FDA.reportPublic FDA data

Fever Scout Continuous monitoring thermometer

Primary DI
00865064000119
Brand
Fever Scout Continuous monitoring thermometer
Company
VIVALNK, INC.
Model
VV200
Device description
The wireless Fever Scout™ 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
00865064000119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865064000119008650640001198650640001190865064000119

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
00865064000164Enfasmart feversense Continuous monitoring thermometerVV2202018-07-30

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Primary DI, Brand, Company table
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