proudP

GUDID 00860006184926

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.

Soundable Health, Inc.

Home uroflowmetry software

• Primary Device ID: 00860006184926
• NIH Device Record Key: 0adc8274-7706-46dc-accb-e9a940f5c669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: proudP
• Version Model Number: SU-UFM-001
• Company DUNS: 116957774
• Company Name: Soundable Health, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006184926 [Primary]

FDA Product Code

• EXY: Uroflowmeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-01-14
• Device Publish Date: 2022-12-23

Devices Manufactured by Soundable Health, Inc.

• 00860006184926 - proudP: 2025-01-14proudP 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.
• 00860006184926 - proudP: 2025-01-14 proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by mic
• 00860006184902 - PRIVY Urine Flow Monitor: 2021-02-23 PRIVY Urine Flow Monitor is a mobile application intended for measuring voided volume of urine and urine flow rate using the sou