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Kool-Kit

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
Kool-Kit FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, single-use FDA UDI
Device Name
Thermal Regulation Pad FDA UDI
Model / Reference
920-USME FDA UDI
Description
Thermal Regulation Pad FDA UDI

Identifiers

Catalog Number
920-USME FDA UDI
Primary DI / UDI-DI
20613031839200 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, single-use 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 14.25 Inch FDA UDI
Width — 11.0 Inch FDA UDI
Depth — 3.00 Inch FDA UDI
Weight — .62 Pound FDA UDI

Category: External circulating-fluid core temperature regulation system pad, single-use

Kool-Kit by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gentherm Medical, LLC

Sources (1)

  • FDA UDI 973fdf17-3e23-431d-b040-05063ebe5465 36 fields · synced May 30, 2026