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
SPECTRUM MEDICAL SRL
CP37V-VT
In Commercial Distribution

  • 18051160302663 ()


  • Cardiopulmonary bypass system centrifugal pump
No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBAP40 AFF CP CENTRIF CC US/CAN 4PK
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20643169785780 ()
  • 00643169785786 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20643169433254 ()
  • 00643169433250 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
Not in Commercial Distribution

  • 20643169433247 ()
  • 00643169433243 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20643169433230 ()
  • 00643169433236 ()


  • Cardiopulmonary bypass system centrifugal pump
Aintree Intubation Catheter with Rapi-Fit Adapter
COOK INCORPORATED
G57626
In Commercial Distribution

  • 00827002576261 ()
C-CAE-19.0-56-AIC-01

  • Endotracheal tube guide, single-use
No Description
NORTH EAST SCIENTIFIC INC
R-420-006
In Commercial Distribution

  • B227NRP3683 ()
R-420-006

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-417-152
In Commercial Distribution

  • B227NRP3682 ()
R-417-152

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
NORTH EAST SCIENTIFIC INC
R-414-151
In Commercial Distribution

  • B227NRP3681 ()
R-414-151

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

  • 00814321020124 ()
6300N

  • 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.
1/4" FloPump (Sterile)
Not in Commercial Distribution

  • 00814321020117 ()
6300S

  • 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.
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
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 (Non-Sterile)
Not in Commercial Distribution

  • 00814321020001 ()
6000N

  • Cardiopulmonary bypass system centrifugal pump
TandemHeart blood pump
CARDIACASSIST, INC.
2100-0113
Not in Commercial Distribution

  • 00814112020043 ()


  • 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
PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20763000134567 ()
  • 00763000134563 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
Not in Commercial Distribution

  • 20763000134550 ()
  • 00763000134556 ()


  • Cardiopulmonary bypass system centrifugal pump
PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20763000134536 ()
  • 00763000134532 ()


  • 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
No Description
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132026776 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050AA
In Commercial Distribution

  • 00813132025397 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050AA
In Commercial Distribution

  • 00813132025366 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132024833 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
425-135-01
In Commercial Distribution

  • 00813132024819 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 112 Centimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
423-135-01
In Commercial Distribution

  • 00813132024796 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
425-011
In Commercial Distribution

  • 00813132024789 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 112 Centimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
423-001
In Commercial Distribution

  • 00813132024772 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 125 Centimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
420-159
In Commercial Distribution

  • 00813132024765 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-159

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
420-006
In Commercial Distribution

  • 00813132024758 ()

  • Outer Diameter: 2.0 Millimeter
  • Length: 150 Centimeter
420-006

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
417-156
In Commercial Distribution

  • 00813132024741 ()

  • Outer Diameter: 1.75 Millimeter
  • Length: 150 Centimeter
417-156

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
417-152
In Commercial Distribution

  • 00813132024734 ()

  • Outer Diameter: 1.45 Millimeter
  • Length: 150 Centimeter
417-152

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
414-159
In Commercial Distribution

  • 00813132024727 ()

  • Outer Diameter: 1.45 Millimeter
  • Length: 150 Centimeter
414-159

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
414-151
In Commercial Distribution

  • 00813132024710 ()

  • Outer Diameter: 1.40 Millimeter
  • Length: 150 Centimeter
414-151

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
410-154
In Commercial Distribution

  • 00813132024703 ()

  • Outer Diameter: 0.97 Millimeter
  • Length: 150 Centimeter
410-154

  • Atherectomy laser system beam guide-catheter, peripheral
No Description
Spectranetics Corporation
410-152
In Commercial Distribution

  • 00813132024697 ()

  • Outer Diameter: 0.97 Millimeter
  • Length: 150 Centimeter
410-152

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132022983 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
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