AccessGUDID - DEVICE: MJM INTERNATIONAL CORP (00897074002876)

GUDID

Device Identifier (DI) Information

Brand Name: MJM INTERNATIONAL CORP
Version or Model: SHOWER CHAIRS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100 SERIES
Company Name: M J M International Corporation

Primary DI Number: 00897074002876
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 159688993 *Terms of Use

Device Description: SHOWER CHAIR TO PROVIDE TRANSFERRING, BATHING AND / OR TOILETING FOR PATIENTS IN HEALTHCARE FACILITIES AND / OR PRIVATE HOMES

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):	Yes
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?
67346	Washing/toileting non-lifting transfer chair	A non-powered, non-lifting chair intended to assist a patient (e.g., hospitalized, disabled, geriatric) with moving/sliding over/away from a toilet or bath (for showering); it does not include lowering/lifting capabilities (i.e., not a lifting chair). It typically has the form of a chair with a wide seat, or a chair attached to a rack with a sliding mechanism and may incorporate wheels and/or a chair tilting mechanism. It may be used in the home and healthcare facility.	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: 722d9821-b18c-4dd7-a4ca-97c8f71636d2
Public Version Date: March 21, 2025
Public Version Number: 3
DI Record Publish Date: February 25, 2025