Device Description : The IBC Mini Sucker is a component of Blood Recovery Suction Systems for use in The IBC Mini Sucker is a component of Blood Recovery Suction Systems for use in open heart procedures, autologus blood recovery or blood suction. It is a disposable, single use component.
Device Class : 2
Duns Number: 788403103
Premarket Exempt : No
Prescription Use : Yes
Device Description : The FloPump 57mL Centrifugal Pump is a device that uses a method other than revo 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.
Device Class : 2
Duns Number: 788403103
Premarket Exempt : No
Prescription Use : Yes
Device Description : The FloPump 57mL Centrifugal Pump is a device that uses a method other than revo 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; orii) 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.
Device Class : 2
Duns Number: 788403103
Premarket Exempt : No
Prescription Use : Yes
Device Description : The IBC FloPump is a single-use, disposable centrifugal blood pump intended for 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.
Device Class : 2
Duns Number: 788403103
Premarket Exempt : No
Prescription Use : Yes
Device Description : The brand name for this component is IBC FloProbe and is part of the AcuFlo syst The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Device Class :
Duns Number: 788403103
Premarket Exempt : No
Prescription Use : Yes
Device Description : The brand name for this component is IBC FloProbe and is part of the AcuFlo syst The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Device Class :
Duns Number: 788403103
Premarket Exempt : No
Prescription Use : Yes
Device Description : The IBC Aortic Punch is a single use, disposable, surgical punch to be used to c The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Device Class :
Duns Number: 788403103
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The IBC Aortic Punch is a single use, disposable, surgical punch to be used to c The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Device Class :
Duns Number: 788403103
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The IBC Aortic Punch is a single use, disposable, surgical punch to be used to c The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Device Class :
Duns Number: 788403103
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The IBC Aortic Punch is a single use, disposable, surgical punch to be used to c The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
Device Class :
Duns Number: 788403103
Premarket Exempt : Yes
Prescription Use : Yes