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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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The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump/FloProbe Kit (Sterile)
Not in Commercial Distribution

  • 00814321020100 ()
6300S(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump/FloProbe Kit (Sterile)
Not in Commercial Distribution

  • 00814321020094 ()
6000S(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Sterile)
Not in Commercial Distribution

  • 00814321020018 ()
6000S

  • Cardiopulmonary bypass system centrifugal pump
No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132029951 ()

  • Outer Diameter: 2.3 Millimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132029944 ()

  • Outer Diameter: 2.0 Millimeter
  • Lumen/Inner Diameter: 0.018 Inch
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution

  • NRP130 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French


  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Thoratec Switzerland GmbH
201-90052
In Commercial Distribution

  • 07640135140634 ()
201-90052

  • Cardiopulmonary bypass system centrifugal pump
Blood Pump
Thoratec Switzerland GmbH
102953
In Commercial Distribution

  • 07640135140627 ()
102953

  • Cardiopulmonary bypass system centrifugal pump
No Description
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132026783 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
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