Future Generation Medical

FDA UDI

Class I (US FDA UDI)

by Global International L. L. C.

Identity

Trade Name: Future Generation Medical FDA UDI
Generic Name: Hot/cold therapy pack, single-use FDA UDI
Device Name: Infant Heel Warmers - W/O Metal Disc FDA UDI
Model / Reference: FG-IHW-5003A FDA UDI
Description: Infant Heel Warmers - W/O Metal Disc FDA UDI

Identifiers

Primary DI / UDI-DI: 10850046230100 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

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Hot/cold therapy pack, single-use

Future Generation Medical by Global International L. L. C. — 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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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: Global International L. L. C.

Sources (1)

FDA UDI 263013d1-076a-4c5c-bbf5-791566f152a0 35 fields · synced May 30, 2026