FDA UDI
In Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 00822383928951
·
Model: KG-RW12
·
Drive Devilbiss Healthcare
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 00822383928951
- Version / Model
- KG-RW12
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 2
- Public Version Date
- 2024-10-03
- Public Version Status
- Update
- Public Device Record Key
- 1565516c-f9a1-471f-831a-fa8367a43054
Device Description
WenzeliteWheelchair Product Description: Kanga 12" Rear Wheel Assembly, Pr.
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 |
|---|---|---|---|---|
| KNO | ACCESSORIES, WHEELCHAIR | Physical Medicine | 890.3910 | 1 |
| INM | CHAIR, WITH CASTERS | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41512 | Push-rim manual wheelchair, non-bariatric | A non-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 by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. 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 | 00822383928951 | GS1 |