Duns Number:649125325
Device Description: Designed for professional use, TytoPro used for comprehensive remote exam and telehealth.T Designed for professional use, TytoPro used for comprehensive remote exam and telehealth.The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades.This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope.TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545.
Catalog Number
900-00002-007
Brand Name
TytoPro
Version/Model Number
TytoPro G2 US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQD
Product Code Name
Stethoscope, Electronic
Public Device Record Key
fa3463a0-8a4e-4cae-b9c8-6fd9646e8482
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
December 09, 2020
Package DI Number
17290016672548
Quantity per Package
6
Contains DI Package
07290016672541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |