Catalog Number

-

Brand Name

Pedi-POM

Version/Model Number

1001-PED

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

7b918da4-c464-4551-a206-d1e836e0d307

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 11, 2018

Package DI Number

20851438008014

Quantity per Package

30

Contains DI Package

10851438008017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-