Duns Number:560053481
Device Description: The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing re The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement.
Catalog Number
-
Brand Name
Bladder Scanner
Version/Model Number
M4-HD
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2021
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
K190769
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
daf90b77-5f9e-480f-8688-6b2c5abe1e3c
Public Version Date
August 31, 2021
Public Version Number
2
DI Record Publish Date
May 18, 2021
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. | 5 |