TytoCare 800-00003

GUDID 07290016672008

The TytoCare 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.

TYTO CARE LTD

Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera

• Primary Device ID: 07290016672008
• NIH Device Record Key: e6fdc8ba-e21d-4567-81ca-c66e04e0ae54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TytoCare
• Version Model Number: TytoCare
• Catalog Number: 800-00003
• Company DUNS: 649125325
• Company Name: TYTO CARE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com
• Phone: +97272210750
• Email: amirh@tytocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672008 [Primary]

FDA Product Code

• LHD: Device, Fertility Diagnostic, Proceptive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-08
• Device Publish Date: 2016-12-22

Devices Manufactured by TYTO CARE LTD

• 07290016672725 - Tyto Insights for Wheeze Detection: 2023-05-22 The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds
• 17290016672685 - TytoHome: 2022-05-19 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 07290016672473 - Tyto Device: 2020-12-17 The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation comp
• 17290016672487 - TytoHome: 2020-12-17 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 17290016672531 - Tyto Device: 2020-12-17 The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation co
• 07290016672541 - TytoPro: 2020-12-17 Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope
• 07290016672404 - Tyto Stethoscope: 2020-10-19 The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at o
• 07290016672411 - Tyto Otoscope: 2020-10-19 The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and still images of the external ea