FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 00822383107622
·
Model: TR19
·
Drive Devilbiss Healthcare
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 00822383107622
- Version / Model
- TR19
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-19
- Public Version
- 4
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 7e31cf94-1d5e-4f7b-a902-59ea4d924a91
- Distribution End Date
- 2019-06-22
Device Description
Transport/WheelchairTransport Chairs Product Description: PolyFlyW/C,TranCh,16"w/SwgFt,AntiTp,1/cs
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
- 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 |
|---|---|---|---|---|
| INM | CHAIR, WITH CASTERS | Physical Medicine | 890.3100 | 1 |
| IOR | Wheelchair, mechanical | Physical Medicine | 890.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41875 | Electric-motor-driven wheelchair, occupant-controlled | An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383107622 | GS1 |