Cordella Data Analysis Platform

Primary DI
00850008997051
Brand
Cordella Data Analysis Platform
Company
Endotronix, Inc.
Model
100543-00
Device description
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System.The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader dataand processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOMSystem, Hemodynamic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOMSystem, Hemodynamic, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230040000Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.2024-06-20MOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008997051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008997051008500089970518500089970510850008997051

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pulmonary artery pressure monitoring systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888 512 5595support@endotronix.com

Regulatory Flags#

DUNS number
806850835
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008997037myCordella Patient App100256-022024-08-13
00850008997044myCordella Patient Management Portal100258-002024-08-13
00850008997068myCordella Patient Kit100171-002024-08-13
00850008997143myCordella Handheld Patient Reader Alloy100102-02 2025-10-13
00850008997006Cordella Sensor Delivery Kit100303-052024-08-14
00850008997013myCordella Handheld Patient Reader100102-012024-08-13
00850008997020Cordella Calibration Equipment100622-002024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415067054838CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
00850008997143myCordella Handheld Patient Reader AlloyEndotronix, Inc.MOM2025-10-13
00850008997006Cordella Sensor Delivery KitEndotronix, Inc.MOM2024-08-14
00850008997013myCordella Handheld Patient ReaderEndotronix, Inc.MOM2024-08-13
00850008997020Cordella Calibration EquipmentEndotronix, Inc.MOM2024-08-13
05414734509206CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-22
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