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Therarest

FDA UDI

Class I (US FDA UDI)

by Arjohuntleigh, Inc.

Identity

Trade Name
Therarest FDA UDI
Generic Name
Foam-filled bed mattress overlay FDA UDI
Device Name
Therarest - Reactive Mattress Replacement Perimeter Plus 84 x 35 x 7 inches FDA UDI
Model / Reference
TRMRLNB35084TEG FDA UDI
Description
Therarest - Reactive Mattress Replacement Perimeter Plus 84 x 35 x 7 inches FDA UDI

Identifiers

Catalog Number
TRMRLNB35084TEG FDA UDI
Primary DI / UDI-DI
05056341697695 FDA UDI
FDA Product Code
IKY FDA UDI
GMDN Term
Foam-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

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Foam-filled bed mattress overlay

Therarest by Arjohuntleigh, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Foam-filled bed mattress overlay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arjohuntleigh, Inc.

Sources (1)

  • FDA UDI 758a5bc1-35dd-4289-9ef8-a3712bf33beb 34 fields · synced May 31, 2026