AccessGUDID - DEVICE: Mor-Medical New Era (00850010988702)

GUDID

Device Identifier (DI) Information

Brand Name: Mor-Medical New Era
Version or Model: DNE-REC-335-FF-LR-PAIL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Moroles Investments, LLC

Primary DI Number: 00850010988702
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045103307 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INN	Chair, Adjustable, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 241e73d8-b48f-401b-9e90-4de916ed47bd
Public Version Date: July 24, 2024
Public Version Number: 1
DI Record Publish Date: July 16, 2024