NeoBLUE blanket LED Phototherapy 005989

GUDID 05713315011849

neoBLUE blanket Large Disposable Mattress Cover (package of 50)

Natus Medical Denmark ApS

Blanket/pad infant phototherapy unit
Primary Device ID05713315011849
NIH Device Record Key6f2962ae-71c7-4ffe-884c-2a1a896d6c85
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoBLUE blanket LED Phototherapy
Version Model Number005989
Catalog Number005989
Company DUNS306633756
Company NameNatus Medical Denmark ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105713315011849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBIUnit, Neonatal Phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-30
Device Publish Date2026-01-22

On-Brand Devices [NeoBLUE blanket LED Phototherapy]

05713315011863neoBLUE blanket LED Light Box without power supply
05713315011856neoBLUE blanket Small Disposable Mattress Cover (package of 50)
05713315011849neoBLUE blanket Large Disposable Mattress Cover (package of 50)
05713315011405neoBLUE blanket LED Light Box with Power Supply
05713315011351neoBLUE blanket LED Phototherapy System with Small pad (US)
05713315011313neoBLUE blanket LED Phototherapy System with Large pad (US)
05713315011283neoBLUE blanket Small Mattress (package of 2)
05713315011276neoBLUE blanket Large Mattress (package of 2)
05713315011269neoBLUE blanket Large Pad Kit
05713315011252neoBLUE blanket Small Pad Kit

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