DEVICE: CardioDay (04250903202469)
Device Identifier (DI) Information
CardioDay
v2.6 Global
In Commercial Distribution
2092504-260
getemed Medizin- und Informationstechnik AG
v2.6 Global
In Commercial Distribution
2092504-260
getemed Medizin- und Informationstechnik AG
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35162 | Electrocardiographic ambulatory recorder |
An 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).
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FDA Product Code
[?]Product Code | Product Code Name |
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DQK | Computer, Diagnostic, Programmable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K162023 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
d2160f5b-4c88-427d-95eb-5525147bcb8c
June 03, 2021
1
May 26, 2021
June 03, 2021
1
May 26, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined