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

Company Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
Address	ROUTE 202
City, State / Province, ZIP / Postal Code	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

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name	Proprietary Device Name	Common Generic Device Name
1	GAMBRO BCT, INC.	COBE 2997	BLOOD CELL SEPARATOR
2	HAEMONETICS CORP.	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
3	HAEMONETICS CORP.	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
4	HAEMONETICS CORP.	HAEMONETICS CELL WASHING SYSTEM	CENTRIFUGAL RED CELL WASHING SYSTEM
5	HETTICH AG	ULTRACW	CELL WASHER
6	HETTICH AG	ULTRACW	CELL WASHER