FDA.reportPublic FDA data

HEATING ELEMENT 440W-104V

Primary DI
00841034117186
Brand
HEATING ELEMENT 440W-104V
Company
RPI
Model
OMH003
Catalog number
OMH003
Device description
Heating Element Only
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMTWarmer, Infant Radiant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841034117186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841034117186008410341171868410341171860841034117186

GMDN Terms#

Term, Definition table
TermDefinition
Infant warmerA mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
818-882-8611techsupport@rpiparts.com

Regulatory Flags#

DUNS number
066232067
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841034110798ACQUISITION MODULE CABLEGEC020GEC0202016-12-09
00841034110804ACQUISITION MODULE CABLEGEC021GEC0212016-12-09
00841034112136TELEMETRY CABLE 2 LEAD SNKBB001KBB0012016-12-09
00841034112143PATIENT CABLE - 3 LEAD DNKCA001KCA0012016-12-09
00841034112150PATIENT CABLE - 3 LEAD DNKCA004KCA0042016-12-09
00841034112167PATIENT CABLE - 3 LEAD DNKCA007KCA0072016-12-09
00841034112174PATIENT CABLE - 3 LEAD DNKCA010KCA0102016-12-09
00841034112181PATIENT CABLE - 3 LEAD DNKCA013KCA0132016-12-09
00841034112198PATIENT CABLE - 3 LEAD DNKCA016KCA0162016-12-09
00841034112204PATIENT CABLE - 3 LEAD DNKCA019KCA0192016-12-09
00841034112211PATIENT CABLE - 3 LEAD DNKCA022KCA0222016-12-09
00841034112228PATIENT CABLE - 3 LEAD DNKCA025KCA0252016-12-09
00841034112235PATIENT CABLE - 3 LEAD DNKCA035KCA0352016-12-09
00841034112242PATIENT CABLE - 3 LD FX SNKCB002KCB0022016-12-09
00841034112259PATIENT CABLE - 3 LD FX SNKCB008KCB0082016-12-09
00841034112266TELEMETRY CABLE 3 LEAD SNKCB028KCB0282016-12-09
00841034112273TELEMETRY CABLE 3 LEAD SNKCB029KCB0292016-12-09
00841034112280TELEMETRY CABLE 3 LEAD SNKCB031KCB0312016-12-09
00841034112297TELEMETRY CABLE 3 LEAD PIKCB032KCB0322016-12-09
00841034112303PATIENT CABLE - 3 LD FX SNKCB036KCB0362016-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMT2026-03-23
10889483587881AirLife™AirLife Finland OyFMT2025-03-26
10889483587904AirLife™AirLife Finland OyFMT2025-03-26
20889483587888AirLife™AirLife Finland OyFMT2025-03-26
20889483587901AirLife™AirLife Finland OyFMT2025-03-26
10889483587959AirLife™AirLife Finland OyFMT2025-03-26
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMT2024-03-09
00865648000313NuBorne Infant WarmerINTERNATIONAL BIOMEDICAL, LTD.FMT2023-06-20
04049098099042Babyroo TN300 Infant Radiant WarmerDRAEGER MEDICAL SYSTEMS, INC.FMT2023-06-08
00749756379205DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
50749756379200DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMT2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMT2021-11-10
00749756772358DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
30749756772359DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-07-12
00749756927550DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756927567DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756927574DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756983983DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756995566DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927555DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927562DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756927579DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756983988DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756995561DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756372305DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
50749756372300DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
10190752181236Airlife™AirLife Finland OyFMT2021-03-09
10190752181199Airlife™AirLife Finland OyFMT2021-03-05
20190752181196Airlife™VYAIRE MEDICAL, INC.FMT2021-03-05