TytoHome

Basic Information

• Brand Name: TytoHome
• Primary DI: 07290016672053
• Version / Model: TytoHome
• Catalog Number: 900-00015
• Company Name: TYTO CARE LTD
• Labeler DUNS: 649125325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-04
• Public Version: 8
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 58202d9a-64e8-42db-80c6-c460d6601815

Device Description

TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHD	Device, Fertility Diagnostic, Proceptive	Unknown		U
ERA	Otoscope	Ear, Nose, Throat	874.4770	1
KYT	Light, Examination, Medical, Battery Powered	General Hospital	880.6350	1
DQD	Stethoscope, Electronic	Cardiovascular	870.1875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13754	Electronic stethoscope	An 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 is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or display.	No	Active
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.	No	Active
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	No	Active
58857	Multi-purpose digital medical camera	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016672053	GS1
Package	17290016672050	GS1	logistic carton	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]