Norav 1200 Series ECGUSB1DEX-K-00-06

GUDID 04260498565856

Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in other Medical Devices (GE Wuxi). Special edition for GE Health Care.

Norav Medical GmbH

Electrocardiographic signal amplifier
Primary Device ID04260498565856
NIH Device Record Key5a884484-ee27-42fd-81a8-71ed177d5aa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorav 1200 Series
Version Model NumberECGUSB1DEX Kit
Catalog NumberECGUSB1DEX-K-00-06
Company DUNS341318999
Company NameNorav Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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+4961345679830
Emailinfo@norav.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104260498565856 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2019-12-05

On-Brand Devices [Norav 1200 Series]

04260498565856Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in
04260498566099Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in
04260498564262Single Channel ECG Acquisition Module for integration in other Medical Devices. Special edition
04260498564255Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in
04260498566891Single Channel ECG Acquisition Module for integration in other Medical Devices. Special edition
04260498566884Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in
04260498567003Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in

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