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Elcam Medical Inc. Company Profile

 

http://www.elcam-medical.com
E: info@elcam-medical.com
T: 201/457-1120
F: 201/457-1125

Address
2 University Plaza, Hackensack, New Jersey, 07601, United States
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Qualifications: ISO 13485, ISO 9001, Supplier to Medical Manufacturers

Markets Supplied: Worldwide

 

Elcam Medical 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 Medical works ...

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Elcam Medical 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 Medical works with the medical industry’s leading companies, with particular expertise in the areas of Fluid Management, IV Therapy, Vital Sign Monitoring, Hemodialysis, and Drug Delivery.

The Elcam Medical Advantage
One-Stop Shop:
 Elcam now offers the broadest range of products from infusion therapy and patient monitoring adding efficiencies to our customers’ sourcing processes.

Unparalleled Customer Experience:
Providing superior customer service and giving our customers a seamless integration of our devices and components into their final products.

Customer Driven Innovation:
Differentiating solutions, based on true customer needs.

In addition, Elcam offers:
Clinical know-how expertise
State of the art design and manufacturing capabilities
Consistent quality for over 40 years
Global presence
On-time delivery

has also created three highly focused sub-brands reflecting Elcam’s leadership:


Is the brand enhancing Elcam’s leadership and focus in the stopcock line of products. Our stopcocks can be customized to meet your specific needs, and they are delivered with the unique Elcam customer experience.


Is the Elcam brand for sourcing your everyday needs in medical control applications for IV therapy, anesthesia, patient monitoring, and hemodialysis. This Elcam brand offers a wide range of devices whether it is a drip chamber, an IV filter, or a simple clamp. Lucomed Medical Products offers these products in any size and quantity with excellent customer service.

IV Therapy and Anesthesia

IV Therapy & Anesthesia

Elcam's Stopcocks and Manifolds are designed for worldwide markets and meet all standards according to ISO 594 and DIN 13090. Elcam's Stopcocks and Manifolds are available in 1,2,3,4 way configurations with various handle styles and colors to match different required application. In addition, the body can be in polycarbonate, polysulfone, antimicrobial, and in lipid resistant material. Elcam offers standard and high flow options. Products can be supplied in materials suitable for ETO, Gamma and E-Beam irradiation and/or lipid based admixtures upon request.

Customization - Our Products can be customized according to your needs. Elcam offers its expertise, state of the art equipment and production capacity for custom made products for you. Our team will listen to your specific request and together with the experience of our R&D Team we will be able to recommend and create a unique product to best meet your customer's needs

Stopcock with tube assembly - Elcam Medical offers its expertise in supplying stopcocks as cost effective sub-assemblies.

Elcam can bond your specified tubing 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.

Elcam Medical strives to provide the building blocks for safer and more effective medical fluid management in acute settings. Elcam Medical widens its Safety Is In The Details campaign with new and innovative components.

Enhancing patient and caregiver safety with new Tritan™ integrated products
It is a well-established fact that when plastic is exposed to a chemical environment, the material may undergo numerous changes. If the plastic is under stress, it may also experience environmental stress cracking (ESC) , which is defined as the crazing and cracking that may occur when plastic under  tensile stress is exposed to aggressive chemicals. The potential for environmental stress cracking is of paramount concern when plastics are used in medical device components such as luers and stopcocks. In these applications, chemicals such as isopropanol and lipid solutions can initiate crazes—microcracks bridged by polymer fibrils—in the plastic and seriously compromise its mechanical integrity. Such an event can lead to serious patient injury or even death due to several adverse events: medication discontinuation, bleeding, air ingress and air embolism, dehydration, bacteria ingress and consequent blood stream infection.  Additionally ESC also jeopardizes medical teams that may come in contact with blood and potentially aggressive drugs leaking from the crazes and cracks.

Nowadays there are raw materials that have shown increased durability to ESC and when it comes to safety in medical care, especially when aggressive agents like chemotherapeutics and lipids are involved, it is important to take into consideration the proper selection of the medical plastic.

Eastman Tritan™ is a new-generation copolyester that has been shown in laboratory settings 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.

Elcam Medical's new Tritan™ Integrated Stopcocks are already available and Connectors, that will be available in Q3, provide protection to patients and care givers from lipid and drug related connectors' erosion.

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. 

