FDA.reportPublic FDA data

Telemetry System. License + Software for up to 7 users

Primary DI
07290110251192
Brand
Telemetry System. License + Software for up to 7 users
Company
NORAV MEDICAL LTD.
Model
NM-700BT
Device description
The NM-700 model, which is part of the PCECG1200 system, is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value.
Published
2017-01-03
Public version status
Update
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
07290110251192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110251192072901102511927290110251192

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system receiverA mains electricity (AC-powered) component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
514773159
Device count
1
Kit
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
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
07290110255572Norav 1200 Series PC-ECGECGUSB1DEXECGUSB1DEX-D-00-102020-06-05
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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