Catalog Number

-

Brand Name

POM EZ-Lite

Version/Model Number

1003

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

-

Product Code

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

f38f6e84-fd0f-48a3-b69d-f1f11399e80b

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 11, 2018

Package DI Number

20851438008083

Quantity per Package

30

Contains DI Package

10851438008086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-