FDA UDI
In Commercial Distribution
🇺🇸 United States
DMI
DI: 00041298001317
·
Model: 517-1072-0200
·
D-M-S HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DMI
- Primary DI
- 00041298001317
- Version / Model
- 517-1072-0200
- Company Name
- D-M-S HOLDINGS, INC.
- Labeler DUNS
- 062028220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-11
- Public Version
- 1
- Public Version Date
- 2023-07-19
- Public Version Status
- New
- Public Device Record Key
- dfaac11d-105d-4a19-8129-9dfd518a0f83
Device Description
Back Pack Wheelchair W/Straps
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
- 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 |
|---|---|---|---|---|
| IMP | Cushion, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38495 | Wheelchair article holder | A container (e.g., a wire basket, nylon tote bag, or plastic box) that provides a wheelchair occupant with a receptacle for items (e.g., personal/shopping items, work supplies). The device can be mounted at various locations on the wheelchair depending on the type of wheelchair and configuration of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041298001314 | GS1 | Master carton | 200 | In Commercial Distribution | |
| Primary | 00041298001317 | GS1 |