AccessGUDID - DEVICE: Wello, Inc (00860011348603)

GUDID

Device Identifier (DI) Information

Brand Name: Wello, Inc
Version or Model: welloStationX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wello, Inc

Primary DI Number: 00860011348603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117825202 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180298	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47e4e864-ec2d-4541-bd6c-3c136de5657e
Public Version Date: August 02, 2024
Public Version Number: 1
DI Record Publish Date: July 25, 2024