FDA.reportPublic FDA data

Norav NR Series

Primary DI
07290110253073
Brand
Norav NR Series
Company
NORAV MEDICAL LTD.
Model
NR1207
Catalog number
NR1207-D-00E-01
Device description
Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, IEC type labelling.
Published
2019-09-30
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
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110253073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110253073072901102530737290110253073

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Sterilization Methods#

Method table
Method

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250903203381CardioMem getemed Medizin- und Informationstechnik AGMWJ2026-05-01
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.MWJ2025-12-17
10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131394Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131400Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.MWJ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.MWJ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.MWJ2025-04-02
00860004541745ANNE ChestSibel Health Inc.MWJ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.MWJ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.MWJ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.MWJ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.MWJ2025-03-26
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04