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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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Heidelberg pH Capsule System - B989HCNS180

The Heidelberg pH capsule system software package intended to add image processing and/or analysis capabilities to a gastric and gastrointestinal telemetric monitoring system used to help diagnose gastric pH disorders and/or measure gastric and gastrointestinal pH via wirelessly transmitted signals from a pH telemetric capsule swallowed by the patient. It may be installed in a portable hand-held receiver or in a computing device to which measured data that is transmitted by a transceiver.
Heidelberg Medical Inc
Heidelberg pH Capsule System Software
In Commercial Distribution

  • B989HCNS180 ()
HCNS18

  • Gastrointestinal telemetric monitoring system application software

Radius T - 00843997016162

Radius T Sensor for Masimo SafetyNet
MASIMO CORPORATION
4779
In Commercial Distribution

  • 00843997016162 ()


  • Wireless patient thermometer, single-use

Radius PPG - 00843997016155

Radius PPG & Radius T for Masimo SafetyNet Kit
MASIMO CORPORATION
4778
In Commercial Distribution

  • 00843997016155 ()


  • Wireless patient thermometer, single-use

Radius T - 00843997004473

Radius T Continuous Thermometer
MASIMO CORPORATION
4823
In Commercial Distribution

  • 00843997004473 ()


  • Wireless patient thermometer, single-use

TempTraq® - 00851203006340

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006340 ()

  • Duration: 72 Hours
634

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006326

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006326 ()
632

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006319

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006319 ()
631

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006302

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006302 ()

  • Duration: 72 Hours
630

  • Wireless patient thermometer, single-use

TempTraq® - 00851203006296

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
In Commercial Distribution

  • 00851203006104 ()
  • 00851203006296 ()

  • Duration: 72 Hours


  • Wireless patient thermometer, single-use

Cell Therapy 360 Wearable Tech V1 - 00851203006227

No Description
BLUE SPARK TECHNOLOGIES, INC.
TT-300
Not in Commercial Distribution

  • 00851203006104 ()
  • 00851203006227 ()

  • Duration: 72 Hours
622

  • Wireless patient thermometer, single-use
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