Mor-Medical New Era

Basic Information

• Brand Name: Mor-Medical New Era
• Primary DI: 00850010988702
• Version / Model: DNE-REC-335-FF-LR-PAIL
• 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: 1
• Public Version Date: 2024-07-24
• Public Version Status: New
• Public Device Record Key: 241e73d8-b48f-401b-9e90-4de916ed47bd

Device Description

Deluxe New Era Patented Infection Control 20" Reclining Shower Chair with Open Front Soft Seat and Insert, Soft Touch Folding Footrest and Legrest, Slide Out Commode Pail, 3" All Locking Casters, 335 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
INN	Chair, Adjustable, Mechanical	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36985	Reclining chair	A manually-operated, general-purpose device designed to support a patient in a seated position; it includes a back rest that reclines for patient comfort. The chair is intended to be used in a variety of settings including recovery from minor procedures, during convalescence, while donating blood, or while receiving chemotherapy. It may have a height-adjustable mechanism and have attached armrests, footrests, and/or legrests.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010988702	GS1