FDA.reportPublic FDA data

TytoHome

Primary DI
17290016672425
Brand
TytoHome
Company
TYTO CARE LTD
Model
TytoHome US
Catalog number
900-00015-009
Device description
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 .
Published
2020-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016672425PackageGS16In Commercial Distribution
27290016672422PackageGS148In Commercial Distribution
07290016672428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001667242517290016672425
2729001667242227290016672422
07290016672428072900166724287290016672428

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22