AccessGUDID - DEVICE: ECG (07290110251062)

GUDID

Device Identifier (DI) Information

Brand Name: ECG
Version or Model: ECGUSB1D-EX-FW11/B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ECG Module
Company Name: NORAV MEDICAL LTD.

Primary DI Number: 07290110251062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514773159 *Terms of Use

Device Description: The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECG\Respiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31733	Electrocardiography telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b182dec0-c90c-4841-b0ad-21f3df33c757
Public Version Date: October 30, 2020
Public Version Number: 4
DI Record Publish Date: October 13, 2016