AccessGUDID - DEVICE: Zippie Kid Kart Xpress (00016958042658)

GUDID

Device Identifier (DI) Information

Brand Name: Zippie Kid Kart Xpress
Version or Model: Xpress
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIXP
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 00016958042658
Issuing Agency: GS1
Commercial Distribution End Date: September 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: **********************************DO NOT USE THIS DI NUMBER FOR ZIPPIE KID KART XPRESS. USE 00016958042672.************************************************** The Kid Kart® Xpress early intervention mobility kids wheelchair features superior positioning, contemporary style, and user-friendly functionality for children 0-3 years old weighing up to 55 lbs.

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":	Yes
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?
46146	Stand-up chair, mechanical	A mechanical device designed to support a patient with a disability (e.g., geriatric, injured, disabled) in a sitting posture and helps the person via its self-raising mechanism to both to sit down from a standing position and stand up from a sitting position. The manual and/or power-assisted (e.g., spring-assisted) features may include a seat that can be elevated and tilted forward to help the person stand, a back rest that reclines for comfort, a seat with tilting sections, and/or casters to permit a reorientation. It is neither a stander (which is intended to support a patient in a prolonged standing position) nor a wheelchair.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: ae533374-1706-47b2-90de-7e83c05df8ec
Public Version Date: May 20, 2025
Public Version Number: 3
DI Record Publish Date: September 12, 2023