TytoHome 900-00015-004

GUDID 17290016672487

TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672487 when packed in 6 pack and with 27290016672484 when packed in 48 pack .

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

• Primary Device ID: 17290016672487
• NIH Device Record Key: 40969d05-3d78-4fe5-a1b4-0d4d4413916b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TytoHome
• Version Model Number: TytoHome G2 US
• Catalog Number: 900-00015-004
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672480 [Primary]
GS1	17290016672487 [Package]; Contains: 07290016672480; Package: carton box [6 Units]; In Commercial Distribution
GS1	27290016672484 [Package]; Contains: 07290016672480; Package: Carton box [48 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-17
• Device Publish Date: 2020-12-09

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