PRODIGY DIABETES CARE, LLC

Address:7224 Statesville Road, Suite A,Charlotte,NC,28269,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Glucose Oxidase, Glucose (CGA) (9) System, Test, Blood Glucose, Over The Counter (NBW) (9) Needle, Hypodermic, Single Lumen (FMI) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Enzyme Controls (Assayed And Unassayed) (JJT) (1)

Premarket Exempt

No Yes

Clear

Prodigy Pocket Blood Glucose Monitoring System - 00384840503021 Catalog Number : 050302

Device Description : Prodigy Pocket Blood Glucose Monitoring System

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Prodigy Pocket Blood Glucose Monitoring System - 00384840503625 Catalog Number : 050362

Device Description : Prodigy Pocket Blood Glucose Monitoring System - Blue (KIT)

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

PRODIGY PRO No Coding Blood Glucose Test Strips - 00384840517004 Catalog Number : 051700

Device Description : PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct)Individually Wrapped Foil PRODIGY PRO No Coding Blood Glucose Test Strips (50 ct)Individually Wrapped Foil Packs for Professional Use

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

PRODIGY Astro PRO Blood Glucose Monitoring System - 00384840517752 Catalog Number : 051775

Device Description : PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multip PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Prodigy AutoCode Blood Glucose Monitoring System - 00384840518858 Catalog Number : 051885

Device Description : Prodigy AutoCode Blood Glucose Monitoring System (Meter Only)

Device Class : 2

Duns Number: 832875905

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Prodigy AutoCode Blood Glucose Monitoring System - 00384840518902 Catalog Number : 051890

Device Description : Prodigy AutoCode Blood Glucose Monitoring System (KIT)

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : JJT, FMI, JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Prodigy Voice Blood Glucose Monitoring System - 00384840519008 Catalog Number : 051900

Device Description : Prodigy Voice Blood Glucose Monitoring System (KIT)

Device Class : 1

Duns Number: 832875905

Premarket Exempt : No

Product Code : JJX, FMI, CGA, NBW

Prescription Use : No

Device Count : 1

Prodigy No Coding Blood Glucose Test Strips - 00384840528000 Catalog Number : 052800

Device Description : 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct).

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Prodigy No Coding Blood Glucose Test Strips - 00384840528109 Catalog Number : 052810

Device Description : 1 Vial of Prodigy No Coding Blood Glucose Test Strips (10 ct).

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Prodigy No Coding Blood Glucose Test Strips - 00384840528253 Catalog Number : 052825

Device Description : 1 Box of Prodigy No Coding Blood Glucose Test Strips (25 ct).

Device Class :

Duns Number: 832875905

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 25

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