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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
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, With Scale, Double Pouched, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100008ATSC
In Commercial Distribution

  • M665100008ATSC3 ()
  • M665100008ATSC1 ()
  • M665100008ATSC0 ()

  • 8 FR


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

  • M665100008ATS3 ()
  • M665100008ATS1 ()
  • M665100008ATS0 ()

  • 8 FR


  • Pleural catheter
Thoracic Catheter, Straight, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
100008AT
In Commercial Distribution

  • M665100008AT3 ()
  • M665100008AT1 ()
  • M665100008AT0 ()

  • 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
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803643
In Commercial Distribution

  • M6658036433 ()
  • M6658036431 ()
  • M6658036430 ()

  • 15 FR


  • Closed-wound drain, non-bioabsorbable
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500040
In Commercial Distribution

  • M6655000403 ()
  • M6655000401 ()
  • M6655000400 ()

  • 40 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500032
In Commercial Distribution

  • M6655000323 ()
  • M6655000321 ()
  • M6655000320 ()

  • 32 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500028
In Commercial Distribution

  • M6655000283 ()
  • M6655000281 ()
  • M6655000280 ()

  • 28 FR


  • Pleural catheter
Thoracic Catheter, Straight, PVC
AXIOM MEDICAL, INCORPORATED
500016
In Commercial Distribution

  • M6655000163 ()
  • M6655000161 ()
  • M6655000160 ()

  • 16 FR


  • Pleural catheter
Closed Wound Drain, Flat, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
401AT
In Commercial Distribution

  • M665401AT3 ()
  • M665401AT1 ()
  • M665401AT0 ()

  • Length: 16 Inch
  • 10 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3645AT
In Commercial Distribution

  • M6653645AT3 ()
  • M6653645AT1 ()
  • M6653645AT0 ()

  • 19 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone
AXIOM MEDICAL, INCORPORATED
3645
In Commercial Distribution

  • M66536453 ()
  • M66536451 ()
  • M66536450 ()

  • 19 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3643ATSP
In Commercial Distribution

  • M6653643ATSP1 ()
  • M6653643ATSP0 ()
  • M6653643ATSP3 ()

  • 15 FR
  • Length: 36 Inch


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3643AT
In Commercial Distribution

  • M6653643AT3 ()
  • M6653643AT1 ()
  • M6653643AT0 ()

  • 15 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone
AXIOM MEDICAL, INCORPORATED
3643
In Commercial Distribution

  • M66536433 ()
  • M66536431 ()
  • M66536430 ()

  • 15 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With ClotStop®
AXIOM MEDICAL, INCORPORATED
3642AT
In Commercial Distribution

  • M6653642AT3 ()
  • M6653642AT1 ()
  • M6653642AT0 ()

  • 10 FR


  • Closed-wound drain, non-bioabsorbable
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