FDA UDI
In Commercial Distribution
🇺🇸 United States
Assista-Rail
DI: 00689281001472
·
Model: AST-S
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Assista-Rail
- Primary DI
- 00689281001472
- Version / Model
- AST-S
- Catalog Number
- 00147
- 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
- 89907df1-7173-4222-81a2-bd2501d36e19
Device Description
The Assista-Rail is a fixed bed rail. The Assista-Rail is intended ONLY for minimal vertical load bearing to provide bed positioning and seating support for people with reduced mobility. The Assista-Rail is intended for home use. The Assista-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. The Assista-Rail is height adjustable to accommodate the thickness of the mattress. The maximum user weight for this product is 300lbs / 136kgs. 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 |
|---|---|---|---|---|
| 34868 | Bedrail | A rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10689281001479 | GS1 | CARTON | 4 | In Commercial Distribution | |
| Primary | 00689281001472 | GS1 |