MULTIPLE BRANDS MANUFACTURED BY TERUMO CARDIOVASCULAR SYSTEMS CORP.

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MULTIPLE BRANDS

Request for Information Form	Contact Information
Company Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
Address	125 BLUE BALL RD.
City, State, Zip	ELKTON, MD 21921
Country	US
FDA Owner/Operator Phone	734-741-6238
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	KOC
FDA Classification Name	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
FDA Device Classification Code	Standards
FDA Regulation Number	876.5820
FDA Common Generic Name	TRANSDUCER PROTECTOR
FDA Proprietary Device Name	MULTIPLE BRANDS
FDA Owner / Operator Number	1828100
FDA Owner / Operator Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
FDA Establishment Registration Number	1124841
FDA Registered Establishment Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	04-01-03
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	ANGIODYNAMICS, INC. ONE HORIZON WAY MANCHESTER, GA 31816 US 518-798-1215 / 800-472-5221	MULTIPLE	ACUTE CATHETERS
2	APHERESIS TECHNOLOGIES, INC. 612 FLORIDA AVE. PALM HARBOR, FL 34683 US 727-787-5616 / 727-787-5616	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS	PLASMA DISCARD BAG
3	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513	CRITICORE MONITOR	UROLOGICAL AND ULTRAFILTRATE MONITOR
4	CONTRACT MEDICAL INTL. GMBH ZUR WETTERWARTE 50 HOUSE 302 DRESDEN, 01109 GM 011-493-512138888 / 781-665-9893	FLOW-QC	HEMODIALYSIS BLOOD CIRCUIT
5	COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235	ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY	ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
6	DYMAX CORP. 110 MARSHALL DR. WARRENDALE, PA 15086 US 908-277-8000 / 908-277-8513	CRITICORE MONITOR	UROLOGICAL AND ULTRAFILTRATE MONITOR
7	ERIKA DE REYNOSA, S.A. DE C.V. BRECHA E99 SUR; PARQUE INDUSTRIAL REYNOS, BLDG. II CD, REYNOSA, TAMPS, 88790 MX 781-699-9000 / 781-699-9068	MULTIPLE	VARIOUS TYPES OF BLOOD TUBING SETS (STERILE FLUID PATH)
8	ERIKA DE REYNOSA, S.A. DE C.V. BRECHA E99 SUR; PARQUE INDUSTRIAL REYNOS, BLDG. II CD, REYNOSA, TAMPS, 88790 MX 781-699-9000 / 781-699-9068	MULTIPLE	VARIOUS TYPES OF BLOOD TUBING SETS AND ACCESSORIES
9	FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER STREET WALTHAM, MA 02451 US 781-699-9000 / 781-699-9068	MULTIPLE	VARIOUS TYPES OF BLOOD TUBING SETS AND ACCESSORIES
10	GAMBRO DASCO S.P.A., BLOOD LINE DIVISION VIA MODENESE, 66 MEDOLLA (MO), 41036 IT / 303-231-4094	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
11	GAMBRO RENAL PRODUCTS S.A. DE C.V. 10014 PACIFICO BLVD. PARQUE INDUSTRIAL PACIFICO TIJUANA, BCN, 22480 MX / 303-231-4094	VAROIUS	STERILE BLOOD TUBING SETS FOR HEMODIALYSIS
12	GAMBRO RENAL PRODUCTS, INC. 10810 W. COLLINS AVE. LAKEWOOD, CO 80215 US / 303-231-4094	VARIOUS	MULTIPLE
13	GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY LAKEWOOD, CO 80401 US / 303-542-5075	MULTIPLE	ACCESSORIES,BLOOD CIRCUIT,HEMODIALYSIS
14	GUJARAT SURGICO, LTD. 155/1, AT POST DHANOT, KADI RD. KALOL, MEHSANA (N.G.), IN 91-79-6563886 / 91-79-6563886	SURGICO ARTERIAL VENOUS BLOOD TUBING SET	ARTERIAL VENOUS BLOOD TUBING SET
15	HAIDYLENA FOR ADVANCED MEDICAL INDUSTRIES 26, MAKRAM EBEID ST. NASR CITY, CAIRO, 11731 EG 202-270-6149 / 202-270-6149	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS	VARIOUS
16	INFUS MEDICAL (THAILAND) CO., LTD. 706 MOO 4, BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN, 10280 TH 66-2-324-0288 / 66-2-324-0288	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS	HEMODIALYSIS BLOOD LINE
17	INNOVATIONS FOR ACCESS, INC. 1815 NW 169TH PLACE, SUITE #6030 BEAVERTON, OR 97006 US 800-297-8485 / 800-297-8485	HEMOBAND	HEMOBAN
18	INTERVENTIONAL HEMOSTASIS PRODUCTS, INC. 1815 NW 169TH PLACE SUITE 6030 BEAVERTON, OR 97006 US 503-638-9743 / 503-638-9743	VASCULAR PRESSURE BAND	PRESSURE BAND,DIALYSIS PRESSURE BAND
19	LILY MEDICAL COMPANY 17595 HARVARD, C-182 IRVINE, CA 92614 US 949-280-0988 / 949-280-0988	VARIOUS MODELS OF HEMODIALYSIS BLOOD CIRCUIT ACCESSORIES	HEMODIALYSIS BLOOD CIRCUIT ACCESSORIES
20	LUCOMED SPA 12, VIA EMILIA-ROMAGNA CARPI, 41012 IT 39-059-697710 / 973-575-0614	HEMODIALYSIS DRAINAGE - RECIRCULATION BAG	HEMODIALYSIS DRAINAGE - RECIRCULATION BAG
21	MEDIMEXICO, S. DE R.L. DE C.V. AV. VALLE IMPERIAL NO. 10523 PARQUE INDUSTRIAL VALLE SUR TIJUANA, B.C., 22180 MX 011-52-6646376668 / 011-526-646376668	DISYSTEMS	VARIOUS ACCESSORIES FOR HEMODIALYSIS BLOOD TUBING SETS
22	MEDISYSTEMS CORP. 701 PIKE STREET, SUITE 1600 SEATTLE, WA 98101 US 206-834-1200 / 206-834-1200	MEDISYSTEMS	VARIOUS ACCESSORIES FOR HEMODIALYSIS BLOOD TUBING SETS
23	NEXTRON MEDICAL TECHNOLOGIES, INC. 45 KULICK RD. FAIRFIELD, NJ 07004 US 800-633-7877 / 800-633-7877		HEMODIALYSIS TUBING
24	SORB TECHNOLOGY, INC. 3631 S.W. 54TH ST. OKLAHOMA CITY, OK 73119 US 724-772-6900 140 / 405-682-1993 13	FAST FORMALERT, AMMONIA TEST PAPER	HEMODIALYSIS ACCESSORIES
25	STIHLER ELECTRONIC GMBH JULIUS-HOLDER-STRASSE 36 STUTTGART, D-70597 GM 49-711-720670 / 631-744-0059	FLUID WARMER	MULTIPLE
26	SU MEDICAL SUPPLIES 17595 HARVARD C-182 IRVINE, CA 92614 US 949-280-0988 / 949-280-0988	VARIOUS MODELS OF HEMODIALYSIS BLOOD CIRCUIT ACCESSORIES	HEMODIALYSIS BLOOD CIRCUIT ACCESSORIES
27	SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. TAICHUNG CITY, 403 TW 886-423-755650 / 886-04-2375-5650	RENAX HEMODIALYSIS BLOOD LINE SET	BLOOD LINE SET FOR HEMODIALYSIS
28	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420	MULTIPLE	TRANSDUCER PROTECTOR