AccessGUDID - DEVICE: Mor-Medical New Era (00850010988122)

GUDID

Device Identifier (DI) Information

Brand Name: Mor-Medical New Era
Version or Model: DNE-710-4L-FF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Moroles Investments, LLC

Primary DI Number: 00850010988122
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 Bariatric 30" Shower Commode Chair, with Open Front Soft Seat and Insert, Soft Touch Folding Footrest, Slide Out Commode Pail, 4" All Locking Casters, 710 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?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: 70fc467a-bdc7-4379-885e-c4e55a3d1648
Public Version Date: October 21, 2024
Public Version Number: 2
DI Record Publish Date: July 16, 2024