Advantage Rail: Bariatric
Basic Information
- Brand Name
- Advantage Rail: Bariatric
- Primary DI
- 00689281001304
- Version / Model
- AR-T-HD
- Catalog Number
- 00130
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-25
- Public Version
- 1
- Public Version Date
- 2021-09-02
- Public Version Status
- New
- Public Device Record Key
- 390d8391-44e6-4ea0-af13-a6b2626f6861
Device Description
The Advantage Rail is a high quality, commercial grade pivoting and locking horizontal bar that connects to a floor mounted mast. The horizontal bar can be lifted, pivoted and lowered to the next locking position around the mast. It is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail mast is installed to a structural floor. Inside the mast is a locking mechanism for the horizontal bar: a castellated collar with 8 grooves (every 45 degrees) to provide a mechanism strong enough to support the user. It is important to set proper height and orientation of the Advantage Rail to optimize the user’s range of motion. The maximum user weight is 450lbs / 205kgs. Note: Product is not intended to support full body weight.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43235 | Fixed-rail armrest | A wall and/or floor fixed-rail system designed to provide arm support for a disabled person to facilitate their movement/mobility. It is permanently-fixed to the wall and/or floor at strategic points in a building or in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00689281001304 | GS1 |