Home GUDID 00732094144048 Welch Allyn, Inc.
Primary DI 00732094144048
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901001
Catalog number 52700-B
Device description Welch Allyn KleenSpec Disposable Ear Specula with Instrumentation Slot; Compatible with MacroView Otoscopes (#23810, #23820); Qty. 48
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 00732094144048 Package GS1 4 In Commercial Distribution 00732094107579 Primary GS1 0 00732094216073 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 00732094144048 00732094144048 732094144048 0732094144048 00732094107579 00732094107579 732094107579 0732094107579 00732094216073 00732094216073 732094216073 0732094216073
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 48 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 00732094322866 Welch Allyn, Inc. 901134 ESCRIBE-CAX-DXACB 2019-07-22 00732094322873 Welch Allyn, Inc. 901134 ESCRIBE-CAX-CXXXX 2019-07-22 00732094322880 Welch Allyn, Inc. 901134 ESCRIBE-CAX-CXACX 2019-07-22 00732094322897 Welch Allyn, Inc. 901134 ESCRIBE-CAX-CXACA 2019-07-22 00732094322903 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXXXA 2019-07-22 00732094322910 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXXCA 2019-07-22 00732094322927 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXACA 2019-07-22 00732094322934 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXAAA 2019-07-22 00732094322941 Welch Allyn, Inc. 901134 ESCRIBE-BAX-DXACX 2019-07-22 00732094322958 Welch Allyn, Inc. 901134 ESCRIBE-BAX-DXACB 2019-07-22 00732094322965 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXXXX 2019-07-22 00732094322972 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXACB 2019-07-22 00732094322989 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXACA 2019-07-22 00732094322996 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXAAX 2019-07-22 00732094323009 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXXXX 2019-07-22 00732094323016 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXXXA 2019-07-22 00732094323023 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXAXA 2019-07-22 00732094323030 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXAAA 2019-07-22 00732094323047 Welch Allyn, Inc. 901134 ESCRIBE-AAX-DXXXX 2019-07-22 00732094323054 Welch Allyn, Inc. 901134 ESCRIBE-AAX-CXXXX 2019-07-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 16972545090017 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 16972545090031 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 00050428029497 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ERA 2026-02-13 KTS0025716 K.T.Surgico K.T.SURGICO ERA 2024-07-24 00311917035000 Walgreens WALGREEN CO. ERA 2023-11-01 20884392954455 Safety 1st DOREL JUVENILE GROUP, INC. ERA 2023-10-15 10884389104514 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 10884389104521 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 17290018446154 Nonagon N9+ NONAGON LTD ERA 2022-09-28 27290018446151 Nonagon N9+ SmartExam NONAGON LTD ERA 2022-09-28 M368122711 LABTRON GF HEALTH PRODUCTS, INC. ERA 2020-09-15 H65811255271 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 H65811255281 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 10304040029203 Henry Schein HENRY SCHEIN, INC. ERA 2018-12-21 10304040029197 Henry Schein HENRY SCHEIN, INC. ERA 2018-09-24 10381780403234 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403289 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403869 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780479369 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 00634782087753 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087760 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087777 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087784 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087791 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087807 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087814 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087821 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087838 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087845 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087852 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12
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