Assure® Titanium Blood Glucose Meter

Basic Information

• Brand Name: Assure® Titanium Blood Glucose Meter
• Primary DI: 00015482600013
• Version / Model: 600001
• Company Name: ARKRAY USA, INC.
• Labeler DUNS: 008171162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-15
• Public Version: 1
• Public Version Date: 2025-09-23
• Public Version Status: New
• Public Device Record Key: 6025787b-a92e-49f2-8661-2059c3b7c072

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZI	Prescription Use Blood Glucose Meter For Near-Patient Testing	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00015482600013	GS1
Package	20015482600017	GS1	Shipper	50	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K200788	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Without condensation
• Type: Handling Environment Temperature
• Temperature Range: 46 – 104 Degrees Fahrenheit