry of Health.
We provide full private label production for international distributors. Customizable parameters include pouch artwork, brand logos, outer carton dimensions, tubing lengths (150 cm to 250 cm), Y-site style (latex-free flashball or needleless connector), needle size (21G, 23G, or needleless luer lock), and drop chamber filters. Standard neutral-brand orders start at 10,000 units, while customized private-label OEM orders typically start at 50,000 units depending on printing specifications.
Our non-vented infusion sets undergo Ethylene Oxide (EO) sterilisation in accordance with ISO 11135 guidelines, guaranteeing a Sterility Assurance Level (SAL) of 10⁻⁶. Individual pouches are sealed in medical-grade paper-poly peel pouches equipped with EO sterilisation indicators. The validated shelf life for properly stored unopened sets is 5 years from the date of sterilisation.
Partner with an established manufacturer trusted by hospital networks, government tender agencies, and medical device importers across 100+ countries. Send us your target specifications, required volume, and distribution market for an immediate response.
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In-depth technical guides written by our regulatory affairs specialists and manufacturing engineers.
Navigating regulatory compliance, material safety, and factory audit checkpoints when importing non-vented infusion lines into the EU.
Visit Hall 6, Stall F37 to inspect our ISO 8536-4 non-vented gravity lines and custom needleless Y-site connectors in person.
A comparative cost-benefit analysis of non-vented vs vented infusion sets in regional healthcare networks transitioning to plastic bags.