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, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogar
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.
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
ZOLL CIRCULATION
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
ZOLL CIRCULATION
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
ZOLL CIRCULATION
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
ZOLL CIRCULATION
AUTOPULSE RESUSCITATION SYSTEM MODEL100
ZOLL CIRCULATION
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