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Last updated: January 2026
This directory lists 47 blood bag manufacturers across the United States, from integrated primary collection system providers to specialized component processing bag manufacturers.
Buyers are typically solving problems around ensuring precise blood component separation, extending the viable shelf life of components through optimized additive solutions, or integrating advanced leukoreduction filters directly into their primary collection systems. They might also be seeking to reduce contamination risk by sourcing robust closed-loop systems that minimize external exposure during processing, or developing specialized aphresis kits for therapeutic applications.
Suppliers in this space range from large, vertically integrated manufacturers handling everything from film extrusion and bag welding to final sterilization, to smaller, more agile firms specializing in custom designs, niche aphresis kits, or rapid prototyping for novel primary blood collection system concepts. The distinction often lies in their capacity, their level of in-house design and regulatory support, and their expertise in handling specific film types or integrating proprietary components like sterile docking ports.
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47 companies nationwide
Based in Cheyenne, WY, AccuPoint Injection Instruments manufactures and supplies quality medical injection products. Specializing in blood transfusion bags, arterial blood collection syringes, and hemodialysis dialysis catheter kits, the company holds CE, ISO, and USFDA approvals for its products.
APlasticBag.com manufactures tamper-evident blood transport bags and other custom plastic bags. Based in Riverside, CA, they handle extrusion, printing, and converting in-house. The company offers rapid production and shipping, with rush orders available within 1-7 business days for various custom plastic bag needs.
ASH Industries provides engineered plastic, metal, and silicone injection molding services, including in-house tooling. The company offers medical molding capabilities from an ISO Class 7 cleanroom and holds ISO 13485 certification. With a biomedical engineer on staff, they produce custom components for the medical device industry.
Cerus Corporation develops and supplies vital technologies and pathogen-protected blood components, including the INTERCEPT® Blood System for Platelets and Plasma. The company partners with blood centers and hospitals, providing solutions like pathogen-reduced cryoprecipitated fibrinogen complex. Cerus focuses on securing global blood safety by enabling the provision of safe blood for patients.
Based in Placentia, CA, Cleanroom Film & Bags (CFB) manufactures ISO 9001:2015 certified cleanroom bags and sterile packaging solutions. They specialize in custom medical, electronic, and aerospace packaging, using pure, virgin resins with a 'No Regrind Guarantee' in their vertically integrated facilities.
Based in Menlo Park, CA, Control Plastics specializes in custom plastic injection molding, components, and cleanroom assembly for the medical device industry. They provide prototyping and production services for plastic and metal parts, holding ISO 13485 and FDA registration for quality manufacturing.
Based in Boston, MA, Creation Technologies provides contract manufacturing and engineering solutions for the medical and life sciences industry. The company operates multiple FDA-registered manufacturing units across the U.S. supporting new product introduction and aftermarket services for complex medical devices and components.
Dravon Medical manufactures high-performance custom fluid bags for various medical applications. The company is ISO 13485 certified and operates under FDA-regulated manufacturing processes, specializing in custom medical bag solutions. All products are proudly made in the USA, ensuring quality and compliance for diverse client needs.
Based in Ames, IA, Genesis Plastics Welding is an ISO 13485-certified contract manufacturer of custom single-use medical devices. They specialize in producing medical fluid bags, including blood bags, using advanced plastics welding services. The company delivers high-precision and quality solutions for critical healthcare industry applications.
Great American Packaging, based in Vernon, CA, manufactures custom poly bags and film. Serving food, ice, medical, and consumer sectors, they adhere to strict quality standards, including FDA- and USDA-grade virgin resin and IFS PACsecure certification. They control all production, ensuring traceability for food and drug safety.
Based in Holliston, MA, HCT Solutions (featuring Douglas Medical Products) manufactures and distributes medical devices. They provide sterile, PVC-free polyolefin fluid bags with multi-port configurations, produced by Douglas Medical Products. HCT specializes in products for pharmacy, vascular access, and critical care, focusing on patient safety and operational efficiency.
Based in Santa Ana, CA, HedoneUsa specializes in the design, production, and distribution of medical devices. Their offerings include Ethylene Oxide gas sterilizers, acidic scrubbers, and surgical suture production. The company also provides a range of medical consumables and disposables, specifically high-quality blood bags for safe collection, storage, and transfusion.
Based in San Clemente, CA, ICU Medical manufactures medical devices for infusion therapy and pharmacy preparation. They produce advanced non-PVC, non-DEHP, non-latex IV containers, including the Fleboflex, designed for safe fluid delivery. Their comprehensive product line supports clinicians in streamlining workflows and reducing risks.
Based in Boca Raton, FL, Instant Systems manufactures high-quality cryopreservation bags from medical-grade materials. These specialized bags are engineered for extreme conditions, maintaining flexibility and preventing cracking to ensure reliable performance for biological material storage, including applications similar to blood bags.
JMS North America Corporation manufactures high-quality blood bags and other medical devices for the healthcare industry. Their manufacturing facilities adhere to stringent quality standards, including ISO13485, ensuring reliable and superior products for blood and cell processing.
