TytoHome 900-00015

GUDID 07290016672053

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.

TYTO CARE LTD

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

• Primary Device ID: 07290016672053
• NIH Device Record Key: 58202d9a-64e8-42db-80c6-c460d6601815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TytoHome
• Version Model Number: TytoHome
• Catalog Number: 900-00015
• 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: true
• 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
• 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
• 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
• 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
• 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
• Phone: +972722210750
• Email: amirh@tytocare.com
• Phone: +972722210750
• Email: amirh@tytocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672053 [Primary]
GS1	17290016672050 [Package]; Package: logistic carton [6 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2019-10-08
• Device Publish Date: 2018-01-04

On-Brand Devices [TytoHome]

• 07290016672213: TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution
• 07290016672053: TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution
• 17290016672302: TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution
• 17290016672425: TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution
• 17290016672487: TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing
• 17290016672685: TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing