FDA.reportPublic FDA data

VectraplexECG System

Primary DI
00857175006029
Brand
VectraplexECG System
Company
VECTRACOR INC
Model
3.4.2
Device description
VectraplexECG System with Cardio Electrical Bio-marker (CEB)
Published
2016-09-26
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
CodeName
DPSElectrocardiograph
MLDMonitor, St Segment With Alarm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102378000VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMIVectracor, Inc.2011-11-02DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857175006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857175006029008571750060298571750060290857175006029

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology application softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828416359
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857175006166Office Medic6.02017-01-23
10857175006071Plastic Mouthpieces (100)Z-5000-26082016-09-26
008571750060673L Calibration Syringe5000-19175000-19172023-06-07
00857175006173Universal SmartECGAHAZ-7000-05002023-06-07
00857175006043Universal ECGZ-7000-0301Z-7000-03012016-09-24
00857175006012Vectraplex CMSV1007052016-09-26
00857175006050Orbit SpirometerZ-7000-0101Z-7000-01012016-09-24
10857175006132Wet Gel Monitoring ElectrodesV1003002016-09-26
40857175006096Adhesive Solid Gel Electrodes (pack of 100)Z-5000-19202016-09-26
10857175006088Nose Clips724050-002016-09-26
20857175006085Nose Clips7242005-002017-02-03
00857175006111Holter Prep Kit701900-002016-09-26

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Primary DI, Brand, Company table
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00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMLD2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMLD2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMLD2026-10-04
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06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
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06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMLD2026-07-13
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DPS2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DPS2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DPS2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DPS2026-06-12
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09