Catalog Number

-

Brand Name

Smart Diabetes

Version/Model Number

EHS-SDMK-V

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K133260

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

28c7e4a3-c8c9-450f-99f1-52c152556782

Public Version Date

January 27, 2022

Public Version Number

1

DI Record Publish Date

January 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-