DEVICE: TytoPro (07290016672756)
Device Identifier (DI) Information
TytoPro
TytoPro G2
In Commercial Distribution
900-00002-062
TYTO CARE LTD
TytoPro G2
In Commercial Distribution
900-00002-062
TYTO CARE LTD
TytoPro used for comprehensive remote exam and telehealth.
This is a convenience kit containing the following DIs: 07290016672787 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672817 Tyto Stethoscope and 07290016672824 Tyto Otoscope.
TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672753 when packed in 6 pack and with 27290016672750 when packed in 48 pack.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| No | |
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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.
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Active | false |
| 12849 | Otoscope, direct |
An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
|
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 |
| 13754 | Electronic acoustic stethoscope |
An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FLL | Thermometer, Electronic, Clinical |
| DQD | Stethoscope, Electronic |
| KYT | Light, Examination, Medical, Battery Powered |
| ERA | Otoscope |
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
b74757e1-52b3-4489-a506-8460593fbb2a
November 25, 2024
3
May 26, 2024
November 25, 2024
3
May 26, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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
stellar@tytocare.com
stellar@tytocare.com