AccessGUDID - DEVICE: Cordella Calibration Equipment (00850008997020)

GUDID

Device Identifier (DI) Information

Brand Name: Cordella Calibration Equipment
Version or Model: 100622-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Endotronix, Inc.

Primary DI Number: 00850008997020
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. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System. The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include: • Interrogates the Cordella Sensor to verify proper working condition. • Facilitates linking of component serial numbers to patient IDs. • Calibrates the Cordella Sensor to a reference pressure at the time of implantation. • Trains patient on optimal Reader placement post-procedure. • Recalibrates the Cordella Sensor to a reference pressure post-implant. • CalEQ is operated by Endotronix personnel only.

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 -20 and 45 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 651126b8-5057-45b1-8a43-24072b37d9db
Public Version Date: August 21, 2024
Public Version Number: 1
DI Record Publish Date: August 13, 2024