CW-2 CELL WASHING SYSTEM MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
Address	ROUTE 202
City, State, Zip	RARITAN, NJ 08869
Country	US
FDA Owner/Operator Phone	908-218-8177
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KSN
FDA Classification Name	CENTRIFUGE, CELL-WASHING, AUTOMATED FOR IMMUNO-HEMATOLOGY
FDA Device Classification Code	Standards
FDA Regulation Number	864.9285
FDA Common Generic Name	CELL WASHING SYSTEM
FDA Proprietary Device Name	CW-2 CELL WASHING SYSTEM
FDA Owner / Operator Number	2250051
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	2250051
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	01-01-93
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	DIAMED CARIBBEAN INC. 6157 N.W. 167 ST. #F-23 MIAMI, FL 33015 US 412-667-45111x210 / 305-558-4510	MULTIPLE	VARIOUS TYPES OF WASH SOLUTION
2	GAMBRO BCT, INC. 10811 WEST COLLINS AVE. LAKEWOOD, CO 80215 US 303-231-4718 / 303-231-4718	COBE 2997	BLOOD CELL SEPARATOR
3	HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 BRAINTREE, MA 02184 US 781-356-9488 / 781-356-9488	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
4	HAEMONETICS CORP. ASHLEY DR., BOTHWELL STRATHCLYDE, SCOTLAND, G71 8DA UK 781-356-9488 / 781-356-9488	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
5	HAEMONETICS CORP. BUNCHER INDUSTRIAL PARK AVENUE C, BUILDING 18 LEETSDALE, PA 15056 US 781-356-9488 / 781-356-9488	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
6	HAEMONETICS CORP. 40 ROBBIE RD. AVON, MA 02322 US 781-356-9488 / 781-356-9488	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
7	HETTICH AG SEESTRASSE 204A BAECH, 8806 SZ 41-178-68020 / 317-773-9073	ULTRACW	CELL WASHER
8	HETTICH AG SEESTRASSE 204A BAECH, 8806 SZ 41-178-68020 / 317-773-9073	ULTRACW	CELL WASHER
9	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC 275 AIKEN ROAD ASHEVILLE, NC 28804 US / 828-658-4400	MULTIPLE	AUTOMATED CELL WASHING SYSTEM
10	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC 275 AIKEN RD. ASHEVILLE, NC 28804 US / 828-658-4400	CELLWASHER II	CELLWASHER