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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Alternating-pressure bed mattress overlay, reusable FDA UDI
Device Name
MATTRESS,EQUALIZE AIRE 9000,32X84, W/PU FDA UDI
Model / Reference
MDTE9C3284P FDA UDI
Description
MATTRESS,EQUALIZE AIRE 9000,32X84, W/PU FDA UDI

Identifiers

Catalog Number
MDTE9C3284P FDA UDI
Primary DI / UDI-DI
10080196380190 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Alternating-pressure bed mattress overlay, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Alternating-pressure bed mattress overlay, reusable

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alternating-pressure bed mattress overlay, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 13c3e3c8-9301-4d25-82b7-de65c7c49787 36 fields · synced May 30, 2026