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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 JUNIOR 5X7IN UREA BLEND CA/48 SINGLE PT USE Not made with Natural Rubber Latex Halyard FDA UDI
Model / Reference
51777 FDA UDI
Description
INSTANT COLD PACK JUNIOR 5X7IN UREA BLEND CA/48 SINGLE PT USE Not made with Natural Rubber Latex Halyard FDA UDI

Identifiers

Primary DI / UDI-DI
10885632413766 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Hot/cold therapy pack, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owens & Minor Distribution, Inc.

Sources (1)

  • FDA UDI ae3263a5-0ab9-4189-be33-b571394630ff 33 fields · synced May 30, 2026