Tyto Stethoscope 800-00001

GUDID 07290016672015

The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds 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. The Tyto stethoscope is intended for use by professional users in a clinical environment or in conjunction with patients or lay users in a non-clinical environment.

TYTO CARE LTD

Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope

• Primary Device ID: 07290016672015
• NIH Device Record Key: b634a263-1353-4adb-8a50-edbff5b7926e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyto Stethoscope
• Version Model Number: Tyto Stethoscope
• Catalog Number: 800-00001
• Company DUNS: 649125325
• Company Name: TYTO CARE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672015 [Primary]
GS1	17290016672012 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160401

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-08
• Device Publish Date: 2016-12-22

On-Brand Devices [Tyto Stethoscope]

• 07290016672190: The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation soun
• 07290016672015: The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation soun
• 07290016672374: The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation soun
• 07290016672343: The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation soun
• 07290016672404: The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation soun