Disposable Acute Blood Purification Consumable Introduction

1. Disposable Acute Blood Purification Consumable Introduction
The Disposable Acute Blood Purification Consumable represents a cutting-edge solution designed for efficient and safe blood purification in critical care settings. Its inherent disposable nature ensures a pristine, one-time use product that minimizes the risk of contamination and cross-infection, thereby enhancing patient safety. Engineered with advanced filtration and purification technologies, this consumable offers unparalleled performance, effectively removing a wide range of pathogenic agents, toxins, and metabolic waste products from the bloodstream. Its compact design and user-friendly features facilitate quick and accurate treatment delivery, while its robust structural integrity guarantees longevity and reliability throughout the procedure. This innovative product exemplifies a commitment to quality and patient care, delivering superior outcomes with each use.

Figure1: Disposable Acute Blood Purification Consumable Product Picture

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2. Disposable Acute Blood Purification Consumable Development Factors
2.1. Technological Innovation Drives Performance Leap-The Core Driver in the Development of Single-Use Acute Blood Purification Consumables
The development of single-use acute blood purification consumables is fundamentally technology-driven, with its core lying in the performance breakthroughs and safety enhancements brought about by material and process innovations. The research and development of novel adsorption materials and membrane materials directly determine the clinical value and application boundaries of these consumables in the treatment of acute and critical illnesses. For example, through polymer-based bioactive controllable grafting technology, functional groups can be precisely constructed on material surfaces, significantly improving blood compatibility, reducing complications such as coagulation and complement activation, while enhancing the selective adsorption capacity for medium and large molecular toxins. Coupled with precise control of pore structure (e.g., stably maintained within the 10-50 nm range), efficient clearance of specific pathogenic substances such as β2-microglobulin can be achieved, demonstrating overall efficacy that matches or even surpasses that of international counterparts. Building on this, the core functionality of consumables is evolving from "broad-spectrum clearance" toward "efficient, precise intervention," with technological objectives no longer limited to small-molecule metabolic toxins but increasingly focused on key mediators of inflammatory responses, such as medium and large molecular toxins, cytokines, and endotoxins. Representative of the new generation of single-use acute blood purification consumables are specific cytokine adsorption columns, which can significantly reduce the levels of inflammatory factors in critically ill patients, such as those with sepsis, within a short timeframe, thereby ameliorating pathological cascades and improving treatment success rates. Overall, the synergistic advancement of materials science, precision manufacturing, and biofunctionalization technologies constitutes the decisive developmental factor driving the continuous upgrading and enhanced clinical value of single-use acute blood purification consumables.

2.2. Clinical Needs in Acute and Critical Care Drive Demand-The Practical Driver in the Development of Single-Use Acute Blood Purification Consumables
The development of single-use acute blood purification consumables is intrinsically and strongly driven by the demands of acute and critical care settings, where the patients involved are often in life-threatening emergencies. This reality dictates that these consumables must continuously evolve in response to clear and urgent clinical needs. Currently, such consumables have become critical tools in the treatment of acute kidney injury, acute drug or toxin poisoning, sepsis, and multiple organ failure, playing an irreplaceable role within critical rescue windows. For instance, in the treatment of highly lethal poisonings such as paraquat, the timely application of single-use Extracorporeal Blood Adsorbers can rapidly reduce the body's toxic load, significantly improve prognosis, and increase patient survival rates-fully demonstrating their "time-sensitive" value. With the ongoing advancement of critical care medicine and the concept of precision medicine, clinical demands for single-use acute blood purification consumables are also undergoing profound changes. Treatment goals have gradually shifted from early-stage life support and functional substitution toward active intervention and precise modulation of pathological processes. In systemic inflammatory response diseases such as sepsis, consumables are required not only to possess efficient clearance capabilities but also to achieve selective adsorption of specific inflammatory factors and immune mediators, thereby modulating immune imbalances and blocking inflammatory cascades. This evolution in demand directly drives continuous upgrades in adsorption selectivity, biocompatibility, and safety stability of consumables, making it a significant developmental factor in the ongoing innovation and iteration of single-use acute blood purification consumables.

