FDA UDI
In Commercial Distribution
🇺🇸 United States
Drive
DI: 00822383511863
·
Model: PL-STDS4Y4706
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Drive
- Primary DI
- 00822383511863
- Version / Model
- PL-STDS4Y4706
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 88ac4df4-72d2-4642-aed1-7bfef26081c8
Device Description
ViperGT,20"Recl,FlpBackRemFull,1/ea
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 57978 | Wheelchair recliner, battery-powered | A battery-powered mobile device designed to tilt (recline) a standard type wheelchair and occupant (not bariatric) to enable healthcare providers give treatment at a degree of tilt most efficient for them. The device includes a platform onto which the wheelchair/occupant is reversed and secured, and rechargeable batteries that drive an electric motor to power the tilting mechanism. It may include additional back- and headrest and may be moved on wheels for repositioning within a room or facility. It is used for treatments in dentistry, ophthalmology, maxillofacial and ear/nose/throat (ENT), podiatry (including diabetic foot care), physical therapy, and personal care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383511863 | GS1 |