Catalog Number

3K-01-16003K

Brand Name

Rosie SmartMeter NFC Professional

Version/Model Number

AC-NFC Meter

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

-

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

4fe27720-b936-4971-aafe-0d41b1d01bed

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

December 07, 2016

Package DI Number

00389154000518

Quantity per Package

63

Contains DI Package

00868665000045

Package Discontinue Date

December 07, 2016

Package Status

Not in Commercial Distribution

Package Type

-