Duns Number:649125325
Device Description: TytoHome used for comprehensive remote exam and telehealth.This is a convenience kit conta TytoHome used for comprehensive remote exam and telehealth.This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672487 when packed in 6 pack and with 27290016672484 when packed in 48 pack .
Catalog Number
900-00015-004
Brand Name
TytoHome
Version/Model Number
TytoHome 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
40969d05-3d78-4fe5-a1b4-0d4d4413916b
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
December 09, 2020
Package DI Number
17290016672487
Quantity per Package
6
Contains DI Package
07290016672480
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 |