Catalog Number

-

Brand Name

Ezy Dose

Version/Model Number

23285

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

-

Product Code

CEN

Product Code Name

Dye-Indicator, Ph (Urinary, Non-Quantitative)

Public Device Record Key

123cbaf9-3be1-4ec3-a413-bf67b5c0d1d9

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

10025715232857

Quantity per Package

144

Contains DI Package

00025715232850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case