AccessGUDID - DEVICE: DRIVEMEDICAL (00822383284705)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: WILDCAT450BK24SS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383284705
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: PowerFolding Power Product Description: Wildcat 450 Black 24" Sling Seat

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?
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
INI	VEHICLE, MOTORIZED 3-WHEELED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070817	000

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: e893699c-e9d6-4fb4-90e0-db2e38846e7e
Public Version Date: February 02, 2024
Public Version Number: 5
DI Record Publish Date: July 01, 2016