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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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TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
5740-2415
Not in Commercial Distribution

  • 00814112020524 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Vascular dilator, single-use
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessories
CARDIACASSIST, INC.
5740-2417
Not in Commercial Distribution

  • 00814112020517 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Vascular dilator, single-use
  • Extracorporeal membrane oxygenator
  • Cardiopulmonary bypass system centrifugal pump
  • Cardiopulmonary bypass system mounting unit
  • Mechanical infusion pump administration set
Curaplex Select Laryngoscope Set, GreenLine, Medium Handle, Mac 2-4 Blades, Miller 0-3 Blades, Pouch
BOUND TREE MEDICAL, LLC
5-5333-57
In Commercial Distribution

  • 00810071637315 ()
5-5333-57

  • Laryngoscope handle, reusable
  • Laryngoscope blade, single-use
Curaplex Select Nasopharyngeal Airway, 24 Fr, 6.0mm, Robertazzi Style, Latex Free, Sterile 10ea/bx
BOUND TREE MEDICAL, LLC
2-0211-8124
In Commercial Distribution

  • 00810071637537 ()
  • 00810071636332 ()
2021-18124

  • Nasopharyngeal airway, single-use
Transpac IT Monitoring Kit, 24" Safeset Reservoir, Needleless Valve, 3ml Flush Device, Un-Bonded Macrodrip
ICU MEDICAL, INC.
42801-36
In Commercial Distribution

  • 10887709120829 ()
  • 00887709120822 ()
42801-36

  • Invasive blood pressure transducer set
129" 10 Drop 24 Hour Admin Set w/Bravo24®, 3-Way Stopcock, Rotating Luer
ICU MEDICAL, INC.
B99165
In Commercial Distribution

  • 10887709019178 ()
  • 00887709019171 ()


  • Basic intravenous administration set, noninvasive
38" Smallbore 24 Hour Ext Set w/2 Bravo24®, 2 Clamps, Rotating Luer
ICU MEDICAL, INC.
B99051
In Commercial Distribution

  • 10887709018485 ()
  • 00887709018488 ()


  • Basic intravenous administration set, noninvasive
8" Smallbore 24 Hour Ext Set w/2 Bravo24®, T-Connector, Clamp, Rotating Luer
ICU MEDICAL, INC.
B9900-629
In Commercial Distribution

  • 10887709018065 ()
  • 00887709018068 ()


  • Basic intravenous administration set, noninvasive
110" (279cm) 60 Drop 24 Hour Primary Set w/2 Bravo24®, Rotating Luer
ICU MEDICAL, INC.
B9900-136
In Commercial Distribution

  • 10887709016313 ()
  • 00887709016316 ()


  • Basic intravenous administration set, noninvasive
110" (279cm) 10 Drop 24 Hour Primary Set w/2 Bravo24®, Rotating Luer
ICU MEDICAL, INC.
B9900-135
In Commercial Distribution

  • 10887709016306 ()
  • 00887709016309 ()


  • Basic intravenous administration set, noninvasive
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