AccessGUDID - DEVICE: CTM Mobility Scooter (00852202007048)

GUDID

Device Identifier (DI) Information

Brand Name: CTM Mobility Scooter
Version or Model: HS-265
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: C.T.M. HOMECARE PRODUCT, INC.

Primary DI Number: 00852202007048
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 043045660 *Terms of Use

Device Description: Advanced Mini Three Wheel Mobility Scooter, Red/Ice Blue

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?
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: d820a68e-2059-4745-b869-91f445801ae0
Public Version Date: April 04, 2023
Public Version Number: 3
DI Record Publish Date: December 27, 2018