Mor-Medical New Era

Basic Information

• Brand Name: Mor-Medical New Era
• Primary DI: 00858288006203
• Version / Model: DNE-385-3TWL
• Company Name: Moroles Investments, LLC
• Labeler DUNS: 045103307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-16
• Public Version: 2
• Public Version Date: 2024-10-21
• Public Version Status: Update
• Public Device Record Key: 89b287f3-b738-4424-bb20-75876df7194f

Device 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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
INM	Chair, With Casters	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40539	Commode, manual	A non-active, manually-operated transportable device in the form of a chair with a receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858288006203	GS1