MediChoice

FDA UDI

Class I (US FDA UDI)

by Owens & Minor Distribution, Inc.

Identity

Trade Name: MediChoice FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: Infant Heel Warmer Fold To Activate Adhesive Heel Strap Non-sterile Non-toxic Food Grade Sodium Acetate And Water 3.5 X 5.5 Inch MediChoice FDA UDI
Model / Reference: IHW002 FDA UDI
Description: Infant Heel Warmer Fold To Activate Adhesive Heel Strap Non-sterile Non-toxic Food Grade Sodium Acetate And Water 3.5 X 5.5 Inch MediChoice FDA UDI

Identifiers

Primary DI / UDI-DI: 10885632057755 FDA UDI
FDA Product Code: MPO 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hot/cold therapy pack, single-use

MediChoice 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 e97179b9-0d51-4614-bf2e-b2684d8a28f6 34 fields · synced May 29, 2026