2.3. Policy, Reimbursement, and Safety Regulations: Dual Drivers for the Large-Scale Development of Single-Use Acute Blood Purification Consumables
The industrialization and scaled adoption of single-use acute blood purification consumables, beyond clinical and technological factors, are also critically driven by the dual forces of policy and reimbursement environments and safety regulatory frameworks. Their combined effect constitutes the key conditions for transitioning products from "usable" to "accessible and sustainable." On the policy and reimbursement front, the state has explicitly included blood purification consumables as a key development direction for high-end medical devices, continuously releasing policy dividends through industrial planning and registration review support. Simultaneously, centralized volume-based procurement initiatives (such as the 2024 23-province alliance procurement for hemodialysis consumables) significantly reduce clinical usage costs while accelerating the entry of technologically mature, quality-stable, and cost-controllable domestic single-use acute blood purification consumables into mainstream hospital systems, enabling rapid adoption. Medical insurance reimbursement and charging mechanisms directly influence clinical willingness and frequency of use. In some regions, treatments such as blood perfusion and related consumables have been included in medical insurance coverage, and explicit consumable charging catalogs (e.g., separately billable item lists) ensure reasonable revenue for medical institutions, thereby institutionally supporting the standardized application and sustained supply of these consumables. At the same time, safety and material upgrades have become unavoidable "hard thresholds." Global medical device regulations are becoming increasingly stringent, compelling continuous iteration in biosafety, material compliance, and quality system development for single-use acute blood purification consumables. For instance, traditional PVC materials containing DEHP plasticizers are gradually being restricted under regulations such as the European MDR due to potential health risks, directly driving the industry toward DEHP-free materials and alternatives with higher biocompatibility, such as TPE and TPU. As single-use invasive devices, sterility assurance and full-process traceability are regulatory imperatives. Manufacturers must establish quality management systems compliant with ISO 13485 requirements and fully implement Unique Device Identification (UDI) systems to ensure safety and control from production and distribution to clinical use. Overall, policy access and reimbursement mechanisms address the questions of "whether and how much to use," while safety regulations and material upgrades determine "whether they can be used sustainably." Together, they constitute important developmental factors for the high-quality and sustainable development of single-use acute blood purification consumables.

3. Disposable Acute Blood Purification Consumable Development Trends
3.1. The evolution of single-use acute blood purification consumables will increasingly exhibit two parallel trends
The evolution of single-use acute blood purification consumables will increasingly demonstrate a parallel progression along two main lines: "material compliance upgrade" and "clinical workflow efficiency-oriented design." At the material level, phthalate substances such as the plasticizer DEHP in traditional PVC medical devices have long been subject to regulatory scrutiny due to potential health risks. For instance, the U.S. FDA, in draft guidance documents related to devices published in the Federal Register, has recommended labeling for devices containing DEHP and considering the progressive reduction or substitution of its use in applications related to certain high-exposure sensitive populations. This drives the industry to continually seek lower-risk material pathways. In the EU market, the Medical Device Regulation (MDR) imposes stricter requirements for risk-benefit justification and information disclosure concerning substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) or have endocrine-disrupting properties that may be released from devices, as stipulated in the General Safety and Performance Requirements. EU health authorities and their scientific committees also continuously issue and update official guidance and expert opinions on how to conduct risk-benefit assessments for such phthalate substances when present in medical devices, making "demonstrating necessity, evaluating alternatives, and reducing patient exposure risk" a routine part of manufacturers' compliance efforts. Under this regulatory logic, developing and adopting safer alternative material systems is increasingly becoming a prerequisite for cross-regional market access and long-term compliance for companies. The application of thermoplastic materials such as TPE, TPU, and DEHP-free solutions in medical tubing and blood-contacting consumables will become more widespread. The core objective is to reduce compliance and safety uncertainties associated with leachable chemical substances, thereby enhancing global market accessibility and confidence in hospital usage.

