FDA.reportPublic FDA data

Enfasmart feversense Continuous monitoring thermometer

Primary DI
00865064000164
Brand
Enfasmart feversense Continuous monitoring thermometer
Company
VIVALNK, INC.
Model
VV220
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.
Published
2018-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162137000Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc.2017-01-19FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865064000164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865064000164008650640001648650640001640865064000164

GMDN Terms#

Term, Definition table
TermDefinition
Wireless patient thermometer, reusableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013311479
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008259233Continuous ECG PlatformVV3502022-11-30
00860008259226Hydrogel AdhesiveA502022-09-14
00860008259202Hydrogel AdhesiveA352022-02-11
00860008259219Hydrogel AdhesiveB082022-02-11
00865064000195Hydrogel AdhesiveA342022-02-11
00865064000188Hydrogel AdhesiveA132020-01-30
00865064000126Enfasmart feversense Adhesive Refill PackVV220A2018-07-30
00865064000133Fever Scout Adhesive Refill VV200A2018-07-30
00865064000157Continuous ECG PlatformVV3302020-01-30
00865064000119Fever Scout Continuous monitoring thermometerVV2002018-07-30

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Primary DI, Brand, Company table
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