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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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Software ELI LINK
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094312812 ()
107347

  • Electrocardiograph, professional, multichannel
SOFTWARE HSCRIBE v6.2.0
WELCH ALLYN, INC.
901000
In Commercial Distribution

  • 00732094281330 ()
11110-003-50

  • Electrocardiographic long-term ambulatory recording analyser application software
Q-STRESS SOFTWARE V4.60
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272352 ()
11090-001-50

  • Electrocardiographic lead set, reusable
Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system
Software Version 10.0.2
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838114258 ()


  • General-purpose ultrasound imaging system
Software Version 10.0.2
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838114241 ()


  • General-purpose ultrasound imaging system
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838059313 ()
867019

  • Bedside information system application software
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software
In Commercial Distribution

  • 00884838092099 ()
867019

  • Bedside information system application software
IntelliVue XDS Software
Philips Medizin Systeme Böblingen GmbH
IntelliVue XDS Software - R
In Commercial Distribution

  • 00884838123175 ()
867019

  • Bedside information system application software
Software version-10.0.X
Philips Ultrasound LLC
795204
In Commercial Distribution

  • 00884838114128 ()
795206

  • General-purpose ultrasound imaging system
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