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Thermogard HQTM Start-Up Kit EX

FDA UDI

Class II (US FDA UDI)

by ZOLL Circulation, Inc.

Identity

Trade Name
Thermogard HQTM Start-Up Kit EX FDA UDI
Generic Name
Intravascular core temperature regulation system start kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
TG2-500D, Extended Length FDA UDI
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. FDA UDI

Identifiers

Catalog Number
8700-001028-01 FDA UDI
Primary DI / UDI-DI
00849111075879 FDA UDI
FDA Product Code
NCX FDA UDI
GMDN Term
Intravascular core temperature regulation system start kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 9 Feet FDA UDI

Category: Intravascular core temperature regulation system start kit

Thermogard HQTM Start-Up Kit EX by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular core temperature regulation system start kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZOLL Circulation, Inc.

Sources (1)

  • FDA UDI 91f6df7e-82a9-420a-be2a-277f0ff49cb6 37 fields · synced Jun 9, 2026