PRODIGY Astro PRO Blood Glucose Monitoring System - PRODIGY Astro PRO Blood Glucose Monitoring System - PRODIGY DIABETES CARE, LLC

Duns Number:832875905

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

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

051775

Brand Name

PRODIGY Astro PRO Blood Glucose Monitoring System

Version/Model Number

051775

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Device Record Status

Public Device Record Key

d9ebe93a-0a53-4be9-ab4d-068a2bbedd8e

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

30384840517753

Quantity per Package

10

Contains DI Package

00384840517752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"PRODIGY DIABETES CARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 8