Precision-molded winged infusion sets engineered for ultra-smooth venipuncture, kink-resistant infusion, and pediatric-to-geriatric clinical safety. Shipped to 70+ countries directly from our cleanrooms in Ahmedabad.
An authoritative guide written for global hospital purchasing officers, medical device distributors, regulatory compliance specialists, and clinical procurement teams evaluating sterile scalp vein needles.
The Scalp Vein Set—commonly referred to in clinical practice as a butterfly needle or winged infusion set—remains one of the most indispensable single-use vascular access devices across global healthcare systems. Designed specifically for venipuncture in superficial, fragile, or small-caliber veins, these devices are widely deployed in pediatric care, geriatric medicine, oncology clinics, phlebotomy, and emergency micro-infusions.
While often viewed as a commodity consumable, modern clinical requirements demand high-precision engineering for scalp vein sets. Inconsistent needle siliconization, poor tube-to-hub bond strength, or non-compliant wing flexibility can lead to vein perforation, hematoma formation, accidental needle-stick injuries (NSIs), and fluid leakage. For international procurement managers, acquiring scalp vein sets is no longer merely a price-per-unit negotiation; it requires a deep dive into manufacturing automation, material biocompatibility (ISO 10993 compliance), non-phthalate (DEHP-free) tubing formulations, and strict adherence to international standards such as ISO 6009 and ISO 9626.
At Shree Umiya Surgical Pvt. Ltd. (Mediplus), established in 1988 in Ahmedabad, India, our engineering protocols integrate automated needle beveling, high-speed vision inspection, and continuous laser siliconization to deliver scalp vein sets that provide consistent insertion force profiles. This document presents an exhaustive breakdown of product specifications, future procurement shifts, technological developments, clinical comparisons, and critical quality control metrics to empower B2B decision-makers worldwide.
When procuring Scalp Vein Sets for large hospital networks or national tenders, verify that your supplier provides verified pull-force test data (>15N for joint integrity), bioburden limits post-sterilisation (<10 CFU per device pre-sterilisation), and full technical construction details under ISO 8536-4 and ISO 9626 standards.
Mediplus offers a versatile range of Scalp Vein Sets engineered to suit varied clinical procedures—ranging from short-term intravenous fluid delivery and blood collection to delicate pediatric drug administration. Each device consists of a stainless-steel cannula, color-coded butterfly wings, flexible kink-resistant extension tubing, and a female Luer fitting with a protective cap.
To ensure rapid size recognition in fast-paced ICU and emergency environments, Mediplus Scalp Vein Sets adhere strictly to ISO 6009 color coding. Below is our standard manufacturing gauge matrix:
| Gauge Size | Hub / Wing Color Code | Outer Diameter (mm) | Needle Length | Tubing Inner/Outer Dia | Recommended Clinical Indication |
|---|---|---|---|---|---|
| 18G | Pink | 1.20 mm | 3/4" (19 mm) | 1.5 mm / 2.3 mm | Rapid blood transfusion, high-volume fluid resuscitation, trauma care. |
| 19G | Cream / White | 1.10 mm | 3/4" (19 mm) | 1.5 mm / 2.3 mm | Blood collection, intravenous medication infusion in adults. |
| 20G | Yellow | 0.90 mm | 3/4" (19 mm) | 1.5 mm / 2.3 mm | Routine adult IV infusion, moderate flow requirements. |
| 21G | Green | 0.80 mm | 3/4" (19 mm) | 1.5 mm / 2.3 mm | Standard phlebotomy, adult vascular access in fragile veins. |
| 22G | Black | 0.70 mm | 3/4" (19 mm) | 1.5 mm / 2.3 mm | Pediatric infusions, delicate adult veins, oncology therapy. |
| 23G | Deep Blue | 0.60 mm | 3/4" (19 mm) | 1.2 mm / 2.0 mm | Pediatric vascular access, small animal veterinary, difficult veins. |
