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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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Magic Wand® Micro HV-60, personal hand-held electronic massage apparatus, variable speed.
VIBRATEX, INC.
Micro HV-60
In Commercial Distribution

  • 10860003633820 ()
  • 00860003633823 ()


  • Hand-held electric massager
Magic Wand® Mini HV-135, personal hand-held electronic massage apparatus, variable speed.
VIBRATEX, INC.
Mini HV-135
In Commercial Distribution

  • 10860003633806 ()
  • 00860003633809 ()


  • Hand-held electric massager
Breathing Circuit and Nose Clip, Single Use, 10 pieces each
MEDIPINES CORPORATION
MPSK10
In Commercial Distribution

  • 00860001261530 ()
  • 00860001261554 ()
MPSK10

  • Nose clip, single-use
  • Breathing mouthpiece, single-use
Breathing Circuit Kit, Single Patient Use, 10
MEDIPINES CORPORATION
AGM316
In Commercial Distribution

  • 00860001261516 ()
  • 00860001261523 ()
  • 00860001261547 ()
  • 00860001261561 ()
AGM316-10, AGM316-50, AGM316-100

  • Breathing mouthpiece, single-use
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
MEDIPINES CORPORATION
AGM100
In Commercial Distribution

  • 00860001261509 ()
AGM100

  • Multiple vital physiological parameter monitoring system, clinical
  • Respiration monitor
  • Patient monitoring system module, multiple-gas
rapid urine test for the semi-quantitative measurement of nicotine and nicotine metabolites
Mossman Associates, Inc.
1
In Commercial Distribution

  • 00860007588907 ()
500-001

  • Nicotine/nicotine metabolite IVD, kit, rapid colorimetric, clinical
Powered Traction Equipment
ANTALGIC-TRAK
AT-100
In Commercial Distribution

  • 00860000487528 ()
  • 00860000487542 ()


  • Static powered traction system
Power Traction Equipment
ANTALGIC-TRAK
AT1000
In Commercial Distribution

  • 00860000487511 ()
  • 00860000487504 ()


  • Static powered traction system
Powered Muscle Stimulator
ELECTRONIC WAVEFORM LAB, INC
HWOTC
In Commercial Distribution

  • 00869844000221 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Powered Muscle Stimulator
ELECTRONIC WAVEFORM LAB, INC
H4
In Commercial Distribution

  • 00869844000207 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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