Catalog Number

3S-01-1400A2

Brand Name

FIA Salut vial packed test strip

Version/Model Number

3S-01-1400A2

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121433,K121433

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

ade5f8e6-f0ab-465b-bb8c-55607f070b44

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Package DI Number

04260236851272

Quantity per Package

400

Contains DI Package

04260236851012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX