Device
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external elect...
Manufacturer
SmartCardia SA
Model: 1007L DI: 07640375610041 Status: New MRI: MR Unsafe Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-24 Current Version: 2026-05-04
Description
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 092046a1-736a-453d-b8bb-9dcc649ebe06
Distribution Status: In Commercial Distribution
DUNS Number: 487152899
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 07640375610041
Type: Primary
Issuing Agency: GS1
GMDN
Code: 33586
Name: General-purpose multi-parameter bedside monitor
Definition:
An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.
FDA Product Codes
QYX
Outpatient Cardiac Telemetry
Premarket Submissions
Submission Number: K240653
Supplement Number: 000