BIOINTELLISENSE, INC.

Address:570 El Camino Real,Redwood City,CA,94062,US

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Device Description : The BioSticker™ System is a wearable remote monitoring system intended for conti The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings.

Device Class :

Duns Number: 116984478

Premarket Exempt : No

Product Code : DRG, NDC

Prescription Use : Yes

Device Count : 1

Device Description : Offload Software for the BioSticker System.

Device Class : 2

Duns Number: 116984478

Premarket Exempt : No

Product Code : DRG, NDC

Prescription Use : Yes

Device Count : 1

- Catalog Number : SKU# B2-ST03-02-0-00-GY

Device Description : The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.

Device Class : 2

Duns Number: 116984478

Premarket Exempt : No

Product Code : DRG, NDC

Prescription Use : Yes

Device Count : 1

- Catalog Number : SKU# B2-ST05-02-0-00-GY

Device Description : The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.

Device Class : 2

Duns Number: 116984478

Premarket Exempt : No

Product Code : DRG, NDC

Prescription Use : Yes

Device Count : 1

- Catalog Number : B2-ST06-04-0-00-GY (US)

Device Description : The BioButton™ is a remote monitoring wearable device intended to collect physio The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.

Device Class : 2

Duns Number: 116984478

Premarket Exempt : No

Product Code : DRG, NDC

Prescription Use : Yes

Device Count : 1

Device Description : Adhesive accessory packs for wearable devices (OMI, ADB); ACCS-1-ST06-1-4

Device Class :

Duns Number: 116984478

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1

Device Description : Adhesive accessory packs for wearable devices - 5 pcs, ADD, HT; SKU: ADH-AC1-BBR-5-1-1-10

Device Class :

Duns Number: 116984478

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1