FDA.reportPublic FDA data

BiliSoft Phototherapy System

Primary DI
00840682116558
Brand
BiliSoft Phototherapy System
Company
Datex-Ohmeda, Inc.
Model
BI3
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K053568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053568000BILISOFT PHOTOTHERAPY SYSTEMLumitex, Inc.2006-04-17LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682116558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682116558008406821165588406821165580840682116558

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

Regulatory Flags#

DUNS number
080887689
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682143660Panda EU In-Bed ScalePS EU12022-12-08
00840682143714Giraffe EU In-Bed ScaleGS EU12022-12-08
00840682116534BiliSoft Phototherapy SystemBI22016-06-24
00840682116565BiliSoft Phototherapy SystemBI12016-06-24
00840682152709Pandai-Res Warmer 1.02020-06-11
00840682103923GiraffeWarmer2016-06-24
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURENA2021-11-10
00840682103909PandaWall Mount Warmer2016-06-24
00840682103916PandaFreestanding Warmer2016-06-24
00840682116855Giraffe Incubator CarestationCS12016-06-24
00840682116862Giraffe OmniBed CarestationCS12016-06-24
00840682142731NoviiPOD 107-PT-0032019-01-29
05060433670091NOVII INTERFACE CABLEGE FECG105-PT-1022016-09-12
05060433670114NOVII INTERFACE CABLEGE MECG105-PT-1042016-09-12
05060433670138NOVII INTERFACE CABLEGE UA105-PT-1062016-09-12
00195278115171NOVIINOVII+ POD2024-06-03
00195278212313NOVIINOVII+ INTERFACE2024-06-03
00840682143677Giraffe In-Bed ScaleGS12022-12-08
00840682143684IV POLE ASSY 12 IN12 Inch IV10217-5378-8002022-12-06
00840682143691ROTATING IV POLERotating IV16600-0851-8002022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPADVANCED INSTRUMENTATIONS, INC.LBI2025-02-07
00810101280504bili-hut™ fully disposable nest & mattress (5-Pack)LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280542bili-hut™ fully disposable convenience kit (5-Pack) LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280023bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
00810101280047bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
00810101280054bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10