FDA.reportPublic FDA data

CardioSTAT

Primary DI
27540279250142
Brand
CardioSTAT
Company
Icentia Inc.
Model
10-006
Device description
CardioSTAT Installation Kit - ECG Recorder 14D Test
Published
2024-12-18
Public version status
Update
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
27540279250142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2754027925014227540279250142

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
Kit
true
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
17540279200027CardioSTAT10-0062025-12-08
17540279105018EART10-5012024-03-26
27540279250029CardioSTAT10-0062024-12-18
27540279250074CardioSTAT10-0062024-12-18
17540279200072CardioSTAT10-0062024-03-26
17540279200140CardioSTAT10-0062024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
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.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
08800069700178AT-PatchATsens Co., Ltd.DSH2022-12-23
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
15099169715117VitaloJAKVITALOGRAPH (IRELAND) LIMITEDDSH2021-06-18
08714729996545AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08714729996552AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
20851398007010Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC.DSH2019-12-20
30851398007017Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC.DSH2019-12-20