FDA.reportPublic FDA data

TI500 Globetrotter Neonatal Transport System

Primary DI
04049098000192
Brand
TI500 Globetrotter Neonatal Transport System
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MU20508
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K001019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001019000TI500 GLOBE-TROTTER TRANSPORT SYSTEMHill-Rom Air-Shields2000-04-27FPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098000192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098000192040490980001924049098000192

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
+18004372437info@draeger.com

Regulatory Flags#

DUNS number
788289952
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098053785Infinity etCO2 SmartPod57407202015-10-24
04049098061858Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs.MU108412015-10-24
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24
04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000215Resuscitaire Radiant Warmer (RW82, RW82 VHA)MU205032015-10-24
04049098000413Restraint strap, replacement, carton of 10MU060112015-10-24
04049098000468Breathing bag set with PEEP valve, disposableMU047762015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04260486610018LMT nomag® IC 1.5LMT Medical Systems GmbHFPL2016-12-23
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
04049098000208Isolette TI500 Transport IncubatorDRAEGER MEDICAL SYSTEMS, INC.FPL2015-10-24
04049098000413Restraint strap, replacement, carton of 10DRAEGER MEDICAL SYSTEMS, INC.FPL2015-10-24