FDA.reportPublic FDA data

A750i Infant Incubator

Primary DI
00868406000082
Brand
A750i Infant Incubator
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
A750i
Device description
A750i Infant Transport Incubator
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K031096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031096000MODIFICATION TO TRANSPORT INCUBATOR 185International Biomedics, Inc.2003-06-24FPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868406000082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868406000082008684060000828684060000820868406000082

GMDN Terms#

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

Contacts#

Phone, Email table
PhoneEmail
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850018561167WeeSpecsWeeSpecs, Medium (> 34 cm), 50/pk9898056076512026-10-13
00850018561174WeeSpecsWEESPECS SUPREME - PREEMIE, 50/CASE9898056042012026-10-13
00850018561242NxtGen Infant Transport IncubatorNxtGen Incubator Skin Temp Sensor739-16032026-10-13
00850018561259NxtGen Infant Transport IncubatorNxtGen Incubator Phototherapy Light387-00572026-10-13
00850018561266NxtGen Infant Transport IncubatorNxtGen Incubator Heated Mattress738-24112026-10-13
00850018561457Prone PlusPRONE PLUS COVER- EXTRA SMALL9898056048412026-10-13
00850018561464Prone PlusPRONE PLUS COVER- MEDIUM9898056048612026-10-13
00850018561471Prone PlusPRONE PLUS COVER - LARGE9898056049012026-10-13
00850018561488Prone PlusPRONE PLUS COVER - SMALL9898056048512026-10-13

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
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
04049098000192TI500 Globetrotter Neonatal Transport SystemDRAEGER MEDICAL SYSTEMS, INC.FPL2015-10-24