TYTO CARE LTD

Address:215 West 40th St.,New York,NY,10018,US

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- Catalog Number : 900-00015-009

Device Description : TytoHome used for comprehensive remote exam and telehealth.TytoCare device with TytoHome used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672425 when packed in 6 pack and with 27290016672422 when packed in 48 pack .

Device Class :

Duns Number: 649125325

Premarket Exempt : No

Product Code : FLL, DQD, KYT, ERA

Prescription Use : No

Device Count : 1

- Catalog Number : 800-00014

Device Description : The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoHome kit components: the Tyto Stethoscope and Tyto Ottoscope. The Tyto device spare part is supplied under catalog number 900-00052 with UDI 17290016672470.Intended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Thermometer:The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.

Device Class :

Duns Number: 649125325

Premarket Exempt : No

Product Code : FLL, KYT

Prescription Use : No

Device Count : 1

- Catalog Number : 900-00015-004

Device Description : TytoHome used for comprehensive remote exam and telehealth.This is a convenience TytoHome used for comprehensive remote exam and telehealth.This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672487 when packed in 6 pack and with 27290016672484 when packed in 48 pack .

Device Class :

Duns Number: 649125325

Premarket Exempt : No

Product Code : FLL, DQD, KYT, ERA

Prescription Use : No

Device Count : 1

- Catalog Number : 800-00028

Device Description : The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It i The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto Otoscope. As a spare part the Tyto Device is provided with catalog number 900-00050 and DI 17290016672531.Intended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Thermometer:The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments

Device Class : 1

Duns Number: 649125325

Premarket Exempt : No

Product Code : KYT, FLL

Prescription Use : No

Device Count : 1

- Catalog Number : 900-00002-007

Device Description : Designed for professional use, TytoPro used for comprehensive remote exam and te Designed for professional use, TytoPro used for comprehensive remote exam and telehealth.The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades.This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope.TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545.

Device Class :

Duns Number: 649125325

Premarket Exempt : No

Product Code : FLL, ERA, KYT, DQD

Prescription Use : No

Device Count : 1

- Catalog Number : 900-00015-063

Device Description : TytoHome used for comprehensive remote exam and telehealth.This is a convenience TytoHome used for comprehensive remote exam and telehealth.This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672685 when packed in 6 pack and with 27290016672682 when packed in 48 pack .

Device Class :

Duns Number: 649125325

Premarket Exempt : No

Product Code : FLL, DQD, KYT, ERA

Prescription Use : No

Device Count : 1