NeoBLUE Nova

Primary DI
05713315011238
Brand
NeoBLUE Nova
Company
Natus Medical Denmark ApS
Model
019040
Catalog number
019040
Device description
neoBLUE Rollstand
Published
2025-05-27
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
K160745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160745000neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated2016-12-12LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315011238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315011238057133150112385713315011238

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
306633756
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315009051Natus8-62-453008-62-453002021-04-12
05713315008689Natus1053 Freefit Charger8-62-393032021-01-04
05713315005848GN Otometrics A/SProbe Tube Holder mk28-62-608002019-04-24
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle8-62-415032016-09-19
05713315001055GN Otometrics A/SFreeFit REM probe8-69-392032016-09-19
05713315001192GN Otometrics A/SPMM RECD Probe Short8-69-392072016-09-19
05713315001208GN Otometrics A/SPMM RECD Probe Long8-69-392082016-09-19
05713315001215GN Otometrics A/SPMM RECD Probe Bin Long8-69-392092016-09-19
05713315001222GN Otometrics A/SPMM RECD Probe Bin Short8-69-392102016-09-19
05713315001246GN Otometrics A/SRECD Eartip Kit1-25-139042016-09-19
05713315001253GN Otometrics A/SRECD Fitting Kit8-62-490002016-09-19
05713315001277GN Otometrics A/SSoundHub 1008-62-423002016-09-26
05713315003301GN Otometrics A/SREM Test tubes, 1.1mm (50 pcs.)8-62-351002018-07-31
05713315004100GN Otometrics A/SAurical FreeFit, Complete Solution8-04-118082016-09-19
05713315004117GN Otometrics A/SAurical FreeFit, Complete Solution8-62-491002016-09-19
05713315005701GN Otometrics A/SREM Tube with ruler8-62-610002018-11-06
05713315008184GN Otometrics A/SOTOair 2 Bluetooth Dongle8-62-649002019-03-18
00571331500960Madsen Zodiac8-04-163218-04-163212026-06-04
05713315009587Madsen Zodiac8-04-163198-04-163192026-06-04
05713315009594Madsen Zodiac8-04-163208-04-163202026-06-04

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
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
00810101280405bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10