FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Drive
DI: 00822383975979
·
Model: MD4024-PIMB-CRD
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Drive
- Primary DI
- 00822383975979
- Version / Model
- MD4024-PIMB-CRD
- 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
- 4
- Public Version Date
- 2024-03-01
- Public Version Status
- Update
- Public Device Record Key
- 659e3880-fea8-4bb5-9c48-a2d6fb23e138
- Distribution End Date
- 2024-02-29
Device Description
Transport/WheelchairWheelchairs K6 Product Description: 24" Bariatric WC, Mnt Bike Solid Tire
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IOR | Wheelchair, mechanical | Physical Medicine | 890.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57979 | Attendant-only-propelled wheelchair, bariatric | A non-powered wheeled mobility device with an oversized seat designed to enable a healthcare provider/carer to transport a bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383975979 | GS1 |