FDA.reportPublic FDA data

Voyager Infant Transport Incubator

Primary DI
00868406000020
Brand
Voyager Infant Transport Incubator
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
Voyager
Device description
Voyager Infant Transport Incubator, with Optional PulseOx
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K103524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103524000VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.2011-04-15FPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868406000020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868406000020008684060000208684060000200868406000020

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
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Delivery Lines415-00012026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Sample Lines415-00002026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Bagger415-00022026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Bagger731-99192026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx NO Supply Hose731-18622026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Kit731-02742026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Test Circuit738-18892026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Circuit738-18502026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Kit731-91472026-10-19
00850018561006ECG Patient CableECG Patient Cable711-00142026-10-13
00850018561037Gel-E DonutGEL-E DONUT, MEDIUM (CASE OF 12)9898031963912026-10-13
00850018561044Gel-E DonutGEL-E DONUT, EXTRA SMALL (CASE OF 12)9898031963712026-10-13
00850018561051Gel-E DonutGEL-E DONUT, SMALL (CASE OF 12)9898031963812026-10-13
00850018561068SquishonSquishon 2 Gel Pillow, 12/pk9898031963612026-10-13
00850018561075SquishonSquishon Mattress9898056033012026-10-13
00850018561082SquishonSquishon 3 Gel Pillow, 12/pk9898056064612026-10-13
00850018561105WeeSpecsWeeSpecs, Small (28-34 cm), 50/pk9898056076412026-10-13
00850018561136WeeSpecsWeeSpecs Supreme Small, 50/pk9898056041612026-10-13
00850018561143WeeSpecsWeeSpecs Supreme, Medium, 50/pk9898056042112026-10-13
00850018561150WeeSpecsWeeSpecs Supreme, Preemie, 50/pk9898056076312026-10-13

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
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
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