Duns Number:654658731
Device Description: Vivid T8 T9 v204 v205 to v206 upgrade kit SW only
Catalog Number
-
Brand Name
Vivid
Version/Model Number
T8 T9 v204 v205 to v206 UPG SW only
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K221147
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
a1a8e8f5-3822-4107-8352-3594cff2e0c7
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 63 |