FDA UDI
In Commercial Distribution
🇺🇸 United States
DMECare Solutions Ever-Soft Lumbar Support Cushion,18"
DI: 00840117321915
·
Model: 13042-18
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DMECare Solutions Ever-Soft Lumbar Support Cushion,18"
- Primary DI
- 00840117321915
- Version / Model
- 13042-18
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-22
- Public Version
- 1
- Public Version Date
- 2025-09-01
- Public Version Status
- New
- Public Device Record Key
- 61d67212-bbfe-49ff-943a-41d320204a54
Device Description
Weight Capacity: 350 LB.
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 41057 | Lumbar cushion | A soft pillow or pad used to provide support and comfort to the user's lower back, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to support the natural curvature of the lower spine, improve posture, relax muscles, and relieve painful pressure points. The device is typically placed between the lower back and the back of a seat/chair while the user is seated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840117321915 | GS1 | ||||
| Package | 00840117321908 | GS1 | Shipper | 4 | In Commercial Distribution |