Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

NEB-PEDM

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"

Yes

For Single-Use

-

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

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

a620b029-99fa-4844-bf54-a6c476835b63

Public Version Date

April 08, 2019

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

50092237614193

Quantity per Package

50

Contains DI Package

00092237614198

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA