Duns Number:649125325
Device Description: TytoHome used for comprehensive remote exam and telehealth.This is a convenience kit conta
Catalog Number
900-00015-063
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
cb32f49c-e886-4c01-a6f6-97c3ed0481ba
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 11, 2022
Package DI Number
17290016672685
Quantity per Package
6
Contains DI Package
07290016672688
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 |