FDA UDI
In Commercial Distribution
🇺🇸 United States
Assembly Required Distributors O+Inc.
DI: 00860004575610
·
Model: WCM2025NF50
·
Assembly Required Distributors Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Assembly Required Distributors O+Inc.
- Primary DI
- 00860004575610
- Version / Model
- WCM2025NF50
- Company Name
- Assembly Required Distributors Inc
- Labeler DUNS
- 170562396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-11
- Public Version
- 2
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- 2367e904-7d6d-45bb-865b-af18723639bf
Device Description
Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity, less front rigging, Green
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 57980 | Bariatric transport wheelchair, collapsible | A wheeled personal mobility device designed for transporting bariatric (obese) persons over short distances and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a heavy-duty framework and extra wide seat-support system for an obese person with a disability or obese person without the full capacity to walk. It also includes footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004575610 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973418 | 000 |