Home GUDID 00850064686012
OptiMap™ Workstation
Primary DI 00850064686012
Brand OptiMap™ Workstation
Company Cortex, Inc.
Model FG0008
Catalog number OPTI-WS
Device description OptiMap Workstation
Published 2025-07-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DQK Computer, Diagnostic, Programmable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQK Computer, Diagnostic, Programmable Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850064686012 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 00850064686012 00850064686012 850064686012 0850064686012
GMDN Terms# Term, Definition table Term Definition Cardiac mapping system An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 119228234 Device count 1 Serial number 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 00884838118898 IECG Philips Medizin Systeme Böblingen GmbH DQK 2026-06-23 05415067055811 EnSite™ ST. JUDE MEDICAL, INC. DQK 2026-06-01 00854277008197 NorthStar Mapping System Imricor Medical Systems, Inc. DQK 2026-05-21 08719689142124 QMAPP Fysicon B.V. DQK 2026-05-19 08719689142131 QMAPP Fysicon B.V. DQK 2026-05-19 08719689142162 QMAPP Fysicon B.V. DQK 2026-05-19 08719689142179 QMAPP Fysicon B.V. DQK 2026-05-19 17540279200027 CardioSTAT Icentia Inc. DQK 2025-12-08 08800069700109 AT-Report ATsens Co., Ltd. DQK 2025-11-05 08800069700246 ATACC-C130A ATsens Co., Ltd. DQK 2025-11-05 08800069700260 AT-Patch ATsens Co., Ltd. DQK 2025-11-05 08800069700277 AT-Patch ATsens Co., Ltd. DQK 2025-11-05 B353UA2251DA1 UbiqVue Lifesignals, Inc. DQK 2025-04-22 B353UA2251SA1 UbiqVue Lifesignals, Inc. DQK 2025-04-22 27540279250029 CardioSTAT Icentia Inc. DQK 2024-12-18 27540279250074 CardioSTAT Icentia Inc. DQK 2024-12-18 27540279250142 CardioSTAT Icentia Inc. DQK 2024-12-18 G637CEA0 Cardiologs Platform PHILIPS FRANCE DQK 2024-09-23 17540279105018 EART Icentia Inc. DQK 2024-03-26 17540279200072 CardioSTAT Icentia Inc. DQK 2024-03-26 17540279200140 CardioSTAT Icentia Inc. DQK 2024-03-26 17540262170016 Change Healthcare Cardiology Hemodynamics Change Healthcare Canada Company DQK 2023-09-19 08800069700178 AT-Patch ATsens Co., Ltd. DQK 2022-12-23 B273CEA0 Cardiologs Platform CARDIOLOGS TECHNOLOGIES DQK 2021-12-08 08714729982845 MDU5 PLUS BOSTON SCIENTIFIC CORPORATION DQK 2021-11-29 08714729982852 MDU5 PLUS BOSTON SCIENTIFIC CORPORATION DQK 2021-11-29 08714729982876 MDU5 PLUS BOSTON SCIENTIFIC CORPORATION DQK 2021-11-29 00191506015084 AVVIGO™ Guidance System II BOSTON SCIENTIFIC CORPORATION DQK 2021-11-17 00191506015169 AVVIGO™ Guidance System II BOSTON SCIENTIFIC CORPORATION DQK 2021-11-17 00191506015176 AVVIGO™ Guidance System II BOSTON SCIENTIFIC CORPORATION DQK 2021-11-17