myCordella Patient Kit

GUDID 00850008997068

myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to doctors • Provides secure communication between patient and doctor • Provides access to patient education materials • Facilitates review of past measurements • Facilitates review of patient goals myCordella Peripherals Medical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.

Endotronix, Inc.

Bedside monitor remote-viewing software, physiological parameter

• Primary Device ID: 00850008997068
• NIH Device Record Key: 196d8dbd-8b06-4a1b-afe4-dec3b861e357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myCordella Patient Kit
• Version Model Number: 100171-00
• Company DUNS: 806850835
• Company Name: Endotronix, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com
• Phone: +1 888 512 5595
• Email: support@endotronix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008997068 [Primary]

FDA Product Code

• OEZ: Cardiovascular Procedure Kit

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: 2024-08-21
• Device Publish Date: 2024-08-13

Devices Manufactured by Endotronix, Inc.

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• 00850008997013 - myCordella Handheld Patient Reader: 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ
• 00850008997020 - Cordella Calibration Equipment: 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ
• 00850008997037 - myCordella Patient App: 2024-08-21 myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly softw
• 00850008997044 - myCordella Patient Management Portal: 2024-08-21 myCordella Patient Management Portal is a component of the myCordella Patient Kit. myCordella Patient Management Portal is a w
• 00850008997051 - Cordella Data Analysis Platform: 2024-08-21 The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patientâ
• 00850008997068 - myCordella Patient Kit: 2024-08-21myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An intuitive, user-friendly display screen that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to doctors • Provides secure communication between patient and doctor • Provides access to patient education materials • Facilitates review of past measurements • Facilitates review of patient goals myCordella Peripherals Medical or consumer health devices that measure blood pressure, heart rate, blood oxygen, and weight. The peripherals transmit information measured to the myCordella Tablet via wireless connection.
• 00850008997068 - myCordella Patient Kit: 2024-08-21 myCordella Patient Kit consists of the myCordella Tablet and Peripherals myCordella Tablet An intuitive, user-friendly display s