Simultaneously, at the design level, the rigid demands of acute care for "rapid circuit establishment, error reduction, and concurrent risk mitigation" will persistently drive the iteration of single-use consumables towards systematization and integration. Companies have explicitly promoted "pre-connected" single-use extracorporeal circuit solutions in official communications. For example, Baxter, in its announcements, defines its ST Set for Continuous Renal Replacement Therapy (CRRT) as a "pre-connected, single-use, extracorporeal circuit," emphasizing its use for blood purification and adaptability to continuous treatment protocols in acute settings like ICUs. This type of pre-sterile connected, integrated design inherently aims to shorten clinician preparation time, reduce on-site connection points, and minimize potential contamination and assembly errors. Similarly, for controlling coagulation and air-related risks, the industry continuously reinforces a design philosophy of "low dead volume, minimal connections, and air-free handling" at the product level. For instance, B. Braun, in its product and technology descriptions, promotes an "airless" design for blood tubing sets, emphasizing enhanced usage safety and clinical operational convenience by eliminating or reducing blood-air contact and simplifying connections. These design directions will become further systematized in acute blood purification consumables, manifested as a greater emphasis on low overall circuit priming volume, integrated pressure monitoring or port structures, and structural optimizations that reduce blood stagnation and air ingress opportunities. This aims to simultaneously improve efficiency and safety margins in time-critical rescue scenarios such as CRRT.

3.2. Parallel Progression of Digital Traceability and Green Compliance
From the perspective of global regulatory and healthcare system practices, the future development of single-use acute blood purification consumables increasingly shows a trend emphasizing both "full lifecycle intelligent management" and "environmentally friendly design." Regarding intelligence, the Unique Device Identification (UDI) system has transitioned from a policy requirement to an industry infrastructure. The U.S. Food and Drug Administration, in its UDI Final Rule and subsequent official guidance, explicitly states that UDI should cover the production, distribution, and use phases of medical devices to enhance adverse event monitoring, product recall efficiency, and patient safety management. Similarly, the Chinese National Medical Products Administration (NMPA), through multiple announcements and supporting documents, has positioned UDI as a key instrument for digitalizing medical device supervision, requiring the progressive implementation of information collection and associated applications for high-risk devices across production, distribution, and clinical use phases.

Under this framework, the UDI for single-use acute blood purification consumables is no longer merely a labeling attribute but functions like an "identity card" embedded within hospital information systems. It is utilized for inventory management, clinical usage documentation, patient billing, and quality traceability, while also providing foundational data support for real-world evidence studies and healthcare quality improvement. This trend is explicitly highlighted as a significant component of digitalization strategies in the annual reports and official communications of several multinational medical device corporations.

Concurrently, environmental considerations are evolving from "additional factors" into unavoidable developmental constraints. The EU, within its MDR and supporting documents, has incorporated environmental risk into a broader scope of safety and performance considerations, requiring manufacturers to systematically assess the full lifecycle risks of devices during the design and material selection phases. Multiple international medical device companies have also publicly stated in their sustainability reports and annual filings that, while ensuring patient and clinician safety, they will reduce the long-term environmental impact of single-use medical products through optimized material selection, reduced unnecessary structural complexity, improved manufacturing processes, and packaging solutions.

For single-use acute blood purification consumables, this implies that future product design must not only meet stringent sterility and performance requirements but also balance safety, traceability, and environmental responsibility within the compliance framework. This adaptation aims to align with the long-term objectives of hospital operational refinement and the sustainable development of healthcare systems.

3.3. Specialized Products and Solution-Oriented Supply
Future trends for single-use acute blood purification consumables will be more prominently reflected in two pathways: "specialized dedicated consumables" and "solution-oriented competition driven by payment systems." Driven by precision medicine and stratified critical care, consumables will less frequently rely on universal specifications for all scenarios. Instead, they will form more clearly defined, dedicated configurations centered around different patient populations and treatment goals. For example, addressing the need for prolonged stable operation required in Continuous Renal Replacement Therapy (CRRT), companies have described pre-connected single-use circuits paired with specific filter configurations as product directions in official communications, demonstrating a trend where the clinical scenario defines the consumable form.

