CATHETER, OXIMETER, FIBEROPTIC MANUFACTURED BY EDWARDS LIFESCIENCES, LLC.

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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	DQE
FDA Classification Name	CATHETER, OXIMETER, FIBEROPTIC
FDA Device Classification Code	Standards
FDA Regulation Number	870.1230
FDA Common Generic Name	CATHETER, OXIMETER, FIBEROPTIC
FDA Proprietary Device Name	CATHETER, OXIMETER, FIBEROPTIC
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	11-21-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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 FIBEROPTIC OXIMETER CATHETERS
2	EDWARDS LIFESCIENCES AG PARQUE INDUSTRIAL ITABO KM. 18.5 CARR. SANCHEZ HAINA, SAN CRISTOBAL, DR 949-250-2500 / 949-250-2698	CATHETER, OXIMETER, FIBEROPTIC	CATHETER, OXIMETER, FIBEROPTIC
3	EDWARDS LIFESCIENCES TECHNOLOGY SARL STATE RD. 402 N.KM 1.4 ANASCO, PR 00610 US 949-250-2500 / 949-250-2698	CATHETER, OXIMETER, FIBEROPTIC	CATHETER, OXIMETER, FIBEROPTIC
4	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US 847-277-5002 / 414-721-3945	MULTIPLE	SVO2 MODULE
5	HOSPIRA HOLDINGS DE COSTA RICA LTD. ZONA FRANCA GLOBAL LA AURORA DE HEREDIA, CS 224-212-4517 / 224-212-4688	MULTIPLE	VARIOUS FIBEROPTIC OXIMETER CATHETERS
6	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 FIBEROPTIC OXIMETER CATHETERS
7	HOSPIRA, INC. 755 JARVIS DR. MORGAN HILL, CA 95037 US 224-212-4517 / 224-212-4688	MULTIPLE	VARIOUS FIBEROPTIC OXIMETER CATHETERS
8	HOSPIRA,INC. 375 N. FIELD DR. LAKE FOREST, IL 60045 US 224-212-4517 / 224-212-4688	MULTIPLE	VARIOUS FIBEROPTIC OXIMETER CATHETERS
9	ICU MEDICAL, INC 4455 ATHERTON DR. SALT LAKE CITY, UT 84123 US 949-366-2183 / 801-264-1384	MULTIPLE	VARIOUS FIBEROPTIC OXIMETER CATHETERS