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 Over Body Blanket is used with the STERIS Patient Warming System. FDA UDI
Model / Reference: Patient Warming System FDA UDI
Description: The STERIS Patient Warming System Over Body Blanket is used with the STERIS Patient Warming System. FDA UDI

Identifiers

Catalog Number: BF035 FDA UDI
Primary DI / UDI-DI: 00724995194239 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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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 df693c88-15c8-41ad-8317-62193982f4f3 35 fields · synced Jun 7, 2026