iUFlow

GUDID B408IF20

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.

KESEM HEALTH PTY LTD

Urine flowmeter, reusable

• Primary Device ID: B408IF20
• NIH Device Record Key: 9721f34e-0c04-4b30-9f22-e23b388f0f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iUFlow
• Version Model Number: IF2
• Company DUNS: 743967162
• Company Name: KESEM HEALTH PTY LTD
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 12 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B408IF20 [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: 2020-08-10
• Device Publish Date: 2020-07-31