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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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FloPump - 00814321020438

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

FloPump - 00814321020148

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

FloPump - 00814321020131

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

FloPump - 00814321020124

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

FloPump - 00814321020117

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

FloPump - 00814321020100

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

FloPump - 00814321020094

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

FloPump - 00814321020018

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

FloPump - 00814321020001

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 - 00814112020043

TandemHeart blood pump
CARDIACASSIST, INC.
2100-0113
Not in Commercial Distribution

  • 00814112020043 ()


  • Cardiopulmonary bypass system centrifugal pump
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