FDA.reportPublic FDA data

Airborne Phototherapy Light

Primary DI
00868406000075
Brand
Airborne Phototherapy Light
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
731-0209
Catalog number
731-0209
Device description
LED Phototherapy Light Bar
Published
2016-09-26
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
LBIUnit, Neonatal Phototherapy

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160238000Airborne Phototherapy LightInternational Biomedical2016-06-14LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868406000075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868406000075008684060000758684060000750868406000075

GMDN Terms#

Term, Definition table
TermDefinition
Overhead infant phototherapy unitA mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.

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
00850018561099Wee Sight Transilluminator 9898056037612023-06-20
00865648000306Aviator Transport IncubatorAviator2023-06-20
00865648000320Voyager Infant Transport IncubatorVoyager2023-06-20
00868406000099185A+ Infant Incubator185A+2023-06-20
00850018561020NxtGen Infant Transport IncubatorNxtGen732-00002023-04-07
00850018561013NxtGen Infant Transport IncubatorNxtGen738-21342022-10-27
00868406000006Aviator Transport IncubatorAviator2016-09-27
00868406000013A750i Infant IncubatorA750i2016-09-27
00868406000020Voyager Infant Transport IncubatorVoyager2016-09-27
00868406000037185A+ Infant Incubator185A+2016-09-27
00850018561273WeeSpecs Infant Eye ProtectionWeeSpecs2023-06-21
00850018561204LC Accu-Bar Temperature Trend Indicator9898056230012023-06-20
00850018561594Infant Heel Warmer122312232023-06-20
00850018561600Infant Heel Snuggler99047990472023-06-20
00850018561648NeoPod T, Neonatal Transport Humidification System940094002023-06-20
00865648000313NuBorne Infant WarmerWarmer2023-06-20
00865648000344Puffin Lite Infant ResuscitatorPuffin2023-06-20
00850018561587Infa-Therm Mattress101510152023-04-07
00865648000337AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx 2.0731-91592021-06-21
00868406000051LifeBorne Puffin Infant Resuscitator738-1099738-10992016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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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
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00810101280542bili-hut™ fully disposable convenience kit (5-Pack) LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280023bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
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