FDA UDI
In Commercial Distribution
🇺🇸 United States
Non-contact Infrared Thermometer DT-100
DI: 18800003445537
·
Model: DT-100
·
Mediana.CO.LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Non-contact Infrared Thermometer DT-100
- Primary DI
- 18800003445537
- Version / Model
- DT-100
- Catalog Number
- 00885
- Company Name
- Mediana.CO.LTD
- Labeler DUNS
- 687879726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-03
- Public Version
- 2
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 47d050f2-5fc7-4bdb-b730-f7412a2e9421
Device Description
The DT-100 non-contact infrared thermometer is intended to be used to measure temperature for consumers including adult, pediatric and neonatal using infrared sensors. It can detect the body temperature from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 | 18800003445537 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160358 | 000 |