Home GUDID 00384840751507 Prodigy Value Pack
Primary DI 00384840751507
Brand Prodigy Value Pack
Company Prodigy Diabetes Care, LLC
Model 075150
Catalog number 075150
Device description Prodigy Value Pack12 x Item # 073200; 4 x Item # 07120
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name CGA Glucose Oxidase, Glucose NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CGA Glucose Oxidase, Glucose Clinical Chemistry 2 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00384840751507 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00384840751507 00384840751507 384840751507 0384840751507
GMDN Terms# Term, Definition table Term Definition Home-use/point-of-care blood glucose monitoring system IVD 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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. 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 Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Regulatory Flags# DUNS number 832875905 Device count 1 Combination product true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00384840104006 Prodigy No Coding Blood Glucose Test Strips 010400 010400 2024-07-10 00384840518902 Prodigy AutoCode Blood Glucose Monitoring System 051890 051890 2016-09-22 00384840519008 Prodigy Voice Blood Glucose Monitoring System 051900 051900 2016-09-22 00384840528253 Prodigy No Coding Blood Glucose Test Strips 052825 052825 2016-09-21 00384840719507 Prodigy Voice Blood Glucose Monitoring System 071950 071950 2016-09-22 00384840725003 Prodigy No Coding Blood Glucose Test Strips 072500 072500 2016-09-21 00384840732001 Prodigy No Coding Blood Glucose Test Strips 073200 073200 2016-09-21 00384840761506 Prodigy iConnect Blood Glucose Monitoring System 076150 076150 2016-09-23 00384840528000 Prodigy No Coding Blood Glucose Test Strips 052800 052800 2016-09-21 00384840528109 Prodigy No Coding Blood Glucose Test Strips 052810 052810 2016-09-21 00384840751002 Prodigy Combo Pre-Pack 075100 075100 2016-09-21 00384840753006 Prodigy No Coding Blood Glucose Test Strips 075300 075300 2016-09-21 00384840517004 PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips 051700 051700 2020-09-22 00384840105003 Prodigy No Coding Blood Glucose Test Strips 010500 010500 2024-07-11 00384843104003 Prodigy No Coding Blood Glucose Test Strips 010400 010400 2024-07-10 00384840750500 Prodigy No Coding Blood Glucose Test Strips 75050 075050 2019-01-16 00384840518858 Prodigy AutoCode Blood Glucose Monitoring System 051885 051885 2016-09-21 00384840701205 Prodigy AutoCode Blood Glucose Monitoring System 070120 070120 2016-09-21 00384840708020 Prodigy Pocket Blood Glucose Monitoring System 070802 070802 2016-09-21 00384840743007 Prodigy AutoCode Blood Glucose Monitoring System 074300 074300 2016-11-07
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