Enfasmart feversense Continuous monitoring thermometer

GUDID 00865064000164

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.

VIVALNK, INC.

Wireless patient thermometer, reusable
Primary Device ID00865064000164
NIH Device Record Keyf95630e7-d463-4a63-9007-f4bccc20358a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnfasmart feversense Continuous monitoring thermometer
Version Model NumberVV220
Company DUNS013311479
Company NameVIVALNK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100865064000164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-30
Device Publish Date2018-07-30

Devices Manufactured by VIVALNK, INC.

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00860008259202 - Hydrogel Adhesive2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci
00860008259219 - Hydrogel Adhesive2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci
00865064000195 - Hydrogel Adhesive2022-02-21 Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of speci
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00865064000188 - Hydrogel Adhesive2020-02-07 The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.
00865064000126 - Enfasmart feversense Adhesive Refill Pack2019-10-23 The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.

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