Duns Number:116957774
Device Description: proudP is a mobile application intended for measuring voided volume of urine and urine flo proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function.This device can be used at office or at home and required to be used in a quiet environment.This device targets patients over 18 years of age.
Catalog Number
-
Brand Name
proudP
Version/Model Number
SU-UFM-001
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EXY
Product Code Name
Uroflowmeter
Public Device Record Key
d3373251-3e5b-4310-9637-9b0c3c05913c
Public Version Date
July 13, 2021
Public Version Number
3
DI Record Publish Date
February 15, 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. | 1 |