AccessGUDID - DEVICE: Enfasmart feversense Continuous monitoring thermometer (00865064000164)

GUDID

Device Identifier (DI) Information

Brand Name: Enfasmart feversense Continuous monitoring thermometer
Version or Model: VV220
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIVALNK, INC.

Primary DI Number: 00865064000164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013311479 *Terms of Use

Device Description: The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
62450	Wireless patient thermometer, reusable	A wearable, battery-powered, electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for recording and data display; it is typically used to monitor temperature during daily activities and sleep. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit); a charging case and software may be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f95630e7-d463-4a63-9007-f4bccc20358a
Public Version Date: November 16, 2020
Public Version Number: 2
DI Record Publish Date: July 30, 2018