FDA.reportPublic FDA data

TytoHome

Primary DI
07290016672763
Brand
TytoHome
Company
TYTO CARE LTD
Model
TytoHome G2 US
Catalog number
900-00015-064
Device description
TytoHome used for comprehensive remote exam and telehealth.This is a convenience kit containing the following DIs: 07290016672770 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672794 Tyto Stethoscope and 7290016672800 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672760 when packed in 6 pack and with 27290016672767 when packed in 48 pack.
Published
2024-05-26
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
DQDStethoscope, Electronic
ERAOtoscope
FLLThermometer, Electronic, Clinical
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2
ERAOtoscopeEar, Nose, Throat1
FLLContinuous Measurement ThermometerGeneral Hospital2
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016672763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016672763072900166727637290016672763

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical cameraAn electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. 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 may include a user display screen for visualization before image capture, and sometimes 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
Kit
true
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
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
17290016672685TytoHomeTytoHome G2 US900-00015-0632022-05-11

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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
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