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Tyto Device

FDA UDI

Class II (US FDA UDI)

by Tyto Care Ltd

Identity

Trade Name
Tyto Device FDA UDI
Generic Name
Multi-purpose digital medical camera FDA UDI
Device Name
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 video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. 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. FDA UDI
Model / Reference
Tyto Device G2 Plastic White,US FDA UDI
Description
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 video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. 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. FDA UDI

Identifiers

Catalog Number
800-00014 FDA UDI
Primary DI / UDI-DI
07290016672473 FDA UDI
FDA Product Code
FLL FDA UDI
KYT FDA UDI
GMDN Term
Multi-purpose digital medical camera FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
880.6350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infrared patient thermometer, skinMulti-purpose digital medical camera

Tyto Device by Tyto Care Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose digital medical camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyto Care Ltd

Sources (1)

  • FDA UDI 53ad74ec-6831-48d9-9436-83ee3f9c6d7d 35 fields · synced May 29, 2026