VIVALNK, INC.

Address:51 EAST CAMPBELL AVE., SUITE 160,Campbell,CA,95008,US

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Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Device Description : The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive an 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.

Device Class : 2

Duns Number: 013311479

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Device Description : The silicon patch is a small, thin layer of soft silicon used for the adherence The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Device Description : The silicon patch is a small, thin layer of soft silicon used for the adherence The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Device Description : VV330 Continuous ECG Platform is a wireless recording system intended for use by VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.

Device Class : 2

Duns Number: 013311479

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

Device Description : The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-inv 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 Class : 2

Duns Number: 013311479

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Device Description : The silicon patch is a small, thin layer of soft silicon used for the adherence The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1