myCordella Handheld Patient Reader

Basic Information

• Brand Name: myCordella Handheld Patient Reader
• Primary DI: 00850008997013
• Version / Model: 100102-01
• Company Name: Endotronix, Inc.
• Labeler DUNS: 806850835
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-13
• Public Version: 1
• Public Version Date: 2024-08-21
• Public Version Status: New
• Public Device Record Key: 1519373d-3597-4fd2-a2dd-095bba80fdfb

Device Description

The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System. The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOM	System, Hemodynamic, Implantable	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61178	Implantable pulmonary artery pressure monitoring system	An assembly of devices intended for regular (e.g., daily) measurement and recording of pulmonary artery pressures, to assist monitoring and treatment of a heart disease patient at high-risk of heart failure. It includes a sensor intended to be implanted in the pulmonary artery, an external monitoring system(s), information software, and typically devices associated with implantation. The monitoring system(s) are intended to wirelessly power and interrogate the implanted sensor via an antenna, and display/record/communicate arterial blood pressure information (e.g., systolic, diastolic and mean pressures, heart rate). It is intended for monitoring in both the home and healthcare facility.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850008997013	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P230040	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 6 – 93 Percent (%) Relative Humidity