TytoHome 900-00015-006

GUDID 17290016672302

TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672302.

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 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: 17290016672302
• NIH Device Record Key: 31bd5098-65ae-4923-97c1-e1a34db0742b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TytoHome
• Version Model Number: TytoHome US
• Catalog Number: 900-00015-006
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672305 [Primary]
GS1	17290016672302 [Package]; Contains: 07290016672305; Package: Carton box [6 Units]; In Commercial Distribution

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-03

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