Catalog Number

K100-0114

Brand Name

EZ-Chek

Version/Model Number

K100-0114

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123805,K123805,K123805,K123805,K123805

Product Code

FJD

Product Code Name

Detector, Leak, Blood

Public Device Record Key

c11a0168-1385-4515-86b1-642ba81c1f23

Public Version Date

August 16, 2019

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

10858293006172

Quantity per Package

1

Contains DI Package

00858293006175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag