FDA.reportPublic FDA data

Tyto Device

Primary DI
07290016672473
Brand
Tyto Device
Company
TYTO CARE LTD
Model
Tyto Device G2 Plastic White,US
Catalog number
800-00014
Device 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 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.
Published
2020-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016672470PackageGS11In Commercial Distribution
07290016672473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001667247017290016672470
07290016672473072900166724737290016672473

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical cameraA battery-powered hand-held digital electro-optical device designed to capture video or still image data for a variety of medical applications (e.g., ophthalmoscopic, otoscopic and dermatoscopic) using dedicated interchangeable lenses. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It typically has a user display screen for visualization before image capture, and a docking cradle for battery recharging and connection to a personal computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97272210750stellar@tytocare.com

Regulatory Flags#

DUNS number
649125325
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290020123008Tyto Insights for Crackles DetectionTyto Insights for Crackles Detection2024-12-23
07290016672305TytoHomeTytoHome US900-00015-0062019-09-03
07290016672428TytoHomeTytoHome US900-00015-0092020-10-10
07290016672480TytoHomeTytoHome G2 US900-00015-0042020-12-09
07290016672688TytoHomeTytoHome G2 US900-00015-0632022-05-11
07290016672756TytoProTytoPro G2 900-00002-0622024-05-26
07290016672763TytoHomeTytoHome G2 US900-00015-0642024-05-26
07290016672886Tyto Insights for Wheeze DetectionTyto Insights for Wheeze Detection _US2024-05-26
07290016672725Tyto Insights for Wheeze DetectionTyto Insights for Wheeze Detection _US2023-05-14
07290016672541TytoProTytoPro G2 US900-00002-0072020-12-09
07290016672404Tyto StethoscopeTyto Stethoscope, Plastic, black, US800-000272020-10-10
07290016672299TytoProTytoPro US900-00002-0052019-09-03
07290016672343Tyto StethoscopeTyto Stethoscope, Zamak, BLK, US800-000192019-09-03
07290016672374Tyto StethoscopeTyto Stethoscope, Zamak, Gray, US800-000232019-09-03
07290016672015Tyto StethoscopeTyto Stethoscope800-000012016-12-22
07290016672039TytoProTytoPro900-000022016-12-22
07290016672046Not in useNot in use2016-12-22
07290016672053TytoHomeTytoHome900-000152018-01-04
07290016672190Tyto StethoscopeTyto Stethoscope800-000082019-01-24
07290016672213TytoHomeTytoHome900-000152019-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22