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FDA-Registered Company Profile for MEDISYSTEMS CORP.

FDA-Supplied Establishment Information:
Establishment Registration Number: 2919260
Company Name: MEDISYSTEMS CORP.
Address: 701 PIKE STREET, SUITE 1600
Address 2:
City: SEATTLE
State WA
Zip / Postal Code: 98101-3016
County: KING
Country: US
Establishment Operation Code(s): AA - Initial Distributor
MS - Specification Developer
Establishment Status Code: A - Active
Year of Most Recent Initial
or Annual Registration:
2007
FDA-Supplied Owner/Operator Information:
Owner/Operator Number: 2919260
Company Name: MEDISYSTEMS CORP.
Address: 701 PIKE STREET, SUITE 1600
Address 2:
City: SEATTLE
State: WA
Zip / Postal Code: 98101-3016
Country: US
Owner/Operator Phone: 206-834-1200
FDA-Supplied Official Correspondent Information:
Official Correspondent Name: MS. LAURA PLATH
Company Name: MEDISYSTEMS CORP.
Address: 701 PIKE STREET, SUITE 1600
Address 2:
City: SEATTLE
State: WA
Zip / Postal Code: 98101 3016
Country: US
Official Corespondent Phone Number: 206-834-1200
Other Establishment Information:
Establishment Phone: 800-369-6324
Fax: 888-373-4366
General Email: info@medisystems.com
Web Site: http://www.medisystems.com
Company Brochure:
Keywords: hemodialysis, needles, blood tubing, apheris
Company Description:
Services Offered:
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.
Differentiation:


FDA-Registered Products Offered by MEDISYSTEMS CORP.

Common Device Name Proprietary Device Name
1 ANTI-STICK INJECTION SITE NEEDLE (STERILE FLUID PATH) MEDIC ANTI-STICK INJECTION SITE NEEDLE (STERILE FLUID PATH)
2 BANDAID SEPTY
3 BLOOD TUBING SETS (STERILE FLUID PATH) VIEW PRODUCT DETAIL
4 COMPRESSION BANDAGE MASTERSEAL
5 DIALYZER HOLDER MEDISYSTEMS DIALYZER HOLDER
6 DIALYZER PRIMING SET (STERILE FLUID PATH) MEDISYSTEMS DIALYZER PRIMING SET (STERILE FLUID PATH)
7 HOLLOW FIBER DIALYZERS VIEW PRODUCT DETAIL
8 STERILE FISTULA NEEDLES VIEW PRODUCT DETAIL
9 TRANSDUCER PROTECTOR (STERILE FLUID PATH) MEDISYSTEMS TRANSDUCER PROTECTOR (STERILE FLUID PATH)
10 VARIOUS ACCESSORIES FOR HEMODIALYSIS BLOOD TUBING SETS MEDISYSTEMS
All FDA-Registered products for this company are displayed above.


Other Products Offered by MEDISYSTEMS CORP.:

 No products have been listed by this company.

Services Offered by the MEDISYSTEMS CORP.:

No services have been listed by this company.


Additional Contact Information for MEDISYSTEMS CORP.:

There is no additional contact information for this company.






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