Home GUDID 00384840719507 Prodigy Voice Blood Glucose Monitoring System
Primary DI 00384840719507
Brand Prodigy Voice Blood Glucose Monitoring System
Company Prodigy Diabetes Care, LLC
Model 071950
Catalog number 071950
Device description Prodigy Voice Blood Glucose Monitoring System (KIT)
Published 2016-09-22
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 FMI Needle, Hypodermic, Single Lumen FMK Lancet, Blood JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 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 FMI Needle, Hypodermic, Single Lumen General Hospital 2 FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery 2 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry 1 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00384841519007 Direct Marking GS1 0 00384843719504 Package GS1 10 In Commercial Distribution 00384840719507 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 00384841519007 00384841519007 384841519007 0384841519007 00384843719504 00384843719504 384843719504 0384843719504 00384840719507 00384840719507 384840719507 0384840719507
GMDN Terms# Term, Definition table Term Definition Manual blood lancing device, reusable A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
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 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 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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