Stream Dx SDX02

GUDID 00860412001565

The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary tract disorders and is designed for home use. Stream Dx will calculate a patient's flow rate and their maximum voided volume based on the collected data. This information will be provided to the caregiver by Stream Dx. The data obtained from the Stream Dx Uroflowmeter is meant to be used exclusively as a tool to aid in diagnosis of a condition. It is not intended to be used alone as the sole method of diagnosis.

ZIEN MEDICAL TECHNOLOGIES, INC.

Urine flowmeter, reusable

• Primary Device ID: 00860412001565
• NIH Device Record Key: 6744c38c-2440-46bb-9a6b-dbeb3de3042f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stream Dx
• Version Model Number: SDX02
• Catalog Number: SDX02
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860412001565 [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: 2023-04-05
• Device Publish Date: 2023-03-28

On-Brand Devices [Stream Dx]

• 00860412001565: The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electr
• 00860412001503: The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electr