CardioDay 2092504-260

GUDID 04250903202469

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.

getemed Medizin- und Informationstechnik AG

Electrocardiographic ambulatory recorder

• Primary Device ID: 04250903202469
• NIH Device Record Key: d2160f5b-4c88-427d-95eb-5525147bcb8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioDay
• Version Model Number: v2.6 Global
• Catalog Number: 2092504-260
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250903202469 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-03
• Device Publish Date: 2021-05-26

On-Brand Devices [CardioDay ]

• 04250903202469: The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review,
• 04250903202520: The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review,