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Simplicity

FDA UDI

Class I (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Simplicity FDA UDI
Generic Name
Waterproof bed mattress cover, single-use FDA UDI
Device Name
Simplicity Fluff Underpad 23X36, Moderate FDA UDI
Model / Reference
7176 FDA UDI
Description
Simplicity Fluff Underpad 23X36, Moderate FDA UDI

Identifiers

Catalog Number
7176 FDA UDI
Primary DI / UDI-DI
10884521581487 FDA UDI
FDA Product Code
KME FDA UDI
GMDN Term
Waterproof bed mattress cover, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6060 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 23 Inch FDA UDI
Width — 36 Inch FDA UDI

Category: Waterproof bed mattress cover, single-use

Simplicity by Cardinalhealth — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Waterproof bed mattress cover, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 11f6fad9-2108-4f80-ba77-cdeba043f1a2 37 fields · synced May 31, 2026