Duns Number:554531949
Device Description: The instrument is suitable for the measurement of bladder volume in hospitals, nursing hom The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and homes. To provide the basis for the implementation of clinical catheterization, evaluate the residual volume after micturition, and make auxiliary diagnosis for the diseases of bladder and renal function. The instrument is also suitable for people with lower body disability and loss of self urination function to master the timing of urination.
Catalog Number
-
Brand Name
Bladder Scanner
Version/Model Number
M4
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
K201316
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
90032db7-f502-4eb5-90b9-a17e25dad7e1
Public Version Date
April 21, 2022
Public Version Number
1
DI Record Publish Date
April 13, 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. | 2 |