Halyard

FDA UDI

Class I (US FDA UDI)

by Owens & Minor Distribution, Inc.

Identity

Trade Name: Halyard FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: INSTANT COLD PACK LARGE 6X9 IN UREA BLEND CA 24 NO SLEEVE SINGLE PT USE Not made with Natural Rubber Latex Halyard FDA UDI
Model / Reference: 51787 FDA UDI
Description: INSTANT COLD PACK LARGE 6X9 IN UREA BLEND CA 24 NO SLEEVE SINGLE PT USE Not made with Natural Rubber Latex Halyard FDA UDI

Identifiers

Primary DI / UDI-DI: 10885632413865 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Hot/cold therapy pack, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5710 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hot/cold therapy pack, single-use

Halyard by Owens & Minor Distribution, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Owens & Minor Distribution, Inc.

Sources (1)

FDA UDI 8c09d4c1-bf5a-4b7f-86ef-36327104a5b5 33 fields · synced May 30, 2026