FDA.reportPublic FDA data

NA

Primary DI
06944413807693
Brand
NA
Company
Edan Instruments, Inc.
Model
Smart ECG Viewer
Published
2016-09-03
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
06944413808065PackageGS110In Commercial Distribution
06944413807693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413808065069444138080656944413808065
06944413807693069444138076936944413807693

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
06944413837164Diagnostic Ultrasound SystemNano L12 EXP2026-03-09
06944413837188Diagnostic Ultrasound SystemNano L122026-03-09
06944413837171Diagnostic Ultrasound SystemNano C52026-03-09
06944413836532Diagnostic Ultrasound SystemNano C5 EXP2026-03-09
06944413849570Holter ECG and ABP SystemHolterABP2026-03-02
06944413858664TOCO-MECG transducerTOCO-EF2026-02-06
06944413858671TOCO-MECG transducerTOCO-EA2026-02-06
06944413814714Trolley(For medical use)MT-5032025-12-09
06944413819726Trolley(For medical use)MT-8032025-12-09
06944413819733Trolley(For medical use)MT-8112025-12-09
06944413807112Remote Event Marker02.01.2100952025-11-29
06944413804197ECG Cable3-lead, 12-pin, Defib-proof, IEC, Snap2025-09-13
06944413815704ECG Cable6-lead, 12-pin, Defib-proof, Adult/pediatric2025-09-13
06944413815711ECG Cable6-lead, Clip, AHA, Adult/pediatric2025-09-13
06944413815728ECG Cable6-lead, Snap, AHA, Adult/pediatric2025-09-13
06944413815735ECG Cable6-lead, Clip, IEC, Adult/pediatric2025-09-13
06944413815742ECG Cable6-lead, Snap, IEC, Adult/pediatric2025-09-13
06944413838963C.O. AccessoriesConnection cable2025-09-14
06944413838406Patient Monitor CX102025-09-05
06944413838413Patient MonitorCX122025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00884838084674DJXPhilips Medical SystemsNSX2019-03-06
10884521762633Vital SyncCovidien LPNSX2018-09-26
10884521762626Vital SyncCovidien LPNSX2018-09-20
04049957000554Dornier MedTechDornier MedTech Systems GmbHNSX2018-09-13
04049957000561Dornier MedTechDornier MedTech Systems GmbHNSX2018-09-13
04049957000578Dornier MedTechDornier MedTech Systems 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
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
6944413808324NAEdan Instruments, Inc.NSX2016-12-03
6944413808331NAEdan Instruments, Inc.NSX2016-12-03
06944413808072NAEdan Instruments, Inc.NSX2016-09-21
06944413807709NAEdan Instruments, Inc.NSX2016-09-13