AccessGUDID - DEVICE: High Resolution 12 lead ECG (07290110252892)

GUDID

Device Identifier (DI) Information

Brand Name: High Resolution 12 lead ECG
Version or Model: PCECG 1200HR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1200HR-D-00U-01
Company Name: NORAV MEDICAL LTD.

Primary DI Number: 07290110252892
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514773159 *Terms of Use

Device Description: PC-ECG Acquisition Device for Resting-ECG and Stress-Test ECG applications with AHA labelling. The very high signal resolution allows the device to be used for scientific diagnostics (e.g. Late Potential or HRV).

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?
36719	Electrocardiographic signal amplifier	An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.	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: No 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: c10f0944-376a-487e-9c8c-7cf0568af880
Public Version Date: September 27, 2019
Public Version Number: 7
DI Record Publish Date: October 26, 2016