Home GUDID 00732094107654 Welch Allyn, Inc.
Primary DI 00732094107654
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901001
Catalog number 411496
Device description ADULT TIPS WITH SLEEVE
Published 2020-06-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name ERA OTOSCOPE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00732094107654 Package GS1 25 In Commercial Distribution 00732094107678 Package GS1 10 In Commercial Distribution 00732094230536 Primary GS1 0 00732094133370 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00732094107654 00732094107654 732094107654 0732094107654 00732094107678 00732094107678 732094107678 0732094107678 00732094230536 00732094230536 732094230536 0732094230536 00732094133370 00732094133370 732094133370 0732094133370
GMDN Terms# Term, Definition table Term Definition Otoscope, direct A portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.
Regulatory Flags# DUNS number 198227881 Device count 34 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false 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 00732094084610 Welch Allyn, Inc. 901092 DS45-11 2016-09-17 00732094089479 Welch Allyn, Inc. 901081 11720 2016-09-17 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
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