FDA UDI
In Commercial Distribution
🇺🇸 United States
Highlander
DI: 00817650023958
·
Model: Highlander II
·
Harmar Summit, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Highlander
- Primary DI
- 00817650023958
- Version / Model
- Highlander II
- Catalog Number
- VPL1400SCWACI
- Company Name
- Harmar Summit, LLC
- Labeler DUNS
- 144008062
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-20
- Public Version
- 2
- Public Version Date
- 2023-04-19
- Public Version Status
- Update
- Public Device Record Key
- b03d1bd0-e5b9-4c1c-be0b-dd81d2c969b2
Device Description
Platform lift, 14 ft, Standard, commercial, hoistway, AC, indoor
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
- 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 |
|---|---|---|---|---|
| PCE | Permanently mounted wheelchair platform lift | Physical Medicine | 890.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17819 | Wheelchair/occupant lift | A mains electricity (AC-powered) device designed for moving (lifting) a wheelchair and the seated occupant from one level to another to provide a means of vertical access. It typically consists of a platform, with no roof, onto which the patient wheels the wheelchair, using controls to move up or down; the lift does not move within a lift shaft. The lift is designed for use in buildings such as hospitals, homes, offices, and stores. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817650023958 | GS1 |
Customer Contacts
- Phone
- +1(800)833-0478
- [email protected]