Tyto Device

Basic Information

• Brand Name: Tyto Device
• Primary DI: 07290016672183
• Version / Model: Tyto Device
• Catalog Number: 800-00007
• Company Name: TYTO CARE LTD
• Labeler DUNS: 649125325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 4
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 9a8ba88c-a814-4fc8-b6fc-5a4bfedfec04

Device Description

The Tyto Device unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto Ottoscope Intended use for Tyto Exam Camera: The Tyto Camera is an electronic camera that enables capturing and transmission of video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. Intended use for Tyto Basal Thermometer: The Tyto Basal Thermometer is an electronic thermometer that enables measuring basal body temperature as an aid in ovulation prediction to aid in conception (not to be used for contraception). In addition, the thermometer enables storage and transmitting the temperature measurement to a clinician on site or at a different location on the IP network with the signal carried on an IP connection between the two locations.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• 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
KYT	Light, Examination, Medical, Battery Powered	General Hospital	880.6350	1
LHD	Device, Fertility Diagnostic, Proceptive	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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	07290016672183	GS1

Customer Contacts

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