AccessGUDID - DEVICE: Switch-it (00016958060850)

GUDID

Device Identifier (DI) Information

Brand Name: Switch-it
Version or Model: CTRL+5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SWI
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 00016958060850
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: The Ctrl+5 box allows you to easily access power seating controls right at your fingertips. Designed with five buttons or toggles, this box can be programmed to control up to 10 separate power seating functions! The Ctrl+5 is equipped with the R-NET bus connector, making setup a snap. Features a 4'8" (150 cm) cable with R-NET male bus connector.

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
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: 0b85d270-381a-4d8e-89b8-6c952b20092c
Public Version Date: May 20, 2025
Public Version Number: 2
DI Record Publish Date: November 14, 2023