AccessGUDID - DEVICE: Norav 1200 Series PC-ECG (07290110255367)

GUDID

Device Identifier (DI) Information

Brand Name: Norav 1200 Series PC-ECG
Version or Model: 1200WR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1200WR-D-00-07
Company Name: NORAV MEDICAL LTD.

Primary DI Number: 07290110255367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514773159 *Terms of Use

Device Description: PC-ECG Wireless Receiver Device for Stress-Test ECG. The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System. Special edition for GE Health Care.

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:	No
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?
36365	Electrocardiography monitoring system receiver	An electrically-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).	Active	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: b4eeb5b6-6e2b-41c7-aaf4-b4200c3f7c5b
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: September 27, 2019