Tyto Device
Basic Information
- Brand Name
- Tyto Device
- Primary DI
- 07290016672473
- Version / Model
- Tyto Device G2 Plastic White,US
- Catalog Number
- 800-00014
- Company Name
- TYTO CARE LTD
- Labeler DUNS
- 649125325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-09
- Public Version
- 2
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 53ad74ec-6831-48d9-9436-83ee3f9c6d7d
Device Description
The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation component of other TytoHome kit components: the Tyto Stethoscope and Tyto Ottoscope. The Tyto device spare part is supplied under catalog number 900-00052 with UDI 17290016672470. Intended use for Tyto Exam Camera: The Tyto Camera is an electronic camera that enables capturing and transmission of video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos 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. Intended use for Tyto Thermometer: The Tyto Thermometer is a clinical infrared thermometer intended for intermittent determination of human body temperature from the center of the forehead as the measurement site on people of all ages. The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used both at home and in clinic environments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | 880.6350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58857 | Multi-purpose digital medical camera | An electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer. | No | Active |
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016672473 | GS1 | ||||
| Package | 17290016672470 | GS1 | Carton box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +97272210750
- [email protected]