PRESSURE DISPLAY BOX MANUFACTURED BY TGI DIRECT

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Request for Information Form	Contact Information
Company Name	TGI DIRECT
Address	3085 E. REID RD.
City, State, Zip	GRAND BLANC, MI 48439
Country	US
FDA Owner/Operator Phone	810-239-5553
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	DXS
FDA Classification Name	GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS
FDA Device Classification Code	Standards
FDA Regulation Number	870.4310
FDA Common Generic Name	PRESSURE DISPLAY BOX
FDA Proprietary Device Name	PRESSURE DISPLAY BOX
FDA Owner / Operator Number	9103660
FDA Owner / Operator Name	TGI DIRECT
FDA Establishment Registration Number	3006367242
FDA Registered Establishment Name	TGI DIRECT
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	06-25-07
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	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US 812-829-4891 / 812-829-4891		DISPOSIBLE INFLATION GUAGE
2	EDWARDS LIFESCIENCES RESEARCH MEDICAL 6864 SOUTH 300 WEST MIDVALE, UT 84047 US 949-250-2500 / 949-250-2698	PRESSURE DISPLAY SET	PRESSURE DISPLAY SET
3	MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-391-9030	PRESSURE DISPLAY BOX	PRESSURE DISPLAY BOX
4	NOVOSCI CORP. 2828 NORTH CRESCENT RIDGE DR. THE WOODLANDS, TX 77381 US 281-363-4949 / 281-363-4949 3364	MONITORR	PRESSURE MONITOR
5	QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. ALLEN, TX 75002 US 972-390-9800 / 972-390-9800 300	PMS-3, MPS SYSTEM	PRESSURE MONITOR SEPARATOR, INCLUDED IN MPS (MYOCARDIAL PROTECTION SYSTEM)
6	SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 MUNCHEN, 80939 GM 49-89-323010 / 49- 89-32301x152	MULTIPLE	VARIOUS
7	TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. ANN ARBOR, MI 48103 US 800-283-7866 / 734-663-4145 6238	PRESSURE GAUGE/MONITOR	VARIOUS MODELS OF PRESSURE MONITORS