FDA.reportPublic FDA data

LMT nomag® IC 1.5

Primary DI
04260486610018
Brand
LMT nomag® IC 1.5
Company
LMT Medical Systems GmbH
Model
0100010
Device description
No description.
Published
2016-12-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPLIncubator, Neonatal Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPLIncubator, Neonatal TransportGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033565000LMT NOMAG IC 1,5Lmt Lammers Medical Technology GmbH2003-11-21FPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260486610018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260486610018042604866100184260486610018

GMDN Terms#

Term, Definition table
TermDefinition
Transport infant incubatorAn electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49451580980info@lmt-medicalsystems.com

Regulatory Flags#

DUNS number
312688686
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260486610339NBAC 3.0T PH I Flex08001692026-04-28
04260486610605NBAC 1.5T GE P Spine08002152026-04-28
04260486610483NHAC 1.5T PH I 1608001982024-04-23
04260486610537NHAC 3.0T PH I 1608002032024-04-23
04260486610582NBAC 1.5T PH I Spine08002212024-04-23
04260486610599NBAC 3.0T PH I Spine08002222024-04-23
04260486610940NBAC 1.5T SMS, Flex08002282023-06-01
04260486610957NBAC 1.5T PH I Flex08002292023-06-01
04260486610377NBAC 3.0T GE H, Flex08001872022-02-14
04260486610544NHAC 3.0T GE P 1608002162022-02-14
04260486610612NBAC 3.0T GE P, Spine08002142022-02-14
04260486610636NBAC 3.0T SMS, Spine08002192021-12-08
04260486610469NHAC 1.5T GE P 1608001962021-10-27
04260486610513NHAC 3.0T GE P 1608002132021-10-27
04260486610230NBAC 1.5T SMS, Flex08001502020-08-23
04260486610438NHAC 1.5T SMS 1608001932020-08-23
04260486610568LMT nomag® IC 1.501000152020-08-23
04260486610575LMT nomag® IC 3.001000252020-08-23
04260486610629NBAC 1.5T SMS, Spine08002182020-08-23
04260486610209NBAC 3.0T SMS, Spine08001432018-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561242NxtGen Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2026-10-13
00850018561259NxtGen Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2026-10-13
00850018561266NxtGen Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2026-10-13
00850018561570NxtGen Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2026-10-13
00868406000082A750i Infant IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2026-10-13
04049098061858Disposable Mechanical Ventilation CircuitDRAEGER MEDICAL SYSTEMS, INC.FPL2025-12-10
04049098041829Disposable Mechanical Ventilation CircuitDRAEGER MEDICAL SYSTEMS, INC.FPL2025-12-10
B510A3158ADVANCED TRANSPORT INCUBATORADVANCED INSTRUMENTATIONS, INC.FPL2025-02-04
05055931111146Reusable Skin Temperature ProbesFLEXICARE MEDICAL LIMITEDFPL2023-07-27
05055931132042Disposable Skin Temperature ProbesFLEXICARE MEDICAL LIMITEDFPL2023-07-27
00865648000306Aviator Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2023-06-20
00865648000320Voyager Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2023-06-20
00868406000099185A+ Infant IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2023-06-20
00850018561020NxtGen Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2023-04-07
00850018561013NxtGen Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2022-10-27
04260486610568LMT nomag® IC 1.5LMT Medical Systems GmbHFPL2020-08-23
04260486610575LMT nomag® IC 3.0LMT Medical Systems GmbHFPL2020-08-23
00854401006327Reusable Skin Temperature ProbesFLEXICARE MEDICAL LIMITEDFPL2019-06-05
00854401006310Disposable Skin Temperature ProbesFLEXICARE MEDICAL LIMITEDFPL2018-12-11
04260486610032LMT nomag® IC 3.0LMT Medical Systems GmbHFPL2017-06-14
00868406000006Aviator Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2016-09-27
00868406000013A750i Infant IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2016-09-27
00868406000020Voyager Infant Transport IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2016-09-27
00868406000037185A+ Infant IncubatorINTERNATIONAL BIOMEDICAL, LTD.FPL2016-09-27
04942962603058Oxygen Sensor For V-808ATOM MEDICAL CORPORATIONFPL2016-09-21
04942962603171Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TRATOM MEDICAL CORPORATIONFPL2016-09-21
04942962608619Semi-Iris Access Port Cover(20 pcs/pkg)ATOM MEDICAL CORPORATIONFPL2016-09-21
04942962613057V-707 with Power Pack(100-120V)ATOM MEDICAL CORPORATIONFPL2016-09-21
04942962615228V-808 Main Unit Only(120 V)ATOM MEDICAL CORPORATIONFPL2016-09-21
04049098000192TI500 Globetrotter Neonatal Transport SystemDRAEGER MEDICAL SYSTEMS, INC.FPL2015-10-24