Catalog Number

48630

Brand Name

StatSensor/StatStrip

Version/Model Number

1.0

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150281,K150281

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

4719a997-a93e-42dd-bbf0-ee4d3ff8366a

Public Version Date

August 09, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

10385480486306

Quantity per Package

1

Contains DI Package

00385480486309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton