FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOS Living
DI: 00057475590239
·
Model: 59023
·
Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIOS Living
- Primary DI
- 00057475590239
- Version / Model
- 59023
- Company Name
- Thermor Ltd
- Labeler DUNS
- 246883458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-20
- Public Version
- 1
- Public Version Date
- 2023-09-28
- Public Version Status
- New
- Public Device Record Key
- fc74c85a-a9fe-43eb-a08f-e886ca1b5eb8
Device Description
Bath Lift
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
- 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 |
|---|---|---|---|---|
| FNG | Lift, Patient, Ac-Powered | General Hospital | 880.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34934 | Patient lifting system bath chair | A lifting device designed with a seat, and typically with legs and a back support, used with a patient lifting system to seat, lift, and transfer an incapacitated, geriatric, or disabled patient from a wheelchair into a bath or a tub (prefilled with bathing water or not) and back out again after the bathing session has been completed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10057475590236 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 00057475590239 | GS1 |