Catalog Number

3L-10-16003E

Brand Name

Rosie SmartMeter Professional Strip

Version/Model Number

AC-11 Pro-Strip

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 07, 2016

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

K140150,K140150

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

5c0df941-c310-44ec-a2fa-89921d9fe9a7

Public Version Date

December 27, 2019

Public Version Number

5

DI Record Publish Date

December 07, 2016

Package DI Number

03894540005253

Quantity per Package

240

Contains DI Package

00868665000052

Package Discontinue Date

December 07, 2016

Package Status

Not in Commercial Distribution

Package Type

-