FDA.reportPublic FDA data

CardioDay V 2.5

Primary DI
04250903200144
Brand
CardioDay V 2.5
Company
getemed Medizin- und Informationstechnik AG
Model
Global
Catalog number
2092504-001
Device description
The CardioDay V2.5 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 V2.5 system is intended to be used by trained operatorsunder the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
Published
2017-04-03
Public version status
Update
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
04250903200144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250903200144042509032001444250903200144

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

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

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