HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35")

FDA UDI

Class II (US FDA UDI)

by Augustine Temperature Management, LLC

Identity

Trade Name: HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35") FDA UDI
Generic Name: Electric pad whole-body heating system FDA UDI
Device Name: The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery. FDA UDI
Model / Reference: U530 FDA UDI
Description: The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery. FDA UDI

Identifiers

Catalog Number: U530 FDA UDI
Primary DI / UDI-DI: 00855913001848 FDA UDI
510(k) Number: K230866 FDA UDI
FDA Product Code: DWJ FDA UDI
GEI FDA UDI
GMDN Term: Electric pad whole-body heating system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5900 FDA UDI
878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electric pad whole-body heating system Electrosurgical return electrode, reusable

HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35") by Augustine Temperature Management, LLC — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K230866 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Augustine Temperature Management, LLC

Sources (1)

FDA UDI 26a4b3c5-d75c-4430-93b4-4dd467dfb53b 35 fields · synced Jun 9, 2026