Catalog Number

3C-01-160033

Brand Name

Rosie SmartMeter Glucose Control Solutions

Version/Model Number

3C-01-160033

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113307,K113307

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

ce1c775f-44f6-41c5-a2af-f0d2ba9b03d8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

00389154000532

Quantity per Package

650

Contains DI Package

00868665000069

Package Discontinue Date

January 24, 2017

Package Status

Not in Commercial Distribution

Package Type

-