DEVICE: TytoCare (07290016672008)
Device Identifier (DI) Information
TytoCare
TytoCare
In Commercial Distribution
800-00003
TYTO CARE LTD
TytoCare
In Commercial Distribution
800-00003
TYTO CARE LTD
The TytoCare unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto Ottoscope
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 Basal Thermometer:
The Tyto Basal Thermometer is an electronic thermometer that enables measuring basal
body temperature as an aid in ovulation prediction to aid in conception (not to be used
for contraception). In addition, the thermometer enables storage and transmitting the
temperature measurement to a clinician on site or at a different location on the IP network
with the signal carried on an IP connection between the two locations.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LHD | Device, Fertility Diagnostic, Proceptive |
KYT | Light, Examination, Medical, Battery Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e6fdc8ba-e21d-4567-81ca-c66e04e0ae54
November 23, 2021
5
December 22, 2016
November 23, 2021
5
December 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97272210750
amirh@tytocare.com
amirh@tytocare.com