AccessGUDID - DEVICE: CardioSen'C (07290008960250)

GUDID

Device Identifier (DI) Information

Brand Name: CardioSen'C
Version or Model: 4.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHL TELEMEDICINE INTERNATIONAL LTD.

Primary DI Number: 07290008960250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531817906 *Terms of Use

Device Description: The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG-modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’sintegrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting 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 [?]
K080047	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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 300 Gram
Height: 4 Centimeter
Width: 7 Centimeter
Length: 13 Centimeter
Device Size Text, specify: Belt (Length) :29 cm

Device Record Status

Public Device Record Key: 24c662a5-bf41-444b-b112-b266225fcca5
Public Version Date: August 29, 2023
Public Version Number: 1
DI Record Publish Date: August 21, 2023