myCordella Handheld Patient Reader Alloy

Primary DI
00850008997143
Brand
myCordella Handheld Patient Reader Alloy
Company
Endotronix, Inc.
Model
100102-02
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.
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
P230040012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230040012Cordella Pulmonary Artery Sensor System (CorPASS)Endotronix, Inc.2024-06-20MOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008997143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008997143008500089971438500089971430850008997143

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity6 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
806850835
Device count
1
Serial number
true
Manufacturing date on label
true

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
00850008997006Cordella Sensor Delivery Kit100303-052024-08-14
00850008997013myCordella Handheld Patient Reader100102-012024-08-13
00850008997020Cordella Calibration Equipment100622-002024-08-13
00850008997051Cordella Data Analysis Platform100543-002024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067047014CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067047021CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067047038CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067047045CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067048325CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067049612CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067054838CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
00850008997006Cordella Sensor Delivery KitEndotronix, Inc.MOM2024-08-14
00850008997013myCordella Handheld Patient ReaderEndotronix, Inc.MOM2024-08-13
00850008997020Cordella Calibration EquipmentEndotronix, Inc.MOM2024-08-13
00850008997051Cordella Data Analysis PlatformEndotronix, Inc.MOM2024-08-13
05414734509206CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-22
05414734509220CardioMEMS™CARDIOMEMS, INC.MOM2023-06-22
05414734509268CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-22
05414734509183CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509190CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509213CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509251CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509275CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509282CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509299CardioMEMS™CARDIOMEMS, INC.MOM2023-06-21
05414734509312CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509398CardioMEMS™CARDIOMEMS, INC.MOM2023-06-21
05414734509909CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509916CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509923CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509978CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734510257CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05415067034724CardioMEMS™CARDIOMEMS, INC.MOM2022-04-27
05415067034731CardioMEMS™CARDIOMEMS, INC.MOM2022-04-27