FDA UDI
In Commercial Distribution
🇺🇸 United States
WOK
DI: 00845699000487
·
Model: SCC28
·
SIZEWISE RENTALS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WOK
- Primary DI
- 00845699000487
- Version / Model
- SCC28
- 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
- 2024-08-06
- Public Version
- 2
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- a65266da-ce5e-414a-8fd3-214434afffce
Device Description
Shower Commode 28
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
- 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 |
|---|---|---|---|---|
| ILS | Adaptor, Hygiene | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40539 | Commode, manual | A non-active, manually-operated transportable device in the form of a chair with a receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845699000487 | GS1 |