Home GUDID 00857560008010 HealthView ECG Manager
Primary DI 00857560008010
Brand HealthView ECG Manager
Company Lumedx Corporation
Model 1.2.5
Catalog number 113-01003
Device description The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
Published 2018-11-30
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 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 00857560008010 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 00857560008010 00857560008010 857560008010 0857560008010
GMDN Terms# Term, Definition table Term Definition Cardiology information system application software An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.
Regulatory Flags# DUNS number 625427471 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false 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 00857560008003 HealthView CardioPACS 6.4.3 113-00749 2018-08-13
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