AccessGUDID - DEVICE: proudP (00860006184926)

GUDID

Device Identifier (DI) Information

Brand Name: proudP
Version or Model: SU-UFM-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Soundable Health, Inc.

Primary DI Number: 00860006184926
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116957774 *Terms of Use

Device Description: 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 and required to be used in a quiet environment. This device targets patients over 18 years of age.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64362	Home uroflowmetry software	An application software program intended to be installed in a smartphone/tablet to enable the measurement/display of urine flow parameters (e.g., flow and volume of urine during urination, time of urination) by a patient/layperson in the home. It may receive and display measurement data from a home-use electronic urine flowmeter, or produce the measurements itself using the sound recorded by the smartphone’s microphone during urination. It typically allows the recorded data to be sent to a healthcare professional for assessment of voiding function; it may in addition be used in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXY	Uroflowmeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0adc8274-7706-46dc-accb-e9a940f5c669
Public Version Date: January 14, 2025
Public Version Number: 2
DI Record Publish Date: December 23, 2022