FDA.reportPublic FDA data

Intravascular heating/cooling system catheter

Definition
A sterile, flexible tube with an attached membrane (e.g., a balloon) intended to be inserted into the central venous system (CVS) to circulate through the membrane a temperature-controlled fluid (e.g., saline solution), in order to heat or cool a patient's blood through the transfer of heat across the membrane. It may have built-in sensors to monitor the patient's body temperature for feedback to a connected control unit. It may be used for body temperature regulation during surgery, intensive care, or for fever management. This is a single-use device.
GUDID devices
40
Last updated
2019-04-02 02:54:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) Zoll Circulation, Inc.IC-38932016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) Zoll Circulation, Inc.IC-45932016-10-10
00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)Zoll Circulation, Inc.N/A2015-03-31
00849111075039Cool Line® Intravascular Heat Exchange Catheter Kit (Non Heparin)Zoll Circulation, Inc.CL-2295AE2015-03-31
00849111075046Cool Line® Intravascular Heat Exchange Catheter Kit Applause (Heparin)Zoll Circulation, Inc.CL-22952015-03-31
00849111075053Cool Line® Intravascular Heat Exchange Catheter Kit US (Surmodics Non-Lidocaine)Zoll Circulation, Inc.CL-22952015-03-31
00849111075060Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) Zoll Circulation, Inc.CL-2295AE2015-03-31
00849111075077ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non HeparinZoll Circulation, Inc.IC-3893AE2015-03-31
00849111075084ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin)Zoll Circulation, Inc.IC-38932015-03-31
00849111075091ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin), Non LidocaineZoll Circulation, Inc.IC-38932015-03-31
00849111075107ICY® Intravascular Heat Exchange Catheter Kit (Heparin)Zoll Circulation, Inc.IC-3893AE2015-03-31
00849111075114QUATTRO® Intravascular Heat Exchange Catheter Kit Surmodics Non-HeparinZoll Circulation, Inc.IC-4593AE2015-03-31
00849111075121QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin)Zoll Circulation, Inc.IC-4593AE2015-03-31
00849111075138QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin)Zoll Circulation, Inc.IC-45932015-03-31
00849111075145QUATTRO® Intravascular Heat Exchange Catheter Kit Appluase (Heparin), Non LidocaZoll Circulation, Inc.IC-45932015-03-31
00849111075152SOLEX® Intravascular Heat Exchange Catheter US Kit Applause (Heparin)Zoll Circulation, Inc.SL-25932015-03-31
00849111075169SOLEX® Intravascular Heat Exchange Catheter EU Kit Applause (Heparin)Zoll Circulation, Inc.SL-2593AE2015-03-31
00849111075176Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit NeZoll Circulation, Inc.CL-22952016-10-10
00849111075183Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom LuerZoll Circulation, Inc.CL-2295AE2015-07-30
00849111075190Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer HeparinZoll Circulation, Inc.CL-22952015-07-30
00849111075213Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit CustomZoll Circulation, Inc.CL-2295AE2015-07-30
00849111075220ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non HeparinZoll Circulation, Inc.IC-3893AE2015-07-30
00849111075237ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)Zoll Circulation, Inc.IC-38932015-07-30
00849111075251ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin)Zoll Circulation, Inc.IC-3893AE2015-07-30
00849111075268QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non-HepZoll Circulation, Inc.IC-4593AE2015-07-30
00849111075275QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EZoll Circulation, Inc.IC-4593AE2015-07-30
00849111075282QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)Zoll Circulation, Inc.IC-45932015-07-30
00849111075305SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause HepZoll Circulation, Inc.SL-25932015-07-30
00849111075312SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EUZoll Circulation, Inc.SL-2593AE2015-07-30
00849111075381InnerCool RTx 10.7F Standard CatheterZoll Circulation, Inc.NA2015-07-01
00849111075398InnerCool RTx 14F Standard CatheterZoll Circulation, Inc.NA2015-07-01
0084911107540410.7F PACKAGED ACCUTROL CATHETERZoll Circulation, Inc.NA2015-07-01
0084911107541114F PACKAGED ACCUTROL CATHETERZoll Circulation, Inc.NA2015-07-01
00849111075428CATHETER INTRODUCER KIT, 14FZoll Circulation, Inc.na2015-07-01
00849111075435CATHETER INTRODUCER KIT, 10.7FZoll Circulation, Inc.NA2015-07-01
00849111075503Quattro, Heparin, Premium Kit, USZoll Circulation, Inc.IC-45932015-07-30
00849111075510Cool Line® Intravascular Heat Exchange Catheter Applause Custom LuerZoll Circulation, Inc.CL-2295CO2015-06-30
00849111075527ICY® Intravascular Heat Exchange Catheter Kit Applause Custom LuerZoll Circulation, Inc.IC-3893CO2015-06-30
00849111075534QUATTRO® Intravascular Heat Exchange Catheter Applause Custom LuerZoll Circulation, Inc.IC-4593CO2015-06-30
00849111075541Solex 7 CO Kit, Applause Custom LuerZoll Circulation, Inc.SL-2593CO2015-06-30