FDA UDI
In Commercial Distribution
🇺🇸 United States
Wello, Inc
DI: 00860011348603
·
Model: welloStationX
·
Wello, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Wello, Inc
- Primary DI
- 00860011348603
- Version / Model
- welloStationX
- Company Name
- Wello, Inc
- Labeler DUNS
- 117825202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-25
- Public Version
- 1
- Public Version Date
- 2024-08-02
- Public Version Status
- New
- Public Device Record Key
- 47e4e864-ec2d-4541-bd6c-3c136de5657e
Device Description
The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body temperature of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 - 70% RH non-condensing.
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
- 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 |
|---|---|---|---|---|
| 67233 | Body temperature screening thermometer station | A freestanding electrically-powered unit designed for contactless measurement of temperature on the forehead/face of a person for screening purposes (e.g., to detect those with a fever). It may be a benchtop device or intended for attachment to a floor mount, and consists of a built-in infrared thermometer, integrated camera, face detection software, and image display screen to help adequate positioning of a person’s face during measurement; it may include a printer for labelling/identification of personnel/patients. It is typically used within healthcare facilities, public or work environments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011348603 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180298 | 000 |