Device Description : Venous Catheter, two-stage, complete reinforcement, Basket tip, straight
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Description : QUART Arterial Filter with BIOLINE Coating, Sterile. The QUART arterial filter ( QUART Arterial Filter with BIOLINE Coating, Sterile. The QUART arterial filter (HBF 140) is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.
Device Class :
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Description : The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Device Class :
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Description : Arterial Cannula, wire reinforced, straight tip without ring
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Description : Arterial Cannula, wire reinforced, straight tip without ring
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Description : Venous Catheter, wire reinforced, Bullet tip, 90° bent
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as The DTI 1/4"x1/16" (2 pcs) is a Double Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : No
Device Description : Air Embolism Protection (AEP) System including a bubble/level monitoring kit. Th Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is an accessory for The Heart-Lung Machine HL 20 , which is a modular system for regulation, control and monitoring of the extracorporeal circulation. Its purpose is the support and maintenance of the extracorporeal blood circulation and is used during cardiac surgeries.
Device Class : 2
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : No
Device Description : PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Device Class :
Duns Number: 316153865
Premarket Exempt : No
Prescription Use : Yes