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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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STENT GRAFT OCL08US 8MM OCCLUDER
MEDTRONIC, INC.
OCL08US
Not in Commercial Distribution

  • 00763000233716 ()

  • Stent Graft Covered Length 31 MM
  • Stent Graft Diameter 8 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT OCL22US 22MM OCCLUDER
MEDTRONIC, INC.
OCL22US
Not in Commercial Distribution

  • 00763000233785 ()

  • Stent Graft Diameter 22 MM
  • Stent Graft Covered Length 35 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT OCL18US 18MM OCCLUDER
MEDTRONIC, INC.
OCL18US
Not in Commercial Distribution

  • 00763000233761 ()

  • Stent Graft Covered Length 33 MM
  • Stent Graft Diameter 18 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT OCL14US 14MM OCCLUDER
MEDTRONIC, INC.
OCL14US
Not in Commercial Distribution

  • 00763000233747 ()

  • Stent Graft Diameter 14 MM
  • Stent Graft Covered Length 33 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT OCL10US 10MM OCCLUDER
MEDTRONIC, INC.
OCL10US
Not in Commercial Distribution

  • 00763000233723 ()

  • Stent Graft Covered Length 31 MM
  • Stent Graft Diameter 10 MM


  • Abdominal aorta endovascular stent-graft
The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery unit, system-based
The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
4.0x12mm
In Commercial Distribution

  • 00195451000621 ()

  • Balloon Length: 12 Millimeter
  • Balloon Diameter: 4.0 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.047 Inch
  • Catheter Length: 138 Centimeter
  • Guidewire Compatibility: 6 French
C2AIVL4012

  • Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.5x12mm
In Commercial Distribution

  • 00195451000614 ()

  • Balloon Diameter: 3.5 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Catheter Length: 138 Centimeter
  • Guidewire Compatibility: 6 French
  • Balloon Length: 12 Millimeter
C2AIVL3512

  • Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.0x12mm
In Commercial Distribution

  • 00195451000607 ()

  • Balloon Length: 12 Millimeter
  • Balloon Diameter: 3.0 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.045 Inch
  • Catheter Length: 138 Centimeter
  • Guidewire Compatibility: 6 French
C2AIVL3012

  • Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
2.5x12mm
In Commercial Distribution

  • 00195451000591 ()

  • Balloon Length: 12 Millimeter
  • Balloon Diameter: 2.5 Millimeter
  • Balloon Proximal Outer Diameter (OD): 0.044 Inch
  • Catheter Length: 138 Centimeter
  • Guidewire Compatibility: 6 French
C2AIVL2512

  • Intravascular lithotripsy system balloon catheter, coronary
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