AccessGUDID - DEVICE: Kaye Products

GUDID

Device Identifier (DI) Information

Brand Name: Kaye Products - VS1
Version or Model: VS1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Kaye Products, Inc.

Primary DI Number: 00810117142780
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 082364654 *Terms of Use

Device Description: Small Vertical Stander without Casters

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?
61704	Manual stander/exerciser	A manually-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement), and a manual mechanical lifting mechanism; the patient is raised from a supine and/or seated position by themselves or with the assistance of a healthcare provider.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILT	Adaptor, Recreational

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: fb8f305b-2c5e-470e-9299-3c552fdc230b
Public Version Date: May 12, 2025
Public Version Number: 2
DI Record Publish Date: July 05, 2023