Home GUDID 40301931467503 BREEZE® 2
Primary DI 40301931467503
Brand BREEZE® 2
Company ASCENSIA DIABETES CARE US INC.
Model 1467A
Catalog number 1467A
Device description Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
Published 2016-09-16
Public version status Update
Distribution status Not 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 00301931467505 Package GS1 5 Not in Commercial Distribution 10301931467502 Package GS1 1 Not in Commercial Distribution 40301931467503 Package GS1 24 Not in Commercial Distribution 20301931467509 Primary GS1 0 0193-1467-50 Secondary NDC/NHRIC 0 00301931467017 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 00301931467505 00301931467505 301931467505 0301931467505 10301931467502 10301931467502 40301931467503 40301931467503 20301931467509 20301931467509 00301931467017 00301931467017 301931467017 0301931467017
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 Special Storage Condition, Specify 0 0 Keep out of direct sunlight. Do not use after expiration date. Storage Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 080028910 Device count 10 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 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 00381934755014 eGLU, 15ct., CCPlus Home POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-06-20 00381934752013 Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk) POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-06-01 MHC19902833042 Members Mark WAL-MART STORES, INC. CGA 2023-05-10 MHC19902833062 Members Mark WAL-MART STORES, INC. CGA 2023-04-18 MHC19902833072 Members Mark WAL-MART STORES, INC. CGA 2023-04-18 00381934748016 Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus Home POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2023-03-25 10385480631645 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-24 10385480631652 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-24 10385480631669 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-24 10385480632307 Nova Primary NOVA BIOMEDICAL CORPORATION CGA 2023-02-22 10673486000719 TECO DIAGNOSTICS TECO DIAGNOSTICS CGA 2022-08-09 00353885012652 OneTouch Ultra Blue Test Strips LifeScan U.S. LLC CGA 2022-07-28 00381934750019 CardioChek Plus Home Self-Test Analyzer POLYMER TECHNOLOGY SYSTEMS, INC. CGA 2022-04-11 MHC18490502 BluLink MHC MEDICAL PRODUCTS, LLC CGA 2021-05-12
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