FDA.reportPublic FDA data

Vectraplex CMS

Primary DI
00857175006012
Brand
Vectraplex CMS
Company
VECTRACOR INC
Model
V100705
Device description
Vectraplex Central Monitoring System
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
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MLDMonitor, St Segment With Alarm
MSXSystem,Network And Communication,Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140852000VECTRAPLEX CMSVectracor, Inc.2015-01-30MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857175006012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857175006012008571750060128571750060120857175006012

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system receiverA mains electricity (AC-powered) component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

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
00857175006029VectraplexECG System3.4.22016-09-26
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMLD2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMLD2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMLD2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMLD2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17