PRIVY Urine Flow Monitor

GUDID 00860006184902

PRIVY Urine Flow Monitor 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.

Soundable Health, Inc.

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• Primary Device ID: 00860006184902
• NIH Device Record Key: d3373251-3e5b-4310-9637-9b0c3c05913c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIVY Urine Flow Monitor
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com
• Phone: 9999999999
• Email: support@soundablehealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006184902 [Primary]

FDA Product Code

• EXY: Uroflowmeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-23
• Device Publish Date: 2021-02-15