DEVICE: Thermogard HQTM Console (00849111075800)

Device Identifier (DI) Information

Thermogard HQTM Console
ThermogardHQ, Lang set A
In Commercial Distribution
8700-001030-01
Zoll Circulation, Inc.
00849111075800
GS1

1
799455241 *Terms of Use
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.
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Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44710 Intravascular core temperature regulation system
An assembly of devices intended to regulate a patient's body temperature by circulating a temperature-controlled fluid (e.g., saline solution) through a dedicated, closed-circuit catheter placed in the central venous system (CVS), to both heat and alternatively cool the patient's blood through the transfer of heat as it moves past the catheter. It typically consists of a powered unit that controls fluid temperature and circulation, a catheter with a membrane for heat transfer, temperature probes, and a start kit. It may be used for body temperature regulation during surgery (e.g., cardiac surgery or neurosurgery), intensive care, or for fever management.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NCX System, Hypothermia, Intravenous, Cooling
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

60a60f0b-f6d1-49e4-b851-2ca83ab55b97
December 18, 2023
2
June 27, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
4085412140
udisj@zoll.com
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