Home GUDID 00732094223910 Welch Allyn, Inc.
Primary DI 00732094223910
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901108
Catalog number 411215
Device description RETINAVUE NETWORK SOFTWARE VERSION 3.X
Published 2023-08-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name NFJ System, image management, ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NFJ System, Image Management, Ophthalmic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00732094223910 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 00732094223910 00732094223910 732094223910 0732094223910
GMDN Terms# Term, Definition table Term Definition Ophthalmic image clinical assessment support software, professional-only A software program intended to be used in a clinical setting to display and analyse/process images of the eye, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of an ophthalmic condition. The images are typically acquired by a slit lamp, fundus camera, or via optical coherence tomography. The software is not dedicated to surgical planning or intraoperative use, and does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 198227881 Device count 1 DM exempt false Premarket exempt false 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 00732094089226 Welch Allyn, Inc. 901020 11840 2016-09-17 00732094089240 Welch Allyn, Inc. 901022 11820 2016-09-17 00732094183948 Welch Allyn, Inc. 901022 11820-L 2016-09-17 00732094354959 Welch Allyn, Inc. 901130 ELI230-ADA-AAAAX 2026-06-09 00732094335392 Welch Allyn, Inc. 901058 75RT 2022-10-03 00732094335422 Welch Allyn, Inc. 901058 74RT 2021-08-25 00732094335439 Welch Allyn, Inc. 901058 74RE 2021-08-25 00732094335446 Welch Allyn, Inc. 901058 73RT 2021-09-28 00732094335453 Welch Allyn, Inc. 901058 73RE 2020-05-15 00732094338751 Welch Allyn, Inc. 901058 74WX 2020-08-26 00732094338768 Welch Allyn, Inc. 901058 74WT 2020-08-26 00732094338775 Welch Allyn, Inc. 901058 74WE 2020-08-26 00732094335385 Welch Allyn, Inc. 901058 75RX 2023-04-26 00732094335408 Welch Allyn, Inc. 901058 75RE 2023-04-26 00732094335415 Welch Allyn, Inc. 901058 74RX 2023-04-26 00732094209167 Welch Allyn, Inc. 901058 75WT-B 2017-12-05 00732094209334 Welch Allyn, Inc. 901058 75MX-B 2017-12-05 00732094209372 Welch Allyn, Inc. 901058 75MT-B 2017-12-05 00732094209518 Welch Allyn, Inc. 901058 75CT-B 2017-12-05 00732094209570 Welch Allyn, Inc. 901058 75CE-B 2017-12-05
Other Devices Sharing Product Codes#