INFANT HEEL WARMER MANUFACTURED BY DEROYAL TECHNOLOGIES, INC.

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Request for Information Form	Contact Information
Company Name	DEROYAL TECHNOLOGIES, INC.
Address	1211 HWY. 33 SOUTH
City, State, Zip	NEW TAZEWELL, TN 37825
Country	US
FDA Owner/Operator Phone	865-938-7828
FDA Medical Specialty Code	PM - Physical Medicine
FDA Product Code	MPO
FDA Classification Name	INFANT HEEL WARMER (CHEMICAL HEAT PACK)
FDA Device Classification Code	General Controls
FDA Regulation Number	890.5710
FDA Common Generic Name	INFANT HEEL WARMER
FDA Proprietary Device Name	INFANT HEEL WARMER
FDA Owner / Operator Number	1044833
FDA Owner / Operator Name	DEROYAL INDUSTRIES, INC.
FDA Establishment Registration Number	1055236
FDA Registered Establishment Name	DEROYAL TECHNOLOGIES, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	06-21-04
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	CARDINAL HEALTH 1500 WAUKEGAN ROAD MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-2325	TINY TOES INFANT HEEL WARMER	INFANT HEEL WARMER
2	COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW TWO LUDLOW PARK DR. CHICOPEE, MA 01022 US 508-261-8587 / 508-261-8587	INFANT HEEL WARMER	INFANT HEEL WARMER
3	RAPID-AID LTD./LTEE 4120 A SLADEVIEW CR. UNITS 1-4 MISSISSAUGA, ONTARIO, L5L 523 CA 800-265-3468 / 800-265-3468	INFANT HEEL WARMER	HOT PACK
4	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US 724-387-4559 / 724-387-4559	HEEL HUGGER	INFANT HEEL WARMER
5	RESPIRONICS MISSOURI 2338 WELDON PKWY. ST. LOUIS, MO 63146 US 724-387-4559 / 724-387-4559	HEEL SNUGGLER	INFANT HEEL WARMER
6	TEN COMFORT CORP. 6F-3, NO. 213, FU-HO RD. YUNG-HO CITY, TAIPEI, 23450 CH 886-2-29220202 / 886-3-5208829	MEDIHEAT INFANT HEEL WARMER	INFANT HEEL WARMER