CardioSen'C

Basic Information

• Brand Name: CardioSen'C
• Primary DI: 07290008960250
• Version / Model: 4.2
• Company Name: SHL TELEMEDICINE INTERNATIONAL LTD.
• Labeler DUNS: 531817906
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-21
• Public Version: 1
• Public Version Date: 2023-08-29
• Public Version Status: New
• Public Device Record Key: 24c662a5-bf41-444b-b112-b266225fcca5

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290008960250	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080047	000

Device Sizes

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius