FDA UDI
In Commercial Distribution
🇺🇸 United States
DALTON PRIMECHAIR
DI: 00815027012666
·
Model: PC-MP3CM3AR20
·
DALTON MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DALTON PRIMECHAIR
- Primary DI
- 00815027012666
- Version / Model
- PC-MP3CM3AR20
- Company Name
- DALTON MEDICAL CORPORATION
- Labeler DUNS
- 874709348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-27
- Public Version
- 1
- Public Version Date
- 2025-06-04
- Public Version Status
- New
- Public Device Record Key
- 164df9e3-010b-44a3-bc64-211a967a6f1d
Device Description
PRIMECHAIR MID-WHEEL DRIVE, WT. LIMIT 300 lbs. W/20" CAPTAIN SEAT
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
- 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 |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40747 | Electric-motor-driven wheelchair, attendant-controlled | An electrically-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk with the assistance of an electric motor. The electronic control of speed and manual control of direction is performed by an attendant; it does not allow for electronic control by the occupant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815027012666 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | OVERALL: 24"W x 29"L x 42.5"H |