PRODIGY Astro PRO Blood Glucose Monitoring System

Basic Information

• Brand Name: PRODIGY Astro PRO Blood Glucose Monitoring System
• Primary DI: 00384840517752
• Version / Model: 051775
• Catalog Number: 051775
• Company Name: Prodigy Diabetes Care, LLC
• Labeler DUNS: 832875905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: d9ebe93a-0a53-4be9-ab4d-068a2bbedd8e

Device Description

PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients

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: 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
NBW	System, Test, Blood Glucose, Over The Counter	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
Primary	00384840517752	GS1
Package	30384840517753	GS1	Master Case	10	In Commercial Distribution
Secondary	08484-0517-75	NDC/NHRIC

Customer Contacts

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

Storage Conditions

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