Steris

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name: STERIS FDA UDI
Generic Name: Electric pad whole-body heating system FDA UDI
Device Name: The STERIS Patient Warming System (PWS) uses a heated surgical table pad and optional overbody blanket immediately upon transfer to the surgical table to provide heat to the patient before, during or after procedures in the Operating Room. FDA UDI
Model / Reference: Patient Warming System FDA UDI
Description: The STERIS Patient Warming System (PWS) uses a heated surgical table pad and optional overbody blanket immediately upon transfer to the surgical table to provide heat to the patient before, during or after procedures in the Operating Room. FDA UDI

Identifiers

Catalog Number: BF030 FDA UDI
Primary DI / UDI-DI: 00724995194208 FDA UDI
FDA Product Code: DWJ 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
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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electric pad whole-body heating system

Steris by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electric pad whole-body heating system.

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HotDog Temperature Management System — Augustine Temperature Management, LLC · Class II
Hot Dog Chest and Torso Warming Blanket — Augustine Temperature Management, LLC · Class II
SpeedHeat — INSPIRATION HEALTHCARE GROUP PLC · Class II
CosyTherm — INSPIRATION HEALTHCARE GROUP PLC · Class II
CosyTherm — INSPIRATION HEALTHCARE GROUP PLC · Class II

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: Steris Corporation

Sources (1)

FDA UDI 531c85e4-38c2-47ac-957a-71e517d93961 35 fields · synced Jun 8, 2026