Simultaneously, addressing the stringent safety margin requirements for low-body-weight, low-blood-volume patients such as in pediatrics, regulatory and corporate announcements have explicitly featured official references to "CRRT-specific single-use components for low-body-weight patients," indicating the continued expansion of single-use consumables adapted for small priming volumes and low blood flow rates. Regarding indications related to systemic inflammation such as sepsis, official corporate news and annual reports disclose that specific blood purification pathways like cytokine adsorption are prioritized as product and market focuses. This objectively points towards "specialized consumables targeting specific inflammatory mediators" further entering the framework of clinical application and evidence-based research.

On the other hand, changes in payment systems and business models are reshaping competition methods. Policy documents for centralized volume-based procurement issued by national healthcare authorities explicitly state overarching objectives such as leveraging volume for price reduction, ensuring quality and supply, and promoting standardized use. While such institutional arrangements enhance accessibility, they also, by design, continually compress the profit margins for homogeneous consumables. This compels companies to achieve comprehensive competitiveness through process improvements, material and structural innovations, and supply chain efficiency to ensure cost control alongside stable quality.

In this context, leading companies increasingly emphasize a "product and service" co-supply model in the official descriptions of their business strategies within annual reports. This involves forming systematic solutions through equipment, compatible single-use consumables, and clinical support services to enhance hospital loyalty and full-process delivery capability. This approach aligns with the acute care setting's demand for systems that are continuously available, maintainable, trainable, and accountable. It is also set to become a primary direction for the future evolution of single-use acute blood purification consumables, shifting competition from individual products towards comprehensive solutions.

4. Leading Manufacturer in the Industry
4.1. Baxter

Baxter is a global multinational medical technology company whose core business revolves around developing, manufacturing, and supplying medical products and solutions for the treatment of critical and chronic illnesses. Its offerings span multiple areas including hospital clinical care, kidney disease care, emergency and critical care management, surgical care, nutritional support, infusion and drug delivery systems. Baxter's products are widely used in clinical settings such as hospitals, renal dialysis centers, and rehabilitation facilities. Committed to enhancing treatment efficiency and safety through medical device innovation and therapeutic advancements, Baxter collaborates with clinical partners to address the evolving clinical and operational challenges within the healthcare industry. The company's mission is centered on improving patient outcomes, supporting the practice of healthcare professionals, and promoting the advancement and personalization of healthcare standards.

In the area of Disposable Acute Blood Purification Consumables, Baxter provides single-use consumables for blood purification treatment processes. These consumables primarily include disposable blood perfusion cartridges and disposable blood tubing sets. Disposable blood perfusion cartridges are designed for use during hemodialysis or continuous renal replacement therapy (CRRT) to remove toxins, inflammatory mediators, or metabolic waste from the blood via adsorption or filtration mechanisms. For instance, Baxter has previously introduced pre-connected single-use circuits (such as the ST Set) for extracorporeal blood purification therapy, which have received certification from the U.S. Food and Drug Administration (FDA). These perfusion cartridges serve as single-use extracorporeal circulation components, enabling the blood purification process through semipermeable membranes or specific adsorption media. Disposable tubing sets refer to single-use blood circuit components designed to safely channel patient blood into the purification system and return it to the body's circulation. A typical product example is the integrated blood perfusion tubing (such as the Cartridge Blood Set) for dialysis treatment, which incorporates structures like arterial and venous access points and blood chambers, and is designed for single use to reduce the risk of cross-contamination. These Disposable Acute Blood Purification Consumables, through strict sterile, integrated design, support the safe and effective implementation of blood circulation purification therapies in clinical settings for patients with acute kidney injury and other critical conditions requiring blood purification treatment.

