Catalog Number

-

Brand Name

Emu-Chex Emulating Indicator Strips 121C 20 Minute

Version/Model Number

26611600

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102894,K102894

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

a046febf-cf37-4ef8-b936-9df909c92d18

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-