FDA UDI
In Commercial Distribution
🇺🇸 United States
YUWELL Infrared Thermometer
DI: 06933257922747
·
Model: YT-1
·
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YUWELL Infrared Thermometer
- Primary DI
- 06933257922747
- Version / Model
- YT-1
- Company Name
- JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
- Labeler DUNS
- 528704000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-30
- Public Version
- 1
- Public Version Date
- 2024-07-08
- Public Version Status
- New
- Public Device Record Key
- c8f5951f-bf60-49f1-9c34-c9499ccbfb6c
Device Description
The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 | 06933257922747 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201864 | 000 |