Home GUDID 00382830044653 NATUS MEDICAL
Primary DI 00382830044653
Brand NATUS MEDICAL
Company NATUS MEDICAL INCORPORATED
Model 013506
Device description Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set
Published 2016-10-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GWJ Stimulator, Auditory, Evoked Response
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWJ Stimulator, Auditory, Evoked Response Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00382830044653 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 00382830044653 00382830044653 382830044653 0382830044653
GMDN Terms# Term, Definition table Term Definition Evoked-potential audiometer An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.
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# 
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