AccessGUDID - DEVICE: RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER (07290008960267)

GUDID

Device Identifier (DI) Information

Brand Name: RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
Version or Model: E-560-0 / E-561-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHL TELEMEDICINE INTERNATIONAL LTD.

Primary DI Number: 07290008960267
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531817906 *Terms of Use

Device Description: The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results.

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?
62641	Electrocardiograph, home-use	A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXH	Transmitters And Receivers, Electrocardiograph, Telephone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063609	000

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
Storage Environment Temperature: between -20 and 65 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 0 and 45 Degrees Celsius
Handling Environment Atmospheric Pressure: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Length: 90 Millimeter
Width: 75 Millimeter
Depth: 30 Millimeter
Weight: 200 Gram

Device Record Status

Public Device Record Key: 4752d3fc-7d8c-4d67-a947-b699a870c10e
Public Version Date: August 30, 2023
Public Version Number: 1
DI Record Publish Date: August 22, 2023