ReliOn™ Premier Blood Glucose Test Strips

Basic Information

• Brand Name: ReliOn™ Premier Blood Glucose Test Strips
• Primary DI: 00681131285742
• Version / Model: 780025
• Company Name: WAL-MART STORES, INC.
• Labeler DUNS: 051957769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-08-21
• Public Version: 1
• Public Version Date: 2019-08-29
• Public Version Status: New
• Public Device Record Key: a0eceb34-59d9-4c93-a5d4-77050573ca80

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. 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
Package	20681131285746	GS1	Master Case	45	In Commercial Distribution
Package	10681131285749	GS1	Case Pack	12	In Commercial Distribution
Primary	00681131285742	GS1
Unit of Use	50681131285747	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121133	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 34 – 86 Degrees Fahrenheit