Elcam is 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 2016 Standard, Neuraxial applications
This standard will eventually be adopted by the medical device industry following a new Sate of California legislation requiring, from January 2017, the use of an epidural connector that would not fit into a connector other than the type for which it is intended.  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.  This line of connectors will include both male and female versions and also vented and non-vented caps for both connectors.  The connectors will be made of the clear Tritan™ material from Eastman, which was shown in laboratory tests to have improved lipid resistance, high clarity, and the BPA-free benefit.

Elcam intends to launch an ISO 80369-6 2016 male Safe2Rotate (S2R) version of connectors for minimizing disconnections and providing another safety layer for neuraxil fluid administration.

ISO 80369-7 2016 Standard, Intravascular (IV) and Hypodermic applications for connectors with 6% (luer) taper
The Elcam ISO/FDIS 80369-7 Connectrs will also address the need of drug resistance connectivity by cooperating with Eastman in implementing the well-known Tritan™ material with its properties of oncology drugs and lipid resistance and chemical compatibility and durability.

ISO/DIS 80369-2 Standard, Respiratory applications
Recently, the breathing systems connectors’ standard has been removed by the ISO organization; however, its final destiny is still ambiguous.  Nonetheless, Elcam has started developing connectors that will comply with this standard as part of its Patient Safety Roadmap.  During 2017, Elcam launch a series of connectors which comply with ISO/DIS 80369-2.

Elcam Medical's Safe2Rotator

The Safe2Rotator is a rotator with a spin-lock feature that provides rotational flexibility to the distal part of the stopcock set.  This is currently available for standard bore products and will be available for large bore products in the near future.  The Safe2 Rotator is easy to use and provides an extra layer of protection in terms of accidental disconnection of medical tubing, including IV or arterial tubing.  In addition, tubing kinks and twists as well as connection breakage are minimized.  The Safe2 Rotator is CE approved, Premarket notification (510K) was submitted.

Specialized Stopcocks - Fighting infections with the Safe-T™ Line

It is a known and documented (1,2) in the medical industry that standard stopcocks are suspected as being contaminated after several hours of clinical use.

At Elcam we prefer confronting this head on. Our Safe-T™ line of stopcocks provide you with a range of solutions for minimizing these contaminations:

C - Safe-T™ – a Closed Stopcock, integrated with a Swabable Luer Activated Valve, allowing for maintenance of a fully closed system through the entire use of the stopcock, as well as eliminating needle stick injuries when using a stopcock

M – Safe (Marvelous Stopcock™) – Named after the abbreviation of Minimal Residual Volume Luer Activated Swabbable Stopcock, it is a closed stopcock with a proprietary flow channel feature, allowing your customers to automatically flush drugs and blood residuals, without the need to expose the system to the open air, and assuring minimal residual volume

B-Safe-T™ – a standard stopcock configuration, impregnated with Silver Ions, which are well known to be antimicrobial. The efficacy of these Silver Ions in a stopcock has been shown in-vitro in variety of lab tests.

Double Safe-T™ – a "Closed Stopcock" as in the C- Safe-T™, while the stopcock material is also impregnated with Silver Ions, providing a double barrier against contamination.

Triple Safe-T™ – A "Closed Stopcock" impregnated with Silver Ions, integrated with Elcam's unique Marvelous™ feature, providing a triple barrier against contamination.

1 O’Grady NP. Et al. Guidelines for the Prevention of Intravascular Catheter-Related Infections. CDC report, August 9, 2002/51 (RR10); 1-26.
2 Loftus R.W, Koff M.D: Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep; 109(3):399-407.

Enhance anesthesia administration safety with Safeport Manifolds™

Unleash the strength of your specialty solutions aimed for the anesthesia market with Elcam's

Safeport Manifold™.

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
  • Clear and visible control over flow direction and fluid path

The Safeport Manifold™ may also come as a closed system with an integrated swabable Luer Activated Valve, for minimizing of leakages and exposure to contamination

Slit Septum needleless line - The alternative

Elcam's slit septum needleless solutions are your perfect fit for those looking for an alternative needleless system.

The line presents a wide range of needless slit septum access sites and cannula for safe and easy access.

All devices are compatible with all common fluids used in IV Therapy, anesthesia and enteral feeding and can be sterilized in both Gama and ETO and are latex free.

Lucomed Medical Products™

When sourcing for medical devices, you need a full range of products from a source you can count on, someone who can support you in every situation.

Lucomed Medical Products™ is the Elcam Brand for sourcing your everyday needs of devices for your IV Therapy and anesthesia sets. Lucomed offers you the widest range of devices available for you from only one source, whether it is a drip chamber, an IV filter or a clamp. At Lucomed you can find it in any size and any quantity.