Kawasumi America, based in Tampa, FL, is an international manufacturer specializing in infusion sets and blood drawing sets. The company provides a range of safe, disposable blood drawing equipment, serving the medical industry with essential devices for blood collection and transfusion applications.
Based in Irvine, CA, KB Medical Group Inc. manufactures a comprehensive range of blood bag options, including single, double, triple, and quadruple configurations. They also provide safety blood collection sets, needles, and needle holders, along with enteral and specimen collection products for medical facilities.
Kentec Medical, based in Irvine, CA, manufactures specialized medical devices for blood management. They produce plasma collection bags, including 1L jumbo bags and collection sets with satellite bags for automated apheresis. Their product range also includes sizes tailored for neonates, infants, and pediatric patients.
Based in Duluth, GA, Macopharma is a major player in the blood industry, providing a wide range of blood collection systems and processing solutions. They offer expertise in disposables, equipment, and software, focusing on innovations for cord blood, leukodepletion, phlebotomy, and platelet solutions to support healthcare professionals.
Based in Austin, TX, OriGen Biomedical is a global medical device manufacturer. The company specializes in producing closed-system cell culture and cryopreservation bags, along with ECMO products. They provide essential solutions for biological fluid management and preservation, serving medical and biotechnology industries.
Based in Camarillo, CA, SaniSure is a global manufacturer of single-use technologies for bioprocessing and advanced therapies. The company provides custom assemblies, engineered components, and solutions for complex flow paths, closed systems, and aseptic applications, including single-use bags and bottles.
Based in San Jose, CA, Sanmina Corporation designs, builds, and services complete medical systems, equipment, and products. They specialize in manufacturing a broad range of laboratory and point-of-use blood diagnostics. This includes capabilities for critical blood-related medical device production, offering comprehensive manufacturing solutions for the healthcare sector.
ThermoGenesis develops automated technologies for cell-based therapeutics and bioprocessing, offering advanced cell processing systems and devices. They provide specialized freezing bags and 3D bag sets for biobanking and cellular storage. Their solutions support every stage of cell therapy workflow, from lab to clinical-grade manufacturing.
Based in Riverside, CA, Trademark Plastics (TPI) is a contract manufacturer specializing in custom plastic injection molding for the healthcare industry. Their 100,000 sq. ft. facility includes two Class 8 cleanrooms and operates 51 injection molding machines. TPI delivers high-precision, ISO 13485 certified solutions for medical components.
Tru-Form Plastics provides custom thermoforming solutions, including sterile barriers and medical device packaging for the medical industry. With AS9100 and ISO 9001:2015 certifications, they offer full-service support from prototyping and in-house tooling to assembly and finishing.
Based in Monrovia, CA, Vinyl Technology provides contract manufacturing for medical devices, specializing in inflatable medical bladders and custom-sewn components. They produce items like blood pressure cuffs, inflatable mattresses, and chair cushions, applying their vinyl technology expertise to various medical applications.
Fresenius Kabi is a company at the forefront of the transfusion industry, pioneering blood-collection technologies. They provide products and solutions essential for blood collection processes, including manufacturing components like blood bags, and contribute to ensuring safe and effective transfusions.
Infusion Concepts Inc. based in Stone Mountain, GA, manufactures specialized medical fluid bags, including blood, plasma, and cryopreservation bags. As an ISO 13485:2016 certified and FDA registered facility, the company provides GMP-compliant manufacturing for standard and custom medical device solutions.
Miltenyi Biotec is a global biotechnology company with a significant US presence in Auburn, CA, manufacturing products for cell and gene therapy, research, and clinical applications. They produce medical devices such as CryoMACS Freezing Bags, which are specialized bags for the cryopreservation of cells and biological samples, manufactured under ISO 13485 quality systems.
Based in Trevor, WI, Vonco Products, LLC specializes in the custom development and contract manufacturing of medical devices, components, and flexible fluid packaging. They transform fluid bag ideas from concept to commercialization, ensuring high standards for health and safety.
Based in Winston-Salem, NC, Charter Medical manufactures single-use fluid transfer bags and DEHP-free bags for the medical device industry. They specialize in filtration components and bag technology for blood management, bioprocessing, and cell & gene therapy applications.
Command Medical Products is a contract manufacturer providing medical device assembly and packaging for the Medical and Life Science Industries. Specializing in sterile single-use devices, they offer RF welding for diverse bag configurations, tube extrusion, and sterilization management. The company serves markets such as bioprocessing, blood, and cardiovascular.
Based in Norcross, GA, C-P Flexible Packaging manufactures FDA-compliant cleanroom bags for medical equipment and other critical applications. Specializing in sealed cleanroom medical bags, their products are produced in the USA, providing specialized flexible packaging solutions for industries with stringent cleanliness standards.
Based in New Carlisle, OH, California Medical Innovations manufactures high-quality dip molding products and services. The company specializes in providing innovative solutions for various applications, directly serving the medical industry with custom plastic components and products.
