CardioDay V 2.5 2092504-001

GUDID 04250903200144

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 operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.

getemed Medizin- und Informationstechnik AG

Electrocardiographic ambulatory recorder

• Primary Device ID: 04250903200144
• NIH Device Record Key: a2766ef2-e968-40a2-95ca-e26ad61d3447
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioDay V 2.5
• Version Model Number: Global
• Catalog Number: 2092504-001
• Company DUNS: 331682898
• Company Name: getemed Medizin- und Informationstechnik AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903200144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162023

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-04-03

Devices Manufactured by getemed Medizin- und Informationstechnik AG

• 04250903202636 - SEER 1000: 2023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202643 - SEER 1000: 2023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202650 - SEER 1000: 2023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202520 - CardioDay: 2023-07-31 The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulator
• 04250903200724 - SEER 1000: 2021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903200731 - SEER 1000: 2021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903200748 - SEER 1000: 2021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
• 04250903202469 - CardioDay: 2021-06-03 The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulator