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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Retia Medical - 00860001506457

Drager Interface Cable (14-pin MDR)
RETIA MEDICAL, LLC
FG-006
In Commercial Distribution

  • 00860001506457 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506440

GE Interface Cable (7-pin Mini-DIN)
RETIA MEDICAL, LLC
FG-005
In Commercial Distribution

  • 00860001506440 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506433

Transducer Interface Cable
RETIA MEDICAL, LLC
FG-004
In Commercial Distribution

  • 00860001506433 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506426

GE Interface Cable (9-pin PDM)
RETIA MEDICAL, LLC
FG-003
In Commercial Distribution

  • 00860001506426 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506419

Philips Interface Cable (3.5 mm Stereo Jack)
RETIA MEDICAL, LLC
FG-002
In Commercial Distribution

  • 00860001506419 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506402

The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit or the operating room.
RETIA MEDICAL, LLC
FG-001
In Commercial Distribution

  • 00860001506402 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506488

Argos Serial Connectivity Kit
RETIA MEDICAL, LLC
FG-009
In Commercial Distribution

  • 00860001506488 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506471

Argos LAN Connectivity Kit
RETIA MEDICAL, LLC
FG-008
In Commercial Distribution

  • 00860001506471 ()


  • Noninvasive haemodynamic monitoring system

Retia Medical - 00860001506464

Spacelabs Interface Cable
RETIA MEDICAL, LLC
FG-007
In Commercial Distribution

  • 00860001506464 ()


  • Noninvasive haemodynamic monitoring system

DeepRhythm Platform - 05903021560698

The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place.
MEDICALGORITHMICS S A
DeepRhythm Platform
In Commercial Distribution

  • 05903021560698 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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