Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, Supplier to Medical Manufacturers
Markets Supplied: Worldwide
is a world class producer of disposable medical devices for the OEM market, and a provider of innovative solutions for specialized flow control needs. Elcam offers an extensive range of products in order to add efficiencies to our customers’ sourcing processes while providing superior customer service. Elcam Medical works with the medical industry’s leading companies, with particular expertise in the areas of Fluid Management, IV Therapy, Vital Sign Monitoring, Interventional Cardiology & Radiology, Dialysis and Drug Delivery.
IV Therapy and Anesthesia
Elcam Medical is your source for the widest variety of IV Therapy & Anesthesia devices including our renowned Elcam Stopcocks brand. Providing differentiating, innovative solutions along with the everyday devices needed for any IV or Anesthesia sets, Elcam leads the effort to maximize patient and caregiver safety.
– Safety in the Details
Elcam Medical strives to provide the building blocks for safer and more effective medical fluid management in acute settings.
- Improving safety with contamination prevention
The Marvelous™ (MRVLS) is a closed-swabbable stopcock with a proprietary flow channel feature specifically designed for IV administration and pressure monitoring applications, assuring minimal residual volume. The Marvelous™ allows to automatically flush drugs and blood residuals, without the need to expose the system to the open air, with minimal manual steps, and with maximal compliance to best practices.
- Additional protection against disconnections
Elcam's Safe2 Rotator™ spinning lock feature, available in both stand-alone connector for tube bonding and stopcock configurations can provide a small yet significant contribution to the efforts of keeping medical teams and patients safe. It was designed to ensure secured connection along the entire treatment so critical to safe and effective IV therapy, The Safe2 Rotator™ and its 360° rotational flexibility can help prevent accidental disconnections, reduce tube kinks and twists in the tubing set, and facilitate convenient approach to injection and sampling ports.
The Safe2 Rotator™ Stopcock configuration is CE approved for non-sterile products and 510(k) cleared.
Elcam Medical has developed a new SafeT™ Stopcocks and Connectors series of Lipid Resistant devices made of Eastmam TritanTM copolyester providing increased safety in drug therapy through protection for patients and care givers from connectors’ erosion by lipids and other aggressive drugs.
The potential for Environmental Stress Cracking (ESC) is a well-known concern when plastics are used in medical device components. The use of lipids and other aggressive solutions may initiate microcracks in the polymer and compromise the material’s mechanical integrity. This event may lead to serious patient injury and also jeopardize medical personnel.
Tritan™ is a new-generation copolyester that has been shown in bench-top testing to be resistant to a large spectrum of medical fluids such as oncology drugs, lipids, drug carrier solvents, and nutrition which minimizes the risk of cracking and increases patient safety.
Tritan™ is also BPA-free, and it is additionally known for its toughness, low residual stresses, and color stability post sterilization.
This new line provides our OEM customers with tools to mitigate lipid and drug related hazards during fluid administration. It will also enable Elcam to offer a BPA-free line of components for customers who are concerned with emerging legislation.
Promoting patient safety by preventing misconnections
Luer connector misconnections are an under-recognized but common dangerous events. The objective of the new ISO 80369 Standards that are gradually being implemented is to prevent these adverse events so crucial to patient safety.
Elcam Medical has taken a proactive approach to the implementation of the new ISO 80369 standard regulations and is in the process of implementing those standard drafts well in advance allowing our customers to prepare themselves for the upcoming change.
The ISO 80369-3 Standard, Enteral Feeding applications
Elcam Medical has launched a new Enteral Feeding Stopcock that includes the Enfit connector design that fully complies with the new standard.
ISO 80369-6 Standard, Neuraxial applications
Among relevant devices that will be affected by this new standard are epidural devices, pain pumps, and their administration sets, regional anesthesia catheters, and needles.
Elcam’s new Neuraxial (NRFit) stopcock is fully compliant with the new ISO 80369-6 standard. The NRFit Stopckocs completed the development stage but have not yet been cleared for marketing by regulatory authorities. They are available for sale as non-sterile bulk devices and It is the responsibility of the customer to obtain regulatory authorization prior to their commercial distribution as a final device.
Elcam's also offers ISO 80369-6 connectors that include both male and female versions. The connectors are made of clear Tritan™.
ISO 80369-7 Standard, Connectors for intravascular or hypodermic applications.
Elcam Medical’s luers comply with ISO 80369-7:2016/2017. Elcam Medical Italy luers are considered as well to comply with the ISO 80369-7:2016/2017. Some of Elcam Italy’s ISO 80369-7 luers are also available with Tritan™, renowned for its improved heat and chemical resistance properties.
ISO/DIS 80369-2 Standard, Respiratory applications
Recently, the breathing systems connectors’ standard has been removed by the ISO organization and its final destiny is still ambiguous. Nonetheless, Elcam is closely monitoring the developments in this area, in order to be ready with compatible connectors on time. – enhancing anesthesia administration
Enhance anesthesia administration safety with Safeport Manifolds™
Infusion of anesthesia during operation is involved with enormous responsibility, requires multiple skills and focus. By enhancing the Safeport™ Manifold into your solutions, you will be able to create ease and simplify the anesthesiologists' work during procedures, by giving them the following benefits:
- Minimize the likelihood of inadvertent injection
- Minimize the risk of inadvertent drugs admixture
- Minimize the risk of backflow
- Provide clear and visible control over flow direction and fluid path
The Safeport™ Manifold is also available as a closed system with integrated swabbable Luer Activated Valves, for minimizing of leakages and exposure to contamination.
