CORTEX CPET System

GUDID 74250179233555

The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic capacity. With the following indications, they support the user in finding or confirming diagnoses, determining therapy programs and monitoring therapies. In a CPET test, a patient undergoes a period of defined physical stress (normally 10-20 minutes). Hereby data is measured about ventilation, gas exchange and heart rate. On basis of these measured data, further data is calculated and displayed, in order to depict the performance of the cardio-respiratory system. In a spirometry test, the patient performs defined breathing maneuvers (VC, FVC, MVV). Thereby measurement data of the respiratory strength and volume is collected and displayed, in order to show the mechanical capacity of the respiratory system. In a Basal-/Resting Metabolic Rate Test the patient performs a rest test (normally 15-20 minutes). Thereby measurement data of the gas exchange is collected and displayed, in order to estimate the Basal-/Resting Metabolic Rate.

Cortex Biophysik GmbH

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• Primary Device ID: 74250179233555
• NIH Device Record Key: 348cfdfe-b7c1-41c1-9227-22ad26b469d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORTEX CPET System
• Version Model Number: MetaLyzer3B
• Company DUNS: 330956525
• Company Name: Cortex Biophysik GmbH
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com
• Phone: +49 341487490
• Email: info@cortex-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	74250179233555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993641

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

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: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [CORTEX CPET System]

• 74250179233555: The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic
• 74250179232794: The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic