SmartCardia 7L Platform

Primary DI
07640375610041
Brand
SmartCardia 7L Platform
Company
SmartCardia SA
Model
1007L
Device 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.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QYXOutpatient Cardiac Telemetry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYXOutpatient Cardiac TelemetryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240653000SmartCardia 7L Platform (MCT)Smartcardia SA2024-10-31QYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640375610041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640375610041076403756100417640375610041

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn 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.

Regulatory Flags#

DUNS number
487152899
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640375610058SmartCardia 7L PlatformSC-100-072026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00868282000237RhythmStar SystemRHYTHMEDIX, LLCQYX2026-04-29
07640375610058SmartCardia 7L PlatformSmartCardia SAQYX2026-04-24
05903021560834DeepRhythmAIMEDICALGORITHMICS S AQYX2026-03-25
05903021560742DeepRhythmAIMEDICALGORITHMICS S AQYX2025-06-06
05903021560131DeepRhythmAIMEDICALGORITHMICS S AQYX2022-08-05
00868282000220RhythmStarRHYTHMEDIX, LLCQYX2020-09-08
00860000272407Rhythm ExpressVIVAQUANT, INC.QYX2020-07-27
00869770000210ZIO AT PatchIRHYTHM TECHNOLOGIES, INC.QYX2019-04-23