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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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NA - 00690103181463

CABLE,EKG F/USE W/DATEX N/S AS/3 PATIENT MONITOR
Edwards Lifesciences LLC
64EKD
In Commercial Distribution

  • 00690103181463 ()

  • Length: 8 Feet
64EKD

  • Electrocardiographic lead set, reusable

Transonic - 00877466000413

No Description
TRANSONIC SYSTEMS INC.
HFW1000
In Commercial Distribution

  • 00877466000413 ()


  • Thermal-dilution cardiac output unit

ScvO2 function upgrade kit - 06944904096773

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046900-00
In Commercial Distribution

  • 06944904096773 ()


  • General-purpose multi-parameter bedside monitor

SCVO2 Module(Package/no accessory) - 06944904096742

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046927-00
In Commercial Distribution

  • 06944904096742 ()


  • General-purpose multi-parameter bedside monitor

CCO/SvO2 update kit(international) - 06944904096735

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-046929-00
In Commercial Distribution

  • 06944904096735 ()


  • General-purpose multi-parameter bedside monitor

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

Retia Medical - 00860001506495

Argos Monitor Power Supply and AC Cord
RETIA MEDICAL, LLC
FG-010
In Commercial Distribution

  • 00860001506495 ()


  • 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
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