TERUMO TERUFLEX HAND SEALER MANUFACTURED BY FUJINOMIYA FACTORY OF TERUMO CORP.

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TERUMO TERUFLEX HAND SEALER

Request for Information Form	Contact Information
Company Name	FUJINOMIYA FACTORY OF TERUMO CORP.
Address	818, MISONODAIRA
City, State, Zip	FUJINOMIYA, SHIZUOKA,
Country	JA
FDA Owner/Operator Phone	81-333-748111
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KSD
FDA Classification Name	DEVICE, HEAT-SEALING
FDA Device Classification Code	General Controls
FDA Regulation Number	864.9750
FDA Common Generic Name	BLOOD TUBING HAND SEALER
FDA Proprietary Device Name	TERUMO TERUFLEX HAND SEALER
FDA Owner / Operator Number	8010026
FDA Owner / Operator Name	TERUMO CORP.
FDA Establishment Registration Number	9681839
FDA Registered Establishment Name	FUJINOMIYA FACTORY OF TERUMO CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-30-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of FUJINOMIYA FACTORY OF TERUMO CORP.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BAXTER HEALTHCARE CORPORATION 25212 W. ILLINOIS ROUTE 120 ROUND LAKE, IL 60073 US 847-948-2000 / 847-473-6141	HEMATRON DIELECTRIC SEALER	HEMATRON DIELECTRIC SEALER
2	CENTRON TECHNOLOGIES, INC. 10601 DECATUR ROAD SUITE 100 PHILADELPHIA, PA 19154 US 215-501-0430 / 215-501-0430	TUBE SEALER, MODEL SE250, SE450, SE700, SE850	GENESIS TUBE SEALER
3	CONROY PRODUCTION AB 1 VALLHALLA VAGEN UPPLANDS VASBY, SE-194 63 SW 46-8-59420250 / 303-234-9412	MULTIPLE	HEAT-SEALING DEVICE
4	ENGINEERING & RESEARCH ASSOCIATES, INC. 100 NORTH TUCSON BLVD. TUCSON, AZ 85716 US 520-881-6555 / 520-545-0637	OMNI SEALER, MINI SEALER, MEDIUM DUTY SEALER, HEAVY DUTY SEALER	TUBE SEALERS
5	FENWAL, INC. THREE CORPORATE DRIVE LAKE ZURICH, IL 60047 US / 847-270-4632	MULTIPLE	VARIOUS STERILE & NON-STERILE DIELECTRIC SEALERS & ACCESSORIES
6	FRESENIUS HEMOCARE DEUTSCHLAND GMBH HANS-BOCKLER-STRASSE 6 SCHWEINFURT, D-97424 GM 49-617-26090 / 781-699-9785	HEAT SEALING DEVICE	HEAT SEALING DEVICE
7	GAMBRO BCT, INC. 10811 WEST COLLINS AVE. LAKEWOOD, CO 80215 US 303-231-4718 / 303-231-4718	SEAL SAFE TUBE SEALER	TUBE SEALING DEVICE
8	HAWO GERATEBAU GMBH OBERE AU 2-4 OBRIGHEIM, 74847 GM 49-626-1977040 / 49-626-162015	HAWO GERATEBAU GMBH	HAWO GERATEBAU GMBH
9	ITL ASIA PACIFIC SDN BHD 2-14 PERSIARAN PERINDUSTRIAN PENGKALAN 29A LAHAT, PERAK, 31500 MY 61-2-6280 8535 / 804-740-9376	CROCCLAMP(TM)	MANUAL CLAMP FOR BLOOD CONTAINER TUBING
10	PAC-DENT INTERNATIONAL (SUZHOU), LTD. XIANGCHENG DISTRICT YUANHE TECHNOLOGY ZONE SUZHOU CITY, JIANGSU PROVINCE, 215000 CH 86-512-67131888 / 909-839-0888	HEAT SEALER	HEAT SEALER
11	PAC-DENT INTL., INC. 21078 COMMERCE POINTE DR. WALNUT, CA 91789 US 909-839-0888 / 909-839-0888	PAC-DENT HEAT SEALER	HEAT SEALER
12	SARSTEDT AG & CO. ROMMELSDORFER STR. NUMBRECHT, N. RHINE-WESTPHALIA, 51588 GM 49-229-330550 / 49-229-3305500	SEALING AND SEGMENTATION SYSTEM	HEAT SEALER
13	TERUMO MEDICAL CORP. 950 ELKTON BLVD. ELKTON, MD 21921 US 800-283-7866 / 410-392-7243	MULTIPLE	HAND SEALER, CRIMPER, STRIPPER