Elcam Stopcocks™ is Elcam's sub brand enhancing our leadership in this field and our 35 years of experience and the expertise in developing and manufacturing medical disposable stopcocks, defined by the benefits professionals value so much:
Elcam Stopcocks™ is renowned for the broadest range of stopcocks and manifolds in the industry, offering unmatched configurations, flow rates, handle styles and variety of high performance materials. Our products can be customized to meet your specific needs.
Innovation - commitment to safety
As a worldwide leader in OEM stopcocks, Elcam continuously strives to create better solutions to real flow control safety problems by combining clinical and engineering knowledge acquired over the years. The Elcam Stopcock road map is a tool we use to assure continuous improvement of our stopcocks – from lipid resistance and BPA-free materials through solutions for secured connections and up to infection control. Our innovative Marvelous™ (MRVLS) stopcock developed to enhance patient and caregiver safety is an excellent example, emphasizing the competitive advantage and differentiation you gain when selecting Elcam Stopcocks™.
Elcam Medical offers its expertise in supplying stopcocks as cost effective sub-assemblies.
Your specified tubing can be bond to one of our stopcocks using either hand or automated processes.We utilize both solvent and UV bonding methods. Stopcock can also be provided with Tube fitment - a Stopcock having either its male or female port designed to accept a tube bond tubing pocket. Available in a variety of dimensions.
Is the Elcam brand for sourcing your everyday needs in medical fluid control applications as IV therapy, anesthesia, and blood lines for dialysis. This Elcam brand offers a wide range of components whether it is a drip chamber, an IV filter, or a simple clamp providing our customers one source for all their needs in the area of disopsable medical flow control components.
Continuous Pressure Monitoring, is a mission-critical application. Here you cannot allow your product, whether an Arterial Line, Central Venous Pressure line, or other pressure monitoring products, to fail.
Elcam's Disposable Integrated Pressure Transducer (Sense-IT™), is the first and only fully integrated pressure transducer. This integration provides you with the reliability and robustness no other transducer can provide, along with the space saving and ease of use so much needed in Intensive Care Units and Operating Rooms.
As in many of Elcam's products, Elcam's DIPT is also adaptable in dimensions such as tube fitments and cables connectors, to perfectly meet your requirements.
Sometimes you have an application where you need to maintain a very low flow. It might be keeping the vein open, or maybe you are producing your own Pressure Transducer and you are looking for a stand-alone flush device as a complimentary to your product line.
Leveraged by Elcam's years of experience in pressure monitoring, Elcam's flush Device is just the right solution for such applications. It allows you to be competitive and flexible, exactly where you need to be.
Interventional Cardiology & Radiology
Elcam's specially designed stopcocks for Interventional applications:
High Pressure Stopcock - Withstands 1200 psi
Featuring our ergonomically designed High Pressure (HP) handle with a high profile and finger-contoured arm grip to facilitate smooth and comfortable rotation. The rounded edges of the handle protect the physician’s gloves and allow maximum efficiency. The product is available in 1 and 3 way configurations with a HP rotator or a standard swivel luer lock nut. The 3-way stopcocks are available with "ON" and "OFF" handles .
Medium Pressure stopcock - Withstands 500 psi
Allows a cost effective solution with your exact pressure requirements for interventional products .
High Pressure Manifold - Withstands 750 psi
Elcam’s HP Manifolds include our newly designed ergonomic handles that improve ease of use and convenience. Available with 2 or 3 gangs with HP rotators.
Elcam Medical’s Interventional Accessories:
- Hemostasis Y for PTCA applications
Elcam’s Y-Click audible-click design offers a true one-handed, ergonomic hemostasis-Y that withstands pressures up to 600 psi, one of the highest pressure ratings of these types of devices. Y-Click also offers a self-closing mechanism to ensure minimization of blood loss during the procedure.
- Self-sealing Hemostatic Flow Valve
H- Flow is ideal for angiographic catheters requiring hemostatic flow control products for safe handling of guidewires. H- Flow Valve is a luer activated self-sealing device that can withstand pressures up to 1200 psi.
Elcam’s capabilties include:
- High-volume precision injection molding
- High-speed automated assembly
- Laser drilling
- LIM molding
- Hand assembly
- Design & development
- Ultrasonic welding
- Design & development
- Regulatory and QA
- Class 100K cleanrooms
- Custom designs
- Subassembly services
- Tube assembly
- GMP Regulation
- ISO 13485
- OHSAS 18001:2007
- All materials used pass ISO 10993-1 and USP XXII Class V requirements
- Most Elcam products are 510(k) cleared
Elcam is an innovative customer-centric, full-service partner with capabilities ranging from design through manufacturing with particular expertise in high volume precision molding, high speed assembly and laser applications.
Our customers include large to small medical device and pharmaceutical companies worldwide. For over 40 years, Elcam consistently provides high quality products at competitive prices and delivered on time. Elcam maintains its leadership position by continuing to innovate and work closely with its partners.
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For more information contact Elcam Medical, Inc.