Catalog Number

-

Brand Name

Fifty50

Version/Model Number

163604

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

K083468,K083468,K083468,K083468

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

e2fd0f50-f2c7-484e-875c-8706b42a637a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20892896000097

Quantity per Package

10

Contains DI Package

10892896000090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton