AccessGUDID - DEVICE: Raz (00628758002000)

GUDID

Device Identifier (DI) Information

Brand Name: Raz
Version or Model: Raz-SP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Raz Design Inc

Primary DI Number: 00628758002000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206941366 *Terms of Use

Device Description: Individually configured, mobile and stationary commode chairs for use during showering and toileting. The Raz-SP is Mobile Shower Commode Chair with stainless steel frame and components, two locking 6” (150mm), two large rear wheels with ergonomic hand rims, and commode pan.

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
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: 72259817-6794-44c3-8adb-4e287e6123a6
Public Version Date: July 11, 2025
Public Version Number: 4
DI Record Publish Date: August 01, 2023