FDA UDI
In Commercial Distribution
🇺🇸 United States
Jay Adjustable Solid Seat
DI: 00016958040128
·
Model: Adjustable Seat Solid
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jay Adjustable Solid Seat
- Primary DI
- 00016958040128
- Version / Model
- Adjustable Seat Solid
- Catalog Number
- GPN-4012
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-21
- Public Version
- 1
- Public Version Date
- 2023-09-29
- Public Version Status
- New
- Public Device Record Key
- 8f12ff4b-9b0a-49df-ac51-5090964d0f8a
Device Description
The Adjustable Solid Seat features ABS plastic to provide you a firm base of support for improved posture and positioning. Each seat size adjusts to accommodate a range of wheelchair widths and depths. Its non-skid surface keeps the cushion in place during transfers and daily use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44511 | Gel-filled chair cushion | A gel-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. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958040128 | GS1 |