Duns Number:743967162
Device Description: A uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of pa A uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of patients suffering from Lower Urinary Tract Symptoms (LUTS) when used in conjunction with the iUFlow mobile application.
Catalog Number
-
Brand Name
iUFlow
Version/Model Number
IF2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
9721f34e-0c04-4b30-9f22-e23b388f0f95
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 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. | 1 |