FDA.reportPublic FDA data

TytoPro

Primary DI
07290016672541
Brand
TytoPro
Company
TYTO CARE LTD
Model
TytoPro G2 US
Catalog number
900-00002-007
Device description
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.
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
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
17290016672548PackageGS16In Commercial Distribution
27290016672545PackageGS148In Commercial Distribution
07290016672541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001667254817290016672548
2729001667254527290016672545
07290016672541072900166725417290016672541

GMDN Terms#

Term, Definition table
TermDefinition
Electronic stethoscopeAn external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It will typically be connected to a computer so that the results can be presented on a screen.

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
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
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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