Duns Number:649125325
Device Description: TytoHome used for comprehensive remote exam and telehealth.TytoCare device with high resol TytoHome used for comprehensive remote exam and telehealth.TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments.this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope.TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050.
Catalog Number
900-00015
Brand Name
TytoHome
Version/Model Number
TytoHome
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)
Yes
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
58202d9a-64e8-42db-80c6-c460d6601815
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
January 04, 2018
Package DI Number
17290016672050
Quantity per Package
6
Contains DI Package
07290016672053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
logistic carton
| 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 |