FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOS Diagnostics
DI: 00057475220495
·
Model: 220DI
·
Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BIOS Diagnostics
- Primary DI
- 00057475220495
- Version / Model
- 220DI
- 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
- 1ff08163-9f95-4741-b117-82a7f8a2b606
Device Description
Glass Thermometer
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
- Yes
- 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 |
|---|---|---|---|---|
| FLK | Thermometer, Clinical Mercury | General Hospital | 880.2920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64142 | Capillary patient thermometer, gallium-alloy | An instrument designed to measure a patient's body temperature which is formed as a slender, hollow, sealed tube made of glass with a bulb at one end filled with a non-toxic liquid gallium alloy (typically alloyed with indium and tin). It works on the capillary principle whereby the registered heat proportionally expands the medium, filling a graduated column. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10057475220492 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00057475220495 | GS1 | ||||
| Package | 80057475220491 | GS1 | 4 | In Commercial Distribution |