FDA.reportPublic FDA data

Norav 1200 Series PC-ECG

Primary DI
07290110255572
Brand
Norav 1200 Series PC-ECG
Company
NORAV MEDICAL LTD.
Model
ECGUSB1DEX
Catalog number
ECGUSB1DEX-D-00-10
Device description
Single Channel ECG Acquisition Module for integration in other Medical Devices.Add On ECG 1Ch Acq.Device NV FW11BSpecial edition for GE Health Care.
Published
2020-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07290110255572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110255572072901102555727290110255572

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.

Contacts#

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

Regulatory Flags#

DUNS number
514773159
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
07290110255367Norav 1200 Series PC-ECG1200WR1200WR-D-00-072019-09-27
07290110250591Receiver for 1200W with ECG trigger (TTL) outputPCECG 1200WR1200WR-D-00-012016-10-26
07290110251192Telemetry System. License + Software for up to 7 usersNM-700BT2017-01-03
07290110255008Norav 1200 Series PC-ECGSW P-MP200HASP-SW-K-P1-012019-10-02
07290110252502Norav 1200 Series PC-ECGECGLAN Green PCLAN-GREEN-PC-012019-09-30
07290110252519"ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3"" prin"ECG-LAN (Green)ECG-LAN-GREEN-K-00-012017-01-03
07290110251062ECG ECGUSB1D-EX-FW11/BECG Module2016-10-13
07290110255558Norav 1200 Series PC-ECGECGUSB1DEX KitECGUSB1DEX-K-00-UC3-082020-06-05
07290110255589Norav 1200 Series PC-ECGECGUSB1DEX KitECGUSB1DEX-K-00-EC3-102020-06-05
07290110255480Norav 1200 Series PC-ECG1200HRT Kit1200HRT-K-00-U-S10-032020-06-03
07290110255497Norav 1200 Series PC-ECG1200HRT1200HRT-D-00U-032020-06-03
07290110255411Norav 1200 Series PC-ECGSW I3HASP-SW-K-I3-012019-10-11
07290110252762Norav 1200 Series PC-ECGSW S1HASP-SW-K-S1-012019-10-02
07290110252779Norav 1200 Series PC-ECGSW S2HASP-SW-K-S2-012019-10-02
07290110252786Norav 1200 Series PC-ECGSW S2toS2HASP-SW-K-S2-S1-012019-10-02
07290110252793Norav 1200 Series PC-ECGSW S2-I1HASP-SW-K-S2I1-012019-10-02
07290110252809Norav 1200 Series PC-ECGSW S2-I1-D1HASP-SW-K-S2I1D1-012019-10-02
07290110252816Norav 1200 Series PC-ECGSW S2-I3-D1HASP-SW-K-S2I3D1-012019-10-02
07290110255022Norav 1200 Series PC-ECGSW S2-I2HASP-SW-K-S2I2-012019-10-02
07290110252601Norav 1200 Series PC-ECGSW S2-I2-D1HASP-SW-K-S2I2D1-012019-10-01

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