zoll.comThermogard HQ? Temperature Management System, Thermogard XP® Temperature Management System
Zoll Circulation, Inc.
ZOLL Circulation, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010617000 | 3003793491 | ZOLL Circulation, Inc. | 1 | N | 2026-01-01 | 2000 Ringwood Ave San Jose CA US 95131 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00849111076074 | Thermogard HQ Surface Start-Up Kit - "The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.""" | 4085412140 | udisj@zoll.com |
| 00849111076081 | ThermoGard XP Surface Start-Up Kit - The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature. | 4085412140 | udisj@zoll.com |
| 00849111076098 | STX SURFACE COOLING - STX Surface Cooling Pad | 4085412140 | udisj@zoll.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 165242 | 1010062364 | P170027 | TherOx Downstream System | MWG | 2019-04-02 |
| 165242 | 1862192726 | K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) | NZE | 2025-10-15 |
| 165242 | 1546316486 | K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | NZE | 2023-11-03 |
| 165242 | 1971619722 | K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console | NCX | 2023-01-13 |
| 165242 | 1234244198 | K221700 | AutoPulse NXT Resuscitation System | DRM | 2023-03-09 |
| 165242 | 1250278631 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console | NCX | 2022-06-02 |
| 165242 | 1300941937 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console | NCX | 2021-12-20 |
| 165242 | 2053814097 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | NCX | 2016-03-24 |
| 165242 | 1702530646 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | NCX | 2015-10-30 |
| 165242 | 1669788767 | K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | NCX | 2014-10-03 |
| 165242 | 1650660664 | K112998 | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | DRM | 2012-03-15 |
| 165242 | 1923736904 | K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | NCX | 2010-10-12 |
| 165242 | 1814526874 | K090970 | FLOCONTROL , MODEL 1028 | MJN | 2009-06-12 |
| 165242 | 1312469058 | K081936 | SOLEX CATHETER, MODEL SL2593 | NCX | 2008-08-13 |
| 165242 | 1778422086 | K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | NCX | 2008-10-17 |
| 165242 | 1315998461 | K072527 | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | DRM | 2008-03-19 |
| 165242 | 1032696664 | K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | NCX | 2007-08-23 |
| 165242 | 1610092856 | K063829 | THERMOGARD THERMAL REGULATION SYSTEM | NCX | 2007-01-22 |
| 165242 | 1681854040 | K063602 | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | DRM | 2006-12-21 |
| 165242 | 1769133812 | K060308 | COOLGARD 3000 | NCX | 2006-04-26 |
| 165242 | 1063024109 | K052443 | ICY CATHETER, MODEL IC-3893A | NCX | 2005-10-17 |
| 165242 | 1994499830 | K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B | NCX | 2005-10-11 |
| 165242 | 1328835904 | K033623 | CELSIUS CONTROL SYSTEM | NCX | 2004-05-21 |
| 165242 | 1001997806 | K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | NCX | 2003-10-23 |
| 165242 | 1080848723 | K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | NCX | 2003-08-01 |
| 165242 | 1844190947 | H030005 | |||
| 165242 | 1619075856 | ||||
| 165242 | 1947708942 |
Product Codes Associated With Registrations#
PMN#
AutoPulse NXT Resuscitation System
Zoll Circulation, Inc.
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Zoll Circulation, Inc.
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
Zoll Circulation, Inc.
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
ZOLL CIRCULATION, INC.
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
Zoll Circulation, Inc.
GUDID#
VitalTemp™ - VitalTemp™ Universal Pad, 2PK, US
2025-12-12
VitalTemp™ - VitalTemp™ Universal Pad, 2PK, US
2025-12-12
Thermogard HQ Surface Start-Up Kit - "The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature."""
2024-05-22
ThermoGard XP Surface Start-Up Kit - The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.
2024-05-22
Thermogard™ Vest, S/M - S/M
2024-05-22
Thermogard™ Vest, L/XL - L/XL
2024-05-22
STX SURFACE COOLING - STX Surface Cooling Pad
2024-08-15
STX SURFACE COOLING - STX SURFACE COOLING Pad L/XL PAD SET
2024-08-15
STX SURFACE COOLING - STX SURFACE COOLING Pad THIGHS ONLY PAD SET
2024-08-15
Thermogard XP, Lang set C, Rohs - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
2023-01-17
Thermogard XP, Lang set C, Rohs, Refurb - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
2023-01-17
Thermogard HQTM Console - The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
2022-06-27
Thermogard HQTM Start-Up Kit - The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
2022-06-27
Thermogard HQTM Start-Up Kit EX - The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.
2022-06-27
Start-Up Kit - 6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
2015-03-31
ICY-3, Japan, Final Packaged Kit (Applause) - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2016-10-10
Quattro, Japan, Final Packaged Kit (Applause) - IC-4593
2016-10-10
Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-03-31
Start-Up Kit Japan - 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
2016-10-10
Thermogard XP® - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
2015-03-31
Thermogard XP® - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
2015-03-31
Thermogard XP® - The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
2015-03-31
Cool Line® Intravascular Heat Exchange Catheter Kit (Non Heparin) - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-03-31
Cool Line® Intravascular Heat Exchange Catheter Kit Applause (Heparin) - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-03-31
Cool Line® Intravascular Heat Exchange Catheter Kit US (Surmodics Non-Lidocaine) - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-03-31
Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-03-31
ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non Heparin - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin), Non Lidocaine - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
ICY® Intravascular Heat Exchange Catheter Kit (Heparin) - The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
QUATTRO® Intravascular Heat Exchange Catheter Kit Surmodics Non-Heparin - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin) - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin) - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
QUATTRO® Intravascular Heat Exchange Catheter Kit Appluase (Heparin), Non Lidoca - The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
2015-03-31
SOLEX® Intravascular Heat Exchange Catheter US Kit Applause (Heparin) - The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.
2015-03-31
SOLEX® Intravascular Heat Exchange Catheter EU Kit Applause (Heparin) - The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.
2015-03-31
Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2016-10-10
Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom Luer - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-07-30
Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-07-30
Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit Custom - The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
2015-07-30