RhythmStar System

Primary DI
00868282000237
Brand
RhythmStar System
Company
RHYTHMEDIX, LLC
Model
SL
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K250793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250793000RhythmStar System (SL)RhythMedix, LLC2026-04-21QYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868282000237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868282000237008682820002378682820002370868282000237

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Regulatory Flags#

DUNS number
058907377
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868282000220RhythmStarRS-100032020-09-08
00868282000206RhythmStarRS-100022016-09-01
00868282000213RhythmStarRS-10002V2019-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640375610041SmartCardia 7L PlatformSmartCardia SAQYX2026-04-24
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