DEVICE: ThermoGard XP Surface Start-Up Kit (00849111076081)

Device Identifier (DI) Information

ThermoGard XP Surface Start-Up Kit
Surface Start-Up Kit
In Commercial Distribution
8700-000936-01
Zoll Circulation, Inc.
00849111076081
GS1

1
799455241 *Terms of Use
The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.
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Device Characteristics

MR Safe
No
No
Yes
Yes
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?
67029 External circulating-fluid core temperature regulation system start kit
A collection of consumable devices intended to be used to facilitate the function of an external circulating-fluid core temperature regulation system. It typically includes tubing to connect the pump mechanism of the system control unit to a patient pad, a heat exchange coil, and other necessary components (e.g., water reservoir, air trap, flow indicator). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NZE Hyperthermia Monitor
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K231182 000
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

62b98002-79fc-417b-bbf4-87be20716df3
May 30, 2024
1
May 22, 2024
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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
No
No CLOSE

Customer Contact

[?]
4085412140
udisj@zoll.com
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