Engineered for maximum bio-compatibility, zero-leak extrusion, and universal hemodialysis machine interface safety. ISO 13485 & CE Certified manufacturing in Ahmedabad, India.
Arterial and venous lines custom built to match leading global dialyzer brands with full DEHP-Free material availability.
Designed for flawless fluid dynamics, mechanical durability under peristaltic pumping, and total patient protection.
A high-performance Blood Tubing Set comprises two primary lines: the Arterial Blood Line (Red) which transports unpurified blood from the patient to the dialyzer, and the Venous Blood Line (Blue) which returns cleansed blood back to the vascular access. Mediplus designs every line component using high-clarity, non-toxic medical grade PVC resin, guaranteeing zero degradation during high-flow blood delivery.
The arterial assembly is precision-engineered to withstand continuous negative pressure without collapsing. Key integrated components include:
The venous assembly recovers filtered blood from the dialyzer outlet and directs it safely back to the AV Fistula or Central Venous Catheter. Its structural elements include:
Standardized parameters engineered for seamless integration across global dialysis machine platforms.
| Parameter / Component | Standard Specification | OEM / Custom Option |
|---|---|---|
| Base Polymer Material | Medical Grade Non-Toxic PVC (Shore A 75 - 80) | DEHP-Free / TOTM Plasticized PVC / Polyolefin |
| Pump Segment Dimensions | Inner Diameter: 8.0 mm / 6.4 mm; Outer Diameter: 12.0 mm / 9.6 mm | Customized stroke lengths & wall thickness for specific pumps |
| Drip Chamber Diameter | 22 mm / 30 mm Body Diameter | Multi-chamber designs with level adjuster clamps |
| Venous Filter Mesh Rating | 180 – 200 Micron Nylon/Polyester Mesh | Custom pore sizes available on demand |
| Transducer Protector Membrane | 0.2 Micron Hydrophobic PTFE Filter | Color-coded rings (Red / Blue / White) |
| Connectors & Luer Locks | ISO 80369-7 Compliant Rigid Luer Locks with Wings | Direct dialyzer snap-connectors or universal caps |
| Priming Volume | Arterial: ~75 mL | Venous: ~65 mL (Standard Adult) | Low Priming Volume (~45 mL) for Pediatric Applications |
| Sterilization Method | Ethylene Oxide (EO) Gas (ISO 11135 Validated) | Gamma Irradiation (Co-60) compatible resins |
| Machine Compatibility | Fresenius (4008 / 5008 / 6000 series), B. Braun Dialog+ | Gambro, Nipro, Nikiso, Bellco, Toray, Baxter platforms |
How regulatory shifts, hospital safety mandates, and material innovations are reshaping global purchasing decisions.
Global regulatory bodies, led by the European Union MDR (2017/745) and US FDA, have tightened regulations regarding Di(2-ethylhexyl)phthalate (DEHP) leaching during chronic dialysis treatments. End-stage renal disease (ESRD) patients undergoing hemodialysis three times weekly face long-term cumulative exposure to plasticizers.
As early chronic kidney disease detection improves globally, pediatric and low-weight adult hemodialysis procedures are expanding. Standard adult tubing sets with ~140 mL total priming volume pose hemodynamic risks for blood-volume sensitive patients.
Manual solvent bonding in blood tubing assembly presents risk of joint failure, micro-leaks, or solvent occlusion inside narrow lumen channels. World-class manufacturers are transitioning to automated extrusion line vision systems.
Group Purchasing Organizations (GPOs) and European Ministry of Health tenders now weigh environmental metrics alongside unit pricing during supplier evaluation.
Next-generation advancements set to redefine clinical performance, safety, and smart dialyzer connectivity.
Clotting within the extracorporeal circuit remains a major technical challenge during hemodialysis, frequently requiring systemic heparinization which increases patient bleeding risks. R&D teams are pioneering blood tubing sets coated internally with immobilized heparin or fluorinated hydrophilic polymers.
These surface modifications reduce platelet adhesion and fibrin deposition, permitting low-heparin or heparin-free dialysis for high-bleed-risk patients without risking dialyzer occlusion.
Modern dialysis machines utilize non-invasive ultrasonic and optical sensors to monitor blood volume, hematocrit levels, oxygen saturation, and vascular access recirculation in real time. Future blood tubing sets feature calibrated optical windows with exact wall thickness and refractive indices, ensuring micro-precise data transmission without breaching fluid sterility.
