FDA.reportPublic FDA data

NxtGen Infant Transport Incubator

Primary DI
00850018561259
Brand
NxtGen Infant Transport Incubator
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
NxtGen Incubator Phototherapy Light
Catalog number
387-0057
Device description
NxtGen Incubator Phototherapy Light
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
LBIUnit, Neonatal Phototherapy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018561259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018561259008500185612598500185612590850018561259

Contacts#

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

Regulatory Flags#

DUNS number
073179368
Device count
1
DM exempt
false
Premarket exempt
true
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
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
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
03760012570102BiliCocoon™ Light BoxNEOMEDLIGHTLBI2026-04-27
03760012570126BiliCocoon™ Bag SystemNEOMEDLIGHTLBI2026-04-27
03760012570133BiliCocoon™ Bag DisposableNEOMEDLIGHTLBI2026-04-27
03760012570171BiliCocoon™ Nest SystemNEOMEDLIGHTLBI2026-04-27
03760012570188BiliCocoon™ Nest PadNEOMEDLIGHTLBI2026-04-27
03760012570195BiliCocoon™ Nest DisposableNEOMEDLIGHTLBI2026-04-27
03760012570218BiliCocoon™ Fixation SystemNEOMEDLIGHTLBI2026-04-27
03760012570225BiliCocoon™ Service KitNEOMEDLIGHTLBI2026-04-27
03760012570249BiliCocoon™ Bag PadNEOMEDLIGHTLBI2026-04-27
05713315011252NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011269NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011276NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011283NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011313NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011351NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011405NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011849NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011856NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011863NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
04049098061858Disposable Mechanical Ventilation CircuitDRAEGER MEDICAL SYSTEMS, INC.FPL2025-12-10
04049098041829Disposable Mechanical Ventilation CircuitDRAEGER MEDICAL SYSTEMS, INC.FPL2025-12-10
00810101280603bili-hut™ disposable nest mattress coverLITTLE SPARROWS TECHNOLOGIES LLCLBI2025-11-25
05713315011214NeoBLUE NovaNatus Medical Denmark ApSLBI2025-05-27
05713315011221NeoblueNatus Medical Denmark ApSLBI2025-05-27
05713315011238NeoBLUE NovaNatus Medical Denmark ApSLBI2025-05-27
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPADVANCED INSTRUMENTATIONS, INC.LBI2025-02-07