Based in Fremont, CA, Evolve manufactures a variety of sterile medical devices within its ISO 14644 class 7 and class 8 clean rooms. The company handles the entire manufacturing process, offering specialized capabilities suitable for medical products requiring stringent sterility and quality controls.
Based in Neptune City, NJ, Flexcraft is a full-service custom blow molding and plastic injection molding manufacturer. With over 50 years of experience, the company produces plastic vials and blood bags using advanced blow molding technology, offering dependable solutions for customers.
Plastikon Industries, Inc. specializes in plastic injection molding and Blow/Fill/Seal (BFS) aseptic filling for the healthcare and pharmaceutical industries. This global manufacturer utilizes medical-grade plastics to produce various components. They offer full-service capabilities, including prototyping, mold design, and clean room environments.
Based in Apex, NC, Polyzen develops and manufactures customized polymer-based materials, films, components, and assemblies for the medical device industry. They specialize in medical film extrusion for devices and delivery systems, offering material formulation, processing, product development, and device manufacturing services.
Spectrum Plastics Group manufactures single-use, multi-port medical bags for preparing, storing, and transporting various fluids and biopharmaceutical solutions. With extensive medical device experience, the company provides comprehensive manufacturing solutions from design to final product. They also produce extruded tubing, catheter technologies, and medical balloons.
Terumo Blood and Cell Technologies is a leading medical technology company specializing in innovative solutions for blood and cell processing. They directly manufacture a range of blood collection and processing products, including whole blood bags, apheresis systems, and automated blood component separators, serving blood centers and hospitals.
Transcendia specializes in film manufacturing and converting, producing pharmaceutical-grade film and medical-grade bags. They engineer products to exact specifications for various demanding applications. The company serves the healthcare industry with high-quality film and bag solutions.
Based in Dover, NH, Welch Fluorocarbon specializes in thermoforming and heat-sealing high-performance films for medical devices. They offer custom design, prototyping, and cleanroom assembly for components like Teflon™ bags and FEP overwrap bags, operating under ISO 13485 standards.
Based in Bethlehem, PA, B. Braun Medical Inc. provides comprehensive medical products, including advanced blood collection systems. They specialize in manufacturing solutions for whole blood and blood component collection and processing, supporting 'bag-to-patient' needs for healthcare providers across the United States.
Cytiva manufactures specialized bags for cord blood products, including specific freezing bags designed for cell therapy processing systems. They provide essential containment solutions for biological materials, offering products like the Cord Blood 791-05 Freezing Bag, which are readily available in stock.
Based in Irvine, CA, KS Group specializes in Class 7 and 8 Clean Room Insert Molding Services. They produce a variety of plastic parts and products utilizing advanced manufacturing techniques. Their expertise makes them a suitable supplier for medical device components requiring stringent clean room environments, including those used in blood bag manufacturing.
Amcor manufactures specialized packaging solutions, including 3-sided bags, bag-on-roll, and bag-in-box. They utilize high clarity films with excellent puncture and abrasion resistance. Products are suitable for demanding sterilization methods like E-beam and Gamma, making them ideal for critical medical and pharmaceutical applications, such as blood bags.
Thermo Fisher Scientific, based in Carlsbad, CA, manufactures single-use bioprocess containers for sterile biopharmaceutical liquid-handling. The company also provides a wide array of high-performance antibodies and scientific tools, enabling innovation across various life science research and industrial applications.
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The film material is critical. Traditional PVC bags, while cost-effective, require plasticizers (like DEHP) which can leach into blood components, raising concerns for vulnerable patients. Non-PVC polyolefin films offer an alternative, reducing leachables and often improving gas permeability, which can extend the viability of certain blood components like platelets. However, non-PVC films require specialized welding and sterilization techniques, and their gas exchange properties must be carefully matched to the specific blood component being stored to optimize shelf life and maintain physiological function.
Integrating a new additive solution requires rigorous evaluation. Key considerations include: 1) Biocompatibility: The solution must be compatible with blood cells and the bag material itself, ensuring no adverse reactions or degradation. 2) Stability: The additive solution must remain stable within the bag over its entire shelf life, and its interaction with the bag material should not lead to leachables or particulate formation. 3) Regulatory Impact: A new additive or a change in formulation often necessitates new regulatory submissions (e.g., FDA 510(k) modification or new application), requiring extensive documentation and testing. 4) Manufacturing Process: Ensure the manufacturer has aseptic filling capabilities and validation protocols to prevent contamination and ensure accurate dosing of the solution within the bag.
The validation pathway for a custom blood bag is exhaustive, starting with Design Control under ISO 13485. This involves a robust risk assessment, materials qualification (including USP Class VI testing), and supplier qualification for all components, like the leukoreduction filter media. Next, Process Validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing steps like RF welding and assembly in a cleanroom environment. Crucially, it includes sterility validation (bioburden, endotoxin, and sterilization cycle validation), package integrity testing, and comprehensive shelf-life stability studies to confirm the product's integrity and functionality over time. Finally, the entire device, including the integrated filter, must meet its intended performance specifications (e.g., leukocyte reduction efficiency) and obtain necessary regulatory clearances like FDA 510(k).