FDA.reportPublic FDA data

ZOLL Circulation, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106170003003793491ZOLL Circulation, Inc.1N2026-01-012000 Ringwood Ave San Jose CA US 95131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00849111076074Thermogard 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."""4085412140udisj@zoll.com
00849111076081ThermoGard 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.4085412140udisj@zoll.com
00849111076098STX SURFACE COOLING - STX Surface Cooling Pad4085412140udisj@zoll.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1652421010062364P170027TherOx Downstream SystemMWG2019-04-02
1652421862192726K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)NZE2025-10-15
1652421546316486K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemNZE2023-11-03
1652421971619722K223746Solex 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 ConsoleNCX2023-01-13
1652421234244198K221700AutoPulse NXT Resuscitation SystemDRM2023-03-09
1652421250278631K220008Solex 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 ConsoleNCX2022-06-02
1652421300941937K213031Solex 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 ConsoleNCX2021-12-20
1652422053814097K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX2016-03-24
1652421702530646K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange CatheterNCX2015-10-30
1652421669788767K141139SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETERNCX2014-10-03
1652421650660664K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000DRM2012-03-15
1652421923736904K101987COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593NCX2010-10-12
1652421814526874K090970FLOCONTROL , MODEL 1028MJN2009-06-12
1652421312469058K081936SOLEX CATHETER, MODEL SL2593NCX2008-08-13
1652421778422086K080908INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEMNCX2008-10-17
1652421315998461K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 100DRM2008-03-19
1652421032696664K072234THERMOGARD XP THERMAL REGULATION SYSTEMNCX2007-08-23
1652421610092856K063829THERMOGARD THERMAL REGULATION SYSTEMNCX2007-01-22
1652421681854040K063602AUTOPULSE RESUSCITATION SYSTEM MODEL100DRM2006-12-21
1652421769133812K060308COOLGARD 3000NCX2006-04-26
1652421063024109K052443ICY CATHETER, MODEL IC-3893ANCX2005-10-17
1652421994499830K051912COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093BNCX2005-10-11
1652421328835904K033623CELSIUS CONTROL SYSTEMNCX2004-05-21
1652421001997806K030421ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEMNCX2003-10-23
1652421080848723K014241COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500DNCX2003-08-01
1652421844190947H030005
1652421619075856
1652421947708942

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NCX192023-01-13
DRM42023-03-09
NZE22025-10-15
MJN12009-06-12

PMN#

GUDID#

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."""

Zoll Circulation, Inc.

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.

Zoll Circulation, Inc.

2024-05-22

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.

Zoll Circulation, Inc.

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.

Zoll Circulation, Inc.

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.

Zoll Circulation, Inc.

2022-06-27

200 records. Showing 1-40. Next