DEVICE: Thermogard HQTM Start-Up Kit EX (00849111075879)

Device Identifier (DI) Information

Thermogard HQTM Start-Up Kit EX
TG2-500D, Extended Length
In Commercial Distribution
8700-001028-01
Zoll Circulation, Inc.
00849111075879
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 Safe
No
No
Yes
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?
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.
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

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 9 Feet
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Device Record Status

91f6df7e-82a9-420a-be2a-277f0ff49cb6
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

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
4085412140
udisj@zoll.com
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