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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

MicroFit - 00868127000200

Multi-component device that connects to a user’s PC computer for measurement, tracking, and reporting of body weight and blood pressure. Device consists of a stand-on body weight scale, non-invasive automatic blood pressure monitor, analog to digital interface unit (CTI), and software (to be installed on the user’s PC computer).
MICROFIT, INC.
FAS-2
In Commercial Distribution

  • 00868127000200 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable
  • Stand-on floor scale, electronic

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

Merit Medical® - 00884450361054

No Description
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
00884450361054
In Commercial Distribution

  • 10884450361051 ()
  • 00884450361054 ()


  • Electrical-only medical device connection cable, reusable
  • Injectate temperature probe

Transonic - 08774660005744

No Description
TRANSONIC SYSTEMS INC.
HCS3002
Not in Commercial Distribution

  • 08774660005744 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660005737

No Description
TRANSONIC SYSTEMS INC.
HCS3021
Not in Commercial Distribution

  • 08774660005737 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660005720

No Description
TRANSONIC SYSTEMS INC.
HCS3012
Not in Commercial Distribution

  • 08774660005720 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660005713

No Description
TRANSONIC SYSTEMS INC.
HCS3011
Not in Commercial Distribution

  • 08774660005713 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000411

No Description
TRANSONIC SYSTEMS INC.
HFW1000
Not in Commercial Distribution

  • 08774660000411 ()


  • Thermal-dilution cardiac output unit

Transonic - 08774660000367

No Description
TRANSONIC SYSTEMS INC.
HCS3002-5
Not in Commercial Distribution

  • 08774660000367 ()


  • Thermal-dilution cardiac output unit
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