HealthyMe UTI Urinary Tract Infection Test Strips

GUDID 20682607651003

Urinary Tract Infection home test

ACON LABORATORIES, INC.

Urine leukocyte IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 20682607651003
• NIH Device Record Key: 7a576b5b-d180-4e00-ac9b-8ad5aace663c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthyMe UTI Urinary Tract Infection Test Strips
• Version Model Number: 765100
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607002085 [Unit of Use]
GS1	00682607651009 [Primary]
GS1	20682607651003 [Package]; Contains: 00682607651009; Package: Carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063295

FDA Product Code

• LJX: TEST, URINE LEUKOCYTE

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: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [HealthyMe UTI Urinary Tract Infection Test Strips]

• 20682607651003: Urinary Tract Infection home test
• 20682607651256: Urinary Tract Infection home test with handle