FDA.reportPublic FDA data

CardioDay

Primary DI
04250903202469
Brand
CardioDay
Company
getemed Medizin- und Informationstechnik AG
Model
v2.6 Global
Catalog number
2092504-260
Device description
The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data.Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
Published
2021-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162023000CardioDay V2.5Getemed Medizin- Und Informationstechnik AG2017-03-24DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250903202469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250903202469042509032024694250903202469

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
331682898
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250903203381CardioMem CM 4000 B2026-05-01
04250903200724SEER 100024 hour - Korean2067634-0672021-06-17
04250903200731SEER 100048 hour - Korean2067634-0682021-06-17
04250903200748SEER 1000 7 day - Korean2067634-0692021-06-17
04250903200991SEER 100024 Hour - Korean2067634-0672025-03-14
04250903201011SEER 100048 Hour - Korean2067634-0682025-03-14
04250903201035SEER 1000 7 Day - Korean2067634-0692025-03-14
04250903200878SEER 100024 hour - UNI2067634-0582025-03-04
04250903200892SEER 100048 hour - UNI2067634-0592025-03-04
04250903200915SEER 1000 7 day - UNI2067634-0602025-03-04
04250903201080SEER 100024 hour - CA2067634-1752025-03-04
04250903201103SEER 100048 hour - CA2067634-1762025-03-04
04250903201127SEER 1000 7 day - CA2067634-1772025-03-04
04250903201585ECG Cable for SEER 10005 Leads, 75 cm, IEC Color Code2104810-0012019-09-12
04250903201592ECG Cable for SEER 10007 Leads, 75 cm, IEC Color Code2104811-0012019-09-12
04250903201608ECG Cable for SEER 10005 Leads, 105 cm, IEC Color Code2104812-0012019-09-12
04250903201615ECG Cable for SEER 10007 Leads, 105 cm, IEC Color Code2104813-0012019-09-12
04250903201622ECG Cable for SEER 10005 Leads, 75 cm, AHA Color Code2104814-0012019-09-12
04250903201639ECG Cable for SEER 10007 Leads, 75 cm, AHA Color Code2104815-0012019-09-12
04250903201646ECG Cable for SEER 10005 Leads, 105 cm, AHA Color Code2104816-0012019-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403523437HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
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
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19