AccessGUDID - DEVICE: Zippie Voyage (00016958053647)

GUDID

Device Identifier (DI) Information

Brand Name: Zippie Voyage
Version or Model: Voyage; Voyage VIP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIZ14. EIZ16, EIZ18
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 00016958053647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: The Zippie Voyage® is a lightweight highly adjustable early intervention stroller. In addition to adjustable tilt and recline, the Voyage also features adjustable head supports, upper body supports and positioning straps. Comes with or without seating.

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: 94e3e4e5-075c-4b62-9bb1-561738848b17
Public Version Date: May 20, 2025
Public Version Number: 2
DI Record Publish Date: September 12, 2023