FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOS Living
DI: 00057475700324
·
Model: 70032
·
Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BIOS Living
- Primary DI
- 00057475700324
- Version / Model
- 70032
- Company Name
- Thermor Ltd
- Labeler DUNS
- 246883458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-07
- Public Version
- 1
- Public Version Date
- 2023-11-15
- Public Version Status
- New
- Public Device Record Key
- 961ef1a1-44ed-4192-ba7a-aa60df95508b
Device Description
Diabetic Socks, White, Large
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQL | Stocking, Medical Support (For General Medical Purposes) | General Hospital | 880.5780 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58831 | Antimicrobial sock | A tubular, fabric device intended to be worn on the feet of a patient to help maintain foot health and reduce the growth of fungi and bacteria through inclusion of an antimicrobial agent [e.g., pure cotton yarn containing silver (Ag) nanoparticles]. It is typically indicated for a patient who suffers from athlete’s foot, diabetic foot, neurological sensory disorders (e.g., unable to feel micro traumas, touch, or temperature), and impaired blood circulation; it is generally intended to reduce the risk of primary and secondary infection. The device is normally available for daily use in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20057475700328 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 00057475700324 | GS1 | ||||
| Package | 10057475700321 | GS1 | Case | 8 | In Commercial Distribution |