Home GUDID 00384840518858 Prodigy AutoCode Blood Glucose Monitoring System
Primary DI 00384840518858
Brand Prodigy AutoCode Blood Glucose Monitoring System
Company Prodigy Diabetes Care, LLC
Model 051885
Catalog number 051885
Device description Prodigy AutoCode Blood Glucose Monitoring System (Meter Only)
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 00384841518505 Direct Marking GS1 0 00384843518855 Package GS1 10 In Commercial Distribution 00384840518858 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 00384841518505 00384841518505 384841518505 0384841518505 00384843518855 00384843518855 384843518855 0384843518855 00384840518858 00384840518858 384840518858 0384840518858
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.
Regulatory Flags# DUNS number 832875905 Device count 1 Combination product true Lot or batch true Serial number 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 00384840751507 Prodigy Value Pack 075150 075150 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 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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