FDA UDI
In Commercial Distribution
🇺🇸 United States
Advantage Pole Bariatric
DI: 00689281000482
·
Model: AR-AP-HD
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Advantage Pole Bariatric
- Primary DI
- 00689281000482
- Version / Model
- AR-AP-HD
- Catalog Number
- 0048
- 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
- 9eb7f930-09cd-4c3b-8a2b-95306049151e
Device Description
The Advantage Pole is a high quality, commercial grade floor mounted support pole. The Advantage Pole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole mast is installed to a structural floor. 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 |
|---|---|---|---|---|
| 41583 | Freestanding support rail | A self-supporting bar that is placed strategically on the floor by a healthcare professional for hospitalized, disabled, or geriatric patients to hold and support themselves when rising from a bed or a chair. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00689281000482 | GS1 |