Home GUDID 00732094199505 Welch Allyn, Inc.
Primary DI 00732094199505
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901001
Catalog number 39421
Device description Welch Allyn Probe Tubes for OAE Hearing Screener; Qty. 100
Published 2020-01-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00732094199505 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 00732094199505 00732094199505 732094199505 0732094199505
GMDN Terms# Term, Definition table Term Definition Audiometer/otoscope A battery-powered, hand-held device intended for: 1) visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening; and 2) evaluation of hearing by generating tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presenting them to a patient (pure-tone audiometery). It consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the ear canal, a pitch generator (speaker), and is intended to be used with a detachable ear speculum which may be included. This is a reusable device.
Regulatory Flags# DUNS number 198227881 Device count 1 Lot or batch true Serial number true Manufacturing date on label 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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