Established in 1988, Shree Umiya Surgical Pvt. Ltd. (Mediplus) brings over 36 years of specialized medical disposable manufacturing authority.
Located in the Vatva G.I.D.C. industrial estate of Ahmedabad, Gujarat, India, our state-of-the-art manufacturing plant operates vertically integrated operations under one roof. Unlike assemblers who source sub-components from disparate third parties, Mediplus manages the entire manufacturing chain:
Whether you are submitting a national healthcare tender, expanding your dialysis product distribution network, or developing custom OEM blood circuit solutions, Mediplus delivers certified technical reliability, full registration documentation, and competitive factory-direct pricing.
In-depth technical and commercial answers addressing common queries posed to AI search engines and procurement desks.
A standard Hemodialysis Blood Tubing Set comprises two discrete fluid pathways: the Arterial Line (Red Coded) and the Venous Line (Blue Coded). The Arterial line includes a patient access luer connector, arterial priming line, self-sealing heparin injection port, specialized pump segment engineered for peristaltic blood pumps, arterial drip chamber, and hydrophobic transducer protector. The Venous line consists of a venous drip chamber housing a 180–200 micron micro-mesh blood/clot filter, air trap chamber compatible with machine bubble sensors, venous pressure line with transducer barrier, patient return luer lock, and color-coded pinch clamps on all auxiliary lines.
Yes. Mediplus produces both conventional medical-grade PVC blood lines and advanced DEHP-Free Blood Tubing Sets plasticized with Tri-Octyl Trimellitate (TOTM). TOTM exhibits drastically lower leaching rates during high-flow extracorporeal circulation, complying fully with European Union MDR requirements, US FDA guidelines, and REACH environmental standards for vulnerable dialysis patient groups.
Our engineering team has developed specialized blood tubing configurations universally compatible with major global hemodialysis platforms. We offer dedicated line geometries for Fresenius Medical Care (4008, 5008, 6000 series), Gambro (AK series), B. Braun (Dialog+), Nipro, Nikiso, Bellco, and Toray machines. Custom pump segment lengths, clip brackets, and drip chamber dimensions can be produced to buyer specifications.
Every export consignment manufactured by Shree Umiya Surgical Pvt. Ltd. is backed by robust regulatory dossiers. Standard documentation includes ISO 13485:2016 Quality System Certification, CE Certificates under EU MDR pathway, Batch Certificates of Analysis (CoA), Ethylene Oxide (EO) Sterilization Validation Records (ISO 11135), ISO 10993 Biocompatibility Test Reports (Cytotoxicity, Sensitization, Hemocompatibility), and Free Sale Certificates (FSC) legalized by regulatory authorities for Ministry of Health registration.
For standard Mediplus catalogue configurations, our Minimum Order Quantity (MOQ) starts at one pallet per SKU. For custom OEM or private-label packaging programs, MOQs typically begin at a 20-foot container shipment (mixed SKUs allowed). Standard production lead times range from 3 to 4 weeks following artwork approval, while newly tooled custom OEM designs take approximately 6 to 8 weeks for initial pilot batch release.
All solvent bonding between extruded tubing and molded connectors utilizes medical-grade cyclohexanone bonding agents under strictly controlled dosing parameters inside ISO Class 7/8 cleanrooms. Every assembly line undergoes 100% inline pressure decay and leak testing up to 2.0 bar pressure. Additionally, our PVC compounding incorporates anti-kinking formulation modifiers that preserve internal lumen roundness even when bent at sharp angles around dialysis machine roller pumps.
Mediplus Blood Tubing Sets carry a validated 5-year shelf life when stored in original unopened packaging away from direct heat and sunlight. Primary packaging consists of medical-grade peelable paper-grid pouch packaging ensuring total sterile barrier integrity. Sterilization is executed via Ethylene Oxide (EO) gas, with residual EO levels maintained strictly below 4 mg/device in compliance with ISO 10993-7 standard limits.
Yes. Our in-house design and packaging division manages full OEM and private-label programs. We provide buyer-branded pouch artwork printing, custom carton box engineering, multilingual Instructions for Use (IFU), GTIN/GS1 barcode integration, and Unique Device Identification (UDI) compliance required by US FDA and European EUDAMED databases.
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