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Halyard

FDA UDI

Class II (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name
Halyard FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, reusable FDA UDI
Device Name
HALYARD* Thermal Pad - Universal-Small FDA UDI
Model / Reference
94725 FDA UDI
Description
HALYARD* Thermal Pad - Universal-Small FDA UDI

Identifiers

Catalog Number
00314-03 -No CE FDA UDI
Primary DI / UDI-DI
10680651947250 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, reusable 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

No

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: External circulating-fluid core temperature regulation system pad, reusable

Halyard by O&M Halyard, Inc. — 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, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O&M Halyard, Inc.

Sources (1)

  • FDA UDI 48906a28-91b3-495c-a3f8-df3a972055f1 35 fields · synced May 29, 2026