FDA.reportPublic FDA data

CardioSTAT

Primary DI
17540279200027
Brand
CardioSTAT
Company
Icentia Inc.
Model
10-006
Device description
CardioSTAT ECG Recorder 2D Test
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223049000CardioSTAT® ECG Test SolutionIcentia, Inc.2023-03-22DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27540279200024PackageGS110In Commercial Distribution
17540279200027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2754027920002427540279200024
1754027920002717540279200027

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
241983607
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540279100020OFIX10-0022024-03-26
17540279105018EART10-5012024-03-26
27540279250029CardioSTAT10-0062024-12-18
27540279250074CardioSTAT10-0062024-12-18
27540279250142CardioSTAT10-0062024-12-18
17540279200072CardioSTAT10-0062024-03-26
17540279200140CardioSTAT10-0062024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
P00020eWave Electrode PatchWearlinq, Inc.DSH2026-07-14
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406470ABPMpro cuff for right armSOMNOmedics AGDSH2026-07-07
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-06-22
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22