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FDA-Registered Company Profile for MEDISYSTEMS CORP.
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FDA-Supplied Establishment Information: |
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Establishment Registration Number: |
2919260 |
Company Name: |
MEDISYSTEMS CORP. |
Address: |
701 PIKE STREET, SUITE 1600 |
Address 2: |
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City: |
SEATTLE |
State |
WA |
Zip / Postal Code: |
98101-3016 |
County: |
KING |
Country: |
US |
Establishment Operation Code(s): |
AA - Initial Distributor
MS - Specification Developer
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Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
FDA-Supplied Owner/Operator Information: |
Owner/Operator Number: |
2919260 |
Company Name: |
MEDISYSTEMS CORP.
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Address: |
701 PIKE STREET, SUITE 1600 |
Address 2: |
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City: |
SEATTLE |
State: |
WA |
Zip / Postal Code: |
98101-3016 |
Country: |
US |
Owner/Operator Phone: |
206-834-1200
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FDA-Supplied Official Correspondent Information: |
Official Correspondent Name: |
MS. LAURA PLATH |
Company Name: |
MEDISYSTEMS CORP. |
Address: |
701 PIKE STREET, SUITE 1600 |
Address 2: |
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City: |
SEATTLE |
State: |
WA |
Zip / Postal Code: |
98101 3016 |
Country: |
US |
Official Corespondent Phone Number: |
206-834-1200
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Other Establishment Information: |
Establishment Phone: |
800-369-6324 |
Fax: |
888-373-4366 |
General Email: |
info@medisystems.com
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Web Site: |
http://www.medisystems.com
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Company Brochure: |
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Keywords: |
hemodialysis, needles, blood tubing, apheris |
Company Description: |
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Services Offered: |
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About Us: |
Medisystems Corporation designs, manufactures, imports and distributes medical devices, primarily for use in dialysis and related blood treatments.
Medisystems' products include tubing sets, needle sets and bag sets used to transport blood or physiologic fluids during hemodialysis, peritoneal dialysis, pheresis and other extracorporeal therapies. Medisystems also has a growing product line of safety needle devices, accessories and medical air filters. Medisystems is the market leader for hemodialysis bloodtubing sets, A.V. fistula needles, apheresis needles and hemodialysis transducer protectors in the United States.
Medisystems is a privately held company incorporated in 1981. Medisystems' headquarters is in Seattle, Washington with a client services group in Denver, Colorado, and an affiliated research facility, Medisystems Research Corporation, in Chicago, Illinois. Medisystems' affiliated manufacturing facilities are Medimexico S. de R.L. de C.V., in Tijuana, Mexico, which manufactures and assembles components and products; and Medisystems Europe s.r.l. , an Italian company which produces injection molded components for Medisystems' finished products. Additional contract manufacturing operations are located in South East Asia and are owned by a Japanese company.
Medisystems' products are registered and available for sale in the United States, Canada, Mexico and Europe. Medisystems is compliant with ISO 9001, EN 46001 and the MDD and has attained an ISO 9001/ EN 46001 certificate and an EC certificate for arterial venous blood tubing sets for Hemodialysis and arterial venous fistula needle product families.
One or more U.S. and foreign patents cover many of the company's products. The company has exclusive, royalty-free licenses to these patents for the hemodialysis and apheresis markets from the inventor, who is also the President and sole shareholder of Medisystems Corporation.
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Differentiation: |
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