FDA UDI
In Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 00822383545141
·
Model: MS-14300
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 00822383545141
- Version / Model
- MS-14300
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-10
- Public Version
- 3
- Public Version Date
- 2019-07-15
- Public Version Status
- Update
- Public Device Record Key
- 671dfbfb-1333-4609-bcf7-396b4ab5147e
Device Description
Pressure PreventionSeat and Back Cushions Product Description: 16"x17.5" Gen.use adj back cush 16"-21"
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
- Yes
- 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 |
|---|---|---|---|---|
| KIC | CUSHION, FLOTATION | Physical Medicine | 890.3175 | 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 |
|---|---|---|---|---|---|---|
| Package | 50822383545146 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00822383545141 | GS1 |