Action®

FDA UDI

Class I (US FDA UDI)

by Action Products, Inc.

Identity

Trade Name: Action® FDA UDI
Generic Name: Gel-filled bed mattress overlay FDA UDI
Device Name: Full Mattress Overlay w/Hitch FDA UDI
Model / Reference: Mattress Overlay FDA UDI
Description: Full Mattress Overlay w/Hitch FDA UDI

Identifiers

Catalog Number: 6301H FDA UDI
Primary DI / UDI-DI: 00089904002228 FDA UDI
FDA Product Code: IKY FDA UDI
GMDN Term: Gel-filled bed mattress overlay FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Gel-filled bed mattress overlay

Action® by Action Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gel-filled bed mattress overlay.

DynaRest Gel Foam Mattress Overlay — Dynarex Corp. · Class I
DynaRest Gel Foam Mattress Overlay — Dynarex Corp. · Class I
Kolbs — K2 HEALTH PRODUCTS · Class I
Coulmed — COULMED PRODUCTS GROUP LLC · Class I
Action® — Action Products, Inc. · Class I
Action® — Action Products, Inc. · Class I
Action® — Action Products, Inc. · Class I
Action® — Action Products, Inc. · Class I

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: Action Products, Inc.

Sources (1)

FDA UDI 53473ade-fbde-4ea6-978f-dafaddf7a61c 36 fields · synced Jun 9, 2026