4.1.1. Key Features of oXiris Blood Purification Set
The oXiris Blood Purification Set is the exclusive 3-in-1 blood purification filter set specifically designed for intensive care unit (ICU) patients, capable of simultaneously delivering three key functions-continuous renal replacement therapy (CRRT), endotoxin adsorption and removal, and cytokine adsorption and removal-on both PRISMAFLEX and PRISMAX systems. It features a unique proprietary three-layer membrane structure: a base AN69 membrane that efficiently removes uremic toxins through diffusion and convection while providing renal support; a polyethyleneimine (PEI) surface treatment that endows the membrane with strong positive charges for highly effective adsorption of endotoxins; and the entire membrane concurrently adsorbs various pro‐inflammatory cytokines (such as IL‐6, TNF‐α, etc.). A surface‐grafted heparin coating significantly reduces thrombotic risk, minimizes treatment interruptions, and ensures adequate dialysis delivery. This set is particularly suitable for critically ill patients with sepsis or septic shock accompanied by acute kidney injury. By using a single device to synchronously remove excessive inflammatory mediators (endotoxins and cytokines), uremic toxins, and excess fluid, it effectively modulates the body's inflammatory response, improves hemodynamics and organ function, simplifies complex treatment workflows, and enhances ICU care efficiency.

4.2. NorrDia

NorrDia is a medical technology enterprise specializing in the fields of blood purification and kidney care, with its business focusing on providing therapies, devices, and consumables for patients with chronic and acute kidney diseases as well as for intensive care clinical settings. By undertaking the research, development, and commercialization of solutions including long-term CRRT, dialysis technologies, and related supporting products, NorrDia is dedicated to enhancing the safety and clinical efficacy of blood purification treatments while supporting clinicians in decision-making and operations for critical illness and renal failure care. Leveraging professional expertise accumulated from industry-leading companies such as Nikkiso Medical and Gambro, NorrDia continuously refines its product portfolio for continuous renal replacement therapy (CRRT), conventional dialysis, and related clinical support offerings, while expanding its global clinical product portfolio and service capabilities through mergers and collaborations.

Regarding Disposable Acute Blood Purification Consumables, NorrDia's product system includes various types of consumables designed to provide essential single-use components for extracorporeal blood purification therapies. Within the category of disposable blood perfusion cartridges, the company offers single-use purification components such as hemoadsorption cartridges. These devices support blood purification in critically ill patients, such as those with sepsis, by selectively adsorbing endotoxins, inflammatory mediators, and other harmful substances from the blood. In the category of disposable tubing sets, NorrDia provides single-use CRRT line kits and accessories for continuous renal replacement therapy. These sets include blood tubing for connecting patients to purification devices and consumables compatible with different CRRT systems, aimed at ensuring sterility, integrity of the blood circuit, and convenience in clinical operations. The designs of these Disposable Acute Blood Purification Consumables all serve to facilitate safe, effective, and repeatable clinical applications in extracorporeal circulation purification treatments.

4.2.1. Key Features of Citraset RCA
NorrDia Citraset RCA is a Disposable Acute Blood Purification Consumable (disposable CRRT set for regional citrate anticoagulation). It is a single-use, sterilized medical device set specifically designed for the AquariusTM System RCA (which includes Aquarius+ software supporting regional citrate anticoagulation). Its core conveniently integrates the AQUAMAX high-flux hemofilter with the dedicated AQUALINE RCA tubing, providing a complete extracorporeal circuit component set. This includes dedicated citrate infusion lines and calcium supplementation lines, enabling effective prevention of clotting within the extracorporeal circuit under regional citrate anticoagulation (RCA), while supporting flexible switching to heparin anticoagulation within the same set without requiring a set change. The product series includes a standard adult version (e.g., Citraset RCA12: Aquamax HF12 filter blood chamber volume 73 mL + Aqualine RCA circuit blood volume 96 mL, total extracorporeal volume 169 mL; Citraset RCA19: HF19 filter 109 mL + 96 mL, total 205 mL) and a low-volume patient-specific version, Citraset S RCA (e.g., HF03 filter 32 mL + Aqualine S RCA 70 mL, total 102 mL; HF07+ filter 49 mL + 70 mL, total 119 mL), minimizing priming blood volume to suit pediatric or low-body-weight critically ill patients. It is particularly indicated for critically ill patients requiring continuous renal replacement therapy (CRRT, including modes such as CVVH, CVVHD, CVVHDF), especially those at high risk of bleeding, with heparin contraindications, or requiring avoidance of systemic anticoagulation risks. Through the RCA mechanism of locally chelating calcium ions, it achieves effective anticoagulation, extends filter life (supporting an extended use mode of up to 100 hours), reduces bleeding complications, and maintains treatment continuity. It is used in conjunction with supporting products like AC-A citrate anticoagulant solution and Citralysat calcium-free dialysate, optimizing acid-base balance and electrolyte management. Its clinical advantages lie in simplifying operational procedures, enhancing safety and efficacy, and reducing nursing burden. It represents the flagship disposable consumable for citrate anticoagulation within the NorrDia Aquarius system, embodying the core values of "flexibility, individualization, and heparin alternative."

