ACT II AUTOMATED COAGULATION TIMER MANUFACTURED BY MEDTRONIC PERFUSION SYSTEMS

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Request for Information Form	Contact Information
Company Name	MEDTRONIC PERFUSION SYSTEMS
Address	7611 NORTHLAND DR.
City, State, Zip	MINNEAPOLIS, MN 55432
Country	US
FDA Owner/Operator Phone	763-514-4000
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GKN
FDA Classification Name	TIMER, CLOT, AUTOMATED
FDA Device Classification Code	Standards
FDA Regulation Number	864.5400
FDA Common Generic Name	AUTOMED CLOT TIMER
FDA Proprietary Device Name	ACT II AUTOMATED COAGULATION TIMER
FDA Owner / Operator Number	2112641
FDA Owner / Operator Name	MEDTRONIC INC.
FDA Establishment Registration Number	2184009
FDA Registered Establishment Name	MEDTRONIC PERFUSION SYSTEMS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	02-25-05
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	HELLER LABORATORIES 100 AV OF THE COLORS SPARKS, NV 89434 US 775-342-2000 / 775-342-2000	MECHROLAB CLOT-TIMER	CLOT-TIMER
2	INTERNATIONAL TECHNIDYNE CORPORATION 330 TALMADGE RD. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON COAGULATION TIMER	CLOT TIMER
3	INTERNATIONAL TECHNIDYNE CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	HEMOCHRON COAGULATION TIMER	CLOT TIMER
4	MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. PARKER, CO 80134 US 763-514-4000 / 763-391-9030	ACT II AUTOMATED COAGULATION TIMER	AUTOMED CLOT TIMER