AccessGUDID - DEVICE: Norav 1200 Series PC-ECG (07290110252663)

GUDID

Device Identifier (DI) Information

Brand Name: Norav 1200 Series PC-ECG
Version or Model: SW M1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HASP-SW-K-M1-01
Company Name: NORAV MEDICAL LTD.

Primary DI Number: 07290110252663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514773159 *Terms of Use

Device Description: Norav 1200 Series PC-ECG Software Kit with the following Option(s): - M1 = Continuous Resting-ECG Monitoring The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

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?
37175	Patient monitoring system module, electrocardiographic, long-term recording	A small dedicated unit used for long-term (typically 24-hours or longer) registration of the electrical activity of a patient's heart, typically while the patient lies in bed. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the heart activity information measured by this module. The signals are stored, e.g., on a cassette (magnetic tape) or digital medium for later analysis on a Holter analyser.	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: bc381bd2-efe0-4414-8280-0f23d820c8b2
Public Version Date: October 09, 2019
Public Version Number: 1
DI Record Publish Date: October 01, 2019