Home GUDID 00382830053686 neoBLUE
Primary DI 00382830053686
Brand neoBLUE
Company NATUS MEDICAL INCORPORATED
Model blanket Light Box
Catalog number 024738, 024915
Device description neoBLUE blanket Light Box
Published 2018-12-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name LBI Unit, Neonatal Phototherapy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LBI Unit, Neonatal Phototherapy General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00382830053686 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00382830053686 00382830053686 382830053686 0382830053686
GMDN Terms# Term, Definition table Term Definition Blanket/pad infant phototherapy unit A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. This device can be suitable for home-use.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 57 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature -30 Degrees Celsius 65 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 962519208 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00382830008365 Bio-logic Disposable Snap Electrodes 101600; 101603 2016-12-30 00382830045247 Echo-Screen III Pro EchoScreen III Refurbished, TEOAE with barcode 023480R 2020-02-20 00382830045278 Echo-Screen III Pro EchoScreen III Refurbished, DPOAE with barcode 023481R 2020-02-20 00382830045292 Echo-Screen III Pro EchoScreen III Refurbished, ABR with barcode 023482R 2020-02-20 00382830045315 Echo-Screen III Pro EchoScreen III Refurbished, TEOAE & DPOAE with bar 023483R 2020-02-20 00382830045339 Echo-Screen III Pro EchoScreen III Refurbished, TEOAE & ABR with barco 023484R 2020-02-20 00382830045353 Echo-Screen III Pro EchoScreen III Refurbished, DPOAE & ABR with barco 023485R 2020-02-20 00382830000727 NATUS MEDICAL 203200 2016-10-26 00382830000734 Bio-logic OAE Foam Tip Pediatric 203201, 29425 2016-12-30 00382830000741 Bio-logic OAE Foam Tip Adult 203202, 29427 2017-03-31 00382830000758 Bio-logic OAE Tree Tip 203208, 29421 2017-03-31 00382830000765 Bio-logic OAE Tree Tip Preemie 203209 2017-03-31 00382830000772 Bio-logic OAE Jumbo Tip 203210 2017-03-31 00382830000789 Bio-logic OAE Foam Tip Pediatric 203211, 29426 2016-12-30 00382830000796 Bio-logic OAE Foam Tip Adult 203212, 29428 2017-03-31 00382830000819 Bio-logic OAE Tree Tip 203218, 29422 2017-03-31 00382830000826 Bio-logic OAE Tree Tip Preemie 203219 2017-03-31 00382830000833 Bio-logic OAE 6mm Tip 203333, 29423 2016-12-30 00382830000840 Bio-logic OAE 6mm Tip 203353, 29424 2016-12-30 00382830000871 Natus Silver Disc Electrode Silicone 101001 2017-05-09
Other Devices Sharing Product Codes# 
natus.com