SPECTRATHERM BLOOD/FLUID WARMER SET CSFWS01 MANUFACTURED BY ACCELLENT EL PASO

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Request for Information Form	Contact Information
Company Name	ACCELLENT EL PASO
Address	31-C BUTTERFIELD TRAIL
City, State, Zip	EL PASO, TX 79906
Country	US
FDA Owner/Operator Phone	866-899-1392
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	LKN
FDA Classification Name	SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
FDA Device Classification Code
FDA Regulation Number	NULL
FDA Common Generic Name	COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
FDA Proprietary Device Name	SPECTRATHERM BLOOD/FLUID WARMER SET CSFWS01
FDA Owner / Operator Number	9048369
FDA Owner / Operator Name	ACCELLENT INC.
FDA Establishment Registration Number	2431982
FDA Registered Establishment Name	ACCELLENT EL PASO
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	12-01-03
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	ACCELLENT INC. 1526-6 CALLE HERTZ JUAREZ, CHIHUAHUA, 32470 MX 866-899-1392 / 915-782-1944	SPECTRATHERM BLOOD/FLUID WARMER SET CSFWS01	COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
2	APHERESIS TECHNOLOGIES, INC. 612 FLORIDA AVE. PALM HARBOR, FL 34683 US 727-787-5616 / 727-787-5616	ATI PLASMA DISCARD BAG	PLASMA DISCARD BAG
3	FRESENIUS HEMOCARE DEUTSCHLAND GMBH HANS-BOCKLER-STRASSE 6 SCHWEINFURT, D-97424 GM 49-617-26090 / 781-699-9785	MULTIPLE	BLOOD CELL SEPARATOR
4	FRESENIUS HEMOCARE NETHERLANDS B.V. RUNDE ZZ 41 EMMER-COMPASCUUM, NL-7881 HM NL 49-617-26080 / 31-591-355745	FRESENIUS CELL SEPARATION SYSTEM	MULTIPLE
5	GAMBRO BCT, INC. 10811 WEST COLLINS AVE. LAKEWOOD, CO 80215 US 303-231-4718 / 303-231-4718	COBE SPECTRA APHERESIS SYSTEM, COBE 2997	BLOOD CELL SEPARATOR
6	GAMBRO INDUSTRIES 7, AV. LIONEL TERRAY, B.P. 126 MEYZIEU CEDEX, F-69883 FR / 303-231-4094	MULTIPLE	PLASMAFILTER
7	GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY LAKEWOOD, CO 80401 US / 303-542-5075	MULTIPLE	SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTI