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.
Surface Start-Up Kit
In Commercial Distribution
8700-000936-01
Zoll Circulation, Inc.
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.
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NZE | Hyperthermia Monitor |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K231182 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
62b98002-79fc-417b-bbf4-87be20716df3
May 30, 2024
1
May 22, 2024
May 30, 2024
1
May 22, 2024
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