DIAGNOSTIC MONITORS MANUFACTURED BY EDWARDS LIFESCIENCES, LLC.

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DIAGNOSTIC MONITORS

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	DXG
FDA Classification Name	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
FDA Device Classification Code	Standards
FDA Regulation Number	870.1435
FDA Common Generic Name	DIAGNOSTIC MONITORS
FDA Proprietary Device Name	DIAGNOSTIC MONITORS
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	02-28-03
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	CARDIAC OUTPUT MONITOR	CARDIAC OUTPUT MONITOR
2	AORTECH INTERNATIONAL PLC 81-83 VICTORIA ROAD PRESTIGE TRAVEL SUITE SURBITON, SURREY, KT6 4NS UK 44-208-3993961 / 44-169-8746699	TRUCCOM	CONTINUOUS CARDIAC OUTPUT MONITOR (NON-STERILE)
3	ASKIT KFT NO. 22 513RD UTCA BUDAPEST, H-1173 HU 361-256-2040 / 240-453-6317	HAEMOTRON	HAEMOTRON
4	BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372	GLUCOFACTS DATA MANAGEMENT SYSTEMS	DATA MANAGEMENT SYSTEMS
5	BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430	GLUCOFACTS DATA MANAGEMENT SYSTEMS	DATA MANAGEMENT SYSTEMS
6	CHEETAH MEDICAL INC. 1313 N. MARKET ST., SUITE 5100 WILMINGTON, DE 19802 US 302-571-1128 / 425-894-9621	CHEETAH NICOM SYSTEM	CARDIAC OUTPUT MONITOR
7	CHEETAH MEDICAL, LTD. 1 HAMASGER RAANANA, 43654 IS 972-9-7433470 / 425-894-9621	CHEETAH NICOM SYSTEM	CARDIAC OUTPUT MONITOR
8	FUTUREMED AMERICA, INC. 15700 DEVONSHIRE ST. GRANADA HILLS, CA 91344 US 818-830-2500 101 / 800-222-6780		BIOFEEDBACK DEVICE
9	HEMO SAPIENS, INC. 325 LOOKOUT DR. SEDONA, AZ 86351 US 928-202-4453 / 928-202-4453	TEBCO	NONINVASIVE CARDIAC OUTPUT
10	HOSPIRA, INC. 755 JARVIS DR. MORGAN HILL, CA 95037 US 224-212-4517 / 224-212-4688	CARDIAC OUTPUT MONITOR	CARDIAC OUTPUT MONITOR
11	HOSPIRA, INC. 13520 EVENING CREEK DR. SUITE 200 SAN DIEGO, CA 92128 US 224-212-4517 / 224-212-4688	MULTIPLE	OXIMETRY AND PROBES
12	HOSPIRA,INC. 375 N. FIELD DR. LAKE FOREST, IL 60045 US 224-212-4517 / 224-212-4688	MULTIPLE	OXIMETRY AND PROBES
13	LIDCO LTD. 16 ORSMAN RD. LONDON, N15QJ UK 440-207-7491500 / 442-077-49x1504	LIDCOPLUS HEMODYNAMIC MONITOR	CARDIAC OUTPUT & HEMODYNAMIC PARAMETERS COMPUTER
14	LYONS MEDICAL INSTRUMENT CORP. 15723 KADOTA ST. SYLMAR, CA 91342 US 818-367-4979 / 818-367-4979		HEMODILUTION CARDIAC OUTPUT COMPUTER
15	MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 REHOVOT, 76100 IS 972-893-23333 / 972-893-23333	HORIZON 9000WS	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
16	OMEGA CRITICAL CARE LIMITED OMEGA HOUSE, 2 CAIRN COURT NERSTON WEST EAST KILBRIDE, G74 4NB UK 44-135-5265733 / 44-135-5265733	TRUCCOM	CONTINUOUS CARDIAC OUTPUT MONITOR (NON-STERILE)
17	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252		CARDIAC OUTPUT MODULE
18	PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252	MULTIPLE	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
19	PULSION MEDICAL SYSTEMS AG STAHLGRUBERRING 28 MUNICH, 81829 GM 498-945-99140 / 919-562-4851	PULSION PICCO	CARDIAC OUTPUT MONITOR
20	R.H. ELECTRONICS LTD. 5 HATZOREF ST. P.O.BOX 740 NAZARETH ILLIT, 17000 IS 972-46-089000 / 972-50-4045133	HORIZON 9000WS	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMABLE, SINGLE-FUNCTION
21	SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. DUBLIN, OH 43016 US 114-420-8-458-3232 / 614-791-5568	CABLE CAL	PRESSURE SIMULATOR
22	VITAL SIGNS, INC. 20 CAMPUS RD. TOTOWA, NJ 07512 US 973-790-1330 / 973-790-1330 356	VITAL PAK PROCEDURE DELIVERY SYSTEM	ANESTHESIA KIT