MUTIPLE MANUFACTURED BY TERUMO CARDIOVASCULAR SYSTEMS CORP.

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MUTIPLE

Request for Information Form	Contact Information
Company Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
Address	6200 JACKSON RD.
City, State, Zip	ANN ARBOR, MI 48103
Country	US
FDA Owner/Operator Phone	800-283-7866
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	DWC
FDA Classification Name	CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
FDA Device Classification Code	Standards
FDA Regulation Number	870.4250
FDA Common Generic Name	VARIOUS MODELS
FDA Proprietary Device Name	MUTIPLE
FDA Owner / Operator Number	9003933
FDA Owner / Operator Name	TERUMO MEDICAL CORP.
FDA Establishment Registration Number	1828100
FDA Registered Establishment Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer OT - Contract Sterilizer RR - Repackager/Relabeller
FDA Listing Date	06-28-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of TERUMO CARDIOVASCULAR SYSTEMS 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	ALPHA OMEGA MFG. INC. 110 MAIN STREET P.O. BOX 387 GRAPELAND, TX 75844 US 936-687-4993 / 936-687-4993	ALPHA OMEGA DUAL 2 COOLER-HEATER	HEATER-COOLER
2	ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 IRVINE, CA 92618 US 949-453-0150 / 949-453-0150 117	COOL GARD 3000	HEAT EXCHANGE SYSTEM
3	MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 HIRRLINGEN, 72145 GM 49-747-8921-0 / 49-747-8921151	HEATER COOLER UNIT, MODEL HCU 30	HEATER COOLER UNIT
4	MAQUET CRITICAL CARE AB 2 ROENTGENVAGEN SOLNA, S-17195 SW 114-687-307409 / 468-730-7125	HEATER COOLER UNIT, MODEL HCU 30	HEATER COOLER UNIT
5	MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-391-9030	MULTIPLE	INSULATOR, CARDIAC
6	ORIGEN BIOMEDICAL, INC. 4020 S. INDUSTRIAL DR. #160 AUSTIN, TX 78744 US 512-474-7278 / 512-474-7278	BB CONTROLLER	PUMP CONTROLLER
7	PEMCO, INC. 5663 BRECKSVILLE RD. INDEPENDENCE, OH 44131 US / 216-524-2990	PEMCO COOLING AND WARMING SYSTEMS, MODELS 1002-HN-100, 1002 HN, AND 1002 N	CARDIOPULMONARY BYPASS COOLING AND WARMING SYSTEM
8	SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 MUNCHEN, 80939 GM 49-89-323010 / 49- 89-32301x152	STOCKERT HEATER COOLER SYSTEM 3T	HEATER COOLER
9	TGI DIRECT 3085 E. REID RD. GRAND BLANC, MI 48439 US 810-239-5553 / 810-239-5553	MULTIPLE	INSULATOR, CARDIAC
10	VITALCOR, INC. 100 EAST CHESTNUT AVE. WESTMONT, IL 60559 US 630-325-5500 / 630-325-5500 111	TEMPERATURE CONTROLLER CARDIOPULMONARY BYPASS	TEMPERATURE CONTROLLER CARDIOPULMONARY BYPASS

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