FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIOS Living
DI: 00057475000585
·
Model: 59058L
·
Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIOS Living
- Primary DI
- 00057475000585
- Version / Model
- 59058L
- Company Name
- Thermor Ltd
- Labeler DUNS
- 246883458
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-31
- Public Version
- 2
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 37ff9435-1f9f-4bbf-a1de-aacbe2f017ed
- Distribution End Date
- 2023-12-01
Device Description
Raised Toilet Seat 6" with Lid
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ILS | Adaptor, Hygiene | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31059 | Raised toilet seat | A non-powered seat designed to enable a person with a disability to sit on the toilet at an elevation above the conventional range for easier sitting and standing. It may be intended to attach to a standard toilet bowl or may be freestanding; it might also include armrests/bars to assist transfer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10057475000582 | GS1 | Case | 2 | Not in Commercial Distribution | 2023-12-01 |
| Primary | 00057475000585 | GS1 |