FDA.reportPublic FDA data

Norav 1200 Series PC-ECG

Primary DI
07290110254322
Brand
Norav 1200 Series PC-ECG
Company
NORAV MEDICAL LTD.
Model
ECGUSB1DEX
Catalog number
ECGUSB1DEX-D-00-05
Device description
Single Channel ECG Acquisition Module for integration in other Medical Devices. Special edition for GE Health Care.
Published
2019-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110254322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110254322072901102543227290110254322

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic signal amplifierAn electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97249893001info@norav.com

Regulatory Flags#

DUNS number
514773159
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
07290110255480Norav 1200 Series PC-ECG1200HRT Kit1200HRT-K-00-U-S10-032020-06-03
07290110255497Norav 1200 Series PC-ECG1200HRT1200HRT-D-00U-032020-06-03
07290110253080Norav NR SeriesNR1207 KitNR1207-K-00-E-S10-012019-10-01
07290110253103Norav NR SeriesNR1207-E KitNR1207E-K-00-E-B10-012019-10-01
07290110253141Norav NR SeriesNR1207-3 KitNR12073-K-00-EB10S5-012019-10-01
07290110254728Norav NR SeriesNR1207 KitNR1207-K-00-E-S10-022019-10-01
07290110254742Norav NR SeriesNR1207 KitNR1207-K-00-U-S10-022019-10-01
07290110254780Norav NR SeriesNR1207-E KitNR1207E-K-00-E-B10-022019-10-01
07290110254810Norav NR SeriesNR1207-E KitNR1207E-K-00-E-S10-012019-10-01
07290110254827Norav NR SeriesNR1207-E KitNR1207E-K-00-U-B10-012019-10-01
07290110254834Norav NR SeriesNR1207-E KitNR1207E-K-00-U-B10-022019-10-01
07290110254902Norav NR SeriesNR1207-3 KitNR12073-K-00-EB10S5-022019-10-01
07290110254919Norav NR SeriesNR1207-3 KitNR12073-K-00-UB10S5-012019-10-01
07290110255206Norav NR SeriesNR1207-E KitNR1207E-K-00-E-012019-10-01
07290110255213Norav NR SeriesNR1207-3 KitNR12073-K-00-E-012019-10-01
07290110255343Norav NR SeriesNR1207-3 KitNR12073-K-00-E-022019-10-01
07290110255404Norav NR SeriesNR1207-E KitNR1207E-K-00-E-B10-062019-10-01
07290110253035Norav NR SeriesNR302NR302-D-00E-012019-09-30
07290110253042Norav NR SeriesNR302 KitNR302-K-00-E-S7-012019-09-30
07290110253059Norav NR SeriesNR314NR314-D-00E-012019-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838113770MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
00884838100978MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
B693SICKBAY034600Sickbay Clinical PlatformMEDICAL INFORMATICS CORP.MWI2026-03-04
03615041990363Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990394Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990431Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990455Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990479Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990486Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990509Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990516Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990547Capsule SurveillancePhilips North America LLCMWI2026-01-08
03615041990554Capsule SurveillancePhilips North America LLCMWI2026-01-08
00199874784175MedibluMEDIBLU MEDICAL LLCMWI2025-12-23
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MWI2025-12-10
00732094358933Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358957Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358971Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
00732094358988Welch Allyn, Inc.WELCH ALLYN, INC.MWI2025-11-24
03615040002456Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002470Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002487Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002494Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002500Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002517Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002524Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
03615040002531Capsule Vitals PLusPhilips North America LLCMWI2025-07-31
03615040002562Capsule Vitals PlusPhilips North America LLCMWI2025-07-31
B693SICKBAY034500Sickbay Clinical PlatformMedical Informatics Corp.MWI2025-07-28
07045432118377NeoBeat Charging StandLaerdal Medical ASMWI2025-07-25