Duns Number:202522751
Device Description: The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for char The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging HD Scanners, that has a separate port for charging a spare HD battery.
Catalog Number
99-03-00022, 99-13-00016
Brand Name
Clarius Ultrasound Scanner
Version/Model Number
Clarius 2-in-1 Charging Station HD
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
623e7e91-3923-4093-a5a8-118851cb1d55
Public Version Date
December 04, 2020
Public Version Number
1
DI Record Publish Date
November 26, 2020
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. | 48 |