Identity
- Trade Name
- Cordella Data Analysis Platform 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. 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 data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data. FDA UDI
- Model / Reference
- 100543-00 FDA UDI
- 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 data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008997051 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Implantable pulmonary artery pressure monitoring system
Cordella Data Analysis Platform 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.
- CardioMEMS™ — Cardiomems, Inc. · Class III
- CardioMEMS™ — ST. JUDE MEDICAL, INC. · Class III
- CardioMEMS™ — ST. JUDE MEDICAL, INC. · Class III
- CardioMEMS™ — ST. JUDE MEDICAL, INC. · Class III
- CardioMEMS™ — Cardiomems, Inc. · Class III
- CardioMEMS™ — ST. JUDE MEDICAL, INC. · Class III
- CardioMEMS™ — ST. JUDE MEDICAL, INC. · Class III
- Merlin.net — Cardiomems, Inc. · Class III
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endotronix, Inc.
Sources (1)
- FDA UDI cd1abb1e-9b43-4a20-9c8b-0f4b3d7181a0 35 fields · synced May 30, 2026