Catalog Number

D4H01-83

Brand Name

Sidekick

Version/Model Number

Sidekick All-In-One Blood Glucose Monitoring System

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

Yes

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

a4d37980-bc89-4c08-80a4-7805aff84c6e

Public Version Date

December 20, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

10021292012707

Quantity per Package

220

Contains DI Package

00021292012700

Package Discontinue Date

November 30, 2018

Package Status

Not in Commercial Distribution

Package Type

case