FDA UDI
In Commercial Distribution
🇺🇸 United States
Zippie Kid Kart Xpress
DI: 00016958042672
·
Model: Xpress
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zippie Kid Kart Xpress
- Primary DI
- 00016958042672
- Version / Model
- Xpress
- Catalog Number
- EIXP
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-27
- Public Version
- 1
- Public Version Date
- 2023-10-05
- Public Version Status
- New
- Public Device Record Key
- 8247b148-7a4a-4855-b5a8-c2332920102d
Device Description
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
- 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 | 00016958042672 | GS1 |