4.3. Fresenius Medical Care

Fresenius Medical Care is a globally leading provider of blood purification products and medical services. Its business revolves around delivering comprehensive clinical solutions for patients with chronic kidney disease and acute kidney failure, encompassing devices, consumables, systems, technical services, and clinical support for hemodialysis and other extracorporeal blood purification therapies. The company provides ongoing dialysis treatment support to a vast number of patients worldwide through its network of owned and partnered dialysis centers. Concurrently, it develops and manufactures dialysis machines, dialyzers, various disposable products, infusion and therapeutic systems, serving clinics, hospitals, and care facilities through a vertically integrated model. This supports clinical needs in routine hemodialysis, peritoneal dialysis, and blood purification treatments under critical care conditions. Official materials indicate that Fresenius Medical Care's products, therapies, and services cover the entire spectrum of kidney disease management. Its research, development, and production systems are designed to enhance clinical outcomes and patient quality of life, while strengthening global blood purification treatment capabilities through innovative technologies and integrated therapy platforms.

Regarding Disposable Acute Blood Purification Consumables, Fresenius Medical Care offers a range of single-use consumable components for critical care and acute renal replacement therapy. Within the category of disposable blood perfusion cartridges, the company's portfolio includes disposable purification cartridges designed for acute care (Acute Care Cartridges). These single-use perfusion cartridges are utilized in extracorporeal purification processes such as renal replacement therapy and therapeutic plasma exchange. Through integrated design, they support multiple treatment modalities and facilitate toxin removal and fluid management. In the category of disposable tubing sets, Fresenius Medical Care provides single-use blood circuits and tubing components for hemodialysis and continuous kidney replacement therapy (CKRT). These consumables include bloodline sets and disposable tubing systems compatible with purification equipment, ensuring safe, sterile transport of blood and effective purification during the extracorporeal circulation process. These Disposable Acute Blood Purification Consumables, as critical components of the clinical treatment workflow, are designed to support extracorporeal blood purification therapies in acute care settings such as the ICU, enhancing operational convenience and patient safety.

4.3.1. Key Features of CytoSorb
Fresenius Medical Care CytoSorb is a Disposable Acute Blood Purification Consumable. It is a single-use, non-pyrogenic, sterilized medical device specifically designed for intensive care unit (ICU) patients. Its core consists of highly porous polymerized beads, providing an exceptionally large adsorption surface area, and operates via physical adsorption as blood flows directly through the device. Utilizing a specific pore size distribution, it selectively targets and adsorbs low- and middle-molecular-weight substances while restricting the entry of larger molecules. This enables the efficient removal of various pro-inflammatory cytokines (such as IL-6, TNF-α, etc.), bilirubin, and myoglobin. It is particularly indicated for critical conditions related to infection and inflammation, such as sepsis (including septic shock), cytokine storm, acute liver failure, and rhabdomyolysis in patients accompanied by multiple organ dysfunction. By rapidly reducing the levels of toxic inflammatory mediators in circulation, mitigating excessive inflammatory responses, and improving hemodynamics and organ function, it helps prevent or reverse organ failure. It is compatible and can be integrated with continuous kidney replacement therapy (CKRT/CRRT) systems (e.g., multiFiltrate PRO), serving as a complementary therapy to achieve multi-organ support and simplify complex treatment workflows in the ICU. Its clinical advantage lies in providing a unique extracorporeal purification capability for large-molecular toxins that are difficult to remove via conventional dialysis, significantly reducing inflammatory burden and improving treatment outcomes. It represents the flagship third-generation adsorption consumable within Fresenius Medical Care's acute blood purification portfolio, specifically targeting the removal of inflammatory mediators.

