CO-SET MANUFACTURED BY EDWARDS LIFESCIENCES, LLC.

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CO-SET

Request for Information Form	Contact Information
Company Name	EDWARDS LIFESCIENCES, LLC.
Address	ONE EDWARDS WAY
City, State, Zip	IRVINE, CA 92614
Country	US
FDA Owner/Operator Phone	949-250-2500
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	KRB
FDA Classification Name	PROBE, THERMODILUTION
FDA Device Classification Code	Standards
FDA Regulation Number	870.1915
FDA Common Generic Name	CO-SET
FDA Proprietary Device Name	CO-SET
FDA Owner / Operator Number	9040666
FDA Owner / Operator Name	EDWARDS LIFESCIENCES, LLC.
FDA Establishment Registration Number	2015691
FDA Registered Establishment Name	EDWARDS LIFESCIENCES, LLC.
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	02-06-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of EDWARDS LIFESCIENCES, LLC.

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	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS TYPES OF THERMODILUTION PROBES
2	ARROW INTERNATIONAL CR, A.S. PRAZSKA 209 HRADEC KRALOVE 04, 500 04 EZ 610-378-0131 / 610-378-0131	VARIOUS STERILE DISPOSABLE THERMODILUTION CATHETERS	VARIOUS STERILE DISPOSABLE THERMODILUTION CATHETERS
3	ARROW INTL., INC. 2 BERRY DR. MT. HOLLY, NJ 08060 US 610-378-0131 / 610-378-0131	VARIOUS STERILE DISPOSABLE THERMODILUTION CATHETERS	VARIOUS STERILE DISPOSABLE THERMODILUTION CATHETERS
4	ARROW INTL., INC. 312 COMMERCE PL. ASHEBORO, NC 27203 US 610-378-0131 / 610-378-0131	VARIOUS STERILE DISPOSABLE THERMODILUTION CATHETERS	VARIOUS STERILE DISPOSABLE THERMODILUTION CATHETERS
5	BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. 198 YISHUN AVE. 7 SINGAPORE, 768926 SN 201-847-6800 / 801-565-2550	CRIITKIT-PLUS IN-LINE ROOM/ICE TEMPERATURE INJECTATE KIT	CLOSED INJECTATE DELIVERY SYSTEM
6	EDWARDS LIFESCIENCES AG PARQUE INDUSTRIAL ITABO KM. 18.5 CARR. SANCHEZ HAINA, SAN CRISTOBAL, DR 949-250-2500 / 949-250-2698	CO-SET	CO-SET
7	EDWARDS LIFESCIENCES TECHNOLOGY SARL STATE RD. 402 N.KM 1.4 ANASCO, PR 00610 US 949-250-2500 / 949-250-2698	CO-SET	CO-SET
8	HOSPIRA HOLDINGS DE COSTA RICA LTD. ZONA FRANCA GLOBAL LA AURORA DE HEREDIA, CS 224-212-4517 / 224-212-4688	MULTIPLE	VARIOUS TYPES OF THERMODILUTION PROBES
9	HOSPIRA LTD. CARRETERA SANCHEZ, KM 18 1/2 PARQUE INDUSTRIAL ITABO, S.A. HAINA, SAN CRISTOBAL, DR 224-212-4517 / 224-212-4688	MULTIPLE	VARIOUS TYPES OF THERMODILUTION PROBES
10	HOSPIRA,INC. 375 N. FIELD DR. LAKE FOREST, IL 60045 US 224-212-4517 / 224-212-4688	MULTIPLE	THERMODILUTION PROBE
11	ICU MEDICAL, INC 4455 ATHERTON DR. SALT LAKE CITY, UT 84123 US 949-366-2183 / 801-264-1384	MULTIPLE	VARIOUS TYPES OF THERMODILUTION PROBES
12	MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY HOUSTON, TX 77023 US 832-667-7000 / 832-667-7131	MILLAR INSTRUMENTS, INC.	MIKRO-TIP CATH. PRESSURE TRANSDUCER
13	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252	MULTIPLE	PROBE, THERMODILUTION
14	PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252	MULTIPLE	PROBE, THEMODILUTION
15	PULSION MEDICAL SYSTEMS AG STAHLGRUBERRING 28 MUNICH, 81829 GM 498-945-99140 / 919-562-4851	MULTIPLE	VARIOUS