Prodigy AutoCode Blood Glucose Monitoring System

Basic Information

• Brand Name: Prodigy AutoCode Blood Glucose Monitoring System
• Primary DI: 00384840518902
• Version / Model: 051890
• Catalog Number: 051890
• Company Name: Prodigy Diabetes Care, LLC
• Labeler DUNS: 832875905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: f162915c-1c98-462f-8a1f-c870e1b3c976

Device Description

Prodigy AutoCode Blood Glucose Monitoring System (KIT)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37243	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.	No	Active
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active
30854	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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00038481518505	GS1
Primary	00384840518902	GS1
Package	00384843518909	GS1	Corrugated Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K073118	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store between 39.2°F to 86°F (4°C to 30°C) and 10% - 85% R.H.