FDA UDI
In Commercial Distribution
🇺🇸 United States
Assembly Required Distributors
DI: 00854362008408
·
Model: WCM2626LS50
·
Assembly Required Distributors Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Assembly Required Distributors
- Primary DI
- 00854362008408
- Version / Model
- WCM2626LS50
- Company Name
- Assembly Required Distributors Inc
- Labeler DUNS
- 170562396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-27
- Public Version
- 2
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- f591af45-d697-4f9c-abe0-30c0f27e923e
Device Description
Stainless steel W/C, 26' width, 550 lb. capacity, rem. desk arm, no seat, no F/R, GREEN, w/ seat belt, 20" seat depth,
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
- 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 |
|---|---|---|---|---|
| 41328 | Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible | A wheeled personal mobility device that incorporates a heavy-duty framework and extra wide seat-support system for a bariatric (obese) person with a disability or an obese person without the full capacity to walk, and is manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device 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 | 00854362008408 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973418 | 000 |