Fully compliant with US clinical protocols, offering validated biocompatibility, zero-spallation peristaltic pump tubing, and complete lot traceability for hospital chains and dialysis centers.
In the high-stakes environment of chronic renal replacement therapy, blood tubing sets (BTS) represent the vital extracorporeal conduit linking the end-stage renal disease (ESRD) patient to the hemodialysis machine. Procurement officers, clinical directors, and medical device distributors across the United States demand strict adherence to biological safety, structural integrity, and fluidic dynamics. As a leading manufacturer and exporter under the Mediplus (Shree Umiya Surgical Pvt. Ltd.) brand, we design extracorporeal circuits engineered to eliminate micro-embolic hazards, withstand continuous peristaltic fatigue, and deliver precise flow velocity under rigorous clinical conditions.
Every blood tubing set supplied to the US market comprises two main functional components: the arterial line (color-coded red for blood withdrawal) and the venous line (color-coded blue for blood return). These components are integrated with precision-moulded drip chambers, arterial bubble traps, heparin injection ports, and universal dialyzer connectors designed for dynamic compatibility with leading US hemodialysis machine platforms including Fresenius Medical Care (2008/5008 series), Baxter-Gambro, and B. Braun Dialog+.
Utilizing high-purity, plasticizer-optimized medical grade PVC and aromatic TPU materials tested to ISO 10993 cytotoxicity, hemolysis, and systemic toxicity standards.
Engineered with high-resilience elastomer formulation for the peristaltic roller pump segment, guaranteeing consistent inner diameter dimensions over 4 to 6-hour treatments.
100% leak-tested ISO 80369-7 compliant luer lock connectors ensuring zero air aspiration risk and positive mechanical lock under high arterial pressure.
| Functional Parameter | Arterial Line Specification | Venous Line Specification | Compliance / Validation Standard |
|---|---|---|---|
| Tubing Material | Medical-grade PVC (DEHP-Free / TOTM Plasticized) | Medical-grade PVC (DEHP-Free / TOTM Plasticized) | ISO 10993-1, USP Class VI |
| Peristaltic Pump Segment | ID 6.4mm / 8.0mm Shore A Hardness 62±3 | N/A (Standard Line ID 4.2mm) | ASTM D2240 Fatigue Tested |
| Drip Chamber Volume | 15 mL - 30 mL with integrated filter | 20 mL - 35 mL with 130-200µm blood filter | ISO 8637-2 Extracorporeal Circuits |
| Transducer Protector | 0.2 µm Hydrophobic PTFE Membrane | 0.2 µm Hydrophobic PTFE Membrane | Bacterial Retention > 99.999% |
| Sterilization Method | 100% Ethylene Oxide (EO) / Gamma Irradiation | 100% Ethylene Oxide (EO) / Gamma Irradiation | ISO 11135 / ISO 11137 (SAL 10⁻⁶) |
| Residual Limits | EO Residual < 1.2 mg/device; ECH < 4.0 mg | EO Residual < 1.2 mg/device; ECH < 4.0 mg | ISO 10993-7 Limits Compliance |
The healthcare infrastructure of the United States requires versatile blood tubing configurations optimized for diverse treatment modalities. From high-volume outpatient dialysis centers managed by Group Purchasing Organizations (GPOs) to specialized acute care units within Veteran Affairs (VA) hospitals, our product portfolio provides specific engineering features tailored to US clinical workflows.
High-speed priming setups with pre-attached recirculation loops, color-coded clamps, and fast-flow drip chambers designed to minimize nursing prep time and expedite patient turnover in 4-shift daily schedules.
Custom self-care blood tubing sets featuring error-proof needleless injection sites (SmartSite / Clave compatible), self-sealing hydrophobic vents, and ultra-flexible tubing tailored for simplified single-patient operation.
Long-duration hemodiafiltration lines engineered for continuous 24 to 72-hour operational stability, equipped with secondary heparin infusion arms and low-priming-volume drip chambers for critically ill patients.
Procurement teams across North America are navigating structural shifts in medical device regulation, environmental legislation, and supply chain risk management. Understanding these macro trends allows US distributors to partner with agile international manufacturers capable of meeting forward-looking specifications.
With increasing regulatory enforcement surrounding phthalate exposure in chronic care, US healthcare networks are mandating non-DEHP plasticizers such as TOTM (Tris(2-ethylhexyl) trimellitate) or DINCH. Our production lines feature complete non-DEHP material options that eliminate leachables while preserving optimal tube elasticity for pump rollers.
US Federal policy mandates under the Executive Order on Advancing American Kidney Health aim to have 80% of new ESRD patients receiving home dialysis or kidney transplants by 2030. This shift is driving demand for pre-connected, low-volume tubing kits equipped with automated safety lockouts and simplified color coding for home users.
Recent disruptions in US domestic medical distribution have prompted healthcare systems to establish direct OEM partnerships with verified global manufacturers. Mediplus provides US importers with contract manufacturing capabilities, private-label packaging, and fixed-volume shipping schedules from Mundra and Nhava Sheva ports.
Full FDA UDI compliance is now mandatory across all Class II and Class III hemodialysis disposables. Our automated packaging infrastructure prints GS1 2D DataMatrix codes directly onto individual sterile pouches and master cartons, enabling seamless inventory tracking for hospital GPOs.
Established in 1988 in Ahmedabad, Gujarat, India, Shree Umiya Surgical Pvt. Ltd. (operating globally as Mediplus) has evolved into an international powerhouse in single-use medical device manufacturing. Spanning over 36 years of specialized polymer engineering, our vertically integrated plant controls every stage of production—from raw resin qualification to final EO sterilization.
Operates under audited Quality Management Systems certified to ISO 13485:2016 and ISO 9001, supporting US buyers with exhaustive technical master files and bio-compatibility dossiers.
Automated tube extrusion, injection moulding, and high-frequency bonding performed strictly within controlled environments with positive pressure differential monitoring.
Every standard and custom order is released with a Certificate of Analysis (CoA), biological indicator sterilization test logs, and raw material batch verification records.
Our Vatva facility integrates industrial rooftop solar energy arrays, significantly lowering the carbon footprint per manufactured unit for eco-conscious procurement teams.
Partner with an ISO 13485 certified manufacturer for your high-volume Blood Tubing Set, Dialysis Catheter, and Extracorporeal Consumable requirements in the United States.
Get Catalog