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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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System, Imaging, Pulsed Doppler, Ultrasonic
Healcerion Co., Ltd.
300L
Not in Commercial Distribution

  • 00860000879835 ()
300L

  • Extracorporeal ultrasound imaging transducer, mounted
Transducer, Ultrasonic, Diagnostic
Healcerion Co., Ltd.
300L
Not in Commercial Distribution

  • 00860000879828 ()
300L

  • Noninvasive vascular ultrasound system probe
System, Imaging, Pulse Echo, Ultrasonics
Healcerion Co., Ltd.
300C
Not in Commercial Distribution

  • 00860000879811 ()
300C

  • Noninvasive vascular ultrasound system probe
Transducer, Ultrasonic, Diagnostic
Healcerion Co., Ltd.
300C
Not in Commercial Distribution

  • 00860000879804 ()
300C

  • Noninvasive vascular ultrasound system probe
Case for storage/transport of ROSC-U, with wheels
RESUSCITATION INTERNATIONAL, LLC
A03-WB-000
In Commercial Distribution

  • 00860000876285 ()
A03-WB-000

  • Cardiac resuscitator, battery-powered
Case used for carrying and/or storage of ROSC-U
RESUSCITATION INTERNATIONAL, LLC
A03-PB-000
In Commercial Distribution

  • 00860000876278 ()
A03-PB-000

  • Cardiac resuscitator, battery-powered
Head Stabilizer used to limit head movement during resuscitation
RESUSCITATION INTERNATIONAL, LLC
A02-55-135
In Commercial Distribution

  • 00860000876261 ()
A02-55-135

  • Cardiac resuscitator, battery-powered
Battery Charger
RESUSCITATION INTERNATIONAL, LLC
A03-10-000
In Commercial Distribution

  • 00860000876254 ()
A03-10-000

  • Cardiac resuscitator, battery-powered
Disposables Pack, 5 ea of XL Torso Restraints and Head Stabilizer Covers
RESUSCITATION INTERNATIONAL, LLC
A02-60-134
In Commercial Distribution

  • 00860000876247 ()
A02-60-134

  • Cardiac resuscitator, battery-powered
Disposables Pack, 10 ea of Torso Restraints and Head Stabilizer Covers
RESUSCITATION INTERNATIONAL, LLC
A02-58-134
In Commercial Distribution

  • 00860000876230 ()
A02-58-134

  • Cardiac resuscitator, battery-powered
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