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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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uCor Heart Failure and Arrhythmia Management System - 00855778005302

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005302 ()
10A1071

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Patch - 00855778005258

No Description
ZOLL MANUFACTURING CORPORATION
Patch
In Commercial Distribution

  • 00855778005258 ()
10A1067

  • Wearable multiple vital physiological parameter monitoring system

Empatica Health Monitoring Platform - 00853858006263

No Description
EMPATICA SRL
Care Portal
In Commercial Distribution

  • 00853858006263 ()


  • Multiple vital physiological parameter monitoring system, home-use

Empatica Health Monitoring Platform - 00853858006256

No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use

Empatica Health Monitoring Platform - 00853858006249

No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use

Empatica Health Monitoring Platform - 00853858006232

No Description
EMPATICA SRL
EmbracePlus
In Commercial Distribution

  • 00853858006232 ()
EMBP-CC-MS

  • Multiple vital physiological parameter monitoring system, home-use

Embrace Neonatal MRI System - 00858755006309

The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
ASPECT IMAGING LTD
Embrace
In Commercial Distribution

  • 00858755006309 ()
70007000

  • Full-body MRI system, permanent magnet

SPY-Q™ or SPY-QCM™ - 00858701006018

No Description
Novadaq Technologies Inc
SQ3500
In Commercial Distribution

  • 00858701006018 ()


  • Angiographic x-ray system application software

Tempus IC2 - 05060472442949

Tempus IC2 Patient Monitor
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-2001-R
Not in Commercial Distribution

867374

  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472442932

Tempus Pro - Printer, SpO2, NIBP, ECG, ETCO2, Temp & IBP
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1026-R
In Commercial Distribution

867423

  • Multiple vital physiological parameter monitoring system, clinical
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