ReliOn™ Premier Blood Glucose Test Strips

GUDID 20681131285746

ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blood glucose meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. Alternative site testing (AST) should only be used during steady-state blood glucose conditions. The ReliOn Premier family of blood glucose monitoring systems are intended for self-testing outside the body (in vitro) by people with diabetes as an aid to monitor the effectiveness of diabetes control. They are not intended for use on neonates, and they are not for the diagnosis or screening of diabetes.

WAL-MART STORES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 20681131285746
• NIH Device Record Key: a0eceb34-59d9-4c93-a5d4-77050573ca80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliOn™ Premier Blood Glucose Test Strips
• Version Model Number: 780025
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• Device Count: 25
• 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: 1-855-776-0662
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131285742 [Primary]
GS1	10681131285749 [Package]; Contains: 00681131285742; Package: Case Pack [12 Units]; In Commercial Distribution
GS1	20681131285746 [Package]; Contains: 10681131285749; Package: Master Case [45 Units]; In Commercial Distribution
GS1	50681131285747 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121133

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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: 2019-08-29
• Device Publish Date: 2019-08-21

On-Brand Devices [ReliOn™ Premier Blood Glucose Test Strips]

• 20681131169817: ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blood glu
• 20681131285746: ReliOn Premier Blood Glucose Test Strips are for use with the ReliOn Premier family of blood glu