AccessGUDID - DEVICE: Cool Cube / TouchDrive 2 (00016958058413)

GUDID

Device Identifier (DI) Information

Brand Name: Cool Cube / TouchDrive 2
Version or Model: CCB / TD2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SWI
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 00016958058413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: The Cool Cube™ central hub input ports interface with multiple types of switches and can effectively control the various desired switch functions. The Switch-It TouchDrive2 (currently not in distribution) uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control.

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?
30018	Wheelchair steering/control unit	An electronic device used by a wheelchair occupant or attendant to guide the wheelchair's movements and direction of travel. This device may be operated by the occupant's hand, mouth, or signals provided by other means, or by the attendant as required. This device will include the installation package.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, 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: 5c4cb579-1a6c-476a-ba28-dc442c1b6b41
Public Version Date: June 18, 2025
Public Version Number: 4
DI Record Publish Date: May 12, 2021