Home GUDID 30749756138650 DeRoyal
Primary DI 30749756138650
Brand DeRoyal
Company DEROYAL INDUSTRIES, INC.
Model HNICU-01
Device description HYDRO-TEMP® Cover with Foam
Published 2016-09-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FMT WARMER, INFANT RADIANT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMT Warmer, Infant Radiant General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30749756138650 Package GS1 50 In Commercial Distribution 50749756138654 Package GS1 200 In Commercial Distribution 00749756138659 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30749756138650 30749756138650 50749756138654 50749756138654 00749756138659 00749756138659 749756138659 0749756138659
GMDN Terms# Term, Definition table Term Definition General-purpose patient temperature probe, single-use A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.
Regulatory Flags# DUNS number 096372255 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20889483587888 AirLife™ AirLife Finland Oy FMT 2025-03-26 20889483587901 AirLife™ AirLife Finland Oy FMT 2025-03-26 10889483587959 AirLife™ AirLife Finland Oy FMT 2025-03-26 00865648000313 NuBorne Infant Warmer INTERNATIONAL BIOMEDICAL, LTD. FMT 2023-06-20 04049098099042 Babyroo TN300 Infant Radiant Warmer DRAEGER MEDICAL SYSTEMS, INC. FMT 2023-06-08 50749756379200 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2023-02-06 30749756772359 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-07-12 50749756927555 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-05-07 50749756927562 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-05-07 50749756927579 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-05-07 50749756983988 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-05-07 50749756995561 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-05-07 50749756372300 DeRoyal DEROYAL INDUSTRIES, INC. FMT 2021-03-22 10190752181236 Airlife™ VYAIRE MEDICAL, INC. FMT 2021-03-09 20190752181196 Airlife™ VYAIRE MEDICAL, INC. FMT 2021-03-05 50190752181203 Airlife VYAIRE MEDICAL, INC. FMT 2021-02-26 20190752106113 AirLife™ Vyaire Medical Oy FMT 2021-01-28 50190752106121 AirLife™ Vyaire Medical Oy FMT 2021-01-28 00840682152709 Panda Datex-Ohmeda, Inc. FMT 2020-06-11 10854758006176 Access Medical Probes TARRY MEDICAL PRODUCTS, INC. FMT 2018-09-13 10885403257353 AirLife Carefusion Finland 320 Oy FMT 2017-10-31 04942962615761 Sunflower Warmer, Stand AC120V ATOM MEDICAL CORPORATION FMT 2016-12-27 04942962615778 Sunflower Warmer, Wall Mount AC120V ATOM MEDICAL CORPORATION FMT 2016-12-27 00841034102762 HEATING ELEMENT 560W-120V RPI FMT 2016-12-09 00841034102779 HEATING ELEMENT 600W-120V RPI FMT 2016-12-09 00841034102793 HEATING ELEMENT 600W-240V RPI FMT 2016-12-09 00841034102809 HEATING ELEMENT 741W-120V RPI FMT 2016-12-09 00841034102816 HEATING ELEMENT 560W-220V RPI FMT 2016-12-09 00841034102823 HEATING ELEMENT 350W-120V RPI FMT 2016-12-09 00841034102830 HEATING ELEMENT RPI FMT 2016-12-09
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