FDA.reportPublic FDA data

NA

Primary DI
6944413808331
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
OTC
false
Sterile
false
Single use
false

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 record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 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