Home GUDID 07290016672350 Tyto Otoscope
Primary DI 07290016672350
Brand Tyto Otoscope
Company TYTO CARE LTD
Model Tyto Otoscope, Zamak, BLK, US
Catalog number 800-00020
Device description The Tyto Otoscope is an electronic otoscope that enables capturing and transmissionof video and still images of the external ear canal and tympanic membrane, whereby aclinician at one location on an IP network can view images and videos of a patient on site orat a different location on the IP network with the signal carried on an IP connection betweenthe two locations.
Published 2019-09-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC 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 07290016672350 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290016672350 07290016672350 7290016672350
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 649125325 Device count 1 Premarket exempt 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 07290020123008 Tyto Insights for Crackles Detection Tyto Insights for Crackles Detection 2024-12-23 07290016672305 TytoHome TytoHome US 900-00015-006 2019-09-03 07290016672428 TytoHome TytoHome US 900-00015-009 2020-10-10 07290016672480 TytoHome TytoHome G2 US 900-00015-004 2020-12-09 07290016672688 TytoHome TytoHome G2 US 900-00015-063 2022-05-11 07290016672756 TytoPro TytoPro G2 900-00002-062 2024-05-26 07290016672763 TytoHome TytoHome G2 US 900-00015-064 2024-05-26 07290016672886 Tyto Insights for Wheeze Detection Tyto Insights for Wheeze Detection _US 2024-05-26 07290016672725 Tyto Insights for Wheeze Detection Tyto Insights for Wheeze Detection _US 2023-05-14 07290016672541 TytoPro TytoPro G2 US 900-00002-007 2020-12-09 07290016672404 Tyto Stethoscope Tyto Stethoscope, Plastic, black, US 800-00027 2020-10-10 07290016672299 TytoPro TytoPro US 900-00002-005 2019-09-03 07290016672343 Tyto Stethoscope Tyto Stethoscope, Zamak, BLK, US 800-00019 2019-09-03 07290016672374 Tyto Stethoscope Tyto Stethoscope, Zamak, Gray, US 800-00023 2019-09-03 07290016672015 Tyto Stethoscope Tyto Stethoscope 800-00001 2016-12-22 07290016672039 TytoPro TytoPro 900-00002 2016-12-22 07290016672046 Not in use Not in use 2016-12-22 07290016672053 TytoHome TytoHome 900-00015 2018-01-04 07290016672190 Tyto Stethoscope Tyto Stethoscope 800-00008 2019-01-24 07290016672213 TytoHome TytoHome 900-00015 2019-01-24
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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