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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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Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
AXIOM MEDICAL, INCORPORATED
100010SC
In Commercial Distribution

  • M665100010SC3 ()
  • M665100010SC1 ()
  • M665100010SC0 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale
AXIOM MEDICAL, INCORPORATED
100010S
In Commercial Distribution

  • M665100010S3 ()
  • M665100010S1 ()
  • M665100010S0 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone
AXIOM MEDICAL, INCORPORATED
100010
In Commercial Distribution

  • M6651000103 ()
  • M6651000101 ()
  • M6651000100 ()

  • 10 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched
AXIOM MEDICAL, INCORPORATED
100008SC
In Commercial Distribution

  • M665100008SC3 ()
  • M665100008SC1 ()
  • M665100008SC0 ()

  • 8 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With Scale
AXIOM MEDICAL, INCORPORATED
100008S
In Commercial Distribution

  • M665100008S3 ()
  • M665100008S1 ()
  • M665100008S0 ()

  • 8 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone
AXIOM MEDICAL, INCORPORATED
100008
In Commercial Distribution

  • M6651000083 ()
  • M6651000081 ()
  • M6651000080 ()

  • 8 FR


  • Pleural catheter
The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system
Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring
AXIOM MEDICAL, INCORPORATED
111197SR
In Commercial Distribution

  • M665111197SR3 ()
  • M665111197SR1 ()
  • M665111197SR0 ()

  • Length: 14 Inch
  • Lumen/Inner Diameter: 8.5 Millimeter


  • Sump drain
Sump Drain, Two Lumens, Silicone, Large Eye, With Suture Ring
AXIOM MEDICAL, INCORPORATED
111178SR
In Commercial Distribution

  • M665111178SR3 ()
  • M665111178SR1 ()
  • M665111178SR0 ()

  • Length: 18 Inch
  • Lumen/Inner Diameter: 6.5 Millimeter


  • Sump drain
Sump Drain, Two Lumens, Silicone, Large Eye
AXIOM MEDICAL, INCORPORATED
111178
In Commercial Distribution

  • M6651111783 ()
  • M6651111781 ()
  • M6651111780 ()

  • Length: 18 Inch
  • Lumen/Inner Diameter: 6.5 Millimeter


  • Sump drain
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