NONE MANUFACTURED BY MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

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Request for Information Form	Contact Information
Company Name	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
Address	2111 EAST GALBRAITH RD.
City, State, Zip	CINCINNATI, OH 45237
Country	US
FDA Owner/Operator Phone	314-654-2000
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FGD
FDA Classification Name	CATHETER, RETENTION, BARIUM ENEMA WITH BAG
FDA Device Classification Code	Standards
FDA Regulation Number	876.5980
FDA Common Generic Name	BARIUM ENEMA KITS
FDA Proprietary Device Name	NONE
FDA Owner / Operator Number	1925021
FDA Owner / Operator Name	MALLINCKRODT, INC.
FDA Establishment Registration Number	1518293
FDA Registered Establishment Name	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	09-21-05
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	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VARIOUS	VARIOUS
2	AVAIL MEDICAL CHINA SECTION A, 2ND FLOOR, XING DA LOGISTIC BLDG., LAN HUA ROAD FUTIAN FREE ZONE, SHENZHEN, 518038 CH 817-877-4343 / 858-457-1988	X-RAY CONTRAST MEDIUM, BARIUM ENEMA KIT, ETC.	BARIUM SULFATE SUSPENSION
3	COLOPLAST MANUFACTURING FRANCE, SAS USINE DU PONTET BP 89 SARLAT, 24203 FR 45-49-111111 / 612-302-4992	NO PROPRIETARY NAME LISTED	VARIOUS
4	DTP, LLC. 6505 EAST CENTRAL, # 103 WICHITA, KS 67206 US / 316-214-9944	PCP-721	CATHETER, RETENTION, BARIUM ENEMA WITH BAG
5	E-Z-EM, INC. 750 SUMMA AVE. WESTBURY, NY 11590 US 800-544-4624 3407 / 516-333-8230 3407	EMPTY ENEMA KITS, BAGS, TUBING, TIPS AND ACCESSORIES	ENEMA BAGS AND ENEMA TIPS
6	INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL P.O. BOX 28, KAMUNTING INDUSTRIAL ESTATE, KAMUNTING PERAK, 34600 MY 919-544-8000 / 919-433-4829	UCH BARIUM RECTAL CATHETER	UCH BARIUM RECTAL CATHETER
7	JIANGSU KANGJIN MEDICAL INSTRUMENT CO., LTD. CHANGFU ROAD, ZHENGLU TOWN CHANGZHOU, JIANGSU, 213111 CH 86-519-8736801 / 86-519-8736801	MANUFACTURER OF CLYSTER BAG	CLYSTER BAG