AccessGUDID - DEVICE: Go Go Elite Traveller Plus 3 Wheel (00606509300124)

GUDID

Device Identifier (DI) Information

Brand Name: Go Go Elite Traveller Plus 3 Wheel
Version or Model: SC53/Avantgarde ET Plus 3 Wheel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: Pride Mobility Products Corp

Primary DI Number: 00606509300124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041477449 *Terms of Use

Device Description: A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
45684	Assistive scooter, electric-motor-driven	A battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INI	Vehicle, Motorized 3-Wheeled

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: c863c864-ee58-403a-9a32-b73efef937ac
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: September 19, 2016