myCordella Patient Kit

Basic Information

• Brand Name: myCordella Patient Kit
• Primary DI: 00850008997068
• Version / Model: 100171-00
• 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: 2
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: 196d8dbd-8b06-4a1b-afe4-dec3b861e357

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
OEZ	Cardiovascular Procedure Kit	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66386	Bedside monitor remote-viewing software, physiological parameter	An application software program intended to be installed on a non-medical off-the-shelf device (e.g., computer/smartphone/tablet) to allow a healthcare professional to view real-time and historical patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from bedside monitors via data transmission through a centralized patient monitor or data network server. It is designed for viewing data only as a remote or telemedicine application (e.g., in a hospital patient monitoring room, or clinician’s office) intended to support, and not replace, standard patient monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850008997068	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity