VIVALNK, INC.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tape And Bandage, Adhesive (KGX) (7) Thermometer, Electronic, Clinical (FLL) (2) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1)

Premarket Exempt

No Yes

Clear

Hydrogel Adhesive - 00860008259202 Catalog Number :

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Hydrogel Adhesive - 00860008259219 Catalog Number :

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Hydrogel Adhesive - 00860008259226 Catalog Number :

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Fever Scout Continuous monitoring thermometer - 00865064000119 Catalog Number :

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

Device Class : 2

Duns Number: 013311479

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Enfasmart feversense Adhesive Refill Pack - 00865064000126 Catalog Number :

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

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Fever Scout Adhesive Refill - 00865064000133 Catalog Number :

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

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Continuous ECG Platform - 00865064000157 Catalog Number :

Device Description : VV330 Continuous ECG Platform is a wireless recording system intended for use by

Device Class : 2

Duns Number: 013311479

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

Enfasmart feversense Continuous monitoring thermometer - 00865064000164 Catalog Number :

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

Device Class : 2

Duns Number: 013311479

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Hydrogel Adhesive - 00865064000188 Catalog Number :

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

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Hydrogel Adhesive - 00865064000195 Catalog Number :

Device Description : Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers o

Device Class : 1

Duns Number: 013311479

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

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