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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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No Description
NORTH EAST SCIENTIFIC INC
R-410-152
In Commercial Distribution

  • B227NRP3680 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-420-159
In Commercial Distribution

  • B227NRP1303 ()
R-420-159

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-417-156
In Commercial Distribution

  • B227NRP1302 ()
R-417-156

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-414-159
In Commercial Distribution

  • B227NRP1301 ()
R-414-159

  • 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
In Commercial Distribution

  • B227NRP1300 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral
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 (Non-Sterile)
Not in Commercial Distribution

  • 00814321020452 ()
6000N(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500N
Not in Commercial Distribution

  • 00814321020445 ()
6500N

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500S
Not in Commercial Distribution

  • 00814321020438 ()
6500S

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400N
Not in Commercial Distribution

  • 00814321020148 ()
6400N

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400S
Not in Commercial Distribution

  • 00814321020131 ()
6400S

  • Cardiopulmonary bypass system centrifugal pump
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