4.4. Chongqing SWS Hemodialysis Care

Chongqing Shanwaishan is a Chinese medical technology enterprise specializing in comprehensive blood purification solutions. Its business spans multiple segments including blood purification equipment, blood purification consumables, intelligent management systems for dialysis centers, and chain hemodialysis medical services, forming a complete industry chain system from equipment and consumables to clinical services. The company engages in the research, development, production, and sales of core purification equipment such as blood perfusion machines, hemodialysis machines, and continuous blood purification equipment (CRRT). Simultaneously, its wholly-owned subsidiary, Chongqing Tianwaitian Biotechnology Co., Ltd., is responsible for the development and production of blood purification consumables. Relying on its intelligent management system for dialysis centers and the operation of chain hemodialysis centers, Shanwaishan provides integrated diagnosis, treatment support, and services for kidney disease patients and critical care clinical settings.

Regarding Disposable Acute Blood Purification Consumables, Shanwaishan's product line includes various disposable components for extracorporeal blood purification therapy, specifically covering two categories: disposable blood perfusion cartridges and disposable tubing sets. The company's independently developed disposable blood perfusion cartridge has obtained a medical device registration certificate issued by the National Medical Products Administration. This perfusion cartridge is used in conjunction with blood purification devices to remove medium and large molecular endogenous toxins from the blood in clinical scenarios such as patients with end-stage renal disease through extracorporeal circulation, representing one of the company's key products in the field of blood purification consumables. Additionally, tubing set products such as disposable extracorporeal circulation circuits and disposable hemodialysis circuits, produced through its wholly-owned subsidiary, provide sterile extracorporeal blood circulation channels and fluid pathways for continuous blood purification and dialysis treatments, supporting the extracorporeal purification therapy process in critical conditions such as acute renal failure. These Disposable Acute Blood Purification Consumables constitute an essential component of Shanwaishan's blood purification product system for safe and efficient clinical treatment.

4.4.1. Key Features of TN Series
The TN series disposable blood perfusion cartridge by Shanwaishan is a third-generation Disposable Acute Blood Purification Consumable. It is a single-use, steam-sterilized, non-pyrogenic medical device specifically designed for hemoperfusion. Its core employs high-performance adsorption particles treated with coating technology (resin based on secondary cross-linking technology), offering excellent biocompatibility and significantly reducing complications. With a specific surface area exceeding 1000 m2/g, it provides an exceptionally large effective adsorption area and robust clearance performance. Its regulated pore density technology confers a relatively specific adsorption capability, making it particularly efficient at targeting middle-molecular-weight toxins such as β2-microglobulin (β2-MG), while simultaneously adsorbing a variety of endogenous/exogenous toxins, inflammatory mediators, drugs, and poisons. A novel spherical shell and cover structure ensures uniform blood flow, greatly reducing the probability of clotting and hemolysis during treatment. The small-volume blood chamber reduces the extracorporeal priming blood volume and lowers treatment risks. The preservation solution is neutral to avoid metabolic acidosis. It is suitable for critically ill patients with multiple organ dysfunction in conditions such as acute and chronic renal failure with middle-molecular-weight toxin accumulation, drug/poison intoxication, liver failure, sepsis, and autoimmune diseases. Through direct hemoperfusion, it rapidly removes pathogenic factors, alleviates toxin load, and improves microcirculation and organ function. It can be used independently or compatibly integrated with CRRT/hemodialysis systems, serving as a supplement to achieve precise extracorporeal purification. It embodies the core advantages of domestic high-performance perfusion consumables: proprietary core technology + steam sterilization process, ensuring safety, stability, and clinical efficacy. It represents the flagship Disposable Acute Blood Purification Consumable for toxin adsorption within Shanwaishan's fully integrated industry chain layout.

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