| 24G | Medium Purple | 0.55 mm | 3/4" (19 mm) | 1.2 mm / 2.0 mm | Neonatal vein access, micro-infusions, sensitive pediatric wards. |
| 25G | Orange | 0.50 mm | 3/4" (19 mm) | 1.2 mm / 2.0 mm | Infant scalp vein cannulation, high-precision drug delivery. |
| 27G | Grey / Light Blue | 0.40 mm | 1/2" to 3/4" | 1.0 mm / 1.8 mm | Micro-pediatric care, specialized neurological or ophthalmology access. |
The global market for medical disposables is undergoing rapid transformation driven by stringent health regulations, environmental directives, and supply chain realignments. Procurement directors planning long-term contracts must anticipate four key market trends:
Regulatory bodies across Europe (EU Directive 2010/32/EU), North America (OSHA Needle-stick Safety and Prevention Act), and Latin America are strictly enforcing the adoption of safety-engineered devices. Future hospital tenders will increasingly disqualify standard scalp vein needles in favor of retractable or shield-encapsulated safety scalp vein sets. Mediplus is expanding its automated production of safety winged infusion sets to meet this global transition.
Due to endocrine-disrupting concerns associated with Di(2-ethylhexyl)phthalate (DEHP), healthcare institutions are transitioning to DEHP-free PVC and Polyurethane (PU) extension tubing for scalp vein sets. This shift is especially crucial in neonatal intensive care units (NICU) and oncology wards. Mediplus provides certified DEHP-free tubing options that retain superior kink-resistance and optical clarity.
Global buyers are reducing reliance on single-country sourcing models to build resilient supply chains. India has emerged as a premier hub for ISO 13485-certified medical device manufacturing, combining cost efficiency with high compliance standards. Mediplus’s modern manufacturing complex in Vatva, Ahmedabad, offers direct access to major sea ports (Mundra and Nhava Sheva), guaranteeing reliable export continuity.
Traceability is moving to the unit level. Global Ministries of Health now require Unique Device Identification (UDI) barcoding on individual blister packaging. Mediplus integrates GS1 DataMatrix barcodes across primary, secondary, and shipper box packaging, enabling seamless electronic inventory management and reverse-traceability during clinical audits.
What separates a premium scalp vein set from a substandard alternative lies in the microscopic precision of the needle point and the structural chemistry of the assembly polymers. Mediplus invests continuously in state-of-the-art infrastructure to ensure zero-defect production output.
The insertion force of a needle directly impacts patient discomfort and vein trauma. Mediplus utilizes Japanese AISI 304 stainless steel tubing with cold-drawn dimensional accuracy. Needle tips undergo automated 3-facet bevel grinding (lancet point design) to create razor-sharp edges.
Furthermore, each cannula is treated with a micro-thin, medical-grade silicone emulsion applied via ultrasonic nozzles. This creates a uniform friction-reducing gradient along the needle shaft, reducing penetration force by up to 35% compared to non-siliconized alternatives.
The butterfly wings serve a dual purpose: providing ergonomic control for the clinician during insertion and establishing a stable anchor point on the patient's skin to prevent needle dislodgement. Mediplus molds its wings using ultra-soft, medical-grade PVC/EVA blends that conform naturally to patient anatomy.
The extension tubing—typically 30 cm in length—is extruded with a precise balance of durometer hardness and elasticity. It features high memory retention, ensuring that even if twisted or bent during clinical movement, the inner lumen remains completely open, preventing occlusion or flow rate drops.
