MULTIPLE MANUFACTURED BY TERUMO CARDIOVASCULAR SYSTEMS CORP.

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Request for Information Form	Contact Information
Company Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
Address	125 BLUE BALL RD.
City, State, Zip	ELKTON, MD 21921
Country	US
FDA Owner/Operator Phone	734-741-6238
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	KRL
FDA Classification Name	DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS
FDA Device Classification Code	Standards
FDA Regulation Number	870.4205
FDA Common Generic Name	BUBBLE TRAP
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1828100
FDA Owner / Operator Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
FDA Establishment Registration Number	1124841
FDA Registered Establishment Name	TERUMO CARDIOVASCULAR SYSTEMS CORP.
FDA Operation Code(s)	MM - Manufacturer RR - Repackager/Relabeller
FDA Listing Date	02-20-02
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	QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. ALLEN, TX 75002 US 972-390-9800 / 972-390-9800 300	ABT-1, K-20 (REORDER CODES 4003100, 4003101)	BUBBLE TRAPS - VARIOUS SIZES - STERILE & NON-STERILE
2	SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 MUNCHEN, 80939 GM 49-89-323010 / 49- 89-32301x152	MULTIPLE	VARIOUS
3	TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. ANN ARBOR, MI 48103 US 800-283-7866 / 734-663-4145 6238	ULTRASONIC AIR SENSOR	VARIOUS MODELS OF ULTRASONIC AIR SENSORS
4	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420	MULTIPLE	BUBBLE TRAP