At Lucomed, we are well aware that delivering products is not enough. You need excellent service and support, from delivery time to design changes, from biocompatibility to optimizing the tube bonding processes. This is exactly the level of customer experience you will find when sourcing from Lucomed Medical Products.

3 Karchmer TB, Cook EM, Palavecino E, et al. Needleless valve ports may be associated with a high rate of catheter-related bloodstream infection [abstract]. In: Program of the 15thAnnual Meeting of the Society for Healthcare Epidemiology of America (LosAngeles, CA). Washington, DC: Society for Healthcare Epidemiology of America, 2005.307
4 Jarvis WR, Murphy C, Hall KK, et al. Health care-associated bloodstream infections associated with negative- or positive-pressure or displacement mechanical valve needleless connectors. Clin Infect Dis 2009; 49:1821–7.

Patient Monitoring

General

Elcam DIPT - Disposable Pressure Transducer

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 DIPT, 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.

Multi-Channel Wireless System for DPT

Add value to grow your business. Allow your customers in the Operating Room and Intensive Care Unit to be more productive and cost effective and provide them the freedom to perform. Elcam's Multichannel Wireless System for Pressure Monitoring allows you all the above and more:

  • Reduces bedside cables' "spaghetti"
  • Enables an easy and quick transfer of patients, avoiding the need to disconnect and re-connect cables
  • Safe matching eliminates cross-signaling between patients
  • Reduces chances of faults due to defective cables
  • Eliminates cable contamination
  • Enables calibration from a DPT without having to approach the monitor

Elcam's Multi-Channel Wireless System provides you with the competitive, differentiating advantage you need to grow your pressure monitoring line of business.

Currently compatible with Philips /HP, GE, Datex, and Drager- Siemens monitors and Elcam's DIPT/DPT transducers

Flush device

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

General
 Elcam's interventional accessories, are focused on ease of use, something which is no longer considered a "nice to have". This ease of use will deliver you the market visibility you desire, while the level of service and flexibility we provide, will allow you a seamless integration of our devices and their unique benefit into your products and portfolio.

Y-Click - Y C o n n e c t o r f o r P T C A A p p l i c a t i o n
A blood-less working area is one of the important properties of the CathLab.
 Elcam’s Y-Click connector provides you with exactly that: an easy-to-use hemostatic device for both diagnostic and interventional procedures. This ergonomically designed device significantly reduces the blood loss during interventional procedures. The Y-Click further improves the physician's performances with its most unique advantages: a self- closing mechanism, one handed operation, and withstands high pressure injections up to 600 psi.

H- Flow valve - S e l f S e a l i n g H a e m o s t a t i c F l o w V a l v e
 Angiographic catheters require hemostatic flow control devices for safe handling of guide wires and flushing with heparin and saline in order to avoid in-catheter clotting and potential emboli. Elcam’s H-Flow Valve is a luer activated self-sealing device which allows convenient placement and positioning of all common guide wires and micro catheters through an angiographic catheter with no leakage.

It withstands repeated high pressure injections up to 1200 psi

Elcam's specially designed stopcocks for Interventional applications:

High Pressure Stopcock - Withstands 1200 psi
The product has a new ergonomically designed ErgoNess 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
A Medium Pressure Stopcock with 500 psi durability allowing a cost effective solution with your exact pressure requirements for interventional products.

High Pressure Manifold - Withstands 500 psi
Elcam’s High Pressure Manifolds are designed to withstand 600 psi pressure and include our newly designed ergonomic handles that improve ease of use and convenience. It is available with 2 or 3 gangs with HP rotators.

Premium High Pressure Manifold – Withstand 800 psi
Elcam’s High Pressure Manifolds are designed to withstand higher pressure durability to fit the additional needs of different interventional applications.

Elcam’s capabilties include:

  • High-volume precision injection molding
  • High-speed automated assembly
  • Laser drilling
  • LIM molding
  • Soldering
  • Packaging
  • Hand assembly
  • Design & development
  • Ultrasonic welding
  • Regulatory and QA
  • Class 100K cleanrooms
  • Custom designs
  • Subassembly services
  • Tube assembly
Quality

Compliant with:

  • GMP Regulation
  • ISO 9001 and 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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Elcam Medical Inc.

http://www.elcam-medical.com
E: info@elcam-medical.com
T: 201/457-1120
F: 201/457-1125

Address
2 University Plaza, Hackensack, New Jersey, 07601, United States
View map

 
 
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