Catalog Number

3S-01-16003A

Brand Name

Rosie SmartMeter Test Strips 50ct(vial)

Version/Model Number

3S-01-16003A

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

03078833-f1dc-431f-a9c8-800e90adab47

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

January 24, 2017

Package DI Number

00389154000488

Quantity per Package

400

Contains DI Package

00868665000076

Package Discontinue Date

January 24, 2017

Package Status

Not in Commercial Distribution

Package Type

-