Home GUDID 20681131169817 ReliOn™ Premier Blood Glucose Test Strips
Primary DI 20681131169817
Brand ReliOn™ Premier Blood Glucose Test Strips
Company WAL-MART STORES, INC.
Model 780050 / 780100
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.
Published 2017-11-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name CGA Glucose Oxidase, Glucose
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CGA Glucose Oxidase, Glucose Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00681131169813 Package GS1 2 In Commercial Distribution 10681131169773 Package GS1 12 In Commercial Distribution 10681131169810 Package GS1 6 In Commercial Distribution 20681131169770 Package GS1 45 In Commercial Distribution 20681131169817 Package GS1 60 In Commercial Distribution 00681131169776 Primary GS1 0 50681131169771 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00681131169813 00681131169813 681131169813 0681131169813 10681131169773 10681131169773 10681131169810 10681131169810 20681131169770 20681131169770 20681131169817 20681131169817 00681131169776 00681131169776 681131169776 0681131169776 50681131169771 50681131169771
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 34 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 051957769 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04719869706904 Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA) TYSON BIORESEARCH INC. CGA 2026-07-13 04719869706911 TysonBio AC500 PRO Blood Glucose Test Strips (50T) TYSON BIORESEARCH INC. CGA 2026-07-13 04719869706942 Tyson Bio AC500 PRO Control Solution (Level 1) (FDA) TYSON BIORESEARCH INC. CGA 2026-07-13 04719869706959 Tyson Bio AC500 PRO Control Solution (Level 3) (FDA) TYSON BIORESEARCH INC. CGA 2026-07-13 05700693930978 ABL90 FLEX Radiometer Medical ApS CGA 2026-07-09 05700693930985 ABL90 FLEX PLUS Radiometer Medical ApS CGA 2026-07-09 05700699446572 SP90 Radiometer Medical ApS CGA 2026-07-09 05700699447579 SP90 Radiometer Medical ApS CGA 2026-07-09 05700699461056 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461087 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461094 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461100 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461131 SC90 Radiometer Medical ApS CGA 2026-07-09 05700699461605 SC90 Radiometer Medical ApS CGA 2026-07-09 MHC1101665142 EasyTouch MHC MEDICAL PRODUCTS, LLC CGA 2026-01-07 MHC18073002 EasyTouch MHC MEDICAL PRODUCTS, LLC CGA 2026-01-07 00311917064635 Walgreens WALGREEN CO. CGA 2025-06-20 00353885013000 OneTouch Ultra LifeScan U.S. LLC CGA 2025-06-20 00194346219254 ReliOn™ Premier Blood Glucose Test Strips WAL-MART STORES, INC. CGA 2025-02-11 00194346219261 ReliOn™ Premier Blood Glucose Test Strips WAL-MART STORES, INC. CGA 2025-02-11 00383568100826 CareLiving BGM101 Blood Glucose Meter Care Living Diagnostics Inc. CGA 2024-08-07 00384840105003 Prodigy No Coding Blood Glucose Test Strips Prodigy Diabetes Care, LLC CGA 2024-07-11 00384840104006 Prodigy No Coding Blood Glucose Test Strips Prodigy Diabetes Care, LLC CGA 2024-07-10 00054749005710 i-STAT G Cartridge ABBOTT POINT OF CARE INC. CGA 2024-04-30 00383568100734 CareLiving MM1100 Blood Glucose Test Strips 100ct Care Living Diagnostics Inc. CGA 2024-04-19 00383568100741 CareLiving MM1100 Blood Glucose Test Strips 50ct Care Living Diagnostics Inc. CGA 2024-04-19 00383568100819 CareLiving Blood Glucose Test Strips 100ct Care Living Diagnostics Inc. CGA 2023-11-15 00383568100857 CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc. CGA 2023-11-15 00383568100710 CareLiving MM1100 Blood Glucose Monitoring System Care Living Diagnostics Inc. CGA 2023-11-14 00381932488013 Assy Vial, eGLU, 13 ct. POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-07-30
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