FDA UDI
In Commercial Distribution
🇺🇸 United States
Bariatric Walker
DI: 00845699000548
·
Model: WOK750
·
SIZEWISE RENTALS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bariatric Walker
- Primary DI
- 00845699000548
- Version / Model
- WOK750
- Company Name
- SIZEWISE RENTALS, L.L.C.
- Labeler DUNS
- 967025602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-07
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 02c36f67-f225-444d-ba57-3a4a9deafbcf
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
- 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 |
|---|---|---|---|---|
| ITJ | Walker, Mechanical | Physical Medicine | 890.3825 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37954 | Bariatric walker, non-foldable | An all- or partially-wheeled mobility aid in the form of a waist-high, non-foldable, extra wide framework with handgrips and four legs designed to provide a stable support for a bariatric (obese) person when standing or ambulating; it may also be used during rehabilitation. It is a sturdy construction made of lightweight metal, plastic and rubber materials that surrounds the front and flanks of the user. The user holds the handgrips to push the device in front of them as they move forward. The device is non-foldable and includes a braking mechanism; it may be width- adjustable. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845699000548 | GS1 |