AccessGUDID - DEVICE: DRIVEMEDICAL (00822383515151)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: TRID-2A37
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383515151
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: PowerAccessories Product Description: SwingawayJoystickBracket,Trident,VR2,1/e

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?
41875	Electric-motor-driven wheelchair, occupant-controlled	An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNO	ACCESSORIES, WHEELCHAIR

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: 50831da9-7d77-4259-a1b1-b55946ac9765
Public Version Date: February 01, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2019