FDA.reportPublic FDA data

NA

Primary DI
06944413808140
Brand
NA
Company
Edan Instruments, Inc.
Model
Smart ECG Net
Published
2016-12-03
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
NSXSoftware, Transmission And Storage, Patient Data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSXSoftware, Transmission And Storage, Patient Data

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
6944413808331PackageGS110In Commercial Distribution
06944413808140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6944413808331069444138083316944413808331
06944413808140069444138081406944413808140

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Regulatory Flags#

DUNS number
529173163
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15
06944413866140Stimulation SystemPR382026-05-15
06944413866157Stimulation SystemPR4 Pro2026-05-15
06944413866164Stimulation SystemPR42026-05-15
06944413866171Stimulation SystemPA362026-05-15
06944413866188Stimulation SystemPA382026-05-15
06944413866195Stimulation SystemPA4 Pro2026-05-15
06944413866201Stimulation SystemPA42026-05-15
06944413866218Stimulation SystemQ32026-05-15
06944413866225Stimulation SystemQ92026-05-15
06944413866232Stimulation SystemQ102026-05-15
06944413866249Stimulation SystemQ122026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18033737712341THD Procto Software SystemTHD SPANSX2022-10-07
58051887042642THD Procto Software SystemTHD SPANSX2022-10-07
08033737713037THD Procto Software SystemTHD SPANSX2021-07-19
18033737712389THD Procto Software SystemTHD SPANSX2021-07-19
00852132007286PatientCare PlatformPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00852132007293BodyGuardian ConnectPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00852132007309ECG Plug-InPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00851831007078Picis Perioperative and Critical CarePicis Clinical Solutions, Inc.NSX2021-03-18
00851831007054Picis Perioperative and Critical Care Picis Clinical Solutions, Inc.NSX2019-11-06
00884838084674IntelliSpace ConsolePhilips Medical Systems HsgNSX2019-03-06
10884521762633Vital SyncCovidien LPNSX2018-09-26
10884521762626Vital SyncCovidien LPNSX2018-09-20
04049957000554Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04049957000561Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04049957000578Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04012030013376seca analytics 115seca GmbH & Co. KGNSX2018-08-15
04012030013383seca analytics 115seca GmbH & Co. KGNSX2018-08-15
04012030013406seca analytics 115seca GmbH & Co. KGNSX2018-08-15
06944413808157NAEdan Instruments, Inc.NSX2017-11-27
00847946019976ChargerZoll Medical CorporationNSX2017-09-06
00884838059313IntelliVue XDS SoftwarePhilips Medizin Systeme Böblingen GmbHNSX2017-08-25
00851831007009Picis Perioperative and Critical CarePicis Clinical Solutions, Inc.NSX2017-04-14
00847946021887ZOLL Code Writer Zoll Medical CorporationNSX2017-03-17
00847946021894ZOLL Code Writer Zoll Medical CorporationNSX2017-03-17
00847946021900RescueNet ePCRZoll Medical CorporationNSX2017-03-17
00847946021917RescueNet ePCRZoll Medical CorporationNSX2017-03-17
00847946021924ZOLL ePCR iOSZoll Medical CorporationNSX2017-03-17
00847946021931ZOLL RescueNet LinkZoll Medical CorporationNSX2017-03-17
00847946021948ZOLL RescueNet LinkZoll Medical CorporationNSX2017-03-17
06944413808126NAEdan Instruments, Inc.NSX2016-12-03