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ThermoGard XP Surface Start-Up Kit

FDA UDI

Class II (US FDA UDI)

by ZOLL Circulation, Inc.

Identity

Trade Name
ThermoGard XP Surface Start-Up Kit FDA UDI
Generic Name
External circulating-fluid core temperature regulation system start kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
Surface Start-Up Kit FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
8700-000936-01 FDA UDI
Primary DI / UDI-DI
00849111076081 FDA UDI
510(k) Number
K231182 FDA UDI
FDA Product Code
NZE FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system start kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: External circulating-fluid core temperature regulation system start kit

ThermoGard XP Surface Start-Up Kit by ZOLL Circulation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system start kit.

Cleared under the same submission

K231182 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZOLL Circulation, Inc.

Sources (1)

  • FDA UDI 62b98002-79fc-417b-bbf4-87be20716df3 36 fields · synced Jun 9, 2026