FDA.reportPublic FDA data

NeoBLUE blanket LED Phototherapy

Primary DI
05713315011252
Brand
NeoBLUE blanket LED Phototherapy
Company
Natus Medical Denmark ApS
Model
006898
Catalog number
006898
Device description
neoBLUE blanket Small Pad Kit
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K182178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182178000neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated2018-12-13LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315011252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315011252057133150112525713315011252

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057133150123581082 Aurical HIT9-04-151019-04-151012026-10-28
057133150123651053 Aurical Freefit9-62-491009-62-491002026-10-28
05713315012389GN Otometrics A/S1053 PMM, RECD Probe, Long (2pcs)9-69-392102026-10-28
057133150123961053 Aurical Freefit9-04-118089-04-118082026-10-28
057133150124021053 Aurical FreeFit9-62-453009-62-453002026-10-28
057133150124261053 AUrical Freefit9-04-118209-04-118202026-10-28
057133150124331053 Aurical Freefit9-62-491109-62-491102026-10-28
057133150124401081 Aurical Aud9-04-145309-04-145302026-10-28
05713315012532GN Otometrics A/S1053 PMM RECD Probe, Long9-69-392062026-10-28
05713315010996AccuScreen Earcouplers0465850465852026-10-14
05713315011009AccuScreen Earcouplers0462000462002026-10-14
05713315012297Disposable Snap Electrodes (25 x 3 pack)0521630521632026-10-14
05713315012303Disposable Snap Electrodes (3 pack)0521650521652026-10-14
05713315000331GN Otometrics A/SHearing Instrument Programmer8-04-148002016-09-17
05713315012341Aurical Otocam 300-III10768-04-132602026-07-20
05713315006890Madsen Accsucreen8-04-139778-04-139772026-07-08
05713315006906Madsen Accuscreen8-04-139788-04-139782026-07-08
05713315008610Natus8-31-2008-31-2002020-12-16
05713315008627Natus8-31-190028-31-190022020-12-16
05713315000713GN Otometrics A/SPatient Responder (Red)8-31-1902016-09-19

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03760012570249BiliCocoon™ Bag PadNEOMEDLIGHTLBI2026-04-27
05713315011269NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
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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
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