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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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OmniME - 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

OmniFlow Therapy System - 00858703006276

Software and sensor designed to provide visual feedback to respiratory patients.
ACCELERATED CARE PLUS CORP
100FLO
In Commercial Distribution

  • 00858703006276 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

Pinestar Technology Inc - 00850021301460

Jumbo Flood Phantom
PINESTAR TECHNOLOGY, INC.
NMC-76801
In Commercial Distribution

  • 00850021301460 ()


  • Nuclear medicine phantom, flood source

Pinestar Technology Inc - 00850021301453

Flood Phantom
PINESTAR TECHNOLOGY, INC.
76-801
In Commercial Distribution

  • 00850021301453 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470051

Square 12" x 12" Phantom Co 57
RADQUAL, LLC
BM55
In Commercial Distribution

  • 00850020470051 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470044

Rect 10" x 16" Phantom Co 57
RADQUAL, LLC
BM07
In Commercial Distribution

  • 00850020470044 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470037

Square Digirad Phantom Co 57
RADQUAL, LLC
BM05
In Commercial Distribution

  • 00850020470037 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470020

Rect 14" x 18" Phantom Co 57
RADQUAL, LLC
BM04
In Commercial Distribution

  • 00850020470020 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470006

Rect 18" x24" Phantom Co 57
RADQUAL, LLC
BM01
In Commercial Distribution

  • 00850020470006 ()


  • Nuclear medicine phantom, flood source

Pathway - 00852423006134

Pathway® TR-10C Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10C
In Commercial Distribution

  • 00852423006134 ()
8615

  • Kinesiology/electromyographic sensor set
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