FDA UDI
In Commercial Distribution
🇺🇸 United States
Tecnimed - 3J MEDICAL SUPPLIES Inc
DI: 00182097000429
·
Model: VisioFocus MINI
·
TECNIMED SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tecnimed - 3J MEDICAL SUPPLIES Inc
- Primary DI
- 00182097000429
- Version / Model
- VisioFocus MINI
- Catalog Number
- 06700
- Company Name
- TECNIMED SRL
- Labeler DUNS
- 445878788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-10
- Public Version
- 3
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 65c3baff-1565-4085-98d7-ca82c87c257f
Device Description
Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: forehead (without contact).
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00182097000429 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 70 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 45 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity