ABT-1, K-20 (REORDER CODES 4003100, 4003101) MANUFACTURED BY QUEST MEDICAL, INC.

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Request for Information Form	Contact Information
Company Name	QUEST MEDICAL, INC.
Address	ONE ALLENTOWN PKWY.
City, State, Zip	ALLEN, TX 75002
Country	US
FDA Owner/Operator Phone	972-390-9800
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 TRAPS - VARIOUS SIZES - STERILE & NON-STERILE
FDA Proprietary Device Name	ABT-1, K-20 (REORDER CODES 4003100, 4003101)
FDA Owner / Operator Number	9914015
FDA Owner / Operator Name	ATRION CORP.
FDA Establishment Registration Number	1649914
FDA Registered Establishment Name	QUEST MEDICAL, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-24-03
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	SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 MUNCHEN, 80939 GM 49-89-323010 / 49- 89-32301x152	MULTIPLE	VARIOUS
2	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
3	TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US 734-741-6238 / 800-283-7866 7420	MULTIPLE	BUBBLE TRAP
4	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE ST. ASHLAND, MA 01721 US 734-741-6238 / 800-283-7866 7420	MULTIPLE	BUBBLE TRAP