Home GUDID 00732094233629 Welch Allyn, Inc.
Primary DI 00732094233629
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901031
Catalog number 39501
Device description OAE HEARING SCREENER ONLY
Published 2020-01-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Sterile true Product Codes# Code, Name table Code Name EWO AUDIOMETER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EWO Audiometer Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00732094233629 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 00732094233629 00732094233629 732094233629 0732094233629
GMDN Terms# Term, Definition table Term Definition Otoacoustic emission system, battery-powered An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).
Regulatory Flags# DUNS number 198227881 Device count 1 Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00817655023106 Welch Allyn, Inc. 901145 419734 2019-10-23 00732094356366 Welch Allyn, Inc. 901006 9293-046-57 2025-09-22 00732094356373 Welch Allyn, Inc. 901006 9293-046-55 2025-09-22 00732094319903 Welch Allyn, Inc. 901011 419832 2023-09-26 00732094326079 Welch Allyn, Inc. 901006 9293-024-51 2023-08-25 00732094247138 Welch Allyn, Inc. 901031 39500-TE 2019-08-28 00732094247145 Welch Allyn, Inc. 901031 39500-NP-TE 2019-08-28 00732094272338 Welch Allyn, Inc. 901152 11094-001-50 2020-03-24 00732094258905 Welch Allyn, Inc. 901134 11012-014-50 2020-03-20 00732094307351 Welch Allyn, Inc. 901145 419751 2019-10-23 00732094307368 Welch Allyn, Inc. 901145 413379 2019-10-23 00732094307375 Welch Allyn, Inc. 901145 419733 2019-10-23 00732094258998 Welch Allyn, Inc. 901011 036840-005 2019-09-26 00732094272673 Welch Allyn, Inc. 901011 036840-006 2019-09-26 00817655020679 Welch Allyn, Inc. 901134 11012-016-50 2019-09-26 00817655020686 Welch Allyn, Inc. 901134 11012-016-51 2019-09-26 00732094296341 Welch Allyn, Inc. 901012 11093-003-50 2019-06-11 00732094223910 Welch Allyn, Inc. 901108 411215 2023-08-24 00732094089226 Welch Allyn, Inc. 901020 11840 2016-09-17 00732094089240 Welch Allyn, Inc. 901022 11820 2016-09-17
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