Home GUDID 06945095511991 zumax
Primary DI 06945095511991
Brand zumax
Company Zumax Medical Co., LTD
Model P4900
Device description Ophthalmoscope Bulb,3.5V
Published 2018-08-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HLJ Ophthalmoscope, Battery-Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HLJ Ophthalmoscope, Battery-Powered Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06945095511991 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06945095511991 06945095511991 6945095511991
GMDN Terms# Term, Definition table Term Definition Direct ophthalmoscope, battery-powered A battery-powered, hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of a built-in light source that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single view hole, and a dial containing several lenses of different powers that can be alternated by the examiner while viewing. It produces an upright, or unreversed, image of about 15 times magnification. Batteries are housed in the instrument’s handle; supplemental devices (e.g., spare light bulbs) may be included.
Regulatory Flags# DUNS number 421348837 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06945095556107 zumax Zumax Medical Co., LTD HLJ 2026-07-06 M368122731 Labtron GF HEALTH PRODUCTS, INC. HLJ 2020-09-22 M368122741 Labtron GF HEALTH PRODUCTS, INC. HLJ 2020-09-22 00192896009509 HEINE - BETA R HANDLE SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009516 HEINE - LITHIUM ION BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009523 HEINE MPACK MINI SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009530 HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009547 HEINE MPACK UNPLUGGED BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009554 HEINE MPACK UNPLUGGED BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009561 HEINE HC 50 CONNECTING CORD SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009578 HEINE MPACK SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009585 HEINE MPACK COMPLETE SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009592 HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00634782089221 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089238 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089252 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089276 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089290 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089313 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782088910 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088934 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088941 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088958 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088965 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088972 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088989 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088996 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782087753 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782087760 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782087784 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12