Address:2000 Ringwood Ave,San Jose,CA,95131,US
Device Description : 9 foot tubing set including integral air trap chamber and stainless steel heat e 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : Yes
Device Description : Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperatu Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperature signal from the Alsius System to a bedside patient monitoring system.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : No
Device Description : Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperatu Hospital Monitoring Interface Accessory (HIMIA) 8 Pin provides patient temperature signal from the Alsius System to a bedside patient monitoring system.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : No
Device Description : An endovascular catheter having a heat exchange element at the distal end, throu An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : Yes
Device Description : An endovascular catheter having a heat exchange element at the distal end, throu An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : Yes
Device Description : The InnerCool Accutrol® Catheter contains an integrated thermistor for temperatu The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : Yes
Device Description : The InnerCool Accutrol® Catheter contains an integrated thermistor for temperatu The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).
Device Class : 2
Duns Number: 799455241
Premarket Exempt : No
Prescription Use : Yes
Device Description : An endovascular catheter having a heat exchange element at the distal end, throu An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An endovascular catheter having a heat exchange element at the distal end, throu An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.
Device Class : 2
Duns Number: 799455241
Premarket Exempt : Yes
Prescription Use : Yes