Vivoo At-Home Urinary Tract Infection Test

GUDID 00860011489146

At-Home Urinary Tract Infection Test

VIVOSENS INC.

Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

• Primary Device ID: 00860011489146
• NIH Device Record Key: 32f4572a-efbd-4491-b984-ad58ea76169f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivoo At-Home Urinary Tract Infection Test
• Version Model Number: VI25V1
• Company DUNS: 086601609
• Company Name: VIVOSENS INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true

Customer Support Contacts

• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io
• Phone: +90538376512
• Email: letstalk@vivoo.io

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011489122 [Primary]
GS1	00860011489146 [Package]; Contains: 00860011489122; Package: Carton [3 Units]; In Commercial Distribution
GS1	10860011489129 [Unit of Use]

FDA Product Code

• JMT: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

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: 2024-12-03
• Device Publish Date: 2024-11-25

Devices Manufactured by VIVOSENS INC.

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