Ever-Soft Foam Cushion
- Primary DI
- 00616784065441
- Brand
- Ever-Soft Foam Cushion
- Company
- DYNAREX CORPORATION
- Model
- 10654
- Device description
- Ever-Soft Foam Cushion 20"x18"x3"
- Published
- 2021-04-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IMP | Cushion, Wheelchair |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784065441 | Package | GS1 | 5 | In Commercial Distribution |
| 00616784065410 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Foam-filled chair cushion | A foam-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair and may contain weight-distribution air cells. This is a reusable device. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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