FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632079979
·
Model: WC2005
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632079979
- Version / Model
- WC2005
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- fc319937-3a32-40fc-b01c-8bf8c4c94f7f
Device Description
Standard Wheelchair Swingaway Footrest Removable Full Padded Armrest 20X16 Inch Seat 300lb Weight Capacity Chrome-plated Carbon Steel Frame Flame-resistant Black Vinyl Upholstery Adjustable Height For Foot Propulsion Not Made With Natural Rubber Latex MediChoice
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 41622 | Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible | A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be 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 | 10885632079979 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052468 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from water damage and sunlight
- Type
- Special Storage Condition, Specify