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DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
Skin Temperature Sensor FDA UDI
Model / Reference
M00328-HPG FDA UDI
Description
Skin Temperature Sensor FDA UDI

Identifiers

Catalog Number
M00328-HPG FDA UDI
Primary DI / UDI-DI
00749756995566 FDA UDI
FDA Product Code
FMT FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Category: General-purpose patient temperature probe, single-use

DeRoyal by Deroyal Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose patient temperature probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Deroyal Industries, Inc.

Sources (1)

  • FDA UDI eb1ceb1d-c4a3-43c9-bfdc-c765f09898f2 35 fields · synced Jun 6, 2026