Catalog Number

070802

Brand Name

Prodigy Pocket Blood Glucose Monitoring System

Version/Model Number

070802

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

a7a9786c-2ac6-403e-86dc-86b125888b27

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

00384843708027

Quantity per Package

10

Contains DI Package

00384840708020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Carton