Norav NR Series NR12073-D-00E-06

GUDID 07290110255374

Norav Wireless 3In1 Acquisition Device NR3 for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.

NORAV MEDICAL LTD.

Electrocardiographic ambulatory recorder
Primary Device ID07290110255374
NIH Device Record Keyb838c2e2-084d-474e-b1f4-bdded183b367
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorav NR Series
Version Model NumberNR1207-3
Catalog NumberNR12073-D-00E-06
Company DUNS514773159
Company NameNORAV MEDICAL LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97249893001
Emailinfo@norav.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110255374 [Primary]

FDA Product Code

MWJElectrocardiograph, Ambulatory (Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-09-30

On-Brand Devices [Norav NR Series]

07290110255381Norav Wireless ECG Acquisition Device NR3 for Resting-ECG with IEC type labelling.
07290110255374Norav Wireless 3In1 Acquisition Device NR3 for Resting-ECG combined with Respiration and Body-Mo
07290110254896Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Mo
07290110254889Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Mo
07290110254872Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Mo
07290110254773Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with AHA type labelling.
07290110254766Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with AHA type labelling.
07290110254759Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with IEC type labelling.
07290110254711Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
07290110254704Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
07290110254698Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
07290110254681Kit includes: Norav Telemetry ECG Acquisition Device NR1 (UDI: 07290110253332) for Telemetry R
07290110254636Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with AHA type la
07290110254629Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with AHA type la
07290110254612Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with IEC type la
07290110254605Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG M
07290110254582Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG M
07290110254575Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG M
07290110254568Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG M
07290110254551Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG M
07290110254544Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254513) for Ambulatory ECG M
07290110254537Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110254520Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110254513Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110254506Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
07290110254483Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
07290110254476Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254421) for Ambulatory ECG M
07290110254469Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
07290110254452Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
07290110254445Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254414) for Ambulatory ECG M
07290110254438Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110254421Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110254414Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110253332Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with IEC type la
07290110253134Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Mo
07290110253097Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with IEC type labelling.
07290110253073Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
07290110253066Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110253059) for Ambulatory ECG M
07290110253059Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110253042Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110253035) for Ambulatory ECG M
07290110253035Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
07290110255404Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) for Resting-ECG wit
07290110255343Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG co
07290110255213Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG co
07290110255206Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG wit
07290110254919Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) for Resting-ECG co
07290110254902Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG co
07290110254834Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Resting-ECG wit
07290110254827Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG wit
07290110254810Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG wit

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