FDA UDI
In Commercial Distribution
🇺🇸 United States
Scalara SL1/CL2
DI: B24010
·
Model: 10
·
Garaventa (Canada) Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scalara SL1/CL2
- Primary DI
- B24010
- Version / Model
- 10
- Company Name
- Garaventa (Canada) Ltd.
- Labeler DUNS
- 252287586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-27
- Public Version
- 2
- Public Version Date
- 2024-04-12
- Public Version Status
- Update
- Public Device Record Key
- 7a5ca258-4ba8-4fb3-8928-ae963fc00515
Device Description
An electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.
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 |
|---|---|---|---|---|
| PCD | Powered Stairway Chair Lift | Physical Medicine | 890.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30038 | Stairlift, chair | A mains electricity (AC-powered) lifting device with an attached seating unit to accommodate a person with a disability, a geriatric or an infirm person to be transported up and down a staircase in a sitting position. 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 for home-use and in public venues and institutions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B24010 | HIBCC |