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January 20, 2005

Kawasumi America Recieves Medical Device License from Health Canada to Market Medical Disposables

Kawasumi Laboratories America, Inc. announced today the receipt of Class II medical device licenses from Health Canada, enabling the company to commercially sell and distribute their Kawasumi branded oncology, hematology and hemodialysis products in the Canadian marketplace.

Tampa, FL (PRWEB) January 20, 2005 -- Kawasumi Laboratories America, Inc. has announced the receipt of Class II medical device licenses from Health Canada, enabling the company to commercially sell and distribute their Kawasumi branded oncology, hematology and hemodialysis products in the Canadian marketplace.

"Kawasumi is pleased to receive this medical device licensure from Health Canada as it supports our strategic direction for expanding our sales and market coverage. This demonstrates that we are truly growing our global company," said Ron Lamb, president of Kawasumi Laboratories America.

Scott Horowitz, marketing manager for Kawasumi added, "we’re excited to offer the Canadian market the same safety products we currently offer in the U.S., which include non-DEHP gravity I.V. sets and our newest K-Shield™ needle safety technology. Just as in the U.S. market, patient safety has become a such a growing concern that Canadian health care facilities and clinicians are now looking for safer IV sets and needle stick prevention alternatives."

Kawasumi’s products are manufactured in accordance with ISO 13485:1996 and the company’s quality systems have been certified by TUV America. Kawasumi’s Class II medical device licenses will cover a portfolio of products including the following:

Non-DEHP Gravity I.V. Administration Sets (License #66630)
Non-DEHP sets are for both fluid administration of chemotherapy and routine infusion applications. Key pharmaceutical applications include Taxol, Taxotere, Remicade and Erbitux. Gravity IV sets are available in both needleless access and standard injection sites as well as filtered (.22 micron) and non filtered sets.

Port Access Infusion Sets (License #66633)
Port access infusion sets are used for accessing patients that have surgically implanted subcutaneous ports. Port access infusion sets have a non-DEHP fluid path and the needle hub and wing design offers secure and accurate needle placement. As an added measure of safety, a K-Shield needle safety accessory device is available.

K-Shield Winged Blood Collection Sets and Small Vein Infusion Sets (License #66631 & #66634)
Blood collection sets ("butterflies") with multiple sample luer adapter and small vein infusion sets are available in both K-Shield safety and non-safety versions. K-Shield provides a safe collection environment for both clinician and patient. The fast and easy to use integrated K-Shield safety device reduces accidental needle sticks. Equally important, the needle point is immediately covered upon removal from venipuncture site, ensuring a clinician’s confidence in safety.

Blood Drawing Kits and Phlebotomy Sets (License #66629 & #66635)
Since Kawasumi’s 600 mL blood drawing kits do not contain unnecessary anticoagulant solution, it makes an economical choice for therapeutic phlebotomy applications. Additional features include a pre-attached 16G venipuncture needle with backeye to optimize blood flow, sample port, and pinch clamp for easy prevention of backflow. Kawasumi also has available two types of low-cost phlebotomy sets with pre-attached needles for accessing all vacuum bottles.

Arterial Venous Fistula Sets (License #66632)
For hemodialysis applications, Kawasumi will be offering a complete line of ultra thin walled and silicon coated arterial venous fistula needles which reduces patient discomfort and minimizes tissue damage at the puncture site. Additional attributes consist of textured finger grips that improve grip during placement and pliable, extremely elastic tubing that resists kinking when bent. The fistula sets come in a variety of needle gauges and lengths as well as with either fixed wing without backeye, fixed wing with backeye or rotatable hub with backeye.

Kawasumi is actively seeking top distributors located in Canada to carry some or all of the Kawasumi brand product line.

For more information on Kawasumi America’s complete line of oncology, hematology and hemodialysis products, or how to become a distributor, call 1-800-KAWASUMI (529-2786) or visit www.kawasumiamerica.com.About Kawasumi

Founded in 1954, Kawasumi Laboratories, Inc. is a leading manufacturer of medical devices and pharmaceuticals. Headquartered in Tokyo, Japan, the company is listed on the Second Section of the Tokyo Stock Exchange. Kawasumi Laboratories America, Inc., based in Tampa, Fla. since 1991, is a wholly owned subsidiary of Kawasumi Laboratories, Inc.

Posted by Industrial at January 20, 2005 07:31 AM

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