Cordiana Dx16

GUDID 07649988821110

DICOM ECG Viewer/Editor

Cordiana Medical Informatics AG

Cardiology information system application software

• Primary Device ID: 07649988821110
• NIH Device Record Key: c6b3dbe3-9f69-4bf6-b5d2-d584b87e300a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cordiana Dx16
• Version Model Number: 0160100
• Company DUNS: 480226145
• Company Name: Cordiana Medical Informatics 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: false
• 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	07649988821110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201060

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: 2022-05-20
• Device Publish Date: 2022-05-12