Thermogard HQTM Start-Up Kit EX

Basic Information

• Brand Name: Thermogard HQTM Start-Up Kit EX
• Primary DI: 00849111075879
• Version / Model: TG2-500D, Extended Length
• Catalog Number: 8700-001028-01
• Company Name: Zoll Circulation, Inc.
• Labeler DUNS: 799455241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-27
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 91f6df7e-82a9-420a-be2a-277f0ff49cb6

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46315	Intravascular core temperature regulation system start kit	A collection of devices intended to be used to facilitate the function of intravascular core temperature regulation system. It typically includes tubing to connect the pump mechanism of the control unit, a heat exchange coil, a spike for insertion into the bag of fluid used in the system (e.g., normal saline), an air trap, a flow indicator, and a Luer-lock connection for the intravascular catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849111075879	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	9	Feet

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius