FDA UDI
In Commercial Distribution
🇺🇸 United States
Matrx Libra Adjust Cushion
DI: 07540147001018
·
Model: LC-ADJ
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Matrx Libra Adjust Cushion
- Primary DI
- 07540147001018
- Version / Model
- LC-ADJ
- Catalog Number
- LCwwdd-ADJ
- Company Name
- Motion Concepts Inc
- Labeler DUNS
- 259777209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 2
- Public Version Date
- 2023-06-23
- Public Version Status
- Update
- Public Device Record Key
- 7fc46923-fce7-49f9-b830-53060eb645e0
Device Description
Matrx Libra Adjust Seat Cushion (includes 2 fluid supplement packs). Adjustable Skin Protection & Positioning Cushion (standard and bariatric sizing). The Matrx Libra cushion uses a combination of high resilient foam and dual layer fluid sac to provide maximum protection around boney prominences and stability to the pelvis. Recommended for all users including those at highest risk of skin breakdown
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
- 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 |
|---|---|---|---|---|
| KIC | Cushion, Flotation | Physical Medicine | 890.3175 | 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 |
| 44361 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147001018 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]