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myCordella Handheld Patient Reader

FDA UDI

Class III (US FDA UDI)

by Endotronix, Inc.

Identity

Trade Name
myCordella Handheld Patient Reader FDA UDI
Generic Name
Implantable pulmonary artery pressure monitoring system FDA UDI
Device Name
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. FDA UDI
Model / Reference
100102-01 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00850008997013 FDA UDI
PMA Number
P230040 FDA UDI
FDA Product Code
MOM FDA UDI
GMDN Term
Implantable pulmonary artery pressure monitoring system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Implantable pulmonary artery pressure monitoring system

myCordella Handheld Patient Reader by Endotronix, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable pulmonary artery pressure monitoring system.

Cleared under the same submission

P230040 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endotronix, Inc.

Sources (1)

  • FDA UDI 1519373d-3597-4fd2-a2dd-095bba80fdfb 36 fields · synced May 31, 2026