FDA UDI
In Commercial Distribution
🇺🇸 United States
Zippie Voyage
DI: 00016958053647
·
Model: Voyage; Voyage VIP
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zippie Voyage
- Primary DI
- 00016958053647
- Version / Model
- Voyage; Voyage VIP
- Catalog Number
- EIZ14. EIZ16, EIZ18
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-12
- Public Version
- 1
- Public Version Date
- 2023-09-20
- Public Version Status
- New
- Public Device Record Key
- 94e3e4e5-075c-4b62-9bb1-561738848b17
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| INM | Chair, With Casters | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958053647 | GS1 |