MARLEN BILIARY DRAINAGE KIT MANUFACTURED BY MARLEN MFG. & DEVELOPMENT CO.

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Request for Information Form	Contact Information
Company Name	MARLEN MFG. & DEVELOPMENT CO.
Address	5150 RICHMOND RD.
City, State, Zip	BEDFORD, OH 44146
Country	US
FDA Owner/Operator Phone	216-292-7060
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	EXF
FDA Classification Name	BAG, BILE COLLECTING
FDA Device Classification Code	Standards
FDA Regulation Number	876.5010
FDA Common Generic Name	BILIARY DRAINAGE KIT
FDA Proprietary Device Name	MARLEN BILIARY DRAINAGE KIT
FDA Owner / Operator Number	1520020
FDA Owner / Operator Name	MARLEN MFG. & DEVELOPMENT CO.
FDA Establishment Registration Number	1520020
FDA Registered Establishment Name	MARLEN MFG. & DEVELOPMENT CO.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-21-92
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	BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. P.O. BOX 1740 TEMPE, AZ 85280 US 908-277-8000 / 908-277-8513	NAVARRE 600 ML DRAINAGE BAG	BILIARY CATHETER AND ACCESSORIES
2	C.R. BARD, INC. 289 BAY RD. QUEENSBURY, NY 12804 US 908-277-8000 / 908-277-8513	UNIVERSAL GRAVITY DRAINAGE BAG	UNIVERSAL GRAVITY DRAINAGE BAG
3	C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513	NAVARRE UNIVERSAL GRAVITY DRAINAGE BAG-600 ML	DRAINAGE BAG
4	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513	BARD NAVARRE 600 ML DRAINAGE BAG	BILIARY CATHETER AND ACCESSORIES
5	MEDICAL DEVICE TECHNOLOGIES, INC. 3600 S.W. 47TH AVE. GAINESVILLE, FL 32608 US 604-221-7676 / 352-338-0440 350	MULTIPLE	VARIOUS DRAINAGE BAGS
6	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US 801-208-4777 / 801-208-4349	MERIT DRAINAGE DEPOT	DRAINAGE CATHETER ACCESSORIES
7	REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. ALPHARETTA, GA 30005 US 770-888-8520 / 770-888-8520	DRAINAGE BAG	DRAINAGE BAG