FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 50822383506925
·
Model: 564065
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 50822383506925
- Version / Model
- 564065
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 2
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- c414820e-f1b1-493c-a68a-8a474e2de521
- Distribution End Date
- 2024-01-29
Device Description
Pressure PreventionLTC and Hospice Product Description: Pressure Pro I Mattress 84"L
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 |
|---|---|---|---|---|
| IKY | MATTRESS, FLOTATION THERAPY, NON-POWERED | General Hospital | 880.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60422 | Gel-filled bed mattress | A large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 50822383506925 | GS1 |