Mor-Medical New Era

FDA UDI

Class I (US FDA UDI)

by Moroles Investments, LLC

Identity

Trade Name: Mor-Medical New Era FDA UDI
Generic Name: Commode, manual FDA UDI
Device Name: Deluxe New Era Patented Infection Control 22" Shower Chair, with Open Front Soft Seat and Insert, Slide Out Commode Pail, 3" All Locking Casters, 385 lbs. wt. capacity FDA UDI
Model / Reference: DNE-385-3TWL FDA UDI
Description: Deluxe New Era Patented Infection Control 22" Shower Chair, with Open Front Soft Seat and Insert, Slide Out Commode Pail, 3" All Locking Casters, 385 lbs. wt. capacity FDA UDI

Identifiers

Primary DI / UDI-DI: 00858288006203 FDA UDI
FDA Product Code: INM FDA UDI
GMDN Term: Commode, manual FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3100 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Commode, manual

Mor-Medical New Era by Moroles Investments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
Drive — Drive Devilbiss Healthcare · 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: Moroles Investments, LLC

Sources (1)

FDA UDI 89b287f3-b738-4424-bb20-75876df7194f 33 fields · synced Jun 6, 2026