MULTIPLE, HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSORS MANUFACTURED BY DEROYAL SURGICAL

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MULTIPLE, HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSORS

Request for Information Form	Contact Information
Company Name	DEROYAL SURGICAL - ROSE HILL
Address	100 ROSE HILL INDUSTRIAL PARK
City, State, Zip	ROSE HILL, VA 24281
Country	US
FDA Owner/Operator Phone	865-938-7828
FDA Medical Specialty Code	HO - General Hospital
FDA Product Code	FMT
FDA Classification Name	WARMER, INFANT RADIANT
FDA Device Classification Code	Standards
FDA Regulation Number	880.5130
FDA Common Generic Name	VARIOUS, SKIN SURFACE TEMPERATURE SENSORS, STERILE AND NON-STERILE
FDA Proprietary Device Name	MULTIPLE, HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSORS
FDA Owner / Operator Number	1044833
FDA Owner / Operator Name	DEROYAL INDUSTRIES, INC.
FDA Establishment Registration Number	1046367
FDA Registered Establishment Name	DEROYAL SURGICAL - ROSE HILL
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	08-20-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of DEROYAL SURGICAL - ROSE HILL

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	ARAGONA MEDICAL, INC. 184 RIVERVALE RD. RIVER VALE, NJ 07675 US 201-664-8822 / 201-664-8822	BABY THERMAL CEILING; MOBILE THERMAL CEILING	BABY WARMER
2	ATOM MEDICAL CORPORATION 3-18-15 HONGO BUNKYO-KU, TOKYO, 113-0033 JA 813-394-50098 / 215-672-6800	MULTIPLE	INFANT RADIANT WARMER
3	CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. BRANFORD, CT 06405 US 203-488-6056 / 203-488-6056	KLEAR-TEMP	DISPOSABLE SKIN TEMP PROBE
4	DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK P.O. BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, 146 CS 506-293-9898 / 865-938-7828 1325	SKIN TEMPERATURE PROBES	VARIOUS SKIN TEMPERATURE PROBES
5	DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE LUEBECK, 23542 GM 49-451-8825367 / 49-451-8825367	MULTIPLE	INFANT WARMER
6	DRAEGER MEDICAL SYSTEMS, INC. 3135 QUARRY RD. TELFORD, PA 18969 US 215-660-2078 / 215-660-2078	MULTIPLE	VARIOUS
7	FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE EAST TAMAKI, NZ 649-574-0100 / 649-574-0123x8309	NO PROPRIETARY NAME LISTED	BED, RADIANT, NEONATAL OPEN
8	J. H. EMERSON CO. 22 COTTAGE PARK AVE. CAMBRIDGE, MA 02140 US 617-864-1414 / 617-864-1414	EMERSON TEMP. SENSOR-CONTROLLER;EASTWOOD-EMERSON RESUSCITATI	VARIOUS TYPES OF INFANT RADIANT WARMERS
9	LUDLOW TECHNICAL PRODUCTS CANADA, LTD. 215 HERBERT ST. GANANOQUE, ONTARIO, K7G 2Y7 CA 508-261-8587 / 508-261-8587	MULTIPLE	INFANT TEMPERATURE PROBE COVERS
10	MEDEX SYSTEMS INTL., INC. 25990 48TH AVE. ALDERGROVE, B.C., V4W 1J2 CA 604-857-8932 / 604-857-8932	STABILET	STABILET
11	MEDIX I.C.S.A. CALLE 89 JOSE ARIAS 293 SAN MARTIN, BUENOS AIRES, B1672ACA AR 541-147-545555 / 541-147-545555	MEDIX SM-401 INFANT WARMER FOR INTENSIVE CARE	INFANT WARMER
12	NOVA HEALTH SYSTEMS, INC. 1001 BROAD ST., 3RD FLR. UTICA, NY 13501 US 800-225-6682 / 800-225-6682	BABISHIELD	INFANT HEAT SHIELD
13	OHMEDA MEDICAL 8880 GORMAN RD. LAUREL, MD 20723 US 847-277-5002 / 414-721-3945 2436	INFANT WARMER SYSTEM (IWS) - VARIOUS MODELS	INFANT WARMER
14	PHOENIX MEDICAL SYSTEMS, LTD. 32/4, JAWAHARLAL NEHRU SALAI EKKADUTHANGAL, CHENNAI TAMIL NADU, 600097 IN 91-44-231-7867 / 818-996-0600	PHOENIX BABY WARMER	BABY WARMER
15	SCALE-TRONIX, INC. 288 CARLTON CAROL STREAM, IL 60188 US 630-653-3377 / 630-653-3377	SCALE-TRONIX 4002 SCALE	SCALE ACCESSORY FOR WARMERS/INCUBATORS