FDA.reportPublic FDA data

NuBorne Infant Warmer

Primary DI
00865648000313
Brand
NuBorne Infant Warmer
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
Warmer
Device description
NuBorne Infant Warmer
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMTWarmer, Infant Radiant

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173516000NuBorne Infant WarmerInternational Biomedical2018-08-17FMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865648000313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865648000313008656480003138656480003130865648000313

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
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561099Wee Sight Transilluminator 9898056037612023-06-20
00865648000306Aviator Transport IncubatorAviator2023-06-20
00865648000320Voyager Infant Transport IncubatorVoyager2023-06-20
00868406000099185A+ Infant Incubator185A+2023-06-20
00850018561020NxtGen Infant Transport IncubatorNxtGen732-00002023-04-07
00850018561013NxtGen Infant Transport IncubatorNxtGen738-21342022-10-27
00868406000006Aviator Transport IncubatorAviator2016-09-27
00868406000013A750i Infant IncubatorA750i2016-09-27
00868406000020Voyager Infant Transport IncubatorVoyager2016-09-27
00868406000037185A+ Infant Incubator185A+2016-09-27
00850018561273WeeSpecs Infant Eye ProtectionWeeSpecs2023-06-21
00850018561204LC Accu-Bar Temperature Trend Indicator9898056230012023-06-20
00850018561594Infant Heel Warmer122312232023-06-20
00850018561600Infant Heel Snuggler99047990472023-06-20
00850018561648NeoPod T, Neonatal Transport Humidification System940094002023-06-20
00865648000344Puffin Lite Infant ResuscitatorPuffin2023-06-20
00850018561587Infa-Therm Mattress101510152023-04-07
00865648000337AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx 2.0731-91592021-06-21
00868406000051LifeBorne Puffin Infant Resuscitator738-1099738-10992016-09-26
00868406000068AeroNOx Nitric Oxide Delivery DeviceAeroNOx731-91482016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMT2026-03-23
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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
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
10190752181205AirlifeAirLife Finland OyFMT2021-02-26