Assure® Titanium Blood Glucose Test Strips

GUDID 10015482600508

The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.

ARKRAY USA, INC.

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 10015482600508
• NIH Device Record Key: 20ca9d14-90be-4a4c-a47f-4a7605365a58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® Titanium Blood Glucose Test Strips
• Version Model Number: 600050
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 50
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx
• Phone: 800-818-8877
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid storing test strips in direct sunlight.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482600501 [Primary]
GS1	10015482600508 [Package]; Contains: 00015482600501; Package: Case Pack [12 Units]; In Commercial Distribution
GS1	20015482600505 [Package]; Package: Shipper [18 Units]; In Commercial Distribution
GS1	50015482600506 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200788

FDA Product Code

• PZI: Prescription Use Blood Glucose Meter For Near-Patient Testing

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: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [Assure® Titanium Blood Glucose Test Strips]

• 10015482601000: The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titaniu
• 10015482600508: The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titaniu