Hcs

FDA UDI

Class I (US FDA UDI)

by Dyad Medical Sourcing, Llc

Identity

Trade Name: HCS FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: Instant Infant Heel Warmer w/Strap FDA UDI
Model / Reference: HCS1105 FDA UDI
Description: Instant Infant Heel Warmer w/Strap FDA UDI

Identifiers

Primary DI / UDI-DI: 00849027001801 FDA UDI
510(k) Number: K053254 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Hot/cold therapy pack, single-use

Hcs by Dyad Medical Sourcing, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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Redicare — REDICARE LLC · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
ASP MEDICAL — Asp Global, LLC · Class I

Cleared under the same submission

K053254 also covers:

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: Dyad Medical Sourcing, Llc

Sources (1)

FDA UDI abc1e543-0a75-4580-bb50-d7638deee04b 34 fields · synced May 31, 2026