Catalog Number

-

Brand Name

Andnesfit Health

Version/Model Number

ADF-B27GTS

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113077

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

ac4e6a62-fdcb-4a6f-9262-9d361bf9cc46

Public Version Date

October 22, 2019

Public Version Number

1

DI Record Publish Date

October 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-