DEVICE: Thermogard HQTM Start-Up Kit (00849111075862)
Device Identifier (DI) Information
Thermogard HQTM Start-Up Kit
TG2-500D
In Commercial Distribution
8700-001027-01
Zoll Circulation, Inc.
TG2-500D
In Commercial Distribution
8700-001027-01
Zoll Circulation, Inc.
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
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NCX | System, Hypothermia, Intravenous, Cooling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 6 Feet |
Device Record Status
a8aa4db3-f87c-4967-94f5-5946e5bb59ef
December 18, 2023
2
June 27, 2022
December 18, 2023
2
June 27, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
4085412140
udisj@zoll.com
udisj@zoll.com