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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
TRUE™ DILATATION Balloon Valvuloplasty Catheter, 24 mm x 4.5 cm,110 cm catheter
Bard Peripheral Vascular, Inc.
0244512
In Commercial Distribution

  • 00801741091018 ()

  • Balloon Length, 4.5 Centimeters
  • Balloon Diameter, 24 Millimeters
  • Shaft Length, 110 Centimeters
0244512

  • Cardiac valvuloplasty catheter
Atlas® PTA Balloon Dilatation Catheter 24 mm x 40 mm, 120 cm Catheter
Bard Peripheral Vascular, Inc.
AT120244
In Commercial Distribution

  • 00801741062766 ()

  • Balloon Length, 40 Millimeter
  • Shaft Length, 120 Centimeter
  • Balloon Diameter, 24 Millimeter
AT120244

  • Peripheral angioplasty balloon catheter, basic
Atlas® PTA Balloon Dilatation Catheter 24 mm x 20 mm, 120 cm Catheter
Bard Peripheral Vascular, Inc.
AT120242
In Commercial Distribution

  • 00801741062759 ()

  • Balloon Length, 20 Millimeter
  • Balloon Diameter, 24 Millimeter
  • Shaft Length, 120 Centimeter
AT120242

  • Peripheral angioplasty balloon catheter, basic
Atlas® PTA Balloon Dilatation Catheter 24 mm x 40 mm, 75 cm Catheter
Bard Peripheral Vascular, Inc.
AT75244
In Commercial Distribution

  • 00801741062568 ()

  • Shaft Length, 75 Centimeter
  • Balloon Length, 40 Millimeter
  • Balloon Diameter, 24 Millimeter
AT75244

  • Peripheral angioplasty balloon catheter, basic
Atlas® PTA Balloon Dilatation Catheter 24 mm x 20 mm, 75 cm Catheter
Bard Peripheral Vascular, Inc.
AT75242
In Commercial Distribution

  • 00801741062551 ()

  • Balloon Length, 20 Millimeter
  • Balloon Diameter, 24 Millimeter
  • Shaft Length, 75 Centimeter
AT75242

  • Peripheral angioplasty balloon catheter, basic
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
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
83" 15 Drop 24 Hour Admin Set w/Inj Site, Bravo24®, Rotating Luer
ICU MEDICAL, INC.
B9900-106
In Commercial Distribution

  • 10887709016191 ()
  • 00887709016194 ()


  • Basic intravenous administration set, noninvasive
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