Procurement teams and clinical evaluators frequently analyze when to deploy a scalp vein set versus an IV cannula or a straight blood collection needle. The table below outlines the strategic clinical positioning of each device:
| Parameter | Scalp Vein Set (Butterfly) | Peripheral IV Cannula | Straight Vacuum Needle |
|---|---|---|---|
| Primary Indication | Short-term infusion (<24h), pediatric/geriatric venipuncture, difficult veins. | Continuous or long-term IV therapy (>24 to 72 hours). | Single-draw phlebotomy / routine blood sampling. |
| Needle/Catheter Material | Rigid Stainless Steel (AISI 304) with soft anchoring wings. | Flexible FEP / PTFE / Polyurethane over-the-needle catheter. | Rigid Stainless Steel without extension tubing. |
| Control & Precision | Maximum: Low angle of entry, precise tactile feedback via wings. | Moderate: Requires two-handed insertion and catheter advancement. | Low to Moderate: Direct barrel attachment, higher lever movement. |
| Vein Damage Risk | Low during short use; higher risk if patient moves excessively due to rigid steel needle. | Very low after needle withdrawal, as soft catheter remains in vein. | N/A (removed immediately after draw). |
| Patient Pain Index | Minimal insertion force due to fine gauge (up to 27G) and short bevel. | Moderate (larger puncture profile due to catheter sheath taper). | Standard puncture sensation. |
Manufacturing medical devices since 1988 under the umbrella of Shree Umiya Surgical Pvt. Ltd. (Mediplus), our enterprise has grown into a globally recognized exporter supplying healthcare facilities across 70+ countries in Europe, the Middle East, Africa, Latin America, and Asia.
We understand that importing medical disposables requires seamless regulatory paperwork. Mediplus provides distributors with comprehensive technical files including:
Mediplus Scalp Vein Sets (Winged Infusion Sets) are manufactured in ISO 13485 and ISO 9001 certified facilities under strict ISO Class 7/8 cleanroom environments in Ahmedabad, India. Our devices hold CE marking under EU MDR compliance, adhere to ISO 6009 color coding standards, ISO 9626 stainless steel needle specifications, and ISO 10993 biocompatibility requirements. Every export lot comes with a Certificate of Analysis (CoA), EO sterilisation validation records, and full batch traceability data.
Our Scalp Vein Sets feature short-bevel, triple-ground AISI 304 stainless steel cannulas treated with a proprietary medical-grade silicone lubricant gradient. This significantly reduces insertion force and penetration resistance, minimizing vessel trauma, phlebitis risks, and patient pain during pediatric, geriatric, or oncology venipunctures.
We offer complete OEM customization including buyer-branded blister packaging, customizable tubing lengths (from 15 cm to 30 cm), DEHP-free or phthalate-free PVC materials, custom gauge combinations (18G to 27G), female Luer lock or Luer slip connectors with protective caps, and UDI / GS1 barcode integration for automated hospital inventory tracking.
Each batch undergoes rigorous pull-testing where the needle-to-wing and wing-to-tubing joints are subjected to tensile loads exceeding 15 Newtons, far surpassing standard ISO 8536 requirements. Tubing assemblies are hydrostatically leak-tested at pressures up to 2 bar (30 psi) to guarantee structural integrity during pressurized micro-infusions.
Mediplus Scalp Vein Sets have a 5-year validated shelf life when stored in original medical-grade peel packaging. Devices are sterilised using validated Ethylene Oxide (EO) cycles adhering to ISO 11135, leaving residual EO levels below 4 µg/g. Minimum order quantities start at 100,000 units for standard catalog items and 200,000 units for customized OEM private label programs.
Our female Luer lock and Luer slip hubs are injection-molded using virgin rigid polypropylene conforming to ISO 80369-7 dimensional tolerances. The tubing-to-hub bond is achieved using automated solvent bonding or UV-curable medical adhesives, followed by 100% online pressure-decay testing to verify hermetic sealing.
Standard catalog orders ship within 3 to 4 weeks after order confirmation. Private-label OEM packaging orders generally require 4 to 6 weeks from artwork approval. Shipments leave via Mundra Port or Nhava Sheva (JNPT) Port, offering direct sea freight connectivity to European, Middle Eastern, Latin American, and African destinations.
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