TRI-OPTIC MEASUREMENT CELL (VARIOUS MODELS) 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	CV - Cardiovascular
FDA Product Code	DRY
FDA Classification Name	MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
FDA Device Classification Code	Standards
FDA Regulation Number	870.4330
FDA Common Generic Name	ON-LINE BLOOD GAS MONITOR
FDA Proprietary Device Name	TRI-OPTIC MEASUREMENT CELL (VARIOUS MODELS)
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)	MS - Specification Developer
FDA Listing Date	01-05-07
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	INTERNATIONAL BIOPHYSICS CORP. 2101-2 E. ST. ELMO SUITE 275 AUSTIN, TX 78744 US 512-326-3244 / 512-326-3244	IBC QUICK CELL (3/8", 1/2", 1/4")	MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
2	MEDTRONIC MEXICO, S. DE R.L. DE C.V. AVENIDA PASEO DEL CUCAPAH10510 PARQUE INDUSTRIAL EL LAGO TIJUANA, B.C., 22570 MX 763-514-4000 / 763-391-9030	TRI-OPTIC MEASUREMENT CELL (VARIOUS MODELS)	ON-LINE BLOOD GAS MONITOR
3	SORIN GROUP ITALIA S.R.L 86,VIA STATALE 12 NORD, MIRANDOLA(MO), 41037 IT 39-053-5 29811 / 39-053-529811	DIDECO DATA MASTER PERFUSION MONITORING SYSTEM	ON-LINE PERFUSION MONITOR
4	SPECTRUM MEDICAL LTD HARRIER 4,METEOR BUSINESS PARK CHELTENHAM ROAD EAST GLOUCESTER, GLOUCESTERHSIRE, GL2 9QL UK 44-124-2650120 / 44-124-2650121	SPECTRUM M3 MONITOR	M3 MONITOR
5	TERUMO CARDIOVASCULAR SYSTEMS CORP. 1311 VALENCIA AVE. TUSTIN, CA 92780 US 734-741-6238 / 734-741-6238	CDI	CDI BLOOD PARAMETER MONITOR
6	TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US 734-741-6238 / 800-283-7866 7420	MULTIPLE BRANDS	BLOOD/GAS MONITOR
7	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420	MULTIPLE	BLOOD/GAS MONITOR