Home GUDID 00732094247145 Welch Allyn, Inc.
Primary DI 00732094247145
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901031
Catalog number 39500-NP-TE
Device description TEOAE HEARING SCRNER SET W O PRINTER
Published 2019-08-28
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false 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 00732094247145 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 00732094247145 00732094247145 732094247145 0732094247145
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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 00732094183948 Welch Allyn, Inc. 901022 11820-L 2016-09-17
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