AccessGUDID - DEVICE: myCordella Handheld Patient Reader (00850008997013)

GUDID

Device Identifier (DI) Information

Brand Name: myCordella Handheld Patient Reader
Version or Model: 100102-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Endotronix, Inc.

Primary DI Number: 00850008997013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806850835 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MOM	System, Hemodynamic, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230040	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 6 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1519373d-3597-4fd2-a2dd-095bba80fdfb
Public Version Date: August 21, 2024
Public Version Number: 1
DI Record Publish Date: August 13, 2024