FDA UDI
In Commercial Distribution
🇺🇸 United States
Incline Platform Lift
DI: B24005
·
Model: 05
·
Garaventa (Canada) Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Incline Platform Lift
- Primary DI
- B24005
- Version / Model
- 05
- Company Name
- Garaventa (Canada) Ltd.
- Labeler DUNS
- 252287586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 4
- Public Version Date
- 2024-04-04
- Public Version Status
- Update
- Public Device Record Key
- 590db7d4-7729-4890-b97d-c10d7fad1c3a
Device Description
X3 - Permanently mounted wheelchair platform lift
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| PCE | Permanently Mounted Wheelchair Platform Lift | Physical Medicine | 890.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17817 | Stairlift, platform | A mains electricity (AC-powered) device designed with a platform typically used to accommodate a user sitting in their wheelchair to be transported up and down a staircase. This electromechanical device is typically attached to one or more rails which follow the shape and angle of the staircase, but may be affixed in another manner. It will typically be installed in public venues, institutions, and for home-use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B24005 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122206 | 000 |