PRODIGY PRO No Coding Blood Glucose Test Strips

Basic Information

• Brand Name: PRODIGY PRO No Coding Blood Glucose Test Strips
• Primary DI: 00384840517004
• Version / Model: 051700
• Catalog Number: 051700
• Company Name: Prodigy Diabetes Care, LLC
• Labeler DUNS: 832875905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 2
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: 775aadac-ceff-4111-bb88-67b793ef1864

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62538	Glucose monitoring system IVD, point-of-care	A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30384840517005	GS1	Inner Case	15	In Commercial Distribution
Primary	00384840517004	GS1
Package	40384840517002	GS1	Master Case	12	In Commercial Distribution
Unit of Use	10384840517001	GS1
Secondary	08484-0517-00	NDC/NHRIC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152599	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity