Home GUDID 00382830045247 Echo-Screen III Pro
Primary DI 00382830045247
Brand Echo-Screen III Pro
Company NATUS MEDICAL INCORPORATED
Model EchoScreen III Refurbished, TEOAE with barcode
Catalog number 023480R
Device description The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
Published 2020-02-20
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 EWO Audiometer GWJ Stimulator, Auditory, Evoked Response
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EWO Audiometer Ear, Nose, Throat 2 GWJ Stimulator, Auditory, Evoked Response Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00382830045247 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 00382830045247 00382830045247 382830045247 0382830045247
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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 5 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 5 Degrees Celsius 38 Degrees Celsius Storage Environment Humidity 5 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -30 Degrees Celsius 55 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 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 00382830000888 Natus Silver-Chloride Disc Electrode Silicone 101004 2017-05-09
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