Thermogard HQTM Start-Up Kit 8700-001027-01

GUDID 00849111075862

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.

Intravascular heating/cooling system start kit
Primary Device ID00849111075862
NIH Device Record Keya8aa4db3-f87c-4967-94f5-5946e5bb59ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermogard HQTM Start-Up Kit
Version Model NumberTG2-500D
Catalog Number8700-001027-01
Company DUNS799455241
Company NameZoll Circulation, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com

Device Dimensions

Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100849111075862 [Primary]

FDA Product Code

NCXSystem, Hypothermia, Intravenous, Cooling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-05
Device Publish Date2022-06-27

Devices Manufactured by Zoll Circulation, Inc.

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00849111076111 - STX SURFACE COOLING2024-08-23 STX SURFACE COOLING Pad THIGHS ONLY PAD SET
00849111076074 - Thermogard HQ Surface Start-Up Kit2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
00849111076081 - ThermoGard XP Surface Start-Up Kit2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
00849111076128 - Thermogard™ Vest, S/M2024-05-30 Thermogard™ Vest, S/M
00849111076135 - Thermogard™ Vest, L/XL2024-05-30 Thermogard™ Vest, L/XL
00849111075787 - Thermogard XP, Lang set C, Rohs2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle
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