Identity
- Trade Name
- TytoHome FDA UDI
- Generic Name
- Multi-purpose digital medical camera FDA UDI
- Device Name
- 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: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210. FDA UDI
- Model / Reference
- TytoHome FDA UDI
- Description
- 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: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210. FDA UDI
Identifiers
- Catalog Number
- 900-00015 FDA UDI
- Primary DI / UDI-DI
- 07290016672213 FDA UDI
- FDA Product Code
- DQD FDA UDIKYT FDA UDIERA FDA UDILHD FDA UDI
- GMDN Term
- Multi-purpose digital medical camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1875 FDA UDI880.6350 FDA UDI874.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skinOtoscope, directElectronic acoustic stethoscopeMulti-purpose digital medical camera
TytoHome by Tyto Care Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tyto Care Ltd
Sources (1)
- FDA UDI a36efaa4-98f5-43e8-8acb-671f115f7ee0 35 fields · synced Jun 8, 2026